Abstract: Actuators for steerable medical devices are disclosed that not only deflect or steer a portion of a medical device (e.g., a distal portion of a catheter shaft), but also include mechanisms for actively returning the deflected portion of the medical device to an initial configuration (e.g., straight or substantially straight). These active return-to-straight mechanisms may return a catheter shaft from a deflected configuration to a substantially straight configuration throughout a medical procedure, may employ one or more tension members extending along the catheter shaft, and may comprise a gross return actuator and a fine return actuator. For example, the gross return actuator may be configured to partially reverse the deflection of the distal portion of the catheter; and the fine return actuator may be configured to continue reversing the deflection. The gross return actuator may automatically trigger or actuate (mechanically or electromechanically) the fine return actuator.

Abstract: A vascular access device may be an integrated catheter. The vascular access device includes a catheter and catheter adapter having a catheter hub and side port. The contact angle of a probe is greater than 90 degrees. The entrance angle of a probe entering the catheter hub from the side port may be less than 45 degrees. The vascular access device may include a component configured to direct the path of a probe towards the catheter opening. The component may be a protrusion extending into the lumen of the side port, internal fluid passageway, and/or extension tube, or a septum within the catheter hub. The vascular access device includes an access adapter in fluid communication with the side port and permitting insertion of a probe into the catheter through the side port with or without a separate luer adapter. Methods of using a vascular access device are further disclosed.

Abstract: A catheter insertion device includes a handle, a needle, a guide wire, and a catheter. The handle may have a proximal region and a distal region. The distal region may include a slot between a top extension and a bottom extension, which extends through a distal end. The needle may have a proximal end positioned in the proximal region and a distal end extending from the distal region. The guide wire may have a proximal end positioned in the proximal region of the handle and a distal end positioned in a lumen of the needle. The catheter may be positioned coaxially over the needle with a proximal end connected to a catheter hub. The catheter hub may be slidably disposed in the slot to enable movement from a first position in the distal region to a second position distal of the distal region.

Abstract: Embodiments of the present disclosure are directed to apparatuses, systems, and methods for merging a balloon catheter onto a locked guidewire. In one implementation, a balloon catheter may include an inflatable balloon affixed thereto and a slit extending from a distal end of a guidewire lumen to a position proximal of the balloon. The slit may be widened by a working member of an adapter to allow passage of the locked guidewire into the guidewire lumen of the balloon catheter. The balloon catheter may be merged onto the guidewire via the slit and delivered to the desired treatment device without requiring the guidewire to be unlocked. Advantageously, access to at least one desired treatment site may be maintained with the guidewire during merging of the balloon catheter.

Abstract: An apparatus for performing a medical procedure includes a balloon comprising an inflatable body. A first releasable or frangible connection is provided to maintain the body at a first diameter up to a first inflation pressure, and to release, such as by disconnecting, and thus allow the body to assume a second diameter, such as at a second inflation pressure greater than the first inflation pressure or upon a manual release of the connection by a clinician. Multiple releasable or frangible connections may be provided, including between portions (folds) of the inflatable body of the balloon. This disclosure also pertains to a non-compliant or semi-compliant balloon having a first inflation diameter corresponding to a first range of inflation pressures and a second inflation diameter corresponding to a second inflation pressure greater than the first range of inflation pressures.

Abstract: A drug or agent coated balloon having a length which is adjustable in vivo is described herein. The balloon is configured to be coated or coatable with one or more drugs where the coating may be applied prior to advancement into a patient body or prior to balloon expansion within the patient body. The length of the expandable portion of the balloon is adjustable to approximate a length of the tissue region to be treated. Moreover, the drug-coated balloon may be used alone or it may be utilized to deploy luminal prostheses having one or more linked or otherwise coupled segments.

Abstract: A balloon catheter is disclosed having a balloon at a distal portion of a catheter shaft and on a surface of the balloon with elongate bodies which are crystals of a water-insoluble drug having independent long axes. The balloon in a deflated state has a plurality of wing portions in a circumferential direction, and a circumferential surface portion along a circumferential direction of the catheter shaft, the wing portions being folded along the circumferential direction of the balloon. Surface of the circumferential surface portion which faces the folded wing portion has a region in which tip portions are not in contact with the surface of the balloon or with other elongate bodies, and surface face of the folded wing portion which faces an outer circumferential side has a region in which the tip portions are in contact with the surface of the balloon or with other elongate bodies.

Abstract: Improved medical guide elements for use with dilators to be inserted into an organ or body structure of a patient, such as the kidney. The guide element includes a proximal segment and a distal segment. The diameter of the distal segment is greater than the diameter of the proximal segment. The change in diameter is abrupt, providing a discrete step transition at a point along the filament which presents a proximally-facing surface on the distal segment. When the proximal segment of the guide element is fully inserted into a dilator having a distal tip adapted for insertion into a patient, the dilator distal tip firmly abuts the proximally-facing end surface of the distal segment. The relative dimensions of the dilator tip and the discrete stepped transition of the guide element provides full shielding or over shielding of the dilator tip, thereby facilitating passage of the dilator tip along the tissue track, through the puncture hole and into the orifice.

Abstract: A microneedle includes a base having a support surface, and a projection that protrudes from the support surface, the projection having a through hole that penetrates the projection in an extending direction of the projection. The projection includes a flow path expansion section which is configured to expand a communication path that communicates between an inner space of the through hole and a space surrounding the projection in response to an increase in pressure of a fluid flowing in the through hole.

Abstract: A microneedle device comprising: a substrate comprising one or more layers; and at least one microneedle which extends from the substrate; wherein the substrate comprises at least one layer which is a high surface energy material layer and which is capable of retaining the at least one microneedle.

Abstract: The utility model discloses a tattoo needle comprising a grip and a tattoo needle nozzle fixed in an inner cavity of the grip. The inner cavity of the grip is provided with an engagement switch. The bottom of a front end of the engagement switch is provided with engaging protrusions, and the top of the front end is spaced apart from an inner cavity wall of the grip, while a rear end of the engagement switch contacts with the inner cavity wall of the grip. The front end and the rear end of the engagement switch can both move upwards and downwards. A corresponding position at an external top part of the tattoo needle nozzle is provided with engaging recesses that match the engaging protrusions. In the present utility model, by adopting a snap-type fixing method, it requires only to press an outer jacket in order to realize the removal of the tattoo needle nozzle from the grip, which is convenient and fast.

Abstract: A catheter assembly and/or an introducer may include one or more features configured to guide a probe and/or a catheter distally through a septum. The catheter assembly may include a catheter adapter and the septum. The catheter adapter may include a distal end, a proximal end, and a lumen extending therebetween. In some embodiments, the septum may be disposed within the lumen. The septum may include a proximal surface that is tapered inwardly in a distal direction such that the proximal surface of the septum is configured to guide the probe and/or the catheter distally through the septum. The catheter assembly may be configured to receive an introducer, which may include an introducer element. A proximal end of the introducer element may include another proximal surface that is tapered inwardly in the distal direction such that the other proximal surface is configured to guide the probe or the catheter distally through the septum.

Abstract: Medical devices including vascular access kits and related methods are disclosed. In some embodiments, a vascular access system may include a first conduit, a second conduit, and a connector that is reversibly or irreversibly coupled to both the first and second conduits such that there is a continuous lumen from the first conduit and the second conduit. In some embodiments the vascular access system may include a connector where the inside geometry of the connector enhances laminar flow. The vascular access system, when implanted and assembled, may be a fully subcutaneous surgical implant.

Abstract: A system relating to improved medical-connector contamination prevention. More particularly, this invention relates to a reduced-touch contamination system for small-bore fluid connectors, including male and female Luer-type connectors.

Abstract: A catheter includes: a first port; a second port; a first lumen communicating with the first port; a second lumen configured to selectively communicate with the first port and/or the second port; and a switching mechanism part selectively switchable between a first switching state in which the first port and the second lumen communicate with each other and a second switching state in which communication between the first port and the second lumen is blocked.

Abstract: In various embodiments, a transcutaneous needle electrode and uses thereof are provided. In certain embodiments the needle electrodes comprise a plurality of electrically conductive needles, where the needles are solid, or where the needles are hollow and have a closed tip, where the needles have an average tip diameter less than about 10 ?m and an average length greater than about 20-50 ?m wherein the electrically conductive needles are electrically coupled to one or more electrical leads.

Abstract: A headset for use in delivering electrical stimulation to the skin surface of the head or in sensing one or more body parameters of the head of a user.

Abstract: Provided is an electrical stimulus device including a member to be wound around an arm of a user, multiple electrodes arranged on one surface of the member, and multiple optical distance sensors arranged on the one surface of the member. An electrical stimulus signal output from an electrical stimulus generation circuit is provided to the user from a specific electrode of the multiple electrodes to provide a stimulus to a muscle of the arm at a position facing the specific electrode, and the multiple optical distance sensors detect displacement of muscles of the arm. Some electrodes of the multiple electrodes are substantially rectangular electrodes inclined with respect to a circumferential direction of the arm of the user at a predetermined angle of lower than 90°.

Abstract: Medical leads have one or more openly coiled filars and a distal body coupled to the openly coiled filars. The openly coiled filars provide a lead with compliance and elasticity while the distal body provides the firmness needed for placement and support of the electrodes. The openly coiled filars may transition to a linear distal portion that extends to the distal body, and the distal body may have proximal tines that fold proximally to become adjacent to the linear distal portion of the filars. The openly coiled filars may instead extend to the distal body and the proximal tines may be laterally arced to then fold against the lateral surface of the coiled filars. The tines may fold distally during explantation to allow the distal body to release and exit the body.

Abstract: A device includes a substrate, an electrode, an electrical pad, and a signal line. The signal line is coupled to the substrate and covered by an insulation layer. The signal line is coupled to the electrical pad and the electrode. At least one of the electrode and the signal line includes a diamagnetic material and paramagnetic material, wherein a ratio of the diamagnetic material and the paramagnetic material is selected based on the susceptibility properties of a physiological tissue. The term paramagnetic herein refers to magnetic susceptibility greater than that of the surrounding tissue and diamagnetic refers to magnetic susceptibility lower than that of the tissue.

Abstract: The present disclosure relates to an active retinal implant for implantation in an eye, comprising an array of stimulation electrodes that deliver stimulation signals to retinal cells. At least one signal generator is provided which generates at least one continuous sinusoidal stimulation signal that comprises at least one adjustable signal parameter, and the at least one signal generator is electrically coupled to at least one stimulation electrode.

Abstract: Disclosed is a system including an electrode and a stylet configured to steer the electrode towards its intended position during implantation, and a method for such system's use. An electrode is provided having regions with varied flexibility. A stylet having bends that are indexed to specific regions of flexibility of the electrode may be inserted into the electrode, and upon minimal radial and/or longitudinal movement of the stylet within the electrode, will cause the magnitude of the angle to which the lead is bent to either increase or decrease so as to aid the operator in placement of the electrode.

Abstract: A method of pacing a His bundle of a patient heart using a stimulation system including a memory, a pulse generator, a stimulating electrode and at least one sensing electrode includes applying a plurality of impulses through the stimulating electrode to induce a plurality of responses from the patient heart. Each impulse of the plurality of impulses is delivered at a different impulse energy corresponding to a respective output setting of the stimulation system. The response characteristics for each of the plurality of responses are measured and each impulse is assigned a classification based on whether the respective response characteristics indicate capture of one or both of the His bundle and a ventricle of the patient heart. The output setting and classification for each impulse is then stored in the memory.

Abstract: A device for the active fixation of an implantable medical lead includes a housing, a tine assembly, and rotatable shaft. The housing includes a proximal end for connecting to the lead and a distal end opposite the proximal end. The housing defines a housing lumen having a longitudinal axis extending between the proximal end and the distal end. The tine assembly is disposed within the housing lumen. The tine assembly includes at least one tine configured to self-bias from a linear configuration within the housing to a curved configuration outside of the housing. The rotatable shaft extends through the housing lumen. The shaft is configured to engage the tine assembly such that rotation of the shaft transitions the at least one tine between the linear configuration and the curved configuration.

Abstract: A magnetic alignment system that can form part of a cochlear implant system. The magnetic alignment system prevents substantial movement of a magnet of an implanted component during an MRI procedure or allows for easy removal of the magnet to facilitate the MRI procedure.

Abstract: Implantable medical systems include implantable medical leads that have magnetic orientation-independent magnetically actuated switches that are placed in the conduction path to the electrode of the lead. Thus, regardless of the orientation of a substantial magnetic field like that from an MRI machine to the lead and switch within the lead, the switch opens when in the presence of that substantial magnetic field. The switch may be placed in close proximity to the electrode such that the opening of the switch disconnects the electrode from the majority of the conduction path which thereby produces a high impedance for RF current and reduces the amount of heating that may occur at the electrode when in the presence of substantial levels of RF electromagnetic energy as may occur within an MRI machine.

Abstract: A device for the noninvasive stimulation of the spinal cord, intended for carrying out diagnostic tests and physiotherapy. A spinal cord electrostimulator includes five stimulation channels with an electrode system, each of the channels includes connected in series a voltage converter, a current generator and an output signal generator and it is configured to be able to generate the following rectangular pulses: rhythmic modulated bipolar, rhythmic modulated monopolar, rhythmic non-modulated monopolar, single non-modulated monopolar. The inputs of each of the channels are coupled to a microcontroller, which is connected to an indication unit, a control unit and a radio module. The microcontroller is configured to trigger at least one said channel, to select a triggering mode independently for each of the channels, to control each of said channels with parameters of the pulses and vary said parameters depending on a degree of damage to a spinal segment.

Abstract: Methods and devices are provided for electrical neural blockade and stimulation of dysfunctional or transferred nerves. For example, a method is provided including identifying a dysfunctional or transferred nerve, attaching an electrode array to the dysfunctional or transferred nerve proximal to the target musculature, delivering an electrical neural blockade signal, and stimulating the dysfunctional or transferred nerve distal to the point of neural blockade. A system is also provided with an electrode array configured to attach proximally to a dysfunctional or transferred nerve and deliver an electrical neural blockade signal with a neuromuscular stimulating electrode array placed distal to the point of neural blockade, and a processor in communication with the electrode arrays and configured to provide stimulation instructions based on the detected activity of the other neuromusculature.

Abstract: An exemplary apparatus and method are provided for suppressing an inflammation or an inflammatory cytokine production. For example, the exemplary apparatus and method can cause a weak pulse current to be passed through a living body or living tissue to suppress the inflammation in the living body or the living tissue. The exemplary apparatus can include a power supply device, and a current control device for receiving a supply of power to intermittently apply a direct current at prescribed intervals. The current control device can include a pulse width modulation control device, and the pulse width modulation control device can generate a pulse wave that is a rectangular wave. A time indicating a peak value for rising in one cycle of the pulse wave (“pulse duration”) can be at least 0.1 millisecond, the peak value can be in the range of 1.0V to 20 V, inclusive, and the duty ratio of the pulse wave can be at least 5.5%.

Abstract: A sub-epidermal electric warning device has electrodes penetrating through the patient's epidermis and bipolar electric warning signals are transmitted to the sub-epidermal tissue by these electrodes. A device for surveillance of vital signs, analyte levels, or treatment parameters is using a sub-epidermal electric warning device for notifying the patient in situations requiring intervention.

Abstract: Apparatus for transcutaneous electrical nerve stimulation in a user, the apparatus comprising: a stimulator for electrically stimulating at least one nerve; a stimulator housing; a monitor for monitoring transient motion of the stimulator housing; an analyzer for analyzing transient motion monitored by the monitor for determining whether transient motion of the stimulator housing has occurred; and a controller for automatically transitioning at least one of the stimulator, the monitor, and the analyzer between a standby mode and a power save mode; wherein the power save mode supports a subset of the functionality of the stimulator and the monitor which is available in the standby mode so as to conserve battery power in the power save mode.

Abstract: The invention generally relates to methods of stimulating tissue based upon filtering properties of the tissue. In certain aspects, the invention provides methods for stimulating tissue that involve analyzing at least one filtering property of a region of at least one tissue, and providing a dose of energy to the at least one region of tissue based upon results of the analyzing step.

Abstract: The present invention relates to a device and system to measure and assess superficial skeletal muscle mechanical and neuromuscular contractile characteristics, and interpret the results to provide metrics with quantifiable and qualitative descriptors relating to muscle function. The present device provides a further type of mechanomyography and a new use for acceleromyography by measuring the mechanical muscle movement of an involuntary stimulated muscle from an automated electro-stimulation protocol to determine muscle contractile properties. Muscle twitch response during the latent, contraction and relaxation phase is measured using an array of multiple accelerometers on a sensor pad to assess and diagnose muscle. function from various measurements.

Abstract: Described is a low voltage, pulsed electrical stimulation device for reducing inflammation in a subject, which can be useful in the treatment of concussions, traumatic brain injury, cancer, and so forth.

Abstract: A cochlear implant includes a cochlear lead, a housing, an antenna, a stimulation processor operably connected to the antenna and to the cochlear lead, a first fixation element, a second fixation element with a different configuration than the first fixation element, and a connector configured to simultaneously connect the first and second fixation elements to the housing in such a manner that the first and second fixation elements are independently detachable from the housing.

Abstract: A cochlear implant configured to be implanted within a patient may comprise an integrated circuit including a driver configured to generate a back telemetry signal encoded with information to be transmitted over a wireless communication link to a sound processor located external to the patient. The cochlear implant may also comprise a filter network that includes a first plurality of impedance components including a damping resistor, and a first and a second impedance component such as a capacitor or an inductor. The cochlear implant may also comprise an isolation network including a second plurality of impedance components configured to isolate, from the filter network and the driver, a forward telemetry signal received by the cochlear implant from the sound processor.

Abstract: Described herein are devices and methods of use thereof for treating dry eye, tired eye, or other forms of ocular discomfort such as from contact lenses. The methods generally include applying spatially and/or temporally patterned stimulation to one or more anatomical structures located in an ocular or nasal region. The electrical stimulation may elicit a reflex that activates the lacrimal gland or may directly activate the lacrimal gland or nerves innervating the lacrimal gland to produce tears. The devices may be implantable or handheld, and may be configured to deliver the spatially and/or temporally patterned stimulation patterns described.

Abstract: Various methods and apparatus for treating a condition associated with impaired glucose regulation in a subject comprising in one embodiment, applying a neural conduction block to a target nerve at a blocking site with the neural conduction block selected to at least partially block nerve pulses. In another embodiment, combinations of down-regulating and or up-regulating with or without pharmaceutical agents are used to treat impaired glucose regulation. In other embodiments, up-regulation or down-regulation of various nerves, such as the vagus and its branches, and the splanchnic is used to modify the production of GLP-1 and GIP, thereby controlling glucose levels. In yet further embodiments, combinations of down-regulating and or up-regulating with or without pharmaceutical agents are used to modify the production of GLP-1 and GIP, to treat impaired glucose regulation.

Abstract: Generally discussed herein are systems, devices, and methods for providing a therapy (e.g., stimulation) and/or data signal using an implantable device. Systems, devices and methods for interacting with (e.g., communicating with, receiving power from) an external device are also provided.

Abstract: Methods and systems for electrical stimulation can include obtaining a biosignal of the patient; altering at least one stimulation parameter of an electrical stimulation system in response to the biosignal; and delivering an electrical stimulation current to one or more selected electrodes of the electrical stimulation system using the at least one stimulation parameter. In some embodiments, a power spectrum is determined from the biosignal. In some embodiments, the biosignal is at least two different biosignals measured at the same or different locations on the patient and a coherence, correlation, or association between the two biosignal is determined.

Abstract: Described are a system and method that utilize bioelectric signaling to balance electrical potentials in a subject's body via neuro-hormonal circuit loops, to increase elasticity of the subject's arteries to promote protein release to dampen arterial blood pressure, and to change arterial electrical charges to reduce narrowing of the arteries. The described system is designed to localize and stimulate the fibers inside the vagus nerve without inadvertent stimulation of non-baroreceptive fibers causing side effects like bradycardia and bradypnea. The system also controls release of specific proteins known to lower blood pressures including tropoelastin (known to increase elasticity in the aorta and other peripheral blood vessels).

Abstract: This document discusses, among other things, systems and methods for managing pain of a subject. A system includes a first sensor circuit to sense a first signal indicative of a functional state of the subject, a second sensor circuit to sense a second signal different from the first signal, and a controller circuit. The controller circuit may determine an operating mode of the second sensor circuit according to the sensed first signal, trigger the second sensor circuit to sense the second signal under the determined operating mode, and generate a pain score using at least the second signal sensed under the determined operating mode. The pain score may be output to a patient or used for closed-loop control of a pain therapy.

Abstract: The present invention provides a feedthrough device including: a feedthrough substrate made of an insulator and having a first surface and a second surface; at least one first feedthrough conductor having a terminal exposed to the first surface of the feedthrough substrate and a body connected to the terminal and not exposed to the outside of the feedthrough substrate; and at least one second feedthrough conductor having a terminal exposed to the second surface of the feedthrough substrate and a body connected to the terminal and not exposed to the outside of the feedthrough substrate, and corresponding to the first feedthrough conductor in a one-to-one manner to be paired therewith, wherein a body of each first feedthrough conductor and a body of each second feedthrough conductor corresponding thereto are arranged to be capacitively coupled with each other.

Abstract: A pericardial implantable cardioverter defibrillator (ICD) may be delivered to the heart through the chest wall using an ultrasound image guided catheter. The ICD may comprise a patch and wire leads which may be secured by a clam shell-like pad at a distal end and comprise a pig-tail shaped securing tail at the other end so that the ICD is firmly attached to the pericardium of a human heart. The ICD may be attached where most needed and serve as either a pacemaker or a defibrillator. In one embodiment, the ICD may emit radio frequency warning signals of heart failure sensed when pacemaker or defibrillator usage is rendered necessary.

Abstract: Wearable devices are provided herein including wearable defibrillators, wearable devices for diagnosing symptoms associated with sleep apnea, and wearable devices for diagnosing symptoms associated with heart failure. The wearable external defibrillators can include a plurality of ECG sensing electrodes and a first defibrillator electrode pad and a second defibrillator electrode pad. The ECG sensing electrodes and the defibrillator electrode pads are configured for long term wear. Methods are also provided for using the wearable external defibrillators to analyze cardiac signals of the wearer and to provide an electrical shock if a treatable arrhythmia is detected. Methods are also disclosed for refurbishing wearable defibrillators. Methods of using wearable devices for diagnosing symptoms associated with sleep apnea and for diagnosing symptoms associated with heart failure are also provided.

Abstract: A medical device includes a display area that has a thin panel having a substantially flat front surface portion, a translucent layer on a back surface of the thin panel, a layer of text or graphics on a back surface of the translucent layer, and arranged so that the text or graphics is not visible to a user on the front side when light is not provided from inside the device housing, a switch to allow a user to select a first mode or a second mode for the device, and circuitry arranged to energize one or more light sources to provide light from behind the thin panel when the device is in the first mode, and to thereby make visible the text or graphics when the device is in the first mode.

Abstract: A light-magnetism harmonizer is provided, including: a shell body, defining a space and including a magnetism-shielding layer outside the space; a light generator, attached to the shell body, emitting light into the space; a magnetic unit, attached to the shell body and located by an inner side of the magnetism-shielding layer, part of magnetic line of force of the magnetic unit going outwardly being shielded by the magnetism-shielding layer, part of magnetic line of force of the magnetic unit going inwardly into the space.

Abstract: The present disclosure relates to the technical field of equipment with a rotating magnetic field. Disclosed are a device with a high energy rotating magnet and a massage chair structure with a rotating magnet. The present disclosure includes a vertically driven revolving axle connected to a motor. A top end of the vertically driven revolving axle is connected to a gear set. The gear set meshes with a driving gear. A base revolving plate is fixed on an upper portion of the driving gear. A magnetic assembly is installed on the base revolving plate. The present disclosure offers improved physical performance, low cost, and an enhanced effect of magnetic therapy.

Abstract: This invention relates to a method of photodynamic therapy (PDT) for bladder cancer and its use as an adjuvant or neoadjuvant therapy in the treatment of bladder cancer. The invention provides a composition comprising hexyl 5-ALA ester (HAL) or a pharmaceutically acceptable salt thereof for use in a method of photodynamic therapy for bladder cancer, wherein said composition is instilled into the bladder of a patient in need of such treatment and the inside of said bladder is exposed to blue light having a fluence rate of 1.5 to 12.

Abstract: A cosmetic method for treating a human body to reduce hyperhidrosis includes applying laser light energy to one or more portions of the human body in which the laser light energy is one or more of: about 450 nm, about 930 nm, about 970 nm and about 1060 nm. An apparatus for accomplishing this method includes a source of laser light energy and a controller for controlling the laser light source to apply laser light energy to target and disrupt sweat glands in the human body.