U.S. patent number 3,752,939 [Application Number 05/223,415] was granted by the patent office on 1973-08-14 for prosthetic device for the deaf.
This patent grant is currently assigned to Beckman Instruments, Inc.. Invention is credited to Melvin C. Bartz.
United States Patent |
3,752,939 |
Bartz |
August 14, 1973 |
PROSTHETIC DEVICE FOR THE DEAF
Abstract
There is disclosed a method and apparatus for inducing the
sensation of intelligible hearing by direct electrical excitation
of the auditory nerve endings distributed along the basilar
membrane within the cochlea. An electrode is positioned within the
lower scala of the cochlea by insertion through the round window.
The electrode consists of a resilient base member shaped to conform
to the inner surface of the lower scala, such base member extending
along the basilar membrane. The base member retains a pair of
conductors which extend parallel to the length of the basilar
membrane. Means are also provided for transmitting an excitation
signal to a receiver implanted with and connected to the
conductors. Several configurations for the electrode are disclosed
as well as several techniques for the excitation thereof.
Inventors: |
Bartz; Melvin C. (Newport
Beach, CA) |
Assignee: |
Beckman Instruments, Inc.
(Fullerton, CA)
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Family
ID: |
22836391 |
Appl.
No.: |
05/223,415 |
Filed: |
February 4, 1972 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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075142 |
Sep 24, 1970 |
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Current U.S.
Class: |
607/57; 381/150;
623/10; 607/137; 181/130; 600/25 |
Current CPC
Class: |
A61N
1/36038 (20170801); A61F 11/004 (20130101); A61N
1/0541 (20130101) |
Current International
Class: |
A61F
11/04 (20060101); A61F 11/00 (20060101); A61N
1/05 (20060101); A61N 1/36 (20060101); H04n
025/00 () |
Field of
Search: |
;179/17R,17BC,17E
;128/1R ;3/1 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
The Crossed Cochlea Effect by Michelson, Actions of American
Laryngological, Rhinological and Othological Society Inc. Presented
1/3/68, Received in Library of Medicine 1/8/69.
|
Primary Examiner: Claffy; Kathleen H.
Assistant Examiner: D'Amico; Thomas
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATION
This application is a continuation-in-part of my copending
application Ser. No. 75,142, filed Sept. 24, 1970 now abandoned.
Claims
I claim:
1. Apparatus for inducing sensations of hearing in a human subject
comprising
an elongate curved electrode adapted to be positioned within the
lower scala of a cochlea of the subject, with the electrode
extending lengthwise along a portion of the lower scala,
receiving means coupled to said electrode for receiving an
electrical excitation signal being an analog of an externally
generated audio signal and for applying said excitation signal
uniformly to said electrode, and
transmitting means responsive to said externally generated audio
signal for transmitting said electrical excitation signal to said
receiving means.
2. The apparatus of claim 1 wherein said electrode includes
an elongate resilient base member shaped to substantially conform
to part of the inner surface of the lower scala, and
a pair of conductors secured to said base member for receiving said
electrical excitation signal from said receiving means, said
conductors extending lengthwise of the base member whereby each of
the conductors is positioned proximate auditory nerve endings
distributed along the same longitudinal section of the cochlea.
3. The apparatus of claim 2 wherein said base member has a
cross-sectional area less than the cross-sectional area of the
portion of the lower scala within which it is positioned whereby
flow of cochlea fluid past the base member is relatively
unimpeded.
4. Apparatus according to claim 2 wherein said transmitting means
comprises:
transducer means responsive to said externally generated audio
signal for converting said audio signal into said electrical
excitation signal; and
transmitting antenna means adapted to be positioned adjacent the
external ear of the subject for radiating said excitation
signal;
and wherein said receiving means for receiving and applying said
excitation signal to said conductors comprises;
receiving antenna means adapted to be positioned under the skin
adjacent said external ear; and
a pair of electrical leads connected between said receiving antenna
means and said conductors.
5. Apparatus according to claim 4 wherein said receiving antenna
means is connected via said electrical leads to said conductors,
said receiving antenna means and said leads being imbedded within a
resilient material, said receiving antenna means being adapted to
be implanted between the skin and the temporal bone of the skull,
posterior to the ear of the subject, and wherein said transducer
means and said transmitting antenna means are positioned exterior
to the skin, said transmitting antenna means being adapted to be
positioned posterior to said ear adjacent to said receiving antenna
means.
6. Apparatus according to claim 4 wherein said transmitting means
further comprises:
means for generating a carrier signal having a frequency outside of
the audio spectrum, said carrier signal being coupled to said
transmitting antenna means; and
means for modulating said carrier signal with said electrical
excitation signal; and wherein said means for receiving and
applying said excitation signal to said conductors further
includes:
tuned circuit means having a resonant frequency corresponding to
the frequency of said carrier signal; and
means coupled between said tuned circuit means and said pair of
electrical leads for demodulating said carrier signal and for
applying said excitation signal to said electrical leads.
7. Apparatus according to claim 6 wherein said modulator means is
an amplitude modulator and wherein said means for demodulating
comprises:
a diode coupled between said tuned circuit means and said pair of
electrical leads.
8. Apparatus according to claim 6 wherein said tuned circuit means,
said demodulator means and said receiving antenna means are formed
on a microelectronic substrate.
9. Apparatus according to claim 2 wherein said transmitting means
comprises:
permanent magnet means permanently attached to the stapes of the
auditory ossicles of the subject; and wherein said receiving means
includes,
an inductive pick-up coil imbedded within said resilient base
member and connected to said conductors, said inductive pick-up
coil being positioned adjacent said permanent magnet.
10. Apparatus according to claim 2 wherein said conductors are
flexible and are imbedded within said base member in side-by-side
relationship proximate to the basilar membrane of the cochlea.
11. Apparatus according to claim 10 wherein a portion of each said
conductor projects beyond the outer periphery of said base
member.
12. Apparatus according to claim 10 wherein said conductors are
positioned on opposite sides of said base member.
13. Apparatus according to claim 2 wherein each of said conductors
includes
multiple point contacts imbedded within said base member, said
point contacts being arranged along a line adapted to extend
parallel to the length of the basilar membrane within the cochlea;
and
a conductive coating on the surface of said base member, said point
contacts being in electrical contact with said coating.
14. Apparatus according to claim 2 wherein said receiving means
applies a potential of at least 0.05 volts across said
conductors.
15. Apparatus for inducing sensations of hearing in a human subject
comprising
elongate electrode means adapted to be positioned in a cochlea of
the subject, lengthwise of a portion of the lower scala, responsive
to an alternating electrical excitation signal for applying a
uniform electrical field to stimulate auditory nerve endings
located along a corresponding lengthwise portion of the basilar
membrane to which said electrode means is proximate, and
generator means for inductively coupling to said electrode means an
alternating electrical excitation signal which is an analog of an
audio signal.
16. The apparatus of claim 15 wherein said electrode means includes
an elongate curved resilient base member and a pair of elongate
conductors secured to said base member lengthwise thereof whereby
said conductors are positioned lengthwise of the cochlea.
17. The apparatus of claim 16 wherein said generator means includes
first means adapted to be implanted under the skin of the subject
for applying said excitation signal to said conductor; and
second means responsive to said audio signal for inductively
coupling said excitation signal to said first means.
18. The apparatus of claim 16 wherein each of said conductors
comprises an elongate member adapted to extend parallel to the
length of the basilar membrane and wherein said generator means
generates a uniform field along a substantial portion of said
basilar membrane.
19. Apparatus according to claim 16 wherein said generating means
is operative to generate a uniform field along a substantial
portion of said basilar membrane.
20. A method for inducing the sensation of hearing in a human
subject comprising:
positioning an electrode within the cochlea, said electrode
including a base member and a pair of conductors retained upon said
base member said electrode being positioned with said conductors
extending longitudinally along a portion of the chamber; and
inductively coupling an electrical excitation signal being an
analog of an externally generated audio signal to said
conductors.
21. The method of claim 20 wherein a potential of not less than
about 0.05 volts is impressed across said conductor.
22. The method of claim 20 wherein the step of inductively coupling
an electrical excitation signal to said conductors comprises:
implanting a receiving antenna under the skin adjacent the external
ear;
connecting said receiving antenna to said conductors;
positioning a transducer externally of the skin, said transducer
converting said externally generated audio signal into said
electrical excitation signal;
coupling the output of said transducer to a transmitting antenna;
and
positioning said transmitting antenna externally of the skin
adjacent the external ear adjacent said receiving antenna.
23. The method of claim 22 wherein the step of coupling the output
of said transducer to a transmitting antenna comprises:
generating a carrier signal having a frequency outside of the audio
spectrum;
coupling said carrier signal to said transmitting antenna;
modulating said carrier signal with said electrical excitation
signal; and wherein said step of connecting said receiving antenna
to said conductors comprises:
connecting said receiving antenna to a tuned circuit having a
resonant frequency corresponding to the frequency of said carrier
signal;
demodulating said carrier signal; and
coupling said demodulated carrier signal to said electrical
leads.
24. The method of claim 20 wherein the step of inductively coupling
an electrical excitation signal to said conductors comprises:
attaching a permanent magnet to the stapes of the auditory
ossicles;
embedding an inductive pick-up coil within said base member;
connecting said inductive pick-up coil to said conductors; and
positioning said inductive pick-up coil adjacent said permanent
magnet.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a prosthetic device for the deaf
and, more particularly, to a method and means for inducing the
sensation of intelligible hearing, by direct electrical excitation
of the auditory nerve endings distributed along the basilar
membrane within the cochlea, in people suffering from sensory
deafness. This condition is untreatable by acoustic amplification
or bone conduction.
2. Description of the Prior Art
The fundamentals of the hearing process, whereby the vibrations of
the surrounding air called "sound" are sensed by the auditory
system and transmitted to the brain, are well defined. For present
purposes, such hearing process may be briefly described as follows:
The auditory system may be divided into its three component parts,
namely the external, the middle and the internal ear. The external
ear is outermost and includes the auricle attached to the side of
the head and the external auditory meatus. Sound vibrations in the
air are focused by the auricle and conveyed to the opening of the
external ear canal which transmits such vibrations to the tympanic
membrane which seals the inner end of the auditory meatus and forms
the dividing line between the external and middle ears.
The middle ear is positioned within a space in the temporal bone of
the skull and serves to transmit the vibratory movements of the
tympanic membrane to the internal ear. The middle ear includes a
series of bones called the "auditory ossicles" which include the
malleus, or hammer; the incus, or anvil; and the stapes or stirrup.
The hammer is directly attached to the tympanic membrane whereas
the stirrup is attached to a membrane positioned in a minute
opening, called the "oval window" in the bony area containing the
internal ear. The auditory ossicles are interconnected so that the
vibratory movements of the tympanic membrane are transmitted to the
oval window, and sound is thus transmitted from the external to the
inner ear.
The portion of the inner ear specifically concerned with hearing
consists of the cochlea, a long, narrow duct within the temporal
bone, which is wound spirally around its axis for approximately two
and one-half turns. The cochlea is divided by a pair of membranes
extending longitudinally therethrough into an upper, a middle and a
lower scala. The oval window presents an opening into the upper
scala, an additional minute opening, called the "round window",
providing an opening into the lower scala, the round window being
closed by a membrane. The cochlea is filled with a fluid, the
perilymph, which is free to circulate through the upper and lower
scalas which are interconnected at the apex of the cochlea.
The membrane between the middle scala and the lower scala, called
the "basilar membrane", extends the entire length of the cochlea
duct. The auditory pathways from the cochlea terminate in the
cerebral cortex of the brain. The auditory nerve endings,
distributed along the basilar membrane, are in direct functional
connection with the hair cells contained in the middle scala.
The vibratory movements of the tympanic membrane which are
transmitted by the auditory ossicles to the oval window are
distributed through the cochlea fluid throughout the cochlea. This
vibratory input manifests itself in an alternating electrical field
within the structure of the cochlea (which electrical field appears
and has been detected at the round window). This electrical field
(generated by the hair cells) is sensed by the nerve endings in the
basilar membrane and transmitted via the auditory nerve to the
cerebral cortex of the brain which interprets such electrical
signals as sound.
The loss of hearing, or a decrease in hearing sensitivity, may
result from damage or abnormalities in the external, the middle or
the internal ear. Where the hearing problem is a loss of
sensitivity, the problem is usually solved by the use of a
conventional hearing aid which simply amplifies the sound before
transmission to the tympanic membrane. On the other hand, where
hearing sensitivity is reduced to a point where additional
amplification or bone conduction is useless, such conventional
hearing aids are incapable of generating the sensation of
hearing.
Where total loss of hearing is due to malfunctions in the external
or middle ear, such as a stiffening of the tympanic membrane or an
improper functioning of the auditory ossicles, hearing can usually
be restored through surgical procedures whereby either the tympanic
membrane or one or more of the auditory ossicles are replaced by
man-made or human substitutes. However, the total loss of hearing
as a result of difficulty in the external or middle ear represent a
minority of actual cases. The majority of instances of total loss
of hearing results from either sensory or neural deafness. In the
former case, deafness results from a reduction in the sensitivity
of the cochlea in the internal ear which may be caused, for
example, from a loss of hair cells, a chemical change in the
perilymph, etc. In the latter case, deafness results from damage to
the auditory nerve itself, either through disease or physical
rupture. In either case, where total deafness results, such that a
conventional amplifying hearing aid is useless, no technology
presently exists for successfully restoring the sensation of
hearing.
Regarding the prior art which is considered to be relevant to the
instant invention, reference is made to an article by Robin P.
Michelson entitled "The Crossed Cochlea Effect", published in the
Transactions of the American Laryngological, Rhinological and
Otoligical Society, pp. 626 to 644, 1968. In this publication
Michelson describes experiments conducted to determine the extent
of auditory reflexes in cats in order to obtain a better
understanding of certain auditory functions and their interactions.
In the experiments in audio signal (sound pressure signal) was
applied to one ear of each cat and monitored by a cochlear
microphonic electrode in the same ear. The signal was modified by
an electrical stimulation in the contralateral ear. The purpose was
to determine the levels of electrical stimulation in the
contralateral ear which might suppress the cochlear microphonic
signal in the acoustically stimulated ear. These levels were found
to be approximately 250 microvolts to 2 millivolts. The center
frequency of the tuning curve indicated a minimum stimulation or
threshold level for acoustic reflex in the range of 250 to 500
microvolts. These stimulation levels are of the same order as the
cochlear microphonic, i.e., the naturally generated electrical
signal within the cochlea. Through these experiments it was
demonstrated that there is an acoustic reflex ineraction between
the two ears of a cat. The acoustic reflex, however, it not the
same as the sensation of hearing. The experiments, therefore, did
not demonstrate that the cats were actually hearing an audio
signal. In fact, as will appear from the description hereinafter,
the electrical and sound pressure stimuli used in these experiments
was well below the minimum perception threshold required for the
cats to hear.
The present invention involves the use of electrical stimulation of
the auditory organ to produce hearing in the deaf. Reference is
made to a second article by Robin P. Michelson entitled "Electrical
Stimulation of the Human Cochlea in Sensory Deafness," published in
Archieves of Otolaryngology, March 1971, Vol. 93, pp. 317-323,
which describes the efforts of other scientists prior to the
present invention to produce hearing by electrical stimulation of
the auditory organ, as well as results achieved with the use of the
present invention. This article refers to an implanted electrode
system developed by James H. Doyle, which system is described in
detail in U.S. Pat. No. 3,449,768. Doyle utilizes what he calls a
"neural potential generator" which produces 1 KHz clock pulses
modulated in amplitude and width to create a complex modulation
scheme which is intended to duplicate the firing rates and
potentials of the neurons along the basilar membrane. A complex
electrode is utilized consisting of a multiplicity of wires driven
from a subcutaneous transformer in a unipolar manner from ground
plane to the individual electrode wires. The electrode is so
dimensioned that once it is inserted in the lower scala it is free
to move therein. Thus, the pulses produced by the neural potential
generator are distributed in a random fashion along the basilar
membrane without regard for the place frequency relationship. The
place frequency relationship, first discovered by Von Bekesy,
simply states that particular portions along the basilar membrane
are related to specific frequencies. The area of the basilar
membrane closest to the round window is associated with the high
frequencies. The opposite end of the basilar membrane near the
helicatrima is associated with the low frequencies. Doyle states
that his patients heard the carrier frequency produced by the
neural potential generator. The Doyle system has not been
successful in inducing the sensation of intelligible hearing.
SUMMARY OF THE INVENTION
In accordance with the present invention, there is disclosed a
method for inducing the sensation of intelligible hearing by direct
electrical stimulation of the auditory nerve endings of the
auditory nerve. Since the present technique completely by-passes
the external and middle ears and the hair cells of the inner ear,
it is possible to induce the sensation of intelligible hearing in
the absence of these structures. Thus, the present invention may be
effectively used to induce the sensation of hearing in people
suffering from deafness caused by abnormalities in any of these
areas. However, the primary use will be in cases of sensory
deafness which has, heretofore, been untreatable.
Briefly, the sensation of hearing is induced by positioning an
electrode within the lower scala of the cochlea, such electrode
being surgically inserted through the round window. The electrode
consists of a resilient base member shaped to conform to the inner
surface of the lower scala, such base member extending along the
basilar membrane. The base member retains a pair of conductors
which extend parallel to the length of the basilar membrane. Means
are also provided for transmitting an excitation signal to a
receiver implanted with and connected to the conductors. The
excitation signal creates an electrical field between the
conductors. This field is transmitted through the conductive
cochlea fluid to the nerve endings in the basilar membrane, thus
replacing the naturally generated auditory electric field.
It is therefore an object of the present invention to provide a
prosthetic device for the deaf.
It is a further object of the present invention to provide a method
and apparatus for inducing the sensation of hearing in individuals
suffering from total or near total sensory deafness.
It is a still further object of the present invention to provide a
method and apparatus for inducing the sensation of hearing by
electrical stimulation of the nerve endings of the auditory
nerve.
It is another object of the present invention to provide a method
and apparatus for inducing the sensation of hearing by positioning
an electrode within the lower scala of the cochlea and coupling
electrical excitation signals to such electrode so as to directly
stimulate the nerve endings of the auditory nerve distributed along
the basilar membrane within the cochlea.
It is still another object of the present invention to provide
means for exciting an intra-cochlear electrode.
Another object of the present invention is the provision of an
intra-cochlear electrode which may be used to stimulate the nerve
endings of the auditory nerve.
Still other objects, features and attendant advantages of the
present invention will become apparent to those skilled in the art
from a reading of the following detailed description of the
preferred embodiments constructed in accordance therewith, taken in
conjunction with the accompanying drawings wherein like numerals
designate like parts in the several figures and wherein:
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a block diagram showing the fundamental elements of the
hearing process;
FIG. 2 is an enlarged, front elevation view, partly in section, of
the human cochlea;
FIG. 3 is an enlarged, cross-sectional view taken along the line
3--3 in FIG. 2;
FIG. 4 is an enlarged, front elevation view of a first embodiment
of intra-cochlear electrode;
FIG. 5 is a cross-sectional view taken along the line 5--5 in FIG.
4;
FIG. 6 is a cross-sectional view of the lower scala of the cochlea,
similar to FIG. 3, showing the intra-cochlear electrode of FIGS. 4
and 5 in place;
FIGS. 7, 8 and 10 are front elevation views, partly in section, of
alternate forms of intra-cochlear electrodes;
FIGS. 9 and 11 are cross-sectional views taken along the lines 9--9
and 11--11, respectively, in FIGS. 8 and 10, respectively;
FIG. 12 is a block diagram of a preferred embodiment of apparatus
for exciting an intra-cochlear electrode;
FIG. 13 is a circuit diagram of a preferred embodiment of the
receiving elements of the circuit of FIG. 12;
FIG. 14 is a view showing the physical configuration of a preferred
embodiment of electrode and receiver; and
FIG. 15 is a pictorial representation of an alternate embodiment of
means for exciting an intra-cochlear electrode.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring now to the drawings and, more particularly, to FIG. 1
thereof, there is shown, in block diagram form, the fundamental
elements of the hearing process. Sound vibrations caused by an
external sound pressure generator 10 set the air in motion
producing spherical pressure waves 11. Pressure waves 11 are caught
by the external ear 12 and transmitted to the tympanic membrane 13
which is displaced in response to such waves. The vibratory
movements of the tympanic membrane 13 are transmitted via the
auditory ossicles 14 to the oval window of the cochlea 15. Air
cells within cochlea 15 function as a transducer to generate an
alternating electrical field within cochlea 15. This electrical
field is sensed by the nerve endings distributed through the
basilar membrane and transmitted via the auditory nerve 16 to the
celebral cortex 17 of the brain, which interprets such electrical
signals as sound.
Referring now to FIGS. 2 and 3, the cochlea 15 is a long, narrow
duct within the temporal bone which is wound spirally around its
axis for approximately 21/2 turns. The cochlea is divided by a pair
of membranes 21 and 22, extending longitudinally therethrough, into
an upper scala 23, a middle scala 24 and a lower scala 25. The oval
window 26, which is sealed by a membrane in contact with the
stirrup of the auditory ossicles, presents an opening into upper
scala 23. The round window 27, which is also closed by a membrane,
provides an opening into lower scala 25. Cochlea 15 is filled with
a fluid, the perilymph, which is free to circulate through upper
scala 23 and lower scala 25 which are interconnected at the apex 28
of cochlea 15.
Membrane 21 between middle scala 24 and lower scala 25, called the
basilar membrane, extends the entire length of cochlea 15. The
auditory nerve 16 of the brain terminates in cochlea 15 and the
nerve endings are distributed along basilar membrane 21. Minute
hair cells 29 extend from basilar membrane 21 into middle scala
24.
The vibratory movements of tympanic membrane 13, which are
transmitted by auditory ossicles 14 to oval window 26, are
distributed through the cochlea fluid throughout cochlea 15. This
vibratory input manifests itself in an alternating electrical field
within the structure of the cochlea (which electrical field appears
and has been detected at round window 27). This electrical field
(generated by hair cells 29) is sensed by the nerve endings of the
auditory nerve in basilar membrane 21 and transmitted via the
auditory nerve 16 to the cerebral cortex 17 of the brain which
interprets such electrical signals as sound.
Where total loss of hearing results from sensory deafness, i.e. a
reduction in the sensitivity of the cochlea, no method or apparatus
presently exists for restoring the sensation of hearing. However,
in accordance with the present invention, it has been discovered
that the sensation of hearing in people suffering from sensory
deafness can be induced by direct electrical excitation of the
auditory nerve endings distributed along basilar membrane 21 within
cochlea 15 by using a bipolar electrode in the lower scala without
the necessity of a complex encoding system such as disclosed in
Doyle.
Referring now to FIGS. 4-6, direct electrical excitation of the
auditory nerve endings within cochlea 15 is achieved by use of an
intra-cochlear electrode, generally designated 30. The body 31 of
electrode 30 is molded of a medically acceptable resilient
material, such as silicone or other rubber or plastic material,
which is of such a shape as to fit through round window 27 and into
lower scala 25 of cochlea 15. Body 31 of electrode 30 includes a
notch 32 which is designed to fit the round window margin and
retain body 31 within lower scala 25 of cochlea 15. Electrode 30
further comprises a pair of gold or other suitable inert conductors
33 and 34 which are imbedded in and retained by base member 31.
External leads 35 and 36 are connected to the ends of conductors 33
and 34, respectively, whereby leads 35 and 36 supply electrical
signals to contacts 33 and 34, respectively. Body 31 may also
include a stiffening member (not shown) imbedded therein, such as a
strand of wire, to obtain the desired degree of resiliency.
As described more fully hereinafter, and as shown in FIG. 6,
electrode 30 is inserted through round window 27 of cochlea 15 into
lower scala 25 where it extends along the basilar membrane for
approximately three-fourths of a turn thereof. According to the
embodiment of FIGS. 4-6, conductors 33 and 34 are positioned
side-by-side, adjacent basilar membrane 21, each of conductors 33
and 34 extending parallel to the length of membrane 21. In
addition, the shape of base member 31 is such so as to provide a
space between the surface 37 thereof opposite conductors 33 and 34
and the wall of lower scala 25 to permit circulation of the cochlea
fluid through lower scala 25 as well as a fluid escape path during
insertion.
With an electrical excitation signal applied to conductors 33 and
34 via leads 35 and 36, respectively, a uniform alternating
electrical field is generated therebetween. Because of the position
of the conductors 33 and 34 in the lower scala, the electrical
field generated therebetween is applied so as to allow place
frequency selection to take place unlike the Doyle system. This
field is tramsmitted through the conductive cochlea fluid to the
nerve endings in basilar membrane 21, thus replacing the naturally
generated auditory electric field. The electric field generated by
conductors 33 and 34 is sensed by the nerve endings distributed
along the basilar membrane 21 and conducted via the auditory nerve
16 to the cerebral cortex 17 of the brain which interprets such
electrical signals as sound.
According to a preferred embodiment of the present invention, and
as shown in FIGS. 4-6, conductors 33 and 34 are made from 2 mil
gold wire wound on a 5 mil mandrel for approximately 30 turns.
Conductors 33 and 34 so formed are inserted into notches in base
member 31 so as to slightly extend beyond the outer periphery of
base member 31. The conductors are then imbedded within base member
31 by filling such notches with additional resilient material.
Three to five strands of 2 mil gold wire may serve as leads 35 and
36 for conducting an electrical excitation signal to conductors 33
and 34. In addition, as explained previously, conductors 33 and 34
extend parallel to the length of basilar membrane 21 for
approximately three-fourths of a turn. This affords conductive
means along a substantial length of basilar membrane 21, thereby
exciting a relatively large frequency spectrum. More specificially,
it has been found through experimentation that the nerve endings
within basilar membrane 21 are frequency selective. The nerve
endings adjacent round window 27 respond to frequencies at the high
end of the audio spectrum and decrease in frequency sensitivity as
the apex 28 of cochlea 15 is approached. Accordingly, by extending
conductors 33 and 34 for a substantial length along basilar
membrane 21, a relatively large frequency spectrum may be
excited.
Referring now to FIG. 7, there is shown an alternate embodiment for
an intra-cochlear electrode, generally designated 40. The external
configuration of electrode 40 is identical to the external
configuration of electrode 30 and includes a base member 41
composed of medically acceptable resilient material. Imbedded
within base member 41 are a pair of inert conductors 42 and 43
which are positioned on opposite sides of base member 41, rather
than being adjacent, on the same side as in the case of electrode
30. However, in spite of this different placement of conductors 42
and 43, the operation of electrode 40 is identical to the operation
of electrode 30. In addition, external lead wires 44 and 45 are
connected by weld, pressure form or solder to one end of conductors
42 and 43, respectively. A notch 46 is also provided for retaining
electrode 40 within cochlea 15 by pressure fit with the round
window margin.
Other configurations of intra-cochlear electrodes suitable to other
manufacturing methods are shown in FIGS. 8-11. In FIGS. 8 and 9, an
intra-cochlear electrode, generally designated 50, includes a base
member 51 and multiple point contacts 52 and 53 plus gold flashing
54 and 55 over the length of base member 51 on opposite sides
thereof. Vacuum deposition or other attachment means may be used
for attaching the gold flashing. Lead wires 56 and 57 are connected
to the multiple point contacts 52 and 53, respectively, to conduct
electrical excitation signals to gold flashing 54 and 55,
respectively.
In FIGS. 10 and 11, an intra-cochlear electrode, generally
designated 60, includes a base member 61 and large, flexible
conductors 62 and 63 imbedded directly within base member 61 plus
flashed or vacuum deposited gold or platinum surfaces 64 and 65
positioned on the surface of base member 61 on opposite sides
thereof. As before, a pair of lead wires 66 and 67 conduct
electrical excitation signals to conductors 62 and 63,
respectively.
Once intra-cochlear electrode 30, 40, 50 or 60 is positioned within
lower scala 25 of cochlea 15, as will be explained more fully
hereinafter, there must then be provided a means for coupling
electrical signals to the conductors thereof. The problem with
inducing electrical signals within the cochlea is, of course, the
fact that no orifices are available for ready access to the
tympanic cavity. The cochlea is well shielded within the heavy bony
structure of the skull so that no direct entrance is possible
without risk of infection. The problem then become one of coupling
electrical signals to the electrode within the cochlea without the
use of normal wire conductive means.
Referring now to FIG. 12, there is shown a preferred embodiment of
apparatus for exciting an intra-cochlear electrode. In this
embodiment of FIG. 12, the vibrations of the surrounding air are
sensed by a microphone 70 which converts the mechanical vibrations
to an electrical signal in the audio spectrum which is applied to a
preamplifier 71. The output of preamplifier 71 is applied via a
tone control network 72, to be described more fully hereinafter, to
a modulator 73. Modulator 73 is operative to modulate the output of
a combination oscillator V.H.F. transmitter 74. The output of
oscillator/transmitter 74 is applied to an antenna 75 which, in its
preferred form, is an inductive coil. The transmitting network,
consisting of elements 70-75, may be mounted externally of the body
to sense the sound waves and convert such sound waves into a
modulated R.F. signal. This modulated R.F. signal is sensed by a
receiving antenna 76, which may also be an inductive coil, and
applied to a receiver 77. The output of receiver 77 is demodulated
by a demodulator 78 to restore the original audio excitation signal
appearing at the output of tone control network 72. Finally, the
output of demodulator 78 is applied to an intra-cochlear electrode
79.
The transmitting network consisting of elements 70 through 75 may
have any suitable configuration since elements 70-75 are positioned
externally of the body, as will be explained more fully
hereinafter, and size and complexity are not problems. On the other
hand, since components 76-78 will be positioned internally of the
body with electrode 79, they should be as simple as possible. A
preferred configuration for elements 76-78 is shown in FIG. 13.
Referring now to FIG. 13, receiver 77 may comprise a tuned circuit
consisting of inductive coil 76 and a capacitor 81 tuned to the
frequency of oscillator/transmitter 74. In the case where modulator
73 is an amplitude modulator, demodulator 78 may simply comprise a
diode connected to one side of capacitor 81. The output of diode 82
may be shunted by a capacitor 83 and conducted via resistors 84 and
85 and a lead 87 to one conductor of electrode 79. An additional
diode 86 shunts the junction between resistors 84 and 85, the other
side of capacitor 81 being connected via a lead 88 to the other
conductor of electrode 79. In such circuit, capacitor 83 and
resistor 84 act as a filter and current limiter, respectively.
Diode 86 is a noise limiting diode such that noise peaks occurring
due to electromagnetic discharges can be limited by forward
conduction of diode 86. Resistor 85 also acts as a current limiting
resistor in feeding the audio signal to electrode 79.
Referring now to FIG. 14, the physical configuration of a preferred
embodiment of the present invention is shown. Intra-cochlear
electrode 79 is made integral with a continuous length 90 of
medically acceptable resilient material in which leads 87 and 88
are imbedded. One end of leads 87 and 88 are connected to the
conductors within electrode 79 whereas the other ends of leads 87
and 88 are connected to a small integrated circuit chip or
substrate 91 carrying the inductors, capacitors, resistors and
diodes. Included with chip 91 is receiving coil 76. Chip 91 is also
imbedded within the resilient material. This entire structure,
generally designated 92, would then be implanted "in vivo". A
typical surgical procedure is as follows: The patient is placed on
an operating table with the appropriate ear in a horizontal
position exposed in a sterile field. The auricle is folded
forwardly and clamped in position and an incision made posterior to
the ear. Entry to the middle ear is gained by elevating the skin
along the auditory meatus which permits a direct by-pass of the
tympanic membrane. With the skin along the auditory meatus and the
tympanic membrane elevated, visual contact may be made with the
middle ear and the oval and round windows at the entrance to the
cochlea. A bony promontory protruding above the round window is
then removed to permit free access to the round window. The round
window membrane is then removed and a portion of the upper margin
excavated for easy access to the lower scala. Electrode 79 is then
inserted through the round window such that the electrode
conductors lay in close proximity to the basilar membrane between
the lower scala and the scala media. Electrode 79 is inserted into
the lower scala until the notch therein slips into the round window
margin. A channel is then excavated in the bony structure along the
auditory canal for ocation of material 90 containing leads 87 and
88, material 90 then being sutured into position. The elevated skin
along the auditory canal is then carefully returned to its original
position and the canal packed to assure proper adhesion.
The skin posterior to the incision is elevated and a small portion
of the muscular structure attached to the skull removed to receive
chip 91 which is then sutured in place. A pair of test leads 93 and
94, as shown in FIG. 14, are connected directly to leads 87 and 88
and extend outwardly from material 90 adjacent chip 91. Test leads
93 and 94 are brought out through the incision. The transmitting
network is then activated and a signal transmitted to receiver 77.
The voltage across the intra-cochlear electrode is monitored on an
oscilloscope via test leads 93 and 94 to insure operability. After
the electrode is tested and found operative, test leads 93 and 94
are clipped and the incision sutured. The external ear is then
returned to its normal position and the surgical procedure is
completed.
With the surgical procedure completed, receiver 77 and antenna 76
in chip 91 are positioned immediately posterior to the ear close to
and under the skin. A unit may then be mounted behind the ear, such
unit including microphone 70, oscillator/transmitter 74 and
transmitting antenna 75. The output of microphone 70 may be
conducted through electrical leads to a pocket-carried unit
containing preamplifier 71, tone control network 72, modulator 73
and a suitable power supply (not shown). The output of modulator 73
is then coupled back to the ear-mounted unit to
oscillator/transmitter 74 and transmitting antenna 75. In this
manner, transmitting and receiving antennas 75 and 76 will be
positioned in close proximity to each other, only a thin layer of
skin separating the two elements. As a result, the current passing
through antenna 75 is induced in antenna 76 and applied to receiver
77.
With the elements so positioned, operation is as described
previously with respect to FIGS. 12 and 13. In summary, the
vibrations of the surrounding air are sensed by microphone 70 and
converted to an amplified, shaped, modulated R.F. signal by
components 71-74. The modulated signal is transmitted by antenna 74
to antenna 76 where receiver 77 and demodulator 78 reproduce the
original audio excitation signal and apply it via leads 87 and 88
to electrode 79. With such electrical excitation signal applied to
electrode 79, an electric field is generated between the conductors
thereof. The electrical field so generated varies in amplitude
proportioned to the pressure vibrations of the surrounding air,
i.e., the audio signal to be heard. In other words, such field is
an analog of the audio signal to be heard. The field generated
between the conductors of electrode 79 is transmitted through the
conductive cochlea fluid to the nerve endings in the basilar
membrane, thus replacing the naturally generated auditory electric
field. The electric field so generated is sensed by the nerve
endings distributed along the basilar membrane and conducted via
the auditory nerve to the cerebral cortex of the brain which
interprets such electrical signals as sound.
Tone control network 72 is provided to shape the frequency spectrum
of the signal applied to electrode 79, if desired. More
specifically, initial tests with the present system have shown that
it is not easy and, as a matter of fact, quite difficult, for a
patient who has never heard to properly interpret the electrical
stimulus now being applied to the auditory nerve endings. For this
reason, it has been necessary to initially shape the frequency
spectrum applied to a particular patient to correspond to stimuli
his brain is capable of interpreting. As the patient gains
experience in interpreting the signals applied to his cochlea, the
frequency spectrum of the applied signal is slowly increased.
Accordingly, tone control 72 is inserted between preamplifier 71
and modulator 73 to provide the desired shaping of the applied
excitation signal.
The above-described system, including the intra-cochlear electrode
shown in FIG. 4 and the electronics described with respect to FIGS.
12-14 have been tested by implantation in selected patients at
Sequoia Hospital, Redwood City, California. The surgery has been
performed by Dr. Robin P. Michelson. In one such implant procedure,
the surgical approach was identical to that described hereinbefore.
The patient was tested the following day by transmitting signals to
the receiver and then in turn to the electrode. The patient
exhibited the ability to distinguish tones over the frequency range
125 Hz to 4,000 Hz. His frequency discrimination at one octave
steps from 250 Hz to 4,000 Hz was excellent. He exhibited amplitude
discrimination of pure tones with a calculated change of less than
2 db. The patient further exhibited a dynamic range, i.e. threshold
to maximum listening level, of approximately 10 db. He was given a
Spondee Test and was able to recognize 6 of 35 words. The patient's
previous score on this test with a hearing aid was zero. In further
tests on this patient, transmitting to the patient a random series
of the numbers one through 10, the patient is presently capable of
correctly distinguishing the numbers approximately 65 percent of
the time. In a second patient, where a similar implant procedure
has been performed, such patient is capable of distinguishing a
random series of the numbers one through ten approximately 90-95
percent of the time.
Several other configurations of excitation means are possible. With
respect to the embodiment of FIG. 12, modulator 73 need not be an
amplitude modulator but may be a frequency modulator, a pulse-width
modulator or any other conventional form of modulator. In addition,
it is theoretically possible to completely eliminate the use of a
modulator. More specifically, the output of tone control network 72
may be applied directly to transmitting coil 75. Receiving coil 76
would then be connected directly to leads 87 and 88 of electrode
79, although filtering and noise and current limiting components
may be employed. In other words, it is theoretically not necessary
to modulate the audio signal on an R.F. carrier and then demodulate
the signal, but rather the audio signal may be directly applied to
receiving antenna 76 and electrode 79. The potential difficulty
with this approach is possible patient sensitivity to random audio
frequency noise in the atmosphere so that the modulation approach
is preferred.
Referring now to FIG. 15, there is shown a still further embodiment
of a means for exciting an intra-cochlear electrode where the
auditory ossicles are intact. As explained previously, the tympanic
membrane 101 couples sound vibrations through the hammer 102, the
anvil 103 and the stirrup 104 to the membrane at the oval window of
the cochlea. Accordingly, a small, permanent magnet 105 may be
attached to the stirrup 104, as shown. An audio pick-up coil 106
may then be imbedded within the base of an intra-cochlear electrode
108 and connected via leads 107 to the conductors thereof. Coil 106
would be sutured adjacent or surrounding magnet 105.
In operation, motion of permanent magnet 105 in proximity to coil
106 induces an d.m.f. within coil 106. This e.m.f. is then carried
by leads 107 to the electrode and presented to the basilar membrane
between the scala media and the lower scala within the cochlea. The
conversion of this e.m.f. to sound would then be as described
previously.
In tests which have been conducted on human patients it has been
found that the threshold of auditory perception under electrical
stimulation is a function of frequency. The voltage measured across
the conductors of the intra-cochlear electrode which is required to
stimulate auditory perception increases as frequency increases. At
1 KHz, three patients exhibited a threshold of auditory perception
of approximately 0.5 volt while at 100 Hz, this threshold was
observed to be approximately 0.1 volt. At higher frequencies, in
the range of 2 to 5 KHz, stimulation levels as high as 1 volt were
required. It has been found that the minimum electrical stimulation
required for auditory perception in human patients is about 0.05
volt. Thus, in order to induce hearing in a human subject, it is
necessary that at least 0.05 volt be impressed across the
conductors of the intracochlear electrode of the present
invention.
Comparative tests between brain reception and electrical or
acoustical stimulation in cats and human subjects have been
recently conducted to determine the stimulation level required to
achieve equivalent hearing results. The brain reception of
electrical and acoustical stimulation in cats was determined by
recording the electrical response of the inferior colliculus, one
of the higher hearing centers in the brain, since obviously a cat
cannot relate to the investigator its level of auditory perception.
The test demonstrated that cats appear to show identical responses
from electrical and acoustical stimulation when stimulated at the
same level as human patients. Since the minimum auditory perception
threshold in humans is approximately 0.05 volt, it can be deduced
that a comparable minimum perception level occurs in cats. Because
the maximum electrical stimulation utilized in the previous tests
described in the aforementioned Michelson article entitled "The
Crossed Cochlea Effect" was 250 microvolts, it is apparent from the
comparative tests discussed hereinbefore that the cats used in the
previous tests could not hear at the levels of stimulation
utilized.
Therefore, and in accordance with the present invention, there is
disclosed a method and apparatus for including the sensation of
hearing by direct electrical stimulation of the auditory nerve
endings of the auditory nerve. Since the present technique
completely by-passes the external and middle ears and most of the
internal ear other than the basilar membrane, it may be effectively
used to induce the sensation of hearing in people suffering from
deafness caused by abnormalities in any of these areas. However,
the primary use will be in the case of sensory deafness which has,
heretofore, been untreatable.
In accordance with the present invention, the sensation of hearing
is induced by positioning an intra-cochlear electrode within the
lower scala of the cochlea, such electrode being surgically
inserted through the round window. The electrode includes a pair of
conductors which extend parallel to the length of the basilar
membrane. Means are disclosed for transmitting an excitation signal
to a receiver implanted with and connected to the conductors. Such
excitation signal creates a uniform, alternating electrical field
between the conductors, which electrical field is transmitted
through the conductive cochlea fluid to the nerve endings in the
basilar membrane, thus replacing the naturally generated auditory
electric field. The electrical field so generated is sensed by the
nerve endings distributed through basilar membrane 21 and conducted
via the auditory nerve to the cerebral cortex of the brain which
interprets such electrical signals as sound.
While the invention has been described with respect to the
preferred physical embodiments constructed in accordance therewith,
it will be apparent to those skilled in the art that various
modifications and improvements may be made without departing from
the scope and spirit of the invention. For example, although the
preferred embodiment of apparatus for generating an alternating
electrical field along the basilar membrane within the cochlea
comprises an electrode adapted to be positioned within the lower
scala of the cochlea, it will be appreciated by those skilled in
the art tht it is theoretically possible, although not presently
practical, to position an electrode within the upper scala or the
middle scala of the cochlea. Accordingly, it is to be understood
that the invention is not to be limited by the specific
illustrative embodiments, but only by the scope of the appended
claims.
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