Axonics Modulation Technologies, Inc.

Axonics, Inc.

John Woock

Dennis Lynn Schroeder

Eric V Schmid

Guangqiang Jiang

Prabodh Mathur

Rabih Nassif

Faizal Abdeen

Andres Dandler

Tony Cowley

Reaz Rahman

Eric Olson

Christian Denhart

Cezanne Farris-Gilbert

Guanqiang Jiang

Madeline Derby

Charles Borlase

Guangqing Jiang

Franklin S Portillo

Flavio Ono

Jiang Guangqiang

Systems and methods for providing a trial neurostimulation to a patient for assessing suitability of a permanently implanted neurostimulation are provided herein. In one aspect, a trial neurostimulation system includes an EPG affixation device that secures the EPG to the patient when connected to a lead extending through a percutaneous incision to a target tissue location, while allowing for ready removal of the EPG for charging or bathing. In another aspect, the system includes an EPG provided with a multi-purpose connector receptacle through which the EPG can deliver neurostimulation therapy to an implanted lead or the EPG can be charged. In yet another aspect, the EPG can include a multi-purpose connector receptacle that is alternatingly connectable with a plurality of differing connector to facilitate differing types of therapies with one or more neurostimulation devices, ground patches or various other devices, such as charging or testing devices.

External pulse generator device and affixation device for trial nerve stimulation and methods of use

Charger holder

A training system for a neurostimulation system that may be used to simulate a neurostimulator programming session and/or lead placement. The system may include a training device that may be coupled to a neurostimulator programmer and may include an interface to allow user interaction and/or display information relevant to the stimulation. The trainer device may include circuitry for simulating a neurostimulator such as an IPG or EPG, and may include circuitry for simulating impedance associated with lead placement.

Trainer for a neurostimulator programmer and associated methods of use with a neurostimulation system

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. The clinician programmer further includes graphical user interface on which the plurality of recommended electrode configurations are displayed for modification and/or selection by a clinician in programming an IPG or EPG coupled with the lead to apply a neurostimulation treatment according to the selected electrode configuration.

Methods for determining neurostimulation electrode configurations based on neural localization

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. A stimulation-induced EMG motor response is recorded with the integrated clinician programmer for each test stimulation on each electrode of the implantable lead via the at least one pair of EMG sensing electrodes so as to facilitate initial positioning of the implantable lead at a target stimulation region.

Electromyographic lead positioning and stimulation titration in a nerve stimulation system for treatment of overactive bladder

Systems and methods for providing a trial neurostimulation to a patient for assessing suitability of a permanently implanted neurostimulation are provided herein. In one aspect, a trial neurostimulation system includes an EPG affixation device that secures the EPG to the patient when connected to a lead extending through a percutaneous incision to a target tissue location, while allowing for ready removal of the EPG for charging or bathing. In another aspect, the system includes an EPG provided with a multi-purpose connector receptacle through which the the EPG can deliver neurostimulation therapy to an implanted lead or the EPG can be charged. In yet another aspect, the EPG can include a multi-purpose connector receptacle that is alternatingly connectable with a plurality of differing connector to facilitate differing types of therapies with one or more neurostimulation devices, ground patches or various other devices, such as charging or testing devices.

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.

Patient remote and associated methods of use with a nerve stimulation system

A clinician programmer may be coupled with an implantable temporary or permanent lead in a patient. Generally, the clinician programmer may comprise a portable housing, a signal/stimulation generator, 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 graphical user interface at least partially comprises the external surface of the housing and has a touch screen display for direct user interaction or for use with a keyboard, mouse, or the like.

Clinician programmer for use with an implantable neurostimulation lead

Systems and methods for providing a trial neurostimulation to a patient for assesssing suitability of a permanently implanted neurostimulation are provided herein. In one aspect, a trial neurostimulation system includes an EPG affixation device that secures the EPG to the patient when connected to a lead extending through a percutaneous incission to a target tissue location, while allowing for ready removal of the EPG for charging or bathing. In another aspect, the system includes an EPG provided with a multi-purpose connector rectacle through which the EPG can deliver neurostimulation therapy to an implanted lead or the EPG can be charged. In yet another aspect, the EPG can include a multi-purpose connector receptacle that is alternatingly connectable with a plurality of differing connector to faciltiate differing types of therapies with one or more neurostimulation devices, ground patches or various other devices, such as charging or testing devices.

External pulse generator device and associated methods for trial nerve stimulation

A multichannel clip device and methods of use that facilitate connection of multiple electrical components of a first device and a second device for testing and/or verification are provided herein. Such multichannel clip devices can include a spring-loaded clip having multiple electrical contacts for coupling with a contact portion of a first device and which are connected to a proximal connector through a flexible stimulation cable. The contacts can be included within a neurostimulation lead connector and the proximal connector adapted to couple with standard connectors on a clinician programmer, each contact being coupled to a corresponding contact of the proximal connector to define multiple separate channels. Such clip devices allow clinicians to test and/or verify multiple neurostimulation lead electrodes with a clinician programmers without requiring separate connection of each electrodes to a probe or test device and further allows for repeated sequencing or multi-plexing of neurostimulation leads during testing.

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Costa Mesa, CA, United States of America

John Woock