Abstract: An apparatus for delivering an aerosolized medication to a patient on a ventilation circuit. The apparatus comprise a multi dose metered syringe preloaded with the aerosolized medication such as albuterol. The syringe comprises a Luer lock at a bottom tip, which is removably attachable to a carbon dioxide sampling port of an endotracheal tube. A plunger adapted to be fitted inside the syringe and actuated for delivering a predefined dose of the aerosolized medication into the endotracheal tube, without disconnecting the ventilation circuit. The delivery of aerosolized medication is synchronized with oxygen inspiration for optimal delivery.

Abstract: A humidifier includes a humidifier tub with an air inlet and an air outlet. An uppermost end of the air outlet terminates at an exit port positioned in a plane disposed below the air inlet. The air inlet is configured so that air enters the humidifier tub through the air inlet in a lateral direction. The humidifier also includes a base plate provided to a bottom of the humidifier tub. The base plate and humidifier tub define a water chamber adapted to receive a volume of liquid water. The humidifier tub further includes a guidance structure adapted to direct air entering the humidifier tub via the air inlet to swirl downwardly and around within the water chamber and into contact with the liquid water before exiting the exit port.

Abstract: A humidification arrangement can be configured to have multiple compartments with each compartment having at least one moisture source and at least one heater. The compartments can be thermally isolated and can be controlled such that the moisture output of both the first and second compartments is set to a function of the same set of input signals.

Abstract: Device for use in the medical field as technical pulmonary re-expansion instrument sand comprising a T-body with one-way valve, a flow occlusion/release system, and pressure release valve, for use with patients with an artificial airway, be this an orotracheal tube or tracheostomy cannula.

Abstract: The present invention relates to a catheter that minimizes or eliminates the recirculation of oxygenated blood. The catheter of the present invention can be used to drain blood from multiple points in the patient, namely the superior vena cava, right atrium, and the right ventricle, while returning blood to the patient's pulmonary artery. Further, the catheter of the present invention is less likely to be moved or dislodged than catheters currently available in the art, thus making the catheter particularly useful for portable lung assist devices. The present invention also relates to methods for inserting the catheter into the patient and using the catheter with a lung assist device.

Abstract: A device for obtaining selective rigidity with respect to a patient is provided. The device includes a scaffold that is arranged to be flexible when in a first relaxed configuration, wherein the scaffold is configured to become substantially more rigid when a suction force is applied thereto. The scaffold comprises first and second opposing outer flexible layers that are sealed together to form a plurality of elongate pockets therein, and an expanded structure disposed within the plurality of elongate pockets and in communication with a vacuum port that receives the suction force.

Abstract: A catheter has extruded length of tubing and an injection molded tip that facilitates insertion of the catheter into the body. The catheter is fabricated by the steps of providing the tubing, for example, by extruding the tubing from a thermoplastic resin cutting the tubing to the desired length, inserting a plug into the tubing, inserting one end of the tubing into an injection mold cavity, creating and forming a tip in an injection molding step, and demolding the tubing with the formed tip.

Abstract: A device and method for delivering a drug from inside a body lumen to tissue surrounding the body lumen. An endoluminal drug delivery device is connectable to a drug source and includes a dual-lumen catheter, including a treatment device lumen for housing a guidewire and/or a treatment device and a needle lumen for housing a retractable needle. The guidewire exits the catheter through an opening at the distal end, and the needle exits the catheter through an exit port in the outer wall of the catheter.

Abstract: Various embodiments concern a force sensing catheter having a proximal segment containing a proximal hub, a distal segment containing a distal hub, and a spring segment that extends from the proximal segment to the distal segment. The spring segment comprises a plurality of struts connected to both of the proximal and distal hubs. Each strut includes a preformed bend. The struts mechanically support the distal segment in a base orientation with respect to the proximal segment, flex at the preformed bends when the distal segment moves relative to the proximal segment in response to a force, and resiliently return the distal segment to the base orientation once the force has been removed. The catheter further comprises a plurality of sensors configured to output signals indicative of relative movement between the proximal and distal segments for determining a magnitude and direction of the force.

Abstract: A catheter assembly comprises a catheter (18), a needle (12) having a sharp distal tip disposed within the catheter (18), a catheter hub (14) connected to the catheter (18) having the needle (12) passing therethrough, the catheter hub (14) including a valve (38) that selectively permits or blocks a flow of fluid through the catheter (18), a valve actuator (54) that moves between a first position and a second position, and a return member (56) that returns the valve actuator (54) from the second position to the first position, and a needle protection member (176) that encloses the sharp distal tip of the needle (12).

Abstract: A steering control apparatus includes a first wire and a second wire extending from a distal end of a catheter to a steering assembly. The steering assembly includes a steering knob disposed at an exterior of the handle, a cylindrical steering shaft projecting from the steering knob and into the interior of the handle, a first cylindrical drum disposed within the handle and connected to the first wire, and a second cylindrical drum within the handle and connected to the second wire. The first drum is configured to engage the steering shaft to produce tension on the first wire. The first drum is coaxial with the steering shaft. The second drum is configured to engage the steering shaft to produce tension on the second wire. The second drum is coaxial with the steering shaft and axially adjacent to the first drum.

Abstract: The present invention provides a bi-directional catheter with nearly double the throw in its catheter tip deflection. In particular, the travel path of each the puller wire includes a U-turn or doubling-back around a pulley which minimizes the offset angle between the puller wire and the longitudinal axis of the control handle while maximizing the travel distance of that puller wire for any given distance traveled by the pulley drawing the puller wire. In one embodiment, the catheter has an elongated catheter body, a catheter tip section with first and second diametrically-opposed off-axis lumens, and a control handle which includes a steering assembly having a lever structure carrying a pair of pulleys for simultaneously drawing and releasing corresponding puller wires to deflect the tip section of the catheter.

Abstract: A catheter assembly (10) comprises a catheter (22), a needle (12) having a sharp distal tip disposed in the catheter (22), a catheter hub (14) housing the catheter (22) and the needle (12), the catheter hub (14) having a collar (34) including a notch (36), a needle shield (20) connected to the catheter hub (14) when the needle (12) is in a first position, and a clip (40) disposed in the needle shield (20) that cooperates with the needle (12), wherein the clip (40) engages the catheter hub (14) in the first position of the needle (12), and the clip (40) disengages the catheter hub (14) via the notch (36) when the needle (12) is retracted to a second position to enclose at least a portion of the needle (12). The clip (40) is mounted in the outer housing (38) of the needle shield (20) via a spade (66) having an outer wall (70) exposed to the outside of the needle shield (20), in order to reduce the overall width of the needle shield (20).

Abstract: A guide wire luer hub has an elongated hub body with a longitudinal lumen having a plurality of transitions between different lumen sections with different diameters and/or taper angles. The guide wire luer hub is adapted for use with a coaxial guide wire tubing extending from a catheter control handle, where the coaxial tubing has an outer cover or tubing coaxially surrounding a guide wire inner body with a lumen adapted to receive a guide wire, including a guide wire having a floppy, U-bend distal end.

Abstract: A dual double balloon catheter includes a catheter having a proximal end portion, a central portion and a distal end portion. The catheter includes a plurality of lumens within the catheter extending from the proximal end portion, and a plurality of inflatable balloons positioned in the central portion and/or the distal end portion, and the balloons being communicatively connected with a corresponding one of the plurality of lumens to selectively inflate/deflate the corresponding inflatable balloon, wherein one or more of inflatable balloons further includes a second one of the plurality lumens associated with a corresponding inner wall of a corresponding inflatable balloon and adapted to receive a radioactive dose or a therapeutic agent for a treatment. The plurality of balloons can have varying sizes in relation to each other and also include lumens within or associated with the inner walls of the balloons to deliver a treatment.

Abstract: Systems and methods for filtering materials from biologic fluids are discussed. Embodiments may be used to filter cerebrospinal fluid (CSF) from a human or animal subject. The method may include the steps of withdrawing fluid comprising CSF, filtering the volume into permeate and retentate by passing the fluid through a tangential flow filter, and returning the permeate to the subject. During operation of the system, various parameters may be modified, such as flow rate.

Abstract: A tissue expander distributes antibiotics or other drugs and treats infections to the surrounding tissue. The tissue expander is provided with a manifold that can be accessed from outside via an injection needle which is connected to a series of channels containing drug effusion ports. When the tissue is infected antibiotics are injected into the manifold which in turn runs through the channels, effuse out the strategically placed ports to treat the infection. The procedure can be repeated until the infection is resolved. Any fluids effusing from the tissue are drained using the drainage channels that connect to a central drainage cavity and is later drained out of the body using a needle or cannula placed into a special drainage collection cavity.

Abstract: Methods and devices to affect types, proportion, quantity, distribution, or proliferation of microorganisms within a female reproductive system.

Abstract: A maternity belly wrap to wrap about the belly portion of a woman having moisturizer applied to skin of the belly portion. The maternity belly wrap includes a strip of material formed of at least one layer of material having a first end and second end. The strip of material has an outer surface and an inner surface and is formed of a material that prevents the moisturizer applied on skin of the belly potion from seeping through the material. The strip of material is elastic for maintaining a constant adherent traction with the belly portion of the woman and for preventing the skin of the belly portion from stretching apart and the elastic fibers of the skin from tearing. A closure system is included for securely fastening together the first and second ends of the strip of material.

Abstract: According to some embodiments, a method of promoting hair growth or hair stimulation in a subject comprises applying vacuum or suction using a handpiece assembly along a targeted portion of the subject's skin surface where hair growth or hair stimulation is desired and providing at least one treatment material to said targeted portion of the subject's skin surface, wherein the application of vacuum or suction helps promote hair growth or stimulate hair.

Abstract: To provide a transdermal absorption sheet with which control of a dissolution rate and suppression of drug diffusion can be achieved, and a method of manufacturing the transdermal absorption sheet. A transdermal absorption sheet 100 is provided with a sheet portion 116, a plurality of frustum portions 114 that is disposed on the sheet portion 116, and needle portions 112 that are disposed on the frustum portions 114, each of the plurality of needle portions 112 includes a first layer 120 containing a drug and a second layer 122 not containing a drug, and at least one of the plurality of needle portions 112 contains an air bubble 124.

Abstract: Methods for the subungual treatment of diseases or disorders of the nail unit including infections, especially fungal infections, and nail psoriasis involving the toenails and fingernails are described. The methods provide a technique for placement of a drug-containing composition subungually with reduced risk of hematoma formation and improved patient comfort.

Abstract: The configuration of an elongate aperture in a membrane draped over a microneedle assembly may be controlled by controlling the manner in which the aperture is formed and/or by controlling the manner in which the membrane is draped. At least a portion of the membrane may be spaced apart from a microneedle so that a gap is defined between the membrane and the microneedle. The gap may be configured for at least partially controlling the formation of the elongate aperture. The shape of the gap may optionally be at least partially defined by a pleat in the membrane. Any pleats may be aligned in a predetermined manner. The elongate aperture may be formed by a piercing member that is passed through a hole in the microneedle assembly prior to piercing the membrane. The piercing member may be a laser beam.

Abstract: A cannula for connecting a medical device to a biological system is taught. The cannula includes a tissue engagement portion, preferably in the form of an annulus, to which a vacuum is applied through the cannula to attract and hold tissue of the biological system in an initial connection while an affixment device is applied to complete the connection. In addition to a working fluid conduit, comprising a main port, a working fluid passage and a working fluid port, and a port to apply the vacuum, the cannula can include a sensor port to allow sensing pressure or other characteristics of the working fluid at a point closely adjacent to the connection between the cannula and the biological system.

Abstract: Break-away connectors are disclosed. The break-away connectors may be configured to be coupled in at least two configurations, for example, a high force configuration and a low force configuration. The break-away connectors may also be incrementally adjustable between the high force configuration and the low force configuration. The break-away connectors may be coupled to a first medical device and a second medical device. Methods of using and/or coupling the break-away connectors are also disclosed.

Abstract: A closed male luer includes a first connector having an upper end portion defining an axial recess, an inner circumferential track surrounding the track and several first ratchet teeth; and a second connector having lower end portion received in the axial recess of the first connector, having several second ratchet teeth selectively meshed with the first ratchet teeth such that rotation of the first connector in a first direction drives the second connection to rotate simultaneously in the first direction, wherein, after an upper end portion of the second connector is connected with a second member, rotation of the first connector in the first direction or rotation of the second connector in a second direction opposite to the first direction results in breakage of the second ratchet teeth done by the first ratchet teeth, hence permitting the second connector to rotate in 360° relative to the first connector.

Abstract: A TENS (transcutaneous electrical nerve stimulation) device and method using a micro current with a carrier signal and a square wave form combined with vibration and/or mechanical muscular manipulation for promoting the release and disbursement of lactic acid treating muscular soreness, cramping or degeneration. This method and nerve stimulation device is packaged to require no input from a user and a user must only apply the sticky electrode pad with the base unit attached on top to the correct part of the body and start the preprogrammed sequence of electrical currents, vibration and/or muscular manipulation. The method involves applying bursts of direct current at higher frequencies for shorter periods of time followed by lower frequency bursts of electrical current for longer periods of time combined with a small vibration motor and/or motorized nodes providing muscular manipulation to certain areas of the body.

Abstract: The present invention is directed to a method and apparatus for electrical stimulation of the pancreatico-biliary system. Electrode sets are placed in the pancreatico-biliary system in an arrangement that induce contractions or relaxation of the portion or whole of the pancreatico-biliary system by electrical stimulation of the surrounding tissue, muscles and nerves. The electrical stimulus is applied for periods of varying duration and varying frequency so as to produce the desired therapeutic effect, including inhibiting fat digestion or fat absorption by a patient and inducing satiety in the patient.

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: Thin-film multi-electrode arrays (MEA) having one or more electrically conductive beams conformally encapsulated in a seamless block of electrically insulating material, and methods of fabricating such MEAs using reproducible, microfabrication processes. One or more electrically conductive traces are formed on scaffold material that is subsequently removed to suspend the traces over a substrate by support portions of the trace beam in contact with the substrate. By encapsulating the suspended traces, either individually or together, with a single continuous layer of an electrically insulating material, a seamless block of electrically insulating material is formed that conforms to the shape of the trace beam structure, including any trace backings which provide suspension support. Electrical contacts, electrodes, or leads of the traces are exposed from the encapsulated trace beam structure by removing the substrate.

Abstract: A lead anchor includes an anchor body having a first end, a second end, at least one least one lateral portion, and a medial portion. The anchor body defines at least one lead channel extending longitudinally from the first end to the second end. A wedge element is disposed adjacent to at least a portion of the at least one lead channel and is configured and arranged to move between an open position and an engagement position. In the engagement position, the wedge element engages a lead disposed in the at least one lead channel to hold the lead within the lead anchor, and in the open position, the wedge releases the lead to move relative to or be released from the lead anchor. The lead anchor further includes an actuator configured and arranged to move the wedge element from the open position to the engagement position.

Abstract: Methods of treating acute heart failure in a patient in need thereof. Methods include inserting a therapy delivery device into a pulmonary artery of the patient and applying a therapy signal to autonomic cardiopulmonary fibers surrounding the pulmonary artery. The therapy signal affects heart contractility more than heart rate. Specifically, the application of the therapy signal increases heart contractility and treats the acute heart failure in the patient. The therapy signal can include electrical or chemical modulation.

Abstract: Apparatus for transcutaneous electrical nerve stimulation in a user, the apparatus comprising: stimulation means for electrically stimulating at least one nerve; an electrode array connectable to said stimulation means, said electrode array comprising a plurality of electrodes for electrical stimulation of the at least one nerve, said electrodes having a pre-formed geometry and known electrode-skin contact area size when in complete contact with the user's skin; monitoring means electrically connected to said stimulation means for monitoring the impedance of the electrical stimulation through said electrode array; and analysis means for analyzing said impedance to estimate a change in the electrode-skin contact area.

Abstract: A magnetic connecting device for closing an electrical circuit through the use of magnetic force and contact plates. The contact plates are configured and shaped in a manner which allows for swiveling without disconnecting.

Abstract: A device and method is provided for biasing lung volume by electrically stimulating tissue associated with the diaphragm or phrenic nerve at a low level.

Abstract: A hybrid method is provided for modulating upper airway function in a subject. The method includes applying first and second therapy signals to the subject to modulate at least one extrinsic laryngeal muscle and at least one intrinsic laryngeal muscle to synergistically control laryngeal motion and vocal fold movement, respectively.

Abstract: A muscle electrostimulation device is configured to apply electrostimulation to a muscle. The electrostimulation includes burst waves each including a pulse group output period and any of pulse group output suspension periods in an alternately repeated manner. In the pulse group output period, rectangular wave pulse signals are output, with output stop times being inserted between the rectangular wave pulse signals. In the pulse group output suspension periods, output of pulse signals stops for a time longer than the output stop times. The repeated burst waves each include rectangular wave pulse signals having positive polarity, and rectangular wave pulse signals having negative polarity.

Abstract: Systems and methods for the treatment of bladder conditions using direct electrical pacing are provided. The systems and methods generally apply high-frequency pacing stimuli directly to the bladder wall, from one or more of the inner and outer bladder surfaces.

Abstract: The present specification discloses devices and methodologies for the treatment of transient lower esophageal sphincter relaxations (tLESRs). Individuals with tLESRs may be treated by implanting a stimulation device within the patient's lower esophageal sphincter and applying electrical stimulation to the patient's lower esophageal sphincter, in accordance with certain predefined protocols. The presently disclosed devices have a simplified design because they do not require sensing systems capable of sensing when a person is engaged in a wet swallow and have improved energy storage requirements.

Abstract: A method and system for applying therapeutic stimulation to a patient stricken with paralysis or other condition. The inventive method includes the steps of: inserting an acupuncture needle against the spine of the patient and applying an electrical potential to the needle with a signal that mimics natural neural impulses in the body. The needle is located depending on the nature of the patient's condition. In the illustrative application, the needle is inserted against the ligamentum flavum of the patient's spine at L3. In the best mode, the patient's legs are moved during the application of the electrical potential. The inventive system is adapted to minimize a notch reaction and includes an electrode inserted into a tissue of the patient and a circuit for applying an electrical potential to the electrodes with a signal that mimics natural neural impulses in the body.

Abstract: Implanted pulse generators with reduced power consumption via signal strength-duration characteristics, and associated systems and methods are disclosed. A representative method for treating a patient in accordance with the disclosed technology includes receiving an input corresponding to an available voltage for an implanted medical device and identifying a signal delivery parameter value of an electrical signal based on a correlation between values of the signal delivery parameter and signal deliver amplitudes. The signal deliver parameter can include at least one of pulse width or duty cycle. The method can further include delivering an electrical therapy signal to the patient at the identified signal delivery parameter value using a voltage within a margin of the available voltage.

Abstract: An electrical neuromodulation system and method of meeting a therapeutic goal for a patient using a neuromodulation device. A modulation parameter value is varied by a step size. The neurostimulation device instructs the neuromodulation device to deliver electrical energy to at least one electrode in accordance with the varied modulation parameter value. A therapeutic feedback indicator is compared to a threshold in response to the delivery of the electrical energy. Whether the therapeutic goal has been met is determined based on the comparison, and the previous steps are repeated to determine the modulation parameter value at the resolution of the step size that minimizes energy consumption of the neuromodulation device required to meet the therapeutic goal when delivering the electrical energy to the electrode(s) in accordance with the varied modulation parameter value.

Abstract: A system for restoring muscle function to the lumbar spine to treat low back pain is provided. The system may include electrodes coupled to an implantable pulse generator (IPG), a handheld activator configured to transfer a stimulation command to the IPG, and an external programmer configured to transfer programming data to the IPG. The stimulation command directs the programmable controller to stimulate the tissue in accordance with the programming data. The system may include a software-based programming system run on a computer such that the treating physician may program and adjust stimulation parameters.

Abstract: An implantable pulse generator (IPG) that generates spinal cord stimulation signals for a human body has a programmable signal generator that can generate the signals based on stored signal parameters without any intervention from a processor that controls the overall operation of the IPG. While the signal generator is generating the signals the processor can be in a standby mode to substantially save battery power.

Abstract: According to various method embodiments, a person is indicated for a therapy to treat a cardiovascular disease, and the therapy is delivered to the person to treat the cardiovascular disease. Delivering the therapy includes delivering a vagal stimulation therapy (VST) to a vagus nerve of the person at a therapeutically-effective intensity for the cardiovascular disease that is below an upper boundary at which upper boundary the VST would lower an intrinsic heart rate during the VST.

Abstract: System and methods for adjusting electrical therapy based on impedance changes are disclosed herein. A method in accordance with a particular embodiment includes applying a therapeutic electrical signal to a patient via an implanted portion of a patient stimulation system that includes a signal delivery device in electrical communication with a target neural population of the patient. The electrical signal is delivered in accordance with a signal delivery parameter having a first value. Using the implanted portion of the patient stimulation system, a change in an impedance of an electrical circuit that includes the signal delivery device is detected. Based at least in part on the detected impedance change, the method can further include automatically adjusting the value of the signal delivery parameter from the first value to a second value different from the first, without human intervention.

Abstract: A stimulator and a method for the treatment of intractable pain syndromes by electrical stimulation of the spinal cord is disclosed. An example method includes positioning a first pair of implantable electrodes to a dura matter in an epidural space proximate to a subject's spinal cord at predetermined locations, positioning a second pair of implantable electrodes to the dura matter in the epidural space proximate to the subject's spinal cord at predetermined locations, and transmitting signals of first and second frequencies through the first and second pairs of implantable electrodes respectively, so that the signals of the first and second frequencies interfere with each other to produce at least one beat signal proximate to the subject's spinal cord. The at least one beat signal has a frequency within a range of more than 250 Hz to about 15,000 Hz.

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

Abstract: Implantable medical devices, implantable medical device systems that include such implantable medical devices, and implantable medical device batteries, as well as methods of making. Such devices can include a battery of relatively small volume but of relatively high power (reported as therapeutic power) and relatively high capacity (reported as capacity density).

Abstract: Systems, methods, and apparatuses monitor mammal conditions, report condition changes, and provide neurocode-based treatment in response to condition changes. A mammal implantable controller includes modules to monitor, wirelessly communicate to external computers, and administer treatment received from a remote computer based on monitoring of changes in mammal condition as analyzed by the remote computer. External computers can be provided in the form of a mobile device (e.g., smartphone/tablet), resident treatment pods, and treatment servers. Treatment can be provided to change biological function or trigger cell death in cancer cells.