WO2016134296A1 - Stimulateur de nerf topique et capteur pour fonction sexuelle - Google Patents

Stimulateur de nerf topique et capteur pour fonction sexuelle Download PDF

Info

Publication number
WO2016134296A1
WO2016134296A1 PCT/US2016/018740 US2016018740W WO2016134296A1 WO 2016134296 A1 WO2016134296 A1 WO 2016134296A1 US 2016018740 W US2016018740 W US 2016018740W WO 2016134296 A1 WO2016134296 A1 WO 2016134296A1
Authority
WO
WIPO (PCT)
Prior art keywords
stimulation
nerve
penis
action potential
producing
Prior art date
Application number
PCT/US2016/018740
Other languages
English (en)
Inventor
Graham H. Creasey
Hoo-Min Toong
Original Assignee
Creasey Graham H
Hoo-Min Toong
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Creasey Graham H, Hoo-Min Toong filed Critical Creasey Graham H
Publication of WO2016134296A1 publication Critical patent/WO2016134296A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]

Definitions

  • a Topical Nerve Stimulator and Sensor (TNSS) device described in the related United States Patent Application Serial No. PGT/US 1.4/40240 filed May 30, 2014 is used to stimulate nerves.
  • a TNSS may apply electrode generated electric field(s) in a low frequency to dermis in the proximity of a nerve.
  • the TNSS also mcliides hardware and logic for high frequency (GHz) communication to mobile devices.
  • a wireless system including a TNSS device is described herein. Its components, features and performance characteristics are set forth in the following technical description. Advantages of a wireless TNSS system over existing transcutaneous electrical nerve stimulation devices are:
  • multiple electrodes of a TNSS can form an array to shape an electric field in the tissues
  • multiple TNSS devices can form an array to shape an electric field in the tissues
  • multiple TNSS devices can stimulate multiple structures, coordinated by a smartphone
  • transmitting antenna of TNSS device can focus beam of electromagnetic energy within tissues in short bursts to activate nerves directly without implanted devices;
  • [0012] include sion of multiple sensors of multiple modalities, including but not limited to position, orientation, force, distance, acceleration, pressure, temperature, voltage, light and other electromagnetic radiation, sound, ions or chemical compounds, making it possible to sense electrical activities of muscles (EMG, EKG), mechanical effects of muscle contraction, chemical composition of body fluids, location or dimensions or shape of an organ or tissue by transmission and receiving of ultrasound;
  • EMG EKG
  • EKG electrical activities of muscles
  • TNS S devices are expected to have service lifetimes of days to weeks and their disposability places less demand on power sources and battery
  • TNSS devices can form a network with each other, with remote controllers, with other devices, with the internet and with other users;
  • a nerve cell normally has a voltage across the cell membrane of 70 millivolts with the interior of the cell at a negative voltage with respect to the exterior of the cell. This is known as the resting potential and it is normally maintained by metabolic reactions which maintain different
  • Ions can be actively "pumped” across the cell membrane through ion channels in the membrane that are selective for different types of ion, such as sodium and potassium.
  • the channels are voltage sensitive and can be opened or closed depending on the voltage across the membrane.
  • An electric field produced within the tissues by a stimulator can change the normal resting voltage across the membrane, either increasing or decreasing the voltage from its resting voltage.
  • a decrease in voltage across the cell membrane to about 55 millivolts opens certain ion channels, allowing ions to flow through the membrane in a self-catalyzing but self-limited process which results in a transient decrease of the trans membrane potential to zero, and even positive, known as depolarization followed by a rapid restoration of the resting potential as a result of active pumping of ions, across the membrane to restore the resting situation which is known as repolarization.
  • This transient change of voltage is known as an action potential and it typically spreads over the entire surface of the cell. If the shape of the cell is such that it has a long extension known as an axon, the action potential spreads along the length of the axon. Axons that have insulating myelin sheaths propagate action potentials at much higher speeds than those axons without myelin sheaths or with damaged myelin sheaths.
  • the action potential reaches a junction, known as a synapse, with another nerve cell
  • the transient change in membrane voltage results in the release of chemicals known as neuro-transmitters that, can initiate an action potential in the other cell.
  • This provides a means of rapid electrical communication between cells, analogous to passing a digital pulse from one cell to another.
  • the action potential reaches a synapse with a muscle cell it can initiate an action potential that spreads over the surface of the muscle cell.
  • This voltage change across the membrane of the muscle cell opens ion channels in the membrane that allow ions such as sodium, potassium and calcium to flow across the membrane, and can result in contraction of the muscle cell.
  • the voltage across the membrane of a cell can be changed by creating an electric field in the tissues with a stimulator. It is important to note that action potentials are created within the mammalian nervous system by the brain, the sensory nervous system or other internal means. These action potentials travel along the body's nerve "highways".
  • the TNSS creates an action potential through an externally applied electric field from outside the body. This is very different than how action potentials are naturally created within the body.
  • electric fields capable of causing actio potentials can be generated by electronic stimulators connected to electrodes that are implanted surgically in close proximity to the target nerves.
  • electronic stimulators connected to electrodes that are implanted surgically in close proximity to the target nerves.
  • Such devices typically use square wave pulse trains of the form shown in Figure 3.
  • Such devices may be used instead of implants and/or with implants such as reflectors, conductors, refractors, or markers for tasgtne target nerves and the like, so as to shape electric fields to enhance nerve targeting and/or selectivity.
  • the amplitude of the pulses, A, applied to the skin may vary between 1 and 100 Volts, pulse width, t, between 100 microseconds and 10 milliseconds, duty cycle (t/T) between 0.1 % and 50%, the frequency of the pulses within a group between 1 and 100/sec, and the number of pulses per group, n, between 1 and several hundred.
  • pulses applied to the skin will have an amplitude of up to 60 volts, a pulse width of 250 microseconds and a frequency of 20 per second, resulting in a duty cycle of 0.5%.
  • balanced-charge biphasic pulses will be used to avoid net current flow.
  • these pulses may be symmetrical, with the shape of the first part of the pulse similar to that of the second part of the pulse, or asymmetrical, in which the second part of the pulse has lower amplitude and a longer pulse width in order to avoid canceling the stimulatory effect of the first part: of the pulse.
  • the location and magnitude of the electric potential applied to the tissues by electrodes provides a method of shaping the electrical field. For example, applying two electrodes to the skin, one at a positive electrical potential with respect to the other, can produce a field in the underlying tissues such as mat shown in the cross-sectional diagram. Figure 5.
  • the diagram in Figure 5 assumes homogeneous tissue.
  • the voltage gradient is highest close to the electrodes and lower at a distance from the electrodes. Nerves are more likely to be activated close to the electrodes than at a distance. For a given voltage gradient, nerves of large diameter are more likely to be activated than nerves of smaller diameter. Nerves whose long axis is aligned with the voltage gradient are more likely to be activated than nerves whose long axis is at right angles to the voltage gradient.
  • an important factor in the formation of electric fields used to create action potentials in nerve cells is the medium through which the electric fields must penetrate.
  • this medium consists of various types of tissue including bone, fat, muscle, and skin. Eac of these tissues possesses different electrical resistivity or conductivity and different capacitance and these properties are anisotropic. They are not uniform in all directions within the tissues. For example, an axon has lower electrical resistivity along its axis than
  • the pulse trains can differ from one another indicated by A, t/T, n, and f as well as have different phase relationships between the pulse trams.
  • combinations of electrodes can be utilized ranging from simple dipoles, to quadripoles, to linear arrangements, to approximately circular configurations, to produce desired electric fields within tissues.
  • Electrodes to a part of the body with complex tissue geometry will thus result in an electric field of a complex shape.
  • the interaction of electrode arrangement and tissue geometry can be modeled using Finite Element Modeling, which is a mathematical method of dividing the tissues into many small elements in order to calculate the shape of a complex electric field. This can be used to design an electric field of a desired shape and orientation to a particular nerve.
  • High frequency techniques known for modifying an electric field may not apply to application of electric fields by TNSSs because they use low frequencies.
  • the present system uses beam selection to move or shift or shape an electric field, also described as field steering or field shaping, by activating different electrodes, such as from an array of electrodes, to move the field. Selecting different combinations of electrodes from an array may result in beam or field steering.
  • a particular combination of electrodes may shape a beam and/or change the direction of a beam by steering. This may shape the electric field to reach a target nerve selected for stimulation.
  • Electrodes to be implanted surgically on or near nerves.
  • Using electrodes on the surface of the skin to focus activation selectively on nerves deep in the tissues has many advantages. These include avoidance of surgery, avoidance of the cost of developing complex implants and gaming regulatory approval for them, and avoidance of the risks of long-term implants.
  • the features of the electric field that determine whether a nerve will be activated to produce an action potential can be modeled mathematically by the Activating Function described by Rattay (Rati ay F.
  • Rattay F The basic mechanism for the electrical stimulation of the nervous system. Neuroscience Vol. 89, No. 2, pp. 335- 346, 1 99).
  • the electric field can produce a voltage, or extracellular potential, within the tissues that varies along the length of a nerve. If the voltage is
  • the Activating Function is proportional to the second-order spatial derivative of the extracellular potential along the nerve. If it is suffic iently greater than zero at a gi ven point it predicts whether the electric field will produce an action potential in the nerve at that point. This prediction may be input to a nerve signature.
  • the nerve to be activated must be accurately selected. This selectivity may be improved by using the system described herein, and described herein as a nerve signature, in several ways, as follows:
  • the TNSS 934 human and mammalian interface and its method of operation and supporting system are managed by a Master Control Program (MCP) 910 represented in function format as block diagrams. It provides the logic for the nerve stimulator system.
  • MCP Master Control Program
  • the primary responsibility of the MCP 910 is to coordinate the activities and communications among the various control programs, the Data Manager 920, the User 932, and the external ecosystem and to execute the appropriate response algorithms in each situation.
  • the MCP 910 accomplishes electric field shaping and/or beam steering by providing an electrode activation pattern to the TNSS device 934 to selectively stimulate a target nerve.
  • the MCP 910 upon notification by the Communications Controller 930 of an external event or request, the MCP 910 is responsible for executing the appropriate response, working with the Data Manager 920 to formulate the correct response and actions. It integrates data from various sources such as Sensors 938 and external inputs such as TNSS devices 934, and applies the correct security and privacy policies, such as encryption and HIPAA required protocols. It will also manage the User Interface (UI) 912 and the various Application Program Interfaces (APIs) 914 that provide access to external programs.
  • UI User Interface
  • APIs Application Program Interfaces
  • the MCP is also responsible for effectively managing power
  • TNSS device consumption by the TNSS device through a combination of software algorithms and hardware components that may include, among other things: computing, communications, and stimulating electronics, antenna, electrodes, sensors, and power sources in the form of conventional or printed batteries.
  • the communications controller is responsible for receiving inputs from the User 932, from a plurality of TNSS devices 934, and from 3rd party apps 936 via communications sources such as Internet or cellular networks.
  • the format of such inputs will vary by source and must be received, consolidated, possibly reformatted, and packaged for the Data Manager 920.
  • User inputs may consist of simple requests for activation of TNSS devices 934 to status and information concerning the User's 932 situation or needs.
  • TNSS devices 934 will provide signaling data that may consist of voltage readings, TNSS 934 status data, responses to control program inquiries, and other signals.
  • the Communications Controller 930 is also responsible for sending data and control requests to the plurality of TNSS devices 934.
  • 3rd party applications 936 can send data, requests, or instructions for the Master Control Program 910 or User 932 via Internet or cellular networks.
  • the Communications Controller 930 is also responsible for communications via the cloud where various software applications reside.
  • the Data Manager (DM) 920 has primary responsibility for the storage and movement of data to and from the Communications Controller 930, Sensors 938, Actuators 940, and the Master Control Program 910.
  • the DM 920 has the capability to analyze and correlate any of the data under its control. It provides logic to select and activate nerves. Examples of such operations upon the data include: statistical analysis and trend identification; machine learning algorithms; signature analysis and pattern recognition, correlations among the data within the Data Warehouse 926, the Therapy Library 922, the Tissue Models 924, and the Electrode Placement Models 928, and other operations.
  • the Data Warehouse (DW) 926 is where incoming data is stored
  • this data can be real-time measurements from TNSS devices 934 or from Sensors (938), data streams from the Internet, or control and instructional data from various sources.
  • the DM 920 will analyze data, as specified above, that is held in the DW 926 and cause actions, including the export of data, under MCP 910 control. Certain decision making processes implemented by the DM 920 will identify data patterns both in time, frequency, and spatial domains and store them as signatures for reference by other programs. Techniques like EMG, even multi- electrode EMG, gather a lot of data that is the sum of hundreds to thousands of individual motor units and the normal procedure is to perform complex
  • the DM 920 will perform big data analysis over the total signal and recognize patterns that relate to specific actions or even individual nerves or motor units. This analysis can be performed over data gathered in time from an individual, or over a population of T SS Users.
  • the Therapy Library 922 contains various control regimens for the TNSS devices 934. Regimens specify the parameters and patterns of pulses to be applied by the TNSS devices 934. The width and amplitude of individual pulses may be specified to stimulate nerve axons of a particular size selectively without
  • the frequency of pulses applied may be specified to modulate some reflexes selectively without modulating other reflexes.
  • Other embodiments of regimens will vary the parameters within ranges previously specified.
  • Tissue Models 924 are specific to the electrical properties of particular body locations where TNSS devices 934 may be placed. As noted previously, electric fields for production of action potentials will be affected by the different electrical properties of the various tissues that they encounter. Tissue Models 924 are combined with regimens from the Therapy Library 922 and
  • Electrode Placement Models 928 to produce desi red actions may be developed by MRI, Ultrasound or other imaging or measurement of tissue of a body or particular part of a body. This may be accomplished for a particular User 932 and/or based upon a body norm.
  • One such example embodiment of a desired action is the use of a Tissue Model 924 together with a particular Electrode Placement Model 928 to determine how to focus the electric field from electrodes on the surface of the body on a specific deep location corresponding to the pudendal nerve in order to stimulate that nerve selectively to reduce incontinence of urine.
  • Other example embodiments of desired actions may occur when a Tissue Model 924 in combination with regimens from the Therapy Library 22 and
  • Electrode Placement Models 928 produce an electric field that stimulates a sacral nerve. Many other embodiments of desired actions follow for the stimulation of other nerves.
  • Electrode Placement Models 928 specify electrode configurations that the TNSS devices 934 may apply and activate in particular locations of the body.
  • a TNSS device 934 may have multiple electrodes and the Electrode Placement Model 928 specifies where these electrodes should be placed on the body and which of these electrodes should be active in order to stimulate a specific structure selectively without stimulating other structures, or to focus an electric field on a deep structure.
  • An example embodiment of an electrode configuration is a 4 by 4 set of electrodes within a larger array of multiple electrodes, such as an 8 by 8 array. This 4 by 4 set of electrodes may be specified anywhere within the larger array such as the uppe right corne of the 8 by 8 array.
  • Electrode configurations may be circular electrodes that may even consist of concentric circular electrodes.
  • the TNSS device 934 may contain a wide range of multiple el ectrodes of which the El ectrode Placement Models 928 will specify which subset will be activated. These Electrode Placement Models 928 complement the regimens in the Therapy Library 922 and the Tissue Models 924 and are used together with these other data components to control the electric fields and their interactions with nerves, muscles, tissues and other organs.
  • Other examples may include TNSS devices 934 having merely one or two electrodes, such as but not limited to those utilizing a closed circuit.
  • Independent sensors 938 and actuators 940 can be part of the TNSS system. Its functions can complement the electrical stimulation and electrical feedback that the TNSS devices 934 provide.
  • An example of such a sensor 938 and actuator 940 include, but are not limited to, an ultrasonic actuator and an ultrasonic receiver that can provide real-time image data of nerves, muscles, bones, and other tissues. Other examples include electrical sensors that detect signals from stimulated tissues or muscles.
  • the Sensor/Actuator Control module 950 provides the ability to control both the actuation and pickup of such signals, all under control of the MCP 910. Application Program Interfaces
  • the MCP 910 is also responsible for supervising the various Application Program Interfaces (APIs) that will be made available for 3rd party developers.
  • APIs Application Program Interfaces
  • Another group of healthcare professionals may desire access to the Therapy Library 922 and Tissue Models 924 to construct better regimens for addressing specific diseases or disabilities. In each case a different specific API 914 may be appropriate.
  • the MCP 910 is responsible for many software functions of the TNSS system including system maintenance, debugging and troubleshooting functions, resource and device management, data preparation, analysis, and communications to external devices or programs that exist on the smart phone or in the cloud, and other functions. However, one of its primary functions is to serve as a global request handler taking inputs from devices handled by the Communications Controller 930, external requests from the Sensor Control Actuator Module (950), and 3rd party requests 936.
  • MCP High Level Master Control Program
  • the RH 960 will determine whi ch of the plurality of User Requests 961 is present such as: activation; display status, deactivation, or data input e.g. specific User condition. Shown in Figure 9B is the RH's 960 response to an activation request. As shown in block 962, RH 960 wil l access the Therapy Library 922 and cause the appropriate regimen to be sent to the correct TNSS 934 for execution, as shown at block 964 labeled "Action.”
  • TNSS/Sensor Inputs The RH 960 will perform data analysis over TNSS 934 or Sensor inputs 965. As shown at block 966, it employs data analysis, which may include techniques ranging from DSP decision making processes, image processing algorithms, statistical analysis and other algorithms to analyze the inputs, hi Figure 9B two such analysis results are shown; conditions which cause a User Alarm 970 to be generated and conditions which create an Adaptive Action 980 such as causing a control feedback loop for specific TNSS 934 functions, which of course can iteratively generate further TNSS 934 or Sensor inputs 965 in a closed feedback loop.
  • 3rd Party Apps Applications can communicate with the MCP 910, both sending and receiving communications.
  • a typical communication would be to send informational data or commands to a TNSS 934.
  • the RH 960 will analyze the incomin application data, as shown at block 972.
  • Figure 9B shows two such actions that result.
  • One action, shown at block 974 would be the presentation of the application data, possibly reformatted, to the User 932 through the MCP User Interface 912.
  • Another result would be to perform a User 932 permitted action, as shown at 976, such as requesting a regimen from the Therapy Library 922.
  • the TNSS has one or more electronic circuits or chips 1000 that perform the functions of:
  • one or more antennae 1010 mat may also serve as electrodes and communication pathways, and a wide range of sensors 1006 such as, but not limited to, mechanical motion and pressure, temperature, humidity, chemical and positioning sensors.
  • sensors 1006 such as, but not limited to, mechanical motion and pressure, temperature, humidity, chemical and positioning sensors.
  • TNSS interfaces to transducers 1014 to transmit signals to the tissue or to receive signals from the tissue.
  • One arrangement is to integrate a wide variety of these functions into an SOC, system on chip 1000.
  • a control unit 1002 for data processing, communications, transducer interface and storage and one or more stimulators 1004 and sensors 1006 that are connected to electrodes 1008.
  • An antenna 1010 is incorporated for external communications by the control unit.
  • an internal power supply 1012 which may be, for example, a battery.
  • An external power supply is another variation of the chip configuration. It may be necessary to include more than one chip to accommodate a wide range of voltages for data processing and stimulation. Electronic circuits and chips will communicate with each other via conductive tracks within the device capable of transferring data and/or power.
  • the TNSS interprets a data stream from the control device, such as that shown in Figure 9A, to separate out message headers and delimiters from control instructions.
  • control instructions contain information such as voltage level and pulse pattern.
  • the TNSS activates the stimulator 1004 to generate a stimulation signal to the electrodes 1 08 placed on the tissue according to the control instructions.
  • the TNSS activates a transducer 1014 to send a signal to the tissue.
  • control instructions cause information such as voltage level and pulse pattern to be retrieved from a library stored in the TNSS.
  • the TNSS receives sensory signals from the tissue and translates them to a data stream that is recognized by the control device, such as the example in Figure 9A.
  • Sensory signals include electrical, mechanical, acoustic, optical and chemical signals among others.
  • Sensory signals come to the TNSS through the electrodes 1008 or from other inputs originating from mechanical, acoustic, optical, or chemical transducers.
  • an electrical signal from the tissue is introduced to the TNSS through the electrodes 1008, is converted from an analog signal to a digital signal and then inserted into a data stream that is sent through the antenna 101 to the control device.
  • an acoustic signal is received by a transducer 1014 in the TNSS, converted from an analog signal to a digital signal and then inserted into a data stream that is sent through the antenna 1010 to the control device.
  • sensory signals from the tissue are directly interfaced to the control device for processing.
  • Sexual function is a complex interaction of nerves, arteries, veins, and control mechanisms.
  • Sexual arousal has origins from sexual thoughts in the cerebral cortex of the brain, that may also be responses to sights, sounds, or smells that are perceived as erotic, and from brainstem activity during sleep.
  • sexual responses may also be produced by tactile stimulation of the genitals or other parts of the body.
  • Sexual function may be modified using the principles described above. Electrical or mechanical stimulation of the nerves on the penis or clitoris or other parts of the body by a TNSS may cause sexual arousal and might be used to produce or prolong erection of the penis or clitoris, and to produce emission of secretions, ejaculation of semen in the male, and orgasm.
  • the nerve signals that produce erection in males ran from the brain 1 100 through the spinal cord 1102 including its sacral region 1 104 to the penis 1 105 via the cavemosal nerves 1 110 which are parasympathetic efferent nerves to the corpora cavernosa and release the vasodilator nitric oxide which causes cells to produce cyclic guanine monophosphate (cGMP).
  • cGMP cyclic guanine monophosphate
  • Electric or mechanical stimulation can be delivered by a TNSS applied to the skin of the penis 1 105 or clitoris can produce action potentials in the sensory nerves 1 106 that travel to the sacral segments of the spinal cord 1104 resulting in a reflex that sends action potentials along the cavemosal nerves 1 110 to the penis or clitoris to produce reflex erection.
  • This can be independent of .nerve signals originating from the cerebral cortex or other sources mentioned previously.
  • action potentials stimulated in sensory nerves in the penis or clitoris can also travel up the spinal cord 1102 to the brain 1 100 producing sexual arousal, which can result in action potentials traveling down the spinal cord 1 102 and the eavemosal nerves ' 1110 to the penis 1105 or clitoris, enhancing erection.
  • sexual function can be produced by electrical stimulation or by mechanical stimulation from small electromechanical devices built mto a TNSS. These forms of stimulation can be under the control of the User via a smartphone or other control.
  • Simple Stimulation can be produced by electrical stimulation or by mechanical stimulation from small electromechanical devices built mto a TNSS. These forms of stimulation can be under the control of the User via a smartphone or other control.
  • Step I User feels the desire to have an erection, ejaculation or orgasm, responding to signals in the brain 1209 and/or from external sexual stimuli such as sights, sounds, smells or touch, 1210 and 1211.
  • Step 2 User activates the TNSS 1201 via the Control Device 1206, such as a smartphone or a dedicated device, such as a key fob. Both the Control Device and TNSS are under software control, responding to an action from the User, and can transmit and receive radio signals to and from each other. There are
  • Step 3 The TNSS sends stimulation 1202 to the appropriate nerves 1203 that cause the penis 1204 to become erect using a pulse signal that may be a selection from, a variety of pulse signals and intensities implemented as one or a plurality of 'buttons' on the Control Device interface or actual buttons on a
  • Stimulation of these nerves may also result in action potentials traveling to other parts of the brain and spinal cord resulting in sexual arousal and refle sexual responses such as ejaculation, orgasm and vaginal lubrication.
  • Step 4 User can reactivate the TNSS either immed iately if further erection or sexual responses are desired or the next time these effects are desired.
  • Stimulation in response to multiple inputs This is a representative sequence of events to illustrate some of the additional functions ' in addition to the Simple Stimulation described above. It includes logging functions, incorporating data from the cloud, and data from other sensors and sources.
  • the User's activation profile is recorded by the TNSS and shared with the Control Device.
  • the activatio profile consists of a User ID, stimulation signal identifier, date and time of day, and if the User interface permits, User conditions at the t ime of activation. Historical data can be gathered and analyzed for the User's benefit.
  • Data 1214 from the Internet may be accepted by the Control Device and/or the TNSS.
  • Types of data may be instructions from a healthcare professional, population data, statistical analyses and trend data relative to the individual user or across populations. This data can be passed through to the user, or cause actions to be taken such as alarms, notifications, etc.
  • Data 1205 can be gathered from sensors on a continuous basis or only when the TNSS is activated. These data can be used to alter the stimulation signals that the TNSS transmits to the User.
  • An example is an acoustic transceiver that can both transmit and receive acoustic data to create acoustic images of the structure beneath the electrodes or elsewhere in the body that may be affected by the neural stimulation.
  • a MEMS device may be used that would allow the TNSS to gather spatial data about the size and shape of the penis and identify the state of the erection, compare it to historical conditions and modify the patterns of stimulation to improve their effect on erection and other sexual responses.
  • the normal command signal 1208 to cause the TNSS 1201 to be activated comes from the User's desire to have an erection or other sexual responses and the User's action 1208 to activate the Control Unit 1206 as described previously. There is a plurality of other feedback loops that can control the erection.
  • the TNSS can transmit an acoustic pulse into the tissues and receive acoustic information 1205 to derive an image of the penis and determine when the penis is losing its erection. Then the TNSS will automatically stimulate the penis to maintain the erection before the User becomes aware of the oncoming flaccid condition of the penis and activates the normal command signal 1206.
  • the Control Device can also be used to automatically activate the TNSS to stimulate the penis to maintain the erection. Data can also be stored in the Control Device or, with the permission of the user, transmitted 1213 via the internet to healthcare providers or others.

Landscapes

  • Health & Medical Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne un procédé et un appareil permettant de modifier la fonction sexuelle par la stimulation électrique sélective d'un nerf de mammifère comprenant : l'application d'un timbre dermique ayant une électrode intégrée à proximité d'un nerf sensoriel associé au pénis ou au clitoris ; la détermination d'une ou de plusieurs stimulations correspondant au nerf sensoriel, par une logique du timbre dermique ; l'application de la stimulation par les électrodes et d'un stimulateur faisant corps avec le timbre dermique pour produire un champ électrique ; et l'activation sélective du nerf sensoriel par le champ électrique pour produire un potentiel d'action dans le nerf sensoriel qui se déplace vers un segment sacré de la moelle épinière donnant lieu à un réflexe qui modifie la fonction sexuelle.
PCT/US2016/018740 2015-02-21 2016-02-19 Stimulateur de nerf topique et capteur pour fonction sexuelle WO2016134296A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562119141P 2015-02-21 2015-02-21
US62/119,141 2015-02-21

Publications (1)

Publication Number Publication Date
WO2016134296A1 true WO2016134296A1 (fr) 2016-08-25

Family

ID=56689488

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2016/018740 WO2016134296A1 (fr) 2015-02-21 2016-02-19 Stimulateur de nerf topique et capteur pour fonction sexuelle

Country Status (1)

Country Link
WO (1) WO2016134296A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019079680A1 (fr) * 2017-10-19 2019-04-25 The Procter & Gamble Company Dispositif de stimulation nerveuse topique
CN111801138A (zh) * 2017-12-27 2020-10-20 性能力医疗有限公司 射精控制

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4585005A (en) * 1984-04-06 1986-04-29 Regents Of University Of California Method and pacemaker for stimulating penile erection
US5571118A (en) * 1995-01-05 1996-11-05 Boutos; David Apparatus for stimulating penile, scrotal, anal, vaginal and clitoral tissue
US20030130715A1 (en) * 2001-01-31 2003-07-10 David Boutos Electrode apparatus for stimulating penile tissue
US20070078493A1 (en) * 2005-10-04 2007-04-05 Medtronic, Inc. Impedance-based penile tumescence sensor
US20070239224A1 (en) * 2004-02-12 2007-10-11 Ndi Medical, Inc. Systems and methods for bilateral stimulation of left and right branches of the dorsal genital nerves to treat urologic dysfunctions
US20110144468A1 (en) * 2004-06-10 2011-06-16 Medtronic Urinary Solutions, Inc. Systems and methods of neuromodulation stimulation for the restoration of sexual function
US20120302821A1 (en) * 2009-10-26 2012-11-29 Emkinetics, Inc. Method and apparatus for electromagnetic stimulation of nerve, muscle, and body tissues
US20130116742A1 (en) * 2008-05-05 2013-05-09 Pierre Lavoisier Device and method for measuring and treating the rigidity and erection of a penis and arterial-venous flows
WO2014194200A1 (fr) * 2013-05-30 2014-12-04 Creasey Graham H Stimulation neurologique topique

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4585005A (en) * 1984-04-06 1986-04-29 Regents Of University Of California Method and pacemaker for stimulating penile erection
US5571118A (en) * 1995-01-05 1996-11-05 Boutos; David Apparatus for stimulating penile, scrotal, anal, vaginal and clitoral tissue
US20030130715A1 (en) * 2001-01-31 2003-07-10 David Boutos Electrode apparatus for stimulating penile tissue
US20070239224A1 (en) * 2004-02-12 2007-10-11 Ndi Medical, Inc. Systems and methods for bilateral stimulation of left and right branches of the dorsal genital nerves to treat urologic dysfunctions
US20110144468A1 (en) * 2004-06-10 2011-06-16 Medtronic Urinary Solutions, Inc. Systems and methods of neuromodulation stimulation for the restoration of sexual function
US20070078493A1 (en) * 2005-10-04 2007-04-05 Medtronic, Inc. Impedance-based penile tumescence sensor
US20130116742A1 (en) * 2008-05-05 2013-05-09 Pierre Lavoisier Device and method for measuring and treating the rigidity and erection of a penis and arterial-venous flows
US20120302821A1 (en) * 2009-10-26 2012-11-29 Emkinetics, Inc. Method and apparatus for electromagnetic stimulation of nerve, muscle, and body tissues
WO2014194200A1 (fr) * 2013-05-30 2014-12-04 Creasey Graham H Stimulation neurologique topique

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019079680A1 (fr) * 2017-10-19 2019-04-25 The Procter & Gamble Company Dispositif de stimulation nerveuse topique
CN111491692A (zh) * 2017-10-19 2020-08-04 宝洁公司 局部神经刺激装置
CN111491692B (zh) * 2017-10-19 2024-04-09 Oab神经电疗科技公司 局部神经刺激装置
CN111801138A (zh) * 2017-12-27 2020-10-20 性能力医疗有限公司 射精控制

Similar Documents

Publication Publication Date Title
US11077301B2 (en) Topical nerve stimulator and sensor for bladder control
US20160243358A1 (en) Topical Nerve Stimulator and Sensor for Control of Autonomic Function
US20210146120A1 (en) Topical Neurological Stimulation
US11779761B2 (en) Non-invasive nerve stimulation
US20200376266A1 (en) Non-Invasive Nerve Stimulation to Delay Urination
US20190009094A1 (en) Method and apparatus for selecting stimulation configuration and target for neuromodulation
CN107405495A (zh) 基于组织激活的体积的电刺激治疗的治疗程序选择
WO2016137926A1 (fr) Neurostimulateur topique et capteur pour la commande d'une fonction autonome
US20200155846A1 (en) Detection and Treatment of Obstructive Sleep Apnea
US20160235982A1 (en) Non-Invasive Selective Human and Mammalian Nerve Stimulation System and Method
WO2016134273A1 (fr) Stimulateur topique de nerf et capteur pour la gestion de la douleur
US20160243356A1 (en) Topical Nerve Stimulator and Sensor for Sexual Function
US20210187301A1 (en) Implantable medical device control system and control method therefor
CA3092366C (fr) Stimulation nerveuse non invasive
US20170239471A1 (en) Topical Nerve Stimulator and Sensor for Pain Management
WO2016134270A1 (fr) Neurostimulateur topique et capteur pour le contrôle de la vessie
WO2016134296A1 (fr) Stimulateur de nerf topique et capteur pour fonction sexuelle
US20200297992A1 (en) Primary Dysmenorrhea Pain Reduction
US11717683B2 (en) Non-invasive nerve stimulation
Salkim Optimisation of a Wearable Neuromodulator for Migraine Using Computational Methods
CN117180612B (zh) 植入式电极、刺激器及其控制方法、存储介质
US20230414286A1 (en) Pathway planning apparatus, surgical system, and computer-readable storage medium
JP7086969B2 (ja) 電気刺激の正確な送達

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 16753174

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 16753174

Country of ref document: EP

Kind code of ref document: A1