Abstract: Embodiments provide methods of conducting operations with an implantable medical device (IMD) and an external controller device for performing authentication operations. In some embodiments, the method comprises: generating or storing an authentication data structure in the external controller device for over-the-air communication between the external device and the IMD, wherein the authentication data structure is generated by: (1) removing attribute fields from a first digital certificate and adding a public key of the external controller device to form an intermediate data structure; (2) creating a digital signature of the first intermediate data structure using a second digital certificate of an issuing certificate authority (CA); and (3) forming the authentication data structure by combining the intermediate data structure, the created digital signature, a public key of the issuing CA, and a digital signature of the public key of the issuing CA created using a third digital certificate of a root CA.

Abstract: The present disclosure provides systems and methods for wirelessly charging an implantable medical device. An external charging device includes a coil, signal generating circuitry to drive current through the coil at a charging frequency to induce current in a second coil in the implantable medical device, monitoring circuitry to generate an output signal to monitor charging operations, and a comb filter. The comb filter is configured to apply filtering to the output signal to remove noise from the output signal, wherein the filtering is applied based on the charging frequency. The external charging device is configured to process the filtered output signal to detect a circuit state of charging circuitry of the implantable medical device during charging operations, and the external charging device is configured to vary the charging frequency based, in part, on detection of the circuit state of the charging circuitry of the implantable medical device.

Abstract: A magnetic field sensor is positioned in proximity to a charging coil in an implantable medical device (IMD). An external device for charging the IMD includes a primary coil and a magnet positioned in proximity to the primary coil. The magnetic field sensor in the IMD detects a static magnetic field of the magnet and provides measurements proportional to the static magnetic field along three axes. These measurements of the static magnetic field are used to determine whether the external device is aligned with the IMD for charging. These measurements of the static magnetic field may also be processed to determine a position of the charger device relative to the IMD in three dimensions. When misaligned, a direction may be generated for a user to reposition the charger device to improve alignment.

Abstract: The present disclosure provides systems and methods for wirelessly charging an implantable medical device. An external charging device includes a coil, signal generating circuitry to drive current through the coil at a charging frequency to induce current in a second coil in the implantable medical device, monitoring circuitry to generate an output signal to monitor charging operations, and a comb filter. The comb filter is configured to apply filtering to the output signal to remove noise from the output signal, wherein the filtering is applied based on the charging frequency. The external charging device is configured to process the filtered output signal to detect a circuit state of charging circuitry of the implantable medical device during charging operations, and the external charging device is configured to vary the charging frequency based, in part, on detection of the circuit state of the charging circuitry of the implantable medical device.

Abstract: A wireless charger device is configured to charge an implantable medical device (IMD). A patient controller obtains one or more power parameters from the charger device during charging of the IMD. The patient controller estimates a temperature range of the IMD using the one or more power parameters from the charger device and compares to a heating threshold. The patient controller then determines whether one or more spacers are recommended in response to the comparison. The one or more spacers are removably attached to the wireless charger device and are configured to lay in a position between the wireless charger device and a patient's skin to increase a charging path.

Abstract: A method of operation of a wireless charger device includes transmitting a wireless charging signal to a receiver device. The method further includes receiving a clamping pulse from the receiver device based on the wireless charging signal. The clamping pulse indicates a first value associated with a falling edge of the clamping pulse and further indicates a second value associated with a rising edge of the clamping pulse. The clamping pulse is detected based on a comparison of a first threshold with the first value and further based on a comparison of a second threshold with the second value, and the second threshold is different than the first threshold. The method further includes determining a charging state of the receiver device based on the clamping pulse.

Abstract: An implantable medical device (IMD) is configured to provide stimulation therapy to a patient. The IMD includes a rechargeable battery, pulse generating circuitry powered by the rechargeable battery and an inductive coupling element including at least one inductor operative to accept radio frequency (RF) power from an external charger and generate a charging voltage. A temperature sensor is configured to measure a temperature of at least a part of the IMD and output measured temperature data. A waveform generating circuit for converting measured temperature data to a waveform signal for controlling a recharging current for the rechargeable battery. The inductive coupling element is configured to communicate the waveform signal to the external charger.

Abstract: An implantable medical device (IMD) includes a rechargeable battery, pulse generating circuitry, an inductive coupling element including at least one inductor operative to accept radio frequency (RF) power from an external charger and generate a charging current. A recharging circuit generates a recharge current for recharging the rechargeable battery, the recharge current being based on the charging current generated from the inductive coupling element. The recharging circuitry is operable to detect a recharging level of the rechargeable battery. A temperature sensor is configured to measure a temperature of at least a part of the IMD and output measured temperature data. A control circuit controls the charging current received at the recharging circuitry to limit the charging current based upon the recharging level and to limit the charging current for a period of time based upon the measured temperature data to communicate a temperature level to the external charger.

Abstract: A wireless charger device is configured to charge an implantable medical device (IMD). A patient controller obtains one or more power parameters from the charger device during charging of the IMD. The patient controller estimates a temperature range of the IMD using the one or more power parameters from the charger device and compares to a heating threshold. The patient controller then determines whether one or more spacers are recommended in response to the comparison. The one or more spacers are removably attached to the wireless charger device and are configured to lay in a position between the wireless charger device and a patient's skin to increase a charging path.

Abstract: A magnetic field sensor is positioned in proximity to a charging coil in an implantable medical device (IMD). An external device for charging the IMD includes a primary coil and a magnet positioned in proximity to the primary coil. The magnetic field sensor in the IMD detects a static magnetic field of the magnet and provides measurements proportional to the static magnetic field along three axes. These measurements of the static magnetic field are used to determine whether the external device is aligned with the IMD for charging. These measurements of the static magnetic field may also be processed to determine a position of the charger device relative to the IMD in three dimensions. When misaligned, a direction may be generated for a user to reposition the charger device to improve alignment.

Abstract: An Implantable Medical Device (IMD) communicates to a charger device using an RF communications channel. Temperature sensors in the IMD obtain temperature measurements during wireless charging, and the IMD then transmits the temperature measurements to the charger device over the RF communications channel. Using these temperature measurements, the charger device determines whether heat mitigation for the IMD is needed during wireless charging.

Abstract: The present disclosure provides systems and methods for wirelessly charging an implantable medical device. An external charging device includes a coil, signal generating circuitry to drive current through the coil at a charging frequency to induce current in a second coil in the implantable medical device, monitoring circuitry to generate an output signal to monitor charging operations, and a comb filter. The comb filter is configured to apply filtering to the output signal to remove noise from the output signal, wherein the filtering is applied based on the charging frequency. The external charging device is configured to process the filtered output signal to detect a circuit state of charging circuitry of the implantable medical device during charging operations, and the external charging device is configured to vary the charging frequency based, in part, on detection of the circuit state of the charging circuitry of the implantable medical device.

Abstract: A system for fluid manipulation includes a composite wafer and a movable compression device. The composite wafer includes a flexible layer and a substantially rigid layer adhered to the flexible layer. The flexible layer defines one or more recesses that are covered by the substantially rigid layer to form one or more reservoirs and one or more fluid channels among the one or more reservoirs. The movable compression device contacts the flexible layer and is configured to progressively compress the flexible layer such that when the movable compression device traverses the flexible layer, fluid is forced through the one or more fluid channels and the one or more reservoirs in a sequence determined by the layout of the one or more fluid channels and the one or more reservoirs. Certain reservoirs may be pre-loaded with fluids and reagents for performing a specified medical test.

Abstract: A valve assembly for use with a flexible container, in which the valve assembly is anchored to the flexible container. The valve assembly provides for the egress of fluid from the flexible container such that the interior surfaces flexible container do not block or otherwise prevent fluid flow or fluidic communication between the interior of the flexible container and the valve assembly. The portion of the valve assembly within the interior of the flexible container includes a support structure that prevents the walls of the flexible container from collapsing down on, and blocking either completely or in part, fluid flow through the opening of the valve inside of the flexible container.

Abstract: A valve assembly for use with a flexible container, in which the valve assembly is anchored to the flexible container. The valve assembly provides for the egress of fluid from the flexible container such that the interior surfaces flexible container do not block or otherwise prevent fluid flow or fluidic communication between the interior of the flexible container and the valve assembly. The portion of the valve assembly within the interior of the flexible container includes a support structure that prevents the walls of the flexible container from collapsing down on, and blocking either completely or in part, fluid flow through the opening of the valve inside of the flexible container.

Abstract: A valve assembly for use with a flexible container, in which the valve assembly is anchored to the flexible container. The valve assembly provides for the egress of fluid from the flexible container such that the interior surfaces flexible container do not block or otherwise prevent fluid flow or fluidic communication between the interior of the flexible container and the valve assembly. The portion of the valve assembly within the interior of the flexible container includes a support structure that prevents the walls of the flexible container from collapsing down on, and blocking either completely or in part, fluid flow through the opening of the valve inside of the flexible container.

Abstract: A system for fluid manipulation includes a composite wafer and a movable compression device. The composite wafer includes a flexible layer and a substantially rigid layer adhered to the flexible layer. The flexible layer defines one or more recesses that are covered by the substantially rigid layer to form one or more reservoirs and one or more fluid channels among the one or more reservoirs. The movable compression device contacts the flexible layer and is configured to progressively compress the flexible layer such that when the movable compression device traverses the flexible layer, fluid is forced through the one or more fluid channels and the one or more reservoirs in a sequence determined by the layout of the one or more fluid channels and the one or more reservoirs. Certain reservoirs may be pre-loaded with fluids and reagents for performing a specified medical test.

Abstract: A valve assembly for use with a flexible container, in which the valve assembly is anchored to the flexible container. The valve assembly provides for the egress of fluid from the flexible container such that the interior surfaces flexible container do not block or otherwise prevent fluid flow or fluidic communication between the interior of the flexible container and the valve assembly. The portion of the valve assembly within the interior of the flexible container includes a support structure that prevents the walls of the flexible container from collapsing down on, and blocking either completely or in part, fluid flow through the opening of the valve inside of the flexible container.