WO2017172998A1

WO2017172998A1 - Wireless electrical stimulation system for physiological response

Info

Publication number: WO2017172998A1
Application number: PCT/US2017/024862
Authority: WO
Inventors: Alex SHEN; Derek Herrera
Original assignee: Spinal Singularity, Inc.
Priority date: 2016-03-29
Filing date: 2017-03-29
Publication date: 2017-10-05

Abstract

The disclosure generally relates to electronic stimulation systems and devices for physical therapy. The system includes wireless modular devices comprising electrodes and a computer device including a mobile phone. The wireless modular devices can be placed on the skin of the subject along the peripheral nerve. Once placed, the wireless modular devices can stimulate various parts of the body and induce a desired physiological response, including sexual activities.

Description

WIRELESS ELECTRICAL STIMULATION SYSTEM FOR PHYSIOLOGICAL

RESPONSE

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57. This application claims priority to U.S. Provisional Application Serial No. 62/314,932, filed March 29, 2016, titled "Wireless Electrical Stimulation System for Physiological Response," the content of which are incorporated herein in their entirety.

FIELD

[0002] This disclosure generally relates to wireless electrical stimulation for physiological response. More particularly, this disclosure pertains to a system that utilizes wireless modular electrical stimulation units.

BACKGROUND

[0003] Electrical Stimulation has been used in a variety of applications for quite some time. Specifically, there are clinical applications that are meaningful in everything from neurology, such as migraines, to physical therapy, such as foot drop. For a subset of the population that suffers from varying forms of paralysis, different means of electrical stimulation can be used to induce muscular and neural response, regardless of whether or not the user can feel/control those muscles. For example, individuals with a complete Spinal Cord Injury often utilize waveforms commonly characterized as Functional Electrical Stimulation to move muscles and regain muscle mass. FES has been meaningful for a variety of physical therapy and clinical applications. Some applications include activation of muscles, strengthening of peripheral nervous system, retention and recruitment of muscle mass, strengthening bone density, improving circulation and other applications.

[0004] This has been adapted in some devices having a computer controller and sensors. Such technologies allow a user to, for example, pedal a stationary bicycle despite having no control over the activation of their muscles. This technology often utilizes a bi-phasic square wave with current ranging from 0-150 mA, Frequency ranging from 0-150 Hz, Pulse Width of 0-500 msec. This pattern is effective at inducing muscular contractions without damaging muscle tissue. The system can comprise an alternating cycle of the bi-phasic square wave with current ranging from 0-150 mA, Frequency of 0- 100 Hz, Pulse Width of 0-500 msec applied at multiple locations on the quadriceps and lower abdomen/back. Other suitable waveforms can be utilized for this application as readily apparent to a person skilled in the art and are within the scope of this disclosure. Popular and commercially available FES devices include MotoMED® and RehaStim® FES Unit. Similar devices using electronic stimulation include TENS units that use pulses mainly to treat pain.

[0005] FES devices such as RehaStim use a controller and electrode channels to induce a muscle movement. The channels can be turned on and off in precise timing to sequentially activate different muscle groups. The patterns and sequences utilize programs which are designed to achieve a desired response, such as rowing motion, cycling motion, contraction of core, etc.

[0006] FES, or other forms of electrical stimulation however, has not been known to be commonly used to aid in complex movements. One such complex movements include movements associated with sexual function. Above mentioned devices require a bulky set-up, often requiring wires, straps, and specifically designed computing devices often limiting movement of the subject other than the movement that the device is specifically designed for. Also, complex physiological movements often involved in sexual activities may require activation of different body parts at a distance from one another. Sexual activities can also differ from individual to individual, meaning FES should be customizable based on subject profiles and parameters identified as affecting such activities.

[0007] Electrical stimulation can be used peripherally in conjunction with other stimulus to improve sexual function in males and females with Spinal Cord Injury and Disease or other forms of paralysis. The other forms of stimulus can include, but are not limited to, masturbation, oral sex, sexual intercourse, vibratory stimulation, etc. Although some individuals with paralysis retain a level of sexual function, the majority that have sexual dysfunction are able to amplify the effects of any stimuli in the genital region to significantly improve their chances for arousal, orgasm, and ejaculation, etc. Flectro- ejaculation procedures have been well known and used for decades. Traditional electro- ejaculation requires directly stimulating the prostate.

[0008] Smartphones, tablets, computers, watches and other computing devices have been used in different applications to control other devices for quite some time. Such devices can be wirelessly coupled via wireless communications mediums. These devices can be used to store and execute various patterns, customize several parameters in operating a remotely controlled device. Furthermore, these devices can use a machine- learning feedback algorithm to optimize and calibrate based on transmitted information to, for example, induce a desired response from the body. A system that uses such devices in relation to the body include the Thync system, disclosed in U.S. Pat. No. 8,903,494. The Thync system comprises a stimulation device wirelessly coupled with a smartphone which deliver a transdermal electrical signal meaningful for neurological purposes. The use of mobile devices can replace some of the features performed by bulky apparatuses and wires.

[0009] As such, mobile devices have been used to transmit electrical signals to perform certain functions on the body. The use of FES with wireless communication has also been studied. For example, a research paper by G.A. Maksay proposes schematics and other designs for a wireless FES unit. Maksay and Gergely "Wireless Surface Stimulator" (2009). Due to limitations in wireless communication technology, FES for sexual function has not been widely successful. For example, previously used communication technologies were limited in allowing modular communication across multiple units.

[00010] Therefore, a need exists for a customizable, wireless multi-module electronic stimulation device for complex physiological movements.

SUMMARY

[00011] The present technology relates to wireless electrical stimulation systems that induce a desired physiological response.

BRIEF DESCRIPTION OF THE DRAWINGS

[00012] FIG. 1 shows an embodiment of a wireless electrical stimulation system. [00013] FIG. 2 shows a schematic embodiment of a wireless electrical stimulation system used on male body.

[00014] FIGS. 3A and 3B shows schematic drawings of genito-femoral nerves on male and female bodies.

[00015] FIGS. 4A-4D shows wave frequencies used in a wireless electrical stimulation system.

[00016] FIG. 5 shows an embodiment of a wireless electrical stimulation system comprising a second computing device and a sensing module.

[00017] FIG. 6 shows a block diagram of a wireless electrical stimulation system using calibration.

[00018] FIG. 7 shows a block diagram of a wireless electrical stimulation system using a sample feedback loop.

DETAILED DESCRIPTION

[00019] Disclosed herein are embodiments of systems that can be used for controlling muscular function and inciting physiological response, for example, by using surface (skin - transdermal) electrodes. Embodiments of the system can be used to adjust settings, start/stop specified programs, and deliver electrical stimuli to different parts of the user's anatomy.

[00020] As used herein, the term "user" is intended to include any person trained and able to perform the procedure, including the patient, doctor, caregiver, nurse, etc. The term "patient" and "individual" are intended to be interchangeable. The term "body" used herein is defined as "an animate body" including human, animal, and the like. The term "subject" herein is defined as a human patient or an animal.

[00021] Although the disclosure may be generally applicable to both men and women, application to men will be described throughout this disclosure for purposes of illustration. Throughout the figures accompanying this disclosure, various anatomical features of patient and structural features of system are illustrated conceptually for ease of illustration. Accordingly, the figures may not necessarily present appropriate scales and proportions of such anatomical features. Rather, the drawings are indicated as a conceptual rendering of such features to aid in the understanding of pertinent embodiments. Stimulation of Peripheral Nerves

[00022] The peripheral nervous system (PNS) is the part of the nervous system that consists of the nerves and ganglia outside of the brain and spinal cord. The PNS includes genitofemoral nerves. Genito-femoral nerves are schematically shown in Figures 3A and 3B. Figure 3A shows the male anatomy and figure 3B shows the female anatomy. As shown, the genito-femoral nerve 180 is located near the quadriceps 192, 193. The genitofemoral nerve splits after departing the L2-L3-L4 region of the lower vertebrae and one half, the femoral branch 185, 181 travels down the quadriceps 192, 193. The other half which is the genital branch 182, 183 travels to the genitals 190, 191.

[00023] Peripheral nerves can be stimulated using electronic stimulation, including FES. Other stimuli can be used to stimulate the peripheral nerves. For example, peripheral nerves can be stimulated using temperature changes, visual, auditory, olfactory, tactile stimuli, the use of assistive devices, alone or in combination with electronic stimulation.

Wireless Stimulation Device

[00024] A schematic of an embodiment of a wireless modular electrical stimulation system having two modules is shown in Figure 1. A wireless modular electrical stimulation system 100 can comprise a computing device 105 and one or more wireless modular electronic stimulation devices 120. The wireless modular electrical stimulation device 120 can comprise at least one electrode 150 and one or more electronic wires 150. The system 100 can comprise a processor 130. In some embodiments, the stimulation device 120 comprises the processor 130. The stimulation modules can be connected to the computing device 105 using a network 1 10. The network can comprise communication channels. The network can comprise Bluetooth, wifi, 802.1 1 , IR, and mesh networking. The stimulation device 120 can comprise a power source (rechargeable and/or disposable), voltage controller, waveform generator, and leads configured to connect to the electrodes 140.

[00025] The computing device 105 can comprise a mobile device. The mobile device can be configured to allow a user to control the stimulation modules through one or more programs, such as a mobile device application. The stimulation device 120 can comprise an electronic circuit assembly. The electrodes 140 can be connected to the electronic circuit assembly by the one or more electric wires 150. The electrodes 140 can comprise transcutaneous and subcutaneous electrodes. The processor 130 can be configured to send and receive signals via the network 1 10. For example, the processor 130 can be configured to receive signals comprising one or more stimulation patterns from the computing device 105. The stimulation patterns can comprise functional electrical stimulation, transcutaneous electrical nerve stimulation, electrical muscle stimulation, or a combination thereof. The stimulation device 120 can comprise a housing. The housing can comprise a form factor shaped and sized to fit the processor 130, wires 150, and the electrodes 140. In some embodiments, the housing comprises a fabric. The network 1 10 can be configured to connect the processor and the computer via Bluetooth. For example, the Bluetooth version 4.2 and later versions can be used.

[00026] The system 100 can be configured to perform modular communication between the computing device 105 and the stimulation device 120. For example, a system comprising two stimulation devices 120 can comprise two channels of communication. The stimulation device 120 can be configured to operate modular and independent from the operation of another stimulation device 120 in the system 100. For example, a system comprising two devices 120 can comprise a first device module sending and processing a first pattern and a second device module sending and processing a second pattern, where the first and second patterns are different. The first pattern and the second pattern can be sent and processed at the same time. The modular wireless stimulation control units can be used in isolation or in conjunction with other units. The system disclosed herein can control up to 8 units at one time and this can be expanded to control as many units as the user or clinician deems necessary.

[00027] The stimulation patterns can be configured such that when the one or more stimulation pattern is applied to the at least a portion of peripheral nervous system, the stimulation produces improvement in at least one of voluntary movement of sexual functions comprising arousal, orgasm, and ejaculation. The system can comprise electrical stimuli which travel through the quadriceps to the genito-femoral nerve where it returns to the spinal cord and branches off to the genital region. By exciting this part of the body with electrical stimuli, users can increase the sensation and control they have over their sexual organs. This process has shown to be repeatable for a significant portion of users with varying neurological disorders and sexual dysfunction. The computing device 105 can comprise at least one storage medium. The at least one storage medium can comprise instructions to direct the at least one pattern of electrical stimulation. The processor 130 can be configured to change the one or more stimulation pattern based on the signals.

[00028] The system 100 can comprise a charging station, not shown. The charging station can be configured to electronically connect with and charge the stimulation device 120. The computing device 105 can be configured to record electrical signals from the plurality of electrodes. For example, the computer device can be configured to modify the stimulation pattern based at least in part on the electrical signals received from the electrodes 140.

[00029] The system 100 can comprise assistive devices comprising a walker, cane, or exoskeleton. This system can be used to control muscle activity and function. When used with other devices, such as a robotic exoskeleton or standing frame, a user's muscles be activated sequentially by the settings programmed in the computing device. This system can be used for timely and meaningful functions like walking, standing and other physical activities. The stimulation device 120 can a safety shutoff switch configured to be activated by the subject and/or a user. In some embodiments, the safety shutoff switch can be configured to be responsive to a drop in current. The modular stimulation control unit can comprise a backup emergency shutoff button. The emergency shutoff button can be configured to allow the user to turn the device off manually without using the mobile computing device. The modular stimulation control units can be configured to sense a break in the circuit (loop). If an electrode falls off of the skin then the control unit will immediately stop sending any output signal to those electrodes until the unit is reset through the smartphone control app.

Wearable Housing Unit

[00030] The system 100 can comprise a device 120 comprising a housing. As shown in figure 2, the system 100 can be configured to stimulate the peripheral nerve. For example, the system 100 can be placed on the thigh 192. The electrodes 150 can use electrical stimulation 170 to stimulate the genitofemoral nerve 180. The housing can comprise a stretchable fabric (not shown) placed on and around the thigh 192. The disclosed systems can be configured to interface with industry standard electrode connections and also provide neoprene wraps that can be secured to keep the electrodes in place on the user's body. These wraps can be configured to insulate individuals other than the subject from accidental electric shock. Each housing can comprise the stimulation unit 120 comprising a processor 130 and an electrode 150. The stimulation unit 120 can receive signals from the computing device 105 wirelessly.

[00031] The form factor of the housing can be configured to maintain position of the electrodes relative to the subject's body during normal operation of the electrodes 150. For example, the housing can maintain in substantially the same position relative to the subject's thigh 192 while the electrodes operate in the frequency ranges of about 0 Hz to about 200 Hz.

[00032] In some embodiments, the housing comprising the stimulation device 150 can be configured to attach to different target anatomies. The target anatomy can comprise different muscle groups. For example, the muscle groups can comprise the quadriceps, hamstrings, abdominals, bladder neck, pelvic floor, bulbospongiosus, and ischiocavernosus muscles. The housing can comprise a material comprising insulating properties configured to protect the subject from electrical shock and temperature changes. The stimulation devices 120 can comprise a rechargeable battery. The rechargeable battery can comprise a scalable charging station.

[00033] The stimulation device 120 is configured to deliver transdermal currents to the leg to improve sexual dysfunction and probability of ejaculatory behavior. For example, the currents can affect spinal reflex activity and activity of the pudendal nerve including broader sacral plexus activity. Such actions may be achieved by stimulating the muscles of the legs or quadriceps 192 including the perineal nerve. By stimulating the perineal nerve, it will send activity back to the pudendal canal which contains the nerves that affect sexual activities including ejaculation.

[00034] The stimulation pattern from the devices 120 can be configured to modulate the activity of nerves in the pudendal cavity. For example, the electronical stimulation can nerves including sciatic, peroneal, or saphenous nerves, etc. The devices 120 can be configured to modulate of the activity of the pudendal nerve in a manner sufficient to modulate the activity of the dorsal penis nerve which is a branch of the pudendal nerve. [00035] The housing can comprise a wearable module. The module can comprise an inner surface and an outer surface. In some embodiments, at least a portion of the electrodes 140 can be exposed to skin of the subject on the inner surface of the module. In some embodiments, the housing comprises a switch connected to the wearable module. The switch can be configured to operate the stimulation devices 120.

Wireless Signals

[00036] The processor 130 can be configured to modify the stimulation pattern based on one or more of inputs. The one or more inputs can comprise direct input by subject, lapse of time, machine learning algorithm, drop in current, and any combination thereof.

[00037] The processor 130 can be configured to process electronic stimulation parameters, including signals. As shown in Figures 4A to 4D, the signals 400 can comprise one or more electronic stimulation parameters comprising current amplitude 420, frequency, voltage, wave lengths 430, and waveforms. Waveforms can comprise square waves comprising monophasic square waves and biphasic square waves. Figure 4A shows a square wave. Waveforms comprising a pulse wave, a non-square wave, waves having small pre-pulses can be used. Fig. 4B shows a pulse wave. Figure 4C shows a waveform having non-square wave 450. Figure 4D shows a wave having small pre-pulses 460 and a driving pulse 470. The amplitude can comprise about 0mA to about 150 mA. The voltage can comprise about 0V to about 150V.

Systems Using Sensors

[00038] Each wireless stimulation control unit can also utilize different sensors to feed information back to the smartphone control unit. This can trigger specific activation of different muscles and also time the decrease or stopping of a unit as well. Ultimately, the system disclosed herein can be configured to allow users to regain a wide variety of functions that are not limited to those mentioned above.

[00039] As shown on Figure 5, a modular wireless electronical stimulation system 500 can comprise sensors 630. The system 500 can comprise a first computing device 504, a second computing device 600, a first modular electrical stimulation device 520 and a second modular electrical stimulation device 522.

[00040] The sensors 630 can comprise one or more sensors are selected from an accelerometer, a joint angle sensor, a flex sensor, a pressure sensor, a temperature sensor, pitch, yaw, roll, spatial orientation, or a combination thereof. The first computing device 504 can be configured to collect data from the sensors and transmit the data to the second computing device 600. The second computing device 600 can be configured to determine stimulation parameter signals based on the data received by the first computing device 600. The data can be viewed by clinicians and other providers for remote subject monitoring and connected health.

[00041] The system 600 can comprise a wireless network connecting 610 the first and second computing devices to each other. The network can also wirelessly connect 510 the sensors 630 and the stimulation modules 520, 522 to computing devices. The sensors 630 can receive information 640 from the subject 584 and send information to computing devices 600, 504.

[00042] The sensors can also send information 640 to the stimulation devices 520, 522. In some embodiments, different sensors 630 can be paired with different stimulation devices 522. In some embodiments, sensors 630 can be paired with select stimulation devices 520 and not with other stimulation devices 522 within the system 500. Each of the modular stimulation devices 520, 522 and the sensors 630 can be connected with one another 640, 642. In some embodiments, the stimulation devices 520, 522 and the sensors 630 are connected to each other with electrical wires. In some embodiments the stimulation devices 520, 522 and sensors 630 are connected to each other with each other wirelessly.

[00043] The second stimulation device 522 can comprise a secondary stimulation 572. For example, the secondary stimulation can comprise at least one of sound, heat, vibration, light, chemical stimulation, or a combination thereof. The secondary stimulation 572 can comprise a second pattern. The second pattern can comprise an electronic stimulation pattern different from the first pattern 570. The system 500 can comprise electronic stimulation patterns comprising a first pattern 570 followed by a second pattern 572, where when the sensor 630 detects physiological changes in the subject 584, the first stimulation pattern stops and the second stimulation pattern is delivered to the subject 584. In some embodiments, the first stimulation pattern is delivered to a first portion of the subject's 584 peripheral nerve and the second stimulation pattern is delivered to a second portion. The first portion can be different from the second portion. Method of Stimulation

[00044] The computing device can be configured to process one or more programs. The one or more programs can be configured to address a specific user's needs. For example, the system can comprise the one or more programs configured to process different modular functions in a cycle and/or a sequence. The cycle can comprise an emergency stop cycle, wherein the user can immediately stop all current going to external devices in the event of an emergency.

[00045] Figure 7 shows a cycle 700 comprising a stop operation mode. The user can place a wireless electrical stimulation device on the subject's skin area. The subject's skin area can comprise abdomen skin, thigh skin, genitalia skin, buttock skin, lower back skin. The user can place an input 710 to begin the cycle. The system can deliver a first stimulation pattern 720 to the subject's genito-femoral nerves using the wireless electrical stimulation module. The system can detect physiological changes of the subject 730. The changes can comprise one or more of arousal, erection, ejaculation, orgasm, or a combination thereof. The system can deliver a second stimulation pattern in response to the physiological changes. The system can compare the physiological changes to a program or an algorithm 740 and alert the user. If the system produces a desired response from the subject, then the system can continue with its operation 750 to eventually stop operation 760. If the desired response is not achieved, then the system can be put to an emergency stop 760, either by the algorithm or the user.

[00046] The system can also use a self -correcting, machine learning cycle 1000 as shown in Figure 7. For example, after the system starts 1010, the user can input data 1020 to the computer. The input data can comprise information about the subject, selection of modules, target anatomy, desired response type, desired stimulation type, etc. The computer can process data 1030. The system can begin stimulation 1050. If a desired response 1050 is not achieved, the computer can calculate error 1060 and process data 1030 to alter stimulation 1050 modes to achieve the desired response. If the desired response 1050 is met, then the system can proceed to the therapy program 1070. The cycle can end 1080 when the program is complete. [00047] The user can also place a second wireless stimulation module. The first wireless electrical stimulation module and the second electrical wireless stimulation module can be placed along the skin areas different from each other.

[00048] This system can also be supplied with a Software Developer's Kit (SDK). The

SDK will allow any other software programmers to create their own timing and activation protocols.

[00049] Some embodiments of the system can comprise wire connection. For example, one or more of the stimulation electrodes in the system can be connected to the computing device using electrical wires, while other electrodes are wirelessly connected to the computing device.

[00050] The system can be configured to connect to the internet and serve as a tool for remote patient monitoring.

[00051] While several embodiments of the present disclosure have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the functions and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the present disclosure. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present disclosure is/are used.

[00052] As used in any embodiment herein, the term "module" may refer to software, firmware and/or circuitry configured to perform any of the aforementioned operations. Software may be embodied as a software package, code, instructions, instruction sets and/or data recorded on non-transitory computer readable storage medium. Firmware may be embodied as code, instructions or instruction sets and/or data that are hard-coded (e.g., nonvolatile) in memory devices. "Circuitry", as used in any embodiment herein, may comprise, for example, singly or in any combination, hardwired circuitry, programmable circuitry such as computer processors comprising one or more individual instruction processing cores, state machine circuitry, and/or firmware that stores instructions executed by programmable circuitry. The modules may, collectively or individually, be embodied as circuitry that forms part of a larger system, for example, an integrated circuit (IC), system on-chip (SoC), desktop computers, laptop computers, tablet computers, servers, smart phones, etc.

[00053] Any of the operations described herein may be implemented in a system that includes one or more storage mediums having stored thereon, individually or in combination, instructions that when executed by one or more processors perform the methods. Here, the processor may include, for example, a server CPU, a mobile device CPU, and/or other programmable circuitry.

[00054] Unless otherwise indicated, all numbers expressing quantities of ingredients, properties such as molecular weight, reaction conditions, and so forth used in the specification and claims are to be understood as being modified in all instances by the term "about." Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements.

[00055] The terms "a," "an," "the" and similar referents used in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., "such as") provided herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.

[00056] Certain embodiments of this invention are described herein, including the best mode known to the inventors for carrying out the invention. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.

[00057] Specific embodiments disclosed herein may be further limited in the claims using consisting of or consisting essentially of language. When used in the claims, whether as filed or added per amendment, the transition term "consisting of" excludes any element, step, or ingredient not specified in the claims. The transition term "consisting essentially of" limits the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristic(s). Embodiments of the invention so claimed are inherently or expressly described and enabled herein.

[00058] Furthermore, numerous references have been made to patents and printed publications throughout this specification. Each of the above-cited references and printed publications are individually incorporated herein by reference in their entirety.

[00059] In closing, it is to be understood that the embodiments of the invention disclosed herein are illustrative of the principles of the present invention. Other modifications that may be employed are within the scope of the invention. Thus, by way of example, but not of limitation, alternative configurations of the present invention may be utilized in accordance with the teachings herein. Accordingly, the present invention is not limited to that precisely as shown and described.

Claims

1. A multi-module electrical stimulation system to improve a subject's sexual function, the system comprising:

one or more wireless modular electronic stimulation devices comprising a plurality of electrodes; and

a processor configured to process signals from a computer device and select and deliver one or more stimulation patterns to the subject using the plurality of electrodes upon receiving the signal;

wherein the stimulation patterns comprise at least one pattern configured to stimulate at least a portion of peripheral nervous system of a subject;

wherein each of the one or more wireless modular electronic stimulation devices are configured to deliver the stimulation pattern independent from another modular transcutaneous stimulation device.

2. The system of claim 1 , further comprising a housing, the housing comprising a form factor configured to house the one or more wireless modular electronic stimulation devices and the processor.

3. The system of claim 2, wherein the form factor of the housing is configured to maintain position of the electrodes relative to the subject's body during normal operation of the electrodes, wherein the normal operation of the electrodes comprises frequency ranges of about 0 Hz to about 200 Hz.

4. The system of claim 1 , further comprising an electric circuit assembly, wherein the one or more wireless modular electronic stimulation devices comprise one or more electronic wires connecting the electrodes to the electric circuit assembly.

5. The system of claim 1 , wherein the electrodes comprise transcutaneous and subcutaneous electrodes.

6. The system of claim 1 , further comprising a network, wherein the network is configured to connect at least the processor and the computer device via Bluetooth technology, wherein the Bluetooth technology comprises Bluetooth version 4.2 and later versions.

7. The system of claim 1 , wherein the signal comprises one or more electronic stimulation parameters, the parameters comprising current amplitude, voltage, frequency, and waveforms.

8. The system of claim 7, wherein the amplitude comprises about 0 to about 150 mA.

9. The system of claim 7, wherein the voltage comprises about 0 to about 150V.

10. The system of claim 7, wherein the waveforms comprise monophasic square waves and biphasic square waves.

1 1 . The system of claim 1 , wherein the stimulation patterns further comprise patterns configured to cause muscular contractions of the subject, the muscle groups comprising quadriceps, hamstrings, abdominals, bladder neck, pelvic floor, bulbospongiosus, and ischiocavernosus muscles.

12. The system of claim 1 , further comprising one or more sensors, wherein the one or more sensors are selected from an accelerometer, a joint angle sensor, a flex sensor, a pressure sensor, a temperature sensor, EMG, or a combination thereof.

13. The system of claim 12, wherein the one or more sensors are wirelessly connected to the computer device and configured to generate and send sensing information to the computer device.

14. The system of claim 13, wherein the computer device is configured to adjust the signal using the sensing information generated by the one or more sensors.

15. The system of claim 13, wherein the processor is configured to select and deliver one or more stimulation patterns independent of the computer device signal.

16. The system of claim 13, further comprising a second computer device connected to the computer device through a network, the computer device configured to collect data from the one or more sensors and transmit the data to the second computer device, and the second computer device is configured to determine stimulation parameter signals based on the data.

17. The system of claim 16, wherein the data is viewed by clinicians and other

providers for remote subject monitoring and connected health.

18. The system of claim 1 , wherein the one or more stimulation patterns comprise one or more of functional electrical stimulation, transcutaneous electrical nerve stimulation, electrical muscle stimulation, or a combination thereof.

19. The system of claim 1 , wherein the one or more stimulation patterns is configured such that when the one or more stimulation pattern is applied to the at least a portion of peripheral nervous system, the stimulation produces improvement in at least one of voluntary movement of sexual functions comprising arousal, orgasm, and ejaculation.

20. The system of claim 1 , wherein the computer device comprises at least one

storage medium, the at least one storage medium comprising instructions to direct the at least one pattern of electrical stimulation, and the processing unit is further configured to change the one or more stimulation pattern based on the signals.

21 . The system of claim 1 , wherein the system comprises at least one secondary stimulation unit, the secondary stimulation unit configured to deliver a secondary stimulation comprising at least one of sound, heat, vibration, light, chemical stimulation, or a combination thereof.

22. The system of claim 1 , further comprising a charging station configured to electronically connect with and charge the wireless modular electrical stimulation devices.

23. The system of claim 1 , wherein the one or more electronic stimulation patterns comprises a first stimulation pattern followed by a second stimulation pattern, wherein the first stimulation pattern stops and the second stimulation pattern is delivered to the subject upon detecting physiological changes in the subject's body.

24. The system of claim 14, wherein the processor is configured to modify the

stimulation pattern based on one or more of inputs, wherein the one or more inputs comprise direct input by subject, lapse of time, machine learning

algorithm, drop in current, and combination thereof.

25. The system of claim 14, wherein the first stimulation pattern is delivered to a first portion of the subject's peripheral nerve and the second stimulation pattern is delivered to a second portion, the first portion being different from the second portion.

26. The system of claim 1 , wherein the computer device is configured to record

electrical signals from the plurality of electrodes, wherein the computer device is configured to modify the stimulation pattern based at least in part on the electrical signals received from the plurality of electrodes.

27. The system of claim 1 , wherein the subject is utilizing an assistive device

comprising a walker, cane, or exoskeleton.

28. The system of claim 1 , wherein the wireless modular electronic stimulation

devices comprise a safety shut off switch configured to be activated by the subject.

29. The system of claim 1 , wherein the wireless modular electronic stimulation devices comprise a safety shutoff responsive to a drop in current.

30. The system of claim 2, wherein the housing comprises a material comprising insulating properties configured to protect the subject from electrical shock and temperature changes.

31 . The system of claim 1 , wherein the wireless modular electronic stimulation devices comprise a rechargeable battery, wherein the rechargeable battery is recharged using a scalable charging station.

32. An electronic stimulation device configured to aid a subject having various

conditions including sexual dysfunction, the device comprising:

a plurality of electrodes, the electrodes configured to innervate the subject's peripheral nervous system using electronic stimulation;

at least one processor connected to the plurality of electrodes configured to deliver at least one stimulation pattern to the plurality of electrodes; and

an input/output device configured to operate the at least one processor; wherein the stimulation pattern is configured to induce one or more of sexual arousal, orgasm, erection, ejaculation, or a combination thereof.

33. The device of claim 32, wherein the electrodes comprise a first electrode and a second electrode, the first and second electrodes connected to the processor using electrical wires.

34. The device of claim 32, wherein the device comprises a wearable module, the module comprising an inner surface and an outer surface and wherein at least a portion of the electrodes are exposed to skin of the subject on the inner surface of the module.

35. The device of claim 32, wherein the subject's peripheral nervous system

comprises the genito-femoral nerve.

36. The device of claim 33, wherein the at least one processor is configured to receive signals from the electrodes and modify the stimulation pattern based at least in part on signal data received from electrodes.

37. The device of claim 33, wherein the stimulation pattern comprises one or more of monophasic and biphasic square waves, 0-150 mA in current, 0-150 V, 0-200 Hz, or a combination thereof.

38. The device of claim 33, wherein the input/output device comprises a computer device and wherein the processor and the computer device are connected via a network, the network comprising Bluetooth, wifi, 802.1 1 , IR, and mesh

networking.

39. The device of claim 38, wherein the computer device is configured to select and execute one or more electronic stimulation patterns, the stimulation patterns comprising at least one stimulation pattern configured to stimulate at least a portion of genito-femoral nervous system of the subject.

40. The device of claim 39, wherein the computer device is configured to receive and record electrical signals from the electrodes, wherein the processor is configured to modify the stimulation pattern based in part on the information received from the computer device.

41 . The device of claim 40, wherein the input/output device comprises a switch

connected to the housing module.

42. The device of claim 32, comprising one or more sensors, the one or more

sensors comprising accelerometer, pitch, yaw, roll, spatial orientation, and EMG.

43. The device of claim 42, wherein the at least one processor is configured to

receive and record data from the one or more sensors and modify the stimulation pattern based at least in part on data received from the sensors.

44. The device of claim 32, further comprising a secondary stimulation unit configured to deliver a secondary stimulation comprising at least one of sound, heat, vibration, light, chemical stimulation, or a combination thereof.

45. The device of claim 32, further comprising a rechargeable power source.

46. A method of aiding a subject's sexual function using one or more wireless

electrical stimulation modules comprising a plurality of electrodes, wherein the one or more electrical stimulation modules are configured to operate

independently from each other, the method comprising: a) placing a first wireless electrical stimulation module on the subject's skin area, the subject's skin area comprising abdomen skin, thigh skin, genitalia skin, buttock skin, lower back skin;

b) delivering a first stimulation pattern to the subject's genito-femoral nerves using the wireless electrical stimulation module;

c) detecting physiological changes of the subject, changes comprising one or more of arousal, erection, ejaculation, orgasm, or a combination thereof; and d) stopping the first stimulation pattern to the subject.

47. The method of claim 46, comprising:

e) placing a second wireless stimulation module, wherein the first wireless

electrical stimulation module and the second electrical wireless stimulation module are placed along the skin areas different from each other.

48. The method of claim 46, wherein the one or more wireless electrical stimulation modules are connected to a computer device using a network, the network comprising wifi, Bluetooth, 802.1 1 , IR, and mesh networking.

49. The method of claim 48, wherein the one or more wireless electrical stimulation modules are configured to send and receive signals to each other and the computer using the network.

50. The method of claim 47, wherein the first wireless electrical stimulation module delivers a first stimulation pattern and the second wireless electrical stimulation module delivers an alternative stimulation pattern, wherein the first and the alternative stimulation patterns are different.

51 . The method of claim 46, comprising: f) delivering a second stimulation pattern in response to the physiological changes detected in step c)