U.S. patent application number 14/743985 was filed with the patent office on 2015-12-24 for baroreceptor mapping system.
The applicant listed for this patent is Cardiac Pacemakers, Inc.. Invention is credited to James E. Blood, Andrew L. De Kock, Doug E. Giwoyna, Jack Gordon, Eric A. Mokelke, Brian Soltis.
Application Number | 20150366467 14/743985 |
Document ID | / |
Family ID | 53525268 |
Filed Date | 2015-12-24 |
United States Patent
Application |
20150366467 |
Kind Code |
A1 |
De Kock; Andrew L. ; et
al. |
December 24, 2015 |
BARORECEPTOR MAPPING SYSTEM
Abstract
A system including a mapping device, a stimulator, and a marker.
The mapping device includes a plurality of electrodes to be
situated on a baroreceptor region of a patient to map baroreceptors
in the baroreceptor region. The stimulator is to stimulate selected
electrodes of the plurality of electrodes to obtain physiological
responses from the patient in response to stimulation of the
selected electrodes. The marker is to be attached to the patient to
mark a location of at least one of the selected electrodes based on
an analysis of the physiological responses from the patient, where
the marker is to maintain its location on the patient as the
mapping device is removed from the patient.
Inventors: |
De Kock; Andrew L.;
(Andover, MN) ; Mokelke; Eric A.; (Flagstaff,
AZ) ; Soltis; Brian; (St. Paul, MN) ; Giwoyna;
Doug E.; (Harris, MN) ; Blood; James E.;
(Shoreview, MN) ; Gordon; Jack; (Minneapolis,
MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Cardiac Pacemakers, Inc. |
St. Paul |
MN |
US |
|
|
Family ID: |
53525268 |
Appl. No.: |
14/743985 |
Filed: |
June 18, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62014390 |
Jun 19, 2014 |
|
|
|
62014496 |
Jun 19, 2014 |
|
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|
Current U.S.
Class: |
600/377 ;
156/212; 600/481 |
Current CPC
Class: |
A61N 1/36117 20130101;
A61B 90/39 20160201; A61N 1/0476 20130101; Y10T 156/1028 20150115;
A61B 5/02028 20130101; A61B 5/021 20130101; A61N 1/0558 20130101;
A61N 1/36185 20130101; A61B 5/6876 20130101; A61B 5/4848 20130101;
A61B 5/024 20130101; A61B 2090/3908 20160201; A61N 1/0556 20130101;
A61B 5/0215 20130101; A61B 5/0531 20130101; A61B 5/053
20130101 |
International
Class: |
A61B 5/0215 20060101
A61B005/0215; A61B 5/00 20060101 A61B005/00; A61B 19/00 20060101
A61B019/00 |
Claims
1. A system, comprising: a mapping device that includes a plurality
of electrodes to be situated on a baroreceptor region of a patient;
a stimulator to stimulate selected electrodes of the plurality of
electrodes to obtain physiological responses from the patient in
response to stimulation of the selected electrodes; and a marker to
be attached to the patient and to mark a location of at least one
of the selected electrodes based on an analysis of the
physiological responses from the patient.
2. The system of claim 1, comprising an implantable device that
includes at least one implantable electrode to be aligned on the
baroreceptor region via the marker and sutured into place on the
baroreceptor region.
3. The system of claim 2, wherein the mapping device includes at
least one marking aperture that extends through the mapping device
and the implantable device includes at least one aligning aperture
that extends through the implantable device, and the marker is to
be attached to the patient through the at least one marking
aperture and the implantable device is to be aligned on the
baroreceptor region via the at least one aligning aperture and the
marker.
4. The system of claim 1, wherein the mapping device includes at
least one aperture that extends through the mapping device and the
marker is to be attached to the patient through the at least one
aperture.
5. The system of claim 1, wherein the mapping device includes at
least one aperture that extends through the mapping device and is
adjacent at least one of the electrodes of the plurality of
electrodes.
6. The system of claim 1, wherein at least one of the electrodes
has a closed curve electrode shape and the mapping device includes
at least one aperture that extends through the mapping device and
through an interior region of the closed curve electrode shape.
7. The system of claim 1, wherein the marker includes at least one
of a pin shape, a thread, a hook, and a stop to regulate insertion
distance of the marker in the patient and the marker is to be
attached to the patient through a through-hole aperture in the
mapping device.
8. The system of claim 1, wherein the mapping device includes a
self-curling sheet that fixes the mapping device to the
patient.
9. The system of claim 1, comprising a sensor to sense the
physiological responses and provide signals that indicate the
physiological responses from the patient, wherein the stimulator
receives the signals and analyzes the signals to determine the
location of the at least one of the selected electrodes to be
marked by the marker.
10. A method comprising: maintaining a mapping device that includes
a plurality of electrodes on a baroreceptor region of a patient;
stimulating selected electrodes of the plurality of electrodes with
a stimulator to obtain physiological responses from the patient in
response to stimulation of the selected electrodes; marking a
location of at least one of the selected electrodes on the
baroreceptor region of the patient with a marker based on an
analysis of the physiological responses from the patient; removing
the mapping device from the patient; and maintaining the marker at
the location of the at least one of the selected electrodes on the
baroreceptor region of the patient.
11. The method of claim 10, wherein marking a location includes
attaching the marker to the patient through at least one marking
aperture that extends through the mapping device.
12. The method of claim 10, wherein marking a location includes at
least one of sticking a pin into the patient through at least one
marking aperture that extends through the mapping device and
suturing a thread into the patient through the at least one marking
aperture that extends through the mapping device.
13. The method of claim 10, comprising: aligning an implantable
device with the marker on the baroreceptor region; and securing, to
the patient, the implantable device aligned with the marker on the
baroreceptor region.
14. The method of claim 10, comprising aligning an implantable
device on the baroreceptor region by positioning the marker through
at least one aligning aperture that extends through the implantable
device.
15. The method of claim 10, wherein the marker is one of a pin and
a sutured thread and comprising aligning an implantable device on
the baroreceptor region by positioning the marker through at least
one aligning aperture that extends through the implantable
device.
16. The method of claim 10, wherein maintaining a mapping device
includes wrapping a self-curling mapping device around at least one
body part of the patient.
17. The method of claim 10, comprising: sensing the physiological
responses from the patient with a sensor; providing signals that
indicate the physiological responses from the patient; receiving
the signals at the stimulator; and analyzing the signals with the
stimulator to determine the location of the at least one of the
selected electrodes on the baroreceptor region of the patient to be
marked by the marker.
18. A method of making a self-curling mapping device, the method
including: unrolling and tacking a self-curling sheet to a flat
surface; applying a layer of adhesive to at least part of the
inward curling portion of the self-curling sheet; laminating the
mapping device onto the self-curling sheet via the adhesive to
provide a laminated assembly; curling the laminated assembly around
a mandrel to allow the adhesive to cure in a curled state; and
uncurling the self-curling mapping device.
19. The method of claim 18, wherein the self-curling sheet includes
a self-curling silicone sheet.
20. The method of claim 18, wherein the layer of adhesive includes
a layer of silicone adhesive.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims priority to Provisional Application
No. 62/014,390, filed Jun. 19, 2014, and to Provisional Application
No. 62/014,496, filed Jun. 19, 2014, both of which are herein
incorporated by reference in their entirety.
TECHNICAL FIELD
[0002] This disclosure relates generally to medical devices, and
more particularly, to systems, devices, and methods for delivering
electrical stimulation.
BACKGROUND
[0003] Neural stimulation has been proposed as a therapy to treat
hypertension, also referred to as high blood pressure. It has been
proposed that electrical stimulation directed at baroreceptor
regions can be used to induce a baroreceptor reflex (baroreflex)
that reduces blood pressure. Through the negative feedback loop of
the baroreflex, the central nervous system regulates the blood
pressure to maintain the blood pressure at a relatively stable
level. For example, high blood pressure that causes arterial
stretching activates baroreceptors to send nerve impulses to the
brain and, in response, the brain controls the pumping activity of
the heart and blood vessel dilation to reduce the blood
pressure.
[0004] The change in the blood pressure that is due to electrical
stimulation of a site in a baroreceptor region fluctuates
dramatically based on the location of the site in the baroreceptor
region, i.e., the change in the blood pressure due to the
stimulation at a first site in the baroreceptor region can be
significantly different than the change in the blood pressure due
to the stimulation at a second site in the baroreceptor region.
Animal experiments indicate that stimulation sites separated by
less than 1 millimeter (mm) can produce dramatically different
changes in the blood pressure. Thus, the implantation of a
stimulation device on a baroreceptor region usually requires
extensive mapping of the region to find a location that provides
effective or the most effective control of the blood pressure.
[0005] Often, surgeons manually hold one or more electrodes at
various locations on the baroreceptor region to map the region
during an implantation procedure. Mapping the baroreceptor region
takes significant time and effort due to the difficulty of manually
positioning the electrode at a site, stimulating the baroreceptor
region at the site, waiting for the change in the blood pressure,
measuring the change in the blood pressure, and letting the blood
pressure return to a steady level before positioning the electrode
at the next site and repeating the process. Longer procedure times
increase the risk to a patient and lead to physician fatigue and
dissatisfaction. In addition, this manual procedure can introduce
mechanical activation of the baroreceptors, which hinders the
evaluation of the change in the blood pressure that is due to the
electrical stimulation. As a result, full mapping of the
baroreceptor region is often not obtained, which can result in
sub-optimal implant location, sub-optimal stimulation therapy, and,
over time, loss of therapeutic value.
SUMMARY
[0006] Example 1 is a system including a mapping device, a
stimulator, and a marker. The mapping device includes a plurality
of electrodes to be situated on a baroreceptor region of a patient
to map baroreceptors in the baroreceptor region. The stimulator is
to stimulate selected electrodes of the plurality of electrodes to
obtain physiological responses from the patient in response to the
stimulation of the selected electrodes. The marker is to be
attached to the patient to mark a location of at least one of the
selected electrodes based on an analysis of the physiological
responses from the patient. The marker is to maintain its location
on the patient as the mapping device is removed from the
patient.
[0007] In Example 2, the system of Example 1, including an
implantable device that includes at least one implantable electrode
to be aligned on the baroreceptor region using the marker.
[0008] In Example 3, the system of any of Examples 1 and 2, where
the mapping device includes at least one marking aperture that
extends through the mapping device and the marker is to be attached
to the patient through the at least one marking aperture.
[0009] In Example 4, the system of any of Examples 1-3, where at
least one of the plurality of electrodes has a closed curve mapping
electrode shape that includes a marking aperture that extends
through an interior region of the closed curve mapping electrode
shape.
[0010] In Example 5, the system of any of Examples 1-4, where the
implantable device includes at least one aligning aperture that
extends through the implantable device and the implantable device
is to be aligned on the baroreceptor region via the marker and the
at least one aligning aperture.
[0011] In Example 6, the system of any of Examples 1-5, where the
implantable device includes an implantable electrode that has a
closed curve implantable electrode shape and an aligning aperture
that extends through an interior region of the closed curve
implantable electrode shape to be aligned on the baroreceptor
region via the marker and the aligning aperture.
[0012] In Example 7, the system of any of Examples 1-6, where the
marker includes at least one of a pin shape, a hook, and a suture
to attach the marker to the patient and a stop to regulate
insertion distance of the marker in the patient.
[0013] In Example 8, the system of any of Examples 1-7, where the
mapping device includes a self-curling sheet that fixes the mapping
device to the patient.
[0014] In Example 9, the system of any of Examples 1-8, including a
sensor to sense the physiological responses and provide signals
that indicate the physiological responses from the patient, where
the stimulator receives the signals and analyzes the signals to
determine the location of the at least one of the selected
electrodes to be marked by the marker.
[0015] Example 10 is a system for mapping and marking baroreceptors
in a baroreceptor region of a patient. The system includes a
mapping device, a sensor, a controller, and a marker. The mapping
device includes a plurality of electrodes to be situated on the
baroreceptor region of the patient. The sensor is to sense a
physiological parameter and provide signals that indicate the
physiological parameter. The controller is to receive the signals
from the sensor and analyze the signals to obtain physiological
responses to stimulation of electrodes of the plurality of
electrodes. Also, the controller is to store data on the electrodes
stimulated and corresponding physiological responses in a map of
the baroreceptor region. The marker is to be attached to the
patient to mark a location of at least one of the electrodes that,
when stimulated, provides an effective physiological response based
on an analysis of the map of the baroreceptor region.
[0016] In Example 11, the system of Example 10, where the
controller analyzes the map of the baroreceptor region to identify
the location of the at least one of the electrodes.
[0017] In Example 12, the system of any of Examples 10 and 11,
where the marker is to remain attached to the patient as the
mapping device is removed from the baroreceptor region of the
patient.
[0018] In Example 13, the system of any of Examples 10-12,
including an implantable device that includes at least one
implantable electrode to be aligned on the baroreceptor region
using the marker.
[0019] Example 14 is a method of making a self-curling mapping
device. The method includes the steps of: unrolling and tacking a
self-curling sheet to a flat surface; applying a layer of adhesive
to at least part of the inward curling portion of the self-curling
sheet; laminating the mapping device onto the self-curling sheet
via the adhesive to provide a laminated assembly; curling the
laminated assembly around a mandrel to allow the adhesive to cure
in a curled state; and uncurling the self-curling mapping
device.
[0020] In Example 15, the method of Example 14, where the
self-curling sheet includes a self-curling silicone sheet and the
layer of adhesive includes a layer of silicone adhesive.
[0021] Example 16 is a system including a mapping device, a
stimulator, and a marker. The mapping device includes a plurality
of electrodes to be situated on a baroreceptor region of a patient.
The stimulator is to stimulate selected electrodes of the plurality
of electrodes to obtain physiological responses from the patient in
response to stimulation of the selected electrodes. The marker is
to be attached to the patient and to mark a location of at least
one of the selected electrodes based on an analysis of the
physiological responses from the patient.
[0022] In Example 17, the system of Example 16, including an
implantable device that includes at least one implantable electrode
to be aligned on the baroreceptor region via the marker and sutured
into place on the baroreceptor region.
[0023] In Example 18, the system of any of Examples 16 and 17,
where the mapping device includes at least one marking aperture
that extends through the mapping device and the implantable device
includes at least one aligning aperture that extends through the
implantable device, where the marker is to be attached to the
patient through the at least one marking aperture and the
implantable device is to be aligned on the baroreceptor region via
the at least one aligning aperture and the marker.
[0024] In Example 19, the system of any of Examples 16-18, where
the mapping device includes at least one aperture that extends
through the mapping device and the marker is to be attached to the
patient through the at least one aperture.
[0025] In Example 20, the system of any of Examples 16-19, where
the mapping device includes at least one aperture that extends
through the mapping device and is adjacent at least one of the
electrodes of the plurality of electrodes.
[0026] In Example 21, the system of any of Examples 16-20, where at
least one of the electrodes has a closed curve electrode shape and
the mapping device includes at least one aperture that extends
through the mapping device and through an interior region of the
closed curve electrode shape.
[0027] In Example 22, the system of any of Examples 16-21, where
the marker includes at least one of a pin shape, a thread, a hook,
and a stop to regulate insertion distance of the marker in the
patient and the marker is to be attached to the patient through a
through-hole aperture in the mapping device.
[0028] In Example 23, the system of any of Examples 16-22, where
the mapping device includes a self-curling sheet that fixes the
mapping device to the patient.
[0029] In Example 24, the system of any of Examples 16-23,
including a sensor to sense the physiological responses and provide
signals that indicate the physiological responses from the patient,
where the stimulator receives the signals and analyzes the signals
to determine the location of the at least one of the selected
electrodes to be marked by the marker.
[0030] Example 25 is a method including: maintaining a mapping
device that includes a plurality of electrodes on a baroreceptor
region of a patient; stimulating selected electrodes of the
plurality of electrodes with a stimulator to obtain physiological
responses from the patient in response to stimulation of the
selected electrodes; marking a location of at least one of the
selected electrodes on the baroreceptor region of the patient with
a marker based on an analysis of the physiological responses from
the patient; removing the mapping device from the patient; and
maintaining the marker at the location of the at least one of the
selected electrodes on the baroreceptor region of the patient.
[0031] In Example 26, the method of Example 25, where marking a
location includes attaching the marker to the patient through at
least one marking aperture that extends through the mapping
device.
[0032] In Example 27, the method of any of Examples 25 and 26,
where marking a location includes at least one of sticking a pin
into the patient through at least one marking aperture that extends
through the mapping device and suturing a thread into the patient
through the at least one marking aperture that extends through the
mapping device.
[0033] In Example 28, the method of any of Examples 25-27,
including: aligning an implantable device with the marker on the
baroreceptor region; and securing, to the patient, the implantable
device aligned with the marker on the baroreceptor region.
[0034] In Example 29, the method of any of Examples 25-28,
including aligning an implantable device on the baroreceptor region
by positioning the marker through at least one aligning aperture
that extends through the implantable device.
[0035] In Example 30, the method of any of Examples 25-29, where
the marker is one of a pin and a sutured thread and including
aligning an implantable device on the baroreceptor region by
positioning the marker through at least one aligning aperture that
extends through the implantable device.
[0036] In Example 31, the method of any of Examples 25-30, where
maintaining a mapping device includes wrapping a self-curling
mapping device around at least one body part of the patient.
[0037] In Example 32, the method of any of Examples 25-31,
including: sensing the physiological responses from the patient
with a sensor; providing signals that indicate the physiological
responses from the patient; receiving the signals at the
stimulator; and analyzing the signals with the stimulator to
determine the location of the at least one of the selected
electrodes on the baroreceptor region of the patient to be marked
by the marker.
[0038] Example 33 is a method of making a self-curling mapping
device. The method including: unrolling and tacking a self-curling
sheet to a flat surface; applying a layer of adhesive to at least
part of the inward curling portion of the self-curling sheet;
laminating the mapping device onto the self-curling sheet via the
adhesive to provide a laminated assembly; curling the laminated
assembly around a mandrel to allow the adhesive to cure in a curled
state; and uncurling the self-curling mapping device.
[0039] In Example 34, the method of Example 33, where the
self-curling sheet includes a self-curling silicone sheet.
[0040] In Example 35, the method of any of Examples 33 and 34,
where the layer of adhesive includes a layer of silicone
adhesive.
[0041] While multiple embodiments are disclosed, still other
embodiments of the present invention will become apparent to those
skilled in the art from the following detailed description, which
shows and describes illustrative embodiments of the invention.
Accordingly, the drawings and detailed description are to be
regarded as illustrative in nature and not restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
[0042] FIG. 1 is a diagram illustrating a system for mapping and
marking baroreceptors in a baroreceptor region of a patient,
according to some embodiments described in the disclosure.
[0043] FIG. 2 is a diagram illustrating a mapping device and a
marker situated on an artery, according to some embodiments
described in the disclosure.
[0044] FIG. 3 is a diagram illustrating a mapping device including
a mapping electrode region and a periphery region, according to
some embodiments described in the disclosure.
[0045] FIG. 4 is a diagram illustrating a mapping device and a
marker, where the mapping device includes a through-hole aperture
through a mapping electrode, according to some embodiments
described in the disclosure.
[0046] FIG. 5 is a diagram illustrating a mapping device and a
marker, where the mapping device includes a through-hole aperture
next to a mapping electrode, according to some embodiments
described in the disclosure.
[0047] FIG. 6A is a diagram illustrating a marker that has a
straight pin shape, according to some embodiments described in the
disclosure.
[0048] FIG. 6B is a diagram illustrating a marker that has a
straight pin shape and includes an insertion stop, according to
some embodiments described in the disclosure.
[0049] FIG. 6C is a diagram illustrating a marker that has a hook
at one end of the marker, according to some embodiments described
in the disclosure.
[0050] FIG. 6D is a diagram illustrating a marker that has a hook
at one end of the marker and includes an insertion stop, according
to some embodiments described in the disclosure.
[0051] FIG. 6E is a diagram illustrating a marker that has a helix
at one end of the marker, according to some embodiments described
in the disclosure.
[0052] FIG. 6F is a diagram illustrating a marker that has a helix
at one end of the marker and includes an insertion stop, according
to some embodiments described in the disclosure.
[0053] FIG. 7A is a diagram illustrating a pin shaped marker
attached to an artery after the mapping device has been removed
from the artery, according to some embodiments described in the
disclosure.
[0054] FIG. 7B is a diagram illustrating a thread marker attached
to an artery after the mapping device has been removed from the
artery, according to some embodiments described in the
disclosure.
[0055] FIG. 8 is a diagram illustrating an implantable device and a
marker attached to an artery, according to some embodiments
described in the disclosure.
[0056] FIG. 9 is a diagram illustrating an implantable device
including an implantable electrode region and a periphery region,
according to some embodiments described in the disclosure.
[0057] FIG. 10 is a diagram illustrating an implantable device and
a marker, where the implantable device includes a through-hole
aperture through an implantable electrode, according to some
embodiments described in the disclosure.
[0058] FIG. 11 is a diagram illustrating an implantable device and
a marker, where the implantable device includes a through-hole
aperture next to an implantable electrode, according to some
embodiments described in the disclosure.
[0059] FIG. 12 is a diagram illustrating an example of an
implantable system, according to some embodiments described in the
disclosure.
[0060] FIG. 13 is a flow chart diagram illustrating a method of
mapping a baroreceptor region, marking an identified effective
location in the baroreceptor region, and attaching an implantable
device on the baroreceptor region at the identified effective
location, according to some embodiments described in the
disclosure.
[0061] FIG. 14 is a diagram illustrating a mapping device prior to
attaching a self-curling silicone sheet, according to some
embodiments described in the disclosure.
[0062] FIG. 15 is a diagram illustrating the self-curling silicone
sheet, according to some embodiments described in the
disclosure.
[0063] FIG. 16 is a diagram illustrating the mapping device
attached to the self-curling silicone sheet by silicone adhesive,
according to some embodiments described in the disclosure.
[0064] FIG. 17 is a diagram illustrating a flattened self-curling
mapping device with the excess of the self-curling silicone sheet
trimmed away, according to some embodiments described in the
disclosure.
[0065] FIG. 18 is a diagram illustrating a curled self-curling
mapping device, according to some embodiments described in the
disclosure.
[0066] FIG. 19 is a flow chart diagram illustrating the method of
producing the self-curling mapping device, according to some
embodiments described in the disclosure.
[0067] FIG. 20 is a diagram illustrating a mapping device that is
used to map the targeted baroreceptor region, according to some
embodiments.
[0068] FIG. 21 is a diagram illustrating the selection of zone 1
and the division of zone 1 into a zone 3 and a zone 4, according to
some embodiments described in the disclosure.
[0069] FIG. 22 is a diagram illustrating the selection of zone 4
and the division of zone 4 into a zone 5 and a zone 6, according to
some embodiments described in the disclosure.
[0070] FIG. 23 is a diagram illustrating the selection of zone 6
and the division of zone 6 into a zone 7 and a zone 8, according to
some embodiments described in the disclosure.
[0071] FIG. 24 is a diagram illustrating the selection of zone 7
and the division of zone 7 into a zone 9 and a zone 10, according
to some embodiments described in the disclosure.
[0072] FIG. 25 is a diagram illustrating all of the zones 1-10 and
indicating the selected zones with different cross-hatching for the
refinement process of FIGS. 20-24, according to some embodiments
described in the disclosure.
[0073] FIG. 26A is a flowchart diagram illustrating a first part of
a mapping algorithm for mapping a baroreceptor region, according to
some embodiments described in the disclosure.
[0074] FIG. 26B is a flowchart diagram illustrating a second part
of the mapping algorithm for mapping the baroreceptor region,
according to some embodiments described in the disclosure.
[0075] FIG. 26C is a flowchart diagram illustrating a third part of
the mapping algorithm for mapping the baroreceptor region,
according to some embodiments described in the disclosure.
[0076] While the invention is amenable to various modifications and
alternative forms, specific embodiments have been shown by way of
example in the drawings and are described in detail below. The
intention, however, is not to limit the invention to the particular
embodiments described. On the contrary, the invention is intended
to cover all modifications, equivalents, and alternatives falling
within the scope of the invention as defined by the appended
claims.
DETAILED DESCRIPTION
[0077] Disclosed herein are systems, devices, and methods for:
mapping a baroreceptor region using a mapping device; marking a
location on the baroreceptor region based on the mapping results;
and positioning an implantable device at the location on the
baroreceptor region after removing the mapping device from the
baroreceptor region.
[0078] The autonomic nervous system (ANS) regulates involuntary
organs, such as respiratory organs, digestive organs, blood
vessels, and the heart. The ANS can function in an involuntary,
reflexive manner to regulate glands and muscles in the skin, eye,
stomach, intestines and bladder, and to regulate cardiac muscle and
the muscles around blood vessels. The ANS includes the sympathetic
nervous system and the parasympathetic nervous system. The
sympathetic nervous system is related to stress and the "fight or
flight response." Among other effects, the "fight or flight
response" increases blood pressure and heart rate to increase
skeletal muscle blood flow, and it decreases digestion to provide
energy for fighting or fleeing. The parasympathetic nervous system
is related to relaxation and the "rest and digest response" which,
among other effects, decreases blood pressure and heart rate and
increases digestion. The heart rate and force are increased when
the sympathetic nervous system is stimulated and decreased when the
sympathetic nervous system is inhibited and the parasympathetic
nervous system is stimulated.
[0079] A pressoreceptive region, also referred to as a baroreceptor
region, senses changes in pressure, such as changes in blood
pressure. Baroreceptors in the baroreceptor region are sensitive to
the stretching of a blood vessel wall that is due to an increase in
the blood pressure. The baroreceptors function as the receptor of
the central reflex mechanism referred to as the baroreflex.
Activated baroreceptors trigger the baroreflex that functions as a
negative feedback loop to reduce the blood pressure. In operation
of the baroreflex, an increase in the blood pressure stretches the
blood vessels, which in turn activates the baroreceptors in the
blood vessel wall. Activation of the baroreceptors inhibits the
sympathetic nervous system and excites the parasympathetic nervous
system, which decreases peripheral vascular resistance and
decreases cardiac rate and contractility to reduce the blood
pressure.
[0080] Baroreceptors can be electrically stimulated to induce the
baroreflex, where, as used herein, electrical stimulation of a
baroreceptor includes stimulating the nerve tissue including the
nerve endings that innervate the baroreceptors. Stimulation of the
nerve tissue near the baroreceptors causes neural signals to be
sent to the central nervous system and induces the baroreflex. The
electrical stimulation of the baroreceptors to induce the
baroreflex has been proposed for various therapies, including
hypertension therapy, heart failure therapy, and arrhythmia
therapy. The electrical stimulation of the baroreceptors can be
unipolar or bipolar stimulation. However, modeling suggests that it
is the tissue directly under a cathode that receives the greatest
amount of energy, such that cathodes can be situated in the
baroreceptor region for mapping the baroreceptor region and the
location of the anode, which appears to be less significant, can be
positioned away from the baroreceptor region.
[0081] Baroreceptors are located throughout the body, including in
the arch of the aorta and the carotid sinuses of the left and right
internal carotid arteries. Baroreceptor distribution may vary from
person-to-person. However, baroreceptors appear to be more highly
concentrated near the bifurcation of the interior carotid artery
(ICA) and external carotid artery (ECA), off of the common carotid
artery (CCA).
[0082] FIG. 1 is a diagram illustrating a system 20 for mapping and
marking baroreceptors in a baroreceptor region of a patient,
according to some embodiments described in the disclosure. The
system 20 includes a mapping device 22, a stimulator 24, and a
marker 26. The system 20 can be used to map and mark the
baroreceptors in a baroreceptor region, such as the carotid sinus
of the ICA, the carotid sinus of the ECA, the area near the
bifurcation of the ICA and the ECA, the arch of the aorta artery,
and others.
[0083] The mapping device 22 includes a plurality of mapping
electrodes 28 to be situated on the baroreceptor region. The
mapping electrodes 28 are used to deliver electrical stimulation to
the baroreceptor region. The mapping device 22 is shaped to fit
onto the baroreceptor region and hold the mapping electrodes 28 on
the baroreceptor region. In FIG. 1, the mapping device 22 is
rectangular shaped and situated on an artery 30. In some
embodiments, the mapping device 22 is configured to wrap fully
around the artery 30 and hold the mapping electrodes 28 in place on
the baroreceptor region. In some embodiments, the mapping device 22
is configured to wrap partially around the artery 30 and hold the
mapping electrodes 28 in place on the baroreceptor region. In some
embodiments, the mapping device 22 is configured to be pressed
against the artery 30 and hold the mapping electrodes 28 in place
on the baroreceptor region. In some embodiments, the mapping device
22 is configured to hold the mapping electrodes 28 in place on the
baroreceptor region, wherever the baroreceptor region may be on the
patient's body.
[0084] The mapping device 22, including the plurality of mapping
electrodes 28, is electrically coupled to the stimulator 24 by a
mapping device cable 32 and a re-usable connector cable 34. In some
embodiments, each of the mapping electrodes 28 is electrically
coupled to a separate lead in the cable 32 and each of the separate
leads is electrically coupled to the stimulator 24 through the
re-usable connector cable 34. In some embodiments, the cable 32 is
electrically coupled directly to the stimulator 24.
[0085] The stimulator 24 selects one or more of the mapping
electrodes 28 and stimulates the selected mapping electrode(s) to
obtain one or more physiological responses from the patient. In
some embodiments, the stimulator 24 can deliver unipolar or bipolar
electrical stimulation to the tissue of the baroreceptor region
through the mapping electrodes 28. In some embodiments, the one or
more physiological responses includes a change in the patient's
blood pressure. In some embodiments, the one or more physiological
responses includes a change in the patient's heart rate. In some
embodiments, the one or more physiological responses includes a
change in the patient's tissue impedance.
[0086] The physiological responses can be obtained manually from
the patient or, at least optionally, in some embodiments, the
physiological responses can be obtained automatically from the
patient using one or more sensors, such as sensor 36. The sensor 36
is in communication with the patient or attached to the patient and
communicatively coupled to the stimulator 24 via communications
path 38. The sensor 36 senses at least one physiological parameter
under consideration and provides signals that indicate the sensed
physiological parameter. The at least one physiological parameter
under consideration can include the patient's blood pressure, the
patient's heart rate, and the patient's tissue impedance. In some
embodiments, the sensor 36 can include a direct pressure sensor. In
some embodiments, the sensor 36 can include a heart rate sensor. In
some embodiments, the sensor 36 can include a tissue impedance
sensor.
[0087] The stimulator 24 receives the signals from the sensor 36,
analyzes the signals to obtain the physiological responses, and
stores the data in a map of the baroreceptor region, indicating the
electrode(s) stimulated and the corresponding physiological
responses. This process is repeated for at least some of the
plurality of mapping electrodes 28 to map the baroreceptor
region.
[0088] The map of the baroreceptor region is analyzed to obtain the
location of at least one of the mapping electrodes 28 that, when
stimulated, provides an effective physiological response, referred
to herein as the identified effective location on the baroreceptor
region. The effective physiological response can be a level of
change that matches or exceeds a threshold level of change in one
or more of the physiological parameters under consideration. In
some embodiments, the stimulator 24 analyzes the map of the
baroreceptor region to obtain the location on the baroreceptor
region of the at least one of the mapping electrodes 28 that
provides the effective physiological response.
[0089] In one example, the stimulator 24 selects one of the mapping
electrodes 28 and, to stimulate the patient, the stimulator 24
provides electrical current through the selected mapping electrode
28. The patient's blood pressure changes in response to the
electrical current through the selected mapping electrode 28, where
the change in the patient's blood pressure begins after the
electrical stimulation has begun and is usually complete within 1
minute from the beginning of the electrical stimulation. In some
embodiments, the stimulator 24 provides between 2 and 5 milliamps
(mA) of electrical current through the mapping electrode 28 to
stimulate the patient. In some embodiments, the stimulator 24
provides between 2.9 and 4.1 mA of electrical current through the
mapping electrode 28 to stimulate the patient. In some embodiments,
the stimulator 24 provides the electrical current over a period of
less than 5 seconds. In some embodiments, the patient's blood
pressure begins changing within 5 seconds of the beginning of the
electrical stimulation and the measurement of the change in blood
pressure ends 1 minute or less after the stimulation has begun.
[0090] To further this example, the sensor 36 includes a pressure
sensor that provides signals that indicate the patient's blood
pressure. The stimulator 24 receives the signals and analyzes the
signals to obtain the change in the patient's blood pressure. The
stimulator 24 stores the data in a map of the baroreceptor region,
indicating the electrode stimulated and the corresponding change in
blood pressure. This process is repeated for at least one other
electrode of the plurality of mapping electrodes 28 to map the
baroreceptor region. The stimulator 24 analyzes the map of the
baroreceptor region to select the location in the baroreceptor
region that provides the largest reduction in the patient's blood
pressure within 1 minute, which in this example is the effective
physiological response. To analyze the map and select the location,
the stimulator 24 compares the magnitudes of the change in blood
pressure for different electrode locations and selects the largest
change in blood pressure, which is a reduction in blood pressure,
and the corresponding electrode location. In some embodiments, the
reduction in blood pressure may be greater than 10 mmHg in response
to a 3 mA stimulation through one of the electrodes.
[0091] In some embodiments, the stimulator 24 includes a
stimulation controller 40, a stimulation pulse generator 42, and
switches 44. The controller 40 is communicatively coupled to the
pulse generator 42 via communications path 46 and to the switches
44 via communications path 48. The pulse generator 42 is
electrically coupled to the switches 44 via conductive path 50 and
the switches 44 are electrically coupled to the re-usable connector
cable 34, the cable 32, and the plurality of mapping electrodes 28
via conductive path 52. In some embodiments, the controller 40 is
communicatively coupled to the sensor 36 via communications paths
38 and 54.
[0092] The controller 40 executes computer-executable instructions
that cause the stimulator 24 to provide the system and methods
described in this disclosure. In some embodiments, the controller
40 is at least one processor. In some embodiments, the stimulator
24 includes memory including one or more non-transitory
computer-readable storage media having computer-executable
instructions embodied thereon that, when executed by the controller
40, cause the stimulator 24 to provide the system and methods
described in this disclosure.
[0093] The controller 40 controls the switches 44 to selectively
connect one or more of the mapping electrodes 28 to the pulse
generator 42. In some embodiments, the controller 40 controls the
switches 44 to connect one or more of the mapping electrodes 28 to
the pulse generator 42 as one or more cathodes. In some
embodiments, the controller 40 controls the switches 44 to connect
one or more of the mapping electrodes 28 to the pulse generator 42
as one or more anodes.
[0094] The controller 40 controls the pulse generator 42 to
stimulate the connected mapping electrodes 28. In some embodiments,
the pulse generator 42 can provide unipolar or bipolar electrical
stimulation to the tissue of the baroreceptor region through the
mapping electrodes 28. In some embodiments, the controller 40
controls the switches 44 to connect two or more of the mapping
electrodes 28 to the pulse generator 42 for bipolar stimulation,
i.e., at least one cathode electrode and at least one anode
electrode. In some embodiments, the controller 40 controls the
switches 44 to connect one or more of the mapping electrodes 28 to
the pulse generator 42 for unipolar stimulation.
[0095] In some embodiments, the controller 40 receives the signals
from the sensor 36 and analyzes the signals to obtain the
physiological responses from the patient. The controller 40 stores
the data in a map of the baroreceptor region, indicating the
electrode(s) stimulated and the corresponding physiological
response. In some embodiments, the controller 40 analyzes the map
of the baroreceptor region to obtain the location of at least one
of the mapping electrodes 28 that, when stimulated, provides an
effective physiological response, referred to herein as the
identified effective location in the baroreceptor region.
[0096] The marker 26 is to be attached to the patient to mark the
location in the baroreceptor region of at least one of the mapping
electrodes 28 based on an analysis of the physiological responses
from the patient. The marker 26 can be attached to the patient
after the mapping device 22 and the stimulator 24 have mapped the
baroreceptor region and the map has been analyzed to identify an
electrode location that, when stimulated, provides an effective
physiological response. The marker 26 is attached to the patient
relative to the identified electrode location to indicate and keep
track of the identified effective location on the baroreceptor
region. The marker 26 maintains its location on the patient while
the mapping device 22 is removed from the patient and after the
mapping device 22 has been removed from the patient.
[0097] An implantable device (not shown in FIG. 1), including an
implantable electrode, is aligned on the baroreceptor region using
the marker 26, where the implantable electrode is situated on the
identified effective location. The implantable device is sutured
into place on the baroreceptor region and the implantable electrode
is used to stimulate the baroreceptors at the identified effective
location to alleviate hypertension. After the implantable device is
attached to the patient, the marker 26 is removed from the patient.
In some embodiments, multiple markers can be used to keep track of
the identified effective location on the baroreceptor region. In
some embodiments, the marker 26 includes a pin. In some
embodiments, the marker 26 includes a thread sutured into
place.
[0098] In one example, the controller 40 controls the switches 44
to selectively connect two of the mapping electrodes 28 to the
pulse generator 42. The controller 40 controls the switches 44 to
connect one of the mapping electrodes 28 to the pulse generator 42
as a cathode and the other of the mapping electrodes 28 to the
pulse generator 42 as an anode. The controller 40 controls the
pulse generator 42 to stimulate the connected mapping electrodes
28, providing bipolar electrical stimulation to the tissue of the
baroreceptor region through the mapping electrodes 28. The patient
provides a physiological response, such as a change in blood
pressure and a change in heart rate, primarily in response to the
stimulation of the tissue under the cathode. In some embodiments,
the pulse generator 42 provides between 2 and 5 milliamps (mA) of
electrical current through the mapping electrodes 28 to stimulate
the patient. In some embodiments, the pulse generator 42 provides
between 2.9 and 4.1 mA of electrical current through the mapping
electrodes 28 to stimulate the patient. In some embodiments, the
pulse generator 42 provides the electrical current over a period of
less than 5 seconds. In some embodiments, the patient's blood
pressure and heart rate begin to change within 5 seconds of the
beginning of the electrical stimulation and the measurement of the
changes end 1 minute or less after the stimulation has begun.
[0099] To further this example, the controller 40 receives signals
from the sensor 36 indicating the patient's blood pressure and
heart rate, and the controller 40 analyzes the signals to obtain
the reductions in the patient's blood pressure and heart rate. The
controller 40 stores the data in a map of the baroreceptor region,
indicating the cathode electrode stimulated and the corresponding
physiological responses. To analyze the map of the baroreceptor
region, the controller 40 compares the magnitudes of the reductions
in the blood pressure and the heart rate at one cathode electrode
to the reductions at another cathode electrode. The controller 40
selects the cathode electrode providing the largest changes to
obtain the location of the one mapping electrode 28 that, when
stimulated, provides the effective physiological response. In some
embodiments, the controller 40 can include a tie breaking scheme,
such as selecting a cathode electrode providing the largest
reduction in blood pressure over a cathode electrode providing the
largest reduction in heart rate.
[0100] In addition, in this example, the marker 26 is attached to
the patient to mark the location of the selected mapping electrode
28 and to keep track of the identified effective location on the
baroreceptor region. The marker 26 maintains its location on the
patient while the mapping device 22 is removed from the patient and
after the mapping device 22 has been removed from the patient.
Next, an implantable device including an implantable electrode is
aligned on the baroreceptor region using the marker 26, where the
implantable electrode is situated on the identified effective
location. The implantable device is sutured into place on the
baroreceptor region and the implantable electrode is used to
stimulate the baroreceptors at the identified effective location to
alleviate hypertension. After the implantable device is attached to
the patient, the marker 26 is removed from the patient.
[0101] FIG. 2 is a diagram illustrating a mapping device 100 and a
marker 102 situated on an artery 104, according to some embodiments
described in the disclosure. The mapping device 100 and the marker
102 can be attached to the artery 104. In some embodiments, the
mapping device 100 is similar to the mapping device 22 (shown in
FIG. 1). In some embodiments, the marker 102 is similar to the
marker 26 (shown in FIG. 1).
[0102] The mapping device 100 can be attached to the artery 104 to
map a baroreceptor region of the artery 104. The mapping device 100
has a first side facing the artery 104 and a second side that
opposes the first side and faces away from the artery 104. In some
embodiments, the mapping device 100 is curled or wrapped around the
artery 104 to hold the mapping device 100 in place on the artery
104. In some embodiments, the mapping device 100 includes a
self-curling sheet that curls the mapping device 100 around the
artery 104 and fixes the mapping device 100 to the baroreceptor
region. In some embodiments, the backing of the mapping device 100
is formed to curl the mapping device 100 around the artery 104 and
fix the mapping device 100 to the baroreceptor region.
[0103] The mapping device 100 includes a plurality of mapping
electrodes 106 formed on a substrate 108. The mapping electrodes
106 can be arranged in an array of mapping electrodes 106. The
substrate 108 includes at least one insulating layer on the first
side of the mapping device 100 and the mapping electrodes 106 are
formed on the insulating layer of the substrate 108. The mapping
electrodes 106 are situated on the first side of the substrate 108
to face the artery 104 and contact the tissue of the baroreceptor
region. In some embodiments, the substrate 108 is formed to curl
the mapping device 100 around the artery 104 and fix the mapping
device 100 to the baroreceptor region. In some embodiments, the
mapping device 100 is configured to wrap fully around the artery
104 and hold the mapping electrodes 106 in place on the
baroreceptor region. In some embodiments, the mapping device 100 is
configured to wrap partially around the artery 104 and hold the
mapping electrodes 106 in place on the baroreceptor region. In some
embodiments, the mapping device 100 is configured to be pressed
against the artery 104 and hold the mapping electrodes 106 in place
on the baroreceptor region.
[0104] The mapping electrodes 106 are made out of a conductive
material and electrically coupled to a mapping device cable 110,
which is electrically coupled to a stimulator, such as stimulator
24 (shown in FIG. 1). In some embodiments, the mapping electrodes
106 include metal. In some embodiments, the mapping electrodes 106
include copper. In some embodiments, each of the mapping electrodes
106 is electrically isolated from the other mapping electrodes 106
on the substrate 108. In some embodiments, the mapping device 100
is built using printed circuit board technology.
[0105] The marker 102 is attached to the artery 104 to indicate and
keep track of the identified effective location in the baroreceptor
region for stimulating the baroreceptor region and obtaining the
desired physiological response from the patient. The marker 102 is
attached to the artery 104 relative to the mapping device 100. In
some embodiments, multiple markers, such as marker 102, can be
attached to the artery 104 relative to the mapping device 100 to
indicate and keep track of the identified effective location in the
baroreceptor region.
[0106] The marker 102 can be attached to the tissue of the artery
104 through a marking aperture in the mapping device 100 or at one
or more locations next to the mapping device 100. The marking
aperture can be a through-hole aperture in the mapping device 100,
which extends completely through the mapping device 100, from the
first side of the mapping device 100 to the second side of the
mapping device 100. In some embodiments, the mapping device 100
includes a through-hole aperture through each of the plurality of
mapping electrodes 106 and the marker 102 is attached to the artery
104 through one of these through-hole apertures. In some
embodiments, the mapping device 100 includes a through-hole
aperture next to each of the plurality of electrodes 106 and the
marker 102 is attached to the artery 104 through one of these
through-hole apertures. In some embodiments, the mapping device 100
includes one or more through-hole apertures at the periphery of the
mapping device 100, outside the plurality of mapping electrodes
106, and one or more markers, such as marker 102, are attached to
the artery 104 through these through-hole apertures.
[0107] FIG. 3 is a diagram illustrating a mapping device 120
including a mapping electrode region 122 and a periphery region 124
that is outside the mapping electrode region 122 as indicated by
dashed lines, according to some embodiments described in the
disclosure. In some embodiments, the mapping device 120 is similar
to the mapping device 100.
[0108] The mapping electrode region 122 includes mapping electrodes
128 and the periphery region 124 includes through-hole apertures
126 that extend through the mapping device 120. Markers, such as
marker 102, can be attached to the tissue of the baroreceptor
region through the through-hole apertures 126 in the periphery
region 124 to indicate and keep track of the identified effective
location in the baroreceptor region. In some embodiments, the
mapping electrodes 128 are similar to the mapping electrodes
106.
[0109] FIG. 4 is a diagram illustrating a mapping device 130 and a
marker 132, according to some embodiments described in the
disclosure. The mapping device 130 includes a mapping electrode 134
that is made from a conductive material and includes a conductive
lead 136 that can be electrically coupled to a mapping device
cable, such as the mapping device cable 110. In some embodiments,
the mapping device 130 is similar to the mapping device 100. In
some embodiments, the marker 132 is similar to the marker 102. In
some embodiments, the mapping electrode 134 is similar to at least
one of the mapping electrodes 106. In some embodiments, the mapping
electrode 134 is similar to each and every one of the mapping
electrodes 106.
[0110] The mapping electrode 134 is shaped to provide stimulation
to the tissue of the baroreceptor region. The mapping electrode 134
has a circular shape and the mapping device 130 includes a
through-hole aperture 138 that extends through an interior region
140 of the mapping electrode 134. This results in the mapping
electrode 134 having a circular closed curve shape or donut shape,
where the interior region 140 of the mapping electrode 134 includes
the through-hole aperture 138, which is surrounded by the
conductive material of the mapping electrode 134. The marker 132
can be attached to the tissue of the baroreceptor region through
the through-hole aperture 138. In some embodiments, the mapping
electrode 134 has a different closed curve shape, such as a
rectangular closed curve shape or a hexagonal closed curve shape.
In some embodiments, the through-hole aperture 138 extends through
the mapping device 130 next to the mapping electrode 134, and not
through the interior region 140 of the mapping electrode 134.
[0111] FIG. 5 is a diagram illustrating a mapping device 150 and a
marker 152, where the mapping device 150 includes a through-hole
aperture 158 that extends through the mapping device 150 next to a
mapping electrode 154, according to some embodiments described in
the disclosure. The mapping device 150 includes the mapping
electrode 154 that is made from a conductive material and includes
a conductive lead 156 that can be electrically coupled to a mapping
device cable, such as the mapping device cable 110. In some
embodiments, the mapping device 150 is similar to the mapping
device 100. In some embodiments, the marker 152 is similar to the
marker 102. In some embodiments, the mapping electrode 154 is
similar to at least one of the mapping electrodes 106. In some
embodiments, the mapping electrode 154 is similar to each and every
one of the mapping electrodes 106.
[0112] The mapping electrode 154 is shaped to provide stimulation
to the tissue of the baroreceptor region. The mapping electrode 154
has a circular shape and the mapping device 150 includes the
through-hole aperture 158 that is situated next to the mapping
electrode 154. The marker 152 can be attached to the tissue of the
baroreceptor region through the through-hole aperture 158. In some
embodiments, the mapping electrode 154 has a different shape, such
as a rectangular shape or a hexagonal shape.
[0113] FIGS. 6A-6F are diagrams illustrating different markers 170,
172, 174, 176, 178, and 180 that can be attached to the tissue of
the patient to indicate and keep track of the identified effective
location in the baroreceptor region, according to some embodiments
described in the disclosure.
[0114] FIG. 6A is a diagram illustrating a marker 170 that has a
straight pin shape, according to some embodiments. The marker 170
includes an end 170a that is stuck into the tissue of the patient.
In some embodiments, the marker 170 is a rigid pin. In some
embodiments, the marker 170 is a rigid pin that includes metal.
[0115] FIG. 6B is a diagram illustrating a marker 172 that has a
straight pin shape and includes an insertion stop 172a, according
to some embodiments. The marker 172 includes an end 172b that is
inserted into the tissue of the patient and the insertion stop 172a
prevents or stops further insertion of the marker 172 into the
patient. In some embodiments, the marker 172 including the
insertion stop 172a is rigid. In some embodiments, at least the
insertion stop 172a is flexible. In some embodiments, the marker
172 includes metal.
[0116] FIG. 6C is a diagram illustrating a marker 174 that has a
hook 174a at one end 174b of the marker 174, according to some
embodiments. The hook 174a is hooked through the tissue of the
patient to attach the marker 174 to the patient. In some
embodiments, the marker 174 is rigid. In some embodiments, the
marker 174 includes metal.
[0117] FIG. 6D is a diagram illustrating a marker 176 that has a
hook 176a at one end 176b and includes an insertion stop 176c,
according to some embodiments. The hook 176a is hooked through the
tissue of the patient to attach the marker 176 to the patient and
the insertion stop 176c prevents or stops further insertion of the
marker 176 into the patient. In some embodiments, the marker 176
including the insertion stop 176c is rigid. In some embodiments, at
least the insertion stop 176c is flexible. In some embodiments, the
marker 176 includes metal.
[0118] FIG. 6E is a diagram illustrating a marker 178 that has a
helix 178a at one end 178b of the marker 178, according to some
embodiments. The helix 178a is twisted into the tissue of the
patient to attach the marker 178 to the patient. In some
embodiments, the marker 178 is rigid. In some embodiments, the
marker 178 includes metal.
[0119] FIG. 6F is a diagram illustrating a marker 180 that has a
helix 180a at one end 180b and includes an insertion stop 180c,
according to some embodiments. The helix 180a is twisted into the
tissue of the patient to attach the marker 180 to the patient and
the insertion stop 180c prevents or stops further insertion of the
marker 180 into the patient. In some embodiments, the marker 180
including the insertion stop 180c is rigid. In some embodiments, at
least the insertion stop 180c is flexible. In some embodiments, the
marker 180 includes metal.
[0120] FIGS. 7A and 7B are diagrams illustrating markers 200 and
202 attached to arteries 204 and 206, respectively, after a mapping
device has been removed from the arteries 204 and 206, according to
some embodiments described in the disclosure. In some embodiments,
the markers 200 and 202 are similar to the marker 26 (shown in FIG.
1). In some embodiments, the markers 200 and 202 are similar to the
marker 102 (shown in FIG. 2).
[0121] As previously described, a mapping device, such as the
mapping device 22 and the mapping device 100, is used to map the
baroreceptor region of the patient and the map is analyzed to
determine which of the mapping electrodes, when stimulated,
provides an effective physiological response. The location of this
mapping electrode on the baroreceptor region is referred to as the
identified effective location in the baroreceptor region. At least
one marker, such as the marker 26 and the marker 102, is attached
to the patient to indicate and keep track of the identified
effective location in the baroreceptor region. The marker is
attached to the patient in relation to the mapping device and the
mapping electrode that, when stimulated, provided the effective
physiological response. The marker indicates and keeps track of the
identified effective location in the baroreceptor region. The
marker maintains its location on the patient as the mapping device
is removed and after the mapping device has been removed from the
patient.
[0122] FIG. 7A is a diagram illustrating a marker 200 attached to
the artery 204 after the mapping device has been removed from the
artery 204, according to some embodiments. The marker 200 can be
one of the markers 170, 172, 174, and 176.
[0123] In some embodiments, the marker 200 was attached to the
tissue of the artery 204 through a through-hole aperture, such as
the through-hole aperture 138 that extends through the mapping
electrode 134 (shown in FIG. 4). The mapping electrode 134 may have
been identified as the mapping electrode that, when stimulated,
provides the most effective physiological response and the marker
200 is attached to the baroreceptor region at the identified
effective location in the baroreceptor region of the patient.
[0124] In some embodiments, the marker 200 was attached to the
tissue of the artery 204 through a through-hole aperture, such as
the through-hole aperture 158 that is next to the mapping electrode
154 (shown in FIG. 5). The mapping electrode 154 may have been
identified as the mapping electrode that, when stimulated, provides
the most effective physiological response and the marker 200 is
attached to the baroreceptor region just above the identified
effective location in the baroreceptor region of the patient.
[0125] FIG. 7B is a diagram illustrating a marker 202 attached to
the artery 206 after the mapping device has been removed from the
artery 206, according to some embodiments. The marker 202 is a
thread that has been sutured into the tissue of the artery 206.
[0126] In some embodiments, the marker 202 was attached to the
tissue of the artery 206 through a through-hole aperture, such as
the through-hole aperture 138 that extends through the mapping
electrode 134 (shown in FIG. 4). The mapping electrode 134 may have
been identified as the mapping electrode that, when stimulated,
provides the most effective physiological response and the marker
202 is attached to the baroreceptor region at the identified
effective location in the baroreceptor region of the patient.
[0127] In some embodiments, the marker 202 was attached to the
tissue of the artery 206 through a through-hole aperture, such as
the through-hole aperture 158 that is next to the mapping electrode
154 (shown in FIG. 5). The mapping electrode 154 may have been
identified as the mapping electrode that, when stimulated, provides
the most effective physiological response and the marker 202 is
attached to the baroreceptor region just above the identified
effective location in the baroreceptor region of the patient.
[0128] In some embodiments, one or more markers, such as the marker
200 and the marker 202, are attached to the tissue of the arteries
204 and 206 through one or more through-hole apertures in the
mapping device. In some embodiments, one or more markers, such as
the marker 200 and the marker 202, are attached to the tissue of
the arteries 204 and 206 through one or more through-hole apertures
in the periphery of the mapping device. In some embodiments, one or
more markers, such as the marker 200 and the marker 202, are
attached to the tissue of the arteries 204 and 206 next to the
mapping device.
[0129] FIG. 8 is a diagram illustrating an implantable device 220
and a marker 222 attached to an artery 224, according to some
embodiments described in the disclosure. The implantable device 220
can be sutured onto the artery 224 to provide long term stimulation
of the baroreceptors at the identified effective location in the
baroreceptor region. In some embodiments, an implantable medical
device is electrically coupled to the implantable device 220 to
provide electrical stimulation to the patient.
[0130] The marker 222 is attached to the artery 224 to indicate and
keep track of the identified effective location in the baroreceptor
region. In some embodiments, multiple markers, such as marker 222,
can be attached to the artery 224 to indicate and keep track of the
identified effective location in the baroreceptor region. In some
embodiments, the marker 222 is similar to one or more of the
markers described in this disclosure, including the markers 26,
102, 132, 152, 170, 172, 174, 176, 200, and 202.
[0131] The implantable device 220 has a first side facing the
artery 224 and a second side that opposes the first side and faces
away from the artery 224. The implantable device 220 includes one
or more implantable electrodes 226 formed on a substrate 228. The
substrate 228 includes at least one insulating layer on the first
side of the implantable device 220 and the implantable electrodes
226 are formed on the insulating layer of the substrate 228. The
implantable electrodes 226 are situated on the first side to face
the artery 224 and contact the tissue of the baroreceptor region.
In some embodiments, each of the implantable electrodes 226 is
electrically isolated from the other implantable electrodes 226 on
the substrate 228. In some embodiments, the implantable device 220
is built using printed circuit board technology.
[0132] The implantable electrodes 226 are made out of a conductive
material and electrically coupled to an implantable device cable
230, which can be electrically coupled to a stimulator, such as a
stimulator in an implantable medical device. In some embodiments,
the implantable electrodes 226 include metal. In some embodiments,
the implantable electrodes 226 include copper.
[0133] The implantable device 220 is aligned on the artery 224
using the marker 222 and one of the implantable electrodes 226 is
situated on the identified effective location. The implantable
device 220 is sutured into place on the artery 224 with sutures 232
and the implantable electrode 226 is used to provide stimulation of
the baroreceptors at the identified effective location in the
baroreceptor region. After the implantable device 220 is attached
to the patient, the marker 222 is removed from the patient. In some
embodiments, multiple markers can be used to keep track of the
identified effective location on the baroreceptor region and
removed after the implantable device 220 is attached to the
patient.
[0134] In some embodiments, the implantable device 220 includes an
aligning aperture that is slid over the marker 222 attached to the
patient. The marker 222 is slid through the aligning aperture to
align the implantable device 220 and one of the implantable
electrodes 226 on the identified effective location in the
baroreceptor region. The marking aperture can be a through-hole
aperture in the implantable device 220, which extends completely
through the implantable device 220, from the first side of the
implantable device 220 to the second side of the implantable device
220. In some embodiments, the implantable device 220 includes a
through-hole aperture through each of the implantable electrodes
226 and the marker 224 is slid through one of these through-hole
apertures to align the implantable device 220 on the artery 224. In
some embodiments, the implantable device 220 includes a
through-hole aperture next to each of the implantable electrodes
226 and the marker 222 is slid through one of these through-hole
apertures to align the implantable device 220 on the artery 224. In
some embodiments, the implantable device 220 includes one or more
through-hole apertures at the periphery of the implantable device
220, outside the implantable electrodes 226, and one or more
markers, such as marker 222, is slid through one or more of these
through-hole apertures to align the implantable device 220 on the
artery 224.
[0135] FIG. 9 is a diagram illustrating an implantable device 240
including an implantable electrode region 242 and a periphery
region 244 that is outside the implantable electrode region 242 as
indicated by dashed lines, according to some embodiments described
in the disclosure. In some embodiments, the implantable device 240
is similar to the implantable device 220.
[0136] The implantable electrode region 242 includes the
implantable electrodes, such as the implantable electrodes 226, and
the periphery region 244 includes through-hole apertures 246 that
extend through the implantable device 240. Markers, such as marker
222, can be slid through one or more of the through-hole apertures
246 to align the implantable device 240 on the patient.
[0137] FIG. 10 is a diagram illustrating an implantable device 250
and a marker 252, according to some embodiments described in the
disclosure. The implantable device 250 includes an implantable
electrode 254 that is made from a conductive material and includes
a conductive lead 256 that can be electrically coupled to an
implantable device cable, such as the implantable device cable 230.
In some embodiments, the implantable device 250 is similar to the
implantable device 220. In some embodiments, the marker 252 is
similar to the marker 222. In some embodiments, the implantable
electrode 254 is similar to at least one of the implantable
electrodes 226. In some embodiments, the implantable electrode 254
is similar to each and every one of the implantable electrodes
226.
[0138] The implantable electrode 254 is shaped to provide
stimulation to the tissue of the baroreceptor region. The
implantable electrode 254 has a circular shape and the implantable
device 250 includes a through-hole aperture 258 that extends
through an interior region 260 of the implantable electrode 254.
This results in the implantable electrode 254 having a circular
closed curve shape or donut shape, where the interior region 260 of
the implantable electrode 254 includes the through-hole aperture
258, which is surrounded by the conductive material of the
implantable electrode 254. The marker 252 is slid through the
through-hole aperture 258 to align the implantable device 250 and
the implantable electrode 256 on the identified effective location
in the baroreceptor region. In some embodiments, the implantable
electrode 254 has a different closed curve shape, such as a
rectangular closed curve shape or a hexagonal closed curve shape.
In some embodiments, the through-hole aperture 258 extends through
the implantable device 250 next to the implantable electrode 254,
and not through the interior region 260 of the implantable
electrode 254.
[0139] FIG. 11 is a diagram illustrating an implantable device 270
and a marker 272, where the implantable device 270 includes a
through-hole aperture 278 that extends through the implantable
device 270 next to an implantable electrode 274, according to some
embodiments described in the disclosure. The implantable device 270
includes the implantable electrode 274 that is made from a
conductive material and includes a conductive lead 276 that can be
electrically coupled to an implantable device cable, such as the
implantable device cable 230. In some embodiments, the implantable
device 270 is similar to the implantable device 220. In some
embodiments, the marker 272 is similar to the marker 222. In some
embodiments, the implantable electrode 274 is similar to at least
one of the implantable electrodes 226. In some embodiments, the
implantable electrode 274 is similar to each and every one of the
implantable electrodes 226.
[0140] The implantable electrode 274 is shaped to provide
stimulation to the tissue of the baroreceptor region. The
implantable electrode 274 has a circular shape and the implantable
device 270 includes the through-hole aperture 278 that is situated
next to the implantable electrode 274. The marker 272 is slid
through the through-hole aperture 278 to align the implantable
device 270 and the implantable electrode 276 on the identified
effective location in the baroreceptor region. In some embodiments,
the implantable electrode 274 has a different shape, such as a
rectangular shape or a hexagonal shape.
[0141] FIG. 12 is a diagram illustrating an example of an
implantable system 300 coupled to an implantable device 302 for
long term stimulation of the baroreceptors at the identified
effective location in the baroreceptor region of a patient,
according to some embodiments described in the disclosure. The
implantable system 300 can be electrically coupled to any of the
implantable devices described in this disclosure, including the
implantable devices 220, 240, 250, and 270, for providing
electrical stimulation to the baroreceptors in a baroreceptor
region. The implantable system 300 can be used to provide
electrical stimulation to the baroreceptors in baroreceptor regions
such as the carotid sinus of the ICA, the carotid sinus of the ECA,
the area near the bifurcation of the ICA and the ECA, the arch of
the aorta artery, and others.
[0142] The implantable system 300 includes the implantable device
302, an implantable medical device (IMD) stimulator 304, and a
sensor 306. The implantable device 302 is similar to one or more of
the implantable devices 220, 240, 250, and 270, and electrically
coupled to the IMD stimulator 304 by an implantable device cable
308.
[0143] The IMD stimulator 304 includes an IMD controller 310, an
IMD pulse generator 312, and IMD switches 314. The controller 310
is communicatively coupled to the pulse generator 312 via
communications path 316 and to the switches 314 via communications
path 318. The pulse generator 312 is electrically coupled to the
switches 314 via conductive path 320, and the switches 314 are
electrically coupled to the implantable device 302 via conductive
path 322 and the cable 308. Also, the controller 310 is
communicatively coupled to the sensor 306 via communications path
324.
[0144] The controller 310 receives signals from the sensor 306,
which indicate the physiological state of the patient. The
controller 310 analyzes the signals to determine whether the
patient needs electrical stimulation through the implantable device
302 and, if so, the parameters of the electrical stimulation,
including one or more of amplitude, pulse width, pulse frequency,
burst duration for a train of pulses, burst cycle duration, and
duty cycle. In some embodiments, the controller 310 stores the
physiological data obtained from the patient via the sensor
306.
[0145] The controller 310 controls the switches 314 to selectively
connect one or more implantable electrodes in the implantable
device 302 to the pulse generator 312, and the controller 310
controls the pulse generator 312 to stimulate the connected
implantable electrodes. In some embodiments, the controller 310
controls the switches 314 to connect one or more of the implantable
electrodes to the pulse generator 312 as cathodes and/or one or
more of the implantable electrodes as anodes. In some embodiments,
the pulse generator 312 controls the switches 314 to connect two or
more of the implantable electrodes to the pulse generator 312 for
bipolar stimulation, i.e., at least one cathode electrode and at
least one anode electrode. In some embodiments, the controller 310
controls the switches 314 to connect one implantable electrode to
the pulse generator 312 for unipolar stimulation.
[0146] FIG. 13 is a flow chart diagram illustrating the method of
mapping a baroreceptor region, marking an identified effective
location in the baroreceptor region, and attaching an implantable
device on the baroreceptor region at the identified effective
location, according to some embodiments described in the
disclosure.
[0147] The method, at 340, includes the step of maintaining a
mapping device on the baroreceptor region. The mapping device
includes a plurality of mapping electrodes that are situated on the
baroreceptor region. In some embodiments, the mapping device is
similar to one or more of the mapping devices 22, 100, 120, 130,
150, and 404. In some embodiments, the mapping device is a
self-curling mapping device that wraps around at least one part of
the patient, such as an artery, to maintain the mapping device and
the mapping electrodes on the baroreceptor region. In some
embodiments, the backing of the mapping device is formed to curl
the mapping device around at least one part of the patient, such as
an artery, to maintain the mapping device and the mapping
electrodes on the baroreceptor region. In some embodiments, the
substrate is formed to curl the mapping device around at least one
part of the patient, such as an artery, to maintain the mapping
device and the mapping electrodes on the baroreceptor region. In
some embodiments, the mapping device includes a self-curling sheet
that curls the mapping device around at least one part of the
patient, such as an artery, to maintain the mapping device and the
mapping electrodes on the baroreceptor region.
[0148] At 342, the method includes the step of stimulating selected
mapping electrodes of the plurality of mapping electrodes on the
baroreceptor region with a stimulator, such as stimulator 24, to
obtain physiological responses from the patient. The physiological
responses are in response to electrical stimulation of the
baroreceptors in the baroreceptor region under the stimulated
mapping electrodes.
[0149] In some embodiments, a sensor, such as sensor 36, senses at
least one physiological parameter of the patient and provides
signals that indicate the sensed physiological parameter. The
stimulator receives these signals and analyzes the signals to
obtain the physiological response of the patient due to the
electrical stimulation of the baroreceptors in the baroreceptor
region under the stimulated mapping electrodes. The stimulator
stores the stimulated mapping electrode and physiological response
information in a map of the baroreceptor region. In some
embodiments, the stimulator analyzes the map of the baroreceptor
region to identify the location of at least one of the selected
electrodes that, when stimulated, provides an effective
physiological response.
[0150] At 344, the method includes the step of marking the location
of at least one of the selected mapping electrodes on the
baroreceptor region of the patient with a marker based on the
analysis of the physiological responses from the patient. The
marker is attached to the patient relative to the mapping device
and the location of the at least one mapping electrode that, when
stimulated, provides an effective physiological response. In some
embodiments, the marker is attached to the patient through at least
one marking aperture that extends through the mapping device. In
some embodiments, marking the location includes sticking a pin into
the patient through at least one marking aperture that extends
through the mapping device. In some embodiments, marking the
location includes suturing a thread into the patient through at
least one marking aperture that extends through the mapping
device.
[0151] Next, at 346, the method includes the step of removing the
mapping device from the patient and, at 348, maintaining the marker
on the patient to mark the location of the at least one mapping
electrode on the baroreceptor region of the patient. In some
embodiments, the marker is maintained on the patient via a hook at
one end of the marker.
[0152] At 350, the method includes the step of aligning an
implantable device on the baroreceptor region using the attached
marker. In some embodiments, aligning the implantable device on the
baroreceptor region includes positioning the marker through at
least one aligning aperture that extends through the implantable
device. In some embodiments, the marker is a pin and aligning the
implantable device on the baroreceptor region includes positioning
the pin through at least one aligning aperture that extends through
the implantable device. In some embodiments, the marker is a
sutured thread and aligning the implantable device on the
baroreceptor region includes positioning the thread through at
least one aligning aperture that extends through the implantable
device.
[0153] At 352, the method includes the step of securing, to the
patient, the implantable device aligned with the marker on the
baroreceptor region. Where, in some embodiments, securing the
implantable device to the patient includes suturing the implantable
device to the patient. At 354, the method includes the step of
removing the marker from the patient.
[0154] FIGS. 14-18 are diagrams illustrating a method of attaching
a mapping device 400 to a self-curling silicone sheet 402 to
produce a self-curling mapping device 404, according to some
embodiments described in the disclosure. The self-curling mapping
device 404 can be wrapped or curled around a body part, such as an
artery, to hold mapping electrodes 406 on a baroreceptor region. In
some embodiments, the self-curling mapping device 404 is similar to
one or more of the mapping devices described in this disclosure,
including the mapping devices 22, 100, 120, 130, and 150.
[0155] FIG. 14 is a diagram illustrating the mapping device 400
prior to attaching the self-curling silicone sheet 402, according
to some embodiments. The mapping device 400 includes the mapping
electrodes 406 electrically coupled to a mapping device cable
408.
[0156] FIG. 15 is a diagram illustrating the self-curling silicone
sheet 402, according to some embodiments. The self-curling silicone
sheet 402 is unrolled and tacked or staked down by tacks 410 to a
flat surface. A layer of silicone adhesive 412 is applied to at
least part of the inward curling portion of the self-curling
silicone sheet 402 for attaching the mapping device 400.
[0157] FIG. 16 is a diagram illustrating the mapping device 400
attached to the self-curling silicone sheet 402 by the silicone
adhesive 412, according to some embodiments. The mapping device 400
is laminated onto the flattened self-curling silicone sheet 402 via
the silicone adhesive 412. In some embodiments, the laminated
assembly is then curled around a mandrel to allow the uncured
silicone adhesive 412 to cure in the curled state, thereby seating
the mapping device 400 properly and setting the curl as permanent.
After curing, the self-curling mapping device 404 is uncurled and
the periphery of the self-curling silicone sheet 402 is trimmed
away to best fit or grip onto the body part of the patient.
[0158] FIG. 17 is a diagram illustrating a flattened self-curling
mapping device 404 with the excess of the self-curling silicone
sheet 402 trimmed away, according to some embodiments.
[0159] FIG. 18 is a diagram illustrating a curled self-curling
mapping device 404, according to some embodiments. The self-curling
mapping device 404 is uncurled during surgery and re-curled around
a body part, such as an artery, to establish a mechanical fix or
grip onto the artery.
[0160] FIG. 19 is a flow chart diagram illustrating the method of
producing the self-curling mapping device 404, according to some
embodiments described in the disclosure.
[0161] At 420, the method includes the step of unrolling and
tacking the self-curling silicone sheet 402 to a flat surface. The
self-curling silicone sheet 402 can be tacked down with tacks 410
to the flat surface. At 422, a layer of silicone adhesive 412 is
applied to at least part of the inward curling portion of the
self-curling silicone sheet 402 for attaching the mapping device
400.
[0162] At 424, the method includes the step of laminating or
bonding the mapping device 400 onto the flattened self-curling
silicone sheet 402 via the silicone adhesive 412. At 426, the
method includes the step of curling the laminated assembly around a
mandrel to allow the uncured silicone adhesive 412 to cure in the
curled state, thereby seating the mapping device 400 properly and
setting the curl as permanent.
[0163] At 428, the method includes the step of uncurling the
self-curling mapping device 404 and trimming away the excess of the
self-curling silicone sheet 402. The self-curling mapping device
404 is uncurled during surgery and re-curled around a part of the
patient's body, such as an artery, to establish a mechanical fix or
grip on the artery.
[0164] Alternatively, in some embodiments, the backing of a mapping
device is formed to provide a self-curling mapping device that can
curl or wrap around at least one part of the patient, such as an
artery, to maintain the mapping device and the mapping electrodes
on the baroreceptor region. In some embodiments, the substrate of
the mapping device, such as substrate 108, is formed to provide a
self-curling mapping device that can curl or wrap the mapping
device around at least one part of the patient, such as an artery,
to maintain the mapping device and the mapping electrodes on the
baroreceptor region.
[0165] Some advantages of a self-curling mapping device, such as
the self-curling mapping device 404, include: a method of fixing
the self-curling mapping device onto the patient without the need
of hand holding the mapping device in place during the mapping
procedure; a method of fixing the self-curling mapping device in
place without the use of a suture during the mapping procedure; a
self-curling mapping device that is stable in its position on the
patient thereby reducing or eliminating electrical noise caused by
the movement of the self-curling mapping device during the mapping
procedure; and a gripping method that allows convenient
re-positioning on the patient.
[0166] FIGS. 20-25 are diagrams illustrating an algorithm for
mapping the baroreceptors in a baroreceptor region of a patient.
The mapping can be achieved utilizing a stimulator, such as the
stimulator 24 (shown in FIG. 1).
[0167] FIG. 20 is a diagram illustrating a mapping device 500 that
is used to map the targeted baroreceptor region, according to some
embodiments. The mapping device 500 includes a plurality of mapping
electrodes 502 that are electrically coupled to the stimulator 24
via mapping device cable 504. In some embodiments, the mapping
device 500 is similar to one or more of the mapping devices
described in this disclosure, including the mapping devices 22,
100, 120, 130, 150, and 404.
[0168] As used in this example, the stimulator 24 includes the
stimulation controller 40, the stimulation pulse generator 42, and
the switches 44. The controller 40 controls the switches 44 to
selectively connect one or more of the mapping electrodes 502 to
the pulse generator 42 as one or more cathodes and/or to
selectively connect one or more of the mapping electrodes 502 to
the pulse generator 42 as one or more anodes. Also, the controller
40 controls the pulse generator 42 to stimulate the baroreceptor
region through the connected mapping electrodes 502, where the
stimulation parameters can include one or more of amplitude, pulse
width, pulse frequency, burst duration for a train of pulses, burst
cycle duration, and duty cycle. The controller 40 controls the
pulse generator 42 to provide unipolar electrical stimulation to
the tissue of the baroreceptor region through the mapping
electrodes 502 or bipolar electrical stimulation to the tissue of
the baroreceptor region through the mapping electrodes 502.
[0169] In some embodiments, to provide unipolar stimulation, the
controller 40 controls the switches 44 to selectively connect one
of the mapping electrodes 502 to the pulse generator 42 as a
cathode and the controller 40 controls the pulse generator 42 to
stimulate the baroreceptor region through the connected mapping
electrode. A circuit path is completed through the body of the
patient to any suitable location on the patient.
[0170] In some embodiments, to provide bipolar stimulation, the
controller 40 controls the switches 44 to selectively connect one
of the mapping electrodes 502 to the pulse generator 42 as a
cathode and to connect another of the mapping electrodes 502 to the
pulse generator 42 as an anode. The controller 40 controls the
pulse generator 42 to provide bipolar stimulation to the
baroreceptor region through the connected mapping electrodes 502,
where the circuit path is completed from anode to cathode or from
cathode to anode.
[0171] In this example, the controller 40 receives the signals from
the sensor 36 and analyzes the signals to obtain the physiological
responses from the patient. The controller 40 stores the data in a
map of the baroreceptor region, indicating the mapping electrode of
the mapping electrodes 502 that was stimulated and the
corresponding physiological response. In addition, the controller
40 analyzes the map of the baroreceptor region to determine which
zones of the mapping electrodes 502 are most likely to include the
mapping electrode of the mapping electrodes 502 that, when
stimulated, provides the effective physiological response. The
location of this mapping electrode is referred to herein as the
identified effective location in the baroreceptor region.
[0172] To begin, the stimulator 24 divides the mapping device 500
into two zones of mapping electrodes 502, a zone 1 at 506 and a
zone 2 at 508 as indicated by the dashed line. The zone 1 at 506
includes the mapping electrodes 502 in the upper half of the
mapping device 500 and the zone 2 at 508 includes the mapping
electrodes 502 in the lower half of the mapping device 500. Next,
for mapping the baroreceptor region under the mapping electrodes
502 in zone 1 at 506, the controller 40 controls the switches 44 to
connect one of the mapping electrodes 502 in zone 1 at 506 to the
pulse generator 42 as a cathode and one or more of the mapping
electrodes in zone 2 at 508 as an anode. The controller 40 controls
the pulse generator 42 to provide bipolar stimulation to the
baroreceptor region through the connected mapping electrodes 502.
Alternatively, in some embodiments, the controller 40 and the pulse
generator 42 provide unipolar stimulation to the one of the mapping
electrodes 502 connected as a cathode.
[0173] The controller 40 receives the signals from the sensor 36
and analyzes the signals to obtain the physiological response from
the patient, which is in response to stimulation of the
baroreceptor region under the cathode connected mapping electrode.
The controller 40 stores the data in the map of the baroreceptor
region, indicating the cathode connected mapping electrode that was
stimulated and the corresponding physiological response. This
process can be repeated for each of the mapping electrodes in zone
1 at 506 to complete the map of the baroreceptor region under the
mapping electrodes 502 in zone 1 at 506. In some embodiments, this
process can be repeated for a select number of mapping electrodes,
such as two or three mapping electrodes, in zone 1 at 506 to
complete the map of the baroreceptor region under the mapping
electrodes 502 in zone 1 at 506.
[0174] Next, for mapping the baroreceptor region under the mapping
electrodes 502 in zone 2 at 508, the controller 40 controls the
switches 44 to connect one of the mapping electrodes 502 in zone 2
at 508 to the pulse generator 42 as a cathode and one or more of
the mapping electrodes in zone 1 at 506 as an anode. The controller
40 controls the pulse generator 42 to provide bipolar stimulation
to the baroreceptor region through the connected mapping electrodes
502. Alternatively, in some embodiments, the controller 40 and the
pulse generator 42 provide unipolar stimulation to the one of the
mapping electrodes 502 connected as a cathode.
[0175] The controller 40 receives the signals from the sensor 36
and analyzes the signals to obtain the physiological response from
the patient, which is in response to stimulation of the
baroreceptor region under the cathode connected mapping electrode.
The controller 40 stores the data in the map of the baroreceptor
region, indicating the cathode connected mapping electrode that was
stimulated and the corresponding physiological response. This
process can be repeated for each of the mapping electrodes in zone
2 at 508 to complete the map of the baroreceptor region under the
mapping electrodes 502 in zone 2 at 508. In some embodiments, this
process can be repeated for a select number of mapping electrodes,
such as two or three mapping electrodes, in zone 2 at 508 to
complete the map of the baroreceptor region under the mapping
electrodes 502 in zone 2 at 508.
[0176] Next, the controller 40 analyzes the maps of the
baroreceptor region to determine which zone of zone 1 at 506 and
zone 2 at 508 is most likely to include the mapping electrode or
mapping electrodes that, when stimulated, provide the effective
physiological response. The zone that is most likely to include
this mapping electrode is selected and the process continues. In
some embodiments, the effective physiological response is the
largest reduction in the blood pressure of the patient. In some
embodiments, the effective physiological response is the largest
reduction in the heart rate of the patient. In some embodiments,
the effective physiological response is the largest change in the
tissue impedance of the patient.
[0177] In some embodiments, the controller 40 displays the map of
the baroreceptor region and, after viewing the map of the
baroreceptor region, a user selects one of the two zones. In some
embodiments, the controller 40 selects the zone that is most likely
to include the mapping electrode or mapping electrodes that, when
stimulated, provide the effective physiological response. In some
embodiments, the controller 40 selects the zone by comparing the
individual physiological response values in one zone to the
individual physiological response values in the other zone and
selecting the zone that has the largest physiological response
value. In some embodiments, the controller 40 selects the zone by
averaging the physiological response values in one zone and
averaging the physiological response values in the other zone and
selecting the zone that provides the largest average physiological
response value. In some embodiments, the controller 40 selects the
zone by summing the physiological response values in one zone and
summing the physiological response values in the other zone and
selecting the zone that provides the largest sum.
[0178] FIG. 21 is a diagram illustrating the selection of zone 1 at
506 and the division of zone 1 at 506 into a zone 3 at 510 and a
zone 4 at 512 as indicated by the dashed line and according to some
embodiments described in the disclosure. The zone 3 at 510 includes
the mapping electrodes 502 in the left side of zone 1 at 506 and
the zone 4 at 512 includes the mapping electrodes 502 in the right
side of zone 1 at 506. Next, for mapping the baroreceptor region
under the mapping electrodes 502 in zone 3 at 510, the controller
40 controls the switches 44 to connect one of the mapping
electrodes 502 in zone 3 at 510 to the pulse generator 42 as a
cathode and one or more of the mapping electrodes in zone 4 at 512
as an anode. The controller 40 controls the pulse generator 42 to
provide bipolar stimulation to the baroreceptor region through the
connected mapping electrodes 502. Alternatively, in some
embodiments, the controller 40 and the pulse generator 42 provide
unipolar stimulation to the one of the mapping electrodes 502
connected as a cathode.
[0179] The controller 40 receives the signals from the sensor 36
and analyzes the signals to obtain the physiological response from
the patient, which is in response to stimulation of the
baroreceptor region under the cathode connected mapping electrode.
The controller 40 stores the data in the map of the baroreceptor
region, indicating the cathode connected mapping electrode that was
stimulated and the corresponding physiological response. This
process can be repeated for each of the mapping electrodes in zone
3 at 510 to complete the map of the baroreceptor region under the
mapping electrodes 502 in zone 3 at 510. In some embodiments, this
process can be repeated for a select number of mapping electrodes,
such as two or three mapping electrodes, in zone 3 at 510 to
complete the map of the baroreceptor region under the mapping
electrodes 502 in zone 3 at 510.
[0180] Next, for mapping the baroreceptor region under the mapping
electrodes 502 in zone 4 at 512, the controller 40 controls the
switches 44 to connect one of the mapping electrodes 502 in zone 4
at 512 to the pulse generator 42 as a cathode and one or more of
the mapping electrodes in zone 3 at 510 as an anode. The controller
40 controls the pulse generator 42 to provide bipolar stimulation
to the baroreceptor region through the connected mapping electrodes
502. Alternatively, in some embodiments, the controller 40 and the
pulse generator 42 provide unipolar stimulation to the one of the
mapping electrodes 502 connected as a cathode.
[0181] The controller 40 receives the signals from the sensor 36
and analyzes the signals to obtain the physiological response from
the patient, which is in response to stimulation of the
baroreceptor region under the cathode connected mapping electrode.
The controller 40 stores the data in the map of the baroreceptor
region, indicating the cathode connected mapping electrode that was
stimulated and the corresponding physiological response. This
process can be repeated for each of the mapping electrodes in zone
4 at 512 to complete the map of the baroreceptor region under the
mapping electrodes 502 in zone 4 at 512. In some embodiments, this
process can be repeated for a select number of mapping electrodes,
such as two or three mapping electrodes, in zone 4 at 512 to
complete the map of the baroreceptor region under the mapping
electrodes 502 in zone 4 at 512.
[0182] Next, the controller 40 analyzes the maps of the
baroreceptor region to determine which zone of zone 3 at 510 and
zone 4 at 512 is most likely to include the mapping electrode or
mapping electrodes that, when stimulated, provide the effective
physiological response. The zone that is most likely to include
this mapping electrode is selected and the process continues. In
some embodiments, the effective physiological response is the
largest reduction in the blood pressure of the patient. In some
embodiments, the effective physiological response is the largest
reduction in the heart rate of the patient. In some embodiments,
the effective physiological response is the largest change in the
tissue impedance of the patient.
[0183] In some embodiments, the controller 40 displays the map of
the baroreceptor region and, after viewing the map of the
baroreceptor region, a user selects one of the two zones. In some
embodiments, the controller 40 selects the zone that is most likely
to include the mapping electrode or mapping electrodes that, when
stimulated, provide the effective physiological response. In some
embodiments, the controller 40 selects the zone by comparing the
individual physiological response values in one zone to the
individual physiological response values in the other zone and
selecting the zone that has the largest physiological response
value. In some embodiments, the controller 40 selects the zone by
averaging the physiological response values in one zone and
averaging the physiological response values in the other zone and
selecting the zone that provides the largest average physiological
response value. In some embodiments, the controller 40 selects the
zone by summing the physiological response values in one zone and
summing the physiological response values in the other zone and
selecting the zone that provides the largest sum.
[0184] FIG. 22 is a diagram illustrating the selection of zone 4 at
512 and the division of zone 4 at 512 into a zone 5 at 514 and a
zone 6 at 516 as indicated by the dashed line and according to some
embodiments described in the disclosure. The zone 5 at 514 includes
the mapping electrodes 502 in the upper half of zone 4 at 512 and
the zone 6 at 516 includes the mapping electrodes 502 in the lower
half of zone 4 at 512.
[0185] Next, the controller 40 controls the switches 44 and the
pulse generator 42 and receives the signals from the sensor 36 and
analyzes the signals, as described above, to map the baroreceptor
regions under the mapping electrodes 502 in zone 5 at 514 and in
zone 6 at 516. In some embodiments, the controller 40 selects a
select number of mapping electrodes, such as two or three mapping
electrodes, in zone 5 at 514 to complete the map of the
baroreceptor region under the mapping electrodes 502 in zone 5 at
514, and a select number of mapping electrodes, such as two or
three mapping electrodes, in zone 6 at 516 to complete the map of
the baroreceptor region under the mapping electrodes 502 in zone 6
at 516.
[0186] In addition, the controller 40 analyzes the maps of the
baroreceptor region to determine which zone of zone 5 at 514 and in
zone 6 at 516 is most likely to include the mapping electrode or
mapping electrodes that, when stimulated, provide the effective
physiological response. The zone that is most likely to include
this mapping electrode is selected and the process continues. In
some embodiments, the effective physiological response is the
largest reduction in the blood pressure of the patient. In some
embodiments, the effective physiological response is the largest
reduction in the heart rate of the patient. In some embodiments,
the effective physiological response is the largest change in the
tissue impedance of the patient.
[0187] In some embodiments, the controller 40 displays the map of
the baroreceptor region and, after viewing the map of the
baroreceptor region, a user selects one of the two zones. In some
embodiments, the controller 40 selects the zone that is most likely
to include the mapping electrode or mapping electrodes that, when
stimulated, provide the effective physiological response. In some
embodiments, the controller 40 selects the zone by comparing the
individual physiological response values in one zone to the
individual physiological response values in the other zone and
selecting the zone that has the largest physiological response
value. In some embodiments, the controller 40 selects the zone by
averaging the physiological response values in one zone and
averaging the physiological response values in the other zone and
selecting the zone that provides the largest average physiological
response value. In some embodiments, the controller 40 selects the
zone by summing the physiological response values in one zone and
summing the physiological response values in the other zone and
selecting the zone that provides the largest sum.
[0188] FIG. 23 is a diagram illustrating the selection of zone 6 at
516 and the division of zone 6 at 516 into a zone 7 at 518 and a
zone 8 at 520 as indicated by the dashed line and according to some
embodiments described in the disclosure. The zone 7 at 518 includes
the mapping electrodes 502 in the left side of zone 6 at 516 and
zone 8 at 520 includes the mapping electrodes 502 in the right side
of zone 6 at 516.
[0189] Next, the controller 40 controls the switches 44 and the
pulse generator 42 and receives the signals from the sensor 36 and
analyzes the signals, as described above, to map the baroreceptor
regions under the mapping electrodes 502 in zone 7 at 518 and at
zone 8 at 520. In some embodiments, the controller 40 selects one
mapping electrode in zone 7 at 518 to complete the map of the
baroreceptor region under the mapping electrodes 502 in zone 7 at
518, and one mapping electrode in zone 8 at 520 to complete the map
of the baroreceptor region under the mapping electrodes 502 in zone
8 at 520.
[0190] In addition, the controller 40 analyzes the maps of the
baroreceptor region to determine which zone of zone 7 at 518 and
zone 8 at 520 is most likely to include the mapping electrode that,
when stimulated, provides the effective physiological response,
which can be the larger or largest physiological response. The zone
that is most likely to include this mapping electrode is selected
and the process continues. In some embodiments, the effective
physiological response is the largest reduction in the blood
pressure of the patient. In some embodiments, the effective
physiological response is the largest reduction in the heart rate
of the patient. In some embodiments, the effective physiological
response is the largest change in the tissue impedance of the
patient.
[0191] In some embodiments, the controller 40 displays the map of
the baroreceptor region and, after viewing the map of the
baroreceptor region, a user selects one of the two zones. In some
embodiments, the controller 40 selects the zone that is most likely
to include the mapping electrode or mapping electrodes that, when
stimulated, provide the effective physiological response. In some
embodiments, the controller 40 selects the zone by comparing the
individual physiological response values in one zone to the
individual physiological response values in the other zone and
selecting the zone that has the largest physiological response
value. In some embodiments, the controller 40 selects the zone by
averaging the physiological response values in one zone and
averaging the physiological response values in the other zone and
selecting the zone that provides the largest average physiological
response value. In some embodiments, the controller 40 selects the
zone by summing the physiological response values in one zone and
summing the physiological response values in the other zone and
selecting the zone that provides the largest sum.
[0192] FIG. 24 is a diagram illustrating the selection of zone 7 at
518 and the division of zone 7 at 518 into a zone 9 at 522 and a
zone 10 at 524 as indicated by the dashed line and according to
some embodiments described in the disclosure. The zone 9 at 522
includes one mapping electrode 502 in the upper half of zone 7 at
518 and the zone 10 at 524 includes another mapping electrode 502
in the lower half of zone 7 at 518.
[0193] Next, the controller 40 controls the switches 44 and the
pulse generator 42 and receives the signals from the sensor 36 and
analyzes the signals, as described above, to map the baroreceptor
region under the mapping electrodes 502 in zone 9 at 522 and zone
10 at 524. In addition, the controller 40 analyzes the maps of the
baroreceptor region to determine which of the mapping electrodes in
zone 9 at 522 and zone 10 at 524 is the mapping electrode that,
when stimulated, provides the effective physiological response.
This mapping electrode is selected and the marking and placement of
the implantable device process continues. In some embodiments, the
effective physiological response is the largest reduction in the
blood pressure of the patient. In some embodiments, the effective
physiological response is the largest reduction in the heart rate
of the patient. In some embodiments, the effective physiological
response is the largest change in the tissue impedance of the
patient.
[0194] FIG. 25 is a diagram illustrating all of the zones 1-10 and
indicating the selected zones with different cross-hatching for the
refinement process of FIGS. 20-24, according to some embodiments
described in the disclosure. The zone 1 at 506 was selected over
the zone 2 at 508, and the zone 4 at 512 was selected over the zone
3 at 510. Also, the zone 6 at 516 was selected over the zone 5 at
514, and the zone 7 at 518 was selected over the zone 8 at 520. To
refine it down to one mapping electrode, either zone 9 at 522 or
zone 10 at 524 is selected.
[0195] In some embodiments, the mapping process described above
with reference to FIGS. 20-25 can be interrupted at any point in
the process and the user can stimulate and/or select mapping
electrodes 502 as desired by the user.
[0196] In one example, the controller 40 controls the pulse
generator 42 to stimulate selected mapping electrodes 502. The
controller 40 receives signals from the sensor 36, which indicate
the blood pressure of the patient, and the controller 40 analyzes
the signals to obtain the reductions in the blood pressure of the
patient. The controller 40 stores the data in a map of the
baroreceptor region, indicating the cathode electrode stimulated
and the corresponding reduction in the blood pressure. The
controller 40 determines a first average of the reductions in the
blood pressure in one zone and a second average of the reductions
in the blood pressure in the other zone. The controller 40 selects
the zone with the largest or highest average reduction in blood
pressure.
[0197] In one example, the controller 40 controls the pulse
generator 42 to stimulate connected mapping electrodes 502. The
controller 40 receives signals from the sensor 36, which indicate
the heart rate of the patient, and the controller 40 analyzes the
signals to obtain the reductions in the heart rate of the patient.
The controller 40 stores the data in a map of the baroreceptor
region, indicating the cathode electrode stimulated and the
corresponding reduction in the heart rate. The controller 40
determines a first average of the reductions in the heart rate in
one zone and a second average of the reductions in the heart rate
in the other zone. The controller 40 selects the zone with the
largest or highest average reduction in heart rate.
[0198] In one example, the controller 40 controls the pulse
generator 42 to stimulate connected mapping electrodes 502. The
controller 40 receives signals from the sensor 36, which indicate
the blood pressure of the patient, and the controller 40 analyzes
the signals to obtain the reductions in the blood pressure of the
patient. The controller 40 stores the data in a map of the
baroreceptor region, indicating the cathode electrode stimulated
and the corresponding reduction in the blood pressure. The
controller 40 determines a first average of the reductions in the
blood pressure in one zone and a second average of the reductions
in the blood pressure in the other zone. A user selects the zone
with the largest or highest average reduction in blood
pressure.
[0199] In one example, the controller 40 controls the pulse
generator 42 to stimulate connected mapping electrodes 502. The
controller 40 receives signals from the sensor 36, which indicate
the heart rate of the patient, and the controller 40 analyzes the
signals to obtain the reductions in the heart rate of the patient.
The controller 40 stores the data in a map of the baroreceptor
region, indicating the cathode electrode stimulated and the
corresponding reduction in the heart rate. The controller 40
determines a first average of the reductions in the heart rate in
one zone and a second average of the reductions in the heart rate
in the other zone. A user selects the zone with the largest or
highest average reduction in heart rate.
[0200] In one example, the controller 40 controls the pulse
generator 42 to stimulate connected mapping electrodes 502. The
controller 40 receives signals from the sensor 36, which indicate
the blood pressure of the patient, and the controller 40 analyzes
the signals to obtain the reductions in the blood pressure of the
patient. The controller 40 stores the data in a map of the
baroreceptor region, indicating the cathode electrode stimulated
and the corresponding reduction in the blood pressure. The
controller 40 compares the reductions in the blood pressure in one
zone to the reductions in the blood pressure in the other zone and
selects the zone including the largest or highest reduction in
blood pressure.
[0201] In one example, the controller 40 controls the pulse
generator 42 to stimulate connected mapping electrodes 502. The
controller 40 receives signals from the sensor 36, which indicate
the heart rate of the patient, and the controller 40 analyzes the
signals to obtain the reductions in the heart rate of the patient.
The controller 40 stores the data in a map of the baroreceptor
region, indicating the cathode electrode stimulated and the
corresponding reduction in the heart rate. The controller 40
compares the reductions in the heart rate in one zone to the
reductions in the heart rate in the other zone and selects the zone
including the largest or highest reduction in heart rate.
[0202] In one example, the controller 40 controls the pulse
generator 42 to stimulate connected mapping electrodes 502. The
controller 40 receives signals from the sensor 36, which indicate
the blood pressure of the patient, and the controller 40 analyzes
the signals to obtain the reductions in the blood pressure of the
patient. The controller 40 stores the data in a map of the
baroreceptor region, indicating the cathode electrode stimulated
and the corresponding reduction in the blood pressure. A user
compares the reductions in the blood pressure in one zone to the
reductions in the blood pressure in the other zone and selects the
zone including the largest or highest reduction in blood
pressure.
[0203] In one example, the controller 40 controls the pulse
generator 42 to stimulate connected mapping electrodes 502. The
controller 40 receives signals from the sensor 36, which indicate
the heart rate of the patient, and the controller 40 analyzes the
signals to obtain the reductions in the heart rate of the patient.
The controller 40 stores the data in a map of the baroreceptor
region, indicating the cathode electrode stimulated and the
corresponding reduction in the heart rate. A user compares the
reductions in the heart rate in one zone to the reductions in the
heart rate in the other zone and selects the zone including the
largest or highest reduction in heart rate.
[0204] FIGS. 26A-26C are flowchart diagrams illustrating a mapping
algorithm for mapping a baroreceptor region, according to some
embodiments described in the disclosure. The mapping device, such
as one of the mapping devices 22, 100, 120, 130, 150, and 404, is
placed on a patient for mapping the baroreceptor region of the
patient. A stimulator, such as stimulator 24, provides the mapping
algorithm.
[0205] At 540, the stimulator divides the mapping device into two
zones of mapping electrodes. At 542, the stimulator connects one of
the mapping electrodes in one zone to a pulse generator, such as
the pulse generator 42, as a cathode and, at 544, the stimulator
connects one or more of the mapping electrodes in the other zone to
the pulse generator as an anode. The stimulator can connect any one
of the mapping electrodes in the other zone or any combination of
the mapping electrodes in the other zone as an anode. In some
embodiments, a surface patch is placed on the patient's skin and
the stimulator connects the surface patch as an anode. In some
embodiments, the stimulator connects an independent electrode that
can be part of the mapping device or from a separate probe as an
anode.
[0206] At 546, the stimulator controls the pulse generator to
provide bipolar electrical stimulation to the baroreceptor region
under the cathode connected mapping electrode through the cathode
and anode connected mapping electrodes. Alternatively, in some
embodiments, the stimulator controls the pulse generator to provide
unipolar electrical stimulation to the baroreceptor region under
the cathode connected mapping electrode using the cathode connected
mapping electrode.
[0207] At 548, the physiological response associated with the
electrical stimulation of the baroreceptor region under the cathode
connected mapping electrode is obtained from the patient. This
physiological response is obtained either manually by a user or
automatically with the stimulator and an attached sensor. Also, at
550, the identity of the cathode connected mapping electrode and
the associated physiological response information is stored in a
map of the baroreceptor region, either manually by a user or
automatically with the stimulator.
[0208] If one or more of the mapping electrodes in the one zone
remain to be connected as a cathode at 552, the stimulator proceeds
to connect a different one of the mapping electrodes in the one
zone as a cathode at 554 and the process repeats itself through the
steps of providing electrical stimulation at 546, obtaining the
associated physiological response at 548, and storing the identity
of the stimulated cathode connected mapping electrode and the
associated physiological response at 550.
[0209] If all of the mapping electrodes or all of a selected number
of the mapping electrodes in the one zone have been stimulated and
mapped at 552, the stimulator proceeds to connect one of the
mapping electrodes in the other zone to the pulse generator as a
cathode at 556 and, at 558, the stimulator connects one or more of
the mapping electrodes in the one zone (that was just mapped) to
the pulse generator as an anode. The stimulator can connect any one
of the mapping electrodes in the zone that was just mapped or any
combination of the mapping electrodes in the zone that was just
mapped as an anode. In some embodiments, the stimulator can connect
a surface patch on the patient's skin as an anode. In some
embodiments, the stimulator can connect an independent electrode
that is part of the mapping device or from a separate probe as an
anode.
[0210] At 560, the stimulator controls the pulse generator to
provide bipolar electrical stimulation to the baroreceptor region
under the cathode connected mapping electrode through the cathode
and anode connected mapping electrodes. Alternatively, in some
embodiments, the stimulator controls the pulse generator to provide
unipolar electrical stimulation to the baroreceptor region under
the cathode connected mapping electrode using the cathode connected
mapping electrode.
[0211] At 562, the physiological response associated with the
electrical stimulation of the baroreceptor region under the cathode
connected mapping electrode is obtained from the patient either
manually by a user or automatically with the stimulator and an
attached sensor. Also, at 564, the identity of the cathode
connected mapping electrode and the associated physiological
response information is stored in a map of the baroreceptor region
either manually by a user or automatically with the stimulator.
[0212] If one or more of the mapping electrodes in the other zone
remain to be connected as a cathode at 566, the stimulator proceeds
to connect a different one of the mapping electrodes in the other
zone as a cathode at 568 and the process repeats itself through the
steps of providing electrical stimulation at 560, obtaining the
associated physiological response at 562, and storing the identity
of the stimulated cathode connected mapping electrode and the
associated physiological response at 564.
[0213] If all of the mapping electrodes or all of a selected number
of the mapping electrodes in the other zone have been stimulated
and mapped at 566, the process continues with analyzing the map of
the baroreceptor region at 570 and selecting the one zone or the
other zone as including the most likely location for long term
stimulation of baroreceptors in the baroreceptor region at 572. In
some embodiments, analyzing the map of the baroreceptor region at
570 can be done manually. In some embodiments, analyzing the map of
the baroreceptor region at 570 can be done automatically with the
stimulator.
[0214] In some embodiments, the permanently implantable device,
such as each of the implantable devices 220, 240, 250, and 270, has
an implantable device electrode that is larger than one of the
mapping electrodes. In some embodiments, the permanently
implantable device has an implantable device electrode that is as
large as or larger than a combination of multiple mapping
electrodes, such that the implantable device electrode covers the
same area on the baroreceptor region as the multiple mapping
electrodes. Where the implantable device electrode is larger than
one of the mapping electrodes or covers the same area as multiple
mapping electrodes, the final zone selected can include multiple
mapping electrodes and meet the needs of the system.
[0215] If the selected zone includes more than the number of
mapping electrodes for meeting the needs of the system at 574, the
stimulator divides the selected zone into two zones at 576 and the
process repeats itself from the step of connecting a mapping
electrode in one zone to the pulse generator as a cathode at 542.
In some embodiments, two or more physiological responses are
obtained for mapping electrodes in a zone, as the zone is selected
and the process repeats itself from the step of connecting a
mapping electrode in one zone to the pulse generator as a cathode
at 542.
[0216] If the selected zone includes the number of mapping
electrodes or less than the number of mapping electrodes for
meeting the needs of the system at 574, the location of the zone is
a good candidate for the identified effective location of
baroreceptors in the baroreceptor region, as indicated at 578. The
process continues with marking the location at 580. In some
embodiments, the mapping process described above with reference to
FIGS. 26A-26C is part of the method of FIG. 13. In some
embodiments, the mapping process described above with reference to
FIGS. 26A-26C can be interrupted at any step in the process and the
user can stimulate and/or select any one or more than one of the
mapping electrodes as being at the identified effective location on
the baroreceptor region.
[0217] Various modifications and additions can be made to the
exemplary embodiments discussed without departing from the scope of
the present invention. For example, while the embodiments described
above refer to particular features, the scope of this invention
also includes embodiments having different combinations of features
and embodiments that do not include all of the described features.
Accordingly, the scope of the present invention is intended to
embrace all such alternatives, modifications, and variations as
fall within the scope of the claims, together with all equivalents
thereof.
* * * * *