U.S. patent application number 12/900449 was filed with the patent office on 2011-04-07 for system for remote monitoring and modulation of medical apparatus.
Invention is credited to John T. McElveen, JR..
Application Number | 20110082520 12/900449 |
Document ID | / |
Family ID | 43823798 |
Filed Date | 2011-04-07 |
United States Patent
Application |
20110082520 |
Kind Code |
A1 |
McElveen, JR.; John T. |
April 7, 2011 |
SYSTEM FOR REMOTE MONITORING AND MODULATION OF MEDICAL
APPARATUS
Abstract
A system for remotely programming a programmable medical
apparatus, comprising a digital interactive communications network
including an encrypted VPN tunnel interconnecting respective
computers and video conferencing devices at a programming site and
a remote programmed site, with VNC linkage of the interconnected
computers, wherein the computers are arranged for programming the
programmable apparatus from the programming site, with at least 1
megabit/second connection in both directions of interconnection,
whereby audio and video signals are synchronized for the
programming the programmable apparatus
Inventors: |
McElveen, JR.; John T.;
(Raleigh, NC) |
Family ID: |
43823798 |
Appl. No.: |
12/900449 |
Filed: |
October 7, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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61249546 |
Oct 7, 2009 |
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61302126 |
Feb 6, 2010 |
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Current U.S.
Class: |
607/57 ;
607/60 |
Current CPC
Class: |
H04R 25/70 20130101;
A61N 1/37282 20130101; G16H 80/00 20180101; A61N 1/37264 20130101;
H04R 25/30 20130101; A61B 5/0022 20130101; G16H 40/67 20180101;
A61N 1/36038 20170801; G06F 19/00 20130101; A61B 5/0031 20130101;
H04R 2225/55 20130101 |
Class at
Publication: |
607/57 ;
607/60 |
International
Class: |
A61F 11/04 20060101
A61F011/04; A61N 1/08 20060101 A61N001/08 |
Claims
1. A system for remotely programming a programmable medical
apparatus, comprising a user location attendable by a user of the
programmable medical apparatus, and a remote programming location
that is communicationally coupled to the remote programming
location by an interactive communication capability by which the
remote programming location can communicatively program the
programmable medical apparatus.
2. The system of claim 1, wherein the remote programming location
is communicationally coupled to the remote programming location by
an interactive communications network.
3. The system of claim 1, wherein the interactive communications
network comprises the Internet.
4. The system of claim 2, wherein the programmable medical
apparatus comprises a cochlear implant.
5. The system of claim 2, wherein the interactive communications
network comprises a virtual private network.
6. The system of claim 1, wherein the programmable medical
apparatus comprises an apparatus selected from the group consisting
of audiological equipment, pacemakers, intelligent prosthetics,
neural prostheses of a programmable character, hearing aids,
implantable pumps, deep brain stimulation apparatus, swallowable
monitoring and diagnostic capsules containing programmable devices,
programmable interfaces utilized in therapeutic intervention for
treatment of human or veterinary subjects, health status monitors,
and devices transmitting telemetry data out of a human or animal
body.
7. The system of claim 1, wherein the programmable medical
apparatus comprises an apparatus selected from the group consisting
of cochlear implants, in-ear hearing aids, bone conduction hearing
aids, implantable hearing aids, auditory feedback speech therapy
devices, and voice-activated medical apparatus.
8. The system of claim 1, wherein the interactive communication
capability is characterized by at least 1 Mb/second communication
rate.
9. The system of claim 1, wherein the interactive communication
capability comprises a digital interactive communications network
including an encrypted VPN tunnel interconnecting respective
computers and video conferencing devices at a programming site and
a remote programmed site, with VNC linkage of the interconnected
computers, wherein said computers are arranged for programming the
programmable apparatus from the programming site.
10. The system of claim 9, wherein the interactive communication
capability comprises an at least 1 megabit/second connection in
both directions of interconnection, whereby audio and video signals
are synchronized for the programming the programmable
apparatus.
11. A method of remotely programming a programmable medical device,
comprising use of the system of claim 1.
12. A system for remotely programming a programmable medical
apparatus, comprising a digital interactive communications network
including an encrypted VPN tunnel interconnecting respective
computers and video conferencing devices at a programming site and
a remote programmed site, with VNC linkage of the interconnected
computers, wherein said computers are arranged for programming the
programmable apparatus from the programming site, with at least 1
megabit/second connection in both directions of interconnection,
whereby audio and video signals are synchronized for the
programming the programmable apparatus.
13. The system of claim 12, wherein the programmable medical
apparatus comprises an apparatus selected from the group consisting
of cochlear implants, in-ear hearing aids, bone conduction hearing
aids, implantable hearing aids, auditory feedback speech therapy
devices, and voice-activated medical apparatus.
14. The system of claim 12, wherein the programming site and remote
programmed site are separated by a distance of at least 1 mile.
15. The system of claim 12, wherein the programming site and remote
programmed site are separated by a distance of at least 50
miles.
16. A system for remotely programming a cochlear implant,
comprising a digital interactive communications network including
an encrypted VPN tunnel interconnecting respective computers and
video conferencing devices at a programming audiologist site and a
remote audiologist patient site, with VNC linkage of the
interconnected computers, wherein said computers are arranged for
programming the cochlear implant from the programming audiologist
site, with at least 1 megabit/second connection in both directions
of interconnection, whereby audio and video signals are
synchronized for the programming the cochlear implant.
17. The system of claim 16, which transmits and receives
interconnection communications between the programming audiologist
site and the remote audiologist patient site that are HIPPA
compliant.
18. The system of claim 16, wherein said digital interactive
communications network includes a T1 line between the programming
audiologist site and the remote audiologist patient site.
19. A method for remotely programming a medical apparatus,
comprising use of the system as claimed in claim 12.
20. A method for remotely programming a cochlear implant,
comprising use of the system as claimed in claim 16.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The benefit of priority of U.S. Provisional Patent
Application 61/249,546, filed Oct. 7, 2009 in the name of John T.
McElveen, Jr. for "SYSTEM FOR REMOTE MONITORING AND MODULATION OF
COCHLEAR IMPLANTS," and the benefit of priority of U.S. Provisional
Patent Application 61/302,126, filed Feb. 6, 2010 in the name of
John T. McElveen, Jr. for "SYSTEM FOR REMOTE MONITORING AND
MODULATION OF COCHLEAR IMPLANTS," are hereby claimed under the
provisions of 35 USC 119(e). The disclosures of said U.S.
Provisional Patent Applications 61/249,546 and 61/302,126 are
hereby incorporated herein by reference, in their respective
entireties, for all purposes.
FIELD OF THE INVENTION
[0002] The present invention relates to a system and method for
remotely monitoring and modulating programmable medical apparatus,
e.g., programmable audiological medical devices such as cochlear
implants and other programmable hearing devices, utilizing an
interactive communications network such as the Internet.
BACKGROUND
[0003] Since its inception in the late 1960s and early 1970s,
telemedicine has continued to evolve as an acceptable and effective
modality for therapeutic intervention. The initial era of
broadcasting or posting non-integrated audio and visual data has
given way to digitization and simultaneous transmission of
interleaved audio and video data streams delivered at higher speeds
over private networks (Bashshur, R., Telemedicine and Health Care,
Telemed J E Health 2002; 8: 5-12). This in turn has led to lower
cost and even faster transmission implementations of telemedicine
utilizing interactive global communication networks such as the
Internet.
[0004] The present invention utilizes the potential of such high
speed, high bandwidth interactive global communications networks
for remotely monitoring and modulating programmable medical
apparatus, including programmable audiological medical devices such
as cochlear implants, in-ear hearing aids, bone conduction hearing
aids, implantable hearing aids, auditory feedback speech therapy
devices, voice-activated medical apparatus, and the like. In a wide
variety of applications, the invention achieves a substantial
advance in the art, by markedly enhancing the performance and
patient experience of medical apparatus.
SUMMARY
[0005] The present disclosure relates to apparatus and method for
remotely monitoring and modulating programmable medical
apparatus.
[0006] In one aspect, the disclosure relates to a system for
remotely programming a programmable medical apparatus, comprising a
user location attendable by a user of the programmable medical
apparatus, and a remote programming location that is
communicationally coupled to the remote programming location by an
interactive communication capability by which the remote
programming location can communicatively program the programmable
medical apparatus.
[0007] The disclosure in another aspect relates to a system for
remotely programming a programmable medical apparatus, comprising a
digital interactive communications network including an encrypted
VPN tunnel interconnecting respective computers and video
conferencing devices at a programming site and a remote programmed
site, with VNC linkage of the interconnected computers, wherein
said computers are arranged for programming the programmable
apparatus from the programming site, with at least 1 megabit/second
connection in both directions of interconnection, whereby audio and
video signals are synchronized for the programming the programmable
apparatus, e.g., cochlear implants, in-ear hearing aids, bone
conduction hearing aids, implantable hearing aids, auditory
feedback speech therapy devices, voice-activated medical apparatus,
and the like.
[0008] A further aspect of the disclosure relates to a method for
remotely programming a programmable medical apparatus, comprising
use of the system as described above.
[0009] In another, specific aspect, the disclosure relates to a
system for remotely programming a cochlear implant, comprising a
digital interactive communications network including an encrypted
VPN tunnel interconnecting respective computers and video
conferencing devices at a programming audiologist site and a remote
audiologist patient site, with VNC linkage of the interconnected
computers, wherein said computers are arranged for programming the
cochlear implant from the programming audiologist site, with at
least 1 megabit/second connection in both directions of
interconnection, whereby audio and video signals are synchronized
for the programming the cochlear implant.
[0010] In another aspect, the disclosure relates to a method for
remotely programming a cochlear implant, comprising use of the
system as described above.
[0011] Other aspects, features and embodiments of the disclosure
will be more fully apparent from the ensuing description and
appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 is a schematic representation of a remote programming
system for remote audiological monitoring and programmatic control
of a cochlear implant in a human patient, according to one
embodiment of the disclosure.
[0013] FIGS. 2A, 2B and 2C are graphs showing preoperative and
postoperative audiological results, comparing remotely programmed
cochlear implant patients in Greenville, S.C., USA with a similar
group of locally programmed cochlear implant patients in Raleigh,
N.C., USA.
[0014] FIG. 3 is a graphical depiction of a map of the United
States, showing a current distribution of cochlear implant
audiologists in the United States.
DETAILED DESCRIPTION
[0015] The present disclosure relates to a system and method for
remote programming of medical apparatus.
[0016] While the disclosure is set out hereinafter primarily in
application to cochlear implants in human patients, as illustrative
of various medical apparatus with which the invention can be
usefully implemented, it will be recognized that the utility of the
invention extends to and encompasses a wide variety of apparatus
whose monitoring, calibration and operation are amenable to remote
intervention as herein generally described.
[0017] Such apparatus and devices include, without limitation,
cochlear implants, in-ear hearing aids, bone conduction hearing
aids, implantable hearing aids, auditory feedback speech therapy
devices, such as the choral feedback systems of U.S. Pat. Nos.
5,961,443; 6,754,632; 7,031,922; and 7,591,779, voice-activated
medical apparatus, and the like.
[0018] The disclosure will now be directed to an illustrative
implementation to cochlear implants.
[0019] The invention in such illustrative cochlear implant
implementation may be configured in a variety of arrangements,
utilizing specifically programmed computers and specialized
videoconferencing equipment installations at respective locations
of a programming audiologist (programming location) and a remote
patient (patient location). The invention thereby affords cochlear
implant centers with a means to access patients who may otherwise
be unable or unwilling to travel to the cochlear implant center for
programming or mapping of their cochlear implant devices.
[0020] The system and method of the invention enable efficient
programming of cochlear implants, in a safe and economic manner
that ensures patient privacy and real-time access with minimal
signal transmission and reception issues.
[0021] The invention in one implementation utilizes a remote
programming arrangement in which the Internet or other interactive
global communication network is employed to access a remote desktop
computer for programming, and for sending and receiving
synchronized, minimally delayed audio/visual signals. The system is
programmatically arranged to insulate the cochlear implant patient
from a corrupt signal or electrical surge during the cochlear
implant mapping process. A desktop computer is provided, programmed
with cochlear implant programming software, to generate a signal
from the remote computer to the patient's cochlear implant.
[0022] In order to avoid signal issues due to electrical surges,
all equipment utilized in programming cochlear implant patients in
accordance with the invention, including routers and Internet
switches, is desirably grounded, connected to surge protection
equipment, and provided with battery backup.
[0023] For the purpose of ensuring patient confidentiality, and
complying with the Health Insurance Portability and Accountability
Act (HIPPA) of 1996 governing remote programming techniques that
interface with the public Internet and involve electronic
transmission of protected health information, all data transmitted
in the operation of the system is encrypted and sent in a special
format safeguarding information. The data may be secured by
establishing a virtual private network (VPN) between the cochlear
implant patient remote site and the cochlear implant center
programming site. Such VPN creates an encrypted "tunnel"
(transmission path) through which all data flowing between the
remote patient site and local programming site are secure.
[0024] Although HIPPA-compliant encrypted communications are
contemplated to comply with applicable regulatory requirements, it
is recognized that non-encrypted communications may be employed in
various implementations of the invention.
[0025] Once the VPN link between the two sites is established, the
cochlear implant audiologist at the local programming site assumes
control of the remote computer using a Virtual Network Computing
(VNC) programming software package. VNC is a graphical desktop
sharing application using RFB protocol for remote control of
another computer, which transmits keyboard and mouse data from one
computer to another, and receives graphical screen feedback from
such other computer, over any suitable interactive communications
that work, such as the Internet. Since VNC is platform-independent,
the local programming site and remote patient site may utilize
computers employing different operating systems.
[0026] Thus, establishment of the VPN link between the remote
patient site and local programming site enables a cochlear implant
audiologist at the local site to take control of the remote
computer using the VNC application, while letting both sites
simultaneously view the computer screen and video link. The remote
site may include presence of a non-implant audiologist to
effectuate the programming of the cochlear implant device in the
patient.
[0027] Simultaneous viewing of the computer screen via the cochlear
implant audiologist and the non-implant audiologist is thereby
accommodated. This has two benefits. If there are any communication
errors or problems with the remote programming procedure, the
remote non-implant audiologist attending the patient can
immediately take control of the programming computer. In addition,
the simultaneous viewing enables training of the non-implant
audiologist to be carried out, since the audiologist at the remote
patient site is able to view the programming technique utilized by
the cochlear implant audiologist at the local programming site.
[0028] The system is arranged so that the audio and visual signals
between the respective sites are synchronized and minimally
delayed. It is generally undesirable to operate the audio, video
and computer programming software simultaneously via the computer,
since delays in signal transition may become unacceptable. Hearing
impaired patients rely, in part, on lip reading, and
synchronization of the audio and video signal is therefore
particularly important.
[0029] Consequently, the system preferably uses a videophone system
that bundles both audio and video signals so that both signals are
synchronized with one another. Because the videophones transmit
information via the Internet, the VPN used to transmit this data
provides a secure arrangement protecting the data and privacy of
the patient. Any suitable videophone system can be employed.
Commercially available videophone systems that may be
satisfactorily utilized in the practice of the present invention
include the D-Link i2eye Broadband Desktop Videophone (DVC 2000),
and the Polycom.RTM. V700.TM. video conferencing system.
[0030] The human eye perceives real-time, smooth motion as 30
frames per second (fps). Transmission at this speed requires a
large bandwidth, which is not cost effective. To compensate,
computers compress the signal at the origin and decompress it at
the receiving site. If the video and audio compression is being
performed on the same computer, it competes with the computer's
other applications, and thus videophones are preferred in the
practice of the present invention. The audio and video information
on the videophone runs independently and does not compete with the
applications running on the cochlear implant computer.
[0031] It is desired that the image resolution on the videophone
provide smooth motion visualization, with good field of view
characteristics.
[0032] The aforementioned Polycom.RTM. V700.TM. video conferencing
system uses a bandwidth of 768 kilobits/sec (kbps) and interleaves
video and audio streams, providing synchronized delivery. Such
bandwidth (768 kbps) is consistent with most small business
Internet connection speeds. The Polycom.RTM. V700.TM. device also
has its own IP address, which allows routers/switches to prioritize
such device over other network devices. The Polycom.RTM. V700.TM.
video conferencing device requires 768 kbps in both directions for
optimal performance, and can use a T1 line or other suitable
connection.
[0033] In utilizing the interconnected computers and video
conferencing equipment, good "site to site" connection is desirable
to minimize signal delay and enhance audio/visual quality. Internet
connections are adequate to satisfy such operational parameters. A
commercial grade Internet connection should be used by both remote
and local sites when performing remote programming, such as the T1
line above mentioned. A consistent 1 megabit/sec connection in both
directions is the minimum required for high performance.
[0034] In order to check for lost packets or long network delays
that would otherwise adversely affect the audio/video signal
between the remote and local sites, suitable software, e.g.,
PingPlotter (Messoft, LLC) may be employed. PingPlotter is a
network troubleshooting tool for Windows.RTM. that uses a
combination of "tracerrout", "ping", and "whois" to demonstrate the
"hops" on the Internet the signal packets are taking, and the
length of time required. It may be preferred to utilize the same
Internet service provider (ISP) for the local and remote sites, in
order to better ensure that transmitted data packets stay on the
ISP's "back-bone". This minimizes the number of "hops" and provides
better and more consistent transmission times.
[0035] In tests of the inventive remote programming system,
patients appeared to genuinely appreciate the convenience of having
their cochlear implant placed and programmed locally (at the
patient site remote from the cochlear implant audiologist site). In
a specific test, involving patients whose devices were remotely
programmed in Greenville, S.C. and locally in Raleigh, N.C., no
significant differences were found between the respective location
cohorts in the scores for the HINT sentence test or the CNC word
test. These results show the equivalence of fitting cochlear
implants locally or remotely, with proper equipment, communication
links, and safeguards.
[0036] Thus, the present invention enables remote programming of
cochlear implant patients using the Internet or other interactive
data communications networks. The empirical tests of the invention
demonstrate that patients programmed remotely have done as well as
locally programmed patients. It therefore is possible to conduct
surgical procedures and cochlear implant mapping in remote
locations, and to subsequently program implants remotely via
Internet data, voice and video transmission, with or without the
assistance of an audiologist or other caregiver at the patient
site. The invention enables effective and high quality cochlear
implant mapping and programming to be performed remotely at
satellite clinics via an Internet or other digital interactive
data/voice/video communication networks. The invention also
contemplates the establishment of remote sites that are arranged
for self-testing with little or no technical medical assistance
being required, such as sites at which an audiologist and/or other
medical personnel are replaced with automated systems that are
interactive with the patient and the remote monitoring and control
site. In still other embodiments, the monitoring and calibration
operations may be effected by a mobile monitoring and calibration
assembly, which may be fixed or motive in character, such as a
vehicular platform that is driven or trailered to a specific
location, e.g., an urban area, a remote area, or a location having
a suitable communications node, and operated using interactive
networks, wireless communications such as a wireless telephony
network for smart phone usage, satellite communications, or other
communication modalities.
[0037] It will also be appreciated that the invention is
susceptible of implementation. In embodiments in which synchronized
audio and video signals are non-essential to the programming of the
programmable medical apparatus, and in which non-synchronized audio
signals can be used, or in which optoelectronic signal transmission
can be utilized for the remote programming, or in which other
signal transmission modalities may be employed to effect the
programming operation.
[0038] Thus, the invention may be practiced to carry out remote
programming with or without a VPN, and with or without audio and
visual signal synchronization, such as by use of interconnected
computers at the respective patient and monitoring sites.
[0039] The invention contemplates application using in vivo
monitoring or ex vivo monitoring programmable devices that are
susceptible to remote or otherwise automated programming, including
calibration and adjustment, such as by running selected or
automated testing routines providing input to a monitoring module
that responsively reprograms the device, to ensure enhanced
operational capability of such device. The testing routines may be
of a routine maintenance character, or may be selected by the
patient, central processor, or medical personnel to determine
whether operation of the programmable devices within allowable
tolerances, or alternatively, such device requires adjustment,
recalibration or the like.
[0040] Programmable devices to which the system and method of the
present invention can be applied include, without limitation,
audiological equipment, pacemakers, intelligent prosthetics, neural
prostheses of a programmable character, hearing aids, implantable
pumps, e.g., for insulin administration, deep brain stimulation
apparatus, swallowable monitoring and diagnostic capsules
containing programmable devices, other programmable interfaces
utilized in therapeutic intervention for treatment of human or
veterinary subjects, health status monitors, e.g., devices
transmitting telemetry data out of a human or animal body, and any
other programmable medical, therapeutic, or diagnostic device.
[0041] The invention may be practiced with any appropriate modes of
communication between the remote monitoring site and the patient
site, and as mentioned, devices can be remotely programmed over the
Internet, or via other interactive communications networks, with or
without virtual private network (VPN) and/or encryption of
communications.
[0042] The features and advantages of the invention are more fully
shown by the following non-limiting example.
Example
[0043] An experimental satellite cochlear implant program was
established in Greenville, S.C., over 250 miles from a tertiary
cochlear implant center in Raleigh, N.C. Medical and audiology
licenses to practice in South Carolina were obtained by the implant
surgeon and the cochlear implant audiologist.
[0044] Both sites were equipped with a desktop computer and
commercially approved cochlear implant programming hardware and
software. The following additional layer of hardware and software
technology was also installed to enable the remote programming
capability: (a) a commercial grade Internet connection was
installed in both locations; (b) for security concerns, routers
with Virtual Private Network (VPN) capabilities (Netgear.RTM.
ProSafe VPN Firewall Model FVS 318, San Jose, Calif.) were
installed to provide secure communication between sites; (c)
Virtual Network Computing (VNC) remote desktop software was
installed and configured at both sites, allowing the computer in
Raleigh to control the desktop in Greenville, S.C.; and (d) a
commercial video conferencing system, the Polycom.RTM. V700.TM.
(Polycom.RTM. Inc., Andover, Mass.) was installed in the Raleigh
and Greenville offices, in an arrangement as schematically
represented in FIG. 1.
[0045] In order to minimize inconvenience and cost for the cochlear
implant patients, the cochlear implant evaluation, cochlear implant
surgery, and cochlear implant mapping were all performed in
Greenville, S.C.
[0046] An experienced cochlear implant audiologist from the
tertiary cochlear implant center in Raleigh trained a "non-cochlear
implant" audiologist in Greenville to perform the initial
evaluation. In addition to standard diagnostic audiological
testing, the initial evaluation included Hearing in Noise Test
(HINT) sentences and Consonant/Nucleus/Consonant (CNC) word lists.
It is noted that other speech reception measures such as Freiburg
could alternatively, or additionally, be utilized. The cochlear
implant audiologist directly screened the patients for cochlear
implant candidacy in Greenville on a quarterly basis, and the
patients were then evaluated by the otologist for possible cochlear
implantation. Informed consents were obtained, and those candidates
who were surgical candidates underwent cochlear implantation at
Greenville Memorial Hospital, in Greenville, S.C.
[0047] The patients were scheduled for programming of their implant
at one month, three months, six months, and twelve months,
postoperatively. HINT and CNC scores were obtained at that time.
The cochlear implant was programmed using the following
protocol:
[0048] (i) The audiologist in Greenville brought the cochlear
implant programming system online and readied it prior to the
patient arriving, confirming the audio and video connection with
the Raleigh office.
[0049] (ii) The Raleigh audiologist who performed the implant
programming opened the VNC remote desktop connection in order to
take over the Cochlear implant programming computer in
Greenville.
[0050] (iii) The patient was then brought into the Greenville
cochlear implant programming room, and was accompanied by the
Greenville audiologist at all times during the programming
procedure. The audiologist with the patient observed the entire
procedure, and was available to take control of the programming
computer in Greenville if necessary.
[0051] (iv) The VNC remote desktop software transmitted keystrokes
and mouse movements from the Raleigh computer to the Greenville
computer, and the Greenville computer returned screen updates to
the computer in Raleigh. Although the cochlear implant audiologist
inputted the commands for programming in Raleigh, the application
on the computer in Greenville actually programmed the implant.
[0052] Using the above protocol, patients had a standard post
cochlear implant test battery performed at one, three, six and
twelve months after implantation. Postoperative HINT and CNC word
scores for the seven post-lingually deafened patients who had
undergone remote mapping and programming of their Nucleus Freedom
cochlear implant were compared with the scores of seven
post-lingually deafened patients who had similar durations of
deafness, and who had been programmed in Raleigh by the same
audiologist over a six to twelve month period. This group also had
the Nucleus Freedom cochlear implant.
[0053] In the Greenville group, there were four males and three
females ranging in age from 15 years to 87 years. Excluding the 15
year old patient, the mean age of the Greenville group was 67
years, with only one year difference from the seven Raleigh
patients ranging in age from 54 to 79 years, with a mean age of 68
years. The Raleigh group consisted of one male and six females.
Each of the subjects was implanted with the Freedom.TM. cochlear
implant (Cochlear Corporation; Englewood, Colo.). The cochlear
implant audiologist assessed the times required for both remote and
on-site programming/mapping.
[0054] Results
[0055] All surgeries were performed without complications. Each of
the patients' implants was successfully programmed at the
Greenville site by the cochlear implant audiologist over 250 miles
away.
[0056] None of the patients experienced apparent signal corruption
or any AC electrical surge during programming. Upgrading from the
D-Link i2eye Broadband Desktop Videophone (D-Link: DVC 2000;
Taiwan) to the Polycom.RTM. V700.TM. video conferencing system
resulted in some experience of signal interruption. Using
PingPlotter, a network troubleshooting and diagnostic tool for
Windows, the problem was traced to the router in Greenville. This
was rectified by installing a T1 line, prioritizing the video
signal, and removing the D-Link settings associated with the
router. The "round trip" signal time between Raleigh and Greenville
was approximately 58 msec.
[0057] The commercial grade Internet connection, and the hardware
and software used for remote programming, proved reliable. The
network latency issues related to remote programming did not
interfere with the mapping, and the audiologist performing the
programming could accurately observe patient responses. The patient
and non-implant audiologist were also able to observe the implant
audiologist during the implant programming procedure.
[0058] The preoperative and postoperative audiological test results
for the Greenville patients are presented in Table 1, and the
results from the Raleigh patients are presented in Table 2. FIG. 2
shows comparisons between the Raleigh and Greenville cohorts for
pure tone averages (PTAs) for the pre- and post-operative intervals
(FIG. 2A); recognition of the HINT sentences for the pre-operative,
3 month, and 6 month intervals (FIG. 2B); and recognition of the
CNC words for those same intervals (FIG. 2C). Selection of the
pre-operative, 3 month, and 6 month intervals allowed inclusion of
the maximum number of tested subjects for the two measures of
speech reception. All seven of the Raleigh subjects are included in
panels (B) and (C), and the same five Greenville subjects (subjects
G3 through G7) are included in each of those panels. All seven
subjects from each of the cohorts are included in panel (A).
TABLE-US-00001 TABLE 1 OUTCOME MEASURES FOR GREENVILLE COCHLEAR
IMPLANT RECEIPENTS G1 G2 G3 G4 G5 G6 G7 Mean Pre-Op PTA 109 101 101
105 106 120 120 108.8571 Aided Post-Op PTA 18 16 29 13 10 18 15 17
Ear Implanted R R L R R L R Pre-Op HINT score 1 6 1 1 11 5 1
3.714286 Pre-Op CNC score 1 1 0 1 2 4 1 1.428571 1 month HINT score
55 32 88 57 84 no show no show 63.2 3 month HINT score no show 88
96 62 99 96 89 88.33333 6 month HINT score 54 NS 99 54 100 99 96
83.66667 12 month HINT score 82 87 100 NA 99 NA 94 92.4 1 month CNC
score 12 0 64 34 38 no show no show 29.6 3 month CNC score no show
70 72 62 82 74 49 68.16667 6 month CNC score 22 NS 74 36 76 72 40
53.33333 12 month CNC score 18 60 84 NA 82 NA 66 62
TABLE-US-00002 TABLE 2 OUTCOME MEASURES FOR Raleigh COCHLEAR
IMPLANT RECEIPENTS R1 R2 R3 R4 R5 R6 R7 Mean Pre-Op PTA 108 113 80
80 106 110 109 100.8571 Aided Post-Op PTA 26 25 28 31 28 30 26
27.71429 Ear Implanted L R R L R L R Pre-Op HINT score 2 4 0 0 0 0
0 0.857143 Pre-Op CNC score 0 4 0 0 0 0 0 0.571429 1 month HINT
score 75 73 49 65 95 30 2 55.57143 3 month HINT score 75 84 83 61
100 74 24 71.57143 6 month HINT score 88 80 84 78 100 78 47
79.28571 12 month HINT score 88 97 73 73 99 NA 62 82 1 month CNC
score 50 38 20 38 64 16 0 32.28571 3 month CNC score 62 46 26 44 84
42 6 44.28571 6 month CNC score 70 72 40 50 74 60 48 59.14286 12
month CNC score 70 66 50 28 90 NA 58 60.33333
[0059] Selection of the 3 and 6 month intervals also was guided by
the observation that speech test scores for adult cochlear implant
patients are generally asymptotic at 3-6 months of experience with
the devices (Wilson B S, Dorman M F, Cochlear implants; a
remarkable past and a brilliant future, Hearing Research 242:3-21,
2008). Thus, these intervals are especially useful "end points" for
assessing possible differences between cohorts or device
variables.
[0060] Each set of bars in FIG. 2 was compared with at test to
evaluate the significance of possible differences. A p value of
0.05 or lower was regarded as indicating a significant
difference.
[0061] None of the comparisons was significant except the
difference between cohorts for the post-operative measures of PTAs
(p<0.001). The difference in the means for the CNC word test at
the 3 month interval was not statistically significant
(p=0.083).
[0062] With the one exception, the results between the Greenville
and Raleigh cohorts were statistically indistinguishable. That one
exception is not an important difference, as the value for the
post-operative PTA is arbitrary in the sense that a wide range of
PTAs can be specified by the fitting audiologist through choices of
settings for thresholds and most comfortable loudness levels for
each of the electrodes in the implant and for the overall gain or
sensitivity of the speech processor. Small changes in these
settings sometimes can produce relatively large changes in the
PTAs. The effect of the settings produced a slightly lower mean PTA
for the Greenville cohort compared with the Raleigh cohort.
[0063] In addition, there was no substantial difference in time
commitment with programming the patients in Greenville, as compared
to the patients in Raleigh. Indeed, the cochlear implant
audiologist's time spent with the patient in Greenville was more
focused, with less tangential discussion.
[0064] Thus, the postoperative HINT and CNC word scores for the
seven patients who had undergone remote mapping and programming of
their cochlear implant were compared with the mean scores of seven
patients who had been programmed by the same audiologist over a
twelve month period, with the times required for remote and direct
programming being compared, and the quality of the Internet
connection assessed using standardized measures for remote
programming performed via VPN with separate software programs used
for video and audio linkage.
[0065] The results show that all seven patients were programmed
successfully via remote connectivity. No untoward patient
experiences were encountered. No statistically significant
differences could be found in comparing postoperative HINT and CNC
word scores for patients who had undergone remote programming
versus a similar group of patients who had their cochlear implant
programmed directly. Remote programming did not require a
significantly longer programming time for the audiologist with
these seven patients.
[0066] It is therefore concluded that remote programming of a
cochlear implant can be performed safely with the system and method
of the present invention, without any deterioration in the quality
of the programming. This ability to remotely program cochlear
implant patients provides the potential to extend cochlear
implantation to underserved areas in the U.S. and elsewhere.
[0067] The invention extends the reach of a cochlear implant
audiologist to patients who may not be able or willing to travel to
a tertiary cochlear implant center. As shown in the map depicted in
FIG. 3, there is substantial disparity in the number of cochlear
implant audiologists in a given region. Globally, a similar or even
greater disparity exists, particularly in underdeveloped countries.
In an empirical study to demonstrate the efficacy of the system and
method of the present invention, patients were programmed over 250
miles away from a tertiary cochlear implant center. As Internet
usage continues to expand, the apparatus and method of the
invention may have potential for use in more remote areas. In
another empirical test of the apparatus and method of the present
invention, an Internet connection was utilized to program a
cochlear implant patient remotely in Nigeria.
[0068] The invention thus is useful for remote programming of
medical apparatus where the programming and the programmed
locations are separated by distances measured in miles, e.g., at
least 1, 5, 10, 20, 50, 100, 250, or 500 or more miles, in various
embodiments of the invention.
[0069] While the invention has been has been described herein in
reference to specific aspects, features and illustrative
embodiments of the invention, it will be appreciated that the
utility of the invention is not thus limited, but rather extends to
and encompasses numerous other variations, modifications and
alternative embodiments, as will suggest themselves to those of
ordinary skill in the field of the present invention, based on the
disclosure herein. Correspondingly, the invention as hereinafter
claimed is intended to be broadly construed and interpreted, as
including all such variations, modifications and alternative
embodiments, within its spirit and scope.
* * * * *