Patent Grant
12156676
Hearing loss, which may be due to many different causes, is generally of two types: conductive and sensorineural. Sensorineural hearing loss is due to the absence or destruction of the hair cells in the cochlea that transduce sound signals into nerve impulses. Various hearing prostheses are commercially available to provide individuals suffering from sensorineural hearing loss with the ability to perceive sound. One example of a hearing prosthesis is a cochlear implant.
Conductive hearing loss occurs when the normal mechanical pathways that provide sound to hair cells in the cochlea are impeded, for example, by damage to the ossicular chain or the ear canal. Individuals suffering from conductive hearing loss may retain some form of residual hearing because the hair cells in the cochlea may remain undamaged.
Individuals suffering from hearing loss typically receive an acoustic hearing aid. Conventional hearing aids rely on principles of air conduction to transmit acoustic signals to the cochlea. In particular, a hearing aid typically uses an arrangement positioned in the recipient's ear canal or on the outer ear to amplify a sound received by the outer ear of the recipient. This amplified sound reaches the cochlea causing motion of the perilymph and stimulation of the auditory nerve. Cases of conductive hearing loss typically are treated by means of bone conduction hearing aids. In contrast to conventional hearing aids, these devices use a mechanical actuator that is coupled to the skull bone to apply the amplified sound.
In contrast to hearing aids, which rely primarily on the principles of air conduction, certain types of hearing prostheses commonly referred to as cochlear implants convert a received sound into electrical stimulation. The electrical stimulation is applied to the cochlea, which results in the perception of the received sound.
It is noted that in at least some instances, there is utilitarian value to fitting a hearing prosthesis to a particular recipient. In some examples of some fitting regimes, there are methods which entail a clinician or some other professional presenting sounds to a recipient of the hearing prosthesis such that the hearing prosthesis evokes a hearing percept. Information can be obtained from the recipient regarding the character of the resulting hearing percept. Based on this information, the clinician can adjust or otherwise establish settings of the hearing prosthesis such that the hearing prosthesis operates according to these settings during normal use.
It is also noted that the electrode array of the cochlear implant generally shows utilitarian results if it is inserted in a cochlea.
In accordance with an exemplary embodiment, there is a device, comprising an insertion tool including an insertion guide that is flexible in a direction lying in at least a plane lying on a longitudinal axis thereof, the insertion guide having a slit and/or a gap extending in the longitudinal direction, the plane extending through the slit and/or gap, wherein the guide configured to maintain a pre-curved electrode assembly in a substantially straight configuration while preventing the electrode assembly from twisting in response to stresses induced by bias forces which urge the assembly to return to its pre-curved configuration, when the insertion guide is flexed in the plane.
In an exemplary embodiment, there is a device, comprising an insertion tool including an elongate insertion guide that is flexible in a direction lying in at least a plane lying on a longitudinal axis thereof, wherein the device is an insertion tool for a cochlear electrode array, and the insertion guide is configured to flex in the plane such that a neutral axis is located substantially away from the longitudinal axis.
In an exemplary embodiment, there is a device, comprising an insertion tool including an elongate insertion guide having a channel through which a cochlear electrode assembly is driven to insert such into a cochlea with electrodes of the assembly aligned within the channel, wherein the insertion guide includes flats inside the channel of the insertion guide that prevent rotation of the electrode array, wherein the flats are located facing one another on opposite sides of the channel, and wherein the insertion tool is configured such that the electrodes of the electrode assembly are located equidistant from the flats when the electrode array is driven through the channel.
Embodiments are described below with reference to the attached drawings, in which:
The exemplary cochlear implant illustrated in
Internal components 144 comprise an internal receiver unit 132 including a coil 136 of the TET system, a stimulator unit 120, and an elongate stimulating lead assembly 118. Internal receiver unit 132 and stimulator unit 120 are hermetically sealed within a biocompatible housing commonly referred to as a stimulator/receiver unit. Internal coil 136 of receiver unit 132 receives power and stimulation data from external coil 130. Stimulating lead assembly 118 has a proximal end connected to stimulator unit 120, and extends through mastoid bone 119. Lead assembly 118 has a distal region, referred to as electrode assembly 145, a portion of which is implanted in cochlea 140.
Electrode assembly 145 can be inserted into cochlea 140 via a cochleostomy 122, or through round window 121, oval window 112, promontory 123, or an opening in an apical turn 147 of cochlea 140. Integrated in electrode assembly 145 is an array 146 of longitudinally-aligned and distally extending electrode contacts 148 for stimulating the cochlea by delivering electrical, optical, or some other form of energy. Stimulator unit 120 generates stimulation signals each of which is delivered by a specific electrode contact 148 to cochlea 140, thereby stimulating auditory nerve 114.
Electrode assembly 145 may be inserted into cochlea 140 with the use of an insertion tool.
Insertion guide tube 210 is mounted on a distal region of an elongate staging section 208 on which the electrode assembly is positioned prior to implantation. A handle 202 is attached to the staging section 208, to be gripped by fingers and/or tweezers, etc. in some embodiments, instead of a handle, a robotic arm adapter is mounted to a proximal end of staging section 208 to facilitate attachment of the guide to a robot, which adapter includes through holes through which bolts can be passed so as to bolt the guide 200 to a robotic arm.
During use, electrode assembly 145 is advanced from staging section 208 to insertion guide tube 210 via ramp 206. After insertion guide tube 210 is inserted to the appropriate depth in cochlea 140, electrode assembly 145 is advanced through the guide tube to exit distal end 212 as described further below.
As shown in
As noted, electrode assembly 145 is biased to curl and will do so in the absence of forces applied thereto to maintain the straightness. That is, electrode assembly 145 has a memory that causes it to adopt a curved configuration in the absence of external forces. As a result, when electrode assembly 145 is retained in a straight orientation in guide tube 300, the guide tube prevents the electrode assembly from returning to its pre-curved configuration. This induces stress in electrode assembly 145. Pre-curved electrode assembly 145 will tend to twist in insertion guide tube 300 to reduce the induced stress. In the embodiment configured to be implanted in scala tympani of the cochlea, electrode assembly 145 is pre-curved to have a radius of curvature that approximates the curvature of medial side of the scala tympani of the cochlea. Such embodiments of the electrode assembly are referred to as a perimodiolar electrode assembly, and this position within cochlea 140 is commonly referred to as the perimodiolar position. In some embodiments, placing electrode contacts in the perimodiolar position provides utility with respect to the specificity of electrical stimulation, and can reduce the requisite current levels thereby reducing power consumption.
As shown in
Conventional insertion guide tubes typically have a lumen dimensioned to allow the entire tapered electrode assembly to travel through the guide tube. Because the guide tube is able to receive the relatively larger proximal region of the electrode assembly, there will be a gap between the relatively smaller distal region of the electrode assembly and the guide tube lumen wall. Such a gap allows the distal region of the electrode assembly to curve slightly until the assembly can no longer curve due to the lumen wall.
Returning to
This is illustrated in
As shown in
As shown in
Tube wall 658 in section 620 has surfaces 644 and 646 which extend radially inward to form a guide channel 680. Specifically, a superior flat 644 provides a substantially planar lumen surface along the length of section 620. As shown in
As noted, electrode assemblies are longitudinally tapered to accommodate the increasingly larger cross-sectional dimensions of an electrode assembly 145 as it passes through guide channel 680, insertion guide tube 610 has a longitudinal seam 660 as shown in
Once electrode assembly 145 is inserted into cochlea 140, insertion guide tube 610 is retracted over electrode assembly 145. The expanded insertion guide tube 610 is to be withdrawn from cochlea 140 and therefore is to pass through the cochleostomy, oval or round window. In a round window insertion, for example, splayed insertion guide tube 610 is to pass through round window aperture 708.
As electrode assembly 145 is advanced through insertion guide tube 610, the tendency of the assembly to twist decreases. This is due to the increasingly greater portion of the electrode assembly which has been deployed, the relatively larger dimensions of the proximal regions of the assembly, and the relatively smaller bias force in the proximal region as compared to the distal region of the assembly. Thus, as the cross-sectional size of the assembly passing through guide channel 680 increases, the tendency of the electrode assembly to twist decreases. Referring again to
As shown in
In section 620 there is a minimal gap, if any, between flats 644, 646 and electrode assembly 145.
In an exemplary embodiment, insertion guide tube 610 is made of polyimide, and the flats comprise silicone molded in the tube. Other materials can be utilized in other embodiments. In some embodiments, the flats and guide tube are unitary.
Accordingly, some embodiments detailed herein and/or variations thereof are directed towards an insertion guide having an insertion guide tube that maintains a perimodiolar or other pre-curved electrode assembly in a substantially straight configuration while preventing the electrode assembly from twisting in response to stresses induced by the bias force which urges the assembly to return to its pre-curved configuration. This can be utilitarian in that such can improve the likelihood that when the electrode assembly is deployed from the distal end of the insertion guide tube, the electrode assembly and insertion guide tube have a known relative orientation.
Thus, in an exemplary embodiment, the guide is partially segmented at a plurality of locations that extend about the longitudinal axis and extend through the plane only on one side of the longitudinal axis (e.g., the locations of the segments do not reach the longitudinal gap/slit). In an exemplary embodiment, the guide includes a slit and/or a gap extending parallel to the longitudinal axis and guide is partially segmented at a plurality of locations that extend about the longitudinal axis and no segments that extend about the longitudinal axis extend to the gap and/or slit.
In an exemplary embodiment, the surfaces that form the slit and/or gap that extends parallel to the longitudinal axis all lie on respective planes.
In an exemplary embodiment, the respective surfaces that establish the longitudinal extending sides of the slit and/or gap are continuous surfaces (concomitant with embodiments where the openings do not cross the slit/gap). This is as opposed to an embodiment where the openings cross the slit and/or gap, in which case the respective surfaces that establish the longitudinal extending sides of the slit and/or gap are not continuous surfaces, but instead are surfaces that are divided. Indeed, where the openings extend to the slit and/or gap, the respective surfaces that establish the longitudinal sides are divided and are not contiguous with each other. This is as opposed to the embodiments where the openings do not extend to the slits and/or gap, where the longitudinal sides of the slits are one surface, and can be characterized by plurality of sub-units that are all contiguous with each other (i.e., a given longitudinal side has a total surface area, and if that service area was arbitrarily divided up into subunits, the various subunits would be contiguous with each other).
In an exemplary embodiment, insertion guide tube 810 is made of polyimide. The slit and/or gap is laser cut, in some embodiments.
While the embodiments detailed above have represented the openings as gaps in the wall of the guide,
Embodiments can include various spacings of the gaps and/or slits, both with respect to the distance between each other and with respect to establishing the width of the opening.
As noted above, in at least some exemplary embodiments, the openings in the tube are always spaced away from the slit and/or gap. This is as differentiated from, for example, the design represented by
It is noted that while the embodiments of
It is also noted that in at least some exemplary embodiments, the widths of the openings are not uniform, but instead can vary.
In an exemplary embodiment, providing the slits and/or gaps such that they extend from one side of the guide to the other side of the guide along the bottom of the guide can have utilitarian aspect of moving the neutral bending axis away from the longitudinal axis of the guide. In this regard, with respect to
It is noted that any bending detailed herein refers to flexible bending/bending in an elastic manner, as opposed to a plastic manner, or at least bending that, for the most part, is elastic. Material will sometimes have a memory of being bent, and will not return to the totally unbent position without some form of additional force. That is still flexible bending. In an exemplary embodiment, when the tube is bent according to at least some scenarios herein, at least 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 59, 96, 97, 98, 99 or 100% of the bending will dissipate upon relieving the force that cause the bending.
Also,
In an exemplary embodiment, with respect to imaginary planes that are normal to the longitudinal axis, which planes are located every 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 or 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 mm or any value or range of values therebetween in 0.1 mm increments, the tube is symmetrical about an axis that extends from the top to the bottom. Also, in some embodiments, for those planes, the tube is not symmetrical about an axis that extends left to right through the center of the tube.
Thus, in view of the above, it can be seen that in an exemplary embodiment, there is an insertion tool including an insertion guide that is flexible in a direction lying in at least a plane lying on a longitudinal axis thereof, the insertion guide having a slit and/or a gap extending in the longitudinal direction, the plane extending through the slit and/or gap, wherein the guide is configured to maintain at least a portion of a pre-curved electrode assembly in a substantially straight configuration (some non-straightness can exist—this is detailed below) while preventing the electrode assembly from twisting in response to stresses induced by bias forces which urge the assembly to return to its pre-curved configuration, when the insertion guide flexibly bent in the plane. In an exemplary embodiment, the portion of the pre-curved electrode assembly that is maintained in a substantially straight configuration is the portion located in the tube, or at least a portion located in a portion of the tube.
In an exemplary embodiment, the insertion guide can correspond to the tubes as detailed herein and/or variations thereof. Accordingly, in an exemplary embodiment, at least a portion of the guide that is flexible can be made of a polymer and/or can be made of a metal-based material. Providing that the tube is flexible and can bend according to at least some of the bending regimes detailed herein, such can be utilized to enable the teachings detailed herein.
Thus, as can be see, there is a device, comprising an insertion tool including an elongate insertion guide that is flexible in a direction lying in at least a plane lying on a longitudinal axis thereof, wherein the device is an insertion tool for a cochlear electrode array, and the insertion guide is configured to flex in the plane such that a neutral axis is located substantially away from the longitudinal axis. In an exemplary embodiment, the guide has a maximum outer radius lying on a plane normal to the longitudinal axis measured from the longitudinal axis, and the neutral axis is at least 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95% or more of the distance of the maximum outer radius from the longitudinal axis when measured on the plane. In an exemplary embodiment, the guide has a maximum outer radius lying on a plane normal to the longitudinal axis measured from the longitudinal axis, and the neutral axis is at least X % of the distance of the maximum outer radius from the longitudinal axis when measured on the plane, where X is 30, 35, 40, 45, 50, 55, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99% or more or any value or range of values therebetween in 0.1% increments (e.g., 55.3% to 88.8%, 75.3%, etc.). In an exemplary embodiment, the neutral axis is within the top and bottom of the slit/gap (or an extrapolated profile thereof). In an exemplary embodiment, the neutral axis is within less than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39 or 40% of the maximum outer radius from the longitudinal axis from the outside of the tube and/or within a distance from the outside of the tube that corresponds to less than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 45, 50, 55, 60, 65, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 225, 250, 275, 300, 325, 350, 375, 400, 450, 500, 550 or 600 percent of the minimum thickness of the tube.
In any event, as can be seen from
In an exemplary embodiment, the insertion tool is configured such that the tube can bend according to any one or more of the bending scenarios detailed herein, as will be described in greater detail below in some instances, such that the change in the length along the surface(s) of the slit and/or gap relative to that in the relaxed state/unbent state/straight state is less than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 percent.
With respect to
In the exemplary embodiment of
In an exemplary embodiment, the arrangements detailed herein can provide, in some instances, a structure that results in little to no twist when bent. In this regard, in an exemplary embodiment, now with reference to
It is noted that embodiments include tubes that meet the aforementioned movement requirements for 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30 or more locations, which locations can be spaced according to the plane locations detailed above, the limiting factor being the length of the tube.
In view of the above, in an exemplary embodiment, the guide is configured such that the amount of twisting is limited (including no twisting) when bent. By way of example only and not by way of limitation, with respect to any of the aforementioned locations, an amount of rotation/twisting relative to a relaxed/straight/unbent state is less than 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30 degrees. It is also noted that in an exemplary embodiment, for any one or more of these locations, the amount of twist/rotation does not change by more than any of the aforementioned values in a longitudinal direction within and/or more than 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 or 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 mm on one or both sides. By way of example only and not by limitation, in an exemplary embodiment, the aforementioned phenomenon can be measured by, for example, creating imaginary planes that are normal to the longitudinal axis, which planes are located every 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 or 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 mm or any value or range of values therebetween in 0.1 mm increments. The locations can be scribed or otherwise identified, and then the tube can be bent according to the angles detailed herein, and then the movement of these locations can be compared to that which was the case prior to bending. Again, two or three or four more different planes can be compared to one another, and the relative change from one to the other can be evaluated. In this regard, the aforementioned consistencies can be present over two or three or four or five or six or seven or eight or nine or 10 or 11 or 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20 of the planes spaced as just detailed, the limiting factor being the length of the tube. It is noted that embodiments include tubes that meet the aforementioned movement requirements for 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30 or more locations, which locations can be spaced according to the plane locations detailed above, the limiting factor being the length of the tube.
In an exemplary embodiment, including or not including the ramp, the length of the flats of the anti-twist section can be more than, less than and/or about equal to 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 2.7, 3.8, 3.9, 4.0, 4.25, 4.5, 4.75, 5, 5.25, 5.5, 5.75, 6, 6.5, 7, 7.5, 8.0, 8.5, 9, 9.5, 10, 11, 12, 13, 14 15 mm or more or any value or range of values therebetween in 0.01 mm increments.
It is noted that the embodiment shown in
Anti-twist section 620 can, in some embodiments, cause a twisted electrode assembly traveling through guide tube 610 to return to its un-twisted state, and retains the electrode assembly in a straight configuration such that the orientation of the electrode assembly relative to the insertion guide tube 2210 does not change.
Electrode assembly 145 has a rectangular cross-sectional shape, with the surface formed in part by the surface of the electrode contact, referred to herein as top surface 650, and the opposing surface, referred to herein as bottom surface 652, are substantially planar. These substantially planar surfaces are utilized in embodiments of the insertion guide tube described herein.
Tube wall 658 in anti-twist section 620 has sections 2244 and 2246 which extend radially inward to form an anti-twist guide channel 680. Specifically, a flat 2244 provides a substantially planar lumen surface along the length of section 620. As shown in the figures, the flat 2244 has a surface 2245 that is substantially planar and which therefore conforms with the substantially planar side of electrode assembly 145. Similarly, flat 2246 has a surface that is substantially planar which conforms with the substantially planar opposite surface of electrode assembly 145 (the referenced surfaces of the assembly are normal to the top surface which has the electrode and the bottom surface, in this embodiment). As shown in
In some embodiments, due to the anti-twist guide channel 680, electrode assembly 145 is unable to twist to relieve the stress caused by the inability of the electrode assembly to assume its pre-curved configuration. This is illustrated in
As noted, electrode assemblies are sometimes longitudinally tapered to accommodate the increasingly larger cross-sectional dimensions of an electrode assembly 145 as it passes through anti-twist guide channel 680, insertion guide tube 2210 has a longitudinal seam 660 (also referred to herein as a slit, and, on other embodiments, 660 is a gap). This seam enables insertion tube 2210 to splay open in a manner analogous to that seen in
Once electrode assembly 145 is inserted into cochlea 140, insertion guide tube 610 is retracted over electrode assembly 145. The expanded insertion guide tube 2210 is to be withdrawn from cochlea 140 and therefore is to pass through the cochleostomy, oval or round window. In a round window insertion, for example, splayed insertion guide tube 2210 is to pass through round window aperture 708.
It is noted that while the embodiments detailed herein depict the electrodes of the electrode array facing the slit/gap, in other embodiments, the array is inserted into the guide such that the electrodes face the opposite, and are located furthest away from the slit/gap.
As electrode assembly 145 is advanced through insertion guide tube 2210, the tendency of the assembly to twist decreases. This is due to the increasingly greater portion of the electrode assembly which has been deployed, the relatively larger dimensions of the proximal regions of the assembly, and the relatively smaller bias force in the proximal region as compared to the distal region of the assembly. Thus, as the cross-sectional size of the assembly passing through guide channel 680 increases, the tendency of the electrode assembly to twist decreases. Referring again by analogy to
Lumen 640 has a height which is greater than the analogous height of the distal region of electrode assembly 145. This space is dimensioned to receive the wider electrode assembly as the larger proximal region passes through guide channel 680.
In anti-twist section 620 there is a minimal gap, if any, between flats 2244, 2246 and electrode assembly 145, thereby enabling anti-twist guide channel 680 to closely control the orientation of the assembly, as noted above. Should a region of electrode assembly 145 located in proximal section 624 be partially twisted relative to a region that is in anti-twist guide channel 680, ramps 2248 (there are two—only one is shown) facilitate the rotation of the assembly as it enters the guide channel. This eliminates the relative twist of this region relative to a more distal region of the assembly. This places the surfaces of the assembly in parallel with the corresponding surfaces of the flats thereby enabling the assembly to continue through anti-twist guide channel 680. In other words, for the assembly to travel through guide channel 680, it is utilitarian for the assembly to be substantially straight. As the assembly travels up the ramps, the ramp facilitates the rotation of the assembly to enable the assembly to enter guide channel 680.
In an exemplary embodiment, insertion guide tube 2210 is made of Nitinol, and the flats comprise silicone molded in the tube. Other materials can be utilized in other embodiments. In some embodiments, the flats and guide tube are unitary. Further, in an exemplary embodiment, the slit and/or gap and/or openings are cut utilizing laser cutting. Any arrangement that can enable the fabrication of embodiments according to the teachings detailed herein can be utilized in at least some exemplary embodiments.
The counter-forces 702, 704 are applied such that the forces are offset from the center of the electrode assembly. In this regard, at least in embodiments where the cross-sectional shape of the electrode assembly is not perfectly circular, flats 2244, 2246 can impart a counter-force to the electrode assembly without substantially relying on friction between the assembly and flats. Such may be the case for electrode assemblies having an elliptical cross-section or the like, etc.
In an exemplary embodiment, the guide is configured such that, for at least some electrode arrays there is a method of insertion of the electrode array such that the electrode array is a perimodal array/a curly/curved array, and the array is straightened while in the tube of the guide, and thus is in a non-relaxed state. In an exemplary embodiment, an amount of twist about the longitudinal axis at a given location of the electrode array along the longitudinal axis of the electrode array at locations within the tube while in the tube is no more than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30 degrees. In an exemplary embodiment, for a location on an imaginary plane normal to a longitudinal axis of the array and on a surface thereof, the location does not change by more than any of the aforementioned angles. In an exemplary embodiment, the aforementioned phenomenon can be measured by, for example, creating imaginary planes that are normal to the longitudinal axis, which planes are located every 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 or 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 mm or any value or range of values therebetween in 0.1 mm increments. The locations can be scribed or otherwise identified, and then the tube can be bent according to the angles detailed herein, and then the rotation at these locations relative to the longitudinal axis can be compared to that which was the case prior to insertion into the tube. It is noted that in at least some exemplary embodiments, twisting at one location can be compared to twisting at another, similarly situated location, along the array. Again, two or three or four more different planes can be compared to one another, and the relative change from one to the other can be evaluated. In this regard, the aforementioned consistencies can be present over two or three or four or five or six or seven or eight or nine or 10 or 11 or 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20 of the planes spaced as noted above, the limiting factor being the length of the array. It is noted that embodiments include methods of insertion that meet the aforementioned movement requirements for 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30 or more locations, which locations can be spaced according to the plane locations detailed above, the limiting factor being the length of the array.
It is noted that the aforementioned twisting/rotation features can be measured relative to a location along the longitudinal direction of the tube. By way of example only and not by way of limitation, any of the aforementioned rotation/twisting features can be measured at a location on the electrode array that is located, relative to, for example, a plane that lies on the most distal location and/or the most proximal location of the flats and/or the anti-rotation clip (described below) and/or a plane that lies in between these aforementioned locations, such as about 30, 35, 40, 45, 50, 55, 60, 65, 70 percent of the distance between these locations (forward and/or rearward). In an exemplary embodiment, the length of the clip can be more than, less than and/or about equal to 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 2.7, 3.8, 3.9 or 4.0 mm or any value or range of values therebetween in 0.01 mm increments.
In an exemplary embodiment, the clip increases a clamping force against the sides of the electrode array by at least 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 2.7, 3.8, 3.9, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 or more times relative to that which would be the case in the absence of the clip, all other things being equal.
It is noted that in at least some exemplary embodiments, the guide is configured so that the array can bow with respect to a plane extending from the top to the bottom of the tube. In this regard, in an exemplary embodiment, the electrode array is permitted some curvature when in the tube. In this regard, with reference to
Conversely, it is noted that in an exemplary embodiment, the array bows laterally left word and right word by an amount no more than 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 or 30 degrees, as measured according to any of the measurements detailed above.
Alternatively, and/or in addition to the above, the tube can be configured such that it has a pre-curved/pre-bent shape when in the relaxed state. In this regard, in an exemplary embodiment, such a tube can allow the array to curve/bow in the plane detailed above by the aforementioned amounts. Accordingly, in an exemplary embodiment, the tube is configured such that, in its relaxed state, the tube bends in the bottom-top plane by an amount more than, less than or equal to about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, or 40 degrees or any value or range of values therebetween in increments of 0.1 degrees, as measured between two locations that are greater than or about equal to 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, or 40 mm away from each other or any value or range of values therebetween in 1 mm increments. That said, in an exemplary embodiment, the tube can be configured to curve or otherwise bow when loaded by any of the aforementioned amounts. That is, in an exemplary embodiment, in the relaxed state, the tube can be straight, but when loaded with an electrode array, the tube can bow in the top bottom plane. In an exemplary embodiment, when loaded, the tube can bow in the top bottom plane by an amount more than, less than or equal to about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39 or 40 degrees or any value or range of values therebetween in increments of 0.1 degrees, as measured between two locations that are greater than or about equal to 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, or 40 mm away from each other or any value or range of values therebetween in 1 mm increments.
With reference to
To be clear, in an exemplary embodiment, the electrode array is an array that has, in its relaxed state, a curvature of at least 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 110, 120, 130, 140, 150, 160, 170, 180 or more degrees, as measured based on two local longitudinal axes at two spaced away locations, such as locations according to any of those detailed herein. That said, some embodiments include the utilization of the insertion guide on a straight array.
While many of the embodiments described above presented openings bounded by surfaces at 90° angles, in some other embodiments, the openings are bounded at least in part by curved surfaces. In this regard,
In an exemplary embodiment, the tube is configured to enable bending more in one lateral plane than in another lateral plane normal thereto. By way of example only and not by way of limitation, with respect to bending in the lateral plane that extends from top to bottom (the plane depicted in
Note that in an exemplary embodiment, the clip does not bend or otherwise bends relatively little. In this regard, in an exemplary embodiment, a flexible material is located over the inboard portions of the legs (e.g., the flat material), and this material compresses to a degree that is greater than the deflection of the legs, if any. Thus, the clip maintains the compression force against the electrode array, and the material of the flats provide the “give” as the array widens.
In an exemplary embodiment, the portion of the tube that extends past the stop 204 is longer than some of the embodiments detailed above. In an exemplary embodiment, the distance from the front face of the stop 204 to the most distal end of the tube is less than, more than or about equal to 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, or 60 mm or more or any values or range of values therebetween in 0.1 mm increments (e.g., about 22.4 mm, 28.1 mm, 15.1 to 39.3 mm, about 15.1 to about 39.3 mm, etc.). In an exemplary embodiment, the tube can be configured such that the angle of total bending (from the front face of the stop to the tip) the tube can subtend an angle that is less than, more than or about equal to 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 45, 50, 55, 60, 65, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 225, 250, 275, 300, 325, 350, 375, 400, 425, 450 degrees or more or any values or range of values therebetween in 1 degree increments, and such can meet one or more or all of the above noted features herein.
In view of the above, it can be seen that in an exemplary embodiment, there is a device, wherein at least a portion of the guide that is flexible is made of a polymer body reinforced with a metal-based material, or at least a stiffer body. Also, as can be seen above, in an exemplary embodiment, there is a device where the guide includes at least a first part and a second part, wherein the first part is configured to enable the array to flex beyond that which would be the case if the first part was the same as the second part, and the second part is configured to maintain the pre-curved electrode assembly in a substantially straight configuration while preventing the electrode assembly from twisting in response to stresses induced by bias forces which urge the assembly to return to its pre-curved configuration, when the insertion guide is flexibly bent in the plane. By way of example only and not by way of limitation, in an exemplary embodiment, the proximal section 624 of the insertion guide tube can enable the electrode array to flex beyond that which is the case in the anti-twist section 620. In an exemplary embodiment, the electrode array can flex/bend such that relative angles of the local longitudinal axis of the array can have a difference from each other in the proximal section (such as the maximum relative angle) that less than, more than, or about equal to 110, 115, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, 180, 185, 190, 195, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 325, 350, 375, 400, 450, 500, 550, 600, 650, 700, 750, 800, 850, 900, 1000, 1100, 1250, 1500 percent or more or any value or range of values therebetween in 1% increments than relative angles (such as the maximum relative angle) of the local longitudinal axis of the array in the anti-twist section.
Also, in an exemplary embodiment, there is a device, wherein the guide includes at least a first part and a second part, the first part being configured to enable the array to twist beyond that which would be the case if the first part was the same as the second part and the second part is configured to maintain the pre-curved electrode assembly in a substantially straight configuration while preventing the electrode assembly from twisting in response to stresses induced by bias forces which urge the assembly to return to its pre-curved configuration, when the insertion guide is flexibly bent in the plane. In an exemplary embodiment, the electrode array can twist such that relative angles about the local longitudinal axis of the array can have a difference from each other in the proximal section (such as the maximum relative angle) that less than, more than, or about equal to 110, 115, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, 180, 185, 190, 195, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 325, 350, 375, 400, 450, 500, 550, 600, 650, 700, 750, 800, 850, 900, 1000, 1100, 1250, 1500 percent or more or any value or range of values therebetween in 1% increments than relative angles (such as the maximum relative angle) about the local longitudinal axis of the array in the anti-twist section.
It is noted that at least some exemplary embodiments of the teachings detailed herein include methods of inserting an electrode array, such as a perimodiolar array and/or a lateral wall array and/or a mid-scala array, into a cochlea, using an insertion tool having at least one or more of the features disclosed herein. Further, in an exemplary embodiment, the methods results in an electrode array having a final perimodiolar position, a mid-scala position or a lateral wall position, within the cochlea. In an exemplary embodiment, the insertion methods include utilizing a tool such that any one or more of the functionalities of the tool detailed herein occurred during the method. By way of example only and not by way of limitation, the aforementioned bendings having one or more of the aforementioned angles can occur. By way of example only and not by way of limitation, the tube placement in the cochlea according to
In an exemplary embodiment, it is noted that in some instances, there is space between the electrode array and the walls of the insertion to in general, and the channel of the tube in particular. This is seen by way of example only and not by way of limitation, in
It is noted that in at least some embodiments, the electrode array is tapered, and a width and/or a height thereof and gradually or step wisely increase with location away from the distal tip. Accordingly, the aforementioned clearances away from the flats can vary for a channel that has uniform internal dimensions. It is noted that in an exemplary embodiment, the aforementioned clearance can be any value or range of values between 0.1 mm and 8 mm, collectively (on a plane normal to the longitudinal axis of the insertion tool on either side of the array) in 0.01 mm increments (e.g., 0.22 mm to 7.78 mm, etc.) for a given location relative to the electrode array. In an exemplary embodiment, the mean, median and/or mode collective clearance over a distance of 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 mm can be any of the aforementioned values just detailed.
In an exemplary embodiment, with respect to two locations along the length of the electrode array, the insertion tool is configured to enable the electrode array to bow within the tube, as measured at a given location within the channel, such as the location of the beginning of the flats, as represented by axis 3909, relative to a longitudinal axis of the electrode array with respect to location along the array where the electrode array extends in a parallel direction of the channel, as is represented by axis 3999, by at least and/or no more than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 30, 35 or 40 degrees or any value or range of values therebetween in 0.1 degree increments. In an exemplary embodiment, these aforementioned angles can be measured at the location where the array is parallel with the channel and any location 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 mm away therefrom.
In an exemplary embodiment, a torque that must be imparted on to the electrode array to twist the electrode array 10 degrees about the longitudinal axis thereof is at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 250, 275, 300, 325, 350, 375 or 400 percent greater due to the bowing relative to that which be the case if the electrode array was perfectly straight within the channel, all other things being equal.
In an exemplary embodiment, the bowing of the array in the channel is somewhat analogous to how a hand auger or a hand drill works, where one handle is offset from the drill bit so that one hand creates a torque to turn the drill bit as the handle is moved in a circular orbit about the drill bit longitudinal axis. Here, this works in reverse, where the wall portion that the electrode array (e.g., the top portion as seen in
Any disclosure of any method action detailed herein corresponds to a disclosure of a device and/or a system for executing that method action. Any disclosure of any method of making an apparatus detailed herein corresponds to a resulting apparatus made by that method. Any functionality of any apparatus detailed herein corresponds to a method having a method action associated with that functionality. Any disclosure of any apparatus and/or system detailed herein corresponds to a method of utilizing that apparatus and/or system. Any feature of any embodiment detailed herein can be combined with any other feature of any other embodiment detailed herein providing that the art enables such, unless such is otherwise noted. Any feature disclosed herein can be specifically excluded from an embodiment, providing that such is enabled, unless otherwise noted. That is, some embodiments have insertion tools that specifically do not have one or more of the features disclosed herein.
While various embodiments of the present invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail can be made therein without departing from the scope of the invention.
This application claims priority to U.S. Provisional Application No. 62/635,153, filed Feb. 26, 2018, and U.S. Provisional Application No. 62/676,036, filed May 24, 2018, naming Peter Raymond SIBARY of Macquarie University, Australia as an inventor, the entire contents of that application being incorporated herein by reference in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2019/051546 | 2/26/2019 | WO |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2019/162930 | 8/29/2019 | WO | A |
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| Number | Date | Country | |
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| 20200405351 A1 | Dec 2020 | US |
| Number | Date | Country | |
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| 62676036 | May 2018 | US | |
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