Abstract: A nasal dilator and bougie is disclosed. The dilator includes, for example, an elongated member terminating in an end and a slidable member having a terminal end movable to the end of the elongated member in a first position. A dilation portion at the end of the elongated member has a first diameter and a second diameter greater than the first diameter when the slidable member is in the first position. An actuator can move the slidable member.

Abstract: Methods and apparatus for treating disorders of the ear, nose, throat or paranasal sinuses, including methods and apparatus for dilating ostia, passageways and other anatomical structures, endoscopic methods and apparatus for endoscopic visualization of structures within the ear, nose, throat or paranasal sinuses, navigation devices for use in conjunction with image guidance or navigation system and hand held devices having pistol type grips and other handpieces.

Abstract: A nasal dilator capable of introducing separating forces in the nasal outer wall tissue, has a resilient member, and a pair of spaced-apart end surfaces which can be forced toward one another from an initial flat position of the dilator to thereby substantially reduce the direct spacing therebetween by an external spacing reducing force. This results in restoring forces in the dilator tending to return it to the original direct spacing between the end surfaces. The resilient member, which is asymmetrical with respect to a centerline of the dilator that is parallel to the long axis of the dilator, has an extended surface at each end surface of the dilator which increases the adhesive surface area. The extended surface is located at each end surface of the resilient member on the side opposite the nose ala (wings) and above the alar furrow.

Abstract: Devices, kits, and methods of treatment are described. More particularly, methods of treating tissue of a passage wall defining a bodily passage, such as a sinus cavity, airway, or sinus passage are described. An exemplary method utilizes an elongate member having an elongate member proximal end, elongate member distal end, and an elongate member body that defines a curve.

Abstract: A medical treatment instrument includes a tube-shaped elongated main body; and an insertion guide part mounted to a distal end of the elongated main body. The insertion guide part includes a frame body mounted to a distal portion of the elongated main body; and a flexible bridge portion which is disposed so as to bridge points of an end edge of the frame body, the flexible bridge portion including a linear body or band-shaped body projecting in a distal direction beyond the elongated main body.

Abstract: A nasal breathing aid includes a base portion and two extending diverging arms. The arms, near their base include inward facing contact elements which are adapted to “pinch” the vomer bone within the nose. The arms, at their outer ends, include outward facing contact elements which are adapted to apply pressure to the inner wall of the nostrils, urging a wider passageway through the nostrils.

Abstract: A rhinoplasty appliance is provided that may be custom-molded to a patient's nasal anatomy, including the nostrils, to maintain the corrected contour of the nostrils after rhinoplastic surgery. The rhinoplasty appliance may include a support wire; a first and second wire flanges; a first and second nostril insertion portions, each having a passage and an aperture to permit flow of air and drainage; a connecting structure to maintain the position of the nostril insertion portions in relation to each other, and to provide support and protection for the columella. The first and second wire flange may help to secure the rhinoplasty appliance in position on the patient's face, and improve retention of the first and second nostril insertion portions in the patient's nostrils. The support wire may be provided as added support for the connecting structure.

Abstract: Devices that are adapted to insert a sinus dilator into a stenotic opening of a paranasal sinus of a subject using minimally invasive dilator insertion procedures are provided. The devices and methods can be used to treat sinusitis and other nasal and/or sinus disorders.

Abstract: Devices and methods for locating sinus ostia and positioning a guide wire within the sinus ostia. The subject devices include a shaft having a distal end, a proximal end, a curved region located between the distal and proximal ends, and an interior channel, an extensible and retractable guide wire movably mounted within the interior channel and a probe tip joined to the guide wire.

Abstract: A balloon dilation catheter includes a substantially rigid inner guide member and a movable shaft coupled to a balloon that is slidably mounted on the substantially rigid inner guide member. To treat a sinus cavity of a subject using the balloon dilation the substantially rigid inner guide member is advanced into a drainage pathway of the sinus (e.g., frontal recess) of the subject via a nasal passageway. The shaft and balloon are advanced in a distal direction over the substantially rigid inner guide member to place the balloon in the drainage pathway. The balloon is inflated to expand or otherwise remodel the drainage pathway.

Abstract: Device for relieving the symptoms of nasal allergies, which comprises a single, one-piece body formed by two tubular elements connected by an intermediate bridge, which elements are provided in order to be inserted into the nasal cavities. The tubular elements have continuous or discontinuous external projections such that at least one free passage is created over the entire height of the tubular element, which allows the evacuation of fluids from the nose.

Abstract: A nasal dilator manufacturing process reduces waste by cutting nested strips of flexible resilient members interconnected by waste webs from a sheet of resilient-layer material. The nested strips are incorporated into a fabrication matrix with other layers (e.g. base or cover layers), then individual nasal dilators are formed by cutting through the matrix around a peripheral outline of a dilator, said cutting severing the nested strips that are part of the fabrication matrix near the waste webs between the flexible resilient members.

Abstract: Therapeutic delivery systems are provided which, in a first embodiment, contain a plurality of multiphase capsules in which first and second therapeutic agents are contained in separate phases within said multiphase capsules, and are disposed to deliver said first and therapeutic agents by at least two different delivery mechanisms.

Abstract: Sinusitis and other disorders of the ear, nose and throat are diagnosed and/or treated using minimally invasive approaches with flexible or rigid instruments. Various methods and devices are used for remodeling or changing the shape, size or configuration of a sinus ostium or duct or other anatomical structure in the ear, nose or throat; implanting a device, cells or tissues; removing matter from the ear, nose or throat; delivering diagnostic or therapeutic substances or performing other diagnostic or therapeutic procedures. Introducing devices (e.g., guide catheters, tubes, guidewires, elongate probes, other elongate members) may be used to facilitate insertion of working devices (e.g. catheters e.g. balloon catheters, guidewires, tissue cutting or remodeling devices, devices for implanting elements like stents, electrosurgical devices, energy emitting devices, devices for delivering diagnostic or therapeutic agents, substance delivery implants, scopes etc.

Abstract: A nasal dilator comprises magnets. The nasal dilator is a set comprising two bodies. Each of the two bodies has a first leg having at a distal portion thereof a magnet; and a second leg connected to the first leg via a bridge comprising flexible material. Each of the two bodies are designed so as to allow said body to be clamped to an ala nasi of a human nose between the distal portions of said first leg and said second leg. The magnets of the bodies are aligned such that with a body clamped to the ala nasi of a nose, the magnet is oriented at an angle to a plane defined by the ala nasi area clamped between said two distal portions of said first leg and second leg. Thanks to the repelling action of the magnets, the alae nasi are pushed apart, resulting in improved ease of breathing.

Abstract: One embodiment of a nasal dilator comprises a pair of pads (100), supported by arms (110, 112) surrounding an air passage (115). Each arm has a bend portion (120) and a pad (121) that grips a wearer's septum (615). Leg portions (125, 125?) extend down from the arms and are connected by a bight that surrounds the wearer's columella (620). The dilator is installed by gripping an optional handle (130) or the bight and inserting the pads and the arms into both nostrils. The dilator is urged upward and inward until the inner side of the bight touches the wearer's columella. To remove the dilator, the user grips the handle or bight and gently pulls downward until the dilator is removed. In an alternative embodiment, optional cushions (102, 122) soften the contact points between the dilator and the user's nasal structures and can supply medications through the user's nasal membranes.

Abstract: A method of treating a sinus cavity of a subject includes advancing a distal portion of a light source through a drainage pathway of a sinus cavity and into the sinus cavity and visually observing a transdermal light emitted from the light source. A distal portion of a substantially rigid inner guide member of a balloon dilation catheter is advanced into the drainage pathway, the balloon dilation catheter including a movable shaft including a balloon that is slidably mounted on the substantially rigid inner guide member. The movable shaft and balloon are advanced distally over the substantially rigid inner guide member to place a portion of the balloon in the drainage pathway whereby the balloon is inflated.

Abstract: The present invention relates to external devices for dilating nasal passageways and to the manufacture thereof. More specifically, the external nasal dilator of the present invention usually comprises a resilient sheet, an adhesive layer, and an adhesive-protecting sheet. In some embodiments of the external nasal dilator, the resilient sheet defines a groove for reducing the peel force that results from bending the dilator over the bridge of the nose. In addition to the groove or in lieu thereof, some embodiments of the external nasal dilator comprise a nasal passage region having a reduced width to reduce the peel force. Finally, the dilator can comprise a sheet of adhesive tape, which in some embodiments can provide an instant tack surface to facilitate application of the dilator.

Abstract: A medical device includes a one-piece resiliently biased band of base material having opposite first and second side surfaces and an adhesive material for temporarily adhesively securing the band to a user's skin. The band can include a longitudinal axis and a lateral axis that intersects the longitudinal axis. Moreover, the band can include first and second lateral portions disposed on opposite sides of the lateral axis. The lateral portions are mirror images of each other such that the band is symmetrical relative to the lateral axis. Each of the lateral portions include a central portion and first and second extending portions spaced apart from each other on opposite sides of the longitudinal axis of the band and extending away from the central portion. Each of the extending portions further include a perimeter edge defining a portion of an edge of the medical device.

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: The present disclosure provides a device and method for facilitating air flow in the nasal passages of a mammal. The nasal support device (NSD) disclosed herein is useful for facilitating air flow during rest, physical exertion, respiratory ailment, etc. The NSD overlies the nose and provides support for maintaining the nasal passages open.

Abstract: A medical treatment tool includes a bendable tube configured to be inserted into a body of a patient; and an operating body disposed in the insertion tube and configured to cause bending of the bendable tube, the operating body including: a plurality of divided members that are divided from each other along axially extending edges of the divided member, portions of the divided member forming a tubular structure, and an annular connecting portion that connects distal portions of the divided members.

Abstract: A method for non-surgically treating an internal nasal valve of a patient comprising, injecting a working device into the internal nasal valve of the patient, wherein the injected working device in the nasal tissue causes an alteration of an internal or external nasal valve. A device introduced by injection into the nose, allowing for structural support or filling of defects in the nose, and causing a change in external shape of the nose. The device and inserts and implants described also have use in cosmetic applications relating to the facial tissue.

Abstract: A surgical instrument for use in a sinus lift includes a substantially cylindrical sleeve which is sealingly insertable into a bore of a jawbone. The sleeve has a lumen and is formed with an inlet channel and an outlet port which is in fluid communication with the lumen. A vibration unit is operatively connected to the instrument for transmitting vibrations into the lumen.

Abstract: A set of sinus balloon catheters are provided for treating a patient's paranasal sinus system, including dilating prepared openings, and natural ostia and ducts and excising sinus cavities. These include a balloon catheter with a bend placing a distal segment at 90° to a proximal segment and a balloon catheter which is substantially straight. The catheters have sufficient stiffness and column strength that the balloon carrying distal segment of the catheter can be pushed into the prepared opening, natural ostium or duct, or sinus to be excised. The catheters have appropriate inflated working diameters and appropriate outer diameters with the balloon deflated that will enable the catheter to be pushed into the respective prepared opening, natural ostium or duct, or sinus cavity to be excised. The methods use the balloon catheters to dilate prepared openings to selected parts of the sinus system, to dilate natural ostia and ducts of the sinus system, and/or to dilate sinus cavities to remove them.

Abstract: Therapeutic delivery systems are provided which, in a first embodiment, contain a plurality of multiphase capsules in which first and second therapeutic agents are contained in separate phases within said multiphase capsules, and are disposed to deliver said first and therapeutic agents by at least two different delivery mechanisms.

Abstract: Described here are paranasal sinus devices for treating paranasal sinus conditions. The devices include a cavity member, ostial member, and nasal portion. One or more of the cavity member, ostial member, and nasal portion may deliver an active agent for sustained release to treat the paranasal sinus condition. Exemplary paranasal sinus conditions are sinus inflammation due to functional endoscopic sinus surgery (FESS) and rhinosinusitis.

Abstract: A spacing device for use in fenestrations of the paranasal sinus, the device including a sheath which forms a hollow body defining at least two apertures. The sheath includes at least one layer loaded with an active substance. The ratio q of the external diameter ra of the hollow body to the internal diameter ri of the hollow body is about 1.2 to 3.0.

Abstract: The device to narrow the nasal columella (1) and to dilate the nasal wings and the nasal valve, according to the invention, includes the first two horizontal branches (13a, 13b) joined, at the distal end (13) to form a U, from the internal wall of the proximal end (14a) and (15a), the first two—right (14) and left (15)—lamellae branch off, they join the internal wall of the distal ends (14b) and (15b) delimiting medially an elongated leaf-shaped space (14c, 15c). From the upper edge of the proximal portion of each horizontal branch (13a) and (13b), to the right (16b) and to the left (17b), a respective second branch gets off; the latter acute angled bends (16), after a short vertical portion, and (17) towards the outside and it continues with a respective second dragonfly-wing shaped lamella, to the right (18) and to the left (19), suitable for being inserted into the nasal vestibule and the nasal valve.

Abstract: A nasal cavity insertion device fixture, whereby the displacement or detachment of a nasal cavity insertion tube is prevented during the sleep of a patient of sleep disorder. A nasal cavity insertion device fixture makes contact with the inner surface of a nasal passage in order to fix an insertion device inserted into the nasal cavity. The nasal cavity insertion device fixture preferably includes a tubular contact portion with an outer peripheral surface thereof which makes contact with the inner surface of the nasal passage.

Abstract: A method is described for modifying at least one property of a tissue of or near a nasal valve of a nose, without using a surgical incision or an implant, to decrease airflow resistance or perceived airflow resistance in a nasal airway. The method may involve contacting a treatment element of a treatment device with the at least one tissue inside the nasal airway, with sufficient force to at least temporarily deform the at least one tissue, applying energy to, or removing energy from, the at least one tissue, using the treatment element, and removing the treatment element from the nostril.

Abstract: An ergonomic insertion tool for insertion and retrieval of an arterial tamponade device which has an elongate connecting strut of resiliently deformable material and an arterial compressor at one end. The tool has a handle with a hand grip portion including an actuating trigger, and an elongate barrel. The barrel has a shaft and an outer sleeve telescopically engaged over the shaft. In a first position, a hooked distal end of the shaft protrudes from the sleeve to engage a bend between adjacent end portions of the connecting strut. On movement into a second position, the sleeve extends over the hooked end and compresses the deformable connecting strut into a deformed, U-shaped configuration to hold the device during insertion or retrieval. On movement back into the first position, the deformed device is released to spring out towards the expanded condition.

Abstract: A spacer for delivery into the natural or man-made openings to the frontal, maxillary, sphenoid, anterior or posterior ethmoid sinuses, or other cells or cavities, anatomical regions such as nostrils, nasal cavities, nasal meatus, and other passageways such as the Eustachian tubes, naso-lachrymal ducts or airway is described. The bioabsorbable polymeric spacers maintain the opening and/or are useful for delivering drugs or other substances to the natural or man-made openings.

Abstract: A system for manipulating a guide catheter within a patient's nasal passages or sinus cavities includes a guide catheter formed from an elongate flexible member having a lumen passing there through. A wire guide is slidably disposed within the lumen of the guide catheter. The system further includes a steering member fixedly secured to a proximal end of the wire guide and a proximal hub secured to a proximal end of the guide catheter. The system further includes a recessed handle having a first recess for fixedly receiving the proximal hub of the guide catheter and a second recess for receiving the steering member, the second recess being dimensioned to permit axial and rotational movement of the steering member while disposed in the second recess.

Abstract: The invention relates to a device for external use on the nose with a special and innovative action mechanism, with hooks that are inserted into the nostrils and apply a vigorous mechanical action, tensioning the (nostril dilator) nose muscle, the (nostril opening) nose wing and upper lip elevator muscles, and the nose wing greater cartilage (greater alar cartilage), this tension applied to the three structures widely opening the nostrils, tensioning and lifting the nose tip and cancelling the action of the nasal septum depressor muscle. The correct position is maintained by pulling the upper end of the device vertically, towards the root of the nose, and attaching it to the ridge of the nose with adhesive tape, thus stopping obstructive sleep apnea, snoring, nose, soft palate and uvula obstructions. The apparatus is formed in a single rigid piece (FIG. 1) weighing less than 10 gr.

Abstract: A medical treatment tool includes: an insert portion at least a part of which is provided by a flexing portion that is adapted to be flexed, the insert portion being adapted to be inserted into a human body of a patient; and an inflatable body provided on an outer circumference of the flexing portion, the inflatable body being inflated in a radial direction of the flexing portion. An axial distal end portion of the inflatable body is fixed to the insert portion while a proximal end portion of the inflatable body is axially movable relative to the insert portion.

Abstract: Dilators are provided for insertion into, and dilation of, a Eustachian tube of an animal, e.g., a human being. The dilators may be placed in the Eustachian tube via the oral or nasal passageway, and the nasopharynx. The dilators are configured to be self-expanding and include a driver configured to expand an expandable portion from a non-expanded configuration to an expanded configuration. Also provided are kits that include the dilator, an insertion device for inserting the dilator, and methods for inserting the dilator into a Eustachian tube.

Abstract: The present invention relates to a stent for splinting a nasal passage. The stent (1) consists of a braided tubular support body (2) which, in unloaded state, has a diameter of at least 4 mm and a length in the range of 25 to 120 mm and particularly of 25 to 100 mm. The stent may have a widened section (15) at the proximal end for splinting of the nasal alar. It may alternatively or in combination have a fixation section (3) at the proximal end of the stent (1) for fixation of the stent (1) in a nasal passage of a user. When fixed the fixation section (3) protrudes from the nostril of the user and can be fixed outside of the nose.

Abstract: A method of treating a constricted sinus passageway of a patient includes traversing the canine fossa region of the patient so as to form a passageway in the sinus cavity. An elongate member is inserted through the passageway, the elongate member having an inflation member such as a balloon disposed thereon. The inflation member is positioned within the constricted passageway. The inflation member is expanded so as to expand at least a portion of the constricted sinus passageway.

Abstract: A method of treating a constricted sinus passageway of a patient includes traversing the canine fossa region of the patient so as to form a passageway in the sinus cavity. An elongate member is inserted through the passageway, the elongate member having an inflation member such as a balloon disposed thereon. The inflation member is positioned within the constricted passageway. The inflation member is expanded so as to expand at least a portion of the constricted sinus passageway.

Abstract: The present invention discloses a nasal dilator comprising at least one breathable layer of adhesive-coated high MVTR layer, such as a polyurethane film, one or more adhesive-coated high modulus “spring” elements for dilating the nasal passages by applying a tension force to the skin, and a carrier delivery system. The carrier delivery system comprises a separation line or split through the carrier to allow for easy delivery of the nasal dilator. The carrier aids in the handling and delivery of the thin adhesive-coated high MVTR layer.

Abstract: A biodegradable nasal splint, wherein the biodegradable nasal splint is configured for placement within a nasal passage so as to stabilize a surgically-corrected septum. A biodegradable nasal splint, wherein the biodegradable nasal splint is configured for placement within a nasal passage so as to exert a lateralizing force to an outfractured inferior turbinate. A method comprising performing a corrective procedure with respect to a patient's nasal passage, positioning a biodegradable nasal splint within the patient's nasal passage, wherein the biodegradable nasal splint is effective to exert a lateralizing force to an inferior turbinate, to stabilize a nasal septum, or combinations thereof.

Abstract: Described here are delivery devices for delivering one or more implants to the body, and methods of using. The delivery devices may deliver implants to a variety of locations within the body, for a number of different uses. In some variations, the delivery devices have a cannula with one or more curved sections. In some variations, a pusher may be used to release one or more implants from the cannula. In some variations, one or more of the released implants may be a self-expanding device. Methods of delivering implants to one or more sinus cavities are also described here.

Abstract: Described here are self-expanding devices and methods of using and making them. The devices may be useful in a variety of locations within the body, for a number of different uses. In some variations, the devices have a first compressed configuration enabling low profile delivery through a delivery device, a second expanded configuration for apposition against tissue, and comprise either a single continuous filament or at least two non-intersecting filaments. In some variations, the device is formed into a shape having a series of peaks and valleys. At least one of the peaks and valleys may have a loop at then end thereof. At least a portion of these devices may be capable of biodegrading over a predetermined period of time, and the devices may be configured for drug delivery. Methods of treating one or more sinus cavities are also described here.

Abstract: A method of confirming the location of an elongate member configured for placement within a patient's sinus cavity comprises introducing the elongate member through a nasal passageway to place a distal tip of the elongate member in a test position, the elongate member configured to emit illuminating light via the distal end of the elongate member. The location of the light is then viewed through the patient's skin to confirm the positioning of the elongate member.

Abstract: A method of treating a constricted sinus passageway of a patient includes traversing the canine fossa region of the patient so as to form a passageway in the sinus cavity. An elongate member is inserted through the passageway, the elongate member having an inflation member such as a balloon disposed thereon. The inflation member is positioned within the constricted passageway. The inflation member is expanded so as to expand at least a portion of the constricted sinus passageway.

Abstract: A nasal dilator is formed as a unitary truss of laminated, vertically-stacked layers. A resilient layer provides stabilization and expansion of nasal wall outer tissues, while an adhesive layer attaches the dilator to the user's skin. Dilator component shapes are designed to facilitate manufacture with reduced material waste. Some embodiments can be assembled by the user to customize the size or configuration to personal preference.

Abstract: A nasal insert may include a wall in the shape of a tube, the wall including a first end defining a first orifice and a second end defining a second orifice. The first end may have a diameter, diagonal measurement, or cross-sectional area larger than that of the second end. The first end may define at least one break in the wall, so that the first end incompletely encircles the first orifice. The second end may completely encircle the second orifice.

Abstract: A method of treating a constricted sinus passageway of a patient includes traversing the canine fossa region of the patient so as to form a passageway in the sinus cavity. An elongate member is inserted through the passageway, the elongate member having an inflation member such as a balloon disposed thereon. The inflation member is positioned within the constricted passageway. The inflation member is expanded so as to expand at least a portion of the constricted sinus passageway.

Abstract: An article to improve nasal passage air flow may be a strip that comprises a flexible resilient material, and has a first end and a second end, and a top surface and a bottom surface, with at least a portion of the bottom surface at the first end of the strip comprising a first adhesive surface, and at least a portion of the bottom surface at the second end of said strip comprising a second adhesive surface. The strip may serve to dilate a user's nasal passage when the first end of the strip is secured using the first adhesive bottom surface to be proximate to an alar facial groove of the user's nose, with the second end of the strip being pulled up at a slight angle and laterally to achieve desired nasal passage expansion and thereafter being secured to the user's face, at roughly a 20-25 degree angle.