Abstract: Methods and devices are disclosed for manipulating the tongue. An implant is positioned within at least a portion of the tongue and may be secured to other surrounding structures such as the mandible and/or hyoid bone. In general, the implant is manipulated to displace at least a portion of the posterior tongue in an anterior or lateral direction, or to alter the tissue tension or compliance of the tongue. Methods and devices for adjusting a glossopexy system are also disclosed. Adjusting a distance between two body-engaging structures can be performed without disengaging a tether from either of the body-engaging structures in some embodiments.

Abstract: Methods and devices are disclosed for remodeling the tongue. One or more spaces or cavities are formed in the tongue using, for example, surgical or RF ablative techniques. The cavities can be closed or collapsed by inserting a tethered soft tissue anchor into the tongue and attaching the tethered portion of the soft tissue anchor to a bony structure such as the mandible or hyoid bone in order to exert a collapsing force on the one or more spaces or cavities. The insertion pathway of the tethered soft tissue anchor may pass adjacent to or even through one or more cavities. Also disclosed herein is a tongue remodeling system that includes means for creating a space in the tongue, and a tissue anchor configured to close the space. The tissue anchor may be tethered or expandable.

Abstract: A self-closing device for implantation within a patient's body includes base material including an inner surface area for securing the base material to a tissue structure, and a plurality of support elements surrounding or embedded in the base material. The support elements are separable to accommodate creating an opening through the base material for receiving one or more instruments through the base material, and biased to return towards a relaxed state for self-closing the opening after removing the one or more instruments. The device may be provided as a patch, cuff, or integrally attached to a tubular graft or in various shapes.

Abstract: Suture passer systems for tissue suspension and tissue compression, and more particularly for palate or tongue suspension, are described. The system can include at least a first elongate tubular body or shaft, a needle having a lateral bias carried by the elongate body, and a retrieval element operably connected to the elongate tubular body. The needle can have a substantially straight configuration when located within the elongate tubular body, and be configured to exit an opening at or near a distal end of the elongate tubular body and assume a laterally biased or curved shape to form a path through tissue. The needle is configured to carry a suture. The retrieval element can be configured to retrieve the suture carried by the needle after the needle has formed a curved or otherwise angled path through tissue. The system can also include one or more bone anchors to secure the suture loops. Methods of placing one or more suture loops into tissue, such as the base of the palate or tongue, are also described.

Abstract: Methods and devices are disclosed for manipulating the palatal tissue. An implant is positioned within at least a portion of the soft palate and may be secured to other surrounding, less mobile structures such as the hard palate or the mucosa overlying the hard palate. The implant may be manipulated to displace at least a portion of the soft palate in an anterior or lateral direction, or to alter the tissue tension or compliance of the soft palate.

Abstract: Suture passer systems for tissue suspension and tissue compression are described. The system can include a shaft and a needle, wherein the needle is freely rotatable with respect to the shaft. The suture may include an overmolded segment. Methods of placing one or more implants, sutures, fastener, bone anchors and other devices are also described. The methods include moving tissue, including the superior pharyngeal constrictor muscle, palatopharyngeal arch, and palatoglossal arch. The methods include hyoid bone suspension.

Abstract: In one embodiment, the present invention includes a method for holding soft tissue in apposition with a bone using a suture, the method including engaging the soft tissue with an engaging portion of a suture thread; engaging an end of the suture thread with a rotatable shaft of an anchor; implanting the rotatable shaft in the bone; and rotating the shaft in a first direction to wrap the engaged suture thread onto the shaft thereby increasing tension on the suture and on the soft tissue.

Abstract: Embodiments of the present invention relate to methods and devices for the treatment of airway obstruction, such as obstructive sleep apnea, and devices and methods that facilitate insertion and retrieval of the same. In one embodiment, disclosed is a tissue tensioner that includes an elongate flexible tether having a first end and a second end, a bone anchor configured to be connected to a patient's mandible, a tissue ingrowth implant configured to be implanted in a patient's tongue and connected to the second end of the tether, and an adjustment mechanism configured to be held by the bone anchor adjacent the patient's mandible and configured to receive the first end of the tether and configured to adjust tension in the flexible tether between the patient's mandible and tongue. Various anchors, tethers, securement mechanisms, and adjustment mechanisms that can be used with glossal and palatal remodeling systems are also disclosed.

Abstract: Methods and devices for rhinoplasty and treating nasal valve stenosis are disclosed herein. The nasal valve acts as a flow-limiter and can contribute to airway obstruction if resistance within the nasal valve is excessive. In one embodiment, a system for treating nasal valve stenosis includes a first elongate implant and a second elongate implant configured to support the nasal valves when implanted. The implants can be coupled together by connecting elements, such as eyelets, tethers, complementary socket joints, and button-rivet supports.

Abstract: A knotless suture anchor provides a method for securing soft tissue to a rigid structure such as bone. The anchor has an inner member that receives suture thread and rotates within an outer tubular member. As the inner member rotates, the suture thread is wrapped onto the inner member thereby increasing contact with the outer tubular member which applies pressure to the wrapped suture thread to retain it in position on the inner member while simultaneously and adjustably tensioning the suture thread. A ratchet prevents undesirable counter-rotation, although the ratchet can be released to permit loosening of the suture thread. Also described is a suture bridge and suture platform for providing further stabilization of a tendon. A method for repairing rotator cuff tears is also described.

Abstract: Embodiments of the present invention relate to methods and devices for the treatment of airway obstruction, such as obstructive sleep apnea, and devices and methods that facilitate insertion and retrieval of the same. In one embodiment, disclosed is a tissue tensioner that includes an elongate flexible tether having a first end and a second end, a bone anchor configured to be connected to a patient's mandible, a tissue ingrowth implant configured to be implanted in a patient's tongue and connected to the second end of the tether, and an adjustment mechanism configured to be held by the bone anchor adjacent the patient's mandible and configured to receive the first end of the tether and configured to adjust tension in the flexible tether between the patient's mandible and tongue. Various anchors, tethers, securement mechanisms, and adjustment mechanisms that can be used with glossal and palatal remodeling systems are also disclosed.

Abstract: Systems and methods of placing one or more suture loops into tissue, such as the base of the tongue, are described. A system can include a variable-thickness suspension line for suspending tissue, including a suture having a first thickness dimension; an elastomer surrounding a portion of the suture and defining a central segment of the suspension line having a second thickness dimension greater than the first thickness dimension, and at least one transition zone extending from the central segment of the suspension line to a lateral end of the suspension line, the transition zones having a thickness dimension that tapers from the second thickness dimension to the first thickness dimension.

Abstract: Suture passer systems for tissue suspension and tissue compression, and more particularly for palate or tongue suspension, are described. The system can include at least a first elongate tubular body or shaft, a needle having a lateral bias carried by the elongate body, and a retrieval element operably connected to the elongate tubular body. The needle can have a substantially straight configuration when located within the elongate tubular body, and be configured to exit an opening at or near a distal end of the elongate tubular body and assume a laterally biased or curved shape to form a path through tissue. The needle is configured to carry a suture. The retrieval element can be configured to retrieve the suture carried by the needle after the needle has formed a curved or otherwise angled path through tissue. The system can also include one or more bone anchors to secure the suture loops. Methods of placing one or more suture loops into tissue, such as the base of the palate or tongue, are also described.

Abstract: Disclosed herein are devices and methods for securing soft tissue to a rigid structure such as bone. Various directional anchors that allow for increasing the stability the attachment of soft tissue to bone are described. Also described is a delivery system for use with the directional anchors that allows for open surgical or arthroscopic application of one embodiment of the device. A method for repairing rotator cuff tears is also described.

Abstract: Methods and devices for the treatment of airway obstruction, sleep apnea and snoring are disclosed. In some embodiments, a glossal suspension system includes a tissue tensioner that includes a suture loop made of one or more sutures configured to suspend the tongue with at least one portion configured to extend laterally through the tongue, and a securement mechanism configured to be attached to a patient's mandible that includes one more more adjustment assemblies for engaging the one or more sutures and adjusting tension on the suture loop. Various tethers and anchors that can he used with the glossal suspension system are also disclosed.

Abstract: Suture passer systems for tissue suspension and tissue compression, and more particularly for tongue suspension, are described. The system can include at least a first elongate tubular body or shaft, a needle having a lateral bias carried by the elongate body, and a retrieval element operably connected to the elongate tubular body. The needle can have a substantially straight configuration when located within the elongate tubular body, and be configured to exit an opening at or near a distal end of the elongate tubular body and assume a laterally biased or curved shape to form a path through tissue. The needle is configured to carry a suture. The retrieval element can be configured to retrieve the suture carried by the needle after the needle has formed a curved or otherwise angled path through tissue. The system can also include one or more bone anchors to secure the suture loops. Methods of placing one or more suture loops into tissue, such as the base of the tongue, are also described.

Abstract: Methods and devices for the treatment of airway obstruction, sleep apnea and snoring are disclosed. In some embodiments, a glossal suspension system includes a tissue tensioner that includes a suture loop made of one or more sutures configured to suspend the tongue with at least one portion configured to extend laterally through the tongue, and a securement mechanism configured to be attached to a patient's mandible that includes one more adjustment assemblies for engaging the one or more sutures and adjusting tension on the suture loop. Various tethers and anchors that can be used with the glossal suspension system are also disclosed.

Abstract: Methods and devices are disclosed for manipulating the palatal tissue. An implant is positioned within at least a portion of the soft palate and may be secured to other surrounding, less mobile structures such as the hard palate or the mucosa overlying the hard palate. The implant may be manipulated to displace at least a portion of the soft palate in an anterior or lateral direction, or to alter the tissue tension or compliance of the soft palate.

Abstract: Methods and devices are disclosed for remodeling the tongue. One or more spaces or cavities are formed in the tongue using, for example, surgical or RF ablative techniques. The cavities can be closed or collapsed by inserting a tethered soft tissue anchor into the tongue and attaching the tethered portion of the soft tissue anchor to a bony structure such as the mandible or hyoid bone in order to exert a collapsing force on the one or more spaces or cavities. The insertion pathway of the tethered soft tissue anchor may pass adjacent to or even through one or more cavities. Also disclosed herein is a tongue remodeling system that includes means for creating a space in the tongue, and a tissue anchor configured to close the space. The tissue anchor may be tethered or expandable.

Abstract: Methods and devices are disclosed for manipulating the palatal tissue. An implant is positioned within at least a portion of the soft palate and may be secured to other surrounding, less mobile structures such as the hard palate or the mucosa overlying the hard palate. The implant may be manipulated to displace at least a portion of the soft palate in an anterior or lateral direction, or to alter the tissue tension or compliance of the soft palate.