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A history of the development of percutaneous electrical stimulation of the auricle ? Srini Nageshwar a , Melvyn Lafitte b a Los Gatos, CA b Geneva, Switzerland Abstract Though it is well known how and when Paul Nogier discovered the “little man in the ear”, the later developments that led to the recent technological advances are mostly uncharted. In particular, the progress which was championed by DyAnsys in developing a percutaneous device and applying electrical stimulation to alleviate various autonomic ailments was heretofore not reported. Key words: PENS; History of Science; human auricle. Contents 1.1 First developments, Paul Nogier & the homunculus ear 1 1.2 Russian discovery of “electrosleep” 3 2.1 Dr. Szeles’ invention of the auricular neurostimulation device using the antecedent concepts 3 2.2 Mapping the human auricle 4 2.3 Adding autonomic nervous system monitoring 4 2.4 Mapping stimulation points to cranial nerves and defining point frequencies 4 2.5 Programming a PENS device 4 3 Comparing methodologies 8 4 Current applications 8 References 8 ? This is a preprint provided by DyAnsys Inc. for educa- tional purposes. Email address: [email protected] (Srini Nageshwar). 1 Ancient and early stages The idea of electrically-induced analgesia dates back to the Greek scholars, Plutarch and Socrates, who noticed the numbing effects of standing in pools of water on a beach that contained electric fish. The early stages of a later development however occurred during the sec- ond half of the 20th century under the pioneering steps of Paul Nogier. The son of a professor of medicine at the Universit´ e de Lyon, he was first educated in physics before turning his attention to medicine. As a medical doctor specialized in internal medicine, Dr. Nogier later engaged with homeopathy and other non-conventional practices. 1.1 First developments, Paul Nogier & the homunculus ear In 1950, Dr. Nogier [15] was “intrigued by a strange scar which certain of his patients had on their external ear.” He found that the scar was due to a treatment for sciatica involving cauterization of the auricular antihelix by a lay practitioner living in Marseille, France. Her name was Mrs. Barrin. The patients were unanimous in stating that they had been successfully relieved of sciatica pain within hours, even minutes, of this ear cauterization. Mrs. Barrin had learned of this auricular procedure from her father, who had learned it from a Chinese Mandarin. As stated by Dr. Nogier, I then proceeded to carry out some cauterizations my- Preprint of manuscript to be published 17 January 2018
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Ahistoryofthedevelopmentofpercutaneous … · also led to the relief of sciatica if given to the same antihelix area, an area of the ear which was painful to pressure. Dr. Nogier

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  • Ahistory of the development of percutaneous

    electrical stimulation of the auricle ?

    Srini Nageshwar a, Melvyn Lafitte b

    aLos Gatos, CA

    bGeneva, Switzerland

    Abstract

    Though it is well known how and when Paul Nogier discovered the “little man in the ear”, the later developments that ledto the recent technological advances are mostly uncharted. In particular, the progress which was championed by DyAnsys indeveloping a percutaneous device and applying electrical stimulation to alleviate various autonomic ailments was heretoforenot reported.

    Key words: PENS; History of Science; human auricle.

    Contents

    1.1 First developments, Paul Nogier & thehomunculus ear 1

    1.2 Russian discovery of “electrosleep” 3

    2.1 Dr. Szeles’ invention of the auricularneurostimulation device using the antecedentconcepts 3

    2.2 Mapping the human auricle 4

    2.3 Adding autonomic nervous systemmonitoring 4

    2.4 Mapping stimulation points to cranial nervesand defining point frequencies 4

    2.5 Programming a PENS device 4

    3 Comparing methodologies 8

    4 Current applications 8

    References 8

    ? This is a preprint provided by DyAnsys Inc. for educa-tional purposes.

    Email address: [email protected] (SriniNageshwar).

    1 Ancient and early stages

    The idea of electrically-induced analgesia dates back tothe Greek scholars, Plutarch and Socrates, who noticedthe numbing effects of standing in pools of water on abeach that contained electric fish. The early stages ofa later development however occurred during the sec-ond half of the 20th century under the pioneering stepsof Paul Nogier. The son of a professor of medicine atthe Université de Lyon, he was first educated in physicsbefore turning his attention to medicine. As a medicaldoctor specialized in internal medicine, Dr. Nogier laterengaged with homeopathy and other non-conventionalpractices.

    1.1 First developments, Paul Nogier & the homunculusear

    In 1950, Dr. Nogier [15] was “intrigued by a strange scarwhich certain of his patients had on their external ear.”He found that the scar was due to a treatment for sciaticainvolving cauterization of the auricular antihelix by a laypractitioner living in Marseille, France. Her name wasMrs. Barrin. The patients were unanimous in statingthat they had been successfully relieved of sciatica painwithin hours, even minutes, of this ear cauterization.Mrs. Barrin had learned of this auricular procedure fromher father, who had learned it from a Chinese Mandarin.As stated by Dr. Nogier,

    I then proceeded to carry out some cauterizations my-

    Preprint of manuscript to be published 17 January 2018

  • self, which proved effective, then tried some other, lessbarbarous processes. A simple dry jab with a needlealso led to the relief of sciatica if given to the sameantihelix area, an area of the ear which was painful topressure.

    Dr. Nogier had previous medical experience with the uti-lization of acupuncture needles, as he had studied theworks of the French acupuncturist Soulié de Morant.Another mentor for Dr. Nogier was the Swiss homeo-pathic physician, Dr. Pierre Schmidt, who utilized mas-sage, spinal manipulations, and acupuncture needles inhis naturopathic practice. Some critics have contendedthat Dr. Nogier developed his ear maps based on trans-lations of Chinese writings, but as will be explained, theChinese themselves acknowledge that it was only afterthey learned of Nogier’s findings in 1958 that they de-veloped their own somatotopic ear charts. A quotationattributed to the physiologist Claude Bernard [3] furtherinspired Nogier:

    It has often been said, that in order to discover things,one must be ignorant. It is better to know nothingthan to have certain fixed ideas in one’s mind, whichare based on theories which one constantly tries toconfirm. A discovery is usually an unexpected connec-tion, which is not included in some theory.A discoveryis rarely logical and often goes against the conceptionsthen in fashion.

    Dr. Nogier discussed his antihelix cauterization experi-ences with another physician, Dr. René Amathieu, whotold him, “the problem of sciatica is a problem of thesacrolumbar hinge”. Nogier conjectured that the upperantihelix area used to treat sciatica could correspond tothe lumbosacral joint, and the whole antihelix could rep-resent the remaining spinal vertebrae, but upside down:“The head would have its correspondence lower on theauricle. The ear could thus roughly resemble an upsidedown embryo in utero.” (cf. figure 1)

    Nogier subsequently obtained pain relief for other prob-lems. Using electrical microcurrents imperceptible to thepatient, Nogier concluded that the pain relief was notdue to a nervous reaction to the pain from needle in-sertion but was in fact caused by the stimulation of aspecific area of the ear. Nogier observed, “To discoversomething is to accomplish one stage of the journey. Topush on to the bottom of this discovery is to accomplishanother.”

    In 1955, Dr. Nogier mentioned his discoveries to Dr.Jacques Niboyet, the undisputed master of acupuncturein France [14]. Niboyet was struck by this novel, earreflex zone, which had not been described in any Chi-nese text. Niboyet encouraged Nogier to present his find-ings to the Congress of the Mediterranean Society ofAcupuncture in February 1956. Attending this meeting

    Fig. 1. Little man in the ear

    was Dr. Gérard Bachmann of Munich, Germany. Bach-mann published Nogier’s findings in a 1957 Europeanacupuncture journal [17], which had worldwide circula-tion, including distribution to the Far East. From thesetranslations from French into German, Nogier’s ear re-flex system was soon known by acupuncturists in Japan.It was subsequently published in China, where it becameincorporated into Chinese ear acupuncture charts. No-gier acknowledged in his own writings that the origins ofauriculotherapy might have begun in ancient China orin ancient Persia. The primary change that he broughtto auricular acupuncture in 1957 was that these ear acu-points were not just a scattered array of different pointsfor different conditions, but that there was a somato-topic inverted fetus pattern of auricular points that cor-responded to the pattern of the actual physical body.Nogier (1972) devoted his pioneering classic, the Treatiseof Auriculotherapy [15], to the musculoskeletal system.Nogier limited his initial writings to the spinal columnand the limbs because the musculoskeletal body is pro-jected onto the external ear in a clear and simple man-ner. The therapeutic applications are free from ambigu-ity and ought to allow the beginner to achieve convincingresults. It is possible to palpate for tender areas of theear and readily notice how they correspond to painfulareas of the body. The first stages of learning the mapof the ear consist of getting to know the morphology ofthe external ear, its reflex cartography, and how to treatsimple pains of traumatic origin. Each doctor needs tobe convinced of the efficacy of this ear reflex method bypersonal results that he or she is right. They are indeedfortunate people who can convince themselves simply bynoting the improvement of a symptom they themselveshave experienced. After he traced the image of the spineand the limbs over different areas of the auricle, Nogierexamined thoracic organs, abdominal organs, and cen-tral nervous system projections onto the external ear.He needed several more years, however, to understandthat the external ear had a triple innervation, and thateach innervation supported the image of an embryologi-cal derivative: the endoderm, mesoderm, and ectoderm.

    2

  • These embryological correspondences to the ear were de-scribed by Nogier (1968) in another later text, Hand-book to Auriculotherapy [16], with illustrated anatomi-cal drawings by his friend and colleague, Dr. René Bour-diol.

    1.2 Russian discovery of “electrosleep”

    Cranial Electrotherapy Stimulation (CES) is the Amer-ican FDA’s term [25] for what the rest of the world calls“electrosleep”. Modern electrosleep devices originated inRussia in 1953, and arrived in the U.S. ten years later,in 1963, when they began to be researched with patientscomplaining of insomnia (e.g., [4, 7, 26]).

    Various uses of small to moderate electrical currents hadbeen researched since the early 1900s in Europe in anattempt to see exactly what current intensity and pulserate were required to put a patient to sleep when appliedto the head. By that, they meant what was required toknock him out or force him to lose consciousness andmaintain the patient in that state for a period of time.Researchers finally gave up on finding a specific type ofcurrent that would reliably put most patients to sleep.Unlike those earlier models, modern CES devices aretypically pocket sized, run off of a 9 volt battery, andpulse from 100 up to 15,000 times per second. The cur-rent intensity usually is at or just below 1 mAmp, but cango up to 4 mAmp with higher pulse rates. Most wouldjust light a flashlight bulb at best, and in the majorityof clinical studies, patients have not felt the stimulationat all during treatment.

    In the early 1950s Russian medical researchers wereworking with these very low levels of current, whichthey applied via two electrodes attached to the closedeyelids and two attached behind the head at the base ofthe skull. They were attempting to find a psychiatricallyuseful current, and while the current level was much toolow to force a person into a sleep state, they found totheir great interest that patients were claiming vastlyimproved sleep during nights following sessions whenthese very minor amounts of stimulation passed acrossthe head. They then began studying this effect specifi-cally, and in 1953 finally came out with the Somniatronelectrosleep device which was regularly employed up tothe 1970s (e.g., [1]).

    Several similar devices were later manufactured in theU.S. for research purposes, and their clinical use beganamong inpatient and outpatient psychiatric patients,usually in University Teaching Hospitals. Several otheruniversities began research with animals in an effort tosee if CES really did change how the brain functioned,if it was safe to use, and what the mechanism of actionmight be.

    They found that the current traveled throughout thebrain, that it increased production and firing of neuro-

    transmitters in neurons [24], and that when researchersdeliberately threw neurotransmitters out of balance inthe brain, electrosleep would resume back the balance.Other researchers found that electrosleep would appar-ently also recover balance in human patients whose neu-rotransmitters had been disturbed by various addictingsubstances.

    2 Renewal & novel stages

    2.1 Dr. Szeles’ invention of the auricular neurostimu-lation device using the antecedent concepts

    A Viennese cardiovascular surgeon (Dr. J. ConstantinSzeles) brought the concepts of Paul Nogier and the Rus-sian electroscope devices together and invented an au-ricular electrical stimulation device. He had to devise afrequency generator that worked at 1 Hz (Paul Nogier’sbase frequency) with a pulse width of 1 ms. He devisedthe treatment protocol of stimulation of 4 days in anon/off tempo. A new device was applied every week. Thetechnique was called Point Stimulation Therapy or P-STIM for short.

    The P-STIM applies electrical stimulation to the ear (au-ricular therapy) over several days [23, 24]. Unlike otherCranial Electro-Stimulation (CES) technologies, whichapply electrical stimulation for only several hours, Dr.Szeles discovered that a ’wearable’ P-STIM, with con-tinuous pulses of low-level current applied over severaldays (and repeated over several weeks), is more effectiveat treatment.

    CES has proved to stimulate a number of neuro-chemicaland physiological conditions that are known to

    • Relieve pain and depression• Release opiates such as endorphins• Promote sympathovagal balance of the ANS• Reduce central sensitization• Increase peripheral artery blood flow

    Since 2002, Dr. Szeles has administered over 16,000treatments; the majority of patients have experiencedalmost complete relief from pain and related symptoms(anxiety, depression and insomnia).

    This device was brought to the US in 2005 by Dr.Robert Bonakdar. Dr. Robert Bonakdar is Director ofPain Management at the Scripps Center for IntegrativeMedicine in La Jolla, California and a member of theScripps Green Hospital Pain Management Committee.It was subsequently cleared as an electro-acupuncturedevice by the FDA in 2005.

    3

  • 2.2 Mapping the human auricle

    Elmar T. Peuker and Timm J. Filler published a land-mark paper [20] on the nerve supply of the human au-ricle in 2002 in Clinical Anatomy. For the first time thenerve supply of the human auricle was understood.

    They said –

    A detailed knowledge on vascularization and innerva-tion of the outer ear is crucial for reconstructive andplastic surgery in this region. Moreover, the innerva-tion of the auricle is the theoretical basis of differ-ent reflex therapies (e.g., ear acupuncture). However,data on the innervation as provided by scientific pub-lications are scarce, incomplete, and inconsistent. Theaim of this study is to describe the system of the au-ricular nerve supply.

    Their abstract summarized the study as follows:

    Knowledge of the innervation of the outer ear is crucialfor surgery in this region. The aim of this study was todescribe the system of the auricular nerve supply. On14 ears of seven cadavers the complete course of thenerve supply was exposed and categorized. A hetero-geneous distribution of two cranial branchial nervesand two somatic cervical nerves was found. At the lat-eral as well as the medial surface the great auricularnerve prevails. No region with triple innervation wasfound. Clin. Anat. 15:35–37. ©2002 Wiley-Liss, Inc.

    2.3 Adding autonomic nervous system monitoring

    Separately, a team of Melvyn Lafitte (France) andSrini Nageshwar (US) worked on developing a device tomeasure and monitor the Autonomic Nervous System(ANS), reviving the old idea of a derivation of the ANS’state inside the kinematics of the cardiac rates [22].The first prototypes were developed in 2004 and ini-tial trials were conducted at the University Hospitalin Geneva, Switzerland. The beat to beat techniqueshowed promise, a US company (DyAnsys Inc.) wasformed to commercialize the invention in 2003. Theproduct was sold in India to detect Diabetic AutonomicNeuropathy in 2005/2006. It was cleared by the FDAfor sale in the US in 2007. A patent was issued for themethodology on 2006.

    It was postulated that the P-STIM device was actuallyaffecting the ANS. Allying the two devices provided amonitoring/treatment solution to the treatment of pain.

    Even though there is no objective measure of pain in anindividual, it appeared that the ANS was always out ofbalance when the individual suffered from chronic pain[6,8,9]. Improvement in the patient’s pain condition wasaccompanied by improvement in the ANS balance. This

    is a very well known fact. There are many referencesthat one can find in the literature. Articles (e.g., [2,5,11,13]) are listed under references in this paper for a smallillustration of all which was found on the matter.

    The device also helped ensure that the stimulation nee-dles were located at the right auricular points. Insertionof the needle caused a quick spike in the sympatheticresponse (even though the patient felt no pain from in-sertion of the needle). If the needle location was correctthe sympathetic response would return to normal. If itdid not, the needle location was not appropriate.

    This was a welcome addition to the treatment and pro-vided insurance companies with objective proof of theefficacy of the treatment.

    2.4 Mapping stimulation points to cranial nerves anddefining point frequencies

    Dr. Terry Olsen published the definitive book on Au-riculotherapy [18]. The book is now in its 4th edition.

    In an effort to map the auricular stimulation points tothe 4 cranial nerves in the auricle, Dr. Oleson collabo-rated with DyAnsys to release a special edition [19] thatwould be applicable to percutaneous electrical stimula-tion products.

    He mentions in his book that the various regions of theear should be stimulated at various Nogier frequencies1.14 Hz (approximated to 1 Hz). 4.56 Hz (5.0 Hz), 9.12Hz (10 Hz), 18.24 Hz (20 Hz), 36.48 Hz (40 Hz). 72.96Hz (80 Hz) and 145.92 Hz (160Hz).

    DyAnsys took the approximately 200 ear points and de-termined

    • The nerves that were being stimulated when eachof these ear points were being electrically stimu-lated. (From the work of Peuker & Timmer)• The frequencies that needed to be used at everyear point. (From the work of Paul Nogier)

    This effectively provided the right points and frequenciesfor percutaneous electrical nervous stimulation (PENS)of the auricle.

    2.5 Programming a PENS device

    Until few months ago, all devices worked at a single set-ting of electrical stimulation. This was the equivalentof treating all patients with one standard dosage of aspecific medicine. Each patient is different and likely re-quires different levels of stimulation. This is what spinalcord stimulators and deep brain stimulators do.

    4

  • Modality PENS Spinal Cord Stimulation Deep Brain Stimulation

    MANUFACTURER DyAnsys, Inc. Boston Scientific Medtronics

    INDICATIONS FOR USE The PENS is an auricularpercutaneous electrical nervestimulation device for use inthe practice of pain manage-ment by qualified healthcareproviders.

    The Advanced Bionics PRECI-SION Spinal Cord StimulatorSystem is indicated as an aidin the management of chronicpain associated with the fol-lowing: failed back surgery syn-drome, intractable low backand leg pain.

    The Activa® RC dual-channelrechargeable neuro-stimulatoruses electrical stimulation tomanage some of the mostdisabling motor symptoms ofParkinson’s disease.

    PATIENT POPULATION Adults Adults Adults

    CLASSIFICATION Class II Class III Class III

    DEVICE PLACEMENT Minimally invasive, behind theear.

    Invasive, under the percuta-neous skin.

    Invasive, the pulse generator isplaced in the chest region be-low the collarbone. From herethe leads are connected to thebrain.

    APPLICATION TECHNIQUE Can be applied at the physi-cians’ clinic

    By undergoing surgery By undergoing surgery

    SHAPE Rectangle Oval Oval

    DIMENSION 47 × 22 × 1 mm3 55 × 46 × 11 mm3 54 × 54 × 11 mm3

    WEIGHT 5 gm (including battery) 40 gm 40 gm

    NEEDLE DIMENSIONS 0.4 × 2 mm (width×length) NA Leads extension available

    LEADS 4 (including a ground elec-trode)

    16 leads, from 4 lead ports 4

    LEAD LOCATION All the leads are placed in theear. The leads with needles areinserted percutaneously in theear.

    In some instances a lead canmove from its original loca-tion, and stimulation at the in-tended pain site can be lost.If this occurs, Patients shouldconsult their physician whomay be able to restore stim-ulation by reprogramming thestimulator in the clinic or repo-sitioning the lead during an-other operation.

    The leads are placed in threemain parts of the brain whereit can be placed: the globuspallidus internus, the tha-lamus, and the subthalamicnucleus. All four electrodesare not activated. Dependingon response, usually one ortwo electrodes are activated.Rarely, three electrodes are ac-tivated.

    NERVES STIMULATED The nerves used for stimula-tion in the ANSiStim are twocranial branchial nerves andtwo somatic cervical nerves,they are as follows:

    • ABVN — Auricular Branchof the Vagus Nerve

    • ATN — Auricular TemporalNerve

    • LON — Lesser OccipitalNerve

    • GAN — Greater AuricularNerve

    Nerves available at dorsal rootganglia, sciatic nerves (L4 toS3) and T10 of the thoracicspinal nerves of the spinal cord.

    Implanted directly in the tar-geted nerves of the brain ac-cording to the following symp-toms:

    (1) Essential Tremor —ventro-intermediate nu-cleus (VIM) of thethalamus

    (2) Dystonia/ Parkinson’s Dis-ease — the globus pal-lidus internus or in thesubthalamic nucleus

    (3) Obsessive Compulsive Dis-order / Depression — nu-cleus accumbent

    (4) Epilepsy — anterior thala-micnucleus

    (5) Neuropathic pain — theinternal capsule, ven-tral posterolateral nu-cleus, and ventral pos-teromedial nucleus

    5

  • Modality PENS Spinal Cord Stimulation Deep Brain Stimulation

    COMMUNICATION Wired Wireless Wireless

    CONNECTOR A 3-pin connector is usedto check the output volt-age of the ANSiStim neuro-stimulator once it is activatedand as well as used to programthe stimulation parameters tothe First Relief.

    No, only wireless communica-tion. A remote control is usedto communicate between thedevice and programmer. IRwaves and RF waves are usedfor wireless communication.

    No, only wireless communi-cation. RF waves are usedfor wireless communication be-tween the programmer andpulse generator for settingstimulation parameter.

    WIRELESS TECHNIQUE No Bluetooth communicationbetween ANSiLite system con-troller and PENS neuro-stimulator.

    45 inches (114.3 cm) betweenWand and Stimulator with95% or higher communicationsuccess rate.Once a commandis initiated by theuser, the sys-tem will respond in lessthan1.5s.

    Bluetooth communication

    PROGRAMMING A programmer (e.g: a cus-tomized smart phone withDyAnsys tools) can set thestimulation parameters andalso readout the programmedparameter that is activated tothe PENS neuro-stimulator asan acknowledgement from thedevice. It also assists in locat-ing points of stimulation.

    A Windows compatible PC isused to program the patientoutput stimulation settings ofthe pulse generator. It is alsocapable of storing the pro-grammed information for eachpatient. It is used to assess thelead location.

    A programmer-like remotecontrol or simulator is used forprogramming, in some prod-ucts (St. Jude) iPads are alsoused for programming.

    POWER:

    FREQUENCY It has three frequency modes,1.Constant at 1.14 Hz; 2. Sweepfrom 1.14 Hz to 9.12Hz; 3.Variable from 1 to 9.12 Hz

    2 to 1200 Hz 2 to 250 Hz (voltage mode); 30to 250 Hz (current mode)

    CURRENT ∼ 1 mA 12.7 mA 0 to 25.5 mA

    (ENERGY SOURCE) BAT-TERY OPERATION

    Yes Yes Yes

    BATTERY TYPE Zinc air batteries, P10. Rechargeable Lithium ion bat-tery.

    Both rechargeable (Lithiumion) and non- rechargeable bat-tery types are available.

    RECHARGE TECHNIQUE NA Wireless charging.ChargingFrequency: 77 – 90 kHz Thecharging distance between thecharger and the IPG is be-tween 0.5 to 2 cm. Centeringthe charger over the stimulatorensures the shortest chargingtime. The charger will beepas it searches for the IPG andwill stop beeping when it isaligned with the IPG.

    Charging unit is used. Charg-ing time is 1 to 2 hours perweek. Recharging is done byplacing the antenna over thepulse generator.

    BATTERY CAPACITY 100 mAh 180 mAh Not found

    NO. / VOLTAGE 3×1.4 V 3.6 V 0 to 10.5 V

    DUTY CYCLE 1 hr ON/1 hr OFF, 2 hrs ON/2 hrs OFF, 3 hrs ON/ 3 hrsOFF, 4 hrs ON/ 4 hrs OFF, 6hrs ON/ 6hrs OFF.

    Round the clock. OFF onlyduring recharging the device.

    Round the clock. OFF onlyduring recharging the device.

    PULSE WIDTH 1000 to 2000 µs 20 to 1000 µs 60 to 4500 µs

    OPERATING TIME, HOURS/ YEARS

    96 hrs / 120 hrs / 144 hrs /168 hrs

    12 years By using non-rechargeable bat-tery the DBS works for 3 to5 years. By using rechargeablebattery, the DBS functions for9 years.

    6

  • ENVIRONMENTAL

    Modality PENS Spinal Cord Stimulation Deep Brain Stimulation

    OPERATING TEMPERA-TURE

    5 °C to 45 °C 0 – 45 °C -18°C to 52°C

    ENVIRONMENT OF USE Clinics, Hospital and Home en-vironments

    Placement can only be done inan operation theatre.

    Placement can only be done inan operation theatre.

    STERILIZATION EtO Sterilization EtO Sterilization EtO Sterilization

    RE-USE Single use device Single use device Single use device

    PACKAGE The ANSiStim neuro-stimulator device and itsaccessories are packed in ablister pack. This is thenplaced in a carton box. Eachcarton box has ten device.

    Neuro-stimulator, Leads, Ex-ternal Programmer, Remotecontrol, Clinicians manual,Warranty card.

    Neuro-stimulator, TorqueWrench, Product literature,Warranty card, RegistrationForm, Patient ID card.

    RISK / SIDE EFFECTS No

    (1) Tissue reaction to implanteven though it is bio-compatible.

    (2) Lead migration, may resultin undesirable changesand reduction in pain re-lief.

    (3) Skin erosion or seroma atthe pulse generator sitcan occur over time.

    (4) Implantable batteries arealways dangerous com-pared to external batteryusage though the effec-tiveness is proven.

    (1) Malfunctioning DBS de-vices (injury to theneuro-stimulator) can re-sult in post-operativeproblems.

    (2) Serious or permanent com-plications.

    (3) Temporary or reversiblecomplications.

    (4) Pain, inflammation, orswelling at the surgerysites.

    (5) Allergic response to im-planted material.

    (6) Implantable batteries arealways dangerous com-pared to external batteryusage though the effec-tiveness is proven.

    LIMITATIONS This device can treat for acutepain like back pain, neck painand major chronic pain condi-tions like cancer pain, oesto-psoriasis, etc.

    This device can treat only fortwo, three particular chronicpains.

    This device can treat diseaseslike Parkinson’s, Alzheimer,dystonia, etc.

    LIMITATIONS WITHOTHER DEVICES

    The device removal process ortechnique is very easy and theproduct is safely disposed.

    This technique requires re-moval of device throughsurgery if the patient needsMRI examination or CT scan.

    This technique requires re-moval of device throughsurgery if the patient needsMRI examination or CT scan.

    7

  • Fig. 2. Programmable PENS battery-operated device

    DyAnsys has developed a next generation device (cf.figure 2) that allows programming of all the electricalparameters and monitoring of the stimulator when it isalready on the patient’s ear. The stimulation levels canalso be increased or decreased depending upon the sub-ject’s condition. This can now become standard practicein the industry.

    3 Comparing methodologies

    A comparison of different modalities of nerve stimula-tion is provided in a table above. It compares PENS withspinal cord stimulation (SCS) and deep brain stimula-tion (DBS).

    The juxtaposition of characteristics of these threemethodologies shows how the auricular nerve stimu-lation can take its rightful place as one of the threemethods of cranial electro-stimulation. Auricular PENSis an office procedure and stimulates a subset of thecranial nerves [23, 24], including the trigeminal and thevagus nerve. SCS (being positioned at the dorsal horn)stimulates more nerves while DBS performs cranial elec-trical stimulation without needing nerves to transmitcurrents into the brain. Both SCS and DBS are surgicalprocedures.

    Auricular neurostimulation is a good first step since itis an office procedure and has been reported to solve 60-70% of the issues that providers face. It is an easy officeprocedure since the ear is the only surface where thenerves are very close to the surface of the skin.

    4 Current applications

    Pain management, drug detoxification & post-operativepain medication are the three major applications forPENS.

    • Management of chronic pain - The providers re-port that 80% of their patients suffer from the big5 - back pain, neck pain [10], fibromyalgia [12], mi-graine and joint pains. It has been proved to be ef-fective for most of the patients in all these cases.• Drug detoxification - The process of drug recoveryconsists of 3 steps� Drug detox – where the PENS device plays a

    major role in detoxing the addict. It is appliedfor 7 -10 days and works in continuous stimu-lation mode.

    � Withdrawal – There is a treatment with Vivit-rol to help the addict through the withdrawalphase.

    � Avoiding relapse – it has been discovered thatcounseling during the entire process is a bighelp to make the withdrawal permanent.

    • Post operative pain management – The PENS de-vice works very well for post operative pain man-agement. A device is put on the patient at the endof the surgery. It is later supplemented with ad-ditional pain medication, if necessary. This mini-mizes/eliminates the use of opioids for post opera-tive pain medication [21].

    The authors wish to thank Irmi Bloching for her greatunwavering support and the core team who stand forthis technology, in particular K. Murugesh.

    References

    [1] Arreed F Barabasz. Treatment of insomnia in depressedpatients by hypnosis and cerebral electrotherapy. AmericanJournal of Clinical Hypnosis, 19(2):120–122, 1976.

    [2] Ansam Barakat, Nicole Vogelzangs, Carmilla MM Licht,Rinie Geenen, Gary J MacFarlane, Eco JC de Geus,Johannes H Smit, Brenda WJH Penninx, and Joost Dekker.Dysregulation of the autonomic nervous system and itsassociation with the presence and intensity of chronicwidespread pain. Arthritis care & research, 64(8):1209–1216,2012.

    [3] Claude Bernard. An introduction to the study of experimentalmedicine. Courier Corporation, 1957.

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