Diagnostic screening tests that can be used to identify if a patient is a good candidates for an implantable vagus nerve stimulation device. One or more analyte, such as a cytokine or inflammatory molecule, can be measured from a blood sample taken prior to implantation of a vagus nerve stimulator to determine the patient's responsiveness to VNS for treatment of an inflammatory disorder.
Systems, devices, and methods for using electrical stimulation to treat demyelination disorders and/or disorder of the blood brain barrier are described. For example, described herein are methods of preventing or reducing demyelination by applying a low frequency (e.g., <20 Hz) stimulation concurrently with a higher frequency (e.g., >20 Hz) stimulation that may be paired with a motor task, in order to reduce and/or reverse demyelination.
Method for reversing demyelination in a patient having a demyelinating disorder may include detecting one or more biomarkers for demyelination from the patient, receiving, in an implanted vagus nerve stimulator, a command to apply a remyelinating stimulation to the patient based on a level of the detected one or more biomarkers for demyelination; and applying electrical stimulation of between about 0.25 mA and about 5 mA at a duty cycle of less than 10 percent to the patient's vagus nerve from the implanted vagus nerve stimulator to reverse demyelination and increase remyelination of the patient's nerves. The electrical stimulation may be adjusted based on the level of the detected one or more biomarkers.
Apparatuses, systems, and methods are disclosed to generate and transmit radio frequency (RF) energy by a first device that may be captured by a second device. The captured RF energy may be used to power the second device. The first device may determine a resonant frequency of a variable tank circuit configured to radiate RF energy. In addition, apparatuses, systems, and methods are disclosed to encode communication data onto the transmitted RF energy, optimizing for data pattern sensitivity and device to device variability. These apparatuses and methods may be configured for use with an implant (e.g., nerve stimulation implant).
H02M 3/155 - Conversion of dc power input into dc power output without intermediate conversion into ac by static converters using discharge tubes with control electrode or semiconductor devices with control electrode using devices of a triode or transistor type requiring continuous application of a control signal using semiconductor devices only
H02M 3/157 - Conversion of dc power input into dc power output without intermediate conversion into ac by static converters using discharge tubes with control electrode or semiconductor devices with control electrode using devices of a triode or transistor type requiring continuous application of a control signal using semiconductor devices only with automatic control of output voltage or current, e.g. switching regulators with digital control
H04B 1/12 - Neutralising, balancing, or compensation arrangements
H02M 3/156 - Conversion of dc power input into dc power output without intermediate conversion into ac by static converters using discharge tubes with control electrode or semiconductor devices with control electrode using devices of a triode or transistor type requiring continuous application of a control signal using semiconductor devices only with automatic control of output voltage or current, e.g. switching regulators
H03F 1/02 - Modifications of amplifiers to raise the efficiency, e.g. gliding Class A stages, use of an auxiliary oscillation
5.
NEUROSTIMULATION PARAMETER AUTHENTICATION AND EXPIRATION SYSTEM FOR NEUROSTIMULATION
Methods and apparatuses (e.g., devices and systems) for securely accessing, activating and/or updating vagus nerve stimulators. In particular, described herein are methods and apparatuses for securing providing, verifying and/or executing digital prescriptions for implantable (including implanted) vagus nerve stimulation systems that may be used for treating inflammation. These methods and apparatuses (including software and/or firmware) may be adapted for used with low-energy requirements of the implanted components.
G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
G16H 20/30 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
H04L 9/32 - Arrangements for secret or secure communications; Network security protocols including means for verifying the identity or authority of a user of the system
Devices, systems and methods for the treatment of chronic inflammatory disorders that include an implantable microstimulator and an external charger/controller wherein the microstimulator is configured to operate using closed-loop feedback. The feedback for the microstimulator can be electrical activity of the vagus nerve and/or heart sensed by the microstimulator. The feedback can be used to modulate the stimulation duration, intensity, frequency, on-time and off-time.
Methods and apparatuses (e.g., devices and systems) for vagus nerve stimulation, including (but not limited to) sub-diaphragmatic vagus nerve stimulation. In particular, the methods and apparatuses described herein may be used to stimulate the posterior sub-diaphragmatic vagus nerve to treat inflammation and/or inflammatory disorders. The implantable microstimulators described herein may be leadless and batteryless.
Systems, devices, and methods for using vagus nerve stimulation to treat demyelination disorders and/or disorder of the blood brain barrier are described. The vagus nerve stimulation therapy described herein is configured to reduce or prevent demyelination and/or promote remyelination to treat various disorders related to demyelination, such as multiple sclerosis. A low duty cycle stimulation protocol with a relatively short on-time and a relatively long off-time can be used.
Methods and apparatuses for treating inflammatory diseases by neurostimulation in patients who have failed to adequately respond or have become intolerant to a drug therapy (such as a TNF inhibitor and/or a JAK inhibitor).
Methods and apparatuses for stimulation of the vagus nerve to treat inflammation including adjusting the stimulation based on one or more metric sensitive to patient response. The one or more metrics may include heart rate variability, level of T regulatory cells, particularly memory T regulatory cells, temperature, etc. Stimulation may be provided through an implantable microstimulator.
Methods and apparatuses (e.g., devices and systems) for securely accessing, activating and/or updating vagus nerve stimulators. In particular, described herein are methods and apparatuses for securing providing, verifying and/or executing digital prescriptions for implantable (including implanted) vagus nerve stimulation systems that may be used for treating inflammation. These methods and apparatuses (including software and/or firmware) may be adapted for used with low-energy requirements of the implanted components.
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
G16H 80/00 - ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
H04W 12/04 - Key management, e.g. using generic bootstrapping architecture [GBA]
Methods and apparatuses (e.g., devices and systems) for vagus nerve stimulation, including (but not limited to) sub-diaphragmatic vagus nerve stimulation. In particular, the methods and apparatuses described herein may be used to stimulate the posterior sub-diaphragmatic vagus nerve to treat inflammation and/or inflammatory disorders. The implantable microstimulators described herein may be leadless and batteryless.
Leadless, implantable microstimulators for treating chronic inflammation. These devices can include a static magnetic field detector (e.g., non-Hall effect sensors/detectors, including those based on a Wiegand effect or generating pulses at a predetermined frequency range and using a detection circuit to determine the decay rate of the pulses), to trigger an emergency shut off of the microstimulator. Also described are methods and apparatuses for regulating the temperature of an implant based applied power from a charger (e.g., voltage across the charger when unloaded and when loaded by the implant) to yield a power control loop correlated with the power drawn by the implant to determine temperature of the implant. A negotiation protocol can exchange data between the charger and the implant (e.g., type of charger, type of implant, nature of the coupling between the two, etc.) to set target power control loop parameters to estimate and regulate implant temperature.
Described herein are methods and systems for using EEG recordings to improve vagus nerve stimulation (VNS) therapy. In particular, described herein are methods and systems for using EEG recordings to detect P300 and/or activation of the nucleus basalis and/or the locus coeruleus to determine the efficacy of VNS. The EEG recordings can be used to provide feedback control to help optimize stimulation parameters and to screen for patients that respond well to VNS therapy.
A nerve cuff for establishing a nerve block on a nerve can have a cuff body with a channel for receiving a nerve, a reservoir for holding a drug, and an elongate opening slit extending the length of the cuff body that can be opened to provide access to the channel and can be closed to enclose the cuff body around the nerve. The nerve cuff can also include an electrode for detecting and measuring electrical signals generated by the nerve. A controller can be used to control delivery of the drug based on the electrical signals generated by the nerve.
Systems, devices, and methods for using vagus nerve stimulation to treat demyelination disorders and/or disorder of the blood brain barrier are described. The vagus nerve stimulation therapy described herein is configured to reduce or prevent demyelination and/or promote remyelination to treat various disorders related to demyelination, such as multiple sclerosis. A low duty cycle stimulation protocol with a relatively short on-time and a relatively long off-time can be used.
Systems, devices, and methods for using vagus nerve stimulation to treat demyelination disorders and/or disorder of the blood brain barrier are described. The vagus nerve stimulation therapy described herein is configured to reduce or prevent demyelination and/or promote remyelination to treat various disorders related to demyelination, such as multiple sclerosis. A low duty cycle stimulation protocol with a relatively short on-time and a relatively long off-time can be used.
Diagnostic screening tests that can be used to identify if a patient is a good candidates for an implantable vagus nerve stimulation device. One or more analyte, such as a cytokine or inflammatory molecule, can be measured from a blood sample taken prior to implantation of a vagus nerve stimulator to determine the patient's responsiveness to VNS for treatment of an inflammatory disorder.
A system for treating chronic inflammation may include an implantable microstimulator, a wearable charger, and optionally an external controller. The implantable microstimulator may be implemented as a leadless neurostimulator implantable in communication with a cervical region of a vagus nerve. The microstimulator can address several types of stimulation including regular dose delivery. The wearable charger may be worn around the subject's neck to rapidly (<10 minutes per week) charge an implanted microstimulator. The external controller may be configured as a prescription pad that controls the dosing and activity of the microstimulator.
Devices, systems and methods for the treatment of chronic inflammatory disorders that include an implantable microstimulator and an external charger/controller wherein the microstimulator is configured to operate using closed-loop feedback. The feedback for the microstimulator can be electrical activity of the vagus nerve and/or heart sensed by the microstimulator. The feedback can be used to modulate the stimulation duration, intensity, frequency, on-time and off-time.
Methods and apparatuses for stimulation of the vagus nerve to treat inflammation including adjusting the stimulation based on one or more metric sensitive to patient response. The one or more metrics may include heart rate variability, level of T regulatory cells, particularly memory T regulatory cells, temperature, etc. Stimulation may be provided through an implantable microstimulator.
A system for treating chronic inflammation may include an implantable microstimulator, a wearable charger, and optionally an external controller. The implantable microstimulator may be implemented as a leadless neurostimulator implantable in communication with a cervical region of a vagus nerve. The microstimulator can address several types of stimulation including regular dose delivery. The wearable charger may be worn around the subject's neck to rapidly (<10 minutes per week) charge an implanted microstimulator. The external controller may be configured as a prescription pad that controls the dosing and activity of the microstimulator.
Systems, devices, and methods for using vagus nerve stimulation to treat demyelination disorders and/or disorder of the blood brain barrier are described. The vagus nerve stimulation therapy described herein is configured to reduce or prevent demyelination and/or promote remyelination to treat various disorders related to demyelination, such as multiple sclerosis. A low duty cycle stimulation protocol with a relatively short on-time and a relatively long off-time can be used.
A nerve cuff for establishing a nerve block on a nerve can have a cuff body with a channel for receiving a nerve, a reservoir for holding a drug, and an elongate opening slit extending the length of the cuff body that can be opened to provide access to the channel and can be closed to enclose the cuff body around the nerve. The nerve cuff can also include an electrode for detecting and measuring electrical signals generated by the nerve. A controller can be used to control delivery of the drug based on the electrical signals generated by the nerve.
Leadless, implantable microstimulators for treating chronic inflammation. These devices can include a static magnetic field detector (e.g., non-Hall effect sensors/detectors, including those based on a Wiegand effect or generating pulses at a predetermined frequency range and using a detection circuit to determine the decay rate of the pulses), to trigger an emergency shut off of the micro stimulator. Also described are methods and apparatuses for regulating the temperature of an implant based applied power from a charger (e.g., voltage across the charger when unloaded and when loaded by the implant) to yield a power control loop correlated with the power drawn by the implant to determine temperature of the implant. A negotiation protocol can exchange data between the charger and the implant (e.g., type of charger, type of implant, nature of the coupling between the two, etc.) to set target power control loop parameters to estimate and regulate implant temperature.
Medical devices, namely, devices used to treat chronic
inflammatory and autoimmune disorders in the nature of
neurostimulators which activate the body's inflammatory
reflex to reduce inflammation.
Medical devices, namely, medical devices for treating
inflammatory and autoimmune diseases and conditions; medical
apparatus for the purpose of treating medical diseases and
conditions through electronic nerve stimulation; and medical
apparatus, namely, electronic nerve stimulators.
(1) Medical devices, namely, medical devices for treating inflammatory and autoimmune diseases and conditions, namely, electronic nerve stimulators; medical apparatus for the purpose of treating medical diseases and conditions through electronic nerve stimulation; and medical apparatus, namely, electronic nerve stimulators.
An extravascular nerve cuff that is configured to hold a leadless, integral, implantable micro stimulator. The nerve cuff may include a cuff body having a pocket or pouch for removably receiving the implantable device within. The nerve cuff can be secured around the nerve such that the electrodes of the device are stably positioned relative to the nerve. Furthermore, the nerve cuff drives the majority of the current from the stimulation device into the nerve, while shielding surrounding tissues from unwanted stimulation.
Medical devices, namely, medical devices for treating inflammatory and autoimmune diseases and conditions; medical apparatus for the purpose of treating medical diseases and conditions through electronic nerve stimulation; and medical apparatus, namely, electronic nerve stimulators
Methods and apparatuses (e.g., devices and systems) for vagus nerve stimulation, including (but not limited to) sub-diaphragmatic vagus nerve stimulation. In particular, the methods and apparatuses described herein may be used to stimulate the posterior sub-diaphragmatic vagus nerve to treat inflammation and/or inflammatory disorders. The implantable microstimulators described herein may be leadless and batteryless.
An extravascular nerve cuff that is configured to hold a leadless, integral, implantable microstimulator. The nerve cuff may include a cuff body having a pocket or pouch for removably receiving the implantable device within. The nerve cuff can be secured around the nerve such that the electrodes of the device are stably positioned relative to the nerve. Furthermore, the nerve cuff drives the majority of the current from the stimulation device into the nerve, while shielding surrounding tissues from unwanted stimulation.
Diagnostic screening tests that can be used to identify if a patient is a good candidates for an implantable vagus nerve stimulation device. One or more analyte, such as a cytokine or inflammatory molecule, can be measured from a blood sample taken prior to implantation of a vagus nerve stimulator to determine the patient's responsiveness to VNS for treatment of an inflammatory disorder.
Diagnostic screening tests that can be used to identify if a patient is a good candidates for an implantable vagus nerve stimulation device. One or more analyte, such as a cytokine or inflammatory molecule, can be measured from a blood sample taken prior to implantation of a vagus nerve stimulator to determine the patient's responsiveness to VNS for treatment of an inflammatory disorder.
A system for treating chronic inflammation may include an implantable microstimulator, a wearable charger, and optionally an external controller. The implantable microstimulator may be implemented as a leadless neurostimulator implantable in communication with a cervical region of a vagus nerve. The microstimulator can address several types of stimulation including regular dose delivery. The wearable charger may be worn around the subject's neck to rapidly (<10 minutes per week) charge an implanted microstimulator. The external controller may be configured as a prescription pad that controls the dosing and activity of the microstimulator.
Described herein are systems and methods for applying extremely low duty-cycle stimulation sufficient to treat chronic inflammation using feedback to adjust the off times between stimulations. In particular, the feedback include an assessment of the level of inflammation by the patient or the healthcare provider, or by measure the level of an inflammatory analyte or biomarker, or by detecting nerve activity correlated with inflammation.
An implanted stimulator can deliver a patient-detectable electrical stimulation to remind or prompt a patient to interact with an implanted therapeutic device (e.g., neurostimulator) when a prompting event occurs. For example, the apparatuses and methods described herein may be configured to apply a prompting patient-detectable electrical vagus nerve stimulation to remind a patient that it is time to administer a therapeutic dose. When the therapeutic device is operated in an automatic fashion, the apparatus can also deliver a patient-detectable warning stimulation prior to the therapeutic stimulation to let the patient know that a therapeutic stimulation will be delivered soon thereafter.
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
G16H 20/30 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
An extravascular nerve cuff that is configured to hold a leadless, integral, implantable microstimulator. The nerve cuff may include a cuff body having a pocket or pouch for removably receiving the implantable device within. The nerve cuff can be secured around the nerve such that the electrodes of the device are stably positioned relative to the nerve. Furthermore, the nerve cuff drives the majority of the current from the stimulation device into the nerve, while shielding surrounding tissues from unwanted stimulation.
Methods and apparatuses for stimulation of the vagus nerve to treat inflammation including adjusting the stimulation based on one or more metric sensitive to patient response. The one or more metrics may include heart rate variability, level of T regulatory cells, particularly memory T regulatory cells, temperature, etc. Stimulation may be provided through an implantable microstimulator.
Methods and apparatuses (e.g., devices and systems) for vagus nerve stimulation, including (but not limited to) sub-diaphragmatic vagus nerve stimulation. In particular, the methods and apparatuses described herein may be used to stimulate the posterior sub-diaphragmatic vagus nerve to treat inflammation and/or inflammatory disorders. The implantable microstimulators described herein may be inductively charged and/or communicated with using the external charger. The implant may include a receiving antenna wrapped around the battery and/or the housing of the microstimulator/microregulator and/or may include a high magnetic permeability material in order to serve as a magnetic core for the antenna coil. Wearable inductive chargers/communication devices for inductively communicating with (including charging) an implanted microstimulator are described herein, which may include magnetically conductive material to enhance communication with an implant, including sub-diaphragmatic implants. Also described herein are inductive chargers/communication devices, including belts, and pads (e.g., mattresses) able to recharge an implanted neurostimulation device.
Leadless, implantable microstimulators for treating chronic inflammation. These devices can include a static magnetic field detector (e.g., non-Hall effect sensors/detectors, including those based on a Wiegand effect or generating pulses at a predetermined frequency range and using a detection circuit to determine the decay rate of the pulses), to trigger an emergency shut off of the microstimulator. Also described are methods and apparatuses for regulating the temperature of an implant based applied power from a charger (e.g., voltage across the charger when unloaded and when loaded by the implant) to yield a power control loop correlated with the power drawn by the implant to determine temperature of the implant. A negotiation protocol can exchange data between the charger and the implant (e.g., type of charger, type of implant, nature of the coupling between the two, etc.) to set target power control loop parameters to estimate and regulate implant temperature.
Methods and apparatuses for stimulation of the vagus nerve to treat inflammation including adjusting the stimulation based on one or more metric sensitive to patient response. The one or more metrics may include heart rate variability, level of T regulatory cells, particularly memory T regulatory cells, temperature, etc. Stimulation may be provided through an implantable microstimulator.
Methods and apparatuses (e.g., devices and systems) for vagus nerve stimulation, including (but not limited to) sub-diaphragmatic vagus nerve stimulation. In particular, the methods and apparatuses described herein may be used to stimulate the posterior sub-diaphragmatic vagus nerve to treat inflammation and/or inflammatory disorders. The implantable microstimulators described herein may be inductively charged and/or communicated with using the external charger. The implant may include a receiving antenna wrapped around the battery and/or the housing of the microstimulator/microregulator and/or may include a high magnetic permeability material in order to serve as a magnetic core for the antenna coil. Wearable inductive chargers/communication devices for inductively communicating with (including charging) an implanted microstimulator are described herein, which may include magnetically conductive material to enhance communication with an implant, including sub-diaphragmatic implants. Also described herein are inductive chargers/communication devices, including belts, and pads (e.g., mattresses) able to recharge an implanted neurostimulation device.
A nerve cuff for establishing a nerve block on a nerve can have a cuff body with a channel for receiving a nerve, a reservoir for holding a drug, and an elongate opening slit extending the length of the cuff body that can be opened to provide access to the channel and can be closed to enclose the cuff body around the nerve. The nerve cuff can also include an electrode for detecting and measuring electrical signals generated by the nerve. A controller can be used to control delivery of the drug based on the electrical signals generated by the nerve.
Devices and methods for stimulation of the vagus nerve to modulate (e.g., reduce, suppress, etc.) bone erosion. Methods and apparatus for modulating bone erosion may modulate levels of Receptor Activator for Nuclear Factor κB Ligand (RANKL), and/or to modulate (increase, enhance, etc.) osteoprotegerin (OPG) and/or OPG/RANKL ratio. Devices may include electrical stimulation devices that may be implanted, and may be activated to apply current for a proscribed duration, followed by a period without stimulation.
An external programmer, such as an external clock synchronization tool, can be used to update or modify the stimulation protocol and/or parameters on an implanted electrical stimulator. In particular, described herein are external clock synchronization tools that can be used to calibrate a low-power clock of the implanted electrical stimulator. These tools may also be used to provide command overrides, including suspending or delaying neurostimulation, stopping neurostimulation, and/or on-demand neurostimulation.
An implanted stimulator can deliver a patient-detectable electrical stimulation to remind or prompt a patient to interact with an implanted therapeutic device (e.g., neurostimulator) when a prompting event occurs. For example, the apparatuses and methods described herein may be configured to apply a prompting patient-detectable electrical vagus nerve stimulation to remind a patient that it is time to administer a therapeutic dose. When the therapeutic device is operated in an automatic fashion, the apparatus can also deliver a patient-detectable warning stimulation prior to the therapeutic stimulation to let the patient know that a therapeutic stimulation will be delivered soon thereafter.
Medical devices, namely, devices used to treat chronic inflammatory and autoimmune disorders in the nature of neurostimulators which activate the body's inflammatory reflex to reduce inflammation
49.
Systems and methods for stimulating and/or monitoring loci in the brain to treat inflammation and to enhance vagus nerve stimulation
Described herein are methods and systems for using EEG recordings to improve vagus nerve stimulation (VNS) therapy. In particular, described herein are methods and systems for using EEG recordings to detect P300 and/or activation of the nucleus basalis and/or the locus coeruleus to determine the efficacy of VNS. The EEG recordings can be used to provide feedback control to help optimize stimulation parameters and to screen for patients that respond well to VNS therapy.
Described herein are systems and methods for applying extremely low duty-cycle stimulation sufficient to treat chronic inflammation using feedback to adjust the off times between stimulations. In particular, the feedback include an assessment of the level of inflammation by the patient or the healthcare provider, or by measure the level of an inflammatory analyte or biomarker, or by detecting nerve activity correlated with inflammation.
Devices, systems and methods for the treatment of chronic inflammatory disorders that include an implantable microstimulator and an external charger/controller wherein the microstimulator is configured to operate using closed-loop feedback. The feedback for the microstimulator can be electrical activity of the vagus nerve and/or heart sensed by the microstimulator. The feedback can be used to modulate the stimulation duration, intensity, frequency, on-time and off-time.
An extravascular nerve cuff that is configured to hold a leadless, integral, implantable microstimulator. The nerve cuff may include a cuff body having a pocket or pouch for removably receiving the implantable device within. The nerve cuff can be secured around the nerve such that the electrodes of the device are stably positioned relative to the nerve. Furthermore, the nerve cuff drives the majority of the current from the stimulation device into the nerve, while shielding surrounding tissues from unwanted stimulation.
A system for treating chronic inflammation may include an implantable microstimulator, a wearable charger, and optionally an external controller. The implantable microstimulator may be implemented as a leadless neurostimulator implantable in communication with a cervical region of a vagus nerve. The microstimulator can address several types of stimulation including regular dose delivery. The wearable charger may be worn around the subject's neck to rapidly (<10 minutes per week) charge an implanted microstimulator. The external controller may be configured as a prescription pad that controls the dosing and activity of the microstimulator.
A diagnostic screening test can be used to identify candidates for implantable vagus nerve stimulation devices. An analyte, such as a cytokine or inflammatory molecule, can be measured both before and after vagus nerve stimulation in order to detennine the responsiveness of the patient. VNS can be delivered noninvasively or minimally invasively using short term electrical or mechanical stimulation.
An extravascular nerve cuff that is configured to hold a leadless, integral, implantable microstimulator. The nerve cuff may include a cuff body having a pocket or pouch for removably receiving the implantable device within. The nerve cuff can be secured around the nerve such that the electrodes of the device are stably positioned relative to the nerve. Furthermore, the nerve cuff drives the majority of the current from the stimulation device into the nerve, while shielding surrounding tissues from unwanted stimulation.
A system for treating chronic inflammation may include an implantable microstimulator, a wearable charger, and optionally an external controller. The implantable microstimulator may be implemented as a leadless neurostimulator implantable in communication with a cervical region of a vagus nerve. The microstimulator can address several types of stimulation including regular dose delivery. The wearable charger may be worn around the subject's neck to rapidly (<10 minutes per week) charge an implanted microstimulator. The external controller may be configured as a prescription pad that controls the dosing and activity of the microstimulator.
Described herein are systems and methods for applying extremely low duty-cycle stimulation sufficient to treat chronic inflammation with progressively longer delays (off periods) from an initial stimulation. In particular, described herein are supra-threshold pulses of electrical stimulation sufficient to result in a long-lasting (e.g., >48 hours) inhibition of pro-inflammatory cytokines and/or effects of chronic inflammation; the delay between initial doses (which may be single-pulse doses) may be extended for subsequent doses, potentially dramatically enhancing battery and device longevity.
Devices, systems and methods for the treatment of chronic inflammatory disorders that include an implantable microstimulator and an external charger/controller wherein the controller is configured to operate using closed-loop feedback.
A system for treating chronic inflammation may include an implantable microstimulator, a wearable charger, and optionally an external controller. The implantable microstimulator may be implemented as a leadless neurostimulator implantable in communication with a cervical region of a vagus nerve. The microstimulator can address several types of stimulation including regular dose delivery. The wearable charger may be worn around the subject's neck to rapidly (<10 minutes per week) charge an implanted microstimulator. The external controller may be configured as a prescription pad that controls the dosing and activity of the microstimulator.
Devices and methods for stimulation of the vagus nerve to modulate (e.g., reduce, suppress, etc.) bone erosion. Methods and apparatus for modulating bone erosion may modulate levels of Receptor Activator for Nuclear Factor κ B Ligand (RANKL), and/or to modulate (increase, enhance, etc.) osteoprotegerin (OPG) and/or OPG/RANKL ratio. Devices may include electrical stimulation devices that may be implanted, and may be activated to apply current for a proscribed duration, followed by a period without stimulation.
Systems, devices and methods for modulation of sirtuins by neurostimulation. In particular, sirtuins may be modulated by stimulation of the vagus nerve. Further described herein generally are methods, systems and devices, for specifically modulating sirtuins, including sub-sets (types or localized regions) of sirtuins by vagus nerve stimulation (VNS).
Systems, devices and methods for modulation of sirtuins by neurostimulation. In particular, sirtuins may be modulated by stimulation of the vagus nerve. Further described herein generally are methods, systems and devices, for specifically modulating sirtuins, including sub-sets (types or localized regions) of sirtuins by vagus nerve stimulation (VNS).
Described herein are methods and systems for applying extremely low duty-cycle stimulation sufficient to treat chronic inflammation. In particular, described herein are single supra-threshold pulses of electrical stimulation sufficient to result in a long-lasting (e.g., >4 hours, greater than 12 hours, greater than 24 hours, greater than 48 hours) inhibition of pro-inflammatory cytokines and/or effects of chronic inflammation. These methods and devices are particularly of interest in treatment of inflammatory bowel disease (IBD).
Described herein are methods and systems for applying extremely low duty-cycle stimulation sufficient to treat chronic inflammation. In particular, described herein are single supra-threshold pulses of electrical stimulation sufficient to result in a long-lasting (e.g., >4 hours, greater than 12 hours, greater than 24 hours, greater than 48 hours) inhibition of pro-inflammatory cytokines and/or effects of chronic inflammation. These methods and devices are particularly of interest in treatment of inflammatory bowel disease (IBD).
A system for treating chronic inflammation may include an implantable microstimulator, a wearable charger, and optionally an external controller. The implantable microstimulator may be implemented as a leadless neurostimulator implantable in communication with a cervical region of a vagus nerve. The microstimulator can address several types of stimulation including regular dose delivery. The wearable charger may be worn around the subject's neck to rapidly (<10 minutes per week) charge an implanted microstimulator. The external controller may be configured as a prescription pad that controls the dosing and activity of the microstimulator.
A system for treating chronic inflammation may include an implantable microstimulator, a wearable charger, and optionally an external controller. The implantable microstimulator may be implemented as a leadless neurostimulator implantable in communication with a cervical region of a vagus nerve. The microstimulator can address several types of stimulation including regular dose delivery. The wearable charger may be worn around the subject's neck to rapidly (<10 minutes per week) charge an implanted microstimulator. The external controller may be configured as a prescription pad that controls the dosing and activity of the microstimulator.
Methods and devices for the treatment of chronic pain by modulation of the cholinergic anti-inflammatory pathway. In particular, the methods and systems described herein may be used to enhance chronic pain therapies such as spinal cord stimulation (SCS). Thus, the present invention describes devices and methods for modulation of the cytokine pathway by stimulation of the neuronal cholinergic anti-inflammatory pathway (NCAP) to enhance the treatment of chronic pain by SCS. The use of NCAP in conjunction with SCS may potentiate the effects of SCS and/or prevent the desensitization of the patient to SCS.
Described herein are devices, including interface modules or prescription pads, and systems including these devices and methods of using them, for treating inflammation or inflammatory disorders, and particularly for interfacing with a user desiring to prescribe treatment of an inflammatory disorder using an implanted stimulator.
A61B 5/055 - Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
An extravascular nerve cuff that is configured to hold a leadless, integral, implantable microstimulator. The nerve cuff may include a cuff body having a pocket or pouch for removably receiving the implantable device within. The nerve cuff can be secured around the nerve such that the electrodes of the device are stably positioned relative to the nerve. Furthermore, the nerve cuff drives the majority of the current from the stimulation device into the nerve, while shielding surrounding tissues from unwanted stimulation.
An extravascular nerve cuff that is configured to hold a leadless, integral, implantable microstimulator. The nerve cuff may include a cuff body having a pocket or pouch for removably receiving the implantable device within. The nerve cuff can be secured around the nerve such that the electrodes of the device are stably positioned relative to the nerve. Furthermore, the nerve cuff drives the majority of the current from the stimulation device into the nerve, while shielding surrounding tissues from unwanted stimulation.
Described herein are methods, devices and system for selecting an optimum position of a stimulation electrode, and particularly methods, devices and systems for optimizing the position of a stimulation electrode for stimulating the inflammatory reflex and thereby inhibiting inflammation. The methods, devices and systems described herein may generally include the analysis of one or more artifact modalities arising after the application of a stimulation pulse. One or more of these artifact modalities (e.g., EMG, ECG, etc.) may be detected and used to generate a comparable indicator of the fitness of the position of the electrode relative to a target, such as a portion of the inflammatory reflex like the vagus nerve.
Described herein are methods, devices and system for selecting an optimum position of a stimulation electrode, and particularly methods, devices and systems for optimizing the position of a stimulation electrode for stimulating the inflammatory reflex and thereby inhibiting inflammation. The methods, devices and systems described herein may generally include the analysis of one or more artifact modalities arising after the application of a stimulation pulse. One or more of these artifact modalities (e.g., EMG, ECG, etc.) may be detected and used to generate a comparable indicator of the fitness of the position of the electrode relative to a target, such as a portion of the inflammatory reflex like the vagus nerve.
Described herein are devices, systems and methods for stimulation of the cholinergic anti-inflammatory pathway (CAP). In particular the devices and systems described herein are for intravascular stimulation of the CAP via the right vagus nerve by stimulating through the superior vena cava with minimal cardiac side effects. The systems described herein typically include one or more electrode leads configured to stimulate the cholinergic anti-inflammatory pathway (e.g., the vagus nerve) from a position within the patient's superior vena cava (SVC). The lead may include one or more electrodes and an anchor for securing the lead. The system may also include an implantable therapy administrator ("ITA") to which the lead may be connected. The ITA may be configured as a controller for controlling the stimulation applied. These devices and/or systems may also be referred to as "immune system pacemakers".
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
Surgical, medical, dental and veterinary apparatus and instruments, artificial limbs, eyes and teeth; orthopedic articles; suture materials; medical devices, including implantable devices used to treat chronic inflammatory diseases and autoimmune disorders. Medical services.
