Cross-Reference to Relate Patent Applications

[fiOCH ] This patent application claims priority to United States· Provisional Patent Application. Serial No. 62/123,332, titled ^euromodulsfion Catfeeierf ^? that was lied on March 23, fil and United States: Provisional Patent AppHeatian Serial No, 62/ 11, 001, titled ¾ulti~ Lumen, nhi-Eleetrode NeuromoduMoii:C¾ihctei, ^w that was filed on October 4, 2019, The disclosures of hoife US 62/823,332 an OS 62/9! 1,00! are incorporated by reierenee heteinJn their entireties.

Background

U Field of the Disclosure f 0002] Disclosed her » are systems, devices an . related; ethods; f®e providing pain control, more specifically f® neutorao efafion sing m electrically st mulatin catheter; Various embodiments of the present disclosure relate generally to systems, devices, and related methods lot using the same, tor providing ga m control and/or re lief using neuromnduiaiion o f peripheral nerves at the spinal cOfci More specifically, particular embodiments of the proront disclosure relate to systems, devices, an related methods for operating tee same, to treat or provide pain eotnroi and additionally by rotain!ng the ability to ii ct, medication tar pate control in target neural tissue using singl lumen or tnultifturoen and ingle electrode or m ufti _“ electrode stimulatlug esthet 2 _* Description ofRelated Art flXKBj Peripheral nerve blocks are powerful i»¾ihods to control posto erative pairo

Typically, in such nerve blocks 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 ¾ 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

[000$] Using nerve sti milation, 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 I¾ 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. Thus, using a low current, 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,

[0007] While 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 limite efficacy for extended duration surgical site pain,

[0001] In such scenarios,, 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. This allows for a controlled and continuous dosing: of nerve block medication, Ibr 2-4 days post-surgery

!000f 1 In coniinnous nerve blocks, it is critical that the catheter tip position Is positioned ver close to the target nerve, in, order to Infuse local anesthetic solution that cun bathe the nerve, thereby main ainin ; a pal u Moekade [0010] Portion ng th catheter tip in dos proximity to the nerve is often accomplished b «slog a stimulating catheter Silmalaimg catheters: are typically thm fledMe lohe, often of 1 *18 gauge. Such catheters are made of an eteefrieali insulating materiaLsoeh da golyeretlmne ao l silicone or ther suitable material. A motel con uctor Is embedded within the waif of the catheter and exposed at both proximal and distal end of the eatlieieo

[01)1 1] The proximal end of the stir ilating catteer,. oiitsldc the b y, h connected to a nerve stims!atot, eh as m elee!fteai pulse generator, The distal end serves as a unipolar eleetrodc and is placed near a target nerve. A Touhy needle (a hollow hypodermic needle, slightly curved atone end and soitehle for inseAing epidural catheters), often 16-18 gauge, is nsed to place the stimulating catheter close to the target nerve. . n example of this placement is shown in Fifth I * which illustrates the Touhy needle 1 ft being used to guide the: stimulatin catheter 12, under the skin 14, and adjacent to the nerve 16,

[Oft] 2| This placement is accomplished using ultrasound guidance and nerve stimulation.

Once the Touhy needle tip 18 is placed in close proximity of the nerve 1ft under ultrasound gnidauee, the simulating: catheter \ Connected to a nerve stimulator 20, such m an electric poise generator, is passed through the Touhy needle IT 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. Typically, 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 electrically miereor eets the nerve stimulator 20 to an e!eclrieallv conductive portion 30 of the catheter 12.

[0013] 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 |4an has not veered from the nerve 16,

[0014] 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,

[0015] It would he desirable, therefore, to provide 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.g„ local anesthetic solution) that is away from the

electrode.

[OO ih] II would be further desirable io idiilee ihe stimulating estheiar for maintaining ustintarrupted delivery of twnton dufation to a patient MM simtdtaaeous!y being able to srycei as djuvant or medication to supplement the neuromodutatioa without reducing or negatively impaeimg the uepo edMatiorfs e¾etiveng:$S

Brief Summary

[001 ?3 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 lumea or a multMumen and singe el ctrode or mu!ti-eieetrodc stimulating catheter (e,g„ 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

[001 B j Imfoodinients of the present disclosu e relate to a catheter, 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

[0019] Each of the embodiments disclosed herein ma Include one or more of the

Juatures describe in eonueebon with any of the other disclosed embod iments.

[0030] It may be understood that both the foregoing general description and the:

following detailed descriptio arc exemplar and explanatory only and are not restrictive of the Invention, as eiaimed.

Brief Description of the Brawings

[002 Jj Fig, l schematically illustrates placement of an electrically stimulating catheter as known from the prior art,

[0022] Fig, 2 iilnstx tes ¾ artial etess-seefion a sing|.¾; lumen catheter In aecordanee ith a first entbedlnient

[0023 J Fig. 3 iOnstrate a single lumen catheter in accordance with: a second e imdlfttent

10024] Fig, 4 illustrated an embo i ent where a catheter s aligned by passing over a needle.

[0025] Fig. 5 Illustrates an embodiment where the catheter includes a plurality of !tmem and electrodes ( ttlild pea, n liimleetrode sfinmlniiog catheter}.

[0020] Fig, fi illustrates a ulihinmem ninlfimieetrode stimulating catheter to provide neuromodntaiian.

[0027] Flgs. , 7 ar cross-seefiona! views of the catheter of Fig 6 showing different wire and lumen eoniguraiions, [002#] The accompanying: drawing!, which arc incorporated in and cohstitote a part of thi s specification, illustrate exemplary embodiments: oί &t present disclosure and together with the description, serve to explain the principles of the disclosure.

Deluded Description

[0029] While the ptoseto disclosure Is described herein with reference to illustrative crabodirnents lor particular applications, It shoul be understood that cnibodirnerits: of the present disclosure are not limited thereto. Other embodiments are possible, and modification can be made to the described em bodiments within the spirit and scope of the teaching herein, us they may he applied to the abovemoted iie!d of the reseot disclosure or to any additional fields In which such embodiments would; he of significant utility.

10 301 la the detailed d@scripii¾a herein references to“on ete *ih a ban embodiment, ^' 'To example eos!mdiineniT etc,, iadieato that the embodiment described m * Inetode a particular feature, structure, or characteristic, but every ; embodiment: may not necessarily include the particular feature, stmetote, or characteristic. M re ver, _: such phrases are not necessarily; relet in t the ate embodiment Farther, when a pariieuiar feature, st etme, or eharaete stfe is described in connection with m embodiment, itis submitted that it is within the knowledge af das skilled in the art fe affect such feature, structure, or ehancferistle in connection with other embodiments he he or not explicitly described, 0CB: i } Disclosed herein is a catheter 4(1: for nenromoduktion that Is effective to control or reduce a n (Fi gore 2). Features disc asset! herein ate located at the proximal end 42 an at th distal; cm! 44 of the catheter An extended intermediate portion 4b, that tna be of any required length, is shown in broken phantom lines o ly. 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. I, 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! tor 20 $ \& enable eli ery of electrical signal an thereby cause neuohbodhMion, Wire 52 may extend wrdtiathe eadMlet dO lumen 54, Aiteraailveiv, th wire 52 ma be embedded in a wall 5b of the catheter. As a furthe alternative, 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 . As disenssed, the eos eetordi may be psed to connec to etrrreoily available sti datjng catheters 1¾ allowing lor them to be repurposed for ueoromodulation, xemplaty eatbelersmo merelally available _: are Siimueath (manofectured by Arrow), CoOiiplexSilm

(rnanolhotured by BBraon), Sonolong, and E~Caih, (manufactured by Pajnnk). Medication may he injected through the neurommloladoo catheter 40. This provides _: a bene it of using:

medications to supplement ne omoduladou and increase analgesic efficacy by combining two modalities (medication and he omodniatioO) fbt pain control Some known methods of 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

medications, and are not: suitable for doing so, Therefore, 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,

10053] 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|llime:tem to 2 eenii elers away from the catheter tip 22, 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

[0034] Utilisin the catheter 40 with the system of Fig, I , 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 nerve stimulator 20 tnay b#¾tachedto the ski 14 via a aste gl ue: or medical adhesive, Alternatively, the pulse generator 20 may he located at a different location, such as a pocket tabletop or oϋr. an ,:e tffieeted v wires 2 , 28 ^: to the catheter 41) and/dr connector 48. The nerve sti «Iator 20 tBay ¼: ®gi¾»tmed ot ffistraeted via a nser iuferlaee, on the device itself, or via a remote ebmpotcr or hand _“ held control ier.

[0015] I» the a¾oV¾s embodiment one terminal 62 (Fig, 1} of the nerv stimulator 20 is electrically Interconnected to the electrically conductive portion 30 of the catheter 40 (Fig.2}. A second terMlnal 6 (Fig. I.) is dec!rteaii interconnected to the skin 14 estemal to the snip ears body completing an electrical circuit. Alternatively, as illustrated in Fig. 3, 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. In this multi-· electrode system, a return electrode on, the skin nol; be teguired to complete the eireuit This removes the; need for a grounding electrode on the surface of the skin, f 0636| As described above, 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|0 - nee le: I ø onii is advanced, an: electrical pulse is transmitted to the needle tip 82, This results in a muscle iwiteh, Once the, nee le tip 82 is properly in piaeeudfaeent to the nerve, the nerve stimulator is the attached to the catheter 80 to electrify the electrode a the tip of the catheter and then the catheter 8 is slid over the needle 10 and advanced alongside the nerve, w le niaintaimng the twitch, 003?) Referring now to Fife, 5 and 6. 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)

[003SJ Sho n in f 10, d is a eross-secfional view of the catheter 90 with multiple lumen

92,94, Multiple 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. Additionally, 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

192, Once 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 _¾ 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,

100401 Fl 7 A - 7C axe cross-sectional vi ws of the catheter 00. 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. Fig. 7£ sto ws central lumen 92 and first wire 72 _, Referring back to fig, 6, the central lumen §2 extends fro proximal end 102 to art opening 106 at the distal end 108. 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# .

[004 TJ I ne peripheral inmen 94 proximal end 1 4 may fie disposed at an angle, u, that ranges from ø 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. in an exemplary use ease of this catheter 90, when a liquid or medicament is Infected through this peripheral lumen 94, the liquid or medicament may exit through the opening 98 2 cm proximally awa from the distal tip 106 of the multi-lumen eattoter 90, The 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. I some embodiments, the partition may he a distinct and independent structural divider to prevent Suid coim tnicsiion between the multiple lumens,

[0042] 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. In such a scenario, only 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

!ø or secured to :ihp ptpximaf end P4 oflhe needk I iif The tip 112 may fee blunt so that in jury k> target nerves % ini ed (e,g., a Touhy needle or a blunt bevel needle) In an: exemplary embodiment For‘kaihetermvermeedler sertton technique^·. 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. Injection of Dextrose S% solution does not cause extinction of mnselc t itcbes because It does not disperse the electric current dr block sohitmt-pOiasSium ton pump receptor thereby may facilitate insertion of stimulating catheter.

j 0043 ] It can be a prcc iated that in other embo irpents, addition a! 1 tt ens upy be disposed or used, each incl tiding an opening that is respectively proxi aily spaced away from the distal tip of the catheter with varying:: distances (e _< g,, _: ihe third lumen 4 cm fro the distal dpi the fourth lumen 1 em from the dkfaitip, ole.). Each: of these lumens may: include thei own separate injection port,

f0044| Poring operation of the muith lumen eatlieton a current may be passed t hrough the catheter, thereby causing nen omodniation of the adjacent nerves. In an exemplary embodiment of the ulthlumco eathctef, 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. In an entbodimcnt, 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 _:

I¾4S j In another embodiment 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, As previously described, ongoing neuromodulation may be interrupted either because a Injection of a liquid or mediea 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

I ! catheter described throughout the present disclosure to overco e these challenges toitii ro ide continuous, uninterrupted neuromodulaitoo, Fufihern ote, the multi4nmen stimulating catheter, as taught herein, 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 .

[0046] In an e e plary embodiment, 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. Bor example, 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. Ip an exemplary embodiment, 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. IP someembodiments, 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.

|004?J lit addition, there may he a weave pattern of metal wires to maintain stillness of the catheter and patency of the catheter and lumen, 1-Iowevep thi s weave pattem _: may not be responsible to maintain electrical conductivity between the nerve stimulator and the electrodes, 1» an. embodiment, 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. In other wwrds, 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,

[90481 aa exemplary embodiment, 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. .4 nerve st ulate !» an electrical pulse generate is us d to provide the:teurotsodolatis¾ wfseu operating the mulfrlu uo stimulating catheter. & an exeuiplary embodiment, 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 Her¾ and a pulse duration of

approximately 1 to l OOti niierosoeonds to the ei rodes ofthe oatlisier. For placement of the catheter _* and to elicit a mese!e twitch, 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 ø.¾§ to 1 millisecond;.

6049 Onee the catfeete is placed, 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.

[00501 In an exemplary erobodiinent, a pump foot depleted) may be provided tot

Injecting an miusioft o bolus of medication through the «¾ectk« port(s). 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. In some embodiments, the pump may be programmable. For example 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,

[90S 11 With the foregoing designs and embodiments described herein, it ca be appreciated that to using a multidumen, multbeleetrode stimulating ealheter, it becomes possible for a user , _< * physician or other bealtheare provider) to infect a small aliquot of liquid or medication (e _> g , local anesthetic solution, opioids, steroids, atpfea~2 agomsh etc.) through bus opening ^: {e.g. _* proximal, or distal port) opening) of the first Junmnpwhiie continuing

neuromodulation using an electrode that is for away from the opening through which the liquid or medication is exiting. To maintain uninterrupted neuromodufotion, the electrode that Is oxMoned closer andfor nearer to the spinal cord of a patient or the centra! nervous system will fee attached to il _l® nerve sthsulator fe.g _> , electrical ptdse genem r}, as taught hereto CoMurrently, 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.

[00S2 J Methods or techniques of placing and/or positioning the rnu!tl-torhen stimulating catheter close to a neural tissue (e.g. _s spinal cord, central nervous systep etc.) are also now described. It can fee appreciated that other methods or teehraqttes of placing the multi-lumen stimulating catheter, as taught herein, May he used, and the described methods herein are in no way limitini,

D05d] Aft exemplar first use case tor positioning the nm!irdumen stimulating catheter is now described. With a eatheter-overmeedle tphnlgue, and at a drst step, the nmiti-fomen catheter my be pre-loaded over an insulated needle such thal th tip of tire needle is exposed beyond the length of the catheter. At a next step, the needle may be attached to a nerve stimulator (e-g., _: electrical pulse generator}, As the catheter-needle unit is advanced under ultrasound guidance towards a nerve, and the needle tip is in close proximity to b nerve, the electrical pulse transmitte to the needle tip to the target nerve will elicit an approp iate usele twitch indicating close proximi ty of the needle tip to the nerve. A fter which, at a subsequent step, the nerve stimulator (e.g., electrical poise generator) may be disconnecte from the needle and connected to the distal electrode of the catheter tip. At a step, the catheter may be slid over the needle and advanced alongside the nerve. As the catheter slides alongside the nerve, an appropriate muscle twitch will be maintained thus: conftrming that the catheter tip is near or i close proximity to: the nerve. At a subsequent step, the nerve stimulator fe.g„ electrical pulse gedcraiof) 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. In: an exemplar embodiment, the needle is an insulated needle whose tip Is bare and capable of conducting eleeirlcity.

9054] An exe plary second use eas for pmitim img the multi A umen, multi -electrode stimulating catheter m described below step-by-step, With m eafoeter-foxoqgfoneedic teetaique,, arid at a -first: step, an fosfoated needle,; with a ti that is bare and capable of acting s a unipolar electrode, ay be attached to a nerve froulaier {mg. electrical pulse generator), aad foe needle hp hay fee positioned m close: proximity to the target nerve under ultrasound guidance. When the needle tip is in. close proximity m the nerve, an appropriate muscle twitch ay be elicited, At a subsequent step, the nerve sti ulator (e.g,, electrica! pulse generator) 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. As the tip of the catheter exits from, or comes o ut oh foe needle tip _* an appropriate m uscl e twitch may be elicited, At a step, the; catheter may he threaded alongside foe nerve whil maintaining the twifoh. At: a step, once the catheter has been advanced S cm beyond foe needle tip, he nerve stimulator (e,g., electrical pulse generator) may be disconnected from foe distal electrode and attached to the proximal electrode, If the 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.

Exemplary Use Case of the Muhi-l Catheter

10055} The following steps may be used to use the ultidumeu, muliueleetrode catheter. At a first step, once foe eafoetot is placed properly using one of the placement techniques described herein, fo electrode: that is closest to the spina! cord or the central nervous system may be attached to a nerve stimulator (e,g„ 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. To complete the circuit, either a surface skin electrode is used or two electrodes of different polarity (e,g, anode and cathode) are used to complete foe circuit In an exemplary embodiment, a thir electrode: may be used that is rto associated with a lumen and a act us the second electrode to; complete the circuit. 0056] A! a seco d, o ti na , step, if pain contro Is not adequate, a Srha!l aliquot of medication (e.g,~ a loc l nesthetic solution, opioids, steroids, alphs~2 agonists, Nay i .? antagonist or any other suitable liquid medicament tor curbing pain In a patient) ay he slowly injected through the Injection port taught herein such that medication will exit from the hole that la farther away from the electrode that Is being use for neutomodularlon. in doing so, the injected ication will not disperse the electricit delivered daring the oeuromoduia lon and t he medication will not block the Na-K pump (receptor) or another receptor depending on the medication Injected mtd mo ulate or prevent finthcf tranatn¾on of the nerve impulse and thereb red nee: pain, In other words, th nenmmodulation wi ll fee maintai ned and uninterrupted b using the ulti-lumen stimulating catheter as escribed above.

|d0&7 ] It will fee: appreciated that the mu |ii !utnen stimulating catheter described herein provides a multitude of benefits over tr ditional stitnalalmg catheters and their techniques for using the same. An advanta of the ttltwlatnen stimniating esthmef described herein is that it allows for oenromodulation of peripheral nerves and spinal cord to occur uninterrupted while retaining the ability to inject medication through the catheter, Anothe advantage Is that th multrilu en ti ulailng catheter may fee placed with the caihetewovermeed!e assembly or through a pm-positioned the needle. Yet another advantage is that 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 ,

jCtOSS Another advantage of the mu -dumen stimulating catheter describe herein is that it 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). etanoiher advantage of the rntitidnoien stimulating catheter sykem describe herein is that tie electrodes, as taaght resig may be _: stimulated from approximately I la 499# Hark (l¾f to Beum odulate f # nerves

| 6 j Yet: another ad vantage of the a amen stimulating catheter sy stem escribe herein Is that the catheter, as taught hereto, may be fabricated or designe with maltiple electrodes and openings, la art exemplary embodiment, _: the distance between the electrodes and/or the openings: may war i¾om _: approximately 0,5 em to 10 eta.

[0061 ! Another advantage of the ntoliidtonen sttmokdng catheter system described herein ¼ 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,).

[CK¾k| 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 nenromodoktion and injection of medication: to occur simultaneously or independent of each other

[6063] 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,

[6064] While pr inei plea of t he present disclosure are descri feed herein wi th ^: reference to illustrative embodiments for particular applieatious, it shoul he understood that the disclosure is not limited thereto. Those having ordiaar skill in the art end access to the teachings provided herein will recognize additional modldcatfens, applications, embodiments, and snbstitdtion of equivalents ail fail within the scope of the ernbodiruents described harem, Accordingly, the invention is not to be considered as limited by the foregoing description.