Abstract: A tool for use in conjunction with a pressure support system that is structured to provide therapy to a patient to treat a condition of the patient by delivering a flow of breathing gas to the patient. The tool may be implemented on a portable electronic device or a PC and is configured to, among other things, provide customized/personalized education and feedback to the patient based, at least in part, on data that is measured by the pressure support system during the provision of therapy to the patient. The tool utilizes certain patient/therapy metrics, wherein each patient/therapy metric comprises raw data that was measured by the pressure support system and that has been processed (e.g., summarized and/or otherwise manipulated) to form the patient/therapy metric.

Abstract: A tool for use in conjunction with a pressure support system that is structured to provide therapy to a patient to treat a condition of the patient by delivering a flow of breathing gas to the patient. The tool may be implemented on a portable electronic device or a PC and is configured to, among other things, provide customized/personalized education and feedback to the patient based, at least in part, on data that is measured by the pressure support system during the provision of therapy to the patient. The tool utilizes certain patient/therapy metrics, wherein each patient/therapy metric comprises raw data that was measured by the pressure support system and that has been processed (e.g., summarized and/or otherwise manipulated) to form the patient/therapy metric.

Abstract: A tool for use in conjunction with a pressure support system that is structured to provide therapy to a patient to treat a condition of the patient by delivering a flow of breathing gas to the patient. The tool may be implemented on a portable electronic device or a PC and is configured to, among other things, provide customized/personalized education and feedback to the patient based, at least in part, on data that is measured by the pressure support system during the provision of therapy to the patient. The tool utilizes certain patient/therapy metrics, wherein each patient/therapy metric comprises raw data that was measured by the pressure support system and that has been processed (e.g., summarized and/or otherwise manipulated) to form the patient/therapy metric.

Abstract: Systems and methods for detecting extubation of an endotracheal tube (ETT) are described. Extubation of the ETT can be identified by comparing to a threshold, a difference between a determined first volume of breathing gas during a first inspiratory period to a determined second volume of breathing gas during a second inspiratory period. If the difference exceeds the threshold, an alarm can be activated indicating extubation. Extubation detection may also be based on a difference between inspiratory pressures during separate inspiratory periods. Partial extubation and full extubation may also be discerned. Further, extubation of an ETT may be detected without the use of an exhalation flow sensor.

Abstract: A breathable gas supply regulation device of gas supplied by a respiratory assistance apparatus in breath assistance comprising a first input receiving a leakage signal produced by a detection member. The device regulates the supply of breathable gas to the patient in response to a received leakage signal, comprises a second input receiving a patient mouth movement measurement signal. The device comprises a processing unit provided for generating a synchronisation signal between the movement signal and the leakage signal. The processing unit generates a modification amount indicating the modification to be applied to the supply of breathable gas.

Abstract: A method of controlled delivery of breathing gases is described the method comprising: applying breathing gas pressure within the first naris of a patient during inhalation; applying breathing gas pressure within the second naris of the patient during inhalation; applying breathing gas pressure within the first naris of the patient during exhalation; and applying breathing gas pressure within the second naris of the patient during exhalation, wherein the breathing gas pressure applied to the first naris during inhalation is higher than the gas pressure applied to the second naris during inhalation and the breathing gas inflow to the patient is substantially through the first naris during inhalation and wherein the breathing gas pressure applied to the first naris during exhalation is lower than the gas pressure applied to the second naris during exhalation and the gas outflow from the patient is substantially through the first naris during exhalation.

Abstract: A respiratory mask assembly for delivering breathable gas to a patient includes a frame and a cushion. The cushion has a non-face contacting portion structured to be connected to the frame, a face-contacting portion structured to engage the patient's face, and an intermediate portion that interconnects the non-face contacting portion and the face-contacting portion. The intermediate portion includes a gusset portion that applies a first component of force to the patient's face through the face-contacting portion. A spring structure is coupled with the face-contacting portion of the cushion. The spring structure applies a second component of force to the patient's face through the face-contacting portion. The first and second components of force applied by the gusset portion and spring structure, respectively, determine a contact force of the cushion applied to the patient's face through the face-contacting portion. The intermediate portion may also include an elastic cuff portion.

Abstract: A breathing circuit component includes an inlet, an outlet and an enclosing wall. The enclosing wall defines a gases passageway between the inlet and the outlet. At least a region of the enclosing wall is formed from a breathable material that allows the passage of water vapor without allowing the passage of liquid water or respiratory gases. The breathing circuit component may be the expiratory limb of a breathing circuit.

Abstract: A respiratory mask assembly for delivering breathable gas to a patient includes a frame and an elbow assembly. The frame has a front surface and a rear surface adapted in use to face the patient. The frame includes a main body providing an aperture therethrough for the introduction of breathable gas into a nasal breathing cavity. The elbow assembly is swivelably coupled to the front surface of the frame. The elbow assembly includes a swivel elbow that defines an intake port and an exhaust port separated from the intake port using a baffle. The elbow assembly includes an end portion that interfaces with the aperture of the frame.

Abstract: A gas sensor for the detection of gases and vapors in air is particularly for the detection of anesthetic gases. A method for the detection and for the monitoring of such gases is also provided including detecting anesthetic gases with the gas sensor.

Abstract: A respiratory care system includes a user interface. A flow indicator is movable in response to inhalation and/or exhalation, or both, by a user through the user interface. An electronic indicator is operable in response to an electronic signal transmitted in response to the movement of the floe indicator. Methods of use and assembly are also provided.

Abstract: Introduced are methods and systems for: gathering human biological signals, such as heart rate, respiration rate, or temperature; analyzing the gathered human biological signals; and controlling a vibrating pillow strip based on the analysis.

Abstract: An entrainment method for stimulation of a visual field in a subject includes presenting a visual stimulation field to a subject, the visual stimulation field disposed at a distance of at least about 6 inches from the subject; and flashing at least one zone of the visual stimulation field for a selected duration and at a selected flash frequency.

Abstract: A method for providing a therapeutic benefit to a person wearing an article having first and second tactile stimulators bilaterally positioned in the article to be in therapeutic contact with the person when the article is worn by the person. A controller (mobile device) activates the first tactile stimulator to provide a first stimulation for a first time period and activating the second tactile stimulator to apply a second stimulation for a second time period beginning at least commensurate with a cessation of the first time period. This process is repeated for a therapeutically effective number of repetitions so that the first and second stimulations are applied bilaterally to the body of the person without a perceivable pause in stimulation between the first stimulation and second stimulation to provide the therapeutic benefit to the person.

Abstract: An efficiently packaged ready to use intermittent urinary catheter. The catheter is retained within a retention chamber having a profile that mimics the profile of the catheter by sealing the upper and a lower films together along a peripheral seal line. The retention chamber includes an enlarged compartment intermediate axial ends of the catheter in which lubricant is stored.

Abstract: A catheter assembly includes an inner liner made of flexible material and an outer layer having a steering mechanism. A catheter assembly is provided that includes an inner liner made of flexible material, and an outer layer having a steering mechanism that includes at least one wire and a corresponding lumen for each of the at least one wire through which the respective wire may travel. The outer layer includes a braided wire assembly that includes at least two wires braided into a wire mesh, and further includes a see-through portion positioned proximate a pull wire extraction location to facilitate extraction.

Abstract: Medical devices, perfusion systems, and methods for detecting a pressure within a space in a subject and for perfusion of fluid into a space in a subject. The space may be a fluid-filled space, or a space that is depleted of fluid due to an obstruction to fluid flow into the space. Methods for forming the medical devices.

Abstract: Medical devices, perfusion systems, and methods for detecting a pressure within a space in a subject and for perfusion of fluid into a space in a subject. The space may be a fluid-filled space, or a space that is depleted of fluid due to an obstruction to fluid flow into the space. Methods for forming the medical devices.

Abstract: Medical devices, perfusion systems, and methods for detecting a pressure within a space in a subject and for perfusion of fluid into a space in a subject. The space may be a fluid-filled space, or a space that is depleted of fluid due to an obstruction to fluid flow into the space. Methods for forming the medical devices.

Abstract: A wall (39) of a catheter (38) (a) includes a braided portion (41) having an outer surface (45), an inner surface (47), and a braided interior (53) between the outer and inner surfaces (45, 47), and (b) is shaped to define first and second longitudinally-running channels (27a, 27b) therethrough. A distal portion of the catheter (38) is shaped to define first and second lateral openings (26a, 26b). An angle between (a) a first line (76) running between the first and second lateral openings (26a, 26b), and (b) a second line (78) that is parallel to a central longitudinal axis of the catheter (38) when the catheter (38) is straight, is between 30 and 150 degrees.

Abstract: A medical device, comprising a hub or housing having a push tab including a main portion extending radially from an upper surface of the hub or housing, and at least one anti-rotation feature for resisting rotation of the hub or housing. A cannula is directly or indirectly connected to the hub or housing. The medical device may be a catheter, the cannula may be a catheter tube, and the hub or housing may be a catheter hub or an introducer needle tip shield for the catheter.

Abstract: A guide extension catheter includes a push member and a distal shaft coupled to and extending distally from the push member. The distal shaft includes a shaft wall and a passageway. The shaft wall includes a helically-shaped proximal end and a distal end. The helically-shaped proximal end coils helically about a first central longitudinal axis of the passageway of the distal shaft. The helically-shaped proximal end of the shaft wall defines a helically-shaped entry port of the distal shaft. The distal shaft may include a helically-shaped collar coupled to the helically-shaped proximal end of the distal shaft, the collar defining the helically-shaped entry port of the distal shaft.

Abstract: A catheter rotation drive apparatus includes first and second drives that are engageable to an output shaft. When the first drive is engaged to the output shaft and rotated, the output shaft rotates in an output rotation direction, and when the second drive is engaged to the output shaft and rotated, the output shaft rotates in the output rotation direction.

Abstract: Various embodiments include a catheter positioning device that may include a sled member, a sled base, an active damping system, a sensor, and a control system. The sled member may be configured to accept a handle of a catheter. The sled base may be configured to move the sled member along a length of the sled base for positioning the catheter within a patient. The active damping system may be configured to apply a force to the sled base to resist movement of the sled base in response to a control signal. The sensor may be configured to generate signals in response to a movement of the sled base. The control system may be configured to receive sensor signals from the sensor and transmit control signals to cause the active damping system to apply the force to resist movement of the sled base indicated in the received sensor signals.

Abstract: Various embodiments provide systems and methods for controlling a catheter with a catheter positioning device by using a remote controller. The catheter positioning device may include a sled member, sled base, counterweight, and passive damping system. The sled member may be configured to accept a handle of the catheter. The sled base may be configured to move the sled member along a length of the sled base in order to position the catheter within a patient. The counterweight may be moveably coupled to the sled base. The passive damping system may be coupled to the sled base and configured to resist movement of the sled base.

Abstract: A medical catheter includes a deflectable and compressible catheter shaft; a pull ring near a distal end of the catheter shaft; a distal tip that includes a tip element and a mounting shaft; and an attachment apparatus for securely attaching the distal tip to the catheter shaft, the attachment apparatus including a compression ring which compresses the catheter shaft and the mounting shaft together. The compression ring can be located around the catheter shaft to compress the catheter shaft against an outer surface of the mounting shaft, or within the catheter shaft to compress the catheter shaft outwardly against an inner surface of the mounting shaft. The catheter can be a non-irrigated ablation catheter, with the tip element being a tip electrode, and it can be an irrigated ablation catheter, with the distal tip including a fluid manifold.

Abstract: A retainer includes a first arcuate wall and a second arcuate wall that together define a channel designed to receive a medical article. The retainer has an open configuration wherein a first end of the first arcuate wall is spaced away from a first end of the second arcuate wall, and a closed configuration wherein the first end of the first arcuate wall is adjacent the first end of the second arcuate wall. A second end of the first arcuate wall opposite the first end of the arcuate wall may be spaced away from the base in the open configuration and pressed against the base in the closed configuration. The retainer also may include a first support and a second support fixed to the base, and a first and second flexible coupling connecting the first and second supports to the first and second arcuate walls.

Abstract: A medical device assembly includes a catheter with a catheter hub, a housing, a first wing, and a second wing. The housing surrounds the catheter hub, but is spaced from the catheter hub to define a channel. The first wing includes a first hook disposed in the channel to permit rotation of the first wing about the catheter hub. The second wing includes a second hook disposed in the channel to permit rotation of the second wing about the catheter hub.

Abstract: Some embodiments provided herein relate to methods, systems and kits for providing consistent intracoronary administration of a biologic to subjects having diverse coronary anatomies. In some embodiments, the biologic is an adeno-associated virus serotype 1 (AAV1) vector encoding sarcoplasmic/endoplasmic reticulum ATPase 2a (SERCA2a) protein.

Abstract: Some embodiments are directed to a catheter system comprising an introducer having a main body, an introducer sheath projecting from the main body, and a first seal supported within the introducer and a catheter having a main body, an outer sheath projecting from the main body, a second seal supported within the catheter, and an inner core configured to be advanced axially through the main body, the second seal, and the outer sheath. The introducer can be configured to be selectively engageable with the catheter so that the catheter can be selectively and removably linked with the introducer in the axial direction. The catheter system can also be configured such that, when the introducer and the catheter are linked, the catheter can be rotatable relative to the introducer. The introducer can be configured to radially restrain an endoluminal prosthesis.

Abstract: An insertion apparatus for inserting an object into a body comprising a housing, a piercing structure with a lumen, wherein the piercing structure extends distally from the housing, a vacuum chamber that communicates with the lumen of the piercing structure, a plunger configured to fit within the vacuum chamber, and a guidewire, wherein the insertion apparatus is configured to be operated with a single hand.

Abstract: Catheters with weeping balloons can be used for various medical purposes. For example, in some embodiments provided herein weeping balloons are used for catheter visualization devices. In some embodiments, weeping balloons are used to deliver therapeutic agents. Weeping balloons can include openings of a selected size and shape through which a fluid gradually flows or “weeps.” The design of the openings can affect performance characteristics such as, but not limited to, fluid flow rate, tear resistance, and mitigation of counter-flow.

Abstract: The present disclosure is directed to a device. The device may include a distal shaft defining a central lumen and an orienting element comprising at least one inflatable member. Wherein a first portion of the orienting element extending from the shaft in a first direction and a second portion of the orienting element extending from the shaft in a second direction. Further, wherein the second direction is substantially opposite the first direction.

Abstract: A balloon catheter visualization device includes a handle, an elongate shaft, and an asymmetrical balloon. The elongate shaft includes a distal end, a proximal end, and defines a lumen and a longitudinal axis extending from the proximal end to the distal end. The proximal end is coupled to the handle. The asymmetrical-shaped balloon including a distal portion and a proximal portion. The proximal portion is coupled to the distal end of the elongate shaft. The proximal portion has one or more reinforcement features including a layer of material coupled to the asymmetrical-shaped balloon and forming an outer contour at the proximal portion of the asymmetrical-shaped balloon that is asymmetrical to an outer contour of the distal portion of the asymmetrical-shaped balloon.

Abstract: The present disclosure provides a method and apparatus for draining. The apparatus includes a body, the body having a first compartment adjacent to a second compartment, the first compartment having an inlet port fluidly connected to an outlet port, the inlet port defining a needle seat within the first compartment, a first rod hole for operation with a second rod hole in the second compartment, and a plurality of venting holes, the second compartment having a plurality of spaced notches along. The apparatus further includes a setting rod, the setting rod having a shaft and a sealing head, the shaft sized to be slideably maintained in the first rod hole and the second rod hole, the sealing head slideably attached to an end of the shaft and sized to obstruct fluid flow from the inlet port at the needle seat.

Abstract: A single stage instrument is used to insert a chest drainage tube into the inter-pleural space to facilitate drainage. The instrument is scissor-like with cylinder-like channels to slidably enclose the distal section of the tube therein when closed. The tip of the instrument is curved to enter the skin incision and the offset pleural incision whereafter the instrument is rotated 180 degrees to align the curved tip with the pleural space. The curved tip facilitates sliding the chest drainage tube through the instrument to effect sufficient insertion length. Once the instrument is in place, the tube is slid along the instrument to ensure that all drainage holes in the chest drainage tube are within the pleural cavity. Thereafter, the instrument is withdrawn leaving the chest drainage tube in place. After withdrawal of the instrument, it is opened laterally for lateral disengagement with the chest drainage tube.

Abstract: A micropuncture kit for direct access of a surgically exposed vessel using direct visual guidance includes a micropuncture access needle having a proximal hub coupled to an elongate shaft defining an inner lumen and a visible depth indicator positioned on the elongate shaft a distance away from a distal tip of the elongate shaft. The kit includes an access guidewire sized to be received through the inner lumen of the micropuncture access needle and a microaccess cannula having an elongate body defining an inner lumen and a plurality of visible depth indicators formed on the elongate body. The guidewire includes a distal tip and at least one visible depth indicator positioned on the access guidewire a distance away from the distal tip of the guidewire. Each of the plurality of visible depth indicators identifies a distance from a distal tip of the cannula. Related systems, devices and methods are provided.

Abstract: A system and method are provided for securing an ingestible electronic device to a pharmaceutical product without damaging the ingestible electronic device. The product includes the ingestible electronic device being placed on the product in accordance with one aspect of the present invention, in accordance with another aspect of the present invention, the ingestible electronic device is placed inside the product. Various embodiments are disclosed in accordance with the present invention for protecting and/or coating of the electronic marker as well as securing the ingestible electronic device onto the product.

Abstract: The invention relates to trans-epithelial frictionally abrasive tissue sampling devices for performing biopsies and methods of inducing an immune response against a pathogen, wherein epithelial cells containing the pathogen are disrupted with the frictionally abrasive tissue sampling device to introduce the pathogen into the bloodstream of a patient.

Abstract: A medical connector includes a housing with a central axis, a hollow bore, and a narrowed passage. The connector further includes a rigid valve member configured to move along the axis of the connector as the connector moves between an open and closed configuration. The connector includes a resilient member coupled to the valve member and the housing.

Abstract: A needleless connector has a body having an internal cavity with a sealing ridge, a port, an output flow channel, and a fluid flow path between the port and output flow channel. The connector also has a collapsible valve disposed within the cavity. The valve includes a cylindrical wall having a center axis, an internal surface, and a shoulder configured to sealingly contact the ridge of the body, thereby blocking the fluid flow path. The valve also includes a head fixedly attached to the wall. The head has a smiley cut at a first angular position about the center axis and a continuous top surface that is generally perpendicular to the axis. The valve also includes a dimple formed in the internal surface of the cylindrical wall. The dimple extends around the internal surface over an angle.

Abstract: An occlusion assembly for compressing a pair of collapsible tubes comprises a frame comprising a tubing guide configured for positioning the collapsible tube. The occlusion assembly also comprises a tubing occluder mounted to the frame with an occluding member constructed and positioned to controllably occlude or release occlusion of the collapsible tube. A door mounted to the frame is positioned to cover at least a portion of the collapsible tube and tubing occluder when closed and provide user access when open. The assembly includes a retainer mechanism engaged by the door when the door is closed to permit operation of the tubing occluder when the door is closed and retain the tubing occluder in a non-occluding configuration when the door is opened.

Abstract: A defibrillation pad for a defibrillator, includes: a pair of electrode pads (10) each including a gel portion (12); lead wires (21, 22); a pair of nonconductive release liners (30A, 30B) each detachably stuck to the corresponding gel portion (12) and each having a through hole (32A, 32B) opposed to the corresponding gel portion; and a connecting member (40) comprising an electric connecting pattern (41) having a predetermined electrical resistance, wherein the pair of gel portions (12), each of which is exposed from the corresponding through hole (32A, 32B), are electrically connected to each other through the electric connecting pattern (41) in a state where each of the pair of release liners (30A, 30B) are stuck to the corresponding gel portion. The connecting member (40) has a cut region (45) by which the pair of gel portions are electrically disconnected to each other when the pair of electrode pads are stuck to a living body.

Abstract: A pad for electrically stimulated wound healing, including a pad configured to be placed on a wound, at least one anode disposed on the pad to contact the wound, and at least one cathode disposed on the pad to contact the wound, the at least one cathode being disposed separately from the at least on anode. The pad wherein the at least one anode and the at least one cathode in contact with the wound provide a flow of electrical current in an intended direction through the wound based on the separate locations of the at least one anode and the at least one cathode.

Abstract: This disclosure provide a nanopillar electrode device, comprising a substrate patterned with a plurality of metal pads. The device may further comprise a plurality of nanopillars electrode arrays, wherein each nanopillar electrode array is attached to the substrate above a metal pad and electrically connected to the pad. The device may further comprise and a chamber surrounding the nanopillar electrodes, which can be used for culturing cells of interest for recording action potentials. The nanopillar electrode device may be configured to apply a voltage through the nanopillar electrodes from a voltage source. Nanopillar electroporation may be used to increase the permeability of cell membranes to allow intracellular recording. Also provided are methods of device fabrication, and methods of use.

Abstract: A method for treating pain or discomfort in a patient is disclosed. The method comprises stimulating a cranial nerve with an electrical signal. The pain or discomfort may be a withdrawal symptom. The cranial nerve may be in an auricular area of the patient. The cranial nerve may be cranial nerve V, cranial nerve VII, cranial nerve IX, cranial nerve X, or branches of greater and lesser occipital nerves thereof and their associated neurovascular bundles. The withdrawal symptom may result from cessation of an opioid. The method may further comprise administering a secondary drug treats one or more of the withdrawal symptoms and addiction. The secondary drug may be administered about one day to about one week after initiating the stimulating step.

Abstract: The present invention consists of an implantable device with at least one package that houses electronics that receives input data or signals, and optionally, power, from an external system through at least one coil attached to the at least one package, processes the input data and delivers electrical pulses to neural tissue through at least one array of multiple electrodes that is/are attached to the at least one package. The invention, or components thereof, is/are intended to be installed in the head, or on or in the cranium, or on the dura, or on or in the brain.

Abstract: Systems and methods for the concurrent treatment of multiple oral diseases and defects while promoting general oral hygiene utilizing electricity are provided for non-human animals. Electrodes are used to deliver an electrical current to the gingival tissues of a mouth in order to achieve a number of therapeutic, prophylactic, and regenerative benefits. These benefits include killing oral microbes, increasing oral vasodilation, reducing oral biofilm, improving oral blood circulation, reversing oral bone resorption, promoting oral osteogenesis, treating gum recession, and fostering gingival regeneration. Other benefits include the treatment of gingivitis, periodontitis, and oral malodor, and other systemic diseases correlated with oral pathogens.

Abstract: A system for lead integrity monitoring includes an implantable medical device (IMD) having a housing enclosing a control circuit; and a lead, having a first sensor. The lead is coupled to the housing and electrically coupled to the control circuit. The system also includes at least one processing device configured to identify a first lead failure alert based on a first set of information; obtain a second set of information generated by a second sensor; perform an evaluation of the first set of information in the context of the second set of information; and confirm or cancel the first lead failure alert based on the evaluation.

Abstract: Methods of preventing, treating, and/or controlling a hemorrhage in an organ of a patient include providing electrical stimulation to the arteries, veins, nerves innervating the arteries or veins, or walls of the organ. The apparatus has at least one electrode operably connected to a stimulus generator and placed in electrical communication with an artery, vein, nerve, or organ wall. An electrical stimulus generator causes an electrical stimulus to be administered to the artery, vein, nerve, or wall through the at least one electrode, where the electrical stimulus is effective for preventing, treating, and/or controlling a hemorrhage.