Abstract: Apparatus, systems, and methods are provided for treating obstructive sleep apnea. A unitary valve assembly removably located inside the exterior profile of a nasal pillow mask uses positive airway pressure from a low-flow hose to automatically create an on-demand therapeutic air splint in the pharynx. During inspiration the mask's valving system allows room air to be inspired. During exhalation another valve governs therapeutic backpressure equal to the prescribed pressure setting of the CPAP blower machine. The mask may be worn when the CPAP blower machine is off, and systems are provided for turning the CPAP blower machine on only when needed.

Abstract: Apparatus, systems, and methods are provided for treating obstructive sleep apnea. A CPAP system with an integrated oximeter sensor is disclosed wherein the sensor communicates with an oximeter processor that controls the blower. A nasal air flow sensor may also be incorporated that provides more data to the processor. A unique lightweight, flexible and stretchable hose for CPAP systems is also disclosed. The hose may have a magnetic connection with the blower.

Abstract: Apparatus, systems, and methods are provided for treating obstructive sleep apnea. A unitary valve assembly removably located inside the exterior profile of a nasal pillow mask uses positive airway pressure from a low-flow hose to automatically create an on-demand therapeutic air splint in the pharynx. During inspiration the mask's valving system allows room air to be inspired. During exhalation another valve governs therapeutic backpressure equal to the prescribed pressure setting of the CPAP blower machine. The mask may be worn when the CPAP blower machine is off, and systems are provided for turning the CPAP blower machine on only when needed.

Abstract: Apparatus, systems, and methods are provided for treating obstructive sleep apnea. A unitary valve assembly removably located inside the exterior profile of a nasal pillow mask uses positive airway pressure from a low-flow hose to automatically create an on-demand therapeutic air splint in the pharynx. During inspiration the mask's valving system allows room air to be inspired. During exhalation another valve governs therapeutic backpressure equal to the prescribed pressure setting of the CPAP blower machine. The mask may be worn when the CPAP blower machine is off, and systems are provided for turning the CPAP blower machine on only when needed.

Abstract: A device for treating a patient suffering from obstructive sleep apnea or snoring can include an expiratory valve connected to a manifold. The expiratory valve can include a body portion including a feedback port configured to be connected to an air flow generator. The expiratory valve can include a plunger at least partially disposed in the body portion. The expiratory valve can include a pressurizing chamber positioned between an end of the plunger and an end of the expiratory valve. The pressurizing chamber can be configured to receive air from the air flow generator through the feedback port.

Abstract: A device for treating a patient suffering from obstructive sleep apnea or snoring can include an expiratory valve connected to a manifold. The expiratory valve can include a body portion including a feedback port configured to be connected to an air flow generator. The expiratory valve can include a plunger at least partially disposed in the body portion. The expiratory valve can include a pressurizing chamber positioned between an end of the plunger and an end of the expiratory valve. The pressurizing chamber can be configured to receive air from the air flow generator through the feedback port.

Abstract: Apparatus and methods for manipulating and securing tissue are described herein. In creating tissue folds within the body of a patient, a tissue manipulation assembly may generally have an elongate tubular member, an engagement member slidably disposed through the tubular member and a distal end adapted to engage tissue via a helical member, tissue stabilizing members positioned at the tubular member distal end which are adapted to stabilize tissue therebetween, and a delivery tube pivotable about the tissue stabilizer. The stabilizing members can be adapted to become angled relative to a longitudinal axis of the elongate tubular member. Moreover, one or all the articulation controls and functions can be integrated into a singular handle assembly connectable to the tissue manipulation assembly via a rigid or flexible tubular body.

Abstract: A medical device for viewing inside a body and for retrieving an object from a location within the body, the medical device comprising an endoscope having a tube defining a working channel and a basket engageable with the object. In one embodiment of the invention, the basket does not require a sheath and is disposed through the working channel such that the endoscope operates to contain or activate the sheathless basket. In another embodiment of the invention, a single push wire with a collar at its end is used in place of a sheath to control the opening and closing of the basket. In another embodiment of the invention, a tapered and funnel-shaped sheath surrounding the basket is used to contain or activate the basket. The invention minimizes the basket crossing profile so as to improve fluid flow in the working channel.

Abstract: Tissue anchors include a flat, broad, and large contact surface for engagement with a portion of tissue. Several embodiments of composite tissue anchors include a support element and an overlay element. Tissue anchor assemblies include two or more tissue anchors, a connector, and a cinching mechanism. In some embodiments, the tissue anchors included in the tissue anchor assemblies are of different types, sizes, and/or shapes.

Abstract: A surgical wound retractor is adapted to dilate a wound stretchable to a desired diameter, the retractor includes a first ring having a diameter greater than that desired for the wound and being adapted for disposition interiorly of the wound. A second ring has a diameter greater than that desired for the wound and is adapted for disposition exteriorly of the wound. A plurality of retraction elements are disposed in a generally cylindrical relationship to each other, between the first ring and the second ring. These elements extend through the wound to exert a radial retraction force on the wound which is dependent on the distance separating the first ring and the second ring Retraction elements, both distensible and non-distensible are contemplated with appropriate attachment means at the rings to provide for variations in the retraction force. With a suitable retraction sleeve, a third ring can be provided to form a circumferential retainer to vary the retraction force.

Abstract: Methods and apparatus for the endoluminal revision of previously performed obesity procedures which have failed are described. One or more endoluminal instruments may be advanced per-orally into the previously formed failed pouch where a number of different procedures can be performed. One or more tissue folds can be formed and secured to reduce the size of the pouch, or the stoma connecting the pouch to the intestinal tract can be reduced in size using endoluminally deployed tissue anchors. These procedures can be performed entirely from within the pouch lumen or upon the exterior surface of the pouch via transgastric entry of the instruments into the peritoneal cavity of a patient. Alternatively, the interior tissue within the pouch can be injured or sclerosed to shrink the pouch lumen. In another alterative, a length of the Roux limb can be shortened endoluminally to create a malabsorptive region.

Abstract: Helical tissue manipulation instruments and methods of their use are described herein. A helical tissue engager is adapted to reversibly engage tissue and is positioned upon a flexible shaft which is advanceable through a rigidizable endoscopic assembly. The flexible shaft defines a marked section proximal to the tissue engager which can include any number of markings, designs, patterns, projections, textures, etc., which acts to provide a visual indication to the user as to the translational movement, rotation, direction of rotation, etc., of the tissue engager and the shaft. An optional guidewire can be advanced through the tissue engager. Additionally, the tissue engager and shaft can be advanced through an optional tubular sheath which may be used for dilating tissue openings prior to passage of the helical engager through the tissue opening.

Abstract: Apparatus and methods for endoluminal advancement are described herein. A shape-lockable tissue anchoring assembly generally has an elongate body, a handle assembly, and an anchoring assembly positioned at or proximal to a distal tip of the elongate body. A distal portion of the elongate body may optionally be steerable or curvable. The anchoring assembly may include various expandable or projecting anchoring features to contact and retain tissue relative to the elongate body such that pleated tissue is temporarily immobile relative to the elongate body. This anchoring can be actuated simultaneously with or independently from shape-locking of elongate body. The anchoring assembly can be actuated simultaneously with the shape-locking of the elongate body. Alternatively, the steerable distal portion of the elongate body can be angled against the pleated tissue to retain it while the endoscope is advanced relative to the pleated tissue.

Abstract: Methods and apparatus for securing and deploying tissue anchors are described herein. A tissue manipulation assembly is pivotably coupled to the distal end of a tubular member. A reconfigurable launch tube is also pivotably coupled to the tissue manipulation assembly, which may be advanced through a shape-lockable endoscopic device, a conventional endoscope, or directly by itself into a patient. A second tool can be used in combination with the tissue manipulation assembly to engage tissue and manipulate the tissue in conjunction with the tissue manipulation assembly. A deployment assembly is provided for securing engaged tissue via one or more tissue anchors, the deployment assembly also being configured to disengage the anchors endoluminally or laparoscopically.

Abstract: Methods and apparatus for securing and deploying tissue anchors are described herein. A tissue manipulation assembly is pivotably coupled to the distal end of a tubular member. A reconfigurable launch tube is also pivotably coupled to the tissue manipulation assembly, which may be advanced through a shape-lockable endoscopic device, a conventional endoscope, or directly by itself into a patient. A second tool can be used in combination with the tissue manipulation assembly to engage tissue and manipulate the tissue in conjunction with the tissue manipulation assembly. A deployment assembly is provided for securing engaged tissue via one or more tissue anchors, the deployment assembly also being configured to disengage the anchors endoluminally or laparoscopically by applying thermal energy through at least one suture cutting element disposed along the deployment assembly.

Abstract: Methods and apparatus for securing and deploying tissue anchors are described herein. A tissue manipulation assembly is pivotably coupled to the distal end of a tubular member. A reconfigurable launch tube is also pivotably coupled to the tissue manipulation assembly, which may be advanced through a shape-lockable endoscopic device, a conventional endoscope, or directly by itself into a patient. A second tool can be used in combination with the tissue manipulation assembly to engage tissue and manipulate the tissue in conjunction with the tissue manipulation assembly. A deployment assembly is provided for securing engaged tissue via one or more tissue anchors, the deployment assembly also being configured to disengage the anchors endoluminally or laparoscopically by applying thermal energy through at least one suture cutting element disposed along the deployment assembly.

Abstract: Apparatus & methods for optimizing anchoring force are described herein. In securing tissue folds, over-compression of the tissue directly underlying the anchors is avoided by utilizing tissue anchors having expandable arms configured to minimize contact area between the anchor and tissue. When the anchor is in its expanded configuration, a load is applied to the anchor until it is optimally configured to accommodate a range of deflections while the anchor itself exerts a substantially constant force against the tissue. Various devices, e.g., stops, spring members, fuses, strain gauges, etc., can be used to indicate when the anchor has been deflected to a predetermined level within the optimal range. Moreover, other factors to affect the anchor characteristics include, e.g., varying the number of arms or struts of the anchor, positioning of the arms, configuration of the arms, the length of the collars, etc.

Abstract: Methods and apparatus for off-axis visualization are described herein. An endoluminal tissue manipulation assembly is disclosed which provides for a stable endoluminal platform and which also provides for effective triangulation of tools. Such an apparatus may comprise an optionally shape-lockable elongate body defining a longitudinal axis and adapted for endoluminal advancement in a patient body, at least one articulatable visualization lumen disposed near or at a distal region of the elongate body, the at least one articulating visualization lumen being adapted to articulate off-axis relative to a longitudinal axis of the elongate body, and at least one articulatable tool arm member disposed near or at the distal region of the elongate body, the at least one articulatable tool arm member being adapted to articulate off-axis and manipulate a tissue region of interest.

Abstract: Methods and apparatus for performing endoluminal procedures are described herein. An endoluminal tissue manipulation assembly is disclosed which provides for a stable endoluminal platform and which also provides for effective triangulation of tools. Such an apparatus may comprise an optionally shape-lockable elongate body defining a longitudinal axis and adapted for endoluminal advancement in a patient body, at least one articulatable visualization lumen disposed near or at a distal region of the elongate body, the at least one articulating visualization lumen being adapted to articulate off-axis relative to a longitudinal axis of the elongate body, and at least one articulatable tool arm member disposed near or at the distal region of the elongate body, the at least one articulatable tool arm member being adapted to articulate off-axis and manipulate a tissue region of interest.

Abstract: Flexible shaft systems having interchangeable end effectors are described herein. A shaft with a flexibility sufficient to allow advancement through a lumen of an endoscopic device has an interface at its distal end for engaging a removable end effector tool. The shaft and end effector tool are configured to enable endoluminal deployment through a patient, e.g., through the esophagus and into the stomach. The removable end effector tool may comprise any number of different tools, such as graspers, forceps, scissors, snares, needles, etc., each being interchangeable upon the flexible shaft distal end. Once a procedure is done within the patient, the flexible shaft may be withdrawn and another distal end effector tool may be interchanged. The new end effector tool and flexible shaft can then be reintroduced into the patient.