Abstract: Described herein are nose-reduced nasal devices configured to reduce or eliminate the unwanted noises associated with use of a nasal device. These noise-reduced nasal devices include a flap-valve airflow resistor and a noise-reduction feature that is a noise-reduction element, a noise-reduction flap valve, or both. The noise-reduction feature typically prevents the flap valve from oscillating or vibrating and producing an audible sound during use, particularly during inhalation through the device. The method and devices described herein may prevent the flap, and particularly the edge region of the flap face or tip of the flap, from oscillating during inhalation.

Abstract: Whole-nose nasal respiratory devices and methods of making and using whole-nose nasal respiratory devices are described and illustrated herein. These devices are typically configured to be adhesively secured to a subject so that they engage both of the subject's nostrils and allow airflow from both nostrils to communicate with an airflow resistor. The airflow resistor is configured so that it inhibits exhalation through the nostrils more than it inhibits inhalation through the nostrils.

Abstract: Whole-nose nasal respiratory devices and methods of making and using whole-nose nasal respiratory devices are described and illustrated herein. These devices are typically configured to be adhesively secured to a subject so that they engage both of the subject's nostrils and allow airflow from both nostrils to communicate with an airflow resistor. The airflow resistor is configured so that it inhibits exhalation through the nostrils more than it inhibits inhalation through the nostrils.

Abstract: Described herein are nasal devices, including nasal devices formed in layers having four or fewer layers. In some variations, the nasal devices include a single integrated layer from which the flap of the airflow resistor is formed as well as the base of the holdfast region. The nasal devices may include a single aligner or rim body on the side of the device facing the subject. The aligner may protect the airflow resistor, and may help center or position the nasal device. In some variations, these nasal devices may include a noise-reduction feature. Also described herein are systems, devices and methods for determining if a passive nasal respiratory device having an airflow resistor configured to inhibit exhalation more than inhalation has been worn by a subject, and thereby confirming compliance.

Abstract: Whole-nose nasal respiratory devices and methods of making and using whole-nose nasal respiratory devices are described and illustrated herein. These devices are typically configured to be adhesively secured to a subject so that they engage both of the subject's nostrils and allow airflow from both nostrils to communicate with an airflow resistor. The airflow resistor is configured so that it inhibits exhalation through the nostrils more than it inhibits inhalation through the nostrils.

Abstract: Described herein are passive nasal device having a resistance to exhalation that is greater than the resistance to inhalation. Also described are devices, methods and systems for sensing and measuring intranasal pressure when a subject is wearing a passive nasal respiratory device that is configured to inhibit exhalation more than inhalation. Also described are adapters for nasal devices and methods of using a nasal device adapter. Adapters may be used so that a passive nasal device may be applied indirectly in communication with a subject's nose; in some variations this may allow the passive nasal device to be re-used. Also described herein are nasal devices having a billowing airflow resistor that is configured to have a greater resistance to exhalation than to inhalation.

Abstract: Described herein are layered nasal devices including layered nasal devices having one or more stiffening members supporting the holdfast region of the nasal device. The stiffening member may be a stress-distributing member or a separate stress-distributing element or member may be included. In some variations the layered nasal device includes a stress distributing element to help prevent wrinkling, de-laminating, buckling, or otherwise disrupting the shape and/or activity of the nasal device. Also described herein are delayed resistance adapters that may be used with a nasal devices that inhibit exhalation more than inhalation (including, but not limited to the adhesive nasal devices described herein). A delayed resistance adapter may be activated to suspend or bypass the increased expiratory resistance of the nasal device. Suspending the increased expiratory resistance may allow the user to allow a user to acclimate to the use of the nasal device.

Abstract: Described herein are devices, methods and systems that regulate the failure of a nasal device by including a pre-determined failure mode, thereby minimizing the risk. Also described herein are nasal respiratory devices that may be remotely activated or inactivated to turn on and off an increased resistance to exhalation compared to inhalation.

Abstract: Described herein are adjustable-resistance respiratory devices, and particularly nasal devices that have an adjustable expiratory resistance while providing a greater resistance to exhalation than to inhalation. The resistance to exhalation may be manually adjustable by a user or remotely adjustable by a third party. For example, described herein are nasal devices having a greater resistance to exhalation than inhalation that includes one or more resistance-modifying members for modifying the resistance of a nasal device. A resistance modifying member may include a cover, a shutter or an adjustable valve for opening/closing a leak pathway through the nasal device. An adjustable-resistance nasal respiratory device may include a control or controls for adjusting the resistance to exhalation. Methods of adjusting the resistance of a nasal device, and systems including nasal devices allowing the resistance to be optimized and/or adjusted are also described.

Abstract: Described herein are nose-reduced nasal devices configured to reduce or eliminate the unwanted noises associated with use of a nasal device. These noise-reduced nasal devices include a flap-valve airflow resistor and a noise-reduction feature that is a noise-reduction element, a noise-reduction flap valve, or both. The noise-reduction feature typically prevents the flap valve from oscillating or vibrating and producing an audible sound during use, particularly during inhalation through the device. The method and devices described herein may prevent the flap, and particularly the edge region of the flap face or tip of the flap, from oscillating during inhalation.

Abstract: Described herein are combined active PAP/passive EPAP interface devices to transmit positive air pressure from a PAP source to the user, but provide passive EPAP when the PAP source is disabled. These interface device may continue to provide benefit to the user even if the PAP source becomes disconnected or otherwise fails. The interface devices described herein include a passive EPAP airflow resistor configured to provide expiratory positive airway pressure (“EPAP”). These interface devices may also include quick connects and/or disconnects for releasably connecting to the source of pressurized breathable gas, a quick release for disconnecting from the source of pressurized breathable gas, and an adhesive user interface region that connects the device the user's face. Also described are adapter for converting a PAP interface devices into combined active PAP/passive EPAP interface devices, and methods of using these devices.

Abstract: Delayed resistance nasal devices include an airflow resistor that is configured to normally have a higher resistance to exhalation than inhalation, but the higher resistance to exhalation may be suspended, or delayed by activation of an airflow resistor bypass. Activation of an airflow resistor bypass bypasses or decreases the effect of the airflow resistor on nasal airflow through the nasal device, decreasing the resistance to exhalation. Methods of decreasing, suspending, or delaying the onset of the inhibition of the exhalation through such nasal respiratory devices are described.

Abstract: Whole-nose nasal respiratory devices and methods of making and using whole-nose nasal respiratory devices are described and illustrated herein. These devices are typically configured to be adhesively secured to a subject so that they engage both of the subject's nostrils and allow airflow from both nostrils to communicate with an airflow resistor. The airflow resistor is configured so that it inhibits exhalation through the nostrils more than it inhibits inhalation through the nostrils.

Abstract: Described herein are nasal respiratory devices including an attachment site for a sensors and sensor adapters for securing at least a portion of a sensor to a nasal respiratory device. Sensor adapters typically have a body frame having at least two regions: an attachment region for securing the sensor adapter to the nasal respiratory device; and a sensor connector region for securing a sensor across from an outlet of the nasal respiratory device.

Abstract: Described herein are nasal devices. In particular, layered nasal respiratory devices are described. Layered nasal device may include a layered airflow resistor that is configured to resist airflow in a first direction more than airflow in a second direction and that includes a flap valve adjacent to a flap valve limiting layer and an adhesive holdfast layer that is configured to secure the layered airflow resistor in communication with the subject's nasal cavity. Methods of using and methods of assembling layered nasal device are also described.

Abstract: Apparatuses for sensing and outputting data associated with the inflation of an expandable member are described herein. In one embodiment, for example, An apparatus includes a sensor and an output device. The sensor is configured to be coupled to a reservoir that supplies a fluid to an expandable member, and is further configured to output a signal associated with a pressure of the fluid. The output device is configured to be in communication with the sensor. The output device is further configured to output a qualitative pressure indication associated with the signal associated with the pressure of the fluid without outputting a quantitative pressure indication.

Abstract: A first instrument having a distal end is sized and configured to penetrate tissue and a proximal end comprising a first handle assembly. A second instrument including an interior lumen is sized and configured to accept passage of the first instrument. The second instrument has a proximal end comprising a second handle assembly sized and configured to releasably interlock with the first handle assembly to form a composite instrument sized and configured to provide percutaneous access to a cancellous bone region. The second handle assembly is also sized and configured to permit controllably release by a user of the first handle assembly from the second handle assembly to allow removal of the first instrument from the interior lumen. At least one additional instrument is sized and configured for passage through the interior lumen of the second instrument upon removal of the first instrument.

Abstract: An apparatus includes a scaffold configured to be disposed in a bone. The scaffold is configured to move from a first configuration to a second configuration. The scaffold in the second configuration is expanded from the first configuration. A selectively-expandable actuator is configured to be removably disposed within the scaffold. The selectively-expandable actuator is configured to move at least a portion of the scaffold to the second configuration when the selectively-expandable actuator is moved to an expanded configuration. A shape of the selectively-expandable actuator is substantially the same as a shape of the scaffold when the selectively-expandable actuator and the scaffold are in the second configuration. The selectively-expandable actuator configured to be removed from the scaffold when in a collapsed configuration. The scaffold is configured to remain substantially in the second configuration after the scaffold has been expanded by the actuator.