Abstract: A method and a composite material used for free forming a bone substitute are provided. The composite material comprises a support cloth, and a partially hardened bone paste coated on the support cloth. The bone paste contains a mixture of calcium sulfate and calcium phosphate in a weight ratio of 1:1 to 1:4. The bone substitute can be made by laminating the composite material either on a bone model or not.

Abstract: An injectable sterilized aqueous composition including at least one hyaluronic acid, at least one polyol and at least one local anesthetic chosen from the group made of benzocaine, chloroprocaine, procaine, etidocaine, aptocaine, chlorobutanol, diamocaine, dyclonine, guafecainol, polidocanol, mepivacaine, prilocaine, articaine, bupivacaine, ropivacaine, tetracaine and salts thereof and isolated isomers thereof. The invention also relates to a process for adapting the rheological properties of a heat sterilized injectable aqueous composition. The invention also relates to a process for producing an injectable sterilized aqueous composition according to the invention, and also to uses of said injectable sterilized aqueous composition according to the invention.

Abstract: Disclosed are a vascular patch using a silk matrix and a method of manufacturing the same, wherein the vascular patch is configured such that a silk matrix having a cross-section with a first thickness, produced from silkworms, is subjected to planar division into two or more silk matrix pieces having a predetermined shape with the first thickness. Furthermore, the manufacturing process is relatively simple, thus reducing the manufacturing cost compared to when manufacturing typical vascular patches, and also, the vascular patch can exhibit outstanding cell culture capacity and is biocompatible.

Abstract: Described herein are molded dehydrated placental tissue compositions, and pharmaceutical compositions thereof. The compositions have numerous medical applications. Methods for making and using the molded dehydrated placental tissue compositions are also described herein.

Abstract: An injectable composite material for bone repair comprises a biological tissue material and bioceramics in order to serve as a three-dimensional scaffold for bone regeneration. The biological tissue material consists of microfibers having a naturally cross-linked structure without additional physical or chemical cross-linking, has superior biological compatibility, and can be slowly and completely degraded in vivo. The bioceramics in the composite material serves as a reinforcing phase. When combining the biological tissue material with the bioceramics, the composite material provides a template for bone tissue regeneration to effectively induce bone growth. The injectable composite material for bone repair can be used to fill bone defects, particularly critical-sized bone defects, and can be combined with a biological agent such as bone marrow to improve its biological activity.

Abstract: A system and method for decellularizing tissue is provided. The system includes a pretreatment chamber including a pretreatment solution (e.g., a surfactant), a decellularization solution comprising carbon dioxide and one or more polar solvents, as well as an environmental chamber comprising a treatment chamber. The environmental chamber is maintained at a temperature greater than 31.1° C. and the carbon dioxide is maintained at a pressure greater than 7.38 megapascals to form supercritical carbon dioxide. Tissue treated with the decellularization system and method can contain less than 0.05 micrograms of DNA per milligram of dry tissue after the tissue is exposed to the decellularization solution for a time period ranging from about 1 minute to about 2 hours with minimal ECM fiber disruption. A two-part decellularization solution comprising a surfactant as well as supercritical carbon dioxide and one or more polar solvents is also provided.

Abstract: Methods of decellularization of tissue, such as mammalian tissue, are provided, along with methods of making an extracellular matrix (ECM) preparation. Systems and apparatus useful in performing the methods are also provided.

Abstract: The composition for bone regeneration, comprises a) a first phase (3) comprising a plurality of cross-linked hydrogel chunks (1) having a mean diameter of less than 1000 ?m and incorporating an amount of mineral particles (2); and b) a second phase (4) comprising a physiologically-compatible aqueous liquid acting as a carrier for the chunks; the chunks being embedded in the second phase (4). The mineral particles (2) have a mean diameter of less than 10 ?m and the amount of the mineral particles (2) is less than 20 weight-% of the first phase.

Abstract: The inventions relates to a method for generating a macroporous hydrogel. In a first step, an aqueous solution of two solutes is produced. The first solute is a polymer that can be cross-linked and is a derivative of polyethylene glycol (PEG) or polyoxazoline (POx) and the second solute is a kosmotropic agent. In a second step, a cross-linking agent is added to the solution. This simultaneously initiates gelation of the polymer and phase-separation, thus creating a macroporous hydrogel. The invention further relates to a macroporous hydrogel, which can be obtained by the inventive method. This macroporous hydrogel is comprised of a cross-linked polymer, which is a derivative of polyethylene glycol (PEG) or polyoxazoline (POx). The hydrogel exhibits interconnected macropores with a size of 200 nm to 1000 ?m, particularly 500 nm to 100 ?m and is characterized by a pH of of 7.0 to 8.0, particularly approx. 7.4.

Abstract: A stent, the stent including a first coating composition disposed on at least a portion of the outer surface of the stent, the first coating composition having at least one bioadhesive and a second coating composition disposed over the first coating composition, the second coating composition having at least one biodegradable polymer, and methods of making and using the same.

Abstract: An absorbable iron-based alloy implantable medical device includes an iron-based alloy matrix, a degradable polymer coating disposed on the surface of the iron-based alloy matrix, and a corrosion inhibition layer disposed on the surface of the iron-based alloy matrix. The corrosion inhibition layer can delay early-stage corrosion of the iron-based alloy matrix, ensure mechanical performance of a medical device in the early stage of the implantation, prevent degradation of a polymer in the early stage of the implantation of the medical device, and reduce the usage of the degradable polymer, thereby reducing risks of inflammatory reactions.

Abstract: An ocular implant is provided for an intraocular delivery of a therapeutic biologic agent. The implant may be used intracamerally or intravitreally. The implant may include a sustained-release biodegradable core and a biodegradable shell, wherein the shell has a longer biodegradable half-life than the core. The core may include a biodegradable gel medium, an active therapeutic biologic agent, and a biologic stabilizer. Upon insertion into the anterior chamber or vitreous body of an eye, the therapeutic biologic agent is released over an extended period, that may range from one day to one year. The therapeutic biologic agent may be, for example, tissue-plasminogen activator, an anti-VEGF agent, or another biopharmaceutical. The biodegradable implant may completely dissolve after implantation and need not be removed.

Abstract: Provided is a biodegradable polymer coating stent effective in delaying the damage of physical properties (particularly radial force) of a core structure. The stent includes a core structure of a bioabsorbable material (e.g., Mg), a first coating layer of a first polymer with biodegradability, and a second coating layer of a second polymer with biodegradability, wherein the first coating layer covers the whole surface of the core structure; the second coating layer covers a part or the whole surface of the first coating layer; the first polymer has a glass transition point of lower than 37° C.; and the second polymer has a glass transition point of 47° C. or higher.

Abstract: Embodiments of a negative pressure wound therapy systems and methods for operating the systems are disclosed. In some embodiments, a system includes a pump assembly, canister, and a wound dressing configured to be positioned over a wound. The pump assembly, canister, and the wound dressing can be fluidically connected to facilitate delivery of negative pressure to a wound. The system can be configured to efficiently deliver negative pressure in continuous and intermittent modes. The system can also be configured to gradually ramp up and down to set pressure values. The system can also be configured to detect and indicate presence of certain conditions, such as low pressure, high pressure, leak, canister full, and the like. Detection and indication of the presence of at least some of these conditions can be enabled and disabled.

Abstract: A catheter (20), which can be part of an intravascular blood pump, possesses a kink sensor which extends over the total length of the catheter and comprises an optical fiber (28A). The optical fiber is attached to an evaluation device (100) which evaluates a preset light quantity transmitted through the optical fiber as to whether a part of the light quantity is coupled out of the optical fiber along the length of the optical fiber. This is interpreted as a kink event and displayed. The optical fiber preferably utilized for the kink sensor is the optical fiber of an optical pressure sensor.

Abstract: An intravascular heart pump assembly can include a rotor with at least one impeller blade, and a cannula. The present application describes various cannulas that can be manufactured from multiple layers of material to improve flexibility, manufacturability, and durability without increasing an outer diameter of the cannula. In one embodiment, the cannula includes an inflow section having a sheet formed of a shape memory material embedded within a polymer and having at least one lateral hole or aperture in the inflow section. The at least one lateral hole is defined by a first hole in the sheet and a second hole in the outer polymer layer of the cannula. The first hole and the second hole overlap so that blood can enter the cannula through the holes.

Abstract: An extracorporeal gas exchange device includes a housing, a rigid shaft rotatable within the housing, a plurality of agitation mechanisms positioned on the rigid shaft, and a plurality of hollow gas permeable fibers adapted to permit diffusion of gas between fluid flowing within the housing and an interior of the plurality of hollow gas permeable fibers. The plurality of hollow gas permeable fibers are positioned radially outward from the plurality of agitation mechanisms. The rotational speed of the rigid shaft is adjustable independent of the flow rate of fluid through the housing.

Abstract: A method for operating a dialysis cassette including a flexible membrane that covers a pump chamber includes allowing a source of fluid to fluidly communicate with the pump chamber of the dialysis cassette, filling the pump chamber with the fluid from the source, mechanically extending the flexible membrane into the pump chamber with a piston head to expel the fluid from the pump chamber through a flow path, and directly sensing a pressure of the fluid flowing through the flow path at a location of the dialysis cassette adjacent to the pump chamber and using the sensed pressure to perform a test prior to delivering fluid to a patient.

Abstract: The invention relates to methods and systems for removal of pathogens from blood or blood products. The invention further relates to methods and systems for treatment and diagnosis of infection in the blood and/or sepsis in a patient in need thereof.

Abstract: A control system controlling the line pressure in a blood supply system (1) in which a pump (14) pumps blood from a reservoir (10) via a primary passage (18) toward a plurality of outlets (16, 26, 26a), wherein one or more outlets are openable to permit flow and closable to block flow, said control system comprises a monitoring arrangement to determine a line pressure in the primary passage, and a controller responsive to the monitoring arrangement and controlling the pump (14) to maintain the line pressure in the primary passage (18) above a pre-set level. The control system practically eliminates the risk of a momentary reduction in blood supply line pressure when an outlet is opened.

Abstract: Described herein are devices and methods for vascular access via the tributaries. A single lumen catheter, with a bidirectional valve at the tip is disclosed. Flow is out the longitudinal tip of the catheter and not the sides. The two-way valve will act passively but has low opening and closing pressures. A method utilizing endo-to-side port placement of said catheter in vasculature is disclosed. Anastomosis methods are described using said catheter.

Abstract: A user-wearable patch pump system for delivery of insulin or other medicament can include a patch pump having a reusable drive unit and a replaceable and refillable cartridge. The cartridge can selectively attach to and be detached from the drive unit. The cartridge can initially be inserted onto the drive unit in a first orientation at an angle to the drive unit and then be rotated to align the cartridge with the drive unit and lock the cartridge in place on the drive unit to form the patch pump.

Abstract: An implantable infusion device includes a reservoir for housing an infusion medium and a drive mechanism having an inlet chamber, a piston and a piston channel. The inlet chamber is in fluid communication with the reservoir. The piston channel is in fluid communication with the inlet chamber, and has a distal end and a proximal end, the proximal end being closer to the inlet channel than the distal end. The piston is axially moveable within the piston channel to drive infusion medium out of the distal end of the piston channel. The clearance between the piston and the channel is sufficiently small to prevent undissolved gas in the inlet chamber from passing through the clearance. The inlet chamber may be sufficiently large to allow undissolved gas to accumulate without adversely affecting the performance of the infusion device.

Abstract: A neural drug delivery system is disclosed. In an embodiment, the system includes two or more microtubes, each having a distal end, a proximal end, and elongate channel body extending therebetween; an electrode having a distal end, a proximal end, and elongate body extending therebetween; an elongate carrying template supporting the microtubes and the electrode in an aligned stack; and an annular needle having a distal end and a proximal end, and housing the carrying template, the microtubes, and the electrode. The system may include at least one pump fluidically connected to the proximal end(s) of one or more of the microtubes. The pump may be configured to deliver a fluid drug on demand through the elongate channel body and out of the distal end of the microtubes.

Abstract: Disclosed is a fluid dispensing device that includes at least one reservoir to hold the therapeutic fluid, at least one other unit requiring communication with ambient air, at least partly, to operate, and at least one housing defining an interior to retain the at least one reservoir and the at least one other unit. The at least one housing has at least one vent port formed on one or more of its walls. The at least one vent port is adapted to direct or communicate air to maintain pressure equilibrium between the air pressure in the interior of the at least one housing and the ambient air pressure outside the at least one housing, and provide communication with the ambient air to the at least one other unit requiring air to enable operation of the at least one other unit.

Abstract: A drive mechanism having integrated status indication includes a drive housing, a status switch interconnect, a drive biasing member, a piston, and a drug container having a cap, a pierceable seal, a barrel, and a plunger seal, wherein the drive biasing member is configured to bear upon an interface surface of the piston. Drive mechanism may include an incremental status stem having a stem interconnect, wherein the stem resides within the drive housing and the piston, and wherein the stem has an interconnect which engages one or more contacts on the piston to provide incremental feedback. A drug delivery pump with integrated status indication includes a housing and an assembly platform, upon which an activation mechanism, an insertion mechanism, a fluid pathway connection, a power and control system, and the drive mechanism having a drug container may be mounted.

Abstract: The present disclosure relates to a syringe for retaining and/or mixing two substances which have been retained separately inside the syringe. In particular the present disclosure relates to a syringe for 1) retaining a dry composition in a vacuum, and 2) mixing the dry composition with an aqueous medium to form a flowable substance. One embodiment relates to a syringe for mixing first and second substances comprising a barrel comprising a vacuum chamber for holding a first substance, a plunger incorporating a reservoir chamber for holding a second substance and configured to be axially displaced in the vacuum chamber, and a valve for controlling and/or establishing a fluid connection between the vacuum chamber and the reservoir chamber.

Abstract: Embodiments include a syringe-based apparatus for delivering fluid, the apparatus comprising a housing having an open proximal end and a distal end defining an inner volume, a needle, an actuator mechanism coupled with the housing, the actuator mechanism comprising a syringe body and a plunger, a medicament reservoir, and a reconstitution fluid reservoir.

Abstract: An autoinjector comprising a body (1) that is adapted to receive a reservoir (S), said reservoir (S) containing fluid and including a piston (P) and a needle (A), such as a pre-filled syringe, said autoinjector further comprising an actuator sleeve (10) that is movable relative to said body (1) between projecting positions in which said actuator sleeve (10) projects out from said body (1) at least in part, and an actuated position in which said actuator sleeve (10) is moved axially into said body (1), said actuator sleeve (10) being in a first projecting position before actuation of the autoinjector, and in a second projecting position after actuation of the autoinjector; said actuator sleeve (10) being urged towards said projecting positions by a spring (9), said autoinjector including a removable cap (20) that is fastened to said body (1) before the autoinjector is used, said removable cap (20), when it is fastened to said body (1), moving said actuator sleeve (10) axially relative to said first projecting

Abstract: A syringe calibrated for use with a predetermined medication and including a barrel, a plunger received through an end of the barrel and movable relative thereto, a tip disposed at one end of barrel and configured to be affixed to a device compatible for use with the syringe, a dosage schedule of the predetermined medication marked on the syringe and expressed as a ratio of a patient characteristic to a dosing unit of measurement, a first set of dosing indicia marked on the syringe and expressed as the predetermined patient characteristic, and a second set of dosing indicia marked on the syringe and expressed as the dosing unit of measurement.

Abstract: A method for manufacturing a syringe barrel includes: providing a syringe barrel comprising a hollow body portion having an inner surface, the syringe barrel being configured such that a gasket is insertable into the syringe barrel and slidable on the inner surface of the body portion; applying a non-reactive silicone oil having a viscosity in a range of 3000 cps to 30000 cps to the inner surface of the body portion by spraying the silicone oil with a coating amount rate of 0.02 mg/cm2 to 0.2 mg/cm2; and heating the silicone oil applied to the inner surface of the body portion in a state in which a liquid is not filled in the syringe barrel, without using a tool to spread or smooth the silicone oil.

Abstract: A dual chambered syringe includes: an inner barrel defining a first inner chamber, the inner barrel having an apertured stopper at its distal end, the inner barrel being open at its proximal end; a shaft adapted to fit within the inner barrel, the shaft having a distal end which is engageable with the aperture of the stopper; a device for controlling engaging and disengaging of the distal end of the shaft with the aperture of the stopper; an outer barrel concentric with the inner barrel defining a second inner chamber, the outer barrel having a distal end for receiving and dispensing fluids and a proximal end into which the distal end of the inner barrel is insertable into the second inner chamber; the apertured stopper engages the second inner chamber of the outer barrel and selectively prevents or permits the passage of fluids between the outer barrel second chamber and the inner barrel first chamber; the inner barrel having an engageable surface on its outside surface; and, the outer barrel having operativ

Abstract: Disclosed are a syringe needle assembly, and a safety syringe and a safety syringe device which use the syringe needle assembly. The syringe needle assembly includes a syringe needle having a needle tip formed on a front end thereof, and a safety tube covering the syringe needle, coupled to a rear end of the syringe needle and opened in an injection direction of the syringe needle. When the syringe needle is inserted into skin, the safety tube is contracted towards a rear side of the needle tip, and when the syringe needle is pulled out from the skin, the safety tube is extended towards a front side of the needle tip.

Abstract: A hollow needle, for use in medical and other areas where thin hollow needles are used to inject or aspirate fluids and gases, is provided and comprises of a thin, rigid tube body that is open on both ends and throughout the length with one sharp end. The needle body is designed and can be manufactured with a curved shape and or other geometric features, can be drawn to a desired curvature with heat, or can be curved afterwards, to specific specifications depending on the application. The needle so configured advantageously allows the user to circumvent an obstacle and or obstacles that otherwise inhibit direct linear access to a point-of-interest by providing a device that can take the sharp point of a needle on an indirect path towards the desired therapy delivery point.

Abstract: Disclosed herein is an injection device with housing that defines a channel and a first injection guide opening. The first injection guide opening enters the channel in a manner that allows a needle to penetrate a vessel in an animal with accuracy and at the same time protect the user from the needle.

Abstract: The present invention provides an injection needle unit (10) comprising: a needle assembly (20) comprising: an injection needle (25) extending along a longitudinal axis and having a distal needle end configured for insertion into a subject and a proximal needle end configured for penetration of a reservoir septum, and a skirt (22) surrounding the proximal needle end and defining a receiving space (28) for reception of a needle mount of a drug delivery device, the skirt (22) comprising a slot (24), and a block structure (32) supported exteriorly of the skirt (22), wherein the block structure (32) is biased towards the longitudinal axis and is capable of radial displacement through the slot (24) from a latched position outside the receiving space (28) to a released position within the receiving space (28).

Abstract: A needle injection array can comprise a plurality of needles that are fluidly interconnected via a fluid manifold. The fluid manifold can be configured to direct fluid from a syringe to arrive at tips of the needles approximately simultaneously. The fluid manifold also be configured to provide approximately equal dosage or fluid volume through each of the needles to an injection site.

Abstract: An instrument is applied to body tissue of a body part to produce vibration to thereby reduce pain of injection or other pain producing stimulus. The device has a frame, and a source of vibration connected to the frame. A removable tip is connectable to the frame which has a distal end that is connected to the source of vibration when the tip is connected to the frame, to thereby vibrate the distal end when the source of vibration is activated. At the distal end of the tip are mutually facing arms which define an opening between them. Each arm forms a projection which extends at an angle from the arm. The projections are shaped to fit the body part so that the arms and projections are sized and dimensioned to position, retain, and transmit vibration to the body part in a position proximate the opening.

Abstract: An attachment (1, 1a) for or on a device (100) for injecting a fluid into or under the skin (200), which is for example suitable for injecting botulinum toxin into facial muscles of a human patient, comprises: a proximal part (2, 2a) which is couplable or is connected to the device (100) and which bears a cannula (3). A distal part (4, 4a) surrounds the cannula (3) at least in places and is rotationally mobile relative to the proximal part (2, 2a) and vice versa, such that an extent (d3) by which the cannula projects out from the distal part (2, 2a) is modifiable. A discrete number of stopping positions is provided with regard to the rotational movement, which correspond to a different extent by which the cannula (3) projects out from the distal part (2, 2a).

Abstract: The present invention relates to a feedback for inhalation. In order to further improve feedback and instructions to further support the correct use of an inhaler, a feedback apparatus (10) for inhalation is provided that comprises an inhaler interface (11), a processor (14), a feedback device (16), and a feature assigner (13). The inhaler interface is configured to temporarily attach the feedback apparatus to an inhalation apparatus. The feedback device is configured to provide a feedback to the user to aid in inhalation with the inhalation apparatus. The feature assigner is configured to identify a type of a predetermined feature of the attached inhalation apparatus, and the feedback device is configured to provide the feedback in dependency of the identified type of feature to instruct the user to adjust inhalation maneuver adapted to the attached inhalation apparatus.

Abstract: The present invention relates to an inhaler device for delivering a dose of medicament in dry powder form from a container to a patient in need thereof. The inhaler comprises first and second airflow paths (80, 85) which are arranged such that during inhalation, a capsule (40) having a longitudinal axis and first and second end sections (90, 95) delimiting the capsule on opposing ends located in a capsule chamber (30) performs an oscillating movement in the capsule chamber parallel to its longitudinal axis between first and second sidewall portions (60, 65) of the capsule chamber.

Abstract: The present disclosure generally relates to the field of controllable nebulizers for aerosol generation. The nebulizer comprises an aerosol release mechanism configured to release aerosols based on control signals received from a controller based on yawn sensor measurements of the patient. The aerosol release during deep and full inhalation, as in yawns, improves drug delivery to the lungs and consequently may lead to reduction of drug dosage.

Abstract: A metered dose inhaler canister combination comprises a canister configured for containing a pharmaceutical composition, the canister having a canister base, a side wall extending from the canister base, an open end distal from the base and a first cooperating formation arranged at said open end and extending generally distally from said canister base; a shroud having a shroud base and a side wall extending from the shroud base to a waist, the base and side wall defining a vessel configured to receive the canister therein, the waist defining an aperture of constricted width configured to receive the canister therethrough, and a second cooperating formation extending generally distally from said waist, wherein the respective first and second cooperating formations adopt an engaged condition in which the canister is retained within the shroud.

Abstract: The present invention relates to an inhaler which is appropriate for delivery of medicament in dry powder form used in respiratory diseases, particularly in asthma and chronic obstructive pulmonary disease (COPD). In addition, the present invention relates to an inhaler which includes a blister package appropriate for carrying the medicament in dry powder form and used to realize an effective inhalation.

Abstract: Devices and methods for allowing for improved assisted ventilation of a patient. The methods and devices provide a number of benefits over conventional approaches for assisted ventilation. For example, the methods and devices described herein permit blind insertion of a device that can allow ventilation regardless of whether the device is positioned within a trachea or an esophagus. In addition, the methods and device allow for timed delivery of ventilations based on a condition of a thoracic cavity to increase the amount and efficiency of blood flow during a resuscitation procedure.

Abstract: Gas mixture used for ventilation of passengers and crew in emergency situations. Depending on the density altitude, it has 7±5% CO2 at 15,000 ft flying altitude increasing to 17±5% CO2 at 30,000 ft flying altitude. The carbon dioxide improves the bioavailability of oxygen in the body. The gas mixture is produced by additive dosage of CO2 to either pure O2 or to a gas mixture having a fraction of N2 and a fraction of O2. The method for ensuring good ventilation in case of loss of cabin pressure, or generally in case of hyperventilation, involves making the gas mixture above available via respiration masks. The use of such a gas mixture also for ensuring good ventilation of people with limited mobility, if such ventilation is required. The prescribed amount of onboard oxygen for aircraft can thus be reduced and flight routes leading directly over high-altitude terrain may be taken.

Abstract: The present disclosure pertains to a method and system configured for detecting a gas delivery malfunction in a spontaneous mechanical ventilation mode. In some embodiments, the system comprises a pressure generator, a subject interface, one or more sensors, one or more processors, electronic storage, a user interface, and/or other components. The detection of a gas delivery malfunction in a spontaneous mechanical ventilation mode is implemented by generating a test flow of gas for delivery to an airway of a subject, and monitoring a responsive flow of gas in the subject interface. If one or more parameters associated with the responsive flow of gas demonstrate inconsistencies with a reference flow of gas responsive to the test flow under a condition that there is no gas delivery malfunction, the system determines that there is a gas delivery malfunction.

Abstract: The disclosed device serves for artificial respiration and has a blower connected to a control. The blower is held by a supporting part, which assumes the task of decoupling and other functions. The blower and the supporting part are arranged in a blower box. Both the control and the blower box are arranged in a housing. The control is connected to at least one indicating device and also to at least one operating element.

Abstract: An airway device for a subject which has an airway tube having a distal end and a proximal end, and a laryngeal mask disposed surrounding the distal end of the airway tube, wherein the inner part of the laryngeal mask has a hollow body filled with a biocompatible thermosensitive hydrogel, wherein the biocompatible thermosensitive hydrogel is gelified within a temperature range such that the biocompatible thermosensitive hydrogel, upon being gelified, allows the laryngeal mask to fit over the circumference of a laryngeal inlet of the subject.

Abstract: A respiratory mask assembly includes a frame having a channel and a cushioning element including a clip portion adapted for interference seal and retention in the channel. The cushioning element includes an interfacing portion constructed from foam and having a wider width than the clip portion.