U.S. patent number RE48,038 [Application Number 15/217,480] was granted by the patent office on 2020-06-09 for recognition of implantable medical device.
This patent grant is currently assigned to Cochlear Limited. The grantee listed for this patent is Cochlear Limited. Invention is credited to Peter Gibson, Bastiaan van Dijk.
United States Patent |
RE48,038 |
van Dijk , et al. |
June 9, 2020 |
Recognition of implantable medical device
Abstract
Controlling the interaction between an external device and an
implanted device, including a method of controlling interaction
between an external device and an implanted device, the method
including at least the steps of: establishing communications
between the implanted device and the external device; the external
device determining an identification of the implant and comparing
the identification with identifications in a stored list; if the
device matches one of said identifications, then using a
corresponding set of operating parameters to interact with said
implant; and otherwise, not interacting with said device.
Inventors: |
van Dijk; Bastiaan (Mechelen,
BE), Gibson; Peter (South Coogee, AU) |
Applicant: |
Name |
City |
State |
Country |
Type |
Cochlear Limited |
Macquarie University, NSW |
N/A |
AU |
|
|
Assignee: |
Cochlear Limited (Macquarie
University, NSW, AU)
|
Family
ID: |
1000004547825 |
Appl.
No.: |
15/217,480 |
Filed: |
July 22, 2016 |
PCT
Filed: |
February 09, 2007 |
PCT No.: |
PCT/AU2007/000142 |
371(c)(1),(2),(4) Date: |
March 27, 2009 |
PCT
Pub. No.: |
WO2007/090243 |
PCT
Pub. Date: |
August 16, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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Reissue of: |
12279055 |
Feb 9, 2007 |
8784312 |
Jul 22, 2014 |
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Foreign Application Priority Data
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Feb 10, 2006 [AU] |
|
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2006900628 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N
1/37247 (20130101); A61B 5/0002 (20130101); A61N
1/36039 (20170801); A61B 5/0031 (20130101); A61N
1/3727 (20130101); A61N 1/36038 (20170801); A61N
1/37252 (20130101); A61B 5/0031 (20130101); A61N
1/3727 (20130101); A61B 5/0002 (20130101); Y10S
128/903 (20130101) |
Current International
Class: |
A61B
5/00 (20060101); A61N 1/372 (20060101); A61B
5/02 (20060101); A61B 5/07 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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0730882 |
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EP |
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0730882 |
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Dec 2000 |
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WO |
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WO 00/72917 |
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WO |
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01/03622 |
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Jan 2001 |
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WO |
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01/06810 |
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Jan 2001 |
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WO 01/03622 |
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WO 01/06810 |
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01/13991 |
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Mar 2001 |
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03/003956 |
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Jan 2003 |
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03/009207 |
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Jan 2003 |
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WO |
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03003956 |
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Jan 2003 |
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WO |
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03009207 |
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Jan 2003 |
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Other References
International Search Report for PCT/AU01/00811 dated Sep. 10, 2001.
cited by applicant .
European Search Report for EP 01 95 1205.2 dated Mar. 31, 2005.
cited by applicant .
EPO Official Communication for EP 01 951 205.2 dated Feb. 2, 2006.
cited by applicant .
EPO Official Communication for EP 01 951 205.2 dated Sep. 14, 2006.
cited by applicant .
EPO Official Communication for EP 01 95 1205.2 dated Jan. 23, 2008.
cited by applicant .
Japanese Office Action for JP 2003-509972 dated Jun. 29, 2010.
cited by applicant .
International Search Report for PCT/AU2007/000142/ dated May 2,
2007. cited by applicant.
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Primary Examiner: Dawson; Glenn K
Attorney, Agent or Firm: Pilloff Passino & Cosenza LLP
Cosenza; Martin J.
Claims
The invention claimed is:
1. An external hearing device adapted to interact with an
.[.implanted.]. .Iadd.implantable .Iaddend.internal device, the
external device being able to be operatively positioned to interact
with either a left ear or right ear .[.implanted.].
.Iadd.implantable internal .Iaddend.device, said external device
including a detector operatively adapted to detect whether the
external device is positioned to interact with the left ear or the
right ear .Iadd.implantable .Iaddend.internal device, and
.Iadd.wherein the external hearing device is configured to,
.Iaddend.in response to said detection, select and utilize a stored
set of operating parameters corresponding to the left ear or the
right ear .Iadd.implantable .Iaddend.internal device to allow the
external device to operate with the .Iadd.implantable
.Iaddend.internal device.
2. The external device according to claim 1, wherein the
.Iadd.implantable .Iaddend.internal device is a cochlear implant
and the external device is a speech processor.
.[.3. The external device according to claim 1, wherein the
detector includes one or more of a proximity sensor, a thermal
sensor or a source localization algorithm stored in the external
device..].
.[.4. The external device according to claim 1, wherein the
operating parameters are selected from a group including one or
more of an electrode map including stimulation levels, selection of
electrodes to stimulate, speech processing strategy or algorithm,
parameters of the speech processing strategy, or when to switch
between different speech processing strategies..].
5. The external device according to claim 1, wherein the external
device is configured to allow a user to manually select whether the
set of operating parameters corresponding to the left ear or the
right ear .Iadd.implantable .Iaddend.internal device are utilized
by the external device.
.[.6. The external device according to claim 1, further comprising
a display, wherein the display is configured to display a message
indicating at least the internal device that the external device is
interacting with..].
7. The external device according to claim 1, wherein the detector
is configured to determine at least one identifier of the left ear
or the right ear .Iadd.implantable .Iaddend.internal device.
8. The external device according to claim 7, wherein the identifier
is a transmitted identification signal.
9. The external device according to claim 7, wherein the identifier
is determined from a set of measured parameters related to one or
more of either the .Iadd.implantable .Iaddend.internal device
.[.and.]. .Iadd.or .Iaddend.physiological properties of .[.the left
ear or the right ear internal device.]. .Iadd.an ear of a recipient
of the external device.Iaddend..
10. The external device according to claim 7, wherein the
identifier is an identification tag or device operating
independently of the normal communication path between the left ear
or the right ear .Iadd.implantable .Iaddend.internal device and the
external device.
11. The external device according to claim 7, wherein the
.[.detector.]. .Iadd.external device .Iaddend.is configured to
compare the identifier of the left ear or right ear
.Iadd.implantable .Iaddend.internal device to a list of known
identifiers to confirm that the .Iadd.implantable .Iaddend.internal
device is known.
12. The external device according to claim 11, wherein the
.[.detector.]. .Iadd.external device .Iaddend.is configured to
select and utilize the set of operating parameters stored on the
external device, the operating parameters corresponding to the
.Iadd.implantable .Iaddend.internal device, and enabling the
external device to operate with the .Iadd.implantable
.Iaddend.internal device based on the comparison of the identifier
of the left ear or right ear .Iadd.implantable .Iaddend.internal
device to the list of known identifiers.
.[.13. The external device according to claim 1, wherein the
operating parameters are selected from a group including one or
more of an electrode map including stimulation levels, selection of
electrodes to stimulate, speech processing strategy or algorithm,
parameters of the speech processing strategy, or when to switch
between different speech processing strategies..].
14. The external device according to claim 1, wherein the external
device .[.automatically.]. selects a .[.set of operating
parameters.]. .Iadd.map .Iaddend.to be utilized by the external
device.
15. The external device according to claim 1, wherein the
.[.detector.]. .Iadd.external device .Iaddend.is configured to
select and utilize the set of operating parameters from a plurality
of operating parameter sets, wherein each operating parameter set
of the plurality of operating parameter sets corresponds to a
particular .Iadd.implantable .Iaddend.internal device.
.[.16. The external device according to claim 1, wherein the
external device is a behind-the-ear (BTE) external device..].
.[.17. The external device according to claim 11, wherein the
detector is configured to periodically determine a new identifier
and compare the new determined identifier to the list of known
identifiers to confirm that the identifier is known..].
.[.18. The external device according to claim 7, wherein the
detector is configured to terminate operation of the external
device if the identifier is determined not to be known..].
.Iadd.19. An external hearing device, the external device being
able to be respectively operatively positioned at a first position
to interact with a left ear implantable device and operatively
positioned at a second position to interact with a right ear
implantable device, said external device configured to detect
whether the external device is positioned to interact with the left
ear implantable device or the right ear implantable device, and in
response to said detection, utilize a stored set of operating
parameters corresponding to the left ear or the right ear
implantable device, wherein a plurality of sets of operating
parameters are stored in the external hearing device, and the
external hearing device is configured to select a respective set of
operating parameters from the plurality of sets of operating
parameters for the respective left ear implantable device and
selects a respective set of operating parameters from the plurality
of sets of operating parameters for the respective right ear
implantable device. .Iaddend.
.Iadd.20. The external hearing device of claim 19, wherein the left
ear implantable device and the right ear implantable device are a
stimulator/receiver unit of a cochlear implant and the external
device is a cochlear implant speech processor. .Iaddend.
.Iadd.21. The external hearing device of claim 19, wherein the
external device configured to, upon a detection that the external
device is positioned to interact with the left ear implantable
device, utilize a first stored set of operating parameters from
amongst the plurality of sets of operating parameters that are
based on a MAP for the left ear, and to, upon a detection that the
external device is positioned to interact with the right ear
implantable device, utilize a second stored set of operating
parameters from amongst the plurality of sets of operating
parameters that are based on a MAP for the right ear, the MAP for
the right ear being different than the MAP for the left ear.
.Iaddend.
.Iadd.22. A method for operating an external device with an
implanted internal device, comprising: establishing communications
between the external device and the internal device; determining,
by the external device, at least one identifier of the internal
device; comparing, by the external device, the identifier of the
internal device to a list of known identifiers to confirm that the
internal device is known; and selecting and utilizing, by the
external device, a set of operating parameters stored on the
external device, the operating parameters corresponding to the
internal device, and enabling the external device to operate with
the internal device. .Iaddend.
.Iadd.23. The method of claim 22, wherein the internal device is a
stimulator/receiver unit of a cochlear implant and the external
device is a cochlear implant speech processor. .Iaddend.
.Iadd.24. The method of claim 22, wherein the operating parameters
include at least one of an electrode map including stimulation
levels, which electrodes to stimulate, type of speech processing
strategy or algorithm, parameters of the speech processing
strategy, or when to switch between different speech processing
strategies. .Iaddend.
.Iadd.25. The method of claim 22, wherein the identifier is
determined from a set of measured parameters related to one or more
of either the internal device or physiological properties of an ear
of a recipient of the external device. .Iaddend.
.Iadd.26. The method of claim 22, wherein the internal device is an
internal device of a hearing prosthesis, and the external device is
an external device of the hearing prosthesis. .Iaddend.
.Iadd.27. The method of claim 22, wherein the internal device is an
internal device of a middle ear implant, and the external device is
an external device of the middle ear implant. .Iaddend.
.Iadd.28. The method of claim 22, wherein the internal device is an
internal device of an implanted acoustic device, and the external
device is an external device of the implanted acoustic device.
.Iaddend.
.Iadd.29. The method of claim 22, wherein the internal device is an
internal device of an acoustic auditory device, and the external
device is an external device of the acoustic auditory device.
.Iaddend.
.Iadd.30. The method of claim 22, wherein the internal device is an
internal device of an electrical auditory device, and the external
device is an external device of the electrical auditory device.
.Iaddend.
.Iadd.31. The method of claim 22, wherein the internal device is an
internal device of a cochlear implant, and the external device is
an external device of the cochlear implant. .Iaddend.
.Iadd.32. The method of claim 22, wherein: the action of utilizing,
by the external device, the set of operating parameters includes
using a different set of operating parameters that are different
than a set of other currently stored operating parameters, the
other currently stored operating parameters being also currently
stored on the external device, and operating the internal device
based on operating parameters selected during the action of
selecting and utilizing, by the external device, a set of operating
parameters; and the method further includes subsequently to the
action of selecting and utilizing: establishing communications
between the external device and a different internal device;
determining, by the external device, at least one identifier of the
different internal device different than the determined at least
one identifier of the internal device; comparing, by the external
device, the different identifier of the different internal device
to the list of known identifiers to confirm that the different
internal device is known; and selecting and utilizing, by the
external device, the set of other currently stored operating
parameters stored on the external device, the other currently
stored operating parameters corresponding to the different internal
device, and enabling the external device to operate with the
different internal device. .Iaddend.
.Iadd.33. The method of claim 32, further comprising the action of
operating the different internal device based on the set of other
currently stored operating parameters after enabling the external
device to operate with the different internal device. .Iaddend.
.Iadd.34. The method of claim 22, wherein the action of utilizing,
by the external device, the set of operating parameters includes
using a different set of operating parameters than a set previously
utilized, and operating the internal device based on the set of
operating parameters that was selected and utilized, by the
external device without changing a mode of operation of the
internal device. .Iaddend.
.Iadd.35. The method of claim 22, wherein the action of selecting a
set of operating parameters includes selecting a set of operating
parameters from a plurality of sets of different operating
parameters that are stored in the external device. .Iaddend.
.Iadd.36. The method of claim 22, wherein the action of selecting a
set of operating parameters includes selecting a set of operating
parameters from a plurality of sets of different operating
parameters that are stored in the external device, wherein at least
one of the sets of different operating parameters of the plurality
of sets of different operating parameters corresponds to a set of
operating parameters for a second implanted device, which at least
one of the sets of different operating parameters is not selected
and not utilized based on the action of comparing the identifier of
the internal device. .Iaddend.
.Iadd.37. The method of claim 22, wherein: the actions of
establishing communications, determining at least one identifier,
comparing the identifier and selecting and utilizing the set of
operating parameters are executed while the external device is
located against the head of a recipient. .Iaddend.
.Iadd.38. The method of claim 22, wherein the action of
establishing communications between the external device and the
internal device is executed via an antenna transmitter coil that is
located proximate a head of a recipient outside the skin of the
recipient and a receiver coil that is located inside the head of
the recipient. .Iaddend.
.Iadd.39. The method of claim 22, wherein the external device
includes a first component held against skin of a recipient via
magnetic interaction with an implanted ferromagnetic material that
is part of the implanted internal device, wherein the action of
establishing communications between the external device and the
internal device is executed using the first component.
.Iaddend.
.Iadd.40. The method of claim 22, wherein the method of operating
is a method of controlling operation of the implanted device with
the external device. .Iaddend.
.Iadd.41. The method of claim 22, wherein the action of
establishing communications between the external device and the
internal device is executed via a transmitter component that is
located proximate a head of a recipient outside the skin of the
recipient and a receiver component that is located inside the head
of the recipient. .Iaddend.
.Iadd.42. The method of claim 22, wherein the external device
includes a first component held against skin of a recipient via
magnetic interaction with an implanted magnet that is part of the
implanted internal device, wherein the action of establishing
communications between the external device and the internal device
is executed using the first component. .Iaddend.
.Iadd.43. An external device adapted to interact with an
implantable internal device, the implantable internal device having
at least one identifier, and the external device having a stored
set of operating parameters; the external device configured to
detect the identifier from the implantable internal device,
determine if the identifier corresponds to one of a plurality of
identifiers, and if the identifier does correspond, select and
utilize a stored set of operating parameters corresponding to the
identifier that corresponds to one of the plurality of identifiers
to allow the external device to operate with the implantable
internal device. .Iaddend.
.Iadd.44. The external device of claim 43, wherein the implantable
internal device is a hearing prosthesis implant and the external
device is a speech processor. .Iaddend.
.Iadd.45. The external device of claim 43, wherein the stored set
of operating parameters include at least one of an electrode map
including stimulation levels, selection of electrodes to stimulate,
speech processing strategy or algorithm, parameters of the speech
processing strategy, or when to switch between different speech
processing strategies. .Iaddend.
.Iadd.46. The external device of claim 43, wherein the implantable
internal device is an internal device of a hearing prosthesis, and
the external device is an external device of the hearing
prosthesis. .Iaddend.
.Iadd.47. The external device of claim 43, wherein the implantable
internal device is an internal device of a middle ear implant, and
the external device is an external device of the middle ear
implant. .Iaddend.
.Iadd.48. The external device of claim 43, wherein the implantable
internal device is an internal device of an implanted acoustic
device, and the external device is an external device of the
implanted acoustic device. .Iaddend.
.Iadd.49. The external device of claim 43, wherein the implantable
internal device is an internal device of an acoustic auditory
device, and the external device is an external device of the
acoustic auditory device. .Iaddend.
.Iadd.50. The external device of claim 43, wherein the implantable
internal device is an internal device of an electrical auditory
device, and the external device is an external device of the
electrical auditory device. .Iaddend.
.Iadd.51. The external device of claim 43, wherein the implantable
internal device is an internal device of a cochlear implant, and
the external device is an external device of the cochlear implant.
.Iaddend.
.Iadd.52. The external device of claim 43, wherein: the stored set
of operating parameters is based on a MAP for an implantable
electrode array of the implantable internal device customized for
the recipient of the implantable internal device. .Iaddend.
.Iadd.53. The external device of claim 43, wherein: the external
device includes a plurality of different stored sets of operating
parameters, wherein respective different stored sets of operating
parameters of the plurality of different stored sets of operating
parameters are respectively based on respective different MAPs for
different implantable electrode arrays of the implantable internal
device. .Iaddend.
.Iadd.54. The external device of claim 43, wherein: the external
device is configured to be worn directly against the head of a
recipient. .Iaddend.
.Iadd.55. The external device of claim 43, wherein: the external
device is configured to be worn directly against the body of a
recipient, and the external device is configured to execute the
following actions: interact with the implantable internal device,
detect the identifier from the implantable internal device,
determine if the identifier corresponds to one of a plurality of
identifiers, and if the identifier does correspond, select and
utilize a stored set of operating parameters corresponding to said
corresponding identifier to allow the external device to operate
with the implantable internal device. .Iaddend.
.Iadd.56. The external device of claim 43, wherein: the implantable
internal device is a stimulator/receiver unit of a cochlear implant
and the external device is a cochlear implant speech processor.
.Iaddend.
.Iadd.57. The external device of claim 43, wherein: the external
device includes a component configured to be worn directly against
the head of a recipient, the component including an antenna
transmitter coil, the external device being in signal communication
with a speech processor of the external device. .Iaddend.
.Iadd.58. The external device of claim 43, wherein: the external
device is a Behind-The-Ear (BTE) device. .Iaddend.
.Iadd.59. The external device of claim 43, wherein the external
device is configured to operate with at least two separate
implantable internal devices, during separate temporal periods,
that have respective different identifiers. .Iaddend.
.Iadd.60. The external device of claim 43, wherein the external
device is configured to determine if the identifier corresponds to
one of at least two different implantable internal device
identifiers, and operate a first way if it is determined that the
identifier corresponds to one of the at least two different
internal device identifiers, and operate a second way different
from the first way if it is determined that the identifier
corresponds to another of the at least two different internal
device identifiers. .Iaddend.
.Iadd.61. The external device of claim 43, wherein the external
device is configured to interact with and operate with respective
different implantable internal devices that have respective
different identifiers during respective different temporal periods
by selecting and using respective stored sets of operating
parameters, stored in the external device, corresponding to the
respective identifiers. .Iaddend.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
.Iadd.The present application is a reissue application of U.S. Pat.
No. 8,784,312, issued Jul. 22, 2014, from application Ser. No.
12/279,055, filed Mar. 27, 2009. .Iaddend.The present application
is a National Stage application of PCT/AU2007/000142 entitled
"IMPLANT ID RECOGNITION", filed on Feb. 9, 2007, which claims
priority from Australian Provisional Patent Application No.
2006900628, filed on Feb. 10, 2006, which are hereby incorporated
by reference .Iadd.in their entirety.Iaddend..
BACKGROUND
1. Field of the Invention
The present invention relates to implantable medical devices, and
more particularly, to recognition of implantable medical
devices.
2. Related Art
Implantable hearing prostheses provide the benefit of hearing to
individuals suffering from severe to profound sensorineural hearing
loss. Sensorineural hearing loss is due to the absence or
destruction of the hair cells in the cochlea which transduce
acoustic signals into nerve impulses. An implantable hearing
prosthesis essentially simulates the cochlear hair cells by
delivering electrical stimulation to the auditory nerve fibers.
This causes the brain to perceive a hearing sensation resembling
the natural hearing sensation.
The present invention is particularly concerned with situations
where a user, patient or recipient, "recipient" herein has an
external processing device that communicates with an implanted
device. For example, in a modern, conventional cochlear implant, an
external speech processor transmits power and data to the implanted
device via an inductive coil arrangement. The implanted device
includes an electrode array to deliver the desired electrical
stimuli to the cochlea of the recipient.
Once implanted, the implant system is typically adjusted to suit
the specific needs of the recipient. As the dynamic range for
electrical stimulation is relatively narrow and varies across
recipients and electrodes, there is a need to individually tailor
the characteristics of electrical stimulation for each recipient.
This procedure, often referred to as "fitting," "programming,"
"mapping" ("mapping" herein) involves measuring and controlling the
amount of electrical current delivered to the cochlea. Typically, a
clinician, audiologist or other medical practitioner (generally and
collectively referred to as "audiologist" herein) uses interactive
software and computer hardware to create individualized programs,
commands, data, settings, parameters, instructions, and/or other
information (generally and collectively referred to as a "MAP"
herein) that define the specific characteristics used to generate
the electrical stimulation signals presented to the electrodes of
the implanted electrode assembly. It is increasingly common for
recipients to have a cochlear implant for each ear, which is
commonly known as bilateral implantation. The advantages of
bilateral implantation vary from recipient to recipient, and may
include improved speech perception, and the ability to localize
sounds. However, due to differences in the anatomy and physiology
of recipients, and in the need to precisely place the electrode
array, there will almost always be differences in the map between
the left and right ears. The recipient will have two speech
processor devices, each operating according to a different MAP. The
speech processor devices are typically identical in appearance, and
may inadvertently be swapped. This is a particular issue for very
young and elderly recipients, as well as those with conditions such
visual impairment. The use of the incorrect speech processor device
will at best lead to reduced speech perception, as the incorrect
MAP is applied, and potentially to pain for the recipient as
excessive stimulation values are utilized for that ear.
SUMMARY
In a broad form, the present invention provides multiple sets of
operating parameters (maps or the like) within each external
device, each set being associated with an identified implant.
Before the external device begins to transmit stimulation or other
operational data to the implant, it determines the identity of the
implant, and then uses the corresponding set.
According to one aspect, the present invention provides a method of
controlling interaction between an external device and an implanted
device, the method including at least the steps of:
establishing communications between the implanted device and the
external device;
the external device determining an identification of the implant
and comparing the identification with identifications in a stored
list;
if the device matches one of said identifications, using a
corresponding set of operating parameters to interact with said
implant; and
otherwise, not interacting with said device.
According to another aspect, the present invention provides an
external device adapted to interact with an implanted device, the
external device being adapted to detect an identification from an
implanted device, determine if the identification corresponds to
one of a plurality of identifications, and if the identification
does correspond, utilise a stored set of operating parameters
corresponding to said identification.
According to another aspect, the present invention provides an
external hearing device adapted to interact with an implanted
device, the external device being able to be operatively positioned
to interact with either a left ear or right ear implanted device,
said external device including sensor means operatively adapted to
detect whether the external device is positioned to interact with
the left ear or the right ear implanted device, and in response to
said sensor utilise a stored set of operating parameters
corresponding to the left ear or the right ear implanted
device.
The present invention accordingly provides an arrangement whereby,
for the bilateral implantee, it does not matter which SP is
selected for which ear--both can store the map for each ear, and
deliver the correct stimulation instructions for the respective
implant. If the implant is not identified, the SP will not operate.
The invention can be applied in any form of implanted device where
multiple external devices may be inadvertently associated with the
wrong implanted device.
The invention is also applicable to implanted devices where the
external device may only be periodically connected, for example, a
totally implantable auditory prosthesis.
BRIEF DESCRIPTION OF THE DRAWINGS
Embodiments of the present invention will now be described with
reference to the accompanying figures, in which:
FIG. 1 illustrates schematically a bilateral implant situation;
FIG. 2 is a conceptual block diagram of the operation of one
implementation of the present invention;
FIG. 3 is a flowchart illustrating the operation of the required
software of one implementation;
FIG. 4 illustrates the general operation of a cochlear implant
system;
FIG. 5 illustrates the operation of another implementation of the
identification system; and
FIG. 6 is a graph illustrating how the characterisation of a
predefined subset of parameters can be used to differentiate
between two similar implants.
DETAILED DESCRIPTION
The present invention is capable of implementation in any desired
type of implantable device which interacts with an external device.
For example, the present invention may be used in conjunction with
any acoustic or electrical auditory device, such as a middle ear
implant, intracochlear array implant, brain stem implant, implanted
acoustic device or any combination, for example combined electrical
and acoustic stimulation. The external device may be continuously,
intermittently or occasionally in communication with the implanted
device. The present invention may also be used in non-auditory
applications where a component is implanted and interacts with an
external device. However, embodiments of the invention are
described with reference to an embodiment in a cochlear implant
system.
FIG. 1 illustrates conceptually a recipient 10 having an
intracochlear device 11, 12 implanted in each ear 13, 14,
respectively. For each implant 11, 12, a corresponding external
device 17, 18 is required. The external device incorporates one or
more microphones, batteries, processor and the necessary software
to process sound signals and transmit them via coils 15, 16 to the
implanted device.
A more detailed description of typical external and implant devices
of a cochlear implant is provided in FIG. 4. It is noted that such
devices are in widespread commercial use, and well understood by
those skilled in the art, so that only a general overview of their
structure and operation will be provided. Moreover, various
structural variations and alternatives exist, as will be well known
to those skilled in the art.
FIG. 4 illustrates an overview of the components of one form of
implantable hearing prosthesis, a cochlear implant. The external
component of the cochlear implant, generally indicated as 142,
includes a behind the ear (BTE) device 116, designed to sit behind
the pinna 122. This houses the required electronics and software
(not shown), and batteries to power the external component as well
as transfer power to the implanted device 144. BTE device 116 is
connected via a lead 118 to the antenna transmitter coil 106, which
is generally disc shaped and includes housing 108 for the coil
itself (not shown). A magnet 110 is provided to assist in correctly
locating the antenna transmitter coil 106 relative to the implanted
device, to optimize efficiency of power and data transfer.
The implanted component 144 includes receiver/stimulator unit 112
and electrode lead 130. Receiver stimulator unit 112 includes a
sealed electronics package 128, and a coil 124 to receive the RF
signals sent from transmitter coil 106. There may also be a back
transmission mechanism, to transfer telemetry data to the external
device 142. A magnet 140 provides assistance in alignment of the
transmission coil 106. Electrode lead 130 passes stimuli to the
electrodes 134 for delivery within the cochlea 132, so as to
produce a neural response in auditory nerve 138.
In operation, the electronics within the BTE device 116 convert
sound detected by microphone(s) 120 into a coded signal. The
external antenna coil 106 transmits the coded signals, together
with power, to the receiver/stimulator unit 112 via a radio
frequency (RF) link.
Once implanted, the parameters for stimulation are typically
adjusted to suit the specific needs of the recipient. As the
dynamic range for electrical stimulation is relatively narrow and
varies across recipients and electrodes, there is a need to
individually tailor the characteristics of electrical stimulation
for each recipient. Audiology measurements may be used to establish
the useful range for each electrode, and such parameters can be
stored within the recipient's BTE device 116 for continual use. As
noted, this procedure is often referred to as "mapping" and is the
term commonly given to the process of measuring and controlling the
amount of electrical current delivered to each electrode, as well
as selecting which electrodes to stimulate corresponding to the
respective sound signal. Other operational issues which may differ
between ears include the speech processing strategy or parameters
of that strategy, when to switch between different strategies, and
other functions and parameters. Different "MAPS" may be applied in
different situations/environments such as home, car, classroom,
theatre etc, so each external device may store many maps. It will
be appreciated that the present invention is applicable to the
selection of all such functions and parameters as may be
customizable for each patient or implant according to the
particular requirements and options of the implant and external
device in question.
Importantly for the present invention, the MAP for each implant
will differ due to variations in the patient's anatomy and
physiology, and in the precise placement of the electrode array,
there will almost always be differences in the MAP between the left
and right ears.
FIG. 2 illustrates one implementation of the present invention.
Microphone(s) 120 receives ambient sound signals which are then
processed by a digital signal processor (DSP) 31. The signals are
processed according to any one of the known speech processing
strategies to produce a set of signals which are intended as the
basis for stimulation. The signals are then converted into specific
sets of stimuli for specific electrodes at specific times and for
specific amplitudes. The set of MAPS (that is, the MAPS
corresponding to different environments) for the appropriate
implanted component 144 is required to perform this process.
According to this implementation, multiple sets of MAPS are stored,
each set of MAPS corresponding to a particular implant identifier.
Embodiments of the implant identifier are described in further
detail below. Module 33 selects the appropriate MAP, and other
parameters as required, based on the implant ID identified by
module 33. Once the stimuli have been determined, the appropriate
coded signals are transmitted via the bidirectional communications
interface 34 to interface 44 of implanted component 144. From the
perspective of implanted component 144, it is not necessary to
change the mode of operation. The receiver/stimulator 41 receives
the signal, converts it to a set of stimuli, for example using an
optional digital signal processor (DSP) 42, and sends the stimuli
to electrodes 134.
Implanted component 144 may contain a module to provide the require
ID signal. This may be any arrangement capable of providing an
appropriate ID signal which is not shared with other implants. It
is ideally unique, but need not be. One option would be to send a
specific electrical signal after power up or after detection that
the external device is in operation. This type of ID is used in
some commercially available devices. Any alternative form of
implant identification can be employed with the present
invention.
One alternative would be to provide some form of specific automatic
identification of which side of the recipient's head an external
device, such as a BTE device, has been placed. This could be done
by the use of a proximity or thermal sensor such as is shown as
reference 200 on FIG. 4. In the thermal case, the sensor will
operatively either be placed near adjacent the user's head, or
facing away, with a substantial difference in heat. This allows the
appropriate left or right map to be selected. However, this does
not prevent the recipient from using a completely wrong device, as
may occur in a classroom situation.
Another alternative would be to provide a source localization
algorithm on the microphone in external device 17, 18. If the
device is on the left ear, most sound will come from the right side
and vice versa allowing determination of which ear the device has
been placed and therefore allowing the appropriate selection of
left or right map.
If no sensor is working and the implanted component is one that
cannot transmit internal voltages, external device 17, 18 may still
have MAPS for the left and right which the recipient 10 may select
themselves, for example by pressing a selection button at
start-up.
An approach suitable for use for an implant which has not been
designed to produce a specific ID signal will be described with
reference to FIGS. 5 and 6. The general approach is in principle
applicable to any implant which is capable of sending the required
parameters via a telemetry system to the external device. The
principle of this approach is that each device has internal
operating values that vary from device to device. The present
example uses certain internal voltages which can be output using
existing telemetry arrangements, and which as a statistical measure
allow for accurate identification of particular implants. However,
any suitable subset of internal parameters could be used as may be
appropriate for a particular implant device.
FIG. 5 illustrates the statistical basis used. In any real system,
manufacturing variations result in various parameters having a
normally distributed range of values about a nominal value. The
parameters are required to fall within minimum and maximum ranges
to be acceptable from a quality perspective. However, some of these
values are relatively constant over time, and are a specific value
of that parameter for the particular implant. When a number of
these parameters are considered separately, then if there is a
sufficient overall match, the implant can be sufficiently
identified.
The choice of the suitable subset of parameters for use in device
identification will depend on device design and the normal variance
of the parameters. Most active implantable devices have a range of
internal parameters that may be suitable, such as regulated supply
voltages, reference voltages and programmable currents.
For example, referring to FIGS. 6A and 6B, the following parameters
might be selected:
Parameter 1=Regulated analogue supply voltage (Vdda)
Parameter 2=Regulated digital supply voltage (Vddd)
Parameter 3=Reference voltage (Vref)
Parameter 4=Voltage measured across internal load for stimulus
level A1
Parameter 5=Voltage measured across internal load for stimulus
level A2, where the value of the internal load resistor and the two
current levels A1 and A2 will vary between implants.
Parameters 6 to 10=Parameters 1 to 5 but measured using a different
voltage measurement range. The gains of the different measurement
ranges will vary between implants, for example due to the
non-linearity of the voltage amplifier in each implant.
Alternatively, other measurements such as the physiological
properties of the ear, eg some aspect of the neural response with
the implant or the impedance of the electrodes in the cochlea, can
be used as parameters for use in device identification.
FIGS. 6A and 6B show the value of various voltages, plotting the
parameter value against the parameter. It can be seen that each
implant has a specific signature which is different from other
implants, so as to provide a specific identification of a
particular implant. It is possible that another implant could have
the set of parameter values, but this is sufficiently unlikely that
that the practical risk of inadvertent connection may be
disregarded.
One implant will now be described. For each implant (at the time of
first surgery, or first fitting) the subset of parameters listed
above is measured and stored as internal ID pattern. To improve the
reliability of the measurement the parameters can be averaged,
which also serves to minimize the statistical variance.
Every time the speech processor is placed on an implant the same
subset of parameters is measured. The ID recognition test passes if
and only if all of the parameters measured lie within, say T*sd of
the value of that parameter in the internal ID pattern. The
parameter T is a threshold that determines the trade-off between
the sensitivity and specificity of the test: a large value of T
means that we have a very low probability of wrongfully rejecting
the correct implant (false negative rate), a small value of T means
we have a low probability of wrongfully accepting the wrong implant
(false positive rate). The parameter sd in the test criteria is the
standard deviation of each parameter on repetitive measurement on
the same implant, which is around 0.6 for the Freedom implant.
Trials have indicated that T=3.25 provides acceptable false
negative and false positive outcomes. It will be understood that
for each type of implant, different parameters may be appropriate,
and different values for T and standard deviation will need to be
applied. The standard deviation may be different for different
parameters.
It will be appreciated that this is a process which will differ for
different external devices and a suitable set of identification
parameters can be selected as has been described.
In practice, every time the speech processor is switched on
stimulation should be halted until an implant is detected. Also,
when a coil-off condition occurs for longer than 3 seconds,
stimulation should halt until the implant is detected again. Before
starting stimulation (at switch on, or after coil-off the test
should pass first.
When an implant is (re)detected, the above mentioned parameters are
measured using 50 averages. This dataset is labelled D(1) . . .
D(n). The speech processor should check that for I=1 . . . n:
R(i)+T*sd<T(i)>R(i)-T*sd
When the test passes, stimulation can start. If the test fails, it
is repeated to rule out statistical errors. When after five (5)
tests, the test still fails the speech processor should refrain
from stimulating and give a helper message on the LCD display of
the implant.
It may be desirable in some applications that the user be able to
overrule the error and start stimulation by a specific button press
combination to manually select the correct operating program for
the implant.
It will be understood that a different process may be used to
implement the invention if desired, and that alternative processes
are likely for different external devices.
FIG. 3 is a flow chart illustrating the process which can be
employed in the BTE device 116 software. It is noted that it would
be possible to perform the ID process primarily from the implant
itself, however, in general it is preferred to minimise the
complexity and processing load for the implanted device.
FIG. 3 shows the step 50 by which the identifier is detected. This
will obviously differ depending upon the identifier used. Once the
identifier is located, at step 51, the appropriate parameters and
mode of operation will be selected, corresponding to the implant
identified. It will be appreciated that the exact set of parameters
will depend upon the type of implant, and apart from the map as
such, may include other operating parameters, mode of stimulation,
type of speech processing algorithm, and such other parameters as
are desired.
It is preferred that the identification process occur as often as
required to ensure safe operation. This may include, for example,
at power on of the BTE device, or whenever communications between
the implant and BTE are interrupted for more than some
predetermined period, for example 3 seconds. In each case, the ID
process should be completed before stimulation occurs.
Once the parameters are determined at step 51, operation of the
device can be initiated. At step 53, operation can continue until
conditions require the ID to be re-checked, as noted above.
It will be understood that the present invention may be applied to
include more than two sets of operating parameters. For example, in
a household where there are multiple implant users, all the SP
devices could be loaded with the parameters for the implants of
everyone in the house. This may be of particular benefit with small
children. The present invention further provides flexibility for
the user. If one SP device is not operating, for example due to low
battery power, the remaining device can be used for the better
ear.
Further features and advantages of the present invention may be
found in International Application No. PCT/AU2007/000142 entitled
"IMPLANT ID RECOGNITION", filed on Feb. 9, 2007, which claims
priority from Australian Provisional Patent Application No.
2006900628, filed on Feb. 10, 2006, which are hereby incorporated
by reference.
It will be appreciated that any other suitable identification
process can be used in accordance with the present invention.
Variations and additions can be readily added as will be apparent
to those skilled in the art.
* * * * *