Abstract: A medical tube includes a distal portion provided on one end side having a first outer diameter, a first inner diameter, and a first thickness; a proximal portion provided on the other end side having a second outer diameter greater than the first outer diameter, a second inner diameter greater than the first inner diameter, and a second thickness greater than the first thickness; and an intermediate portion provided between the distal portion and the proximal portion and having an outer diameter, an inner diameter, and a thickness which gradually vary. Thus, a medical tube is provided having improved operability and which reduces the likelihood of bending during an operation.

Abstract: A catheter apparatus includes an elongated body having a distal portion including a distal end, a plurality of flexible segments, and at least one intermediate segment that is less flexible than the flexible segments. Adjacent flexible segments are spaced from each other longitudinally by the at least one intermediate segment. Each of the flexible segments include a sidewall having at least one elongated gap extending at least partially therethrough and forming interlocking members. The at least one intermediate segment is shorter than the flexible segments.

Abstract: The various embodiments herein relate to a boosting catheter for positioning through a conventional guiding catheter into the vasculature of a patient, the boosting catheter having a distal tubular member and a proximal elongated shaft coupled to the distal tubular member.

Abstract: A catheter system can include a tubular body, and at least one of a targeting system coupled to the tubular body, an expandable member, or a fluid injection port. A method of identifying a bifurcation can include inserting a catheter system into a first vessel, positioning the catheter system at a first location, expanding an expandable member to occlude the first vessel, delivering contrast material so the contrast material pooling proximate to the expandable member, and reviewing a shape of the contrast material in the first vessel under fluoroscopy.

Abstract: A catheter (1) comprising an elongate tubular body (2) having a proximal end (3), a distal end (4), and an inner lumen (5) extending through the elongate tubular body (2), wherein the elongate tubular body (2) comprises a proximal section (6) and a distal section (7), wherein at least the proximal section (6) comprises at least two layers, wherein the proximal end (3) is connected with a catheter hub (8) being an adapter of greater radial outside dimension than the elongate tubular body (2), wherein the catheter hub (8) has an inner lumen (9) of larger inside diameter than the elongate tubular body (2), and wherein the innermost layer (10) of the proximal section (6) extends into the catheter hub (8) and flares from the proximal section (6) to the catheter hub (8). The catheter ensures a smooth transition of a medical device, e.g. a stent to be transferred from a storage device like a sheath into the tubular body of the catheter.

Abstract: A balloon catheter including a catheter shaft, a balloon and a support assembly. The catheter shaft defines an internal shoulder and carries the balloon. The support assembly includes a first member and a second member. The second member defines opposing, leading and trailing ends, and is arranged over the first member such that the leading end is distal the trailing end. The leading end is free of direct physical attachment to the first member. The support assembly extends within a lumen of the catheter shaft and the leading end bears against the internal shoulder. A pushing force applied at a proximal region of the catheter shaft is transferred onto the internal shoulder via the support assembly. The support assembly is simple and inexpensive. Further, the leading end of the second member is transversely moveable relative to the first member, thereby minimizing possible kinking of the first member.

Abstract: Various embodiments of a steerable sheath or catheter are disclosed. The sheath or catheter may comprise a preformed curve or angle proximate the distal end of the sheath or catheter and may comprise either an outer straighter or an inner straightener to deform, or control, the degree of curvature. Other embodiments comprise at least two lumens axially along the sheath or catheter wall that are anchored proximate the distal end of the sheath or catheter and extend proximally to the operator, allowing either pushing or pulling control of the region of the sheath or catheter located distal to the anchoring points of the push or pull wires. The push/pull wires may be used to deform, or at least partially straighten, a precurved section of the sheath or catheter or may be use deform, or at least partially curve a straight section of the sheath.

Abstract: A vascular access site management system includes a stabilization body and a flow housing that is rotatable relative to the stabilization body. The flow housing may have a flow path extending through it to allow fluids to be introduced into or extracted from a patient via a catheter connected to the vascular access site management system. The vascular access site management system may also include a needle free connector fluidly connected to the flow housing via a section of tubing.

Abstract: Some embodiments of a medical device anchor system include an anchor device that receives a catheter (or other medical instrument) and secures the catheter in place relative to a skin penetration point. In some embodiments, the anchor device can secure the catheter in an operative position relative to the skin without the use of sutures or skin tapes. In particular embodiments, the anchor device can be adjusted to a folded condition so that subcutaneous anchors are partially rotated prior to removal from the skin penetration point.

Abstract: Some embodiments of a medical device anchor system include an anchor device that secures a medical instrument (such as a catheter or the like) in place relative to a skin penetration point using subcutaneous anchors.

Abstract: Some embodiments of a medical anchor device include an elongate body coupled with deployable subcutaneous anchors to secure a catheter instrument (or other medical instrument) in place relative to a skin penetration point. In some circumstances, the elongate body may be in the form of catheter hub body, and the subcutaneous anchors can be deployed from the hub body by adjustment of a movable actuator. A locking member can interact with the actuator so as to retain the actuator in the deployed orientation during the medical procedure.

Abstract: A method includes: providing an assembly including: an inner needle, an inner needle hub, a catheter, a catheter hub, a catheter operating member, and a support member; puncturing a blood vessel of a patient with the inner needle and the catheter, while the support member is at a first position in which the support member supports the catheter; advancing the catheter operation member relative to the needle hub such that the catheter advances in the blood vessel, such that the support member is caused to move from the first position to a second position in which the support member does not support the catheter, and such that the catheter hub detaches from the needle hub; and retracting the inner needle hub and the inner needle relative to the catheter hub and the catheter, while maintaining the catheter in the blood vessel.

Abstract: An apparatus includes a catheter, an introducer, and an actuator. A distal end portion of the introducer is configured to be coupled to a peripheral intravenous line. The introducer defines an inner volume having a first portion that defines an axis parallel to and offset from an axis defined by a second portion. A first portion of the actuator is movably disposed in the first portion of the inner volume. A second portion of the actuator is movably disposed in the second portion of the inner volume and coupled to the catheter movably disposed in the second portion of the inner volume. The actuator moves the catheter between a first position, in which the catheter is disposed within the introducer, and a second position, in which at least a portion of the catheter is disposed within the peripheral intravenous line.

Abstract: Embodiments of the present invention are directed to guidewire advancement and blood flashback systems. In particular, the insertion tool includes a frangible guidewire lever configured to break and prevent further movement of the guidewire if the guidewire becomes caught. Such a feature can prevent breakage of a distal portion of the guidewire which otherwise could undesirably lead to an embolism. The insertion tool can further include a blood flash indicator that has a simplified coupling with the needle. The insertion tool can further include a guidewire advancement assembly configured to allow the clinician to hold the insertion tool proximate a distal end and operate the guidewire advancement with one hand while providing increased control over the insertion tool. The insertion tool can further include a safety clip coupled with the catheter hub and configured to close about the needle tip when the catheter is detached from the device.

Abstract: The invention is directed towards a retaining device for retaining at least one medical line. The retaining device includes a flexible body having a top and bottom surface with at least one slot formed in the top surface. The at least one slot extends to a depth greater than the largest medical line the retaining device is destined to be used with. An attachment mechanism is coupled to the flexible body for securing the flexible body to a supportive surface.

Abstract: A device for emptying stool from the rectum of a patient by means of a shaft body which is introduced into the bowel via the anus and is able to buckle or fold axially and radially, and which is provided with a dumbbell- or hourglass-shaped balloon body for assuring the transanal positioning of the device. The invention is further characterized by the special design of and choice of material for the shaft body and the balloon envelope and by the specific positioning of the balloon body on the shaft body, wherein the axial deflection of the free forward end of the shaft body is limited or an uncontrolled deflection of the shaft is prevented, and the probability of perforation of the bowel wall under the effect of force acting on the shaft body from an axial direction is therefore decisively reduced by the intestinal tube described according to the invention.

Abstract: A dilator releasably connected with an endoscope to dilate a stricture as the dilator that is releasably connected to a portion of a cylindrical body of the endoscope passes through the stricture. The endoscopic dilator is moveable between an open position and a closed position configured to enable the dilator to be secured to the endoscope. When the dilator is in the closed position, an inner surface or a component on the inner surface of the dilator frictionally secures dilator to the portion of the cylindrical body of the endoscope. When in the open position, the dilator is not frictionally secured to the portion of the cylindrical body of the endoscope.

Abstract: A dilator releasably connected with an endoscope to dilate a stricture as the dilator that is releasably connected to a portion of a cylindrical body of the endoscope passes through the stricture. The endoscopic dilator is moveable between an open position and a closed position configured to enable the dilator to be secured to the endoscope. When the dilator is in the closed position, an inner surface or a component on the inner surface of the dilator frictionally secures dilator to the portion of the cylindrical body of the endoscope. When in the open position, the dilator is not frictionally secured to the portion of the cylindrical body of the endoscope.

Abstract: A two-part bioactive agent delivery system, the system including a disposable part comprising an agent reservoir, a bolus chamber, the volume of the bolus chamber being less than the volume of the agent reservoir, an agent outlet, and a valve having a first position communicating the agent reservoir with the bolus chamber and a second position communicating the bolus chamber with the outlet; and a reusable part including a valve driver, a power source and control electronics, the control electronics being adapted to control the valve driver to actuate the valve to deliver bioactive agent from the agent reservoir to the agent outlet; the system further having a spring extending between the agent reservoir piston and a surface of the reusable part or of the disposable part to pressurize the agent reservoir when the spring is compressed and the agent reservoir contains a quantity of bioactive agent.

Abstract: A medical fluid suspension generating apparatus for performing medical procedures includes a Venturi-agitating tip assembly composed of a multi-channel arrangement at a proximal first end thereof and a tip at a distal second end thereof. The apparatus also includes a compressed medical fluid unit fluidly connected to the multi-channel arrangement at a proximal first end of the Venturi-agitating tip assembly and a medical solution fluidly connected to the multi-channel arrangement at a proximal first end of the Venturi-agitating tip assembly. Pressurized gas, from the compressed medical fluid unit, and the medical solution are combined within the Venturi-agitating tip assembly in a manner generating an enriched medical suspension that is ultimately dispensed from the suspension delivery apparatus.

Abstract: A method for increasing permeability of a cellular layer of epithelial cells includes contacting the cellular layer with a nanostructured surface including a plurality of first nanostructures arranged thereon and projecting outward therefrom. A fractal dimension of the plurality of nanostructures is greater than 1. The permeability of the cellular layer by a compound is increased as compared to the permeability of the cellular layer prior to contact with the surface.

Abstract: An access port includes an access port body and a needle-penetrable septum. The access port body can be of integral single-piece construction, and can define a reservoir aligned with an access opening. The access port body can further define an annular groove between the reservoir and the opening. The annular groove can have a diameter greater than a diameter of the access opening and a diameter of the reservoir. The needle-penetrable septum can include an upper portion disposed in the access opening and an annular flange disposed in the annular groove. The annular flange can extend radially outward from a lower portion of the septum, and can have a diameter greater than a diameter of the upper portion of the septum. The needle-penetrable septum can further include an annular reinforcement structure disposed within the annular flange.

Abstract: A vascular access site management system includes a stabilization body and a flow housing that is rotatable relative to the stabilization body. The flow housing may have a flow path extending through it to allow fluids to be introduced into or extracted from a patient via a catheter connected to the vascular access site management system. The vascular access site management system may also include a needle free connector fluidly connected to the flow housing via a section of tubing.

Abstract: A tamper evident closure assembly is for use with a fitting having an outer sidewall with internally-directed threads, externally-directed splines, and an open post. The closure assembly includes a cap, a collar, and a frangible attachment coupling the cap and collar. The cap, collar, and frangible attachment are formed integrally as an integral unit. A radial lug on the cap engages with the fitting threads. A pawl on the collar allows rotation of the integral unit on the fitting in a first rotational direction and prevents rotation in a second rotational direction. Application of the integral unit to the fitting engages the radial lug with the threads on the fitting and the post and the cap form a fluid seal. Tampering with the integral unit when the integral unit is applied to the fitting severs the frangible attachment, thereby defining the cap and collar as separate pieces.

Abstract: A one-piece fluid line connector for connecting a fluid feed line to a fluid container, comprising a main body having a male luer lock fitting, and a cap coupled to the main body by a living hinge. The living hinge is configured such that the cap is moveable to an aligned position in which the cap is aligned with a central axis of the male luer lock fitting of the main body. The cap includes a through-hole configured such that, in the aligned position, the shape of the through-hole permits a correspondingly-shaped female luer lock fitting to pass therethrough and engage the male luer lock fitting.

Abstract: A system to detect occlusion of an intravenous catheter may include a housing, which may include a distal end configured to couple to a proximal end of a catheter adapter and an inner lumen forming a fluid pathway. The system may also include one or more transmitters, which may be disposed within the housing. The transmitters may be configured to transmit first energy waves along a length of an intravenous catheter at a first frequency, and a portion of the first energy waves that are reflected back from the catheter may be detected by the system. Based on the portion of the first energy waves that are reflected back from the catheter, the transmitters may transmit second energy waves along the length of the catheter at a second frequency, which may be greater than the first frequency and configured to reduce formation of blood clots within the catheter.

Abstract: A coupling device (100) for transferring a fluid is provided. The coupling device comprises a first housing (110), a tube portion (140) projecting into the first housing, and a second housing (200) displaceably arranged within the first housing. The coupling device further comprises a third housing (300) releasably connectable to the second housing and displaceably arranged within the first housing when connected to the second housing. In a first position of the second housing, the first and second channels constitute a passage which is sealed by the first and second sealing elements when the second housing and the third housing are connected. In a second position, the tube portion projects through the first and second sealing elements and into the sealed passage for enabling a transfer of fluid through the coupling device.

Abstract: A burr hole plug includes a base having a flange configured to rest on the skull of a patient and a sidewall configured to extend into a burr hole. The burr hole plug also includes a flexible cover configured to be disposed entirely over, and coupled to, the base. The flexible cover includes a skirt to fit around an outer perimeter of the base and a rim that fits inside the sidewall of the base. Between the skirt and the rim is an inset region having a shape corresponding to a shape of the flange of the base. Alternatively or additionally, the burr hole plug may include two lead retention members, each of the lead retention members including a lead engagement surface to engage and hold a lead; and a locking member for locking the two lead retention members in the base.

Abstract: A system to deliver current to an area of interest of a subject is described that includes a power source, a controller electrically coupled to the power source, at least one first electrode electrically coupled to the controller, and at least one second electrode electrically coupled to one of the power source and the controller, with the area of interest positioned between the at least one first electrode and the at least one second electrode. A method of stimulating at least one of bone growth, tissue healing and pain control within an area of interest of a patient is described that includes inserting first and second electrode spaced at a predetermined distance, and further includes directing an electric current between the first and second electrodes so that at least a portion of the electric current passes through the area of interest positioned between the first electrode and the second electrode.

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: A method of facial treatment of a user while wearing a treatment system is disclosed. The treatment system includes a flexible film and circuitry disposed on or within the flexible film. The method includes conformally disposing the flexible film over a face of the user and applying a radio frequency (RF) wave, generated by the circuitry, on skin of the face. The method eliminates the need for a user (or a third-party operator) to hold the device by hand. In addition, the thin film can be configured as a face mask allowing treatment over a large area of skin at any given time.

Abstract: A tool has an outer assembly, which includes a deployment tube, extending around, and moveable with respect to an inner assembly of the tool; the inner assembly includes a single pull wire and a distal member configured to engage an end of an implantable medical device. The deployment tube includes an articulating segment located just proximal to an enlarged distal-most portion, which contains the device and the distal member. Relatively soft and stiff sections of a composite sidewall define the articulating segment and extend alongside one another, such that, when the pull wire is actuated, the composite sidewall causes bending of the segment in two directions. A handle assembly of the tool includes a control member for the pull wire, and may further include a flushing subassembly that has a connector port located at an end of the handle assembly that is opposite a proximal port of the handle.

Abstract: An electrostimulation device comprising an electrode coupler configured as an earbud, the earbud shaped to form fit inside an ear canal of a human ear and composed of a pliable material that conforms to the ear canal when inserted therein, the pliable material forming at least two electrostimulation electrodes, each electrostimulation electrode conductively connected to a conductive lead adapted to receive a nerve electrostimulation signal, and the earbud adapted to transmit the nerve electrostimulation signal through the electrostimulation electrodes from the conductive leads to tissue within the ear canal when disposed therein.

Abstract: An electrical stimulation system includes a stimulator having at least one electrode and a power supply. The electrode is connectable to the power supply, and the power supply delivers electrical stimulation energy in the form of a capacitive discharge voltage through the stimulator and electrode to tissue proximate a target anatomy to induce an observable response in the target anatomy during a medical procedure.

Abstract: The invention relates to the prevention and the treatment of a hemoglobinopathy and symptoms thereof by vascular electrical stimulation therapy (VEST). Preferred hemoglobinopathies are sickle-cell diseases. In a particular embodiment, the invention relates to the prevention and the treatment of vaso-occlusive crisis in patients suffering from a sickle cell disease, by VEST. VEST may be combined with administration of a NSAID to alleviate vaso-occlusive crisis. The invention also relates to the long-term treatment of a symptom associated with a sickle cell disease by VEST.

Abstract: A cochlear including a housing, an antenna, a stimulation processor operably connected to the antenna, and an electrode array, operably connected to the stimulation processor, including a flexible body defining a longitudinal axis, a proximal region and a distal region, a plurality of electrically conductive contacts on the flexible body, and at least one stiffener within the flexible body.

Abstract: An improved stimulus coil for use in wireless stimulation of biological tissue (e.g., nerves, muscle tissue, etc.) and, in one exemplary implementation, to glaucoma therapy based on the wireless administration of energy to the eye of a mammalian subject (e.g., human, rodent, etc.) to reduce an elevated intraocular pressure (IOP) involving the use of an improved stimulus coil. The improved stimulus coil may be implanted in the eye of a mammalian subject or positioned on the exterior of the eye, such as (by way of example) by being disposed within a contact lens worn by a mammalian subject.

Abstract: Devices, systems and methods are disclosed for treating or preventing dementia, such as Alzheimer's disease. The methods comprise transmitting impulses of energy non-invasively to selected nerve fibers, particularly those in a vagus nerve, that modulate the activity of a patient's locus ceruleus. The transmitted energy impulses, comprising magnetic and/or electrical energy, stimulate the selected nerve fibers to cause the locus ceruleus to release norepinephrine into regions of the brain that contain beta-amyloids. The norepinephrine counteracts neuroinflammation that would damage neurons in those regions and the locus ceruleus, thereby arresting or slowing the progression of the disease in the patient.

Abstract: Methods and apparatuses (e.g., devices and systems) for vagus nerve stimulation, including (but not limited to) sub-diaphragmatic vagus nerve stimulation. In particular, the methods and apparatuses described herein may be used to stimulate the posterior sub-diaphragmatic vagus nerve to treat inflammation and/or inflammatory disorders. The implantable microstimulators described herein may be leadless and batteryless.

Abstract: Systems and methods for pacing cardiac conductive tissue are described. A medical system includes an electrostimulation circuit to generate His-bundle pacing (HBP) pulses. A sensing circuit senses a physiologic signal, and detect a local His-bundle activation discrete from a pacing artifact of the HBP pulse. A control circuit verifies capture status in response to the HBP pulses. Based on the capture status, the control circuit determines one or more pacing thresholds including a selective HBP threshold representing a threshold strength to capture only the His bundle but not the local myocardium, and a non-selective HBP threshold representing a threshold strength to capture both the His bundle and the local myocardium. The electrostimulation circuit may deliver HBP pulses based on the selective and non-selective HBP thresholds.

Abstract: The present invention relates to implantable neuromodulation systems and methods, and in particular to modular neuromodulation systems suitable for implantation in a minimally invasive manner, methods of manufacturing the modular neuromodulation systems, and methods of treating rheumatoid arthritis using the modular neuromodulation systems. Particularly, aspects of the present invention are directed to a medical device that includes an implantable neurostimulator including a housing having a width of less than 10 mm and a height of less than 10 mm, one or more feedthroughs that pass through the housing, and an electronics module within the housing and connected to the one or more feedthroughs. The medical device further includes a lead assembly including a lead body including a conductor material, a lead connector that connects the conductor material to the one or more feedthroughs, and one or more electrodes connected to the conductor material.

Abstract: Methods and systems for providing neuromodulation to a patient are disclosed. The disclosed methods and systems use sensed neural responses to construct and optimize models of the neural elements recruited during the neuromodulation. The models are used to estimate neural recruitment associated with a therapeutic effect and/or with side-effects to stimulation. The models can be used to adjust neuromodulation in a closed-loop fashion.

Abstract: An Interactive Virtual Assistant for patients using a neural stimulation system utilizes a processor, speaker, and microphone to actively interact with a patient and address patient needs during neural stimulation therapy and to generate meaningful recommendations and alerts for the patient.

Abstract: A method of optimally placing spinal cord stimulator (SCS) leads includes acquiring components of somatosensory evoked potentials (SSEPs), compound action potentials and triggered EMG; analyzing the waveforms; and quantifying waveform features in a single display such that a surgeon can quickly and easily determine optimal placement (as it relates to laterality and level of placement on the spinal cord) of SCS leads in a patient under general anesthesia without additional expert help.

Abstract: System and methods are provided for determining a stimulation threshold for closed loop spinal cord stimulation (SCS). The system and methods provide a lead coupled to an implantable pulse generator (IPG). The system and methods deliver SCS pulses from the IPG to the lead electrodes in accordance with an SCS therapy and determine an evoked compound action potential (ECAP) amplitude based on an ECAP waveform resulting from the SCS therapy. The system and methods increase the SCS therapy by increasing at least one of an amplitude, a duration, and number of the SCS pulses associated with the SCS therapy. The system and methods also include iteratively repeat the delivering, determining and increasing operations until the ECAP amplitude exhibits a downward trend divergence. The system and methods define a stimulation threshold based on the ECAP amplitude at the trend divergence.

Abstract: Ambulatory medical devices may occasionally improperly administer a therapeutic stimulation pulse to a patient upon an incorrect detection of arrhythmia in the patient. To address these improperly administered therapeutic stimulation pulses, an ambulatory medical device includes processes and systems for verifying an initial declaration of an arrhythmia. The ambulatory medical device described include at least one first sensing electrode and at least one second sensing electrode distinct from the at least one first sensing electrode. First electrocardiogram (ECG) signals detected by the first sensing electrode are analyzed to provide an initial declaration of the arrhythmia condition of the patient. As a treatment protocol is being initiated in response to the analysis of the first ECG signals, second ECG signals detected by the second sensing electrode are analyzed to verify the initial declaration of the arrhythmia.

Abstract: A method and apparatus for treatment of hypertension and heart failure by increasing secretion of endogenous atrial hormones by pacing of the heart. Pacing is done during the ventricular refractory period resulting in premature atrial contraction that does not result in ventricular contraction. Pacing results in the atrial wall stress, peripheral vasodilation, ANP secretion. Concomitant reduction of the heart rate is monitored and controlled as needed with backup pacing.

Abstract: In some examples, a system may be used for delivering cardiac therapy or cardiac sensing. The system may include an in implantable medical device including a housing configured to be implanted on or within a heart of a patient, a fixation element configured to attach the housing to the heart; and a sensor configured to produce a signal that indicates motion of the implantable medical device. Processing circuitry may be configured to identify one or more impingements between the housing and another structure, such as a tissue of the heart, based on the signal from the sensor and provide an indication of the one or more impingements to a user.

Abstract: Devices and methods for improving device therapy such as cardiac resynchronization therapy by determining a value for a device parameter are described. An ambulatory medical device (AMD) can include a sensor circuit to sense a physiological signal and generate two or more signal metrics, and detect an event of worsening cardiac condition using the two or more signal metrics. In response to the detection of worsening cardiac condition, the AMD can determine, for a stimulator, a value of at least one stimulation parameter based on temporal responses of two or more signal metrics. The temporal responses include near-term and long-term responses to the stimulation. The AMD can program the stimulator with the determined parameter value, and generate stimulation according to the determined parameter value to stimulate target tissue.

Abstract: A system and method of positioning an atrial pacing lead for delivery of a cardiac pacing therapy that includes sensing electrical activity of tissue of a patient from a plurality of external electrodes and determining a distribution of bi-atrial activation in response to the sensed electrical activity. A target site for delivering the atrial pacing therapy is adjusted based on a change in bi-atrial dyssynchrony that is determined in response to the determined distribution of bi-atrial activation, and placement of the atrial pacing lead for delivery of the atrial pacing therapy is determined in response to the adjusting.