Abstract: Compositions and methods for the surface appearance of the skin a subject are provided. An injectable composition comprising at least hyaluronic acid or a salt thereof; and an effective amount of at least mepivacaine or a salt thereof are provided. The hyaluronic acid optionally has an average molecular weight ranging from 50,000 to 10,000,000 Daltons, and may be crosslinked hyaluronic acids, non-crosslinked hyaluronic acids, or a combination, in some embodiments. The compositions and methods of the present invention are useful for treating and preventing the cutaneous signs of chronological aging and/or induced by external factors such as stress, air pollution, tobacco or prolonged exposure to ultraviolet (UV) exposure, impaired surface appearance of the skin, impaired viscoelastic or biomechanical properties of the skin, and/or the long-lasting filling of volume defects of the skin.

Abstract: A Sodium Bicarbonate Catheter Lock Solution that prevents clot formation inside the catheter lumen and ensures patency of the catheter and also eliminates bleeding and other complications caused through the use of anticoagulants and other solutions as a catheter locking solution. Said lock solution may be used with or without other components such as antimicrobials/antibiotics and/or anti-coagulants/anti-clotting agents.

Abstract: Antimicrobial formulations and coatings for medical devices and processes therefor are disclosed. The formulations include at least one water permeable polymer with at least one antimicrobial agent in a liquid medium and are prepared by wet milling the components and can form antimicrobial coatings having uniformly dispersed particles having an average size of no greater than 50 microns.

Abstract: A venous access catheter shaft and method of using and manufacturing such a catheter is provided. In one aspect of the invention, a catheter is provided comprising a base polymer having a Shore A durometer of 85A or lower, with 2.0% percent by weight of surface modifier, and a radiopaque filler comprising between 20-40 percentage by weight. In another aspect of the invention, a method reducing thrombus accumulation on a venous access catheter is provided wherein the catheter surface's resistance to thrombus formation is enhanced during indwell time by lowering the durometer rating of the base polymer of the catheter without increasing the amount of surface modifier additive. In another aspect of the invention, a method of manufacturing a catheter shaft is provided, wherein the shaft is formed comprising a base polymer having a Shore A durometer of 85A or lower, with 2.0% percent by weight of surface modifier, and a radiopaque filler comprising 30% by weight barium sulfate, and optionally a colorant of 0.

Abstract: A medical guide wire including a core wire having a distal end-side small-diameter portion and a proximal end-side large-diameter portion, and a coil spring installed on an outer periphery of the distal end-side small-diameter portion of the core wire along an axial direction, having a front end-side small-diameter portion, a tapered portion and a rear end-side large-diameter portion, and fixed to the core wire, wherein the front end-side small-diameter portion of the coil spring has a length of 5 to 100 mm, and the outside diameter of a coil thereof is at most 0.012 inch, the front end portion of the coil spring is fixed to the core wire by a gold-containing solder, and a length of a distal end portion stiffened by the gold-containing solder is 0.1 to 0.5 mm.

Abstract: Radiopaque polymer compositions and methods for making the compositions are provided. These radiopaque polymer compositions include polymer compositions comprising a crosslinked polymer network, the network comprising a first repeating unit derived from a monofunctional monomer and a second repeating unit derived from a multifunctional non-iodinated monomer wherein neither of the two monomers is fluorinated. Devices formed from radiopaque polymer compositions are also provided.

Abstract: Disclosed is a medical instrument coating, being coated on the surface of a nickel-titanium alloy component of a medical instrument. The medical instrument coating comprises an elementary copper phase, an amorphous titanium-containing substance and a transition layer comprising a copper-nickel intermetallic phase. Also mentioned is a preparation method for the medical instrument coating.

Abstract: Provided herein is a device comprising: a. stent; b. a plurality of layers on said stent framework to form said device; wherein at least one of said layers comprises a bioabsorbable polymer and at least one of said layers comprises one or more active agents; wherein at least part of the active agent is in crystalline form.

Abstract: Provided are systems and methods for delivery of fluid to a wound therapy dressing. In exemplary embodiments, a pressure source provides negative pressure to a wound dressing and a biasing mechanism provides positive pressure to a fluid reservoir.

Abstract: Described are devices, methods, and kits for controlled incremental filtration (CIF), as well as methods of designing CIF devices. For example, a method for CIF may modulate a concentration of particles of a desired size in a fluid. The fluid including the particles may be flowed along a flow path through a central channel to contact a plurality of gaps that fluidically couple the central channel to at least one adjacent side channel network. Flow resistance may be decreased along at least a portion of the flow path effective to modulate the concentration of particles. The method may include selecting the plurality of gaps to be larger than the particles. The method may include causing a consistent flow fraction fgap in the central channel to traverse each gap in the plurality of gaps and flow through the at least one side channel network along the flow path.

Abstract: The present invention provides devices, systems, and methods for control of and communication with ventricular assist devices. In certain embodiments, the invention includes an implantable controller that is operatively programmed to direct physiological flow through a ventricular assist device that can be substantially synchronized to the cardiac cycle of the subject. In certain embodiments, the implantable controller is also communicatively connected to an external control unit, such that the implantable controller can transmit data to the external control unit, and instructions can be sent from the external control unit to the implantable controller. In certain embodiments, a system and method for secure communication between a remote device and the implanted ventricular assist device is provided.

Abstract: Systems and devices for an updatable blood pump are disclosed herein. The blood pump can be part of a mechanical circulatory support system that can include a system controller and the blood pump. The blood pump can include a rotary motor and a control unit that can communicate with the system controller. The system controller can initiate the update process and can provide the update to the blood pump. Upon initiation of the update process, the control unit can stop the rotary motor. While the rotary motor is stopped, the blood pump can be updated. At the completion of the update, the rotary pump can be restarted.

Abstract: An improved intravascular blood pump and related methods involving the broad inventive concept of equipping the intravascular blood pump with guiding features such that the intravascular blood pump can be selectively positioned at a predetermined location within the circulatory system of a patient.

Abstract: Provided are nanoporous silicon nitride membranes and methods of making such membranes. The membranes can be part of a monolithic structure or free-standing. The membranes can be made by transfer of the nanoporous structure of a nanoporous silicon or silicon oxide film by, for example, reactive ion etching. The membranes can be used in, for example, filtration applications, hemodialysis applications, hemodialysis devices, laboratory separation devices, multi-well cell culture devices, electronic biosensors, optical biosensors, active pre-concentration filters for microfluidic devices.

Abstract: The present disclosure provides a system for oxygenating blood. The system may include an implantable blood pump that may draw a supply of blood from the circulatory system of a mammalian subject, such as a human being. The blood pump may provide the supply of blood to an adaptor, where the supply of blood may be supplied to either or both of a first branch or second branch. The first branch may lead to an external blood oxygenator. The oxygenator may oxygenate the blood, and the blood may be returned to the circulatory system of the mammalian subject. The second branch may bypass the oxygenator and may connect to the circulatory system of the mammalian subject. In this regard, while the blood is supplied to the second branch, the oxygenator may be disconnected and blood may be prevented from entering the first branch.

Abstract: The present invention provides a system, a method, devices and a computer implemented with a method for the monitoring and the control of a subject's organ perfusion. The present invention further provides for the use of a system, a method, devices and a computer implemented with a method for the monitoring and the control of a subject's organ perfusion.

Abstract: Interventional procedures on the carotid arteries are performed through a transcervical access while retrograde blood flow is established from the internal carotid artery to a venous or external location. A system for use in accessing and treating a carotid artery includes an arterial access device, a shunt fluidly connected to the arterial access device, and a flow control assembly coupled to the shunt and adapted to regulate blood flow through the shunt between at least a first blood flow state and at least a second blood flow state. The flow control assembly includes one or more components that interact with the blood flow through the shunt.

Abstract: A method for the re-anticoagulation of platelet rich plasma in a blood apheresis system includes priming the blood apheresis system with anticoagulant, such that a volume of anticoagulant is transferred to a PRP container. The method may then transfer the anticoagulant within the PRP container to a red blood cell container, and collect a volume of platelet rich plasma within the PRP container. The platelet rich plasma may be collected in a plurality of cycles. Between collection cycles, the method may transfer a portion of the volume of anticoagulant from the red blood cell container to the PRP container.

Abstract: An injector head with rotation mechanism allows selection between a state in which a syringe assumes a priming orientation with a through hole of the syringe positioned upper than the injector head body, and a state in which the syringe assumes a contrast agent injectable orientation with the through hole of the syringe positioned lower than the injector head body.

Abstract: A method and apparatus for a connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump is provided. The reservoir, a base and a cap are connected to form an integrated unit that is capable of being inserted and secured in an infusion pump housing. The cap and the infusion pump are each provided with at least one sensor or at least one detectable feature, arranged to interact with at least one corresponding detectable feature or sensor on the other of the cap and infusion pump device, to detect one or more of the presence, position or other characteristic of the cap when the cap is aligned or coupled with the infusion pump housing. The detectable feature and sensor may be magnetic, RF, mechanical, optical or any combination.

Abstract: Devices are provided that include a faceplate for a medical device. In embodiments, an identifier chip adapted to be affixed to an exterior portion of a faceplate provides a unique identifier for the faceplate. Accordingly, the identifier chip enables tracking and monitoring of an associated medical device. And, in embodiments, the faceplate includes a visual communication alert indicator to enable the faceplate to provide visual cues a user. As such, the status of the medical device and the faceplate can be easily communicated to the user. Methods to use the faceplate are also provided.

Abstract: A method for discharging fluid from a syringe and for mitigating occlusion conditions includes actuating the plunger of a syringe into a barrel. The method monitors fluid pressure within the barrel of the syringe and determines that an occlusion exists when the fluid pressure exceeds a predetermined threshold. The method actuates the plunger out of the barrel by a predetermined amount in response to the detected occlusion and actuates the plunger of the syringe into the barrel until a measured fluid pressure within the barrel of the syringe exceeds another predetermined threshold.

Abstract: An applicator device including a housing, an impactor for impacting a microneedle array and accelerating the microneedle array toward the target site, wherein the impactor is capable of moving along an arcuate path to move the microneedle array toward the target site. Also, an applicator device including a housing, a patch applicator pivotally supported by the housing, and a torsion spring. The patch applicator has a retaining portion and a patch contacting portion, and the patch contacting portion is capable of moving along a substantially arcuate path between a first position and a second position. The torsion spring is capable of biasing the patch applicator relative to the housing.

Abstract: An infusion set includes a base with a rigid piercing cannula or a soft catheter and rigid introducer needle. The infusion set also includes a line set with a fluid connector. The base and line set are configured such that the fluid connector can be used as a protector for the piercing cannula or the soft catheter, either before the device is attached to a user, or after the device is detached from the user, or both.

Abstract: An embodiment is directed to pressure plate for attachment to an infusion pump, where the pressure plate includes a tubing support surface at least partially surrounded by a raised perimeter support. The pressure plate includes a plurality of guide structures extending from the raised perimeter support that define a passageway for an infusion pump tube. Additionally an attachable flow stop assembly is included that includes an attachable occlusion arch and an attachable flow stop arm. The attachable occlusion arch includes a plurality of tab structures that couple to the raised perimeter support. The occlusion arch further includes an aperture configured to surround an infusion pump tube threaded therethrough. The attachable flow stop arm is operatively coupled to the raised perimeter support adjacent the attachable occlusion arch in a spring-biased fashion such that the aperture in the occlusion arch may be selectively occluded by the flow stop arm.

Abstract: Techniques for modeling therapy fields for therapy delivered by medical devices are described. Each therapy field model is based on a set of therapy parameters and represents where therapy will propagate from the therapy system delivering therapy according to the set of therapy parameters. Therapy field models may be useful in guiding the modification of therapy parameters. As one example, a processor compares an algorithmic model of a therapy field to a reference therapy field and adjusts at least one therapy parameter based on the comparison. As another example, a processor adjusts at least one therapy parameter to increase an operating efficiency of the therapy system while substantially maintaining the modeled therapy field.

Abstract: An autoinjector having a body (1010; 2010) receiving a reservoir, a piston, a needle, an actuating 5 sleeve (1011;2011) having a contact end to contact the body of the user and displaceable relative to the body between projected positions, in which the actuating sleeve at least partially projects out of the body receiving a reservoir, and an actuation position, in which the actuating sleeve is axially displaced towards the interior of the body receiving a reservoir. The actuating sleeve is in a first projected position prior to actuation of the autoinjector and in a second projected position after actuation of the autoinjector. The actuating sleeve or the body receives a reservoir having a flexible tab adapted to deform laterally relative to the actuating sleeve and/or relative to the body receiving a reservoir when the actuating sleeve is displaced from its first projected position towards its actuation position then from its return actuation position towards its second projected position.

Abstract: Provided is a cassette unit suitable for use with an auto-injector having a drive unit. The cassette unit comprises a cassette unit housing defining a cassette unit housing cavity, which is in receipt of a syringe, a rearward entrance to said cavity and a forward needle projection aperture. The cassette unit also comprises in capping relationship with the rearward entrance of the cassette unit housing, a cassette unit end-cap, said cassette unit end-cap defining a drive rod-receiving opening for receipt of a drive rod for providing forward axial drive to said plunger; a biasing element defining a biasing relationship between the cassette unit end-cap and an end flange of the syringe barrel, thereby urging the syringe forwards in relation to the cassette unit end-cap; and a damping element defining a damping relationship between the cassette unit end-cap and the flange of the syringe, thereby acting to damp rearward movement of the syringe relative to the cassette unit end-cap.

Abstract: An auto-injector for administering a dose of a liquid medicament (M) is presented having an elongate case arranged to be held by a user, a tubular chassis telescoped in the case and biased against the case so as to protrude from the case. The injector also includes a syringe with a hollow injection needle, a drive spring and a plunger for forwarding load of the drive spring to a stopper of the syringe. A trigger button is distally arranged in or on the case, wherein the trigger button is initially coupled to the case in a manner to protrude distally from the case and interlocked to the chassis in a manner preventing the trigger button from disengaging the case.

Abstract: The present invention relate to a method and corresponding apparatus for just in time mixing of a solid or powdered formulation and its subsequent delivery to a biological body. In some embodiments, a powdered formulation is maintained in a first chamber of a plurality of chambers. A plurality of electromagnetic actuators are in communication with the plurality of chambers. The actuators, when activated, generate a pressure within at least the first chamber. The pressure results in mixing of the powdered formulation and a diluent in time for delivering into the biological body.

Abstract: An injector includes a trigger mechanism including: a trigger member disposed about an axis having an aperture and a protrusion, and a ram assembly having a ram configured to pressurize a medicament container for expelling a medicament therefrom, the ram assembly further having a trigger engagement member configured to engage the aperture of the trigger member when the trigger member is in a pre-firing condition; an energy source associated with the ram for powering the ram to expel the medicament; and a user-operable firing-initiation member having an aperture engaged with the protrusion of the trigger member and operable for causing an axial translation of the trigger member in a proximal direction from the pre-firing condition to a firing condition in which the trigger engagement member is released from the retaining portion to allow the energy source to fire the ram.

Abstract: The present invention is directed at a dose setting mechanism for a drug delivery device, comprising an outer sleeve and an inner sleeve located at least partially within the outer sleeve wherein the outer sleeve is connected to the inner sleeve. To reduce noise excitations of the dose setting mechanism, at least one intermediate element is at least partially located in a clearance between the inner sleeve and the outer sleeve in such way that it reduces the relative movement of the inner sleeve and the outer sleeve along a play between the inner sleeve and the outer sleeve. The invention is further directed to a pen-type injector equipped with a respective dose setting mechanism.

Abstract: A dose setting mechanism for a drug delivery device is provided comprising a dose setting member and a further element. Maximum dose stop features are provided on a housing and on the further element.

Abstract: An injected dose detection device which includes a housing having a joint surface surrounding an injection device and a through hole formed on the joint surface configured to communicate with an internal part of the housing, a vibration sensor disposed in the internal part of the housing configured to detect at least one vibration signal based on a minimum vibration threshold, a vibration transmitting element positioned directly between the vibration sensor and the injection device and configured to transmit the at least one vibration signal and a processing unit configured to process the at least one vibration signal for generating injected dose information corresponding to the injected dose.

Abstract: An auto-injector comprising an elongate housing containing a syringe. The housing having a an orifice intended to be applied against an injection site. The syringe is slidably arranged with respect to the housing. A spring pushing the needle from a covered position into an advanced position, operating the syringe and covering the needle. An activator arranged to lock the spring prior to manual operation and capable of, upon manual operation, releasing the spring means for injection. A first gear arrangement and a second gear arrangement arranged for converting torque from a first end and a second end of the torsion spring into a translative force. The first end groundable in the housing while the second end acts on a plunger through the second gear arrangement for advancing the needle and supplying the dose.

Abstract: A protective sheath (100) for a cannula (210) arranged on a hub (200) which can be fitted onto a syringe (300), the sheath including female elements intended to cooperate with male elements (201) of the hub (200) for guiding thereof, and characterized in that the female elements include a retracted position before use RBU, a retracted position during use RU, and a retracted position after use RAU, wherein the whole length of the cannula (210) is inside the sheath (100), the female elements further include an ejection position E, wherein whole or part of the cannula (210) protrudes out of the sheath (100), and further characterized in that at least two of the RBU, RU, and RAU positions are substantially transversally aligned.

Abstract: A holder with a safety shield for a drug delivery device; the shield obstructing access to a needle of the drug delivery device following use thereof. The safety shield may be actively deployed, in which case the health care worker must perform an action beyond complete depression of the pusher into the body of the drug delivery device to deploy the shield. Alternatively, the safety shield may be deployed passively or automatically, in which case deployment of the shield occurs upon complete depression of the pusher into the body, with no additional action required of the health care worker. The safety shield is spring-loaded and released to its extended position by a mechanical coupling of a series of position members, including levers, formed on the holder and the drug delivery device.

Abstract: According to the invention, an injection device (D) comprises a pre-filled syringe and a safety device. The pre-filled syringe comprises a barrel with an inner cavity in fluid communication with a hypodermic needle attached to a distal end of the pre-filled syringe and a piston fluid-tightly sealing a proximal end of the inner cavity. The safety device comprises a support body for retaining the pre-filled syringe therein, an outer body operably connected to the piston, a needle shield and a releasable retaining means (R). The retaining means comprises a radial projection and a longitudinal recess adapted to receive the radial projection. The radial projection is connected to or integral part of one of the support body or the outer body and a longitudinal recess formed into the other of the support body or the outer body. The needle shield, the support body and the outer body are telescopable relative to each other.

Abstract: Medical device assemblies having a connection mechanism for securely connecting a hub to fluid storage containers in a luer slip relationship are described. An exemplary medical device includes a hub forming a cavity, a second indicating element disposed within the cavity that engages the hub. Additional features of the medical device include a second indicating element contoured to form a line contact with the hub. In a specific configuration, the hub includes a first indicating element attached to the hub and extending proximally into the cavity having a protrusion. In a more specific configuration, the medical device includes a fluid storage container that has an indication system for visually indicating optimal fluid-tight engagement of the hub and the fluid storage container.

Abstract: A fluid transfer device such as a syringe may include a fluid chamber in communication with a male connector tip. The male connector tip is tapered to form a friction fit when inserted in a corresponding female hub. A disconnecting member, e.g., in the form of a lever member has a front surface moveable along the male connector tip between a first position proximal to the fluid chamber and a second position spaced from the first position towards a distal end of the male connector tip so as to release the friction fit. A catch is arranged to catch the female hub after it has been released from the friction fit by the lever member moving towards the second position. The catch may be released when the lever member pivots back towards the first position under the resilient bias of a spring tongue.

Abstract: A portable vein viewer apparatus may be battery powered and hand-held to reveal patient vasculature information to aid in venipuncture processes. The apparatus comprises a first laser diode emitting infrared light, and a second laser diode emitting only visible wavelengths, wherein vasculature absorbs a portion of the infrared light causing reflection of a contrasted infrared image. A pair of silicon PIN photodiodes, responsive to the contrasted infrared image, causes transmission of a corresponding signal. The signal is processed through circuitry to amplify, sum, and filter the outputted signals, and with the use of an image processing algorithm, the contrasted image is projected onto the patient's skin surface using the second laser diode. Revealed information may comprise vein location, depth, diameter, and degree of certainty of vein locations. Projection of vein images may be a positive or a negative image. Venipuncture needles may be coated to provide visibility in projected images.

Abstract: In laparoscopic surgery, small (5-12 mm diameter) incisions are made in an abdominal wall through which instruments dissect and remove specimens that may be several centimeters in diameter. Removal of a sample typically requires either enlarging these incisions or morcellating the sample to pass through sub-centimeter ports. A laparoscopic device permits extraction of the sample to be removed in a female using a vagina, which has sufficient elasticity to accommodate removal of large specimens. A posterior portion of the vagina communicates to an abdomen through a few tissue layers, and is distant from vital anatomic structures. Utilizing the vagina is optimal due to its ease of access to the abdomen and repair, minimal scarring and post-operative pain, and faster recovery following surgery. A deployable collection bag is housed in a sheath, which is deployed into the vagina or an abdominal cavity to extract a large (multiple-centimeter) specimen(s) through the vagina.

Abstract: A fluid dispenser device comprising: a dose counter for indicating the number of doses that have been dispensed or that remain to be dispensed, said counter comprising: at least one rotary counter element provided with indicator means, such as digits or numbers, and provided with a first set of teeth and with a second set of teeth; a movable actuator element adapted to co-operate with said first set of teeth of said counter element so as to turn it; and anti-return means adapted to co-operate with said second set of teeth so as to prevent said counter element from turning in the direction opposite to the direction that is imposed by said actuator element; said anti-return means comprising a tip that is substantially V-shaped, and that, after each actuation of the counter, co-operates with a respective tooth of said second set of teeth in a blocking position, said tip comprising a first branch that is adapted to co-operate in the blocking position with a blocking shoulder of said tooth, and a second branch tha

Abstract: An inhalation therapy device includes an atomizer for atomizing a drug which is advantageously present in the form of a fluid into an atomization chamber so that an aerosol or mist is provided in the atomization chamber. The patient or user can inhale the aerosol produced by the atomizer from the atomization chamber via a mouthpiece. The ampoule is inserted into an ampoule holder holding the fluid-containing ampoule. The inhalation therapy device also includes an opening unit for opening the fluid-containing ampoule. The ampoule holder advantageously includes a first part, disposed displaceably in relation to the opening unit, thereby allowing an ampoule present in the ampoule holder to be displaced in the direction of the opening unit.

Abstract: A single lumen endobronchial tube for selective mechanical ventilation of the lungs can include a medical tube having a single lumen with an opening at each of opposed distal and proximal ends of the tube, the opening at the proximal end of the tube being adapted for connection to an external mechanical ventilation device, and the opening at the distal end of the tube being adapted for delivery of a medical gas; a wall extending throughout the tube's entire length having an internal wall surface, an external wall surface and a thickness therebetween, a portion of the wall having an aperture and a shaft adapted to house a mechanism for sealing the aperture; a distal bronchial cuff positioned along the external wall surface and adapted to expand radially outward; and at least a first proximal tracheal cuff positioned along the external wall surface and adapted to expand radially outward.

Abstract: The present application discloses a bridle device and a method of placing a bridle on a person using the bridle device. In one exemplary embodiment, the bridle device comprises a retrieval portion and a delivery portion. The delivery portion has a retrieval member and a retrieval magnet attached to the retrieval member. The delivery portion has a delivery member and a delivery magnet that is movable relative to a distal portion of the delivery member. In certain embodiments, the delivery portion has a delivery tube and a delivery magnet attached to a flexible elongated member received in the delivery tube. The delivery magnet is movable relative to a distal portion of the delivery tube and both poles of the delivery magnet are exposed outside of the delivery tube.

Abstract: An improved patient interface assembly and pressure support system integrate a pressure sensor and a valve into the patient interface assembly and employs closed loop control between the sensor and the valve in order to limit delay between the time at which a condition indicative of abnormal breathing or flow load during normal breathing is experienced by a patient and the time at which altered pressure support is received by the patient.

Abstract: The invention relates to a respiratory mask arrangement that can be used in the framework of CPAP therapy for treating sleep-related disturbances, for example. In one embodiment a respiratory mask arrangement comprises a sealing lip device to be placed on the facial surface of a mask user, a covering device which defines a mask interior in cooperation with the sealing lip device, and a respiratory gas conduit unit for delivering respiratory gas to the mask interior that is defined by the covering device and is connected to the nostril and/or oral opening of the mask user. At least some sections of the covering device are embodied as an air-permeable structure.

Abstract: A respiration appliance (10) is configured to entrain the breathing of the subject. The breathing of the subject is entrained to modulate the autonomic nervous system of the subject to decrease sympathetic nerve activity and/or to reduce sympathetic/parasympathetic balance in order to provide relaxation to the subject. The respiration appliance (10) restricts the exhalation of the subject, while permitting substantially unencumbered inhalation, to impact the breathing of the subject in a manner that enhances relaxation.

Abstract: A device for interventional surgical or medical procedures is presented. The device is generally in the form of a balloon and is used to position itself or other working elements up against or through lumen walls in the body. The balloon is comprised of at least two materials of different elastic modulus, which allows for a flexible but relatively non-distensible, unfolding component of the balloon as well as an elastomeric, inflatable component of the balloon. The elastomeric component is fixedly attached to the flexible but relatively non-distensible component and together they form a pressure vessel that can be inflated within the lumens of the body.