U.S. patent application number 13/722185 was filed with the patent office on 2013-05-02 for neurostimulator system, apparatus, and method.
This patent application is currently assigned to AUTONOMIC TECHNOLOGIES, INC.. The applicant listed for this patent is Anthony V. Caparso, Kellie Fletcher, Patrick Hard, Karen Tsuei. Invention is credited to Anthony V. Caparso, Kellie Fletcher, Patrick Hard, Karen Tsuei.
Application Number | 20130110195 13/722185 |
Document ID | / |
Family ID | 48173169 |
Filed Date | 2013-05-02 |
United States Patent
Application |
20130110195 |
Kind Code |
A1 |
Fletcher; Kellie ; et
al. |
May 2, 2013 |
NEUROSTIMULATOR SYSTEM, APPARATUS, AND METHOD
Abstract
An apparatus (10) for applying stimulation therapy to a patient
includes an implantable medical device (20) and a remote controller
(50) for inductively powering the medical device and communicating
with the medical device. The remote controller (50) includes a
feedback portion (220) for helping to establish a communication
link between the remote controller and the implantable medical
device (20).
Inventors: |
Fletcher; Kellie; (Oakland,
CA) ; Hard; Patrick; (Redwood City, CA) ;
Caparso; Anthony V.; (San Francisco, CA) ; Tsuei;
Karen; (Redwood City, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Fletcher; Kellie
Hard; Patrick
Caparso; Anthony V.
Tsuei; Karen |
Oakland
Redwood City
San Francisco
Redwood City |
CA
CA
CA
CA |
US
US
US
US |
|
|
Assignee: |
AUTONOMIC TECHNOLOGIES,
INC.
Redwood City
CA
|
Family ID: |
48173169 |
Appl. No.: |
13/722185 |
Filed: |
December 20, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12688524 |
Jan 15, 2010 |
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13722185 |
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12765712 |
Apr 22, 2010 |
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12688524 |
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61578415 |
Dec 21, 2011 |
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61145003 |
Jan 15, 2009 |
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61171749 |
Apr 22, 2009 |
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61177895 |
May 13, 2009 |
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Current U.S.
Class: |
607/46 |
Current CPC
Class: |
A61N 1/37518 20170801;
A61N 1/0558 20130101; A61N 1/36075 20130101; A61N 1/0529 20130101;
A61N 1/37247 20130101; A61N 1/37282 20130101; A61N 1/37241
20130101; A61N 1/36071 20130101; A61N 1/3787 20130101; A61N 1/37264
20130101; A61N 1/37235 20130101; A61N 1/36132 20130101; A61N 1/0526
20130101 |
Class at
Publication: |
607/46 |
International
Class: |
A61N 1/36 20060101
A61N001/36 |
Claims
1. An apparatus for applying stimulation therapy to a patient, the
apparatus comprising: an implantable medical device; and a remote
controller for inductively powering the medical device and
communicating with the medical device, the remote controller
comprising a feedback portion for helping to establish a
communication link between the remote controller and the
implantable medical device.
2. The apparatus recited in claim 1, wherein the feedback portion
comprises a vibratory feedback having a frequency that varies in
response to the relative position of the remote controller and the
medical device.
3. The apparatus recited in claim 2, wherein at least one of the
frequency and intensity of the vibratory feedback changes as the
relative position of the remote controller and the medical device
approach an optimal communication position.
4. The apparatus recited in claim 1, wherein the feedback portion
comprises a visual feedback comprising visual indication having a
characteristic that varies in response to the relative position of
the remote controller and the medical device.
5. The apparatus recited in claim 4, wherein the characteristic
that varies in response to the relative position of the remote
controller and the medical device comprises at least one of a
graphic display and an LED indicator.
6. The apparatus recited in claim 1, wherein the feedback portion
comprises a audible feedback comprising an audible signal having a
characteristic that varies in response to the relative position of
the remote controller and the medical device.
7. The apparatus recited in claim 6, wherein the characteristic
that varies in response to the relative position of the remote
controller and the medical device comprises at least one of a tone,
volume, tone rate, and a voice command.
8. The apparatus recited in claim 1, wherein the feedback portion
comprises at least one of a visual feedback, an audible feedback, a
vibratory feedback, a shape/pressure feedback, a thermal feedback,
and a gyroscopic feedback.
9. The apparatus recited in claim 1, wherein the feedback portion
provides an optimal communication feedback responsive to a relative
position between the remote controller and the medical device.
10. The apparatus recited in claim 9, wherein the optimal
communication feedback is communicated by at least one of a visual
feedback, an audible feedback, and a vibratory feedback.
11. The apparatus recited in claim 9, wherein the feedback further
comprises a communication maintenance feedback responsive to
maintaining an optimal communication position of the remote
controller and the medical device, once established.
12. The apparatus recited in claim 11, wherein the communication
maintenance feedback is communicated by at least one of a visual
feedback, an audible feedback, and a vibratory feedback.
13. The apparatus recited in claim 11, wherein the communication
maintenance feedback comprises a gyroscopic feedback that is
adapted to memorize the optimal communication position of the
remote controller and determine a deviation from the memorized
position, the communication maintenance feedback being configured
to provide at least one of a visual feedback, an audible feedback,
and a vibratory feedback in response to the deviation.
14. A method for coupling a remote controller to an implantable
medical device, the method comprising the steps of: positioning the
remote controller relative to the medical device; adjusting the
position of the remote controller relative to the medical device in
response to an optimal communication feedback provided by the
remote controller; and maintaining the position of the remote
controller in response to a communication maintenance feedback
provided by the remote controller.
15. An apparatus for applying stimulation therapy to a patient, the
apparatus comprising: an implantable medical device storing at
least one of stimulation parameters and therapy settings; and a
remote controller for inductively powering the medical device, the
medical device being adapted to apply stimulation therapy to the
patient according to the stimulation parameters and therapy
settings.
16. The apparatus recited in claim 15, wherein the medical device
is capable of providing the stimulation therapy under the power of
the remote controller without requiring any parameters or settings
from the remote controller.
17. A method for applying stimulation therapy to a patient, the
method comprising the steps of: implanting an implantable medical
device in the patient; storing at least one of stimulation
parameters and therapy settings on the medical device; using a
remote controller to inductively power the implanted medical
device; and applying via the implanted medical device stimulation
therapy to the patient according to the stimulation parameters and
therapy settings.
18. The method recited in claim 17, further comprising the steps
of: storing therapy related questions on the medical device; using
the remote controller to retrieving the stored questions from the
implanted medical device; and using the remote controller to query
the patient with the stored questions.
Description
RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/578,415, filed Dec. 21, 2011. This application
is also a continuation-in-part of U.S. patent application Ser. No.
12/688,524, filed Jan. 15, 2010, titled "APPROVAL PER USE IMPLANTED
NEUROSTIMULATOR," which claims the benefit of U.S. Provisional
Application No. 61/145,003 filed Jan. 15, 2009. This application is
also a continuation-in-part of U.S. patent application Ser. No.
12/765,712, filed Apr. 22, 2010, titled "IMPLANTABLE
NEUROSTIMULATOR WITH INTEGRAL HERMETIC ELECTRONIC ENCLOSURE,
CIRCUIT SUBSTRATE, MONOLYTHIC FEED-THROUGH, LEAD ASSEMBLY AND
ANCHORING MECHANISM," which claims the benefit of U.S. Provisional
Application No. 61/171,749 filed Apr. 22, 2009, and U.S.
Provisional Application No. 61/177,895 filed May 13, 2009. The full
disclosures of these applications are hereby incorporated by
reference in their entirety.
FIELD OF THE INVENTION
[0002] The invention relates generally to systems, devices, and
methods for using an implantable medical device to deliver therapy
to a patient. More specifically, according to one aspect of the
invention, systems, devices, and methods according to the invention
are used to deliver electrical stimulation to a peripheral, central
or autonomic neural structure. In one particular aspect, the
invention relates to neurostimulator systems, devices, and methods
for treating primary headaches, such as migraines, cluster
headaches, trigeminal autonomic cephalalgias and/or many other
neurological disorders, such as atypical facial pain and/or
trigeminal neuralgias.
BACKGROUND OF THE INVENTION
[0003] Primary headaches are debilitating ailments that afflict
millions of individuals worldwide. The specific pathophysiology of
primary headaches is not known. Known causes of headache pain
include trauma, vascular defects, autoimmune deficiencies,
degenerative conditions, infections, drug and medication-induced
causes, inflammation, neoplastic conditions, metabolic-endocrine
conditions, iatrogenic conditions, musculoskeletal conditions, and
myofacial causes. In many situations, however, even though the
underlying cause of the headache may be identified and treated, the
headache pain itself may persist.
[0004] Recent clinical studies in treatment of headaches have
targeted the manipulation of sphenopalatine (pterygopalatine)
ganglion (SPG), a large, extra cranial parasympathetic ganglion. A
ganglion is a mass of nervous tissue found in some peripheral and
autonomic nerves. Ganglia are located on the roots of the spinal
nerves and on the roots of the trigeminal nerve. Ganglia are also
located on the facial, glossopharyngeal, vagus and
vestibulochoclear nerves. The SPG is a complex neural ganglion with
multiple connections, including autonomic, sensory, and motor
connections. The SPG includes parasympathetic neurons that
innervate, in part, the middle cerebral and anterior cerebral blood
vessels, the facial blood vessels, and the lacrimal glands.
[0005] The maxillary branch of the trigeminal nerve and the nerve
of the pterygoid canal (also known as the vidian nerve which is
formed by the greater and deep petrosal nerves) send neural
projections to the SPG. The fine branches from the maxillary nerve
(pterygopalatine nerves) form the sensory component of the SPG.
These nerve fibers pass through the SPG and do not synapse. The
greater petrosal nerve carries the preganglionic parasympathetic
axons from the superior salivary nucleus, located in the Pons, to
the SPG. These fibers synapse onto the postganglionic neurons
within the SPG. The deep petrosal nerve connects the superior
cervical sympathetic ganglion to the SPG and carries postganglionic
sympathetic axons that again pass through the SPG without any
synapses.
[0006] The SPG is located within the pterygopalatine fossa. The
pterygopalatine fossa is bounded anteriorly by the maxilla,
posteriorly by the medial plate of the pterygoid process and
greater wing of the sphenoid process, medially by the palatine
bone, and superiorly by the body of the sphenoid process. The
lateral border of the pterygopalatine fossa is the pterygomaxillary
fissure, which opens to the infratemporal fossa.
[0007] Various clinical approaches have been used to modulate the
function of the SPG in order to treat headaches, such as cluster
headaches or chronic migraines. These approaches vary from lesser
or minimally invasive procedures (e.g., transnasal anesthetic
blocks) to procedures or greater invasiveness (e.g., surgical
ganglionectomy). Other procedures of varying invasiveness include
those such as surgical anesthetic injections, ablations, gamma
knife procedures, and cryogenic surgery. Although most of these
procedures can exhibit some short term efficacy in the order of
days to months, the results are usually temporary and the headache
pain eventually reoccurs.
SUMMARY OF THE INVENTION
[0008] The invention relates to systems, devices, and methods for
using an implantable medical device ("IMD") to deliver therapy to a
patient. According to one aspect, the invention relates to an IMD
for delivering electrical stimulation to a peripheral, central or
autonomic neural structure. In this aspect, the IMD may comprise a
neurostimulator for treating primary headaches, such as migraines,
cluster headaches, trigeminal autonomic cephalalgias and/or many
other neurological disorders, such as atypical facial pain and/or
trigeminal neuralgias.
[0009] In one embodiment, an IMD and an associated handheld remote
controller ("RC") each may have an operating memory for storing a
programmable operating instructions and data, both input and
recorded, that govern the operation of each respective device. The
IMD and RC each may also include processing hardware, associated
with the operating memory, for executing the programmable operating
instructions in accordance with the input and recorded data.
According to one aspect, the IMD may receive from the RC operating
instructions, data, or both operating instructions and data, that
at least partially govern the therapies applied via the IMD. The
governed therapies may include either or both therapies delivered
within a clinical trial and a post-market usage.
[0010] The IMD administers therapy in accordance with stimulation
parameters stored on the IMD. The stimulation parameters may be
programmed into the IMD in a variety of manners. For example, the
stimulation parameters may be programmed via a programming system,
which can be either local to or remote from the device. Local
programming of the IMD can be accomplished, for example, with the
patient near a physician's workstation, which can communicate
wirelessly with the device (e.g., via Bluetooth, long range
induction, etc.) or with the RC acting as an interface or wand to
the device. Remote programming of the IMD can be accomplished by
establishing communication with the RC via one or more
communication networks. For example, a remotely located physician's
workstation can communicate with a patient's personal computer via
an internet connection, which relays the stimulation parameters to
the IMD via the RC acting as an interface.
[0011] According to another aspect of the invention, the RC is
configured to prompt for and elicit from the patient subjective and
objective data, which the patient enters via the RC. The RC records
the patient input data, and also records data associated with the
treatment applied by the IMD. The data can then be transmitted to
the physician's workstation or possibly mobile device such as a
PDA, cell phone, tablet, etc., so that the physician can use the
data to verify the stimulation parameters for current therapy or to
determine control or stimulation parameter adjustments for
subsequent therapies or determine if the current stimulation
parameters provide effective therapy to the patient.
[0012] Accordingly, the present invention relates to an apparatus
for applying stimulation therapy to a patient includes an
implantable medical device and a remote controller for inductively
powering the medical device and communicating with the medical
device. The remote controller includes a feedback portion for
helping to establish a communication link between the remote
controller and the implantable medical device, answering patient
subjective and objective data, and other system alerts.
[0013] The invention also relates to a method for coupling a remote
controller to an implantable medical device. The method includes
the steps of positioning the remote controller relative to the
medical device. The method also includes the step of adjusting the
position of the remote controller relative to the medical device in
response to an optimal communication feedback provided by the
remote controller. The method includes the further step of
maintaining the position of the remote controller in response to a
communication maintenance feedback provided by the remote
controller.
[0014] The invention also relates to an apparatus for applying
stimulation therapy to a patient. The apparatus includes an
implantable medical device storing at least one of stimulation
parameters and therapy settings and a remote controller for
inductively powering the medical device. The medical device is
adapted to apply stimulation therapy to the patient according to
the stimulation parameters and therapy settings.
[0015] The invention further relates to a method for applying
stimulation therapy to a patient. The method includes the step of
implanting an implantable medical device in the patient. The method
also includes the step of storing at least one of stimulation
parameters and therapy settings on the medical device. The method
also includes the step of using a remote controller to inductively
power the implanted medical device. The method includes the further
step of applying via the implanted medical device stimulation
therapy to the patient according to the stimulation parameters and
therapy settings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] FIG. 1 is a schematic illustration of devices that form a
portion of a system for delivering therapy using an implantable
medical device, according to the invention;
[0017] FIGS. 2A and 2B illustrate a portion of the system implanted
in a patient;
[0018] FIG. 3 is a schematic block diagram of the system for
delivering therapy using an implantable medical device, according
to the invention;
[0019] FIG. 4 is a schematic block diagram of a portion of the
system of FIG. 3, according to the invention; and
[0020] FIGS. 5-7B are functional block diagrams illustrating
various steps in a process that can be performed by the medical
device of FIG. 1, according to the invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0021] The invention relates to systems, devices, and methods for
imparting a therapy on a patient. More particularly, the invention
relates to devices, systems, and methods for applying patient
stimulation therapies a patient. According to one aspect of the
invention, the devices, systems, and methods of the invention
provide for feedback to the patient that helps to improve the
effectiveness of the stimulation therapy.
[0022] FIG. 1 illustrates by way of example a medical device
forming a portion of a system that can be implemented in accordance
with the invention. Referring to FIG. 1, according to one aspect of
the invention, a medical device 10 includes an implantable medical
device ("IMD") 20 and a handheld remote controller ("RC") 50 for
interfacing with and controlling operation of the IMD. In this
description, the term "implantable" is meant to describe that the
medical device is configured for in vivo placement in the patient
by surgical or other means. In the illustrated embodiment, the IMD
20 is shown and described as an implantable neurostimulator. The
IMD 20 may, for example, be a neurostimulator of the type shown and
described in co-pending U.S. Patent Application Publication No. US
2010/027413 A1, the disclosure of which is hereby incorporated by
reference in its entirety.
[0023] The neurostimulator embodying the IMD 20 illustrated and
described herein is an example of just one particular IMD that may
be implemented in accordance with the systems, devices, and methods
of the invention. Those skilled in the art will appreciate that the
systems, devices, and methods of the invention can be applied to
implantable stimulators other than the neurostimulator illustrated
in FIG. 1 without departing from the spirit of the invention. Those
skilled in the art will also appreciate that the systems, devices,
and methods of the invention can be applied to IMDs other than
stimulators, in general, and other than neurostimulators, more
specifically.
[0024] The IMD 20 illustrated in FIG. 1 includes a stimulator body
22, a stimulator lead 24 including one or more stimulating
electrodes 26, and an anchoring portion 28. The IMD 20 is an
inductively powered system having stored programmed stimulation
parameters and bi-directional telemetry to facilitate communication
between the implanted device and the external RC 50. The body 22
comprises an electronics enclosure that can house, for example, an
application-specific integrated circuit, various passive
components, and an antenna/coil for radio frequency transfer of
power and communication. The lead 24 provides an electrical
connection between the electronics housed in the body portion 22
and the stimulating electrodes 26. Each of the one or more
electrodes 26 provides a site for electrical stimulation of the
target anatomy.
[0025] The IMD 20 of the example embodiment of FIG. 1 is powered
inductively by the RC 50 and has electronics, micro-electronic
components, and integrated circuits necessary to store settings,
parameters, and other data. During a therapy session, the IMD 20,
powered by the RC 50, delivers electrical stimulation per the
stimulation parameters stored on the IMD. Each of the electrodes 26
is controllable independently, which allows the physician to select
which electrodes will serve as anodes and which electrodes will
serve as cathodes in any combination. The IMD 20 can apply the
stimulation therapy in accordance with the stimulation parameters
stored on the IMD. Additionally, the IMD 20 can acquire and
transmit to the RC 50 therapy session data gathered during a
therapy session. The IMD 20 includes a non-volatile memory for
storing the stimulation parameters and other clinical trial related
information.
[0026] The RC 50 provides inductive power to the IMD 20 and
communicates (e.g., via radio frequency) with the IMD. Through this
communication, the RC 50 can access settings and parameters stored
on the IMD 20 and also record therapy session data (in real-time or
at a predetermined time). For example, in an embodiment used in a
clinical trial, the RC 50 may record therapy session data in real
time while also accessing clinical trial specific data (e.g., trial
type, specific questions to be asked, therapy randomization
strings, language settings, etc.) in real-time or at some
predetermined time before, during, or after the therapy session. In
another example, in an embodiment used in a post-market patient
usage, the RC 50 may record therapy session data in real time while
also recording post-market specific data (e.g., specific questions
to be asked) in real-time or at some predetermined time before,
during, or after the therapy session.
[0027] Also, in this description, reference is made to stimulation
parameters that may be programmed and/or stored on the IMD 20 and
accessed and transmitted to/from the RC 50. The term "stimulation
parameters," as used herein, is meant to encompass the parameters
that define the stimulation therapy applied to the patient by the
medical device 10. In a clinical trial setting, the stimulation
parameters may include parameters for each of several therapy modes
or configurations used during the clinical trial. The stimulation
parameters include, but are not limited to, the parameters set
forth below in Table 1:
TABLE-US-00001 TABLE 1 Stimulation Parameters Amplitude Frequency
Pulse Width Pulse Interval Electrode Settings Patient Limits
Amplitude Ramp Rates Pulse Width Ramp Rates Biphasic or Monophasic
Stimulation Pulses
[0028] Additionally, in this description, reference will be made to
therapy settings programmed and/or stored on the IMD 20 and
accessed and transmitted to/from the RC 50. The term "therapy
settings," as used herein, is meant to refer to patient specific
settings and data that customize the medical device 10 according to
patient needs/preferences and physician/clinician requirements. The
therapy settings include, but are not limited to, the settings set
forth below in Table 2:
TABLE-US-00002 TABLE 2 Therapy Settings Language Preference Screen
Brightness, Color, etc. Screen Appearance/Fonts Text Size Patient
Preferred Feedback Modes Volume Patient Diary Questions Diary
Date/Time Schedule Patient Diary Entries Diary Dates/Times Hardware
Identification/Ser. No.
[0029] Additionally, in this description, reference will be made to
therapy session data that can be recorded, stored and transmitted
by the RC 50. The term "therapy session data," as used herein, is
meant to refer to data related to the therapy applied by the
medical device 10 during a session. The therapy session data
includes, but is not limited to, the data set forth below in Table
3:
TABLE-US-00003 TABLE 3 Therapy Session Data Electrode Impedances
Electrode Opens/Shorts Date/Time of Therapy Start Date/Time of
Therapy End Therapy Session Duration Manual Patient Adjustments
Patient Attempted djustments Ramp Times Maximum Amplitude Actual
Amplitudes Time at Each Setting Patient Diary Entries Diary
Dates/Times Software/Firmware Versions Serial Number Data Data
Integrity Check Data IMD Register Values Tilt/Fault Data
Communication Loss Data
[0030] Referring to FIG. 1, the RC 50 includes a body portion 52
and an antenna portion 54. The body portion 52 is ergonomically
shaped/contoured and includes a graphical user interface ("GUI") 56
that includes a display 60 and a user navigation/input controls 62.
The display 60 may, for example, comprise an LED or LCD display,
color or B&W, that displays the status, settings, and other
data related to the operation of the RC 50. The RC 50 interface 56
may be fully customizable, i.e., the color, brightness, font, text
size, sound volume, etc. can be adjusted to suit the patient. The
user navigation/input device 62 illustrated in FIG. 1 comprises
control buttons 64 that are located at an ergonomic position on the
RC 50 so that they can be accessed with either right or left hand
while the controller is held in the therapy position. The user
navigation/input device 62 could, however, comprise alternative
devices, such as a touch screen, track ball, touch pad, thumb
wheel, etc. The navigation/input device 62 may also be customizable
in that the buttons and other devices may have functions that are
programmable or assignable by the user.
[0031] The RC 50 also includes a power button 68 and I/O ports in
the form of a USB/charging port 70. The RC 50 may include multiple
ports and other connectivity features for providing flexibility in
communications, data transfer, software/firmware
uploading/downloading. Such additional ports may also be used to
provide for connectivity and expandability with peripheral devices,
such as a Bluetooth or other add-on communications module, or a
remote inductive coil device.
[0032] The RC 50 includes a power source that includes batteries
(disposable or rechargeable) and may also be powered externally via
a cable connection (e.g., via AC outlet or USB). The antenna
portion 54 includes a coil for inductively powering the IMD 20 and
for communicating with the IMD. The RC 50 is configured to power
and communicate with the IMD 20 when the RC 50 is brought into a
predefined proximity (e.g., within 5 centimeters) of the IMD.
[0033] The RC 50 is illustrative of one example controller that may
be implemented in accordance with the systems, apparatuses, and
methods of the invention. Those skilled in the art will appreciate
that certain aspects of the systems, apparatuses, and methods of
the invention can be applied to controllers other than the RC 50
illustrated in FIG. 1 without departing from the spirit of the
invention.
[0034] For example, FIG. 4 illustrates one possible internal
configuration of the RC 50. The configuration illustrated in FIG. 4
is an example configuration that shows certain components that may
be employed by the RC 50. Those skilled in the art will appreciate
that the configuration illustrated in FIG. 4 is but one of many
example configurations of components that may be implemented in the
RC 50. Components may be added, omitted or may be arranged
differently than shown in FIG. 4 without departing from the spirit
of the invention.
[0035] Referring to FIG. 4, the RC 50 includes a power supply 200
and a controller logic portion 202. The controller logic portion
202 includes one or more processors 204 (e.g., microprocessors,
ASICs, etc.) and a memory portion 206 (e.g., non-volatile memory).
The logic portion 202 controls the operation of the RC 50 according
to programmed instructions and data or other parameters that are
programmed onto or retrieved from the IMD 20.
[0036] The RC 50 also includes a graphical user interface ("GUI")
210, which may comprise the input buttons 62, 64 and display screen
60 described above, along with any associated electronics, such as
graphics drivers, input buffers, etc. The RC 50 also includes a
power and communication antenna 212 that, as the name implies,
includes the antenna(s) necessary to power the IMD 20 and
communicate with the IMD.
[0037] The power supply 200 may, for example, comprise a chargeable
battery system with conventional AC wall power being available to
charge the batteries or power the device directly. The power supply
200 supplies power to the controller logic portion 202, the GUI
210, and the power/communication antenna 212. The power supply 200
may power these components directly or indirectly via another
component.
[0038] The RC 50 may also include a remote antenna 240, which may
be an optional component that can be added as an accessory to the
RC. The remote antenna 240 is a power/communication antenna that
may be similar or identical to the antenna 212. The remote antenna
240 can be connected to the RC 50, for example, via a cable that
plugs into socket 242. The remote antenna 240 would thus be powered
by the power supply 200 of the RC 50.
[0039] In use, to establish communication between the RC 50 and the
IMD 20, the antenna portion 54 of the RC 50 needs to be positioned
within a certain distance of the IMD (e.g., within 5 centimeters).
Additionally, the position of the RC 50 and, more particularly, the
antenna portion 54 (i.e., direction, angle, etc.) can also affect
the strength of the communication between the RC 50 and the IMD
20.
[0040] According to the invention, the RC 50 also includes a
feedback portion 220 that provides feedback to the user for
establishing and maintaining the communication link between the RC
50 and IMD 20 when applying stimulation therapy using the medical
device 10. One particular feature of the feedback portion 220 is
that it provides an indication to the patient that the RC 50 is in
the proper or optimal position relative to the implanted IMD 20 for
powering and communicating with the IMD. The feedback portion 220
may have other uses, such as indicating that the RC 50 is powered
up, that a therapy session has ended, other alerts (for example
that more therapy session need to be purchased or approved before
using the RC again or contact your doctor) or to alert the patient
of an error or loss of communication.
[0041] The feedback portion 220 may incorporate one or more modes
for providing feedback to the patient. For example, as shown in
FIG. 4, the feedback portion 220 may include vibratory feedback
222, visual feedback 226, audible feedback 230, shape/pressure
feedback 224, thermal feedback 228, and gyroscopic feedback 232.
The feedback provided by the various feedback modes are perceptible
to the patient via one or more senses (e.g., sight, touch,
hearing). Each feedback mode has one or more characteristics that
change or adjust in response to conditions (e.g., communication
signal strength, RC/IMD relative positions, etc.) that are
indicated by the feedback. For example, in providing the feedback,
the feedback mode characteristic(s) can be changed in response to
the amount of data exchanged between the RC 50 and the IMD 20,
which can be associated with the communication signal strength
between the RC and the IMD. Additionally, or alternatively,
parameters such as receiving antenna coil voltage at the RC 50 or
IMD 20 can be measured, and the RC can adjust the feedback mode
characteristic(s) in response to this measurement. Also, the
feedback modes can be used in an "alarm clock" or "alert" mode to
alert the patient of occurrences, such as software/firmware
updates, stimulation parameter/therapy setting updates, diary
entries/requirements, scheduled therapy, or even appointments,
scheduling, etc. These feedback mode features may be available at
any time the RC 50 is in communication with the network 170, either
wired or wirelessly.
[0042] The vibratory feedback 222 may comprise a vibration motor
that has either a fixed or a variable speed configuration. The
vibratory feedback 222 can be throttled in response to the sensed
relative position of the RC 50 and the IMD 20 by adjusting the
speed of the vibration motor, e.g., by throttling motor voltage or
via pulse width modulation. This throttling results in a
corresponding change in the frequency of the vibration that can be
sensed by the patient by touch, e.g., with the hand that is holding
the RC 50 in the position of FIG. 2B. For example, in providing the
vibratory feedback, the speed of the vibration motor can be changed
in response to the communication signal strength between the RC 50
and the IMD 20, which can be determined as a function of the amount
of data exchanged between the RC and the IMD, or as a function of
the receiving antenna coil voltage of the RC or IMD.
[0043] The visual feedback 226 may comprise one or more light
indicators (e.g., LEDs) on the RC 50 or a portion of the display
screen 60. The visual feedback 226 can be throttled in response to
the sensed relative position of the RC 50 and the IMD 20 by
adjusting the intensity of the light indicators, the number of
lights illuminated, or via a graphical display on the screen 60.
The visual feedback 226, of course, requires sight by the patient
while the RC is held in the patient's hand as shown in FIG. 2B. For
example, in providing the visual feedback, LED brightness, LED
numbers, and/or a visual display on the screen 60 can be changed in
response to the communication signal strength between the RC 50 and
the IMD 20, which can be determined as a function of the amount of
data exchanged between the RC and the IMD, or as a function of the
receiving antenna coil voltage of the RC or IMD.
[0044] The audible feedback 230 may comprise one or more audible
indicators (e.g., speakers) on the RC 50. The audible feedback 230
can be throttled in response to the sensed relative position of the
RC 50 and the IMD 20 by adjusting the volume, tone, pitch, etc. of
the audible indicator. The audible feedback 230 can also
incorporate recorded verbal feedback or instructions for achieving
the optimal relative positions of the EC 50 and IMD 20. The audible
feedback 230 does not require sight by the patient while the RC is
held in the patient's hand as shown in FIG. 2B. For example, in
providing the audible feedback, the volume, tone, pitch, etc. of
the audible indicator can be changed in response to the
communication signal strength between the RC 50 and the IMD 20,
which can be determined as a function of the amount of data
exchanged between the RC and the IMD, or as a function of the
receiving antenna coil voltage of the RC or IMD.
[0045] The shape/pressure feedback 224 may comprise one or more
piezoelectric, dielectric, shape memory alloy, or slow actuators
that can change or alter their shape. The shape/pressure feedback
224 can be throttled, or the position of the pressure/shape change
can be moved in response to the sensed relative position of the RC
50 and the IMD 20. The shape/pressure feedback 224 does not require
sight by the patient while the RC is held in the patient's hand as
shown in FIG. 2B. For example, in providing the shape/pressure
feedback, the shape/pressure feedback 224 can be adjusted in
magnitude or location in response to the communication signal
strength between the RC 50 and the IMD 20, which can be determined
as a function of the amount of data exchanged between the RC and
the IMD, or as a function of the receiving antenna coil voltage of
the RC or IMD.
[0046] The thermal feedback 228 may comprise one or more
thermoelectric elements, such as peltier elements, that can change
temperature. The thermal feedback 228 can be throttled in response
to the sensed relative position of the RC 50 and the IMD 20 by
adjusting the applied current/voltage. The temperature feedback 228
does not require sight by the patient while the RC is held in the
patient's hand as shown in FIG. 2B. For example, in providing the
thermal feedback, the temperature can be changed in response to the
communication signal strength between the RC 50 and the IMD 20,
which can be determined as a function of the amount of data
exchanged between the RC and the IMD, or as a function of the
receiving antenna coil voltage of the RC or IMD.
[0047] The gyroscopic feedback 232 may comprise one or more
electronic gyroscopes that can stabilize the position and position
of the RC 50 once the communication is achieved. The gyroscopic
feedback 232 can be used to help maintain the optimal relative
positioning between the RC 50 and IMD 20 once achieved. For
example, the gyroscopic feedback 232 can be tied to the audible or
visual feedbacks 230, 226 and can use them to provide instruction
for maintaining the achieved optimal position. While the gyroscopic
feedback 232 does not require sight by the patient while the RC is
held in the patient's hand as shown in FIG. 2B, the other feedbacks
used in conjunction may require sight. The gyroscopic feedback 232
could have additional uses. For example, the gyroscopic feedback
232 could be used to "memorize" an optimal position relative to the
IMD 20 and could be used in conjunction with another of the
feedback modes (e.g., audible, vibration, visual, etc.) to help
guide the user to the optimal communication position.
[0048] One of the primary functions of the feedback portion 220 is
to provide feedback on the proper positioning of the
power/communication antenna 212 relative to the IMD 20. To do this,
each of the feedback modes has one or more characteristics that
adjust or change in magnitude in response to the position of the RC
50 relative to the IMD 20. In addition to this, each of the
feedback modes may employ an additional indicator that signals when
the optimal positioning of the RC 50 and IMD 20 are achieved, and
when that optimal positioning is lost. The feedback modes may be
employed individually or in combination with each other, and may be
selectable and configurable to a patient/physician preference.
[0049] The primary feedback modes for establishing optimal
communication between the RC 50 and IMD 20 are the vibratory
feedback 22, the visual feedback 226, and the audible feedback 230.
Once the optimal communication feedback is established, the
feedback modes can provide feedback indicating whether the optimal
communication is maintained and how to position/reposition the RC
50 to maintain the optimal communication. This communication
maintenance feedback can be provided by any of the feedback modes.
The optimal communication feedback and the communication
maintenance feedback can be communicated using the same or
different feedback modes. For the purpose of providing clarity to
the patient, those skilled in the art will appreciate that it may
be desirable to use different feedback modes for these
functions.
[0050] For example, the vibratory feedback 222 may be used to
provide the optimal communication feedback and the audible feedback
230 may be used to provide the communication maintenance feedback.
In this configuration, the vibration feedback 222 may increase or
decrease in frequency as the relative positions are adjusted, with
a higher frequency being indicative of better features that help
guide the patient toward the optimal RC position. When the optimal
relative positions are achieved, the audible feedback 230 may
provide an audible indication. Thereafter, the audible feedback 230
may provide additional audible indication for maintaining the
optimal communication position.
[0051] As another example, the audible feedback 230 and/or the
visual feedback 226 may be used to provide the optimal
communication feedback and the communication maintenance feedback.
In this configuration, the audible feedback 230 may increase or
decrease in tone, volume, frequency, etc. as the relative positions
are adjusted, and the visual feedback 226 may increase in
intensity, brightness, number of lights as the relative positions
are adjusted. When the optimal relative positions are achieved, the
audible feedback 230 may provide an audible indication. Thereafter,
the audible feedback 230 and/or the visual feedback 226 may provide
additional audible indication for maintaining the optimal
communication position.
[0052] As a further example, any of the vibratory feedback 222, the
audible feedback 230, and the visual feedback 226 may be used to
provide the optimal communication feedback and the gyroscopic
feedback 232, in combination with the audible feedback 230, may be
used to provide the communication maintenance feedback. Once the
optimal relative positions are achieved and the optimal
communication feedback indication is issued, the gyroscopic
feedback 230 may store or "memorize" the position or position of
the RC 50. Thereafter, the gyroscopic feedback 230 may, via the
audible feedback 230, provide the communication maintenance
feedback. In doing so, the audible feedback 230 may be in the form
of an audible beep or tone, or even can be voice commands
instructing the patient on where to move the RC 50.
[0053] Additionally, during use of the remote antenna, the feedback
portion 220, particularly the visual feedback 226, can become
advantageous. This is because the antenna 240, being remote from
the RC 50 allows the patient to clearly view the display screen 60
while holding the remote antenna in against the his/her head.
[0054] Advantageously, the feedback portion 220 of the RC 50 helps
guide the patient to the optimal communication position of the RC
50 relative to the IMD 20. According to the invention, the
vibratory feedback 222 can be of a particular advantage in the
embodiment illustrated in FIGS. 2A and 2B since, in use, the RC 50
is held by the patient in a position where visual feedback may be
difficult or impossible. Additionally, since the feedback may
include both optimal communication feedback and communication
maintenance feedback, it is advantageous that the RC 50 includes
two feedback modes (e.g., vibratory and audible) that can be used
to differentiate between the two types of feedback.
[0055] The feedback portion 220 of the RC 50 may provide additional
enhancements to either or both the optimal communication feedback
and communication maintenance feedback. For example, the feedback
portion 220 may include surface texturing, vibrations, or thermal
feedback that is distributed to different locations on the RC 50.
These distributed feedback modes can provide direction to the
patient on how or in which direction to adjust the position of the
RC 50 in order to achieve optimal communication. For instance, the
feedback modes could be distributed to locations where the patient
would normally rest their palms or fingers on the RC 50 or,
additionally or alternatively, where the RC rests on the patient's
face during use. These distributed feedback modes can serve as the
optimal communication feedback and/or the communication maintenance
feedback in order to help direct the patient to and maintain the
optimal communication position.
[0056] In operation, the RC 50 transfers energy to the IMD 20 via
near field electromagnetic induction. The RC 50 transmits power
signals via the power antenna, located in the antenna portion 54,
at a specific frequency. The IMD 20 includes a power coil/antenna
that is tuned to resonate close to the frequency at which the RC 50
transmits the power signal and thereby generates, through
induction, power for the IMD.
[0057] The RC 50 also communicates with the IMD 20 to provide, for
example, stimulation parameters, software/firmware upgrades, and
other operating instructions and data prior to or subsequent to IMD
implantation. The RC 50 may also receive from the IMD 20 therapy
session data, handshaking communications, and current stimulation
parameter settings.
[0058] The antenna(s) employed in the antenna portion 54 of the RC
50 may have various designs. For example, the antenna portion 54
may include a first antenna for inductively powering the IMD 20 and
for transmitting communications to the IMD. The antenna portion 54
may also include a second antenna for receiving communication
transmissions from the IMD 20.
[0059] FIGS. 2A and 2B illustrate, by way of example, an
implementation of the system 10 in which the IMD 20 is implanted in
a patient in order to treat primary headaches, such as migraines,
or other neurological disorders. As illustrated in FIG. 2A, the IMD
20 is implantable in a patient's head 30. In this particular
implementation, the IMD 20 is implanted such that the stimulator
body 22 is positioned medial to the zygoma 32 on the
lateral/posterior maxilla 34 within the buccal fat pad of the
cheek, and the integral fixation apparatus 28 is anchored to the
zygomaticomaxillary buttress 36, such as by using standard
craniomaxillofacial bone screws, for example. The stimulation lead
26 can be placed within the pterygopalatine fossa or, more
specifically, in very close proximity to the sphenopalatine
(pterygopalatine) ganglion (SPG) ganglion 38.
[0060] Referring to FIG. 2B, to operate the IMD 20, the patient
manually positions the RC 50 adjacent his/her head 30 so that the
antenna portion 54 is positioned in the proximity of the IMD 20.
The patient can manipulate the position of the RC 50 in response to
the indications provided by the feedback portion 220 to achieve a
strong inductive link between the controller and the IMD 20.
[0061] Once a communication and power link is established via a
feedback method, the IMD 20 administers the therapy in accordance
with the instructions of the RC 50 and the stimulation parameters
stored on the IMD. During use, the patient may be able to adjust
certain stimulation parameters (amplitude, pulse width, frequency,
combination thereof, or specific protocols with autonomic preset
adjustment in two or more parameters at once) or parameters (ramp
time, etc.) via the input device 62, e.g., by manipulating the
control buttons 64. These adjustments are physician/clinician
approved & configurable.
[0062] The RC 50 and IMD 20 are components of a system for applying
stimulation therapy to a patient. Referring to FIG. 3, an example
of a system 100 in which the RC 50 and IMD 20 are implemented
includes multiple computer platforms, each of which may have a
different remote location. These multiple platforms can be
networked for communication with each other via a variety of wired
(indicated in solid lines) and wireless (indicated in dashed lines)
connections. The example system of FIG. 3 includes the medical
device 10 (i.e., the IMD 20 and the RC 50), a physician workstation
("physician WS") 110, a patient personal computer/docking station
("patient PC") 120, and a remote database ("remote DB") 140.
[0063] The wireless communication/power connection between the RC
50 and the IMD 20 is illustrated in dashed lines at 102. This
connection 102 may, for example, employ a medical implant specific
communication protocol, such as a medical implant communication
system (MICS) protocol. This specialized protocol helps institute a
degree of safety and reliability in communications between the RC
50 and the IMD 20, especially while the IMD is implanted in the
patient.
[0064] The physician WS 110, patient PC 120 (or cell phone, PDA,
etc.), and remote DB 140 can be interconnected via a communication
network 170 that includes wired connections (e.g., a wired internet
connection), indicated generally with solid lines and wireless
connections (e.g., a WiFi internet connection, a Bluetooth
connection, or a GSM/CDMA/LTE mobile network connection), indicated
generally with dashed lines. In the embodiment illustrated in FIG.
3, the physician WS 110 is has a wired connection 116 and a
wireless connection 118 with the remote database 140. The patient
PC 120 has a connected wired connection 126 and a wireless
connection 128 with the remote database 140. The physician WS 110
and the patient PC 120 have a wired connection 146 and a wireless
connection 148 with each other. The physician WS 110 and the
database WS can also communicate with each other via a wired 162 or
a wireless 164 connection. The physician WS 110, patient PC 120,
remote DB 140, and database WS 150 can communicate with each other
via the network 170 using any combination of the wired and wireless
network connections.
[0065] The RC 50 can be connected to the physician WS 110 via a
direct wired connection 112 (e.g., via a USB port or docking
station), or via a wireless connection 114 (e.g., a WiFi
connection, a Bluetooth connection, or a GSM/CDMA/LTE mobile
network connection). Connected with the physician's WS 110, the RC
50 may act in a pass-through mode, allowing the physician to access
the IMD 20 for programming or data retrieval via the physician WS.
The RC 50 may indicate the occurrence of these events via the
feedback portion 220. The feedback portion 220 may alert the
patient to other occurrences, such as software updates, required
diary entries, stimulation parameter changes, etc.
[0066] The RC 50 can also be connected to the patient personal
computer 120 via a direct wired connection 122 (e.g., via the USB
port or docking station), or via a wireless connection 124 (e.g., a
WiFi connection, a Bluetooth connection, or a GSM/CDMA/LTE mobile
network connection). The RC 50 may indicate this occurrence via the
feedback portion 220, for example, by displaying a "PC Control"
message on the display screen 60. The RC 50 can also communicate
with the remote DB 140 via the network 170. Additionally, the RC 50
can be connected directly to the remote DB 140 via a wireless
connection 142 (e.g., a GSM/CDMA/LTE mobile network
connection).
[0067] From the above, those skilled in the art will appreciate
that the system 100 has a highly selectable configuration, and that
the communication between the RC 50, physician WS 110, patient PC
120, and remote DB 140 may be configured to occur in various
combinations. In this configuration, the network 170 allows for the
omission of certain portions or components of the system 100 and
also for redundancy in various communication channels through the
network.
[0068] For example, referring to FIG. 4A, in one communication
configuration or mode, the RC 50 may communicate with the patient
PC 120 via wireless connection 124, with the physician WS 110 via
wired connection 112, and with the remote DB 140 via the wireless
connection with the patient PC and either the wired 126 or wireless
128 connection between the patient PC and the remote DB.
[0069] In another example communication configuration or mode,
referring to FIG. 4B, the RC 50 may communicate with the physician
WS 110 and with the patient PC 120 via wired connections 112 and
122, respectively, and with the remote DB 140 via the wired
connection 122 and either the wired connection 126 or wireless
connection 128.
[0070] In yet another example communication configuration or mode,
referring to
[0071] FIG. 4C, the RC 50 may communicate with the physician WS 110
via the wired connection 112 and with the remote DB 140 directly
via the wireless connection 142. In this configuration, the patient
PC is not necessary to establish the necessary communication
channels.
[0072] In a further example communication configuration or mode,
referring to FIG. 4D, the RC 50 may communicate with the physician
WS 110 via the wireless connection 114 and with the remote DB 140
directly via the wireless connection 142. Again, in this
configuration, the patient PC is not necessary to establish the
necessary communication channels.
[0073] Referring to FIG. 3, the system 100 also includes a database
maintenance and reporting workstation ("database WS") 150 that is
operatively connected to the remote DB 140 and/or the physician WS
110 via wired 152 or wireless 154 connections. The architecture in
which the database WS 150 and the remote DB 140 are implemented can
vary. For example, the database WS 150 may comprise a workstation
on a local area network, and the remote DB 140 may be is stored on
a server in that local area network. Alternatively, the remote DB
140 may be a cloud-based database that the RC 50, patient PC 120,
physician WS 110, and database WS 150 access via the internet.
[0074] The system 100 also includes a patient diary 160 in which
the patient records data associated with the treatments
administered via the IMD 20. The data can be in the form of
responses to questions asked by the system, and the questions can
be either subjective or objective in nature. The questions can be
prompted and answered both prior to, during, and/or after the
therapy is applied. In this manner, answering the questions may
serve as a gate to patient therapy by which therapy is denied until
certain diary questions are answered. Post therapy diary questions
can be answered immediately after the stimulation therapy is
applied or sometime thereafter. The timing and content of the
questions asked both pre and post therapy can be
physician/clinician selected. Post therapy diary questions can be
answered via the RC 50 directly or via the patient PC 120. The
patient diary can be considered a portion of the therapy/clinical
trial settings & data (Table 2).
[0075] The patient diary 160 is illustrated in FIG. 3 as being part
of the RC 50 because this is where the data included in the diary
is entered into the system 100 by the patient. The patient diary
160 may reside in a remote location or combination of locations.
For example, the patient diary 160, while collected and entered at
the RC 50, may be accumulated and stored at the remote DB 140 or at
the physician WS 110. As another alternative, the patient diary 160
may comprise an internet based diary stored on a remote server and
accessible via the internet. As a further alternative, the patient
diary 160 may comprise a cloud based system in which the diary is
accessible via the internet.
[0076] Once entered, when the RC 50 is operatively connected for
communication with the system 100 (wired or wirelessly), the data
from the patient diary 160 can be transmitted to the remote DB 140,
to the physicians WS 120, to the patient PC 110, or to a cloud
based storage system. Thereafter, the physician can access the data
via the workstation 110. Additionally, the patient may also be able
to access certain data from the patient diary 160, such as
previously answered diary questions, unanswered diary questions or
additional questions, via the patient PC 120. In an internet or
cloud-based implementation, the patient can access the patient
diary 160 online via web access. The feedback portion 220 may serve
to provide feedback or indication (visual, audible, vibratory,
etc.) regarding the diary entries. Such indications may, for
example, include indications that questions require answering,
questions are complete, etc.
[0077] The questions queried to the patient for entry in the
patient diary 160 can be subjective questions or objective
questions. Subjective questions can serve to help describe or
categorize the headache episode in terms of symptoms, severity,
duration, lasting effects, etc. The data from the subjective
questions in the patient diary thus give patient specific details
and sensory perceptions that can be used to evaluate and adjust the
therapy regimen for that particular patient. Objective questions
elicit from the patient factual details not subject to the patients
perception, and thus generate data that can collected along with
objective data from other patients and used to evaluate efficacy
for the group as a whole. The subjective and objective data
collected in the patient diary includes, but is not limited to, the
data set forth below in Table 4:
TABLE-US-00004 TABLE 4 Patient Diary Data Subjective Data Objective
Data Headache Pain Level Headache Occurrence Sensitivity to Light
Headache Start/End Time Sensitivity to Sound Acute Medication Usage
Aura Before Rescue Medication Usage Nausea/Vomiting Medication
Start Time Throbbing/Pulsating Pain Foods/Beverages Ingested Prior
Location (Side)--Left/Right/Both Sleep Pattern Activity/Movement
Aleve Pain Location--Work, Home, etc. Stress Level
Activity--Reading, Computer, etc. Tiredness Autonomic Symptoms
[0078] The questions for obtaining the patient diary data can be
queried by the RC 50 at specific times or according to a
predetermined schedule. For example, when the RC 50 is initially
powered on, the patient may be prompted via any of the feedback
modes to answer questions regarding headache pain levels, location
(side) of the headache pain, acute medications taken, sensitivity
to light/sound, the presence of nausea or vomiting, and the
presence of autonomic symptoms (e.g., red/tearing eyes, blocked
nose, eyelid swelling, etc.). When therapy is stopped, the patient
may be prompted to answer questions regarding headache pain. At a
predetermined time after therapy stops, such as one hour after
therapy, the patient may be prompted to answer questions regarding
headache pain levels, rescue medications taken, sensitivity to
light/sound, the presence of nausea or vomiting, and the presence
of autonomic symptoms.
[0079] Additionally, the therapy applied by the medical device 10
may be controlled or otherwise limited or scheduled according to a
therapy cycle of a predetermined duration and which includes
predetermined intervals according to which therapy is applied. As
an example, a therapy cycle may be a 90 minute cycle during which
therapy can be applied only during the first 15 minutes.
Additionally, prior to beginning therapy, the therapy cycle may
require that the headache diary questions be answered. The example
therapy cycle may permit continuous or intermittent use during the
initial 15 minutes of the 90 minute cycle, and the RC 50 will
display the remaining therapy time during the initial 15 minutes of
the therapy cycle. Once the 15 minute therapy time expires, no
additional therapy is permitted for the remaining 75 minutes of the
90 minute therapy cycle. In applying scheduled therapy, any of the
feedback modes can be used to alert the patient.
[0080] According to the invention, the system 100 can facilitate
administering stimulation therapy as a part of an ongoing regimen
in combating disorders, such as migraine headaches. At the patient
level, the physician can program the IMD 20 via the workstation 110
to set the, individualized stimulation parameters, the
individualized settings for the RC 50 (e.g., language, diary
questions, screen settings, etc.), and any software/firmware
updates that may be necessary. The RC 50 then can upload these
items to the IMD 20. At home, the patient self-administers, within
physician prescribed limits, the stimulation therapy on an
as-needed basis, or in accordance with a schedule assigned by a
physician/clinician.
[0081] The physician WS 110 is outfitted with software that allows
the workstation to communicate with the RC 50 when connected
thereto via either the wired connection 112 or the wireless
connection 114. The physician WS 110 also may communicate with the
RC 50 connected remotely to the patient PC 120, via the internet
connection 146, 148. The physician WS 110, being additionally
connected with the remote database 140, can also access the remote
database as a central repository for information relating to
patient data, stimulation settings, therapy settings, manufacturer
notices, software/firmware updates, and other bulletins. Through
the remote database 140, physicians/clinicians may receive
stimulation parameters for loading onto an RC 50, which can then be
downloaded to the IMD 20 via the RC 50.
[0082] The physician WS 110 can be a PC based system used by the
physician to configure the IMDs 20 prior to implantation or post
implantation. The programmer (physician) can interface with the RC
50 wirelessly or through the USB connection. In an embodiment, the
RC 50 communicates with the physician WS 110 through the wired
connection 112, and the controller may enter a pass-through mode in
which all or some of the controls are disabled, leaving the
controller to simply serves as a communication bridge between the
physician WS 110 and the IMD 20. The RC 50 may also communicate
with the physician WS wirelessly via the wireless connection 114.
Through this communication, the programmer can instruct the RC 50
to communicate with the IMD 20, transmitting and receiving data via
their built-in bi-directional telemetry capabilities. This allows
the programming physician to, for example, install or update
software/firmware and to set and adjust the stimulation parameters
and therapy settings in the IMD 20.
[0083] The patient PC 110 can be a PC based system with installed
proprietary software that provides for communicating with the RC 50
and relaying data to the remote DB 140. The patient PC 110 is not,
however, limited to a PC based system. The system 100 can be
adapted to provide for charging and communicating with the RC 50 in
a variety of manners. For example, the system 100 may include a
standalone charging/docking station with wireless internet
communication capabilities for transmitting data to the remote DB
140. In this configuration, a PC is not necessary. As another
example, the RC 50 could be fitted with a simple AC power cord for
charging and short-range wireless communication capabilities (e.g.,
Bluetooth) for transmitting data to the remote DB 140 via an
external device, such as a Bluetooth enabled PC or cell phone, or a
PDA type device.
[0084] The remote DB 140 may be built on any platform that allows
information to be stored, read, and updated. For example, the
remote database can be an industry standard such as Oracle,
Microsoft SQL Server, etc., that permits standard SQL (Structured
Query Language) commands and queries to store, access, and
manipulate the data contained therein. The remote DB 140 may also
be an internet or web based (e.g., cloud based) platform for
storing stimulation parameters (Table 1), Therapy Settings (Table
2), Therapy Session Data (Table 3) and patient diary data (Table
4). The remote DB 140 can additionally serve as a central
repository for storing and distributing manufacturer
notices/bulletins, instruction manuals and other materials, and
software/firmware updates. The remote DB 140 can further serve as a
central platform for administering a clinical trial. The remote DB
140 can include a table or tables that contain the serial numbers
of all IMDs 20 that have been implanted in patients, and can also
contain the therapy status of those patients.
[0085] For example, the database may include all the results of the
clinical trial for all patients enrolled in the trial including,
but not limited to, the patients' histories, therapy protocol for
the patients, therapy efficacy, and treatment regimens for the
patients and results to-date. To address privacy concerns, the data
stored on the remote DB 140 may be blind to the identity of the
patients. The remote DB 140 may, however, may store non-identifying
clinically relevant patient data, such as height, weight, blood
pressure, sex, and age of the clinical trial participants.
[0086] According to one aspect of the invention, the stimulation
parameters and therapy settings programmed onto the IMD 20 can
include all of the patient and device specific information
necessary to perform the stimulation therapy on the patient. It is
not necessary to include any patient or therapy specific data
(e.g., stimulation parameters/therapy settings) on the RC 50
itself. Due to this, the RC 50 is necessary only to inductively
power the IMD 20. This offers a great advantage in that any RC 50,
whether it is the patient's personal unit, a physician's unit, or a
replacement unit can be used to apply stimulation therapy via the
IMD 20 without any pre-programming or set up. The RC 50 may thus be
a turn-key unit ready to operate right out of the box.
[0087] As another advantage, the RC 50 can also perform its
querying and recording functions without any preprogramming either.
The RC 50 reads the patient diary questions and schedule from the
IMD 20, administers the diary questions, and records the patient
diary data accordingly. The RC 50 also reads and records the
therapy session data and clinical trial data in real time during
the therapy session. The RC 50 thus additionally initiate and
administers the patient diary questions, records the therapy
session data, and records the patient diary data without
pre-programming any patient or trial specific parameters, settings,
or data into the RC.
[0088] As a further advantage, storing the stimulation parameters
and therapy settings on the IMD 20 helps ensure that the therapy
will be applied according to the correct patient specific
parameters and settings. This also helps ensure that the correct
therapy type, patient language, and diary questions are
applied/queried to the patient. All of these features
advantageously improve the reliability and accuracy of the medical
device 10 over a device that includes patient specific settings or
parameters on the remote unit.
[0089] According to one aspect of the invention, the system 100,
and the devices and methods implemented therein, enable a patient
to respond to a therapy regimen. The stimulation therapy is applied
as an ongoing treatment regimen tailored by the physician to treat
the patient's specific medical condition. The system 100, the
medical device 10, and the methods by which the stimulation therapy
is applied enable the evaluation of the patient's response by the
physician so that the efficacy of that particular patient's
treatment regimen can be monitored, adjusted, and improved.
[0090] FIG. 5 illustrates a flowchart diagram of a process 300 by
which therapy is applied using the medical device 10. The process
300 illustrated in FIG. 5 is an example of one process that may be
used to apply therapy using the medical device 10. Those skilled in
the art will appreciate that certain steps in the process may be
adjusted, added, omitted, or performed in different order than that
illustrated in the figures and described herein without departing
from the spirit of the invention. For example, certain steps
illustrated and described as being performed in a certain order may
be performed simultaneously or in a different order, and certain
steps illustrated and described as a single step may comprise
multiple steps.
[0091] For example, an additional step could be implemented in
which the application of therapy described in FIG. 5 may be
predicated on gaining approval for using the medical device 10 to
apply the therapy. Such approval requirements may be similar or
identical to those described in U.S. patent application Ser. No.
12/688,524, filed Jan. 15, 2010, titled "APPROVAL PER USE IMPLANTED
NEUROSTIMULATOR," the disclosure of which is hereby incorporated by
reference in its entirety. As another example, in an initial use of
an RC 50 with an IMD 20 where the RC has not previously
communicated with that particular IMD, the RC may enter an initial
mode where the RC prompts the patient (via any of the feedback
modes) with an initial set of predetermined diary questions (e.g.,
a subset of those set forth in Table 4). Thereafter, the RC 50 will
use the patient/clinical trial appropriate questions programmed on
the IMD 20.
[0092] Referring to FIG. 5, when a patient senses the onset of an
event, such as a migraine headache, the patient activates the RC
50, at step 302. The process 300 then proceeds to step 304, where
the patient couples the RC 50 to the IMD 30. During coupling step
304, the RC 50 may provide feedback--audible, tactile, or both,
that assists the patient in achieving the proper positioning of the
RC 50 relative to the IMD 30. Once the RC 50 and IMD 30 are
coupled, the process 300 proceeds to step 306, where the RC can
retrieve stimulation parameters (Table 1) or therapy settings
(Table 2). For example, at step 306, the RC 50 may retrieve patient
diary questions to query the patient.
[0093] The process 300 then proceeds to step 310, where the RC 50
prompts, via any of the feedback modes, the patient for answers to
any pre-treatment questions. These questions can be designed to
elicit from the patient the patient diary data set forth in Table
4. This step 310 may be optional, as it is conditioned on whether
the supervising physician/clinician has opted to require
pre-treatment questions as a gateway to therapy. The process 300
then proceeds to step 312, where the patient initiates and conducts
the therapy session. During the therapy session, if permitted by
the supervising physician/clinician, the patient can adjust any
adjustable parameters within the physician defined limits. The
therapy session ends at step 314 due to either expiration of a
timeout period or due to cessation by the patient.
[0094] The process 300 proceeds to step 320, where the RC 50
records the therapy session data (Table 3) and/or any necessary
therapy settings (Table 2). The process 300 then proceeds to step
322, where the RC 50 prompts the patient for answers to any
post-treatment questions, if the prompting for answers to such
questions is enabled by the supervising physician/clinician. At
step 342, the IMD 30 records the therapy session data. The process
300 proceeds to step 324, where the RC 50 transmits the recorded
data, if this function is enabled. Alternatively, the recorded data
may be stored until such a time that transmission of the data is
convenient to the patient.
[0095] When the RC 50 transmits the recorded data to the remote
database, the remote database updates its records and analyzes the
data. The database can be utilized to compare the data to
pre-programmed data and determines whether an appropriate party,
e.g., the patient's physician or an administrator of the clinical
trial, should be contacted. If so, the party is contacted and can
take the appropriate action, as needed.
[0096] Referring to FIG. 6, according to the invention, the step
304 of coupling the RC 50 to the IMD 20 includes the initial step
330 of positioning the RC 50 relative to the IMD 20. In this step,
the patient initially moves the RC 50 toward the position
illustrated in FIG. 2B. Alternatively, the patient could bring the
remote antenna coil 240 into the same or similar position. At step
332, the patient adjusts the position of the RC 50 (or remote coil
240) in response to the optimal communication feedback. As
discussed above, the optimal communication feedback may comprise
any of the various feedback modes of the feedback portion 220,
alone or in combination. At step 334, the patient maintains the
position of the RC 50 relative to the IMD 20 in response to the
communication maintenance feedback. The communication maintenance
feedback may comprise any of the various feedback modes of the
feedback portion 220, alone or in combination.
[0097] Referring to FIG. 7A, according to the invention, the steps
306, 312 include the initial step 340 of storing the stimulation
parameters and therapy settings on the IMD 20. This can be done, as
discussed above, via the physician WS 110. At step 342, the RC 50
provides inductive power to the IMD 20. At step 344, the IMD 20
applies stimulation therapy to the patient according to the
stimulation parameters and therapy settings.
[0098] Advantageously, according to step 340, the stimulation
parameters and therapy settings programmed onto the IMD 20 can
include all of the patient and device specific information
necessary to perform the stimulation therapy on the patient. The RC
50 does not require any patient or therapy specific data and is
required only to inductively power the IMD 20.
[0099] Referring to FIG. 7B, according to the invention, the step
310 includes the step 350 that the RC 50 retrieves questions from
the IMD 20. At step 352, the RC 50 prompts the patient to answer
the questions retrieved from the IMD 20. Advantageously, the RC 50
can thus perform its querying and recording functions without any
patient specific preprogramming. The RC 50 reads the patient diary
questions and schedule from the IMD 20, administers the diary
questions, and records the patient diary data accordingly.
[0100] The processes illustrated in FIGS. 6, 7A, and 7B therefore
offer the advantage in that as a further advantage, storing the
stimulation parameters and therapy settings on the IMD 20 helps
ensure that the therapy will be applied according to the correct
patient specific parameters and settings. This also helps ensure
that the correct therapy type, patient language, and diary
questions are applied/queried to the patient. All of these features
advantageously improve the reliability and accuracy of the medical
device 10 over a device that includes patient specific settings or
parameters on the remote unit.
[0101] From the above description of the invention, those skilled
in the art will perceive improvements, changes and modifications.
Such improvements, changes and modifications within the skill of
the art are intended to be covered by the appended claims.
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