Abstract: A patient interface device (8) structured to engage a patient's sub-nasal area is provided and includes a body (22), a cushion (50) and a custom cushion support assembly (100). Patient interface device body includes a sidewall (27) with an upper side (32) including a number of passages (40).Cushion includes a resilient body (52). Cushion body is disposed on patient interface device body. Patient interface device cushion body includes an engagement portion (60) structured to engage a patient's sub-nasal area, and a pocket (70) disposed under cushion body engagement portion. Custom cushion support assembly includes a body (102) with an upper surface (104) including a custom contour (110). Custom cushion support assembly body is disposed in patient interface device cushion body pocket. In this configuration, custom contour deforms patient interface device cushion body engagement portion to correspond to patient's sub-nasal area.

Abstract: A respiratory device for dispensing medication provided comprising a mask for covering a patient's mouth and/or nose, a medication dispenser for housing medication to be received by a patient upon activation of a button via depression of a lever coupled to a spacer body of the an interactive spacer. The button located on the dispenser. The interactive spacer eccentrically located and spacing the mask from the medication dispenser, the spacer comprises a power supply end an interactive controller for providing at least one of sound and light upon activation of first switch located on the device.

Abstract: A medical device sealing system for use with a positive pressure ventilation mask and a nasal cannula. The system includes a plurality of sealing elements. The sealing elements include an opening sized to receive a nasal cannula. The sealing elements are spaced apart a distance sufficient to cause the sealing elements to engage the edges of a mask and to form a seal between the edges of a mask and a patient.

Abstract: A seal device or gasket assembly usable with respiration or ventilation mask systems and that is preferably at least one of adhesive or deformable. The gasket is disposed between the mask and the wearer and reduces the escape of respiration gases between the perimeter edge interface of the mask with the anatomy of the wearer and limits exposure of the epidermis located within the perimeter of the mask and between the mask and the wearer to the respiration gas flows. The mask system is particularly useful for improving communication of the respiration gases for those wearers having facial hair, abnormal dontia, and/or other abnormal facial features.

Abstract: A fluid connector between patient interface and a respiratory therapy device and a vent adaptor for a respiratory pressure therapy system. The fluid connector comprising two parts, the first of which includes a seal and a latching portion and the second a complementary latching portion configured to engage the former to provide a fluid flow patch between the two parts. The vent adaptor comprising a vent assembly comprising a vent housing and an annular plate including an array of holes to discharge the pressurised gas to atmosphere and an deformable membrane which presses against the annular plate.

Abstract: A method, system and apparatus for assessing the coupling between lung perfusion and ventilation in a patient who is mechanically ventilated or who is breathing spontaneously through a conventional artificial airway is provided. Embodiments of the apparatus comprise an adaptor configured to fit between the artificial airway and mechanical ventilator, a measuring chamber in constant fluid communication with the adaptor via one or more measuring chamber sampling ports, and a monitoring unit where data obtained from temperature and relative humidity sensors located in the measuring is calibrated, sampled, logged and analyzed together with anthropometric patient data to display a coupling index Qi and to enable ongoing diagnostic cardio-pulmonary monitoring of a patient by comparing changes in the patient's index during a monitoring interval.

Abstract: A wearable health and lifestyle device including at least a measurement module configured to be worn by a user in at least a first wearing position, the measurement module comprising a 3-axis accelerometer unit configured to provide acceleration data and inclination data, a temperature measurement unit configured to provide temperature data, a light radiation measurement unit configured to provide light radiation data, said light radiation measurement unit comprising at least one multi-spectral sensor configured to measure wavelength bands over the range 290 nm to 1150 nm, a storage module configured to receive and store said acceleration data, said inclination data, said temperature data and said light radiation data, and an analysis module configured to analyze a data set comprising acceleration data, inclination data, temperature data and light radiation data.

Abstract: A distal end portion of an elongate shaft member of a catheter may be inserted into liquid within a vessel. While the distal end portion of the elongate shaft member is inserted in the liquid in the vessel, a manipulable portion of the catheter system may be manipulated within the liquid to remove undesired fluid therefrom. The liquid may be pressurized to cause the liquid to flow into a lumen of the elongate shaft member from the distal end of the elongate shaft member at least toward the proximal end of the elongate shaft member to flush undesirable fluid from the lumen. The distal end portion of the elongate shaft member of the catheter may be inserted into the liquid within the vessel while at least the elongate shaft member is in a substantially horizontal orientation.

Abstract: A urine collection catheter is provided. The catheter includes: a conduit having an open distal end; a drainage tube positioned at least partially within the conduit; and a bladder superior wall support. The drainage tube includes one or more fluid ports or perforations for permitting fluid flow into a drainage lumen defined by the drainage tube. The bladder superior wall support includes a support cap and a plurality of support members extending from a proximal surface of the support cap through the open distal end of the conduit. The support cap is capable of being moved between a retracted position and a deployed position. In the deployed position, the distal end of the drainage tube is spaced apart from the support cap, such that the support cap supports portions of the superior wall of the bladder from occluding the one or more fluid ports or perforations of the drainage tube.

Abstract: A system for deploying a device includes an elongated flexible instrument (108) and a shape sensing system (104) coupled to the flexible instrument. A hub (106) includes a shape profile configured to receive and maintain the flexible instrument with the shape sensing system therein. The shape profile includes a shape to track a position or a rotation of the hub relative to a reference position using the shape sensing system. The hub is configured to be coupled to a deployable device (102) such that a change in the position or rotation of the hub indicates a corresponding change in the deployable device.

Abstract: A treatment method involves introducing a catheter into a blood vessel in an arm of the patient and is advanced to position the distal end of the catheter in a blood vessel in a lower limb on one side of the patient's body. A treatment device is inserted into the catheter and advanced to a treatment target in the lower limb on the one side of the patient's body. The catheter is then moved to shift the distal end of the catheter from the blood vessel in the lower limb on the one side of the patient's body to a blood vessel in the lower limb on the other side of the patient's body. A treatment instrument can then be introduced into the catheter and advanced to carry out treatment on a treatment target in the lower limb on the other side of the patient's body.

Abstract: Disclosed embodiments enable equipment and methodologies that improve diagnosis and treatment of patients with severe traumatic brain injuries who do not have ready access to surgical theaters

Abstract: Medical systems are disclosed which may include an elongate shaft member and a plurality of steering lines operable to cause bending of the elongate shaft member via movement of at least one of the steering lines. A respective second end portion of a first proximal steering line may terminate at a first proximal termination portion of the elongate shaft member, and a respective second end portion of the first distal steering line may terminate at a first distal termination portion of the elongate shaft member. The elongate shaft member may be formed of materials of different hardness to provide preferential bending in desired directions.

Abstract: In various examples, a system includes a steerable medical device including a handle including a longitudinal axis. An elongate shaft extends distally from the handle. The elongate shaft includes a distal tip and a lumen through the elongate shaft. At least four pullwires are disposed within the handle and extending to and anchored proximate the distal tip of the elongate shaft. At least two actuators are associated with the handle. The at least two actuators are operably coupled to the at least four pullwires with actuation of the first actuator causing tension in the first or second pullwire to deflect the distal tip in a first or second tip direction, respectively, and actuation of the second actuator causing tension in the third or fourth pullwire to deflect the distal tip in a third or fourth tip direction, respectively.

Abstract: The present invention pertains to a device for securing a medical implement to the body of a patient. The device preferably comprises a base having a locking device and an articulation strap connected to a cover. The cover further comprises a gear rack, where the gear rack is insertable into the locking device. The base further comprises a top surface with an adhesive film and release paper and a bottom surface attached to a patient attachment member. The base also has a cutout section. The base is preferably sloped at an angle between five and ten degrees. The cover preferably has at least two living hinges and the articulation strap has at least two living hinges. The locking device further comprises a sliding surface.

Abstract: A temporary low profile intraluminal catheter for infusing agents into, or extracting fluids from, a bodily lumen comprising securement means, wherein said securement means allows said catheter to be placed with minimal intrusion into said bodily lumen is disclosed. With such design affording a more efficient, verifiable placement of said catheter with less complication due to infection and biofilm related issues, among other types of complications.

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 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: In general, medical sheath systems that include a curved support sheath are described. In one embodiment, the support sheath includes a curved tube includes a distal portion fixed in an orientation perpendicular to the proximal end during advancement of an interventional tool through the support sheath.

Abstract: An apparatus includes a proximal coil, a distal potion, a navigation sensor, and a communication wire. The proximal coil is formed by a wire wrapped in a helical configuration. The proximal coil is flexible. The distal portion is positioned at a distal end of the proximal coil. The distal portion is non-extensible. The distal portion may be formed by a rigid tube. The distal portion may alternatively be formed by a soldered region of the proximal coil. The navigation sensor is located within the distal portion. The navigation sensor is configured to generate signals in response to movement within an electromagnetic field. The communication wire is in electrical communication with the navigation sensor such that the communication wire is configured to communicate signals from the navigation sensor.

Abstract: A non-compliant medical balloon comprises a base balloon including a pair of spaced-apart, generally conical end sections and a generally cylindrical center section connected therebetween. A braided fabric sleeve surrounds at least a portion of the base balloon, wherein the sleeve is formed of at least three substantially inelastic fibers intertwined in such a way that no two of the three fibers are twisted exclusively around one another. The sleeve is permanently affixed to the outer surface of the base balloon so as to prevent excessive expansion of the base balloon when the base balloon is internally pressurized.

Abstract: A system for endoscopic surgery within a body lumen of a patient including a flexible catheter having an expandable balloon at a distal portion and an access opening. The expandable balloon is expandable from a collapsed insertion configuration to an expanded configuration to provide an expanded chamber on a first side of the catheter. The access opening provides a window to access target tissue. The catheter includes a lumen dimensioned to receive an endoscopic instrument therethrough such that a distal end of the endoscopic instrument is positionable within the expanded chamber and angled laterally within the expanded chamber to access the target tissue through the window.

Abstract: Methods for treating hydrocephalus using a shunt, the shunt having one or more CSF intake openings in a distal portion, a valve disposed in a proximal portion of the shunt, and a lumen extending between the one or more CSF intake openings and the valve, the method comprises deploying the shunt in a body of a patient so that the distal portion of the shunt is at least partially disposed within a CP angle cistern, a body of the shunt is at least partially disposed within an IPS of the patient, and the proximal portion of the shunt is at least partially disposed within or proximate to a JV of the patient, wherein, after deployment of the shunt, CSF flows from the CP angle cistern to the JV via the shunt lumen at a flow rate in a range of 5 ml per hour to 15 ml per hour.

Abstract: A method and apparatus to deliver biological altering substances through body cavities including ears, nose, mouth, anus and vagina, utilizing at least osmotic, olfactory and inhaling transfusion of active ingredients includes a first reservoir configured to be disposed against sublingual surfaces and hold a first drug. The device is configured to transmit the first drug through sublingual surfaces into the bloodstream. A second reservoir, coupled to the first reservoir, is disposed below a nostril, and configured to hold a substance and transmit the substance into air passing from the exterior of the nostril into the nasal cavity.

Abstract: A wearable device for administering a pharmaceutical has a housing, a heart monitor disposed in the housing, a microprocessor connected to the heart monitor, a receptacle for holding a pharmaceutical disposed in the housing, the receptacle being in communication with a conduit leading out of the housing, an actuator connected to the receptacle and being configured to release the contents of the receptacle into the conduit upon a command from the microprocessor, and a power source disposed in the base body and being configured to power the microprocessor, the heart monitor and the actuator. The microprocessor is programmed to actuate the actuator to release the contents of the receptacle when a heart rate measured by the heart monitor falls outside a preprogrammed range.

Abstract: A system for integrating an antibacterial-element receptacle into an autoinjector cap facilitates the pre-injection treatment, the post-injection treatment, and prevents the accidental delivery of the injection. The system includes a cap assembly, an autoinjector body, and an antiseptic-soaked dressing. The cap assembly encloses the needle of the autoinjector and prevents the accidental trigger of the injection mechanism. The autoinjector body refers to the body of any conventional autoinjector. The antiseptic-soaked dressing is applied to the patient's skin prior to the delivery of the injection to disinfect and sterilize the injection area. The antiseptic-soaked dressing is housed in the cap assembly, between a receptacle and a removable cover. The removable is releasably mounted to the receptacle to allow access to the antiseptic-soaked dressing.

Abstract: An apparatus for delivering an active ingredient into the skin of an animal at a defined depth, the apparatus including: a microprojection array including a plurality of microprojections having a density of at least 2,000 projections per cm2; and an applicator that drives the microprojection array towards the skin in use so that the microprojection array impacts on the skin with a mass-to-velocity ratio of between 0.0005 g/m/s and 0.1 g/m/s per cm2.

Abstract: An applicator for a skin care product is provided, together with a cosmetic skin care product comprising an applicator and a skin care composition, and a method of using the applicator to regulate a skin condition. The applicator has a substrate with a magnetic array printed thereon, the magnetic array having at least one layer of one or more dipolar pairs of alternating magnetic poles. The applicator further has a vibration source. The magnetic field strength generated by the magnetic array is at its maximum at the poles. When activated, the vibration source causes side to side movement of the applicator, meaning that the full magnetic field is experienced by all diamagnetic materials to which the applicator is applied.

Abstract: According to embodiments of the present invention, a subcutaneous implant delivery apparatus is provided. The apparatus includes a receiving portion configured to receive a subcutaneous implantable device; and a stabilizing portion configured to cooperate with the receiving portion to hold the subcutaneous implantable device in a fixed position. The receiving portion and the stabilizing portion are movable relative to each other between a released configuration, wherein the receiving portion and the stabilizing portion are configured to move apart from each other to allow the receiving portion to be inserted under a skin layer, and a closed configuration, wherein the receiving portion and the stabilizing portion are configured to move toward each other to allow the subcutaneous implantable device to be held adjacent to the skin layer. According to further embodiments of the present invention, a method of delivering a subcutaneous implantable device for accessing a vascular site is also provided.

Abstract: Disclosed herein are improved methods and apparatuses for providing hemostasis within a cavity defined by an internal surface of a bleeding tissue space. A catheter comprising a proximal end and a distal end may be advanced into the cavity through a proximal opening of the tissue space into the cavity. A distal balloon coupled to the catheter may be positioned adjacent a distal opening of the tissue space, and expanded to seal the distal opening. A hemostatic agent may be applied from the catheter to the internal surface of the tissue space to inhibit bleeding of the tissue space. The hemostatic agent may be applied without occluding the proximal opening, the distal opening, and a path extending therebetween with the hemostatic agent.

Abstract: A medical device made of a hybrid polymeric structure includes a tubular body including a first layer and a second layer. The first layer includes a fibrous matrix comprising a plurality of randomly oriented nanofibers made at least in part of a first polymeric material and pores formed between at least a portion of the nanofibers. The second layer is made at least in part of a second polymeric material. At least a portion of the second layer is disposed about and between the plurality of nanofibers such that at least a portion of the second polymeric material is embedded into at least a portion of the pores of the fibrous matrix.

Abstract: A retention feature configured to provide interference between a threaded connection of a Luer access device and a separate device, wherein the Luer access device further comprises a septum that provides a soft interfaced between the two threadedly connected devices. The retention features of the instant invention are designed to provide the user with a tactile sensation of a tightening threaded connection, despite a soft interface between the interconnected devices. The retention features of the instant invention further prevent “spring back” and unintentional disengagement of the interconnected devices.

Abstract: Various embodiments of an antimicrobial insert for a stopcock medical connector are provided. More specifically, the present invention relates to an antimicrobial insert that is seated within at least a portion of the annular bore of the connector's tap, wherein fluid within the annular bore contacts the antimicrobial insert, thereby preventing microbial proliferation within the stopcock medical connector.

Abstract: An apparatus or method for forming a sterile connection. The apparatus includes at least two sterile tubes each disposed within a flange. Each flange has an external face that completely covers the mouth of the tube. Each flange is designed to be displaced when force is applied to the tube to move the tubes toward one another such that the external face of each flange is displaced radially or axially outwards away from the mouth of the tube. When the external faces are displaced, the external face of each flange opens and tubes connect and form a sterile connection therebetween.

Abstract: An example tracheal tube cover is described. The tracheal tube cover includes a tube section including an inner passage. The tube section is configured to detachably secure to an end of a tracheal tube. The tracheal tube cover includes a cap section positioned over and surrounding a portion of the tube section. The cap section includes an inner cavity. The tracheal tube cover includes one or more connectors coupling the cap section to the tube section. The inner passage of the tube section is in fluid communication with the inner cavity of the cap section.

Abstract: A medical catheter control valve includes a valve body defining a fluid channel and a single open-end hole extended across the fluid channel, and a click-on mechanism consisting of a plunger unit with a through hole and a spring member and mounted in the single open-end hole. When click the plunger unit, the plunger unit is shifted to keep the through hole in alignment with the fluid channel for allowing a fluid to pass through the fluid channel. When push back the plunger unit, the through hole is deviated from the fluid channel and the fluid channel is blocked. Thus, the medical catheter control valve can be conveniently controlled with one single hand.

Abstract: The present invention relates to a wire fixing device for a cardiac pacemaker electrode, including: an electrode fixator used for clamping the tail of an electrode, where the electrode fixator includes an electrode clamping component, first hooks and second hooks; the electrode clamping component includes a first clamping piece and a second clamping piece that are semicircular cylindrical, one side edge of the first clamping piece and one side edge of the second clamping piece are connected in a hinged manner by a clamp hinge connector, and a circular tube is formed when the electrode clamping component is closed; several first hooks are provided on the back of the first clamping piece, several second hooks are provided on the back of the second clamping piece, and hook tips of the first hooks and the second hooks are all bent towards a rotation direction of the electrode clamping component during closing; and the first hooks and the second hooks can be interlaced with each other when the electrode clamping c

Abstract: One aspect of the present disclosure can include an intrafascicular neural electrode. The intrafascicular neural electrode can include a microwire body having a proximal end, a distal anchoring end, and a middle portion extending between the proximal end and the distal anchoring end. The distal anchoring end can substantially match the mechanical and biological properties of the target nerve. The microwire body can have a middle anchoring portion extending between the proximal end and the distal end, wherein at least a portion of the distal end and/or the middle anchoring portion substantially match(es) the mechanical and biological properties of the target nerve. The electrode can be made of graphene. The microwire body, except for the distal anchoring end, can be coated with an insulation material, preferably with a biocompatible agent adsorbed onto the insulation material.

Abstract: An assembly includes a medical device provided with an anchoring member adapted to penetrate tissue of a cavity of the heart. The assembly further includes an implantation accessory including an elongated tubular element provided with a fastening mechanism for handling and guiding the medical device to an implantation site. The fastening mechanism includes an elastic deformable component cooperating with a rigid component, that is able to disconnect the medical device from the tubular element under the effect of a rotation exerted to the tubular element. The elastic deformable component cooperates with the rigid component such that the elastic deformable component exerts on the latter a radial constriction effect, and the elastic component and the rigid component being disconnected under the combined effect of a torsion torque and a traction exerted to the elastic deformable component, to thereby reduce the radial constriction until release of the rigid component.

Abstract: A medical device includes a pulse generator and a filter. The pulse generator is configured to generate a stimulation signal and to provide the stimulation signal to tissue of a patient via an implantable lead assembly. The filter is configured to couple to the implantable lead assembly. A combined impedance of the implantable lead assembly and the filter with respect to a current induced by an external electro-magnetic field satisfies an impedance threshold when the external electro-magnetic field has a first frequency and when the external electro-magnetic field has a second frequency. The combined impedance has a peak impedance value when the external electro-magnetic field has a third frequency that is between the first frequency and the second frequency.

Abstract: Medical device systems include processing circuitry configured to acquire sensed cardiac signals associated with cardiac activity of a heart of a patient, and to analyze the sensed cardiac signals to determine if a noise signal is present within the cardiac signals.

Abstract: The self-contained endocavitary probe device for managing stress incontinence is capable of being inserted into the vaginal or rectal cavity of a person. The device includes at least one self-contained electrical power supply so as to supply power to at least one device for measuring the variation in a parameter resulting from physical stress and to at least one electrical muscle stimulation device in contact with at least one muscle capable of maintaining urinary continence. The electrical stimulation device is activated in the event of variation in the parameter.

Abstract: Methods and apparatus are provided for multi-vessel neuromodulation, e.g., via a pulsed electric field. Such multi-vessel neuromodulation may effectuate irreversible electroporation or electrofusion, necrosis and/or inducement of apoptosis, alteration of gene expression, action potential attenuation or blockade, changes in cytokine up-regulation and other conditions in target neural fibers. In some embodiments, the multi-vessel neuromodulation is applied to neural fibers that contribute to renal function. Such multi-vessel neuromodulation optionally may be performed bilaterally.

Abstract: Apparatus, system, and method for activating muscle contractions along a GE tract portion. Implantable apparatus includes: elongated member configured for positioning lengthwise in GI tract across a target GI tract portion; plurality of electrodes distributed longitudinally spaced in a series along the elongated member; and array of controlled relays coupled to the electrodes, that facilitates selective transition of each electrode between positively connected, grounded, and disconnected states.

Abstract: A leadless pacing device may include a housing, a distal extension extending distally of a distal end of the housing, one or more electrodes supported by the housing, a distal electrode supported by the distal extension, and a processing module located within an interior space of the housing and electrically coupled to the one or more electrodes supported by the housing and the distal electrode supported by the distal extension. The housing may be positioned within a coronary sinus and the distal extension may be positioned within a vessel extending from the coronary sinus. The processing module may determine whether cardiac events occurred based on near-field signals and/or far-field signals sensed using the one or more electrodes supported by the housing and the distal electrode. The processing module may generate cardiac stimulation pulses based on the determination of whether a cardiac event occurred and where it occurred.

Abstract: A peripheral nerve stimulator can be used to stimulate a peripheral nerve to treat essential tremor, Parkinson tremor, and other forms of tremor. The peripheral nerve stimulator can be either a noninvasive surface stimulator or an implanted stimulator. Stimulation can be electrical, mechanical, or chemical. Stimulation can be delivered using either an open loop system or a closed loop system with feedback.

Abstract: Described is a system for transcranial stimulation to improve cognitive function. During operation, the system generates a customized stimulation pattern based on damaged white matter. Further, data is obtained representing natural brain oscillations of a subject. Finally, while the subject is awake, one or more electrodes are activated in phase with the natural brain oscillations and based on the customized stimulation pattern.

Abstract: A method of neurostimulation may include delivering an electrical signal to a plurality of electrodes connected to a patient. The electrical signal may include a plurality of spaced-apart packets of electrical pulses. The method may include modulating at least one of a quantity of the plurality of electrical pulses within ones of the plurality of packets of electrical pulses, a width in time of the plurality of electrical pulses within ones of the plurality of packets of electrical pulses, an amplitude in voltage of the plurality of electrical pulses within ones of the plurality of packets of electrical pulses, a separation in time between adjacent ones of the plurality of electrical pulses within ones of the plurality of packets of electrical pulses, and a separation in time between adjacent ones of the plurality of packets of electrical pulses to modulate the electrical signal.

Abstract: Apparatus and methods are described herein that provide a vibratory device that can apply a vibratory signal to a portion of a head of a user such that the vibratory signal can be conducted via bone to a vestibular system of the user and cause a portion of the vestibular system to move in a manner equivalent to that of a therapeutically effective vibratory signal applied to an area overlaying a mastoid bone of the user. The vibratory device can be associated with frequencies less than 200 Hz. The vibratory device can be effective at treating a physiological condition associated with the vestibular system.

Abstract: A method of operating an implantable neuromodulator coupled to an electrode array implanted adjacent tissue of a patient having a medical condition comprises conveying electrical modulation energy to tissue of the patient in accordance with a modulation parameter set, wherein conveying the electrical modulation energy to tissue of the patient in accordance with the modulation parameter set stimulates dorsal horn neuronal elements more than dorsal column neuronal elements.