EP3941570A1 - Cathéter de neuromodulation - Google Patents

Cathéter de neuromodulation

Info

Publication number
EP3941570A1
EP3941570A1 EP20776489.5A EP20776489A EP3941570A1 EP 3941570 A1 EP3941570 A1 EP 3941570A1 EP 20776489 A EP20776489 A EP 20776489A EP 3941570 A1 EP3941570 A1 EP 3941570A1
Authority
EP
European Patent Office
Prior art keywords
catheter
electrically
conductive portion
lumen
electrically conductive
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
EP20776489.5A
Other languages
German (de)
English (en)
Other versions
EP3941570A4 (fr
Inventor
Sanjay K. SINHA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ennovation LLC
Original Assignee
Ennovation LLC
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 Ennovation LLC filed Critical Ennovation LLC
Publication of EP3941570A1 publication Critical patent/EP3941570A1/fr
Publication of EP3941570A4 publication Critical patent/EP3941570A4/fr
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551—Spinal or peripheral nerve electrodes
    • 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
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36071—Pain
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A61B8/0841—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating instruments
    • 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
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0502—Skin piercing electrodes
    • 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
    • A61N1/06—Electrodes for high-frequency therapy

Definitions

  • teal aiesttetic solution is i.njeeted around a nerve teat innervates a region surglea! site) from which pain is generated.
  • the peripheral nerve blocks efieedcely block nrodous: stlmuliirom being transmitted to: the brain, thereb rednefng om sensation.
  • a peripteral nerve block Is per fitoned " by iosertmg 3 ⁇ 4 needle: through the skin and directed towards the nerve to be blocked, When the needle tip is positione very close to the nerve, Ipeal anesthetic solution is injected : to surround (“b the” ⁇ the nerve or lexus of nerves.
  • the needle Is gnided m op of two ways :ioward the: nerve, Using ultrasound, guidance, the target nerve is visualized with n ultrasound seam The needle tip is advanced toward the nerve « in real-time ultrasound visualization
  • a nerve stimulator which is an electrical current generator, connects to a block needle on one end an generates a pulse of current
  • the pulse Is usually at : milliampere, at a frequency of 2-4 I3 ⁇ 4 and duration of CU .0 millisecond
  • the block needle’s shah is electrically Insulated, except lor the needle tip, whic acts as a unipolar electrode and creates, an decide field bey ond the needle tip, In this utilization,: current travels toward the tip and the surrounding tissue, and return back to the nerve stlnmiator through the wire connected to a s h ⁇ surface ⁇ eiectrode, theraby completing tire circuit
  • the electric field causes depolarisation of the nerve, an innervated muscles twitch.
  • the needle tip is known to fee close to the nerve, allowing a clinician to fee sure ihai local solution is injected an will result in a successful, nerve block,, iOOClbJ in some scenarios, nerve stimulation Is combined with live ultrasound guidance to perform nerve blocks,
  • Nerve blocks successfully mitigate pain, they often last about 24 hours, whereas surgical pain duration may extend for days: or weeks Miowing surgery, Nerve blocks are thetefere of strictureacy for extended duration surgical site pain,
  • a continuous nerve block may be indicated, A: catheter, for euum te thin, flexible, l b-18 gauge catheter, is placed close to a nerve, A ediclxxai putap is attached to the catheter, an eunt nuons!y inthses local anesthetic, such as a diluted local anesthetic, to the nerve kite.
  • A catheter, for euum te thin, flexible, l b-18 gauge catheter, is placed close to a nerve, A ediclxxai putap is attached to the catheter, an eunt nuons!y inthses local anesthetic, such as a diluted local anesthetic, to the nerve kite.
  • a nerve stimulator 20 such m an electric poise generator
  • the catheter tip 23 comes out of the 1 ouhy needle 10 close to the nerve I T A !irst wire 24 electrically interconnects the nerve stinrolaior 20 to la electrode 26 affixed to the: skin 14.
  • a conducti ve get or other conductive media is inserted between the electrode 26 and the skin 14 to enhance electrical conductivity,
  • a second wire 28 electricallysymmetricor eets the nerve stimulator 20 to an e!eclrieallv conductive portion 30 of the catheter 12.
  • Energikng the nerve stimulator 211 creates an electric field in the tisane 32 around the cstiteter tip 22, When this electric ikld of appropriate intensity (0.3-1.0 milliamperes) overlaps (or encompasses) the nerve 1# it depolarises the nerve 16 causing a twitch of the muscles innervated by that nerve 1ft, A clinician then threads the catheter 12 alongside the nerve 1ft hiie niTntainiag a nrusele twitch, The twitch: ensures that the catheter tip 22 is adjaeent to the nerve
  • Conventional stimulating catheters of the type illustrated In Fig, 1, have one terminal opening 34 and one electrode 30 at the distal ft 22, If liquid medication exits via that terminal opening 34, th ongoing neuromod uiadoa is usually interrupted either because: of dispersion or dilution of the ejeeme Held dr the !fooid medication, for example a local anesthetic solution, Mocks the Sodium-Potassium pum (04., muscle receptor), preventing further trarss i lon of the nerve impulse, hicaro odufotion would resume only after the effects of the injected medication have resolved,
  • a stimulating catheter having multiple lumen ial terminate at varying distances from multiple electrodes so that nenr nodtdatio may be n intained and nninterrnpted fey using one of the electrodes for nenromodulution and a lumen for Infection of a niedieation ( c.gchev local anesthetic solution) that is away from the
  • [OO ih] II would be further desirable io idixiee ihe stimulating estheiar for maintaining ustintarrupted delivery of twnton dufation to a patient MM sidtaaeous!y being able to srycei as djuvant or medication to supplement the neuromodutatioa without reducing or negatively impaeimg the uepo edMatiorfs e3 ⁇ 4etiveng:$S
  • Embodiments of the resoot dlsdosure relate to, wuoug other things, systems, de ices, sod related met ods for OperMmg the same, to treat or provide pa d control fey neatoomdufatfou and by retainin the oferuty to ifoeeimedication to target: neural tissue usin either a stogie special or a multMumen and singe el ctrode or mu!ti-eieetrodc stimulating catheter (e,g swirl trmifoiumea, midflmleetrode oeuromodulatioa catheter ⁇ .
  • Etnhodhngnis of the present isclosure e cribe multi wleetrode catheters designed to include either 1 electrodes, of which one or two or all may fee used to provide neu odulatiu
  • the fMrd electrode is mi associated wi th an opening and is used only for rwnmmodulatfon or to serve rs an electrode fo complete the electrical : eircoii for delivering: a neurooioditladon
  • the catheter may he a single lumen, single electrode o a muftid « en, maltfedeetro c aeoromodulation cotheter, This aeuro aoduiation catheter may he used for neuromoduladon only, for infeetionfs) of medication only, or lor a combination thereof
  • Fig, 4 illustrated an embo i ent where a catheter s aligned by passing over a needle.
  • Fig. 5 Illustrates an embodiment where the catheter includes a plurality of !tmem and electrodes ( ttlild pea, n liimleetrode sfinmlniiog catheter ⁇ .
  • Fig, fi illustrates a ulihinmem ninlfimieetrode stimulating catheter to provide neuromodntaiian.
  • the neuro odnlattng catheter 40 includes a connector 48.
  • the connector 4t connects at the praxltoat end 42, When the cathet r is inserte to a position similar to tha shown in Fig.
  • the : connector 48 is positione outside th body:, above the skin 14
  • the connector 48 may include a contact post TP to electrical ly connect with wire 28 extending: Irani the nerve stimulator TO, Wire 5:2 extends from contact post 50 to the electrically eoodocii ye; portion: 30 of the catheter ti p 22,
  • the connector 48 therchy electrically intcrcohneets the eetrleally conductive portion 30 of the catheter 40 to the nerve stimn!
  • Wire 52 may extend wrdtiathe eadMlet dO lumen 54, Aiteraailveiv, th wire 52 ma be embedded in a wall 5b of the catheter.
  • the wire 52 may be an electrically conductive layer coating a portion of an interior surface of the wall 5b, 032 .la m embitemteni
  • the connector 48 further includes a injection port 51, The port 58 enables injection of medication or other fluids. This may be use as an adjuvant to Improve analgesic efficacy .
  • the eos eetordi may be psed to connec to etrrreoily available sti datjng catheters 13 ⁇ 4 allowing lor them to be repurposed for ueoromodulation, xemplaty eatbelersmo merelally available : are Siimueath (manofectured by Arrow), CoOiiplexSilm
  • ncu o odnlanon iUde solid lends, without a lumen, w eb does not incinde a port for injecting mcdteatlon. While other leads may have lumens, they are not designed for injecting
  • this embodiment provides lor a device and method with a port 58, which allows for incdication itrjeetion via a lumen 54 and milfzes neuro oduladon to increase andl esic efficacy,
  • the catheter 40 may include a plurality of boles 00 formed through the wall 56 and at the catheter tip 22, and/or along the body of the catheter, adjacent the catheter tip, lor example, ffi)pt 2 :m
  • the u!ti-bo!ed catheter Is specifically formed to deliver medications, and the position of the holes 60 may he in any desired eoutigurutioo,
  • the catheter tip may: be etalieed 30 and effective to function as a unipolar lead. Medication or li ui infected ffopr injection port 58 will exit at the holes 6CI and a the opening at the catheter tip 22
  • fhe oetve stimulator: 20 is electrically intcreomieeted to the: contact post SQ
  • the nerve stimulator 29 may connect to the connecior 48 either via Jack 51 , or directly without use of a jaeb.
  • An effective nerve stimulator 20 is a commercially available pulse geueraior capable of roviding: an electrical pulse: of 0/te20 mAmps, with a frequenc of 2-10,000 lie and pulse duration o 0 14000 microseconds.
  • the pulse generator 20 may he located at a different location, such as a pocket tabletop or o ⁇ r. an ,:e tffieeted v wires 2 , 28 : to the catheter 41) and/dr connector 48.
  • the catheter 70 Includes fwu wlres:72, 74 each independentl either extending down inmen 54, embedded In wall ⁇ 6 or coated on an interior surface of wall 56, One wire 72 terminates at eiceiricali conductive po tion 30 at the catheter tip 22.
  • the othcr wire 74 terminates at a second e!eetrieail conductive portion 76 formed on the wall 56 of the Catheter 70 at: a location spaced front the catheter tip 22. While the spacing between electrically conductive portion 30 and second electricall condnetive portion 76 may be an effective distance, an exemplary distance: i between 2 ceuihneters and 4 eentimeters. These wires a attached to the anode terminal and cathode terminal of the nerve stimulator to provide electrodes of different pofeoty.
  • a return electrode on, the skin nol is teguired to complete the eireuit This removes the; need for a grounding electrode on the surface of the skin, f 0636
  • the catheter 40, 70 is positioned b being threaded through a pre-posllioned needle, Alternatively:, as illustrated in Fig, 4, a catheter 80: ma he formed to go over the needle 10, as opposed to through the needle. The catheter ma he placed close to a nerve with the cathetermvewneedle teehntc Ue. IJtilkdng the catheter over the needle, enables preloading of 1:hc catheter S0 ove the needle 10 with the needle tip 82 remaining exposed.
  • the needle 10 la then connected to a nerve stimulator and advanced into place toward a nerve under ultra und guidance, As: the catheter i
  • life catheter 99 ma include a plurality of lumens. Illustrated are a central Ihhi «»t 02 and periplte l lu en 94 formed a jacent: wall 55 of the catheter. Multiple lumens provide multiple channels for dcltverfog currem, medication and suitable forms of energy, such as ligh or sound, to modulate nerves,
  • the central lumen 92 terminates at the catheter dp 22 and provides access for needle tip,
  • a first electrically conductive portion 30 is adjacent the catheter tip 22 and electrically connected a; nerve stimulator via ise 72,
  • a second electrically conductive portio 75 is spaced from the first electrically conductive porifon and : electrically connected to a nerve stimulator, other power source or ground via wire 74.
  • a third eettiea!ly conductive; portion 96 is located adjacent 8 distal opening 95 Of peripheral lumen M. This third electrically conducti ve portion 96 is electrically imercormeeted to a nerve stimulator, other power source or ground via wire I Of)
  • Electrodes 39,75,96 are locate ⁇ along the length of the catheter 90 and/or clustered toward the distal tip 22. This provides an ability to oeuromodu!ate a larger area of tissue.
  • the ultiple electrodes 3476,96 are connected to conducting wires ; 72,74, 199 either extending through the lumens 92,94 embedded in: wall 56 or coated dnan inside suffice of wall 56 , Interconnecting the wire 73,74,1 (19 will cause the multiple electrodes 30,76,96 to fee of the same polarity.
  • each of th electrodes 34 76, 96 can be connected to the electrical pulse generator via wires 72,74,109 in a manner that they are of different polarities.
  • [9Gu9j Ibe y liLiumen simulating catheter 99 has a distal end 22 and a proximal end
  • the muM-hmien sthnuiteing catheter 90 has: Been placed In a proper location near a nerve, it in electricall interconnected to an electrical pulse generator (ne ve stimulator 20 of Fig. ! ⁇ via wire 72.
  • the catheter 90 km at least two lumens, such as central lumen 92 and peripheral lumen 94 , Lumens 92, 94 are preferably not in fluid communication with each other.
  • Each lumen may include a 3 ⁇ 4 connector attached or secured to I ts proximal end 102 J 04,
  • Each lumen 92, 94 may iurtherineinde on inj cotton: port at the provimal end 102, 104 for injecting a medication or hquid (c.g., a local anesthetic solution, opioids, steroids, alpha-2 agonists, Nm 1.7 antagonist or mw other suitable: liquid medkamenf for curbing pain in a patient).
  • Medication or liquid injected at proximal end 102 of first lumen 92 will exit out of cathete tip 106
  • white medication injected at proximal end of second lumen 94 will exit out of tip 9S of secon lumen 94.
  • Each lume &f also he configured and dimensioned such that; a nerve stimulator f .g, electrical pulse gzrnrn ymy be efeettically iMereonneeted /to the proximal d 102,104 via ires 72,74 00 aad efretoeally ioierco tecied to an eieefrode 30,76,96,
  • Fig. 74 shows a central tern 92 and peripheral lumen 94 along with; wires 7244,100.
  • Fig, 7B shows central lumen 92, first wire 72 and second wire 74.
  • a Isqtto or medfca e may bo tnjec ed at the proximal end 102 of this central Innieo 92 and will exit at the itpening 106.
  • the peripheral lume 94 ma W f minate ai difrerem or variable distance fro the distal end 10# .
  • TJ I ne peripheral inmen 94 proximal end 1 4 may fie disposed at an angle, u, that ranges from ⁇ degree to 9 ( 1: degree, and i preferably between 30 degrees and 60 degrees, relative a longitudinal axis of the central lumen 93.
  • the peripheral lumen 94 may he eoaiiguted and dimensioned to terminate at a distal opening 98 that is approximately 3: cm proxi a!Iy awa from the distal opening 106 of the central lumen 91. In some e bodi ents, this eco d distal opening 98 is spaced from I cm to 6 cm proximally away fro the distal opening 106.
  • nfriple lumens 92,94 may he separated by a partition 66.
  • 12ie partition 56 may: he integral with f lie construction of the niti lumen catheter such that the partition and the catheter; walls are formed a a single piece.
  • the partition may he a distinct and independent structural divider to prevent Suid coim tnicsiion between the multiple lumens,
  • a needle 110 may bo disposed through the central lumen 92,
  • the needle 1 10 extends from an opening at the proximal end 102 and extends through the: entire length of the eentnd lumen 92 and exits through the opening 106 at the distal en fOf,
  • the needle 1 10 may be Used to place or position the multidumen catheter 90 inside a sufrieet (e,g., inside a patieof s todyT
  • the needle 110 may be cleetrleally Insulated along abortion of the shal l wit only a d being an exposed electrical eonduetor.
  • the needle tip 112 is electrically cpnduetive, white the: reminder of the needle 110 is insulated an not conductive.
  • the needle tip 1 12 Is sho wn in Figure 6 extending beyond the distal end 1 OS of the central lumen 92, In this embodiment, the needle tip 112 is electrically conductive,
  • the nerve stimulator ma be attached
  • the needle 110 includes a lumen 116 for injecting liquid edicatio s or solution like dextrose S% solution to distend or hydro- disseet the tissue before t e sliding the stimulating catheter alongside the nerve.
  • a ire may be: used to connect (wg,, elecirkall connect) the nerve stsmulaiorfe-g, * electrical pulse generator), pass axially along the length of one of the lumens, and connect the stimulator to e etrodcs disposed at the distal ends of the catheter lumen.
  • the nerve stimulator (e.g,, electrical pulse generator) may include an electrode in the neuro odnlatlng catheter and theft eonhect to a shin electrode of opposite polarity tb complete the circuit :
  • the second conduct! ve portion 76 iunctiona as a reference electrode or electrode of opposite: polarity m complete a circuit.
  • the peripheral lumen 94 ma be used to deliver ikphi msdicaiiom
  • the central lumen 92 and the peripheral lumen 94 are not in fluid communication
  • B eca use the lumens 92, 4 are not in fluid communication
  • liquid medicament exiting at distal opening 98 will not cause dispersion of electricity thereby not iptermpt g the ongoing neoromodulatien
  • ongoing neuromodulation may be interrupted either because a Injection of a liquid or necessarilya eat may e isc : dispersion of the electricit stemming from the nerve stimulator (e,g,, the electric hel delivery become weakened ⁇ or because: the liquid or medicament may block the Na-K receptors and prevent further transmissio of the nerve impulse, It is advantageous to use the multi-lumen stimulating
  • the multi4nmen stimulating catheter may be; configured d dimensioned to connect to the nerve stimulator, taught herein, to cause a tiny current to pass through the catheter, tterehy neutomodulating the nerves, without itimrmptian of he neurc iodo!ation therapy .
  • the mul i “ lumen catheter 90 may Include additional electrodes disposed in close proximity to eac of tlie distal end openings !0i, 98 of the respective lumens.
  • the eleetmde 30 is positioned at the distal end 166 of the central lumen 92 and electrically interconnecte to the wire 2%
  • the secondary electrode: 76 may be separately positioned near the distal cad an electrically interconnected to the second wire 74.
  • the second electrode 7$ that does not have a corresponding lumen, opening or injection port and functions as a reference electrode or electrode of opposite polarity to complete the circuit
  • Each of the wires 72, 74, lil0 i « be cPtmecled electrically to the nerve stimulator.
  • the electrodes 30, 76, 78 may he connected By separate wires 72, 74, 100 embedded ip a wall 56 of die mulli-iurnen catheter 90 io corresponding connectors at the proximal ends of the idtiTumen catheter, :
  • the wires may be secured: in or to the wall, lu an exemplary embodiment, each wire may be embedded in the wall of the catheter and he electrically insulated.
  • each of these electrodes 30, 70, 7 may he separately connected to a nerve stimulator at eortesponding proximal ends of the catheter 90: vis a connector and may function as independent electrodes.
  • the central lunien electrode 30 may function as a fjpi independen electrode and the peripheral lumen electrode 78 may function as a second independent electrode, oof coupled or restricted to the first electrode 30,
  • a connecter may be attached or secured to a proximal en of the multi -lumen stimulating catheter.
  • Each of the plural l umen may have its own connector.
  • the connectors may he configured to permit each of the respective proximal ends of the plnral Inmens to be : connected to the nerv stimnlatoi
  • Each : connector also iu odes one or snore delivery ports or injections ports to allow for intentions of a llquid or medication.
  • the electrical ulse: generator ap deliver a current of varying intensity ranging fern approximately 0.01 to 20 Mil Harrt peres, a if eqnency cT approximately 1 to 4920 Her3 ⁇ 4 and a pulse duration of
  • the pulse generate may he sot at approximately 1 to 2 Berta, an intensity of approximately ; j to S Mllilamperea, and a ptdse duration of approximately ⁇ .3 ⁇ 4 ⁇ to 1 millisecond;.
  • neipoptotin op may be initiatod.
  • the Intensity of the current may fee gradually increased until a twitehiag or a hmm g sensation is felt the appropriate dermatome or die region of the body that Is being targeted, T $ curren intensit may have a range of approximately 9.01 to 29 Milllomperes, Whoa the twitching of a muscle group is roquirad, the feqneney of the electrical pulse may he set between approximately I to d Harm If a huteing sensation is required, the frequency may be set between approximately 10 to 4990 Hertz.
  • a pump foot depleted may be provided tot
  • the pump may be Incorporated Into the design of the nerve stimulator so that the co bin d : device may deliver the electrical impulses for nemomodutelbn and an infection of medication.
  • the pump may be programmable.
  • the pump may be programmed to deliver a continuous infusion of medication or a bolus of medication or a combination of both.
  • a computer * one or more processors, and one or more interlacing units may he used to control the pump ' s programming,
  • an ir etk of a liquid or raedieameut may be administered from: the opening bat & distab or farther away, from the spinal code or cent al nervous system, This is m, appreciable ad vantage of using be nlii-dumeo sftnmludng catheter, as taught hereto, over traditional sti bafiog catheters.
  • the needle may be attached to a nerve stimulator (e-g., : electrical pulse generator ⁇ ,
  • a nerve stimulator e-g., electrical pulse generator ⁇
  • the nerve stimulator e.g., electrical poise generator
  • the catheter may be slid over the needle and advanced alongside the nerve.
  • the nerve stimulator fe.g., electrical pulse gedcraiof
  • the nerve stimulator may then fee disconnected ti the distal tip electrode and attached to the proximal electrode, li the proximal electrode is close to the nerve, then an appropriate muscle t itch will again he clieited. Ifthere is on muscle twitch, the catheter can then be advanced further until a twitch is elicited.
  • the needle is an insulated needle whose tip Is bare and capable of conducting eleeirlcity.
  • the nerve sti ulator e.g,, electrica! pulse generator
  • the nerve sti ulator ma he diwmntected from the needle and attached to foe catheter at its proximal en to electrify the distal electrode (e.g,, at foe catheter dpi, and foe catheter may then be threaded through foe needle.
  • the tip of the catheter exits from, or comes o ut oh foe needle tip * an appropriate m uscl e twitch may be elicited
  • the; catheter may he threaded alongside foe nerve whil maintaining the twifoh.
  • he nerve stimulator e,g., electrical pulse generator
  • proximo! electrode Is In close: proximity to the nerve the» a; uscle twitch may also fee elicited. If there Is no twitch * the catheter should be advanced fhrfoer until a, muscle twitch is e!icited, Subsequently, the needle Is withdrawn leaving the catheter in place.
  • fo electrode that is closest to the spina! cord or the central nervous system may be attached to a nerve stimulator (e,giere electrical pulse gcuerator) and sdnmfote with a current of varying intensity ranging from approximately 11,1 to 50 milhamps, at a frequency ranging from approximately 2 to 4999 Iferto, and a pulse duration ranging from approximately 9.1 to 1900 microseconds.
  • a nerve stimulator e,g
  • sdnmfote with a current of varying intensity ranging from approximately 11,1 to 50 milhamps, at a frequency ranging from approximately 2 to 4999 Iferto, and a pulse duration ranging from approximately 9.1 to 1900 microseconds.
  • a surface skin electrode is used or two electrodes of different polarity (e,g, anode and cathode) are used to complete foe circuit
  • a thir electrode may be used that is rto associated with a lumen and a act us the second electrode to; complete the circuit.
  • a Srha!l aliquot of medication e.g, ⁇ a loc l nesthetic solution, opioids, steroids, alphs ⁇ 2 agonists, Nay i .?
  • the .muMdunleu stimulating catheter may Include two or more electrodes that may fee use tor neiomPObUlarion of peripheral nerves Of eraniai nerves: (e.g., vagus, trigeminal, hypoglossal, etc, ⁇ or nerves at or surrounding the spinal cord. These electrodes may deliver electrical stimulation foeu i io ulathml from one or all of the eiechodes stmuitaneonsly or deliver the electrical stimulus Ifo only one electrode while the other one is silent or of dlitereni polarity ,
  • mu -dumen stimulating catheter includes two or more separate injection ports for injecting medication that connect separately to their corresponding openings on or atthe distal end of the catheter that are portioned close to the electrodes, Each of these openings: Includes a separate lumen that may connect to the proaintal injection ports. These lumens do not eoutmu eaie with each other.
  • Yet another advantage of the multi-!urnen stipulating catheter sysietn described herein is It pa be used fo electrically stimulating neural tissue using one electrode while simultaneously retaining the ability to inject medication through an opening that Is close to the electrode that is not electrically sri tiated (ie., the silent or not active electrode).
  • tie electrodes as taaght resig may be : stimulated from approximately I la 499# Hark (l3 ⁇ 4f to Beum odulate f # nerves
  • ntoliidtonen sttmokdng catheter system described herein 1 ⁇ 4 dtafihe openmg(s) and. ihe sketmdeCs ⁇ , as iaughi herein, may he portioned in various eoniigefaiions each that each electrode may e: closel associated : with aft opening, or along the eatheter shaft, in diriment: paterns [tog , a hole on alternate electrodes or holes between two electrodes, etc,).
  • An advantag of the toultl-lnmen sdmalattog eatheter described herein is that It provides a system that combines a nerve stimaktor (e g,, electrical pulse generator) and an infusion pump into a single, combined device that may connect to a proximal end of a eatheter and allow nenromodotechnisch and injection of medication: to occur simultaneously or independent of each other
  • a nerve stimaktor e g, electrical pulse generator
  • the neuromoduktios catheters may be used to treat any suitable pain, including, bat not limited tea acute postoperati ve satglca! pain, persiMent pain after surgery, cbfttoie pain, headaches, eompiex rcglona! pattt syndrome, pesHraomatle pain stomp pain posriamputation, ppst-herpetie fteftralgia, Peripheral field stimulation, eleelromcnpuncinre, stimulation of the Dorsal Knot CkngliPn (DRO), stimitation of medial branch nerve, and Kiluhepz stimulation,
  • DRO Dorsal Knot CkngliPn

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  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Public Health (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Veterinary Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Electrotherapy Devices (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention concerne un système de fourniture d'une maîtrise de la douleur qui comprend un cathéter de neuromodulation à lumières multiples ayant une extrémité proximale et une extrémité distale. Le cathéter comprend une première lumière et une seconde lumière s'étendant à travers celui-ci. La première lumière se termine à proximité de l'extrémité distale du cathéter et la seconde lumière se termine à proximité d'un point espacé d'une extrémité distale de la première lumière. L'extrémité proximale d'au moins une lumière comprend un connecteur configuré pour interconnecter électriquement une électrode à l'extrémité distale de cette lumière avec un générateur d'impulsions électriques. Au moins l'une des lumières est également conçue pour recevoir des médicaments liquides.
EP20776489.5A 2019-03-25 2020-03-24 Cathéter de neuromodulation Pending EP3941570A4 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962823332P 2019-03-25 2019-03-25
US201962911001P 2019-10-04 2019-10-04
PCT/US2020/024435 WO2020198213A1 (fr) 2019-03-25 2020-03-24 Cathéter de neuromodulation

Publications (2)

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EP3941570A1 true EP3941570A1 (fr) 2022-01-26
EP3941570A4 EP3941570A4 (fr) 2022-11-23

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EP20776489.5A Pending EP3941570A4 (fr) 2019-03-25 2020-03-24 Cathéter de neuromodulation

Country Status (4)

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EP (1) EP3941570A4 (fr)
JP (1) JP2022527620A (fr)
AU (1) AU2020244792A1 (fr)
WO (1) WO2020198213A1 (fr)

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5458631A (en) * 1989-01-06 1995-10-17 Xavier; Ravi Implantable catheter with electrical pulse nerve stimulators and drug delivery system
US7306596B2 (en) * 2004-05-26 2007-12-11 Baylis Medical Company Inc. Multifunctional electrosurgical apparatus
US7620451B2 (en) * 2005-12-29 2009-11-17 Ardian, Inc. Methods and apparatus for pulsed electric field neuromodulation via an intra-to-extravascular approach
US9446229B2 (en) * 2003-04-08 2016-09-20 Omar Omar-Pasha Catheter
US7386350B2 (en) * 2005-01-11 2008-06-10 Vilims Bradley D Combination electrical stimulating and infusion medical device
US7890166B2 (en) * 2005-06-09 2011-02-15 Medtronic, Inc. Regional therapies for treatment of pain
US8032222B2 (en) * 2007-06-19 2011-10-04 Loushin Michael K H Device for electrically and mechanically stimulating a compartment in a body
US20130053922A1 (en) * 2009-10-22 2013-02-28 Zaghloul Ahmed Dipole electrical stimulation employing direct current for recovery from spinal cord injury
US8986283B2 (en) * 2011-05-18 2015-03-24 Solo-Dex, Llc Continuous anesthesia nerve conduction apparatus, system and method thereof

Also Published As

Publication number Publication date
AU2020244792A1 (en) 2021-11-11
WO2020198213A1 (fr) 2020-10-01
EP3941570A4 (fr) 2022-11-23
JP2022527620A (ja) 2022-06-02

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