Abstract: A neurostimulation system having an external or an implantable pulse generator programmed to innervate a specific nerve or group of nerves in a patient through an electrode as a mode of treatment, having a patient remote that wirelessly communicates with the pulse generator to increase stimulation, decrease stimulation, and provide indications to a patient regarding the status of the neurostimulation system. The patient remote can allow for adjustment of stimulation power within a clinically effective range and for turning on and turning off the pulse generator. The patient remote and neurostimulation system can also store a stimulation level when the pulse generator is turned off and automatically restore the pulse generator to the stored stimulation level when the pulse generator is turned on.

Abstract: The present invention provides improved methods for positioning of an implantable lead in a patient with an integrated EMG and stimulation clinician programmer. The integrated clinician programmer is coupled to the implantable lead, wherein the implantable lead comprises at least four electrodes, and to at least one EMG sensing electrode minimally invasively positioned on a skin surface or within the patient. The method comprises delivering a test stimulation at a stimulation amplitude level from the integrated clinician programmer to a nerve tissue of the patient with a principal electrode of the implantable lead. Test stimulations are delivered at a same stimulation amplitude level for a same period of time sequentially to each of the four electrodes of the implantable lead.

Abstract: Methods and systems for obtaining and analyzing electromyography responses of electrodes of an implanted neurostimulation lead for use neurostimulation programming are provided herein. System setups for neural localization and/or programming include a clinician programmer coupleable with a temporary or permanent lead implantable in a patient and at least one pair of EMG sensing electrodes minimally invasively positioned on a skin surface or within the patient. The clinician programmer is configured to determine a plurality of recommended electrode configurations based on thresholds and EMG responses of the plurality of electrodes and rank the electrode configuration according to pre-determined criteria.

Abstract: The various implementations described herein include a percutaneous port for promoting tissue in-growth around the percutaneous port. In one aspect, the percutaneous port includes a tubular structure having an outer surface, and a coil having an outer surface and comprised of a plurality of loops. Furthermore, at least a portion of the outer surface of the coil is joined to the outer surface of the tubular structure.

Abstract: The various implementations described herein include methods used to manufacture a percutaneous port for promoting tissue in-growth around the percutaneous port. In one aspect, the method includes providing a tubular structure having an outer surface and providing a coil having an outer surface and comprised of a plurality of loops. The method further includes joining at least a portion of the outer surface of the coil to the outer surface of the tubular structure.

Abstract: Methods and systems for obtaining and analyzing electromyography responses of electrodes of an implanted neurostimulation lead for use neurostimulation programming are provided herein. System setups for neural localization and/or programming include a clinician programmer coupleable with a temporary or permanent lead implantable in a patient and at least one pair of EMG sensing electrodes minimally invasively positioned on a skin surface or within the patient. The clinician programmer is configured to determine a plurality of recommended electrode configurations based on thresholds and EMG responses of the plurality of electrodes and rank the electrode configuration according to pre-determined criteria.

Abstract: An integrated electromyography (EMG) and signal/stimulation generation clinician programmer may be coupled with an implantable temporary or permanent lead in a patient and at least one EMG sensing electrode minimally invasively positioned on a skin surface or within the patient. Generally, the integrated clinician programmer may comprise a portable housing, a signal/stimulation generator, and EMG signal processor, and a graphical user interface. The housing has an external surface and encloses circuitry at least partially disposed within the housing. The signal/stimulation generator may be disposed within the housing and configured to deliver test stimulation to a nerve tissue of the patient via the implantable lead. The EMG signal processor may be disposed within the housing and configured to record a stimulation-induced EMG motor response for each test stimulation via the at least one EMG sensing electrode.

Abstract: The present invention provides improved methods for positioning of an implantable lead in a patient with an integrated EMG and stimulation clinician programmer. The integrated clinician programmer is coupled to the implantable lead, wherein the implantable lead comprises at least four electrodes, and to at least one EMG sensing electrode minimally invasively positioned on a skin surface or within the patient. The method comprises delivering a test stimulation at a stimulation amplitude level from the integrated clinician programmer to a nerve tissue of the patient with a principal electrode of the implantable lead. Test stimulations are delivered at a same stimulation amplitude level for a same period of time sequentially to each of the four electrodes of the implantable lead.

Abstract: The electrode array is a device for making electrical contacts with cellular tissue or organs. The electrode array includes an assembly of electrically conductive electrodes arising from a substrate where the electrodes are hermetically bonded to the substrate. A method of manufacture of an electrode array and associated circuitry is disclosed where the braze preform tab disappears during the braze bonding process and is completely drawn into the substrate feedthrough holes such that the braze perform tab is completely involved in the braze joint and is no longer connecting the adjacent electrodes.

Abstract: A brain implant device includes a housing containing communication and control electronics coupled to a conduit configured for monitoring signals from a brain's motor cortex and providing stimulation signals to the brain's sensory cortex. The brain implant device is capable of wireless communication with an external communication and control signal source by means of an antenna provided in the housing. The conduit is flexible and may contain upwards of 128 electrical conductors providing electrical connections between the device electronics and related sites on the motor and/or sensory cortex by means of a plurality of electrically conductive protuberances extending from the conduit and adapted for contact with such sites.

Abstract: A hermetically sealed biocompatible pressure sensor module configured for implant at a desired site at which a pressure is to be measured. Anodic bonding of the pressure module package components which have similar thermal coefficients of expansion provides low stress bonding and maintains long term reliability, dependability and accuracy. The pressure sensor module includes a pressure sensitive membrane which is in direct contact with the environment at which a pressure is to be measured. The pressure sensor module forms a part of a pressure measuring system which uses a telemetry link between the pressure sensor module and an external controller for data transmission and transfer. Operating power for the pressure sensor module is provided by the external controller and an internal rechargeable energy storage component. Accordingly, the pressure measuring system provides a dual stage power and data transfer capability for use with an implantable system.

Abstract: The invention is a method of hermetically bonding a ceramic part to a metal part by welding and brazing a component assembly comprised of metal parts, a ceramic part, and a metal ferrule having alignment lips. The ceramic part is preferably a hollow tube of partially-stabilized zirconia that is brazed to an alignment ferrule that is preferably titanium or a titanium alloy, such as Ti-6Al-4V. On one end the component assembly is brazed to an end cap for closure. On the other end the alignment ferrule is preferably brazed to a ring that is preferably comprised of a noble metal, such as platinum, iridium, or alloys of platinum and iridium. The ring is laser welded to an eyelet that is preferably comprised of a noble metal.

Abstract: The invention is a component assembly and method of hermetically bonding a ceramic part to a metal part by welding and brazing a component assembly comprised of metal parts, a ceramic part, and an intermediate metal ferrule. The ceramic part is preferably a hollow tube of partially-stabilized zirconia that is brazed to an alignment ferrule that is preferably titanium or a titanium alloy, such as Ti-6Al-4V. On one end the component assembly is brazed to an end cap for closure. On the other end the alignment ferrule is preferably brazed to a ring that is preferably comprised of a noble metal, such as platinum, iridium, or alloys of platinum and iridium. The ring is then laser welded to an eyelet that is preferably comprised of a noble metal.

Abstract: Forming an implantable component assembly by bonding a stainless steel part to a titanium part by heating a component assembly comprised of the titanium part, the stainless steel part, and a compact filler layer of titanium-nickel particulate material placed between the two parts and heated at a temperature that is less than the melting point of either the stainless steel part or the titanium part. The component assembly is held in intimate contact at temperature in a non-reactive atmosphere for a sufficient time to develop a hermetic and strong bond between the stainless steel part and the titanium part. The bonded component assembly is optionally treated with acid to remove any residual free nickel and nickel salts, to assure a biocompatible component assembly, when implanted in a human body.

Abstract: A method of bonding a stainless steel part to a titanium part by heating a component assembly comprised of the titanium part, the stainless steel part, and a laminated titanium-nickel filler material placed between the two parts and heated at a temperature that is less than the melting point of either the stainless steel part or the titanium part. The component assembly is held in intimate contact at temperature in a non-reactive atmosphere for a sufficient time to develop a hermetic and strong bond between the stainless steel part and the titanium part. The bonded component assembly is optionally treated with acid to remove any residual free nickel and nickel salts, to assure a biocompatible component assembly, if implanted in living tissue.

Abstract: A method of bonding a stainless steel part to a titanium part by heating a component assembly comprised of the titanium part, the stainless steel part, and a laminated titanium-nickel filler material placed between the two parts and heated at a temperature that is less than the melting point of either the stainless steel part or the titanium part. The component assembly is held in intimate contact at temperature in a non-reactive atmosphere for a sufficient time to develop a hermetic and strong bond between the stainless steel part and the titanium part. The bonded component assembly is optionally treated with acid to remove any residual free nickel and nickel salts, to assure a biocompatible component assembly, if implanted in living tissue.

Abstract: The invention is directed to an apparatus substantially eliminating destructive low-temperature, humidity-enhanced phase transformation of yttria-stabilized zirconia in general, as well as eliminating low-temperature degradation of yttria-stabilized tetragonal zirconia polycrystalline ceramic (Y-TZP). The martensitic-type phase transformation from tetragonal to monoclinic is accompanied by severe strength degradation in a moist environment at low-temperature, specifically at room temperature as well as at body temperature. This class of materials has been chosen as the packaging material for small implantable neural-muscular sensors and stimulators because of the high fracture toughness and high mechanical strength. This destructive phase transformation has been substantially eliminated, thus ensuring the safety of long-term implants, by subjecting the sintered components to post-machining hot isostatic pressing, such that the average grain size is less than about 0.5 microns.

Abstract: A method of bonding a stainless steel part to a titanium part by heating a component assembly comprised of the titanium part, the stainless steel part, and a laminated titanium-nickel filler material placed between the two parts and heated at a temperature that is less than the melting point of either the stainless steel part or the titanium part. The component assembly is held in intimate contact at temperature in a non-reactive atmosphere for a sufficient time to develop a hermetic and strong bond between the stainless steel part and the titanium part. The bonded component assembly is optionally treated with acid to remove any residual free nickel and nickel salts, to assure a biocompatible component assembly, if implanted in living tissue.

Abstract: The invention is a method of making a hermetic via in a ceramic substrate that is comprised of noble metal powder in a glass-free paste that contains an admixture of a particulate phase of niobium pentoxide. The electrically conductive platinum provides excellent electrical conductivity while the niobium pentoxide phase prevents shrinkage of the paste during thermal processing and binds to both the ceramic and the noble metal particulates in the via, thus maintaining a hermetic seal around the via.

Abstract: The electrode array is a device for making electrical contacts with cellular tissue or organs. The electrode array includes an assembly of electrically conductive electrodes arising from a substrate where the electrodes are hermetically bonded to the substrate. The electrodes also include an insulating layer which leaves at least one zone or at least one hole exposed for making focused electrical contact with the tissue. A hole passing completely or partially through the electrode may further provide an anchor to the living tissue, thereby stabilizing the array with respect to the tissue being examined. Also, a method of manufacture of an electrode array and associated circuitry is disclosed.