Abstract: One aspect is a method of fabricating a housing for an implantable medical device, including forming a first housing portion of metal using an additive manufacturing process such that features are integrated into the first portion. A second housing portion of metal is also formed. The first and second housing portions are joining thereby sealing an internal space of the housing within first and second portions and fully containing the features such that they are hermetically sealed relative to an external space outside the housing.

Abstract: One aspect is a housing for an implantable medical device, including first housing portion of metal, an intermediate portion of metal and having first and second sides opposite one another and having integrated features, and a second housing portion of metal. The first housing portion is sealed to the first side of the intermediate portion and the second housing portion is sealed to the second side of the intermediate portion thereby forming an housing internal space within first and second housing portions and containing the intermediate portion and its features, such that the features are hermetically sealed within the housing relative to an external space that is outside the housing.

Abstract: The device includes radio frequency (RF) communication components installed within a case of the device and an antenna with an inverted E shape mounted within a header of the device. The antenna has three branches extending from a main arm: a capacitive branch connecting one end of the main arm to the case; an RF signal feed branch connecting a middle portion of the main arm to the internal RF components of the device via a feedthrough; and an inductive branch connecting the opposing (far) end of the main arm to the case to provide a shunt to ground.

Abstract: An implantable lead connector configured for long term implantation and to electrically interconnect multiple medical devices and to channel electrical signals between said interconnected devices and a target organ, comprising: a first port adapted to receive a first signal suitable to stimulate a target tissue, a second port adapted to receive a second signal suitable to stimulate a target tissue, and a third port configured to connect to a target organ, wherein at least one of said first and second ports is configured to connect to a signal generator not integrated with said connector.

Abstract: An implantable medical device (IMD) has a housing enclosing an electronic circuit. The housing includes a shield member defining a first portion of an interior cavity of the implantable medical device and a skirted feedthrough assembly. The feedthrough assembly includes a shield extender having a top face and a sidewall that extends from the top face so that the top face and the sidewall are a single continuous component. At least one feedthrough aperture extends through the top face.

Abstract: A implantable active medical device includes a chassis plate having a first major surface and an opposing second major surface, an elongate lead connector fixed to the first major surface and extending orthogonally away from the first major surface and a circuit board fixed to the first major surface and extending orthogonally away from the first major surface. A hermetic housing defines a sealed housing cavity. The hermetic housing is fixed to the first major surface. The elongate lead connector and the circuit board are disposed within the sealed housing cavity.

Abstract: A hermetically sealed filtered feedthrough assembly for an active implantable medical device includes an electrically conductive ferrule hermetically sealed by a first braze to an insulator. A conductor is hermetically sealed to and disposed through the insulator. A filter capacitor has an active electrode plate and a ground electrode plate which are disposed within and supported by a capacitor dielectric in an interleaved, partially overlapping relationship. A first passageway is disposed through the capacitor dielectric having a capacitor internal metallization which is connected to the active electrode plate. A capacitor external metallization electrically connects to the ground electrode plate. An oxide-resistant metal addition includes a conductive core with a conductive cladding of a different material. A first electrical connection is between the oxide-resistant metal addition and the capacitor external metallization.

Abstract: A device, including an implantable electronic circuit integrated at least one of in or on a substrate, wherein the device includes a hermetic enclosure having a space therein, wherein the substrate forms at least a portion of the hermetic enclosure.

Abstract: Various fixation techniques for implantable medical device (IMDs) are described. In one example, an assembly comprises an IMD; and a set of active fixation tines attached to the IMD. The active fixation tines in the set are deployable from a spring-loaded position in which distal ends of the active fixation tines point away from the IMD to a hooked position in which the active fixation tines bend back towards the IMD. The active fixation tines are configured to secure the IMD to a patient tissue when deployed while the distal ends of the active fixation tines are positioned adjacent to the patient tissue.

Abstract: A flexible antenna is associated with an active implantable medical device to facilitate communication between the implantable medical device and an external component in the outside world via, for example, long range or far field telemetry. The flexibility of the antenna allows it to conform to the shape of the location at which it is situated, such as on the cranial bone of a patient for an antenna associated with a cranially implanted medical device. The conformability of the antenna helps to maintain the antenna in the desired shape and to maintain it in the desired location relative to implantable medical device and the patient and improves patient comfort.

Abstract: A leadless cardiac pacemaker is provided which can include any number of features. In one embodiment, the pacemaker can include a tip electrode, pacing electronics disposed on a p-type substrate in an electronics housing, the pacing electronics being electrically connected to the tip electrode, an energy source disposed in a cell housing, the energy source comprising a negative terminal electrically connected to the cell housing and a positive terminal electrically connected to the pacing electronics, wherein the pacing electronics are configured to drive the tip electrode negative with respect to the cell housing during a stimulation pulse. The pacemaker advantageously allows p-type pacing electronics to drive a tip electrode negative with respect to the can electrode when the can electrode is directly connected to a negative terminal of the cell. Methods of use are also provided.

Abstract: Systems and methods are provided for delivering vagus nerve stimulation and cardioversion/defibrillation therapies to patients for treating chronic heart failure. The vagus nerve stimulation and cardioversion/defibrillation therapies may be provided using a single implantable pulse generator, which can coordinate delivery of the therapies to provide an acute vagus nerve stimulation therapy in advance of delivering cardioversion-defibrillation energy.

Abstract: On aspect is a housing for an implantable medical device, including a first portion of metal and having integrated features and a second portion also of metal. The first and second portions are sealed together thereby forming the housing with an internal space that is within first and second portions and that fully contains the features such that they are hermetically sealed relative to an external space outside the housing.

Abstract: A battery terminal for an implantable battery is described. The battery terminal includes a foil stack, first and second side elements, and a weld joint coupling the foil stack and the side elements. The side elements define a varying height profile and a greatest height adjacent an inner surface of the side element in contact with the foil stack. Each element may define a height profile along the width that tapers toward an outer surface, biasing mass of the element close to the foil stack.

Abstract: A method of interconnecting a conductor and a hermetic feedthrough of an implantable medical device includes welding a lead to a pad on a feedthrough. The feedthrough includes a ceramic insulator and a via hermetically bonded to the insulator. The via includes platinum. The pad is bonded to the insulator and electrically connected to the via, includes platinum, and has a thickness of at least 50 ?m. The lead includes at least one of niobium, platinum, titanium, tantalum, palladium, gold, nickel, tungsten, and oxides and alloys thereof.

Abstract: An implantable pulse generator includes a device housing containing pulse generator circuitry and a header connected to the device housing. The header includes a core assembly defining first and second lead bore cavities sized for receiving terminal pins of leads, first and second labels, and an outer layer. The first label is printed onto a surface of the core assembly proximate the first lead bore cavity and includes a first color. The second label is printed onto the surface of the core assembly proximate the second lead bore cavity and includes a second color different from the first color. The outer layer is overmolded over the core assembly so as to encapsulate the first and second labels and to allow access to the first and second lead bore cavities.

Abstract: An implantable medical device includes a housing forming an internal cavity, the housing defining a profile with a height and a width and further defining a thickness perpendicular to its profile. The thickness of the housing is shorter than both the height and the width of the profile of the housing. The implantable medical device further includes at least one battery within the internal cavity, at least one capacitor adjacent the battery within the internal cavity, the capacitor and the battery being located along a common plane within the internal cavity, and circuitry within the internal cavity. The circuitry extends over both the battery and the capacitor within the internal cavity such that the circuitry is in a stacked arrangement relative to the battery and the capacitor.

Abstract: A medical lead screening connector includes a housing, a plurality of electrical contacts disposed within the housing, where each lead receptor channel includes at least two lead receptor contacts, and a cover hingedly attached to the housing. The cover includes a protrusion that is arranged and configured to register with one of the lead receptor channels and contacts a lead body received in the lead receptor channel when the cover is in a closed position.

Abstract: Processes for manufacture and assembly of implantable medical devices are described. In particular, techniques are provided for nondestructive electrical isolation assessment of feedthrough assemblies of the implantable medical devices. The feedthrough assemblies may include an insulating structure, a plurality of terminal pins extending through the insulator and a ferrule having an inner lumen into which the insulating structure is disposed. One or more insulating seals may be disposed at the interface of the ferrule-to-insulating structure and/or the terminal pin-to-insulating structure. The electrical isolation assessments may be based on the dielectric properties of the components of the feedthrough assemblies, such as the insulating structure.

Abstract: Methods of using subcutaneously implantable sensor devices and associated systems having a communication module that is controlled based upon the detection of a predetermined chemical agent.

Abstract: The device includes radio frequency (RF) communication components installed within a case of the device and an antenna with an inverted E shape mounted within a header of the device. The antenna has three branches extending from a main arm: a capacitive branch connecting one end of the main arm to the case; an RF signal feed branch connecting a middle portion of the main arm to the internal RF components of the device via a feedthrough; and an inductive branch connecting the opposing (far) end of the main arm to the case to provide a shunt to ground.

Abstract: Thermal management solutions for wireless power transfer systems are provided, which may include any number of features. In one embodiment, an implantable wireless power receiver includes at least one thermal layer disposed on an interior surface of the receiver configured to conduct heat from a central portion of the receiver towards edges of the receiver. The thermal layer can comprise, for example, a copper layer or a ceramic layer embedded in an acrylic polymer matrix. In some embodiments, a plurality of thermal channels can be formed within the receiver to transport heat from central regions of the receiver towards edges of the receiver via free convection. In yet another embodiment, a fluid pipe can be connected to the receiver and be configured to carry heat from the receiver to a location remote from the receiver. Methods of use are also provided.

Abstract: A therapeutic agent eluting element includes an elongate body member and one or more therapeutic agents elutable from the body member. The elongate body member is configured to be implanted subcutaneously along side of a therapy delivery element. The elongate body member may be formed from a polymeric material, and the agent eluting element may consist essentially of the body member and the one or more therapeutic agents. The therapeutic agent eluting element may be a part of a system or kit that includes a therapy delivery element and a tunneling tool, such as a dilator, sheath, catheter passer, or the like.

Abstract: A case for an implantable medical device includes a metal case portion, having an inside and an outside, configured to attach to at least one other case portion to define a biocompatible case for the implantable medical device. The metal case portion has a plurality of grooves disposed on at least one of the inside and the outside, the grooves being oriented substantially perpendicular to an expected direction of eddy currents produced by an inductive recharging coil in proximity thereto.

Abstract: A feed-through has a base body, for example in the form of a disk-shaped metal part. The base body includes at least one opening through which at least one conductor, for example an essentially pin-shaped conductor, embedded in a glass or glass ceramic material, is guided. The base body includes a material having a low melting point, such as a light metal, and the glass or glass ceramic material is selected in such a manner that the melting temperature thereof is lower than the melting temperature of the material of the base body.

Abstract: Passive prosthetic devices for focally cooling a brain and methods for inhibiting seizures are disclosed. The prosthetic devices replace a thermally insulating bone flap with a thermally conductive insert having an inner surface that contacts the relatively warm meninges or brain and an outer surface that contacts the relatively cool scalp. In an embodiment, the prosthesis is unitary; in another, a biocompatible casing is filled with a highly conductive core; in another, a filled polymer block is attached to a plate; and in another, the bone flap is filled with a conductive polymer. In one embodiment, a filled polymer containing elements that exhibit the magnetocaloric effect provide heat transfer that can be enhanced by application of a suitable magnetic field. Focal cooling as low as 1.2° C. has been found effective at inhibiting seizures.

Abstract: Some embodiments of an infusion pump system may be configured to provide air pressure equilibrium between the ambient air pressure external to the infusion pump system and the internal air pressure inside the infusion pump system. In particular embodiments, the infusion pump system can be equipped with an air-transmissible, liquid-tight seal along an interface between a pump body and a cap device configured to attach to the pump body.

Abstract: A sterilizable containment that includes an inner packaging and an outer packaging. The outer packaging encloses the inner packaging and includes at least two electric feedthroughs. The inner packaging includes at least two electric contacts, wherein each of the at least two electric contacts of the inner packaging matches one of the at least two electric feedthroughs of the outer packaging to provide an electric connection between a respective feedthrough and the corresponding contact when the inner and the outer packaging are closed. Each of the contacts of the inner packaging feed electrical charge from outside of the inner packaging to the inside of the inner packaging and vice versa. The inner packaging includes electrically conducting media that allows propagation of electrical charge between the contacts of the inner packaging and an implantable medical device included inside in a packaging when the containment is filled.

Abstract: A medical implant and an electrode device for a medical implant, wherein the electrode device includes a distal end, a proximal end, and an electric transmission line that extends between the distal end and the proximal end. The transmission line includes at least one adaptive element. The at least one adaptive element includes a magnetodielectric material, which, under the action of a magnetic field, changes one or more of its electric and magnetic properties.

Abstract: A system includes a first sterile medical device container. The first sterile medical device container is transparent to radiofrequency (RF) signals in a particular frequency range. The system also includes a sterile medical device within the first sterile medical device container. The sterile medical device is capable of radiofrequency communication through the first sterile medical device container using the particular frequency range. The system further includes a second container fully enclosing the first sterile medical device container and the sterile medical device, the second container including RF shielding material that is substantially opaque to the RF signals in the particular frequency range.

Abstract: An operating room cable for electrically coupling a lead to a trial stimulator includes a trial stimulator connector electrically coupleable with the trial stimulator and a lead connector for receiving the lead. The lead connector includes a housing. A first lead aperture is defined in a second end of the housing in proximity to a first side of the housing. A first inner passage extends along an interior of the housing from the first lead aperture to the second end of the housing. A first stylet slit is defined along the first side of the housing and extends from a first end of the housing to the second end of the housing. The first stylet slit is formed between upper and lower casings of the housing. The first stylet slit is continuous with the first lead aperture and the first inner passage.

Abstract: This invention relates to polymer compositions comprising: (I) at least one polyester which comprises: (a) a dicarboxylic acid component comprising: i) 70 to 100 mole % of terephthalic acid residues; ii) 0 to 30 mole % of aromatic dicarboxylic acid residues having up to 20 carbon atoms; and iii) 0 to 10 mole % of aliphatic dicarboxylic acid residues having up to 16 carbon atoms; and (b) a glycol component comprising 2,2,4,4-tetramethyl-1,3-cyclobutanediol residues, wherein the total mole % of the dicarboxylic acid component is 100 mole %, the total mole % of the glycol component is 100 mole %; and wherein the inherent viscosity of the polyester is from 0.1 to 1.2 dL/g as determined in 60/40 (wt/wt) phenol/tetrachloroethane at a concentration of 0.5 g/100 ml at 25° C.; and (II) at least one fluoroalkyl derivative.

Abstract: Designs and methods of construction for an implantable medical device employ an internal support structure. The single-piece support structure holds various electronic components such as a communication coil and a circuit board, and further is affixed to a battery, thus providing a subassembly that is mechanically robust. The support structure further provides electrical isolation between these and other components. A method of construction allows for the subassembly to be adhered to a case of the implantable medical device at the support structure, and possibly also at the battery, without electrically shorting the battery to the case.

Abstract: An implantable medical device (IMD) has a housing enclosing an electronic circuit. The housing includes a first housing portion, a second housing portion and a joint coupling the first housing portion to the second housing portion. A polymer enclosure member surrounds the joint and circumscribes the housing in various embodiments. Other embodiments of an IMD housing are disclosed.

Abstract: The present subject matter provides feedthrough or interconnect systems for components of an implantable medical device and methods for their manufacture. A feedthrough system includes a wire or nailhead having a protruded tip. The wire or nailhead extends from an aperture in an encasement of a first component and is connected to a terminal conductor adapted to electrically connect to circuitry within the encasement. A ribbon wire has a distal end adapted to electrically connect to a second component and a proximal end having a pattern adapted to fit to the protruded tip of the wire or nailhead to provide for subsequent attachment of the ribbon wire to the nailhead.

Abstract: A control module for an electrical stimulation system includes an electronic subassembly and a connector assembly coupled to the electronic subassembly. The connector assembly defines a port suitable for receiving a proximal end portion of an electrical stimulation lead. The connector assembly includes connector contacts coupled to the electronic subassembly and open to the port. The connector contacts are suitable for coupling to terminals disposed along the proximal end portion of the electrical stimulation lead when the electrical stimulation lead is received by the port. A covering is conformably disposed over the electronic subassembly and the connector assembly. The covering has an inner surface, an outer surface, and multiple layers.

Abstract: Techniques for forming a header for an implantable medical device via a two-shot molding process are described. The two-shot molding processes may include a first molding step that creates a first-shot assembly and a second molding step that creates a second-shot assembly. The first-shot assembly may be formed to include one or more protrusions configured to interact with a second-shot mold and/or molding material in the second molding step. The second molding step may be configured to overmold the first-shot assembly. The header may include an attachment plate at least partially embedded in molding material and configured to be mechanically coupled to a body of the implantable medical device.

Abstract: Designs and methods of construction for an implantable medical device employ an internal support structure. The single-piece support structure holds various electronic components such as a communication coil and a circuit board, and further is affixed to a battery, thus providing a subassembly that is mechanically robust. The support structure further provides electrical isolation between these and other components. A method of construction allows for the subassembly to be adhered to a case of the implantable medical device at the battery, and possibly also at the support structure. The battery includes an insulating cover having holes. An adhesive is used consistent with the location of the holes to affix the battery to the case without electrically shorting the battery to the case.

Abstract: A leadless implantable medical device (LIMD) includes a housing formed from a battery and an end cap. A proximal end of the end cap forms an LIMD proximal end and a distal end of the battery case forms an LIMD distal end. A non-conductive coupler mechanically secures a terminal end of the battery case to a mating end of the end cap, while maintaining the battery case and end cap electrically separated. A first electrode projects from the proximal end of the end cap. An intra-cardiac (IC) device extension projects from the distal end of the battery case. The extension includes a second electrode that is electrically connected to the battery case. The second electrode is located remote from the LIMD distal end. An electronics module is located within an internal cavity of the end cap and communicates with the first and second electrodes.

Abstract: An implantable medical device having a concave ceramic housing component; a concave metal housing component attached to the ceramic housing component to form a hermetically sealed enclosure; and an electronic trans-housing magnetic flux component disposed within the enclosure. Another aspect of the invention provides an implantable medical device having a ceramic housing component; a metal housing component; a circumferential sealing member attached to a periphery of the ceramic housing component and to a periphery of the metal housing component to form a hermetically sealed enclosure; and an electronic trans-housing magnetic flux component disposed within the enclosure.

Abstract: Structures and methods relating to electrodes for incorporation into a feedthrough with a profile adapted for subcutaneous sensing of physiologic and cardiac signals. Electrode assemblies are adapted for integration with feedthroughs and provide reliable insulation from the implantable medical device housing. Various structures and manufacturing processes are implemented to provide a large sensing surface with a low profile. The subcutaneous sensing electrode assembly can provide a leadless sensing system and further enhances installation and follow-up procedures.

Abstract: An implantable medical device includes a housing. An opening is present in the housing. The implantable medical device includes an antenna in the housing, where the antenna is located below the opening. The implantable medical device includes a cover coupled to edges of the housing defining the opening to close the opening. The cover enables passage of radio frequency signals at one or more communication frequencies to and from the antenna. The implantable medical device also includes an antenna shield positioned above the cover. The antenna shield reduces passage of radio frequency signals to and from at least a portion of the antenna during use.

Abstract: A battery module includes a plurality of flat cells and a plurality of nipping plates. Each of the flat cells has a cell main body and at least one electrode tab. The cell main body includes a power storage element sealed in a package member. The electrode tab is electrically connected to the power generating member and protruding outwardly from the cell main body. The flat cells are stacked on one another such that the electrode tabs are electrically connected in a stacking direction. Adjacent ones of the nipping plates in the stacking direction nip the electrode tab and a portion of the cell main body of a corresponding one of the flat cells from both opposite side surfaces of the corresponding one of the flat cells along the stacking direction.

Abstract: A sleep apnea treatment device may include a flexible carrier configured to be implanted in a body of a subject. The device may also include at least one electrode disposed on the flexible carrier, the at least one electrode being configured to modulate nerve fibers of the subject. A flexible antenna may be disposed on the flexible carrier, the flexible antenna electrically connected to the at least one electrode in a manner permitting at least some energy received by the flexible antenna to be transferred to the at least one electrode.

Abstract: An implantable medical device includes two conductive enclosures that are attached together, wherein the first enclosure contains electronics, and the second enclosure contains a power source. The second enclosure, all or a portion of which is located outside the first enclosure, includes an inner layer, an outer layer, and a header plate, all of which are configured to provide redundant sealing for the power source. The inner and outer layers, formed by separate metal sheets nested one within the other, are preferably in direct mechanical and electrical contact. The first sheet, which forms the inner layer, approximately conforms to a profile of the power source, located therein, and the second sheet, which forms the outer layer, conforms to a profile of the first sheet. An insulative housing, which contains connector contacts of the device, is directly secured to the first and second conductive enclosures, for example, by mounting brackets.

Abstract: Embodiments described herein provide methods for treating various conditions and diseases using an optical signal. In one or more embodiments an apparatus is providing having an optical window, which is used to deliver an optical signal to provide stimulation to one or more tissue sites in the body such as the brain, optic nerve, eye, ganglia, spine, or other like site. The optical signals can be used to treat a variety of neurological diseases and conditions including epilepsy, migraine headaches and chronic pain. In particular applications the optical signals can be used to treat, inhibit or prevent epileptic or other neurological seizures by providing an optical input to a foci or surrounding tissue in the brain causing the seizure. The optical signal may also be combined with an electrical signal to produce an aggregate effect in tissue for treating the disease or condition such as a neurological disease or condition.

Abstract: The present invention provides an implantable medical device having at least two electrodes coupled to the device housing. The electrodes may be configured for sensing physiological signals such as cardiac signals and alternatively for providing an electrical stimulation therapy such as a pacing or defibrillation therapy. In accordance with aspects of the disclosure, the device housing provides a hermetic enclosure that includes a battery case hermetically coupled to a circuit assembly case. At least one of the at least two electrodes is coupled to an exterior surface of the battery case. The battery case is electrically insulated from the cathode and anode of the battery.

Abstract: An implantable medical device can include an integrated circuit comprising an electrostatic discharge (ESD) protection circuit. The ESD protection circuit can include an active circuit, a first passive circuit, and a second passive circuit. For example, at least one of the first or second passive circuits can include an array of capacitors in a series configuration, a parallel configuration, or a combination of series and parallel configurations. The first and second passive circuits can be configured to establish a specified time constant, and, in response to an applied ESD, the first and second passive circuits can provide a control signal to active circuit to switch the active circuit from a substantially non-conductive mode to a substantially conductive mode.

Abstract: According to the invention methods and structures for determining whether impingement of x-ray radiation upon potentially vulnerable discrete components, circuits and/or circuit pathways of an implantable medical device (IMD) causes modifications or damage thereto. The invention includes structures for deflecting impingement of x-ray radiation from said potentially vulnerable components, circuits and/or circuit pathways. The x-ray radiation can be generated by various imaging modalities or unknown sources. Myriad IMDs can utilize the teaching of the present invention, including for example, a pacemaker, a drug delivery pump, a nerve stimulation device, a muscle stimulation device, an implantable cardioverter-defibrillator, a subcutaneous defibrillator, a deep brain stimulator or the like.

Abstract: An implantable electroacupuncture device (IEAD) treats depression, bipolar disorder or Anxiety through application of stimulation pulses applied at acupoints GV20 and/or EXHN3. The IEAD comprises an implantable, coin-sized, self-contained, leadless electroacupuncture device having at least two electrodes attached to an outside surface of its housing. The device generates stimulation pulses in accordance with a specified stimulation regimen. Power management circuitry within the device allows a primary battery, having a high internal impedance, to be used to power the device. The stimulation regimen generates stimulation pulses during a stimulation session of duration T3 minutes applied every T4 minutes. The duty cycle, or ratio T3/T4, is very low, no greater than 0.05. The low duty cycle and careful power management allow the IEAD to perform its intended function for several years.