Patent Description:
Neurostimulation is an established neuromodulation therapy for the treatment of movement disorders. For example, neurostimulation has been shown to improve cardinal motor symptoms of Parkinson's Disease (PD), such as bradykinesia, rigidity, and tremors. Types of neurostimulation include deep brain stimulation (DBS) and spinal cord stimulation (SCS).

Neurostimulation systems typically include an implantable pulse generator (IPG). IPGs are generally not immune to interference from magnetic resonance imaging (MRI) systems and other sources of electromagnetic interference (EMI). Accordingly, for at least some known IPGs, neurostimulation therapy is often disabled and the device is placed into an MRI-safe mode of operation while the patient undergoes an MRI scan, or when the patient expects to be subjected to relatively large levels of EMI (e.g., when going through a body scanner and/or metal detector as part of a security screening). For other known IPGs, specialized bipolar stimulation program settings (i.e., those which do not utilize the IPG can/case for stimulation) can be utilized during an MRI scan for maintaining effective and desirable therapy. However, specialized programming places additional burdens on the clinician and/or neurologist in creating such customized stimulation programs and for patient use of them in those interference scenarios.

Accordingly, it would be desirable to provide an IPG that is capable of maintaining effective and desirable neurostimulation therapy even while experiencing interference from MRI systems and/or other sources of EMI, without requiring the use of specialized stimulation programs or settings.

<CIT> discloses techniques for minimizing interference between first and second medical devices of a therapy system. <CIT> discloses an electromagnetic radiation immune medical assist system including a medical assist device operatively connected with a photonic catheter. <CIT> discloses an electrical circuit connected in series with a lead of a pacemaker between the pacemaker and the heart to protect the pacemaker against high voltages/currents.

In one embodiment, the present disclosure is directed to protection circuitry for an implantable pulse generator (IPG) of a neurostimulation system. The protection circuitry is coupled to an IPG ground, a plurality of electrodes, and an IPG case, and operable to protect IPG stimulation and sensing circuitry from damage during electrostatic discharge and cardiac defibrillation, and to mitigate unintended stimulation during electromagnetic interference. The protection circuitry includes an IPG ground connection, a plurality of protection Zener diodes, wherein one of the protection Zener diodes is electrically coupled between the IPG case and a float Zener diode, and wherein the remaining protection Zener diodes are electrically coupled between the plurality of electrodes and the float Zener diode, and the float Zener diode electrically coupled between the plurality of protection Zener diodes and the IPG ground.

In another embodiment, the present disclosure is directed to a neurostimulation system. The neurostimulation system includes an implantable pulse generator (IPG) ground, an IPG case, a stimulation lead comprising a plurality of electrodes, and an IPG coupled to the IPG ground, the IPG case, and the stimulation lead, the IPG including protection circuitry operable to protect IPG stimulation and sensing circuitry from damage due to electrostatic discharge and cardiac defibrillation, and to mitigate unintended stimulation during electromagnetic interference. The protection circuitry includes an IPG ground connection, a plurality of protection Zener diodes, wherein one of the protection Zener diodes is electrically coupled between the IPG case and a float Zener diode, and wherein the remaining protection Zener diodes are electrically coupled between the plurality of electrodes and the float Zener diode, and the float Zener diode electrically coupled between the plurality of protection Zener diodes and the IPG ground.

In another embodiment, the present disclosure is directed to a method of assembling protection circuitry for an implantable pulse generator (IPG) of a neurostimulation system including an IPG ground, a plurality of electrodes, and an IPG case. The method includes providing an IPG ground connection, electrically coupling one of a plurality of protection Zener diodes between the IPG case and a float Zener diode, electrically coupling the remaining protection Zener diodes between the plurality of electrodes and the float Zener diode, and electrically coupling the float Zener diode between the plurality of protection Zener diodes and the IPG ground.

The foregoing and other aspects, features, details, utilities and advantages of the present disclosure will be apparent from reading the following description and claims, and from reviewing the accompanying drawings.

Corresponding reference characters indicate corresponding parts throughout the several views of the drawings.

The present disclosure provides systems and methods for improved protection circuitry for an implantable pulse generator (IPG) of a neurostimulation system. The improved protection circuitry is coupled to an IPG ground, a plurality of electrodes, and an IPG case, and operable to protect IPG stimulation and sensing circuitry from damage during electrostatic discharge and cardiac defibrillation, and to mitigate unintended stimulation during electromagnetic interference. The improved protection circuitry includes an IPG ground connection and a plurality of protection Zener diodes. One of the protection Zener diodes is electrically coupled between the IPG case and a float Zener diode, and the remaining protection Zener diodes are electrically coupled between the plurality of electrodes and the float Zener diode. The float Zener diode is electrically coupled between the plurality of protection Zener diodes and the IPG ground.

The improved protection circuitry described herein also exhibits a substantial advantage in imposing a minimal increase in IPG manufacturing costs and assembly complexity, because only a single additional component (i.e., the float Zener diode) is required in the bill of material (BOM) for the construction of the IPG. Accordingly, the improved protection circuitry provides a simple and costeffective solution to a relatively complex and difficult MRI/EMI problem.

Neurostimulation systems are devices that generate electrical pulses and deliver the pulses to nervous tissue of a patient to treat a variety of disorders. One category of neurostimulation systems is deep brain stimulation (DBS). In DBS, pulses of electrical current are delivered to target regions of a subject's brain, for example, for the treatment of movement and effective disorders such as PD and essential tremor. Another category of neurostimulation systems is spinal cord stimulation (SCS).

Neurostimulation systems generally include a pulse generator and one or more leads. A stimulation lead includes a lead body of insulative material that encloses wire conductors. The distal end of the stimulation lead includes multiple electrodes, or contacts, that intimately impinge upon patient tissue and are electrically coupled to the wire conductors. The proximal end of the lead body includes multiple terminals (also electrically coupled to the wire conductors) that are adapted to receive electrical pulses. In DBS systems, the distal end of the stimulation lead is implanted within the brain tissue to deliver the electrical pulses. The stimulation leads are then tunneled to another location within the patient's body to be electrically connected with a pulse generator or, alternatively, to an "extension. " The pulse generator is typically implanted in the patient within a subcutaneous pocket created during the implantation procedure.

The pulse generator is typically implemented using a metallic housing (or can) that encloses circuitry for generating the electrical stimulation pulses, control circuitry, communication circuitry, a rechargeable battery, etc. The pulse generating circuitry is coupled to one or more stimulation leads through electrical connections provided in a "header" of the pulse generator. Specifically, feedthrough wires typically exit the metallic housing and enter into a header structure of a moldable material. Within the header structure, the feedthrough wires are electrically coupled to annular electrical connectors. The header structure holds the annular connectors in a fixed arrangement that corresponds to the arrangement of terminals on the proximal end of a stimulation lead.

Referring now to the drawings, and in particular to <FIG>, a stimulation system is indicated generally at <NUM>. Stimulation system <NUM> generates electrical pulses for application to tissue of a patient, or subject, according to one embodiment. System <NUM> includes an implantable pulse generator (IPG) <NUM> that is adapted to generate electrical pulses for application to tissue of a patient. Alternatively, system <NUM> may include an external pulse generator (EPG) positioned outside the patient's body. IPG <NUM> typically includes a metallic housing ( or can) that encloses a controller <NUM>, pulse generating circuitry <NUM>, a battery <NUM>, far-field and/or near field communication circuitry <NUM>, and other appropriate circuitry and components of the device. Controller <NUM> typically includes a microcontroller or other suitable processor for controlling the various other components of the device. Software code is typically stored in memory of IPG <NUM> for execution by the microcontroller or processor to control the various components of the device.

IPG <NUM> may comprise one or more attached extension components <NUM> or be connected to one or more separate extension components <NUM>. Alternatively, one or more stimulation leads <NUM> may be connected directly to IPG <NUM>. Within IPG <NUM>, electrical pulses are generated by pulse generating circuitry <NUM> and are provided to switching circuitry. The switching circuit connects to output wires, traces, lines, or the like (not shown) which are, in turn, electrically coupled to internal conductive wires (not shown) of a lead body <NUM> of extension component <NUM>. The conductive wires, in turn, are electrically coupled to electrical connectors (e.g., "Bal-Seal" connectors) within connector portion <NUM> of extension component <NUM>. The terminals of one or more stimulation leads <NUM> are inserted within connector portion <NUM> for electrical connection with respective connectors. Thereby, the pulses originating from IPG <NUM> and conducted through the conductors of lead body <NUM> are provided to stimulation lead <NUM>. The pulses are then conducted through the conductors of lead <NUM> and applied to tissue of a patient via electrodes <NUM>. Any suitable known or later developed design may be employed for connector portion <NUM>.

For implementation of the components within IPG <NUM>, a processor and associated charge control circuitry for an implantable pulse generator is described in <CIT>, entitled "SYSTEMS AND METHODS FOR USE IN PULSE GENERATION". Circuitry for recharging a rechargeable battery of an implantable pulse generator using inductive coupling and external charging circuits are described in <CIT>, entitled "IMPLANTABLE DEVICE AND SYSTEM FOR WIRELESS COMMUNICATION".

An example and discussion of "constant current" pulse generating circuitry is provided in <CIT> entitled "PULSE GENERATOR HAVING AN EFFICIENT FRACTIONAL VOLTAGE CONVERTER AND METHOD OF USE". One or multiple sets of such circuitry may be provided within IPG <NUM>. Different pulses on different electrodes may be generated using a single set of pulse generating circuitry using consecutively generated pulses according to a "multi-stimset program" as is known in the art. Alternatively, multiple sets of such circuitry may be employed to provide pulse patterns that include simultaneously generated and delivered stimulation pulses through various electrodes of one or more stimulation leads as is also known in the art. Various sets of parameters may define the pulse characteristics and pulse timing for the pulses applied to various electrodes as is known in the art. Although constant current pulse generating circuitry is contemplated for some embodiments, any other suitable type of pulse generating circuitry may be employed such as constant voltage pulse generating circuitry.

Stimulation lead(s) <NUM> may include a lead body of insulative material about a plurality of conductors within the material that extend from a proximal end of lead <NUM> to its distal end. The conductors electrically couple a plurality of electrodes <NUM> to a plurality of terminals (not shown) of lead <NUM>. The terminals are adapted to receive electrical pulses and the electrodes <NUM> are adapted to apply stimulation pulses to tissue of the patient. Also, sensing of physiological signals may occur through electrodes <NUM>, the conductors, and the terminals. Additionally or alternatively, various sensors (not shown) may be located near the distal end of stimulation lead <NUM> and electrically coupled to terminals through conductors within the lead body <NUM>. Stimulation lead <NUM> may include any suitable number and type of electrodes <NUM>, terminals, and internal conductors.

Controller device <NUM> may be implemented to recharge battery <NUM> of IPG <NUM> (although a separate recharging device could alternatively be employed). A "wand" <NUM> may be electrically connected to controller device through suitable electrical connectors (not shown). The electrical connectors are electrically connected to coil <NUM> (the "primary" coil) at the distal end of wand <NUM> through respective wires (not shown). Typically, coil <NUM> is connected to the wires through capacitors (not shown). Also, in some embodiments, wand <NUM> may comprise one or more temperature sensors for use during charging operations.

The patient then places the primary coil <NUM> against the patient's body immediately above the secondary coil (not shown), i.e., the coil of the implantable medical device. Preferably, the primary coil <NUM> and the secondary coil are aligned in a coaxial manner by the patient for efficiency of the coupling between the primary and secondary coils. Controller device <NUM> generates an AC-signal to drive current through coil <NUM> of wand <NUM>. Assuming that primary coil <NUM> and secondary coil are suitably positioned relative to each other, the secondary coil is disposed within the magnetic field generated by the current driven through primary coil <NUM>. Current is then induced by a magnetic field in the secondary coil. The current induced in the coil of the implantable pulse generator is rectified and regulated to recharge the battery of IPG <NUM>. The charging circuitry may also communicate status messages to controller device <NUM> during charging operations using pulse-loading or any other suitable technique. For example, controller device <NUM> may communicate the coupling status, charging status, charge completion status, etc..

External controller device <NUM> is also a device that permits the operations of IPG <NUM> to be controlled by a user after IPG <NUM> is implanted within a patient, although in alternative embodiments separate devices are employed for charging and programming. Also, multiple controller devices may be provided for different types of users (e.g., the patient or a clinician). Controller device <NUM> can be implemented by utilizing a suitable handheld processor-based system that possesses wireless communication capabilities. Software is typically stored in memory of controller device <NUM> to control the various operations of controller device <NUM>. Also, the wireless communication functionality of controller device <NUM> can be integrated within the handheld device package or provided as a separate attachable device. The interface functionality of controller device <NUM> is implemented using suitable software code for interacting with the user and using the wireless communication capabilities to conduct communications with IPG <NUM>.

Controller device <NUM> preferably provides one or more user interfaces to allow the user to operate IPG <NUM> according to one or more stimulation programs to treat the patient's disorder(s). Each stimulation program may include one or more sets of stimulation parameters including pulse amplitude, pulse width, pulse frequency or inter-pulse period, pulse repetition parameter (e.g., number of times for a given pulse to be repeated for respective stimset during execution of program), etc. In the methods and systems described herein, stimulation parameters may include, for example, a number of pulses in a burst (e.g., <NUM>, <NUM>, or <NUM> pulses per burst), an intra-burst frequency (e.g., <NUM>), an inter-burst frequency (e.g., <NUM>), and a delay between the pulses in a burst (e.g., less than <NUM> millisecond (ms)).

IPG <NUM> modifies its internal parameters in response to the control signals from controller device <NUM> to vary the stimulation characteristics of stimulation pulses transmitted through stimulation lead <NUM> to the tissue of the patient. Neurostimulation systems, stimsets, and multi-stimset programs are discussed in <CIT>, entitled "NEUROMODULATION THERAPY SYSTEM," and <CIT>, entitled "METHOD AND APPARATUS FOR PROVIDING COMPLEX TISSUE STIMULATION PATTERNS". Example commercially available neurostimulation systems include the EON MINI™ pulse generator and RAPID PROGRAMMER™ device from Abbott Laboratories.

The systems and methods described herein provide protection circuitry that provides improved protection for stimulation and sensing circuitry during heart defibrillation and/or electrostatic discharge transients. Further, the improved IPG protection circuitry described herein enhances the IPG's capability of maintaining safe and effective neurostimulation therapy for patients during an MRI scan and other EMI events. The systems and methods described herein are particularly useful in SCS systems, but may also be used in other neurostimulation systems (e.g., DBS systems). Specifically, the improved IPG protection circuitry described herein overcomes therapy degradation concerns and other concerns related to relatively large interference voltages being generated on IPG leads from MRI and/or other EMI, providing substantial benefits for clinicians, neurologists, and patients. The systems and methods described herein also enable using a stimulation current regulator powered by a floating power supply. This enables maintaining effective and safe stimulation therapy during MRI and/or other EMI for patients who use relatively strong stimulation settings (described in detail herein). An example and discussion of "floating power supply" powered current regulator circuitry is provided in <CIT>.

During MRI or other EMI, to avoid degradation of stimulation therapy, to avoid unintended stimulation, and to avoid other IPG performance concerns, a high-impedance electrical loop must be maintained between a case or can of IPG <NUM> and all of the electrodes in the stimulation lead. For example, during an MRI scan, induced interference voltages on the electrodes may reach levels as high as +/- <NUM> Volts in implantable SCS devices. At least some known systems handle this interference by forcing patients to disable stimulation therapy during the exposure to interference, or to utilize a customized bipolar stimulation program for maintaining effective and desired therapy under interference conditions.

In contrast, the systems and methods described herein allow stimulation and sensing circuitry in IPG <NUM> to be voltage level shifted above or below the IPG ground as interference is detected. This allows for automatic compensation of induced interference voltages, and it allows stimulation therapy to be maintained during exposure to interference without the need for additional stimulation programs customized exclusively for use during MRI/EMI exposure.

<FIG> is a circuit diagram of IPG circuitry <NUM> using known protection circuitry <NUM>. IPG circuitry <NUM> includes an IPG case <NUM>, a plurality of electrodes <NUM>, and known protection circuitry <NUM>. Known protection circuitry <NUM> includes a plurality of protection Zener diodes <NUM> directly electrically coupled to an IPG ground <NUM> (e.g., a negative battery terminal). Each electrode <NUM> and IPG case <NUM> is electrically coupled to IPG ground <NUM> through an associated protection Zener diode <NUM>. Protection Zener diodes <NUM> typically have a reverse breakdown voltage of <NUM> Volts.

As shown in circuit schematic of <FIG>, each electrode <NUM> is electrically coupled to a common node <NUM> through a respective first capacitor <NUM> and respective first resistor <NUM>. Further, common node <NUM> is electrically coupled to a can electrode <NUM> through a second resistor <NUM>, and can electrode <NUM> is electrically coupled to IPG case <NUM> through a second capacitor <NUM>. IPG case <NUM> is electrically coupled to IPG ground <NUM> through a protection Zener diode <NUM>. Interference voltage <NUM> (e.g., resulting from MRI or other EMI) is also represented in the schematic diagram of IPG circuitry <NUM>.

Notably, known protection circuitry <NUM> in <FIG> does not allow for the compensation of large interference voltages while delivering stimulation therapy, especially at relatively strong stimulation settings. Relatively strong stimulation settings, as used herein, may include, for example, large amplitude stimulation. For example strong stimulation settings may include applying stimulation currents in a range from <NUM>-<NUM> milliamperes (mA) (which may result in voltages in a range from <NUM>-<NUM> Volts across tissue, electrodes, etc.), whereas more typical stimulation settings may include applying stimulation currents in a range from <NUM>-<NUM> mA.

<FIG> is a circuit diagram of one embodiment of IPG circuitry <NUM> using improved protection circuitry <NUM> in accordance with the systems and methods described herein. IPG circuitry <NUM> may be implemented within, for example, IPG <NUM> (shown in <FIG>). IPG circuitry <NUM> provides substantial performance improvements over IPG circuitry <NUM>, as described in detail herein. For IPG circuitry <NUM> and IPG circuitry <NUM>, like components are labeled with like reference numerals.

IPG circuitry <NUM> includes improved protection circuitry <NUM> including a plurality of protection Zener diodes <NUM>. However, in contrast to protection Zener diodes <NUM> (shown in <FIG>), in this embodiment, protection Zener diodes <NUM> have a reverse breakdown voltage of <NUM> Volts (instead of <NUM> Volts). The lower reverse breakdown voltage for protection Zener diodes <NUM> results in improved device protection and reliability for IPG <NUM>. Specifically, the lower reverse breakdown voltage results in improved IPG reliability via reduced heating of protection Zener diodes <NUM> during cardiac defibrillation or electrostatic discharge events, which may induce relatively high currents through protection Zener diodes <NUM>.

As shown in <FIG>, improved protection circuitry <NUM> also includes a float Zener diode <NUM> electrically coupled between IPG case <NUM>, protection Zener diodes <NUM>, and IPG ground <NUM>. Float Zener diode <NUM> is coupled in a reverse orientation relative to protection Zener diodes <NUM> (i.e., the anode of float Zener diode <NUM> is directly coupled to the commonly-connected anode terminals of protection Zener diodes <NUM>). In this embodiment, float Zener diode <NUM> has a reverse breakdown voltage of <NUM> Volts. Alternatively, float Zener diode <NUM> may have any suitable reverse breakdown voltage. Notably, during cardiac defibrillation or electrostatic discharge events, relatively little current flows through float Zener diode <NUM> because IPG ground <NUM> is substantially unaffected by those events.

The inclusion of float Zener diode <NUM> in improved protection circuitry <NUM> results in a floating node <NUM> (VFLOAT) at the connection between float Zener diode <NUM> and protection Zener diodes <NUM>. Floating node <NUM> floats up and down based on the magnitude of interference <NUM> (and allows protection Zener diodes <NUM> to float up and down with respect to IPG ground <NUM>). This substantially mitigates reverse breakdown current conduction of protection Zener diodes <NUM>, which alleviates unintended stimulation currents from flowing through IPG <NUM> and patient tissue. Further, if one of electrodes <NUM> experiences significant electromagnetic interference, floating node <NUM> helps to protect the IPG stimulation and sensing circuitry connected to electrodes <NUM> from being damaged. Floating node <NUM> also helps to protect the IPG stimulation and sensing circuitry connected to electrodes <NUM> in the event of electrostatic discharge and cardiac defibrillation between electrodes <NUM> and/or can electrode <NUM>.

Further, floating node <NUM> enables a floating power supply (e.g., for powering a stimulation current regulator in IPG <NUM>) to be biased by a common-mode voltage source above or below IPG ground <NUM>. That common-mode voltage source may be used to automatically compensate for large induced voltages from interference <NUM> caused by MRI or other EMI, all while consuming relatively little additional battery current. For example, the determination of when and how much to compensate for the induced interference voltages can be performed using one or more low-power voltage comparator circuits (not shown) that receive inputs from an EMI antenna or from a Kelvin-connect electrode that is not used for stimulation therapy and from an IPG case connection (e.g., IPG case <NUM>). An example and discussion of the use of an EMI antenna or a "Kelvin-connect electrode" for monitoring interference from MRI/EMI is provided in <CIT>.

<FIG> is a circuit diagram of IPG circuitry <NUM> configured to operate in a mode for delivering stimulation therapy in combination with a stimulation current regulator <NUM>. IPG circuitry <NUM> and stimulation current regulator <NUM> may be implemented, for example, in an IPG of a bipolar SCS system that includes a single anode (at VANODE) and a single cathode (at VCATHODE). Stimulation current regulator <NUM> includes a digital to analog converter (DAC) <NUM>, an error amplifier <NUM>, a high-impedance stimulation current conducting device <NUM> (e.g., a MOSFET), a floating power supply (VB) <NUM>, a variable resistor <NUM>, and a voltage multiplier <NUM> (VM). A common-mode voltage source <NUM> (VCOM) may be used to bias stimulation current regulator <NUM> above or below IPG ground <NUM> during interference from MRI/EMI.

In this embodiment, in addition to a first stimulation electrode <NUM> (E0) and a second stimulation electrode <NUM> (E2), IPG circuitry <NUM> further includes a non-active electrode <NUM> (E1) (i.e., an electrode that is not used for stimulation). Non-active electrode <NUM> may be a Kelvin-connect electrode that is used to monitor electromagnetic interference in IPG circuitry <NUM>, as noted above. Alternatively, an EMI antenna may be used to monitor electromagnetic interference, as noted above. In embodiments where an EMI antenna is utilized to monitor electromagnetic interference, the neurostimulation circuitry electrically connected to the EMI antenna should also be protected from static damage and cardiac defibrillation. This can be readily achieved via an electrical connection to the cathode terminal of a Zener protection diode, in the very same manner described above which is used for the protection of the neurostimulator system connections to the electrodes in a stimulation lead.

Further, common-mode voltage source <NUM> (VCOM) is shown connected between IPG case <NUM> and IPG ground <NUM>. A case voltage (VCASE) and a common voltage (at common node <NUM>) may be adjusted over time based on how much interference is detected using an EMI antenna or non-active electrode <NUM> and IPG case <NUM>. As shown in <FIG>, an anode of each
protection Zener diode <NUM> is connected to floating node <NUM> (VFLOAT). For mitigation of undesirable stimulation interference caused by MRI/EMI events, this embodiment may operate in tandem with methods and system for operating simulation current regulator <NUM> from a floating power supply, as described in <CIT>.

<FIG> and <FIG> are graphs <NUM> and <NUM> showing experimental values for currents and voltages, respectively, using known IPG protection circuitry (i.e., as shown in <FIG>) while applying stimulation therapy in the absence of interference. <FIG> and <FIG> are graphs <NUM> and <NUM> showing experimental values for undesirable currents and voltages, respectively, using known IPG protection circuitry while simultaneously applying SCS therapy and experiencing interference typically induced during an MRI scan. Further, <FIG> and <FIG> are graphs <NUM> and <NUM> showing experimental values for currents and voltages, respectively, using the improved IPG protection circuitry described herein (i.e., as shown in <FIG>) while simultaneously applying the same SCS therapy and experiencing the same level of interference. In these examples, the SCS therapy is applied using relatively strong stimulation settings (e.g., with a stimulation amplitude of <NUM> mA and a pulse width of <NUM> microseconds (µs)).

As shown in graphs <NUM> and <NUM>, the stimulation currents and voltages are well-controlled using known IPG protection circuitry (i.e., as shown in <FIG>) when no interference is present. However, as shown in graphs <NUM> and <NUM>, undesirable currents and voltages are generated in known IPG circuitry and patient tissue when stimulation is applied and interference is present.

Notably, as shown in graphs <NUM> and <NUM>, even when interference is present, stimulation currents and voltages are well-controlled in the IPG circuitry and patient tissue using the improved IPG protection circuitry described herein (i.e., as shown in <FIG>). Specifically, the stimulation currents in graph <NUM> (where interference is present) are similar to the currents in graph <NUM> (where no interference is present), which confirms substantially increased immunity to interference from MRI/EMI for the improved protection circuitry.

Further, the voltages shown in graph <NUM> are indicative that the protection Zener diodes and/or the floating Zener diode in the improved IPG protection circuitry have enough "operating headroom" for remaining in a reversebiased state throughout the duration of many MRI/EMI events (i.e., they do not exhibit reverse breakdown current conduction). This improved electrical behavior of the Zener diodes is important for mitigating undesirable stimulation currents which would otherwise degrade the effectiveness and/or comfort of neurostimulation therapy for patients during MRI/EMI.

Accordingly, the improved protection provided by IPG circuitry <NUM> (and, in particular, improved protection circuitry <NUM>) allows IPG <NUM> to maintain effective and safe stimulation therapy, even during exposure to electromagnetic interference. This substantially improved functionality enhances the robustness, comfort, and satisfaction of stimulation therapy for patients, as well as overall IPG device performance and reliability. In addition, improved protection circuitry <NUM> helps to reduce the programming burdens of clinicians and neurologists, and simplifies stimulation therapy program usage for patients.

The embodiments described herein provide systems and methods for improved protection circuitry in an implantable pulse generator (IPG) of a neurostimulation system. The improved protection circuitry is coupled to an IPG ground, a plurality of electrodes, and an IPG case, and operable to protect IPG stimulation and sensing circuitry from damage during electrostatic discharge and cardiac defibrillation, and to mitigate unintended stimulation during electromagnetic interference. The improved protection circuitry includes an IPG ground connection and a plurality of protection Zener diodes. One of the protection Zener diodes is electrically coupled between the IPG case and a float Zener diode, and the remaining protection Zener diodes are electrically coupled between the plurality of electrodes and the float Zener diode. The float Zener diode is electrically coupled between the plurality of protection Zener diodes and the IPG ground.

Although certain embodiments of this disclosure have been described above with a certain degree of particularity, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the scope of this disclosure. All directional references (e.g., upper, lower, upward, downward, left, right, leftward, rightward, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise) are only used for identification purposes to aid the reader's understanding of the present disclosure, and do not create limitations, particularly as to the position, orientation, or use of the disclosure. Joinder references (e.g., attached, coupled, connected, and the like) are to be construed broadly and may include intermediate members between a connection of elements and relative movement between elements. As such, joinder references do not necessarily infer that two elements are directly connected and in fixed relation to each other. It is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative only and not limiting. Changes in detail or structure may be made without departing from the scope of the invention as defined in the appended claims.

When introducing elements of the present disclosure or the preferred embodiment(s) thereof, the articles "a", "an", "the", and "said" are intended to mean that there are one or more of the elements. The terms "comprising", "including", and "having" are intended to be inclusive and mean that there may be additional elements other than the listed elements.

Claim 1:
Protection circuitry (<NUM>) for an implantable pulse generator, IPG, of a neurostimulation system, the protection circuitry coupled to an IPG ground (<NUM>), a plurality of electrodes (<NUM>, <NUM>), and an IPG case (<NUM>), and operable to protect IPG stimulation and sensing circuitry (<NUM>) from damage during electrostatic discharge and cardiac defibrillation, and to mitigate unintended stimulation during electromagnetic interference, the protection circuitry comprising:
an IPG ground connection;
a plurality of protection Zener diodes (<NUM>), wherein one of the protection Zener diodes is electrically coupled between the IPG case and a float Zener diode (<NUM>), and wherein the remaining protection Zener diodes are electrically coupled between the plurality of electrodes and the float Zener diode; and
the float Zener diode electrically coupled between the plurality of protection Zener diodes and the IPG ground.