Abstract: A prior art demand valve has been modified to make it more responsive to persons with impaired oxygen delivery by replacing its sensing diaphragm and associated mechanically actuated valve actuator with a solenoid activated proportional control valve coupled to an analog pressure transducer via a pulse width modulated current driver circuit. The pressure transducer responds to detected pressure changes in a patient's breathing tube.

Abstract: A system for improving a person's sleep includes a bedding layer having a plurality of individually controllable thermally adjustable zones, a plurality of temperature sensors, where at least one temperature sensor per thermally adjustable zone is dispersed throughout the bedding layer. Further, a controller is configured to control the heating power of each thermally adjustable zone, and detect in which the body presence is detected.

Abstract: The disclosure relates generally to an extended use systems and devices for management of bladder function for people with urinary dysfunction. The system includes a catheter and a valve that can control fluid flow. The catheter can be placed inside the bladder using devices that facilitate insertion and extraction. The placement of the catheter can be done by a trained individual such as a patient, as well as a clinician, a nurse, or a caretaker. Once placed inside the bladder, the catheter can be fully-internal, meaning no portion of the catheter is visible from outside of the patient's body.

Abstract: An adjustable diameter catheter includes a wall extending in an axial direction surrounding a lumen of the catheter, the wall having at least one outer spring and at least one inner spring arranged coaxially to the outer spring. The at least one outer spring surrounds the at least one inner spring. The at least one inner and outer springs each have a distal end which are connected to one another. The at least one inner and outer springs each have a plurality of windings. A winding direction of the at least one outer spring is opposite to a winding direction of the at least one inner spring.

Abstract: Aspects of the present disclosure include a catheter, such as an endovascular catheter configured for catheter rotation during a catheterization procedure, e.g., an endovascular catheterization procedure. The catheter includes a first tubular member and a second tubular member surrounding at least a portion of the central portion of the first tubular member, where the first and second tubular members are rotatable with respect to each other. Methods for performing a catheterization and kits that include the catheter are also provided.

Abstract: A therapy specific, pre-programmed, hand-held auto-injection device for delivering a drug to a patient includes a housing, a plurality of syringes carried by the housing, at least one actuator disposed within the housing coupled to the plurality of syringes, and a controller disposed within the housing and communicatively coupled to the at least one actuator. The controller is configured to receive an infusion and aspiration profile, which includes an infusion and aspiration protocol for controlling at least one of the plurality of syringes. The controller is also configured to operate the at least one actuator based on the infusion and aspiration protocol by either expelling a fluid from a respective barrel of the plurality of syringes into the infusion and aspiration location or drawing a fluid from the infusion and aspiration location into a respectively barrel of the plurality of syringes.

Abstract: A jointed system for delivering a medical device to a target location within a human anatomy, comprising: a first segment that is a hollow cylinder, wherein a first flange and a second flange are attached to the distal end and extend distally away from the first segment; a second segment that is a hollow cylinder and has a proximal end and a distal end, wherein a third flange and a fourth flange are attached to the proximal end and extend proximally away from the second segment; a connector element having four cylindrical lugs extending radially away from a central point, wherein each lug passes, respectively, through a circular hole, and further wherein the connector element defines at least two separate openings extending in a direction from the distal end of the first segment to the proximal end of the second segment.

Abstract: A catheter hub assembly. The catheter hub assembly includes a catheter hub body, a septum and a septum retainer, the catheter hub body having a distal end, a proximal and an internal wall defining an internal fluid passageway therebetween, the internal wall defining a transitional step within the internal fluid passageway, the septum positioned within the internal fluid passageway such that a distal end of the septum abuts up against the transitional step, the septum retainer at least partially receivable within the internal fluid passageway and having an outer wall shaped and sized to interlock with the inner wall of the catheter hub body, the outer wall including one or more lateral ribs configured to inhibit rotation of the septum retainer relative to the catheter hub body.

Abstract: The present invention is directed to an echogenic coil member for a catheter assembly and methods of manufacturing same. The catheter assembly includes a catheter having a proximal end and a distal end that defines a lumen extending from the proximal end to the distal end. Thus, the echogenic coil member is configured within the lumen of the catheter. Further, the coil member includes a plurality of outwardly extending projections that contain a plurality of discontinuities. As such, the discontinuities are configured to enhance ultrasonic imaging of the catheter assembly.

Abstract: Apparatus and associated methods relate to a catheter manipulation handle with user interface controls for steering a catheter in situ while providing an augmented (e.g., motorized, powered and tunable precision steering, and perforation safeguards) control and feedback user experience. In an illustrative example, the catheter manipulation handle may provide motor assisted operation to automatically rotate and/or deflect a distal tip of the catheter to steer and guide the distal tip to a target location in the patient's vasculature system. The augmented feedback may include, for example, haptic feedback via the handle. Haptic, audible, and/or visual feedback via the handle may indicate, for example, proximity or engagement of the distal tip with sensitive tissue. In some examples, the handle's augmented operation may advantageously amplify feedback signals to enhance the user's perception of the patient's safety with respect to the safe passage of the distal tip through the patient's vasculature.

Abstract: The present disclosure provides a medical device comprising an actuator restraining assembly configured to assist in restraining a catheter shaft in a deflected configuration. The actuator restraining assembly may include a brake element, a release element, a connecting sheath, and a connecting rod disposed in a catheter handle, wherein the connecting sheath and connecting rod are attached to an actuator mechanism, and wherein the at brake element is attached to the connecting sheath and the release element is attached to the connecting rod. The brake element is sized and configured to contact an inner wall of the handle to thereby provide resistance to movement of actuator mechanism in a proximal direction with respect to the handle. In one embodiment, the actuator restraining assembly is configured to allow for temporary, i.e., reversible, restraining of the catheter shaft in the deflected configuration.

Abstract: A deflectable medical device incorporates a strut that is configured to reduce or eliminate axial shortening of the deflectable portion of the medical device, for example, the deflectable distal end portion of a catheter or access sheath. The strut may is coaxially disposed in the medical device in the section that is contemplated to undergo the repeated deflection. The strut provides improved column strength and axial restoration. The strut may be stent-like device, an elongate device having opposing ends coupled by a connecting lattice involving a plurality of helical connecting elements or a tube having a plurality of circumferentially-extending slots arranged in longitudinally-extending rows.

Abstract: A transcranial fastening device (1) for a drainage catheter (3), comprising an external body (5) being equipped with a passage (P), the passage (P) being equipped with blocking means (9) of the drainage catheter (3) adapted to allow a sliding of the drainage catheter (3) through the passage (P) along a first movement direction (M1) and to prevent a sliding of the drainage catheter (3) through the passage (P) along a second movement direction (M2).

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

Abstract: One embodiment is directed to a method for creating translumenal vascular access, comprising utilizing a dilator adaptor to assist with forming a substantially atraumatic geometric outer junction between a dilator member/introducer member assembly and a guidewire which may be somewhat undersized relative to a lumen formed through the dilator member, thereby creating a geometric fit gap which may be suboptimal from a tissue interfacing perspective. The dilator adaptor may be interposed between the guidewire and dilator member to assist in remedying this fit mismatch, and in generally providing a preferred outer instrument interface for insertion through a small defect in a vessel to gain access to a lumen defined through the vessel.

Abstract: A controller (10) for manually controlling a guidewire (50) includes a housing (100) including a passage (112) for receiving the guidewire. A gripper (140) is actuatable to grasp the guidewire (50) in the passage (112). A cap (200) is connected to the housing (100). The cap (200) is rotatable relative to the housing (100) to actuate the gripper (140). The housing (100) includes an element (160) for maintaining the cap (200) in a receiving position. The cap (200) when in the receiving position places the controller (10) in a condition for receiving the guidewire (50).

Abstract: Composite fiber reinforced balloons for medical devices are prepared by applying a web of fibers to the exterior of a preformed underlayer balloon, encasing the web with a matrix material to form an assembly, and inserting the assembly into a preformed outer layer balloon to form the composite balloon.

Abstract: The present teachings provide a device and methods of making and using thereof. Specifically, one aspect of the present teachings provides a self-expandable device with a braided structure comprising a shunt, a distal retention flange, and a proximal retention flange. Upon the device being deployed at a treatment location, the distal retention flange or the proximal retention flange transitions to have a diameter that is greater than the diameter of the shunt portion. And the shunt portion has a braid angle ?. Another aspect of the present teachings provide that the ratio of flange/shunt diameter equals or greater than 1/sin ?. Yet another aspect of the present teachings provides an axial constraining mechanism to reinforce the shunt portion.

Abstract: A hydrocephalus shunt arrangement for draining cerebrospinal fluid (CSF) in a patient includes a ventricle catheter, a first drainage line, a control valve, a second drainage line, and an intracranial device. The ventricle catheter is inserted into a ventricle space of the brain of a patient. The first drainage line is connected to the ventricle catheter. The control valve is connected to the first drainage line and controls the drainage of CSF from the cranium of the patient through the second drainage line into a drainage area inside an abdominal cavity of the patient. The intracranial device is implanted under the skin of the patient in or at the cranium and connected to the ventricle catheter or the control valve. The intracranial device includes a corrugated metal membrane covering a chamber disposed within a rigid housing. The control valve produces a desired, controlled, drainage of excess CSF.

Abstract: A micro-needle device for delivering a dental local anesthetic that includes a micro-needle array and a hollow spheroid shaped container. The micro-needle array has a base and two or more elongate micro-needles. The elongate micro-needles have an interior surface defining an opening through the elongate micro-needle and the base has a first major surface and a second major surface through which the opening of the elongate micro-needle passes to provide a passage across the base. The hollow spheroid shaped container includes an inside surface, where the first major surface of the base and the inside surface of the hollow spheroid shaped container define a volume that is in fluid connection with each opening of the two or more of the elongate micro-needle. This allows the dental local anesthetic to flow from the volume of the micro-needle device through the opening of the two or more of the elongate micro-needle.

Abstract: A transdermal drug delivery device comprises needles for piercing the skin of a patient to form pores in a predefined pattern; and carriers in the same pattern that may be loaded with a drug for delivery. The carriers are applied to the pores to deliver the drug through the pores to a location beneath the surface of the skin. The carriers may remain outside the pores, be introduced into the pores after the needles have been removed, or be inserted alongside the needles while they are still in place.

Abstract: Fluid transfer device and method that allows for sterile wet connections, allows the connection to be reversed, and allows the connection to be reconnected, while leaving the connectors sterile and reusable under pressure. In certain embodiments, the device includes a first member and a second member, the latter adapted to receive the former in locking engagement upon actuation of the device to create fluid communication between the two in a sterile manner. Each of the members include a door that when opened, allows the first member to be linearly displaced into the second member to allow fluid to be transferred. When fluid transfer is complete, the first member can be retracted from the second member, and the doors closed.

Abstract: An oral care implement having conductive protrusions. In one embodiment, the oral care implement includes a handle and a head coupled to the handle. Furthermore, the oral care implement includes a power source. A plurality of conductive protrusions may be electrically coupled to the power source. The plurality of conductive protrusions may include a base proximate the head and a distal end spaced from the head. Furthermore, at least one of the conductive protrusions may taper from the base to the distal end.

Abstract: A system and method for improving limb function through the use of percutaneous mechanical and neural interfaces. The system generally uses a hollow long bone axial rod that is inserted into the long bone medullary cavity. A transfer rod with a central channel is mounted to the long bone axial rod. An exterior body attachment is connected to the transfer rod and attachment rings attach muscle groups, fascia layers and dermal layers to the transfer rod. Additionally, the system is configured to collect and transmit nerve signaling data to an external processor and additionally configured to transmit data from the external processor to the plurality of nerves.

Abstract: A neurostimulation paddle lead, method of neurostimulation, and neurostimulation system are provided. The neurostimulation paddle lead carries a plurality of electrodes comprising at least four columns of electrodes having a spacing between two inner electrode columns less than a spacing between the inner electrode columns and adjacent outer electrode columns. The inner electrode columns may also be longitudinally offset from the outer electrode columns. The methods and neurostimulation systems steer current between the electrodes to modify a medial-lateral electrical field created adjacent spinal cord tissue.

Abstract: The present invention provides a single surgical method, procedure and/or system that creates open visual and physical access to an identified spinal treatment site that comprises both targeted vertebral and spinal levels to be treated, wherein the spinal levels comprise at least one dorsal root ganglion. A spinal treatment procedure is performed generally in combination with implantation of a neuromodulation system that may comprise placement of electrical lead(s) on the at least one dorsal root ganglion, wherein each lead is in operative connection with a pulse generator that may also be implanted during the surgical method. Electrical stimulation may be generated with the pulse generator through the electrical leads to the at least one dorsal root ganglion during and/or after the closure of the identified spinal treatment site.

Abstract: This system includes a conductor microcable and an insulating microcatheter, including a hollow tube housing the microcable with the possibility of relative axial translation therebetween. The microcatheter is suitable for permanent implantation. The microcatheter, in its distal portion, includes at least one lateral window formed by a through orifice formed on the wall of the hollow tube. The window forms a stimulation site defined on the wall of the target vein facing the window of the microcatheter, and provides for a region of the microcable surface located at the window to form a stimulation electrode. In its distal portion, the microcable is not isolated at least in the region of the window of the microcatheter. The microcatheter is telescopically moveable on the microcable, so as to modify the position of the stimulation site of the target vein.

Abstract: An insulated electrode system for delivering a plurality of tumor treating electromagnetic fields including an array of electrode elements for proximate location on a body of a patient. Each electrode element of the array having an insulation layer. Each electrode element being independently electrically accessible and configured to be assigned to emanate an electromagnetic field relative to at least one other of the electrode elements.

Abstract: Methods of treatment of disorders of the knee, such as medial osteoarthritis and knee instability due to anterior cruciate ligament deficiency, are provided herein.

Abstract: In one aspect, the present disclosure is directed to a method for identifying a site with a patient for treatment. The method may include engaging a plurality electrodes with an interior wall of the patient at a plurality of locations. The method may also generating a virtual map of a plurality of electrodes, wherein each of the plurality of electrodes is displayed with a first indicia. The method may also include displaying each of the plurality of electrodes engaged with the interior wall with a second indicia, measuring electrical activity, identifying at least one site for treatment based on the measured resulting electrical activity, and displaying each of the plurality of electrodes identified for treatment with a third indicia.

Abstract: Provided is a urination disorder treatment device which easily confirms with high accuracy whether it is appropriately used or not. In the urination disorder treatment device, a control portion compares a stimulation pulse 58 by a pair of body-surface electrode pads with a detection pulse 60 of a toe to judge whether a nerve passing through the sacral bone or the vicinity of the sacral bone is appropriately stimulated by the stimulation pulse 58 or not. Further, the detection pulse 60 is generated by reactions of the tibial nerve and/or the peroneal nerve extended up to the tiptoe which are connected to the nerve passing through the sacral bone or the vicinity of the sacral bone by way of the ischiadic nerve.

Abstract: Provided is an electric stimulation treatment device which is capable of outputting a stimulation voltage more efficiently than a conventional device. A urination disorder treatment device includes a pair of body-surface electrode pads 37, an indifferent electrode pad 39 which is larger in area than a body-surface electrode pad 37 with a relatively larger area, of the pair of body-surface electrode pads 37, and disposed in the vicinity of the pair of body-surface electrode pads 37, and a control portion 48 which supplies an electric signal to the pair of body-surface electrode pads 37 and the indifferent electrode pad 39.

Abstract: Methods are provided for treating diseases by altering body mass composition in a human subject through application of galvanic vestibular stimulation (GVS) using electrodes placed in electrical contact with the subject's scalp at a location corresponding to each of the subject's left and right vestibular systems. The methods may be used to treat obesity-related diseases such as diabetes, hypertension, type 2 diabetes mellitus and osteoporosis. GVS may be applied for a predetermined period of time at regular intervals.

Abstract: Apparatus and methods for managing pain uses a single composite modulation/stimulation signal with variable characteristics to achieve the same results as separate varying electromagnetic signals. The composite signal is utilized for modulating the expression of genes involved in diverse pathways including inflammatory/immune system mediators, ion channels and neurotransmitters, in both the Spinal Cord (SC) and Dorsal Root Ganglion (DRG) where such expression modulation is caused by spinal cord stimulation or peripheral nerve stimulation using the disclosed apparatus and techniques.

Abstract: One aspect of the present disclosure relates to a system for treating obstructive sleep apnea in a subject. The system can include a power source and a neuromuscular stimulator in electrical communications with the power source. The neuromuscular stimulator can include a controller and at least one electrode. The controller can be configured to receive certain power and stimulation parameters associated with a therapy signal from the power source. The at least one electrode can be configured to deliver the therapy signal to a target tissue associated with control of a posterior base of the tongue of the subject.

Abstract: Electrical stimulation therapy is provided to a patient in order to induce a patient sensation. The patient sensation may be selected from a number of patient sensations. A set of therapy parameter values are associated with each of the number of patient sensations. A user interface allows a user to adjust one or more characteristics of the patient sensation.

Abstract: This document discusses, among other things, systems and methods for managing pain of a subject. A system includes one or more physiological sensors configured to sense a physiological signal indicative of patient brain activity. The physiological signals may include an electroencephalography signal, a magnetoencephalography signal, or a brain-evoked potential. The system may extract from the brain activity signal one or more signal metrics indicative of strength or pattern of brain electromagnetic activity associated with pain, and generate a pain score using the one or more signal metrics. The pain score can be output to a patient or a process. The system may select an electrode configuration for pain-relief electrostimulation based on the pain score, and deliver a closed-loop pain therapy according to the selected electrode configuration.

Abstract: Systems and methods for active charge-balancing for high frequency neural stimulation are disclosed.

Abstract: An implantable medical device system is configured to detect a tachyarrhythmia from a cardiac electrical signal and start an ATP therapy delay period. The implantable medical device determines whether the cardiac electrical signal received during the ATP therapy delay period satisfies ATP delivery criteria. A therapy delivery module is controlled to cancel the delayed ATP therapy if the ATP delivery criteria are not met and deliver the delayed ATP therapy if the ATP delivery criteria are met.

Abstract: Systems and methods for evaluating electrostimulation of a heart are disclosed. A system can comprise an electrostimulation circuit that can deliver multi-site electrostimulation, including pacing at two or more sites of the heart during the same cardiac cycle. The system can comprise a heart sound sensor circuit configured to sense a heart sound (HS) signal during multi-site stimulation. The heart sound sensor circuit can also sense HS signals in response to uni-site stimulation at a specified site capturing at least a portion of the heart. The system can comprise a pacing analyzer circuit that uses the HS signals during the multi-site stimulation and during the uni-site stimulation to determine a capture status indication that indicates whether the multi-site stimulation captures the two or more sites of the heart, and can be one of a full capture indication, a partial capture indication, or a loss of capture indication.

Abstract: An implantable medical device (IMD) may include a plurality of coils that may be used to recharge a power supply of the IMD and/or provide telemetry for the IMD. The IMD may be configured to couple all of the coils in series, such that currents that are induced by each of the coils are added together when the IMD is exposed to an electromagnetic field. The IMD may be configured to alter the coupling of the coils such that the coils are coupled in series opposition, such that currents that are induced by some coils of the IMD are opposed by currents that are induced by other coils of the IMD.

Abstract: A system level scheme for networking of implantable devices, electronic patch devices/sensors coupled to the body, and wearable sensors/devices with cellular telephone/mobile devices, peripheral devices and remote servers is described.

Abstract: Implantable medical device systems and methods of use including an implantable first medical device having a lead with a transducer thereon and an implantable second medical device having a receiver for receiving energy emitted by the transducer. The lead may be placed in an internal thoracic vein, and other locations may be used as well. The implantable second medical device may be placed in or on the heart or an associated blood vessel.

Abstract: An apparatus has advanced amplifier Classes and low pass filter technologies for using software generated ascending or level waveforms that are effective when applying cardiac defibrillation and cardioversion waveforms which significantly reduce damage to the heart muscle. The apparatus comprises a waveform energy control system for delivering software generated waveforms comprising differentially driven Class D and Class B amplifier sections, wherein the Class D amplifier section produces Phase 1 ascending waveforms and has a programmable lowpass filter (LPF) and wherein the Class B amplifier section delivers hard-switched Phase 2 waveforms.

Abstract: This disclosure describes an implantable medical electrical lead and an ICD system utilizing the lead. The lead includes a lead body defining a proximal end and a distal portion, wherein at least a part of the distal portion of the lead body defines an undulating configuration. The lead includes a defibrillation electrode that includes a plurality of defibrillation electrode segments disposed along the undulating configuration spaced apart from one another by a distance. The lead also includes at least one electrode disposed between adjacent sections of the plurality of defibrillation sections. The at least one electrode is configured to deliver a pacing pulse to the heart and/or sense cardiac electrical activity of the heart.

Abstract: An operation teaching device used in operation teaching during movement and/or rotation operation of an object (2h) to adjust the object to a predetermined position and direction, including: a TOF type depth image camera (40) for obtaining three-dimensional shape information about the object; extraction means for extracting a feature region from the three-dimensional shape information acquired by the TOF type depth image camera (40) using a luminance image of the object obtained from information about light receiving intensity of the projection light, the projection light being reflected from the object and received with light receiving means; and generation means for generating information for the operation teaching by calculating a deviation between the three-dimensional shape information including the feature region of the object in the predetermined position and direction and the three-dimensional shape information including the feature region of the object in a current position and direction.

Abstract: There is provided a phototherapy apparatus, in which the therapeutic light is delivered through one or more massage components. The massage component provides mechanical massage to the subject biological tissue and modifies the properties of the subject tissue in thickness, density, etc. to facilitate the absorption of the therapeutic light and enhance the effect of the phototherapy procedure. The light source of the phototherapy apparatus is actively cooled by a synthetic jet cooler.

Abstract: The invention provides a laser system and method for administering multiple beams of laser energy in tissue treatment applications. The system administers the beams simultaneously in a distribution pattern of spatially separated overlapping and non-overlapping regions on a tissue. The simultaneous administration and distribution pattern permit the beams to propagate within a tissue without producing the light scattering effects that characterize the sequential application of multiple laser beams to a tissue.

Abstract: An intracranial treatment apparatus comprises an outer shaft having a proximal end and a distal end for positioning within the tissue region of the brain. The outer shaft defines a lumen extending between the proximal end and the distal end of the outer shaft and having at least one aperture adjacent the distal end of the outer shaft. An inner light-delivery element having a distal end and a proximal end is adapted to be operatively connected to the light source. The light-delivery element is configured to be received within the lumen and extend from the proximal end of the shaft to adjacent the distal end of the shaft. The light-delivery element is adapted to deliver light from the light source through the at least one aperture of the outer shaft to the tissue region of the brain in proximity to the distal end of the outer shaft.

Abstract: A radiation planning system includes a predictor-corrector optimizer unit which computes a predicted dose based on a collection of control points with a current approximate dose, each control point with a corresponding set of leaf positions, and determines an additional control point with a corresponding set of leaf positions based on a difference of the predicted fluence and the current approximate fluence through a least cost or shortest path in a layered graph structure of realizable leaf positions. Tools are described to help a planner to evaluate the effect of parameter changes to the current plan based on an identified zone of influence. The planner interactively views the current plan based on a visualization of the plan objectives and correlations between the objectives.