CA2414898A1 - Insertion tool system for an electrode array - Google Patents
Insertion tool system for an electrode array Download PDFInfo
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- CA2414898A1 CA2414898A1 CA002414898A CA2414898A CA2414898A1 CA 2414898 A1 CA2414898 A1 CA 2414898A1 CA 002414898 A CA002414898 A CA 002414898A CA 2414898 A CA2414898 A CA 2414898A CA 2414898 A1 CA2414898 A1 CA 2414898A1
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- electrode array
- removable means
- cochlea
- anchor
- tie
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- 238000003780 insertion Methods 0.000 title claims abstract description 24
- 230000037431 insertion Effects 0.000 title claims abstract description 24
- 210000003477 cochlea Anatomy 0.000 claims abstract description 51
- 238000000034 method Methods 0.000 claims description 15
- 239000007787 solid Substances 0.000 claims description 3
- 239000000560 biocompatible material Substances 0.000 claims 1
- 238000003491 array Methods 0.000 abstract 1
- 239000000463 material Substances 0.000 description 10
- 210000003811 finger Anatomy 0.000 description 7
- 210000000860 cochlear nerve Anatomy 0.000 description 5
- 230000008901 benefit Effects 0.000 description 4
- 210000005036 nerve Anatomy 0.000 description 4
- 230000000638 stimulation Effects 0.000 description 4
- 238000001356 surgical procedure Methods 0.000 description 4
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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
- A61N1/0526—Head electrodes
- A61N1/0541—Cochlear electrodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/34—Trocars; Puncturing needles
- A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00743—Type of operation; Specification of treatment sites
- A61B2017/00787—Surgery of the ear
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Surgery (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Heart & Thoracic Surgery (AREA)
- General Health & Medical Sciences (AREA)
- Otolaryngology (AREA)
- Radiology & Medical Imaging (AREA)
- Pathology (AREA)
- Cardiology (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Electrotherapy Devices (AREA)
Abstract
A device (10) used for inserting an electrode array (15) into a cochlea of a subject. Particularly, the device (10) is adapted for insertion of electrode arrays (15) having an elongate carrier member (21) and a removable means (22) extending through the carrier member (21). The device includes a handle (11), an elongate positioning member (12) mounted to the handle (11), an actuator member (17) movable relative to the elongate positioning member (12), and at least one anchor member (16) connected to the actuator member (17) and engageable with the removable means (22). On insertion of the electrode array (15) into a subject's cochlea, the actuator member (17) can be moved relative to the elongate positioning member (12) to withdraw the removable means (22) from the carrier member.
Description
Insertion Tool System fox an Electrode A,xxay Field of flee Invention The present in~rez~tion relates to a device and method far the insertion of an electrode array into a cochlea of a subjeot and, further, az~ electrode array adapted for izxsertion by said device.
Background A.xi:
t~
In .many people who are prQfQUndly deaf, the reason for deafness is absence of, or destruction af, the hair cells in the coohlea, which transduce acoustic signals into nerve impulses, These people are thus ux7,able to derive suitable bezxefit~rom canventit~na.I hearing aid systems, no matter how loud I5 the acoustic stimulus is made, because there is damage to or absence of the mecha~xxsm for nerve impulses to be generated ~rozu. sound in the noxrual manner.
It is far this purpose that cochlear implant systems have been.
developed. Such systems bypass the hair cells iz~ the cochlea and directly 2o deliver electrical sti~nnxl.etlon to the auditory nerve fibres, thereby allowing the brain to pe~tceive a hearing sensation resembling the natural hearing sex~satian ~narmally delivered to the ~xudxtory nerve. US Patent ~5~~~30, the conte~,ts of ~nrhich are incorporated herein by reference, provides a description of orle type of traditional cochlear impla~,t system.
2s Typically, cochlear implant systems have consisted of essentially two components, a~, external component commonly refe~xed to as a processor uxu,t e,x~.d an internal implanted component commonly referred to as a stirnulatoxlxeceiver unit ' ~ Tradi-tionally, both of these cornpanents have Cooperated together to provide the sound sensation to a user.
30 'I'k~e external component has traditionally consisted of a microphvz~e for detecting sounds, such as speech and environrne~xtal, sounds, a speech processor that converts the detected sounds, particularly speech, into a coded signal, a power source such e.s a bat~lery, and an 'external transmitter coil.
The coded signal autp~,t by the speech processor is transmitted 35 transcutaneously to the implanted stimulator/rece'iver unit situated 'within a recess of the temporal bone of the user. 'phis transcutaneaus trarxsmission occurs via the external transmitter coil which is positioned to communicate with azx implanted xeceiver coil. provided wvith the stiznulator/receiver unit.
This comauunication serves two essential purposes, firstly to txanscutane~rusly transmit the ceded sound signal and secondly to provide pwwer to the implanted stimulator/xeceiver unit, Conventionally, tlxis link has been in the farm of axe RF link, but other such links have been proposed and implemented with varying degxees of success.
the implanted stimulatar/xeceiver unit traditionally includes a receiver coil that receives the coded signal and power from the external processa~;
component, and a stimulatoz' that processes the coded signal alxd outputs a stimulation signal to an intracochlear electrode assembly which applies the electrical stimulation directly to the auditory nerve producing a hearing sensation correspozldiug to the original detected sound.
Traditionally, the external componentry has been carried an the body ~.5 of the user, such as in a pocket of the user's clcatbing, a belt pouch or in a harness, while the xxjicroghone has been mounted ou a clip mo~tzx.ted behind the ear or oil the lapel of the user.
fore recently, due' in the main to imprc~~rements in technology, the physical dimensions of the speech processor lxav~e been able to be reduced 2o allowing for the external componentry to be housed in a small unit capable of being warn behind the ear of the user. 'This unit allows tlxe microphone, po~snrer unit and the speech processor to be b.oused in a single unit capable of being discretely worn behind the ear, with the e~cternal transmitter coil still positioned on the side of the user's head to allovu' for the transmission of the 25 coded sound signal ~xom fine speech processor and power to the implanted stimulator' unit.
Together with improvements in available technology, much research has been undertaken in the area of understanding the way solmd is naturally processed by the human auditory system. ' 'W'ith such an increased 3o understanding of how the cochlea naturally processes sounds of varying frequency and magnitude, there is a need to provide an improved cochlear implaia,t system that delivers electxi.cal stimulation to the auditory nerve t,n a way that takes into account the natural ciaaxacteiistics of the cochlea.
It is Ia~.own in the art that the cochlea' i.s ~tonotopically mapped. In.
s5 other ~rvords, the cochlea razz be partitioned into regions, with each region being responsive to signals in a particular frequency range, for example, the basal end of the cock~lea is best respansi'vE to high frequencies, and the apical end is best re pensive to low ~requency sounds- 'I'k~is property of the cochlea is exploited by prr~vxding the electrode assembly with an array of electrodes, each electrode being arranged and constructed to deliver a cochlea stxzxlulafiing signal within, a preselected frequency range to the appropriate cochlea region. The electrical currer~.ts and electric fields from each electrode stimWate the nerves disposed on the rnadiala of the cochlea, It has been found that in order far these electrodes to be effective, the magnitude of the current/ flowing from these electrodes and the intensity of ~.0 the corresponding electric fields, are a function of the distance betweexr 'the electrodes az~d the modiola. If this distance is relatively great, 'the threshold current magnitude nxust be larger than if the distance is relatively small.
Moreover, the current from each electrode xnay flow in all directiQUs, anal the electrical fields corresponding to adyacent electrodes .may overlap, thereby 25 causing cross-electrode interference, Izx order to .reduce the threshold stimulation amplitude and to eliminate cross-electrode xnfierference, it is advisable to keep 'r~,e distance between the electra~.e array and the madir~la as small as possible. This is best accomplished by pTOViding the electrode array in the shape which generally follows the shape of the modiola. Also, this 20 ~nray the delivery of the electrical sti~x~.ulation to' the auditory nerve is most effective as tire electrode contacts are as close to the auditory nerves that axe particularly responsive to selected pitches of sound waves.
rn order to achieve~this electrode array position close t~o the izxsi,de wall of the Gachlea, the electrode needs to be designed i,n such a way that it 25 assumes this positron upon or immediately following i~xse~ction into the cochlea. This is a challenge as the array needs to be shaped such that it assumes a curved shape to conform with the shape of the modiola, axrd must also be shaped such t},rat the insertion process causes minimal tt~auma to the sensitive structures of the cochlea. In this sense, it is desirable that the 3a electrode array is in a generally straight configuration during the in,sertian procedure.
Several procedures have been adapted ,to prr~vade an electrode assembly that is relatively straightforward to insert '~rhile adopting a curved configuration following insertion in the cochlea: In this regard, it is known to 35 make an electrode array tlxat zneludes ~ a spiral-'shaped carrier which has a natural spiral shape generally conforming to the configuratia~x of a cochlea.
Such an array may also include a straightening, elexzlent or stylet. This enables the carrier to be inseWd into the cochlea in a sfixaight configuration.
The stylet is then removed as the carrier is moved into the cachlca such that it begins to take an its natural spiral-shape.
Typically the stylet~is removed following the insertion. of the el~ciiode array into the cochlea by clamping an exposed erid c~f the stylet with tweeters azxd gradually rez~.oving the stylet. It may also be possible for the stylefi to be remo~'ad while sim,ultaneausly in~oducing the electrode array into the cochlea. In either case, hav~rever, the technique is difficult to coordinate and 1o requires both hands of a st~z'geon to perform.
A niunber of foals have been developed to assist in tlxe insertion of the electrode array andjor subsequent removal of the straightening element.
Typically, such devices have been difficult to use and have requirod complex mechanisms to achieve the desired i:esult. This has resulted in toal.s that are difficult to zxlanufacture, difficult to clean far re-use as well as havi~xg an increased probability of failure due to their complexity:
The present invention is directed to an insertion, tool for an electrode assembly which is constructed to overcome the abov'ementioned problems of prior devices.
2p In providing the above description of the prior art, the present applicant is not conceding tlxat any or all of the 'above descripi~an is part of the present cam~.z~.oxi general knowledge of a person sJciued in the art of the present invention i_n. Australia.
Throughout this specification the word "comprise'', or variations such as "comprises" or "comprising'', will be understood to imply the inclusion of a stated eleznenfi, integer or step, ax group of elements, integers or steps, but not the exclusion of any other element, integer ox step, or group of elements, integcxs or steps. , Summa of the Invez~tiori According to a first aspect, fihe present invention is a device for inserting an electrode array into a cochlea of a subject, the electrode array having an elongate carrier member axtd a removable means extending through the carrier me~nbei fox at least a portion thorear, the device i.noluding a handle, an elongate positioning member moutxted to the handle, an actuator member movable relative to the ela~xgate positioning member, and at least one vn,chc~r member connected to the actuator member and e~.gageable with the removable means. wheroin on insertion of the electrode array into a subject's cochlea, the actuator member can be moved relative to tfze elongate positioning menober to withdraw the removable means from the cazxier me~x~,ber. ' 5 rn this aspect, the device can be adapted to insert an. electrode arrey having a removable meazrs positioned thErein, whereizx the removable means has a capture n~.ember located at or adjacent a proximal end of the removable means.
Accordxz~$ to a second aspect, the presezxt invention is an electrode x0 array for insertiozz in to a cochlea o~ a subject, the electrode array including an elozzgate carrier member haring a plurality of electrodes mounted thereon and a removable means extendW g through the carrier member for at least a portion thereof, tlxe removable means further havi.ug a capW re member positioned at or adje.ceut:a proximal ez~,d of the removable means.
In a tbi.xd aspect, 'the present invention is a method of inserting an electrode array iota a cochlea of a subject and, f~xxtlaer, removing a removable xxieans of the eleci~ode array following insertion using a device of the first aspect, the metlxod including the steps of: ' (a] loading an, electrode array having a removable xzaeans onto the 2o positioning mezxzber; ' (b] connecting one end of a tie member' to the azxchor member and a~.otb.er end of the tie merxxber fio the removable zxzean.s of the electrode array;
(c] gradually izxtroducing the electrode array into the c~aaxrlea; and (d) causing or allaw'~g the removable weans to be relatively withdrawn frorx~, the electrode array.
Typically, the posi,t~onin.g member conxprises a proximal portion located adjacent the handle anal a distal portion extendi.zxg from said proxixx~,al portion to a distal end. The distal portion may be angled relative to the proximal portion and the b.a~ldle such that when tire device is in use, the 3o distal portion does not obstruct a surgeon's view of the cochlea.
In a preferred embodiment, at least the distal porhian of the positioning member is rotatably .miovable rela'dve to the handle and the proximal portion of the positioning member. This en~.badiment has the advantage 'that when an electrode array is loaded onto the pvsitiozzi,z~g member, rotation of the positioning member will change the orientation of the electrode array to ~, particular orientation suitable for an izxdividual. surgery, Palternatively, the entire pasitic~ning member may be xotatably movable relative to the handle.
In a furthor embodiment, the pasitzoning member may be removable from the handle.
The elongate pc~sitianing member may hare a lumen, extending ' therethraugh. In one embodiment, the elongate positioning member can be adapted to at least partially enter a cochleostc~my prepared by a surgeon.
Vin.
another ert~.bodiment, at least the dis'ka.l end of the elongate positioning member be shaped such that it abuts with the bone around the cochleost~az~.y.
1o Preferably, 'the anchor member is posxtxoned in the proximal portion of the positioning means. IrS. eriather embodiment, the e.nchar member can be positioned in the pro~cimal poxtion adjacent its connectio~x ~rvitla. the distal portion of said member. In another embodiment, the anchor member may be positioned in the distal portion of the elongate member.
The anchor member may comprise a hook or a laap~like str~.cture which is adapted to engage wxtla, a tie member extending from tb.e removable means of the electrode axxay. The anchor member 'may be made of any suitable ma'texial such as a plastics materiel. or a zx~,etal or metal alloy.
.l~J,texnati~Iy, the anchor member may comprise a pulley member which 2o xeceives and engages the tie member. ' The tie member is preferably a ~lexiblE member and may be made Exam any suitable material ~nrhich includes, but is not limited to, a suture-type material. Such xixaterial has the advantage that it is biocompatible, The tie member preferably has one end which xs engageable with the 25 anchor mernbex an,d then e~ctends distally to a second end w'hy.ch is engageable with the capture membez~ located at or adjacent the proximal end of the xezx~o~rable ~zxeazxs of fine electrode array.
In another embodiment, the tie member can extend prox~i,melly from the removable means, around the anchor member and then back distally to a 34 secondary secured anchor mounted to the positioning member. In this embodiment, the tie member can move slidably around the arichox member upon movement of 'the actuator member relative to the handle.
In. another embodiment, the anchor member oan oomprlse a pulley rzxenxbex which xeceives the tie nxe;cxlbex. In, one embodiment, the secondary 3s secured anchor can be engaged with the pxoxizx~.al, en.d of the tie memlaer. The secondary secured anchor cari be ~x~ounted to the distal portion of the positiotxing member.
In another ez~,bodiment, the anchor mezxiber may be m~auz~ted on the actuator member. In this ezxxbodiment, the tie mexxxber preferably extends proximally from the xemavable means, around a pulley member or other tie zx~,ez~nber sliding member, and then back distally to the azxchor member.
'1'kxe pulley ixxex~.ber or other tie member sliding member can be xz~.ounted on the elongate positioning member. It will be appreciated that this member could also be mounted an the handle if fihe elongate pasitiazxing member is movable 1o relative to the handle. In this enibadizxxent, movement of the actuator member in the distal direci~axx xelative to the positianixtg znEmber results in the tie member withdrawing the removable means from the array.
pxefcrabl~r, the eslds of the tie member forth. secure connections ~nri.'tb.
the xespective anchor member and capture xxaeznber. Either or both connections may be made at any' stagE during the manufacture a~ the device of the presezxt invention or alternatively could be.me,de immediately prior t~a a surgical procedure by the surgeon.
The tie member :t'nay be connected in a number of ways. For example, in a preferred eixabodixnent, the anchor member and the capture member comprise hooks and the ends of the tie member farm, loops which may ex-ter~d over and engage with the anchor member- and the capture x~.en~.ber.
;A,ltexxxatively, the tie member may, in its entirety, form a single loop which at both ends extends over and engages with the anchor end aapfiure members.
.Alternatively, the tie member may include a bead xn.ember at each end such that the bead members engage with complementary structures on the anchor member and the capture member.
In a further embodiment, flxe azxchor member may_ also comprise a claazx~,el, said chazxzxel extextdio,g along at least a portion of the length t~f the positioning member. In this embodiment, the tie member is received within 3o the channel and may be retained therein by friction fit.
In a preferred embodirzxezxt, fibE ppsitioning member includes a slat at its distal End, said slot adapted to receive and engage a proximal end of the elec~:ode array. ~ a further embodiment, the slot is positioned in the distal portion of the positioning member, This enables ixxsertion of the electrode array into the cochlea. Once in position, the electrode array may be caused to slide from. this slot and into posi~on ~rvithin the cochlea of a subject.
Izx another embodiment, the distal portion of 'rhe positioning member may be ,pxovzded with an electrode array already znaunted thereon. For insertion into the cochlea of a subject, a suxgean xrvould assemble the dis'ral portion of the positioning muxxzbex, including the electrode array together with the handle. Izx tlxxs embodiment, the action of assembling tlxe various ooanponents together results in the proximal end t~f the tie rnezxlber engaging with the anchor means. ~ .
In another embodiment, the actuator member m~.y have a distal end adapted to engage with the electrode arxay. k'oz~ example, the distal end may 0 be fork-shaped azxd adapted to grip the carrier member of the array. Izx this embodiment, the actuator member preferably has a stopper ixxember at a position distal its distal ezxd. Tb,e stopper is preferably adapted to prevent the actuator member from moving 'beyond a predetermined distance xela'~.ve to the positioning member.
t.5 The actuator member of the present invention may comprise a slide member wlxi.clx is slxdably nlorrable along a length of the handle.
The slide member~'may be connected to the anchor member by a connector txae~.us which tuay aozx~.pz~se ~, nuxnbcx of structures including, but not limited to, a flexible cord, a solid rnd or altErnatively, a continuation of ~o the tie member described above. The latter embodiment is ezxvlsaged particularly where the anchor member acts as a pulley. The tie member would engage with and extend over the pulley to a connection paint w~i~x t3xe actuator member.
Tl~e aetuatox member xnay include at least one finger grip ~.e~aaber to 25 enable manipulatiozx by a suxgeozx.
Typically, the actuatax xaezxxber may be moved from a first location on the handle adjacent the positioning membEx to ~a secozxd location on the hazxdle distal the positioning member by the surgeon. Movement in this manner will cause fhe connection means to draw the anchor member, or in 3o certain eznbodi,zxxezits, the tie member. towards the handle.
In a preferred embodiment, the tie member is cann.ected to both the anchor member and the captuxe xxaerxzber of the removable means, such that drawing the ancliar memt~er tawaxds tlzt~ handle causes the removable zxxeaaxs to be withdrawn from the electrode array. Preferably, the actuator memlaer 3s moves relatively smoothly along a length, of fihe lxandle azxd without the need for application of a great an~.auzxt of pressure. In this way, a surgeon using the device of the ix~~re~xtxaii may xxaa~re the aGt~xatar nxe,uyber v~rith the same hand as holds the device. Tt is. envisaged that the actuator member may lie x~.aved by an index, ox other, ~ixager ox thumb o:f a suxgeaz~ usxrrg tb,e device.
The elongate carrzer of the electrode array rxiay be straight or curved.
s ~'uxtb,ex, the elaz~gate carrier member may be adapted to adopt a spiral cox~figuratian.
Preferably, the elongate carrier member has a first configuration selected td allow the electrode array to be inserted into the cochlea of a subject and at least a second configuration ~irhexein said electrode array 1o applies the preselected tissue stimulati,cr~. .A,s Xs desxxable to insert an electrode array irzta a cochleae in axr izxitially straight cc~nfiguratian, it xs preferred that the first configuration of the elecfirode array is substantially s'rxaxght_ Moreover, it is preferred that the elongate carrier member adopts a spi.xal car~figu~atia~vVhen in the second configuration.
15 The xezxxavable rneaus of the electrode array may be a stiffening means.
In this embodiment, the elongate carrier xoembar of tl~.e alectrade array has a lurn,en which receives fhe, removable stiffening means, the stifFexri.ng means having a configuration selected far biasing the elongate carrier member into the ~,xst configuration zo The elan~ate carriar member may be formed from, a~ resiliently flexible and biacompatible material. Furthermore, it is preferred 'h~.at the elozxgate carrier member is pxefarmecl from a plastics ~inaterial with memory and, moreover, is prefarmed to the second configux~ttiazx. fll,ternatively, the material may be a biacompatible silicone or suitable elastomeric material, z5 such as a polyuxe~khane.
In one embodiment, the stxffex~ing means may comprise a stiffening element formed ~xarn a non-biaresorbable material.. In, 'khis ert~bodiment, the stiffening element may caz~prise a metallic stylet extending through the receiving portion of the body of the elongate carrier member. Preferably, 'the 3o stylet is farmed from a 'biocompatible metal or metallic alloy. An example of s. suitable metal is platxzruzn.
The stiffenxxag element may be formed from a shape memory or heat sensitive material such as a bimetallic element or share memory alloy (such as nickel/ti.tanium~ and shaped to take a straight or substa~.tially straight 35 configuration at room temperature but which beads into another shape upon exposure to body temperature. , 1d The'lurnen of the elongate carraPx zz~.ember may extend at least Xz~to, and more preferably through, tl~e body of the elongate carrier rrlembex.
The assembly or device according to the respective aspects of the invention can furthex i~xclude a stiffening sheath thafi envelops the elongate camxex member of the electrode array. The sheath xaa~r be made of a material.
that is relatively stiffer then We material of the body of the elongate carrier member. Where used, the stiffening sh~a~ can, in combination with 'the stiffening element, act to bias the el,ox~gate carrier member i~.ta 'thE first configuration. Removal of either the stiffening element or stiffeili~xg sheath, ~1o in this embodiment, preferably results in the elongate carrier member adopting the fully curved seGazxd co~x~.guration desired of an implant fox x~xsert9.oz~ i~,ta the cochlea.
Erief Description of the Drawings Figure 1 is a side elevation ~ri.e~v of a device according to the present ix~ve~itzo~~,;
~'igure ~ is a side elevational and partly cut-away view of the device according to the laresent inveWon; -2o Figuxe 3 is a side elevational rrienr of anathEr embodiment of a device according to the present invention;
Figure 4 is a side elevatioiial vievu~ of still f~xrther ex~,badiment of a device according to the present invention; .
Figure 5 is a bottom view of yet another embadxznezat of the device of the present invention; and Figure a is a side view of the device of k'xguxe 5 in use.
Preferred lVlode of Carryin~ Out The Invention 3o One embodiment of an insertion device according to the present invention is depicted genexalJ,y as 3.p i,n Figure 2.
The device ZO con~pxises a handle ~3. and a~n elongate pasi~ion.xn.g n~,exxlber 1~. The positioni_n.g member 12 has a proximal portion ~.S and a distal portit~n 19 that extends to a distal end ~.3. ~'T'he distal portion 19 receives and supports an electrode a~Tay ~5 to alloznr positioning of the array 15 within a cochlea of a subject.
The device 1o further incl~.des an anchor 16 which is positia~.ed at a location, along the length of tb.e positioning member 12 and extends through a $],ot (not visible in Figuxe.2) in that membex. 'Z'hE anchor 16 is coun.ected to a finger actuable coeval '19 that exte~xd.s outwardly through. a slot in the handle 11 ~xom a slide member (not visible that extends through the lxandle '11 and the pxoximal portion 18 of the positioning membex ~.2 to the anchoz' '16.
Flecfrode array ~.~ includes an elr~ngate carrier 21 with a plurality of electrodes (not shown for reasons of claxxty) mounted thereon. The electrode axray '15 also includes a, stylet 22 which, in the gresent ernbc~diment, is 1o designed to keep the electrode array 15 in a straight configtuation wlxile it is being inserted into a cochlea of a subject. The starlet 22 has a capt-axe member 23 positioned at i,ts proximal end.
'1'h,e device of the present :invention includes a tie ataaember 31 which has a first end 32 and a second end 33. As depicted in Fig. 2, the first end is engageable wxtf~ anchor ~.6 and the seca~xd end 33 is engageeble with capture member 23 of the styl,et 22. Tie member 31 is preferably a flexible cord made from a suture-type material. Use of other wire materials, such as platinum wire oan also be.envisaged.
The tie member 31 ~.ay be connected in a number of Ways. Far 2o example, as depicted, the ends of '~a,e tie member 81 farm loops 34 which may extend over and engage respectively with anchor 16 and capttu'e member 23.
In. use, the finger actuabJ,e coeval ~7 is moved fromv a first location an handle 11 adjacent positioning mEx,~ber ~.2 to a second lacatic~n on the handle 11 distal the posxfii,oniug member 12. Movement in this tx~.avxxner will cause the rod member to draw the <xzxcl~or 1B relatively towards the handJ.e ~.1.
As depicted in Figure 2, the positioning member ~.2 comprises a proximal portion 1S located adjacent handle ~,~ and a distal portion ~$
extending froxx,~ said proximal portion '1S. The distal portion. ~.'~ is angled relative the proximal portion 18 and the handle 1~ such that when the device 10 is used to insert an electrode axxay x5, the distal portion 19~ does not obstruct the surgeon's ~riew of the cochlea. The distal portion 19 is further rotatably movable relative to the handle 11 and the proximal portion 7.8 such that when an electrode array 15 is lr~aded onto th,s distal. end W of positioning member ~~, rotation of the distal portion 19 will cha~xge the orientation of the electrode array 15 to a particular orientation suitable for an individual surgery.
As further shown. izx Figure 2, the anchor 1~ is positioned iv the region of the proximal portkozx ~.8 of the positioning nxember 12.
While, ~or clarity, rigiue 2 depicts the pie member 31 as fxee from the disfial portion 19 of the positioning member 12 it is try be understood that the, tie member 31 zzxay be received by a channel (xxot shown] in the distel.
portion 1~. The tie member 31 can be re'kaiz~Ed within the channel by friction fit or alternatively rzxay be loosely contained within the confines of the charxrrel.
The distal portp.on 19 fuxther includes a slot (not shawl.) that is adapted to receive and engage a proximal end 24 of the electxade array 15. This 'i0 provides a means to introduce the elecfirode array 15 into the eao~.l.ea of a subject Izx use, it is preferred that the electrode array 15 is inserted into the cochlea in a straight configuration and when within the cochlea, caused to take on a spiral configuration, 'This is often achieved by providing the electrode arxey with a straightena.ng stylet 22. As the electrode array 15 is advanced into the cochlea, a surgeon will typically simultaneously withdraw the stylet 22 such that the array 15 is free to take oz~ its spiral configuration., the preferred configuration of an electrode array ~nrhen in position within a cochlea.
The stylet is removed by the surgeon using the Finger actuable control 1~ to move the slide relative to the handle in a directic~ri depicted by A, which in turn draws anchor 16 toward handle 11. P~.s the tie member 81 is con,zxected to both the anchor 16 and the stylet ~2, the stylet 22 is gradually pulled free from the electfode array 15. The ezxtire device is then withdrawtx z5 slov~rly from the surgical site. ThE electrode array z5 is retained ~vith~i~, the cochlea due to the slight spring force of its pre-curved shape which is greater than the slight friction fit of the electrode array 15 in the slot of the distal.
porti4n 19. The electrode array 15 therefore slidos cut of the distal portion as the device 1~ is withdrawn.
80 In an alternative arrangement depicted in Figure s, floe device 50 is essentially' identical to device ~.0 except that the tie member 31 extends proximally from its connection with the stylet ~2, around the anchor member 1Q and then extend$ distally before being secured to a secondary secured anchor 85. On using the device 50. refraction df the actuable control 17 35 results in tlxe tie zxxezxrl~er 3~. slidi~xg around the aizchor 16. h1.
essence, the anchor '16 acts as a pulley member. $ecause of the advantage provided by the anchor ~.G, a movement of ~ mm of the control 17 results i.ra. a movement of 2X mm of the stylet 22. This is advantageous as it decreases the necessary finger movement by the surgeon during use of the device. For example, the control 17 need ozxly be.,x~xorred relaUive to the handle 1'i by a distazxce of l~mm to cause the stylet to move a distance of 32mm.
Figure 4 depicts a further embodiment of the device designated as 60.
fn the case of device E0, the actuable controlwnember 71 comprises a cylindrical member 7~ positioned outside and relatively movable to the handle z1. The cylindrical member 72 has an an~.~xlai fizxge~r abutment o zxzexnbex 73 that, i,n use, carx be pulled back relative to the handle by the index and middle fingers of the surgeon, In this regard., the device 60 can be gripped in a manner similar to that used to grip and contra?. a syringe, with the thumb 78 used to stabilise the end of the handle 12. As depicted, the tie member 31 extends proximally from its connection with the styles 2z 'through the i.~,side of the positionizxg member 7~ to an anchor member 7~ conn.ected to the cylindrical member 72. In the depicted embodiment, the positioning member 94 is mounted to the handle 11 but is relatively rc~tatable therefio.
I~, use, the tie member 31 would be firstly fed through the hallow positioning member ~4 'to load the electrode array ~.5 into a stot formed adjacent its distal e~,d, 77. The pos~.ti,onxng z~,~xx~.ber 74 ~nrotxld then be mounted on the handle 11 and rotated relative thereto so as to be at the orientation desired for the surgery. The control 71 would then be slid fox~nrard to a,n end stop such that the anchor meter 7~ is relatively close to the distal end of the handle 11. The loop ~~ at txze proxi,zxzal end of the tie member 31 can then be engaged with the anchor member 76. The device 6U
can then be held in a syringe-style manner with the thumb 78 vn the proximal end of the handle 17. and the index and middle fingers ~9 an the control 7x. 'phe device can then be moved relatively forward to commence insertion of the array ~5 through the cocb,lec~stc~zx~y. 'Z'he coxy,trr~l 71 can then 30, be moved relatively praxim.ally to the handle 11 using the index and middle fingers 79 tQ witl7.draw the stylet 22 from its lumen within the array 15.
~Jnce xz~sertian is complete, the device GO can be urithdra~vn, leaving the array ~.5 in place within the cochlea. .
Two insertion techniques ara availeble through use t~f the device ~o. In the standard iusextion technique, the electrode array I5 is inserted fuhy and then the styles 22 is withdrawn. In another technique, the array ~5 can be inserted until the distal tip of the array 15 is near the lack of the basal turn of the cochlea- Ozxce there, the stylet 22 can begin to be withdraws by moving the control ~~ relatively proximally while still contizxuizzg to advance the array zz~,to the cochlea using the device 60. Using this fiechnique, the electrode array ~5 preferably follows a trajectory which is aloe ar near the middle of the lumen of the scala tympaz~i o~ the cochlea. This avoids or lessens pxessuxe on the outside (lateral) wall of the cochlea.
A~,c~tb,ex de~rice arrangement is depicted generally as 8a in Figures 5 and fi. Tn this arrangement, the actaatar member cc~rz~prisas a push rod 8~.
2o extending distally from a distal erzd of s. haxldle $~. The push rod 81 extends through a positioning member in the form of guide tube 83 alxd ends in a fork 84. As depicted in Figure 6, the fork 84 can grip the pxt~xxtxlal end of the-electxade a,xxsy ~5. '~lxe electrode Ieads 15a of the array 15 extend out of the guide tube through a slot 88 farmed adjacexxt the distal. end of the lobe 83.
The device 80 includes a stopper 85 on the push rod 8'1 that comes i.~,to abutment with the proximal end of the guide tube 88 if the push rod $~. is moved xzz a pxaxix~.al directxazx ralatxvc to the guide tube s3.
(fin mounting of the array 15 within the guide tube 83 and into the txzxes of the fork s4, the tie member 31 is conl7.ected to the device 8~ as depicted in 2o k'iguxe ~. The tie member 31 extends proximally fron~z its ssco~.d end 33 connected to the capture member 23 of the s~t~rlet: The tie member extends around a pulley member 86 mounted on the guide tube 83 and bath dist2~lly to an anchor 87 on the push rod 8'1. The anchor 87 extends outwardly through a slot formed in the guide tube 83.
During use, the device 80 15 used to advance the array into the cochleostozxxy. Unce the distal end of the guide tube 83 stops on the bone around the cochleastomy, the push rod S'1 cazl be advanced further to push the array 15 out of the guide tube 8'1. This results in the anchor 8T waving farwardly relatively to tire pulley 88 so causing the stylet to be wxthdra'wn 3o from the array 15. Each 1mm movement forward 'of the push rod 81 results i~, a 2zxxxn withdrawal of the stylet from the array 15.
An advantage of device $o is that the stylet is automatically withdrawn on advancement of the arra~r ~L5 :i~. tc~ the cochtlea.
One of the further ~ad~az~,tages of the present invention is that tha electrode array ~5 is readily removable from the insertion device prior to use.
This is advantageous as it is envisaged That some surgeons may choose not to usp the device or find it unsuitabre far use in certain circumsta~.ces. Ta remove the electrode azxa~r, the surgeon needs simply to cut the tie meml~ex 31 and carefully remove the array ~.a from the positioning member ~.2. 't7~nce removed, the azra~r can be inserted by hand, using standard devices such as 5 je'tnrellexy forceps.
Zt ~vxl,J. be appreciated by persons skilled zx~ the art that numerous variations and/or modifications may be rn,ade tQ the invention as shown in fine specific embodiments without departing from the spirit or scope of the invention as broadly described. The present embc~di~xze~,ts are, therefore, to 10 be considered in alI respects as illustrative an,~1 not restrictive.
Background A.xi:
t~
In .many people who are prQfQUndly deaf, the reason for deafness is absence of, or destruction af, the hair cells in the coohlea, which transduce acoustic signals into nerve impulses, These people are thus ux7,able to derive suitable bezxefit~rom canventit~na.I hearing aid systems, no matter how loud I5 the acoustic stimulus is made, because there is damage to or absence of the mecha~xxsm for nerve impulses to be generated ~rozu. sound in the noxrual manner.
It is far this purpose that cochlear implant systems have been.
developed. Such systems bypass the hair cells iz~ the cochlea and directly 2o deliver electrical sti~nnxl.etlon to the auditory nerve fibres, thereby allowing the brain to pe~tceive a hearing sensation resembling the natural hearing sex~satian ~narmally delivered to the ~xudxtory nerve. US Patent ~5~~~30, the conte~,ts of ~nrhich are incorporated herein by reference, provides a description of orle type of traditional cochlear impla~,t system.
2s Typically, cochlear implant systems have consisted of essentially two components, a~, external component commonly refe~xed to as a processor uxu,t e,x~.d an internal implanted component commonly referred to as a stirnulatoxlxeceiver unit ' ~ Tradi-tionally, both of these cornpanents have Cooperated together to provide the sound sensation to a user.
30 'I'k~e external component has traditionally consisted of a microphvz~e for detecting sounds, such as speech and environrne~xtal, sounds, a speech processor that converts the detected sounds, particularly speech, into a coded signal, a power source such e.s a bat~lery, and an 'external transmitter coil.
The coded signal autp~,t by the speech processor is transmitted 35 transcutaneously to the implanted stimulator/rece'iver unit situated 'within a recess of the temporal bone of the user. 'phis transcutaneaus trarxsmission occurs via the external transmitter coil which is positioned to communicate with azx implanted xeceiver coil. provided wvith the stiznulator/receiver unit.
This comauunication serves two essential purposes, firstly to txanscutane~rusly transmit the ceded sound signal and secondly to provide pwwer to the implanted stimulator/xeceiver unit, Conventionally, tlxis link has been in the farm of axe RF link, but other such links have been proposed and implemented with varying degxees of success.
the implanted stimulatar/xeceiver unit traditionally includes a receiver coil that receives the coded signal and power from the external processa~;
component, and a stimulatoz' that processes the coded signal alxd outputs a stimulation signal to an intracochlear electrode assembly which applies the electrical stimulation directly to the auditory nerve producing a hearing sensation correspozldiug to the original detected sound.
Traditionally, the external componentry has been carried an the body ~.5 of the user, such as in a pocket of the user's clcatbing, a belt pouch or in a harness, while the xxjicroghone has been mounted ou a clip mo~tzx.ted behind the ear or oil the lapel of the user.
fore recently, due' in the main to imprc~~rements in technology, the physical dimensions of the speech processor lxav~e been able to be reduced 2o allowing for the external componentry to be housed in a small unit capable of being warn behind the ear of the user. 'This unit allows tlxe microphone, po~snrer unit and the speech processor to be b.oused in a single unit capable of being discretely worn behind the ear, with the e~cternal transmitter coil still positioned on the side of the user's head to allovu' for the transmission of the 25 coded sound signal ~xom fine speech processor and power to the implanted stimulator' unit.
Together with improvements in available technology, much research has been undertaken in the area of understanding the way solmd is naturally processed by the human auditory system. ' 'W'ith such an increased 3o understanding of how the cochlea naturally processes sounds of varying frequency and magnitude, there is a need to provide an improved cochlear implaia,t system that delivers electxi.cal stimulation to the auditory nerve t,n a way that takes into account the natural ciaaxacteiistics of the cochlea.
It is Ia~.own in the art that the cochlea' i.s ~tonotopically mapped. In.
s5 other ~rvords, the cochlea razz be partitioned into regions, with each region being responsive to signals in a particular frequency range, for example, the basal end of the cock~lea is best respansi'vE to high frequencies, and the apical end is best re pensive to low ~requency sounds- 'I'k~is property of the cochlea is exploited by prr~vxding the electrode assembly with an array of electrodes, each electrode being arranged and constructed to deliver a cochlea stxzxlulafiing signal within, a preselected frequency range to the appropriate cochlea region. The electrical currer~.ts and electric fields from each electrode stimWate the nerves disposed on the rnadiala of the cochlea, It has been found that in order far these electrodes to be effective, the magnitude of the current/ flowing from these electrodes and the intensity of ~.0 the corresponding electric fields, are a function of the distance betweexr 'the electrodes az~d the modiola. If this distance is relatively great, 'the threshold current magnitude nxust be larger than if the distance is relatively small.
Moreover, the current from each electrode xnay flow in all directiQUs, anal the electrical fields corresponding to adyacent electrodes .may overlap, thereby 25 causing cross-electrode interference, Izx order to .reduce the threshold stimulation amplitude and to eliminate cross-electrode xnfierference, it is advisable to keep 'r~,e distance between the electra~.e array and the madir~la as small as possible. This is best accomplished by pTOViding the electrode array in the shape which generally follows the shape of the modiola. Also, this 20 ~nray the delivery of the electrical sti~x~.ulation to' the auditory nerve is most effective as tire electrode contacts are as close to the auditory nerves that axe particularly responsive to selected pitches of sound waves.
rn order to achieve~this electrode array position close t~o the izxsi,de wall of the Gachlea, the electrode needs to be designed i,n such a way that it 25 assumes this positron upon or immediately following i~xse~ction into the cochlea. This is a challenge as the array needs to be shaped such that it assumes a curved shape to conform with the shape of the modiola, axrd must also be shaped such t},rat the insertion process causes minimal tt~auma to the sensitive structures of the cochlea. In this sense, it is desirable that the 3a electrode array is in a generally straight configuration during the in,sertian procedure.
Several procedures have been adapted ,to prr~vade an electrode assembly that is relatively straightforward to insert '~rhile adopting a curved configuration following insertion in the cochlea: In this regard, it is known to 35 make an electrode array tlxat zneludes ~ a spiral-'shaped carrier which has a natural spiral shape generally conforming to the configuratia~x of a cochlea.
Such an array may also include a straightening, elexzlent or stylet. This enables the carrier to be inseWd into the cochlea in a sfixaight configuration.
The stylet is then removed as the carrier is moved into the cachlca such that it begins to take an its natural spiral-shape.
Typically the stylet~is removed following the insertion. of the el~ciiode array into the cochlea by clamping an exposed erid c~f the stylet with tweeters azxd gradually rez~.oving the stylet. It may also be possible for the stylefi to be remo~'ad while sim,ultaneausly in~oducing the electrode array into the cochlea. In either case, hav~rever, the technique is difficult to coordinate and 1o requires both hands of a st~z'geon to perform.
A niunber of foals have been developed to assist in tlxe insertion of the electrode array andjor subsequent removal of the straightening element.
Typically, such devices have been difficult to use and have requirod complex mechanisms to achieve the desired i:esult. This has resulted in toal.s that are difficult to zxlanufacture, difficult to clean far re-use as well as havi~xg an increased probability of failure due to their complexity:
The present invention is directed to an insertion, tool for an electrode assembly which is constructed to overcome the abov'ementioned problems of prior devices.
2p In providing the above description of the prior art, the present applicant is not conceding tlxat any or all of the 'above descripi~an is part of the present cam~.z~.oxi general knowledge of a person sJciued in the art of the present invention i_n. Australia.
Throughout this specification the word "comprise'', or variations such as "comprises" or "comprising'', will be understood to imply the inclusion of a stated eleznenfi, integer or step, ax group of elements, integers or steps, but not the exclusion of any other element, integer ox step, or group of elements, integcxs or steps. , Summa of the Invez~tiori According to a first aspect, fihe present invention is a device for inserting an electrode array into a cochlea of a subject, the electrode array having an elongate carrier member axtd a removable means extending through the carrier me~nbei fox at least a portion thorear, the device i.noluding a handle, an elongate positioning member moutxted to the handle, an actuator member movable relative to the ela~xgate positioning member, and at least one vn,chc~r member connected to the actuator member and e~.gageable with the removable means. wheroin on insertion of the electrode array into a subject's cochlea, the actuator member can be moved relative to tfze elongate positioning menober to withdraw the removable means from the cazxier me~x~,ber. ' 5 rn this aspect, the device can be adapted to insert an. electrode arrey having a removable meazrs positioned thErein, whereizx the removable means has a capture n~.ember located at or adjacent a proximal end of the removable means.
Accordxz~$ to a second aspect, the presezxt invention is an electrode x0 array for insertiozz in to a cochlea o~ a subject, the electrode array including an elozzgate carrier member haring a plurality of electrodes mounted thereon and a removable means extendW g through the carrier member for at least a portion thereof, tlxe removable means further havi.ug a capW re member positioned at or adje.ceut:a proximal ez~,d of the removable means.
In a tbi.xd aspect, 'the present invention is a method of inserting an electrode array iota a cochlea of a subject and, f~xxtlaer, removing a removable xxieans of the eleci~ode array following insertion using a device of the first aspect, the metlxod including the steps of: ' (a] loading an, electrode array having a removable xzaeans onto the 2o positioning mezxzber; ' (b] connecting one end of a tie member' to the azxchor member and a~.otb.er end of the tie merxxber fio the removable zxzean.s of the electrode array;
(c] gradually izxtroducing the electrode array into the c~aaxrlea; and (d) causing or allaw'~g the removable weans to be relatively withdrawn frorx~, the electrode array.
Typically, the posi,t~onin.g member conxprises a proximal portion located adjacent the handle anal a distal portion extendi.zxg from said proxixx~,al portion to a distal end. The distal portion may be angled relative to the proximal portion and the b.a~ldle such that when tire device is in use, the 3o distal portion does not obstruct a surgeon's view of the cochlea.
In a preferred embodiment, at least the distal porhian of the positioning member is rotatably .miovable rela'dve to the handle and the proximal portion of the positioning member. This en~.badiment has the advantage 'that when an electrode array is loaded onto the pvsitiozzi,z~g member, rotation of the positioning member will change the orientation of the electrode array to ~, particular orientation suitable for an izxdividual. surgery, Palternatively, the entire pasitic~ning member may be xotatably movable relative to the handle.
In a furthor embodiment, the pasitzoning member may be removable from the handle.
The elongate pc~sitianing member may hare a lumen, extending ' therethraugh. In one embodiment, the elongate positioning member can be adapted to at least partially enter a cochleostc~my prepared by a surgeon.
Vin.
another ert~.bodiment, at least the dis'ka.l end of the elongate positioning member be shaped such that it abuts with the bone around the cochleost~az~.y.
1o Preferably, 'the anchor member is posxtxoned in the proximal portion of the positioning means. IrS. eriather embodiment, the e.nchar member can be positioned in the pro~cimal poxtion adjacent its connectio~x ~rvitla. the distal portion of said member. In another embodiment, the anchor member may be positioned in the distal portion of the elongate member.
The anchor member may comprise a hook or a laap~like str~.cture which is adapted to engage wxtla, a tie member extending from tb.e removable means of the electrode axxay. The anchor member 'may be made of any suitable ma'texial such as a plastics materiel. or a zx~,etal or metal alloy.
.l~J,texnati~Iy, the anchor member may comprise a pulley member which 2o xeceives and engages the tie member. ' The tie member is preferably a ~lexiblE member and may be made Exam any suitable material ~nrhich includes, but is not limited to, a suture-type material. Such xixaterial has the advantage that it is biocompatible, The tie member preferably has one end which xs engageable with the 25 anchor mernbex an,d then e~ctends distally to a second end w'hy.ch is engageable with the capture membez~ located at or adjacent the proximal end of the xezx~o~rable ~zxeazxs of fine electrode array.
In another embodiment, the tie member can extend prox~i,melly from the removable means, around the anchor member and then back distally to a 34 secondary secured anchor mounted to the positioning member. In this embodiment, the tie member can move slidably around the arichox member upon movement of 'the actuator member relative to the handle.
In. another embodiment, the anchor member oan oomprlse a pulley rzxenxbex which xeceives the tie nxe;cxlbex. In, one embodiment, the secondary 3s secured anchor can be engaged with the pxoxizx~.al, en.d of the tie memlaer. The secondary secured anchor cari be ~x~ounted to the distal portion of the positiotxing member.
In another ez~,bodiment, the anchor mezxiber may be m~auz~ted on the actuator member. In this ezxxbodiment, the tie mexxxber preferably extends proximally from the xemavable means, around a pulley member or other tie zx~,ez~nber sliding member, and then back distally to the azxchor member.
'1'kxe pulley ixxex~.ber or other tie member sliding member can be xz~.ounted on the elongate positioning member. It will be appreciated that this member could also be mounted an the handle if fihe elongate pasitiazxing member is movable 1o relative to the handle. In this enibadizxxent, movement of the actuator member in the distal direci~axx xelative to the positianixtg znEmber results in the tie member withdrawing the removable means from the array.
pxefcrabl~r, the eslds of the tie member forth. secure connections ~nri.'tb.
the xespective anchor member and capture xxaeznber. Either or both connections may be made at any' stagE during the manufacture a~ the device of the presezxt invention or alternatively could be.me,de immediately prior t~a a surgical procedure by the surgeon.
The tie member :t'nay be connected in a number of ways. For example, in a preferred eixabodixnent, the anchor member and the capture member comprise hooks and the ends of the tie member farm, loops which may ex-ter~d over and engage with the anchor member- and the capture x~.en~.ber.
;A,ltexxxatively, the tie member may, in its entirety, form a single loop which at both ends extends over and engages with the anchor end aapfiure members.
.Alternatively, the tie member may include a bead xn.ember at each end such that the bead members engage with complementary structures on the anchor member and the capture member.
In a further embodiment, flxe azxchor member may_ also comprise a claazx~,el, said chazxzxel extextdio,g along at least a portion of the length t~f the positioning member. In this embodiment, the tie member is received within 3o the channel and may be retained therein by friction fit.
In a preferred embodirzxezxt, fibE ppsitioning member includes a slat at its distal End, said slot adapted to receive and engage a proximal end of the elec~:ode array. ~ a further embodiment, the slot is positioned in the distal portion of the positioning member, This enables ixxsertion of the electrode array into the cochlea. Once in position, the electrode array may be caused to slide from. this slot and into posi~on ~rvithin the cochlea of a subject.
Izx another embodiment, the distal portion of 'rhe positioning member may be ,pxovzded with an electrode array already znaunted thereon. For insertion into the cochlea of a subject, a suxgean xrvould assemble the dis'ral portion of the positioning muxxzbex, including the electrode array together with the handle. Izx tlxxs embodiment, the action of assembling tlxe various ooanponents together results in the proximal end t~f the tie rnezxlber engaging with the anchor means. ~ .
In another embodiment, the actuator member m~.y have a distal end adapted to engage with the electrode arxay. k'oz~ example, the distal end may 0 be fork-shaped azxd adapted to grip the carrier member of the array. Izx this embodiment, the actuator member preferably has a stopper ixxember at a position distal its distal ezxd. Tb,e stopper is preferably adapted to prevent the actuator member from moving 'beyond a predetermined distance xela'~.ve to the positioning member.
t.5 The actuator member of the present invention may comprise a slide member wlxi.clx is slxdably nlorrable along a length of the handle.
The slide member~'may be connected to the anchor member by a connector txae~.us which tuay aozx~.pz~se ~, nuxnbcx of structures including, but not limited to, a flexible cord, a solid rnd or altErnatively, a continuation of ~o the tie member described above. The latter embodiment is ezxvlsaged particularly where the anchor member acts as a pulley. The tie member would engage with and extend over the pulley to a connection paint w~i~x t3xe actuator member.
Tl~e aetuatox member xnay include at least one finger grip ~.e~aaber to 25 enable manipulatiozx by a suxgeozx.
Typically, the actuatax xaezxxber may be moved from a first location on the handle adjacent the positioning membEx to ~a secozxd location on the hazxdle distal the positioning member by the surgeon. Movement in this manner will cause fhe connection means to draw the anchor member, or in 3o certain eznbodi,zxxezits, the tie member. towards the handle.
In a preferred embodiment, the tie member is cann.ected to both the anchor member and the captuxe xxaerxzber of the removable means, such that drawing the ancliar memt~er tawaxds tlzt~ handle causes the removable zxxeaaxs to be withdrawn from the electrode array. Preferably, the actuator memlaer 3s moves relatively smoothly along a length, of fihe lxandle azxd without the need for application of a great an~.auzxt of pressure. In this way, a surgeon using the device of the ix~~re~xtxaii may xxaa~re the aGt~xatar nxe,uyber v~rith the same hand as holds the device. Tt is. envisaged that the actuator member may lie x~.aved by an index, ox other, ~ixager ox thumb o:f a suxgeaz~ usxrrg tb,e device.
The elongate carrzer of the electrode array rxiay be straight or curved.
s ~'uxtb,ex, the elaz~gate carrier member may be adapted to adopt a spiral cox~figuratian.
Preferably, the elongate carrier member has a first configuration selected td allow the electrode array to be inserted into the cochlea of a subject and at least a second configuration ~irhexein said electrode array 1o applies the preselected tissue stimulati,cr~. .A,s Xs desxxable to insert an electrode array irzta a cochleae in axr izxitially straight cc~nfiguratian, it xs preferred that the first configuration of the elecfirode array is substantially s'rxaxght_ Moreover, it is preferred that the elongate carrier member adopts a spi.xal car~figu~atia~vVhen in the second configuration.
15 The xezxxavable rneaus of the electrode array may be a stiffening means.
In this embodiment, the elongate carrier xoembar of tl~.e alectrade array has a lurn,en which receives fhe, removable stiffening means, the stifFexri.ng means having a configuration selected far biasing the elongate carrier member into the ~,xst configuration zo The elan~ate carriar member may be formed from, a~ resiliently flexible and biacompatible material. Furthermore, it is preferred 'h~.at the elozxgate carrier member is pxefarmecl from a plastics ~inaterial with memory and, moreover, is prefarmed to the second configux~ttiazx. fll,ternatively, the material may be a biacompatible silicone or suitable elastomeric material, z5 such as a polyuxe~khane.
In one embodiment, the stxffex~ing means may comprise a stiffening element formed ~xarn a non-biaresorbable material.. In, 'khis ert~bodiment, the stiffening element may caz~prise a metallic stylet extending through the receiving portion of the body of the elongate carrier member. Preferably, 'the 3o stylet is farmed from a 'biocompatible metal or metallic alloy. An example of s. suitable metal is platxzruzn.
The stiffenxxag element may be formed from a shape memory or heat sensitive material such as a bimetallic element or share memory alloy (such as nickel/ti.tanium~ and shaped to take a straight or substa~.tially straight 35 configuration at room temperature but which beads into another shape upon exposure to body temperature. , 1d The'lurnen of the elongate carraPx zz~.ember may extend at least Xz~to, and more preferably through, tl~e body of the elongate carrier rrlembex.
The assembly or device according to the respective aspects of the invention can furthex i~xclude a stiffening sheath thafi envelops the elongate camxex member of the electrode array. The sheath xaa~r be made of a material.
that is relatively stiffer then We material of the body of the elongate carrier member. Where used, the stiffening sh~a~ can, in combination with 'the stiffening element, act to bias the el,ox~gate carrier member i~.ta 'thE first configuration. Removal of either the stiffening element or stiffeili~xg sheath, ~1o in this embodiment, preferably results in the elongate carrier member adopting the fully curved seGazxd co~x~.guration desired of an implant fox x~xsert9.oz~ i~,ta the cochlea.
Erief Description of the Drawings Figure 1 is a side elevation ~ri.e~v of a device according to the present ix~ve~itzo~~,;
~'igure ~ is a side elevational and partly cut-away view of the device according to the laresent inveWon; -2o Figuxe 3 is a side elevational rrienr of anathEr embodiment of a device according to the present invention;
Figure 4 is a side elevatioiial vievu~ of still f~xrther ex~,badiment of a device according to the present invention; .
Figure 5 is a bottom view of yet another embadxznezat of the device of the present invention; and Figure a is a side view of the device of k'xguxe 5 in use.
Preferred lVlode of Carryin~ Out The Invention 3o One embodiment of an insertion device according to the present invention is depicted genexalJ,y as 3.p i,n Figure 2.
The device ZO con~pxises a handle ~3. and a~n elongate pasi~ion.xn.g n~,exxlber 1~. The positioni_n.g member 12 has a proximal portion ~.S and a distal portit~n 19 that extends to a distal end ~.3. ~'T'he distal portion 19 receives and supports an electrode a~Tay ~5 to alloznr positioning of the array 15 within a cochlea of a subject.
The device 1o further incl~.des an anchor 16 which is positia~.ed at a location, along the length of tb.e positioning member 12 and extends through a $],ot (not visible in Figuxe.2) in that membex. 'Z'hE anchor 16 is coun.ected to a finger actuable coeval '19 that exte~xd.s outwardly through. a slot in the handle 11 ~xom a slide member (not visible that extends through the lxandle '11 and the pxoximal portion 18 of the positioning membex ~.2 to the anchoz' '16.
Flecfrode array ~.~ includes an elr~ngate carrier 21 with a plurality of electrodes (not shown for reasons of claxxty) mounted thereon. The electrode axray '15 also includes a, stylet 22 which, in the gresent ernbc~diment, is 1o designed to keep the electrode array 15 in a straight configtuation wlxile it is being inserted into a cochlea of a subject. The starlet 22 has a capt-axe member 23 positioned at i,ts proximal end.
'1'h,e device of the present :invention includes a tie ataaember 31 which has a first end 32 and a second end 33. As depicted in Fig. 2, the first end is engageable wxtf~ anchor ~.6 and the seca~xd end 33 is engageeble with capture member 23 of the styl,et 22. Tie member 31 is preferably a flexible cord made from a suture-type material. Use of other wire materials, such as platinum wire oan also be.envisaged.
The tie member 31 ~.ay be connected in a number of Ways. Far 2o example, as depicted, the ends of '~a,e tie member 81 farm loops 34 which may extend over and engage respectively with anchor 16 and capttu'e member 23.
In. use, the finger actuabJ,e coeval ~7 is moved fromv a first location an handle 11 adjacent positioning mEx,~ber ~.2 to a second lacatic~n on the handle 11 distal the posxfii,oniug member 12. Movement in this tx~.avxxner will cause the rod member to draw the <xzxcl~or 1B relatively towards the handJ.e ~.1.
As depicted in Figure 2, the positioning member ~.2 comprises a proximal portion 1S located adjacent handle ~,~ and a distal portion ~$
extending froxx,~ said proximal portion '1S. The distal portion. ~.'~ is angled relative the proximal portion 18 and the handle 1~ such that when the device 10 is used to insert an electrode axxay x5, the distal portion 19~ does not obstruct the surgeon's ~riew of the cochlea. The distal portion 19 is further rotatably movable relative to the handle 11 and the proximal portion 7.8 such that when an electrode array 15 is lr~aded onto th,s distal. end W of positioning member ~~, rotation of the distal portion 19 will cha~xge the orientation of the electrode array 15 to a particular orientation suitable for an individual surgery.
As further shown. izx Figure 2, the anchor 1~ is positioned iv the region of the proximal portkozx ~.8 of the positioning nxember 12.
While, ~or clarity, rigiue 2 depicts the pie member 31 as fxee from the disfial portion 19 of the positioning member 12 it is try be understood that the, tie member 31 zzxay be received by a channel (xxot shown] in the distel.
portion 1~. The tie member 31 can be re'kaiz~Ed within the channel by friction fit or alternatively rzxay be loosely contained within the confines of the charxrrel.
The distal portp.on 19 fuxther includes a slot (not shawl.) that is adapted to receive and engage a proximal end 24 of the electxade array 15. This 'i0 provides a means to introduce the elecfirode array 15 into the eao~.l.ea of a subject Izx use, it is preferred that the electrode array 15 is inserted into the cochlea in a straight configuration and when within the cochlea, caused to take on a spiral configuration, 'This is often achieved by providing the electrode arxey with a straightena.ng stylet 22. As the electrode array 15 is advanced into the cochlea, a surgeon will typically simultaneously withdraw the stylet 22 such that the array 15 is free to take oz~ its spiral configuration., the preferred configuration of an electrode array ~nrhen in position within a cochlea.
The stylet is removed by the surgeon using the Finger actuable control 1~ to move the slide relative to the handle in a directic~ri depicted by A, which in turn draws anchor 16 toward handle 11. P~.s the tie member 81 is con,zxected to both the anchor 16 and the stylet ~2, the stylet 22 is gradually pulled free from the electfode array 15. The ezxtire device is then withdrawtx z5 slov~rly from the surgical site. ThE electrode array z5 is retained ~vith~i~, the cochlea due to the slight spring force of its pre-curved shape which is greater than the slight friction fit of the electrode array 15 in the slot of the distal.
porti4n 19. The electrode array 15 therefore slidos cut of the distal portion as the device 1~ is withdrawn.
80 In an alternative arrangement depicted in Figure s, floe device 50 is essentially' identical to device ~.0 except that the tie member 31 extends proximally from its connection with the stylet ~2, around the anchor member 1Q and then extend$ distally before being secured to a secondary secured anchor 85. On using the device 50. refraction df the actuable control 17 35 results in tlxe tie zxxezxrl~er 3~. slidi~xg around the aizchor 16. h1.
essence, the anchor '16 acts as a pulley member. $ecause of the advantage provided by the anchor ~.G, a movement of ~ mm of the control 17 results i.ra. a movement of 2X mm of the stylet 22. This is advantageous as it decreases the necessary finger movement by the surgeon during use of the device. For example, the control 17 need ozxly be.,x~xorred relaUive to the handle 1'i by a distazxce of l~mm to cause the stylet to move a distance of 32mm.
Figure 4 depicts a further embodiment of the device designated as 60.
fn the case of device E0, the actuable controlwnember 71 comprises a cylindrical member 7~ positioned outside and relatively movable to the handle z1. The cylindrical member 72 has an an~.~xlai fizxge~r abutment o zxzexnbex 73 that, i,n use, carx be pulled back relative to the handle by the index and middle fingers of the surgeon, In this regard., the device 60 can be gripped in a manner similar to that used to grip and contra?. a syringe, with the thumb 78 used to stabilise the end of the handle 12. As depicted, the tie member 31 extends proximally from its connection with the styles 2z 'through the i.~,side of the positionizxg member 7~ to an anchor member 7~ conn.ected to the cylindrical member 72. In the depicted embodiment, the positioning member 94 is mounted to the handle 11 but is relatively rc~tatable therefio.
I~, use, the tie member 31 would be firstly fed through the hallow positioning member ~4 'to load the electrode array ~.5 into a stot formed adjacent its distal e~,d, 77. The pos~.ti,onxng z~,~xx~.ber 74 ~nrotxld then be mounted on the handle 11 and rotated relative thereto so as to be at the orientation desired for the surgery. The control 71 would then be slid fox~nrard to a,n end stop such that the anchor meter 7~ is relatively close to the distal end of the handle 11. The loop ~~ at txze proxi,zxzal end of the tie member 31 can then be engaged with the anchor member 76. The device 6U
can then be held in a syringe-style manner with the thumb 78 vn the proximal end of the handle 17. and the index and middle fingers ~9 an the control 7x. 'phe device can then be moved relatively forward to commence insertion of the array ~5 through the cocb,lec~stc~zx~y. 'Z'he coxy,trr~l 71 can then 30, be moved relatively praxim.ally to the handle 11 using the index and middle fingers 79 tQ witl7.draw the stylet 22 from its lumen within the array 15.
~Jnce xz~sertian is complete, the device GO can be urithdra~vn, leaving the array ~.5 in place within the cochlea. .
Two insertion techniques ara availeble through use t~f the device ~o. In the standard iusextion technique, the electrode array I5 is inserted fuhy and then the styles 22 is withdrawn. In another technique, the array ~5 can be inserted until the distal tip of the array 15 is near the lack of the basal turn of the cochlea- Ozxce there, the stylet 22 can begin to be withdraws by moving the control ~~ relatively proximally while still contizxuizzg to advance the array zz~,to the cochlea using the device 60. Using this fiechnique, the electrode array ~5 preferably follows a trajectory which is aloe ar near the middle of the lumen of the scala tympaz~i o~ the cochlea. This avoids or lessens pxessuxe on the outside (lateral) wall of the cochlea.
A~,c~tb,ex de~rice arrangement is depicted generally as 8a in Figures 5 and fi. Tn this arrangement, the actaatar member cc~rz~prisas a push rod 8~.
2o extending distally from a distal erzd of s. haxldle $~. The push rod 81 extends through a positioning member in the form of guide tube 83 alxd ends in a fork 84. As depicted in Figure 6, the fork 84 can grip the pxt~xxtxlal end of the-electxade a,xxsy ~5. '~lxe electrode Ieads 15a of the array 15 extend out of the guide tube through a slot 88 farmed adjacexxt the distal. end of the lobe 83.
The device 80 includes a stopper 85 on the push rod 8'1 that comes i.~,to abutment with the proximal end of the guide tube 88 if the push rod $~. is moved xzz a pxaxix~.al directxazx ralatxvc to the guide tube s3.
(fin mounting of the array 15 within the guide tube 83 and into the txzxes of the fork s4, the tie member 31 is conl7.ected to the device 8~ as depicted in 2o k'iguxe ~. The tie member 31 extends proximally fron~z its ssco~.d end 33 connected to the capture member 23 of the s~t~rlet: The tie member extends around a pulley member 86 mounted on the guide tube 83 and bath dist2~lly to an anchor 87 on the push rod 8'1. The anchor 87 extends outwardly through a slot formed in the guide tube 83.
During use, the device 80 15 used to advance the array into the cochleostozxxy. Unce the distal end of the guide tube 83 stops on the bone around the cochleastomy, the push rod S'1 cazl be advanced further to push the array 15 out of the guide tube 8'1. This results in the anchor 8T waving farwardly relatively to tire pulley 88 so causing the stylet to be wxthdra'wn 3o from the array 15. Each 1mm movement forward 'of the push rod 81 results i~, a 2zxxxn withdrawal of the stylet from the array 15.
An advantage of device $o is that the stylet is automatically withdrawn on advancement of the arra~r ~L5 :i~. tc~ the cochtlea.
One of the further ~ad~az~,tages of the present invention is that tha electrode array ~5 is readily removable from the insertion device prior to use.
This is advantageous as it is envisaged That some surgeons may choose not to usp the device or find it unsuitabre far use in certain circumsta~.ces. Ta remove the electrode azxa~r, the surgeon needs simply to cut the tie meml~ex 31 and carefully remove the array ~.a from the positioning member ~.2. 't7~nce removed, the azra~r can be inserted by hand, using standard devices such as 5 je'tnrellexy forceps.
Zt ~vxl,J. be appreciated by persons skilled zx~ the art that numerous variations and/or modifications may be rn,ade tQ the invention as shown in fine specific embodiments without departing from the spirit or scope of the invention as broadly described. The present embc~di~xze~,ts are, therefore, to 10 be considered in alI respects as illustrative an,~1 not restrictive.
Claims
CLAIMS:
1. ~A device for inserting an electrode array into a cochlea of a subject, the electrode array having an elongate carrier member and a removable means extending through the carrier member for at least a portion thereof,the device including a handle, an elongate positioning member mounted to the handle, an actuator member movable relative to the elongate positioning member,and at least one anchor member connected to the actuator member and engageable with the removable means, wherein on insertion of the electrode array into a subject's cochlea, the actuator member can be moved relative to the elongate positioning member to withdraw the removable means from the carrier member.
2.~The device of claim 1 adapted to insert an electrode array having a removable means positioned therein, wherein the removable means has a capture member located at or adjacent a proximal end of the removable means.
3. The device of claim 1 or claim 2 wherein the positioning member comprises a proximal portion located adjacent the handle and a distal portion extending from said proximal portion to a distal end 4. ~The device of any one of the preceding claims wherein the anchor member is positioned in the proximal portion or the distal portion of the positioning member.
5. The device of any one of claims 1 to 3 wherein the anchor member is positioned on the actuator member.
6. The device of any one of the preceding claims wherein the anchor member is adapted to engage with a tie member extending from the removable means of the electrode array.
7. The device of claim 6 wherein the tie member is a flexible member made from a biocompatible material.
8. The device of claim 6 or claim 7 wherein the tie member has one end which is engageable with the anchor member and then extends distally to a second end which is engageable with the capture member located at or adjacent the proximal end of the removable means of the electrode array.
9. The device of claim 6 wherein the tie member extends proximally from the removable means, around the anchor member and then back distally to a secondary secured anchor mounted to the positioning member.
10. The device of any one of the preceding claims wherein the actuator member has a distal end adapted to engage with the electrode array.
11. ~The device of claim 10 wherein the actuator member has a stopper member at a position distal its distal end said stopper member adapted to prevent the actuator member from moving beyond a predetermined distance relative to the positioning member.
12. The device of any one of the preceding claims wherein the actuator member comprises a slide member which is slidably movable along a length of the handle.
13. The device of any one of the preceding claims wherein the slide member is connected to the anchor member by a connector means.
15. The device of claim 13 wherein the connector means is selected from a flexible cord, a solid rod or a continuation of the tie member.
16.~An electrode array for insertion into a cochlea of a subject, the electrode array including an elongate carrier member having a plurality of electrodes mounted thereon and a removable means extending through the carrier member for at least a portion thereof, the removable means further having a capture member positioned at or adjacent a proximal end of the removable means.
17. The electrode array of claim 14 wherein the removable means is a stylet adapted to substantially straighten the electrode array along its length during insertion of said electrode array towards a cochlea.
18. A method of inserting an electrode array into a cochlea of a subject and, further, removing a removable means of the electrode array following insertion using a device of the first aspect, the method including the steps of:
(a) loading an electrode array having a removable means onto the positioning member;
(b) connecting one end of a tie member to the anchor member and another end of the tie member to the removable means of the electrode array;
(c) gradually introducing the electrode array into the cochlea; and (d) causing or allowing the removable means to be relatively withdrawn from the electrode array.
10. The device of any one of the preceding claims wherein the actuator member has a distal end adapted to engage with the electrode array.
11. The device of claim 10 wherein the actuator member has a stopper member at a position distal its distal end said stopper member adapted to prevent the actuator member from moving beyond a predetermined distance relative to the positioning member.
12, The device of any one of the preceding claims wherein the actuator member comprises a slide member which is slidably movable along a length of the handle.
13. The device of any one of the preceding claims wherein the slide member is connected to the anchor member by a connector means.
15. The device of claim 13 wherein the connector means is selected from a flexible cord, a solid rod or a continuation of the tie member.
16. An electrode array for insertion into a cochlea of a subject, the electrode array including an elongate carrier member having a plurality of electrodes mounted thereon and a removable means extending through the carrier member for at least a portion thereof, the removable means further having a capture member positioned at or adjacent a proximal end of the removable means.
17. The electrode array of claim 14 wherein the removable means is a stylet adapted to substantially straighten the electrode array along its length during insertion of said electrode array towards a cochlea.
18. A method of inserting an electrode array into a cochlea of a subject and, further, removing a removable means of the electrode array following insertion using a device of claim 1, the method including the steps of:
(a) loading an electrode array having a removable means onto the positioning member;
(b) connecting one end of a tie member to the anchor member and another end of the tie member to the removable means of the electrode array;
(c) gradually introducing the electrode array into the cochlea; and (d) causing or allowing the removable means to be relatively withdrawn from the electrode array.
1. ~A device for inserting an electrode array into a cochlea of a subject, the electrode array having an elongate carrier member and a removable means extending through the carrier member for at least a portion thereof,the device including a handle, an elongate positioning member mounted to the handle, an actuator member movable relative to the elongate positioning member,and at least one anchor member connected to the actuator member and engageable with the removable means, wherein on insertion of the electrode array into a subject's cochlea, the actuator member can be moved relative to the elongate positioning member to withdraw the removable means from the carrier member.
2.~The device of claim 1 adapted to insert an electrode array having a removable means positioned therein, wherein the removable means has a capture member located at or adjacent a proximal end of the removable means.
3. The device of claim 1 or claim 2 wherein the positioning member comprises a proximal portion located adjacent the handle and a distal portion extending from said proximal portion to a distal end 4. ~The device of any one of the preceding claims wherein the anchor member is positioned in the proximal portion or the distal portion of the positioning member.
5. The device of any one of claims 1 to 3 wherein the anchor member is positioned on the actuator member.
6. The device of any one of the preceding claims wherein the anchor member is adapted to engage with a tie member extending from the removable means of the electrode array.
7. The device of claim 6 wherein the tie member is a flexible member made from a biocompatible material.
8. The device of claim 6 or claim 7 wherein the tie member has one end which is engageable with the anchor member and then extends distally to a second end which is engageable with the capture member located at or adjacent the proximal end of the removable means of the electrode array.
9. The device of claim 6 wherein the tie member extends proximally from the removable means, around the anchor member and then back distally to a secondary secured anchor mounted to the positioning member.
10. The device of any one of the preceding claims wherein the actuator member has a distal end adapted to engage with the electrode array.
11. ~The device of claim 10 wherein the actuator member has a stopper member at a position distal its distal end said stopper member adapted to prevent the actuator member from moving beyond a predetermined distance relative to the positioning member.
12. The device of any one of the preceding claims wherein the actuator member comprises a slide member which is slidably movable along a length of the handle.
13. The device of any one of the preceding claims wherein the slide member is connected to the anchor member by a connector means.
15. The device of claim 13 wherein the connector means is selected from a flexible cord, a solid rod or a continuation of the tie member.
16.~An electrode array for insertion into a cochlea of a subject, the electrode array including an elongate carrier member having a plurality of electrodes mounted thereon and a removable means extending through the carrier member for at least a portion thereof, the removable means further having a capture member positioned at or adjacent a proximal end of the removable means.
17. The electrode array of claim 14 wherein the removable means is a stylet adapted to substantially straighten the electrode array along its length during insertion of said electrode array towards a cochlea.
18. A method of inserting an electrode array into a cochlea of a subject and, further, removing a removable means of the electrode array following insertion using a device of the first aspect, the method including the steps of:
(a) loading an electrode array having a removable means onto the positioning member;
(b) connecting one end of a tie member to the anchor member and another end of the tie member to the removable means of the electrode array;
(c) gradually introducing the electrode array into the cochlea; and (d) causing or allowing the removable means to be relatively withdrawn from the electrode array.
10. The device of any one of the preceding claims wherein the actuator member has a distal end adapted to engage with the electrode array.
11. The device of claim 10 wherein the actuator member has a stopper member at a position distal its distal end said stopper member adapted to prevent the actuator member from moving beyond a predetermined distance relative to the positioning member.
12, The device of any one of the preceding claims wherein the actuator member comprises a slide member which is slidably movable along a length of the handle.
13. The device of any one of the preceding claims wherein the slide member is connected to the anchor member by a connector means.
15. The device of claim 13 wherein the connector means is selected from a flexible cord, a solid rod or a continuation of the tie member.
16. An electrode array for insertion into a cochlea of a subject, the electrode array including an elongate carrier member having a plurality of electrodes mounted thereon and a removable means extending through the carrier member for at least a portion thereof, the removable means further having a capture member positioned at or adjacent a proximal end of the removable means.
17. The electrode array of claim 14 wherein the removable means is a stylet adapted to substantially straighten the electrode array along its length during insertion of said electrode array towards a cochlea.
18. A method of inserting an electrode array into a cochlea of a subject and, further, removing a removable means of the electrode array following insertion using a device of claim 1, the method including the steps of:
(a) loading an electrode array having a removable means onto the positioning member;
(b) connecting one end of a tie member to the anchor member and another end of the tie member to the removable means of the electrode array;
(c) gradually introducing the electrode array into the cochlea; and (d) causing or allowing the removable means to be relatively withdrawn from the electrode array.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AUPR3800A AUPR380001A0 (en) | 2001-03-19 | 2001-03-19 | Insertion tool system for an electrode array |
| AUPR3800 | 2001-03-19 | ||
| AUPR6688 | 2001-07-30 | ||
| AUPR6688A AUPR668801A0 (en) | 2001-07-30 | 2001-07-30 | Cochlear implant electrode array insertion tool |
| PCT/AU2002/000333 WO2002074211A1 (en) | 2001-03-19 | 2002-03-19 | Insertion tool system for an electrode array |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2414898A1 true CA2414898A1 (en) | 2002-09-26 |
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ID=25646621
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002414898A Abandoned CA2414898A1 (en) | 2001-03-19 | 2002-03-19 | Insertion tool system for an electrode array |
Country Status (5)
| Country | Link |
|---|---|
| US (2) | US7063708B2 (en) |
| EP (1) | EP1370205B1 (en) |
| JP (2) | JP4105953B2 (en) |
| CA (1) | CA2414898A1 (en) |
| WO (1) | WO2002074211A1 (en) |
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| US7917220B2 (en) | 2006-08-30 | 2011-03-29 | Med-El Elektromedizinische Geraete Gmbh | System, apparatus, and method for facilitating interface with laryngeal structures |
| US9108054B2 (en) | 2013-06-12 | 2015-08-18 | Med-El Elektromedizinische Geraete Gmbh | Method for modifying larynx position by trans-positioning muscle and electrode stimulation |
| US9409014B2 (en) | 2013-06-12 | 2016-08-09 | Med-El Elektromedizinische Geraete Gmbh | Method for modifying larynx position by trans-positioning muscle and electrode stimulation |
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| DE10018334C1 (en) * | 2000-04-13 | 2002-02-28 | Implex Hear Tech Ag | At least partially implantable system for the rehabilitation of a hearing impairment |
| WO2002074211A1 (en) * | 2001-03-19 | 2002-09-26 | Cochlear Limited | Insertion tool system for an electrode array |
| US7050858B1 (en) | 2001-04-06 | 2006-05-23 | Advanced Bionics Corporation | Insertion tool for placement of electrode system inside the cochlear lumen |
| US8843216B2 (en) | 2001-12-10 | 2014-09-23 | Cochlear Limited | Control of shape of an implantable electrode array |
| US7792586B2 (en) * | 2002-02-22 | 2010-09-07 | Cochlear Limited | Insertion device for an electrode array |
| AU2003901852A0 (en) * | 2003-04-16 | 2003-05-01 | Cochlear Limited | Cochlear electrode array |
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| US7917220B2 (en) | 2006-08-30 | 2011-03-29 | Med-El Elektromedizinische Geraete Gmbh | System, apparatus, and method for facilitating interface with laryngeal structures |
| US8136532B2 (en) | 2006-08-30 | 2012-03-20 | Med-El Elektromedizinische Geraete Gmbh | System, apparatus, and method for facilitating interface with laryngeal structures |
| US8380313B2 (en) | 2006-08-30 | 2013-02-19 | Med-El Elektromedizinische Geraete Gmbh | System, apparatus, and method for facilitating interface with laryngeal structures |
| US8430860B2 (en) | 2006-08-30 | 2013-04-30 | Med-El Elektromedizinische Geraete Gmbh | System, apparatus, and method for facilitating interface with laryngeal structures |
| US8460270B2 (en) | 2006-08-30 | 2013-06-11 | MED-EL Elektromedizinische Gerete GmbH | System, apparatus, and method for facilitating interface with laryngeal structures |
| US8788036B2 (en) | 2006-08-30 | 2014-07-22 | Med-El Elektromedizinische Geraete Gmbh | Method for facilitating interface with laryngeal structures |
| US9108054B2 (en) | 2013-06-12 | 2015-08-18 | Med-El Elektromedizinische Geraete Gmbh | Method for modifying larynx position by trans-positioning muscle and electrode stimulation |
| US9409014B2 (en) | 2013-06-12 | 2016-08-09 | Med-El Elektromedizinische Geraete Gmbh | Method for modifying larynx position by trans-positioning muscle and electrode stimulation |
Also Published As
| Publication number | Publication date |
|---|---|
| US20030171758A1 (en) | 2003-09-11 |
| JP4105953B2 (en) | 2008-06-25 |
| US7063708B2 (en) | 2006-06-20 |
| EP1370205A1 (en) | 2003-12-17 |
| JP2008100097A (en) | 2008-05-01 |
| JP4922141B2 (en) | 2012-04-25 |
| EP1370205B1 (en) | 2013-08-14 |
| US8460315B2 (en) | 2013-06-11 |
| WO2002074211A1 (en) | 2002-09-26 |
| US20060058861A1 (en) | 2006-03-16 |
| JP2004518513A (en) | 2004-06-24 |
| EP1370205A4 (en) | 2006-06-14 |
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| Date | Code | Title | Description |
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| EEER | Examination request | ||
| FZDE | Discontinued |