Abstract: The present disclosure relates to devices, systems and processes for delivering therapeutic fluids. Embodiments disclosed herein are directed to medical devices for housing a therapeutic fluid, and methods and systems for monitoring in an infusion delivery device, using a pressure sensor of the device, one or more of: (A) fill event detection; (B) fill volume detection; (C) mechanical compliance calibration/air detection of an infusion management system after fill event and priming; (D) occlusion detection after removal of insertion seal assembly; (E) detecting fluid path deployment of an infusion delivery device; (F) monitoring for occlusion detection during pump use; and (G) detecting an empty reservoir.

Abstract: Disclosed are techniques and a device operable to determine a total amount of insulin delivered to the user over a predetermined time period. The total amount of insulin includes a total basal dosage delivered in basal dosages and a total bolus dosage delivered in bolus dosages over the predetermined time period. A proportion of the total amount of insulin delivered to the user provided via the total basal dosage amount over the predetermined time period is calculated. In response determining the proportion of the total amount of insulin attributed to the total basal dosage amount of insulin exceeds a threshold, an average basal dosage to be delivered within a subsequent time period that is approximately equal to the threshold may be determined. An instruction may be generated and output to deliver a modified basal dosage that substantially maintains the average basal dosage over the subsequent time period.

Abstract: Disclosed herein are systems and methods for the delivery of a co-formulation of insulin and a second drug, such as GLP-1, using an automated insulin delivery system. In a first embodiment, a dose of insulin is calculated by a medication delivery algorithm and a reduction factor is applied to account for the effect of second drug on the user's daily insulin requirement. In a second embodiment of the invention, a total amount of the second drug administered to the user during the past 24 hours is used to modify the correction factor and the insulin-to-carbohydrate ratio used by the medication delivery algorithm to cause a reduction in the insulin delivered to the user to account for the effect of the administration of the second drug portion of the co-formulation.

Abstract: A dual chamber syringe, comprising a syringe barrel having a forward end, a rearward end and at least one bypass protrusion arranged along the longitudinal extent of the syringe barrel; a finger grip element coupled to the rearward end of the syringe barrel, the finger grip comprises at least one protrusion extending radially inwardly from an inner surface thereof; a plunger rod operatively coupled with the finger grip element; a guiding track is formed on the plunger rod and comprises a helical track portion and a longitudinal track portion; and wherein upon relative displacement of the plunger rod and said finger grip element, the at least one protrusion is guided along the guiding track.

Abstract: A fluid injection device including a syringe with a body (1), a piston (3), and a needle (2) with an injection tip (20); a piston rod (5); and a sleeve (10) around the syringe and axially movable between a non-projecting position in which said sleeve (10) does not cover the injection tip (20) and a projecting position. The sleeve (10) urged, while in said non-projecting position, towards its projecting position by a spring (30). The sleeve (10) has an inner portion (11) extending inside the body, and an outer portion (12) extending outside the body (1), the inner portion (11) including a radially-deformable tab (110) snap-fastened in a window (6) of the body (1), blocking the sleeve in its non-projecting position. A hollow member (40) co-operates, after injection, with the radially-deformable tab (110), so that after the fluid is injected, the sleeve is moved automatically towards its projecting position.

Abstract: An injector for injecting a medicament in a patient. The injector includes a container comprising a fluid chamber containing a first volume of a medicament, and an injection conduit associated with the fluid chamber for defining a fluid pathway therefrom to inject the medicament from the fluid chamber through the injection conduit to an injection location. The injector also includes a firing mechanism associated with the fluid chamber for expelling the medicament from the fluid chamber through the injection conduit, arid a volume-control mechanism operable to control a fraction of the first volume of medicament that is injected when the firing mechanism is actuated to inject the medicament.

Abstract: A syringe finger ring and finger ring inserts, that in various embodiments, provides or connects to a syringe that comprises a syringe body capable of having a volume of material therein and a plunger disposed to enter the syringe body and dispense material from the syringe body by movement of plunger, and a novel a finger ring and related structures having an open area and connected, by various structures, to the plunger adapted to receive a finger within the finger ring open area, including a spacer of various embodiments inserted within the open area to selectively reduce the open area and provide more controllable engagement of the syringe plunger by the operator finger in distal and proximal strokes.

Abstract: A syringe assembly includes a barrel defining a chamber therein, pressurized sterile air in the chamber, a plunger including a piston slidable in the chamber in a sealing relation to displace a fluid in the chamber, a seal configured to retain the pressurized sterile fluid in the chamber between the piston of the plunger and the seal when the plunger is stationary, and a needle assembly extending distally from the barrel and in fluid communication with the chamber of the barrel.

Abstract: An injection device is disclosed wherein a dose can be set by rotating a dose setting member, whereby a push button is elevated from one end of the device a distance proportional to the set dose from a position fixed relative to the housing, and wherein the set dose can then be injected by pressing the push button back to its non-elevated position, through which motion a screw will move approximately the same distance or a smaller distance. The invention provides a method of reducing the dose force and/or the push-button movement during injection.

Abstract: A safety housing based implant/medicament injecting system. The system includes a needle assembly prefilled with an implant/medicament for injection and an injecting needle/cannula, a housing for accommodating the needle assembly under usual bias inside said housing, a plunger means having a plunger rod configured for stage-wise forward motion including an initial-injecting plunger forward motion with the needle assembly within the housing to first engage the needle assembly with the housing and a subsequent continuing-injecting plunger forward motion independent of the needle assembly for injecting the implant/medicament. The needle assembly configured to return post-injecting to be secured inside said housing blocking any subsequent use thereof.

Abstract: A medical sharps safety device that is affixable to a conventional medical syringe or other sharp device.

Abstract: A device for cutting, separation, and discharge of a syringe according to an embodiment of the present disclosure includes a barrel unit, a main body including a driving unit configured to rotate the barrel unit, and a cutting body configured to cut a needle portion of a syringe during rotation of the barrel unit, wherein transfer of the syringe inserted into the barrel unit, cutting of the needle portion, discharge of the needle portion, and discharge of a syringe main body are performed by only one rotation of the barrel unit.

Abstract: A total artificial heart system includes at least one artificial ventricle coupled to (or capable of being coupled to) a chamber or a vessel of a human heart, and at least one drive system coupled to the artificial ventricle, the drive system including at least one implanted electric motor. The drive system causes the artificial ventricle to contract and expand.

Abstract: An artificial chamber including a first conduit, a second conduit, a third conduit, and a wall defining a space; in which the first conduit and the second conduit are positioned opposite one another; in which the third conduit is opposite the wall; and in which the wall has a concave surface is disclosed. The chamber can be part of a system for providing pulmonary support. The system includes the chamber and a first pump connected to the third conduit, and connected to a fourth conduit; in which the chamber receives fluid via the first conduit and the second conduit, in which the first pump receives fluid from the chamber via the third conduit; and in which the fourth conduit transports fluid from the first pump to a first blood vessel. Methods of making a chamber and a system, and methods of using the chamber and system are also disclosed.

Abstract: Catheter blood pumps that include an expandable pump portion. The pump portions include a collapsible blood conduit that defines a blood lumen. The collapsible blood conduits include a collapsible scaffold adapted to provide radial support to the blood conduit. The pump portion also includes one or more impellers.

Abstract: The present invention relates to an attachment device having a sewing ring frame and a locking element mounted on the sewing ring frame. The locking mechanism includes a flange element projecting from the outer surface of the sewing ring frame and a retractable locking pin projecting towards the interior of the sewing ring frame. The flange is coupled to the locking pin and the biasing element. The locking mechanism is transitionable between a locked configuration in which the locking pin is in an engaged position to an unlocked configuration in which the locking pin is in a disengaged position.

Abstract: A method (100) of manufacturing a lead for an implantable medical device. The method includes: depositing (110) a base layer (3) of biocompatible, electrically non-conductive material; depositing (120) one or more complementary layers (5) of biocompatible, electrically non-conductive material to the base layer (3), wherein the base layer (3) and complementary layer (5) form at least one slot (7); and depositing (130) biocompatible, electrically conductive material (9) into the slot (7). There is also disclosed a lead for an implantable medical device and an apparatus (41) to manufacture the lead.

Abstract: [Problem] To provide a cosmetic mask which imparts effective stimulation to the appropriate position and has a tightening effect. [Solution] This cosmetic mask is worn on the face of a user, is able to cover at least the cheeks, and is equipped with a pair of simulators which impart electric or ultrasonic stimulation to a location corresponding to either the zygomatic muscle or masseter muscle of the user. The cosmetic mask may be equipped with a stimulator fitting unit for fitting the stimulators to a cheek position, and maybe constituted so that at least some of the stimulators are detachable. The cosmetic mask may also be equipped with a nosepiece which matches the protruding shape of the nose, a left-right fitting portion which is fitted while applying tensile force to the left and right sides of the face, and a vertical fitting portion which is fitted while applying tensile force from the lower surface of the mandible over both sides of the face to the top of the head.

Abstract: Implementations described and claimed herein provide paddle leads for dorsal root ganglia (DRG) stimulation and methods of implanting the same. In one implementation, the paddle lead has a small profile facilitating deployment into a target space in the neuroforamen dorsal to the DRG and below the vertebral lamina. A paddle body of the paddle lead may include a living hinge and/or a contoured profile to further facilitate implantation in the target space. For suture assisted deployment as well as to resist migration of the paddle lead once deployed, the paddle lead may include a suture loop configuration. The paddle lead further includes an electrode array having electrode contacts arranged in a two dimensional configuration pattern to create an electrical field optimized for stimulation of the DRG.

Abstract: Electrical stimulation of neural activity in the neural innervation of the spleen that is associated with neurovascular bundles provides a useful way to treat acute medical conditions, such as trauma, hemorrhaging and shock.

Abstract: A neuromodulator includes an electromagnetic (EM) wave generator configured to generate EM waves remote from a patient and to direct the EM waves to one or more target regions within the patient. Frequencies of the EM waves fall outside a range of frequencies that activates neurons. Intersection of the EM waves in each target region creates envelope-modulated electric and magnetic fields having one or more frequencies that fall within the range of frequencies that activates neurons. The neuromodulator includes control circuitry configured to control parameters of the EM waves produced by the EM wave generator. The neuromodulator may use feedback based on one or more of patient input and/or sensing of physiological signals in order to close the loop and control the EM waves.

Abstract: Systems, devices, and methods for electroporation ablation therapy are disclosed, with the system including a pulse waveform signal generator for medical ablation therapy that may be coupled to an ablation device including at least one electrode for ablation pulse delivery to tissue. The signal generator may generate and deliver voltage pulses to the ablation device in the form of a pulse waveform in a predetermined sequence where the signal generator may independently configure a set of electrodes of an ablation device. The signal generator may further perform active monitoring of a set of electrode channels and discharge excess energy using the set of electrode channels.

Abstract: A transvaginal stimulation device comprises a probe body sized to fit entirely within a vaginal cavity of a female patient. The probe body has a stimulating side defined by a length and a width of the probe body. The transvaginal stimulation device further comprises a pair of electrodes disposed on the stimulating side of the probe body and laterally spaced from each other. A method for treating stress urinary incontinence in a female patient comprises inserting the intravaginal device into a vaginal cavity of the female patient, positioning the pair of electrodes against an anterior wall of the vagina of the female patient, and conveying stimulation energy between the pair of electrodes to stimulate at least one muscle of a urethral sphincter muscle of the female patient without substantially stimulating pelvic floor muscles of the female patient.

Abstract: An apparatus, system and method are provided for a wireless electrical stimulation. The apparatus generally includes at least two electrical stimulation units. Each electrical stimulation unit includes electrodes connected to the unit. The apparatus also includes a receiver configured for receiving the one or more control signals from a remote controller for remotely, wirelessly controlling each of the electrical stimulation units to selectively apply a time-varying electric potential to the electrodes to provide an electrical stimulation to tissue in electrical contact with the electrodes. The apparatus generally includes a heating device.

Abstract: Presented herein are techniques for electrically stimulating a recipient's vestibular nerve in order to mask vestibular noise signals (vestibular noise) generated by the peripheral vestibular system (e.g., prevent erroneous balance information generated by the peripheral vestibular system from being sent to the brain of the recipient). A vestibular nerve stimulator in accordance with embodiments presented herein includes a plurality of electrodes implanted in an inner ear of a recipient at a location that is adjacent to the otolith organs of the inner ear. The vestibular nerve stimulator is configured to generate one or more continuous pulse trains and to deliver the one or more continuous pulse trains to the inferior branch of the recipient's vestibular nerve.

Abstract: An exemplary cochlear implant alignment system includes a cochlear implant system and a component alignment presentation system. The cochlear implant system includes an electrode lead and a cochlear implant that generates a wireless back telemetry signal during an insertion procedure of the electrode lead into a cochlea of a receipt. The cochlear implant system also includes an external headpiece configured to detect the wireless back telemetry signal generated by the cochlear implant and a sound processor configured to generate a Received Signal Strength Indicator (RSSI) signal based on a signal strength of the detected wireless back telemetry signal. The component alignment presentation system includes a processing device configured to receive the RSSI signal from the sound processor and to present an indication of a degree of alignment of the headpiece with the cochlear implant to assist a user in 15 aligning the headpiece with the cochlear implant during the insertion procedure.

Abstract: Methods for treating a patient using therapeutic renal neuromodulation and associated devices, systems, and methods are disclosed herein. One aspect of the present technology is directed to biomarker sampling in the context of neuromodulation devices, systems, and methods. Some embodiments, for example, are directed to catheters, catheter systems, and methods for sampling biomarkers that change in response to neuromodulation. A system can include, for example, an elongated shaft and a neuromodulation and sampling assembly having a neuromodulation and a sampling element.

Abstract: Methods and apparatuses for stimulation of the vagus nerve to treat inflammation including adjusting the stimulation based on one or more metric sensitive to patient response. The one or more metrics may include heart rate variability, level of T regulatory cells, particularly memory T regulatory cells, temperature, etc. Stimulation may be provided through an implantable microstimulator.

Abstract: Disclosed are methods and systems for treating epilepsy by stimulating a main trunk of a vagus nerve, or a left vagus nerve, when the patient has had no seizure or a seizure that is not characterized by cardiac changes such as an increase in heart rate, and stimulating a cardiac branch of a vagus nerve, or a right vagus nerve, when the patient has had a seizure characterized by cardiac changes such as a heart rate increase.

Abstract: Systems and methods for enhancing muscle function of skeletal muscles in connection with a planned spine surgery intervention in a patient's back are provided. The method includes implanting one or more electrodes in or adjacent to tissue associated with one or more skeletal muscles within a back of a patient, the one or more electrodes in electrical communication with a pulse generator programmed for enhancing muscle function of the one or more skeletal muscles. Electrical stimulation is delivered, according to the programming during a time period associated with the planned spine surgery intervention, from the pulse generator to the tissue associated with the one or more skeletal muscles via the one or more electrodes, thereby improving neuromuscular control system performance of the one or more spine stabilizing muscles in connection with the planned spine surgery intervention to reduce the patient's recovery time associated with the planned spine surgery intervention.

Abstract: Disclosed and described here are an adapter for a neuromonitoring system for placement of an electrode in a subject and a method for confirming placement of an electrode on an appropriate nerve fiber of a dorsal root ganglion during a dorsal root ganglion stimulation procedure.

Abstract: Systems, devices, and techniques are described for determining a posture state of a patient based on detected evoked compound action potentials (ECAPs). In one example, a medical device includes stimulation circuitry configured to deliver electrical stimulation and sensing circuitry configured to sense a plurality of evoked compound action potential (ECAP) signals. The medical device also includes processing circuitry configured to control the stimulation circuitry to deliver a plurality of electrical stimulation pulses having different amplitude values, control the sensing circuitry to detect, after delivery of each electrical stimulation pulse of the plurality of electrical stimulation pulses, a respective ECAP signal of the plurality of ECAP signals, and determine, based on the plurality of ECAP signals, a posture state of the patient.

Abstract: Apparatus, systems, and methods are provided for optimizing intracardiac filling pressures and cardiac output in patients with heart failure, conduction disease, and atrial fibrillation. The system is able to adjust and optimize intracardiac filling pressures and cardiac output by adjusting heart rate and the effective amount of total body blood volume. The device includes an adjustable member that may create a mean pressure differential in order to manifest an effective “mechanical diuresis” by sequestering extraneous blood volume to the high-capacitance of the venous vasculature. The system is therefore designed to reduce intracardiac filling pressures while maintaining or even increasing cardiac output.

Abstract: For use by an implantable system including a first and second leadless pacemakers (LPs) implanted, respectively, in first and second cardiac chambers, a method comprises storing, within memory of the first LP, a paced activation morphology template corresponding to far-field signal components expected to be present in an EGM sensed by the first LP when a pacing pulse delivered to the second cardiac chamber by the second LP captures the second cardiac chamber. The method also includes the first LP comparing a morphology of a portion of an EGM sensed by the first LP to the paced activation morphology template to determine whether a match therebetween is detected, and determining whether capture of the second cardiac chamber occurred or failed to occur, based on whether the first LP detects a match between the morphology of the portion of the EGM and the paced activation morphology template.

Abstract: The invention discloses a device for collection of tiny charges in the Nano-Coulomb-range and below, comprising at least one capacitor stack build by n capacitors and 2n switches (n?N), at least one further capacitor outside the capacitor stack as buffer capacity, at least two additional switches and a DC input source. The n capacitors are dedicated to be sequentially charged by the DC input source one after the other, wherein the 2n switches in the capacitor stack couple the n capacitors sequentially to the DC input source. The at least one further capacitor is dedicated to be charged from the n capacitors of the capacitor stack at once.

Abstract: Implantable medical devices have a feedthrough from the device to the outside world to pass electrical current from electronics inside the implant to the patient or vice versa. A plurality of sensors and/or signal wires in a wire bundle must connect to the feedthrough and implant in living tissue in the patient. Chemical and physical forces work against the wire connections on the feedthrough. Disclosed embodiments include a biocompatible housing that can be used for an implantable medical device. The biocompatible housing includes a recess with at least one wire exit port, the recess having at least one feedthrough assembly mounted therein. A wire of the feedthrough assembly passes out the wire exit port, and the recess has a top hermetically sealed over it.

Abstract: In some examples, a feedthrough assembly for a medical device may include a ferrule. The ferrule defines an aperture extending through the ferrule from an outer end surface defined by the ferrule to an end inner end surface defined by the ferrule. The aperture includes a first portion having a first diameter and a second portion having a second diameter less than the first diameter. The aperture defines a longitudinal axis extending therethrough and the ferrule defines a ledge between the first and second portions of the aperture that extends radially inward toward the longitudinal axis. The feedthrough assembly further may include a conductive pin within the aperture and an insulating member surrounding at least a portion of the pin. The insulating member may electrically insulate the conductive pin from the ferrule, and the ledge and a surface of the insulating member adjacent the ledge may define a space therebetween.

Abstract: An external defibrillator system such as a WCD is also capable of providing transthoracic pacing and drug delivery (e.g., pain-reducing drugs and/or a sedatives) to a patient. The drug(s) may be included in the therapy electrode electrolyte and dispensed for defibrillation, cardioversion and/or pacing therapy. Alternatively, the drug(s) may be stored in a separate reservoir and dispensed during pacing therapy. The drug(s) may be dispensed to a patient after a successful defibrillation therapy. The pacing therapy may be delivered a set time-period after the drug(s) were dispensed. A relatively small electric current may be delivered to the area of the patient on which the drug(s) were dispensed to facilitate drug absorption.

Abstract: A WCD system is configured to monitor various characteristics of the WCD system including about the patient. The WCD system is further configured to transmit a notification of a notifiable event to responders that are outside a local area of the patient, and to silence the notification for any responder(s) that are inside the local area of the patient.

Abstract: Disclosed is a delivery system for a component, for example, a splitting lead. A splitting lead can have a proximal portion to engage a controller and a distal portion to split apart into sub-portions that travel in multiple directions during implantation into a patient. The delivery system can include a handle and a component advancer to advance and removably engage a portion of the component. The component advancer can be coupled to the handle and advance the component into the patient by applying a force to the portion in response to actuation of the handle by the operator. Also, the delivery system can include an insertion tip with first and second ramps to facilitate advancement of first and second sub-portions into the patient in first and second directions. The leads may have various electrode configurations including, for example, wrapped or embedded electrodes, helical or elliptical coils, thin metallic plates, etc.

Abstract: Methods, systems, and apparatuses are described for managing temperatures induces my alternating electric fields by selectively activating/deactivating electrodes of a pair of transducer arrays according to defined parameters.

Abstract: A system for inducing synthesis of Vitamin D in a body includes a wearable illumination device formed in a structure that is wearable on the body, and including a plurality of light sources configured to radiate an ultraviolet light to a skin of a worn part; and a control device connected to the plurality of light sources and configured to drive the plurality of light sources to radiate the ultraviolet light, wherein the wearable illumination device includes a light diffusion panel configured to equalize an irradiance of the ultraviolet light reaching the skin by causing diffusion of the ultraviolet light radiated from the plurality of light sources.

Abstract: A phototherapy device for modulating an optical dosage delivered to targeted tissues extraorally based on measured tissue properties, such that the targeted tissues receive a particular dose of optical power.

Abstract: Dermatological systems and methods for providing a therapeutic laser treatment using a handpiece delivering one or more therapeutic laser pulses to a target skin area along a first optical path, and sensing the temperature of the target skin area based on infrared energy radiating from the target skin area along a second optical path generally counterdirectional to the first optical path, and sharing a common optical axis with the first optical path for at least a portion of the first and second optical paths. The handpiece may also provide contact cooling for a first skin area comprising the target skin area.

Abstract: Methods and devices are disclosed for non-invasive optogenetic stimulation of autonomic efferent fibers to regulate glucose metabolism in the liver and brown adipose tissue and to treat metabolic disorders.

Abstract: A therapeutic light assembly used for reducing a patient's viral load including a housing containing at least one therapeutic light source configured to emit light at air exiting the patient's airway, a power source coupled to the at least therapeutic light source, and a tubing attachment coupled to the housing configured to secure the housing to a patient's tubing.

Abstract: The invention relates to a device and a method for UV antisepsis, in particular for intracorporeal in vivo UV antisepsis on the human and animal body in the event of colonization with multiresistant pathogens (MRPs) such as methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus epidermidis (MRSE). The device comprises a light emitting diode chip, LED chip, configured to emit radiation in the UVC spectral range, wherein the LED chip forms a light emitting diode, LED, with a package; a spectral filter element set up to limit the radiation emitted by the LED chip substantially to wavelengths below 235 nm; and an optical element for directional emission of the radiation emitted by the LED.

Abstract: An emission enhancement structure having at least one energy augmentation structure; and an energy converter capable of receiving energy from an energy source, converting the energy and emitting therefrom a light of a different energy than the received energy. The energy converter is disposed in a vicinity of the at least one energy augmentation structure such that the emitted light is emitted with an intensity larger than if the converter were remote from the at least one energy augmentation structure. Also described are various uses for the energy emitters, energy augmentation structures and energy collectors in a wide array of fields, particularly medical uses for treatment of cell proliferation disorders.

Abstract: Disclosed herein are methods and systems to optimize a radiation therapy treatment plan using dose distribution values predicted via a trained artificial intelligence model. A server trains the AI model using a training dataset comprising data associated with a plurality of previously implemented radiation therapy treatments on a plurality of previous patients and dose distributions associated with one or more organs of each previous patient. The server then executes the trained AI model to predict dose distribution for a patient. The server then displays a heat map illustrating the predicted values, transmits the predicted values to a plan optimizer to generate an optimized treatment plan for the patient, and/or transmits an alert when a treatment plan generated by a plan optimizer deviates from rules and thresholds indicated within the patient's plan objectives.

Abstract: A system and method are provided for assessing a radiation therapy plan to be implemented on a particular radiation therapy system that includes a multi-leaf collimator (MLC). The method includes receiving a radiation therapy plan and calculating at least one metric indicating transmission characteristics of a beam delivered using the particular radiation therapy system to perform the radiation therapy plan using a model of the MLC having a plurality of zones, wherein each zone is classified based on the transmission characteristics. The method also includes evaluating the at least one metric against a tolerance for variation between the radiation therapy plan and an implementation of the radiation therapy plan on the particular radiation therapy system and generating an alert indicating that the at least one metric is outside the tolerance.