U.S. patent application number 17/148961 was filed with the patent office on 2021-12-02 for floatable catheters for neuromodulation.
The applicant listed for this patent is Cardionomic, Inc.. Invention is credited to Duane G. Frion, Steven D. Goedeke, Steven L. Waldhauser.
Application Number | 20210370068 17/148961 |
Document ID | / |
Family ID | 1000005779549 |
Filed Date | 2021-12-02 |
United States Patent
Application |
20210370068 |
Kind Code |
A1 |
Waldhauser; Steven L. ; et
al. |
December 2, 2021 |
FLOATABLE CATHETERS FOR NEUROMODULATION
Abstract
Embodiments of the present disclosure provide for catheters for
use in electrical neuromodulation. The catheter of the present
disclosure includes an elongate body having a first end and a
second end. The elongate body includes a longitudinal center axis
that extends between the first end and the second end. The elongate
body further includes three or more surfaces that define a convex
polygonal cross-sectional shape taken perpendicularly to the
longitudinal center axis. The catheter further includes one or more
electrodes on one surface of the three or more surfaces of the
elongate body, where conductive elements extend through the
elongate body. The conductive elements can conduct electrical
current to combinations of the one or more electrodes.
Inventors: |
Waldhauser; Steven L.;
(Savage, MN) ; Goedeke; Steven D.; (Forest Lake,
MN) ; Frion; Duane G.; (Brooklyn Center, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Cardionomic, Inc. |
New Brighton |
MN |
US |
|
|
Family ID: |
1000005779549 |
Appl. No.: |
17/148961 |
Filed: |
January 14, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15446872 |
Mar 1, 2017 |
10894160 |
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17148961 |
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PCT/US2015/047770 |
Aug 31, 2015 |
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15446872 |
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62047270 |
Sep 8, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 25/09 20130101;
A61N 1/0587 20130101; A61N 1/0558 20130101; A61M 25/007 20130101;
A61N 1/36132 20130101; A61M 25/10 20130101; A61N 1/36114 20130101;
A61M 2025/018 20130101; A61M 25/0147 20130101; A61M 25/005
20130101 |
International
Class: |
A61N 1/36 20060101
A61N001/36; A61M 25/01 20060101 A61M025/01; A61N 1/05 20060101
A61N001/05; A61M 25/00 20060101 A61M025/00; A61M 25/09 20060101
A61M025/09; A61M 25/10 20060101 A61M025/10 |
Claims
1. (canceled)
2. A catheter for use in electrical neuromodulation, the catheter
comprising: an elongate body having a proximal portion and a distal
portion, the distal portion comprising: a balloon expandable to be
carried by a flow of blood to a pulmonary artery; and an electrode
array configured to extend from the elongate body, the electrode
array comprising a plurality of electrodes in a column and row
configuration and electrically isolated from each other, the
electrode array configured to apply bipolar neuromodulation energy
to the right pulmonary artery to increase cardiac contractility to
treat acute heart failure, wherein the elongate body comprises: an
inflation lumen extending from the proximal portion to the balloon;
and a conductor lumen containing a plurality of conductors
extending from the proximal portion to the electrode array, each
one of the conductors of the plurality of conductors coupled to one
electrode of the plurality of electrodes, the proximal portion
comprising a connector port coupled to the plurality of conductors,
the connector port configured to be coupled to a stimulation
system.
3. The catheter of claim 2, further comprising a pressure
sensor.
4. The catheter of claim 3, wherein the elongate body comprises the
pressure sensor.
5. The catheter of claim 2, wherein the elongate body comprises a
marker configured to make the elongate body visible under an
imaging modality.
6. The catheter of claim 2, wherein the elongate body comprises a
pressure sensor, and wherein the elongate body comprises a marker
configured to make the elongate body visible under an imaging
modality.
7. A catheter for use in electrical neuromodulation, the catheter
comprising: an elongate body having a proximal portion and a distal
portion, the distal portion comprising: a balloon expandable to be
carried by a flow of blood to a pulmonary artery; and an electrode
array comprising a plurality of electrodes electrically isolated
from each other, the electrode array configured to apply
neuromodulation energy to the pulmonary artery to increase cardiac
contractility, wherein the elongate body comprises: an inflation
lumen extending from the proximal portion to the balloon; and a
conductor lumen containing a plurality of conductors extending from
the proximal portion to the electrode array, each one of the
conductors of the plurality of conductors coupled to one electrode
of the plurality of electrodes.
8. The catheter of claim 7, wherein the proximal portion comprises
a connector port coupled to the plurality of conductors, the
connector port configured to be coupled to a stimulation
system.
9. The catheter of claim 7, wherein the balloon is configured to be
carried by the flow of blood to the right pulmonary artery.
10. The catheter of claim 7, wherein the elongate body comprises a
pressure sensor.
11. The catheter of claim 7, wherein the electrode array comprises
a column and row configuration, wherein the electrode array is
configured to extend from the elongate body, and wherein the
elongate body comprises a pressure sensor.
12. A catheter for use in electrical neuromodulation, the catheter
comprising: an elongate body having a proximal portion and a distal
portion, the distal portion comprising: a balloon expandable to be
carried by a flow of blood to a pulmonary artery; and an electrode
array comprising a plurality of electrodes electrically isolated
from each other, the electrode array configured to apply energy to
the pulmonary artery, wherein the elongate body comprises: an
inflation lumen extending from the proximal portion to the balloon;
and a conductor lumen containing a plurality of conductors
extending from the proximal portion to the electrode array, each
one of the conductors of the plurality of conductors coupled to one
electrode of the plurality of electrodes.
13. The catheter of claim 12, wherein the proximal portion
comprises a connector port coupled to the plurality of conductors,
the connector port configured to be coupled to a stimulation
system.
14. The catheter of claim 12, wherein the balloon is configured to
be carried by the flow of blood to the right pulmonary artery.
15. The catheter of claim 12, wherein the electrode array comprises
a column and row configuration.
16. The catheter of claim 12, wherein the electrode array is
configured to extend from the elongate body.
17. The catheter of claim 12, wherein the electrode array is
configured to be used in at least one of a unipolar, a bipolar, or
a multipolar configuration.
18. The catheter of claim 12, wherein the electrode array is on an
outer surface of the elongate body.
19. The catheter of claim 12, wherein the elongate body comprises a
pressure sensor.
20. The catheter of claim 12, wherein the elongate body comprises a
predefined curve between the proximal portion and the distal
portion.
21. The catheter of claim 12, wherein the electrode array comprises
a column and row configuration, wherein the electrode array is
configured to extend from the elongate body, and wherein the
elongate body comprises a pressure sensor.
Description
TECHNICAL FIELD
[0001] The present disclosure relates generally to catheters, and
more particularly to catheter and electrode systems for use in
electrical neuromodulation.
BACKGROUND
[0002] Acute heart failure is a cardiac condition in which a
problem with the structure or function of the heart impairs its
ability to supply sufficient blood flow to meet the body's needs.
The condition impairs quality of life and is a leading cause of
hospitalizations and mortality in the western world. Treating acute
heart failure is typically aimed at removal of precipitating
causes, prevention of deterioration in cardiac function, and
control of the patient's congestive state.
[0003] Treatments for acute heart failure include the use of
inotropic agents, such as dopamine and dobutamine. These agents,
however, have both chronotropic and inotropic effects and
characteristically increase heart contractility at the expense of
significant increments in oxygen consumption secondary to
elevations in heart rate. As a result, although these inotropic
agents increase myocardial contractility and improve hemodynamics,
clinical trials have consistently demonstrated excess mortality
caused by cardiac arrhythmias and increase in the myocardium
consumption.
[0004] As such, there is a need for selectively and locally
treating acute heart failure and otherwise achieving hemodynamic
control without causing unwanted systemic effects.
SUMMARY
[0005] Embodiments of the present disclosure provide for catheter
and electrode systems for use in electrical neuromodulation. The
catheter and electrode systems of the present disclosure, for
example, may be useful in electrical neuromodulation of patients
with cardiac disease, such as patients with chronic cardiac
disease. As discussed herein, the configuration of the catheter and
electrode systems of the present disclosure allows for a portion of
the catheter to be positioned within the vasculature of the patient
in the main pulmonary artery and/or one or both of the pulmonary
arteries (the right pulmonary artery and/or the left pulmonary
artery). Once positioned, the catheter and electrode systems of the
present disclosure can provide electrical energy to stimulate the
autonomic nerve fibers surrounding the main pulmonary artery and/or
one or both of the pulmonary arteries in an effort to provide
adjuvant cardiac therapy to the patient.
[0006] In a first example, the catheter of the present disclosure
includes an elongate body having a first end and a second end. The
elongate body includes a longitudinal center axis that extends
between the first end and the second end. The elongate body further
includes three or more surfaces that define a convex polygonal
cross-sectional shape taken perpendicularly to the longitudinal
center axis. The catheter further includes one or more, but
preferably two or more, electrodes on one surface of the three or
more surfaces of the elongate body, where conductive elements
extend through the elongate body. The conductive elements can
conduct electrical current to combinations of the one or more
electrodes or in the instance of a single electrode a second
electrode is provided elsewhere in the system for flow of
current.
[0007] By way of example for the first embodiment, the surfaces
defining the convex polygonal cross-sectional shape of the elongate
body can be a rectangle. Other shapes are possible. In one
embodiment, the one or two or more electrodes are only on the one
surface of the three or more surfaces of the elongate body. The one
or more electrodes can have an exposed face that is co-planar with
the one surface of the three or more surfaces of the elongate body.
The one surface of the three or more surfaces of the elongate body
can further include anchor structures that extend above the one
surface. In addition to the surfaces defining the convex polygonal
cross-sectional shape, the elongate body of the catheter can also
have a portion with a circular cross-section shape taken
perpendicularly to the longitudinal center axis.
[0008] The catheter of the present embodiment can also include an
inflatable balloon on a peripheral surface of the elongate body.
The inflatable balloon includes a balloon wall with an interior
surface that along with a portion of the peripheral surface of the
elongate body defines a fluid tight volume. An inflation lumen
extends through the elongate body, the inflation lumen having a
first opening into the fluid tight volume of the inflatable balloon
and a second opening proximal to the first opening to allow for a
fluid to move in the fluid tight volume to inflate and deflate the
balloon.
[0009] In a second example, the catheter of the present disclosure
includes an elongate body having a peripheral surface and a
longitudinal center axis extending between a first end and a second
end. The elongate body of this second example has an offset region
defined by a series of predefined curves along the longitudinal
center axis. The predefined curves include a first portion having a
first curve and a second curve in the longitudinal center axis, a
second portion following the first portion, where the second
portion has a zero curvature (e.g., a straight portion), and a
third portion following the second portion, the third portion
having a third curve and a fourth curve. An inflatable balloon is
positioned on the peripheral surface of the elongate body, the
inflatable balloon having a balloon wall with an interior surface
that along with a portion of the peripheral surface of the elongate
body defines a fluid tight volume. An inflation lumen extends
through the elongate body, the inflation lumen having a first
opening into the fluid tight volume of the inflatable balloon and a
second opening proximal to the first opening to allow for a fluid
to move in the fluid tight volume to inflate and deflate the
balloon. One or more electrodes are positioned on the elongate body
along the second portion of the offset region of the elongate body.
Conductive elements extend through the elongate body, where the
conductive elements conduct electrical current to combinations of
the one or more electrodes.
[0010] The portions of the elongate body of this second example can
have a variety of shapes. For example, the second portion of the
elongate body can form a portion of a helix. The elongate body can
also have three or more surfaces defining a convex polygonal
cross-sectional shape taken perpendicularly to the longitudinal
center axis, where the one or more electrodes are on one surface of
the three or more surfaces of the elongate body. For this
embodiment, the convex polygonal cross-sectional shape can be a
rectangle. The one or more electrodes are only on the one surface
of the three or more surfaces of the elongate body. The one or more
electrodes can have an exposed face that is co-planar with the one
surface of the three or more surfaces of the elongate body.
[0011] In a third example, the catheter of the present disclosure
includes an elongate body with a peripheral surface and a
longitudinal center axis extending between a first end and a second
end. The elongate body includes a surface defining a deflection
lumen, where the deflection lumen includes a first opening and a
second opening in the elongate body. An inflatable balloon is
located on the peripheral surface of the elongate body, the
inflatable balloon having a balloon wall with an interior surface
that along with a portion of the peripheral surface of the elongate
body defines a fluid tight volume. An inflation lumen extends
through the elongate body, the inflation lumen having a first
opening into the fluid tight volume of the inflatable balloon and a
second opening proximal to the first opening to allow for a fluid
to move in the fluid tight volume to inflate and deflate the
balloon. One or more electrodes are located on the elongate body,
where the second opening of the deflection lumen is opposite the
one or more electrodes on the elongate body. Conductive elements
extend through the elongate body, where the conductive elements
conduct electrical current to combinations of the one or more
electrodes. The catheter also includes an elongate deflection
member, where the elongate deflection member extends through the
second opening of the deflection lumen in a direction opposite the
one or more electrodes on one surface of the elongate body.
[0012] In a fourth example, the catheter of the present disclosure
can include an elongate body having a peripheral surface and a
longitudinal center axis extending between a first end and a second
end. The elongate body includes a surface defining an electrode
lumen, where the electrode lumen includes a first opening in the
elongate body. The catheter further includes an inflatable balloon
on the peripheral surface of the elongate body, the inflatable
balloon having a balloon wall with an interior surface that along
with a portion of the peripheral surface of the elongate body
defines a fluid tight volume. An inflation lumen extends through
the elongate body, the inflation lumen having a first opening into
the fluid tight volume of the inflatable balloon and a second
opening proximal to the first opening to allow for a fluid to move
in the fluid tight volume to inflate and deflate the balloon. The
catheter further includes an elongate electrode member, where the
elongate electrode member extends through the first opening of the
electrode lumen of the elongate body, where the electrode member
includes one or more electrodes and conductive elements extending
through the electrode lumen, where the conductive elements conduct
electrical current to combinations of the one or more
electrodes.
[0013] The elongate electrode member can form a loop that extends
away from the peripheral surface of the elongate body. The elongate
electrode member forming the loop can be in a plane that is
co-linear with the longitudinal center axis of the elongate body.
Alternatively, the elongate electrode member forming the loop is in
a plane that is perpendicular to the longitudinal center axis of
the elongate body.
BRIEF DESCRIPTION OF THE FIGURES
[0014] FIG. 1 provides an illustration of an embodiment of the
catheter according to the present disclosure.
[0015] FIG. 2 provides an illustration of an embodiment of the
catheter according to the present disclosure.
[0016] FIG. 3 provides an illustration of an embodiment of the
catheter according to the present disclosure.
[0017] FIG. 4 provides an illustration of an embodiment of the
catheter according to the present disclosure.
[0018] FIG. 5 provides an illustration of an embodiment of the
catheter according to the present disclosure.
[0019] FIG. 6 provides an illustration of an embodiment of the
catheter according to the present disclosure.
[0020] FIG. 7 provides an illustration of an embodiment of the
catheter according to the present disclosure.
[0021] FIG. 8 provides an illustration of an embodiment of the
catheter according to the present disclosure.
[0022] FIG. 9 provides an illustration of an embodiment of the
catheter according to the present disclosure.
[0023] FIG. 10 provides an illustration of an embodiment of the
catheter according to the present disclosure.
[0024] FIG. 11 provides an illustration of a main pulmonary artery
of a heart.
[0025] FIG. 12 provides an illustration of a stimulation system for
use with the catheter of the present system.
DETAILED DESCRIPTION
[0026] Embodiments of the present disclosure provide for a catheter
and electrode systems for use in electrical neuromodulation. The
catheter and electrode systems of the present disclosure, for
example, may be useful in electrical neuromodulation of patients
with cardiac disease, such as patients with chronic cardiac
disease. As discussed herein, the configuration of the catheter and
electrode systems of the present disclosure allows for a portion of
the catheter and electrode systems to be positioned within the
vasculature of the patient in the main pulmonary artery and at
least one of the pulmonary arteries (the right pulmonary artery
and/or the left pulmonary artery). Once positioned, the catheter
and electrode systems of the present disclosure can be used to
provide electrical energy to stimulate the autonomic nerve fibers
surrounding the main pulmonary artery and/or one of the pulmonary
arteries in an effort to provide adjuvant cardiac therapy to the
patient.
[0027] The Figures herein follow a numbering convention in which
the first digit or digits correspond to the drawing Figure number
and the remaining digits identify an element or component in the
drawing. Similar elements or components between different Figures
may be identified by the use of similar digits. For example, 110
may reference element "10" in FIG. 1, and a similar element may be
referenced as 210 in FIG. 2. As will be appreciated, elements shown
in the various embodiments herein can be added, exchanged, and/or
eliminated so as to provide any number of additional embodiments of
the present disclosure.
[0028] The terms "distal" and "proximal" are used in the following
description with respect to a position or direction relative to the
treating clinician taken along the catheter of the present
disclosure. "Distal" or "distally" are a position distant from or
in a direction away from the clinician. "Proximal" and "proximally"
are a position near or in a direction toward the clinician taken
along the catheter of the present disclosure.
[0029] The catheters and electrode systems provided herein includes
one or more electrodes, but preferably two or more electrodes, as
discussed herein. It is understood that the phrase one or more
electrodes can be replaced herein with two or more electrodes if
desired.
[0030] Referring to FIG. 1, there is shown a perspective view of a
catheter 100 according one example of the present disclosure. The
catheter 100 includes an elongate body 102 having a first end 104
and a second end 106 distal from the first end 104. As illustrated,
the elongate body 102 includes a longitudinal center axis 108
extending between the first end 104 and the second end 106 of the
elongate body 102. The elongate body 102 also includes a portion
110 that has three or more surfaces 112 defining a convex polygonal
cross-sectional shape taken perpendicularly to the longitudinal
center axis 108.
[0031] As used herein, the convex polygonal cross-sectional shape
of the elongate body 102 includes those shapes for which every
internal angle is less than 180 degrees and where every line
segment between two vertices of the shape remains inside or on the
boundary of the shape. Examples of such shapes include, but are not
limited to, triangular, rectangular (as illustrated in FIG. 1),
square, pentagon and hexagon, among others.
[0032] Catheter 100 further includes one or more, preferably two or
more, electrodes 114 on one surface of the three or more surfaces
112 of the elongate body 102. Conductive elements 116 extend
through the elongate body 102, where the conductive elements 116
can be used, as discussed herein, to conduct electrical current to
combinations of the one or more electrodes 114. Each of the one or
more electrodes 114 is coupled to a corresponding conductive
element 116. The conductive elements 116 are electrically isolated
from each other and extend through the elongate body 102 from each
respective electrode 114 through the first end 104 of the elongate
body 102. The conductive elements 116 terminate at a connector
port, where each of the conductive elements 116 can be releasably
coupled to a stimulation system, as discussed herein. It is also
possible that the conductive elements 116 are permanently coupled
to the stimulation system (e.g., not releasably coupled). The
stimulation system can be used to provide stimulation electrical
energy that is conducted through the conductive elements 116 and
delivered across combinations of the one or more electrodes 114.
The one or more electrodes 114 are electrically isolated from one
another, where the elongate body 102 is formed of an electrically
insulating material as discussed herein. As illustrated, the one or
more electrodes 114 can be located only on the one surface of the
three or more surfaces 112 of the elongate body 102.
[0033] There can be a variety of the number and the configuration
of the one or more electrodes 114 on the one surface of the three
or more surfaces 112 of the elongate body 102. For example, as
illustrated, the one or more electrodes 114 can be configured as an
array of electrodes, where the number of electrodes and their
relative position to each other can vary depending upon the desired
implant location. As discussed herein, the one or more electrodes
114 can be configured to allow for electrical current to be
delivered from and/or between different combinations of the one or
more electrodes 114. So, for example, the electrodes in the array
of electrodes can have a repeating pattern where the electrodes are
equally spaced from each other. For example, the electrodes in the
array of electrodes can have a column and row configuration (as
illustrated in FIG. 1). Alternatively, the electrodes in the array
of electrodes can have a concentric radial pattern, where the
electrodes are positioned so as to form concentric rings of the
electrodes. Other patterns are possible, where such patterns can
either be repeating patterns or random patterns.
[0034] As illustrated, the one or more electrodes 114 have an
exposed face 118. The exposed face 118 of the electrode 114
provides the opportunity for the electrode 114, when implanted in
the patient, to be placed into proximity and/or in contact with the
vascular tissue of the patient, as opposed to facing into the
volume of blood in the artery. As the one or more electrodes 114
are located on one surface of the three or more surfaces 112 of the
elongate body 102, the electrodes 114 can be placed into direct
proximity to and/or in contact with the tissue of any combination
of the main pulmonary artery, the left pulmonary artery and/or the
right pulmonary artery.
[0035] By locating the one or more electrodes 114 on the one
surface of the three or more surfaces 112, the exposed face 118 of
the electrode can be positioned inside the patient's vasculature to
face and/or contact the tissue of the main pulmonary artery, the
left pulmonary artery and/or the right pulmonary artery. When the
one or more electrodes 114 are in contact with luminal surface of
the patient's vasculature, the one or more electrodes 114 will be
pointing away from the majority of the blood volume of that region
of the pulmonary artery. This allows the electrical pulses from the
one or more electrodes 114 to be directed into the tissue adjacent
the implant location, instead of being directed into the blood
volume.
[0036] The exposed face 118 of the one or more electrodes 114 can
have a variety of shapes. For example, the exposed face 118 can
have a flat planar shape. In this embodiment, the exposed face 118
of the electrodes 114 can be co-planar with the one surface of the
three or more surfaces 112 of the elongate body 102. In an
alternative embodiment, the exposed face 118 of the electrodes 114
can have a semi-hemispherical shape. Other shapes for the exposed
face 118 of the electrodes 114 can include semi-cylindrical,
wave-shaped, and zig-zag-shaped. The exposed face 118 of the
electrodes 114 can also include one or more anchor structures.
Examples of such anchor structures include hooks that can
optionally include a barb. Similarly, the electrodes can be shaped
to also act as anchor structures.
[0037] In an additional embodiment, the one surface of the three or
more surfaces 112 of the elongate body 102 that include the exposed
face 118 of the one or more electrodes 114 can further include
anchor structures 120 that extend above the one surface of the
three or more surfaces 112. As illustrated, the anchor structures
120 can include portions that can contact the vascular tissue in
such a way that the movement of the one or more electrodes 114 at
the location where they contact the vascular tissue is minimized.
The anchor structures 120 can have a variety of shapes that may
help to achieve this goal. For example, the anchor structures 120
can have a conical shape, where the vertex of the conical shape can
contact the vascular tissue. In an additional embodiment, the
anchor structures 120 can have a hook configuration (with or
without a barb).
[0038] As illustrated, the elongate body 102 of catheter 100 can
also include a portion 122 with a circular cross-section shape
taken perpendicularly to the longitudinal center axis 108. The
elongate body 102 of catheter 100 also includes a surface 124
defining a guide-wire lumen 126 that extends through the elongate
body 102. The guide-wire lumen 126 has a diameter that is
sufficiently large to allow the guide wire to freely pass through
the guide-wire lumen 126. The guide-wire lumen 126 can be
positioned concentrically relative the longitudinal center axis 108
of the elongate body 102.
[0039] Alternatively, and as illustrated in FIG. 1, the guide-wire
lumen 126 is positioned eccentrically relative the longitudinal
center axis 108 of the elongate body 102. When the guide-wire lumen
126 is positioned eccentrically relative the longitudinal center
axis 108 the guide-wire lumen 126 will have a wall thickness 128
taken perpendicularly to the longitudinal center axis that is
greater than a wall thickness 130 of a remainder of the catheter
taken perpendicularly to the longitudinal center axis. For this
configuration, the differences in wall thickness 128 and 130 help
to provide the elongate body 102 with a preferential direction in
which to bend. For example, the wall thickness 128 of the elongate
body 102 being greater than the wall thickness 130 will cause the
side of the elongate body 102 with the greater wall thickness to
preferentially have the larger radius of curvature when the
elongate body 102 bends. By positioning the exposed face 118 of the
electrodes 114 on the side of the elongate body 102 having the
great wall thickness (e.g., wall thickness 128), the one or more
electrodes 114 can be more easily and predictably brought into
contact with the luminal surface of the vasculature in and around
the main pulmonary artery and at least one of the pulmonary
arteries.
[0040] The catheter 100 shown in FIG. 1 can be positioned in the
main pulmonary artery and/or one or both of the pulmonary arteries
of the patient, as described herein. To accomplish this, a
pulmonary artery guide catheter is introduced into the vasculature
through a percutaneous incision and guided to the right ventricle
using known techniques. For example, the pulmonary artery guide
catheter can be inserted into the vasculature via a peripheral vein
of the arm (e.g., as with a peripherally inserted central
catheter). Other approaches can include, but are not limited to, an
Internal Jugular approach, as is known. Changes in a patient's
electrocardiography and/or pressure signals from the vasculature
can be used to guide and locate the pulmonary artery guide catheter
within the patient's heart. Once in the proper location, a guide
wire can be introduced into the patient via the pulmonary artery
guide catheter, where the guide wire is advanced into the main
pulmonary artery and/or one of the pulmonary arteries. Using the
guide-wire lumen 126, the catheter 100 can be advanced over the
guide wire so as to position the catheter 100 in the main pulmonary
artery and/or one or both of the pulmonary arteries of the patient,
as described herein. Various imaging modalities can be used in
positioning the guide wire of the present disclosure in the main
pulmonary artery and/or one of the pulmonary arteries of the
patient. Such imaging modalities include, but are not limited to,
fluoroscopy, ultrasound, electromagnetic, electropotential
modalities.
[0041] Using a stimulation system, as discussed herein, stimulation
electrical energy can be delivered across combinations of one or
more of the electrodes 114. It is possible for the patient's
cardiac response to the stimulation electrical energy to be
monitored and recorded for comparison to other subsequent tests. It
is appreciated that for any of the catheters discussed herein any
combination of electrodes, including reference electrodes (as
discussed herein) positioned within or on the patient's body, can
be used in providing stimulation to and sensing cardiac signals
from the patient.
[0042] FIG. 2 provides an additional embodiment of the catheter 200
as provided herein. The catheter 200 includes the features and
components as discussed above, a discussion of which is not
repeated but the element numbers are included in FIG. 2 with the
understanding that the discussion of these elements is implicit. In
addition, the elongate body 202 of the catheter 200 includes a
serpentine portion 232 proximal to the one or more electrodes 214.
When implanted in the vasculature of the patient, the serpentine
portion 232 of the elongate body 202 can act as a "spring" to
absorb and isolate the movement of the one or more electrodes 214
from the remainder of the elongate body 202 of the catheter 200.
Besides having a serpentine shape, the serpentine portion 232 can
have a coil like configuration. Other shapes that achieve the
objective of absorbing and isolating the movement of the one or
more electrodes 214 from the remainder of the elongate body 202 of
the catheter 200 once implanted are possible. During delivery of
the catheter 200, the presences of the guide wire in the guide-wire
lumen 226 can help to temporarily straighten the serpentine portion
232 of the elongate body 202.
[0043] Referring now to FIG. 3 there is shown an additional
embodiment of the catheter 300 as provided herein. The catheter 300
can include the features and components as discussed above for
catheters 100 and/or 200, a discussion of which is not repeated but
the element numbers are included in FIG. 3 with the understanding
that the discussion of these elements is implicit. In addition, the
catheter 300 of the present embodiment includes an inflatable
balloon 334. As illustrated, the elongate body 302 includes a
peripheral surface 336, where the inflatable balloon 334 is located
on the peripheral surface 336 of the elongate body 302. The
inflatable balloon 334 includes a balloon wall 338 with an interior
surface 340 that along with a portion 342 of the peripheral surface
336 of the elongate body 302 defines a fluid tight volume 344.
[0044] The elongate body 302 further includes a surface 345 that
defines an inflation lumen 346 that extends through the elongate
body 302. The inflation lumen 346 includes a first opening 348 into
the fluid tight volume 344 of the inflatable balloon 334 and a
second opening 350 proximal to the first opening 348 to allow for a
fluid to move in the fluid tight volume 344 to inflate and deflate
the balloon 334. A syringe, or other known devices, containing the
fluid (e.g., saline or a gas (e.g., oxygen)) can be used to inflate
and deflate the balloon 334.
[0045] The catheter 300 shown in FIG. 3 can positioned in the main
pulmonary artery and/or one or both of the pulmonary arteries of
the patient, as described herein. As discussed herein, a pulmonary
artery guide catheter is introduced into the vasculature through a
percutaneous incision, and guided to the right ventricle using
known techniques. Once in the proper location, the balloon 334 can
be inflated, as described, to allow the catheter 300 to be carried
by the flow of blood from the right ventricle to the main pulmonary
artery and/or one of the pulmonary arteries. Additionally, various
imaging modalities can be used in positioning the catheter of the
present disclosure in the main pulmonary artery and/or one of the
pulmonary arteries of the patient. Such imaging modalities include,
but are not limited to, fluoroscopy, ultrasound, electromagnetic,
electropotential modalities.
[0046] The catheter 300 can be advance along the main pulmonary
artery until the second end 306 of the catheter 300 contacts the
top of the main pulmonary artery (e.g., a location distal to the
pulmonary valve and adjacent to both the pulmonary arteries). Once
the second end 306 of the catheter 300 reaches the top of the main
pulmonary artery the pulmonary artery guide catheter can be moved
relative the catheter 300 so as to deploy the catheter 300 from the
pulmonary artery guide catheter.
[0047] Markings can be present on the peripheral surface of the
catheter body 302, where the markings start and extend from the
first end 302 towards the second end 306 of the catheter body 302.
The distance between the markings can be of units (e.g.,
millimeters, inches, etc.), which can allow the length between the
second end 306 of the catheter 300 and the top of the main
pulmonary artery to be determined.
[0048] The ability to measure this distance from the top of the
main pulmonary artery may be helpful in placing the one or more
electrodes 314 in a desired location within the main pulmonary
artery. In addition to measuring the distance from which the second
end 306 of the elongate body 302 is placed from the top of the main
pulmonary artery, the elongate body 302 can also be used to
identify, or map, an optimal position for the one or more
electrodes 314 within the vasculature. For example, the second end
306 of the elongate body 302 can be positioned at the desired
distance from the top of the main pulmonary artery using the
markings on the peripheral surface of the catheter body 302.
[0049] Using the stimulation system, as discussed herein,
stimulation electrical energy can be delivered across combinations
of the one or more electrodes 314. It is possible for the patient's
cardiac response to the stimulation electrical energy to be
monitored and recorded for comparison to other subsequent tests. It
is appreciated that for any of the catheters discussed herein any
combination of electrodes, including reference electrodes (as
discussed herein) positioned within or on the patient's body, can
be used in providing stimulation to and sensing cardiac signals
from the patient.
[0050] Referring now to FIG. 4 there is shown an additional
embodiment of the catheter 400 as according to the present
disclosure. The catheter 400 can include the features and
components as discussed above for catheters 100, 200 and/or 300, a
discussion of which is not repeated but the element numbers are
included in FIG. 4 with the understanding that the discussion of
these elements is implicit. In addition, the catheter 400 of the
present embodiment includes a surface 452 defining a deflection
lumen 454. The deflection lumen 454 includes a first opening 456
and a second opening 458 in the elongate body 402. In one
embodiment, the second opening 458 can be opposite the one or more
electrodes 414 on one surface of the three or more surfaces 412 of
the elongate body 402.
[0051] The catheter 400 further includes an elongate deflection
member 460. The elongate deflection member 460 includes an elongate
body 461 having a first end 463 and a second end 465. The elongate
deflection member 460 extends through the first opening 456 to the
second opening 458 of the deflection lumen 454. The deflection
lumen 454 has a size (e.g., a diameter) sufficient to allow the
deflection member 460 to pass through the deflection lumen 454 with
the first end 463 of the deflection member 460 proximal to the
first end 404 of the elongate body 402 and the second end 465 of
the deflection member 460 extendable from the second opening 458 of
the deflection lumen 454. Pressure applied from the first end 463
of the deflection member 460 can cause the deflection member 460 to
move within the deflection lumen 454. For example, when pressure is
applied to the deflection member 460 to move the first end 463 of
the deflection member 460 towards the first opening 456 of the
deflection lumen 454, the pressure causes the second end 465 of the
deflection member 460 to extend from the second opening 458.
[0052] As generally illustrated, the elongate deflection member 460
can be advanced through the deflection lumen 454 so that elongate
deflection member 460 extends laterally away from the one or more
electrodes 414 on the one surface of the three or more surfaces 412
of the elongate body 402. The elongate deflection member 460 can be
of a length and shape that allows the elongate deflection member
460 to be extended a distance sufficient to bring the one or more
electrodes 414 into contact with the vascular luminal surface
(e.g., a posterior surface of the main pulmonary artery and/or one
or both of the pulmonary arteries) with a variety of pressures.
Optionally, the elongate deflection member 460 can be configured to
include one or more of the electrode 414, as discussed herein.
[0053] For the various embodiments, the elongate body 461 of the
deflection member 460 is formed of a flexible polymeric material.
Examples of such flexible polymeric material include, but are not
limited to, medical grade polyurethanes, such as polyester-based
polyurethanes, polyether-based polyurethanes, and
polycarbonate-based polyurethanes; polyamides, polyamide block
copolymers, polyolefins such as polyethylene (e.g., high density
polyethylene); and polyimides, among others.
[0054] In an additional embodiment, the elongate body 461 of the
elongate deflection member 460 can also include one or more support
wires. The support wires can be encased in the flexible polymeric
material of the elongate body 461, where the support wires can help
to provide both column strength and a predefined shape to the
elongate deflection member 460. For example, the support wires can
have a coil shape that extends longitudinally along the length of
the elongate body 461. The coil shape allows for the longitudinal
force applied near or at the first end 463 of the deflection member
460 to be transferred through the elongate body 461 so as to
laterally extend the second end 465 of the deflection member 460
from the second opening 458 of the deflection lumen 454.
[0055] The support wires can also provide the deflection member 460
with a predetermined shape upon laterally extending from the second
opening 458 of the deflection lumen 454. The predetermined shape
can be determined to engage the luminal wall of the pulmonary
artery in order to bring the electrodes 414 into contact with the
vascular tissue. The predetermined shape and the support wires can
also help to impart stiffness to the deflection member 460 that is
sufficient to maintain the electrodes 414 on the luminal wall of
the pulmonary artery under the conditions within the vasculature of
the patient.
[0056] The support wires can be formed of a variety of metals or
metal alloys. Examples of such metals or metal alloys include
surgical grade stainless steel, such as austenitic 316 stainless
among others, and the nickel and titanium alloy known as Nitinol.
Other metals and/or metal alloys, as are known, can be used.
[0057] The catheter 400 shown in FIG. 4 can positioned in the main
pulmonary artery and/or one or both of the pulmonary arteries of
the patient, as described herein. As discussed herein, a pulmonary
artery guide catheter is introduced into the vasculature through a
percutaneous incision, and guided to the right ventricle using
known techniques. Once in the proper location, the balloon 434 can
be inflated, as described, to allow the catheter 400 to be carried
by the flow of blood from the right ventricle to the main pulmonary
artery and/or one of the pulmonary arteries. Additionally, various
imaging modalities can be used in positioning the catheter of the
present disclosure in the main pulmonary artery and/or one of the
pulmonary arteries of the patient. Such imaging modalities include,
but are not limited to, fluoroscopy, ultrasound, electromagnetic,
electropotential modalities.
[0058] The catheter 400 can be advance along the main pulmonary
artery until the second end 406 of the catheter 400 contacts the
top of the main pulmonary artery (e.g., a location distal to the
pulmonary valve and adjacent to both the pulmonary arteries). Once
the second end 406 of the catheter 400 reaches the top of the main
pulmonary artery the pulmonary artery guide catheter can be moved
relative the catheter 400 so as to deploy the catheter 400 from the
pulmonary artery guide catheter.
[0059] Markings, as discussed herein, can be present on the
peripheral surface of the catheter body 402 that can assist in
positioning the catheter 400 within the main pulmonary artery. The
ability to measure this distance from the top of the main pulmonary
artery may be helpful in placing the one or more electrodes 414 in
a desired location within the main pulmonary artery. In addition to
measuring the distance from which the second end 406 of the
elongate body 402 is placed from the top of the main pulmonary
artery, the elongate body 402 can also be used to identify, or map,
an optimal position for the one or more electrodes 414 within the
vasculature. For example, the second end 406 of the elongate body
402 can be positioned at the desired distance from the top of the
main pulmonary artery using the markings on the peripheral surface
of the catheter body 402.
[0060] When desired, the elongate deflection member 460 can be
extended laterally from the elongate body 402 to a distance
sufficient to cause the one surface of the three or more surfaces
412 of the elongate body 402 having the one or more electrodes to
contact a surface of the main pulmonary artery, such as the
anterior surface of the main pulmonary artery, and thereby bring
the one or more electrodes 414 into contact with the main pulmonary
artery or one of the pulmonary arteries (the left pulmonary artery
or the right pulmonary artery). The elongate deflection member 460,
as will be appreciated, biases and helps to place the one or more
electrodes 414 along the vessel surface (e.g., along the posterior
surface of the main pulmonary artery or one of the pulmonary
arteries (the left pulmonary artery or the right pulmonary
artery)).
[0061] Due to its adjustable nature (e.g., how much pressure is
applied to the elongate deflection member 460), the elongate
deflection member 460 can be used to bring the one or more
electrodes 414 into contact with the luminal surface of the main
pulmonary artery or one of the pulmonary arteries with a variety of
pressures. So, for example, the elongate deflection member 460 can
bring the one or more electrodes 414 into contact with the luminal
surface of the main pulmonary artery or one of the pulmonary
arteries with a first pressure. Using the stimulation system, as
discussed herein, stimulation electrical energy can be delivered
across combinations of the one or more electrodes 414 in the
electrode array. It is possible for the patient's cardiac response
to the stimulation electrical energy to be monitored and recorded
for comparison to other subsequent tests.
[0062] It is appreciated that for any of the catheters discussed
herein any combination of electrodes, including reference
electrodes (as discussed herein) positioned within or on the
patient's body, can be used in providing stimulation to and sensing
cardiac signals from the patient.
[0063] If necessary, the distance the elongate deflection member
460 extends laterally from the elongate body 402 can be changed
(e.g., made shorter) to allow the elongate body 402 to be rotated
in either a clockwise or counter-clockwise direction, thereby
repositioning the one or more electrodes 414 in contact with the
luminal surface of the main pulmonary artery or one of the
pulmonary arteries. The stimulation system can again be used to
deliver stimulation electrical energy across combinations of one or
more of the electrodes 414 in the electrode array. The patient's
cardiac response to this subsequent test can then be monitored and
recorded for comparison to previous and subsequent test. In this
way, a preferred location for the position of the one or more
electrodes 414 along the luminal surface of the main pulmonary
artery or one of the pulmonary arteries can be identified. Once
identified, the elongate deflection member 460 can be used to
increase the lateral pressure applied to the one or more
electrodes, thereby helping to better anchor the catheter 400 in
the patient.
[0064] Referring now to FIG. 5, there is shown an additional
embodiment of a catheter 562. The catheter 562 includes an elongate
body 502 having a peripheral surface 536 and a longitudinal center
axis 508 extending between a first end 504 and a second end 506.
The catheter 562 can include the features and components as
discussed above for catheters 100, 200, 300 and/or 400, a
discussion of which is not repeated but the element numbers are
included in FIG. 5 with the understanding that the discussion of
these elements is implicit.
[0065] The catheter 562 of the present embodiment includes an
inflatable balloon 534. As illustrated, the elongate body 502
includes a peripheral surface 536, where the inflatable balloon 534
is located on the peripheral surface 536 of the elongate body 502.
The inflatable balloon 534 includes a balloon wall 538 with an
interior surface 540 that along with a portion 542 of the
peripheral surface 536 of the elongate body 502 defines a fluid
tight volume 544.
[0066] The elongate body 502 further includes a surface 545 that
defines an inflation lumen 546 that extends through the elongate
body 502. The inflation lumen 546 includes a first opening 548 into
the fluid tight volume 544 of the inflatable balloon 534 and a
second opening 550 proximal to the first opening 548 to allow for a
fluid to move in the fluid tight volume 544 to inflate and deflate
the balloon 534. A syringe, or other known devices, containing the
fluid (e.g., saline or a gas (e.g., oxygen)) can be used to inflate
and deflate the balloon 534.
[0067] The elongate body 502 further includes an offset region 564
defined by a series of predefined curves along the longitudinal
center axis 508. As used herein, "predefined curves" are curves
formed in the elongate body 502 during the production of the
catheter 562, where when deformed such curves provide a spring like
force to return to their pre-deformation shape (i.e., their
original shape). As illustrated, the series of predefined curves
includes a first portion 566 that has a first curve 568 in the
longitudinal center axis 508 followed by a second curve 570 in the
longitudinal center axis 508 of the elongate body 502. The length
and degree of each of the first curve 568 and second curve 570,
along with the distance between such curves helps to define the
height of the offset region 564. As discussed herein, the height of
the offset region 564 can be determined by the inner diameter of
one or more locations along the main pulmonary artery and/or one of
the pulmonary arteries.
[0068] The first portion 566 of the elongate body 502 is followed
by a second portion 572 of the elongate body 502. The longitudinal
center axis 508 along the second portion 572 can have a zero
curvature (i.e., a straight line), as illustrated in FIG. 5. The
second portion 572 of the elongate body 502 is followed by a third
portion 574 of the elongate body 502. The longitudinal center axis
508 transitions from the second portion 572 along a third curve
576, which then transitions into a fourth curve 578. As
illustrated, after the fourth curve 578, the longitudinal center
axis 508 is approximately co-linear with the longitudinal center
axis 508 leading up to the first curve 568. It is noted that the
curves of the first portion 566 and the second portion 574 can also
all be in approximately the same plane. It is, however, possible
that the curves of the first portion 566 and the second portion 574
are not in the same plane. For example, when the curves of the
first portion 566 and the second portion 574 are not in the same
plane the longitudinal center axis 508 can include a helical curve
through these portions of the elongate body 502. Other shapes are
possible.
[0069] The elongate body 502 can further include one or more
electrodes 514, as discussed herein, along the second portion 572
of the offset region 564 of the elongate body 502. As illustrated,
the one or more electrodes 514 can be on the surface of the
elongate body 502 in the second portion 572 of the offset region
564. Conductive elements 516 extend through the elongate body 502,
where the conductive elements 516 can be used, as discussed herein,
to conduct electrical current to combinations of the one or more
electrodes 514. Each of the one or more electrodes 514 is coupled
to a corresponding conductive element 516. The conductive elements
516 are electrically isolated from each other and extend through
the elongate body 502 from each respective electrode 514 through
the first end 504 of the elongate body 502. The conductive elements
516 terminate at a connector port, where each of the conductive
elements 516 can be releasably coupled to a stimulation system, as
discussed herein. It is also possible that the conductive elements
516 are permanently coupled to the stimulation system (e.g., not
releasably coupled). The stimulation system can be used to provide
stimulation electrical energy that is conducted through the
conductive elements 516 and delivered across combinations of the
one or more electrodes 514. The one or more electrodes 514 are
electrically isolated from one another, where the elongate body 502
is formed of an electrically insulating material as discussed
herein.
[0070] There can be wide variety for the number and configuration
of the one or more electrodes 514 on the one surface of the second
portion 572 of the elongate body 502. For example, as illustrated,
the one or more electrodes 514 can be configured as an array of
electrodes, where the number of electrodes and their relative
position to each other can vary depending upon the desired implant
location. As discussed herein, the one or more electrodes 514 can
be configured to allow for electrical current to be delivered from
and/or between different combinations of the one or more electrodes
514. The electrodes in the array of electrodes can have a repeating
pattern where the electrodes are equally spaced from each other.
So, for example, the electrodes in the array of electrodes can have
a column and row configuration. Alternatively, the electrodes in
the array of electrodes can have a concentric radial pattern, where
the electrodes are positioned so as to form concentric rings of the
electrodes. Other patterns are possible, where such patterns can
either be repeating patterns or random patterns. As discussed
herein, the catheter 562 further includes conductive elements 516
extending through the elongate body, where the conductive elements
516 conduct electrical current to combinations of the one or more
electrodes 514.
[0071] As discussed herein, the length and degree of each of the
curves, along with the distance between such curves, helping to
define the first portion 566 and the third portion 574 of the
longitudinal center axis 508 helps to define the relative height of
the offset region 564. For the various embodiments, the height of
the offset region 564 can be determined by the inner diameter of
one or more locations along the main pulmonary artery and/or one of
the pulmonary arteries. In this way the first portion 566 and the
third portion 574 can bring the second portion 572 and the one or
more electrodes 514 on the surface of the elongate body 502 into
contact with the vascular wall of the patient in the main pulmonary
artery and/or one of the pulmonary arteries. In other words, the
transitions of the first portion 566 and the third portion 574 of
the elongate body 502 in the offset region 564 can act to bias the
second portion 572 and the one or more electrodes 514 against the
vascular wall of the patient in the main pulmonary artery and/or
one of the pulmonary arteries.
[0072] The elongate body 502 further includes a surface 524
defining a guide-wire lumen 526 that extends through the elongate
body 502. As provided herein, the guide-wire lumen 526 can be
concentric relative the longitudinal center axis 508 of the
elongate body 502 (as illustrated in FIG. 5). Alternatively, the
guide-wire lumen 526 can be eccentric relative the longitudinal
center axis 508 of the elongate body 502. As discussed herein, the
guide-wire lumen 526 can have a wall thickness 528 that is greater
than a wall thickness 530 of a remainder of the catheter 562 taken
perpendicularly to the longitudinal center axis 508. In an
additional embodiment,
a portion of the elongate body 502 includes a serpentine portion,
as discussed and illustrated herein, proximal to the one or more
electrodes 514.
[0073] For the present embodiment, a guide-wire used with the
catheter 562 can serve to temporarily "straighten" the offset
region 564 when the guide-wire is present in the guide-wire lumen
526 that passes along the offset region 564. Alternatively, the
guide-wire can be used to impart the shape of the offset region 564
to the catheter 562. In this embodiment, the elongate body 502 of
the catheter 562 can have a straight shape (e.g., no predefined
lateral shape). To impart the offset region 564 the guide wire is
"shaped" (e.g., bent) to the desired configuration of the offset
region at point that corresponds to the desired longitudinal
location for the offset region on the elongate body 502. The offset
region 564 of the catheter 562 can be provided by inserting the
guide wire with the predefined lateral shape.
[0074] In FIG. 5 the catheter 562 of the present embodiment further
includes a surface 552 defining a deflection lumen 554, as
discussed herein. The catheter 562 further includes an elongate
deflection member 560, also as discussed herein. As generally
illustrated, the elongate deflection member 560 can be advanced
through the deflection lumen 554 so that elongate deflection member
560 extends laterally away from the one or more electrodes 514 on
the second portion 572 of the elongate body 502. The elongate
deflection member 560 can be of a length and shape that allows the
elongate deflection member 560 to be extended a distance sufficient
to bring the one or more electrodes 514 into contact with the
vascular luminal surface (e.g., a posterior surface of the main
pulmonary artery and/or one or both of the pulmonary arteries) with
a variety of pressures.
[0075] In an additional embodiment, the elongate body 561 of the
elongate deflection member 560 can also include one or more support
wires 581. The support wires 581 can be encased in the flexible
polymeric material of the elongate body 561, where the support
wires 581 can help to provide both column strength and a predefined
shape to the elongate deflection member 560. For example, the
support wires 581 can have a coil shape that extends longitudinally
along the length of the elongate body 561. The coil shape allows
for the longitudinal force applied near or at the first end 563 of
the deflection member 560 to be transferred through the elongate
body 561 so as to laterally extend the second end 565 of the
deflection member 560 from the second opening 558 of the deflection
lumen 554.
[0076] The support wires 581 can also provide the deflection member
560 with a predetermined shape upon laterally extending from the
second opening 558 of the deflection lumen 554. The predetermined
shape can be determined to engage the luminal wall of the pulmonary
artery in order to bring the electrodes 514 on the second portion
572 of the offset region 564 into contact with the vascular tissue.
The predetermined shape and the support wires 581 can also help to
impart stiffness to the deflection member 560 that is sufficient to
maintain the electrodes 514 on the luminal wall of the pulmonary
artery under the conditions within the vasculature of the
patient.
[0077] The support wires 581 can be formed of a variety of metals
or metal alloys. Examples of such metals or metal alloys include
surgical grade stainless steel, such as austenitic 316 stainless
among others, and the nickel and titanium alloy known as Nitinol.
Other metals and/or metal alloys, as are known, can be used.
[0078] Referring now to FIG. 6, there is shown an additional
embodiment of a catheter 662 according to the present disclosure.
The catheter 662 can include the features and components as
discussed above for catheters 100, 200, 300, 400 and/or 500, a
discussion of which is not repeated but the element numbers are
included in FIG. 6 with the understanding that the discussion of
these elements is implicit.
[0079] The catheter 662 seen in FIG. 6 is similar to the catheter
562 of FIG. 5, where the elongate body 602 of catheter 662 further
includes three or more surfaces 612 defining a convex polygonal
cross-sectional shape taken perpendicularly to the longitudinal
center axis 608, as discussed for the catheters 100, 200, 300 and
400 herein. As illustrated, the one or more electrodes 614 are on
one surface of the three or more surfaces 612 of the elongate body
602. In the present embodiment, the three or more surfaces 612 of
the elongate body 602 help to form the second portion 672 of the
elongate body 602. If desired, the elongate body 602 can includes a
serpentine portion proximal to the one or more electrodes 614.
[0080] Referring now to FIG. 7, there is shown an additional
embodiment of a catheter 782 according to the present disclosure.
The catheter 782 can include the features and components as
discussed above for catheters 100, 200, 300, 400, 500 and/or 600, a
discussion of which is not repeated but the element numbers are
included in FIG. 7 with the understanding that the discussion of
these elements is implicit.
[0081] The catheter 782 includes an elongate body 702 having a
peripheral surface 736 and a longitudinal center axis 708 extending
between a first end 704 and a second end 706. The elongate body 702
includes a surface 752 defining a deflection lumen 754, where the
deflection lumen 754 includes a first opening 756 and a second
opening 758 in the elongate body 702. The catheter 782 further
includes an inflatable balloon 734 on the peripheral surface 736 of
the elongate body 702, the inflatable balloon 734 having a balloon
wall 738 with an interior surface 740 that along with a portion 742
of the peripheral surface 736 of the elongate body 702 defines a
fluid tight volume 744, as discussed herein. An inflation lumen 746
extends through the elongate body 702, where the inflation lumen
746 has a first opening 748 into the fluid tight volume 744 of the
inflatable balloon 734 and a second opening 750 proximal to the
first opening 748 to allow for a fluid to move in the fluid tight
volume 744 to inflate and deflate the balloon 734.
[0082] One or more electrodes 714 are on the elongate body 702,
where the second opening 758 of the deflection lumen 754 is
opposite the one or more electrodes 714 on the elongate body 702.
The catheter 782 further includes an elongate deflection member
760, as discussed herein, where the elongate deflection member 760
extends through the second opening 758 of the deflection lumen 754
in a direction opposite the one or more electrodes 714 on one
surface of the elongate body 702. The catheter 782 also includes
conductive elements 716, as discussed herein, that extend through
the elongate body 702, where the conductive elements 716 conduct
electrical current to combinations of the one or more electrodes
714.
[0083] The catheter 782 further includes a surface 724 defining a
guide-wire lumen 726 that extends through the elongate body 702. As
illustrated, the guide-wire lumen 726 is concentric relative the
longitudinal center axis 708. As discussed herein, the guide-wire
lumen 726 could also be eccentric relative longitudinal center axis
708 of the elongate body 708. Such embodiments are discussed
herein, where the guide-wire lumen 726 can have a wall thickness
taken perpendicularly to the longitudinal center axis 708 that is
greater than a wall thickness of a remainder of the catheter 782
taken perpendicularly to the longitudinal center axis 708. The
catheter 782 can also include a serpentine portion of the elongate
body 702 proximal to the one or more electrodes 714, as discussed
herein.
[0084] Referring now to FIG. 8, there is shown an additional
embodiment of a catheter 882 according to the present disclosure.
The catheter 882 can include the features and components as
discussed above for catheters 100, 200, 300, 400, 500, 600 and/or
700, a discussion of which is not repeated but the element numbers
are included in FIG. 8 with the understanding that the discussion
of these elements is implicit.
[0085] The catheter 882 includes an elongate body 802 having a
peripheral surface 836 and a longitudinal center axis 808 extending
between a first end 804 and a second end 806. The elongate body 802
includes a surface 852 defining a deflection lumen 854, where the
deflection lumen 854 includes a first opening 856 and a second
opening 858 in the elongate body 802. The catheter 882 further
includes an inflatable balloon 834 on the peripheral surface 836 of
the elongate body 802, the inflatable balloon 834 having a balloon
wall 838 with an interior surface 840 that along with a portion 842
of the peripheral surface 836 of the elongate body 802 defines a
fluid tight volume 844, as discussed herein. An inflation lumen 846
extends through the elongate body 802, where the inflation lumen
846 has a first opening 848 into the fluid tight volume 844 of the
inflatable balloon 834 and a second opening 850 proximal to the
first opening 848 to allow for a fluid to move in the fluid tight
volume 844 to inflate and deflate the balloon 834.
[0086] One or more electrodes 814 are on the elongate body 802,
where the second opening 858 of the deflection lumen 854 is
opposite the one or more electrodes 814 on the elongate body 802.
As illustrated, the elongate body 802 has three or more surfaces
812 defining a convex polygonal cross-sectional shape taken
perpendicularly to the longitudinal center axis 808. The one or
more electrodes 814 are on one surface of the three or more
surfaces 812 of the elongate body 802, as discussed herein.
[0087] The catheter 882 further includes an elongate deflection
member 860, as discussed herein, where the elongate deflection
member 860 extends through the second opening 858 of the deflection
lumen 854 in a direction opposite the one or more electrodes 814 on
one surface of the elongate body 802. The catheter 882 also
includes conductive elements 816, as discussed herein, that extend
through the elongate body 802, where the conductive elements 816
conduct electrical current to combinations of the one or more
electrodes 814.
[0088] The catheter 882 further includes a surface 824 defining a
guide-wire lumen 826 that extends through the elongate body 802. As
illustrated, the guide-wire lumen 826 is concentric relative the
longitudinal center axis 808. As discussed herein, the guide-wire
lumen 826 could also be eccentric relative longitudinal center axis
808 of the elongate body 808. Such embodiments are discussed
herein, where the guide-wire lumen 826 can have a wall thickness
taken perpendicularly to the longitudinal center axis 808 that is
greater than a wall thickness of a remainder of the catheter 882
taken perpendicularly to the longitudinal center axis 808. The
catheter 882 can also include a serpentine portion of the elongate
body 802 proximal to the one or more electrodes 814, as discussed
herein.
[0089] Referring now to FIG. 9, there is shown an additional
embodiment of a catheter 984 according to the present disclosure.
The catheter 984 can include the features and components as
discussed above for catheters 100, 200, 300, 400, 500, 600, 700
and/or 800, a discussion of which is not repeated but the element
numbers are included in FIG. 9 with the understanding that the
discussion of these elements is implicit.
[0090] The catheter 984 includes an elongate body 902 having a
peripheral surface 936 and a longitudinal center axis 908 extending
between a first end 904 and a second end 906. The catheter 984
further includes an inflatable balloon 934 on the peripheral
surface 936 of the elongate body 902, the inflatable balloon 934
having a balloon wall 938 with an interior surface 940 that along
with a portion 942 of the peripheral surface 936 of the elongate
body 902 defines a fluid tight volume 944, as discussed herein. An
inflation lumen 946 extends through the elongate body 902, where
the inflation lumen 946 has a first opening 948 into the fluid
tight volume 944 of the inflatable balloon 934 and a second opening
950 proximal to the first opening 948 to allow for a fluid to move
in the fluid tight volume 944 to inflate and deflate the balloon
934.
[0091] The catheter 982 includes a surface 924 defining a
guide-wire lumen 926 that extends through the elongate body 902. As
illustrated, the guide-wire lumen 926 is concentric relative the
longitudinal center axis 908. As discussed herein, the guide-wire
Lumen 926 could also be eccentric relative longitudinal center axis
908 of the elongate body 908. Such embodiments are discussed
herein, where the guide-wire lumen 926 can have a wall thickness
taken perpendicularly to the longitudinal center axis 908 that is
greater than a wall thickness of a remainder of the catheter 982
taken perpendicularly to the longitudinal center axis 908. The
catheter 982 can also include a serpentine portion of the elongate
body 902 proximal to the one or more electrodes 914, as discussed
herein.
[0092] The elongate body 902 of the catheter 984 further includes a
surface 986 defining an electrode lumen 988. The electrode lumen
988 includes a first opening 990 and a second opening 992 in the
elongate body 902. The catheter 984 also includes an elongate
electrode member 994, where the elongate electrode member 994
retractably extends through the first opening 990 of the electrode
lumen 988 of the elongate body 902. The electrode lumen 988 has a
size (e.g., a diameter) sufficient to allow the elongate electrode
member 994 to pass through the electrode lumen 988 to that the
elongate electrode member 994 can retractably extend through the
first opening 990 of the electrode lumen 988 of the elongate body
902. The elongate electrode member 994 can retractably extend
through the first opening 990 of the electrode lumen 988 of the
elongate body 902 from pressure (e.g., compression or tension)
applied by the user through the elongate electrode member 994
proximal to the second opening 992 in the elongate body 908. For
the various embodiments, the elongate electrode member 994 is
formed of a flexible polymeric material. Examples of such flexible
polymeric material include, but are not limited to, those provided
herein.
[0093] The elongate electrode member 994 includes one or more
electrodes 996 and conductive elements 998 extending through the
electrode lumen 988. As illustrated, the one or more electrodes 996
are on the surface 901 of the elongate electrode member 994.
Conductive elements 998 extend through the elongate electrode
member 994, where the conductive elements 998 can be used, as
discussed herein, to conduct electrical current to combinations of
the one or more electrodes 996. Each of the one or more electrodes
996 is coupled to a corresponding conductive element 998.
[0094] The conductive elements 998 are electrically isolated from
each other and extend through the elongate electrode member 994
from each respective electrode 996 through the second end 992 of
the electrode lumen 988. The conductive elements 998 terminate at a
connector port, where each of the conductive elements 998 can be
releasably coupled to a stimulation system, as discussed herein. It
is also possible that the conductive elements 998 are permanently
coupled to the stimulation system (e.g., not releasably coupled).
The stimulation system can be used to conduct electrical current to
combinations of the one or more electrodes 994 via the conductive
elements 998. The one or more electrodes 996 are electrically
isolated from one another, where the elongate electrode member 994
is formed of an electrically insulating material as discussed
herein.
[0095] There can be a variety of the number and the configuration
of the one or more electrodes 996 on the elongate electrode member
994. For example, as illustrated, the one or more electrodes 996
can be configured as an array of electrodes, where the number of
electrodes and their relative position to each other can vary
depending upon the desired implant location. As discussed herein,
the one or more electrodes 996 can be configured to allow for
electrical current to be delivered from and/or between different
combinations of the one or more electrodes 996. So, for example,
the electrodes in the array of electrodes can have a repeating
pattern where the electrodes are equally spaced from each other.
Other patterns are possible, where such patterns can either be
repeating patterns or random patterns.
[0096] As illustrated, the one or more electrodes 996 have an
exposed face 903. The exposed face 903 of the electrode 996
provides the opportunity for the electrode 996, when implanted in
the patient, to be placed into proximity and/or in contact with the
vascular tissue of the patient, as opposed to facing into the
volume of blood in the artery. To accomplish this, the one or more
electrodes 996 can be located on only one side of the elongate
electrode member 994 (as illustrated in FIG. 9). This allows the
one or more electrodes 996 to be brought into contact with the
vascular luminal surface (e.g., a posterior surface of the main
pulmonary artery and/or one or both of the pulmonary arteries). As
the one or more electrodes 996 are located on only one side of the
elongate electrode member 994, the electrodes 996 can be placed
into direct proximity to and/or in contact with, the tissue of any
combination of the main pulmonary artery, the left pulmonary artery
and/or the right pulmonary artery.
[0097] The exposed face 903 of the one or more electrodes 996 can
have a variety of shapes, as discussed herein (e.g., a partial ring
configuration, where each of the one or more electrodes 996 is
positioned to face away from the elongate body 902). The exposed
face 903 of the electrodes 996 can also include one or more anchor
structures. Examples of such anchor structures include hooks that
can optionally include a barb.
[0098] As generally illustrated, the elongate electrode member 994
can be advanced through the electrode lumen 988 so that the
elongate electrode member 994 extends laterally away from the
elongate body 908. The elongate electrode member 994 can be of a
length and shape that allows the elongate electrode member 994 to
be extended a distance sufficient from the elongate body 908 to
bring the one or more electrodes 996 into contact with the vascular
luminal surface (e.g., a posterior surface of the main pulmonary
artery and/or one or both of the pulmonary arteries).
[0099] As illustrated in FIG. 9, the elongate electrode member 994
forms a loop 905 that extends away from the peripheral surface 936
of the elongate body 902. The loop 905 can have a variety of
configurations relative the longitudinal axis 908 of the elongate
body 902. For example, as illustrated in FIG. 9, the elongate
electrode member 992 forming the loop 905 is in a plane 907 that is
co-linear with the longitudinal center axis 908 of the elongate
body 902.
[0100] The catheter 984 further includes an elongate deflection
member 960, as previously discussed. As discussed herein, pressure
is applied to the deflection member 960 to move the first end 963
of the deflection member 960 towards the first opening 956 of the
deflection lumen 954. The pressure in addition to moving the first
end 963 of the deflection member 960 towards the first opening 956
also causes the second end 965 of the deflection member 960 to
extend from the second opening 958. As generally illustrated, the
elongate deflection member 960 can be advanced through the
deflection lumen 954 so that elongate deflection member 960 extends
laterally away from the one or more electrodes 996 on the elongate
electrode member 994. The elongate deflection member 960 can be of
a length and shape that allows the elongate deflection member 960
to be extended a distance sufficient to help bring the one or more
electrodes 996 into contact with the vascular luminal surface
(e.g., a posterior surface of the main pulmonary artery and/or one
or both of the pulmonary arteries) with a variety of pressures.
Optionally, the elongate deflection member 960 can be configured to
include one or more of the electrode, as discussed herein.
[0101] The catheter 984 shown in FIG. 9 can be positioned in the
main pulmonary artery and/or one or both of the pulmonary arteries
of the patient, as described herein. To accomplish this, a
pulmonary artery guide catheter is introduced into the vasculature
through a percutaneous incision and guided to the right ventricle
using known techniques. For example, the pulmonary artery guide
catheter can be inserted into the vasculature via a peripheral vein
of the arm (e.g., as with a peripherally inserted central
catheter). Changes in a patient's electrocardiography and/or
pressure signals from the vasculature can be used to guide and
locate the pulmonary artery guide catheter within the patient's
heart. Once in the proper location, a guide wire can be introduced
into the patient via the pulmonary artery guide catheter, where the
guide wire is advanced into the main pulmonary artery and/or one of
the pulmonary arteries. Using the guide-wire lumen 926, the
catheter 984 can be advanced over the guide wire so as to position
the catheter 984 in the main pulmonary artery and/or one or both of
the pulmonary arteries of the patient, as described herein. Various
imaging modalities can be used in positioning the guide wire of the
present disclosure in the main pulmonary artery and/or one of the
pulmonary arteries of the patient. Such imaging modalities include,
but are not limited to, fluoroscopy, ultrasound, electromagnetic,
electropotential modalities.
[0102] Using a stimulation system, as discussed herein, stimulation
electrical energy can be delivered across combinations of one or
more of the electrodes 996. It is possible for the patient's
cardiac response to the stimulation electrical energy to be
monitored and recorded for comparison to other subsequent tests. It
is appreciated that for any of the catheters discussed herein any
combination of electrodes, including reference electrodes (as
discussed herein) positioned within or on the patient's body, can
be used in providing stimulation to and sensing cardiac signals
from the patient.
[0103] Referring now to FIG. 10, there is shown an additional
embodiment of a catheter 1084 according to the present disclosure.
The catheter 1084 can include the features and components as
discussed above for catheters 100, 200, 300, 400, 500, 600, 700,
800 and/or 900, a discussion of which is not repeated but the
element numbers are included in FIG. 10 with the understanding that
the discussion of these elements is implicit. The catheter 1084
illustrates an embodiment in which the elongate electrode member
1094 forms the 1005 loop in a plane 1007 that is perpendicular to
the longitudinal center axis of the elongate body.
[0104] It is appreciated that more than one of the elongate
electrode member can be used with a catheter.
[0105] For the various embodiments, the electrode can have a
variety of configurations and sizes. For example, the electrodes
discussed herein can be ring-electrodes that fully encircle the
body on which they are located. The electrodes discussed herein can
also be a partial ring, where the electrode only partially
encircles the body on which they are located. For example, the
electrodes can be partial ring electrodes that preferably only
contact the luminal surface of the main pulmonary artery and/or
pulmonary arteries, as discussed herein. This configuration may
help to localize the stimulation electrical energy, as discussed
herein, into the vascular and adjacent tissue structures (e.g.,
autonomic fibers) and away from the blood. The electrodes and
conductive elements provided herein can be formed of a conductive
biocompatible metal or metal alloy. Examples of such conductive
biocompatible metal or metal alloys include, but are not limited
to, titanium, platinum or alloys thereof. Other biocompatible metal
or metal alloys are known.
[0106] For the various embodiments, the elongate body of the
catheters provided herein can be formed of a flexible polymeric
material. Examples of such flexible polymeric material include, but
are not limited to, medical grade polyurethanes, such as
polyester-based polyurethanes, polyether-based polyurethanes, and
polycarbonate-based polyurethanes; polyamides, polyamide block
copolymers, polyolefins such as polyethylene (e.g., high density
polyethylene); and polyimides, among others.
[0107] Each of the catheters discussed herein can further include
one or more reference electrodes positioned proximal to the one or
more electrodes present on the elongate body. These one or more
reference electrodes each include insulated conductive leads that
extend from the catheter so as to allow the one or more reference
electrodes to be used as common or return electrodes for electrical
current that is delivered through one or more of the one or more
electrodes on the elongate body of the catheter.
[0108] The catheters of the present disclosure can be used to treat
a patient with various cardiac conditions. Such cardiac conditions
include, but are not limited to, acute heart failure, among others.
As discussed herein, the one or more electrodes present on the
catheter can be positioned within the main pulmonary artery and/or
one or both of the pulmonary arteries. Preferably, the one or more
electrodes are positioned in contact the luminal surface of the
main pulmonary artery (e.g., in physical contact with the surface
of the posterior portion of the main pulmonary artery). As will be
discussed herein, the one or more electrodes on the catheter
provided herein can be used to provide pulse of electrical energy
between the electrodes and/or the reference electrodes. The
electrodes of the present disclosure can be used in any one of a
unipolar, bi-polar and/or a multi-polar configuration. Once
positioned, the catheter of the present disclosure can provide the
stimulation electrical energy to stimulate the nerve fibers (e.g.,
autonomic nerve fibers) surrounding the main pulmonary artery
and/or one or both of the pulmonary arteries in an effort to
provide adjuvant cardiac therapy to the patient (e.g., electrical
cardiac neuromodulation).
[0109] In addition to the catheters of the present disclosure, one
or more sensing electrodes can be located on or within the patent.
Among other things, the sensing electrodes can be used to detect
signals indicting changes in various cardiac parameters, where
these changes can be the result of the pulse of stimulation
electrical energy delivered to stimulate the nerve fibers (e.g.,
autonomic nerve fibers) surrounding the main pulmonary artery
and/or one or both of the pulmonary arteries. Such parameters
include, but are not limited to, the patient's heart rate (e.g.,
pulse), among other parameters. The sensing electrodes can also
provide signals indicting changes in one or more electrical
parameter of vasculature (electrical activity of the cardiac
cycle). Such signals can be collected and displayed, as are known,
using known devices (e.g., electrocardiography (ECG) monitor) or a
stimulation system, as discussed herein, which receives the
detected signals and provides information about the patient.
[0110] Other sensors can also be used with the patient to detect
and measure a variety of other signals indicting changes in various
cardiac parameters. Such parameters can include, but are not
limited to, blood pressure, blood oxygen level and/or gas
composition of the patient's exhaled breath. For example, catheter
of the present disclosure can further include a pressure sensor
positioned within or in-line with the inflation lumen for the
inflatable balloon. Signals from the pressure sensor can be used to
both detect and measure the blood pressure of the patient.
Alternatively, the catheter of the present disclosure can include
an integrated circuit for sensing and measuring blood pressure
and/or a blood oxygen level. Such an integrated circuit can be
implemented using 0.18 .mu.m CMOS technology. The oxygen sensor can
be measured with optical or electrochemical techniques as are
known. Examples of such oxygen sensors include reflectance or
transmissive pulse oximetry those that use changes in absorbance in
measured wavelengths optical sensor to help determined a blood
oxygen level. For these various embodiments, the elongate body of
the catheter can include the sensor (e.g., a blood oxygen sensor
and/or a pressure sensor) and a conductive element, or elements,
extending through each of the elongate body, where the conductive
element conducts electrical signals from the blood oxygen sensor
and/or the pressure sensor.
[0111] The detected signals can also be used by the stimulation
system to provide stimulation electrical energy in response to the
detected signals. For example, one or more of these signals can be
used by the stimulation system to deliver the stimulation
electrical energy to the one or more electrodes of the catheter.
So, for example, detected signals from the patent's cardiac cycle
(e.g., ECG waves, wave segments, wave intervals or complexes of the
ECG waves) can be sensed using the sensing electrodes and/or timing
parameter of the subject's blood pressure. The stimulation system
can receive these detected signals and based on the features of the
signal(s) generate and deliver the stimulation electrical energy to
the one or more electrode of the catheter. As discussed herein, the
stimulation electrical energy is of sufficient current and
potential along with a sufficient duration to stimulate one or more
of the nerve fibers surrounding the main pulmonary artery and/or
one or both of the pulmonary arteries so as to provide
neuromodulation to the patient.
[0112] Referring now to FIG. 11, there is shown an illustration of
a main pulmonary artery 11500 of a heart 11502. The main pulmonary
artery 11500 begins at the base of the right ventricle 11504,
having a diameter of approximately 3 centimeter (1.2 in) and a
length of about approximately 5 centimeters (2.0 in). The main
pulmonary artery 11500 branches into two pulmonary arteries (left
and right) 11501, which deliver deoxygenated blood to the
corresponding lung. As illustrated, the main pulmonary artery 11500
has a posterior surface 11506 that arches over the left atrium and
is adjacent the pulmonary vein. As discussed herein, the one or
more electrodes of the catheter of the present disclosure are
positioned at least partially within the main pulmonary artery
and/or a pulmonary artery with the electrode in contact with the
posterior surface 11506. One preferred location for positioning the
one or more electrodes of the catheter of the present disclosure is
the right pulmonary artery as disclosed in U.S. Provisional Patent
Application 62/______ entitled "METHODS FOR ELECTRICAL
NEUROMODULATION OF THE HEART" filed on Sep. 8, 2014, which is
incorporated herein by reference in its entirety. Other locations
along the lumen of the main pulmonary artery and/or pulmonary
arteries are also possible.
[0113] Preferably, the one or more electrodes of the catheter of
the present disclosure are in contact with the posterior surface
11506 of the main pulmonary artery 11500 and/or pulmonary arteries
11501. From this location, the stimulation electrical energy
delivered through the one or more electrodes may be better able to
treat and/or provide therapy (including adjuvant therapy) to the
patient experiencing a variety of cardiovascular medical
conditions, such as acute heart failure. The stimulation electrical
energy can elicit responses from the autonomic nervous system that
may help to modulate a patient's cardiac contractility. The
stimulation electrical energy is intended to affect heart
contractility more than the heart rate, thereby helping to
improving hemodynamic control while possibly minimizing unwanted
systemic effects.
[0114] As discussed herein, the catheter of the present disclosure
can be positioned in the pulmonary artery of the patient, where the
one or more electrodes are positioned in contact the luminal
surface of the main pulmonary artery (e.g., in physical contact
with the surface of the posterior portion of the main pulmonary
artery). The stimulation system is electrically coupled to the one
or more electrodes via the conductive elements, where the
stimulation system can be used to deliver the stimulation
electrical energy to the autonomic cardiopulmonary fibers
surrounding the main pulmonary artery.
[0115] The stimulation system is used to operate and supply the
stimulation electrical energy to the one or more electrodes of the
catheter. The stimulation system controls the various parameters of
the stimulation electrical energy delivered across the one or more
electrodes. Such parameters include control of each electrodes
polarity (e.g., used as a cathode or an anode), pulsing mode (e.g.,
unipolar, bi-polar and/or multi-polar), a pulse width, an
amplitude, a frequency, a voltage, a current, a duration, a
wavelength and/or a waveform associated with the stimulation
electrical energy. The stimulation system may operate and supply
the stimulation electrical energy to different combinations and
numbers of the one or more electrodes, including the reference
electrodes discussed herein. The stimulation system can be external
to the patient's body for use by the professional to program the
stimulation system and to monitor its performance. Alternatively,
the stimulation system could be internal to the patient's body.
When located within the patient, the housing of the stimulation
system can be used as a reference electrode for both sensing and
unipolar pulsing mode.
[0116] As discussed herein, the stimulation system can be used to
help identify a preferred location for the position of the one or
more electrodes along the luminal surface of the main pulmonary
artery. To this end, the one or more electrodes of the catheter are
introduced into the patient and tests of various locations along
the luminal surface of the main pulmonary artery using the
stimulation system are conducted so as to identify a preferred
location for the electrodes, as discussed herein. During such a
test, the stimulation system can be used to initiate and adjust the
parameters of the stimulation electrical energy. Such parameters
include, but are not limited to, terminating, increasing,
decreasing, or changing the rate or pattern of the stimulation
electrical energy. The stimulation system can also deliver
stimulation electrical energy that are episodic, continuous,
phasic, in clusters, intermittent, upon demand by the patient or
medical personnel, or preprogrammed to respond to a signal, or
portion of a signal, sensed from the patient.
[0117] By way of example, the stimulation electrical energy can
have a voltage of about 0.1 microvolts to about 75 volts (V), where
voltage values of 1 V to 50 V, or 0.1 V to 10 V are also possible.
The stimulation electrical energy can be delivered at a frequency
of about 1 Hertz (Hz) to about 100,000 Hz, where frequency values
of about 2 Hz to about 200 Hz are also possible. The stimulation
electrical energy can have a pulse width of about 100 microseconds
to about 100 milliseconds. The stimulation electrical energy can
also have a variety of wave forms, such as for example, square
wave, biphasic square wave, sine wave, or other electrically safe
and feasible combinations. The stimulation electrical energy may be
applied to multiple target sites simultaneously or
sequentially.
[0118] An open-loop or closed-loop feedback mechanism may be used
in conjunction with the present disclosure. For the open-loop
feedback mechanism, a professional can monitor cardiac parameters
and changes to the cardiac parameters of the patient. Based on the
cardiac parameters the professional can adjust the parameters of
the stimulation electrical energy applied to autonomic
cardiopulmonary fibers. Non-limiting examples of cardiac parameters
monitored include arterial blood pressure, central venous pressure,
capillary pressure, systolic pressure variation, arterial blood
gases, cardiac output, systemic vascular resistance, pulmonary
artery wedge pressure, gas composition of the patient's exhaled
breath and/or mixed venous oxygen saturation. Cardiac parameters
can be monitored by an electrocardiogram, invasive hemodynamics, an
echocardiogram, or blood pressure measurement or other devices
known in the art to measure cardiac function. Other parameters such
as body temperature and respiratory rate can also be monitored and
processed as part of the feedback mechanism.
[0119] In a closed-loop feedback mechanism, the cardiac parameters
of the patient are received and processed by the stimulation
system, as discussed herein, where the parameters of the
stimulation electrical energy are adjusted based at least in part
on the cardiac parameters. As discussed herein, a sensor is used to
detect a cardiac parameter and generate a sensor signal. The sensor
signal is processed by a sensor signal processor, which provides a
control signal to a signal generator. The signal generator, in
turn, can generate a response to the control signal by activating
or adjusting one or more of the parameters of the stimulation
electrical energy applied by the catheter to the patient. The
control signal can initiate, terminate, increase, decrease or
change the parameters of the stimulation electrical energy. It is
possible for the one or more electrodes of the catheter to be used
as a sensor a recording electrode. When necessary these sensing or
recording electrodes may delivery stimulation therapy as discussed
herein.
[0120] The stimulation system can also monitor to determine if the
one or more electrodes have dislodged from their position within
the main pulmonary artery and/or one or both of the pulmonary
arteries (the right pulmonary artery and the left pulmonary
artery). For example, the stimulation system can monitor the
voltage levels of the stimulation electrical energy delivered and
received by the one or more electrodes once the catheter is
implanted. If the voltage levels received by the one or more
electrode change by a predetermined percentage, a warning signal is
produced by the stimulation system and the stimulation electrical
energy is stopped.
[0121] Referring now to FIG. 12, there is shown an embodiment of
the stimulation system 12600. The stimulation system 12600 includes
an input/output connector 12602 that releasably joins the
conductive elements of the catheter of the present disclosure. It
is also possible that the conductive elements are permanently
coupled to the stimulation system (e.g., not releasably coupled).
An input from the sensor can also be releasably coupled to the
input/output connector 12602 so as to receive the sensor signal(s)
discussed herein.
[0122] The input/output connector 12602 is connected to an analog
to digital converter 12604. The output of the analog to digital
converter 12604 is connected to a microprocessor 12606 through a
peripheral bus 12608 including address, data and control lines.
Microprocessor 12606 can process the sensor data, when present, in
different ways depending on the type of sensor in use. The
microprocessor 12606 can also control, as discussed herein, the
pulse control output generator 12610 that delivers the stimulation
electrical energy to the one or more electrodes via the
input/output connector 12602.
[0123] The parameters of the stimulation electrical energy can be
controlled and adjusted, as needed, by instructions programmed in a
memory 12612 and executed by a programmable pulse generator 12613.
The instructions in memory 12612 for the programmable pulse
generator 12613 can be set and/or modified based on input from the
closed-looped system, via the microprocessor 12606. The
instructions in memory 12612 for the programmable pulse generator
12613 can also be set and/or modified through inputs from a
professional via an input 12614 connected through the peripheral
bus 12608. Examples of such an input include a keyboard with a
display screen or through a touch screen (not shown), as are known.
The stimulation system 12600 can also include a communications port
12615 that connects to the peripheral bus 12608, where data and/or
programming instructions can be received by the microprocessor
12606 and/or the memory 12612.
[0124] Input from either a professional via the input 12614, the
communications port 12615 or from the closed-looped system via the
microprocessor 12606 can be used to change (e.g., adjust) the
parameters of the stimulation electrical energy. The stimulation
system 12600 can also include a power source 12616. The power
source 12616 can be a battery or a power source supplied from an
external power supply (e.g., an AC/DC power converter coupled to an
AC source). The programmable pulse generator 12612 can also include
a housing 12618.
[0125] The microprocessor 12606 can execute one or more algorithms
in order to provide stimulation with closed loop feedback control.
The microprocessor 12606 can also be controlled by a professional
via the input 12614 to initiate, terminate and/or change (e.g.,
adjust) the parameters of the stimulation electrical energy. The
closed loop feedback control can be used to help maintain one or
more of a patient's cardiac parameters at or within a threshold
value or range programmed into memory 12612. For example, under
closed loop feedback control measured cardiac parameter value(s)
can be compared and then it can be determine whether or not the
measured value(s) lies outside a threshold value or a
pre-determined range of values. If the measured cardiac parameter
value(s) do not fall outside of the threshold value or the
pre-determined range of values, the closed loop feedback control
continues to monitor the cardiac parameter value(s) and repeats the
comparison on a regular interval. If, however, the cardiac
parameter value(s) from a sensor indicate that one or more cardiac
parameters are outside of the threshold value or the pre-determined
range of values one or more of the parameters of the stimulation
electrical energy will be adjusted by the microprocessor 12606. The
adjustments can be made using process control logic (e.g., fuzzy
logic, negative feedback, etc.) so as to maintain control of the
pulse control output generator 12610.
[0126] Although preferred illustrative variations of the present
disclosure are described above, it will be apparent to those
skilled in the art that various changes and modifications may be
made thereto without departing from the embodiments of the present
disclosure. It is intended in the appended claims to cover all such
changes and modifications that fall within the true spirit and
scope of the disclosure.
* * * * *