AU2024202249B2 - Device for, and method of, neuromodulation with closed-loop micromagnetic hybrid waveforms to relieve pain - Google Patents

Abstract

#$%^&*AU2024202249B220250911.pdf##### ABSTRACT A device for Closed Loop Hybrid Modulation Methodology, including the following four methods of neural stimulation: METHOD 1: A priming electrical signal followed by a second 5 magnetic signal. METHOD 2: A magnetic priming signal followed by a second electrical signal. METHOD 3: A priming magnetic signal followed by a second magnetic signal. METHOD 4: A priming hybrid electric and magnetic signal followed by a second hybrid electric and magnetic signal. 10 ABSTRACT A device for Closed Loop Hybrid Modulation Methodology, including the following four methods of neural stimulation: 5 METHOD 1: A priming electrical signal followed by a second magnetic signal. METHOD 2: A magnetic priming signal followed by a second electrical signal. METHOD 3: A priming magnetic signal followed by a second magnetic signal. METHOD 4: A priming hybrid electric and magnetic signal followed by a second hybrid electric and 10 magnetic signal. 20 24 20 22 49 08 A pr 2 02 4 A B S T R A C T A d e v i c e f o r C l o s e d L o o p H y b r i d M o d u l a t i o n M e t h o d o l o g y , 2 0 2 4 2 0 2 2 4 9 0 8 2 0 2 4 A p r i n c l u d i n g t h e f o l l o w i n g f o u r m e t h o d s o f n e u r a l s t i m u l a t i o n : 5 M E T H O D 1 : A p r i m i n g e l e c t r i c a l s i g n a l f o l l o w e d b y a s e c o n d m a g n e t i c s i g n a l . M E T H O D 2 : A m a g n e t i c p r i m i n g s i g n a l f o l l o w e d b y a s e c o n d e l e c t r i c a l s i g n a l . M E T H O D 3 : A p r i m i n g m a g n e t i c s i g n a l f o l l o w e d b y a s e c o n d m a g n e t i c s i g n a l . M E T H O D 4 : A p r i m i n g h y b r i d e l e c t r i c a n d m a g n e t i c s i g n a l f o l l o w e d b y a s e c o n d h y b r i d e l e c t r i c a n d 1 0 m a g n e t i c s i g n a l . WO 2021/163428 PCT/US2021/017783 1 1 130 10 10 60 50 62 64 50 34 66 66 32 132 & 12 12 FIG. 13 13/13 20 24 20 22 49 08 A pr 2 02 4 W O 2 0 2 1 / 1 6 3 4 2 8 P C T / U S 2 0 2 1 / 0 1 7 7 8 3 A p r 2 0 2 4 0 0 0 0 0 * * * * 2 0 2 4 2 0 2 2 4 9 0 8 1 3 0 1 0 1 0 6 0 5 0 6 2 6 4 5 0 3 4 6 6 6 6 3 2 1 3 2 1 2 1 2 F I G . 1 3 1 3 / 1 3

Description

1 1

130 10 10 2024202249

60 50 62 64 50

34

66

66

32 132

&

12

12

FIG. 13

13/13

Devicefor, Device for, and method and method of,neuromodulation of, neuromodulationwithwith closed- closed- 08 Apr 2024

loop micromagnetic loop hybrid micromagnetic hybrid waveforms waveforms to relieve to relieve painpain

Cross-Reference to Cross-Reference to Related Related Applications Applications

Thepresent The presentapplication applicationisis a adivisional divisionalapplication application from from Australian Australian

5 5 PatentApplication Patent ApplicationNo. No. 2022215308. 2022215308. The entire The entire disclosures disclosures of of AustralianPatent Australian Patent Application Application No. No. 2022215308, 2022215308, its corresponding its corresponding 2024202249

International Patent International Patent Application Application No. No. PCT/US2021/017783 and PCT/US2021/017783 and U.S. U.S.

patentapplication patent applicationserial serialnumber number 62/975,811, 62/975,811, are are all all incorporated incorporated

hereinby herein byreference. reference.

10 10 Technical Field Technical Field

This disclosure This disclosurerelates relatesto to systems systemsand and methods methods for providing for providing closed closed

loop hybrid loop hybridstimulation stimulationofofneural neural structures, structures, and, and, more more specifically, specifically,

for managing for pain managing pain with with either either multiple multiple signals signals or aor a single single signal signal

havingmodulated having modulated characteristics. characteristics.

15 15 BackgroundArt Background Art Theterm The termSpinal Spinal Cord Cord Stimulation Stimulation (SCS) (SCS) is used is used to describe to describe an an advanced management advanced management therapy therapy forfor chronicpain chronic painin in which whichaa varying varying electric field electric fieldisis applied appliedtoto the Dorsal the DorsalColumns (DC)ofofthe Columns (DC) thespinal spinalCord Cord via an via electrode array an electrode array(or (or electrode electrode arrays) arrays) implanted implantedinin theepidural the epidural 20 20 space. Conventional space. ConventionalSCS SCS also also called called “tonic,”traditionally "tonic," traditionallyconsisting consistingofof an electric an electric field fieldvarying varying between 40-250HzHz between 40-250 that that is is directedtotoa a directed

targeted pain targeted painlocation locationby byoverlaying overlayingititwith witha aperceived perceivedtingling tingling sensation, known sensation, known asas paresthesia, paresthesia, created created by by thethe stimulating stimulating electric electric

field. This field. therapy This therapy hashas beenbeen clinically clinically utilized utilized for about for about half a century. half a century.

25 25 Theprincipal The principalmode modeof of action action is is based based on on thethe Gate Gate Control Control Theory Theory

formulatedbybyMelzack formulated Melzack and and Wall, Wall, although although a fulla understanding full understanding of of the mechanism the mechanism hashas yet yet to elucidated. to be be elucidated. The The concept concept behind behind tonic tonic SCSisisthat SCS thatthe theparesthesia paresthesia induced induced by the by the applied applied varying varying electric electric

field masks, field or "closes masks, or “closes the the gates gates to", to”, pain signals travelling pain signals travelling to to the the 30 30 brain, however, brain, however, the the relationship relationshipbetween between frequency, frequency,waveform waveform

shape, amplitude and pulse width and the mechanism by which

SCS provides an analgesic effect is not fully understood.

Spinal cord stimulation (SCS) using electrical pulses has proven to

decrease opioid pain medication usage as it addresses the

5 neuropathic cause of a patient's pain. But there are significant 2024202249

disadvantages of electrical stimulation.

A leading barrier to traditional SCS is encapsulation of the

electrodes by glial cells, referred to as "glial encapsulation" or "glial

scar" caused by gliosis. This scarring typically occurs within 50-

10 100 um of the probe.

The scarring results in increased impedance, increased signal noise,

and increased distance to the target neurons, with a net result of

decreased stimulation efficacy.

As a further complication, in an attempt to maintain efficacy, the

15 implantable pulse generator (IPG) compensates by increasing

amplitude, causing a decrease in IPG lifetime.

If increases to the amplitude fail to overcome the impedance, the

remaining options are a surgical revision or removal of the device,

with corresponding increases in morbidity and mortality.

20 Given the issues with electrical stimulation, there is an interest in

magnetic stimulation. Several studies have shown advantages of

magnetic-based neuromodulation as compared to traditional

electrical stimulation, including:

the magnetic field is not affected by glial encapsulation,

25 depolarization of the targeted neurons can occur from a greater distance more consistently,

magnetic stimulation affords high orientation specificity, and

increased battery life due to decreased IPG energy consumption (as opposed to traditional SCS IPG which 30 requires compensatory increases amplitude to overcome glial encapsulation).

Magnetic stimulation causes depolarization of both the extracellular matrix and intracellular matrix.

The proposed Closed-Loop Omnidirectional, Neuromodulation with

Eddy currents (CLONE) would be able to overcome these anatomic

5 and physiological obstacles.

Disclosure of Invention 2024202249

A closed loop hybrid waveform that uses two stimuli, one is a

conventional tonic or burst spinal cord stimulation with an electric

field varying between 40-1500 Hz and the second stimulus

10 consisting of a continuous or varying electromagnetic field (EMF)

or magnetic field (with either an electromagnet, temporary magnet,

or permanent magnet) to modulate neurons, ganglions, glial cells,

and promote second messengers to down-regulate the nociceptors

for relieving chronic pain of the central nervous system, peripheral

15 nervous system, sympathetic nervous system, parasympathetic

nervous system.

Transcranial magnetic stimulation (TMS) is a technique to

stimulate the nervous system non-invasively through the intact

scalp and skin. The TMS machine delivers a short pulse of electric

20 current into a TMS coil to generate a quick changing magnetic field

surrounding the coil. TMS stimulates the neuronal circuits with the

eddy current induced by the changing magnetic field, based on

Faraday's law. A sub-centimeter

One apparatus for creating magnetic fields is a microcoil. A

25 microcoil, is a tiny electrical conductor such as a wire in the shape

of a spiral or helix, which could be a solenoid or a planar structure.

In the field of quantum sciences, microcoils play an increasing role

for fast spin control in nanoscale devices as multi-qubit spin

registers and quantum memories or for the actuation of single

30 nuclear spins e.g. around a Nitrogen-vacancy center.

Like the coils used in TMS, when current is applied to a microcoil, a

magnetic field is generated. Temporal changes of the magnetic field

induce the electrical field, which evokes action potentials, through

eddy currents, similar to TMS.

5 Micro Magnetic Stimulation (uMS) uses sub-millimeter coils. uMS 2024202249

can induce electric currents in the tissue from a distance (i.e.,

through an insulation layer).

In nature these currents are closed-loop circular currents with a

higher spatial focality. Magnetic lines form continuous closed -

10 loops because magnetic monopole does not exist in nature. We

always find magnetic poles - North and South poles which are

coupled together in such a way that field lines originating from one

pole end at the other loop, forming a closed-loop. Thus, magnetic

field-lines behave in a different manner to electric field-lines, which

15 begin on positive charges, end on negative charges, and never form

closed-loops.

Furthermore, the fact that uMS coils can deliver stimulation while

being insulated from the tissue increases their biocompatibility and

compatibility with magnetic resonance imaging, SO long as no

20 ferromagnetic material is present.

The mechanisms of action of magnetic stimulation are

fundamentally different from that of electrical stimulation.

Electrical stimulation activates neural elements by operating on the

electric potential of the extracellular matrix and manipulating the

25 transmembrane potentials. In contrast, eddy currents act not only

upon the extracellular matrix but also on the intracellular matrix as

the magnetic stimulation fields penetrate the cellular

compartments.

In addition, unlike electrical stimulation, uMS does not require

30 direct galvanic contact with the tissue. In contrast, a metal

electrode implanted in the tissue may lead to oxidation-reduction

reaction at the electrode-tissue interface changing the pH of

surrounding tissue which may provoke an immune response.

Histopathology analysis has shown glial encapsulation, as noted

5 above. With uMS however, it induces a current from a distance,

without placing a metal in direct contact with the tissue. 2024202249

Last unlike electrical stimulation uMS does not require a charge-

balanced stimulation waveform. In electrical stimulation, charge

balancing is necessary to avoid excessive charge accumulation at

10 the neural interface, and thus undesired stimulation and

electroporation. Electroporation occurs when the external electric

field of the membrane potential of the cell exceeds a 0.2-1 V

threshold, which leads to a change in the molecular structure of the

membrane, and a subsequent membrane perforation with pore

15 formation increasing the membrane permeability to ions, and

molecules. Electroporation with a transmembrane potential of

approximately 1 V could cause necrosis, due to membrane rupture

and the subsequent cytoplasmic contents leakage. In uMS, no net

charge is transferred from the electrode into tissue.

20 The device will also have a synaptic plasticity effect. Synaptic

plasticity involves several processes by which the central nervous

system undergoes neural changes. Two of these mechanisms which

commonly affect the efficacy of a synapse are long-term potentiation

(LTP) and long-term depression (LTD). The device will also have a

25 Metaplastic effect. Metaplasticity refers to neural changes that are

induced by activity at one point in time and that persist and affect

subsequently induced LTP or LTD. Metaplasticity refers to

neuronal changes that are elicited at one point in time, by what is

commonly called "priming" activity. By virtue of their persistence,

30 these neuronal changes are able to regulate synaptic plasticity

processes minutes, hours, or days later. A key feature

of metaplasticity is that this change, can outlast the triggering

("priming") bout of activity and persists until the second bout of

activity occurs to induce LTP or LTD. This effect slowly decays

over time. It is also possible to convert a decaying LTP or LTD into

5 a longer-lasting form, through plasticity-related proteins (PRP),

facilitating the persistence of otherwise decaying LTP or LTD. 2024202249

The device can either cause a Homosynaptic or Heterosynaptic

Metaplastic effect. Homosynaptic Metaplastic affects the priming

synaptic activity on plasticity mechanisms, but the effects are

10 confined to the primed synapses. Heterosynaptic metaplasticity

affects not only the activated synapses but also neighboring non-

activated synapses, which can cause long-range interactions

between synapses spread across dendritic compartments, in both

intracellular and intercellular signaling pathways.

15 The closed loop system will be responsive to evoked compound

action potential (ECAP) to provide feedback to adjust to the best

waveform and stimulation. This closed-loop system will include

adjustable parameters such as amplitude variation, and feedback

parameters such as conduction velocity, rheobase, chronaxie and

20 the occurrence of late response - neural response resulting from

dorsal root activation.

Therefore, the device will utilize two forms of closed-loop features,

the natural magnetic (North Pole to South Pole) form, as discussed

above and with the feedback from ECAP's.

25 It may also have a gradiometer, magnetometer or both, to detect

evoked magnetic fields, current sources, and record nerve

conduction velocities to allow a more detailed evaluation of the

neural electrical activity. It is possible that the ECAP and evoked

magnetic fields may be combined to form a hybrid evoked action

30 potential (HEAP), which could potentially lead to a more precise

delivery charge to the target neurons, ganglions, or glial cells. These

components would be embedded on a flexible silicon wafer

embedded into pseudoelastic memory metal or shape memory

polymer (SMP) or a combination of the two, made up of an input

5 unit, central processing unit (memory unit, control unit, and

arithmetic and logic unit), output unit, printed circuit board (PCB), 2024202249

connected to a multiplexer and a demultiplexer to allow for more

precise stimulation and recording.

The device is a Closed Loop Omnidirectional Neuromodulation with

10 Eddy currents (CLONE).

Four hybrid methods will be evaluated, but the platform is not

limited to these four methods.

The methods include two signals: First, a priming signal that will

lower the depolarization threshold, and a second signal that will

15 depolarize the target tissue with the lowest effective charge dose,

thus improving energy efficiency of the device and lowering side

effects and tissue toxicity.

In summary:

METHOD 1: A priming electrical signal followed by a second 20 magnetic signal.

METHOD 2: A magnetic priming signal followed by a second electrical signal.

METHOD 3: A priming magnetic signal followed by a second magnetic signal.

25 METHOD 4: A priming hybrid electric and magnetic signal followed by a second hybrid electric and magnetic signal.

In greater detail:

METHOD 1 A closed-loop hybrid waveform that uses two stimuli,

one conventional tonic or burst spinal cord stimulator with an

30 electric field varying between 40-1500 Hz and a second stimulus in

the form of a continuous or varying magnetic field to modulate

neurons, ganglions, glial cells, and promote second messengers to

down-regulate the nociceptors for relieving chronic pain.

METHOD 2: A closed-loop hybrid waveform that uses two stimuli,

one that is a continuous or varying magnetic field and the second

5 stimulus consisting of a conventional tonic or burst spinal cord 2024202249

stimulator with an electric field varying between 40-1500 Hz to

modulate neurons, ganglions, glial cells, and promote second

messengers to down-regulate the nociceptors for relieving chronic

pain.

10 METHOD 3: A closed-loop hybrid waveform that uses two stimuli,

one formed from a continuous or varying magnetic field and the

second stimulus formed from another continuous or varying

magnetic field to modulate neurons, ganglions, glial cells, and

promote second messengers to down regulate the nociceptors for

15 relieving chronic pain.

METHOD 4: A closed-loop hybrid waveform that uses two stimuli,

one formed from a hybrid electric and magnetic signal and a second

stimulus formed from another hybrid electric and magnetic signal

to modulate neurons, ganglions, glial cells, and promote second

20 messengers to down regulate the nociceptors for relieving chronic

pain.

Methods 1, 2, 3, 4 will cause depolarization at a much lower

threshold than then is currently possible.

The methods above are more effective than known methods, will not

25 be limited by glial encapsulation and will have reduced battery

usage. Both of these attributes decrease morbidity and mortality

related to surgical revisions and battery replacements, respectively.

Additionally, the magnetic field can overcome glial encapsulation.

One of the leading barriers to the current spinal cord stimulation

30 systems is encapsulation of the electrodes by glial cells and

fibroblasts, referred to as glial scar or glial encapsulation. The

magnetic field is able to pass through the scar tissue without

degradation, in contrast to traditional systems. Glial encapsulation

occurs within hours after the implantation and continues

5 indefinitely thereafter. This natural inflammatory / immune

response, decreases the efficacy of the treatment, in several ways, 2024202249

A) Increasing impedance, B) Increase distance (separation) from the

target neurons, C) Decreasing implantable pulse generator (IPG)

longevity, due to compensatory increase in amplitude in attempts to

10 overcome the impedance and distance to target.

The apparatus that is used to form this hybrid wave form is

preferably an array or paddle or paddle array of electrodes -

referred as contacts or leads - that allows for reduction in chronic

pain without being affected by glial encapsulation.

15 One of the advantages of this system is the ability to prolong

battery life, due to small charges (nanocoulombs) being applied to

the stimulator leads or arrays. A) No need to increase amplitude to

overcome glial encapsulation, B) Less energy to cause an action

potential, due to lower threshold caused by the priming stimulus. C)

20 Feedback from ECAP, Evoked Magnetic Fields, and HAP, that will

prevent overstimulation, thereby using less energy overtime. D)

unidirectional stimulation, also requires less energy.

Disclosed herein is an apparatus and methods for managing pain in

a patient by using closed-loop hybrid stimulation of neural

25 structures, with either multiple signals or a single signal having

modulated characteristics. Hybrid modulation for pain

management, in accordance with the disclosure, contemplates the

use of multiple separate varying stimuluses which are

independently applied via an array of electrodes (referred as

30 contacts or leads) to a particular neural structure using a variety of

temporal and amplitude characteristics, to modulate chronic pain

without being affected by glial encapsulation. Specifically, disclosed

is an apparatus and method for modulating the expression of the

neurovasculature of the spine and second messengers involved in

diverse pathways including inflammatory/immune system

5 mediators, ion channels and neurotransmitters, in both the Spinal

Cord (SC) and Dorsal Root Ganglion (DRG). In one embodiment, 2024202249

such expression modulation is caused by spinal cord stimulation or

peripheral nerve stimulation. In one embodiment, the amplitudes

and frequencies of the signal or signals used to create the hybrid

10 stimulation of neural structures may be optimized for improved

pain relief with minimal power usage in an IPG, as described

herein.

In one embodiment of hybrid modulation therapy, the tonic or burst

signal may be either monophasic, or biphasic, with the polarity

15 being either cathodic or anodic. In another embodiment the hybrid

wave form may include one stimulus, either EMF or tonic or burst.

Turning to the physical device, the collapsible nerve stimulator has

two primary states: a long and narrow profile for insertion, and a

wider, expanded profile for operation.

20 The result is a large surface area is available for nerve stimulation

but the need for a large incision is avoided.

The implantation process is summarized as follows:

A needle is inserted into the epidural space.

A guidewire is then inserted to the target location

25 The device with a sheath is loaded over the guidewire.

When the head of the device is in the desired location, the sheath of the device is drawn back, allowing the sections of the lead near the tip to expand;

The device may also have an internal tensioning cable, thus 30 allowing the distal end of the paddle lead to retract or deploy;

This process is reversible if the device needs to be repositioned, or removed entirely;

The needle is then removed, and then distal portion of the array is connected to the IPG.

Turning to stimulation devices generally, there are two primary

types: paddle leads (flat) and percutaneous leads (cylindrical).

5 Paddle leads are surgically implanted because they are wider than

percutaneous arrays, and are placed in a retrograde manner, due to 2024202249

anatomical constrains. This makes implantation of a paddle array

using a needle a technical conundrum.

The flat and wide profile of a paddle lead results in physical

10 stability. Generally, a paddle lead only includes electrodes on a

single side, which is place facing the nerve to be stimulated. This

directed stimulation conserves power - critical in a device powered

by batteries.

Percutaneous or cylindrical leads are implanted through a needle.

15 Thus, a round profile is common for compatibility with the needle.

Implantation is simplified by the use of the needle as compared to

surgical implantation.

But the simplicity of implantation is offset by decreased physical

stability and circumferential stimulation, which draws additional

20 power.

The collapsible neural stimulator is insertable in the manner of a

lead, but once in position, can be expanded into the shape of a

paddle.

The components include an array/lead housed inside a sheath. The

25 collapsible neural stimulator is passed over a guide wire, which is

later withdrawn.

As the sheath is withdrawn, the lead is able to expand in width

within the body.

The material of the expanding lead is preferably a biological

compatible material - such as pseudoelastic memory metal or

shape memory polymer (SMP) or a combination of the two - that

when warmed by the body seeks to conforms to the neural structure

5 for stimulation or recording. 2024202249

Electrodes are placed on the folding sections of the lead, and

optionally on the body of the lead. The electrodes are anticipated to

include between four and sixty-four points.

With the anticipated placement of two identical arrays in adjacent

10 positions, this results in a total of eight to one hundred and twenty-

eight contact points.

During use, the device must be powered. Multiple sources of power

exist. A battery is optionally placed within the body, using chemical

energy converted to electrical energy to power the device.

15 As a further alternative, an internal generator recharges the

battery, converting motion of the user into electrical power.

This generator, referred to as a nanogenerator due to its small size,

may work in multiple ways. For example, piezoelectric, triboelectric,

or pyroelectric. The piezoelectric and triboelectric nanogenerators

20 convert mechanical energy into electricity. Pyroelectric

nanogenerators can convert thermal energy into mechanical energy.

As mechanical energy surrounding us is available, transduction

mechanisms based on electromagnetic, piezoelectric, electrostatic,

and triboelectric principles are available to convert mechanical

25 energy into electric energy.

Turning to the methodology of stimulation, specifically Closed Loop

Hybrid Modulation Methodology:

The priming electrical signal lowers the threshold for depolarization

of nerve fibers while simultaneously modulating neurons,

ganglions, glial cells. The priming electrical signal also lowers the

impedance of the stimulated tissue, which allows for better

penetration of the electric field into the neural tissue. The frequent

pulsing of the priming electrical signal also contributes to a lower

5 threshold for depolarization of nerve fibers via membrane

integration of the electrical or EMF stimulus. Additionally, the 2024202249

priming electrical signal contributes to neuronal desynchronization,

which is a mechanism that helps with the reestablishment of

neuronal circuits that have been unnaturally synchronized to

10 maintain a nociceptive input into the brain. The plurality of

electrodes permits varying stimulation of the targeted area. That is,

one or more of the electrodes on the array bodies transmit the

stimulation pulses to targeted tissue depending on the desired

stimulation in accordance to the measured ECAP, evoked magnetic

15 field, or HEAP. The hybrid system may run on alternating current,

direct current, or both.

In a first embodiment, the device stimulates or modulates the

interaction between neurons and ganglions of a subject by: A)

exposing neurons, ganglions, and glial cells of the subject to a first

20 stimulus; and B) simultaneously exposing the neurons, ganglions,

and glial cells of the subject to a second stimulus; wherein the first

stimulus and the second stimulus have at least one uncommon

parameter amongst them. In one embodiment, the first stimulus is

composed of constant or varying electrical signal and the second

25 stimulus is a varying or constant EMF. In another embodiment, the

aforementioned stimulations may have different values for

frequency, amplitude, phase polarity, relative phase, harmonic

content, or width for rectangular waveforms.

In a second embodiment, the device stimulates or modulates the

30 interaction between neurons, ganglions, and glial cells of a subject

by: A) exposing neurons, ganglions, glial cells of the subject to a first

stimulus or signal; and B) simultaneously exposing the neurons,

ganglions, and glial cells of the subject to a second stimulus or

signal; wherein the first stimulus and the second stimulus have at

least one uncommon parameter amongst them. In one embodiment,

5 the first stimulus is composed of varying or constant EMF and the

second stimulus is a constant or varying electrical signal. In 2024202249

another embodiment, the aforementioned stimulations may have

different values for frequency, amplitude, phase polarity, relative

phase, harmonic content, or width for rectangular waveforms.

10 In a third embodiment, the device stimulates or modulates the

interaction between neurons, ganglions, glial cells of a subject by: A)

exposing neurons, ganglions, and glial cells of the subject to a first

stimulus; and B) exposing the neurons, ganglions, and glial cells of

the subject to a second stimulus; wherein the first stimulus and the

15 second stimulus have a common parameter amongst them. In one

embodiment, the first stimulus comprises a first varying or constant

EMF and the second stimulus comprises of a varying or constant

EMF. In another embodiment, the first varying or constant EMF

and second varying or constant EMF are provided by a composite

20 electrical stimulation. In still another embodiment, the composite

electrical stimulation may be any frequency, amplitude, phase

polarity, relative phase, harmonic content, or width for rectangular

waveforms.

In a fourth embodiment, the device stimulates or modulates the

25 interaction between neurons, ganglions, glial cells of a subject by: A)

providing lead arrays having a plurality of electrode contacts

electrically attached to an electrical stimulation source; B)

electrically coupling a first subgroup of the plurality of electrode

contacts to a first electrical stimulation or EMF source; C)

30 electrically coupling a second subgroup of the plurality of electrode

contacts to a second electrical stimulation or EMF source; D)

exposing neurons, ganglions, and glial cells of the subject to the first

electrical stimulation or EMF from the first subgroup of electrode

contacts; and E) simultaneously exposing the neurons, ganglions,

and glial cells of the subject to the electrical stimulation or EMF

5 from the second subgroup of electrode contacts. 2024202249

In a fifth embodiment, the device modulates pain in a subject

comprising activating neurons and ganglions by regulating any of

the second messengers for calcium binding proteins, cytokines, cell

adhesion or specific immune response proteins. A) Lowering a

10 threshold for depolarization of nerve fibers in the subject with a

first electrical stimulation or EMF for a first period of time; and B)

simultaneously modulating neurons and ganglions with a second

varying electrical stimulation or EMF during a second period of

time not identical to the first period of time causing down-

15 regulation of nociceptors.

In a sixth embodiment, the method for managing pain in a subject

includes: A) lowering a threshold for depolarization of nerve fibers

in the subject with a first varying electrical stimulation or EMF for

a first period of time; and B) simultaneously modulating second

20 messenger activity with a second varying electrical stimulation or

EMF during a second period of time not identical to the first period

of time causing down regulation of the nociceptors.

In a seventh embodiment, the method for managing pain in a

subject includes: A) lowering a threshold for depolarization of nerve

25 fibers in the subject with a first varying electrical stimulation or

EMF for a first period of time; and B) simultaneously modulating

neurons, ganglion, and glial cells activity with a second varying or

constant EMF during a second period of time not identical to the

first period of time; wherein the first varying electrical stimulation

30 or EMF is provided by an electric signal having an amplitude set to

a value corresponding to a percentage of a Priming Threshold of the

subject, and wherein a second varying or constant EMF is provided

by an electric signal having an amplitude set to a value

corresponding to a percentage of the paresthesia threshold (PT).

In one embodiment of hybrid modulation therapy, the priming

5 signal may be monophasic, or biphasic, in which the polarity of the 2024202249

first phase of the biphasic priming signal may be either cathodic or

anodic. With this embodiment, the tonic or burst signal may have

waveform characteristics that are different from those of the

priming signal. The tonic or burst signal may be either monophasic,

10 or biphasic, with the polarity of the first phase of the biphasic tonic

or burst signal being either cathodic or anodic.

In a seventh embodiment, a method for stimulating/modulating the

interaction between neurons and ganglions of a subject includes: A)

exposing neurons, ganglions, and glial cells of the subject to a first

15 stimulus; and B) simultaneously exposing the neurons, ganglions,

and glial cells of the subject to a second stimulus; wherein the first

stimulus and the second stimulus have different respective phase

polarities. In one embodiment, the first stimulus and the second

stimulus comprise electrical stimulations or EMF. In another

20 embodiment, the electrical stimulations or EMF have different

values for any of their respective frequency, amplitude, waveform

shape, or width in the case of rectangular waveforms.

In an eighth embodiment, a method for stimulating and modulating

the interaction between neurons, ganglions, and glial cells of a

25 subject includes: A) providing lead arrays having a plurality of

electrode contacts electrically coupleable to an electrical stimulation

source; B) electrically coupling a first subgroup of the plurality of

electrode contacts to a first electrical stimulation or EMF source; C)

electrically coupling a second subgroup of the plurality of electrode

30 contacts to a second electrical stimulation or EMF source; D)

exposing neurons and ganglions of the subject to the first electrical

stimulation or EMF from the first subgroup of electrode contacts;

and E) simultaneously exposing the neurons, ganglions, and glial

cells of the subject to the second electrical stimulation or EMF from

the second subgroup of electrode contacts wherein the first electrical

5 stimulation or EMF and the second electrical stimulation or EMF

have different respective phase characteristics. 2024202249

In a ninth embodiment, the method for managing pain in a subject

includes: A) lowering a threshold for depolarization of nerve fibers

in the subject with a first varying electrical stimulation or EMF;

10 and B) simultaneously modulating neurons, ganglions, and glial

cells with a second varying electrical stimulation or EMF. In one

embodiment, the first varying stimulus and the second stimulus

have any of different respective frequencies, amplitudes, phases,

harmonic content, or width for rectangular waveforms. In another

15 embodiment, the first and second varying electromagnetic fields

may be provided by either a single electrical stimulation or EMF or

by two different electrical stimulations or EMF's.

In a tenth embodiment, a system is provided comprising a signal

generation module and one or more leads. The leads are configured

20 for exposing neurons, ganglions, and glial cells simultaneously to a

first electrical stimulation or EMF and a second electrical

stimulation or EMF. The signal generation module is configured for

having an operating mode for providing a first and a second electric

signal having at least one common parameter amongst them or at

25 least one uncommon parameter amongst them to the one or more

leads.

Also disclosed herein is an apparatus comprising a signal

generation module that is configured for electrically coupling with

one or more leads. In addition, the leads will be able to capture

30 ECAP's, evoked magnetic fields, or HEAP to improve charge

delivery to spinal targets. Coupling of the apparatus with one or

more leads may provide the system.

Optionally, the signal generation module comprises at least a first

and a second electric signal source or terminal and the one or more

5 leads comprise at least a first and a second subgroup of electrodes. 2024202249

The first subgroup of electrodes can be electrically coupled to the

first electric signal source and/or terminal and the second subgroup

of electrodes can be electrically coupled to the second electric signal

source and/or terminal.

10 Optionally, the signal generation module is configured for having an

operating mode for providing at least first and second electric

signals or EMF's corresponding to the first and second electrical

stimulation or EMF as described herein. Optionally, the first and

second electric signals or EMFs have a different frequency.

15 Optionally, the signal generation module is configured for having an

operating mode for providing electric signals to the electrodes

corresponding to the electrical stimulation or EMF stimulus of any

of the methods described herein.

Other parameters of the first and second electric signals may be

20 different, such as the pulse width and/or amplitude. The first

electric signal can be fired synchronously, i.e., simultaneously, with

the second electric field, or asynchronously, e.g., with a given time

delay, relative to the first electric signal.

Optionally, the signal generation module is arranged for generating

25 a composite electric signal or EMF. The composite electric signal

can be a summed signal of the first and second electric signals or

EMF. Optionally, the signal generation module is arranged for

generating a hybrid signal, such as a frequency-modulated signal,

amplitude modulated signal, harmonic modulated signal. The

composite signal and/or the hybrid signal can be provided to the one

or more leads.

Optionally, the signal generation module comprises two or more

electric signal sources or EMF, such as signal generators, that are

5 independently controllable, and are configured for delivering 2024202249

electric signals or EMF with parameters that can be set separately

for each of the electric signal sources.

Optionally, the apparatus is a not permanently implantable - for

use when running a trial with a patent - the system comprising a

10 signal generation module comprising at least two signal generators

configured for delivering electric signals or EMF with parameters

that can be set separately for each of the signal generators, for

example a priming / tonic /burst signal and an EMF signal.

Optionally, an implantable hybrid generator is provided, that is

15 adapted for electrically coupling with one or more leads, or

optionally is coupled with one or more leads. The implantable

hybrid generator comprises generator circuitry and a housing. The

housing can hermetically seal the generator circuitry and can be

made of a durable biocompatible material. The generator has an

20 output interface for establishing electrical connection with

electrodes implemented in one or more leads, e.g., a first and second

terminal for electrically coupling to a first and second subgroup of

electrodes implemented on one or more leads.

Optionally the implantable hybrid generator comprises two or more

25 signal generators and timer electronic circuitry that can slave one of

the signal generators to another signal generator, such that a delay

can be produced between signals generated from the at least two

signal generators.

In an eleventh embodiment, an EMF device is provided including an

30 output unit for connection to at least one electrode array, or a

plurality of arrays of electrodes, and a signal generator, wherein the

stimulation device is arranged for providing a hybrid stimulation

signal to at least one electrode array, or a plurality of arrays of

electrodes via the output unit. The hybrid stimulation signal can be

5 an EMF. At least one electrode array is configured for exposing

neurons and ganglions to the hybrid stimulation signal. The 2024202249

electromagnetic stimulation device can be a pain treatment device.

Optionally, the EMF device may have an output unit that includes

a first output for connection to a first lead and a second output for

10 connection to a second lead. The first lead can include a first array

of electrodes. The second lead can include a second array of

electrodes.

Optionally, the signal generator is arranged for providing a first

electric signal or EMF to the first output and a second electric

15 signal or EMF to the second output. The first electric signal or EMF

and the second electric signal or EMF can differ in a parameter

such as amplitude, frequency, phase, phase polarity, waveform

shape, and width. The first electric signal or EMF and the second

electric signal or EMF may correspond in a parameter such as

20 amplitude, frequency, phase, phase polarity, waveform shape, and

width. The second electric signal or EMF can be a tonic or burst

stimulation signal, and the first electric signal or EMF can have a

frequency higher than the frequency of the tonic or burst

stimulation signal.

25 Optionally, the signal generator is arranged for generating a hybrid

electric signal, such as a frequency modulated signal, amplitude

modulated signal, harmonic modulated signal. The hybrid electric

signal can be provided to at least one electrode.

In a twelfth embodiment, a method for operating a signal

30 generation module is provided. The method includes connecting the

signal generation module to one or more leads. The leads can

already have been implanted into the body of a subject. The method

includes generating, using the signal generation module, a first

electric signal or varying EMF at least one of the one or more leads

5 and generating, using the signal generation module, a second

electric signal or varying EMF at least one of the one or more leads. 2024202249

The first electric signal or varying EMF and the second electric

signal or varying EMF can have at least one uncommon parameter

amongst them.

10 In a thirteenth embodiment, an electrically conducting material is

provided, such as a metal, e.g., in the form of an electrode, for use in

administering an EMF into a subject for the treatment of pain. The

EMF can include a first electromagnetic stimulus and a second

EMF. The first stimulus and the second stimulus may have at least

15 one uncommon parameter amongst them. The first stimulus and

the second stimulus can be signals, or a composite signal, or hybrid

signal as described herein.

In an fourteenth embodiment, an EMF system is disclosed with a

memory for storing a plurality of hybrid signal parameter

20 programs; a selection device for selecting one of the plurality of

hybrid signal parameter programs; a hybrid signal generator

controllable by a selected of the plurality of hybrid signal parameter

programs; and an output unit for connection to at least one

electrode; wherein the stimulation device is configured to provide a

25 hybrid stimulation signal generated by the hybrid signal generator

in accordance with a selected of the hybrid signal parameter

programs to the at least one electrode via the output unit. The

system may further comprise an enclosure of biocompatible

material surrounding the hybrid signal generator and output unit.

30 In one embodiment, the hybrid signal generator generates a first

and second electric signals or EMF's on in an operational mode

thereof. In one embodiment, the system may be combined with at

least one electrode comprising at least a first and a second subgroup

of electrodes, and wherein the first subgroup of electrodes is

electrically coupled to the first electric signal and the second

5 subgroup of electrodes is electrically coupled to the second electric

signal or EMF. 2024202249

In a fifteenth embodiment, a collapsible nerve stimulator is

disclosed with two primary states: a long and narrow profile for

insertion, and a wider (paddle lead), expanded profile for operation.

10 Two arrays, with anywhere from 8 to 64 lead contacts or more.

Dynamic change will result in paddle lead with anywhere between

16 to 128 contacts or more. The plurality of electrodes permits

varying stimulation of the targeted area. That is, one or more of the

electrodes on the lead bodies transmit the stimulation pulses to

15 targeted human tissue depending on the desired stimulation in

accordance to the measured ECAP, evoked magnetic field, or HEAP.

The bonding of the percutaneous lead bodies is accomplished by a

plurality of pseudoelastic memory metal or shape memory polymer

(SMP) bridges, molded to each of the percutaneous arrays, by the

20 process of photolithography. The plurality of bridges provides

structural integrity to the array yet permits the desired flexibility of

the lead body. The array is housed in a sheath and has a guidewire.

Once the sheath is retracted the array has an expandable region to

allow the electrode array to form into a paddle lead. This process is

25 reversible if the device needs to be repositioned, or removed

entirely. A method of deploying and securing the electrode is

described. The tip of the array may have a circular, elliptical,

parabolic, or hyperbolic opening for the guidewire. The plurality of

elongate members is a plurality of leads, and the leads are fixedly

30 secured to one another where the leads intersect with one another.

The plurality of elongate members is a plurality of a pseudoelastic

memory metal or polymer that when exposed to body temperature,

allows it to conform to the underlying neural structure when

introduced into the body. The paddle array may or may not have an

insulation material that would allow for unidirectional stimulation,

5 however it may not, which would allow for circumferential

stimulation. 2024202249

In another embodiment, a planar coil that provides magnetic flux

which creates a modulating effect on the interaction between

neurons, ganglions, and glial cells. The planar coil is coil can be

10 between 2 to 1,000,000 turns. The planar coil can be stacked on top

of itself to provide and additive effect, producing greater flux. The

shape of the planar coil can be circular, elliptical, oval, parabolic, or

hyperbolic shape. It can also be in the shape of a triangle, square,

rectangle, rhomboid, parallelogram, trapezoid, pentagon, hexagon,

15 heptagon, octagon, nonagon, and decagon. The turns can either be

in a clockwise, counter-clock wise fashion or both.

A cylindrical coil that provides magnetic flux which creates a

modulating effect on the interaction between neurons, ganglions,

and glial cells. The cylindrical coil is coil can be between 2 to

20 1,000,000 turns. The planar coil can be stacked on top of itself to

provide and additive effect, producing greater flux. The shape of the

planar coil can be circular, elliptical, oval, parabolic, hyperbolic

shape, or a mixture of them. It can also be in the shape of a triangle,

square, rectangle, rhomboid, parallelogram, trapezoid, pentagon,

25 hexagon, heptagon, octagon, nonagon, decagon, or a mixture of

them. The turns can either be in a clockwise, counter-clock wise

fashion or both.

During use, the device must be powered. Multiple sources of power

exist. A battery is optionally placed outside the body or within the

30 body, using chemical energy converted to electrical energy to power

the device. Power may also be provided wirelessly. This may be

accomplished using coupled radio-frequency antennas, acoustic

transducers, optogenetics, or optoelectronics.

As a further alternative, an internal generator recharges the

battery, converting kinetic energy into electrical power.

5 This generator, referred to as a nanogenerator due to its small size, 2024202249

may work in multiple ways. For example, piezoelectric, triboelectric,

or pyroelectric. The piezoelectric and triboelectric nanogenerators

convert mechanical energy into electricity. Pyroelectric

nanogenerators can convert thermal energy into mechanical energy.

10 In another embodiment, the nanogenerator may be able to be

incorporated into the array, thereby negating the necessity of an

IPG.

In another embodiment the aforementioned device may be used in

spinal cord injury (SCI) patients, by helping the mesenchymal stem

15 cells, exosomes, and second messengers migrate to the target area

of injury via 40 Hz EMF frequency.

In another embodiment, the device may include utilize Endoscopic

ultrasound. This will enable 3-dimensional imaging of the target

tissue, for the intervention or surgery. This map will be

20 incorporated into the software programing of the device. This is not

the current standard of care.

The ACTIVE system = Adaptive, Computational, Tomographic Map,

Image Overlay (3D), Vector Overlay, with Epidural ultrasound.

The ADAPTIVE = Artificial Intelligence, Definition, Adaptive,

25 Pacing, Tomographic Map, Image (3D), Vector, with Epidural

ultrasound.

In another embodiment, cylindrical coil is housed in a circular disc,

on the device, that rotates between 0 to 360 degrees, thus allowing

the device to steer the electrical or eddy currents providing a

neuromodulation effect between neurons - the neurons including

nociceptors - ganglions, neurovasculature, and glial cells. The

rotating disc may rely on the 3D software program with epidural

ultrasound above, as well as postoperative imaging or both.

5 In another embodiment, the planar coil is housed in a circular disc, 2024202249

on the device, that tilts on one axis or several axes, thus allowing

the device to steer the electrical or eddy currents providing a

neuromodulation effect between neurons - the neurons including

nociceptors - ganglions, neurovasculature, and glial cells. The

10 tilting disc may rely on the 3D software program with epidural

ultrasound above, as well as postoperative imaging or both.

In another embodiment the ultrasound maybe used to provide

neuromodulation to alleviate pain as such,

Focused Ultrasound (FUS), through amplitude modulation creates a

15 neuromodulation effect on the interaction between neurons,

ganglions, and glial cells of the central nervous system, peripheral

nervous system, sympathetic nervous system, parasympathetic

nervous system. FUS between 1-20 megahertz. FUS provides an

inhibitory effect at low intensities (increased firing of inhibitory

20 interneurons), while providing an excitatory effect at high

intensities (increased firing rate of excitatory neurons).

In another embodiment the device maybe use for Deep Brain

Stimulation (DBS), Tumor treating fields (TTF) for cancer, Vagus

Nerve Stimulation (for Epliepsy and Arrhymias), Cardiac

25 Dromotrophy (Ventricular arrhythmias, Atrial arrhythmias, Heart

Failure, Sick Sinus Syndrome, Syncope / positional orthostatic

tachycardia (POTS), Heart Transplantation), Sleep apnea,

Peripheral nerve stimulation, Spinal Cord Injury (using 40 Hz

stimulation to cause migration of the Stem Cells to their target),

30 Bioelectronics for prosthesis, Diaphragmatic Pacers.

In another embodiment the device may have a fiber optic endoscope

to allow for real time footage of the intervention or procedure. This

is not the current standard of care.

It will be appreciated that any of the aspects, features and options

5 described in view of the methods apply equally to the system, signal 2024202249

generation module and stimulation device. It will be understood

that any one or more of the above aspects, features and options as

described herein can be combined.

Brief Description of the Drawings

10 The invention can be best understood by those having ordinary skill

in the art by reference to the following detailed description when

considered in conjunction with the accompanying drawings in

which:

Figure 1A illustrates a view of a cylindrical embodiment of the

15 collapsible neural stimulator.

Figure 1B illustrates a view of insertion of the collapsible neural

stimulator that expands increasing in width.

Figure 2 illustrates a view of a cylindrical neural stimulator.

Figure 3 illustrates an anatomical view of insertion of the

20 collapsible neural stimulator.

Figure 4 illustrates a close-up view of insertion of the collapsible

neural stimulator.

Figure 5 illustrates a schematic view of a first means of powering of

the collapsible neural stimulator.

25 Figure 6 illustrates a schematic view of a second means of powering

of the collapsible neural stimulator.

Figure 7 illustrates a schematic view of a third means of powering

of the collapsible neural stimulator, integrated into the lead of the

stimulator.

Figure 8 illustrates a front isometric of an embodiment of the

5 Closed- Loop Omnidirectional Neuromodulation with Eddy 2024202249

Currents (CLONE).

Figure 9 illustrates a rear isometric of an embodiment Closed- Loop

Omnidirectional Neuromodulation with Eddy Currents (CLONE).

Figure 10 illustrates a front view and side view of an embodiment of

10 Closed- Loop Omnidirectional Neuromodulation with Eddy

Currents (CLONE).

Figure 11 illustrates an isometric of a cylindrical embodiment of the

Closed- Loop Omnidirectional Neuromodulation with Eddy

Currents (CLONE).

15 Figure 12 illustrates a side view of a cylindrical embodiment of the

Closed- Loop Omnidirectional Neuromodulation with Eddy

Currents (CLONE).

Figure 13 illustrates exemplary coils for use as electrodes.

Best Mode for Carrying Out the Invention

20 The present disclosure will be more completely understood through

the following description, which should be read in conjunction with

the drawings. In this description, like numbers refer to similar

elements within various embodiments of the present disclosure. The

skilled artisan will readily appreciate that the methods, apparatus

25 and systems described herein are merely exemplary and that

variations can be made without departing from the spirit and scope

of the disclosure.

The techniques disclosed herein may be achieved with minimally

invasive procedures which are preferred over those that require

extensive surgical intervention and healthcare expenses although in

particular circumstances, a surgical implantation may be required.

5 In an embodiment, a lead comprises a cylindrical arrangement of

multiple electrodes, e.g., between 8 and 64. The diameter of the lead 2024202249

may be small enough to allow for percutaneous implantation into

the spinal canal using an epidural needle under standard clinical

practice. The electrodes are made of biocompatible materials such

10 as titanium nitride, boron-doped diamond (BDD), poly(3,4-

ethylenedioxythiophene (PEDOT), thiol-ene acrylate polymers,

Silicon Carbide, platinum-iridium alloys, which are also resistant to

corrosion. For example, a 50 cm long lead implemented with eight

electrodes may have a diameter of 1.35 mm, with each cylindrical

15 electrode having a length of 3.0 mm, and a spacing between

electrodes of 4.0 mm. Conducting wires may run from the electrodes

to the distal part of the lead into metal connectors. The wires may

be enclosed within a triple-insulated containment made of a

biocompatible material, such as a pseudoelastic memory metal or

20 SMP.

Reference will now be made in detail to the presently preferred

embodiments of the invention, examples of which are illustrated in

the accompanying drawings. Throughout the following detailed

description, the same reference numerals refer to the same

25 elements in all figures.

Referring to Figure 1A and 1B, a view of a cylindrical embodiment

of the collapsible neural stimulator is shown.

The collapsible neural stimulator 1 includes a guide wire 10, a

sheath 12 with electrodes 50 placed along the lead 14 (see Figure 2).

30 The body 30 folds along the first hinge 32 and the second hinge 34.

The collapsible spinal stimulator 1 is formed from a main section

60, with first arm 62, second arm 64, and folding ramp 66.

Referring to Figure 2, a view of insertion of the collapsible neural

stimulator is shown.

5 The collapsible neural stimulator 1 is inserted percutaneously 2024202249

through the epidural space between the vertebrae 206. A guide tube

12 directs the lead 14 between vertebrae T12 and L1. This insertion

point is only shown by way of example.

Referring to Figures 3 and 4, an anatomical view and a close-up

10 view of insertion of the collapsible neural stimulator are shown.

The collapsible neural stimulator 1 is inserted into the patient 200,

through the skin 202 and into the spine 204, between the vertebras

206 using a percutaneous epidural approach.

The lead 14 passes over a guidewire 10 and within a sheath 12 until

15 in position.

Referring to Figures 5, 6, and 7, three schematic views of means of

powering of the collapsible neural stimulator are shown.

In Figure 5, the power and control unit 160 is fully internal. One or

more piezoelectric generators 70, each including a cantilever arm 72

20 and weight 74, generate electricity for storage in the IPG 90. This

power is carried to the collapsible neural stimulator 1 using a power

transmission cable 92.

In Figure 6, power is provided by a triboelectric generator 80. The

motion of a first element 82 with respect to a second element 84

25 creates power for storage in the IPG 90, again carried to the

collapsible neural stimulator 1 using a power transmission cable 92.

In Figure 7, power is provided by a triboelectric generator 80, but

the triboelectric generator 80 is now integrated into body of the

collapsible neural stimulator 1. As before, the motion of a first

element 82 with respect to a second element 84 creates power for

storage in the IPG 90.

Referring to Figures 8 through 10, a second embodiment of the

5 neural stimulator is shown. 2024202249

The nerve stimulator 100 includes a body 102 with optional arms

104 that include suture holes 106.

The nerve stimulator 100 is connected to implantable pulse

generator via the electrical contacts 110. The contacts 110 carry

10 electrical signals to and from the nerve stimulator 100 across the

array via wires 112.

The leads connect to the components of the nerve stimulator 100,

including one or more recording / reference electrodes 120, a first

magnetic planar coil 122, a second magnetic planar coil 124, an

15 anode 126, and a cathode 128.

During operation, an implantable pulse generator causes the first

magnetic planar coil 122 and the second magnetic planar coil 124 to

emit magnetic signals, and the anode 126 and cathode 128 to emit

electrical signals. The resulting evoked compound action potential is

20 sensed by the recording / reference electrodes 120, which is reported

back to the implantable pulse generator. The implantable pulse

generator processes the resulting data, calculates a response, and

issues a follow-up set of magnetic and electrical signals. This

process repeats as the implantable pulse generator continues to

25 optimize signaling to result in the most-effective pain reduction

while managing power consumption to conserve its power reserves.

Referring to Figures 11 and 12, a cylindrical embodiment of the

collapsible neural stimulator is shown.

Again shown are a nerve stimulator 100 with body 102, recording /

reference electrodes 120, a first magnetic cylindrical coil 122, a

second magnetic cylindrical coil 124, an anode 126, and a cathode

128.

5 Referring to Figure 13, exemplary coils are shown. Embodiments of 2024202249

the electrodes 50 include planar coil 130 and cylindrical coil 132.

Equivalent elements can be substituted for the ones set forth above

such that they perform in substantially the same manner in

substantially the same way for achieving substantially the same

10 result.

It is believed that the system and method as described and many of

its attendant advantages will be understood by the foregoing

description. It is also believed that it will be apparent that various

changes may be made in the form, construction, and arrangement of

15 the components thereof without departing from the scope and spirit

of the invention or without sacrificing all of its material advantages.

The form herein before described being merely exemplary and

explanatory embodiment thereof.

Claims (7)

The claims defining the invention are as follows: 14 Aug 2025

1. A neural stimulator for insertion into nervous system (central nervous system or peripheral nervous system) of a patient, the neural stimulator comprising:

a lead; 2024202249

the lead having a proximal portion and a distal portion; and

the distal portion able to unfold and expand after insertion into the patient;

the distal portion when unfolded, is wider than the proximal portion, thus permitting insertion of a lead that unfolds to a greater size than able to be directly inserted;

the lead is constructed of a pseudoelastic memory metal or shape- memory polymer that causes the lead to unfold when the lead is warmed by body heat from the patient;

whereby the lead automatically unfolds, reducing a number of steps that a surgeon must take to place the lead; and

wherein a planar coil is incorporated in the pseudoelastic memory metal or shape-memory polymer, the planar coil conforming to structure in a central or peripheral nervous system to provide more effective neuromodulation.

2. The neural stimulator for insertion into nervous system of a patient of claim 1, wherein: the pseudoelastic memory metal or shape- memory polymer is a biological compatible material.

3. The neural stimulator for insertion into nervous system of a patient of claim 1, wherein: a cylindrical coil is incorporated in a pseudoelastic memory metal or 14 Aug 2025 shape-memory polymer, the cylindrical coil conforming to structure in a central or peripheral nervous system to provide more effective neuromodulation.

4. The neural stimulator for insertion into nervous system of a patient 2024202249

of claim 3 wherein:

the cylindrical coil is housed in a circular disc that can rotate between 0 to 360 degrees, thus allowing the neural stimulator to steer electrical or eddy currents providing a neuromodulation effect.

5. The neural stimulator for insertion into nervous system of a patient of claim 2, further comprising:

two or more magnets that interact to hold a first medial portion of the lead to a second medial portion of a second lead as a means to increase a strength of a magnetic field.

6. The neural stimulator for insertion into nervous system of a patient of claim 1, further comprising:

an implantable pulse generator connected to the lead.

7. The neural stimulator for insertion into nervous system of a patient of claim 1, further comprising:

a nanogenerator that functions as an implantable pulse generator;

the nanogenerator converting kinetic energy into electrical energy;

the electrical energy used to charge the lead.

1 1

10 10 2024202249

60 50 62 64 50

66 66 34 32

30 12

12

FIG. 1A FIG. 1B

1/13