WO2010111506A1 - Dispositif de stimulation piézoélectrique - Google Patents

Dispositif de stimulation piézoélectrique Download PDF

Info

Publication number
WO2010111506A1
WO2010111506A1 PCT/US2010/028690 US2010028690W WO2010111506A1 WO 2010111506 A1 WO2010111506 A1 WO 2010111506A1 US 2010028690 W US2010028690 W US 2010028690W WO 2010111506 A1 WO2010111506 A1 WO 2010111506A1
Authority
WO
WIPO (PCT)
Prior art keywords
waveform
body part
piezoelectric element
predetermined body
accordance
Prior art date
Application number
PCT/US2010/028690
Other languages
English (en)
Inventor
Anthony Diubaldi
Stephen Wahlgren
Michael R. Tracey
Original Assignee
Ethicon, Inc.
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 Ethicon, Inc. filed Critical Ethicon, Inc.
Publication of WO2010111506A1 publication Critical patent/WO2010111506A1/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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/20—Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A61B5/202—Assessing bladder functions, e.g. incontinence assessment
    • A61B5/205—Determining bladder or urethral pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/6874—Bladder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H23/00—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms
    • A61H23/02—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive
    • A61H23/0245—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive with ultrasonic transducers, e.g. piezoelectric
    • 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
    • A61N1/18—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
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/36017—External stimulators, e.g. with patch electrodes with leads or electrodes penetrating the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/028—Microscale sensors, e.g. electromechanical sensors [MEMS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5005—Control means thereof for controlling frequency distribution, modulation or interference of a driving signal
    • 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
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/378—Electrical supply
    • A61N1/3787—Electrical supply from an external energy source

Definitions

  • the present invention is directed to piezoelectric stimulation of a predetermined body part, e.g., a nerve.
  • Nerve and muscle cells have membranes that are composed of lipids and proteins, and have unique properties of excitability such that an adequate disturbance of the cell's resting potential can trigger a sudden change in the membrane conductance.
  • a neuronal process can be divided into unit lengths, which can be represented in an electrical equivalent circuit. Each unit length of the process is a circuit with its own membrane resistance, membrane capacitance and axonal resistance.
  • a nerve cell can be excited by increasing the electrical charge within the nerve, thus increasing the membrane potential inside the nerve with respect to the surrounding extracellular fluid.
  • This fundamental feature of the nervous system i.e., its ability to generate and conduct electrical impulses, can take the form of action potentials (AP), which are a single electrical impulse passing down an axon.
  • This action potential (nerve impulse or spike) is an "all or nothing" phenomenon. That is, once the threshold stimulus intensity is reached, an action potential will be generated.
  • Nerve stimulation may be realized by applying electrical pulses having different frequencies, amplitudes and waveforms. Stimulating electrical signals may be generated by electrodes disposed close to the target nerve or tissue of interest.
  • Transcutaneous Electrical Nerve Stimulators produce an electrical signal at frequencies up to approximately 200 Hz to stimulate nerves for relatively small periods of time.
  • TENS use a small electrical device to deliver low frequency (10 Hz to 100 Hz) electrical impulses through the skin via electrode pads affixed to the skin. Electrodes are located at selected locations on the patient's skin and the electrical energy is transferred between the two electrodes. Electrical energy is generally applied in the form of low frequency electrical impulses. The impulses pass through the skin and interact with the nerves that lie beneath the skin.
  • a typical TENS device includes a stimulator, lead wires and electrodes attached to the surface of the skin of the patient.
  • the stimulator is an electrical pulse generator that delivers electrical pulses at a predetermined or selectable frequency.
  • TENS devices are only effective in treating nerves very close to the surface of the skin because the low frequency electrical impulses diminish in strength very quickly due to tissue impedance and thus are not sufficient in intensity to stimulate nerves deep beneath the skin.
  • implantable electrodes may be surgically implanted proximate a target nerve or tissue of interest to be stimulated. The need for invasive surgery makes such implanted electrodes undesirable.
  • a nerve cell can also be excited by mechanical vibration which increases the membrane potential inside the nerve with respect to the surrounding extracellular fluid.
  • This mechanical vibration or resonance can be detected by nerve endings if above a certain threshold frequency; that is, a minimum threshold level of stimuli is required before the action potential is triggered or fired. If the threshold stimulus intensity is reached an electrical signal is passed along the axon of the nerve and an action potential is fired.
  • PCT International Publication WO 2005/079909 discloses a method and apparatus for the detection and treatment of respiratory disorders using implanted devices to mechanically stimulate afferent nerves so as to indirectly cause an increase of the tone of upper airway muscles normally involved with maintenance of upper airway patency.
  • the tone of the upper airway muscles typically decrease during Obstructive Sleep Apnea (OBS), contributing to a collapse and obstruction of the airway.
  • OBS Obstructive Sleep Apnea
  • This reflex mechanism is substituted or enhanced during sleep to restore or maintain airway patency by the application of electrical or mechanical stimulation applied to the afferent nerves.
  • a mechanical element for example, a piezo-electric element
  • a controller sends an electrical signal to the piezo-electric element thereby eliciting a vibration.
  • Vibration of the element elicits stimulation of mechanoreceptor afferent nerve endings within the upper airway.
  • the amplitude, frequency and duration of the mechanical stimulation are controlled such that sufficient stimulation of afferent nerves is achieved without sensory stimulation sufficient to cause arousal from sleep.
  • the mechanical stimulation of afferent nerves would typically be achieved by a period of several seconds of vibration at frequencies in the range of 10-50 Hz, and is tuned to the frequency at which the target receptors are most sensitive.
  • the electrical signal used to invoke the mechanical vibrations must inherently be produced by an implanted pulse generator. Otherwise, transcutaneous delivery of such a low frequency electrical signal generated by a non-invasive signal generator would not be sufficient in strength or intensity to trigger stimulation of the afferent nerve beneath the skin as most of the energy would be dissipated at the level of the skin.
  • a pulse generator that generates only low frequency would require surgery to be implanted.
  • U.S. Patent Application Publication No. 2006/0167500 discloses a neurostimulator using an implanted piezo-electric chip as an electrode.
  • the neurostimulator includes driving circuitry connected to an ultrasound transducer and at least one piezoelectric chip located proximate a nerve fiber.
  • the ultrasound transducer is positioned to create a pressure wave that is incident on the piezoelectric chip.
  • the excitation of the piezoelectric materials in the piezoelectric chip generates an electric current that can then be used to stimulate an action potential or inhibit the creation of an action potential in the nerve.
  • a mechanical signal is transmitted through the skin and is converted to an electrical signal by the piezoelectric chip.
  • An aspect of the present invention is directed to piezoelectric stimulation of a nerve of interest to invoke firing of an action potential by transcutaneously applying high frequency burst packets of electrical energy.
  • Another aspect of the present invention is directed to piezoelectric stimulation of a nerve of interest to invoke firing of an action potential by transcutaneously applying a continuous high frequency waveform.
  • Still another aspect of the present invention is directed to a stimulation device including an external non-implantable transmitting device powered by a power source and generating an electrical waveform signal.
  • a surface electrode applies the generated electrical waveform signal transcutaneously.
  • An implantable piezoelectric element receives the applied electrical waveform signal generated transcutaneously and, in turn, causes mechanical deformation resulting in mechanical vibration of the implantable piezoelectric element sufficient to stimulate a predetermined body part such as the stimulation and firing of an action potential in a nerve.
  • Yet another aspect of the present invention is directed to a method for stimulating a predetermined body part such as a nerve using a device in accordance with the preceding paragraph.
  • a piezoelectric element is implanted proximate the predetermined body part.
  • An electrical waveform signal is generated using an external non-implantable transmitting device powered by a power source.
  • the generated electrical waveform signal is applied transcutaneously through skin via a surface electrode.
  • a piezoelectric element implanted proximate the predetermined body part receives the applied electrical waveform signal generated transcutaneously causing it mechanically to deform resulting in mechanical vibration of the piezoelectric element sufficient to stimulate the predetermined body part.
  • Figure 1 depicts an exemplary schematic illustration of a piezoelectric neurostimulator in accordance with the present invention
  • Figure 2 is an exemplary schematic illustration of a transdermal transmission device in accordance with an embodiment of the present invention for generating a high frequency burst packet
  • Figures 3A-3C are illustrative waveforms generated by the device in Figure 2;
  • Figures 4A & 4B are illustrations of an exemplary implantable piezoelectric element within a cage in its non-expanded and expanded states, respectively;
  • Figure 5 is an illustration of an exemplary implantable piezoelectric element with a securing projection
  • Figure 6 is an exemplary schematic illustration of a signal transmitting device in accordance with another embodiment of the present invention for generating a high frequency continuous waveform; and [0021] Figure 7 depicts another exemplary schematic illustration of a piezoelectric neurostimulator in accordance with the present invention including a dampening mechanism.
  • Neurostimulator 100 includes an external non-imp lantable transmitting device 105 preferably in the form of a transdermal patch or the like that is removably adhered to the skin 115 such as by using an adhesive.
  • An electrical waveform signal generated by the transmitting device 105 and transmitted through the skin is applied across a mechanical element 125 such as a piezoelectric element disposed proximate a desired or intended nerve of interest 120 to be stimulated.
  • Piezoelectric element 125 is comprised of a piezoelectric material that has the ability to resonate.
  • the piezoelectric element 125 is made from a biocompatible material and/or encased in a biocompatible coating. Examples of such piezoelectric materials include natural crystals such as quartz or topaz, as well as other naturally occurring materials such as bone, ceramics with perovskite or tungsten-bronze structures.
  • the piezoelectric element may be disposed either in direct or indirect contact with the nerve of interest. In the latter case, stimulation of the nerve of interest may be achieved indirectly by positioning the piezoelectric element in a biological volume conducting medium so that the surfaces of the material contact the fluid, whereby the generated pressure waves in the medium can be significant and sufficient to stimulate compound action potential in nerve fibers.
  • Biological volume conducting media in this context could be muscle or fat (with extracellular fluid) adjacent to the nerve of interest. Since the volume conducting medium envelopes the nerve of interest the medium vibrates with the vibration/resonance of the piezoelectric element resulting in the firing of an action potential in the nerve without direct contact.
  • the piezoelectric element is made of a piece of quartz having a thickness of approximately 100 ⁇ m, a width of approximately lmm and a length of approximately 10 mm.
  • a piezoelectric element of such dimensions may be implanted into a patient using a conventional 16 gauge needle.
  • the dimensions of the piezoelectric element may be modified, as desired, depending on many factors such as its method of implantation into the body.
  • Piezoelectric element 125 may be surrounded by a housing 400 or cage as illustrated in greater detail in Figures 4 A & 4B.
  • housing 400 is a collapsible cage made of a suitable metal such as Nitinol, stainless steel, a titanium alloy, or a biocompatible polymer such as polypropylene or polyethylene terapthalate.
  • the collapsible cage is advantageous in that it can exist in a collapsed state shown in Figure 4A that is sufficiently small in dimension to allow insertion through an opening into the body. Once inserted into the body, as described further below, the cage assumes an expanded state shown in Figure 4B which has a size sufficiently large to prevent it from passing out through the opening from which it was inserted. Housing or cage 400 automatically returns to its expanded state ( Figure 4B) when an external compression force is removed.
  • Piezoelectric element 125 can be mechanically affixed to the housing or cage 400 in any suitable manner, such as by using a biocompatible adhesive.
  • the expandable cage may be made of an absorbable material such as Ethisorb® (an absorbable synthetic composite made from polyglactin and polydioxanon) from Ethicon, Inc. of Somerville, N.J., or a combination of absorbable and non-absorbable materials.
  • Ethisorb® an absorbable synthetic composite made from polyglactin and polydioxanon
  • the absorbable material would preferably dissolve after a predetermined period of time so that the implantable piezoelectric element could be expelled from the body in a non-invasive manner.
  • the housing may have a stable structure rather than a collapsible structure that itself has an outer diameter (D) that is smaller than the diameter of an opening in the body to allow insertion therethrough, as shown in Figure 5.
  • the housing may further have one or more projections 500, such as screw threads, barbs, hooks or the like, extending outwardly therefrom that can be attached to the sidewall of an organ, tissue or other internal physiological structure by being pushed or driven therein.
  • the implantable piezoelectric element 125 could be sutured to an organ, tissue or other internal physiological structure, or adhered thereto using a suitable biocompatible adhesive.
  • the collapsible cage 400 is compressed and loaded into a single or multi-lumen catheter for delivery and placement at a desired nerve of interest.
  • the catheter may be any catheter such as a Foley catheter.
  • Fluroroscopy, ultrasound or other similar technology known to those skilled in the art may be used to aid in delivery and placement of the implantable piezoelectric element 125. If a multilumen catheter is used, other lumens may be used to provide an access for visualization, or monitor a physiological state of the body while placing the implantable piezoelectric element 125.
  • An expulsion element such as a push rod or the like is inserted into the primary lumen behind the housing 400 enclosing the piezoelectric element 125, and once the distal end of the catheter is properly positioned within the body, the expulsion element is moved toward the distal end of the catheter to thereby expel the piezoelectric element 125 enclosed in the housing 400 from the distal end of the catheter and into the body.
  • the collapsible cage 400 is no longer restrained in its collapsed state, and automatically returns to its fully expanded state.
  • suitable implantation methods such as placement via the working channel in a cystoscope or similar surgical tool, or placement via laparoscopic or open surgical methods.
  • piezoelectric element 125 may also be suitable, such as that shown in Figure 5.
  • the method of implantation of such devices would be similar to that described above, with the expulsion element within the catheter being used to drive the projecting element 500 so that it is anchored in an organ, tissue or internal physiological structure in the body.
  • Other mechanisms for securing e.g., barbs, hooks, anchors, projections, sutures, adhesives
  • Piezoelectric element 125 may be constructed using pieces of quartz of various sizes, as desired.
  • Selection of the material, structure and dimensions of the piezoelectric element is designed to achieve the desired resonance frequency required to stimulate the nerve of interest and trigger firing of an action potential.
  • Application of an electrical field generated transcutaneously causes mechanical deformation (e.g., alternating stress) in the piezoelectric material causing it to vibrate or resonate.
  • the vibration frequency is chosen to be the resonant frequency of the block, typically in the range of approximately 100 kHz to approximately 1 MHZ.
  • the piezoelectric element vibrates/resonantes mechanically due to the piezoelectric effect.
  • Piezoelectric element 125 is designed so that it has a predetermined resonant frequency so as to trigger the firing of an action potential in the nerve of interest.
  • Nerves are stimulated and action potentials are generated by low frequency waveforms in the range of approximately 1 Hz - approximately 40 Hz.
  • the pudendal nerve is stimulated by a low frequency signal on the order of approximately 10 Hz - approximately 40 Hz.
  • an external signal generator in order to stimulate such a nerve transdermally from the surface of the skin, an external signal generator must produce a high frequency waveform in the range of approximately 100 kHz - approximately 1 MHz in order to overcome the impedance of the skin and tissue so as to provide the necessary intensity of the stimulus to cause firing of the action potential for the nerve of interest.
  • Such high frequency waveforms cannot be employed to directly stimulate a nerve since they do not respond to such high frequency signals.
  • an action potential may be triggered in a nerve of interest with the transmitting device 105 in Figure 1 generating either a high frequency burst packet or a high frequency continuous waveform.
  • the transmitting device 105 generates high frequency burst packets using a transdermal signal transmission device, as disclosed in U.S. Patent Application No. 11/146,522, filed on June 7, 2005, entitled “System and Method for Nerve Stimulation” (U.S. Patent Application Publication 2005/0277998) and assigned to the same entity as the present invention, which is herein incorporated by reference in its entirety.
  • Transdermal signal transmission device 205 includes a power source 220 such as a lithium ion film battery by CYMBETTM Corp. of Elk River, Minn., model number CPF141490L, and two waveform generators 210, 215 that are electrically coupled to and powered by the power source 220.
  • Waveform generators 210, 215 may be of any suitable type, such as those sold by Texas Instruments of Dallas, Tex. under model number NE555.
  • a first waveform generator 210 generates a first waveform or signal having a predetermined frequency known to stimulate a nerve of interest in the body.
  • nerves are stimulated by low frequency signals.
  • the pudendal nerve is stimulated at frequencies in the range of approximately 10 Hz - approximately 40 Hz.
  • the second waveform generator 215 is provided to generate a carrier waveform, which is received with the first waveform as input to an amplitude modulator 230, such as an On-Semi MC1496 modulator by Texas Instruments.
  • FIG. 3 A and 3B An illustrative example of the waveforms is shown in Figures 3 A and 3B, wherein the first waveform produced by the first waveform generator 210 is a square wave having a frequency of approximately 10 Hz - approximately 40 Hz, and the second waveform produced by the second waveform generator 215 is a sinusoidal signal having a frequency in the range of approximately 10 Hz - approximately 400 kHz.
  • Multiplying the second waveform (carrier waveform) 304 by the first waveform 302 results in a modulated waveform or output signal 306 having generally the configuration shown in Figure 3C.
  • the modulated signal 306 matches the resonant frequency of the piezoelectric element to produce mechanical vibration sufficient to stimulate the target nerve of interest and fire the action potential.
  • the modulated signal 306 is provided to an appropriate surface electrode 110, such as DURA-STICK Self Adhesive Electrodes from Chattanooga Group, Inc. of Hixson, Tenn., that applies the modulated waveform transcutaneously through the skin 115.
  • Surface electrode 110 is depicted by a single block, however, it represents more than one physical structure, as shown in Figure 1.
  • the use of the modulated signal enables transmission of the waveform through physiological tissue due to the high frequency nature of the second waveform 304, yet allows it to be detected (and responded to) by the physiological target of interest due to the low frequency envelope of the modulated signal 306. These high frequency packets cause the piezoelectric element 125 to mechanically resonate.
  • the individual burst packets are comprised of the high frequency carrier waveform in the frequency range of approximately 100 kHz - approximately 1 MHz.
  • nerves are stimulated and action potential are generated by low frequency waveforms in the range of approximately 1 Hz - approximately 40 Hz. Accordingly, the nerve of interest will only respond to the leading edge (e.g., representing a predetermined duration) of an individual burst packet due to the high frequency of the packet.
  • leading edge e.g., representing a predetermined duration
  • packets arrive approximately every approximately 10 Hz - approximately 40 Hz.
  • the nerve of interest responds to only the leading edge of each packet.
  • the above-described signal transmission device 205 may further include a biofeedback mechanism to create a closed-loop system and provide a system wherein nerve stimulation is selective, that is, applied only when necessary as opposed to constantly.
  • One or more biofeedback devices 235 are preferably implanted within the body.
  • Each biofeedback device 235 preferably includes at least one sensor 240 for monitoring, detecting or sensing a parameter such as a bio-physiological property, and a data transmission device 245 that transmits data or information gathered by the sensor back outside the body to be further processed as described more fully below.
  • Transdermal signal transmission device 205 may include a microcontroller or microprocessor 255 and a receiving device 250 such as a MAX 1472 from Maxim Semiconductors of Sunnyvale, Calif, that is electrically coupled to and powered by the power source 220. Data from one or more of the biofeedback devices 235 is received by receiving device 250 and transmitted to the microcontroller 255. Communication from the transmitter 245 to a receiver 250 is depicted in Figure 2 by a wired connection, however, any type of communication interface is contemplated and within the intended scope of the invention including a wireless link.
  • Microcontroller 255 is programmed to analyze the data, and based thereon control the input data to the first and second waveform generators 210, 215 so as to control signal transmission by the transdermal signal transmission device 205.
  • the biofeedback device 235 may be a pressure sensor 240 that is implanted within the bladder. Pressure measured within the bladder over time is indicative of the existence and magnitude of bladder contractions. When such pressure measurements indicate spastic bladder muscle activity (as compared to normal bladder contractions which will result in a slow and steady rise of pressure within the bladder), a feedback signal can be communicated from the transmitter 245 to the receiving device 250 and subsequently to the microcontroller 255.
  • the microcontroller 255 will, via control of the waveform generators 210, 215, cause the electrodes 110 to transmit the modulated signal. Receipt of the modulated electrical stimulus signal across the mechanical device 125 will cause it to vibrate and stimulate the pudendal nerve.
  • signal transmitting device 605 generates a high frequency continuous waveform, rather than a high frequency burst packet.
  • Signal transmitting device 605 in accordance with this second embodiment differs from the transdermal signal transmission device 205 of Figure 2 in that only a single waveform generator 610 is employed for generating a continuous high frequency waveform (e.g., at approximately 100 kHz - approximately 1 MHz), rather than modulated high frequency burst packets.
  • a continuous high frequency waveform e.g., at approximately 100 kHz - approximately 1 MHz
  • nerves typically require a relatively low frequency to trigger firing of the action potential. Accordingly, application of such a high frequency continuous waveform, even taking into consideration any degradation in intensity due to tissue impedance, may still be too high to trigger firing of the action potential of the target nerve of interest.
  • the resonant frequency of the mechanical device may have to be shifted downward to a lower frequency (e.g., to approximately 1 Hz - approximately 40 Hz) that the nerve of interest responds to trigger an action potential by employing a dampening or suppression mechanism 700 such as a spring or a cantilever whereby the resonant frequency depends on the length of the cantilever edge, as shown in Figure 7.
  • a dampening or suppression mechanism 700 such as a spring or a cantilever whereby the resonant frequency depends on the length of the cantilever edge, as shown in Figure 7.
  • the mechanical element may be encapsulated in a fluid such that the fluid resistance reduces, dampens or suppresses the number of oscillations or vibrations to a desired lower resonant frequency.
  • dampening or suppression techniques for downshifting the resonant frequency may be used instead of, or in combination with, any of the techniques described herein in order to realize a desired resonant frequency necessary for triggering of an action potential in a target nerve of interest.
  • This translation of energy from a high frequency to a low frequency signal may be achieved by restricting the resonance in only a single direction and is illustrated by way of the following example employing a cantilever.
  • the frequency of an electric field equals the harmonic order (n) multiplied by the frequency constant (in one direction - assume in the vertical direction) of a material, divided by the thickness of a crystal, for example, quartz.
  • the harmonic constant of quartz is 2870 kHz-mm.
  • the quartz crystal In order for the quartz crystal to be able to absorb the incoming resonance at 210 kHz the frequency has to be translated into a low frequency resonance of approximately 40 Hz, and requires that the movement be restricted to only the vertical direction with the length of the crystal much longer than its thickness.
  • the specific dimensions of the crystal are calculated as follows:
  • F x is the frequency of the electric field in one direction (in this case the x direction)
  • n is the harmonic order
  • k x is the frequency constant in the x direction (in this case for quartz listed above)
  • t is the thickness of the crystal.
  • Resonant frequency is defined as follows:
  • L is the length
  • E Young's Modulus
  • p the density.
  • the Young's Modulus of quartz is 71.7 GPa
  • the density of quartz is 2.66 g/cm 3 .
  • the biofeedback device, microcontroller and receiver may be eliminated wherein the signal generated by the transmitting device remains continuous rather than being controlled or adjusted based on any feedback data.
  • Piezoelectric devices allow for specific targeting of a nerve to be stimulated.
  • stimulation may be selective targeting one or more of the mechanical devices at different times.
  • use of multiple piezoelectric devices provides the enhanced flexibility of designing each device to have the same or different resonant frequencies, as desired.
  • the present invention has been described with respect to stimulation of a nerve of interest, however, stimulation of any body part is contemplated and within the intended scope of the present invention.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Biophysics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rehabilitation Therapy (AREA)
  • Pain & Pain Management (AREA)
  • Epidemiology (AREA)
  • Physiology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne un procédé pour stimuler une partie prédéterminée du corps telle qu'un nerf en utilisant un dispositif de stimulation comprenant un dispositif émetteur non implantable extérieur alimenté par une source d'alimentation et générant un signal de forme d'onde électrique. Une électrode de surface applique le signal de forme d'onde électrique généré de manière transcutanée. Un élément piézoélectrique implantable reçoit le signal de forme d'onde électrique appliqué généré de manière transcutanée et, à son tour, entraîne une déformation mécanique entraînant une vibration mécanique de l'élément piézoélectrique implantable suffisante pour stimuler la partie prédéterminée du corps. Le signal de forme d'onde électrique peut être une forme d'onde continue haute fréquence ou des paquets de salves haute fréquence.
PCT/US2010/028690 2009-03-27 2010-03-25 Dispositif de stimulation piézoélectrique WO2010111506A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US21119709P 2009-03-27 2009-03-27
US61/211,197 2009-03-27

Publications (1)

Publication Number Publication Date
WO2010111506A1 true WO2010111506A1 (fr) 2010-09-30

Family

ID=42563061

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2010/028690 WO2010111506A1 (fr) 2009-03-27 2010-03-25 Dispositif de stimulation piézoélectrique

Country Status (1)

Country Link
WO (1) WO2010111506A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011119951A1 (fr) * 2010-03-26 2011-09-29 Ethicon, Inc. Dispositif de stimulation piézoélectrique
TWI569742B (zh) * 2015-10-08 2017-02-11 楊志鴻 壓電刺激元件、具有該壓電刺激元件之壓電刺激器、鞋墊

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001041869A1 (fr) * 1999-12-09 2001-06-14 Urosurge, Inc. Dispositif d'electroacupuncture implantable
US20060178703A1 (en) * 2004-12-27 2006-08-10 Huston Jared M Treating inflammatory disorders by electrical vagus nerve stimulation
US20060195153A1 (en) * 2004-02-11 2006-08-31 Diubaldi Anthony System and method for selectively stimulating different body parts
US20060229688A1 (en) * 2005-04-08 2006-10-12 Mcclure Kelly H Controlling stimulation parameters of implanted tissue stimulators
US20060247721A1 (en) * 2005-04-29 2006-11-02 Cyberonics, Inc. Identification of electrodes for nerve stimulation in the treatment of eating disorders
WO2007092301A2 (fr) * 2006-02-03 2007-08-16 Kang Ting Système à force cyclique à transduction mécanique
WO2009029614A1 (fr) * 2007-08-27 2009-03-05 The Feinstein Institute For Medical Research Dispositifs et procédés permettant d'inhiber l'activation de granulocytes par stimulation neurale

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001041869A1 (fr) * 1999-12-09 2001-06-14 Urosurge, Inc. Dispositif d'electroacupuncture implantable
US20060195153A1 (en) * 2004-02-11 2006-08-31 Diubaldi Anthony System and method for selectively stimulating different body parts
US20060178703A1 (en) * 2004-12-27 2006-08-10 Huston Jared M Treating inflammatory disorders by electrical vagus nerve stimulation
US20060229688A1 (en) * 2005-04-08 2006-10-12 Mcclure Kelly H Controlling stimulation parameters of implanted tissue stimulators
US20060247721A1 (en) * 2005-04-29 2006-11-02 Cyberonics, Inc. Identification of electrodes for nerve stimulation in the treatment of eating disorders
WO2007092301A2 (fr) * 2006-02-03 2007-08-16 Kang Ting Système à force cyclique à transduction mécanique
WO2009029614A1 (fr) * 2007-08-27 2009-03-05 The Feinstein Institute For Medical Research Dispositifs et procédés permettant d'inhiber l'activation de granulocytes par stimulation neurale

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011119951A1 (fr) * 2010-03-26 2011-09-29 Ethicon, Inc. Dispositif de stimulation piézoélectrique
TWI569742B (zh) * 2015-10-08 2017-02-11 楊志鴻 壓電刺激元件、具有該壓電刺激元件之壓電刺激器、鞋墊

Similar Documents

Publication Publication Date Title
US8588930B2 (en) Piezoelectric stimulation device
AU2019202771B2 (en) Implant unit delivery tool
US11730469B2 (en) Implant unit delivery tool
CN104080510B (zh) 检测睡眠紊乱呼吸预兆的装置和方法
US7277749B2 (en) Treatments for snoring using injectable neuromuscular stimulators
JP2020099738A (ja) アンテナを含むインプラント型睡眠時無呼吸処置デバイス
Larson et al. Miniature ultrasonically powered wireless nerve cuff stimulator
US20060247717A1 (en) Electrical stimulation of the gastrointestinal tract to regulate motility
WO2009131639A1 (fr) Blocage de potentiels d'action exogène par un dispositif médical implantable
AU2010216210B2 (en) Treatment of a pelvic condition through indirect electrical stimulation
JP2022516262A (ja) 超音波を使用して電力を供給するインプランタブルデバイスの電力制御
JP2022516839A (ja) 埋め込み可能な装置を動作させるための超音波ベースのプロトコル
WO2010111506A1 (fr) Dispositif de stimulation piézoélectrique
CN116159244B (zh) 一种注射式微型神经刺激器及神经刺激系统
KR102162060B1 (ko) 체내 이식형 의료기기 제어시스템 및 그의 제어방법
KR102162063B1 (ko) 체내 이식형 의료기기 제어시스템 및 그의 제어방법
Towe et al. Wireless microstimulators for treatment of peripheral vascular disease
KR20190100766A (ko) 체내 이식형 의료기기
KR102036535B1 (ko) 체내 이식형 의료기기
KR20190100765A (ko) 체내 이식형 의료기기

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: 10725915

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: 10725915

Country of ref document: EP

Kind code of ref document: A1