Abstract: Disclosed is an apertured hydrogel that is used in connection with an insertion device to provide comfort at the site of entry into the skin. In one embodiment, the hydrogel contains antimicrobial properties to help inhibit microbial growth at the site of insertion of the device into the skin. In the invention the apertured hydrogel is provided with a medical dressing and comprises a hydrogel having an upper surface and a lower surface, a film covering the upper surface of the hydrogel, a base sheet releasably covering to the lower surface of the hydrogel, an aperture in the film and hydrogel from the upper surface to the lower surface of the hydrogel, wherein the base sheet extends beyond the hydrogel to form a tab.

Abstract: A nebulizer and a method of breathing using the nebulizer is described. The nebulizer and breathing techniques are capable of delivering medicament into the sinus cavity of a user.

Abstract: There is provided a control unit for controlling the operation of a nebulizer, the nebulizer comprising a reservoir chamber for storing a liquid to be nebulised, an actuator, and a nebulizing element comprising a plurality of nozzles arranged to nebulize the liquid upon operation of the actuator; wherein the control unit is configured to obtain an indication of the size of the nozzles in the nebulizing element; and control the operation of the actuator based on the obtained indication to provide nebulised liquid at a required output rate and/or with droplets of a required size.

Abstract: Dispensers, in particular dispensers for dispensing a dose of a gaseous, gas borne or droplet substance from a substance source and dispensers containing dosage counters are described herein.

Abstract: According to one aspect of this invention, there is provided a medical facial mask having intubation port to insert an endotracheal tube; air ventilation port to perform artificial ventilation during intubation procedure; and a display device to display image of a patient's airway, wherein the image is transmitted from an image acquisition device which is inserted in the patient's airway.

Abstract: A patient interface device includes a bladder assembly having a headgear bladder member, a nose bridge bladder member, and a connecting tube member provided between the headgear bladder member and the nose bridge bladder member. The headgear bladder member is in sealed fluid communication with the nose bridge bladder member through the connecting tube member, and is filled with a fluid medium. The bladder assembly is structured such that the nose bridge bladder member will be inflated as a pressure on the headgear bladder member increases and such that the nose bridge bladder member will be deflated as the pressure on headgear bladder member decreases. Inflation of the nose bridge bladder member causes the top of a cushion member to move toward the patient's nose bridge, and deflation of the nose bridge bladder member causes the top of the cushion member to move away from the patient's nose bridge.

Abstract: A liquid separator removing a liquid from a sample of a breathing gas flowing through an airway adapter having a channel surrounded by a wall is disclosed herein. The separator includes a chamber receiving the sample, and a membrane having an outer surface exposed to the gas flow, the membrane at least partially surrounding the chamber, which membrane separates the liquid received by the chamber. The separator also includes a supporting structure for supporting the membrane, and a connector operationally attached to the supporting structure, the connector being connectable to the adapter. The connector comprises a cavity providing a flow path for the sample from the chamber through an opening of the cavity to a sample tube. The membrane branches from a central part of the channel into at least two different branches extending to different directions.

Abstract: A PAP system for delivering breathable gas to a patient includes a flow generator to generate a supply of breathable gas to be delivered to the patient; a humidifier including a heating plate to vaporize water and deliver water vapor to humidify the supply of breathable gas; a heated tube configured to heat and deliver the humidified supply of breathable gas to the patient; a power supply configured to supply power to the heating plate and the heated tube; and a controller configured to control the power supply to prevent overheating of the heating plate and the heated tube.

Abstract: A supplemental oxygen delivery system is described in which Aerosol is delivered into a housing which sits in the circuit from the supplemental oxygen supply and optional humidifier. The supplemental oxygen passes through this chamber in which the aerosol is located, and collects the aerosol transporting it to a patient via a nasal cannula or a face mask. An aerosol generator is mounted to the housing and delivers aerosol into an oxygen stream flowing between an inlet and an outlet of the housing. The housing also has a removable plug in the base thereof for draining any liquid that accumulates in the housing. There is no disruption of oxygen delivery to patients using nasal cannulas who currently have to use a separate face-mask when receiving nebulized medication.

Abstract: An apparatus for the supply of humidified gases to a patient is disclosed that comprises a gases supply passage downstream of a humidified gases supply, and upstream of a patient in use, where at least one sensor is embedded in or located on the outside of the wall of the passage. In preferred forms the wall of the passage divides the sensor(s) from a flow of gases in the passage. In use, a controller receives an output of the sensor(s) and derives from the output of the sensor(s) an estimation of a property of gases flowing through the passage or provides a control output to the humidified gases supply according to the output of the sensor(s).

Abstract: A housing for a solid, fluidal substance for removing an undesired respiratory gas component of a respiratory gas flow, the housing comprising a space for receiving the solid, fluidal substance, a wall surrounding part of the space, a first separator surrounding part of the space, the first separator being configured to allow the respiratory gas to flow and to prevent the solid, fluidal substance from escaping from the space through the first separator, a second separator surrounding part of the space, the second separator being configured to allow the respiratory gas to flow and to prevent the solid, fluidal substance from escaping from the space through the second separator; and a limiter disposed between the first separator and the second separator, the limiter being configured to limit movement of the solid, fluidal substance inside the space.

Abstract: A deflectable, flexible device includes an elongate body, a convoluted tip portion at a distal end of the elongate body, and a lumen to receive one or more wires. The convoluted tip portion includes an electroformed pleated region which is formed by electrodepositing a metal on a mandrel having a pleated region. The convoluted tip portion may be hermetically sealed to permit repeated sterilization. The electroformed pleated region may include one or more fluid emission orifices. The convoluted tip portion extends or bends in response to fluid pressure manipulation, contact with tissue, manipulation with an internal spring or wire, or by a user pushing, pulling, or twisting the catheter directly or via an introducer sheath or the like. The convoluted tip portion may further include an RF ablation element or other energy-driven technique to create continuous linear lesions or a sensing element.

Abstract: A safety balloon catheter includes a flexible, multi-lumen balloon catheter having a hollow stretch valve. The catheter has a balloon, a hollow inflation lumen extending to the balloon interior and conveying inflation fluid to and from the balloon interior, a hollow second lumen, and a balloon drainage port fluidically connecting the balloon interior to the second lumen. The valve has distal and proximal portions, is shaped to permit a fluid to pass therethrough, and is positioned in the second lumen such that, in a steady state, the valve prevents the inflation fluid from passing through the drainage port, and, in a catheter-stretched state, the distal portion slides within the second lumen permitting inflation fluid to pass through the drainage port and into the second lumen and the second lumen wall at the proximal portion holds the proximal portion steady within the second lumen as the distal portion slides therein.

Abstract: A catheter assembly (10) having a catheter (12) with lumens (20a,20b), extension tubes (14a,14b) and a hub (16). Distal ends (36) of the extension tubes and the proximal end (24) of the catheter are secured in and to the hub. Fittings (50) are first affixed in the distal ends of the extension tubes and have annular collars (56) that are embedded in the hub when the hub is molded over the distal ends of the extension tubes during manufacturing. An array of annular barbs (60) secure the cylindrical portion (52) of each fitting in the respective extension tube distal end (36).

Abstract: A catheter assembly includes a catheter, a first intra-catheter stiffener element, and a second intra-catheter stiffener element. The catheter includes a first lumen in fluid communication with a first distal opening and a second lumen in fluid communication with a second distal opening. The first intra-catheter stiffener element is configured for disposition through the first lumen such that a distal end thereof extends distally of the first distal opening, the first intra-catheter stiffener element including a first coupler at a proximal end thereof. The second intra-catheter stiffener element is configured for disposition through the second lumen such that a distal end thereof extends distally of the second distal opening, the second intra-catheter stiffener element including a second coupler at a proximal end thereof.

Abstract: A surgical apparatus includes an elongated handle assembly having opposed proximal and distal end portions and an interior cavity. An elongated sheath extends from the proximal end of the handle assembly, through the interior cavity of the handle assembly and out from the distal end portion of the handle assembly. The sheath includes an interior lumen extending therethrough and a distal end portion of the sheath is deflectable. The surgical apparatus includes a steering mechanism operatively associated with the handle assembly for controlling deflection of the deflectable distal end portion of the sheath. The steering mechanism includes a pull wire retraction assembly configured to selectively retract a pull wire to deflect the distal end portion of the sheath and a telescoping tube system for straightly guiding the pull wire as the pull wire retraction assembly moves within the interior cavity of the handle assembly.

Abstract: A catheter for use in a patient's heart, especially for mapping a tubular region of the heart, has a catheter body, a deflectable intermediate section and a distal mapping assembly that has a generally circular portion adapted to sit on or in a tubular region of the heart. A control handle of the catheter allows for single-handed manipulation of various control mechanisms that can deflect the intermediate section and contract the mapping assembly by means of a deflection control assembly and a rotational control assembly. The deflection control assembly has a deflection arm and a rocker member. The rotational control assembly has an outer rotational member, an inner rotational member and a cam. A pair of puller members are responsive to the deflection control assembly to bi-directionally deflect the intermediate section. A third puller member is responsive to the rotational control assembly to contract the generally circular portion of the mapping assembly.

Abstract: Improvements in an easily wearable catheter. A housing secures the components of the catheter, i.e. the valve, the removable cap, the twist valve, and the hose, to the user by means of an attachment. The present retainer for a peritoneal dialysis catheter relates generally to continuous ambulatory peritoneal dialysis methods and systems and, more particularly, to a user-wearable catheter housing which does not require any tape, belt or other bulky retainer to keep the catheter attached to the user.

Abstract: An apparatus is for performing a medical procedure using an inflation fluid. The apparatus includes a shaft with two inflation lumens for transmitting the inflation fluid. A balloon supported by the shaft has an interior capable of being inflated by the inflation fluid transmitted through the inflation lumens of the shaft. The tubes defining the inflation lumens provide two outlets for transmitting different flows of the inflation fluid to the interior of the balloon. A stent and related methods are also disclosed.

Abstract: A medical balloon for deployment of stents is disclosed. The medical balloon includes a central section; a proximal and a distal cone section; a proximal and a distal shaft section; a proximal sleeve which is arranged coaxial to and radially inside the proximal shaft section. The proximal end of the proximal shaft section is permanently connected and/or unitarily formed with the proximal end of the proximal sleeve, and distal thereto, at least part of the proximal cone section is connected with the proximal sleeve by an adhesive bond, and a distal sleeve which is arranged coaxial to and radially inside the distal shaft section. Methods of manufacturing a medical balloon are disclosed.

Abstract: Medical dressings and medical dressing kits that can be used to provide negative pressure wound therapy. The medical dressings include one or more normally-closed valves, and may include stand-off elements, barrier elements, closure elements, and septum elements. The medical dressing kits may further include pumps, fluid traps, and/or fittings.

Abstract: An embodiment of a system for shunting aqueous humor from an anterior chamber of an eye includes an implant having an elongated body made of biocompatible material and a delivery device. At least a portion of the elongated body is implantable between a sclera and a ciliary body while the elongated body resides entirely within the confines of the sclera and a cornea with the proximal end of the implant being configured to reside within an anterior chamber angle and a lumen extending from at least one inlet port of the implant, through at least a portion of the elongated body, to one or more outlet ports of the implant so as to drain fluid from the anterior chamber toward a choroid of the eye. The delivery device includes an elongated member with a curved distal end portion to deliver the implant using an ab interno procedure.

Abstract: An implant device to provide an artificial fluid path in fluid communication with the lacrimal apparatus is implanted through a fistula opening into the lacrimal apparatus using a working member disposed through the implant device and a break-away sheath. Implantation kits and tool assemblies including the working member, implant device and break-away sheath facilitate implantation of the implant device.

Abstract: An adjustable hydrocephalus valve for pressure equalization of the cerebrospinal fluid in the cranium of a hydrocephalus patient. The valve is adjustable to change the opening and closing pressure of the valve. The valve housing has a cover portion that can be depressed to thereby disengage a locking device to permit adjustment of the valve. The cover portion bulges outwardly, but bulges inwardly when depressed. The cover portion snaps when moved between the outward bulge and the inward bulge to thereby generate an audio and/or visual signal indicating that the cover portion has been switched from the outward bulge to the inward bulge, and vice versa.

Abstract: An external device for applying a substance to the perineum comprises: a bottom wall; and an elastic side wall extending from the bottom wall; wherein said bottom wall and side wall together form an open cup-shaped body for holding the substance.

Abstract: An applicator assembly includes a body having a proximal and a distal end, a container slidably coupled to the body, a valve cap coupled to the container, and an application member attached to the distal end, wherein an interior of the container is placed in fluid communication with the application member by way of a fluid conduit that is only accessible when one of the body and the container are axially translated in an opposite direction away from each other.

Abstract: Oxygen diffusive wound dressings and methods of manufacturing and use are described herein. The wound dressing may generally provide a ready supply of oxygen to a wound being treated via one or more oxygen conduits which are designed to pass oxygen from ambient air or other oxygen reservoirs into proximity to the wound, and may also provide for exudate removal through transecting channels in fluid communication with both the wound surface and a hydrophilic absorbent material.

Abstract: A device for delivery of material or stimulus to targets within a body to produce a desired response, the targets being at least one of cells of interest, cell organelles of interest and cell nuclei of interest. The device includes a number of projections for penetrating a body surface, with the number of projections being selected to produce a desired response, and the number being at least 500. A spacing between projections is also at least partially determined based on an arrangement of the targets within the body.

Abstract: A transcutaneous implant tool is used to push a medical element through an incision and into a patient's subcutaneous tissue, while a fin of the tool is engaged beneath the patient's skin at the incision site. The tool preferably includes an injection rod for moving the medical element out through an opening of a bore of the tool. The fin, which is located in proximity to the opening, preferably includes a distal-facing surface that extends proximally from the opening at an acute angle with respect to a longitudinal axis of the bore; and the injection rod preferably includes a distal surface that is approximately coplanar with the distal-facing surface of the fin, when the distal surface of the rod is located in proximity to the opening of the bore.

Abstract: The present invention provides an osmotic orthodontic appliance, comprising: an actuation structure forming a hollow tube filled with a supersaturated solution; a dental aligner structure mounted on the actuation structure for fixing the actuation structure on teeth; and a pumping structure connected one end of the hollow tube, comprising a semipermeable device and a supporting structure. The osmotic orthodontic appliance of the present invention could provide steady movement and force output; it is a solution for the periodic actuation problem of conventional orthodontic appliances.

Abstract: Systems and methods for applying stimulating current to a patient for treating insufficient uterine contractions are provided. The system includes stimulation electrodes of a balloon electrode array device, a ring electrode array device, an electrode probe device, or a mesh electrode array device. Some aspects of the invention also provide a connector and cable device for coupling the stimulation electrodes to electronics for generating and providing the stimulating current to the stimulation electrodes.

Abstract: A burr hole cover is configured to be recessed in a burr hole formed in a patient and includes a base and a cap provided with complementary features to allow a portion of a medical device, such as a brain lead, to be situated in the burr hole cover and then secured by rotation of the cap relative to the base. The features include channels on the base and matching cut-outs on the cap, and slots and locking pockets on the base that are configured to be aligned with locking tabs and locking protrusions on the cap. Because the burr hole cover is recessed in the burr hole, the medical device can extend proximally of the burr hole at the level of the cranium. A bottom surface of the cap may be provided with guides for the lead extending distally in towards the brain.

Abstract: A cochlear implant includes an active base section with a front surface configured to lie against an inner modiolar wall of the scala tympani. Electrode contacts are on the front surface configured to face the inner modiolar wall to deliver electrode stimulation signals to nearby modiolar neural tissue. A passive apex section has a front surface without electrode contacts configured to lie against an outer lateral wall of the scala tympani. A U-shape transition bend section is at an apical end of the active base section bending in a reverse direction and transitioning into a basal end of the passive apex section such that the back surface of an apical tip of the passive apex section lies adjacent to a back surface of a basal end of the active base section at an electrode opening in the cochlea when the electrode is implanted in the patient.

Abstract: Various embodiments concern an implantable paddle lead. The paddle can be attached to a distal portion of an elongate lead body. The paddle can comprise a main panel and a ridge that peripherally surrounds the main panel. The main panel can comprise a first face and a second face opposite the first face. One or more electrodes can be exposed on the first face but not exposed on the second face. The paddles can be sutured to anatomical structures. The sutures can be threaded through the main panel but not through the ridge. The paddle can be thicker along the ridge than along the main panel.

Abstract: This invention provides a device for implantation directly into the spinal cord for the purpose of treating back pain. Electrodes on a backing that conforms directly to the spinal cord are installed as a source of electrical stimulation and pain relief. The electrode array is maintained on the spinal cord by way of a spring or support structure that is anchored to an anatomical structure outside the spinal cord but near the site of implantation. Suitable anchoring structures include the vertebrae and the dura. Secured in this fashion, the support structure maintains a gentle pressure of the electrode array against the spinal cord so as to stay in electrical contact but minimize injury or inflammation. The device may accommodate and buffer movement of the spinal cord both laterally and in a caudal-rostral fashion so that the electrode array remains in place.

Abstract: An epicardial stimulation lead includes a lead body having a connector at a proximal end for coupling the lead to a generator of an active implantable medical device. The lead also includes a distributor housing at a distal end of the lead body and means for anchoring the distal end of the lead body to the epicardium. The lead also includes an active part having a plurality of microcable conductors, the proximal ends being coupled to the distributor housing, the distal ends being free. Each microcable has a diameter of at most equal to 2 French. Each microcable includes at least one denuded area in the insulating coating forming a stimulation electrode adapted to contact or penetrate an epicardium wall. Each microcable also includes a transverse elongated member extending at an angle relative to the main direction of the microcable for penetrating into the epicardial wall.

Abstract: An electro stimulation system for providing signals to a subject including: at least one electrical power supply; a first switching device for intermittently connecting the output of an electrical power supply to one or more connection probes electrically connected to the subject; a second switching device for intermittently connecting one or more connection probes electrically connected to the subject to form an electrical current return path for current supplied by the electrical power supply; and switching control devices connected to the first and second switching devices; wherein the intermittent connection of the output of an electrical power supply or the intermittent formation of electrical current return paths vary during a treatment and wherein the switching of the first and second devices occurs independently of each other.

Abstract: An embodiment in accordance with the present invention provides a device and method to deliver direct ionic current safely to target neural tissue, while also eliminating interruptions in the output of the device that can result from the non-ideal operation of the valves used to control the current flow in the device. The device includes two valve-operated systems that work in tandem. The first and second current producing systems are configured to be used together in order to eliminate the periodic interruptions in current flow. In use, one system drives current through the target tissue, while the other system closes all of the valves first and then opens its valves in sequence. This intermediate step of closing all of the valves prevents unintended current shunts through either system. The device also includes two conductors to direct the flow of direct current into the target tissue.

Abstract: A housing for an electrostimulation device comprising a charger plug and a stimulation plug, designed to receive respectively a connector linked to a charger and a connector linked to a stimulation electrode, characterized in that it comprises a mobile locking element designed to alternately lock the charger plug or the stimulation plug.

Abstract: One aspect of the invention provides a method for customizing cochlear implant stimulation of a living subject. The cochlear implant includes an electrode array having a plurality of electrodes implanted in a cochlea of the living subject. The method includes determining a position for each of the plurality of electrodes and spiral ganglion nerves that the electrode array stimulates, determining a geometric relationship between neural pathways within the cochlea and the electrode array implanted therein, and using one or more electrodes of the electrode array to stimulate a group of SG neural pathways of the cochlea based on the location of the one or more electrodes and their geometric relationship with the neural pathways.

Abstract: This disclosure is directed to extra, intra, and transvascular medical lead placement techniques for arranging medical leads and electrical stimulation and/or sensing electrodes proximate nerve tissue within a patient.

Abstract: Devices and methods for stimulation of the vagus nerve to modulate (e.g., reduce, suppress, etc.) bone erosion. Methods and apparatus for modulating bone erosion may modulate levels of Receptor Activator for Nuclear Factor ? B Ligand (RANKL), and/or to modulate (increase, enhance, etc.) osteoprotegerin (OPG) and/or OPG/RANKL ratio. Devices may include electrical stimulation devices that may be implanted, and may be activated to apply current for a proscribed duration, followed by a period without stimulation.

Abstract: A system and method for delivering coupled burst and tonic stimulation of nervous tissue is provided. The system and method includes providing a lead with at least one stimulation electrode configured to be implanted at a target position proximate to nervous tissue of interest. The system and method further includes coupling the lead to an implantable pulse generator (IPG). The method delivers a first current pulse configured as a tonic stimulation waveform to the at least one electrode. The tonic stimulation waveform is configured to excite A-beta fibers of the nervous tissue. After a tonic-burst delay, the IPG delivers second current pulses configured as a burst stimulation waveform to at least one electrode. The burst stimulation waveform is configured to excite C-fibers of the nervous tissue.

Abstract: The present disclosure describes a medical device to provide neurostimulation therapy to a patient's brain. The device can be surgically implanted and can remain in the patient until end of life. The present disclosure also describes accessories which guide the implantation of the device, and the components that form a leadless stimulator implantation kit.

Abstract: A tissue stimulation system and computer software and method of monitoring a neurostimulation lead having a plurality of electrodes implanted within a patient (e.g., adjacent the spinal cord) is provided. Neurostimulation lead models are provided, each of which includes estimated electrical parameter data (e.g., electrical field potential data) corresponding to a predetermined position of the neurostimulation lead. Electrical energy is transmitted to or from the electrodes, and electrical parameter data (e.g., electrical field potential data) is measured in response to the transmitted electrical energy. The measured electrical parameter data is compared with the estimated electrical parameter data of each of the neurostimulation lead models, and a position of the neurostimulation lead is determined based on the comparison.

Abstract: A neurostimulation device is provided comprising an input, a neurostimulation probe, a stimulation unit and a distribution calculation module. At the input stimulation data is received comprising information relating to a stimulation preferability and an orientation of at least one fiber bundle. The neurostimulation probe comprises an array of stimulation electrodes which are coupled to the stimulation unit. The stimulation unit, in accordance with a specified current distribution, provides currents to the respective stimulation electrodes for generating an electric field gradient. The distribution calculation module is coupled to the input and the stimulation unit for based on the stimulation data determining a preferred position and orientation for the electric field gradient, and based on the preferred position and orientation for the electric field gradient, calculating the specified current distribution.

Abstract: Systems and methods for stimulation of neurological tissue generate stimulation trains with temporal patterns of stimulation, in which the interval between electrical pulses (the inter-pulse intervals) changes or varies over time. Compared to conventional continuous, high rate pulse trains having regular (i.e., constant) inter-pulse intervals, the non-regular (i.e., not constant) pulse patterns or trains that embody features of the invention provide a lower average frequency.

Abstract: Some embodiments provide a method, comprising performing a neural stimulation test routine for stimulating a neural target in a cervical region of a patient, wherein for each of a plurality of head positions, performing the neural stimulation test routine includes testing a plurality of electrode configurations. The method further comprises recording threshold data for each of the tested electrode configurations for the plurality of head positions, and recommending an electrode configuration based on the recorded threshold data.

Abstract: A medical device system and method for detecting cardiac lead dislodgement measures intervals between sensed cardiac events for detecting an event interval pattern including at least one short event interval consecutively followed by a long event interval. Responsive to detecting the event interval pattern, a cardiac signal amplitude associated with a detected short event interval is measured. Dislodgement of the cardiac lead is detected in response to the measured amplitude.

Abstract: Medical device systems and methods with multiple communication modes. An example medical device system may include a first medical device and a second medical device communicatively coupled to the first medical device. The first medical device may be configured to communicate information to the second medical device in a first communication mode. The first medical device may further be configured to communicate information to the second medical device in a second communication mode after determining that one or more of the communication pulses captured the heart of the patient.