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| United States Patent Application |
20050101878
|
| Kind Code
|
A1
|
|
Daly, Christopher Newton
;   et al.
|
May 12, 2005
|
Method and apparatus for measurement of evoked neural response
Abstract
The invention provides a method of electrical artefact compensation in
measurement of a neural response. The neural response is evoked by a
first stimulus, after which a compensatory stimulus is applied in order
to counteract a stimulus artefact caused by the first stimulus. The
invention also provides for short circuiting the stimulating electrode
subsequent to the first stimulus. A system for implementing such steps is
also provided. The invention may be of application in measurement of
physiological responses, including neural responses and in particular a
neural response of the auditory nerve.
| Inventors: |
Daly, Christopher Newton; (Bilgola Plateau, AU)
; Nygard, Tony Mikeal; (Kariong, AU)
; Eder, Helmut; (Lane Cove, AU)
|
| Correspondence Address:
|
CHRISTIE, PARKER & HALE, LLP
PO BOX 7068
PASADENA
CA
91109-7068
US
|
| Serial No.:
|
475141 |
| Series Code:
|
10
|
| Filed:
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October 17, 2003 |
| PCT Filed:
|
April 18, 2002 |
| PCT NO:
|
PCT/AU02/00500 |
| Current U.S. Class: |
600/559; 600/554 |
| Class at Publication: |
600/559; 600/554 |
| International Class: |
A61B 005/00; A61B 005/05 |
Foreign Application Data
| Date | Code | Application Number |
| Apr 18, 2001 | AU | PR 4462 |
| Aug 17, 2001 | AU | PR 7111 |
Claims
1. A method of electrical artefact compensation in measurement of a neural
response, the neural response evoked by a first stimulus, the method
comprising the step of: subsequent to the first stimulus, applying a
compensatory stimulus in order to counteract a stimulus artefact caused
by the first stimulus.
2. The method of claim 1 wherein the first stimulus comprises: a first
phase during which an electrical stimulus of first polarity is applied;
and a second phase, subsequent to the first phase, during which an
electrical stimulus of second polarity opposite to the first polarity is
applied.
3. The method of claim 2 wherein the first phase and second phase are
charge balanced.
4. The method of claim 2 or claim 3 wherein the compensatory stimulus is
of the first polarity.
5. The method of claim 1 wherein the compensatory stimulus is of
controlled profile and duration.
6. The method of claim 1 wherein the compensatory stimulus is adaptive,
whereby characteristics of the compensatory stimulus are chosen in order
to optimise the extent of cancellation of the artefact which exists
following the first stimulus.
7. The method of claim 6 further comprising the step of: determining
characteristics of the compensatory stimulus from a measured
effectiveness of a previously applied compensatory stimulus.
8. The method of claim 7 wherein the step of determining characteristics
of the compensatory stimulus is performed in an iterative manner, to
provide an ongoing optimisation of the compensatory stimulus, based on
the effectiveness of one or more previously applied compensatory stimuli.
9. The method of claim 7 or claim 8 wherein the measured effectiveness of
the previously applied compensatory stimulus is determined by: obtaining
at least one neural response measurement of an actual performance of the
previously applied compensatory stimulus; and comparing the actual
performance against a target performance, in order to determine an error
between the actual performance and the target performance.
10. The method of claim 9 wherein the step of measuring the actual
performance of the previously applied compensatory stimulus comprises:
(i) applying the first stimulus and the previously applied compensatory
stimulus, and subsequently obtaining a measurement comprising a first
plurality of temporally spaced neural samples from a sensor.
11. The method of claim 10 wherein the step of measuring the actual
performance of the previously applied compensatory stimulus further
comprises: (ii) repeating step (i) in order to obtain a second plurality
of measurements.
12. The method of claim 11 wherein the step of measuring the actual
performance of the previously applied compensatory stimulus further
comprises: (iii) discarding an initial number of said second plurality of
measurements to allow the sensor and other measurement components to
settle.
13. The method of claim 12 wherein the step of measuring the actual
performance of the previously applied compensatory stimulus further
comprises: (iv) taking an average of the remaining non-discarded
measurements of the second plurality of measurements, to obtain an
averaged measurement.
14. The method of claim 13 wherein the step of measuring the actual
performance of the previously applied compensatory stimulus further
comprises: (v) determining a stimulus artefact from the averaged
measurement, and assessing the performance of the previously applied
compensatory stimulus with reference to the determined stimulus artefact.
15. The method of claim 10 wherein step (i) comprises obtaining
substantially 64 neural samples at substantially 48 .mu.s intervals.
16. The method of claim 11 wherein step (ii) comprises obtaining
substantially 20 measurements.
17. The method of claim 16 wherein step (iii) comprises discarding
substantially the first 10 of said measurements.
18. The method of claim 14 wherein the step of determining the stimulus
artefact from the averaged measurement comprises determining a deviation
of the averaged measurement from a desired response.
19. The method of claim 7 wherein the step of determining characteristics
of the compensatory stimulus from the measured effectiveness of the
previously applied compensatory stimulus is performed by: determining an
incremental change to be made to characteristics of the previously
applied compensatory stimulus in order to reduce the error between the
actual performance and the target performance; and deriving the
characteristics of the compensatory stimulus by altering the
characteristics of the previously applied compensatory stimulus in
accordance with the incremental change.
20. The method of claim 19 wherein the incremental change is determined so
as to maximise a rate of convergence of the actual performance to the
target performance.
21. The method of claim 19 or claim 20 wherein the incremental change is
determined so as to minimise oscillation or overshoot of the actual
performance relative to the target performance.
22. The method of claim 1 wherein the compensatory stimulus comprises a
substantially rectangular pulse, whereby the amplitude and duration of
the pulse define an amount of charge to be inserted by the pulse.
23. A method of electrical artefact compensation in measurement of a
neural response, the neural response evoked by a first stimulus, the
method comprising: subsequent to the first stimulus, applying a
compensatory stimulus in order to counteract a stimulus artefact caused
by the first stimulus; the compensatory stimulus comprising a
substantially rectangular pulse, whereby the amplitude and duration of
the pulse define an amount of charge to be inserted by the pulse;
determining characteristics of the compensatory stimulus from the
measured effectiveness of the previously applied compensatory stimulus
by: determining an incremental change to be made to characteristics of
the previously applied compensatory stimulus in order to reduce the error
between an actual performance and the target performance; and deriving
the characteristics of the compensatory stimulus by altering the
characteristics of a previously applied compensatory stimulus in
accordance with the incremental change; and wherein the incremental
change defines a change in the amount of charge to be inserted by the
pulse which is required in order to improve the actual performance of the
compensatory stimulus compared to the target performance.
24. The method of claim 23 wherein, for a given charge to be applied by
the compensatory stimulus, the incremental change further defines whether
a relatively narrow pulse of relatively large amplitude should be applied
or whether a relatively broad pulse of relatively small amplitude should
be applied in delivering the required amount of charge by the
compensatory stimulus.
25. The method of claim 24 wherein the compensatory stimulus has a fixed
duration and a variable amplitude.
26. The method of claim 1 wherein the compensatory stimulus is completed
prior to an expected time of commencement of an electrically evoked
compound action potential.
27. The method of claim 1 wherein the neural response is the auditory
nerve neural response.
28. The method of claim 27 wherein the first stimulus is applied by an
auditory prosthesis.
29. The method of claim 28 wherein the auditory prosthesis comprises a
cochlear implant having an intra-cochlear electrode array including
electrodes used as stimulus electrodes and/or as sense electrodes.
30. The method of claim 29 wherein the first stimulus is applied by one or
more stimulus electrodes of the array.
31. The method of claim 30 wherein the compensatory stimulus is applied by
the one or more stimulus electrodes.
32. The method of claim 30 wherein the compensatory stimulus is applied by
one or more electrodes in the array other than the stimulus electrodes.
33. The method of claim 32 wherein additional compensatory stimuli are
applied by electrodes in close physical proximity to the stimulating
electrodes, substantially simultaneously with application of the
compensatory stimulus.
34. A method of electrical artefact compensation in measurement of a
neural response, the neural response evoked by a first stimulus applied
by at least one stimulating electrode, the method comprising the step of:
subsequent to the first stimulus, short circuiting at least each
stimulating electrode to an electrode reference voltage.
35. The method of claim 34 wherein the at least one stimulating electrode
is an electrode of an auditory prosthesis for stimulus of the auditory
nerve.
36. The method of claim 35 wherein the auditory prosthesis comprises an
electrode array having a plurality of electrodes.
37. The method of claim 36 wherein the electrode array comprises between
22 and 30 intra-cochlear electrodes.
38. The method of claim 36 or claim 37 wherein the method further
comprises the step of shorting electrodes in the array other than the
stimulating electrodes.
39. The method of claim 38 wherein the step of shorting electrodes in the
array other than the stimulating electrodes comprises shorting electrodes
in physical proximity to the stimulating electrodes.
40. (canceled)
41. A neural stimulus system operable to apply a first stimulus in order
to evoke a neural response, the neural stimulus system comprising means
for electrical artefact compensation in measurement of the neural
response, the means for electrical artefact compensation being operable
to apply a compensatory stimulus in order to counteract a stimulus
artefact caused by the first stimulus.
42. The neural stimulus system of claim 41 wherein measurement of the
neural response is performed by detection of a signal present on
designated sense electrodes.
43. The neural stimulus system of claim 42 wherein the sense electrodes
are distinct from the stimulus electrodes.
44. The neural stimulus system of any one of claims 41 to 43 wherein the
neural stimulus system is an auditory prosthesis.
45. The neural stimulus system of claim 44 wherein the auditory prosthesis
is a cochlear implant.
46. The neural stimulus system of claim 44 wherein the response measured
is the evoked compound action potential of the auditory nerve.
47. The neural stimulus system of claim 44 wherein the auditory prosthesis
comprises an array of intra-cochlear and extra-cochlear electrodes.
48. The neural stimulus system of claim 41 wherein the neural stimulus
system is operable to apply the first stimulus such that the first
stimulus comprises: a first phase during which an electrical stimulus of
first polarity is applied; and a second phase, subsequent to the first
phase, during which an electrical stimulus of second polarity opposite to
the first polarity is applied.
49. The neural stimulus system of claim 48 wherein the first phase and
second phase are charge balanced.
50. The neural stimulus system of claim 48 or claim 49 wherein the means
for electrical artefact compensation is operable to apply the
compensatory stimulus such that the compensatory stimulus is of the first
polarity.
51. The neural stimulus system of claim 41 wherein the means for
electrical artefact compensation is operable to control a profile and a
duration of the compensatory stimulus.
52. The neural stimulus system of claim 41 wherein the means for
electrical artefact compensation is operable to control characteristics
of the compensatory stimulus in order to optimise the extent of
cancellation of the stimulus artefact.
53. The neural stimulus system of any one claim 41 further comprising
means for measuring an effectiveness of a previously applied compensatory
stimulus.
54. The neural stimulus system of claim 53 wherein the means for measuring
an effectiveness of a previously applied compensatory stimulus comprises
means to obtain at least one neural response measurement of an actual
performance of the previously applied compensatory stimulus, and
comprises means to compare the actual performance against a target
performance, in order to determine an error between the actual
performance and the target performance.
55. The neural stimulus system of claim 54 wherein the means to obtain at
least one neural response measurement of an actual performance of the
previously applied compensatory stimulus is operable to obtain a
measurement comprising a first plurality of temporally spaced neural
samples from a sensor.
56. The neural stimulus system of claim 55 wherein the means to obtain at
least one neural response measurement of an actual performance of the
previously applied compensatory stimulus is operable to obtain a
measurement comprising substantially 64 neural samples spaced at
substantially 48 .mu.s intervals.
57. The neural stimulus system of claim 41 wherein the means for
electrical artefact stimulation is operable to apply the compensatory
stimulus such that the compensatory stimulus comprises a substantially
rectangular pulse.
58. The neural stimulus system of claim 57 wherein the means for
electrical artefact stimulation is operable to apply the compensatory
stimulus such that the compensatory stimulus comprises a substantially
rectangular pulse having a relatively narrow width and a relatively large
amplitude, and is also operable to apply the compensatory stimulus such
that the compensatory stimulus comprises a substantially rectangular
pulse having a relatively broad width and a relatively small amplitude.
59. The neural stimulus system of claim 41 wherein the neural response is
the auditory nerve neural response.
60. The neural stimulus system of claim 41 wherein the neural stimulus
system comprises an auditory prosthesis.
61. The neural stimulus system of claim 60 wherein the auditory prosthesis
comprises a cochlear implant having an intra-cochlear electrode array
including electrodes used as stimulus electrodes and/or as sense
electrodes.
62. The neural stimulus system of claim 61 wherein the first stimulus is
applied by the one or more stimulus electrodes.
63. The neural stimulus system of claim 62 wherein the compensatory
stimulus is applied by the one or more stimulus electrodes.
64. The neural stimulus system of claim 62 wherein the compensatory
stimulus is applied by one or more electrodes in the array other than the
stimulus electrodes.
65. The neural stimulus system of claim 41 further operable to apply one
or more additional compensatory stimuli.
66. A neural stimulus system comprising at least one stimulating electrode
operable to apply a first stimulus in order to evoke a neural response,
the neural stimulus system being operable to compensate for electrical
stimulus artefacts by short circuiting at least each stimulating
electrode to an electrode reference voltage.
67. The neural stimulus system of claim 66 wherein the neural stimulus
system is an auditory prosthesis for stimulus of the auditory nerve.
68. The neural stimulus system of claim 67 wherein the auditory prosthesis
comprises an electrode array having a plurality of electrodes.
69. The neural stimulus system of claim 68 wherein the electrode array
comprises between 22 and 30 intra-cochlear electrodes.
70. The neural stimulus system of claim 68 or claim 69 wherein the neural
stimulus system is further operable to short electrodes in the array
other than the stimulating electrodes.
71. (canceled)
72. A method of electrical artefact compensation in measurement of a
physiological response, the physiological response evoked by a first
stimulus, the method comprising the step of: subsequent to the first
stimulus, applying a compensatory stimulus in order to counteract a
stimulus artefact caused by the first stimulus.
73. The method of claim 34 wherein the step of short circuiting occurs
subsequent to the step of: delivering a compensatory stimulus in order to
counteract a stimulus artefact caused by the first stimulus.
74. The method of claim 73 wherein the step of short circuiting extends
for a relatively short time period immediately following the compensatory
stimulus.
75. The method of claim 74 wherein the step of short circuiting extends
for a period of substantially 1 .mu.s.
76. The neural stimulus system of claim 66 wherein the system is further
operable to apply a compensatory stimulus in order to counteract a
stimulus artefact caused by the first stimulus.
77. The neural stimulus system of claim 76 wherein the system is operable
to apply the compensatory stimulus after application of the compensatory
stimulus.
78. The neural stimulus system of any one of claims 66, 76 or 77 wherein
the system is operable to short circuit at least each stimulating
electrode to the electrode reference voltage for a relatively short
period of time.
79. The neural stimulus system of claim 78 wherein the system is operable
to short circuit at least each stimulating electrode to the electrode
reference voltage for substantially 1 .mu.s.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to a method and apparatus for
measuring the evoked responses of nerves to electrical stimulation, and
more particularly to a system and apparatus to assist recovery of such
data from an auditory prosthesis.
DESCRIPTION OF THE PRIOR ART
[0002] Cochlear implants have been developed to assist people who are
profoundly deaf or severely hearing impaired, by enabling them to
experience hearing sensation representative of the natural hearing
sensation. In most such cases, these individuals have an absence of or
destruction of the hair cells in the cochlea which naturally transduce
acoustic signals into nerve impulses which are interpreted by the brain
as sound. The cochlear implant therefore bypasses the hair cells to
directly deliver electrical stimulation to the auditory nerves with this
electrical stimulation being representative of the sound.
[0003] Cochlear implants have traditionally consisted of two parts, an
external speech processor unit and an implanted stimulator/receiver unit.
The external speech processor unit has been worn on the body of the user
and its main purpose has been to detect the external sound via a
microphone and convert the detected sound into a coded signal through an
appropriate speech processing strategy.
[0004] This coded signal is then sent to the receiver/stimulator unit
which is implanted in the mastoid bone of the user, via a transcutaneous
link. The receiver/stimulator unit then processes this coded signal into
a series of stimulation sequences which are then applied directly to the
auditory nerve via a series of electrodes positioned within the cochlea,
proximal to the modiolus of the cochlea.
[0005] As the implant is surgically implanted within the recipient there
is a need to obtain data about the actual performance of the electrode
array following implantation as well as the response of the auditory
nerve to stimulation. Such data collection enables detection and
confirmation of the normal operation of the device, and allows the
stimulation parameters to be optimised to suit the needs of the patient.
[0006] Typically, following the surgical implantation of the cochlear
implant, the recipient must have the implant fitted or customised to
conform with the specific recipient demands. This procedure collects and
determines patient specific parameters such as threshold levels (T
levels) and maximum comfort levels (C levels) for each stimulation
channel. Essentially, this is manually performed by applying stimulation
pulses for each channel and receiving an indication from the implant
recipient as to the level and comfort of the resulting sound. For
implants with a large number of channels for stimulation, this process is
quite time consuming and rather subjective as it relies heavily on the
recipients subjective impression of the stimulation rather than any
specific measurement. This aspect is further complicated in the case of
children and prelingually or congenitally deaf patients who are unable to
supply an accurate impression of the resultant hearing sensation, and
hence fitting of the implant may be sub-optimal. In such cases an
incorrectly fitted implant may result in the recipient not receiving
optimum benefit from the implant and in the cases of children may
directly hamper the speech and hearing development of the child.
[0007] Therefore, as previously mentioned, there is a need to obtain
objective measurements of patient specific data especially in cases where
an accurate subjective measurement is not possible.
[0008] One proposed method of interrogating the performance of the
implanted device and making objective measurements of patient specific
data such as T and C levels is to directly measure the response of the
auditory nerve to an electrical stimulus. The measurement of Electrically
Evoked Compound Action Potentials (ECAPs) provides an objective
measurement of the response of the nerves to electrical stimulus.
Following electrical stimulation, the neural response is caused by the
superposition of single neural responses at the outside of the axon
membranes. The ECAP can then be measured in response to various
stimulations and from this the performance of the implant can be assessed
and patient parameters can be interpolated.
[0009] Indeed, there is a need to measure the response of nerves to
electrical stimulation in many applications, and not just in the area of
cochlear implants. The measurement of ECAPs has proven to provide a
useful objective measurement in many such applications. By measuring the
ECAP in response to a stimulation, the effectiveness of the stimulation
can be assessed in relation to the neural response evoked by the
stimulation.
[0010] A number of ECAP measurement methods and apparatus have been
developed which attempt to measure the response of the nerves to
electrical stimulus. In the area of cochlear implants where electrical
stimulus is delivered to the nerve cells within the cochlea, such systems
have essentially attempted to use the electrodes implanted within the
cochlea to both deliver stimulation and to detect the responses of the
nerves to such stimulation.
[0011] U.S. Pat. No. 5,758,651 describes one system and apparatus for
recovering ECAP data from a cochlear implant. This system measures the
neural response to the electrical stimulation by using the stimulus array
to not only apply the stimulation but to also detect and receive the
response. In this system the array used to stimulate and collect
information is a standard intra-cochlear and/or extra-cochlear electrode
array. Following the delivery of a stimulation pulse via chosen stimulus
electrodes, all electrodes of the array are open circuited for a period
of time prior to and during measurement of the induced neural response.
The purpose of open circuiting all electrodes during this period is to
reduce the detected stimulus artefact measured with the ECAP nerve
response.
[0012] Whilst prior art systems of this type have proven useful in
capturing and investigating evoked neural responses in the cochlea, there
are still a number of intrinsic limitations associated with such systems,
which have affected the quality of the measurements of the neural
response. In the main this has been due to the presence of stimulus
artefacts in the measurement detected, resulting in a measurement being
taken which is not necessarily a true indication of the actual ECAP
response present.
[0013] The process of distinguishing the actual ECAP from stimulus
artefacts has presented considerable difficulties, including problems
such as the fact that the signals that are to be measured are extremely
low level signals (down to the order of 10 uV). In cochlear implant
applications in particular, an intracochlear electrode usually delivers a
stimulus pulse with an amplitude typically in the range of 1V to 10V,
which is many orders of magnitude greater than the ECAP response that is
to be measured resulting from this stimulation.
[0014] Providing for a system that is firstly able to deliver a stimulus
of sufficient amplitude and also to detect the elicited response of the
nerves to that particular stimulation has therefore been problematic. Due
to the nature of the neural response, the sensing system must be ready to
record this response within a short delay (preferably less then 50 us)
after completion of the stimulus. In order to properly resolve the very
small neural signal a large amplifler gain is required (typically of
about 60 dB to 70 dB), however the neural signal is often superimposed on
a much larger artefact which makes it difficult to extract the neural
signal of interest due to the finite dynamic range of the amplifier and
the need for high gain to resolve the signal.
[0015] Prior to the present invention, the only way useful measurements
have been able to be obtained from the associated artefacts has been
through the use of extensive post processing techniques. These techniques
have attempted to apply complicated mathematical algorithms to the
associated measurements in an attempt to cancel out the presence of the
artefacts in the measurements. Such a system does not provide immediate
results which can be acted upon, as the measured results often require
time consuming analysis before they can be used. With the need to use
such results immediately to adjust patient T and C levels, existing
methods are not satisfactory.
[0016] Any discussion of documents, acts, materials, devices, articles or
the like which has been included in the present specification is solely
for the purpose of providing a context for the present invention. It is
not to be taken as an admission that any or all of these matters form
part of the prior art base or were common general knowledge in the field
relevant to the present invention as it existed in Australia before the
priority date of each claim of this application.
SUMMARY OF THE INVENTION
[0017] According to a first aspect, the present invention provides a
method of electrical artefact compensation in measurement of a neural
response, the neural response evoked by a first stimulus, the method
comprising the step of:
[0018] subsequent to the first stimulus, applying a compensatory stimulus
in order to counteract a stimulus artefact caused by the first stimulus.
[0019] It has now been realised that stimulus artefacts in a nerve
stimulus system arise due to a number of different mechanisms in the
system and the surrounding tissue. The present invention, in addressing
such artefacts at the time of attempting to measure evoked neural
responses, allows for some reduction or compensation for the effects of
stimulus artefacts, which can reduce or remove the need to resort to
post-measurement processing.
[0020] In particular, it has been realised that stimulus artefacts arise
due to charging of the tissue during stimulation. The first aspect of the
present invention provides a method whereby compensation may be made for
such artefacts. That is, application of the compensatory stimulus may
prove effective in counteracting a residue charge distribution in the
tissue caused by the first stimulus.
[0021] In preferred embodiments of the first aspect of the invention, the
first stimulus comprises:
[0022] a first phase during which an electrical stimulus of first polarity
is applied; and
[0023] a second phase, subsequent to the first phase, during which an
electrical stimulus of second polarity opposite to the first polarity is
applied.
[0024] Further, the first phase and second phase may be charge balanced.
[0025] In such embodiments, it has been realised that the tissue is
charged in accordance with the first polarity during the first phase, and
is charged in accordance with the second polarity during the second
phase, and a residual charge may remain in the tissue following the
second phase, for example due to spatial charge redistribution in the
tissue during the stimulus. The residual charge contributes to the
interface stimulus artefact. Accordingly, in such embodiments of the
first aspect of the invention, the compensatory stimulus is preferably of
the first polarity, and is preferably of controlled profile and duration,
such as to compensate for the interface stimulus artefact. In such
embodiments, the compensatory stimulus may be considered as a third phase
stimulus.
[0026] Preferably, the compensatory stimulus is adaptive, in that
characteristics of the compensatory stimulus are chosen in order to
optimise the extent of cancellation of the artefact which exists
following the first stimulus. Accordingly, the method of the first aspect
of the invention preferably comprises the further step of;
[0027] determining characteristics of the compensatory stimulus from a
measured effectiveness of a previously applied compensatory stimulus.
[0028] Such a step is preferably performed in an iterative manner, to
provide an ongoing optimisation of the compensatory stimulus, based on
the effectiveness of one or more previously applied compensatory stimuli.
By performing an iterative determination of the characteristics of the
compensatory stimulus, such embodiments of the present invention allow
the compensatory stimulus to be adaptive.
[0029] In such embodiments, the measured effectiveness of the previously
applied compensatory stimulus is preferably determined by:
[0030] obtaining at least one neural response measurement of an actual
performance of the previously applied compensatory stimulus; and
[0031] comparing the actual performance against a target performance, in
order to determine an error between the actual performance and the target
performance.
[0032] In more detail, the step of measuring the actual performance of the
previously applied compensatory stimulus may comprise one or more of the
following steps:
[0033] (i) applying the first stimulus and the previously applied
compensatory stimulus, and subsequently obtaining a measurement
comprising a first plurality of temporally spaced neural samples from a
sensor;
[0034] (ii) repeating step (i) in order to obtain a second plurality of
measurements;
[0035] (iii) discarding an initial number of said second plurality of
measurements to allow the sensor and other measurement components to
settle;
[0036] (iv) averaging the remainder of the second plurality of
measurements to obtain an averaged measurement; and
[0037] (v) determining a stimulus artefact from the averaged measurement.
[0038] Step (i) may comprise obtaining 64 neural samples at 48 .mu.s
intervals (which is around 20 kHz), step (ii) may comprise obtaining 20
measurements, while step (iii) may comprise discarding the first 10 of
said measurements, such that the averaged measurement is obtained from
the remaining 10 measurements. The step of determining the stimulus
artefact from the averaged measurement may comprise determining a
deviation of the averaged measurement from a desired response.
[0039] The step of determining characteristics of the compensatory
stimulus from the measured effectiveness of the previously applied
compensatory stimulus is preferably performed by:
[0040] determining an incremental change to be made to characteristics of
the previously applied compensatory stimulus in order to reduce the error
between the actual performance and the target performance; and
[0041] deriving the characterstics of the compensatory stimulus by
altering the characteristics of the previously applied compensatory
stimulus in accordance with the incremental change.
[0042] Preferably, the incremental change is determined so as to (a)
maximise a rate of convergence of the actual performance to the target
performance, and (b) minimise oscillation or overshoot of the actual
performance relative to the target performance.
[0043] In many applications of the present invention, the compensatory
stimulus will comprise a substantially rectangular pulse, the amplitude
and duration of the pulse defining an amount of charge to be inserted by
the pulse. Accordingly, in such embodiments, the incremental change
preferably defines a change in the amount of charge which is required in
order to improve the actual performance of the compensatory stimulus
compared to the target performance. Further, for a given charge to be
applied by the compensatory stimulus, the incremental change may further
define whether a relatively narrow pulse of relatively large amplitude
should be applied or whether a relatively broad pulse of relatively small
amplitude should be applied in delivering the required amount of charge
by the compensatory stimulus.
[0044] In preferred embodiments of the invention, the compensatory
stimulus may be limited to having a variable amplitude only, and having a
fixed duration. Such embodiments allow measurements subsequent to the
compensatory stimulus to commence at a known time, regardless of an
amount of charge to be delivered by the compensatory stimulus.
[0045] Preferably, the compensatory stimulus is completed prior to an
expected time of commencement of an electrically evoked compound action
potential.
[0046] In preferred embodiments of the first aspect of the invention, the
neural response is the auditory nerve neural response, and the first
stimulus is applied by an auditory prosthesis. The auditory prosthesis
may comprise a cochlear implant with an intra-cochlear electrode array,
including electrodes used as stimulus electrodes and/or as sense
electrodes.
[0047] In embodiments where the auditory prosthesis is a cochlear implant
comprising an electrode array, the first stimulus will typically be
applied by one or more electrodes of the array, designated as stimulating
electrodes. In embodiments of the first aspect of the invention, the
compensatory stimulus will typically be applied by those same stimulating
electrodes. However, it is to be appreciated that a compensatory stimulus
may alternately or additionally be applied by other electrodes in the
array. For example, application of additional, simultaneous compensatory
stimuli may be appropriate in those electrodes in close physical
proximity to the stimulating electrodes, due to the physical charge
distribution caused by the first stimulus. The characteristics of such
additional stimuli may be chosen responsive to an expected charge
distribution in tissue adjacent to those different electrodes, caused by
the first stimulus.
[0048] According to a second aspect, the present invention provides a
method of electrical artefact compensation in measurement of a neural
response, the neural response evoked by a first stimulus applied by at
least one stimulating electrode, the method comprising the step of:
[0049] subsequent to the first stimulus, short circuiting at least each
stimulating electrode to an electrode reference voltage.
[0050] It is preferable that the short circuiting of at least each
stimulating electrode to an electrode reference voltage occurs for a
short period of time, approximately 1 us, and preferably occurs
immediately following the delivery of a compensatory stimulus such as is
provided for by the first aspect of the present invention.
[0051] It is again noted that it has now been realised that stimulus
artefacts in a nerve stimulus system arise due to a number of different
mechanisms in the system and the surrounding tissue. The present
invention, in addressing such artefacts at the time of attempting to
measure evoked neural responses, allows for some reduction or
compensation for the effects of stimulus artefacts, which can reduce or
remove the need to resort to post-measurement processing.
[0052] Further, it has now been recognised that artefacts may arise in a
stimulus system itself following a stimulus, and in particular may arise
in electrodes of the system used for applying stimuli and/or electrodes
of the system used for sensing a neural response. The second aspect of
the present invention provides a method for compensating for such
artefacts in the stimulating electrodes, by shorting the stimulating
electrodes following application of the stimulus or a compensatory
stimulus. Connection of the stimulating electrodes directly to the
electrode array reference voltage quickly returns the stimulating
electrodes to that voltage. Additionally, it has been realised that
simply allowing passive tissue load settling, that is leaving all
electrodes open circuited after a stimulus, increases the likelihood that
the tissue voltage will stray from the electrode array reference voltage.
In this event, subsequent connection of sensing electrodes for
measurement of the neural response can occur at a time when a significant
voltage difference exists between the actual tissue voltage and the
electrode array reference voltage. At the time of connection of the
sensing electrodes, such a voltage can give rise to significant charge
injection into the sensing electrodes, potentially causing measurement of
the actual neural response to be inaccurate or impossible and adding
another source of artefact.
[0053] Preferably, the stimulus system is an auditory prosthesis for
stimulus of the auditory nerve. It is anticipated that an auditory
prosthesis in relation to which the method of the second aspect of the
invention is used, will comprise an electrode array having multiple
electrodes. For example, where the auditory prosthesis is a cochlear
implant, the electrode array may comprise 22 to 30 intra-cochlear
electrodes. In some embodiments of the invention, shorting of electrodes
in the array other than the stimulating electrodes may be appropriate.
For example, those electrodes in physical proximity to the stimulating
electrodes may be influenced by charge build-up caused by the stimulating
electrodes, and may therefore benefit from being short circuited for a
brief settling period following the first stimulus, or following delivery
of a compensatory stimulus. However it is possible that short circuiting
a large number of electrodes in the electrode array following the first
stimulus may lead to larger than acceptable current injection between the
tissue and the electrodes. Hence, in many embodiments of the second
aspect of the invention, only the stimulating electrodes are short
circuited after application of a stimulus.
[0054] It will be appreciated that the method of the first aspect of the
invention and the method of the second aspect of the invention may both
be implemented to assist in reducing stimulus artefacts for a single
measurement of neural response. In particular, the step of the second
aspect of the invention may be performed after the step of the first
aspect of the invention, and prior to commencement of measurement of the
evoked neural response.
[0055] According to a third aspect, the present invention provides a
neural stimulus system operable to apply a first stimulus in order to
evoke a neural response, the neural stimulus system comprising means for
electrical artefact compensation in measurement of the neural response,
the means for electrical artefact compensation being operable to apply a
compensatory stimulus in order to counteract a residue charge
distribution caused by the first stimulus.
[0056] According to a fourth aspect, the present invention provides a
neural stimulus system comprising at least one stimulating electrode
operable to apply a first stimulus in order to evoke a neural response,
the neural stimulus system being operable to compensate for electrical
stimulus artefacts by short circuiting at least each stimulating
electrode to an electrode reference voltage.
[0057] Preferably, measurement of the neural response is performed by
detection of a signal present on designated sense electrodes. Preferably,
the sense electrodes are different to the stimulus electrodes.
[0058] Preferably, the neural stimulus system is an auditory prosthesis,
such as a cochlear implant. Preferably the response measured is the
evoked compound action potential of the auditory nerve. The auditory
prosthesis preferably comprises an array of intra-cochlear and
extra-cochlear electrodes.
[0059] By compensating for stimulus artefacts, embodiments of the
invention may assist in enabling high resolution neural response
measurements to be acquired.
[0060] It has further been realised that application of a compensatory
stimulus may prove to be of assistance generally when a first stimulus is
applied to physiological tissue with a capacitive characteristic, where a
response of the physiological tissue to the first stimulus is desired to
be measured.
[0061] Accordingly, in a fifth aspect, the present invention provides a
method of electrical artefact compensation in measurement of a
physiological response, the physiological response evoked by a first
stimulus, the method comprising the step of:
[0062] subsequent to the first stimulus, applying a compensatory stimulus
in order to counteract a stimulus artefact caused by the first stimulus.
BRIEF DESCRIPTION OF THE DRAWINGS
[0063] Examples of the invention will now be described with reference to
the accompanying drawings in which:
[0064] FIG. 1 illustrates a sequence of stimulus, artefact compensation
and evoked neural response measurement in accordance with the present
invention;
[0065] FIG. 2 illustrates a typical evoked neural response;
[0066] FIG. 3 is a circuit diagram illustrating an electrode array of an
auditory prosthesis in accordance with the present invention;
[0067] FIG. 4a illustrates a stimulus artefact present following a bipolar
stimulation, while FIG. 4b illustrates the effect of a compensatory
pulse;
[0068] FIG. 5 is a flow chart illustrating the implementation algorithm of
the present invention;
[0069] FIG. 6a illustrates the manner in which an MFD is obtained
according to the present invention, while FIG. 6b illustrates the manner
in which the polarity of a measured MFD may be determined;
[0070] FIG. 7 illustrates the manner in which the compensatory pulse is
varied in accordance with preferred embodiments of the invention;
[0071] FIG. 8 illustrates possible compensatory phase shapes which may be
applied in alternate embodiments of the present invention; and
[0072] FIG. 9 shows equivalent pulse shape lines from FIG. 8 and their
effect on pulse shapes of varying charge.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0073] The following discussion will be made on the basis of the present
invention being implemented in a cochlear implant, such as is discussed
in U.S. Pat. No. 4,532,930, the contents of which are incorporated herein
by reference. However, it is to be appreciated that the present invention
may have application in other types of auditory prostheses and indeed may
have application in measurement of neural responses, or in general, a
physiological response to an electrical stimulation.
[0074] FIG. 1 illustrates the occurrence over time of a first stimulus 20,
artefact compensation period 30 and evoked neural response measurement
phase 40 in accordance with the present invention.
[0075] The first stimulus 20 includes a first phase 21 during which an
electrical stimulus of negative polarity is applied by an intra-cochlear
active stimulus electrode to the auditory nerve. Subsequently, a second
phase 22 of positive polarity is applied by the active electrode. As will
be appreciated, an intra-cochlear reference stimulus electrode may
simultaneously apply complementary pulses. Alternatively, stimulation may
occur with reference to all other electrodes of the electrode array, or
with reference to an extra-cochlear electrode. It is to be noted that in
this embodiment the first phase 21 and second phase 22 are of equal
duration and amplitude and are therefore charge balanced. It is also
envisaged that more than two phases of stimulation could be applied
within the scope of the present invention. The first phase 21 and the
second phase 22 could, for example, have a duration of the order of 15-50
.mu.s, with an amplitude of up to around 10V. Further, first phase 21 and
second phase 22 could be differently shaped, for example shaped as half
sines, or as stepped half-sine approximations.
[0076] Subsequent to the stimulus 20, a third phase compensatory stimulus
23 is applied, in the present embodiment by the same active stimulating
electrode, in order to counteract a residue charge distribution caused by
the first stimulus 20. As noted above, it has been realised that the
tissue in a cochlear implant system is charged by the negative pulse
during the first phase 21, and is charged by the positive pulse during
the second phase 2, and a relatively significant charge may remain
following the second phase 22, for example due to charge redistribution
during the stimulus. The remaining charge contributes to the tissue
stimulus artefact. Accordingly, the compensatory stimulus 23 is of
negative polarity.
[0077] The tissue artefact is mainly comprised of the effect of charge in
the tissue which is left over from the stimulation and is being
redistributed. The tissue artefact is most severe at the stimulus
electrodes, but it will also couple to surrounding electrodes, dependant
mainly on their proximity. For this reason the sense electrodes, to be
used during measurement phase 40, are preferably selected to be different
from the stimulus electrodes.
[0078] The amplitude and duration of phase 23 have been chosen in order to
compensate for the interface stimulus artefact. In accordance with the
invention, the compensatory stimulus 23 is adaptive, in that
characteristics of the compensatory stimulus 23 are chosen depending on
characteristics of the first stimulus 20. This is discussed further with
reference to FIGS. 4 to 9 in the following.
[0079] Following compensatory stimulus 23, a load settling period 24 is
applied, during which the stimulating electrodes are short circuited in
accordance with the second aspect of the invention. Load settling period
24 is applied for approximately 1 us, however this period in FIG. 1 is
not to scale with respect to the remainder of the Figure.
[0080] Load settling period 24 assists in compensating for artefacts which
may arise in the stimulus electrodes of the implant by substantially
restoring the tissue voltage and all internal stimulus and sensing
circuit nodes back to the electrode array reference voltage. By shorting
the stimulating electrodes following application of the stimulus 20 and
compensatory pulse 23, the stimulating electrodes quickly return to the
electrode array reference voltage. This method provides an alternative to
allowing passive tissue load setting, in which all electrodes are left
open circuited after a stimulus, which can increase the likelihood that
the tissue will stray from the electrode array reference voltage. In such
passive load settling, subsequent connection of sensing electrodes for
measurement of the neural response can occur at a time when a significant
voltage difference exists between the actual tissue voltage and the
electrode array reference voltage. At the time of connection of the
sensing electrodes, such a voltage can give rise to significant charge
injection into the sensing electrodes, potentially causing measurement of
the actual neural response to be inaccurate or impossible.
[0081] Programmable initial delay period 50 assists in dealing with cases
whereby the tissue artefact is too large and exceeds the dynamic range of
the amplifer. This delay period holds the amplifier in a reset state
until start of measurement is desired. The delay period is usually set to
the minimum value consistent with capturing the neural response signal.
[0082] The stimulus artefact caused by stimulus 20 is typically
time-varying, and so the portion of signal present during measurement due
to the artefact changes over time. Hence, the stimulus artefact
introduces an artefact slew to measurements of the neural response. The
third phase 23 or compensatory phase is preferably adjusted to minimise
the artefact slew seen at the sensing electrodes, which may be either the
same electrodes as those used for stimulation or which may be any of the
other electrodes on the array. The parameters of this third or
compensatory phase may be different for different sensing electrode
positions, for example in response to space/time differences in the
charge field. The system of the present invention is therefore capable of
delivering a wide variety of stimulus waveforms which could be used
dependant on the goals of the measurement and/or the manner in which the
measurement is carried out.
[0083] The present embodiment of the invention manipulates the stimulus
waveform applied prior to or during the measurement process in such a way
as to minimise the artefacts associated with the measurement. As
previously mentioned, in the present embodiment this is essentially done
via the application of a smaller programmable third phase stimulus pulse
immediately after the balanced biphasic stimulus, resulting in the system
delivering an unbalanced triphasic stimulus.
[0084] The purpose of delivering this programmable third stimulus phase
following the standard balanced biphasic stimulus pulse is to minimise or
cancel the tissue artefact that would otherwise be present in the
measurement, making it much easier to capture the neural signal at high
amplifier gains, thereby allowing a higher resolution measurement of an
ECAP response to be obtained. As the tissue artefact is mainly the effect
of residual tissue potential (voltage) in the tissue which is left from
the stimulation that is being redistributed, the third phase compensates
for this. Preferably, characteristics of the third or compensatory phase
are determined by taking into consideration the time-varying charge
recovery nature of the tissue.
[0085] It is possible that the stimulus pulse could also be an unbalanced
biphasic stimulus or a balanced triphasic stimulus, with the introduction
of a compensatory phase performing the same function as is described
above. Also, it is possible that the compensatory pulse may precede the
stimulus and be non-rectangular or complex in shape and polarity. The
invention resides in the provision of a compensatory stimulus to negate
the effects of the tissue artefact and as such there are a number of
different ways such a scheme may be implemented, all of which would fall
within the scope of the present invention.
[0086] FIG. 2 illustrates a typical evoked neural response, which may
arise in response to a stimulus 30 as depicted in FIG. 1. Period 70 in
FIG. 2 illustrates a stimulation period, during which a stimulus is
applied to an auditory nerve. The neural response 72 typically commences
approximately 100 us after the onset of the stimulus phase 70, as
indicated by period 71. The duration of the more significant features of
the response is around 1000 us, as indicated by period 73, while the
response measurement period or window is usually around 1.5 to 3
milliseconds.
[0087] Turning now to FIG. 3, a circuit diagram of an electrode array of a
cochlear implant in accordance with the present invention is represented,
by which the first stimulus 20, artefact compensation period 30 and
evoked neural response measurement phase 40 may be applied. The electrode
array is operable to apply the first stimulus 20 in order to evoke a
neural response, and is operable to apply a compensatory stimulus 23 in
order to counteract a residue tissue potential caused by the first
stimulus 20. The electrode array is further operable to compensate for
stimulus artefacts by short circuiting at least each stimulating
electrode to an electrode array reference voltage, following application
of a stimulus.
[0088] FIG. 3 illustrates four of the 24 electrode output switch networks
and is merely an illustrative example of the system, to enable the
operation of the circuit in its switching and sensing modes to be
understood. Each of the four electrodes are indicated as A, B, C, D. As
can be seen, each electrode can be connected to either the reference
V.sub.dd.sub..sub.--.sub.OS line or the 10-line via switches S1 and S2
respectively, for each electrode. V.sub.dd.sub..sub.--.sub.OS represents
the positive supply voltage rail for the output switches, V.sub.ss
represents the negative supply rail and the IO-line represents the
current source. The operation of these switches for the generation of
charge balanced biphasic pulses is detailed in the applicants own U.S.
Pat. No. 4,532,930.
[0089] For the present invention, each electrode has two additional
switches (S3 and S4) to allow for connection to the sensing amplifier. In
the quiescent state, all electrodes are usually short circuited to
V.sub.dd.sub..sub.--.sub.OS to ensure long term charge recovery and no DC
current. However, during the measurement period only the stimulating
electrodes are shorted, for a very short time interval, in order to
minimise current flow to the sensing electrodes which may introduce an
unwanted stimulus artefact into the measurement.
[0090] The switch configuration of the present invention also includes
another switch S.sub.IPG which is used in conjunction with an internal
load resistor R.sub.INT to allow the IO-line to settle to a voltage close
to V.sub.dd.sub..sub.--.sub.OS before the start of the stimulus phases.
The purpose of allowing the IO-line to settle is to minimise the
amplitude of the voltage spikes on the leading edge of the stimulus pulse
due to the discharging of the IO-line capacitance into the load.
[0091] At the end of the third phase 23, there is a short load "settling
period" 24, to restore the electrodes and the internal circuitry nodes
back to as close to V.sub.dd.sub..sub.--.sub.OS as possible. In practice
this load settling period can take a duration of .about.1 us, and during
this time the stimulation electrodes are shorted to
V.sub.dd.sub..sub.--.sub.OS by closing both the S1 switches. During this
load settling period S.sub.DAC is also opened.
[0092] Following the load settling period the stimulation electrodes are
opened leaving all electrodes in the open circuit state. The
V.sub.dd.sub..sub.--.sub.OS switch is then opened thereby changing the
circuit from the stimulation mode to the sensing mode. Following the
above steps, measurement period 40 may proceed, after any appropriate
initial delay 50. Importantly, measurement period 40 preferably commences
prior to an onset of the neural response, so that obtained measurements
record a leading edge of the neural response. The characteristic ECAP
signal typically occurs approximately 100 us after the onset of the
stimulus pulse 20 (as indicated by onset period 60 in FIG. 1) and usually
has a duration of approximately 1000 us. It has been found that the
signal's amplitude grows with the increasing number of nerve fibres
captured as the amplitude of the stimulus increases above the threshold
limit.
[0093] Measurement of the neural response is performed by detection of a
signal present on designated sense electrodes of the implant. Preferably,
the sense electrodes are different to the stimulus electrodes. By
compensating for stimulus artefacts, embodiments of the invention may
assist in enabling high resolution neural response measurements to be
acquired.
[0094] FIG. 4a illustrates a bipolar stimulation signal consisting of a
first stimulation phase of negative polarity followed by a second
stimulation phase of positive polarity, applied by an active electrode.
Following the bipolar stimulation, a stimulus artefact is present, As can
be seen, a significant stimulus artefact remains after the final charge
has been delivered at the end of a standard two phase stimulus. This
artefact has the effect of a gradual slewing or decay towards V.sub.DD
which can be as large as of the order of millivolts at the relevant time
and can take several hundred microseconds before becoming negligible.
Given the extremely low level of neural response ECAP signals, down to
the order of 10 microvolts, this significant remaining artefact can
obscure the actual ECAP response, and can saturate the ECAP measurement
system.
[0095] FIG. 4b illustrates application of a compensatory stimulus,
comprising a substantially rectangular pulse, of negative polarity. As
opposed to FIG. 4a, at the time measurements commence, significant
cancellation of the stimulus artefact has been achieved such that neural
measurements are of the order of microvolts. As can be seen, application
of the compensatory stimulus significantly hastens settling of the
stimulus artefact, enabling a neural response measurement system or
circuits to commence operation significantly more quickly following the
bipolar stimulus, without saturation of the measurement system being
caused by residual stimulus artefacts.
[0096] In applying a compensatory stimulus, it is important that the shape
and characteristics of this stimulus are such that it does provide
effective compensation for stimulus artefacts and that it does not worsen
such artefacts. Consequently, the characteristics of the compensatory
stimulus should be carefully determined. Given the detailed knowledge
required of both the stimulus system and the patient physiology in order
to perform such optimisation of the compensatory stimulus, manual
adjustment of the parameters of the third phase would be a tedious and
complicated process, which would not easily lend itself to clinical
applications. Hence, in accordance with preferred embodiments of the
invention, a method is proposed in order to address this problem,
allowing the user to adjust parameters of the third phase without
requiring extensive prior knowledge of the electrical workings of the
electrode/tissue interface, thereby allowing convenient clinical use of
such a system.
[0097] Turning to FIG. 5, a flow chart is shown which reveals a manner of
implementing an algorithm in accordance with the present invention, to
optimise the parameters of the compensatory phase so as to appropriately
cancel or counteract the effects of the stimulus artefact.
[0098] Firstly an OK Samples counter is set which determines the number of
"correct" MFD's (Measurements for Decision) which must be obtained by the
algorithm before the process can be considered to be complete. An MFD is
considered to be correct when the error of the measurement is less than
the tolerance set by the user, and this will be discussed in more detail
below. In a preferred embodiment the counter would be set to require that
four correct MFD's must be obtained before the adjustment of the
compensatory means can be considered completed.
[0099] Subsequently, a first MFD is obtained, without the use of any
compensatory phase. As the polarity of a measured MFD may swap depending
on the manner in which sense electrodes are connected to the input of an
amplifier, obtaining such an MFD allows the polarity of the measured MFD
(denoted by variable P) and hence the manner in which the sense
electrodes are connected to the input of the amplifier to be determined.
FIG. 6b illustrates an output of a neural response detection amplifier
for both positive and negative polarity situations. P takes a value of +1
or -1, and is subsequently used to influence whether an increase or
decrease in charge applied by the compensatory phase should occur in
response to a given error, as discussed further below.
[0100] The next step requires the MFD to be obtained, which in the present
embodiment involves averaging 10 measurements, each comprising 64
collected telemetry samples in the manner as shown in FIG. 6a.
[0101] Following the delivery of the stimulus, including the compensatory
stimulus, a series of telemetry measurements are taken of the evoked
neural response. In a preferred embodiment 10 telemetry measurements are
taken, each comprising 64 telemetry samples. It has been found that,
following stimulation, the initial telemetry measurements tend to differ
only slightly from the steady state telemetry measurements, however
whilst there is only a very small settling period for the telemetry
measurements it is wise to discard some initial telemetry measurements
due to this phenomena. A preferred embodiment may be to discard the first
10 telemetry measurements.
[0102] It has also been found that to eliminate the effects of noise and
telemetry measurement inaccuracies it is desirable to extract the MFD
from an average of a number of telemetry measurements. In a preferred
embodiment, 10 collected telemetry measurements are averaged from which
the MFD is extracted.
[0103] The MFD that is obtained for example from a single measurement or
from the average of a plurality of measurements is referred to as the
"measurement for decision" (MFD) and it is this MFD that is used in the
algorithm to decide upon the appropriate parameters of the compensatory
phase. FIG. 6 illustrates how an MFD is obtained.
[0104] Once the MFD has been obtained an error is determined for the MFD,
in order to determine whether the compensatory phase is appropriately
adjusted. In the present embodiment, the error of a given MFD is
determined by examining each point along the MFD to determine variations
of the MFD from the target response. The variations at each point along
the MFD are summed, and when the sum is equal to zero, that is when the
MFD conforms to the target response or exhibits positive and negative
excursions from the target response which sum to zero, the MFD is
considered "correct". That is, the measured neural response substantially
conforms to a target response, indicating that the stimulus artefact has
been substantially cancelled. In accordance with such embodiments of the
invention, the error of the MFD could be determined in accordance with
the following algorithm:
Error (.mu.s)=.SIGMA.[Sample n (.mu.s)-First Sample (.mu.s)-Target Offset
(converted to .mu.s)]
[0105] An alternate method in which the error of a given MFD may be
determined is to simply calculate the difference between the first and
last telemetry sample of the MFD. The difference between the first and
last telemetry samples represents the amount by which the stimulus
artefact has settled or decayed during the telemetry sample period, which
is around three milliseconds in the present embodiment. As previously
mentioned, in a preferred embodiment 64 telemetry measurements are used
for this algorithm, to ensure that the majority of elements of the
artefact and response have subsided from the measurement by the time the
final sample is taken. Thus, where substantial subsidence of both the
neural response and the stimulus artefact have occurred by the time the
final sample is taken, the difference between the first sample and the
final sample will be representative of the actual amplitude of the
stimulus artefact present at the time the first sample is taken. This
alternate method of determining the error of the MFD, could for example
determine the error in .mu.s in accordance with the following formula;
Error (.mu.s)=Last Sample (.mu.s)-First Sample (.mu.s)-Target Offset
(converted to .mu.s)
[0106] It should be appreciated that this is a very simplistic description
of how the error is determined, for example, such a method assumes that
there is a flat neural response, which is not usually the case. It is
envisaged that other methods of determining the error in artefact
cancellation could also be employed which do not make such simplifying
assumptions of the present embodiment of the invention, such as by taking
into account non-flat neural responses.
[0107] In both the preferred embodiment and in the latter alternate
embodiment of determining the error of an MFD, the "Target Offset"
variable indicates a deviation of the measurement from the desired
target, The Target Offset is specified in .mu.V and in a preferred
embodiment this value should be set to 0 .mu.V. In calculating the error
the Target Offset variable is converted to .mu.s.
[0108] Returning to FIG. 5, once the error of the MFD has been determined,
an assessment is made as to whether the error of the MFD is acceptable.
In the present embodiment, in assessing whether the MFD is acceptable the
following criteria must be met:
.vertline.Error (.mu.s).vertline..ltoreq.Target Tolerance (.mu.s)
[0109] The "Target Tolerance" variable essentially tightens or relaxes the
criteria which determines whether or not an MFD is considered to be
correctly adjusted or not. This variable is in units of microseconds and
determines the tolerance in the pulse widths of the measured telemetry
pulse in comparison to an ideal value. In a preferred embodiment this
variable would alternate between a "relaxed" and a "normal" setting, with
the "relaxed" setting typically being 1.0 .mu.s and the "normal" setting
being 0.2 .mu.s. It is envisaged that the recommended default setting
would be "normal".
[0110] If it is decided that the MFD is not acceptable and the error is
outside the target tolerance, the compensatory phase is adjusted in order
to bring the MFD to within acceptable limits. In essence, the amount of
charge delivered by the compensatory phase is adjusted. This process is a
two-step process with the first step involving the calculation of the new
charge to be delivered by the compensatory phase, and the next step
determining and calculating the corresponding values of phase width and
phase current of the compensatory phase.
[0111] The new charge to be delivered by the compensatory phase is
determined as follows:
New Charge (pC)=Old Charge (pC)+.DELTA.Charge (pC)
Whereby
.DELTA.Charge (pC)=Stepratio (nC/V)*Error (converted to V)*P
[0112] The "Stepratio" variable gives the rate at which the algorithm
adjusts the compensatory phase charge in order to meet the required
target measurement and describes the change in charge applied by the
compensatory phase as a result of a given target error, the calculation
of which is discussed above. In a preferred embodiment this variable is
initially set at 1000 nC/V and any increase of this value will cause the
algorithm to converge to the target faster but has the possibility of
causing overshoot and oscillations, whilst any reduction in the value
will cause slower but more stable convergence to the target measurement.
P is the variable determined previously, relating to the polarity of
connection of sense electrodes to the input of the amplifier.
[0113] In preferred embodiments of the invention, the compensatory
stimulus comprises a rectangular pulse of fixed duration t.sub.c and
variable amplitude, as depicted in FIG. 7. To commence the adaptive
optimisation of the compensatory pulse, an initial value of charge
delivered by the compensatory pulse could be chosen arbitrarily, for
example to be 20% of the charge delivered by one phase of the initial
bi-phasic stimulus. As discussed above, the charge to be delivered by the
compensatory stimulus is altered in accordance with the "stepratio"
variable, which is implemented by altering the amplitude of the pulse,
illustrated in an exaggerated manner in FIG. 7 by .DELTA.A. By providing
a compensatory stimulus of fixed duration, such embodiments of the
invention allow the measurement period t.sub.m to commence at a known
time, rather than requiring the measurement period to be delayed until
completion of a variable duration compensatory pulse. FIG. 7 further
illustrates the neural response to be measured, which is not to scale
with respect to the compensatory stimulus.
[0114] Once the new charge to be delivered by the compensatory phase is
determined, derivation of the 3rd phase current is a simple matter
(bearing in mind that the compensatory pulse is of fixed duration), as
follows:
3rd Phase Current (.mu.A)=[3rd Phase Charge (pC)]/[3rd Phase Width
(.mu.s)].
[0115] The width of the third phase could be arbitrarily chosen, and for
example could be of the order of 10 .mu.s.
[0116] In alternate embodiments, should it be desired to use a
compensatory stimulus of both varying width and amplitude, the
corresponding values of phase width and phase current level to be
delivered by the compensatory phase can be derived as follows:
Compensatory Charge (pC)=Compensatory Phase Width (.mu.s)* Compensatory
Phase Current (.mu.A)
[0117] The relationship of the Compensatory Phase Width to the
Compensatory Phase Current can be better understood by what is termed the
Phase Shape variable. This variable is used to determine the "shape" of
the compensatory phase. When selecting the shape of the compensatory
phase it is possible to select almost any shape, however in the
embodiment shown in FIGS. 8 and 9 a choice is made between a relatively
narrow pulse, a relatively normal width pulse and a shallow pulse shape,
to deliver a given charge. As can be seen in FIG. 8, a very narrow pulse
has a much higher current/time compared to a low current/time
characteristic of a shallow pulse, however the charge (l*t) delivered by
all three shapes is the same. Therefore, whilst all these three shapes
deliver the same charge, they have different ratios of l/t.
[0118] With this in mind, FIG. 9 shows equivalent pulse shape lines (l/t
constant) and their effect on pulse shapes of varying charge. In essence
for each of the three pulse shapes, narrow, normal and shallow, there is
one value of l/t. In a preferred embodiment the values may be: Narrow -80
A/s, Normal -40 A/s and Shallow 20 A/s.
[0119] Therefore the following relationship can be established: 1
Compensatory Phase Current ( A ) Compensatory
Phase Width ( s ) = Pulse Shape ( A /
s )
[0120] From which the following relationship can be derived:
[Compensatory Phase Current (mA)].sup.2=Compensatory Phase Charge
(pC)*Pulse Shape (A/s)
[0121] Therefore from this the Compensatory Phase Width and Compensatory
Phase Current can be determined and adjusted accordingly so that a new
MFD can be obtained and assessed for error. However, it is to be
appreciated that alternate embodiments of this type may prevent
commencement of sampling at a common time for all values of pulse width,
as commencement of sampling should not occur until after conclusion of
the compensatory pulse.
[0122] Referring again to FIG. 5, if it is decided that the MFD is
acceptable and the error is within the target tolerance, the OK Samples
counter is incremented and the counter is then interrogated to determine
whether the measurement process is complete and the desired number of
correct MFD's has been measured.
[0123] If the number of correct MFD's is less than the desired number then
the above measurement and error determination process is continued until
this criteria has been satisfied.
[0124] When a desired number of correct MFD's have been obtained, a
Time-out variable is applied to the algorithm which stops the algorithm
from further adjustments after a specified time delay. In a preferred
embodiment this time delay may be 5 seconds. Following this time the
compensatory phase is set to zero and the process is completed As can be
seen, the described embodiments provide for adjustment of the
characteristics of the compensatory phase without need for detailed user
involvement. To provide differing levels of user input, the system may
provide for user input of variables such as the number of telemetry
measurements obtained per MFD, the Stepratio variable, and/or the pulse
shape.
[0125] Throughout this specification the word "comprise", or variations
such as "comprises" or "comprising", will be understood to imply the
inclusion of a stated element, integer or step, or group of elements,
integers or steps, but not the exclusion of any other element, integer or
step, or group of elements, integers or steps.
[0126] It will be appreciated by persons skilled in the art that numerous
variations and/or modifications may be made to the invention as shown in
the specific embodiments without departing from the spirit or scope of
the invention as broadly described. The present embodiments are,
therefore, to be considered in all respects as illustrative and not
restrictive.
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