U.S. patent application number 17/385788 was filed with the patent office on 2022-01-20 for advanced electrode array location evaluation.
The applicant listed for this patent is Ryan Orin MELMAN. Invention is credited to Ryan Orin MELMAN.
Application Number | 20220016416 17/385788 |
Document ID | / |
Family ID | 1000005880363 |
Filed Date | 2022-01-20 |
United States Patent
Application |
20220016416 |
Kind Code |
A1 |
MELMAN; Ryan Orin |
January 20, 2022 |
ADVANCED ELECTRODE ARRAY LOCATION EVALUATION
Abstract
A method, including sequentially activating a plurality of
respective electrode pairs of an implanted cochlear implant, at
least one of the electrodes of the respective electrode pairs being
a respective electrode of an electrode array implanted in a
cochlea, thereby generating respective localized electric fields,
concurrently respectively measuring, for the plurality of activated
respective electrode pairs, an electrical characteristic between
the respective electrodes of the respective electrode pairs
resulting from the respective localized electric fields, thereby
obtaining a measurement set, determining, from the measurement set,
a distance between the electrode array and a wall of the
cochlea.
Inventors: |
MELMAN; Ryan Orin;
(Macquarie University, AU) |
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Applicant: |
Name |
City |
State |
Country |
Type |
MELMAN; Ryan Orin |
Macquarie University |
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AU |
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Family ID: |
1000005880363 |
Appl. No.: |
17/385788 |
Filed: |
July 26, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15936282 |
Mar 26, 2018 |
11071856 |
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17385788 |
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62559782 |
Sep 18, 2017 |
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15936282 |
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62633054 |
Feb 20, 2018 |
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62559782 |
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62642566 |
Mar 13, 2018 |
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62633054 |
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62647896 |
Mar 26, 2018 |
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62642566 |
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62476295 |
Mar 24, 2017 |
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62647896 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/36039 20170801;
H04R 25/70 20130101; A61N 1/0541 20130101; A61N 1/08 20130101; A61N
1/36038 20170801 |
International
Class: |
A61N 1/05 20060101
A61N001/05; A61N 1/36 20060101 A61N001/36; A61N 1/08 20060101
A61N001/08 |
Claims
1-78. (canceled)
79. A method, comprising: sequentially activating a plurality of
respective electrode pairs of an implanted electrode array;
concurrently respectively measuring, for the plurality of activated
respective electrode pairs, an electrical characteristic between
the respective electrodes of the respective electrode pairs,
thereby obtaining a measurement set; and determining, from the
measurement set, a distance between the electrode array and tissue
of a recipient of the electrode array.
80. (canceled)
81. The method of claim 79, wherein: the action of concurrently
respectively measuring, for the respective electrode pairs, an
electrical characteristic includes measuring an electrical
characteristic using first and second electrodes of the electrode
array, which electrodes are different from the electrodes of the
electrode pair.
82. The method of claim 79, wherein: each of the electrode pairs
used to create the measurement set comprises a unique pair of
electrodes.
83. (canceled)
84. The method of claim 83, wherein: the respective first and
second electrodes are disposed symmetrically about the respective
third and fourth electrodes.
85. The method of claim 79, wherein: the electrode array of a
cochlear implant electrode array; and both of the electrodes of the
respective electrode pairs are respective electrodes of the
electrode array implanted in a cochlea.
86-108. (canceled)
109. A method, comprising: obtaining first data by: operating a
first set of electrodes as a source and sink in and/or on a mammal
while operating a second set of electrodes as recorder electrodes
in and/or on a mammal thereby obtaining first electrical data from
the second set of electrodes; obtaining second data by: operating a
third set of electrodes as a source and sink in and/or on the
mammal, the third set being different than the first set, while
operating the second set of electrodes as recorder electrodes in
and/or on a mammal and thereby obtaining second electrical data
from the second set of electrodes; evaluating data by evaluating
the first electrical data and the second electrical data; and
determining spatial positioning data based on the evaluation of the
data.
110. The method of claim 109, wherein: the first electrical data is
a first impedance based data between the electrodes of the second
set; the second electrical data is a second impedance based data
between the electrodes of the second set; the action of evaluating
the first electrical data and the second electrical data includes
comparing the first electrical data to the second electrical data;
and the action of determining the spatial positioning data includes
determining a distance of the second set of electrodes from a
gradient.
111. The method of claim 109, wherein: the electrodes of the first
set are located closer to one another than the electrodes of the
third set and are between electrodes of the third set.
112. The method of claim 109, further comprising: obtaining third
data by: operating a fourth set of electrodes as a source and sink
in and/or on the mammal, the fourth set different than the third
set, while operating the second set of electrodes as recorder
electrodes in and/or on the mammal, thereby obtaining third
electrical data from the second set of electrodes, wherein the
action of evaluating data includes evaluating the third electrical
data while also evaluating the second electrical data and the first
electrical data, and the electrodes of the first set are located
closer to one another than the electrodes of the third set and
between electrodes of the third set, and the electrodes of the
third set are located closer to one another than the electrodes of
the fourth set and between electrodes of the fourth set.
113. The method of claim 109, wherein: the recorder electrodes are
part of a cochlear electrode array that is located in a cochlea;
and the determined spatial positioning data is distance data of the
recorder electrodes from a modiolus wall of the cochlea.
114. A method, comprising: energizing an electrode implanted in a
recipient, the electrode being part of an assembly located in
and/or on a recipient; receiving data from one or more recording
electrodes located in and/or on a recipient; and determining data
based on the received data.
115. The method of claim 114, wherein: the determined data is
spatial position data of the assembly based on the received data;
and the spatial position data of the assembly is a distance of the
assembly from a wall of tissue of the recipient.
116. The method of claim 115, wherein: the determined data is
spatial position data of the assembly based on the received data;
and the wall of tissue of the recipient is a wall that is a barrier
of a cavity in the recipient that normally contains bodily
fluid.
117. The method of claim115, wherein: the determined data is
spatial position data of the assembly based on the received data;
and the wall of tissue of the recipient is a modiolus wall of a
cochlea; the assembly is an electrode array of a cochlear implant;
the electrode is located in a duct of the cochlea; and the spatial
position is distance of the electrode array from the modiolus wall
relative to the one or more recording electrodes and/or a location
between two or more of the recording electrodes.
118. The method of claim 114, wherein: the determined data is
spatial position data of the assembly based on the received data;
and the assembly is a cochlear electrode array; the method further
comprises: determining, based on the determined spatial position
data, that at least one or more of the following has occurred: (i)
a tip fold over; (ii) a longitudinally local lateral angular
position of the electrode array has shifted relative to another
longitudinally local position; (iii) the electrode array has been
over inserted into a cochlea of the recipient; (iv) the electrode
array has become unfixed subsequent to full implantation into the
recipient; or (v) the electrode array has migrated during
implantation.
119. The method of claim 114, wherein: the determined data is
spatial position data of the assembly based on the received data;
and the assembly is an electrode array assembly; the spatial
position data is a plurality of respective distances of the
assembly at respective locations along the array from respective
locations of a wall of tissue of the recipient.
120. The method of claim 114, wherein: the determined data is
spatial position data of the assembly based on the received data;
and the actions of energizing, receiving and determining are
actions that are part of a vertical electrical sounding method
applied to a mammal.
121. The method of claim 114, wherein: the determined data is
spatial position data of the assembly based on the received data;
and the actions of energizing, receiving and determining are
actions that are part of a surgical procedure to implant the
assembly in the recipient; and the method further comprises
repositioning the electrode array based on the determined spatial
position data.
122. The method of claim 114, wherein: the data received from one
or more recording electrodes is electrical data from at least two
electrodes implanted in a human head of the recipient, the at least
two electrodes corresponding to the one or more recording
electrodes located in and/or on the recipient; and the determined
data is a physiological feature of an interior of a duct of a
cochlea based on the received data.
123. The method of claim 122, wherein: the physiological feature is
the relative absence of perilymph in the duct.
124. The method of claim 122, wherein: the physiological feature is
the relative absence of fibrous tissue growth due to implantation
of the electrode array into the duct of the cochlea.
125. The method of claim 122, wherein: the physiological feature is
the presence of significant fibrous tissue growth due to
implantation of the electrode array into the duct of the
cochlea.
126. The method of claim 125, further comprising: executing an NRT
method; and evaluating results of the NRT method by taking into
account the presence of the significant fibrous tissue growth.
127. The method of claim 126, further comprising: determining that
the fibrous tissue has established a dead patch with respect to
taking NRT measurements.
128. The method of claim 122, wherein: the physiological feature is
a second puncture in a wall of the cochlea in addition to that
through which the electrode array entered the cochlea.
129. The method of claim 114, wherein: the assembly is an electrode
array of a cochlear implant located in a cochlea.
130. The method of claim 114, wherein: the determined data is
spatial position data of the assembly based on the received
data.
131. The method of claim 129, wherein: the action of energizing the
electrode and the action of receiving data from one or more
recording electrodes is part of a process of executing vertical
electrical sounding.
132. The method of claim 121, further comprising: determining a
positional feature of the electrode array based on the vertical
electrical sounding; and the determined positional feature is a
distance of the electrode array from a modiolus wall of the
cochlea.
133. The method of claim 131, further comprising: determining a
positional feature of the electrode array based on the vertical
electrical sounding.
134. The method of claim 114, wherein: the action of determining,
based on the determined spatial position data, includes determining
that at least two or more of the following has occurred: (i) a tip
fold over; (ii) a longitudinally local lateral angular position of
the electrode array has shifted relative to another longitudinally
local position; (iii) the electrode array has been over inserted
into a cochlea of the recipient; (iv) the electrode array has
become unfixed subsequent to full implantation into the recipient;
or (v) the electrode array has migrated during implantation.
135. The method of claim 114, wherein: the action of determining,
based on the determined spatial position data, includes determining
that at least three or more of the following has occurred: (i) a
tip fold over; (ii) a longitudinally local lateral angular position
of the electrode array has shifted relative to another
longitudinally local position; (iii) the electrode array has been
over inserted into a cochlea of the recipient; (iv) the electrode
array has become unfixed subsequent to full implantation into the
recipient; or (v) the electrode array has migrated during
implantation.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This Application is a Divisional of U.S. patent application
Ser. No. 15/936,282, filed Mar. 26, 2018, which is a
Continuation-in-Part of the following applications, and
incorporates by reference and claims priority to all the subject
matter therein in their entirety. [0002] U.S. Provisional
Application No. 62/476,295, filed Mar. 24, 2017, entitled ADVANCED
ELECTRODE ARRAY LOCATION EVALUATION; [0003] U.S. Provisional
Application No. 62/559,782, filed Sep. 18, 2017, entitled ADVANCED
ELECTRODE ARRAY INSERTION WITH CONDITIONING; [0004] U.S. patent
application Ser. No. 15/707,197, filed Sep. 18, 2017, entitled
ADVANCED ELECTRODE ARRAY INSERTION WITH CONDITIONING; [0005] U.S.
Provisional Application No. 62/633,054, filed Feb. 20, 2018,
entitled ADVANCED ELECTRODE DATA ANALYSIS; [0006] U.S. Provisional
Application No. 62/642,566, filed Mar. 13, 2018, entitled
ELECTRICAL FIELD USAGE IN COCHLEAS; and [0007] U.S. Provisional
Application No. 62/647,896, filed Mar. 26, 2018, entitled
ELECTRICAL TECHNIQUES FOR BIOMARKER DETECTION IN A COCHLEA.
BACKGROUND
[0008] 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.
[0009] 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.
[0010] 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.
[0011] 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.
[0012] 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.
[0013] It is also noted that the electrode array of the cochlear
implant generally shows utilitarian results if it is inserted in a
cochlea.
SUMMARY
[0014] In accordance with an exemplary embodiment, there is a
method, comprising sequentially activating a plurality of
respective electrode pairs of an implanted cochlear implant, at
least one of the electrodes of the respective electrode pairs being
a respective electrode of an electrode array implanted in a
cochlea, thereby generating respective localized electric fields
concurrently respectively measuring, for the plurality of activated
respective electrode pairs, an electrical characteristic between
the respective electrodes of the respective electrode pairs
resulting from the respective localized electric fields, thereby
obtaining a measurement set and determining, from the measurement
set, a distance between the electrode array and a wall of the
cochlea.
[0015] In accordance with another embodiment, there is a method,
comprising obtaining first data by operating a first set of
electrodes as a source and sink in and/or on a mammal while
operating a second set of electrodes as recorder electrodes in
and/or on a mammal thereby obtaining first electrical data from the
second set of electrodes, obtaining second data by operating a
third set of electrodes as a source and sink in and/or on the
mammal, the third set being different than the first set, while
operating the second set of electrodes as recorder electrodes in
and/or on a mammal and thereby obtaining second electrical data
from the second set of electrodes, evaluating data by evaluating
the first electrical data and the second electrical data, and
determining spatial positioning data based on the evaluation of the
data.
[0016] In accordance with another embodiment, there is a method,
comprising executing vertical electrical sounding utilizing
electrodes of an electrode array of a cochlear implant located in a
cochlea and determining a positional feature of the electrode array
based on the vertical electrical sounding.
[0017] In accordance with another embodiment, there is a method,
comprising energizing an electrode implanted in a recipient, the
electrode being part of an assembly located in and/or on a
recipient receiving data from one or more recording electrodes
located in and/or on a recipient; and determining spatial position
data of the assembly based on the received data.
[0018] In accordance with another embodiment, there is a method,
comprising energizing an electrode implanted in a recipient, the
electrode being part of an assembly located in and/or on a
recipient, receiving data from one or more recording electrodes
located in and/or on a recipient; and determining spatial position
data of the assembly based on the received data.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] Embodiments are described below with reference to the
attached drawings, in which:
[0020] FIG. 1 is a perspective view of an exemplary hearing
prosthesis in which at least some of the teachings detailed herein
are applicable;
[0021] FIG. 2 is a side view of an embodiment of an insertion guide
for implanting a cochlear implant electrode assembly such as the
electrode assembly illustrated in FIG. 1;
[0022] FIGS. 3A and 3B are side and perspective views of an
electrode assembly extended out of an embodiment of an insertion
sheath of the insertion guide illustrated in FIG. 2;
[0023] FIGS. 4A-4E are simplified side views depicting the position
and orientation of a cochlear implant electrode assembly insertion
guide tube relative to the cochlea at each of a series of
successive moments during an exemplary implantation of the
electrode assembly into the cochlea;
[0024] FIG. 5A is a side view of a perimodiolar electrode assembly
partially extended out of a conventional insertion guide tube
showing how the assembly may twist while in the guide tube;
[0025] FIGS. 5B-5I are cross-sectional views of the electrode
assembly illustrated in FIG. 5A;
[0026] FIG. 6 is a cross-sectional view of a conventional electrode
assembly;
[0027] FIG. 7 depicts an exemplary functional diagram of an
exemplary embodiment;
[0028] FIG. 8 depicts an exemplary implantable component of a
cochlear implant according to an exemplary embodiment;
[0029] FIG. 9 depicts a component that places the cochlear implant
of FIG. 8 into signal communication with another component;
[0030] FIG. 10 depicts the cochlear implant of FIG. 8 in signal
communication with a communication device that enables
communication between the cochlear implant and a control unit
according to an exemplary embodiment;
[0031] FIGS. 11-14 depict some exemplary arrangements of source and
sink and recorder electrodes in a functional manner for conceptual
purposes;
[0032] FIGS. 15-23 conceptually depict current spread in some
embodiments, which current spread forms the foundation in some
embodiments for the methods detailed herein;
[0033] FIG. 24 depicts in a conceptual manner distances of an
electrode from a tissue of interest;
[0034] FIGS. 25-33 conceptually depict data obtention according to
an exemplary method;
[0035] FIGS. 34-44 present flowcharts for exemplary methods;
[0036] FIGS. 45-47 depict schematics of data resulting from some
embodiments;
[0037] FIGS. 48 and 50 and 51 and 55 present respective schematics
associated with an electrode array;
[0038] FIG. 49 presents a schematic of a conceptual dipole;
[0039] FIG. 52 presents a chart of conceptual data;
[0040] FIG. 53 presents a conceptual schematic of different heights
relative to an array;
[0041] FIG. 54 presents a chart of conceptual data;
[0042] FIG. 56 presents conceptual data in a two dimensional
manner;
[0043] FIG. 57 presents some schematics and some details associated
with a theory of operation of an embodiment;
[0044] FIGS. 58 and 59 present additional conceptual schematics of
a theory of operation; and
[0045] FIG. 60 presents exemplary waveforms.
DETAILED DESCRIPTION
[0046] FIG. 1 is a perspective view of an exemplary cochlear
implant 100 implanted in a recipient having an outer ear 101, a
middle ear 105, and an inner ear 107. In a fully functional ear,
outer ear 101 comprises an auricle 110 and an ear canal 102.
Acoustic pressure or sound waves 103 are collected by auricle 110
and channeled into and through ear canal 102. Disposed across the
distal end of ear canal 102 is a tympanic membrane 104 that
vibrates in response to sound waves 103. This vibration is coupled
to oval window or fenestra ovalis 112 through the three bones of
the middle ear 105, collectively referred to as the ossicles 106,
and comprising the malleus 108, the incus 109, and the stapes 111.
Ossicles 106 filter and amplify the vibrations delivered by
tympanic membrane 104, causing oval window 112 to articulate, or
vibrate. This vibration sets up waves of fluid motion of the
perilymph within cochlea 140. Such fluid motion, in turn, activates
hair cells (not shown) inside the cochlea which in turn causes
nerve impulses to be generated which are transferred through spiral
ganglion cells (not shown) and auditory nerve 114 to the brain
(also not shown) where they are perceived as sound.
[0047] The exemplary cochlear implant illustrated in FIG. 1 is a
partially implanted stimulating medical device. Specifically,
cochlear implant 100 comprises external components 142 attached to
the body of the recipient, and internal or implantable components
144 implanted in the recipient. External components 142 typically
comprise one or more sound input elements for detecting sound, such
as microphone 124, a sound processor (not shown), and a power
source (not shown). Collectively, these components are housed in a
behind-the-ear (BTE) device 126 in the example depicted in FIG. 1.
External components 142 also include a transmitter unit 128
comprising an external coil 130 of a transcutaneous energy transfer
(TET) system. Sound processor 126 processes the output of
microphone 124 and generates encoded stimulation data signals which
are provided to external coil 130.
[0048] 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.
[0049] 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.
[0050] Electrode assembly 145 may be inserted into cochlea 140 with
the use of an insertion guide. FIG. 2 is a side view of an
embodiment of an insertion guide for implanting an elongate
electrode assembly generally represented by electrode assembly 145
into a mammalian cochlea, represented by cochlea 140. The
illustrative insertion guide, referred to herein as insertion guide
200, includes an elongate insertion guide tube 210 configured to be
inserted into cochlea 140 and having a distal end 212 from which an
electrode assembly is deployed. Insertion guide tube 210 has a
radially-extending stop 204 that may be utilized to determine or
otherwise control the depth to which insertion guide tube 210 is
inserted into cochlea 140.
[0051] 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 robotic arm adapter 202 is
mounted to a proximal end of staging section 208 to facilitate
attachment of the guide to a robot, which adapter includes through
holes 203 through which bolts can be passed so as to bolt the guide
200 to a robotic arm, as will be detailed below. 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.
[0052] FIGS. 3A and 3B are side and perspective views,
respectively, of representative electrode assembly 145, which
electrode array is utilized, in some embodiments, to execute some
of the method actions detailed herein vis-a-vis source and/or sink
and/or recorder electrodes. As noted, electrode assembly 145
comprises an electrode array 146 of electrode contacts 148.
Electrode assembly 145 is configured to place electrode contacts
148 in close proximity to the ganglion cells in the modiolus. Such
an electrode assembly, commonly referred to as a perimodiolar
electrode assembly, is manufactured in a curved configuration as
depicted in FIGS. 3A and 3B. When free of the restraint of a stylet
or insertion guide tube, electrode assembly 145 takes on a curved
configuration due to it being manufactured with a bias to curve, so
that it is able to conform to the curved interior of cochlea 140.
As shown in FIG. 3B, when not in cochlea 140, electrode assembly
145 generally resides in a plane 350 as it returns to its curved
configuration. That said, it is noted that embodiments of the
insertion guides detailed herein and/or variations thereof can be
applicable to a so-called straight electrode array, which electrode
array does not curl after being free of a stylet or insertion guide
tube etc., but instead remains straight
[0053] FIGS. 4A-4E are a series of side-views showing consecutive
exemplary events that occur in an exemplary implantation of
electrode assembly 145 into cochlea 140. Initially, electrode
assembly 145 and insertion guide tube 310 are assembled. For
example, electrode assembly 145 is inserted (slidingly or
otherwise) into a lumen of insertion guide tube 300. The combined
arrangement is then inserted to a predetermined depth into cochlea
140, as illustrated in FIG. 4A. Typically, such an introduction to
cochlea 140 is achieved via cochleostomy 122 (FIG. 1) or through
round window 121 or oval window 112. In the exemplary implantation
shown in FIG. 4A, the combined arrangement of electrode assembly
145 and insertion guide tube 300 is inserted to approximately the
first turn of cochlea 140.
[0054] As shown in FIG. 4A, the combined arrangement of insertion
guide tube 300 and electrode assembly 145 is substantially
straight. This is due in part to the rigidity of insertion guide
tube 300 relative to the bias force applied to the interior wall of
the guide tube by pre-curved electrode assembly 145. This prevents
insertion guide tube 300 from bending or curving in response to
forces applied by electrode assembly 145, thus enabling the
electrode assembly to be held straight, as will be detailed
below.
[0055] 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.
[0056] As shown in FIGS. 4B-4D, electrode assembly 145 may be
continually advanced through insertion guide tube 300 while the
insertion sheath is maintained in a substantially stationary
position. This causes the distal end of electrode assembly 145 to
extend from the distal end of insertion guide tube 300. As it does
so, the illustrative embodiment of electrode assembly 145 bends or
curves to attain a perimodiolar position, as shown in FIGS. 4B-4D,
owing to its bias (memory) to curve. Once electrode assembly 145 is
located at the desired depth in the scala tympani, insertion guide
tube 300 is removed from cochlea 140 while electrode assembly 145
is maintained in a stationary position. This is illustrated in FIG.
4E.
[0057] 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.
[0058] Returning to FIGS. 3A-3B, perimodiolar electrode assembly
145 is pre-curved in a direction that results in electrode contacts
148 being located on the interior of the curved assembly, as this
causes the electrode contacts to face the modiolus when the
electrode assembly is implanted in or adjacent to cochlea 140.
Insertion guide tube 500 retains electrode assembly 145 in a
substantially straight configuration, thereby preventing the
assembly from taking on the configuration shown in FIG. 3B. The
inability of electrode assembly 145 to curve to accommodate the
bias force induces stress in the assembly. Pre-curved electrode
assembly 145 will tend to twist while exiting insertion guide tube
510 to reduce this stress. With the distal end of the electrode
assembly curved to abut the lumen wall, the assembly twists
proximally.
[0059] This is illustrated in FIGS. 5A-5I. FIG. 5A is a side view
of perimodiolar electrode assembly 145 partially extended out of a
conventional insertion guide tube 500, showing how the assembly may
twist while in the guide tube. FIGS. 5B-5F are cross-sectional
views taken through respective sections 5B-5B, 5C-5C, 5D-5D, 5E-5E,
and 5F-5F of electrode assembly 145 in FIG. 5A.
[0060] As shown in FIGS. 5A-5F, the portion of electrode assembly
145 in insertion guide tube 510 is twisted about its longitudinal
axis, resulting in electrode contacts 148 in the twisted region to
have a different radial position relative to insertion guide tube
510. As shown in FIGS. 5A and 5G-I, as electrode assembly 145
exists insertion guide tube 500, the assembly is free to curve in
accordance with its bias force. However, the orientation of
electrode contacts in the deployed region of the assembly is
adversely affected by the twisted region of the assembly remaining
in guide tube 510.
[0061] Accordingly, the insertion guide can have 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 generally ensures 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.
[0062] As shown in FIG. 6, 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. To be clear, it is noted that the
electrode assembly/electrode array shown in the figures is but an
exemplary embodiment, and in other embodiments, a round, oval,
etc., shaped electrode array, straight or curved, can be used.
[0063] More particularly, as will now be detailed, in some
exemplary embodiments, the electrode array is utilized to obtain
data regarding electrode array position within the cochlea, such as
by way of example only and not by way of limitation, position
information indicating relative location to the modiolus wall. FIG.
7 depicts an exemplary system for utilizing the cochlear implant to
obtain such information. Presented in functional terms, there is a
test unit 3960 in signal communication with unit 8310, which in
turn is in signal communication, optionally with a unit 7720 and a
unit 8320, the details of which will be described below.
[0064] Unit 3960 can correspond to an implantable component of a
cochlear implant, as seen in FIG. 8. More specifically, FIG. 8
depicts an exemplary high-level diagram of a receiver/stimulator
8710 of a cochlear implant, looking downward. As can be seen, the
receiver/stimulator 8710 includes a magnet 160 that is surrounded
by a coil 137 that is in two-way communication (although in other
embodiments, the communication is one-way) with a stimulator unit
122, which in turn is in communication with the electrode array
145. Receiver/stimulator 8710 further includes a cochlear
stimulator unit 122, in signal communication with the coil 137. The
coil 137 and the stimulator unit 122 are encased in silicon as
represented by element 199. In an exemplary embodiment,
receiver/stimulator 8710 is utilized as test unit 3960, and is used
to acquire information about electrode array position.
[0065] FIG. 9 depicts an exemplary RS (receiver/stimulator)
interface 7444 which is presented by way of concept. An inductance
coil 7410 is configured to establish a magnetic inductance field so
as to communicate with the corresponding coil of the
receiver-stimulator of the cochlear implant. Interface 7444
includes a magnet 7474 so as to hold the inductance coil 7410
against the coil of the receiver/stimulator of the cochlear implant
in a manner analogous to how the external component of the cochlear
implant is held against the implanted component, and how the coils
of those respective components are aligned with one another. As can
be seen, an electrical lead extends from the coil 7410 to control
unit 8310, representing signal communication between interface
7444, and control unit 8310.
[0066] FIG. 10 depicts an exemplary embodiment of the
receiver/stimulator 8710 in signal communication with the control
unit 8310 via electrical lead that extends from the interface
device 7444 having coil 7410 about a magnet 7474 as can be seen.
The interface device 7444 communicates via an inductance field with
the inductance coil of the receiver/stimulator 8710 so that the
data acquired by the implantable component 8710
(receiver/stimulator) can be transferred to the control unit
8310.
[0067] Note also that in at least some alternate exemplary
embodiments, control unit 8310 can communicate with the so-called
"hard ball" reference electrode of the implantable component of the
cochlear implant so as to enable communication of data from the
receiver/stimulator 8710 to control unit 8310 and/or vice
versa.
[0068] It is noted that in the embodiment of FIG. 10, control unit
8310 is in signal communication with the various other components
as detailed herein, which components are not depicted in FIG. 10
for purposes of clarity.
[0069] Also functionally depicted in FIG. 7 is the optional
embodiment where an electrode array insertion robotic
system/actuator system 7720 and an input device 8320 is included in
the system. In an exemplary embodiment, the input device 8320 could
be a trigger of a hand held device that controls the actuator
system 7720 and can stop and/or start insertion of the electrode
array. In an exemplary embodiment, the input device 8320 could be a
trigger on the tool 8200.
[0070] Control unit 8310 can be a signal processor or the like or a
personal computer or the like or a mainframe computer or the like
etc., that is configured to receive signals from the test unit 3960
and analyze those signals to evaluate an insertion status of the
electrode array. More particularly, the control unit 8310 can be
configured with software the like to analyze the signals from test
unit 3960 in real time and/or in near real time as the electrode
array is being advanced into the cochlea by actuator assembly 7720
(if present, and if not present, while the array is being
inserted/advanced by hand). The control unit 8310 analyzes the
input from test unit 3960 as the electrode array advanced by the
actuator assembly 7720 and evaluates the input to determine if
there exists an undesirable insertion status of the electrode array
and/or evaluates the input to determine if the input indicates that
a scenario could occur or otherwise there exists data in the input
that indicates that a scenario is more likely to occur relative to
other instances where the insertion status of the electrode array
will become undesirable if the electrode array is continued to be
advanced into the cochlea, all other things remaining the same
(e.g., insertion angle/trajectory, etc., which can be automatically
changed as well--more on this below). In an exemplary embodiment,
upon such a determination, control unit 8310 could halt the
advancement of the array into the cochlea by stopping the
actuator(s) of actuator assembly 7720 and/or could slow the
actuator(s) so as to slow rate of advancement of the electrode
array into the cochlea and/or could reverse the actuator(s) so as
to reverse or otherwise retract the electrode array within the
cochlea (either partially or fully). Alternatively, in embodiments
where actuator assembly 7720 is not present, control unit 8310
could provide an indication to the surgeon or the like to halt
and/or slow the insertion, etc. In at least some exemplary
embodiments, control unit 8310 can be configured to override the
input from input unit 8320 input by the surgeon or the user.
Control unit 8310 can be programmed to execute one or more or all
of the teachings detailed herein.
[0071] Some exemplary embodiments utilize the receiver/stimulator
8710 as a test unit 3910 that enables vertical electrical sounding
techniques or resistivity tomography techniques to be executed in
the cochlear to determine spatial relationships (or other
information--this is by way of example and not by limitation)
between the electrode array and the structure of the cochlea or
other structures of the recipient. In an exemplary embodiment, the
receiver/stimulator 8710 is utilized to execute one or more or all
of the method actions detailed below, alone or in combination with
an external component of a cochlear implant, and/or with the
interface 7444, which can be used after the receiver/stimulator
8710 is fully implanted in the recipient and the incision to
implant such has been closed (e.g., days, weeks, months or years
after the initial implantation surgery). The interface 7444 can be
used to control the receiver/stimulator to execute at least some of
the method actions detailed herein (while in some other
embodiments, the receiver/stimulator can execute such in an
autonomous or semi-autonomous manner, without being in
communication with an external component) and/or can be used to
obtain data from the receiver/stimulator after execution of such
method actions.
[0072] More specifically, because the electrode array includes a
plurality of electrodes (in some embodiments, 22 electrodes), many
if not all of which can be individually used as sources and/or
sinks and many if not all of which can be utilized as "read"
electrodes, the techniques of vertical electrical sounding and
resistivity tomography can be applied utilizing a cochlear
electrode array. Briefly, while the standard technology utilizes
the placement and subsequent movement of source and sink electrodes
and measurement electrodes at the surface of the earth to obtain
information, where the relative movement is recorded so that the
process can be executed, here, the different electrodes are
utilized to replicate the movement feature of the vertical
electrical sounding/resistivity tomography techniques.
[0073] Without being bound by theory, vertical electrical sounding
(VES) is a geophysical method for investigation of a geological
medium. The method is based on the estimation of the electrical
conductivity or resistivity of the medium. The estimation is
performed based on the measurement of voltage/electrical field
induced by the distant grounded electrodes (current electrodes).
FIGS. 11-14 depict some exemplary configurations of possible
measurement setups. The electrodes A and B are current electrodes
which are connected to a current source; N and M are potential
electrodes (measurement electrodes) which are used for the voltage
measurements. As source, the direct current or low frequency
alternating current is used. It is noted that ture direct current
sometimes can have deleterious effects on tissue, and thus in some
other embodiments, instead of using direct current, embodiments
approximate direct current by measuring after transient effects of
a current pulse (or other AC waveform) have subsided. The
interpretation of the measurements can be performed based on the
apparent resistivity values. The depth of investigation can depend
on the distance between the current electrodes. In some
embodiments, a location of the recording pair with respect to the
current electrodes can also infludence the depth of investigation.
For example, such can relate to a current path created by the
dipole. The current can form an "arc" between the two dipoles
(source/sink electrodes) with the maximum current penetration mid
way between the source/sink electrodes. In some embodiments, if the
measurement electrodes are adjacent one of the source/sink
electrodes then the current penetration depth is less than the
maximum. In order to obtain the apparent resistivity as the
function of depth, the measurements for each position are performed
with several different distances between current electrodes. The
apparent resistivity is calculated as
.rho. k = k .times. U MN I AB ##EQU00001##
here, k is a geometric factor, U.sub.MN is voltage between
electrodes M and N, I.sub.AB is current in the line AB. The
geometric factor is defined by
k = 2 .times. .pi. 1 r AM - 1 r BM - 1 r AN + 1 r BN
##EQU00002##
here r is the distance between electrodes.
[0074] It is noted that in some embodiments, the numerator for the
geometric factor is 4.pi., as the equations above are for a
hemisphere (i.e. the air acts as an insulation on one side of the
array for geophysical applications).
[0075] The equation here is for a hemisphere (i.e. the air acts as
an insulation on one side of the array for geophysical
applications). In some embodiments, interpretation of gathered data
is performed based on the dependency .rho..sub.k(AB/2). The
application of large electrode arrays allows for reconstructing
complex 3D structure of geological media (such as that which
results from electrical resistivity tomography). However, the
interpretation of such measurement is rather difficult. In this
case, advanced interpretation techniques based on numerical methods
can be applied.
[0076] Some embodiments utilize the basic idea is that voltage
equals the charge divided the value that equals 4 times pie times
the square of the distance from the source times the resistance (or
impedance). Conversely, the electric fields differential of the
voltage gradient drops off at a rate of 1 over the distance cubed
(as opposed to the voltage fall-off at a rate of 1 over the
distance squared). (It is briefly noted that the term resistance is
sometimes used herein with respect to impedance and visa-versa. Any
disclosure of a resistance/resistance related feature corresponds
to a disclosure of an impedance/impedance related feature, and
visa-versa, providing that the art enables such.)
[0077] It is noted that some embodiments detailed herein modify or
otherwise adapt the VES for geological exploration to that which
can be utilized for a cochlea. For example, adapting the VES
teachings in the art of geological exploration to take into account
that there is no air layer that prevents the current from traveling
in a spherical manner (as opposed to a hemispherical manner
vis-a-vis application in geological exploration). Thus, any
disclosure herein for VES or the like includes a disclosure where
such is modified to take into account the environment of a cochlea
with (or without) perilymph therein.
[0078] Generally applying the above techniques to an electrode
array in a cochlea, FIG. 15 functionally depicts an electrode array
145 in a cochlea, with current flow lines 1500 emanating from
electrode 15 as a source A and traveling to electrode 18 as a sink
B (or vice versa). (It is noted that the region above the electrode
can be considered, in some embodiments, to be infinite in impedance
for the demonstrated current spreads.) FIG. 15 functionally
represents that the deepest current flows occur halfway between the
stimulating electrode pair (electrodes 15 and 18). The amount of
current flowing at depth Z reduces with the cube of the depth
(where r in the above equations has been replaced by the variable
Z). With respect to a unitized value based on the distance between
the electrodes, the depths of the three layers depicted in FIG. 15
each correspond to one half the electrode spacing. As can be seen,
50% of the current is located in the first layer, which corresponds
to the layer having a distance of half the distance between the
electrodes, 20% of the current exist in the second layer, and then
about 9.5% of the current exists in the third layer. (The layers
are equally spaced.) The teachings herein and the calculations
treat the electrodes as points for simplicity. But in other
embodiments, such need not be the case. In some embodiments, one
can integrate over the surface area of the electrode, to increase
accuracy, and then calculate the charge distribution generated by
the shape. Additionally, charge emerges from the perimeter of a
conductor at high frequencies (because, in some instances, these
measurements are taken 10's of .mu.S after engaging the current
source, we are measuring a high frequency response). Due to
symmetry, and for simplicity the centerline to centerline can be
utilitarian for a distributed conductor.
[0079] FIG. 15 depicts the electrode array 145 located in perilymph
of the cochlea in general isolation from other tissue, where the
impedance to electrical conduction of the perilymph is relatively
low relative to other tissue of the recipient, such as for example
bone. FIG. 16 depicts the electrode array 145 in perilymph, except
also relative to the bony tissue of the modiolus wall, or other
high-resistance tissue (high resistance relative to the
perilymph)/high-impedance tissue. (It is noted that the bottom
layers in which the remaining 20 or so percent of the current
exists have been lumped into a single layer for convenience. In
reality, there will be a plurality of layers between the third
layer and the bone/high resistance tissue/high impedance tissue,
each layer corresponding to a layer having a thickness of half the
distance between the source and sink electrodes). FIG. 16 depicts
the distance D1 which is the distance from the electrode array to
the bottom of the second layer, which distance D1 corresponds to
the distance between the source and the sink electrodes, which
corresponds to the fact that each layer has been defined as a layer
having a thickness of half of the distance D1.
[0080] The idea with FIG. 16 is that the further the electrode
array 145 in general, and the source and sink electrodes in
particular (and/or recording electrodes in particular) are away
from the modiolus wall or other high resistive tissue, the lower
the impedance to current between the source and sink electrodes.
That is, because there will be more perilymph for the bulk of the
electrical current to flow through relative to that which would be
the case if the electrode array 145 was closer to the modiolus
wall/tissue of higher resistivity relative to the perilymph, the
impedance will be lower. Accordingly, FIG. 16 depicts the electrode
array 145 a distance from the bone/high resistance tissue (e.g.
modiolus wall) a distance where basically none of the electrical
current between electrodes 15 and 18 will travel through the bone.
Thus, the impedance to electrical current in the homogeneous medium
(perilymph) is relatively low, and the effective impedance between
the source and the sink electrodes, as determined by for example,
the recording electrodes 16 and 17, will be relatively low,
indicating that the bone/high resistance tissue is relatively far
away from the electrodes.
[0081] For purposes of discussion, the resistivity of current flow
between the source and the sink will be conceptually unitized as 1
for the arrangement of FIG. 16.
[0082] FIG. 17 schematically depicts a scenario where the electrode
array 145 is located closer to the modiolus wall/the tissue of high
resistivity relative to that which is the case in FIG. 16.
Basically, the tissue of high resistivity is located within an area
in which a recognizable percentage of the charge flows. Here, about
0.01% of the charge flows through the tissue of higher resistivity.
This is a relatively minor amount. However, this changes the
resistivity of the current flow between the source and sink
electrodes. For purposes of discussion, the resistivity of current
flow between the source and sink will be conceptually unitized as
1.1 for the arrangement of FIG. 17. In this regard, by measuring
the resistivity or other electrical features of the electrode array
in this arrangement, a determination can be made that the tissue of
higher resistivity (e.g., modiolus wall) is closer than that which
is the case for the scenario of FIG. 16.
[0083] FIG. 18 schematically depicts a scenario where the electrode
array 145 is located closer to the modiolus wall/the tissue of high
resistivity relative to that which is the case in FIG. 17.
Basically, the tissue of high resistivity is located within an area
in which a recognizable percentage of the charge flows. Here, about
10% of the charge flows through the tissue of higher resistivity.
This changes the resistivity of the current flow between the source
and sink electrodes. For purposes of discussion, the resistivity of
current flow between the source and sink will be conceptually
unitized as 10 for the arrangement of FIG. 18. In this regard, by
measuring the resistivity or other electrical features of the
electrode array in this arrangement, a determination can be made
that the tissue of higher resistivity (e.g., modiolus wall) is
closer than that which is the case for the scenario of FIG. 17.
[0084] FIG. 19 schematically depicts an scenario where the
electrode array 145 is located closer to the modiolus wall/the
tissue of high resistivity relative to that which is the case in
FIG. 18. Basically, the tissue of high resistivity is located
within an area in which a recognizable percentage of the charge
flows. Here, about 20.5% of the charge flows through the tissue of
higher resistivity. This changes the resistivity of the current
flow between the source and sink electrodes. For purposes of
discussion, the resistivity of current flow between the source and
sink will be conceptually unitized as 50 for the arrangement of
FIG. 19. In this regard, by measuring the resistivity or other
electrical features of the electrode array in this arrangement, a
determination can be made that the tissue of higher resistivity
(e.g., modiolus wall) is closer than that which is the case for the
scenario of FIG. 18.
[0085] FIG. 20 schematically depicts a scenario where the electrode
array 145 is located closer to the modiolus wall/the tissue of high
resistivity relative to that which is the case in FIG. 19. Here, it
is located at the distance D1 (the distance that equals the
distance between the source and sink electrodes). Basically, the
tissue of high resistivity is located within an area in which a
recognizable percentage of the charge flows. Here, about 30% of the
charge flows through the tissue of higher resistivity. This changes
the resistivity of the current flow between the source and sink
electrodes. For purposes of discussion, the resistivity of current
flow between the source and sink will be conceptually unitized as
150 for the arrangement of FIG. 20. In this regard, by measuring
the resistivity or other electrical features of the electrode array
in this arrangement, a determination can be made that the tissue of
higher resistivity (e.g., modiolus wall) is closer than that which
is the case for the scenario of FIG. 18.
[0086] FIG. 21 schematically depicts a scenario where the electrode
array 145 is located closer to the modiolus wall/the tissue of high
resistivity relative to that which is the case in FIG. 20. Here,
the wall is located at half the distance D1 (the distance that
equals the distance between the source and sink electrodes).
Basically, the tissue of high resistivity is located within an area
in which a recognizable percentage of the charge flows. Here, about
50% of the charge flows through the tissue of higher resistivity.
This changes the resistivity of the current flow between the source
and sink electrodes. For purposes of discussion, the resistivity of
current flow between the source and sink will be conceptually
unitized as 700 for the arrangement of FIG. 21. In this regard, by
measuring the resistivity or other electrical features of the
electrode array in this arrangement, a determination can be made
that the tissue of higher resistivity (e.g., modiolus wall) is
closer than that which is the case for the scenario of FIG. 20.
[0087] FIG. 22 schematically depicts a scenario where the electrode
array 145 is located closer to the modiolus wall/the tissue of high
resistivity relative to that which is the case in FIG. 21. Here,
the wall is located essentially right against the electrodes.
Basically, the tissue of high resistivity is located within an area
in which a recognizable percentage of the charge flows. Here,
almost all of the charge flows through the tissue of higher
resistivity. This changes the resistivity of the current flow
between the source and sink electrodes. For purposes of discussion,
the resistivity of current flow between the source and sink will be
conceptually unitized as 3000 for the arrangement of FIG. 22. In
this regard, by measuring the resistivity or other electrical
features of the electrode array in this arrangement, a
determination can be made that the tissue of higher resistivity
(e.g., modiolus wall) is closer than that which is the case for the
scenario of FIG. 21.
[0088] In an exemplary embodiment, because the spacing of the
source and sink electrodes is known, by measuring the resistivity
(or impedance, or any pertinent electrical property) utilizing one
or more of the electrodes of the electrode array or other
components of a system that can enable the teachings detailed
herein, a distance from the electrode array to the modiolus wall
(or other tissue of interest) can be determined.
[0089] Note that spacing between the source and sink electrodes
changes the depth of penetration vis-a-vis the percentage of
current that travels through a given layer. As noted above, D1 is a
value that is based on the distance between the source and sink
electrodes. Increase D1, and the distance of the layers changes.
This is depicted in FIG. 23, where the percentage values of the
current flow in a given layer are presented, corresponding to
spacing A-B (electrodes 15 and 18), and the percentage values the
current flow corresponding to spacing A'-B' (electrodes 14 and 19)
are also presented. As can be seen, the depth from the electrode
array that 50% of the current flows therein becomes larger with the
increased electrode spacing. Accordingly, in a scenario where, for
example, the relatively high resistivity tissue is located at the
level where 50% of the current flow for electrodes A' and B'
(corresponding to the location where 70% of the current flows for
electrodes A and B) the effective total impedance for A' and B'
could be unitized as 350 (as opposed to the unitized resistivity of
150 for electrodes A and B--the arrangement of FIG. 20).
Accordingly, by varying the distance of the source and sink
electrodes, the different resulting effective resistivities (or
other measured electrical phenomenon) will provide information
regarding the distance from the electrode array to the tissue of
relatively higher resistivity (e.g., bone of the modiolus
wall).
[0090] FIG. 24 depicts an exemplary scenario of an electrode array
145 spaced away from the modiolus wall (bone) but at distances that
are different with respect to location along the length of the
electrode array. More specifically, three exemplary heights are
presented, with D1 being larger than D2, and D2 being larger than
D3. The distances are indicated at the location equidistant between
the source and sink electrodes (the electrodes are labeled for
D2--the same would be the case for D1 and D3). In an exemplary
embodiment, electrode 15 and electrode 18 are utilized as the
source and sink, respectively, and electrode 16 and electrode 17 (M
and N) are utilized as the measurement electrodes. The
resistivity/impedance at electrodes 16 and 17 is measured for a
given charge applied to electrodes 15 and 17. Next (or before),
electrode 14 and electrode 19 are utilized as the source and sink,
respectively, and electrodes 16 and 17 are utilized as the
measurement electrodes. That said, electrodes 15 and 18 can be
utilized as the measurement electrodes. The resistivity/impedance
at electrodes 16 and 17 (or 15 and 18) is measured for a given
charge applied to electrodes 14 and 18. Based on these
measurements, the distance D2 can be determined. (Additional
measurements can be utilized, by, for example, further spacing the
source and sink electrodes, etc.) This process can be duplicated to
determine D1 and D3 as well.
[0091] It is noted that in some embodiments, electrode B (or A) can
be further than those detailed. Indeed, in some exemplary
embodiments, electrode B (or A) can be the ball electrode/the extra
cochlear electrode).
[0092] It is noted that the depth of median current flow can be
asymmetrical. This can be determined by separation of electrodes
from the stimulating polar electrodes. Electrical sensitivity can
be dependent on inhomogeneities between the measurement electrodes,
as well as the source electrode and one or both of the measurement
electrodes (or the sink electrode and one or both of the
measurement electrodes). In some exemplary embodiments, two
recording measurements are taken, one with A left of the
measurement electrodes and one with A right of the reader
electrodes, and the results are combined to compensate for
asymmetry.
[0093] FIG. 25 conceptually illustrates an exemplary scenario where
one of the source/sink electrodes (electrode B) is sufficiently far
that effects of asymmetry or the like can be neglected. Here, the
voltages can be calculated using the equations presented in FIG.
25, and reproduced below:
V MN - V M - V N = 1 4 .times. .pi..sigma. .function. [ 1 AM - 1 AN
] = I .sigma. .times. k ##EQU00003## k = 1 4 .times. .pi.
.function. [ 1 AM - 1 AN ] = 1 4 .times. .pi. .times. .times. an
.function. ( n + 1 ) ##EQU00003.2##
[0094] Assuming dipole spacing [0095] |MN|=a [0096] |AM|=na
[0097] In some exemplary embodiments, a rule of thumb is applied
where the separation |AM|<20.times.|AB| for errors to be less
than 5%. K is effectively the correction factor for the voltage
spread with distance, and is determined by the geometric
arrangement of electrodes.
[0098] In view of the above, it can be seen that in some exemplary
embodiments, because the location of the investigation is known,
and because the depth of the investigation is approximately known,
one can build depth projection based on current.
[0099] FIGS. 26-32 conceptually illustrate an exemplary embodiment
where the electrodes of the electrode array are utilized as source
and sink electrodes and as recorder electrodes. FIG. 26 depicts an
exemplary embodiment where electrodes 12 and 15 are utilized as the
source and sink electrodes, and electrodes 13 and 14 are utilized
as the measurement electrodes. This results in data 1 being
developed, which data is correlated to a generic depth of current
travel (where, as noted above, the further the source and sink, the
further the depth of current travel). In an exemplary embodiment,
data 1 corresponds to the voltage between electrodes 13 and 14.
FIG. 27 depicts an exemplary embodiment where electrodes 13 and 16
are utilized as the source and sink electrodes, and electrodes 14
and 15 are utilized as the measurement electrodes. This results in
data 2 being developed, which data is correlated to the generic
depth. In an exemplary embodiment, data 2 corresponds to the
voltage between electrodes 14 and 15. FIG. 28 depicts an exemplary
embodiment where electrodes 14 and 17 are utilized as the source
and sink electrodes, and electrodes 15 and 16 are utilized as the
measurement electrodes. This results in data 3 being developed,
which data is correlated to the generic depth. In an exemplary
embodiment, data 3 corresponds to the voltage between electrodes 15
and 16.
[0100] The source and sink and recorder electrodes are moved for
some or all of the electrodes of the electrode array. FIG. 29
conceptually represents data 1 to 7 developed utilizing electrode
pairs that are spaced apart from one another by two electrodes (the
measurement electrodes), where alignment for the given data
corresponds to the halfway point between the source and sink
electrodes utilized to develop the data (e.g., for data 7,
electrodes 18 and 21 were the source and sink electrodes, and
electrodes 19 and 20 were the measurement electrodes). Additional
data points or fewer data points can be developed depending on the
embodiment.
[0101] FIG. 29 also depicts data 9, which data is developed using
electrodes 13 and 18 as the source and sink electrodes, and
electrodes 15 and 16 are utilized as the measurement electrodes.
This results in data 9 being developed, which data is correlated to
the generic depth. In an exemplary embodiment, data 9 corresponds
to the voltage between electrodes 15 and 16. FIG. 30 depicts data
10, which data is developed using electrodes 13 and 18 as the
source and sink electrodes, and electrodes 16 and 17 are utilized
as the measurement electrodes. This results in data 10 being
developed, which data is correlated to the generic depth. In an
exemplary embodiment, data 10 corresponds to the voltage between
electrodes 16 and 17. FIG. 31 depicts data 11, which is developed
using electrodes 14 and 15 as the measurement electrodes and
electrodes 13 and 18 as the source and sink.
[0102] FIG. 32 depicts data 12, which is developed using electrodes
13 and 18 as the source and sink electrodes, and electrodes 14 and
16 as the measurement electrodes.
[0103] Variations of the above exemplary embodiments can be
executed to obtain various data points having utilitarian
value.
[0104] FIG. 33 depicts data 13 and 14, which data was developed
utilizing, respectively, electrodes 17 and 18 as measurement
electrodes, and electrodes 15 and 20 as the source and sink
electrodes, and electrodes 18 and 19 as the measurement electrodes,
and electrodes 16 and 21 as the source and sink electrodes. FIG. 33
also depicts data 15, which data was developed using electrodes 13
and 20 as the source and sink, and electrodes 16 and 17 as the
measurement electrodes. Using electrodes 13 and 20 as the source
and sink electrodes, data 17 is developed using electrodes 14 and
15 as the measurement electrodes, data 16 is developed using
electrodes 15 and 16 as the measurement electrodes, data 18 is
developed using electrodes 17 and 18 as the measurement electrodes,
data 19 is developed using electrodes 18 and 19 as the measurement
electrodes, etc.
[0105] Consistent with the teachings detailed above, as the
distance between the source and sink expands, the further the
electrical field will radiate from the electrode array (e.g., the
further 50% of the current generated by the electrical field will
be located from the electrode array). The further that the
electrical field radiates from the electrical array, the more the
electrical field will radiate through the relatively highly
resistive bone of the cochlea (relative to the resistivity of the
perilymph), which will result in different readings for the
respective data. For example, where the voltage is measured between
electrodes 16 and 17, for a given current, the voltage of data 4
should be lower than the voltage of data 10 and the voltage of data
10 should be lower than the voltage of data 15, etc. Without being
bound by theory, at some point (where the distance between the
source and sink electrodes has increased by a certain amount), the
voltage between electrodes 16 and 17 should noticeably spike,
indicating that a substantial amount of the current extends into
the bone of the cochlea (modiolus wall, for example), Relative to
that which was the case when the source and sink electrodes were
closer to each other.
[0106] From the above, it is to be understood that in an exemplary
embodiment, the various electrodes of the electrode array can be
sequentially activated and other electrodes of the electrode array
can be utilized as measurement electrodes to obtain electrical
characteristics associated therewith resulting from the electrical
field that results from the activation electrodes. Because the
distance between the source and sink electrodes is known (and
because the distance between the measurement electrodes is known),
the data from the measurement electrodes can be correlated to
determine the distance of the electrode array to the modiolus wall.
In an exemplary embodiment, this is done utilizing vertical
electrical sounding techniques. That is, a data set can be
developed by activating various permutations of the electrodes as
source and sinks, and utilizing various permutations of the
electrodes as measurement electrodes, and applying vertical
electrical sounding techniques, because the distance between the
electrodes is known, the distance from the electrode array to bone
of the cochlea (modiolus wall, for example), or other structure
that has a different resistivity than the perilymph in the cochlea,
can be determined.
[0107] FIG. 34 depicts an exemplary flowchart for an exemplary
method, method 3400, which includes method action 3410, which
includes sequentially activating a plurality of respective
electrode pairs of an implanted cochlear implant, at least one of
the electrodes of the respective electrode pairs being a respective
electrode of an electrode array implanted in a cochlea, thereby
generating respective localized electric fields. In an exemplary
embodiment, this corresponds to utilizing electrodes 12 and 15 as a
source and a sink, and then using electrodes 13 and 16 as a source
and a sink, and so on.
[0108] Method 3400 also includes method action 3420, which includes
concurrently respectively measuring, for the plurality of activated
respective electrode pairs, an electrical characteristic between
the respective electrodes of the respective electrode pairs
resulting from the respective localized electric fields, thereby
obtaining a measurement set. In an exemplary embodiment, this
corresponds to utilizing electrodes 13 and 14 as the measurement
electrodes when the electrode pair corresponds to electrodes 12 and
15, and utilizing electrodes 14 and 15 as the measurement
electrodes when the electrode pair corresponds to electrodesl3 and
16. From the measurements of the measurement electrodes, a
correlated data set is developed.
[0109] Method 3400 also includes method action 3430, which includes
determining, from the measurement set, a distance between the
electrode array and a wall of the cochlea. Consistent with the
teachings detailed above, the measurement set can comprise, in some
embodiments, respective voltages measured between the respective
electrodes of the respective electrode pairs. That said, in other
embodiments, other electrical characteristics can be used to
establish the measurement set. Combinations of electrical
characteristics can be utilized to establish the measurement set.
Any electrical characteristic that can enable the teachings
detailed herein and/or variations thereof can be utilized in at
least some exemplary embodiments.
[0110] As will be understood from the above, in some exemplary
embodiments of method action 3420, the electrical characteristic
includes measuring an electrical characteristic using first and
second electrodes of the electrode array, which electrodes are
different from the electrodes of the electrode pair. In at least
some embodiments, the electrode pairs used to create the
measurement set comprises a unique pair of electrodes. In some
embodiments, a respective first electrode of each electrode pair is
selected from a first set of consecutive electrodes, a respective
second electrode of each electrode pair is selected from a second
set of consecutive electrodes, and respective third and fourth
electrodes are disposed between the respective first and second
electrodes, the third and fourth electrodes being utilized to
measure the electrical characteristic. In some exemplary
embodiments, the respective first and second electrodes are
disposed symmetrically about the respective third and fourth
electrodes. In some exemplary embodiments, both of the electrodes
of the respective electrode pairs are respective electrodes of the
electrode array implanted in the cochlea. This as opposed to some
embodiments where, for example, one of the electrodes of the pairs
is an extra-cochlear electrode (e.g., the so called hardball
electrode, etc.).
[0111] FIG. 35 presents a flowchart for an exemplary method, method
3500, including method action 3510, which includes obtaining first
data by operating a first set of electrodes as a source and sink in
and/or on a mammal (e.g., electrodes of a cochlear electrode array
located in a cochlea) while operating a second set of electrodes as
recorder electrodes in and/or on a mammal (again, for example, the
cochlear electrode array located in a cochlea) thereby obtaining
first electrical data from the second set of electrodes. In an
exemplary embodiment, the first electrical data corresponds to
voltage measurements at the electrodes of the second set of
electrodes. Again, consistent with the teachings detailed herein,
any electrical characteristic that can enable the teachings
detailed herein can be utilized in some embodiments.
[0112] Method 3500 further includes method action 3520, which
includes obtaining second data by operating a third set of
electrodes as a source and sink in and/or on the mammal, the third
set being different than the first set, while operating the second
set of electrodes as recorder electrodes in and/or on the mammal
and thereby obtaining second electrical data from the second set of
electrodes. Method 3500 also includes method action 3530, which
includes evaluating data by evaluating the first electrical data
and the second electrical data, and method action 3540, which
includes determining spatial positioning data based on the
evaluation of the data, wherein the spatial positioning data is a
distance of one or more of the electrodes of the first set or
second set from a structure within the mammal.
[0113] In an exemplary embodiment, the first electrical data is a
first impedance based data (voltage, current, impedance--any data
that is based on impedance) between the electrodes of the second
set. The second electrical data is a second impedance based data
between the electrodes of the second set. Further, the action of
evaluating the first electrical data and the second electrical data
includes comparing the first electrical data to the second
electrical data, and the action of determining the spatial
positioning data includes determining a distance of the second set
of electrodes from a gradient. In some exemplary embodiments, the
gradient is a resistivity gradient. For example, a gradient
established between the perilymph and bone of the cochlea.
[0114] It is noted that the gradient can also be established by the
membrane that is located between bone of the cochlea and the
perilymph, if such is present.
[0115] In some embodiments, the electrodes of the first set are
located closer to one another than the electrodes of the third set
and are between electrodes of the third set.
[0116] In an exemplary embodiment, there is a method 3600 as
represented by the flowchart on FIG. 36, which method includes
method action 3610, which includes executing method 3500. Method
3610 also includes method action 3620, which includes obtaining
third data by operating a fourth set of electrodes as a source and
sink in and/or on the mammal, the fourth set different than the
third set, while operating the second set of electrodes as recorder
electrodes in and/or on the mammal, thereby obtaining third
electrical data from the second set of electrodes. In an exemplary
embodiment, the action of evaluating data includes evaluating the
third electrical data while also evaluating the second electrical
data and the first electrical data, and the electrodes of the first
set are located closer to one another than the electrodes of the
third set and are between electrodes of the third set, and the
electrodes of the third set are located closer to one another and
between electrodes of the fourth set.
[0117] In some embodiments, the recorder electrodes are part of a
cochlear electrode array that is located in a cochlea, as noted
above. Also, the determined spatial positioning data is distance
data of the recorder electrodes from a modiolus wall of the
cochlea. In some embodiments, the determined spatial positioning
data is an orientation of the recorder electrodes relative to
structure of the cochlea. For example, the orientation can be
whether the electrodes face directly at the modiolus wall, or
whether the electrodes face away from the modiolus wall. In an
exemplary embodiment, the orientation is an approximate angle from
a centerline of the electrode to a centerline of the modiolus wall.
In an exemplary embodiment, the orientation is an approximate angle
that represents the difference from the ideal orientation of the
electrodes relative to the modiolus wall and the actual angle.
[0118] FIG. 37 represents an exemplary flowchart for an exemplary
method, method 3700, which includes method action 3710, which
includes executing method 3500. Method 3700 further includes method
action 3720, which includes, obtaining third data by operating a
fourth set of electrodes as a source and sink in and/or on the
mammal, the fourth set different than the third set, while
operating a fifth set of electrodes as recorder electrodes in
and/or on the mammal, thereby obtaining third electrical data from
the second set of electrodes. Method 3700 further includes method
action 3730, which includes obtaining fourth data by operating a
sixth set of electrodes as a source and sink in and/or on a mammal,
the sixth set different than the fourth set, while operating the
fifth set of electrodes as recorder electrodes in and/or on the
mammal, thereby obtaining fourth electrical data from the seventh
set of electrodes. In this exemplary method, in an exemplary
embodiment, the action of evaluating data includes also evaluating
the third electrical data and the fourth electrical data, the
electrodes are part of a cochlear electrode array that is located
in a cochlea, and the action of determining spatial positioning
data based on the evaluation of the data includes determining a
distance of the electrodes of the second set from a modiolus wall
of the cochlea based on the evaluation of the second and first
electrical data and determining a distance of the electrodes of the
fifth set from a modiolus wall of the cochlea based on the
evaluation of the third electrical data and the fourth electrical
data.
[0119] FIG. 38 depicts a flowchart for an exemplary method, method
3800, which includes method action 3810, which includes executing
method 3500. Method 3800 also includes method actions 3820 and
3830, which respectively include executing method actions 3720 and
3730. Method 3800 also includes method action 3840, which includes
obtaining distance data of a seventh set of electrodes used as
recording electrodes from the modiolus wall, the seventh set being
different than the second set and the fifth set. Subsequent to
this, method 3800 includes method action 3850, which includes
determining that the electrode array is at least one of over
inserted into the cochlea, has experienced a tip fold over, or is
angularly misaligned by comparing the distance data of at least two
of the seventh set, fifth set and second set to one another. Some
additional details of such features are described below.
[0120] Table I below depicts an exemplary regime utilizing a 22
electrode array according to the teachings detailed herein, where
each row can correspond to any of the first set of electrodes and
second set of electrodes of method action 3510, and where, in an
exemplary embodiment, method action 3510 is executed C number of
times, and in an exemplary embodiment, each time for a different
first set, where C can be 19 times for 22 electrode array, or 27
times for a 30 electrode array, etc. In an exemplary embodiment, C
is any integer between 1 and 3 minus the number of electrodes of
the array, or any number between 1 and 2 minus the number of
electrodes of the array (where, for example, an extra cochlear
electrode is used). Any different row from that previously used can
corresponds to the third set of electrodes of method action 3520,
and method action 3520 can be executed C minus 1 times (to avoid
duplication, but in some other embodiments, can be executed C
times, as duplication does not prevent method 3500 from being
executed--it is just an additional action) or C minus 1 minus the
aforementioned minuses.
TABLE-US-00001 TABLE I Measurement Source or Sink Sink or Source
electrode No. Read Electrode Electrode No. (A) Electrode No. (B)
(M) No. (N) 1 4 2 3 2 5 3 4 3 6 4 5 4 7 5 6 5 8 6 7 6 9 7 8 7 10 8
9 8 11 9 10 9 12 10 11 10 13 11 12 11 14 12 13 12 15 13 14 13 16 14
15 14 17 15 16 15 18 16 17 16 19 17 18 17 20 18 19 18 21 19 20 19
22 20 21
[0121] Table II below depicts an exemplary regime utilizing a 22
electrode array according to the teachings detailed herein, where
each row can correspond to any of the first set of electrodes and
second set of electrodes of method action 3510 (and the second sets
can be the measurement electrodes as listed, or one of the
measurement electrodes with the alternate electrode, or both
(actually all three--with respect to the first row, the measurement
electrodes can be 2 and 3, 2 and 4 and/or 3 and 4 (three sets in
total maximum)), and where, in an exemplary embodiment, method
action 3510 is executed D number of times (and potentially more to
accommodate for the fact that for a given source and sink, there
can be various applications of the measurement electrodes, as just
noted), and in an exemplary embodiment, each time for a different
first set, where D can be 18 times for 22 electrode array, or 26
times for a 30 electrode array, etc. In an exemplary embodiment, D
is any integer between 1 and 4 minus the number of electrodes of
the array, or any number between 1 and 3 minus the number of
electrodes of the array (where, for example, an extra cochlear
electrode is used). Any different row from that previously used can
corresponds to the third set of electrodes of method action 3520,
and method action 3520 can be executed D minus 1 times (to avoid
duplication, but in some other embodiments, can be executed D
times, as duplication does not prevent method 3500 from being
executed--it is just an additional action) or D minus 1 minus the
aforementioned minuses.
TABLE-US-00002 TABLE II Source or Sink or Sink Source Measurement
Read Alternate Electrode Electrode electrode No. Electrode
Measurement No. (A) No. (B) (M) No. (N) electrode 1 5 2 3 4 2 6 3 4
5 3 7 4 5 6 4 8 5 6 7 5 9 6 7 8 6 10 7 8 9 7 11 8 9 10 8 12 9 10 11
9 13 10 11 12 10 14 11 12 13 11 15 12 13 14 12 16 13 14 15 13 17 14
15 16 14 18 15 16 17 15 19 16 17 18 16 20 17 18 19 17 21 18 19 20
18 22 19 20 21
[0122] Table III below depicts an exemplary regime utilizing a 22
electrode array according to the teachings detailed herein, where
each row can corresponds to any of the first set of electrodes and
second set of electrodes of method action 3510, and where, in an
exemplary embodiment, method action 3510 is executed E number of
times (and potentially more to accommodate for the fact that for a
given source and sink, there can be various applications of the
measurement electrodes, as just noted), and in an exemplary
embodiment, each time for a different first set, where E can be 17
times for 22 electrode array, or 25 times for a 30 electrode array,
etc. In an exemplary embodiment, E is any integer between 1 and 5
minus the number of electrodes of the array, or any number between
1 and 4 minus the number of electrodes of the array (where, for
example, an extra cochlear electrode is used). Any different row
from that previously used can correspond to the third set of
electrodes of method action 3520, and method action 3520 can be
executed E minus 1 times (to avoid duplication, but in some other
embodiments, can be executed E times, as duplication does not
prevent method 3500 from being executed--it is just an additional
action) or E minus 1 minus the aforementioned minuses.
[0123] It is noted that the below table indicates that the second
set of electrodes of method action 3510 can be any combination of
the measurement electrodes. For example, for a source and sink
corresponding to electrodes 1 and 6, the measurement electrodes can
be 2 and 3, 2 and 4, 2 and 5, 3 and 4, 3 and 5 or 4 and 5.
TABLE-US-00003 TABLE III Source or Second Sink Sink or Measure-
First Alternate Electrode Source ment Read Alternate Measure- No.
Electrode electrode Electrode Measurement ment (A) No. (B) No. (M)
No. (N) electrode electrode 1 6 2 3 4 5 2 7 3 4 5 6 3 8 4 5 6 7 4 9
5 6 7 8 5 10 6 7 8 9 6 11 7 8 9 10 7 12 8 9 10 11 8 13 9 10 11 12 9
14 10 11 12 13 10 15 11 12 13 14 11 16 12 13 14 15 12 17 13 14 15
16 13 18 14 15 16 17 14 19 15 16 17 18 15 20 16 17 18 19 16 21 17
18 19 20 17 22 18 19 20 21
[0124] From the above, it can be seen that embodiments include
expanding the trend above, one electrode at a time to expand the
source and sink distance, while, for each expansion, the
measurement electrodes can be varied accordingly to the trend
above. Table IV below depicts a generalized version of the tables
above.
TABLE-US-00004 TABLE IV Source Sink or or Sink Source Measurement
Read Electrode Electrode electrode No. Electrode Alternate
Measurement No. (A) No. (B) (M) No. (N) electrode(s) 1 A plus N A
plus 1 A plus 2 A + 3 to A + N - 1 2 A plus N 3 4 A + 3 to A + N -
1 3 A plus N 4 5 A + 3 to A + N - 1 4 A plus N 5 6 A + 3 to A + N -
1 5 A plus N 6 7 A + 3 to A + N - 1 6 A plus N 7 8 A + 3 to A + N -
1 7 A plus N 8 9 A + 3 to A + N - 1 8 A plus N 9 10 A + 3 to A + N
- 1 9 A plus N 10 11 A + 3 to A + N - 1 10 A plus N 11 12 A + 3 to
A + N - 1 11 A plus N 12 13 A + 3 to A + N - 1 12 A plus N 13 14 A
+ 3 to A + N - 1 13 A plus N 14 15 A + 3 to A + N - 1 14 A plus N
15 16 A + 3 to A + N - 1 15 A plus N 16 17 A + 3 to A + N - 1 16 A
plus N 17 18 A + 3 to A + N - 1 17 A plus N 18 19 A + N - 1, A + N
- 2 18 A plus N 19 20 A + N - 1 19 A plus N 20 21 N/A
[0125] In the above table, N is the increment for each iteration.
For a 22 electrode array, N can be 3, 4, 5, 6, 7, 8, 9, 10, 11, 12,
13, 14, 15, 16, 17, 18, 19, 20 or 21 (as limited by the top
end--e.g., when A is electrode 16, N cannot be 20).
[0126] It is noted that while the read/measurement electrodes in
the above tables are located between the source and sink
electrodes, in some embodiments, as noted above, one measurement
electrode is between the source and sink electrode, and one is
outside/not in between the source and sink. Further, in some
embodiments, both measurement electrodes are outside the source and
sink (not between the source and sink).
[0127] Note also that in some embodiments, more than 2 measurement
electrodes can be used for a given activation of a source and sink.
Indeed, in some embodiments, for a given source and sink
activation, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17,
18, 19 or 20 or more electrodes can be used as the measurement
electrodes. For example, in the case where there electrodes 2 and 5
are the source and sink, electrode 3 and 4 and 6 and 7 and 8 and 9
and 10 etc. can simultaneously be the measurement electrodes (e.g.,
the voltage difference between electrodes 3 and 4, 3 and 6, 3 and
7, 3 and 8, 3 and 9, 3 and 10, 4 and 6, 4 and 7, 4 and 8, 4 and 9,
4 and 10, 6 and 7, 6 and 8, 6 and 9, 6 and 10, 7 and 8, 7 and 9, 7
and 10, 8 and 9, 8 and 10 and 9 and 10 can all potentially be
simultaneously read or read in sequence in any order.
[0128] From the above, it can be seen that embodiments include
expanding the trend above, one electrode at a time to expand the
source and sink distance, while, for each expansion, the
measurement electrodes can be varied accordingly to the trend
above. Table V below depicts a generalized version based on the
above.
TABLE-US-00005 TABLE V Source or Sink Sink or Source Electrode
Electrode Measurement electrode No. (A) No. (B) No. (M) Read
Electrode No. (N) 1 A plus N Not A and not A plus N Not A and not A
plus N and not M 2 A plus N Not A and not A plus N Not A and not A
plus N and not M 3 A plus N Not A and not A plus N Not A and not A
plus N and not M 4 A plus N Not A and not A plus N Not A and not A
plus N and not M 5 A plus N Not A and not A plus N Not A and not A
plus N and not M 6 A plus N Not A and not A plus N Not A and not A
plus N and not M 7 A plus N Not A and not A plus N Not A and not A
plus N and not M 8 A plus N Not A and not A plus N Not A and not A
plus N and not M 9 A plus N Not A and not A plus N Not A and not A
plus N and not M 10 A plus N Not A and not A plus N Not A and not A
plus N and not M 11 A plus N Not A and not A plus N Not A and not A
plus N and not M 12 A plus N Not A and not A plus N Not A and not A
plus N and not M 13 A plus N Not A and not A plus N Not A and not A
plus N and not M 14 A plus N Not A and not A plus N Not A and not A
plus N and not M 15 A plus N Not A and not A plus N Not A and not A
plus N and not M 16 A plus N Not A and not A plus N Not A and not A
plus N and not M 17 A plus N Not A and not A plus N Not A and not A
plus N and not M 18 A plus N Not A and not A plus N Not A and not A
plus N and not M 19 A plus N Not A and not A plus N Not A and not A
plus N and not M
[0129] In the above table, the measurement electrodes are only
limited as noted.
[0130] Also, in some embodiments, an extra-cochlea electrode can be
used as the source or the sink electrode (in some embodiments,
there is high utility for using the extra-cochlear electrode as the
sink) for greater depth sensing. In which case, table V would
result in the elimination of one of the electrodes as the source or
sink and the inclusion of that electrode as one of the measurement
electrodes.
[0131] To be clear, methods include any one or more permutations of
the above, where data is obtained from the pertinent measurement
electrodes. In some embodiments, every permutation is executed with
the electrode array. In some embodiments, only some permutations
are presented.
[0132] FIG. 39 presents another exemplary flowchart for an
exemplary method, method 3900, which includes method action 3910,
which includes executing vertical electrical sounding utilizing
electrodes of an electrode array of a cochlear implant located in a
cochlea. This is executed using any of the method actions, alone or
in combination, detailed herein, or variations thereof, or any
other technique that will enable vertical electrical sounding
utilizing electrodes and electrode array of a cochlear implant
located in the cochlea. Method 3900 also includes method action
3920, which includes determining a positional feature of the
electrode array based on the vertical electrical sounding. In an
exemplary embodiment, the determined positional feature is a
distance of the electrode array from a modiolus wall of the
cochlea. In an exemplary embodiment, the determined positional
feature is a distance of the electrode array from a lateral wall of
the cochlea. In an exemplary embodiment, the determined positional
feature is respective distances from structure of the cochlea
(lateral wall, modiolus wall, etc.) for one or more respective
locations of the electrode array. For example, the one or more
respective distances can be the respective distances from any one
or more of electrodes 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13,
14, 15, 16, 17, 18, 19, 20, 21, and/or 22 to the structure, and, if
an array with more electrodes are present, for those additional
electrodes. For example, these can be distances from locations L9,
L10, L11, L12, L13, L14, L15, L16, and L17 in FIG. 5A, and for the
other electrodes not shown accordingly. In an exemplary embodiment,
the one or more respective distances can be the respective
distances from any location in between, including the location on
the electrode array in the geometric center (e.g., 50% of the way
between) between any group of two or more electrodes 1, 2, 3, 4, 5,
6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, and/or
22 to the structure, and, if an array with more electrodes are
present, for those additional electrodes. For example, these can be
distances from locations L1, L2, L3, L4, L5, L6, L7 and L8 in FIG.
5A, and for other respective locations for the electrodes not
shown.
[0133] In an exemplary embodiment, relative to distance from the
distal tip of the electrode array, the one or more respective
distances can be the respective distances from any one or more
locations at or about 0.1, 0.2, 0.3, 0.4, 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, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8,
4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1,
6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4,
7.5, 7.6, 7.7, 7.8, 7.9, or 8.0 cm along the array from the tip,
depending on the length of the array, of course, or any value or
range of values therebetween in 0.01 cm increments, providing that
the array enables such.
[0134] In an exemplary embodiment of the method action 3920, the
determined positional feature is a tip fold over of the electrode
array. In an exemplary embodiment, this is determined by
determining distances for respective locations along the array from
a given structure of the cochlea, and determining that a distance
value or values "does not make sense" relative to other distance
values other than in a scenario where there is a tip fold over (or
that such is a possibility). Any data that results from vertical
electrical tomography or any of the other techniques detailed
herein that can be utilized to determine or otherwise estimate that
a tip fold over has occurred, can be utilized in at least some
exemplary embodiments.
[0135] In an exemplary embodiment, the determined positional
feature of method action 3920 is a puncture of the electrode array
through a wall of the cochlea. Again, such a determination can be
achieved, in an exemplary embodiment, by evaluating or otherwise
determining distances for respective locations along the array from
a given structure of the cochlea, and determining that a distance
value or values is inconsistent with a properly positioned array,
and is otherwise indicative of an array that has punctured a wall
of the cochlea. In an exemplary embodiment, the determined
positional feature of method action 3920 is in over insertion of
the electrode array to the cochlea, while in some embodiments of
the method action 3920, the determined positional feature is a
longitudinal location of the electrode array within the cochlea. It
is noted that the various positional features detailed herein are
not mutually exclusive when executing method action 3920. That is,
in an exemplary embodiment, the method action 3920 is executed, a
number of different positional features can be determined based on
a single set of data.
[0136] In some exemplary embodiments, there is an exemplary method,
such as method 4000 represented by the flow chart on FIG. 40,
wherein the method includes method action 4010, which includes
executing method 3900, which results in the determined positional
feature being a longitudinal location of the electrode array within
the cochlea. Method 4000 also includes method action 4020, which
includes the action of determining based on the longitudinal
location of the electrode array within the cochlea that an
electrode array fixation failure has occurred. In an exemplary
embodiment, method action 4020 is executed during the surgical
process in which the electrode array has been inserted (e.g.,
subsequent to insertion, during closure of the access incision
through the outer skin of the recipient, etc.), while in an
exemplary embodiment, method action 4020 is executed after the
recipient has left the surgery room. In an exemplary embodiment,
method action 4020 is executed after 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 months or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 years
after implantation and fixture of the electrode array.
[0137] In an exemplary embodiment, the determined positional
feature is a distance from fibrous tissue that has grown since the
array was implanted in the recipient. In this regard, the
determined position feature can be executed after 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 months or 3 or 4 or 5 or 6 or 7 or 8
or 9 or 10 years after implantation of the electrode array.
[0138] FIG. 41 presents a flowchart for an exemplary method, method
4100, which includes method action 4110, which includes energizing
an electrode implanted in a recipient, the electrode being part of
an assembly located in and/or on a recipient. In an exemplary
embodiment, the assembly is an electrode array of a cochlear
implant, and the electrode that is energized is intracochlear
electrode array, although as noted above, in embodiments where an
extra cochlear electrode array is utilized as the source under the
sink, where such is utilized as the source, and extra cochlear
electrode array can be energized. Method 4100 also includes method
action 4120, which includes receiving data from one or more
recording electrodes located in and/or on a recipient. In an
exemplary embodiment, this can correspond utilizing the measurement
electrodes that are located along the array as noted above. Method
4100 also includes method action 4130, which includes determining
spatial position data of the assembly based on the received data.
In an exemplary embodiment, the spatial position data can be any of
the data detailed herein or variations thereof, such as the
distance from the modiolus wall, etc. As will be understood, in an
exemplary embodiment, the actions of energizing, receiving, and
determining can be, in some embodiments, actions that are part of a
vertical electrical sounding method applied to a mammal.
[0139] It is noted that by spatial position data, such does not
include mere indicators that an event has occurred (e.g., that the
electrode array has moved, etc.). The spatial position data
obtained in method action 4130 is data that indicates a position of
the array.
[0140] In an exemplary embodiment of method action 4130, the
spatial position data of the assembly is a distance of the assembly
from a wall of tissue of the recipient (e.g., the modiolus wall,
etc.). In an exemplary embodiment, the wall of tissue of the
recipient is a wall that is a barrier of a cavity in the recipient
that normally contains bodily fluid. In an exemplary embodiment,
the wall of tissue of the recipient is a modiolus wall of a
cochlea, the assembly is an electrode array of a cochlear implant,
the electrode is located in a duct of the cochlea, and the spatial
position is distance of the electrode array from the modiolus wall
relative to the one or more recording electrodes or a location
between two or more of the recording electrodes (anywhere between,
such as a location 50% of the way between two electrodes). In some
exemplary embodiments where the assembly is a cochlear electrode
array, method 4100 includes determining, based on the determined
spatial position data (e.g., such as the distance from the modiolus
wall, or other structure of the cochlea, for one or more locations
along the electrode array), that at least one or more of the
following has occurred: [0141] (i) a tip fold over; [0142] (ii) a
longitudinally local lateral angular position of the electrode
array has shifted relative to another longitudinally local
position; [0143] (iii) the electrode array has been over inserted
into a cochlea of the recipient; [0144] (iv) the electrode array
has become unfixed subsequent to full implantation into the
recipient; or [0145] (v) the electrode array has migrated during
implantation.
[0146] Consistent with the teachings detailed herein, in an
exemplary embodiment of method 4100 where the assembly is an
electrode array assembly, the spatial position data can be a
plurality of respective distance of the assembly at respective
locations along the array from respective locations of a wall of
tissue of the recipient.
[0147] FIG. 42 presents a flowchart for an exemplary method, method
4200, which includes method action 4210, which includes executing
method 4100, wherein the actions of energizing, receiving and
determining are actions that are part of a surgical procedure to
implant the assembly in the recipient. Method 4200 further includes
method action 4220, which comprises repositioning the electrode
array based on the determined spatial position data. In this
regard, in an exemplary embodiment, the spatial positioning data,
such as the distance from the modiolus wall, for example, can be
evaluated to determine that the electrode array is at a position
that is less than utilitarian relative to that which would
otherwise be the case if the electrode array was positioned at
another location, such as by way of example only and not by way of
limitation, at a location where one or more locations along the
electrode array are located closer to the modiolus wall. Thus, in
an exemplary embodiment, based on the spatial positioning data,
when the determination is made that the electrode array should be
repositioned, method action 4220 can be executed based on that
data.
[0148] FIG. 43 presents an exemplary flowchart for an exemplary
method, method 4300, which includes method action 4310, which
includes obtaining electrical data from at least two electrodes
implanted in a human head, such as by implementing the teachings
detailed herein and/or variations thereof, such as by using a
cochlear electrode array. Method 4300 also includes method action
4320, which includes determining a physiological feature of an
interior of a duct of a cochlea based on the obtained electrical
data. In an exemplary embodiment, the determined physiological
feature is the relative absence of perilymph in the duct, while in
some other embodiments, the determined physiological feature is the
relative absence of fibrous tissue growth due to implantation of
the electrode array into the duct of the cochlea (the latter having
utilitarian value when method action 4320 is executed after 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 days or 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 months or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10
years after implantation of the electrode array). In an exemplary
embodiment, the determined physiological feature is the presence of
significant fibrous tissue growth due to implantation of the
electrode array into the duct of the cochlea (again, which can have
utilitarian value when executed after 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 days or 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 months
or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 years after implantation
of the electrode array).
[0149] FIG. 44 depicts an exemplary flowchart for an exemplary
method. Method 4400, which includes method action 4410, which
includes executing method 4300, where the determined physiological
feature is the presence of significant fibrous tissue growth due to
implantation of the electrode array into the duct of the cochlea.
Method 4400 also includes method action 4420, which includes
executing NRT (Neural Response Telemetry) method, such as by using
the electrodes of a cochlear electrode array implanted in a
cochlea. In this regard, in an exemplary embodiment, cochlear
implants according to some embodiments are configured to enable the
execution of an NRT method. Method 4400 further includes method
action 4430, which includes evaluating results of the NRT method by
taking into account the presence of the significant fibrous tissue
growth. In this regard, in an exemplary embodiment, the presence of
significant fibrous tissue growth can skewer otherwise change the
results of the NRT method. In an exemplary embodiment, by
discounting the results of the NRT method based on the presence of
the fibrous tissue growth, more utilitarian value of the NRT method
can be obtained. In an exemplary embodiment, the method of method
4400 also includes the action of determining that the fibrous
tissue has established a dead patch with respect to taking NRT
measurements.
[0150] It is noted that sometimes, NRT is referred to in the art as
evoked compound action potentials (ECAP).
[0151] In an exemplary embodiment, there is a cochlear implant
configured to execute one or more of the actions detailed herein,
which cochlear implant is configured to communicate the results of
such actions to control unit 8310. Corollary to this is that
control unit 8310 can be configured to activate the
receiver/stimulator of the cochlear implant to execute one or more
of the method actions detailed herein, such as the measurements/the
collection of the data. In an alternative embodiment, the
receiver/stimulator of the cochlear implant can execute such
autonomously. The receiver/stimulator of the cochlear implant, can,
in some embodiments, be configured to transmit the data based on or
otherwise resulting from the execution of one or more of the method
actions to the control unit 8310. Control unit 8310 analyzes the
data in some embodiments. Indeed, in some embodiments, at least
based in part on that data, control unit 8310 can control an
automated robot that inserts an electrode array into a cochlea.
[0152] In an exemplary embodiment, the cochlear implant can be
configured to take NRT/ECAP measurements to obtain the NRT/ECAP
data, which cochlear implant is configured to communicate the
results of such measurements to control unit 8310. In this regard,
the ECAP measurement device/ECAP data collection device can
correspond to a receiver/stimulator of a cochlear implant, which
has an inductance coil and can be utilized as detailed above,
albeit with respect to measuring ECAP or otherwise developing or
collecting ECAP data and conveying such measurements to the control
unit 8310. Corollary to this is that control unit 8310 can be
configured to activate the receiver/stimulator of the cochlear
implant to execute the measurements/the collection of the data. In
an alternative embodiment, the receiver/stimulator of the cochlear
implant can execute such autonomously. The receiver/stimulator of
the cochlear implant, can transmit the data based on or otherwise
resulting from the execution of NRT/ECAP measurements to the
control unit 8310. Control unit 8310 analyzes the data in some
embodiments, and, at least based in part on that data, in some
embodiments, can control an automated robot that inserts an
electrode array into a cochlea.
[0153] It is noted that in some exemplary embodiments, the
electrode arrays detailed herein are utilized to obtain data
analogous to the data obtained via Electrical resistivity
tomography (ERT) or electrical resistivity imaging (ERI), and in
some embodiments, the electrode array is utilized to execute such.
These techniques are traditionally geophysical techniques for
imaging sub-surface structures from electrical resistivity
measurements made at the surface. Accordingly, where the electrode
array of the cochlear implant is used to execute such techniques,
such can be used to obtain imaging.
[0154] For example, induced polarization, measures the transient
response. In some embodiments, the cochlear implant and/or the
system of which it is apart, such as the control unit noted above,
are configured to execute 1D, 2D and/or 3D Electrical Resistivity
Tomography (ERT).
[0155] In an exemplary embodiment, the above-noted action of
obtaining electrical data from at least two electrodes implanted in
a human head includes doing so as part of an ERT/ERI method, and
the action of determining a physiological feature of an interior of
a duct of a cochlea based on the obtained electrical data results
in an image.
[0156] FIG. 45 depicts an image that results from a synthetic
model, and FIG. 46 depicts an image that results from resistive
projection measurements, and FIG. 47 depicts an image of an
inverted projection, where darker colors are lower impedance. In an
exemplary embodiment, these images are obtained using ERT/ERI via a
cochlear electrode array inserted into a cochlea, to obtain image
information associated with the cochlea.
[0157] It is noted that any equations and/or theories detailed
herein are presented for purposes of explanation and conceptual
understanding only. In some embodiments, such equations and
theories may be applicable. In other embodiments, such equations
and theories may not be applicable, or otherwise may be applicable
only with further modifications or variations. By way of example
only and not by way of limitation, while some of the equations
presented above are for a hemispherical scenario owing to the fact
that air acts as an insulator when utilized in the geological
regime, such is not the case with respect to utilization of an
electrode array that is located in a cochlea that is filled with
perilymph.
[0158] Still further, below is presented some exemplary teachings
that can have utilitarian value with respect to at least some
exemplary embodiments. It is noted that the below is for purposes
of explaining some embodiments, in other embodiments may not
utilize some or all of the following teachings. It is noted that in
some exemplary embodiments, there are methods systems and/or
apparatuses that use some or all of the following teachings. In
this regard, in an exemplary embodiment, there is a method that is
executed to obtain various data/results detailed herein utilizing
one or more of the following teachings. In an exemplary embodiment,
there is an apparatus and/or system that is configured to obtain
various data/results detailed herein utilizing one or more of the
following teachings. In this regard, in an exemplary embodiment,
there is a system and/or apparatus that includes structure to
execute some or all of the following teachings. By way of example
only and not by way of limitation, in an exemplary embodiment, such
structure can be a personal computer or the like that is programmed
to achieve such goals, which personal computer is in signal
communication with a controller of an electrode array that is
implanted in a cochlea or the like. That said, in an alternate
embodiment, the personal computer can be configured to receive data
obtained by use of the controller of the electrode array, which
data can be downloaded or the like or otherwise provided to the
computer system (e.g., such as via utilization of a flash drive or
the like, which flash drive contains data obtained from the
cochlear implant). It is further noted that in at least some
exemplary embodiments, computational techniques are utilized to
obtain values or estimates for the various data/results detailed
herein.
[0159] During electrical stimulation of the cochlea, a voltage
dipole is generated between the stimulating electrode pair.
Assuming a purely resistive system (our spherical chicken in a
vacuum) the charge (q) on each electrode, of the dipole, is equal
to the applied current.
[0160] This is seen by way of example in FIG. 48, which depicts a
stimulating electrode array.
[0161] In a homogeneous medium of admittance (.sigma.) The voltage
potential generated by the dipole, at point (r, .theta.), is
determined as the super position of two charge sources, as defined
in Equation 1.
Equation .times. .times. 1 : Voltage .times. .times. due .times.
.times. to .times. .times. dipole ( r + = r 2 + a 2 - 2 .times.
racos .function. ( .theta. ) , r - = r 2 + a 2 + 2 .times. racos
.function. ( .theta. ) ) ##EQU00004## V ( r , .theta. ) = 1 4
.times. .pi..sigma. .times. ( q r + - q r - ) .times.
##EQU00004.2##
[0162] The differential of the voltage field gives the electric
field.
.times. Equation .times. .times. 2 : Electric .times. .times. field
.times. .times. from .times. .times. the .times. .times. voltage
.times. .times. gradient .times. .times. E ( r , .theta. ) =
.gradient. V ( r , .theta. ) ##EQU00005##
[0163] The current density (J) at depth r is determined by the
electric field induced in the medium multiplied by the admittance
of the medium, Equation 3.
J ( r , .theta. ) = .sigma. .times. .times. E ( r , .theta. )
Equation .times. .times. 3 : Current .times. .times. Density
##EQU00006##
[0164] Thus integrating current density across a region and
multiplying it by the area of the region will result in estimate
the actual current flowing through a specific region.
[0165] What is clear from these equations is that the amount of
current flowing at depth `r` is inversely proportional to the cube
of the depth, i.e. we have a lower sensitivity to deep regions then
shallow regions, but also that the sensitivity of the depth is
proportional to the spacing of the dipole as shown in FIG. 49.
[0166] Indeed, in geophysical applications, which typically only
consider only hemispherical voltage gradients because the air is an
insulator, the total fraction of the current flowing (i.sub.f)
shallower then depth z can be approximated by Equation 4. Note that
for a completely immersed fully metallic electrode in a homogeneous
medium this would be halved, as half the current will be flowing
above the electrode also.
Equation .times. .times. 4 : Total .times. .times. .times. fraction
.times. .times. of .times. .times. current .times. .times. flowing
.times. .times. shallower .times. .times. then .times. .times.
depth .times. .times. z . .times. Note .times. .times. a .times.
.times. is .times. .times. the .times. .times. separation .times.
.times. in .times. .times. FIG .times. . .times. 48. ##EQU00007## i
f = 2 .pi. .times. tan - 1 .function. ( z a ) .times.
##EQU00007.2##
[0167] Applying Equation 4 we observe that at its deepest 50
percent of the current sensitivity lies within the region of z=a,
and around 70% of the current is flowing at a depth equal to the
electrode separation.
[0168] It is not only the stimulating electrodes which determine
the sensitivity of the measurement to depth. The sense electrodes
"image" a portion of the gradient, and thus have their main
sensitivity restricted to the region between the electrodes.
[0169] For example; the Kumar four-point impedance method, which
involves a BP+3 stimulation and recording between the intermediate
two electrodes, shown in FIG. 50 (this matches the
wenner/schlumberger array when n=1).
[0170] Would only measure the effects of the electric field between
electrodes M and N, in addition the cross sectional area is
restricted to the region between M and N when calculating
impedance. A geometrical factor needs to be calculated to
compensate for the area of sensitivity between the recording
electrodes.
[0171] If we refer to the separation between electrodes by their
initial pairs (i.e. |AM| is the distance between electrodes A and
M), then using Equation 1, the voltage electrode M (V.sub.M) would
be defined as Equation 5. The voltage at the second recording
electrode would be the same equation substituting N for M.
Equation .times. .times. 5 : Voltage .times. .times. At .times.
.times. electrode .times. .times. M .times. .times. based .times.
.times. on .times. .times. dipole .times. .times. AB . .times. V M
= I 4 .times. .pi..sigma. .times. ( 1 AM - 1 MB ) ##EQU00008##
[0172] Thus the voltage measured by the recording pair would be as
described by Equation 6.
Equation .times. .times. 6 : Voltage .times. .times. measured
.times. .times. between .times. .times. electrode .times. .times.
pair .times. .times. MN ##EQU00009## V MN = V M - V N = 1 4 .times.
.pi..sigma. .function. [ ( 1 AM - 1 MB ) - ( 1 AN - 1 NB ) ]
##EQU00009.2##
[0173] If we set k to equal the following,
k = 4 .times. .pi. .function. [ ( 1 AM - 1 MB ) - ( 1 AN - 1 NB ) ]
- 1 ##EQU00010##
then the whole equation can be re written as Equation 7, which is
the standard impedance calculation, with correction factor k for
the geometry of the current spread. (Note that if we treat the
silicone of the electrode array as an insulator it may make more
sense to halve the geometric factor as in the 2D plane current will
not flow above the array.)
Equation .times. .times. 7 : Calculation .times. .times. of .times.
.times. impedance .times. .times. ( .rho. ) .times. .times. based
.times. .times. on .times. .times. voltage .times. .times. and
.times. .times. current .times. .times. .times. measurement
##EQU00011## 1 .sigma. = .rho. = V MN I .times. k .times.
##EQU00011.2##
[0174] Assuming constant electrode spacing the geometric factor
k=4.pi.|MN| for the Kumar method, assuming symmetrical conductance
either side of the electrode array. If we assume current only flows
towards the modiolus then the geometric factor becomes
k=2.pi.|MN|.
[0175] As the Kumar method is symmetrical the deepest penetration
will occur in the center of the array. i.e when r=r+=r. in Equation
1. In Cartesian co-ordinates, with the origin at the positive
electrode this is x=|AB|/2. Since we are only interested in the
horizontal current component we are looking to solve Equation 3,
with respect to x.
Equation .times. .times. 8 : Horizontal .times. .times. .times.
Current .times. .times. density .times. .times. in .times. .times.
the .times. .times. center .times. .times. of .times. .times. the
.times. .times. array .times. .times. ( r + = r - = r )
##EQU00012## J x = - .sigma. .times. dV dx = .times. - I 2 .times.
.pi. .times. d dx .function. [ 1 r + - 1 r - ] = .times. - I 4
.times. .pi. .times. d dx .function. [ 1 x 2 + y 2 - 1 ( x - AB ) 2
+ y 2 ] = .times. - I 4 .times. .pi. .function. [ x x 2 + y 2 3 - x
- AB ( x - AB ) 2 + y 2 3 ] = .times. - I 4 .times. .pi. .function.
[ x r 3 - x - AB r 3 ] = .times. I 4 .times. .pi. .times. AB r 3
##EQU00012.2##
[0176] Thus the fraction of current (.delta.I) flowing at depth (y)
can be calculated as J.sub.xhdy, Using our calculated value of
J.sub.x from Equation 8 gives Equation 9.
Equation .times. .times. 9 : Current .times. .times. ( .delta.
.times. .times. I ) .times. .times. flowing .times. .times. through
.times. .times. .times. of .times. .times. thickness .times.
.times. dy . .times. .delta. .times. .times. I x = I 4 .times. .pi.
.times. AB ( AB 2 ) 2 + y 2 3 .times. dy ##EQU00013##
[0177] Thus the total current flowing through segment I.sub.x in
the region bounded by y.sub.1 and y.sub.2 is obtained by
integrating J.sub.x dy between y1 and y2 as shown in
Equation .times. .times. 10 : Current .times. .times. flowing
.times. .times. through .times. .times. region .times. .times. at
.times. .times. x = AB / 2 ##EQU00014## I x = .intg. y .times. 1 y
2 .times. I x .times. dy = I 4 .times. .pi. .times. .intg. y 1 y 2
.times. AB ( AB 2 ) 2 + y 2 3 .times. dy = I .pi. .function. [ tan
- 1 .times. 2 .times. y 2 AB - tan - 1 .times. 2 .times. y 1 AB ]
##EQU00014.2##
[0178] If we take the limit as y.sub.2.fwdarw..infin., we obtain
the total proportion of current flowing below a depth of
y.sub.1.
Equation .times. .times. 11 : Proportion .times. .times. of .times.
.times. current .times. .times. flowing .times. .times. below
.times. .times. depth .times. .times. y 1 .times. .times. for
.times. .times. the .times. .times. full .times. .times. spherical
.times. .times. voltage .times. .times. gradient . .times. I x = I
.pi. .function. [ .pi. 2 - tan - 1 .times. 2 .times. y 1 AB ]
.times. ##EQU00015##
[0179] Thus if we have an inhomogeneity at a depth of 1.5 electrode
separations, .about.10% of the applied current will penetrate to
this depth so even if this inhomogeneity had infinite impedance it
will increase the measured impedance by no more than .about.10%
(Sensitivity to depth is doubled if assume current can only
propagate in one direction, as per geophysics)
[0180] Within a depth of half an electrode separation 75% of the
current flow can be accounted for (50% if we use the geophysical
assumption).
[0181] Note that the depth analysis here holds for the setup shown
in FIG. 50, and will change depending on the geometry of the
measurement electrodes with respect to the stimulating electrode
pair, but fundamentally, the wider the stimulating electrodes are
spaced the more sensitive the measurement is to inhomogeneity at
depth.
[0182] Using this technique widening the stimulating electrode
dipole while keeping the measurement pair unchanged. By convention,
the depth of investigation is specified as the median current
depth. i.e. the depth at which equal current flows above and below
in a homogenous medium.
[0183] We can model the cochlea as a 2 layer system. i.e. the
electrode array is in perilymph with the second layer as otic bone
as shown in FIG. 51.
[0184] If we keep the recording electrode pair constant and widen
the stimulating dipole, equivalent to using a schlumberger array,
it is possible to plot the measured impedance vs median depth of
current as shown in FIG. 52, where the different lines show
expected behavior for changes in values of .rho..sub.1 and
.rho..sub.2 with respect to each other. Note that the apparent
resistivity values are for illustrative purposes only. Note
Additional layers will introduce additional knee points in the
impedance graph.
[0185] A number of depth estimates at different electrodes can be
combined to produce a depth profile as shown in FIG. 53, which
shows a profile of layer "depth" measured at different
electrodes.
[0186] There are a number of methods for estimating the depth of
the inhomogeneity: [0187] 1. The knee point, marked with a circle
in FIG. 52, sits at the approximate depth of the second layer;
[0188] 2. Forward modelling, adapting parameters (.rho..sub.1,
.rho..sub.2 and h) to get a matching curve; [0189] 3. Mathematical
Inversion methods.
[0190] Some embodiments include creating Impedance Sections. In
this regard, an alternative method of representing the measured
data is to produce an impedance section. Such a section is a
mapping of measurement points. Where the x axis of measurement is
the center of the recording dipole, and the depth of the
measurement is determined as the median current depth of the dipole
at the point of measurement, as shown in FIG. 54. Which depicts a
pseudo section of a Wenner array.
[0191] It is noted that the output becomes effectively a finite
element mesh and can be solved as such.
[0192] In an exemplary embodiment, generation of pseudo sections
(FIG. 46) from a synthetic model (FIG. 45) to calculate inversions
FIG. 47 can be executed. Some embodiments include compensating for
topography. We can combine these with depth of insertion
measurements or a cochlear size measurements/estimation to achieve
an approximate topological correction factor.
[0193] As the pseudo section is effectively an FEA matrix, we can
warp the matrix according to a logarithmical spiral. Even if the
size estimation is incorrect, it should be sufficient to achieve
good estimates.
[0194] Some embodiments relate to increasing depth resolution. In
this regard, note that the actual stimulating electrode position,
the math is determined by the separation of the stimulating dipole,
so sub electrode depth resolution can be achieved by stimulating
using a double electrode array so that the centroid of the dipole
is half way between the combined electrodes as shown in FIG.
55.
[0195] Note that in a homogeneous medium the centroid of charge
will appear halfway between the active electrode pair (ICE14 &
ICE15) with the negative charge centroid between (ICE18 &
ICE19). Thus we have successfully widened the dipole by less than
an electrode spacing. This applies for multipolar stimulation
also.
[0196] Some embodiments also address alternative dipole
configurations. Note that there are a number of different array
types, and are listed in FIG. 56, with their geometric factors.
They each provide a tradeoff between resolution, depth of
penetration and signal strength.
[0197] Note that some configurations, such as the pole-dipole, are
asymmetrical and will likely require measurements with a reversed
setup to mitigate for some of the asymmetry observed in the
output.
[0198] There are mathematical inversion methods, such as recursive
Bessel for stratified layers, as shown in the lecture notes by
Richard M. Allen, Introduction to Applied Geophysics Berkley
University, such as Tangent Law: The electrical current is bent at
a boundary, as represented by way of example in FIG. 57.
[0199] With reference to FIG. 58, one can use for image theory for
multiple boundaries, for two layer cases:
V p = .times. I .times. .times. .rho. 1 2 .times. .pi. .times. ( 1
r + 2 .times. k r 1 + 2 .times. k 2 r 2 + + 2 .times. k n r n + ) =
.times. I .times. .times. .rho. 1 2 .times. .pi. .times. ( 1 r + 2
.times. n = 1 .infin. .times. k n r n ) ##EQU00016## where
##EQU00016.2## r n = r 2 + ( 2 .times. nh ) 2 ##EQU00016.3##
The integral method can be based on:
V p = I .times. .times. .rho. 1 2 .times. .pi. .times. .intg.
.infin. .times. K .function. ( .lamda. ) .times. J 0 .function. (
.lamda. .times. .times. r ) .times. d .times. .times. .lamda.
##EQU00017## [0200] J0 is the Bessel function of zero order. [0201]
K(.lamda.) given by relationship:
[0201] K .function. ( .lamda. ) = T 1 .function. ( .lamda. ) .rho.
1 ##EQU00018##
Ti(.lamda.) solved for recursively upward from bottom layer to
layer 1 using, with reference to FIG. 59:
T i .function. ( .lamda. ) = [ T i + 1 + .rho. i .times. tanh
.function. ( .lamda. .times. .times. h i ) ] [ 1 + T i + 1 .times.
tanh .function. ( .lamda. .times. .times. h i ) / .rho. i ]
##EQU00019## where .times. .times. tanh .function. ( .lamda.
.times. .times. h i ) = e 2 .times. .lamda. .times. .times. h i - 1
e 2 .times. .lamda. .times. .times. h i + 1 ##EQU00019.2## and
.times. .times. T n .function. ( .lamda. ) = .rho. n
##EQU00019.3##
[0202] Some embodiments include matrix inversion techniques and/or
polarization measurements and/or time domain decay techniques. In
this regard, Polarisability metric is area under then IPG divided
by the peak voltage Vm. Note we can use the trapazoidal rule,
provided we can get two measurements on the IPG. This should be
good enough.
[0203] FIG. 60, presents a graphic illustrating the above.
[0204] Some embodiments include spectral induced Polarisation
methods. This relies on a high resolution of IPG sampling, i.e.
will need to adjust the IPG at each spectral frequency to get
multiple sample points on the decay curve. A minimum of 10 are
recommended.
Cole .times. - .times. Cole .times. .times. model .times. .times.
for .times. .times. Complex .times. .times. impedance .rho.
.function. ( .omega. ) = .rho. 0 .function. [ 1 - m 0 .function. (
1 - 1 1 + ( j .times. .times. .omega. .times. .times. .tau. ) a ) ]
, Equation .times. .times. 12 ##EQU00020##
where [0205] .rho..sub.0=Resistivity [0206] m.sub.0=Intrisic
Chargeability (First point measured on the decay curve) [0207]
.omega.=Frequency [0208] .tau.=Decay Time Constant (approx. 90%-10%
decay time of IPG) [0209] .alpha.=parameter controlling frequency
dependence (c=1 is simple exponential decay) [0210] Time domain
decay curve can be defined by
[0210] Time .times. .times. domain .times. .times. intrinsic
.times. .times. chargeability .times. .times. curve m .function. (
t ) = m 0 .times. n = 0 .infin. .times. ( - 1 ) n .times. ( t .tau.
) n .times. .times. .alpha. .GAMMA. .function. ( 1 + n .times.
.times. .alpha. ) , Equation .times. .times. 13 ##EQU00021##
where .GAMMA. is the Gamma function. The aim is to use forward
modelling using Equation 13 to get best fit of the measured decay
curve.
[0211] In an exemplary embodiment, there is a method, comprising,
obtaining electrical data from at least two electrodes implanted in
a human head and determining a physiological feature of an interior
of a duct of a cochlea based on the obtained electrical data. In an
exemplary embodiment of the method as described above and/or below,
the determined physiological feature is the relative absence of
perilymph in the duct. In an exemplary embodiment of the method as
described above and/or below the determined physiological feature
is the relative absence of fibrous tissue growth due to
implantation of the electrode array into the duct of the cochlea.
In an exemplary embodiment of the method as described above and/or
below the determined physiological feature is the presence of
significant fibrous tissue growth due to implantation of the
electrode array into the duct of the cochlea. In an exemplary
embodiment of the method as described above and/or below, the
method further includes executing an NRT method, and evaluating
results of the NRT method by taking into account the presence of
the significant fibrous tissue growth. In an exemplary embodiment
of the method as described above and/or below, the method further
comprises determining that the fibrous tissue has established a
dead patch with respect to taking NRT measurements. In an exemplary
embodiment of the method as described above and/or below, the the
determined physiological feature is a second puncture in a wall of
the cochlea in addition to that through which the electrode array
entered the cochlea.
[0212] In an exemplary embodiment, there is a method, comprising
energizing an electrode implanted in a recipient, the electrode
being part of an assembly located in and/or on a recipient,
receiving data from one or more recording electrodes located in
and/or on a recipient, and determining spatial position data of the
assembly based on the received data. In an exemplary embodiment of
this method, the actions of energizing, receiving and determining
are actions that are part of a surgical procedure to implant the
assembly in the recipient, the method further comprises
repositioning the electrode array based on the determined spatial
position data.
[0213] Many of the above teachings are found in appendix A and U.S.
Provisional Application No. 62/476,295, filed Mar. 24, 2017,
entitled ADVANCED ELECTRODE ARRAY LOCATION EVALUATION, which
appendix is included in this application in its entirety and the
subject matter of that application is included herein in its
entirety by incorporation by reference. In an exemplary embodiment,
one or more or all of the teachings detailed in appendix A (where
any reference to Appendix A herein also refers by reference to U.S.
Provisional Application No. 62/476,295, filed Mar. 24, 2017,
entitled ADVANCED ELECTRODE ARRAY LOCATION EVALUATION) and one or
more or all of the teachings detailed in U.S. Provisional
Application No. 62/476,295, filed Mar. 24, 2017, entitled ADVANCED
ELECTRODE ARRAY LOCATION EVALUATION, are combined with one or more
or all of the teachings found in appendix F, which appendix is
included in the application in its entirety. In this regard, in an
exemplary embodiment, there is a method that includes executing one
or more of the method actions in appendix A along with one or more
of the method actions detailed in appendix F. By way of example
only and not by way of limitation, in an exemplary embodiment,
there is a method that includes inserting an electrode array into a
cochlea while executing the depth sounding method actions disclosed
in appendix A along with the execution of the ECOG method actions
disclosed in appendix F, in a manner where the actions do not
interfere with one another, at least not to a degree that
eliminates the efficacy of one or more method actions or at least
not substantially reduces the efficacy of one or more the method
actions. It is also noted that embodiments include a device and/or
system as disclosed in appendix A in combination with a device
and/or system as disclosed in appendix F, and in some embodiments,
there is a single device and/or a single system and/or a
compilation of devices and/or systems that have one or more of the
functionalities of any device and/or system in appendix A as well
as one or more of the functionalities of any device and/or system
in appendix F.
[0214] Moreover, there is a device and/or system and/or a
combination thereof that is configured to execute any one or more
of the method actions in appendix A in an automated and/or semi
automated manner and that is also configured to execute any one or
more of the method actions in appendix F. Corollary to this is that
in an exemplary method, there is a method that includes methods
corresponding to that which results from the functionality of any
one or more of the functionalities disclosed in appendix A in
combination with any one or more of the functionalities disclosed
in appendix F.
[0215] The present application also includes the subject matter
disclosed in appendix B and U.S. Provisional Application No.
62/559,782, filed Sep. 18, 2017, entitled ADVANCED ELECTRODE ARRAY
INSERTION WITH CONDITIONING, which appendix is included in this
application in its entirety and the subject matter of that
application is included herein in its entirety by incorporation by
reference. In an exemplary embodiment, one or more or all of the
teachings detailed in appendix B (where any reference to Appendix B
herein also refers by reference to U.S. Provisional Application No.
62/559,782, filed Sep. 18, 2017, entitled ADVANCED ELECTRODE ARRAY
INSERTION WITH CONDITIONING) and one or more or all of the
teachings detailed in U.S. Provisional Application No. 62/559,782,
filed Sep. 18, 2017, entitled ADVANCED ELECTRODE ARRAY INSERTION
WITH CONDITIONING, are combined with one or more or all of the
teachings found in appendix F, which appendix is included in the
application in its entirety.
[0216] In this regard, in an exemplary embodiment, there is a
method that includes executing one or more of the method actions
detailed in appendix B along with one or more of the method actions
detailed in appendix F. By way of example only and not by way of
limitation, in an exemplary embodiment, there is a method that
includes inserting an electrode array into a cochlea while
executing the tip fold over identification actions of appendix B
along with the execution of the ECOG method actions disclosed in
appendix F, in a manner where the actions do not interfere with one
another, at least not to a degree that eliminates the efficacy of
one or more method actions or at least not substantially reduces
the efficacy of one or more the method actions. It is also noted
that embodiments include a device and/or system as disclosed in
appendix B in combination with a device and/or system as disclosed
in appendix F, and in some embodiments, there is a single device
and/or a single system and/or a compilation of devices and/or
systems that have one or more of the functionalities of any device
and/or system in appendix B as well as one or more of the
functionalities of any device and/or system in appendix F.
[0217] Moreover, there is a device and/or system and/or a
combination thereof that is configured to execute any one or more
of the method actions in appendix B in an automated and/or semi
automated manner and that is also configured to execute any one or
more of the method actions in appendix F. Corollary to this is that
in an exemplary method, there is a method that includes methods
corresponding to that which results from the functionality of any
one or more of the functionalities disclosed in appendix B in
combination with any one or more of the functionalities disclosed
in appendix F.
[0218] The present application also includes the subject matter
disclosed in appendix C and U.S. Provisional Application No.
62/633,054, filed Feb. 20, 2018, entitled ADVANCED ELECTRODE DATA
ANALYSIS, which appendix is included in this application in its
entirety and the subject matter of that application is included
herein in its entirety by incorporation by reference. In an
exemplary embodiment, one or more or all of the teachings detailed
in appendix C (where any reference to Appendix C herein also refers
by reference to U.S. Provisional Application No. 62/633,054, filed
Feb. 20, 2018, entitled ADVANCED ELECTRODE DATA ANALYSIS) and one
or more or all of the teachings detailed in U.S. Provisional
Application No. 62/633,054, filed Feb. 20, 2018, entitled ADVANCED
ELECTRODE DATA ANALYSIS, are combined with one or more or all of
the teachings found in appendix F, which appendix is included in
the application in its entirety. In this regard, in an exemplary
embodiment, there is a method that includes executing one or more
of the method actions detailed in appendix C along with one or more
of the method actions detailed in appendix F. By way of example
only and not by way of limitation, in an exemplary embodiment,
there is a method that includes inserting an electrode array into a
cochlea while executing the derivative and/or gradient evaluations
of appendix C along with the execution of the ECOG method actions
disclosed in appendix F, in a manner where the actions do not
interfere with one another, at least not to a degree that
eliminates the efficacy of one or more method actions or at least
not substantially reduces the efficacy of one or more the method
actions. It is also noted that embodiments include a device and/or
system as disclosed in appendix C in combination with a device
and/or system as disclosed in appendix F, and in some embodiments,
there is a single device and/or a single system and/or a
compilation of devices and/or systems that have one or more of the
functionalities of any device and/or system in appendix C as well
as one or more of the functionalities of any device and/or system
in appendix F.
[0219] Moreover, there is a device and/or system and/or a
combination thereof that is configured to execute any one or more
of the method actions in appendix C in an automated and/or semi
automated manner and that is also configured to execute any one or
more of the method actions in appendix F. Corollary to this is that
in an exemplary method, there is a method that includes methods
corresponding to that which results from the functionality of any
one or more of the functionalities disclosed in appendix C in
combination with any one or more of the functionalities disclosed
in appendix F.
[0220] The present application also includes the subject matter
disclosed in appendix D and U.S. Provisional Application No.
62/642,566, filed Mar. 13, 2018, entitled ELECTRICAL FIELD USAGE IN
COCHLEAS, which appendix is included in this application in its
entirety and the subject matter of that application is included
herein in its entirety by incorporation by reference. In an
exemplary embodiment, one or more or all of the teachings detailed
in appendix D (where any reference to Appendix D herein also refers
by reference to U.S. Provisional Application No. 62/642,566, filed
Mar. 13, 2018, entitled ELECTRICAL FIELD USAGE IN COCHLEAS) and one
or more or all of the teachings detailed in U.S. Provisional
Application No. 62/642,566, filed Mar. 13, 2018, entitled
ELECTRICAL FIELD USAGE IN COCHLEAS, are combined with one or more
or all of the teachings found in appendix F, which appendix is
included in the application in its entirety. In this regard, in an
exemplary embodiment, there is a method that includes executing one
or more of the method actions detailed in appendix D along with one
or more of the method actions detailed in appendix F. By way of
example only and not by way of limitation, in an exemplary
embodiment, there is a method that includes inserting an electrode
array into a cochlea while executing the anatomical identification
method(s) of appendix D along with the execution of the ECOG method
actions disclosed in appendix F, in a manner where the actions do
not interfere with one another, at least not to a degree that
eliminates the efficacy of one or more method actions or at least
not substantially reduces the efficacy of one or more the method
actions. It is also noted that embodiments include a device and/or
system as disclosed in appendix D in combination with a device
and/or system as disclosed in appendix F, and in some embodiments,
there is a single device and/or a single system and/or a
compilation of devices and/or systems that have one or more of the
functionalities of any device and/or system in appendix D as well
as one or more of the functionalities of any device and/or system
in appendix F.
[0221] Moreover, there is a device and/or system and/or a
combination thereof that is configured to execute any one or more
of the method actions in appendix D in an automated and/or semi
automated manner and that is also configured to execute any one or
more of the method actions in appendix F. Corollary to this is that
in an exemplary method, there is a method that includes methods
corresponding to that which results from the functionality of any
one or more of the functionalities disclosed in appendix D in
combination with any one or more of the functionalities disclosed
in appendix F.
[0222] The present application also includes the subject matter
disclosed in appendix E and U.S. Provisional Application No.
62/647,896, filed Mar. 26, 2018, entitled ELECTRICAL TECHNIQUES FOR
BIOMARKER DETECTION IN A COCHLEA, which appendix is included in
this application in its entirety and the subject matter of that
application is included herein in its entirety by incorporation by
reference. In an exemplary embodiment, one or more or all of the
teachings detailed in appendix E (where any reference to Appendix E
herein also refers by reference to U.S. Provisional Application No.
62/647,896, filed Mar. 26, 2018, entitled ELECTRICAL TECHNIQUES FOR
BIOMARKER DETECTION IN A COCHLEA) and one or more or all of the
teachings detailed in U.S. Provisional Application No. 62/647,896,
filed Mar. 26, 2018, entitled ELECTRICAL TECHNIQUES FOR BIOMARKER
DETECTION IN A COCHLEA, are combined with one or more or all of the
teachings found in appendix F, which appendix is included in the
application in its entirety. In this regard, in an exemplary
embodiment, there is a method that includes executing one or more
of the method actions detailed in appendix E along with one or more
of the method actions detailed in appendix F. By way of example
only and not by way of limitation, in an exemplary embodiment,
there is a method that includes inserting an electrode array into a
cochlea while executing the blood presence method(s) of appendix E
along with the execution of the ECOG method actions disclosed in
appendix F, in a manner where the actions do not interfere with one
another, at least not to a degree that eliminates the efficacy of
one or more method actions or at least not substantially reduces
the efficacy of one or more the method actions. It is also noted
that embodiments include a device and/or system as disclosed in
appendix E in combination with a device and/or system as disclosed
in appendix F, and in some embodiments, there is a single device
and/or a single system and/or a compilation of devices and/or
systems that have one or more of the functionalities of any device
and/or system in appendix E as well as one or more of the
functionalities of any device and/or system in appendix F.
[0223] Moreover, there is a device and/or system and/or a
combination thereof that is configured to execute any one or more
of the method actions in appendix E in an automated and/or semi
automated manner and that is also configured to execute any one or
more of the method actions in appendix F. Corollary to this is that
in an exemplary method, there is a method that includes methods
corresponding to that which results from the functionality of any
one or more of the functionalities disclosed in appendix E in
combination with any one or more of the functionalities disclosed
in appendix F.
[0224] In an exemplary embodiment, one or more or all of the
teachings disclosed in appendix A and/or B, and/or C and/or D
and/or E and/or F are combined with one or more or all of the
teachings found in the other of appendix A and/or B and/or C and/or
D and/or E and/or F. In this regard, in an exemplary embodiment,
there is a method that includes executing one or more of the method
actions disclosed in appendix A along with, in one option, one or
more of the method actions disclosed in appendix B and/or along
with, in another option, one or more of the method actions
disclosed in appendix C, and/or along with, in another option, one
or more of the method actions disclosed in appendix D and/or along
with, in another option, one or more of the method actions
disclosed in appendix E and/or along with, in another option, one
or more of the method actions disclosed in appendix F.
[0225] Also, in an exemplary embodiment, there is a method that
includes executing one or more of the method actions disclosed in
appendix B, along with, in one option, one or more of the method
actions disclosed in appendix A and/or along with, in another
option, one or more of the method actions disclosed in appendix C,
and/or along with, in another option, one or more of the method
actions disclosed in appendix D and/or along with, in another
option, one or more of the method actions disclosed in appendix E
and/or along with, in another option, one or more of the method
actions disclosed in appendix F. Also, in an exemplary embodiment,
there is an apparatus and/or a system and/or a combination of
either and/or both that is configured to execute at least two or
more of the method actions of the just disclosed method.
[0226] Also, in an exemplary embodiment, there is a method that
includes executing one or more of the method actions disclosed in
appendix B along with, in one option, one or more of the method
actions disclosed in appendix A and/or along with, in another
option, one or more of the method actions disclosed in appendix C,
and/or along with, in another option, one or more of the method
actions disclosed in appendix D and/or along with, in another
option, one or more of the method actions disclosed in appendix E
and/or along with, in another option, one or more of the method
actions disclosed in appendix F. Also, in an exemplary embodiment,
there is an apparatus and/or a system and/or a combination of
either and/or both that is configured to execute at least two or
more of the method actions of the just disclosed method.
[0227] Also, in an exemplary embodiment, there is a method that
includes executing one or more of the method actions disclosed in
appendix C along with, in one option, one or more of the method
actions disclosed in appendix A and/or along with, in another
option, one or more of the method actions disclosed in appendix B
and/or, and/or along with, in another option, one or more of the
method actions disclosed in appendix D and/or along with, in
another option, one or more of the method actions disclosed in
appendix E and/or along with, in another option, one or more of the
method actions disclosed in appendix F. Also, in an exemplary
embodiment, there is an apparatus and/or a system and/or a
combination of either and/or both that is configured to execute at
least two or more of the method actions of the just disclosed
method.
[0228] Also, in an exemplary embodiment, there is a method that
includes executing one or more of the method actions disclosed in
appendix D along with, in one option, one or more of the method
actions disclosed in appendix A and/or along with, in another
option, one or more of the method actions disclosed in appendix B
and/or, and/or along with, in another option, one or more of the
method actions disclosed in appendix C and/or along with, in
another option, one or more of the method actions disclosed in
appendix E and/or along with, in another option, one or more of the
method actions disclosed in appendix F. Also, in an exemplary
embodiment, there is an apparatus and/or a system and/or a
combination of either and/or both that is configured to execute at
least two or more of the method actions of the just disclosed
method.
[0229] Also, in an exemplary embodiment, there is a method that
includes executing one or more of the method actions disclosed in
appendix E along with, in one option, one or more of the method
actions disclosed in appendix A and/or along with, in another
option, one or more of the method actions disclosed in appendix B
and/or, and/or along with, in another option, one or more of the
method actions disclosed in appendix C and/or along with, in
another option, one or more of the method actions disclosed in
appendix D and/or along with, in another option, one or more of the
method actions disclosed in appendix F. Also, in an exemplary
embodiment, there is an apparatus and/or a system and/or a
combination of either and/or both that is configured to execute at
least two or more of the method actions of the just disclosed
method.
[0230] Also, in an exemplary embodiment, there is a method that
includes executing one or more of the method actions disclosed in
appendix F along with, in one option, one or more of the method
actions disclosed in appendix A and/or along with, in another
option, one or more of the method actions disclosed in appendix B
and/or, and/or along with, in another option, one or more of the
method actions disclosed in appendix C and/or along with, in
another option, one or more of the method actions disclosed in
appendix D and/or along with, in another option, one or more of the
method actions disclosed in appendix E. Also, in an exemplary
embodiment, there is an apparatus and/or a system and/or a
combination of either and/or both that is configured to execute at
least two or more of the method actions of the just disclosed
method. (By way of example, there can be a method that has an
action of appendix F, an action of Appendix A, an action of
Appendix B, an action of appendix C, an action of Appendix D and an
action of Appendix E. By way of example, there can be a method that
has two actions of appendix F, an action of Appendix A, an action
of Appendix C, an action of Appendix D and an action of Appendix E.
By way of example, there can be a method that has one action of
appendix F, an action of Appendix A, two actions of Appendix B, an
action of Appendix D and no action of appendix E.)
[0231] Also, in an exemplary embodiment, there is an apparatus
and/or a system and/or a combination of either and/or both that is
configured to have the functionality of an apparatus and/or system
disclosed in appendix A along with, in one option, one or more of
the functionalities of an apparatus and/or system disclosed in
appendix B and/or along with, in another option, one or more of the
functionalities of an apparatus and/or system disclosed in appendix
C, and/or along with, in another option, one or more of the
functionalities of an apparatus and/or system disclosed in appendix
D and/or along with, in another option, one or more of the
functionalities of an apparatus and/or system disclosed in appendix
E and/or along with, in another option, one or more of the
functionalities of an apparatus and/or system disclosed in appendix
F. Also, in an exemplary embodiment, there is a method that
includes using the device(s) and/or system(s) and/or executing a
method associated with the functionalities of the just disclosed
device(s) and/or system(s).
[0232] Also, in an exemplary embodiment, there is an apparatus
and/or a system and/or a combination of either and/or both that is
configured to have the functionality of an apparatus and/or system
disclosed in appendix B and/or along with, in one option, one or
more of the functionalities of an apparatus and/or system disclosed
in appendix A and/or along with, in another option, one or more of
the functionalities of an apparatus and/or system disclosed in
appendix C, and/or along with, in another option, one or more of
the functionalities of an apparatus and/or system disclosed in
appendix D and/or along with, in another option, one or more of the
functionalities of an apparatus and/or system disclosed in appendix
E and/or along with, in another option, one or more of the
functionalities of an apparatus and/or system disclosed in appendix
F. Also, in an exemplary embodiment, there is a method that
includes using the device(s) and/or system(s) and/or executing a
method associated with the functionalities of the just disclosed
device(s) and/or system(s).
[0233] Also, in an exemplary embodiment, there is an apparatus
and/or a system and/or a combination of either and/or both that is
configured to have the functionality of an apparatus and/or system
disclosed in appendix C along with, in one option, one or more of
the functionalities of an apparatus and/or system disclosed in
appendix A and/or along with, in another option, one or more of the
functionalities of an apparatus and/or system disclosed in appendix
B, and/or along with, in another option, one or more of the
functionalities of an apparatus and/or system disclosed in appendix
D and/or along with, in another option, one or more of the
functionalities of an apparatus and/or system disclosed in appendix
E and/or along with, in another option, one or more of the
functionalities of an apparatus and/or system disclosed in appendix
F. Also, in an exemplary embodiment, there is a method that
includes using the device(s) and/or system(s) and/or executing a
method associated with the functionalities of the just disclosed
device(s) and/or system(s).
[0234] Also, in an exemplary embodiment, there is an apparatus
and/or a system and/or a combination of either and/or both that is
configured to have the functionality of an apparatus and/or system
disclosed in appendix D along with, in one option, one or more of
the functionalities of an apparatus and/or system disclosed in
appendix A and/or along with, in another option, one or more of the
functionalities of an apparatus and/or system disclosed in appendix
B, and/or along with, in another option, one or more of the
functionalities of an apparatus and/or system disclosed in appendix
C and/or along with, in another option, one or more of the
functionalities of an apparatus and/or system disclosed in appendix
E and/or along with, in another option, one or more of the
functionalities of an apparatus and/or system disclosed in appendix
F. Also, in an exemplary embodiment, there is a method that
includes using the device(s) and/or system(s) and/or executing a
method associated with the functionalities of the just disclosed
device(s) and/or system(s).
[0235] Also, in an exemplary embodiment, there is an apparatus
and/or a system and/or a combination of either and/or both that is
configured to have the functionality of an apparatus and/or system
disclosed in appendix E along with, in one option, one or more of
the functionalities of an apparatus and/or system disclosed in
appendix A and/or along with, in another option, one or more of the
functionalities of an apparatus and/or system disclosed in appendix
B, and/or along with, in another option, one or more of the
functionalities of an apparatus and/or system disclosed in appendix
C and/or along with, in another option, one or more of the
functionalities of an apparatus and/or system disclosed in appendix
D and/or along with, in another option, one or more of the
functionalities of an apparatus and/or system disclosed in appendix
F. Also, in an exemplary embodiment, there is a method that
includes using the device(s) and/or system(s) and/or executing a
method associated with the functionalities of the just disclosed
device(s) and/or system(s).
[0236] To be clear, there are various respective embodiments which
respectively include any one or more of the respective teachings in
appendix A/U.S. Provisional Application No. 62/476,295, filed Mar.
24, 2017, entitled ADVANCED ELECTRODE ARRAY LOCATION EVALUATION,
appendix B/U.S. Provisional Application No. 62/559,782, filed Sep.
18, 2017, entitled ADVANCED ELECTRODE ARRAY INSERTION WITH
CONDITIONING, appendix C/U.S. Provisional Application No.
62/633,054, filed Feb. 20, 2018, entitled ADVANCED ELECTRODE DATA
ANALYSIS, appendix D/U.S. Provisional Application No. 62/642,566,
filed Mar. 13, 2018, entitled ELECTRICAL FIELD USAGE IN COCHLEAS,
appendix E/U.S. Provisional Application No. 62/647,896, filed Mar.
26, 2018, entitled ELECTRICAL TECHNIQUES FOR BIOMARKER DETECTION IN
A COCHLEA and/or appendix F can be combined, providing that the art
enables such.
[0237] In view of the above, it is to be understood that in some
exemplary embodiments, there are methods that utilize voltage
and/or impedance measurements in a variety of manners to achieve a
variety of goals/outcomes. With respect to appendices A-E, which
are generally directed towards the utilization of voltage and/or
impedance measurements utilizing so-called four point impedance
measurements, it can be seen that different measurements can be
applied utilizing an electrode array as it is being inserted into
the cochlea and/or after it is inserted to do various things, such
as, for example, to determine a positional feature of the electrode
array based on the vertical electrical sounding, determine spatial
derivatives of electrical properties between electrodes of the
electrode array; identify changes between voltage measurements at
read electrodes between different temporal locations, detect a
voltage change across the plurality of electrodes based on a
monitored relative magnitude that is representative of a voltage
change at a reference electrode, identify a presence of an
asymmetry in the voltage measurements, focus readings from read
electrodes of the electrode array at a same location within the
cochlea relative to other locations within the cochlea while the
electrode array is moving, determine a location, density and
temporal feature of the impedance change, identify tip fold over,
identify scala dislocation, determine a distance from modiolus of
the array, identify a phenomenon that exists in the recipient,
determine that the electrode array has reached a specific location
in the cochlea, identify the presence or absence of blood in the
cochlea, and/or determine, based on the telemetry, that a physical
characteristic associated with the electrode array that is strictly
local to the electrode array existed and/or exists. Combined with
appendix F, embodiments can include one or more of the above
actions interleaved with neural response measurements while the
electrode array is being moved. All of these embodiments, in some
embodiments, can be combined with the conditioning of information
in the received telemetry and perform the analysis based on the
conditioned information.
[0238] By way of example only and not by way of limitation, in an
exemplary embodiment, there is a method that includes inserting an
electrode array into a cochlea while executing the blood presence
method(s) of appendix E along with the execution of the ECOG method
actions disclosed in appendix F, in a manner where the actions do
not interfere with one another, at least not to a degree that
eliminates the efficacy of one or more method actions or at least
not substantially reduces the efficacy of one or more the method
actions. It is also noted that embodiments include a device and/or
system as disclosed in appendix E in combination with a device
and/or system as disclosed in appendix F, and in some embodiments,
there is a single device and/or a single system and/or a
compilation of devices and/or systems that have one or more of the
functionalities of any device and/or system in appendix E as well
as one or more of the functionalities of any device and/or system
in appendix F.
[0239] Moreover, there is a device and/or system and/or a
combination thereof that is configured to execute any one or more
of the method actions in appendix E in an automated and/or semi
automated manner and that is also configured to execute any one or
more of the method actions in appendix F. Corollary to this is that
in an exemplary method, there is a method that includes methods
corresponding to that which results from the functionality of any
one or more of the functionalities disclosed in appendix E in
combination with any one or more of the functionalities disclosed
in appendix F.
[0240] Thus, in an exemplary embodiment, there is a method,
comprising, starting at temporal location 1 and ending at temporal
location 2, wherein temporal location 1 can correspond to any of
the times between the first entry of the electrode array into the
cochlea to a time where the surgeon determines that the electrode
array is fully inserted into the cochlea, or any time. There
between, or in some other embodiments, time periods that begin
before and end after the aforementioned temporal locations,
inserting a cochlear implant electrode array into a cochlea.
However, in this exemplary embodiment, the temporal location 1 is
the location where the first electrode enters the cochlea and
temporal location 2 is where the last electrode enters the cochlea.
The method further includes at least at various times between
location 1 and location 2, measuring voltages between various
electrodes of the electrode array. This can be done according to
any of the teachings of appendices A, B, C, D and/or E in some
embodiments. The method further includes analyzing some and/or all
of the measured voltages, and determining whether or not the
electrode array was inserted and/or is being inserted in a manner
that results in a predetermined placement. By way of example only
and not by way of limitation, the predetermined placement can be
perimodiolar placement (sometimes referred to as a modiolous wall
hugging placement), a mid scalla placement, and/or a lateral wall
placement. In an exemplary embodiment, the placement can correspond
to an insertion depth of the electrode array into the cochlea,
etc.
[0241] In an exemplary embodiment of this method, the determining
action is executed between temporal location 1 and temporal
location 2 and/or after temporal location 2.
[0242] In some embodiments, the action of determining whether or
not the electrode array was inserted and/or is being inserted in a
manner that results in a predetermined placement is an action of
determining that the electrode array is being inserted in a manner
that will not result in a predetermined placement, and the action
of determining is executed before temporal location 2 and/or after
temporal location 2. In an exemplary embodiment, the patient is
made without imaging, and/or is made based solely on the
measurements obtained from the electrode array.
[0243] In an exemplary embodiment, the action of determining
whether or not the electrode array was inserted and/or is being
inserted in a manner that results in a predetermined placement is
executed automatically by a surgical instrument, such as by way of
example only and not by way of limitation, any of the devices
and/or systems disclosed in Appendix A, B, C, D and/or E. in an
exemplary embodiment, the surgical instrument provides an
indication, such as an automatic indication, of the determination
to a surgeon or other healthcare professional that the electrode
array was or was not or is or is no being inserted in a manner that
results in the predetermined placement.
[0244] It is noted that in at least some exemplary embodiments, the
various determinations and/or analyses are executed in real time
and/or in close temporal proximity to the insertion of the
electrode array, such during insertion of the electrode array
and/or within one, two, three, four, five, six, seven, eight, nine
or ten minutes of full insertion. In an exemplary embodiment, the
method can further include obtaining data indicative of a type of
electrode array being inserted into the cochlea, wherein the action
of analyzing the measured voltages during temporal location 1 and
temporal location 2 includes comparing the measured voltages to
predetermined values corresponding to what the voltage measurements
should be for the type of electrode array.
[0245] It is noted that the following focuses on "type of array,"
but it is noted that embodiments instead and/or in addition to this
can correspond to the type of insertion. That is, any disclosure
herein of a type of array also corresponds to a disclosure of the
type of insertion for that electrode array, and vice versa.
[0246] In an exemplary embodiment, there is a method detailed
herein, wherein the method further includes obtaining data
indicative of a type of electrode array and/o data indicative of
the type of insertion that should be executed for the electrode
array (modiolous, mid-scala or lateral wall) being inserted into
the cochlea, wherein the action of analyzing the measured voltages
during temporal location 1 and temporal location 2 includes
evaluating the voltage measurements to determine a distance from a
wall of a cochlea, and the action of determining whether or not the
electrode array was inserted and/or is being inserted in a manner
that results in the predetermined placement includes comparing the
determined distance to that which should correspond to the type of
electrode array. In an exemplary embodiment, there is the action of
obtaining data indicative of a type of electrode array being
inserted into the cochlea, wherein the action of determining
whether or not the electrode array was inserted and/or is being
inserted in a manner that results in a predetermined placement is
executed automatically by a surgical instrument (e.g., any of those
disclosed in any of the appendices), wherein the surgical
instrument is configured to control a flow of current to various
electrodes of the electrode array and to measure voltages at
various electrodes of the electrode array according to a plurality
of possible regimes (any of the current flow regimes and/or any of
the measurement regimes disclosed in any of the appendices herein),
and the method further comprises providing the surgical instrument
with the data indicative of the type of electrode array (or type of
insertion), using the surgical instrument, automatically applying
between temporal location 1 and 2, a subset of the possible regimes
(i.e., applying some but not all of the possible regimes to which
the surgical instrument is configured to apply--note that this is
not merely capable of applying, but constitutes a number of regimes
that are programmed into the controller at that time were only some
of the regimes are utilized), thereby measuring the voltage,
wherein the surgical instrument determines the subset
(automatically) to be applied based on the provided data indicative
of the type of the electrode array. That said, in an exemplary
embodiment, a healthcare professional determines the routine. In an
exemplary embodiment, healthcare professional can input the type of
insertion and/or the type of array into the surgical instrument,
and the surgical instrument can identify various routines that will
be utilized based on that input
[0247] In an exemplary embodiment, the subset of the possible
regimes is a subset of voltage measurements that reveal data
related to the type of electrode array begin inserted (and/or the
type of insertion), and the non-used regimes include measurements
of voltages that that reveal data unrelated to, or at least less
related to (relative to the data related to the type) the type of
electrode array (and/or type of insertion) being inserted and
related to other types of electrode arrays not being inserted. By
way of example only and not by way of limitation, in an exemplary
embodiment, data unrelated to or less related to a lateral wall
array may include data indicative of a distance from the modiolous
wall, and data unrelated to or less related to a modiolous array
may include determining whether or not there is blood in the
cochlea.
[0248] In an exemplary embodiment, the method includes obtaining
data indicative of a type of electrode array being inserted into
the cochlea, wherein the action of determining whether or not the
electrode array was inserted and/or is being inserted in a manner
that results in a predetermined placement is executed automatically
by a surgical instrument, the surgical instrument is configured to
analyze the voltage measurements according to a plurality of
possible regimes, and the method further comprises providing the
surgical instrument with the data indicative of the type of
electrode array (or type of insertion) and using the surgical
instrument, automatically applying between temporal location 1 and
2, a subset of the possible regimes, thereby analyzing the
voltages, wherein the surgical instrument determines the subset to
be applied based on the provided data indicative of the type of the
electrode array.
[0249] In an exemplary embodiment, there is a system, such as any
of the systems detailed in any of the appendices, as modified
according to the following, where the system includes a cochlear
implant sub-system including an electrode array and a control
sub-system, wherein the system is configured to (i) operate
electrodes of the electrode array as a source and a sink (and/or in
accordance to any of the teachings in any of the appendices); (ii)
operate electrodes of the electrode array as read electrodes
(and/or in accordance with any of the teachings in any of the
appendices); and (iii) enable communication between the control
sub-system and the cochlear implant sub-system.
[0250] In an exemplary embodiment, the control sub-system is
configured to analyze signals from the cochlear implant sub-system,
and adapt at least one of an analysis routine or the operation of
the electrodes of the electrode array based on the analysis. This
as opposed to a system that operates the same way irrespective of
the analysis of the signals and/or irrespective of the signals
received from the electrode array.
[0251] In an exemplary embodiment of the systems detailed herein,
the analysis routine includes selecting data to analyze relative to
other data from read electrodes, and the action of adapting the
analysis routine includes selecting the data to analyze instead of
the other data. By way of example only and not by way of
limitation, in an exemplary embodiment, data from some electrodes
can be analyzed and data from other electrodes are not
analyzed.
[0252] In an exemplary embodiment, the control sub-system is
configured to analyze signals from the cochlear implant sub-system
during a first temporal period and the control sub-system is
configured to adapt at least one of the analysis routine or the
operation of the electrodes based on the analysis during the first
temporal period so that at least one of the analysis routine or the
operation the electrodes is different during a second temporal
period later than the first temporal period. In an exemplary
embodiment, with respect to the operation of the electrodes, the
magnitude of the current and/or the frequency is applied given
electrodes can be varied. In an exemplary embodiment, the current
can be applied to some electrodes and not applied to other
electrodes, etc.
[0253] In an exemplary embodiment, the control sub-system is
configured to analyze signals from the cochlear implant sub-system
during a first temporal period and identify one or more possible
position scenarios relating to the electrode array from a group of
scenarios relating to the electrode array (any of the scenarios
detailed in any of the appendices), and the control sub-system is
configured to adapt at least one of the analysis routine or the
operation of the electrodes based on the identified one or more
possible position scenarios so that at least one of the analysis
routine or the operation of the electrodes is different during a
second temporal period later than the first temporal period (e.g.,
the first temporal period can be the initial insertion time of the
electrode array, and the second temporal period can be a leader
insertion time period of the electrode array), and the control
sub-system is configured such that if one or more possible position
scenarios was different from that identified, the control
sub-system would adapt at least one of the analysis routine or the
operation of the electrodes based on the identified one or more
possible position scenarios in a different manner and there still
would be a difference during the second temporal period relative to
the first temporal period (that is, the adaption can be different
for different position scenarios, and there would be adaption in
these instances--the ideas that the system will adapt to focus on
certain features at the expense of other features in view of the
given scenario, whereas during the first period of time, other
features are focused upon because the scenario is not known).
[0254] In an exemplary embodiment, the control sub-system is
configured to analyze signals from the cochlear implant sub-system
during a first temporal period and the control sub-system is
configured, based on the analysis during the first temporal period,
to adapt at least one of an analysis routine or the operation of
the electrodes of the electrode array so as to focus an analysis of
signals received during a second temporal period after the first
time period on some aspects of cochlear implant electrode array
insertion rather than other aspects of such (e.g., dislocation
instead of blood, wall distance instead of fold over,--any of the
aspects of appendices--etc.), wherein the first temporal period and
the second temporal period both elapse during array insertion into
the cochlea.
[0255] In an exemplary embodiment, the control sub-system is
configured to execute one or more of the method actions
respectively detailed in two or more of Appendix A, Appendix B,
Appendix C, D, E or F, and the action of adapting results in the
control-sub system executing one or more of the method actions
detailed in Appendix A, B, C, D, E or F but at least not one other
method action that the control sub-system is configured to execute
(again, the sub-system could execute it--it is
programmed/configured to do so, but it does not do so).
[0256] In an exemplary embodiment, the control sub-system is
configured to execute one or more of the method actions
respectively detailed in two or more of Appendix A, B, C, D, E or
F, and the action of adapting results in the control-sub system
executing one or more of the method actions detailed in Appendix A,
B, C, D, E or F but no other method actions that the control
sub-system is configured to execute.
[0257] It is noted that the control subsystem can be part of the
cochlear implant, and in other embodiments, the control subsystem
can be a separate component.
[0258] In an exemplary embodiment, the control sub-system is
configured to analyze signals from the cochlear implant sub-system
during a first temporal period, the control sub-system is
configured to, based on the analysis during the first temporal
period, to identify an electrode array insertion scenario from
amongst a plurality of insertion scenarios, the control sub-system
is configured to, based on the identified electrode array insertion
scenario, adapt at least one of an analysis routine or the
operation of the electrodes of the electrode array based on the
identified scenario so that some analysis and/or operation of the
electrodes is executed and other analysis and/or operation of the
electrodes is not executed, wherein the control sub-system is
configured to execute both the executed analysis/operation and the
non-executed analysis operation. In an exemplary embodiment, the
control sub-system is configured to condition data based on the
received signals and use the conditioned data as part of the
analysis of the signals.
[0259] In an exemplary embodiment, the control sub-system is
configured to execute one or more of the method actions
respectively detailed in two or more of Appendix A, Appendix B,
Appendix C, D, E or F (and there is a method of executing one or
more of the things it is configured to execute), and the action of
adapting results in the control-sub system executing one or more of
the method actions detailed in Appendix A, B, C, D, E or F but at
least not one other method action that the control sub-system is
configured to execute that the sub-system previously executed.
[0260] In an exemplary embodiment, there is a system, comprising a
control unit configured to receive telemetry from an implantable
system of a cochlear implant electrode array and analyze the
telemetry (which can be any system disclosed in any of the
appendices as modified accordingly) wherein the telemetry includes
data based on electrical phenomenon associated with the electrode
array, and the control unit is configured to execute one or more of
the method actions respectively detailed in two or more of Appendix
A, B, C, D, E or F. In an exemplary embodiment the system is
configured to receive input from a healthcare professional that
automatically enables the execution of the one or more of the
method actions respectively detailed in two or more of Appendix A,
B, C, D, E or F but at least not one other method action and/or no
other method action that the control sub-system is configured to
execute. In an exemplary embodiment, the system is configured to
receive input that automatically enables the execution of the one
or more of the method actions respectively detailed in two or more
of Appendix A, B, C, D, E or F, but at least not one other method
action and/or no other method action that the control sub-system is
configured to execute.
[0261] The system can be configured to receive input that at least
partially overrides the lack of enablement of at least one of the
other method actions so that such is enabled. By way of example
only and not by way of limitation, the system can be configured to
receive input from a healthcare professional or the like such that
the lack of enablement is overridden, and the method actions are
again executed. Note also that in an exemplary embodiment, the
system can be configured to automatically do this based on the
collection of data that would indicate such has utilitarian value.
By way of example only and not by way of limitation, in a scenario
where some of the method actions are disabled, which disabling can
be a result of, for example, an analysis of the data indicating
that those method actions are not utilitarian, later data can
indicate that the method actions would again be utilitarian, and
thus the system would reenable those method actions.
[0262] In an exemplary embodiment, the system is configured to
identify 2 or more, 3 or more, 4 more, 5 or more or all 6 of:
[0263] tip fold over;
[0264] scala dislocation;
[0265] distance from modiolus of the array;
[0266] phenomenon that exists in the recipient;
[0267] that the electrode array has reached a specific location in
the cochlea; and blood in the cochlea.
[0268] In an exemplary embodiment, the system is configured to
perform at least 2 or more, or at least 3 or more or at least 4
more or at least 5 or more or at least 6 or more or at least 7 or
more or at least 8 or more or at least 9 or more or all of the
following:
[0269] determine a positional feature of the electrode array based
on the vertical electrical sounding;
[0270] condition information in the received telemetry and perform
the analysis based on the conditioned information;
[0271] determine, based on the telemetry, that a physical
characteristic associated with the electrode array that is strictly
local to the electrode array existed and/or exists;
[0272] determine spatial derivatives of electrical properties
between electrodes of the electrode array;
[0273] identify changes between voltage measurements at read
electrodes between different temporal locations;
[0274] detecting a voltage change across the plurality of
electrodes based on a monitored relative magnitude that is
representative of a voltage change at a reference electrode;
[0275] identify a presence of an asymmetry in the voltage
measurements;
[0276] focus readings from read electrodes of the electrode array
at a same location within the cochlea relative to other locations
within the cochlea while the electrode array is moving;
[0277] interleave neural response measurements with impedance
measurements between electrodes of the cochlear implant electrode
array while the electrode array is being moved; and
[0278] determine a location, density and temporal feature of the
impedance change.
[0279] In an exemplary embodiment, the system is configured to
perform at least 2 or more, or at least 3 or more or at least 4
more or at least 5 or more or at least 6 or more or at least 7 or
more or at least 8 or more or at least 9 or more or 10 or more or
11 or more or 12 or more or 13 or more or 14 or more or 15 or more
or 16 or more or 17 or more or 18 or more or 19 or more or 20 or
more or 21 or more or 22 or more or 23 or more or 24 more or 25 or
more or 26 or more or 27 or more or 28 or more or 29 or more or 30
or more of any action or functionality disclosed in any of the
appendices or throughout any of the appendices herein (all can come
from one appendix, all can come from separate appendices, etc.)
[0280] In an exemplary embodiment, there is a method that includes
executing at least 2 or more, or at least 3 or more or at least 4
more or at least 5 or more or at least 6 or more or at least 7 or
more or at least 8 or more or at least 9 or more or 10 or more or
11 or more or 12 or more or 13 or more or 14 or more or 15 or more
or 16 or more or 17 or more or 18 or more or 19 or more or 20 or
more or 21 or more or 22 or more or 23 or more or 24 more or 25 or
more or 26 or more or 27 or more or 28 or more or 29 or more or 30
or more of any action disclosed in any of the appendices or
throughout any of the appendices herein (all can come from one
appendix, all can come from separate appendices, etc.).
[0281] In view the above, it can be seen that in at least some
exemplary embodiments, there are methods that include executing the
method actions of the various appendices in a single method, such
as during insertion of the electrode array or during the operation
that is the insertion of the electrode array (the latter which
would include after the electrode array is fully inserted, which
would include the scenario where based on the measurements for the
analysis of the measurements, the electrode array would have to be
repositioned--fully inserted means that the surgeon has inserted
the electrode array as far as he or she would insert the electrode
array--scenarios exist where after full insertion, based on data,
the surgeon may withdraw the electrode array a little bit--that
would be after the electrode array is fully inserted, but still
during the surgery). The idea is that in at least some exemplary
embodiments, there is utility to executing some of the aspects of
the difference appendices during the same method. For example,
there can be utilitarian value with respect to analyzing data for
blood in the cochlea as well as analyzing the data for dislocation
as well as analyzing the data to determine that the electrode array
should not be inserted any further and/or for determining the
possibility that the electrode array is contacting the basilar
membrane. It is also to be understood that in at least some
exemplary embodiments, these methods actions can be executed during
some parts of the operation and not others electrode array
insertion process but not other parts based on data and/or the
results of the analysis and/or based on statistically significant
data, such as the likelihood that there will be trauma in the
cochlea is reduced after the electrode array reaches a certain
location within the cochlea, and thus it is less utilitarian to
continue to attempt to identify such.
[0282] In view of the above, it can also be seen that there are
systems and/or devices that are configured to execute various
method actions of the appendices and/or have the functionality of
the various devices and/or systems of the appendices, and that
during a cochlear implant operation, such as during electrode array
insertion, some functionalities will be used and some
functionalities will not be used, depending on the circumstances,
while other functionalities will be used and other functionalities
will not be used depending on other circumstances.
[0283] Appendix F details various ECOG methods and various methods
to determine whether or not the array is in contact with the
basilar membrane. In this regard, embodiments include methods
where, during insertion of the electrode array, one or more of the
method actions detailed in appendix F is executed along with one or
more of the method actions detailed in any of the other appendices.
In this regard, in an exemplary embodiment, there is an exemplary
method, comprising inserting a cochlear implant electrode array
into a cochlea, and executing neural response measurements (e.g.,
those of Appendix F, or NRT using stimulation from the electrode
array to evoke a neural response) and executing impedance
measurements with the electrode array during the insertion (as
opposed to after insertion). In an exemplary embodiment the action
of executing the neural response measurements and the action of
executing impedance measurements includes segregating the
respective measurements into respective temporal periods. In this
regard, in an exemplary embodiment, the impedance measurements, or,
more specifically, the current generated by the electrodes for the
impedance measurements, can interrupt the measurements for the ECOG
and/or the NRT, and/or vice versa. In an exemplary embodiment, one
can skew the other and/or the other can skew the one. Accordingly,
in an exemplary embodiment, the neural response measurements and
the impedance measurements are separated in a temporal manner so as
to avoid any skewing that effectively skews the results.
[0284] In an exemplary embodiment, there is a method that includes
the action of determining an insertion location of the electrode
array and adjusting a timing of neural response measurements and/or
impedance measurements based on the location of the electrode
array. In this regard, in an exemplary embodiment, there can be
utilitarian value with respect to executing one or more of the
method actions associated with appendices A-E when the electrode
array is not proximate the stop zone detailed in Appendix F. Thus,
if the electrode array is not proximate the stop zone, the neural
response measurements may not be taken in some embodiments, or in
other embodiments, the neural response measurements will not be
taken as frequently relative to that which would be the case if the
electrode array was proximate/approaching the stop zone.
Conversely, in an exemplary embodiment, there can be utilitarian
value with respect to executing one or more of the method actions
associated with appendix F when the electrode array is approaching
the stop zone, at least in a manner that is temporally more
frequent relative to that which is the case when the electrode
array is further away from the stop zone. In this regard, the
impedance measurements may be taken less frequently relative to
that which is the case when the electrode array is away from the
stop zone. Is also noted that in an exemplary embodiment, such as
where the tip of the electrode array is approaching the basal turn,
in exemplary embodiment, the impedance measurements may be taken
more frequently than at other locations and/or the neural response
measurements may be taken at a frequency less than that which would
be the case at the other locations.
[0285] In view of the above, it can be seen that in at least some
exemplary embodiments, the methods include actively managing the
different types of measurements so as to optimize or otherwise
focus on obtaining certain information relative to obtaining other
information based on the conditions associated with the electrode
array at a given time.
[0286] In an exemplary embodiment, the action of executing the
neural response measurements and the action of executing impedance
measurements includes executing such in respective temporal periods
that do not overlap. In an exemplary embodiment, the action of
executing the neural response measurements and the action of
executing impedance measurements includes executing such in
respective temporal periods that are temporally separated by
periods of no measurements. These periods can be based on a given
time period and/or can be based on a number of electrodes inserted
into the cochlea since the last action and/or the distance that the
electrode array has been inserted since the last action, etc.
[0287] In an exemplary embodiment, there is the action of
determining an insertion location of the electrode array, and
concentrating the execution of the neural response measurements
over the impedance measurements and vis-a-versa based on the
location of the electrode array. In an exemplary embodiment, there
is a method that includes determining an insertion location of the
electrode array and at least one of: [0288] increasing a temporal
average execution of the neural response measurements and
decreasing a temporal average execution impedance measurements
based on the location of the electrode array; or [0289] decreasing
a temporal average execution of the neural response measurements
and increasing a temporal average execution impedance measurements
based on the location of the electrode array.
[0290] In an exemplary embodiment, there is a method as detailed
herein further comprising an action of determining an insertion
location of the electrode array, and concentrating the execution of
the neural response measurements over the impedance and executing
the neural response measurements and/or not executing the impedance
measurements while the electrode array is being extended into a
third portion of the cochlea beyond the first portion.
[0291] In an exemplary embodiment, there is the action of
determining an insertion location of the electrode array, and
concentrating the execution of the neural response measurements
over the impedance measurements and vis-a-versa based on the
location of the electrode array. In an exemplary embodiment, there
is a method as detailed herein further comprising:
[0292] determining an insertion location of the electrode
array;
[0293] executing the neural response measurements and/or not
executing the impedance measurements while the electrode array is
being extended into a first portion of the cochlea; and
[0294] halting the neural response measurements and/or executing
the impedance measurements while the electrode array is being
extended into a second portion of the cochlea further into the
cochlea than the first portion.
[0295] In an exemplary embodiment, the method(s) further
include:
[0296] determining an insertion location of the electrode
array;
[0297] executing the neural response measurements a first number of
times within a first temporal period while the electrode array is
being extended into a first portion of the cochlea such that there
is an average per second of measurements for the first period;
and
[0298] executing the neural response measurements a second number
of times within a second temporal period while the electrode array
is being extended into a second portion of the cochlea further into
the cochlea than the first portion such that there is an average
per second of measurements for the second period, wherein the
average for the first period is greater than or less than the
average for the second period.
[0299] In an exemplary embodiment, the method(s) further
include:
[0300] determining an insertion location of the electrode
array;
[0301] determining an insertion location of the electrode
array;
[0302] executing the impedance measurements a first number of times
within a first temporal period while the electrode array is being
extended into a first portion of the cochlea such that there is an
average per second of measurements for the first period;
[0303] executing the impedance measurements a second number of
times within a second temporal period while the electrode array is
being extended into a second portion of the cochlea further into
the cochlea than the first portion such that there is an average
per second of measurements for the second period, wherein the
average for the first period is greater than or less than the
average for the second period.
[0304] In an exemplary embodiment, the method(s) further
include:
[0305] determining an insertion location of the electrode
array;
[0306] determining that the array is a modilous array or
non-modiolous array;
[0307] determining an insertion location of the electrode array;
and
[0308] adjusting a timing of neural response measurements and/or
impedance measurements based on the location of the electrode array
and based on the determined type of array.
[0309] In an exemplary embodiment, the method(s) further
include:
[0310] determining an insertion location of the electrode
array;
[0311] determining that the array is a modilous array or
non-modiolous array;
[0312] determining an insertion location of the electrode array;
and
[0313] concentrating the execution of the neural response
measurements over the impedance measurements and vis-a-versa based
on the location of the electrode array and based on the determined
type of the array.
[0314] In an exemplary embodiment, the method(s) further
include:
[0315] determining an insertion location of the electrode
array;
[0316] determining that the array is a modilous array or
non-modiolous array;
[0317] determining an insertion location of the electrode array;
and
[0318] concentrating the execution of the neural response
measurements over the impedance measurements and vis-a-versa based
on the location of the electrode array and based on the determined
type of the array.
[0319] In an exemplary embodiment, there is an exemplary method,
comprising inserting a cochlear implant electrode array into a
cochlea, and executing neural response measurements (e.g., those of
Appendix F, or NRT using stimulation from the electrode array to
evoke a neural response) and executing impedance measurements with
the electrode array prior to full insertion into the cochlea.
[0320] In an exemplary embodiment, the neural response measurements
are acoustically-evoked inner ear potential measurements.
[0321] In an exemplary embodiment, the methods detailed herein
further comprise determining a location of the electrode array
based on the acoustically-evoked inner ear potentials and
determining a spatial property of the electrode array, such as
location, based on the impedance measurements. In an exemplary
embodiment, the neural response measurements are
acoustically-evoked inner ear potential measurements, and the
method(s) further comprise evaluating the measurements for an array
insertion stop condition while inserting the array based on the
acoustically-evoked inner ear potential, and evaluating the
measurements for an array insertion stop condition while inserting
the array based on based on the impedance measurements.
[0322] In an exemplary embodiment, the neural response measurements
are acoustically-evoked inner ear potential measurements, and the
method further comprises evaluating the measurements for an array
insertion stop condition while inserting the array based on the
acoustically-evoked inner ear potentials and evaluating the
measurements for any one or more of an array condition detailed in
Appendix A, B, C, D, E or F.
[0323] In an exemplary embodiment, method as detailed herein can
include the action of repeatedly determining locations of the
electrode array during insertion as the electrode array is advanced
into the cochlea and switching from neural response measurements to
impedance measurements and/or vis-a-versa based on the determined
locations. In some embodiments, the methods include repeatedly
determining locations of the electrode array during insertion as
the electrode array is advanced into the cochlea and switching from
neural response measurements to impedance measurements and/or
vis-a-versa based on the determined locations. In an exemplary
embodiment, the methods include repeatedly determining locations of
the electrode array during insertion as the electrode array is
advanced into the cochlea, relying on the neural response
measurements to identify a location of the electrode array and/or
to halt an insertion of the electrode array based on a feature of
the cochlea that exists only in the presence of stimulus that
evokes the neural response and/or based on the electrode array
contacting the basilar membrane, relying on the impedance
measurements to identify a location of the electrode array and/or
to halt an insertion of the electrode and/or identify a spatial
feature of the array based on a feature of the cochlea that exists
irrespective of the presence or absence of the stimulus that evokes
the neural response.
[0324] In an exemplary embodiment, the methods can include
repeatedly determining locations of the electrode array during
insertion as the electrode array is advanced into the cochlea,
applying the impedance measurements while limiting or suspending
the neural response measurements when an apical tip of the array is
determined to be at the basil turn or proximate an anatomical
structure in the cochlea present in a statistically significant
percentage of humans; and applying the neural response measurements
while limiting or suspending the impedance measurements when the
apical tip of the array is determined to be away from the basil
turn or away from the anatomical structure.
[0325] In an exemplary embodiment, the methods can include
identifying, during insertion, that a situation of interest related
to the electrode array exists, which did not exist prior to the
insertion, determining that the situation of interest is based on
measurements from the neural response measurements or the impedance
measurements and/or determining that the situation of interest can
be better analyzed by the neural response measurements or the
impedance measurements, and limiting measurements for a first
period of time after the determination(s) to one of neural response
measurements or impedance measurements based on the
determination(s).
[0326] In an exemplary embodiment, the methods can include
identifying, during insertion, that the situation of interest no
longer exists and/or a second situation of interest related to the
electrode array exists, which did not exist prior to the insertion,
second determining that the second situation of interest, if
present, is based on measurements from the neural response
measurements or the impedance measurements and/or second
determining that the situation of interest can be better analyzed
by the neural response measurements or the impedance measurements
and/or determining that in the absence of the situation of
interest, it is less useful than was the case during the first
period of time to limit the measurements, and that for a second
period of time after the second determination(s), lifting the
limitation.
[0327] In an exemplary embodiment, there is a method that includes
executing real time measurements of voltages at electrodes of an
electrode array as the electrode array is moving within a cochlea
during insertion of the electrode array therein, analyzing during
insertion, some but not all of the measurements to identify one or
more first occurrences from a group of first occurrences, and
analyzing after insertion, at least some of the measurements not
analyzed during the insertion to identify one or more second
occurrences from a group of second occurrences.
[0328] In an exemplary embodiment of this exemplary method, this
method can have utilitarian value with respect to limiting the
analysis to things that are more important or otherwise critical
during the insertion phase, which can be accomplished within 15,
20, 25, 30 seconds, 45 seconds, 60, 75, 90, 100, 120, 130, 140,
150, 180 seconds, or within 4 or 5 or 6 or 7 or8 or 9 or 10 minutes
(e.g., for initial entry to the cochlea to full insertion),
depending on the embodiment. Thus, processing power of the surgical
instruments/systems/devices can be concentrated, during insertion,
on the areas where immediate feedback/real-time feedback will
provide or otherwise can provide utilitarian instruction to the
surgeon or other healthcare professional during the insertion
process, thus increasing the likelihood that the resulting analysis
or otherwise resulting data captured is utilitarian to the surgeon
or healthcare professional because the system is not bogged down or
otherwise addressing other areas that are not of a concern. After
this, secondary analyses are executed one the data when there is
more time to execute these analyses. It is noted that this
embodiment of this method can be applicable to a scenario where
analyses require more processing power or otherwise analyses where
in-depth analysis is executed during the insertion process occurs
(so as to get specific results/accurate results that are critical
or otherwise utilitarian to evaluating the insertion process), at
the expense of other analyses, as well as scenarios where there is
only so much data that can be processed at any one time, even under
a streamlined processing scenario, as well as scenarios where the
analysis can be executed during the insertion process, but the
feedback would result in overload to the surgeon or other
healthcare professional.
[0329] It is also noted that another variation of this method could
be such that processing power of the surgical
instruments/systems/devices and/or the focus of measurements at
some electrodes but not others and/or focus of current supply to
some electrodes but not others can be concentrated, during
insertion, on the areas where immediate feedback/real-time feedback
will provide or otherwise can provide utilitarian instruction to
the surgeon or other healthcare professional during the insertion
process, thus increasing the likelihood that the resulting analysis
or otherwise resulting data captured is utilitarian to the surgeon
or healthcare professional because the system is not bogged down or
otherwise addressing other areas that are not of a concern.
[0330] In an exemplary embodiment of the above method, the first
group and the second group of occurrences overlap one another, and
the second group has more occurrences than the first group. It is
briefly noted that the occurrences can be occurrences related to
the electrode array, such as electrode array tip fold over,
electrode array scala puncture, etc. is also noted that the
occurrences can be occurrences related to phenomenon inside the
cochlea, such as blood in the cochlea. In an exemplary embodiment,
the occurrence can be the scenario where the electrode array
approaches or otherwise is located within a certain distance of a
wall of the cochlea. In an exemplary embodiment, the occurrence can
be the approach meant of the electrode array to a physical feature
of the cochlea, such as a construction. An occurrence can
correspond to any of the occurrences in appendix A, B, C, D, E or
F. in some embodiments, an occurrence can correspond to any of the
features or things that are identified or otherwise result from the
analysis of any of the analysis executed in any of the appendices
A, B, C, D, E or F.
[0331] In an exemplary embodiment, the action of analyzing after
insertion includes a verification of an insertion of the electrode
array into to the cochlea. In an exemplary embodiment, the action
of analyzing during insertion is a triage exercise relative to the
analyzing after insertion.
[0332] In an exemplary embodiment, there is an extra action of
taking additional measurements after full insertion of the
electrode array into the cochlea, wherein the action of analyzing
after insertion, at least some of the measurements not analyzed
during the insertion to identify one or more second occurrences
from a group of second occurrences includes analyzing at least some
of the measurements taken after full insertion. Again, this is
consistent with the embodiment detailed above where electric
current and/or measurements are limited to certain electrodes and
not applied to others on purpose so as to if you will, conserve
resources during the insertion process and otherwise focus the
measurements at areas where there is more utilitarian value during
insertion. After the full insertion, when the electrode is
stationary, and thus there is more time, a larger battery of tests
are executed, and, by way of example, a larger number of
measurements applied to a larger number of electrodes can be
applied and/or a larger number of currents can be applied to a
larger number of electrodes.
[0333] In an exemplary embodiment, the action of analyzing during
insertion is executed to at least in part identify a potential of
damage to the array or to the cochlea that is statistically more
likely to cause damage to the cochlea relative to other insertion
scenarios, and the action of analyzing after insertion is executed
to at least in part evaluate placement of the electrode array for
long term usage. In an exemplary embodiment, the action of
analyzing during insertion is executed to at least in part identify
an insertion stop condition, and the action of analyzing after
insertion is executed to at least in part evaluate placement of the
electrode array for long term usage.
[0334] In an exemplary embodiment, there is a system, comprising a
cochlear implant sub-system including an electrode array, and a
control sub-system, wherein the system is configured to: [0335]
operate electrodes of the electrode array as a source and a sink;
[0336] operate electrodes of the electrode array as read
electrodes; and [0337] enable communication between the control
sub-system and the cochlear implant sub-system.
[0338] In an exemplary embodiment, of this system, the control
sub-system is configured to: [0339] obtaining data indicative of a
type of electrode array being inserted into the cochlea (and/or the
type of insertion); [0340] execute two or more analysis regimes to
analyze the signals from the cochlear implant sub-system; [0341]
implement one or more analysis regimes of the two or more analysis
regimes to analyses the signals from the cochlear implant
sub-system as opposed to one or more other analysis regimes of the
analysis regimes based on the data indicative of a type of
electrode array (and/or type of insertion); and [0342] analyze
signals from the cochlear implant sub-system based on the
implemented analysis regime.
[0343] In an exemplary embodiment, the analysis regimes can be any
of those in Appendix A, B, C, D, E or F. In an exemplary
embodiment, the system identifies the pertinent analysis regime(s)
for the given type and apply such as opposed to applying all
possible analysis regimes for which the system is programmed and/or
as opposed to applying analysis regimes that are applicable or more
applicable to other types.
[0344] In an exemplary embodiment, a first regime analyzes the
signals for data indicative of blood in the cochlea, a second
regime analyzes the signals for data indicative of tip fold over,
and the system is configured to automatically use the first regime
and not use the second regime if the input indicative of the type
of electrode array indicates that the type is a non-perimodiolar
array, and the system is configured to automatically use the second
regime and not use the first regime if the input indicative of the
type of electrode array indicates that the type is a perimodiolar
array. In an exemplary embodiment, a first regime analyzes the
signals for data indicative of blood in the cochlea, a second
regime analyzes the signals for data indicative of tip fold over,
the system is configured to automatically use the first regime and
not use the second regime if the input indicative of the type of
electrode array indicates that the type is a lateral wall array
and/or a mid-scala array, and the system is configured to
automatically use the second regime and not use the first regime if
the input indicative of the type of electrode array indicates that
the type is a non-lateral wall array and/or a non-mid-scala
array.
[0345] In an exemplary embodiment, a first regime analyzes the
signals for data indicative of a sub-optimal insertion for a first
type of array, a second regime analyzes the signals for data
indicative of a sub-optimal insertion for a second type of array
different from the first type of array, and the system is
configured to automatically use the first regime and not use the
second regime if the input indicative of the type of electrode
array indicates that the type is the first type, and the system is
configured to automatically use the second regime and not use the
first regime if the input indicative of the type of electrode array
indicates that the type is a second type.
[0346] In an exemplary embodiment, there is a first regime that
analyzes the signals for data indicative of a distance of the array
from a wall of the cochlea, there is a a second regime analyzes the
signals for data indicative of scala dislocation. The system is
configured to obtain information indicative of a depth of the
electrode array during insertion of the electrode array into the
cochlea and determine that the electrode array is fully inserted
into the cochlea based on the obtained depth information, and the
system is configured to automatically use the second regime if the
input indicative of the type of electrode array indicates that the
type is a non-perimodiolar array until a determination is made that
the electrode array is inserted a certain depth into the cochlea
and then automatically use the first regime or another regime (and
in some embodiment, stop using the second regime), and the system
is configure to automatically not use the first regime if the input
indicative of the type of electrode array indicates that the type
is a perimodiolar array until a determination is made that the
electrode array is fully inserted into the cochlea and then
automatically use the first regime.
[0347] In an exemplary embodiment, the system is configured to
automatically switch between implemented analysis regimes based on
input indicative of a depth of insertion of the electrode array. In
an exemplary embodiment, the system is configured to automatically
switch between implemented analysis regimes based on the analysis
of the signals.
[0348] In an exemplary embodiment, some regimes are focused on
identifying a buckling electrode. In this regard, in an exemplary
embodiment, there is a regime that seeks to identify such, such as
those described in appendix B, and this regime is implemented with
respect to a perimodiolar array insertion. In an exemplary
embodiment, some regimes are focused on determining a location
where there remains to be residual hearing. In an exemplary
embodiment, a regime can correspond to such, such as implementing
an ECOG measurement, and in an exemplary embodiment, if the type is
a lateral wall array insertion and/or a mid-scala insertion, the
system will implement ECOG measurements, and may not do so if the
array insertion is a perimodiolar insertion. Note also that in some
instances, preoperative imaging may be executed in some instances
but not others, depending on the type of array. In an exemplary
embodiment, the regime can attempt to identify dislocation and/or
basilar membrane contact, and this regime can be implemented in the
case of a lateral wall array and/or a mid-scala array, but not in
the case of a perimodiolar insertion. In some embodiments, the
regime can be a basilar membrane contact regime, and this regime
can be implemented in all instances.
[0349] In an exemplary embodiment, the systems can identify whether
or not the electrode array is being inserted too quickly, can
identify a trajectory of the insertion of the electrode array,
and/or whether or not the electrode array is hitting something,
and/or whether or not there is blood present in the cochlea. In
some embodiments, any one or more of these can be implemented. In
an exemplary embodiment, the system can be configured to identify
the occurrence of any of these scenarios (or identify the
trajectory), and based on empirical and/or statistical data,
determine whether or not the insertion of the electrode array could
be problematic, and provide a warning or otherwise provide an
indication to the surgeon or other healthcare professional. In an
exemplary embodiment, the analysis can include an evaluation
between the data known for a given electrode array type and/or
insertion type, and take this into account with respect to the
evaluation of the data. Indeed, in an exemplary embodiment, such
can reduce the likelihood of so-called false positives. By way of
example, an indication that there exists blood in the cochlea might
be discounted if the electrode array as a perimodiolar array. An
indication that there has been dislocation might be discounted if
the electrode array as a lateral wall array.
[0350] In an exemplary embodiment, the systems can identify a bad
insertion based on the speed of which the electrode array is being
inserted (e.g., too quickly), a trajectory of the insertion of the
electrode array (also more easily if the type of array is
known/type of insertion), if the electrode array is hitting
something, and/or if there is blood present in the cochlea.
[0351] In an exemplary embodiment, systems and/or methods disclosed
herein may be such that the following is more of a focus than other
phenomenon: tip fold over (during early or mid-part of the
insertion, at least and/or as the array approaches the basal turn),
blood (when the tip of the array is about the middle part or the
electrode 8, 9, 10, or 11 final position (relative to the cochlea
after final insertion) dislocation, basilar membrane (for lateral
wall, but for mid to later part of the insertion), increase in the
ECOG voltage/plateau, etc. in this regard, the aforementioned
phenomenon are things that can be a focus on during insertion, at
least at the times and or situations identified, more so than other
phenomenon. In an exemplary embodiment, the devices and/or systems
in our methods limit themselves to looking at only one or more of
these phenomenon, at least during the times indicated.
[0352] In an exemplary embodiment, there is the action of
determining positional feature of the electrode array based on the
vertical electrical sounding. In an exemplary embodiment, this is
executed for a perimodiolar array, and in some instances, only
after insertion, and can be executed for a lateral wall but only
sometimes/limited times during insertion, to make sure the array is
not twisted. In an exemplary embodiment, the conditioning of
information in the received telemetry and perform the analysis
based on the conditioned information; determine, based on the
telemetry, that a physical characteristic associated with the
electrode array that is strictly local to the electrode array
existed and/or exists is executed for all types of arrays and/or
for all types of insertions. Also, for all arrays, the
determination of spatial derivatives of electrical properties
between electrodes of the electrode array. For all arrays, but more
so for lateral wall, t teachings detailed herein are executed to
identify changes between voltage measurements at read electrodes
between different temporal locations. In some embodiments, there is
the action of detecting a voltage change across the plurality of
electrodes based on a monitored relative magnitude that is
representative of a voltage change at a reference electrode, for
all arrays. Also, in some embodiments, for all arrays, there is the
action of identifying a presence of an asymmetry in the voltage
measurements.
[0353] Some embodiments limit the focusing of readings from read
electrodes of the electrode array at a same location within the
cochlea relative to other locations within the cochlea while the
electrode array is moving to lateral wall arrays.
[0354] Some embodiments utilize, for all arrays, the interleaving
of neural response measurements with impedance measurements between
electrodes of the cochlear implant electrode array while the
electrode array is being moved. That said, in some embodiments,
this is limited to only the lateral wall arrays.
[0355] In some embodiments, there is a determination at a location
of density and temporal features of the impedance changes but only
for lateral wall arrays. In some embodiments, tip fold over
analysis is executed only for perimodiolar arrays.
[0356] In some embodiments, scala dislocation is executed only for
lateral wall arrays. In some embodiments, the distance from the
modiolous of the array is executed only for perimodiolar arrays,
while in other embodiments, it is executed for all types of arrays
and/or for perimodiolar and or mid scala arrays. Evaluations of
data to identify phenomenon that exists in the recipient are
executed for all arrays in some embodiments. Also, evaluations that
indicate that the electrode array has reached a specific location
in the cochlea are executed for all arrays in at least some
exemplary embodiments. Conversely, evaluations of whether or not
there exists blood in the cochlea can be executed in a manner
limited only to lateral wall and/or midscale arrays.
[0357] It is noted that the above examples are just that: examples
embodiments include methods and/or systems and/or devices where
various analyses and/or phenomenon to be detected and/or types of
measurements are limited to insertions of one type of electrode
arrays were two types of electrode arrays but not all three types
of electrode arrays. Accordingly, embodiments include disclosures
in any of the appendices herein that are limited to only one type
of electrode array versus other types of electrode arrays/types of
insertions (e.g., limited to perimodiolar, perimodiolar and mid
scala, mid-scala, mid-scala and lateral wall, or lateral wall).
Thus, the methods can be so limited and/or the systems and/or
devices can be so limited such that the systems and/or devices do
not execute a given analysis and/or a given action and/or a given
functionality even though such a program to to do so or otherwise
configured to do so because of the type of insertion and/or the
type of electrode array.
[0358] In an exemplary embodiment, the teachings detailed herein
(where anytime that phrase is used herein, such includes
everything, including the appendices) are utilized for diagnostic
feedback based on the Electrode Specific Guidance--known trajectory
combined with other metrics which strengthen the evidence for a
diagnosis. By way of example, in a scenario whether is an
identification of tip-foldover, the wide bipolar VT measure flags a
possible tip-foldover. Conversely, the profile and evolution of the
modiolar distance measure of the entire array does not match the
expected behavior. Thus, the indication of a tip fold over can be
discounted in some embodiments, and thus there is a method of doing
so based on the aforementioned scenario Also by way of example, in
a scenario where the ECoG plummets during the insertion of the
array, and where the modiolar distance measure indicates the apical
electrode is hugging the modiolus however the mid-array electrodes
are bowing outwards. This would then suggest the contact with the
basilar membrane is at the mid-array not the apical electrode, and
thus there is a method for determining rather wise deciding that
the contact with the basilar membrane is at the mid-array.
[0359] Consistent with Appendix E, it is noted that in an exemplary
embodiment includes a method of inserting an electrode array into a
cochlea and while the electrode array is being pushed into the
cochlea, a tone or sound or otherwise acoustic stimulation is
applied as part of an ECoG method. This sound can be continuous or
semicontinuous during the insertion process. In an exemplary
embodiment, the sound is used to stimulate the tissue and evoke the
neural response for the amount of time that is at least 10, 15, 20,
25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95 or 100%
of the time between the first electrode entering the cochlea until
the last electrode enters the cochlea and/or the electrode array is
fully inserted into the cochlea/until the electrode array reaches a
location that corresponds to the furthest the electrode array is
ever inserted into the cochlea. In an exemplary embodiment, the
impedance measurements are taken while the aforementioned sound is
stimulating the tissue/evoking the neural responses. In an
exemplary embodiment, the ECoG measurements are taken while the
aforementioned sound the stimulating the tissue/evoking mineral
responses. Again, in an exemplary embodiment, the method of
inserting the electrode array into the cochlea is executed while
the sound is being played and otherwise evoking the neural
responses, and during this time, the electrodes are being used to
take the impedance measurements and/or the ECoG measurements.
Accordingly, in an exemplary embodiment, there is a method that
includes executing a portion of an ECoG method in general, and
specifically, executing the acoustic stimulus to evoke the neural
response, and while this neural response is occurring, taking the
impedance measurements to execute one or more or all of the actions
associated with the impedance measurements detailed herein (again,
which includes any of the disclosures of Appendix A, B, C, D, E or
F).
[0360] It is briefly noted that any disclosure herein of the taking
of impedance measurements also corresponds to a disclosure of an
embodiment of utilizing those impedance measurements according to
any of the teachings detailed herein, providing that the art
enables such.
[0361] In view of the above, an exemplary embodiment includes a
method where, while the sound is applied, the ECOG measurements are
interleaved with the impedance measurements.
[0362] Note also that while in some embodiments, the sound is
constantly played, in other embodiments, the sound is played for
only those portions of the insertion where it is more likely than
not that the ECOG measurements will be utilitarian. For example,
the sound could be begun to be played at a location somewhere
before the do not exceed location such that there is very little
likelihood that the electrode array will reach that location while
the sound is not played. This will results, in some embodiments, to
the sound being played during times where the ECOG measurements are
not needed or otherwise less valuable than at other areas.
[0363] In an exemplary embodiment, the methods herein and the
systems herein are such that the electrodes that are energized for
the impedance measurements are not used as measurement electrodes
for the ECOG measurements. In an exemplary embodiment, an exemplary
method includes executing both ECOG measurements and impedance
measurements during insertion, where the most distal electrode is
not used as a source or sink. In an exemplary embodiment, an
exemplary method includes executing both ECOG measurements and
impedance measurements during insertion of the electrode array,
where the second and or third and/or fourth most distal electrodes
are never utilized as a source and/or a sink electrode. In an
exemplary embodiment of this embodiment, the most distal electrode
is used as a source and/or a sink.
[0364] An exemplary embodiment includes utilizing electrodes that
are utilized as a source and/or a sink during impedance
measurements as measurement electrodes for the ECOG measurements,
except that the time period between the utilization of such as a
source and/or a sink and the utilization as a measurement electrode
is such that any polarization or otherwise charge buildup is
reduced relative to that which would be the case if the electrodes
were used as a source and a sink and a measurement electrode in a
shorter time period.
[0365] 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 (again, which includes the above and the
appendices) 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 embodiment or teaching
disclosed herein can be explicitly excluded in some embodiments,
providing that the art enables such unless otherwise noted. Any
embodiment detailed herein can be explicitly excluded from
combination with any feature of any other embodiment detailed
herein providing that the art enables such, unless such is
otherwise noted.
[0366] Embodiments include one or more of the teachings of Appendix
A, B, C, D, E and/or F. It is noted that some embodiments are such
that any reference to Appendix B herein includes a reference to
Appendix as an alternative, unless otherwise noted.
[0367] 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.
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