U.S. patent application number 12/741710 was filed with the patent office on 2010-09-23 for steerable epicardial pacing catheter system placed via the subxiphoid process.
This patent application is currently assigned to UNIVERSITY OF VIRGINIA PATENT FOUNDATION. Invention is credited to George T. Gillies, Srijoy Mahapatra.
Application Number | 20100241185 12/741710 |
Document ID | / |
Family ID | 40626198 |
Filed Date | 2010-09-23 |
United States Patent
Application |
20100241185 |
Kind Code |
A1 |
Mahapatra; Srijoy ; et
al. |
September 23, 2010 |
STEERABLE EPICARDIAL PACING CATHETER SYSTEM PLACED VIA THE
SUBXIPHOID PROCESS
Abstract
The epicardial pacing system and related method includes an
epicardial catheter configured to be disposed in the middle
mediastinum of the thorax of a subject for use in electrical pacing
of the heart at one or more locations on the epicardial surface.
The epicardial pacing catheter may include at least one electrode
whereby the electrode is insulated on at least one side to allow
pacing of the heart without damage to adjacent anatomical
structures.
Inventors: |
Mahapatra; Srijoy;
(Charlottesville, VA) ; Gillies; George T.;
(Charlottesville, VA) |
Correspondence
Address: |
UNIVERSITY OF VIRGINIA PATENT FOUNDATION
250 WEST MAIN STREET, SUITE 300
CHARLOTTESVILLE
VA
22902
US
|
Assignee: |
UNIVERSITY OF VIRGINIA PATENT
FOUNDATION
Charlottesville
VA
|
Family ID: |
40626198 |
Appl. No.: |
12/741710 |
Filed: |
November 7, 2008 |
PCT Filed: |
November 7, 2008 |
PCT NO: |
PCT/US08/82835 |
371 Date: |
May 6, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60986786 |
Nov 9, 2007 |
|
|
|
61023727 |
Jan 25, 2008 |
|
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Current U.S.
Class: |
607/17 ; 128/898;
607/129 |
Current CPC
Class: |
A61N 1/0587
20130101 |
Class at
Publication: |
607/17 ; 128/898;
607/129 |
International
Class: |
A61N 1/05 20060101
A61N001/05; A61B 17/00 20060101 A61B017/00 |
Claims
1. An epicardial pacing system, said system comprising: an
epicardial catheter configured to be disposed in the middle
mediastinum of the thorax of a subject for use in electrical pacing
of the heart at one or more locations on the epicardial surface,
said epicardial pacing catheter comprising: a proximal portion,
distal portion, and a longitudinal structure there between; and at
least one electrode in communication with the distal portion,
wherein the at least one electrode is insulated on at least one
side to allow pacing of the heart without damage to adjacent
anatomical structures.
2. The system of claim 1, wherein said disposing comprises a
minimally invasive procedure.
3. The system of claim 1, wherein said disposing comprises a
non-surgical procedure.
4. The system of claim 1, wherein said disposing comprises an
interventional procedure.
5. The system of claim 1, wherein the middle mediastinum includes
the pericardial space.
6. The system of claim 1, wherein said epicardial pacing catheter
is a lead.
7. The system of claim 1, further comprising at least one
electrical wire in communication with said at least one electrodes,
said electrical wire extending longitudinally through said
longitudinal structure toward the proximal end, wherein said at
least one electrical wire is adapted for transmitting and receiving
electrical energy.
8. The system of claim 7, further comprising a control means in
communication with the proximal portion, wherein said control means
is controllably connected to said at least one electrical wire.
9. The system of claim 8, wherein said control means is
removable.
10. The system of claim 9, wherein said control means is a control
handle.
11. The system of claim 1, wherein said at least one electrode
comprises a conducting material.
12. The system of claim 11, wherein said conducting material
comprises at least one of the following: copper, platinum, gold,
silver, iridium and/or alloys thereof.
13. The system of claim 1, said catheter further comprising an
insulating material, said insulating material in communication with
said at least one electrode and a portion of said catheter located
opposite the heart.
14. The system of claim 13, wherein said insulating material is
non-conductive.
15. The system of claim 13, wherein said insulating material
mitigates the transmission of electrical energy away from the
heart.
16. The system of claim 1, said catheter further comprising a
distal tip, wherein said distal tip comprises a non-conducting
material.
17. The system of claim 1, wherein said at least one electrode is
semi-cylindrical or arc-like in shape.
18. The system of claim 1, wherein the surface of said at least one
electrode is roughened, profiled, or otherwise prepared so as to
maximize surface area.
19. The system of claim 1, wherein said at least one electrode
comprises at least one electrode pair.
20. The system of claim 19, wherein said at least one electrode
pair comprises an anode and cathode.
21. The system of claim 1, wherein said at least one electrode is
deployable.
22. The system of claim 1, wherein the cross section of said
longitudinal structure comprises an oval, circle, ellipse, or
semi-circular shape.
23. The system of claim 1, wherein at least a portion of said
longitudinal structure comprises a biocompatible material.
24. The system of claim 1, wherein at least a portion of said
longitudinal structure comprises a lubricious material having a low
coefficient of friction.
25. The system of claim 1, wherein at least a portion of said
longitudinal structure comprises at least one of the following:
silicone, polyurethane, or Teflon, any combination thereof, or
similarly lubricious material.
26. The system of claim 1, wherein at least a portion of said
longitudinal structure is impregnated with sirilimus.
27. The system of claim 1, wherein at least a portion of said
longitudinal structure comprises a drug eluting surface.
28. The system of claim 1, wherein said longitudinal structure is
between about 15 and about 100 centimeters in length.
29. The system of claim 1, wherein said longitudinal structure is
between about 2 and about 6 millimeters in diameter.
30. The system of claim 1, further comprising at least one distal
fluid aperture located at the distal tip of said distal portion,
said at least one distal fluid aperture in communication with a
fluid lumen extending longitudinally through said longitudinal
structure toward said proximal portion, wherein said at least one
distal fluid aperture is adapted for passage of fluid.
31. The system of claim 30, wherein said passage comprises emitting
fluid.
32. The system of claim 30, wherein said passage comprises
extracting fluid.
33. The system of claim 30, wherein said passage comprises emitting
and extracting fluid.
34. The system of claim 30, wherein said passage comprises emitting
a drug or agent.
35. The system of claim 30, further comprising at least one
proximal fluid aperture at said proximal portion, wherein the at
least one proximal fluid aperture is in communication with said
fluid lumen, and wherein the at least one proximal fluid aperture
is adapted for passage of fluid.
36. The system of claim 35, wherein said passage comprises emitting
fluid.
37. The system of claim 35, wherein said passage comprises
extracting fluid.
38. The system of claim 35, wherein said passage comprises emitting
and extracting fluid.
39. The system of claim 35, wherein said passage comprises emitting
a drug or agent.
40. The system of claim 35, further comprising a fluid control
means for controlling said fluid passage.
41. The system of claim 40, wherein said control means comprises a
control handle in communication with said epicardial pacing
catheter.
42. The system of claim 40, wherein said control means is in
communication with an external fluid source.
43. The system of claim 40, wherein said control means is in
communication with an external drug or agent source.
44. The system of claim 1, wherein said catheter further comprising
a stabilization means for stabilizing said epicardial pacing
catheter.
45. The system of claim 44, wherein said stabilization means
comprises at least one deployable member.
46. The system of claim 45, wherein said deployable member
comprises a screw, hook, or tab.
47. The system of claim 45, wherein said deployable member is in
communication with said at least one electrode.
48. The system of claim 45, wherein said deployable member
comprises a conductive material.
49. The system of claim 48, wherein said conducting material
comprises at least one of the following: copper, platinum, gold,
silver, or iridium, and/or alloys thereof.
50. The system of claim 45, further comprising a stabilizer
actuator, wherein said stabilizer actuator deploys said at least
one deployable member.
51. The system of claim 50, wherein said stabilizer actuator
comprises: at least one longitudinal member in communication with
at least one of the following: gear, hinge, joint, rack and pinion,
pulley, linear actuator, or linear-rotational actuator, or any
combination thereof.
52. The system of claim 51, wherein said at least one longitudinal
member comprises at least one of the following: push-rod, pull-rod,
wire, string, pole, thread, filament, cord, strand or rope.
53. The system of claim 50, wherein said stabilizer actuator
comprises a micro electrical mechanical system (MEMS).
54. The system of claim 44, further comprising a control means for
controlling said stabilization.
55. The system of claim 54, wherein said control means comprises a
control handle.
56. The system of claim 45, wherein said at least one deployable
member comprises a catheter-side surface and anatomical-side
surface.
57. The system of claim 56, wherein said catheter-side surface
comprises a rough surface and said anatomical-side surface
comprises a lubricious surface.
58. The system of claim 56, wherein said at least one deployable
member is adapted to engage proximate anatomical structures.
59. The system of claim 56, wherein said catheter-side and
anatomical-side surfaces comprise non-conductive materials.
60. The system of claim 56, wherein said catheter-side surface
comprises a material having a larger coefficient of friction than
said anatomical-side surface.
61. The system of claim 56, wherein said at least one deployable
member in a deployed state prevents or impedes said distal portion
from slipping or moving.
62. The system of claim 56, wherein said distal portion can be
moved around within the middle mediastinum when said stabilization
means is in a non-deployed state.
63. The system of claim 56, wherein said anatomical-side surface
comprises at least one of the following: silicone, polyurethane, or
Teflon, combination thereof, or similarly lubricious material.
64. The system of claim 56, wherein said catheter-side surface
comprises a textured surface to increase friction.
65. The system of claim 56, wherein said at least one deployable
member comprises a radio-opaque material.
66. The system of claim 44, wherein said stabilization means
comprises one or more protrusions for engaging proximal anatomical
structures.
67. The system of claim 66, wherein at least one of said one or
more protrusions is non-deployable.
68. The system of claim 66, wherein said one or more protrusions
comprise a non-conducting material.
69. The system of claim 68, wherein said non-conducting material
comprises at least one of the following: silicone, polyurethane, or
Teflon, combination thereof, or similarly lubricious material.
70. The system of claim 68, wherein the non-conducting material
comprises a radio-opaque material.
71. The system of claim 1, further comprising a steering means for
positioning the epicardial pacing catheter.
72. The system of claim 71, further comprising a second steering
means for steering said epicardial pacing catheter.
73. The system of claim 71, further comprising a third and fourth
steering means for steering said epicardial pacing catheter.
74. The system of claim 71, wherein said steering means allows
orientation of said epicardial pacing catheter about one point of
curvature.
75. The system of claim 71, wherein said steering means allows
orientation of said epicardial pacing lead about two or more points
of curvature.
76. The system of claim 75, wherein the most proximal point of
curvature is located about 15 cm from the proximal end.
77. The system of claim 75, wherein the most distal point of
curvature is located between about 1 and about 20 cm from the
distal end.
78. The system of claim 75, wherein the most distal point of
curvature is a bidirectional center of curvature.
79. The system of claim 75, wherein the most distal point of
curvature is greater than tri-directional.
80. The system of claim 71, wherein said steering means comprises
at least one of the following: guide wire, pull string, digitating
member or tensioning line.
81. The system of claim 71, wherein said steering means comprises a
non-conductive material.
82. The system of claim 71, wherein said steering means comprises a
material of high-tensile strength.
83. The system of claim 71, further comprising a control means for
controlling said steering means.
84. The system of claim 83, wherein said control means comprises a
removable handle in communication with the proximal portion.
85. The system of claim 1, wherein said epicardial pacing catheter
is adapted to be in communication with a power supply.
86. The system of claim 85, wherein said epicardial pacing catheter
is adapted to be in communication with a processor.
87. The system of claim 86, wherein said epicardial pacing catheter
is adapted to be in communication with said power supply and said
processor by hardwire, wireless, or a combination thereof.
88. The system of claim 87, wherein said wireless comprises
BlueTooth, Infrared, other optical, photo-optical, or radio-based
type of telemetry or communication.
89. The system of claim 85, further comprising an interface member
in communication with said power supply and processor.
90. The system of claim 89, wherein said interface member is used
by a patient, a physician, a technician, or a clinician.
91. The system of claim 90, wherein said interface member may be in
remote or local communication with a control means.
92. The system of claim 91, wherein said control means comprises an
external control handle.
93. The system of claim 1, wherein navigation of said epicardial
pacing catheter is carried out through a puncture of the
thorax.
94. The system of claim 93, wherein said puncture comprises a
sub-xiphoid puncture.
95. The system of claim 93, wherein a pressure probe needle is used
in navigating the epicardial pacing catheter.
96. The system of claim 95, wherein said pressure probe needle
comprises an access needle.
97. The system of claim 95, wherein said pressure probe needle
comprises a sensor for sensing pressure in the thorax.
98. The system of claim 1, further comprising an access needle, the
access needle adapted to be inserted into the thorax.
99. The system of claim 98, further comprising a guidewire, wherein
the guidewire is adapted to be inserted into said access
needle.
100. The system of claim 98, wherein said guidewire and said access
needle are navigated into the pericardial sack.
101. The system of claim 100, wherein said epicardial pacing
catheter is adapted to be inserted into or around said
guidewire.
102. The system of claim 1, wherein said epicardial pacing catheter
is configured to be used with a sheath, said sheath comprising a
distal portion, proximal portion, and a longitudinal structure
there between, wherein said sheath is adapted for receiving said
epicardial pacing catheter therein.
103. A method for use with an epicardial pacing catheter, said
method comprising: disposing said epicardial pacing catheter in the
middle mediastinum of the thorax of a subject; pacing the heart at
one or more locations with electrical energy from an at least one
electrode; and at least partially insulating the electrical energy
to allow pacing of the heart without damage to adjacent anatomical
structures.
104. The method of claim 103, wherein said disposing comprises a
minimally invasive procedure.
105. The method of claim 103, wherein said disposing comprises a
non-surgical procedure.
106. The device of claim 103, wherein said disposing comprises an
interventional procedure.
107. The method of claim 103, wherein said middle mediastinum
includes the pericardial space.
108. The method of claim 103, wherein said at least one electrode
may be used to stabilize said epicardial pacing catheter.
109. The method of claim 103, wherein said at least one electrode
is deployed.
110. The method of claim 103, further comprising irrigating said
middle mediastinum.
111. The method of claim 110, wherein said irrigating comprises
emitting a fluid, drug, or agent.
112. The method of claim 110, wherein said irrigating comprises
extracting a fluid, drug, or agent.
113. The method of claim 110, wherein said irrigating comprises
both emitting and extracting a fluid, drug, or agent.
114. The method of claim 103, further comprising stabilizing said
epicardial pacing catheter.
115. The method of claim 114, further comprising a at least one
deployable member, wherein said deployable member is used for
stabilizing.
116. The method of claim 115, wherein said at least one deployable
member comprises a screw, hook, or tab.
117. The method of claim 115, wherein said at least one deployable
member comprises a non-conductive material.
118. The method of claim 115, wherein said at least one deployable
member comprises a conductive material.
119. The method of claim 118, wherein said at least one deployable
member is in electrical communication with said at least one
electrode.
120. The method of claim 103, further comprising steering said
epicardial pacing catheter.
121. The method of claim 120, wherein said steering is about at
least one point of curvature.
122. The method of claim 103, further comprising supplying power to
said epicardial pacing catheter.
123. The method of claim 103, further comprising processing data
received from said epicardial pacing catheter.
124. The method of claim 103, further comprising controlling said
at least one electrode.
125. The method of claim 124, wherein said controlling comprises
controllably connecting a control handle to said epicardial pacing
catheter.
126. The method of claim 103, wherein said disposing is carried out
through a puncture of the thorax.
127. The method of claim 126, wherein said puncture comprises a
sub-xiphoid puncture.
128. The method of claim 126, wherein said disposing is carried out
through a pressure probe needle.
129. The method of 128, wherein said pressure probe needle
comprises an access needle.
130. The method of 128, wherein said pressure probe needle
comprises a sensor for sensing pressure in the thorax.
131. The method of claim 103, further comprising inserting an
access needle into the thorax of said subject.
132. The method of claim 131, further comprising inserting a
guidewire into said access needle.
133. The method of claim 132, further comprising inserting a sheath
over said guidewire.
134. The method of claim 133, further comprising inserting said
epicardial pacing catheter into said sheath.
Description
RELATED APPLICATIONS
[0001] The present invention claims priority from U.S. Provisional
Application Ser. No. 60/986,786, filed November, 09, 2007, entitled
"Passive Fixation, Steerable Epicardial Lead to be Placed via the
Subxiphoid Process for Pacing Left Ventricle, Right Ventricle,
Right Atrium and Left Atrium and Cardiac Defibrillation," and U.S.
Provisional Application Ser. No. 61/023,727, filed Jan. 25, 2008,
entitled "Steerable Epicardial Lead to be Placed via the Subxiphoid
Process for Left Ventricular Pacing and Related Method;" the
disclosures of which are hereby incorporated by reference herein in
their entirety.
[0002] This application is related to PCT International Application
No. Serial No. PCT/US2008/056643, filed Mar. 12, 2008, entitled,
"Access Needle Pressure Sensor Device and Method of Use," the
disclosure of which is hereby incorporated by reference herein in
its entirety.
[0003] This application is related to PCT International Application
No. Serial No. PCT/US2008/056816, filed Mar. 13, 2008, entitled,
"Epicardial Ablation Catheter and Method of Use," the disclosure of
which is hereby incorporated by reference herein in its
entirety.
[0004] This application is related to PCT International Application
No. Serial No. PCT/US2008/057626, filed Mar. 20, 2008, entitled,
"Electrode Catheter for Ablation Purposes and Related Method
Thereof," the disclosure of which is hereby incorporated by
reference herein in its entirety.
FIELD OF THE INVENTION
[0005] The present technology relates generally to the field of
medical devices to be used for cardiological procedures. More
specifically, the technology is in the subfield of catheterization
devices to be used for epicardial pacing.
BACKGROUND OF THE INVENTION
[0006] Congestive heart failure effects between 4 and 5 million
people in the United States and accounts for about $15 billion per
year in hospitalization costs alone. While medical therapy, such as
prescription drugs, may benefit a number of patients, side effects
prevent some patients from completing therapy. Moreover, few
patients are completely cured of their symptoms.
[0007] In recent years simultaneous pacing of both ventricles (via
a biventricular pacemaker) has been shown in multiple studies to
improve the quality of life and extend survival of such patients.
The American College of Cardiology and American Heart Association
has, therefore, recommended that all patients having class II, III
or IV heart failure with a wide QRS complex (electrocardiograph
deflections of the Q, R and S waves) receive a biventricular
pacemaker. This recommendation alone encompasses up to one million
people per year in the US, and uses for this type of device are
expanding.
[0008] Unfortunately, due to inherent difficulties in placing left
ventricular (LV) leads, less than 15% of eligible patients are able
to receive this device. Unlike the RV, the electrical lead can not
be placed directly into the LV due to the unacceptably high risk of
stroke. The lead must, therefore, be placed on the surface of the
LV. In order to accomplish this placement, a lead is threaded
through the right atrium (RA) using a venous system, and passed
through the coronary sinus (CS) to any of a number of small veins
in communication with the surface of the LV.
[0009] Quantitative clinical results, especially those reporting
the statistics of negative outcomes, are seldom published. However,
in procedures conducted at the inventors' high volume university
hospital, 20% of patients have been found to have a very difficult
access to the CS, resulting in an abandonment of the procedure. In
an additional 20% of patients, a vein in communication with an
optimal location on the LV can not be found within the CS. As an
example, if one is trying to place a lead on the lateral aspect of
the LV (an ideal location), but there is no vein extending from
within the CS to the lateral aspect of the LV, a lead can not be
placed here. Worse still, many of these patients have multiple
areas of dead heart tissue, so even if a lead can be placed within
a vein, it might not pace the heart. Even moving the lead slightly
would help, but the vein acts like a railroad track to limit
placement. All of these limitations result in an unpredictable
procedure time, making it difficult for hospitals and doctors to
plan the operation.
[0010] At present, the most effective option to pace the LV is
through invasive surgery requiring cardiac surgeons. The newest
techniques allow surgeons to either open a patient's chest or cut
between the ribs to place the lead anywhere on the LV. Even the
most "minimally invasive" leads currently available require a
lateral thoracotomy necessitating a surgeon. Both the Ncontact.RTM.
and Heartlander.RTM. tools, which are not designed to pace, require
surgical incisions.
[0011] There are two significant barriers to widespread application
of these surgical techniques. First, surgical procedures are
generally more invasive and require longer recovery times. Second,
most cardiologists consider it the standard of care to attempt an
initial placement of a lead via CS access; only after that fails is
surgery considered. To avoid the need for additional surgical
intervention, a cardiologist may choose a sub-optimal location for
lead placement. This is typically in keeping with the wishes of
most patients; minimally invasive techniques are preferred whenever
possible.
[0012] There is therefore a need in the art whereby one would be
able to place a lead for pacing on any optimal site of the LV based
solely on what is clinically efficient for the patient and not the
heart's anatomy. Moreover, if this could be accomplished by a
cardiologist (non-surgeon) without the need for invasive surgery,
the procedure would be used more often. Thus, instead of only 15%
of patients receiving biventricular pacing, close to 100% of
patients could receive it.
[0013] The following U.S. patent documents discuss catheterization
tools for cardiology: U.S. Pat. Nos. 7,142,919 to Hine et al.;
7,130,699 to Huff et al.; 7,120,504 to Osypka; 7,101,362 to Vinney;
7,090,637 to Danitz et al.; 7,089,063 to Lesh et al.; 7,059,878 to
Hendrixson et al.; 7,041,099 to Thomas et al.; 7,027,876 to
Casavant et al.; 7,008,418 to Hall et al.; 6,973,352 to Tsutsui et
al.; 6,936,040 to Kramm et al.; 6,921,295 to Sommer et al.;
6,876,885 to Swoyer et al.; 6,868,291 to Bonner et al., all of
which are incorporated by reference herein in their entirety. No
reference discloses the conceptual arrangements for an integrated
cardiological device for epicardial pacing.
[0014] To overcome these limitations, we have conceived the subject
device and method of use, as described in the Summary of the
Invention and Detailed Description of the Drawings below.
[0015] These and other objects, along with advantages and features
of the invention disclosed herein, will be made more apparent from
the description, drawings and claims that follow.
SUMMARY OF THE INVENTION
[0016] An aspect of an embodiment (or partial embodiment thereof)
of the present invention includes an apparatus and means for
treating congestive heart failure and arrhythmias (both
bradycardias and tachycardias) of the heart. For example, the
invention provides for a novel means and method of placing an
epicardial lead within a patient for the purpose of permanent
multi-site, cardiac pacing and defibrillation, including left
ventricular pacing.
[0017] An aspect of an embodiment (or partial embodiment thereof)
of the present invention includes a lead that paces LV, RV, LA and
RA at the same time or in sequence. It could even pace two separate
points on the same chamber (the LV or the RV) at the same time or
at some offset. This has an important advantage, for example, if a
region of tissue ever dies in heart attack, the present invention
method can still pace from elsewhere.
[0018] An aspect of an embodiment (or partial embodiment thereof)
of the present invention may include placing a bipolar pacing lead
through a subxiphoid incision and then channeling it back to a
pacemaker. The procedure may evolve through three distinct stages.
In the earliest stage, one would place the lead on the left
ventricle and tunnel it underneath the pectoral muscle back to the
chest wall where the pacemaker would normally be placed. In the
second, one would place the lead back to the subxiphoid process,
attach it to a battery that is positioned just on the outside of
the xiphoid process and have it wirelessly communicate with the
main pacemaker. Lastly one would place a button-like object right
on the top of the left ventricle and then communicate wirelessly
back to the main pacemaker. Still yet, another embodiment of the
means and method of the invention may include having the battery,
anode and cathode means all compounded on the end of the lead so
that there would not be any need to have another excision to bring
any of the components back out of the heart.
[0019] An aspect of an embodiment or partial embodiment of the
present invention (or combinations of various embodiments in whole
or in part of the present invention) comprises an epicardial pacing
system. The system may comprise: an epicardial catheter configured
to be disposed in the middle mediastinum of the thorax of a subject
for use in electrical pacing of the heart at one or more locations
on the epicardial surface. The epicardial pacing catheter
comprising: a proximal portion, distal portion, and a longitudinal
structure there between; and at least one electrode in
communication with the distal portion, wherein the at least one
electrode is insulated on at least one side to allow pacing of the
heart without damage to adjacent anatomical structures.
[0020] An aspect of an embodiment or partial embodiment of the
present invention (or combinations of various embodiments in whole
or in part of the present invention) comprises a method for use
with an epicardial pacing catheter. The method may comprise:
disposing the epicardial pacing catheter in the middle mediastinum
of the thorax of a subject; and pacing the heart at one or more
locations with electrical energy from an at least one electrode;
and at least partially insulating the electrical energy to allow
pacing of the heart without damage to adjacent anatomical
structures.
[0021] The epicardial pacing system and related method includes an
epicardial catheter configured to be disposed in the middle
mediastinum of the thorax of a subject for use in electrical pacing
(and/or other diagnostic or therapeutic procedure) of the heart at
one or more locations on the epicardial surface. The epicardial
pacing catheter may include at least one electrode whereby the
electrode is insulated on at least one side to allow pacing of the
heart without damage to adjacent anatomical structures.
[0022] These and other objects, along with advantages and features
of the invention disclosed herein, will be made more apparent from
the description, drawings and claims that follow.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] The accompanying drawings, which are incorporated into and
form a part of the instant specification, illustrate several
aspects and embodiments of the present invention and, together with
the description herein, serve to explain the principles of the
invention. The drawings are provided only for the purpose of
illustrating select embodiments of the invention and are not to be
construed as limiting the invention.
[0024] FIG. 1 schematically illustrates the overall configuration
of the epicardial pacing catheter system.
[0025] FIG. 2 schematically illustrates the pericardium and heart
alone (FIG. 2(A)) and an example embodiment in position relative to
the heart (FIG. 2(B)).
[0026] FIG. 3 schematically illustrates an example embodiment
passively disposed within the pericardial sack of the heart.
[0027] FIGS. 4(A)-(C) schematically illustrate a number of
exemplary embodiments of the steering means employed to position
the distal portion of an exemplary embodiment of the epicardial
pacing catheter in un-tensioned, partial steering, and full
steering modes, respectively.
[0028] FIGS. 5(A)-5(D) schematically illustrate a number of
exemplary embodiments of the epicardial pacing catheter 10 near the
distal portion.
[0029] FIGS. 6(A)-6(F) schematically illustrate cross sectional
views of an exemplary embodiment of the technology from the most
distal end to a more proximal point.
[0030] FIGS. 7(A) and (B) schematically illustrate cross sectional
views of an exemplary embodiment of the most proximal portion of an
exemplary embodiment of the epicardial pacing catheter and the most
distal portion of an exemplary embodiment of the control means,
respectively.
[0031] FIGS. 8(A)-(C) schematically illustrate cross-sectional
views of an example embodiment further comprising a stabilization
means for stabilizing the example embodiment. The stabilization
means illustrated in an un-deployed position, partially deployed
position, and deployed position, respectively.
[0032] FIG. 9 schematically illustrates an example embodiment of
the epicardial pacing catheter further comprising deployable
electrodes fixed or adjacent to the heart.
[0033] FIG. 10(A) schematically illustrates a top view of an
exemplary embodiment of the epicardial pacing catheter.
[0034] FIG. 10(B) schematically illustrates a bottom view of an
exemplary embodiment of the epicardial pacing catheter.
[0035] FIG. 10(C) schematically illustrates an axial view of an
exemplary embodiment of the epicardial pacing catheter looking at
the distal tip of the insulating hood.
[0036] FIG. 10(D) schematically illustrates a perspective view of
an exemplary embodiment of the epicardial pacing catheter.
[0037] FIG. 11(A)-11(E) schematically illustrate cross sectional
views of an exemplary embodiment of the epicardial pacing catheter
from a point located proximal to the at least one electrode and
distal to the distal point of curvature to a point located at the
most proximal point of the epicardial pacing catheter. FIG. 11(F)
schematically illustrates a cross sectional view of an exemplary
embodiment of the control handle at the most distal point.
[0038] FIG. 12(A) schematically illustrates a cross section of an
exemplary embodiment of the epicardial pacing catheter comprising a
deployable anode and cathode in an un-deployed state.
[0039] FIG. 12(B) schematically illustrates a cross section of an
exemplary embodiment of the epicardial pacing catheter comprising a
deployable anode and cathode in a fully-deployed state.
[0040] FIG. 13(A) schematically illustrates a cross section of an
exemplary embodiment of the epicardial pacing catheter comprising a
deployable screw or the like in an un-deployed state.
[0041] FIG. 13(B) schematically illustrates a cross section of an
exemplary embodiment of the epicardial pacing catheter comprising a
deployable screw or the like in a fully-deployed state.
[0042] FIG. 14(A) schematically illustrates a cross section of an
exemplary embodiment of the epicardial pacing catheter comprising a
deployable anode and cathode in an un-deployed state.
[0043] FIG. 14(B) schematically illustrates a cross section of an
exemplary embodiment of the epicardial pacing catheter comprising a
deployable anode and cathode in a fully-deployed state.
[0044] FIG. 15(A) schematically illustrates an example embodiment
of an external control handle.
[0045] FIG. 15(B) schematically illustrates an example embodiment
of the proximal steering control means or a least part of the
steering control means integral to the control handle.
[0046] FIG. 15(C) schematically illustrates an example embodiment
wherein the proximal steering control means or a least part of the
steering control means integral to the control handle has been
activated.
DETAILED DESCRIPTION OF THE DRAWINGS
[0047] The following detailed description is of the best presently
contemplated modes of carrying out the invention. This description
to be taken in a limiting sense, but is made merely for the purpose
of illustrating general principles of embodiments of the
invention.
[0048] FIG. 1 schematically illustrates an overview of an exemplary
embodiment of the epicardial pacing system 5 comprising an
epicardial pacing catheter 10 in communication with at least one
electrode 43, a control means or control handle 150, an interface
member 162, a processor 164 or computer, power supply 166 or
battery, or voice control instrumentation/system 168.
[0049] The control means 150 may be in communication with the
proximal portion of the catheter 10, wherein the control means 150
is controllably connected to at least one electrode 43. In one
embodiment, the control means may be a control handle or controller
as desired or required. In another embodiment, the control handle
(or control means) may be removable. The epicardial pacing catheter
10 may further comprises a processor 164 or computer. The processor
164 may be in communication with said epicardial pacing catheter 10
and system. The processor 164 may be located at or near the
patient's shoulder, for example. The epicardial pacing catheter 10
further comprises an interface member 162 in communication with
said epicardial pacing catheter 10. The interface member 162 may be
in remote and/or local communication with the processor 164, pacing
system 5, catheter 10, controller 150, power supply 166, and/or
voice control instrumentation to provide information to and/or from
a patient, physician, technician, or a clinician. Further, any of
the components and systems illustrated in FIG. 1 may be in
communication with each other, as well as other systems, computers,
devices, printers, displays, PDAs, networks, memory storage, and
voice control instrumentations as desired or required.
[0050] As discussed, the epicardial pacing system 5 may comprise a
power supply 166. The power supply 166 may comprise a small battery
located at the subxiphoid area, preferably of a silicone
silver-gallium kind designed specifically for use in implantable
cardiac defibrillators (ICDs). The power characteristics of the
particular battery may be such that it can maintain the same
voltage for a long period of time before falling off suddenly.
[0051] The epicardial pacing system 5 and epicardial pacing
catheter 10 may further comprise a wireless communication system,
wherein the processor 164, power supply 166, voice control
instrumentation 168, interface member 162 or desired components of
the system 5 may be wirelessly connected to one another. In another
embodiment, the battery and processor 164 are both located in the
subxiphoid area.
[0052] It should be appreciated that any of the components or
modules referred to with regards to any of the present technology
embodiments discussed herein, may be integrally or separately
formed with one another. Further, redundant functions or structures
of the components or modules may be implemented. Moreover, the
various components may be communicated locally and/or remotely with
any user/clinician/patient or machine/system/computer/processor.
Moreover, the various components may be in communication via
wireless and/or hardwire or other desirable and available
communication means, systems and hardwares.
[0053] Next, as will be illustrated in Figures that follow, the
epicardial pacing catheter 10 in accordance with the present
technology may comprise a proximal portion, a distal portion, and a
longitudinal structure there between. It should be appreciated that
the distal portion may be considered at the distal end tip of the
epicardial pacing catheter 10; or a portion or segment at or in the
vicinity of the distal end tip of the epicardial pacing catheter 10
or a portion or segment leading up to (or partially up to but not
all the way up to) the distal end of the catheter 10 as desired or
required. The length and location of the distal portion may vary as
desired or required in order to practice the technology according
to medical procedures and anatomical considerations.
[0054] It should also be appreciated that the proximal portion may
be considered the tip of the beginning of the catheter 10; or a
portion or segment at or in the vicinity of the proximal end of the
catheter 10 or a portion or segment leading up to (or partially up
to but not all the way up to) the proximal end of the catheter 10
as desired or required. The length and location of the proximal
portion may vary as desired or required in order to practice the
technology according to medical procedures and anatomical
considerations.
[0055] The proximal portion, distal portion and longitudinal
structure there between may be integrally formed from a
biocompatible material having requisite strength and flexibility
for deployment within a patient. The proximal portion, distal
portion, and longitudinal structure there between may have a
lubricious outer surface comprising a material having a low
coefficient of friction, such as, but not limited to, silicone,
polyurethane, or Teflon, or combination thereof. The proximal
portion, distal portion, and longitudinal structure there between
may further have an outer surface comprising a drug eluting surface
and/or a surface impregnated with sirilimus to prevent the
production of fibrosis within a patient. The longitudinal structure
may be between about 15 cm and about 100 cm in length, and between
about 2 mm and about 6 mm in diameter. It should be appreciated
that the length of the longitudinal structure may be longer or
shorter as may be desired or required according to medical
procedures, device/system operations and anatomical considerations.
The cross section of the longitudinal structure comprises an oval,
circle, ellipse, polygon, or semi-circular shape. The longitudinal
structure may be any one of: lumen, conduit, channel, passage, pip,
tunnel or bounded tubular surface.
[0056] The epicardial pacing catheter 10 further comprises at least
one electrode 43 in communication with the distal portion, wherein
the at least one electrode 43 is insulated on at least one side to
allow pacing of the heart without damage to adjacent
structures.
[0057] The at least one electrode 43 may be constructed of
platinum, gold, silver, iridium, or any alloy thereof, or other
conducting materials known in the art. The at least one electrode
43 may comprise a roughened, profiled, or otherwise prepared
surface to increase the total surface area for energy transmission.
The at least one electrode 43 may be semi-cylindrical or arc-like
in shape, and may be contoured to be compatible with proximate
anatomical structures. The at least one electrode 43 may be between
about 0.3 mm and about 4 mm in length, and may be spaced between
about 1 mm and about 25 mm from each other. Further, the at least
one electrode 43 may be a pair of electrodes, commonly referred to
as an anode and cathode in the art. Finally, the at least one
electrode 43 may be deployable. It should be appreciated that the
length of the electrodes may be longer or shorter as may be desired
or required according to medical procedures, device/system
operations and anatomical considerations.
[0058] It should be appreciated that the various sheaths, catheters
and guidewires, or any related components disclosed herein, may
have a circular or oval-shaped cross-section or various
combinations thereof. Further, it should be appreciated that
various sheaths, catheters and guidewires, or any related
components disclosed herein may have any variety of cross sections
as desired or required for the medical procedure or anatomy.
[0059] Moreover, it should be appreciated that any of the
components or modules referred to with regards to any of the
present invention embodiments discussed herein, may be a variety of
materials and/or composites as necessary or required. Still
further, it should be appreciated that any of the components or
modules (or combination thereof) may provide shape, size and volume
contoured by adjusting its geometry and flexibility/rigidity
according to the target location or anatomy (or region, including
structure and morphology of any location) being treated.
[0060] FIG. 2(A) schematically illustrates the pericardium and
heart alone. The pericardium 22 is shown in close proximity to the
epicardium 23.
[0061] FIG. 2(B) schematically illustrates three contiguous
sections of an example embodiment implanted around the heart 21.
The epicardial pacing catheter 10 of the epicardial pacing system 5
is positioned in the pericardial space, cavity or sack 24, or the
area between the pericardium 22 and epicardium 23. All of the
electrodes 43 are facing the heart 21. The epicardial pacing
catheter 10 further comprises outward facing bumper tabs 31 and
inward facing friction tabs 32 to stabilize the epicardial pacing
catheter 10 from moving within the pericardial sack 24, once it is
implanted.
[0062] Although not shown, an aspect of an embodiment of the
present technology may be implemented with an access needle
(introducer needle), conduit or the like. The access needle or
conduit is adapted to be inserted into the epicardial region or
other body part or body space so as to provide an access or
guideway for the epicardial pacing catheter 10. An example of an
access system is disclosed in PCT International Application No.
Serial No. PCT/US2008/056643, filed Mar. 12, 2008, entitled,
"Access Needle Pressure Sensor Device and Method of Use," of which
is hereby incorporated by reference herein in its entirety. See for
example, but not limited thereto, FIGS. 2 and 5 of the '056643 PCT
Application. The access needle sensor device or the like serves as
a guideway for introducing other devices into the pericardium 22,
for instance, sheath catheters that might subsequently be employed
for procedures within the pericardium 22 or other applicable
regions, space or anatomy. Other devices that the access device may
accommodate with the practice of this invention include, but are
not limited thereto, the following: ablation catheters, guide
wires, other catheters, visualization and recording devices, drugs,
and drug delivery devices, lumens, steering devices or systems,
drug or cell delivery catheters, fiber endoscopes, suctioning
devices, irrigation devices, electrode catheters, needles, optical
fiber sensors, sources of illumination, vital signs sensors, and
the like. These devices may be deployed for procedures in an
integral body part or space.
[0063] It should be appreciated that any data, feedback, readings,
or communication from the system (for example, catheters, access
needles, sensors, systems, etc.) may be received by the user,
clinician, physician, or technician or the like by visual graphics,
audible signals (such as voice or tones, for example) or any
combination thereof. Additionally, the data, feedback, or
communication may be reduced to hard copy (e.g., paper) or computer
storage medium. It should be appreciated that the pressure related
readings and data may be transmitted not only locally, but remotely
as well.
[0064] Moreover, an aspect of the invention may be in the field of
voice control over medical systems and devices of use in
specialized electrophysiology procedures that employ subxiphoid
access for the purpose of navigating an interventional or surgical
probe onto the epicardial surface of the heart, via pericardial
transit. In its most particular form, the invention may be in the
specialized category of voice control over instruments and systems
that measure the intrathoracic and intrapericardial pressures
during the process of navigating said intrathoracic or surgical
probe within the patient following subxiphoid insertion.
[0065] An aspect of an embodiment or partial embodiment of the
subject invention (or combinations of various embodiments in whole
or in part of the present invention) is one of providing the
working electrophysiologist with a means and method for controlling
the operational parameters (e.g., the display functions) of
diagnostic and therapeutic cardiological equipment by voice, thus
eliminating either the need to temporarily take their hands off the
patient or the need to have an additional EP Lab technician
available to perform such tasks. (Such personnel are often needed
to insure that the clinician need never touch anything outside the
sterile field.). Generally, examples of voice control
instrumentation that teach applications in medical applications but
not in electrophysiological approaches to cardiological problems
include U.S. Pat. Nos. 7,286,992; 7,259,906; 7,247,139; 6,968,223;
6,278,975; 5,970,457; 5,812,978; 5,544,654 and 5,335,313, all of
which are hereby incorporated by reference in their entirety.
[0066] Additionally, present invention system and method may
further comprise imaging said the access needle and the epicardial
pacing system (and components thereof) with at least one of
magnetic resonance imaging, computed tomography, fluoroscopy, or
other radiological modalities. In some embodiments, readings are
provided from said sensing of pressure for navigating said needle
access and the epicardial pacing system (and components
thereof).
[0067] Although not shown, as mentioned above, the deploying of the
epicardial pacing catheter 10 into the pericardial sack 24 may be
minimally invasive, non-surgical, and/or interventional. The
deploying of the epicardial pacing catheter 10 may be performed by
a non-surgeon and/or cardiologist through use of an access needle
and subsequent passage of a guidewire. The access needle may first
be inserted through the chest and into the pericardium 22, with the
guidewire then put in place. The epicardial pacing catheter 10 may
then be coaxially slid over the guidewire to access the pericardial
sack 24.
[0068] Although not shown and involving another approach, the
insertion of a sheath into the pericardial sack 24 may be aided by
the use of an access needle and subsequent passage of a guidewire.
The access needle may first be inserted into the epicardium, with
the guidewire then put in place. The sheath may then be coaxially
slid over the guidewire to access the pericardial sack 24. After
positioning the sheath in the desired location, the epicardial
pacing catheter 10 may then be inserted through the sheath to reach
the epicardium 23.
[0069] For example, the guideway provides coaxial alignment for the
at least one of guide wire, sheath or catheter, which can be inside
or outside the needle. The at least one guide wire, sheath, or
catheter can also be coaxially aligned with one another. Further,
multiple lumens may be implement and configured between the
plurality of distal apertures and plurality proximal apertures. It
should be appreciated that coaxial alignment does not need to be
exact, but rather one conduit, lumen, sheath, or guidewire slid
outside or inside of another.
[0070] For example, with the present technology, an epicardial
access needle-stick may be implemented in the subxiphoid area of
the chest and the epicardial pacing catheter 10 only need be
advanced a short distance to get to the heart 21. However, it may
immediately be steered though an acute angle to avoid the heart
itself Because of this, aspects of the present invention devices
and those used in conventional techniques can be contrasted. For
instance, conventional endocardial catheters may typically be up to
100 cm in length or longer since they must go from the shoulder to
the heart, while an embodiment of the present technology could be,
for example, about 20 cm or less since it may only need to go from
the chest to the heart. It should be appreciated that the length
may be greater than about 20 cm as well. It should be appreciated
that the length of the present invention catheter may be longer or
shorter as may be desired or required according to medical
procedures, device/system operations and anatomical
considerations.
[0071] It should be appreciated that as discussed herein, a subject
may be a human or any animal. It should be appreciated that an
animal may be a variety of any applicable type, including, but not
limited thereto, mammal, veterinarian animal, livestock animal or
pet type animal, etc. As an example, the animal may be a laboratory
animal specifically selected to have certain characteristics
similar to a human (e.g. rat, dog, pig, monkey), etc. It should be
appreciated that the subject may be any applicable human
patient.
[0072] FIG. 3 schematically illustrates an example embodiment of
the epicardial pacing catheter 10 of the epicardial pacing system 5
passively disposed within the pericardial sack 24 (shown with hash
marks) of the heart 21. A cross section of the heart is shown,
revealing critical internal structures, including various great
vessels. The epicardial pacing catheter 10 may be used to pace the
left ventricle, right ventricle, right atrium, and left atrium. It
should be appreciated that the present technology may be used to
pace the left ventricle, left atrium, right atrium, right ventricle
and/or any combination thereof. The epicardial pacing catheter 10
may first be inserted into the pericardium 22 at the insertion
point 33, which may be located at an anterior portion (towards the
sternum) of the pericardium 22, adjacent to the left ventricle. The
catheter is then advanced posteriorly (towards the spine) within
the pericardial sack 24 towards the left atrium, right atrium and
transverse sinus. The catheter is further advanced around the
posterior of the heart, and pushed anteriorly toward the right
ventricle. Once the catheter is in contact with the left ventricle,
right ventricle, right atrium and left atrium, a deployable
stabilization means may be deployed. Both outward facing bumper
tabs 31 and inward facing friction tabs 32 are shown, and prevent
the catheter from moving or slipping. The inward facing friction
tabs 32 may interact with the outside wall of structures such as,
but not limited to, the transverse sinus, superior vena cava, right
inferior pulmonary vein, and the right superior pulmonary vein to
prevent the catheter from dislodging. The outward facing bumper
tabs 31 may push on the pericardium to further secure the catheter
10 against the epicardium (for example, as shown in FIG. 2).
[0073] FIGS. 4(A)-(C) provide schematic illustrations of some of
the operational aspects of an exemplary embodiment of the steering
means, system or device associated with the epicardial pacing
catheter 10 of the epicardial pacing system. The epicardial pacing
catheter 10 further comprises a distal steering means (not shown)
and a proximal steering means (not shown) which may have the
steering characteristics taught by Mahapatra et al. in PCT
International Application No. PCT/US2008/056816, filed Mar. 13,
2008, entitled, "Epicardial Ablation Catheter and Method of Use,"
hereby incorporated by reference herein in its entirety. The
steering means may comprise guidewires, tensioning lines, pull
strings, digitating distal tips, magnetic guidance means, wires,
rods, chains, bands, chords, ropes, string tubes, filaments,
threads, fibers, strands, other extended elements, or any other
method known in the art.
[0074] For instance, referring to FIGS. 4(A)-(C) of '056816 PCT
International Application, there is provided the mechanism of
action for obtaining bi-directional steering of the distal tip or
portion that may be implemented for the present invention via
tensioning or steering means whereby the tip or end is straight,
towards the left, and towards the right, respectively.
[0075] Moreover, for instance and referring to FIGS. 7(A)-7(B) of
'056816 PCT International Application there is provided some
details of an exemplary mechanism of action for directional
steering of the proximal segment of the device that may be
implemented for the present technology.
[0076] Steering adjustments are made along the proximal point of
curvature 42 and distal point of curvature 41 using the proximal
steering means (as shown in FIG. 15(B)) and distal steering means
(not shown) respectively. The proximal point of curvature 42 may be
located between about 1 cm and about 25 cm from the proximal end
and the distal point of curvature 41 may be located between about 1
cm and about 20 cm from the distal end. It should be appreciated
that the proximal and distal points of curvature may be located at
other longer or shorter points and may be implemented as may be
desired or required according to medical procedures, device/system
operations and anatomical considerations. The steering means are
used to direct the epicardial pacing catheter 10 through or
navigate it within a patient's body. It should be noted that, while
two steering means and points of curvature are shown, the
epicardial pacing catheter 10 may further comprise a third and
fourth steering means for steering the epicardial pacing catheter
10 around a third and fourth point of curvature. Moreover, though a
bi-directional distal point of curvature 41 is shown, it should be
appreciated that all points of curvature may be uni-directional,
bi-direction, tri-direction, quadra-directional, or greater than
quadra-directional.
[0077] Specifically, FIG. 4(A) shows an embodiment of the
epicardial pacing catheter 10 in the non-deflected state. FIG. 4(B)
shows the epicardial pacing catheter 10 in a partially-deflected
state. FIG. 4(C) shows the epicardial pacing catheter 10 in a
fully-deflected state, as would be the case when it has been
navigated into the pericardial space of a subject's heart, or other
space or structure. In the fully-deflected state, the at least one
electrode 43 is held against a patient's heart by the stabilization
means, shown as the inward facing friction tabs 32 and outward
facing bumper tabs 31.
[0078] The devices, systems, compositions and methods of various
embodiments of the invention disclosed herein may utilize aspects
disclosed in the following references, applications, publications
and patents. Similarly, the steering means, actuator means (as will
be discussed below) and navigation means of the various embodiments
of the invention disclosed herein may utilize aspects disclosed in
the following references, applications, publications and patents,
and which are hereby incorporated by reference herein in their
entirety: [0079] 1. U.S. Patent Application Publication No.
20050251094, Nov. 10, 2005, "System and method for accessing the
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Eric D. [0080] 2. U.S. Patent Application Publication No.
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coronary sinus to facilitate insertion of pacing leads", Peterson,
Eric D. [0081] 3. U.S. Pat. No. 6,928,313, Aug. 9, 2005, "System
and method for accessing the coronary sinus to facilitate insertion
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"Guiding catheter assembly for embolic protection by proximal
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proximal articulation and pre-formed distal end", Simpson, John A.,
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20070016068, Jan. 18, 2007, "Ultrasound methods of positioning
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Patent Application Publication No. 20070016072, "Endovenous access
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sinus access catheter with forward-imaging", Amundson, David, et
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"Catheter/guide wire steering apparatus and method", Jacobsen,
Stephen C., et al. [0116] 36. U.S. Patent Application Publication
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"Stent delivery system and method of use", Hall, Todd A., et al.
[0118] 38. U.S. Patent Application Publication No. 20050027243,
Feb. 3, 2005, "Steerable catheter", Gibson, Charles A. [0119] 39.
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[0123] FIGS. 5(A)-5(D) schematically illustrate a number of
embodiments of the epicardial pacing catheter 10 of the epicardial
pacing system near the distal portion.
[0124] FIG. 5(A) schematically illustrates an exemplary embodiment
wherein the epicardial pacing catheter 10 may be used to pace the
left ventricle (LV) of a patient's heart. A number of electrodes 43
are adapted to transmit electrical energy to the left ventricle,
and are shown facing the left ventricle. The number of electrodes
43 may vary depending on the number of locations required or
desired to be paced. The electrodes 43 may be insulated on at least
one side away from the heart, as to prevent electrical energy from
being transmitted to proximate anatomical structures. The
insulation may be about 2 mm thick, and may extend longitudinally
through the epicardial pacing catheter 10. It should be appreciated
that the thickness may be wider or narrower as desired or required
according to medical procedures, device/system operations and
anatomical considerations. Further, the insulation may comprise
Teflon, silicone, polyurethane, and/or any combination thereof or
any other non-conductive material known in the art.
[0125] Outward facing bumper tabs 31 are deployable, and are used
to stabilize the epicardial pacing catheter 10 by pushing against
the pericardium. As shown, the outward facing bumper tabs 31 are in
the non-deployed state as to allow the epicardial pacing catheter
10 to move within the pericardium. Although not shown, the
epicardial pacing catheter may further comprise inward facing
friction tabs 32 or other stabilization means.
[0126] The epicardial pacing catheter 10 further comprises a distal
tip 51 in communication with the epicardial pacing catheter 10. The
distal tip 51 extends from the body of the catheter 10 and may
further insulate the electrodes 43 from proximate anatomical
structures and/or be used to push through harder anatomical
structures and adhesions as desired or required.
[0127] FIG. 5(B) schematically illustrates an exemplary embodiment
wherein the epicardial pacing catheter 10 may be used to pace the
left ventricle (LV) and left atrium (LA) of a patient's heart.
Additional electrodes 43 near the distal point of curvature 41 are
shown. These electrodes 43 may be in communication with the outside
wall of the left atrium in order to pace said structure. Additional
outward facing bumper tabs 31 are present to press against the
pericardium in more distal locations. Inward facing friction tabs
32 are now shown. The inward facing friction tabs 32 may be
deployed to catch, drag, stick to, or pull on adjacent anatomical
structures to keep the epicardial pacing catheter 10 from moving.
FIG. 5(B) shows an example embodiment wherein both the inward
facing friction tabs 32 and outward facing bumper tabs 33 are in
the non-deployed state to allow movement of the catheter 10.
[0128] FIG. 5(C) schematically illustrates an exemplary embodiment
wherein the epicardial pacing catheter 10 may be used to pace the
left ventricle (LV), left atrium (LA), and right atrium (RA).
Additional electrodes 43 are located near the distal point of
curvature 41. These electrodes 43 may be in communication with the
outside wall of the right atrium in order to pace said structure.
Further, additional outward facing bumper tabs 31 are present to
press against the pericardium in more distal locations.
[0129] FIG. 5(D) shows an example embodiment wherein the epicardial
pacing catheter 10 may be used to pace multiple points on the left
ventricle (LV), left atrium (LA), right atrium (RA), and right
ventricle (RV). Additional electrodes 43 are shown in a more distal
location in order to transmit electrical energy to the right
ventricle. Further, additional inward facing bumper tabs 32 are
present to catch, drag, stick to, or pull on adjacent anatomical
structures to keep the epicardial pacing catheter 10 from
moving.
[0130] It should be appreciated that in FIGS. 5(A)-5(D) both the
number of inward facing friction tabs 32 and outward facing bumper
tabs 31 may vary as desired or required to stabilize the epicardial
pacing catheter 10. Moreover, inward facing friction tabs 32 may be
located proximal or distal to any outward facing bumper tab 31.
Further, outward facing bumper tabs 31 may be located proximal or
distal to any inward facing friction tab 32. Further, outward
facing bumper tabs 31 and inward facing friction tabs 32 may be
positioned at the same location on the epicardial pacing catheter
10 as desired or required.
[0131] It should be appreciated that in FIGS. 5(A)-5(D) any number
of electrodes 43 may be present as desired or required to pace a
number of locations on the heart of a patient. Moreover, each
electrode 43 could be turned on separately in a unipolar or bipolar
fashion, allowing for pacing of different chambers and different
parts of the same chamber at different times. This has an important
advantage: if a region of tissue ever dies in heart attack, pacing
can be accomplished from a different location.
[0132] It should be appreciated that the inward facing friction
tabs and outward facing bumper tabs may be alternated with one
another, be staggered with one another, or grouped in numbers among
each other as desired or required according to medical procedures,
device/system operations and anatomical considerations.
[0133] FIGS. 6(A)-6(F) schematically illustrate cross sectional
views of an exemplary embodiment of the epicardial pacing catheter
10 of the epicardial pacing system from the most distal end to a
more proximal point.
[0134] FIG. 6(A) schematically illustrates a cross sectional view
of an exemplary embodiment of the most distal portion of the
epicardial pacing catheter 10 of the epicardial pacing system. The
epicardial pacing catheter 10 further comprises a fluid lumen 61.
The fluid lumen occupies internal cross-sectional area of the
epicardial pacing catheter 10. The fluid lumen 61 may extend from
an aperture (not shown) in the proximal end of the catheter 10 to a
distal fluid aperture 55. Both the distal fluid aperture 55 and a
proximal fluid aperture (not shown) are adapted for the emitting
and extracting of a fluid, drug, or agent. The fluid, drug, or
agent may be used, but is not necessarily used, to cool the
electrodes 43, regulate heart activity, or distend proximal
anatomical structures. The proximal fluid aperture (not shown) is
connected to an external fluid, drug, or agent source (not shown).
The emitting and extracting of a fluid, drug, or agent may be
controlled by an external control handle 150 (as shown, for
example, in FIG. 15) in communication with the proximal end and
fluid, drug, or agent source. It should be appreciated that the
fluid, drug, or agent to flow through the epicardial pacing
catheter 10 may be at least one of the following: agent, substance,
material, saline solutions, thrombolytic agents, clot lysis agents,
chemotherapies, cell slurries, gene therapy vectors, growth
factors, contrast agents, angiogenesis factors, radionuclide
slurries, anti-infection agents, anti-tumor compounds,
receptor-bound agents and/or other types of drugs, therapeutic
agent and/or diagnostic agent or any combination thereof.
[0135] FIG. 6(B) schematically illustrates a more proximal cross
section of an example embodiment of the epicardial pacing catheter
10 of the epicardial pacing system located proximal to the distal
point of curvature 41. Both the first distal steering pull-wire 68
and second distal steering pull-wire 69 occupy internal
cross-sectional area of the epicardial pacing catheter 10 and
extend longitudinally to the most proximal portion of said catheter
10. The first distal steering pull-wire 68 and second distal
steering pull-wire 69 may be controllably connected to a control
means (as shown, for example, in FIG. 15) in communication with the
proximal portion of the epicardial pacing catheter 10.
[0136] The epicardial pacing catheter 10 may further comprise a
stabilization means. The stabilization means may be deployable and
may comprise an inward facing friction tab 32, an outward facing
bumper tab 31, a non-deployable protrusion, a screw, a hook, or
other means known in the art.
[0137] In an example embodiment, a tab deployment rod 64 extends
longitudinally from the most proximal portion of the epicardial
pacing lead 10 to the most distal inward facing friction tab 32 or
outward facing bumper tab 31. The tab deployment rod 64 may be a
longitudinal structure, such as, but not limited to, a push-rod,
pull-rod, wire, string, or rope. The tab deployment rod 64 made be
made of a non-conductive material having high tensile strength as
is known in the art. The tab deployment rod 64 may further be
controllably connected to a control means (as shown, for example,
in FIG. 15) in communication with the epicardial pacing catheter
10, said control means used to control the deployment of the
stabilization means. Further, the tab deployment rod 64 is in
communication with a number of tab deployment arms 65, wherein each
tab deployment arm 65 can be actuated to deploy the inward facing
friction tab 32 or outward facing bumper tab 31.
[0138] FIG. 6(C) schematically illustrates a more proximal cross
section of an exemplary embodiment of the epicardial pacing
catheter 10 of the epicardial pacing system. The anode wire 62
extends longitudinally from the most proximal portion of the
epicardial pacing catheter 10 to the most distal anode 63. The
anode wire 62 may be in communication with one or more anodes 63
located throughout the epicardial pacing catheter 10. Further, the
anode wire 62 is adapted for transmitting and receiving electrical
energy. The anode wire 62 may be controllably connected to a
control means (as shown, for example, in FIG. 15) in communication
with the proximal portion of the epicardial pacing catheter 10.
[0139] An outward facing bumper tab 31 is shown in communication
with the epicardial pacing catheter 10. The outward facing bumper
tab 31 may be deployed by a tab deployment arm 65 in communication
with the tab deployment rod 64.
[0140] FIG. 6(D) schematically illustrates a more proximal cross
section of an exemplary embodiment of the epicardial pacing
catheter 10 of the epicardial pacing system located proximal to the
proximal point of curvature 42. The epicardial pacing catheter 10
further comprises a second steering means. The second steering
means comprises a first proximal steering pull-wire 70 and a second
proximal steering pull-wire 71. Both the first proximal steering
pull-wire 70 and second proximal steering pull-wire 71 occupy
internal cross-sectional area of the epicardial pacing catheter 10
and extend longitudinally to the most proximal portion of said
catheter 10. The first proximal steering pull-wire 70 and second
proximal steering pull-wire 71 may be controllably connected to a
control means (as shown, for example, in FIG. 15) in communication
the proximal portion of the epicardial pacing catheter 10.
[0141] FIG. 6(E) schematically illustrates a more proximal cross
section of an example embodiment of the epicardial pacing catheter
10 of the epicardial pacing system. A cathode wire 66 extends
longitudinally from the most proximal portion of the epicardial
pacing catheter 10 to the most distal cathode 67. The cathode wire
66 may be in communication with one or more cathodes 67 located
throughout the epicardial pacing catheter 10. Further, the cathode
wire 66 is adapted for transmitting and receiving electrical
energy. The cathode wire 66 may be controllably connected to a
control means (as shown, for example, in FIG. 15) in communication
with the proximal portion of the epicardial pacing catheter 10.
[0142] FIG. 6(F) schematically illustrates a more proximal cross
section of an example embodiment of the epicardial pacing catheter
10 of the epicardial pacing system. An outward facing bumper tab 31
is shown in communication with the epicardial pacing catheter 10.
The outward facing bumper tab 31 may be deployed by a tab
deployment arm 65 in communication with a tab deployment rod 64. It
should be appreciated that the number of port holes, lumens, wires
or rods may vary as may be desired or required according to medical
procedures, device/system operations and anatomical
considerations.
[0143] FIGS. 7(A) and 7(B) schematically illustrate a cross
sectional view of an exemplary embodiment of the proximal end 73 of
the epicardial pacing catheter 10 of the epicardial pacing system
and the most distal end 74 of the control means 150 respectively.
In FIG. 7(A), twelve electrode wires, including six anode wires 62
and six cathode wires 66, occupy internal cross-sectional area of
the epicardial pacing catheter 10. Each anode wire 62 and cathode
wire 66 extends longitudinally through the epicardial pacing
catheter 10 towards the distal portion. The cathode wire 66 may be
in communication with one or more cathodes 67 located throughout
the epicardial pacing catheter 10. The anode wire 62 may be in
communication with one or more anodes 63 located throughout the
epicardial pacing catheter 10.
[0144] It should be appreciated that any number of electrodes 43,
otherwise known as anodes 63 and cathodes 67, may be present as
desired or required to pace a number of locations on the heart of a
patient. A single anode wire 62 may be used to provide electrical
energy to a multitude of anodes 63, or each anode wire 62 can
provide electrical energy to a single anode 63. A single cathode
wire 66 may be used to provide electrical energy to a multitude of
cathodes 67, or each cathode wire 66 can provide electrical energy
to a single cathode 67. Moreover, electrical energy can be
transmitted to each electrode 43 separately in a unipolar or
bipolar fashion, allowing for pacing of different chambers and
different parts of the same chamber at different times.
[0145] Further, a first proximal steering pull-wire 70, first
distal steering pull-wire 68, second proximal steering pull-wire
71, and second distal steering pull-wire 69 occupy internal
cross-sectional area of the epicardial pacing catheter 10. Each
first proximal steering pull-wire 70, first distal steering
pull-wire 68, second proximal steering pull-wire 71, and second
distal steering pull-wire 69 extends longitudinally through the
epicardial pacing catheter 10 towards the distal portion. Each
first proximal steering pull-wire 70, first distal steering
pull-wire 68, second proximal steering pull-wire 71, and second
distal steering pull-wire 69 may comprise guidewires, tensioning
lines, pull strings, digitating distal tips, magnetic guidance
means, wires, rods, chains, bands, chords, ropes, string tubes,
filaments, threads, fibers, strands, other extended elements, or
any other method known in the art.
[0146] Further, a first tab deployment rod 64 and second tab
deployment rod 72 occupy internal cross-sectional area of the
epicardial pacing catheter 10. Each first tab deployment rod 64 and
second tab deployment rod 72 extends longitudinally from the most
proximal portion 73 of the epicardial pacing lead 10 to the most
distal inward facing friction tab 32 or outward facing bumper tab
31. The first tab deployment rod 64 and second tab deployment rod
72 may comprise a longitudinal structure, such as, but not limited
to, a push-rod, pull-rod, wire, string, magnetic guidance means,
chains, bands, chords, or rope. The first tab deployment rod 64 and
second tab deployment rod 72 may comprise a non-conductive material
having high tensile strength as is known in the art. The first tab
deployment rod 64 and second tab deployment rod 72 may further be
controllably connected to the distal end 74 of a control means 150
in communication with the proximal end 73 of the epicardial pacing
catheter 10, said control means used to control the deployment of
the tabs.
[0147] It should be noted that, while a first tab deployment rod 64
and second tab deployment rod 72 are shown, any number of tab
deployment rods may be present as desired or required, up to an
including the sum of inward facing friction tabs 32 and outward
facing bumper tabs 31 (See FIGS. 6(A)-(E)).
[0148] Although not shown, in an example embodiment, a
biocompatible cover may be in communication with the most proximal
end 73 of the epicardial pacing catheter 10. The biocompatible
cover may prevent fibrosis from occurring around the exposed
structures of the epicardial pacing catheter 10.
[0149] Although not shown, in an example embodiment, the proximal
end 73 of the epicardial pacing catheter 10 may be located just
under the skin of a patient. The proximal end 73 can be reached by
a non-surgical, minimally-invasive incision of the skin, carried
out by a clinician or cardiologist.
[0150] Although not shown, in an example embodiment, all structures
beginning at the proximal end 73 may protrude from said proximal
end 73 of the epicardial pacing catheter 10. In this way, the
proximal end 73 could act as a male connector in a male-female
connection. It should be appreciated that the corresponding
male-female connection may be reversed as well.
[0151] FIG. 7(B) shows a cross sectional view of an example
embodiment of the most distal portion 74 of a control handle 150.
In this particular embodiment, the control handle 150 can be
controllably connected to the most proximal portion 73 of the
epicardial pacing catheter 10. Wire grippers 75 around each of the
internal structures facilitate a secure connection between
structures integral the control handle 150 and structures integral
the epicardial pacing catheter 10.
[0152] Although not shown, in an example embodiment, all structures
within the control handle 150 may end before the distal end 74. In
this way, the distal end 74 can act as a female connector in a
male-female connection.
[0153] It should be appreciated that the number of lumens, wires,
rods or elements discussed with regards to FIG. 7 may vary as may
be desired or required according to medical procedures,
device/system operations and anatomical considerations.
[0154] FIGS. 8(A)-(C) schematically illustrate cross-sectional
views of an example embodiment wherein the epicardial pacing
catheter 10 further comprises a stabilization means for stabilizing
the epicardial pacing catheter 10. The stabilization means may
comprise at least one deployable member. The stabilization means
allows the rotational orientation of the distal portion of the
epicardial pacing catheter 10 to remain fixed in place relative to
the surface of the heart. If the distal portion of the epicardial
pacing catheter 10 were allowed to rotate so that the electrodes 43
faced away from the heart, pacing could not be achieved and
adjacent anatomical structures would receive harmful electronic
energy.
[0155] FIGS. 8(A)-(C) illustrate an exemplary embodiment wherein
the stabilization means is an inward facing friction tab 32. The
inward facing friction tab 32 comprises a catheter-side surface 82
and an anatomical-side surface 83. The anatomical-side surface 83
comprises a lubricious surface that may be navigated through
anatomical structures without sticking or catching. The
catheter-side surface 82 comprises a rough surface having a larger
coefficient of friction than the anatomical-side surface. The
catheter-side surface may further comprise a textured surface to
increase friction. Both the catheter-side surface 82 and
anatomical-side surface 83 comprise a non-conductive material, such
as, but not limited to polyurethane, Teflon, silicone, a
radio-opaque material, or similarly lubricious material, or other
materials known in the art.
[0156] FIG. 8(A) illustrates an exemplary embodiment wherein the
stabilization means further comprises a stabilizer actuator,
wherein said stabilizer actuator deploys the inward facing friction
tab 32. Though the stabilizer actuator is illustrated as a tab
deployment rod 64 in communication with a tab joint 84, tab hinge
81, and tab deployment arm 65, the stabilizer actuator may comprise
any longitudinal member in communication with at least one of the
following: gear, hinge, joint, rack and pinion, pulley, linear
actuator, or linear-rotational actuator, or any combination
thereof. Further, the longitudinal member may be, for example, a
push-rod, pull-wire, wire, string, rope, pole, thread, filament,
cord, strand or other means known in the art. The stabilizer
actuator may further comprise a micro electrical mechanical system
(MEMS).
[0157] In an embodiment, a tab deployment rod 64 extends
longitudinally from the most proximal portion of the epicardial
pacing lead 10 to the most distal inward facing friction tab 32.
The tab deployment rod 64 may be a longitudinal structure, such as,
but not limited to, a push-rod, pull-rod, wire, string, pole,
thread, filament, cord, strand or rope. The tab deployment rod 64
made be made of a non-conductive material having high tensile
strength as is known in the art. The tab deployment rod may further
be controllably connected to a control means or control handle (as
shown, for example, in FIG. 15) in communication with the
epicardial pacing catheter 10 of the epicardial pacing system 5,
and the control means may be used to control the deployment of the
tabs.
[0158] The tab deployment rod 64 is in communication with a tab
joint 84, the tab joint 84 in connection with a tab deployment arm
65 having its endpoint within the inward facing friction tab 32.
The tab deployment arm is in further communication with a tab hinge
81.
[0159] When the inward facing friction tab 32 is in the
non-deployed state, the epicardial pacing catheter 10 may be moved,
navigated, or slid within the middle mediastinum. In this way, the
epicardial pacing catheter 10 can be inserted, placed, navigated or
removed from the pericardial sack.
[0160] FIG. 8(B) illustrates an embodiment wherein the
stabilization means is an inward facing friction tab 32 in the
partially-deployed state. When the tab deployment rod 64 is pushed
toward the distal end of the epicardial pacing catheter 10, the tab
deployment arm 65 is pulled or tensioned. This causes the inward
facing friction tab 32 to separate from the catheter body, exposing
the rough catheter-side 82 to proximate anatomical structures.
[0161] FIG. 8(C) illustrates an embodiment wherein the
stabilization means is an inward facing friction tab 32 in the
fully-deployed state.
[0162] Although not shown, the outward facing bumper tabs 31 may be
deployed using the same means and methods as described above.
[0163] Although not shown, the stabilization means may comprise one
or more protrusions for engaging proximal anatomical structures
such as the pericardium and/or the epicardium. The protrusions may
be non-deployable. Further, the protrusions may comprise a
non-conductive material, such as, but not limited to, silicone,
polyurethane, Teflon, a radio-opaque material, or other materials
known in the art.
[0164] It should be appreciated that the hinge devices and joint
devices may be a number of elements such as, but not limited
thereto, a fulcrum, swivel, gear, elbow, pivot, thrust or the
like.
[0165] It should be appreciated that the tab devices may be a
number of elements such as, but not limited thereto, finger, stud,
post, tongue, spring, projection, pin, pedestal, extension, offset,
knob, protuberance or the like.
[0166] FIG. 9 schematically illustrates an example embodiment of
the epicardial pacing catheter 10 of the epicardial pacing system
in relation to the heart 21 and further comprising at least one
deployable member. The epicardial pacing catheter 10 has been
steered around its distal point of curvature 41, and is positioned
in the pericardial space, cavity or sack 24, or the area between
the pericardium 22 and epicardium 23. In an embodiment, the
deployable member comprises at least one electrode 43, and each
electrode 43 is facing the heart 21. The electrodes 43 may be
deployed from the epicardial pacing catheter 10 and are fixed to
the epicardium 23 when in the fully-deployed state. The epicardial
pacing catheter 10 may further comprises an insulating hood 101 in
communication with the epicardial pacing catheter 10.
[0167] FIG. 10(A) schematically illustrates a top view of an
example embodiment of the epicardial pacing catheter 10 of the
epicardial pacing system. The epicardial pacing catheter further
comprises a insulating hood 101 extending from beyond the distal
point of curvature 41 to a distal tip 51. The hood may serve as a
cushioning and/or alignment means for the distal tip 51 relative to
adjacent anatomical structures. It should be appreciated that some
portion of the distal tip shall have insulation to protect from
adjacent anatomical structures. The shape of the distal tip and
hood may vary according to medical procedures, device/system
operations and anatomical considerations.
[0168] FIG. 10(B) schematically illustrates a bottom view of an
exemplary embodiment of the epicardial pacing catheter 10 of the
epicardial pacing system. An anode 63 and cathode 67 are shown in
communication with the epicardial pacing catheter 10. In an
embodiment, the contact zones containing the anode 63 and cathode
67 electrodes are about 2 mm in length and about 1 mm in width, and
are located centrally within the underside surface of the
insulating hood 101. It should be appreciated that the width of the
electrodes may be longer or shorter as may be desired or required
according to medical procedures, device/system operations and
anatomical considerations. The insulating hood extends from a
distal location beyond the distal point of curvature 41 to a distal
tip 51.
[0169] FIG. 10(C) schematically illustrates an axial view of an
exemplary embodiment of the epicardial pacing catheter 10 of the
epicardial pacing system looking at the distal tip 51 of the
insulating hood 101. A single electrode 43 can be seen on the
underside of the epicardial pacing catheter 10.
[0170] FIG. 10(D) schematically illustrates a side view of an
exemplary embodiment of the epicardial pacing catheter 10
comprising an insulating hood 101, distal tip 51, and two
electrodes 43. The insulating hood 101 extends over the side of the
epicardial pacing catheter 10.
[0171] It should be appreciated that in FIGS. 10(A)-(D) any number
of electrodes 43 may be present as desired or required to pace any
number of locations on the heart of a patient. Moreover, each
electrode 43 could be powered separately in a unipolar or bipolar
fashion, allowing for pacing of different parts of the same chamber
at different times.
[0172] FIG. 11(A)-11(E) schematically illustrate cross sectional
views of an exemplary embodiment of the epicardial pacing catheter
10 of the epicardial pacing system from a point located proximal to
the most distal anode 62 or cathode 67 and distal to the distal
point of curvature 41 to a point located at the most proximal point
73 of the epicardial pacing catheter 10. FIG. 11(F) schematically
illustrates a cross sectional view of an exemplary embodiment of
the external control handle 150 at the most distal point 74.
[0173] FIG. 11(A) schematically illustrates a cross section of an
example embodiment of the epicardial pacing catheter 10 located
more distal than the distal point of curvature 41 and proximal to
the most distal anode 62 or cathode 67. An anode wire 62, cathode
wire 66, electrode pull-wire 112, and second-electrode pull-wire
113 occupy internal cross-sectional area of the epicardial pacing
catheter 10 and extend longitudinally to the most proximal portion
73 of said catheter 10. The anode wire 62, cathode wire 66,
electrode pull-wire 112, and second-electrode pull-wire 113 may
comprise longitudinal structures, such as, but not limited to,
push-rods, pull-rods, wires, strings, or ropes. Further, the anode
wire 62, cathode wire 66, electrode pull-wire 112, and
second-electrode pull-wire 113 may be controllably connected to a
control handle 150 in electrical communication with the most
proximal point 73 of the epicardial pacing catheter 10.
[0174] The anode wire 62 and electrode pull-wire 112 extend
longitudinally from the most proximal portion 73 of the epicardial
pacing catheter 10 to the most distal anode 63. The cathode wire 66
and second electrode pull-wire 113 extend longitudinally from the
most proximal portion 73 of the epicardial pacing catheter 10 to
the most distal cathode 67.
[0175] FIG. 11(B) schematically illustrates a more proximal cross
section of an example embodiment of the epicardial pacing catheter
10 located at the distal point of curvature 41. The epicardial
pacing catheter 10 further comprises a first distal steering
pull-wire 68 and a second distal steering pull-wire 69 fixed to
distal steering anchors 110 in communication with the epicardial
pacing catheter 10. The distal steering anchors 110 comprise a
material with requisite strength to hold the first distal steering
pull-wire 68 and second distal steering pull-wire 69 in place. The
first distal steering pull-wire 68 and second distal steering
pull-wire 69 occupy internal cross-sectional area of the epicardial
pacing catheter 10 and extend longitudinally to the most proximal
point 73 of said catheter 10. The first proximal steering pull-wire
68 and second proximal steering pull-wire 69 may be controllably
connected to a control handle 150 in communication with the most
proximal point 73 of the epicardial pacing catheter 10.
[0176] FIG. 11(C) schematically illustrates a more proximal cross
section of an example embodiment of the epicardial pacing catheter
10 located between the distal point of curvature 41 and proximal
point of curvature 42.
[0177] FIG. 11(D) schematically illustrates a more proximal cross
section of an example embodiment of the epicardial pacing catheter
10 located at the proximal point of curvature 42. The epicardial
pacing catheter 10 further comprises a proximal steering pull-wire
70 fixed to a proximal steering anchor 111 in communication with
the epicardial pacing catheter 10. The proximal steering anchor 111
comprises a material with requisite strength to hold the proximal
steering pull-wire 70. The proximal steering pull-wire 70 occupies
internal cross-sectional area of the epicardial pacing catheter 10
and extends longitudinally to the most proximal point 73 of said
catheter 10. The proximal steering pull-wire 70 can be controllably
connected to a control handle 150 or control means in communication
with the most proximal point 73 of the epicardial pacing catheter
10.
[0178] FIG. 11(E) schematically illustrates a more proximal cross
section of an example embodiment of the epicardial pacing catheter
10 located at the most proximal point 73.
[0179] It should be noted that, while a single anode wire 62,
electrode pull-wire 112, cathode wire 66, and second electrode
pull-wire 113 are shown, any number of anode wires 62, electrode
pull-wires 112, cathode wires 66, and second electrode pull-wires
113 may be present as desired or required, up to and including, for
example, the total number of electrodes 43 (or the sum of the
anodes 63 and cathodes 67).
[0180] Although not shown, in an example embodiment, a
biocompatible cover may be in communication with the most proximal
end 73 of the epicardial pacing catheter 10. The biocompatible
cover can prevent fibrosis from occurring around the exposed wires
of the epicardial pacing catheter 10.
[0181] Although not shown, in an example embodiment, the proximal
end 73 of the epicardial pacing catheter 10 is located just under
the skin of a patient (or location(s) as desired or required). The
proximal end 73 can be reached by a non-surgical,
minimally-invasive incision of the skin, carried out by a clinician
or cardiologist.
[0182] Although not shown, in an example embodiment, all structures
beginning at the proximal end 73 may protrude from said proximal
end 73 of the epicardial pacing catheter 10. In this way, the
proximal end 73 could act as a male connector in a male-female
connection. The male-female arrangement may be reversed if desired
or required.
[0183] FIG. 11(F) schematically illustrates a cross sectional view
of an example embodiment of the most distal portion 74 of a control
handle 150. In this particular embodiment, the control handle 150
can be controllably connected to the most proximal portion 73 of
the epicardial pacing catheter 10. Wire grippers 75 (or other
retention means or devices) around each of the internal structures
facilitate a secure connection between structures integral the
control handle 150 and structures integral the epicardial pacing
catheter 10.
[0184] Although not shown, in an example embodiment, all structures
within the control handle or control means may end before the
distal end 74. In this way, the distal end 74 can act as a female
connector in a male-female connection (or female-male
connection).
[0185] FIG. 12(A) schematically illustrates a cross section of an
exemplary embodiment of the epicardial pacing catheter 10 of the
epicardial pacing system comprising a deployable stabilization
means in an un-deployed state. The deployable stabilization means
comprises an anode 63 and cathode 67 in communication with a hook
124. The hook 124, anode 63, and cathode 67 comprise conductive
materials, such as, but not limited to, copper, platinum, gold,
silver or iridium, and/or alloys thereof.
[0186] The stabilization means further comprises a stabilizer
actuator, wherein said stabilizer actuator deploys the anode 63 and
cathode 67 in communication with the hooks 124. Though the
stabilizer actuator is illustrated as an electrode pull-wire 112 in
communication with a joint 121, and hinge 122, the stabilizer
actuator may comprise any longitudinal member in communication with
at least one of the following: gear, hinge, joint, rack and pinion,
pulley, linear actuator, or linear-rotational actuator, or any
combination thereof. Further, the longitudinal member may be, for
example, a push-rod, pull-wire, wire, string, rope, pole, thread,
filament, cord, strand or other means known in the art. The
stabilizer actuator may further comprise a micro electrical
mechanical system (MEMS).
[0187] It should be appreciated that the hook devices may be a
number of elements such as, but not limited thereto, pin, claw,
latch, finger, stud, spring, post, tongue, projection, pin,
pedestal, extension, offset, knob, protuberance or the like.
[0188] In an embodiment, an electrode pull-wire 112 extends
longitudinally from the most proximal portion of the epicardial
pacing lead 10 to the most distal electrode 43, which may comprise
an anode 63 or cathode 67. The electrode pull-wire 112 is in
communication with a joint 121, the joint 121 in further
communication with a hinge 122.
[0189] In an embodiment, the electrode pull-wire 112 may comprise a
conductive material having high tensile strength as is known in the
art. The electrode-pull wire 112 may further be controllably
connected to a control means (for example, as shown in FIG. 15) in
communication with the epicardial pacing catheter 10 and epicardial
pacing system. The control means may be used to control the
deployment of the anode 63 and cathode 67 in communication with
hooks 124, and any of the devices, systems, subsystems, elements,
and devices discussed throughout this disclosure.
[0190] In an embodiment, the epicardial pacing catheter 10 further
comprises an insulating distal tip 51 in communication with the
epicardial pacing catheter. The epicardial pacing catheter 10
further comprises a number of bumpers 120 in communication with the
bottom of the epicardial pacing catheter 10. In an approach, the
bumpers enable the epicardial pacing catheter 10 to sit on the
surface of the heart in a non-deployed state without allowing the
anode 63 or cathode 67 to be in communication with the
epicardium.
[0191] When the deployable anode 63 and cathode 67 are in the
non-deployed state, the epicardial pacing catheter 10 may be moved
or navigated within the middle mediastinum. In this way, the
epicardial pacing catheter 10 can be inserted, placed, navigated or
removed from the pericardial sack.
[0192] FIG. 12(B) schematically illustrates a cross section of an
exemplary embodiment of the epicardial pacing catheter 10
comprising a deployable anode 63 and cathode 67 in a fully-deployed
state. When the electrode pull-wire 112 is pushed toward the distal
end of the epicardial pacing catheter 10, the anode 63 and cathode
67 are splayed outward to a 90 degree angle, or an angel(s) as
desired or required. This causes the anode 63 and cathode 67 to
separate from the catheter body, allowing the hooks 124 to engage
proximate anatomical structures, such as the epicardial wall. When
the deployable anode 63 and cathode 67 are in the fully-deployed
state, the rotational orientation of the distal portion of the
epicardial pacing catheter 10 remains fixed in place relative to
the surface of the heart. If the distal portion of the epicardial
pacing catheter 10 were allowed to rotate so that the electrodes 43
faced away from the heart, pacing could not be achieved and
adjacent anatomical structures would receive harmful electronic
energy.
[0193] It should be appreciated that in FIGS. 12(A) and (B) any
number of deployable electrodes 43 may be present as desired or
required to pace any number of locations on the heart of a
patient.
[0194] It should be appreciated that when the electrode pull-wire
112 is pulled toward the proximal end of the epicardial pacing
catheter 10, the anode 63 and cathode 67 are drawn back into place
within the catheter 10.
[0195] FIG. 13(A) schematically illustrates a cross section of an
exemplary embodiment of the epicardial pacing catheter 10 of the
epicardial pacing system comprising a deployable stabilization
means in an un-deployed state. The deployable stabilization means
comprises a number of screws 130 in communication with an anode 63
and cathode 67. The screws 130, anode 63, and cathode 67 comprise
conductive materials, such as, but not limited to, copper,
platinum, gold, silver and/or iridium, and/or alloys thereof.
[0196] The stabilization means further comprises a stabilizer
actuator, wherein said stabilizer actuator deploys the screws 130
in communication with the anode 63 and cathode 67. Though the
stabilizer actuator is illustrated as an electrode pull-wire 112 in
communication with a gear 131, the stabilizer actuator may comprise
any longitudinal member in communication with at least one of the
following: gear, hinge, joint, rack and pinion, pulley, linear
actuator, or linear-rotational actuator, or any combination
thereof. Further, the longitudinal member may be, for example, a
push-rod, pull-wire, wire, string, rope, pole, thread, filament,
cord, strand, or other means known in the art. The stabilizer
actuator may further comprise a micro electrical mechanical system
(MEMS).
[0197] It should be appreciated that the screw devices may comprise
a number of elements such as, but not limited thereto, any
translatable protrusion or extension for instance. Some
non-limiting examples may include: toggle, press, slide, spring,
stud, post, tongue, projection, pedestal, protuberance, contact, or
the like.
[0198] In an embodiment, an electrode pull-wire 112 extends
longitudinally from the most proximal portion of the epicardial
pacing lead 10 to the most distal electrode 43, which may be an
anode 63 or cathode 67. The electrode pull-wire 112 may be a
longitudinal structure, such as, but not limited to, a push-rod,
pull-rod, wire, string, or rope. The electrode pull-wire 112 may be
made of a conductive material having high tensile strength as is
known in the art. The electrode-pull wire 112 may further be
controllably connected to a control means (as shown, for example,
in FIG. 15) in communication with the epicardial pacing catheter 10
and epicardial pacing system. The control means may be used to
control the deployment of the screws 130 in communication with the
anode 63 and cathode 67.
[0199] The epicardial pacing catheter 10 further comprises an
insulating distal tip 51 in communication with the epicardial
pacing catheter.
[0200] When the screws 130 are in the non-deployed state, the
epicardial pacing catheter 10 may be moved or navigated within the
middle mediastinum. In this way, the epicardial pacing catheter 10
can be inserted, placed, navigated, translated, rotated or removed
from the pericardial sack.
[0201] FIG. 13(B) schematically illustrates a cross section of an
exemplary embodiment of the epicardial pacing catheter 10
comprising fully-deployed screws 130 in communication with the
anode 63 and cathode 67. When the electrode pull-wire 112 is pushed
toward the distal end of the epicardial pacing catheter 10, the
gears 131 are activated and the screws 130 are
rotationally-actuated. This causes the screws 130 to engage
proximate anatomical structures, such as the epicardial wall. When
the screws 130 are in the fully-deployed state, the rotational
orientation of the distal portion of the epicardial pacing catheter
10 remains fixed in place relative to the surface of the heart. The
electrical energy is transmitted from the anode 63 and cathode 67
through the screws 130 and into the heart.
[0202] It should be appreciated that in FIGS. 13(A) and (B) any
number of deployable screws 130 may be present as desired or
required to pace any number of locations on the heart of a
patient.
[0203] FIG. 14(A) schematically illustrates a cross section of an
exemplary embodiment of the epicardial pacing catheter 10
epicardial pacing system comprising a deployable stabilization
means in an un-deployed state. The deployable stabilization means
comprises an anode 63 and cathode 67 in communication with a hook
124. The hooks 124, anode 63, and cathode 67 comprise conductive
materials, such as, but not limited to, copper, platinum, gold,
silver and/or iridium, or alloys thereof.
[0204] The deployable stabilization means further comprises a
stabilizer actuator, wherein said stabilizer actuator deploys the
anode 63 and cathode 67 in communication with the hooks 124. Though
the stabilizer actuator is illustrated as an electrode pull-wire
112 and second electrode pull-wire 113 in communication with a
number of joints 121, and hinges 122, the stabilizer actuator may
comprise any longitudinal member in communication with at least one
of the following: gear, hinge, joint, rack and pinion, pulley,
linear actuator, or linear-rotational actuator, or any combination
thereof. Further, the longitudinal member may be, for example, a
push-rod, pull-wire, wire, string, thread, filament, cord, strand,
rope, pole, or other means known in the art. The stabilizer
actuator may further comprise a micro electrical mechanical system
(MEMS).
[0205] In an embodiment, an electrode pull-wire 112 and second
electrode pull-wire 113 extend longitudinally from the most
proximal portion of the epicardial pacing lead 10 to the most
distal anode 63 and cathode 67 respectively. The electrode
pull-wire and second electrode pull-wire 113 are in communication
with a number of joints 121, the joints 121 in further
communication with a number of hinges 122. The electrode pull-wire
112 and second electrode pull-wire 113 may comprise longitudinal
structures, such as, but not limited to, push-rods, pull-rods,
wires, thread, filament, cord, strand, strings, or ropes. The
electrode pull-wire 112 and second electrode pull-wire 113 may be
made of a conductive material having high tensile strength as is
known in the art. The electrode-pull wire 112 and second electrode
pull-wire 113 may further be controllably connected to a control
means (for example, as shown in FIG. 15) in communication with the
epicardial pacing catheter 10 and epicardial pacing system. The
control means may used to control the deployment of the anode 63
and cathode 67 in communication with hooks 124.
[0206] The epicardial pacing catheter 10 further comprises an
insulating distal tip 51 in communication with the epicardial
pacing catheter. The epicardial pacing catheter 10 may further
comprise a number of bumpers 120 in communication with the
epicardial pacing catheter 10. The bumpers 120 enable the
epicardial pacing catheter 10 to sit on the surface of the heart in
a non-deployed state without allowing the anode 63 or cathode 67 to
communicate with the heart.
[0207] When the deployable anode 63 and cathode 67 are in the
non-deployed state, the epicardial pacing catheter 10 may be moved
or navigated within the middle mediastinum. In this way, the
epicardial pacing catheter 10 can be inserted, placed, navigated,
translated, rotated or removed from the pericardial sack.
[0208] FIG. 14(B) schematically illustrates a cross section of an
exemplary embodiment of the epicardial pacing catheter 10
comprising a deployable anode 63 and cathode 67 in a fully-deployed
state. When the electrode pull-wire 112 and second electrode
pull-wire 113 are pulled toward the proximal end of the epicardial
pacing catheter 10, the anode 63 and cathode 67 are splayed outward
to a 90 degree angle. This causes the anode 63 and cathode 67 to
separate from the catheter body, allowing the hooks 124 to engage
proximate anatomical structures, such as the epicardial wall. When
the deployable anode 63 and cathode 67 are in the fully-deployed
state, the rotational orientation of the distal portion of the
epicardial pacing catheter 10 remains fixed in place relative to
the surface of the heart. The electrical energy is transmitted from
the anode 63 and cathode 67 through the hooks 124 and into the
heart.
[0209] It should be appreciated that in FIGS. 14(A) and (B) any
number of deployable anodes 63 and cathodes 67 may be present as
desired or required to pace any number of locations on the heart of
a patient.
[0210] It should be appreciated that when the electrode pull-wire
112 and second electrode pull-wire are pushed toward the distal end
of the epicardial pacing catheter 10, the anode 63 and cathode 67
are drawn back into place within the catheter 10.
[0211] It should be appreciated that regarding deployment discussed
throughout, varying degrees of deployment may be achieved or
implemented as desired or required.
[0212] FIG. 15(A) schematically illustrates an example embodiment
of an external control handle 150 (that may be associated with,
although not shown, the epicardial pacing catheter of the system).
The epicardial pacing catheter and system further comprises a
control means, wherein said control means is an external control
handle 150. The external control handle 150 may be in communication
with the most proximal point 73 of the epicardial pacing catheter
10. The external control handle 150 may have integral to it the
distal steering control means 154, the proximal control means 154,
the irrigation control means (not shown) and the control means for
the stabilization means 151. The stabilization control means 154
may be used to regulate the degree of extension of said
stabilization means via a pull-wire or pushrod arrangement or some
other suitable tensioning or actuating means know in the art. The
external control handle 150 may further comprise a pull-rod control
aperture 152, wherein a tab deployment rod 64 and second tab
deployment rod (not shown) may be inserted.
[0213] The external control handle 150 is preferably sized to be
grasped, held and operated by a user. It should be appreciated that
other control and operating interface members, devices, or means
may be utilized for the handle. Attached to the proximal end of the
control handle 150 is the handle proximal port (not shown) from
which anode wires 62 and cathode wires 67 extend in order to make
electrical connections to diagnostic or electrical devices (not
shown). Electrical wires (for example, shown in FIGS. 6, 7, and 11)
may extend through the proximal portion to each of the electrodes
43 of the epicardial pacing catheter 10.
[0214] FIG. 15(B) schematically illustrates an example embodiment
of the proximal steering control means 153 integral to the control
handle 150. The proximal steering control means 153 is controllably
connected to the first proximal steering pull-wire 70 and second
proximal steering pull-wire 71.
[0215] FIG. 15(C) schematically illustrates an example embodiment
wherein the proximal steering control means 153 integral to the
control handle 150 has been activated. As the proximal steering
control means 153 is activated by a user, the first proximal
steering pull-wire 70 becomes taught, and the second proximal
steering pull-wire 71 loosens, creating slack 155. Both the first
proximal steering pull-wire 70 and second proximal steering
pull-wire 71 extend longitudinally through the control handle 150,
into the epicardial pacing catheter 10, and are anchored at the
proximal point of curvature 42. As the first steering pull-wire 70
becomes taught, the epicardial pacing catheter bends toward the
proximal steering anchor and around the proximal point of curvature
42.
[0216] For example, the control handle may have channels for the
steering pull wires and thumb wheel knobs for tightening or
loosening the pull wires.
[0217] One skilled in the art can see that many other embodiments
of means and methods for using the epicardial pacing catheter 10 of
the epicardial pacing system according to the technique of the
technology, and other details of construction and use thereof,
constitute non-inventive variations of the novel and insightful
conceptual means, system and technique which underlie the present
invention.
[0218] The devices, systems, compositions, computer program
products, and methods of various embodiments of the invention
disclosed herein may utilize aspects disclosed in the following
references, applications, publications and patents and which are
hereby incorporated by reference herein in their entirety: [0219]
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[0230] 12. U.S. Pat. No. 7,041,099 to Thomas, et al., issued May
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6,936,040 to Kramm, et al., issued August 2005. [0235] 17. U.S.
Pat. No. 6,921,295 to Sommer, et al., issued July 2005. [0236] 18.
U.S. Pat. No. 6,918,908 to Bonner, et al., issued August 2005.
[0237] 19. U.S. Pat. No. 6,899,710 to Hooven, issued May 2005.
[0238] 20. U.S. Pat. No. 6,876,885 to Swoyer, et al., issued May
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to Vaska, et al., issued November 2001. [0244] 26. U.S. Pat. No.
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[0273] 55. H. Mair et al., "Epicardial Lead Implantation Techniques
for Biventricular Pacing via Left Lateral Mini-Thoracotomy,
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[0276] It should be appreciated that various sizes, dimensions,
contours, rigidity, shapes, flexibility and materials of any of the
embodiments discussed throughout may be varied and utilized as
desired or required.
[0277] It should be appreciated that the catheter device and
epicardial system and their related components discussed herein may
can take on all shapes along the entire continual geometric
spectrum of manipulation of x, y and z planes to provide and meet
the anatomical and structural demands and requirements.
EXAMPLES AND EXPERIMENTAL RESULTS
[0278] Practice of the invention will be still more fully
understood from the following examples and experimental results,
which are presented herein for illustration only and should not be
construed as limiting the invention in any way.
Example No. 1
[0279] Step 1--Access and place a guidewire in the pericardial
space using our EpiNeedle Access system.
[0280] Step 2--Use a sheath, preferably our EpiSheath, or a general
long 8 Fr sheath to place over the guidewire and maintain
access.
[0281] Step 3--Place the lead of the subject invention with handle
though the sheath.
[0282] Step 4--Guide the lead in the epicardial space using the two
steering points and the sheath under fluoroscopic guidance
(although this lead may be guided via one or more other imaging
methods to include ICE, CT, MRI, Visual Endoscopy, or Echo
Methods). The lead should be advanced along the border of the heart
apically to base along the LV. Once it crosses the AV groove to the
LA it should be deflected downward and advanced through the
transverse sinus. Once across the transverse sinus it will need to
be deflected up to the SVC and then down to the RA and finally the
RV.
[0283] Step 5--Slide the sheath back to the inferior portion of the
RV.
[0284] Step 6--At this point the handle should be hooked up to an
EP analyzer. The lead should be clocked for a more anterior
position or counter-clocked for a more posterior position until the
largest LV signals are found. If multi-chamber pacing is sought one
should pick a point when at least two poles of the LV, and of each
other chamber, has an amplitude of at least 1 mV in the atrium and
5 mV in the ventricle. Note there is no need for all points to have
high amplitudes. Next, the tabs should be deployed. This should
push the lead more tightly against the heart and actually increase
the voltage. Then, pacing should be attempted in the LV. If
threshold is less than 2.5 V it is a good site on any pole. The
same should then be done with the other points. If no point is good
the tab should be let down and then the lead repositioned.
[0285] Step 7--Once a good position is found the handle should be
removed and the sheath withdrawn completely outside of the
patient.
[0286] Step 8--The lead should be plugged into either a custom
ICD/BiV or attached to our wire interface for a standard ICD. The
poles that are not used to pace should be plugged in this case. In
the custom ICD, all poles would be active and the user (or an
automated system) may decide when to pace.
[0287] Step 9--The lead extender to the ICD would then either be
tunneled back to the ICD in the shoulder (or elsewhere), placed by
the nearby abdominal ICD. Or a battery-powered wireless box will be
used to communicate with the main ICD in the shoulder. At this
point the patient should be recovered. No stitch is needed for the
lead access.
[0288] In summary, while the present invention has been described
with respect to specific embodiments, many modifications,
variations, alterations, substitutions, and equivalents will be
apparent to those skilled in the art. The present invention is not
to be limited in scope by the specific embodiment described herein.
Indeed, various modifications of the present invention, in addition
to those described herein, will be apparent to those of skill in
the art from the foregoing description and accompanying drawings.
Accordingly, the invention is to be considered as limited only by
the spirit and scope of the following claims, including all
modifications and equivalents.
[0289] Still other embodiments will become readily apparent to
those skilled in this art from reading the above-recited detailed
description and drawings of certain exemplary embodiments. It
should be understood that numerous variations, modifications, and
additional embodiments are possible, and accordingly, all such
variations, modifications, and embodiments are to be regarded as
being within the spirit and scope of this application. For example,
regardless of the content of any portion (e.g., title, field,
background, summary, abstract, drawing figure, etc.) of this
application, unless clearly specified to the contrary, there is no
requirement for the inclusion in any claim herein or of any
application claiming priority hereto of any particular described or
illustrated activity or element, any particular sequence of such
activities, or any particular interrelationship of such elements.
Moreover, any activity can be repeated, any activity can be
performed by multiple entities, and/or any element can be
duplicated. Further, any activity or element can be excluded, the
sequence of activities can vary, and/or the interrelationship of
elements can vary. Unless clearly specified to the contrary, there
is no requirement for any particular described or illustrated
activity or element, any particular sequence or such activities,
any particular size, speed, material, dimension or frequency, or
any particularly interrelationship of such elements. Accordingly,
the descriptions and drawings are to be regarded as illustrative in
nature, and not as restrictive. Moreover, when any number or range
is described herein, unless clearly stated otherwise, that number
or range is approximate. When any range is described herein, unless
clearly stated otherwise, that range includes all values therein
and all sub ranges therein. Any information in any material (e.g.,
a United States/foreign patent, United States/foreign patent
application, book, article, etc.) that has been incorporated by
reference herein, is only incorporated by reference to the extent
that no conflict exists between such information and the other
statements and drawings set forth herein. In the event of such
conflict, including a conflict that would render invalid any claim
herein or seeking priority hereto, then any such conflicting
information in such incorporated by reference material is
specifically not incorporated by reference herein.
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