Abstract: This invention relates to dialysis systems and methods. In some implementations, a method includes applying vacuum pressure to a device of a dialysis system, and then determining, based on a detected fluid level or measured pressure, whether the device is functioning properly.

Abstract: An arteriovenous graft system is described. The arteriovenous graft system includes an arteriovenous graft that is well suited for use during hemodialysis. In order to minimize or prevent arterial steal, at least one valve device is positioned at the arterial end of the arteriovenous graft. In one embodiment, for instance, the arteriovenous graft system includes a first valve device positioned at the arterial end and a second valve device positioned at the venous end. In one embodiment, the valve devices may include an inflatable balloon that, when inflated, constricts and closes off the arteriovenous graft. If desired, a single actuator can be used to open and close both valve devices.

Abstract: Apparatus and methods for providing extracorporeal blood circulation and oxygenation control include multi-stage de-airing of blood to provide automated cardiopulmonary replacement to preserve the viability or one or more organs in a clinically dead organ donor or harvested donor organ for subsequent transplantation to an organ receiver patient.

Abstract: Systems and methods for processing a fluid including a suspension of biological cellular components are disclosed including a single-use kit comprising a container for the fluid; a separation device for retaining selected biological cellular components and allowing other biological cellular components of said fluid to pass therethrough; a flow path connecting the container to the separation device, the container being configured, when in use, to be positioned so that gravity tends to flow fluid through the flow path. The flow path has a segment in close proximity to the container with a configuration including a positive slope, so that biological cellular components moving through the segment are subjected to a gravitational force tending to impede movement through the flow path segment. The flow path segment preferably has a generally circular configuration, and a diameter of approximately 1.5 inches. Alternatively, the flow path segment may have a generally S-shaped configuration.

Abstract: Disclosed herein are cell separation devices, methods and systems, as well as compositions and reagents for use in cell separation methods.

Abstract: A mechanism for transferring energy from an external power source to an implantable medical device is disclosed. A sensor may be used to measure a parameter that correlates to a temperature of the system that occurs during the transcutaneous coupling of energy. For example, the sensor may measure temperature of a surface of an antenna of the external power source. The measured parameter may then be compared to a programmable limit. A control circuit such as may be provided by the external power source may then control the temperature based on the comparison. The programmable limit may be, for example, under software control so that the temperature occurring during transcutaneous coupling of energy may be modified to fit then-current circumstances.

Abstract: An infusion set adapted to be secured to a skin surface includes a fixed base member connectable to the skin surface and a movable member. A needle or cannula is connected to the movable member and movable relative to the fixed base member. The movable member is movable from a first position in which the needle or cannula is not exposed externally of the fixed base member to a second position in which the needle or cannula is exposed externally of the fixed base member. A release member retains the movable member in the first position. Removal of the release member allows movement of the movable slide member to the second position.

Abstract: Provided herein is a method of delivering nucleic acid molecules to a compartmentalized tissue or organ of a subject. Also provided herein are uses and processes for delivering a nucleic acid molecule to the parenchyma of a compartmentalized tissue or organ. The methods and uses can be used in the treatment of diseases and conditions and in industrial, agricultural and veterinary applications. Also provided herein are compositions containing an adenovirus or adeno-associated virus or other recombinant virus formulated for administration to the parenchyma of a tissue or organ.

Abstract: An autoinjector includes a rear body assembly (10) connected to a front body assembly, wherein the rear body assembly (10) contains a drive mechanism (60 . . . ) and the front body assembly contains a syringe (13) or cartridge with a needle at its forward end, the front body assembly including a viewing window (22) through which at least part of the contents of the syringe (13) or cartridge are visible, a removable cap (14) fitted to the forward end of the front body assembly the rear body assembly and the removable cap having respective aligned cut-away regions together defining a frame for the viewing window. Also disclosed is a modular scheme which uses a common platform for the provision of a range of autoinjectors of different fill volumes, with only the length of the plunger (60), and the axial extent of the cut out varying between different versions.

Abstract: A fluid dispensing device is provided for dispensing a measured amount of fluid into a living organism. The device has a needle having a first end and a second end. The needle is adapted for interfacing, on the first end, with a septum of a flexible hollow membrane, and at a second end thereof, for subcutaneously inserting into a living organism. The needle is guided by a guide to permit an injection into the living organism at a substantially non-orthogonal angle with respect to a surface of the living organism. The first and second ends of the needle pierce their respective piercing surface while translating together in a common direction. In other embodiments, the dispensing device includes a main housing, a flexible fluid reservoir, an injection assembly and a trigger mechanism. The main housing houses the operative components of the device.

Abstract: Exemplary embodiments provide wearable automatic injection devices for subcutaneously injecting a therapeutic agent into a patient's body at controlled rates, for example, in a single bolus. Exemplary embodiments provide methods for assembling wearable automatic injection devices for subcutaneously injecting a therapeutic agent into a patient's body at controlled rates. Exemplary embodiments provide methods for using wearable automatic injection devices for subcutaneously injecting a therapeutic agent into a patient's body at controlled rates.

Abstract: An automatic mixing device, an actuating device removably mounted to the automatic mixing device and a retractable syringe having the automatic mixing device are provided. The actuating device has an initially compressed spring and a trigger member that initiates spring decompression to drive depression of a mixing plunger of the automatic mixing device. A seal located in the outer chamber is capable of axial movement upon depression of the mixing plunger, from a first position in sealing engagement with one or more apertures in an inner barrel to a second position intermediate the apertures and vents in an outer barrel. This allows depression of the mixing plunger to force a first substance from the outer chamber through the apertures to mix with a second substance in an inner chamber of the inner barrel. The mixed substance in the inner barrel is then delivered by the syringe with subsequent needle retraction.

Abstract: The invention provides a syringe assembly comprising a syringe barrel having an inside surface defining a chamber, an open proximal end, and a distal end having an opening therethrough. An elongated plunger rod extends between a first end and a second end, with a cap or guard disposed on the first end of the plunger rod. A plunger head extends within the chamber of the syringe barrel, and is adapted for slidable movement within the syringe barrel between the proximal end and the distal end, with the second end of the plunger rod connected with the plunger head through a pivotable connection. The plunger rod is adapted to pivot with respect to the plunger head between a first position in which the guard is adjacent the distal end of the syringe barrel and a second position in which the plunger rod is in general axial alignment with the syringe barrel, and is further adapted for axial movement so as to cause sliding movement of the plunger head through the syringe barrel to expel contents thereof.

Abstract: When a laminated gasket product is demolded from a mold in production thereof by a conventional production process, the gasket product is rubbed against the mold and, therefore, minute scratches are formed on a surface of the gasket product. The minute scratches may impair the reliable sealability of a liquid drug. A method for producing a gasket (13) for use in a prefilled syringe (10) includes the steps of: preparing a gasket forming mold; molding a gasket (13) in the mold, the gasket having a surface laminated with a lamination film (15) and including a circumferential surface portion (17); demolding the gasket (13) from the mold, and then simultaneously forming a groove (22) and a projection (24) each extending circumferentially of the gasket in a portion of the lamination film (15) present in the circumferential surface portion (17) of the gasket.

Abstract: The invention relates to an injection unit, preferably a pen-shaped injection unit, for administering or delivering a fluid product. The injection unit comprises a housing, an axially movable piston rod mounted in the housing in a non-rotatable manner, a delivery apparatus having a threaded nut that is able to move the piston rod in order to deliver product, a dosing device having a dosing sleeve, a rotary knob, a discharge button arranged coaxially on the dosing sleeve, and a receptacle for the product. The dosing device is connected to the delivery apparatus via a coupling mechanism, wherein the coupling mechanism includes of at least two coupling surfaces that each carry a toothing comprising teeth, wherein the coupling surfaces are used to generate an acoustic and/or tactile signal corresponding to the set or corrected dose of the product to be administered during the dosing operation or during correction of the dose.

Abstract: Various handheld medical dispensing configurations and methods including the following: Handheld medical dispensing system comprises a syringe, which has a plunger, releasably mounted to syringe actuation apparatus, the apparatus having an actuator configured such that it can move the plunger more than once to dispense a plurality of amounts of substance from the syringe. A method of dispensing fluid from a syringe comprises holding a medical substance delivery system including a syringe, which has a needle, and which is secured to syringe actuation apparatus configured to dispense predetermined amounts of the substance from the syringe, penetrating the needle at one patient site and using the apparatus to deliver a predetermined amount of the substance, and penetrating the needle at another patient site and using the apparatus to deliver a predetermined amount of the substance.

Abstract: Provided is a cassette unit suitable for use with an auto-injector having a drive unit. The cassette unit comprises a cassette unit housing defining a cassette unit housing cavity arranged for receipt of a syringe; a needle projection aperture; a needle cover defining a needle sheath for sheathing of a needle tip of the syringe; a removable cap that in a capping position fits over and thereby, acts such as to close off, the needle projection aperture, the removable cap defining a cap interior; provided to the removable cap, a cap insert; and provided to the cap insert, a connector defining one or more needle cover gripping elements for gripping the needle cover and the connector defines a central hub and the one or more needle gripper elements attach to the central hub and in spaced arrangement relative to each other.

Abstract: A sharp extractor has a ram that is actuatable to move from a disengaged position to an engaged position to dislodge a sharp from a medical device, and then return back to the disengaged position. With the medical device secured in axial alignment with the ram, the actuator is actuated to move to its engaged position, whereupon the sharp is detached from the medical device. The dislodged sharp is channeled directly into a medical waste container. Upon removing the sharp from the medical device, the medical device can be treated as standard medical waste, thereby reducing the cost associated with disposal of the medical device. With the volume of the sharp being greatly reduced as a result of removal from the relatively bulky medical device, the frequency of having to dispose the sharps can be greatly reduced, thereby further reducing cost associated with the disposal of the sharps.

Abstract: There is provided a nebulizer (2), comprising a first plate (20) configured to hold a transducer (14); a second plate (22) having an aperture therein, the first plate being positioned on a first side of the second plate such that the transducer is adjacent the aperture; and a third plate (24) configured to hold a mesh plate through which liquid can pass to form droplets, the third plate being positioned on a second side of the second plate opposite the first side such that the mesh plate (16) is adjacent the aperture, with the aperture, transducer and mesh plate forming a cavity for holding liquid to be nebulized. A method for manufacturing such a nebulizer is also provided.

Abstract: A method of assembling a nozzle assembly is disclosed. The method includes: providing a nozzle member having a central passage defined by at least an inner side surface and an inner distal surface; inserting a fluid atomizer into the central passage of the nozzle member; and, with a distal surface of the fluid atomizer arranged adjacent the inner distal surface of the nozzle member, flexing legs of the fluid atomizer in a radially-outward direction for engaging each leg of the legs with the inner side surface of the nozzle member. A fluid atomizer is also disclosed. A nozzle assembly is also disclosed. A method of utilizing a nozzle assembly is also disclosed.

Abstract: A child-resistant closure system for a container comprises a protective cap, a dispensing tip, and a cylindrical base. The dispensing tip includes a pair of buttons adapted to control whether the dispensing tip is in a locked condition so as to prevent actuation or an unlocked condition so as to permit actuation, via the shoulders, of a sprayer pump unit that is partially contained within the dispensing tip. The cylindrical base has a pair of spaced apart upwardly extending legs. In an locked condition of the dispensing tip, the upwardly extending legs are not aligned with slots defined in a horizontal circumferential portion of the dispensing tip such that downward movement of the dispensing tip in relation to the base is blocked by the upwardly extending legs to prohibit actuation of the sprayer pump unit and to lock the dispensing tip.

Abstract: Nebulization of a medicament for delivery to a subject is monitored. In one embodiment, whether there is any medicament to be nebulized, a rate of nebulization, and/or other aspects of the nebulization of the medicament are monitored. Information related to the one or more monitored aspects of the nebulization may be provided to a subject. For example, by monitoring whether there is any medicament to be nebulized, whether the nebulization of the medicament is complete may be determined.

Abstract: Ventilator management systems are provided. In one aspect, a ventilator management system includes a memory that includes an initial configuration profile configured to designate operating parameters for a ventilation device, and a processor. The processor is configured to receive ventilator data from the ventilation device, the ventilator data includes at least one of operating parameters of the ventilation device or physiological statistics of a patient associated with the ventilation device, and determine, based on the ventilator data, a modification to the initial configuration profile for the ventilation device. The processor is also configured to generate a modified configuration profile for the ventilation device based on the determined modification. Methods and machine-readable media are also provided.

Abstract: The present disclosure describes an endotracheal tube for a child, the tube having a balloon mounted near the distal end of the tube. The tube has a ventilation lumen and an inflation line used to inflate the balloon. The balloon is mounted to the tube at a lower mounting point and an upper mounting point. The upper mounting point is above the level of the vocal cords. The balloon has a lower and upper diameter when inflated, and the upper diameter is from 1.1 to 1.5 times larger than the outer diameter of the tube.

Abstract: An intubation device for intubating a patient includes a handle for holding the intubation device by a user, a single-use intubation blade that includes a retainer clip and a mounting lug held fixedly to the intubation blade by the retainer clip, a ratchet collar that is rotatably connected to the handle. The ratchet collar is rotatable with respect to the intubation blade in a first travel direction to mount the intubation blade to the handle and in a second travel direction to dismount the intubation blade from the handle. The intubation device also includes a disabling mechanism for preventing re-use of the intubation. The disabling mechanism includes a break-away section of the retainer clip, and gear teeth that have a first gear tooth surface. When the ratchet collar is rotated the first gear tooth surface breaks the break-away section dislocating the mounting lug.

Abstract: A patient interface device (10) includes a patient sealing assembly (60) including a cushion (70), and a frame member (80) coupled to the cushion, and an adjustable forehead support assembly (200) provided at the distal end (120) of the frame member. The adjustable forehead support assembly includes an adjustment mechanism (202) coupled to a forehead cushion (204), wherein the adjustment mechanism includes a forehead cushion support member (212) having a base portion (216) coupled to the forehead cushion and an vertical/upright rotatable wheel member (214). Rotation of the wheel member causes movement of the frame member and the cushion relative to the forehead cushion.

Abstract: A patient interface device includes a support structure, a pivot arm pivotably coupled to the support structure and structured to pivot about an axis, a patient coupling member, such as a mask or a forehead support, coupled to the pivot arm, and a cam wheel rotateably coupled to the support structure and engaging the pivot arm, wherein rotation of the cam wheel relative to the support structure and the pivot arm causes the pivot arm to pivot about the axis and the patient coupling member to move either forward or backward along a path of movement. Also, an alternative patient interface device includes a cam wheel rotatable about a cushion member that changes a position of a main body portion of the cushion member relative to a headgear frame member of the patient interface device.

Abstract: An elbow assembly for use in a respiratory mask, which includes an elbow, an inlet port, an exhaust port, and a baffle separating the inlet port from the exhaust port. A mask assembly includes a cushion comprising at least one gusset and an aperture for connection to the elbow assembly.

Abstract: A heating apparatus includes a heating element (48) which converts electrical power to heat energy, a heatable element (44) having a first surface and a second surface, and a dielectric laminate layer (46) between the heating element and the first surface of the heatable element, wherein the dielectric laminate layer (46) is thermally conductive to transfer heat energy from the heating element (48) to the heatable element (44), and wherein the second surface of the heatable element is configured heat a liquid in a container.

Abstract: A respiratory assistance device 10 includes: a mask 13 having an expiratory hole 13a; an expiratory valve 15 provided in the mask 13, for opening and closing the expiratory hole 13a; and a control unit 17 for performing overall control on the entire device. The mask 13 and the expiratory valve 15 together form an opening and closing device. The expiratory valve 15 is deformable by deformation of a piezo element 15a. The expiratory valve 15 is disposed on an inner surface 13f so that a deformation direction thereof, i.e., a thickness direction thereof, extends along the inner surface 13f of the mask 13 and a side surface 15m slides along the inner surface 13f by the deformation thereof.

Abstract: The present invention relates to a musical instrument for producing a harmonious scale of musical notes. The instrument includes nine separate sound actuators each of which is configured to cause the musical instrument to generate a different frequency selected from the group of frequencies comprising 174 Hz, 285 Hz, 396 Hz, 417 Hz, 528 Hz, 639 Hz, 741 Hz, 852 Hz and 963 Hz, the musical instrument being configured such that physically manipulating the sound actuators causes the musical instrument to generate the frequency corresponding to the sound actuator manipulated. The invention is also directed at a system for—writing music to be played with a musical instrument incorporating the harmonious scale of musical notes as described above.

Abstract: A device and method for minimizing exposure of soft mucosa tissues to radiation, the device including a low-volume intracavity balloon catheter having multiple expansion portions, including an isometrically expanding portion and a substantially planar anterior portion.

Abstract: A catheter assembly (1) includes an inner member (12) having a proximal end (15), a distal end (13), and a lumen configured to store a hydrating fluid (28) An outer member (10) has a proximal end (19), a distal end (16), and a lumen configured to receive therein a portion of the inner member (12) The outer member (10) is movable relative to the inner member (12) at least one of, between a first position (FIG. 1) preventing fluid (28) from passing out of the at least one drainage opening (14) from within the lumen of the inner member (12) and a second position (FIG. 2) allowing fluid (28) to pass out of the at least one drainage opening (14) from within the lumen of the inner member (12).

Abstract: A variable diameter tube for use in a vessel inserter for performing hemodynamics researches and related operations comprises two coupled different-characteristic materials which are coupled to one another to provide a single stretchable tube assembly.

Abstract: The present invention provides a catheter for use in delivering and/or recovering materials to and/or from a tissue site in the body, the catheter comprising one or more macroporous regions adapted to selectively deliver molecules and/or recover cells from the tissue site, based on one or more physical-chemical-biological characteristics. The macroporous region can be provided in the form of a helical hollow wires, and can be adapted to both recover cells from the tissue site (e.g., bacterial or other cells present in interstitial fluid) and optionally to permit the infusion of medicament to the site, under corresponding conditions.

Abstract: A protective catheter tip has a generally tubular body portion defining an interior cavity. The proximal end of a urinary catheter is at least partially received within the protective tip, with the protective tip being retained on the urinary catheter without the need for a sleeve connecting the protective tip and the catheter. The protective tip may include a projection received within a draining hole or eye at the proximal end of the catheter to retain the protective tip on the catheter. The protective tip may instead include one or more projections that apply a frictional force to an outer surface of the catheter to retain the protective tip on the catheter. The protective tip may instead be retained on the catheter by a tether extending between the protective tip and a distal end of the catheter. The protective tip may also be provided in two pieces.

Abstract: An MR compatible steerable sheath with elastomeric member is provided. The elastomeric member is configured to serve as a reservoir and receive contrast media therewithin. The elastomeric member is positioned on the distal end of the steerable sheath and may circumferentially surround the sheath shaft or be offset from a longitudinal axis thereof. In operation, the contrast media allows a user to view the distal tip of the steerable sheath by virtue of the contrast media contained within the elastomeric member.

Abstract: In one form, a direction changing device is provided including: a first mounting section; and a second mounting section, wherein an axial direction of the first mounting section and an axial direction of the second mounting section intersect each other or are parallel to each other in plan view, and in a condition where a catheter or a sheath introducer in which the catheter is inserted is mounted to the first mounting section and the second mounting section, the catheter or the sheath introducer adopts a curved shape such that a catheter or sheath introducer portion mounted to the first mounting section extends proximally to distally in one direction and a catheter or sheath introducer portion mounted to the second mounting section extends proximally to distally in another direction with the directions being different from each other.

Abstract: Devices and methods for performing a transseptal puncture procedure using a device which includes either an untapered or tapered blunt end cannula disposed in an introducer carrying a sharp guidewire disposed longitudinally through the lumen of the blunt cannula, and a blunt end dilator wherein the guidewire is flexible and has an atraumatic shape at its tip. The cannula gives the more flexible introducer a defined shape and steerabilty allowing an ordinarily skilled physician to easily access a selected location on the septal wall of the heart for transseptal puncture and introducer placement thereacross without employing an exposed sharp end needle during the procedure.

Abstract: A guidewire for backloading and inserting a percutaneous pump affixed to a cannula includes a proximal section made of a first material, with a first diameter, a rounded proximal end, and a distal end. The guidewire also includes a distal section made of a second material, with a second diameter which is greater than the first diameter, a distal end, and a proximal end abutting the distal end of the proximal section. The first material of the proximal section is selected to be softer than a material of the percutaneous pump to reduce damage to the pump during backloading. The distal section of the guidewire is configured to be stiffer than the proximal section to insert the percutaneous pump in a desired location without damaging the guidewire.

Abstract: Balloon catheter comprises an elongate catheter shaft having a proximal section, a distal section, and an inflation lumen defined therein and a multilayer balloon on the distal section of the shaft comprising a first layer made of a first polymer material having a first Shore durometer hardness, a second layer made of a second polymer material having a second Shore durometer hardness greater than the first Shore durometer hardness, wherein the second layer is an inner layer relative to the first layer, and a third layer made of a third polymer material having a third Shore durometer hardness less the first Shore durometer hardness, wherein the third layer is an inner layer relative to the second layer. Method of making a balloon catheter is also provided.

Abstract: A balloon catheter includes a catheter tube and an inflatable balloon. The ends of the balloon are attached to the catheter tube. The outside surface of the balloon in an uninflated state is provided with a relief structure which in an inflated state of the balloon is substantially disappeared. A method for producing such a relief structure is by winding a wire helically around the outer surface of the balloon.

Abstract: The present invention is directed to methods for reducing systemic absorption of therapeutic compounds or agents while enhancing efficiency of delivery and targeting of intranasal administration of such compounds or agents to the central nervous system. More specifically, use of ultrasound technology in conjunction with intranasal delivery of a therapeutic compound, or pharmaceutical composition, wherein the intranasal delivery is preferably to the upper one third of a patient's nasal cavity, thereby reducing therapeutic compound or agent absorption into the blood. At the same time, the present invention results in reducing the delivery of therapeutic compounds and/or agents to the peripheral tissues, increases therapeutic delivery of the compounds and/or agents to the central nervous system generally, and increases targeting of the therapeutics and/or agents to specific target regions within the central nervous system.

Abstract: A device for positioning a subcutaneous port during an access procedure, said device comprising a dome (1) of plastic material, said dome being shaped to fit directly over the subcutaneous port, and a flange (3) extending laterally from the dome which is able to contact a surrounding skin area, wherein the device is a unitary device which is configured to be deformable or fracturable so as to facilitate removal of the device from the surrounding skin area.

Abstract: A cassette for operatively connecting administration set tubing to an infusion pump includes a thumb tab having a thumb surface, and a tubing connector having an in-line occluder spaced laterally from the thumb tab. The cassette is configured such that a user's hand will cradle the cassette by pressing a thumb of the user's hand against the thumb surface and wrapping at least one finger of the user's hand around and under the thumb tab, whereby a user may apply pressure to tubing connected to the tubing connector at a location corresponding to the in-line occluder in a direction generally opposite to a direction in which the thumb is pressed against the thumb surface, thereby bypassing the in-line occluder and allowing flow through the tubing.

Abstract: A closure assembly for a syringe having a nozzle or access portion and a discharge port including a closure cap or syringe cap having a access engaging portion removably connectible in flow restricting relation to the discharge port. A connecting structure is mounted on the access engaging portion and disposed and configured to define an interactive engagement with an attachment structure of the nozzle or access portion of the syringe. Structural and operative features of the connecting structure enable a “push-on connection” of the closure cap or syringe cap to the nozzle or access portion and a “rotate-off disconnection” of the closure cap or syringe cap from the nozzle or access portion. The closure cap or syringe cap may be used independently of or in combination with an end cap and an included indicator member, wherein the combination closure cap or syringe cap and end cap define a tamper evident cap for the syringe.

Abstract: The invention relates to a device for the punctual stimulation of endings, located in the region of the ears, of nerves leading to brain stem nuclei, and device (1) having a battery-powered therapeutic current generator (3), which is arranged in a housing (2) to be worn in the ear region and is provided with an electronic circuit that forms a low-frequency therapeutic current, and said device also having at least one flexible line (5) proceeding from the therapeutic current generator (3) for connecting to an electrode to be positioned at a nerve ending and having a base electrode (7), which is likewise connected to the therapeutic current generator and by means of which the therapeutic circuit leading across the former electrode is closed, wherein the device (1), at least by means of an external part of said device (1), can be adapted to the shape of the body point of patient intended for the positioning of the device due to a mechanically pliable structure.

Abstract: An intravascular electrode lead and an intravascular stimulation device including the same. The intravascular electrode lead includes an electrode shaft; a plurality of filaments being made of a conductive, non-biodegradable material, running in longitudinal direction within the electrode shaft and protruding distally beyond a distal end of the electrode shaft, each filament terminating in at least one electrically active area; and a support member being arranged distally from the distal end of the electrode shaft and being dilatable from a compressed state to an radially expanded state, wherein the support member is attached to the filaments and made of a biodegradable material.

Abstract: An implantable medical device having a hermetically-sealed biocompatible housing configured to be implanted in a recipient. The implantable medical device includes at least one trans-housing transformer configured to transfer electrical signals through the housing.

Abstract: The invention relates to a method and apparatus for diagnosis of conductor anomalies, such as insulation failures, in an implantable medical device, such as an implantable cardioverter defibrillator (ICD), a pacemaker, or a neurostimulator. Insulation failures are detected and localized by identifying changes in electrical fields via surface (skin) potentials. Small variations in potential are detected along the course of the electrode near the site of insulation failure.