Abstract: The invention relates to a gas regulating valve (1) for a respiratory system comprising:—a main path between an inlet (2) and an outlet (3), and—an evacuation path between the outlet (3) and an evacuation orifice (4), characterised in that:—the main path is provided with at least a non-return valve for preventing gas to circulate from the outlet (3) to the inlet (2), and—the evacuation path is provided with an obstructing membrane (10) arranged and designed for being deformed by gas from the inlet (2) to partially or fully obstruct the evacuation path. The invention also relates to a mask integrating such gas regulating valve, and to a respiratory system also comprising such gas regulating valve.

Abstract: A CPAP apparatus for supplying pressurized breathable gas to a patient includes a blower device including an electric motor, an impeller driven by the motor, and a housing to receive the motor and the impeller, a housing element that defines a blower receiving chamber to receive the blower device, and a suspension device to elastically support the blower device within the chamber of the housing element. The suspension device includes at least one elastic support chamber coupled to both the blower device and the housing element.

Abstract: A process is provided for operating a respirator and/or anesthesia device in the APRV mode with at least one pressure release phase with the step of setting a first point in time for terminating the pressure release phase. The process includes measuring the electrical impedance and/or impedance change of the lungs and setting the first point in time such that the measured impedance and/or impedance change are taken into account. A device is provided for carrying out the process according to the present invention.

Abstract: This disclosure describes systems and methods for providing novel back-up ventilation that allows the patient to trigger or initiate the delivery of breath. Further, this disclosure describes systems and methods for triggering ventilation when base flow and/or inspiratory flow is unknown or indeterminable by the ventilator.

Abstract: Described are systems and methods for compensating long term sensitivity drift of catalytic type electrochemical gas sensors used in systems for delivering therapeutic nitric oxide (NO) gas to a patient by compensating for drift that may be specific to the sensors atypical use in systems for delivering therapeutic nitric oxide gas to a patient. The long term sensitivity drift of catalytic type electrochemical gas sensors may be addressed using calibration schedules, which can factor in the absolute change in set dose of NO being delivered to the patient that can drive one or more baseline calibrations. The calibration schedules can be used to reduce the amount of times the sensor goes offline.

Abstract: An apparatus, for assisted ventilation (1), includes at least one ventilatory device (2) connected to and controlled by a driver (3), and at least one sensor device (4) connected to the driver (3) and adapted to provide it with a signal of electrical activity produced by the diaphragm. The apparatus further includes at least one calculation device (5) connected to the driver (3), to the sensor device (4) and to the ventilatory device (2), the calculation device (5) receiving from the sensor device (4) a signal of diaphragmatic activity (Eadi) and from the ventilatory device (2) a ventilatory pressure signal (Paw) and providing the driver (3) with calibration parameters (Cal) calculated on the basis of a signal of diaphragmatic electrical activity (Eadi*) and a ventilatory pressure signal (Paw*) upon switching-off said ventilatory device (2) so as to cause an expiratory pause.

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: The embodiments of the present tracheostomy valves include a flexible diaphragm abutting a rib shaped substantially as a flat plate. Opposite the rib, the diaphragm abuts a boss and forms an uninterrupted seal therewith. As the tracheostomized patient inhales, the diaphragm bends about the rib, interrupting the seal and allowing air to flow smoothly into the valve. The features of the various embodiments contribute to a positive seal at all times except during inhalation, and low resistance to airflow through the valve during inhalation.

Abstract: A medical tubing holder system includes a connector, a holding assembly and a retainer block. The holding assembly has an arm, and optional flanges to capture part of medical tubing, such as an endotracheal tube. The retainer block is distal from the holding assembly. The retainer block defines an aperture that receives a tube therein. The aperture is smaller than a tube flange placed between the block and the holding assembly, so as to capture the tube flange. An attachment element joins the holding assembly to the retainer block, and has length that is adjustable to selectively vary a distance between the block and the holding assembly. The attachment element effectively secures the retainer block, holding the tube flange, to the holding assembly and connector, which is secured to the patient's head, to prevent self or accidental extubation. A related method is provided.

Abstract: A respiratory mask for use with a patient, and that is suited for use with children, includes a flexible cushion arranged to interface with and deliver air to the patient's nose. The cushion has a tube connection portion at one or both sides adjacent the patient's nares, the tube connection portion being arranged to connect to an air delivery tube. This location, plus the very low profile of the mask, allows a patient (e.g. an infant) to sleep on their face more comfortably. A more rigid support structure adjacent the cushion is provided to stabilize the cushion and prevent it from collapsing. Headgear is also provided and arranged for releasable attachment to the support structure.

Abstract: A cushion (26) for a patient interface device includes a support wall portion and a sealing flap (40) extending in inwardly from the support wall portion and toward a longitudinal axis of the cushion. The sealing flap has a distal edge (44)which defines an opening (46) in the sealing flap. The opening extends from the nose bridge to the upper lip and is created by two planes (hinged nearer the upper lip) that intersect at a large angle (e.g., 90 degrees to 150 degrees) near the upper lip.

Abstract: A full face mask made of cloth having a nasal portion, an oral portion and transition portions is disclosed. The nasal and oral portions are made of a cloth that is impermeable to air and have nasal and oral interfaces on them to facilitate a seal with a user's face. The transition portions have easy removal clips for the lower headgear straps and sealing assistance members for better sealing.

Abstract: An elbow assembly for a mask system includes an elbow including a slot and a port, an anti-asphyxia valve adapted to be received within the slot and including a flap portion adapted to selectively close the port depending on the presence of pressurized gas, and a support member to secure the anti-asphyxia valve to the elbow. The support member includes a slot that is adapted to interlock with a protrusion provided to the anti-asphyxia valve.

Abstract: A respiratory treatment device comprising at least one chamber, a chamber inlet configured to receive exhaled air into the at least one chamber, at least one chamber outlet configured to permit exhaled air to exit the at least one chamber, and an exhalation flow path defined between the chamber inlet and the at least one chamber outlet. A restrictor member positioned in the exhalation flow path is moveable between a closed position, where a flow of exhaled air along the exhalation flow path is restricted, and an open position, where the flow of exhaled air along the exhalation flow path is less restricted. A vane in fluid communication with the exhalation flow path is operatively connected to the restrictor member and is configured to reciprocate between a first position and a second position in response to the flow of exhaled air along the exhalation flow path.

Abstract: Introduced are methods and systems for: gathering human biological signals, such as heart rate, breathing rate, or temperature; analyzing the gathered human biological signals; and controlling home appliances based on the analysis.

Abstract: Apparatus and methods for deactivating renal nerves extending along a renal artery of a mammalian subject to treat hypertension and related conditions. An ultrasonic transducer (30) is inserted into the renal artery (10) as, for example, by advancing the distal end of a catheter (18) bearing the transducer into the renal artery. The ultrasonic transducer emits unfocused ultrasound so as to heat tissues throughout a relatively large impact volume (11) as, for example, at least about 0.5 cm3 encompassing the renal artery to a temperature sufficient to inactivate nerve conduction but insufficient to cause rapid ablation or necrosis of the tissues. The treatment can be performed without locating or focusing on individual renal nerves.

Abstract: An elongated medical device with a modified drive surface for use with the driving mechanism of a robotic system. The elongated medical device has a distal portion configured to navigate the lumen of a human body channel and a proximate portion with a surface different from that of the distal portion and adapted to better interact with the driving mechanism than the surface of the distal portion.

Abstract: The invention relates to a catheter device, having a catheter (1), an actuation device (8) at a first end of the catheter and also a mechanical transmission element (9, 10) for transmitting a movement along the catheter to the actuation device, the actuation device having a coupling element (14) which is connected to the transmission element (9, 10) and can be actuated by the latter relative to the longitudinal direction of the catheter in a first degree of freedom, and also a conversion element (15) which can be actuated by the coupling element and which converts the actuation movement at least partially into a movement in a second degree of freedom. As a result, a combined movement at the distal end of the catheter can be produced particularly simply for compression and release of a functional element.

Abstract: A two-piece catheter securement system has a fixation pad with an adhesive undersurface and an antimicrobial flap. On an upper surface of the pad are cooperative first attachment members. An upper capture and retention shell has an outer shell wall. The first and second ends of the shell may have a plurality of slots for capturing and retaining administration and catheter tubing. The shell has an inner shell ceiling having a plurality of spaced apart second attachment members thereon. The first and second attachment members are aligned to cooperatively engage when the shell is urged into releasable engagement with the pad with the slots capturing and retaining the tubes.

Abstract: A camera system (1) for monitoring the inside of a body (1), includes: a camera support tube (13) of which one end part (13a) is inserted into the body; a camera unit (11) which joins with the support tube inside the body; a camera side cable (12) which is connected to the camera unit, and is drawn out toward the outside of the body through the camera support tube; a control system (3) which includes at least a display (18); and a string-like member (38) which directly or indirectly fixes the camera support tube to the body surface.

Abstract: A method of making a flexible medical article or tube, for example, a sheath for a vascular access device, is provided. The method can include extruding a polymer, for example, a polycarbonate-urethane copolymer, to form a tube and annealing the extruded polymer. The method can further include cutting the extruded tube to a desired length before or after annealing, flaring one end of the annealed tube and over-molding the flared portion onto a hub, and forming the other end of the tube into a tip. A sheath formed by such a method is also provided.

Abstract: A winged injection needle including an injection needle main body, a base that supports the base end of the injection needle main body and wings that protrude from the base toward the left and right sides to function as handles, the wings being constructed with plate members that are freely foldable through hinge sections so that in the folded state, they protrude from the base toward the left and right sides to function as handles, while in the expanded state, they extend from the base along the injection needle main body toward the leading edge of the injection needle to function as a safety cover that covers the injection needle main body.

Abstract: An introducer sheath includes an inner liner having a passageway extending longitudinally therethrough, a coil positioned over the inner liner, and an outer jacket positioned over the liner and the coil. The outer jacket is bonded to the inner liner between the coil turns. The coil turns have a cross-section comprising opposing end portions, and a center portion disposed between the opposing end portions. The center portion has a thickness not exceeding about one-third of a thickness of the end portions for reducing a bending modulus of the coil, and the end portions have a generally curved outer surface. At least a distal end portion of the outer jacket has a durometer between about 70 and 90 on the Shore D scale.

Abstract: Computerized oral prescription administration (COPA) devices, systems, and methods are provided. In one embodiment, a substance dispensing apparatus, comprising a mouthpiece having a recess customized to match with an intended user's unique dentition; a user verification mechanism configured to determine whether the intended user's unique dentition is positioned within the recess; and an actuator coupled to the mouthpiece and in communication with the user verification mechanism, the actuator configured to dispense a substance from a reservoir coupled to the mouthpiece in response to the user verification mechanism determining that the intended user's unique dentition is positioned within the recess.

Abstract: Implantable infusion devices configured to improve fill and evacuation procedures.

Abstract: A coupling assembly for securing an end of a tube to a connecting shaft of a device is provided. The coupling assembly comprises an inner sleeve having a first end, an opposite second end, a first end section at the first end and a second end section at the second end, and an outer sleeve having a first end, an opposite second end and a second end section at the second end. The second end section of the outer sleeve is sized and shaped to receive at least the first end section of the inner sleeve therein. An interior surface of the second end section of the outer sleeve is provided with a protrusion or a recess to engage a corresponding recess or protrusion on an exterior surface of the inner sleeve. The second end section of the inner sleeve is flexible.

Abstract: A bi-directional cannula for perfusing blood in two directions. The cannula has a distal opening in fluid communication with a cannula first lumen. The cannula has a secondary opening proximal of the distal opening, and may include a movable tubular extension selectively extendable from the cannula via the secondary opening. The tubular extension may be in fluid connection with the cannula first lumen and/or a cannula second lumen. The tubular extension may have distal and/or side openings, with the openings providing antegrade fluid perfusion. The cannula second lumen may be separate from the first lumen, so that perfusion can be selectively provided to just the cannula distal opening, just the secondary opening/tubular extension, or simultaneously to both the distal opening and secondary opening/tubular extension.

Abstract: The electrode set for a stimulation device, such as a TENS or EMS stimulation device comprises at least a plurality of neighboring electrically active zones close to each other said active zones forming a succession of poles of alternating polarity or being grouped to form groups of poles of alternating polarity, wherein at least one of said active zone or group of zones has a lateral size (D2) of approximately 1 mm to 40 mm, wherein at least one of spacing (D1) between neighboring active zones or groups of zones is approximately of 1 mm to 40 mm, and said set further comprises contacting means connected to said active zones or groups of active zones.

Abstract: An implantable medical therapy delivery device includes a non-conductive filament extending along a length of an outer surface of an insulative body of the device, wherein the filament includes a plurality of fixation projections and is secured to the outer surface of the insulative body such that the projections protrude outward from the outer surface and are spaced apart from one another along the length of the outer surface. The filament may be wound about the length with an open pitch. In some cases, the insulative body includes an open-work member forming at least a portion of the outer surface thereof, and the filament may be interlaced with the open-work member. In these cases, the filament may be bioabsorbable, for example, to provide only acute fixation via the projections thereof, while the open-work member provides a structure for tissue ingrowth and, thus, more permanent or chronic fixation.

Abstract: A system of implanting electrode leads for restoring muscle function to the lumbar spine to treat low back pain is provided. The system provides efficient implantation of the leads, including the ability to verify deployment of anchoring mechanisms on the lead using an impedance assessment, such that the implanted lead may be secured within the patient and used to restore muscle function of local segmental muscles associated with the lumbar spine stabilization system.

Abstract: One aspect of the present disclosure relates to lead assemblies for stimulating tissue. The lead assemblies can include lead bodies that are slidably coupled to each other and include one or more contacts that are moveably disposed within the slits of the lead bodies. The positions of the one or more contacts can be adjusted to change the direction of stimulation. For example, the positions of the one or more contacts can be adjusted based on theoretically-optimal positions determined from a patient-specific computer model. Parameters of the stimulation applied by the one or more contacts can also be optimized based on the patient-specific computer model.

Abstract: A device includes a housing configured to be implanted in a patient. The device also includes a first magnetic field direction sensor located at a first location within the housing and configured to generate a signal representative of a first direction of a magnetic field at the first location, a second magnetic field direction sensor located at a second location within the housing and configured to generate a signal representative of a second direction of the magnetic field at the second location, and a magnetic field strength sensor configured to generate a signal representative of a strength of the magnetic field. The device further includes a control module configured to identify a source of the magnetic field based on at least one of the signal representative of the strength of the magnetic field and the signals representative of the first and second directions of the magnetic field.

Abstract: A cosmetic device 10 for performing iontophoresis on the skin 40 of a human, includes carbon sheet electrodes 33A and 33B to be mounted on the skin 40 of the human, and provides an electric signal to the carbon sheet electrodes 33A and 33B, the electric signal being obtained by superimposing an AC signal and a high-frequency signal that has a frequency higher than a frequency of the AC signal while setting a position to which the high-frequency signal is superimposed at a polar region of the AC signal that does not contribute to the iontophoresis.

Abstract: A system and method for preventing the undesirable dissipation of charge throughout a tissue surface while maintaining the charge density at a desired tissue treatment site. The invention embodies a physical perimeter conductor positioned in proximity to a tissue surface and a conductance control circuit working in combination to collect surface charge applied within the confines of the perimeter conductor and to maintain a desired relationship between the contained surface charge density and time.

Abstract: A system for providing non-invasive neuromodulation to a patient includes a mouthpiece and a controller. The mouthpiece includes an elongated housing, a printed circuit board, control circuitry mounted within the elongated housing, and a cable for connecting to a controller. The controller includes an elongated u-shaped element, an electronic receptacle, and a microcontroller. A method for providing non-invasive neurorehabilitation of a patient including connecting a mouthpiece to a controller, transmitting a numeric sequence to the mouthpiece, generating a first hash code, transmitting the first hash code to the controller, generating a second hash code, comparing the second hash code with the first hash code, enabling electrical communication between the mouthpiece and the controller only if the first hash code matches the second hash code, contacting the mouthpiece with the patient's intraoral cavity, and delivering neurostimulation to the patient's intraoral cavity.

Abstract: A method for providing electrical stimulation to a user, the method comprising: providing an electrical stimulation device, in communication with a controller, at a head region of the user; with the electrical stimulation device, providing a stimulation treatment having a waveform configured for neuromodulation in the user; with the controller, performing an adjustment to the stimulation treatment, wherein performing the adjustment includes: generating a transformed waveform with application of a transfer function to the waveform, wherein the transfer function scales the waveform and selectively attenuates extreme waveform values while maintaining a frequency characteristic of the waveform in the transformed waveform; and applying the transformed waveform with the electrical stimulation device, thereby modulating the stimulation treatment.

Abstract: A universal implant for an implantable medical device, the universal implant including a plurality of functional components, having a plurality of hardware components disposed in a housing, and an auxiliary component interface disposed in a surface of the housing and configured to electrically connect any one of a plurality of auxiliary components to said hardware components. The universal implant further includes a determinator configured to identify one or more of the auxiliary components, select one or more of said functional components based on the identified auxiliary components, and adapt said selected functional components for operation with the identified auxiliary components.

Abstract: A multiple output current stimulator circuit with fast turn on time is described. At least one pair of input side and output side transistors is arranged in a current mirror connected to a supply transistor by cascode coupling. The output side transistor supplies stimulation current to an electrode in contact with tissue. An operational amplifier connected to a reference voltage and to the output side transistor drives the supply transistor to maintain the voltage at the output side transistor equal to the reference voltage. The at least one pair of transistors includes multiple pairs of transistors whose output side transistors drive respective electrodes with stimulation currents. The stimulator determines the initiation and duration of stimulation current pulses supplied to each electrode. At circuit activation, large currents are generated which discharge capacitances in the output side transistors causing rapid output side transistor turn on.

Abstract: The present disclosure provides a grip sensor for quantifying pain experienced by a patient during spinal cord stimulation (SCS). The grip sensor includes an electronics enclosure, an annular outer shell substantially surrounding the electronics enclosure and sized to be held by the patient, a pressure sensor embedded in the outer shell and communicatively coupled to the electronics enclosure, the pressure sensor configured to measure a grip strength of the patient as SCS is applied to the patient, and a plurality of galvanic skin response sensors communicatively coupled to the electronics enclosure and configured to measure an electrical impedance of the skin of the patient as SCS is applied to the patient.

Abstract: One system includes a stimulation device such as a vagus nerve stimulation lead, and a controller for controlling the stimulation device according to a set of stimulation parameters. A memory of the stimulation device contains a state transition model, and for each state defines a set of stimulation parameters and at least one expected response during the application of stimulation with the parameters. A matrix determines the transition rules between states based on physiological levels measured versus target levels. A state transition control unit determines, in an organized timely method, possible transitions between states according to the rules on physiological levels obtained in response to the implementation of the stimulation parameters of the current state, and a transition from a current state to a new state causes a corresponding change in the parameter set used for stimulation.

Abstract: A method for defining connections between a plurality of lead bodies and a plurality of output ports of a neurostimulator, and an external control device for performing the method are disclosed. The external control device includes a user interface and control circuitry. The method includes displaying the lead bodies and the output ports of the neurostimulator; selecting a first one of the lead bodies; dragging a connector from the first lead body to a first one of the output ports of the neurostimulator; and dropping the connector onto the first output port of the neurostimulator, thereby defining a connection between the first lead body and the first output port of the neurostimulator. In another embodiment, a method includes defining the connection between the first lead body and the first output port, and graphically displaying the connection between the first lead body and the first output port of the neurostimulator.

Abstract: A neuromodulation system comprises a plurality of electrical terminals configured for being respectively coupled to electrodes, modulation output circuitry configured for respectively outputting a plurality of individual electrical pulse trains in a plurality of timing channels to the electrical terminals, wherein each of the timing channels prevents the respective pulse train from having a specific characteristic, and control circuitry configured for controlling the modulation output circuitry in a manner that outputs the pulse trains to a common set of the electrical terminals, thereby creating a combined electrical pulse train at the common set of electrical terminals that has the specific characteristic. A method of providing therapy to a patient comprises delivering a plurality of electrical pulse trains respectively in a plurality of timing channels to a common set of electrodes implanted within the patient, thereby creating a combined electrical pulse train at the common set of electrical terminals.

Abstract: A medical device system including at least a first implantable medical device and a second implantable medical device is configured to establish by a control module of the first implantable medical device whether the second implantable medical device is present in a patient and self-configure an operating mode of the control module in response to establishing that the second implantable medical device is present.

Abstract: The present disclosure relates to cardiac evoked response detection and, more particularly, reducing polarization effects in order to detect an evoked response following delivery of a stimulation pulse. An implantable medical device (IMD) is configured to deliver a ventricular pacing pulse. A signal is sensed in response to the ventricular pacing stimulus. A window is placed over the sensed signal to obtain a set of data from the signal after a paced event. The set of data extracted from the sensed signal comprises a maximum amplitude, a maximum time associated with the maximum amplitude, a minimum amplitude, and a minimum time associated with the minimum amplitude. Responsive to processing the extracted data, the window is delayed to avoid polarization effects. A determination is then made as to whether the ventricular pacing stimulus is capturing the paced ventricle in response to determining whether the maximum time is greater than the minimum time.

Abstract: An implantable medical device that includes electrical circuitry for providing a therapy to a patient. The device also includes a housing forming an inner chamber that is adapted for receiving, at least a portion of the electrical circuitry. The device further includes a thermally conductive material that is configured to disperse heat from a first portion of the implantable medical device that is located in proximity to a heat generating component of the electrical circuitry, to a second portion of the implantable medical device that is not located in proximity to said heat generating component. The thermally conductive material is a discrete component separate from the electrical circuitry and the housing.

Abstract: A controller-transmitter transmits acoustic energy through the body to an implanted acoustic receiver-stimulator. The receiver-stimulator converts the acoustic energy into electrical energy and delivers the electrical energy to tissue using an electrode assembly. The receiver-stimulator limits the output voltage delivered to the tissue to a predetermined maximum output voltage. In the presence of interfering acoustic energy sources output voltages are thereby limited prior to being delivered to the tissue. Furthermore, the controller-transmitter estimates the output voltage that is delivered to the tissue by the implanted receiver-stimulator. The controller-transmitter measures a query spike voltage resulting from the electrical energy delivered to the tissue by the receiver-stimulator, and computes a ratio of the predetermined maximum output voltage and a maximum query spike voltage. The maximum query spike voltage is computed by detecting a query spike voltage plateau.

Abstract: Among other things, in general, an acousto-mechanical transducer for the interconversion of electricity and acoustic waves is described. Methods are also described for the construction of such transducers.

Abstract: An external defibrillator can have a synchronous shock operating mode and an asynchronous shock operating mode and include a controller to set the defibrillator in the synchronous shock operating mode or the asynchronous shock operating mode. The defibrillator can also include a shock module to cause the defibrillator to deliver shock therapy to the patient according to the operating mode of the defibrillator, and a prompt module to transmit a prompt, after delivery of the shock therapy, that includes the operating mode of the defibrillator.

Abstract: The defibrillator may include a heart rhythm detector to detect the heart rhythm of a patient, a manual mode controller structured to set the defibrillator in a synchronous shock operating mode or an asynchronous shock operating mode depending on an input from a human operator, a shock module to cause the defibrillator to deliver a shock to the patient according to the operating mode, and an automatic mode controller structured to, after the shock module has delivered the shock to the patient, set the external defibrillator to the synchronous shock operating mode or the asynchronous shock operating mode depending on the detected heart rhythm of the patient and without input from the human operator.

Abstract: Appropriate cardiac therapy is determined by data sensed and analyzed by the disclosed defibrillators and other medical devices that one or both of treat and monitor a patient. The disclosed devices sense various patient physiological parameters including patient pulse and breathing data to determine whether the patient has a pulse and to determine if the patient is breathing. Depending on the analysis of the generated patient physiological data, the disclosed devices determine the appropriate therapy for the patient, which can include providing breathing assistance to the patient and providing electrotherapy and other therapies to the patient. Some of the disclosed medical devices can be wearable by the patient. The disclosed devices can include therapy modules like electrotherapy for delivering therapies to the patient while other devices monitor but do not deliver the therapies to the patient.