WO2008058336A1 - Dispositif d'introduction d'électrodes à force progressive - Google Patents

Dispositif d'introduction d'électrodes à force progressive Download PDF

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Publication number
WO2008058336A1
WO2008058336A1 PCT/AU2007/001756 AU2007001756W WO2008058336A1 WO 2008058336 A1 WO2008058336 A1 WO 2008058336A1 AU 2007001756 W AU2007001756 W AU 2007001756W WO 2008058336 A1 WO2008058336 A1 WO 2008058336A1
Authority
WO
WIPO (PCT)
Prior art keywords
insertion member
lumen
electrode array
longitudinal force
array according
Prior art date
Application number
PCT/AU2007/001756
Other languages
English (en)
Inventor
John Chambers
Original Assignee
Cochlear Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from AU2006906380A external-priority patent/AU2006906380A0/en
Application filed by Cochlear Limited filed Critical Cochlear Limited
Priority to DE212007000074U priority Critical patent/DE212007000074U1/de
Publication of WO2008058336A1 publication Critical patent/WO2008058336A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—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

Definitions

  • the present invention relates generally to an implantable electrode array for use with an implantable medical device, and in particular, to an implantable electrode array for an implantable hearing prosthesis.
  • a variety of implantable medical devices have been proposed to deliver controlled electrical stimulation to a region of a subject's body to perform a desired function.
  • One such device which has been successful in providing hearing sensation to individuals with sensorineural hearing loss has been a cochlear implant.
  • cochlear implant For individuals with sensorineural hearing loss, there is damage to or an absence of hair cells within the cochlea which convert acoustic signals into nerve impulses which are perceived by the brain as sound.
  • Such individuals are unable to derive suitable benefit from conventional hearing aid systems, and hence rely upon cochlear implants to provide them with the ability to perceive sound.
  • Cochlear implant devices typically comprise external and implanted internal components that cooperate with each other to provide sound sensations to an individual.
  • the external component traditionally includes a microphone that detects sounds, such as speech and environmental sounds, a speech processor that selects and converts certain detected sounds, particularly speech, into a coded signal, a power source such as a battery, and an external transmitter antenna.
  • the coded signal output by the speech processor is transmitted transcutaneously to an implanted receiver/stimulator unit, commonly located within a recess of the temporal bone of the individual.
  • This transcutaneous transmission occurs via the external transmitter antenna which is positioned to communicate with an implanted receiver antenna disposed within the receiver/stimulator unit.
  • This communication provides transmission of the coded sound signal while also providing power to the implanted receiver/stimulator unit.
  • this link has been in the form of a radio frequency (RF) link, although other communication and power links have been proposed and implemented with varying degrees of success.
  • RF radio frequency
  • the implanted receiver/stimulator unit also includes a stimulator that processes the coded signal and outputs an electrical stimulation signal to an intra-cochlea electrode assembly mounted to a carrier member.
  • the electrode assembly has a plurality of electrodes that apply electrical stimulation to the auditory nerve to produce a hearing sensation corresponding to the original detected sound.
  • the present invention is an implantable electrode array of a tissue stimulating device comprising: a carrier member having one or more tissue stimulating electrodes; a lumen wall defining a lumen extending at least a portion of the length of the carrier member; and an insertion member having a proximal end and a distal end and being receivable within the lumen, said insertion member being arranged to receive a longitudinal force applied at or adjacent said proximal end; wherein said lumen and said insertion member are configured such that when said longitudinal force is applied in a first direction the insertion member engages said lumen wall to advance said carrier member relatively into a location in said tissue and further wherein when said longitudinal force is applied in a second different direction
  • the tissue stimulating device can be a cochlear implant and the location can comprise the interior of the cochlea of a subject.
  • the present invention is a method of inserting an electrode array into a cochlea of a subject, the electrode array comprising: a carrier member having one or more electrodes arranged thereon for applying stimulation to said cochlea; a lumen wall defining a lumen extending at least a portion of the length of the carrier member; and an insertion member having a proximal end and a distal end and being receivable within the lumen, the method comprising: placing said electrode array into said cochlea; applying a first longitudinal force to the insertion member such that the insertion member engages the lumen wall to further relatively advance the carrier member into the cochlea; applying a second longitudinal force to the insertion member, said second longitudinal force being at least generally opposite to said first longitudinal force to relatively retract the insertion member at least partially from said lumen; and reapplying said first and said second longitudinal forces to the insertion member until said insertion member is fully withdrawn from the lumen.
  • FIG. 1 is a simplified pictorial representation of a prior art cochlear implant system
  • FIG. 2 is a simplified representation of the friction forces associated with inserting a electrode array of a prior art cochlear implant system
  • FIG. 3 is a perspective view of an electrode array in accordance with an embodiment of the present invention.
  • FIG. 4 is an enlarged cross-sectional view of the insertion member and lumen arrangement of FIG. 3;
  • FIG. 5 is a simplified representation of the friction forces associated with inserting an electrode array of the present invention.
  • FIG. 6 is a cross-sectional view of an alternative embodiment of an electrode array of the present invention.
  • FIGS. 7 A - 7E show the steps of manufacturing the electrode carrier of the present invention in accordance with one embodiment
  • FIGS. 8 A - 8 C show steps for forming the insertion member of the present invention in accordance with one embodiment
  • FIGS. 9A - 9B show steps for shaping the insertion member of the present invention in accordance with one embodiment.
  • FIG. 10 show the insertion member in accordance with one embodiment of the present invention following the shaping steps of FIGS. 9 A - 9B.
  • Known cochlear implant devices typically consist of two main components, an external component including a speech processor 29, and an internal component including an implanted receiver and stimulator unit 22.
  • the external component includes a microphone 27.
  • the speech processor 29 is, in this illustration, constructed and arranged so that it can fit behind the outer ear 11. Alternative versions may be worn on the body. Attached to the speech processor 29 is a transmitter coil 24 which transmits electrical signals to the implanted unit 22 via a radio frequency (RF) link.
  • RF radio frequency
  • the implanted component includes a receiver coil 23 for receiving power and data from the transmitter coil 24.
  • a cable 21 extends from the implanted receiver and stimulator unit 22 to the cochlea 12 and terminates in an electrode array 20. The signals thus received are applied by the array 20 to the basilar membrane 8 and the nerve cells within the cochlea 12 thereby stimulating the auditory nerve 9.
  • the operation of such a device is described, for example, in U.S. Pat. No. 4,532,930.
  • the cochlear implant electrode array 20 comprises an elongate carrier having a plurality of electrodes provided thereon at intervals along the carrier. Because the cochlea 12 is tonotopically mapped, that is, partitioned into regions each responsive to stimulus signals in a particular frequency range, the electrode array 20 is typically positioned such that each electrode delivers a stimulating signal to a particular region of the cochlea 12. In the conversion of sound to electrical stimulation, frequencies are allocated to individual electrodes of the electrode array 20 that lie in positions in the cochlea 12 that are close to the region that would naturally be stimulated in normal hearing. This enables the device to bypass the hair cells in the cochlea 12 to directly deliver electrical stimulation to auditory nerve fibres, thereby allowing the brain to perceive hearing sensations resembling natural hearing sensations.
  • the tonotopic nature of the cochlea 12 results in the basal end of the cochlea 12 being best responsive to high frequency sounds and the apical end of the cochlear 12 being best responsive to low frequency sounds. Failure to position the electrode array 20 in a manner which accesses and stimulates the basal region and the apical region of the cochlea 12 can limit the effectiveness of the cochlear implant and the individual's ability to discern and interpret a variety of speech patterns and sounds. The depth of insertion of the electrode array 20 into the cochlea 12 can be important to ensure that maximum benefit is obtained by the device. Whilst the array 20 of FIG.
  • the array 20 is ideally inserted deeply into the cochlear 12 to apply stimulation to the apical region where necessary.
  • the extent to which the electrode array 20 is introduced into the cochlea is limited largely by the finite size of the electrode array 20 and the opposing factional forces which arise from its factional contact with the internal walls of the cochlea 12. Any such insertion must also desirably avoid any or relatively significant trauma or damage to tissue structures within the cochlea.
  • the magnitude of the currents flowing from each electrode and the intensity of the corresponding electric field being generated are a function of the distance between the electrodes and the tissue being stimulated. If the distance is relatively great, the magnitude of the current required to illicit a response must be larger than if the distance is relatively small. Moreover, the current from each electrode may flow in all directions, and the electrical fields corresponding to adjacent electrodes may overlap, thereby causing cross-electrode interference. In order to reduce the stimulation amplitude and to eliminate cross-electrode interference, it is advisable to keep the distance between the electrode array 20 and the tissue as small as possible. This is best accomplished by providing the electrode assembly in an electrode array 20 which generally conforms to the shape of the cochlea.
  • FIG. 2 shows a diagrammatical representation of a prior art electrode array 20 being inserted into a cochlea (here represented by 33).
  • the electrode array 20 comprises a carrier 30 having a plurality of electrodes (not shown) provided thereon.
  • the electrodes are typically arranged adjacent an internal surface thereof, such that when the array 20 is positioned within the cochlea 33, the electrodes are located proximal the inner wall of the cochlea 33, adjacent the nerve cells to be stimulated.
  • the carrier 30 is typically formed in a curved state that is straightened for insertion through the use of a straightening stylet 32.
  • the straightening stylet 32 is inserted into a lumen extending substantially the length of the carrier 30.
  • the straightened carrier 30 is inserted as deeply into the cochlea 33 as possible.
  • the stylet 32 is withdrawn from the carrier 30 thereby allowing the carrier 30 to assume its final pre-curved state, wherein the electrodes are positioned adjacent the inner wall of the cochlea.
  • Such movement will generally result in back and forth movement of the carrier 30 within the cochlea due to the fact that the coupling friction between the stylet and the lumen of the carrier 30 is substantially symmetrical and distributed substantially uniformly between location A andiocatT ⁇ ln BIs " sh ⁇ wnT " Hence, relatively cleeper insertion of the ca ⁇ e ⁇ ⁇ intb the cochlea is generally not possible and in many instances, withdrawal of the stylet may result in a degree of retraction of the carrier from the cochlea.
  • FIG. 3 represents one embodiment of an electrode array 40 of the present invention.
  • the electrode array 40 comprises an elongate carrier 42 having a plurality of electrodes 41 provided along a surface thereof.
  • Each of the electrodes 41 are connected to an implanted stimulator unit of the type as described in relation to FIG. 1, by way of one or more wires (not visible) which deliver the stimulation current that is to be applied to the cochlear at the appropriate electrode 41.
  • a lumen 45 extends substantially the length of the carrier 42 and can receive an insertion member 44.
  • the insertion member 44 and lumen 45 arrangement is shown more clearly in the magnified view provided by FIG. 4.
  • the distal end of the insertion member 44 is shaped to define one or more stepped regions or teeth 46 which extend radially from the insertion member 44.
  • the insertion member 44 may be in the form of a semi-rigid, single filament wire which is formed in a manner as discussed in more detail below.
  • the lumen 45 is shaped to substantially conform to the shape of the stepped regions or teeth 46 of the insertion member 44, with the internal walls of the lumen having recessed portions 47 formed therein.
  • the recessed portions 47 define a series of peaks and troughs which form a substantially saw-tooth profile as shown.
  • the internal walls of the lumen 45 are able to expand/contract to facilitate insertion of the insertion member 44 into the lumen 45 prior to insertion of the electrode assembly 40 into the cochlea.
  • the asymmetric teeth-like shaping of the contact surfaces of the lumen and insertion member create a directionally dependent, mechanical contact friction characteristic that is aligned primarily to their longitudinal axis. This allows the mechanical force conveyed to the carrier member to be greater during insertion than withdrawal, which thereby facilitates deeper insertion of the carrier member within the cochlea.
  • further progressive insertion is possible so as to achieve deeper insertion and positioning of the electrode array 40. This is achieved through repeated withdrawal and re-insertion of the insertion member 44.
  • Applying a longitudinal insertion force to the insertion member 44 causes the stepped regions or teeth 46 located on the distal end of the insertion member 44 to engage with the recessed portions 47 formed in the internal walls of the lumen 45 to advance the electrode array 40.
  • the stepped regions or teeth 46 of the insertion member 44 apply a longitudinal axial compressive force to the peaks of the recessed portions 47 of the lumen of the carrier 42 that increases the internal lumen 45 diameter to allow the insertion member 44 to withdraw a given amount. This in turn reduces withdrawal friction between the insertion member 44 and the lumen 45 thereby relatively reducing the likelihood of the electrode array 40 being withdrawn during the withdrawal action of the insertion member 44.
  • the stepped regions or teeth 46 of the insertion member 44 are again received within the troughs of the recessed portions 47 formed in the walls of the lumen 45, thereby gripping the walls of the lumen such that the longitudinal acting insertion force progressively relatively propels the electrode array 40 further into the cochlea.
  • the insertion force applied to the insertion member is conveyed to the electrode array 40 by the friction generated when the stepped regions or teeth 46 of the insertion member engage with the walls of the lumen 45. This in turn generates a resulting tensional force applied to the electrode array 40, causing the lumen 45 to narrow and engage the teeth 46 of the insertion member more strongly.
  • the electrode array 40 is progressively inserted deeper into the cochlea through repeated withdrawal and insertion of the insertion member 44. As shown in FIG. 5, the insertion force applied to the insertion member 44 at location A' is conveyed along its axis to the electrode array 40 at location B' due to asymmetric factional engagement of the insertion member 44 with the lumen 45. Once the electrode array 40 has achieved a desired depth, the insertion member 44 is then completely removed from the lumen 45.
  • FIG. 6 An alternative embodiment of an electrode array 50 of the present invention is shown in FIG. 6.
  • the electrode array 50 comprises an elongate carrier 52 upon which a plurality of stimulating electrodes (not shown) are positioned.
  • the carrier 52 is made from a flexible material, such as a silicone rubber, having a lumen 55 that extends substantially the length of the carrier 52 and provides a space within the carrier which receives an insertion member 54.
  • the outer radius 51 of the lumen 55 is provided with a series of recesses 57 which together form a series of peaks and troughs resembling a saw-tooth configuration.
  • a distal end of the insertion member 54 is provided with a projection
  • the projection 56 in the form of a tooth that substantially conforms to the shape of the recesses 57 formed in the outer radius 51 of the lumen 55.
  • the projection 56 does not extend radially from the insertion member 54 but extends from an outer side of the insertion member 54, proximal the outer radius 51 of the lumen 55.
  • FIGS 7A-7E show one embodiment of the steps required to form the carrier 42 of the electrode array 40.
  • a mould plug 60 having a shape that conforms to the desired shape of the lumen 45 is located inside a cavity mould 62 in the manner as shown.
  • the mould plug 60 has a hollow centre 60a extending the length thereof, and the cavity mould 62 is internally coated with a mould release agent as is known in the art.
  • the cavity mould 62 has an inlet 61 and an outlet 63.
  • the carrier material 64 is injected into the cavity mould 62 through the inlet 61, such that the carrier material flows in the direction of the arrows as shown.
  • the carrier material 64 may be a silicone rubber, or other similar flexible material, having a suitable flow rate to flow about the mould plug 60.
  • FIG. 1C following injection of the carrier material 64 and setting of the carrier material 64 about the mould plug 60, the cavity mould 62 is removed and the mould plug 60 and carrier material 64 is placed within an expansion guard 65, as shown.
  • the expansion guard 65 has an internal cavity greater than the internal cavity of the cavity mould 62.
  • an end of the mould plug 60 is attached to a pressurised fluid source such that pressurised fluid, for example air, is admitted into the hollow centre 60a of the mould plug 60, in the direction of the arrow as shown.
  • pressurised fluid for example air
  • the pressurised fluid travels along the hollow centre 60a and is forces out the opposing end of the mould plug 60, thereby causing the moulded carrier material 64 to expand away from the external surface of the mould plug 60, such that the mould plug 60 can be removed from the carrier material 64.
  • This then leaves behind a finished carrier core member 66 having an internal lumen 68 shaped as desired, as is shown in FIG. 7E.
  • the carrier core member 66 as shown in FIG. 7E forms the central core of the carrier around which the wiring and stimulating electrodes are assembled.
  • the manner in which the electrodes and corresponding wiring is assembled to the carrier body is known in the art and will not be discussed in any more detail.
  • the internal lumen 68 is shaped to substantially conform to at least a portion of an insertion member.
  • One method of forming a suitable insertion member will now be described in relation to FIGS. 8 A -8C and FIGS. 9 A and 9B.
  • the insertion member is formed from a wire 71 as shown in FIG. 8B.
  • the depicted wire 71 is a platinum metal wire. It could also be formed from another medical grade material, such as stainless steel.
  • the wire has a degree of rigidity along its length such that a force applied at an end thereof will be longitudinally transferred to the opposing end of the wire 71.
  • a tube element 72 with axial hole 72A (FIG. 8A) is positioned on an end of the wire 71 as shown in FIG. 8C.
  • the tube element 72 is in the depicted embodiment made from the same material as the wire 71, here platinum metal. Following positioning on the wire 71, the tube element 72 is secured in position through a swaging process or the like. This creates an elongate member 73 in the form of a wire 71 having an enlarged tubular element 72 formed at an end thereof.
  • the tube element 72 of the elongate member 73 is placed in a shaping mechanism 74, as is shown in FIGS. 9A and
  • the shaping mechanism 74 comprises two fixed position rollers 75 and a moveable roller 76 which are positioned about the tube element 72 of the elongate member 73.
  • the tube element 72 of the elongate member 73 is positioned between the fixed rollers 75 and the moveable roller 76 is moved in the direction of the arrow such that the tube element 72 is in contact with each of the rollers.
  • a limiting disc 77 is provided on each of the shafts 78 of the rollers 75, 76. The limiting discs 77 limit the distance through which the acting pressure may r be applied by the rollers 75, 76 against the tube element 72, which controls the final shape and dimensions of the tube element 72.
  • the surface of the rollers 75, 76 determines the final shape of the tube element 72 and this process is largely independent of any mechanical slack that may exist in the bearing mechanism supporting the rollers 75, 76. As shown in FIG. 10, the process enables an insertion member 79 to be formed, such that the tube element 72 in FIG. 8A becomes affixed or swaged to elongate member 73 in FIG. 8B.

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  • Health & Medical Sciences (AREA)
  • Otolaryngology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne un réseau d'électrodes (40) implantables d'un dispositif de stimulation de tissu. Le réseau (40) comprend un élément de support (42) ayant une ou plusieurs électrodes (41) de stimulation de tissu. Une paroi de lumière définissant une lumière (45) s'étend au moins sur une partie de la longueur de l'élément de support (42). Un élément d'introduction (44) ayant une extrémité proximale et une extrémité distale peut être logé à l'intérieur de la lumière (45) et est disposé pour recevoir une force longitudinale appliquée ou adjacente à son extrémité proximale. La lumière (45) et l'élément d'introduction (44) sont configurés de telle sorte que, lorsque la force longitudinale est appliquée dans une première direction, l'élément d'introduction (44) vient au contact de la paroi de lumière pour faire avancer l'élément de support (42) de façon relative dans le tissu. Ils sont également configurés de telle sorte que, lorsque la force longitudinale est appliquée dans une seconde direction différente, l'élément d'introduction (44) est relativement rétractable à partir de ladite lumière (45).
PCT/AU2007/001756 2006-11-15 2007-11-15 Dispositif d'introduction d'électrodes à force progressive WO2008058336A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
DE212007000074U DE212007000074U1 (de) 2006-11-15 2007-11-15 Elektrodeneinführhilfe zur schrittweisen Krafteinwirkung

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AU2006906380A AU2006906380A0 (en) 2006-11-15 Progressive force electrode inserter
AU2006906380 2006-11-15

Publications (1)

Publication Number Publication Date
WO2008058336A1 true WO2008058336A1 (fr) 2008-05-22

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PCT/AU2007/001756 WO2008058336A1 (fr) 2006-11-15 2007-11-15 Dispositif d'introduction d'électrodes à force progressive

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WO (1) WO2008058336A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019108210A1 (fr) * 2017-11-30 2019-06-06 Advanced Bionics Ag Élément raidisseur à fentes pour faciliter l'insertion d'un fil d'électrode dans la cochlée d'un patient

Citations (5)

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Publication number Priority date Publication date Assignee Title
WO1999011321A1 (fr) * 1997-09-02 1999-03-11 Advanced Bionics Corporation Electrode cochleaire dont le systeme d'enserrement de la columelle inclut un positionneur souple
US6321125B1 (en) * 1998-08-26 2001-11-20 Advanced Bionics Corporation Cochlear electrode system including distally attached flexible positioner
US6397110B1 (en) * 1998-08-26 2002-05-28 Advanced Bionics Corporation Cochlear electrode system including detachable flexible positioner
US6438425B1 (en) * 1999-10-12 2002-08-20 Medtronic, Inc. Textured silicone tubing for electrical pacing leads
US20050251237A1 (en) * 2004-05-10 2005-11-10 Advanced Bionics Corporation Implantable electrode, insertion tool for use therewith, and insertion method

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4532930A (en) 1983-04-11 1985-08-06 Commonwealth Of Australia, Dept. Of Science & Technology Cochlear implant system for an auditory prosthesis

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999011321A1 (fr) * 1997-09-02 1999-03-11 Advanced Bionics Corporation Electrode cochleaire dont le systeme d'enserrement de la columelle inclut un positionneur souple
US6321125B1 (en) * 1998-08-26 2001-11-20 Advanced Bionics Corporation Cochlear electrode system including distally attached flexible positioner
US6397110B1 (en) * 1998-08-26 2002-05-28 Advanced Bionics Corporation Cochlear electrode system including detachable flexible positioner
US6438425B1 (en) * 1999-10-12 2002-08-20 Medtronic, Inc. Textured silicone tubing for electrical pacing leads
US20050251237A1 (en) * 2004-05-10 2005-11-10 Advanced Bionics Corporation Implantable electrode, insertion tool for use therewith, and insertion method

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019108210A1 (fr) * 2017-11-30 2019-06-06 Advanced Bionics Ag Élément raidisseur à fentes pour faciliter l'insertion d'un fil d'électrode dans la cochlée d'un patient
US11433246B2 (en) 2017-11-30 2022-09-06 Advanced Bionics Ag Slotted stiffening member for facilitating an insertion of an electrode lead into a cochlea of a patient
US11969603B2 (en) 2017-11-30 2024-04-30 Advanced Bionics Ag Slotted stiffening member for electrode lead insertion

Also Published As

Publication number Publication date
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