U.S. patent application number 09/796590 was filed with the patent office on 2001-10-25 for delivery methods for left ventricular conduit.
This patent application is currently assigned to Percardia, Inc.. Invention is credited to Furnish, Greg R., Furnish, Simon M., Hall, Todd A., Phelps, David Y., Pompili, Vincent, Wilk, Peter J., Wolf, Scott J..
Application Number | 20010034547 09/796590 |
Document ID | / |
Family ID | 23453100 |
Filed Date | 2001-10-25 |
United States Patent
Application |
20010034547 |
Kind Code |
A1 |
Hall, Todd A. ; et
al. |
October 25, 2001 |
Delivery methods for left ventricular conduit
Abstract
Described herein are various methods and apparatuses for
delivering stents or conduits and other devices into the myocardium
of a patient. One preferred stent delivery system provides access
to the insertion site in the myocardium by advancing a delivery
catheter through a blockage in a coronary artery, or around the
blockage through a coronary vein or through a channel or tunnel
formed around the blockage. In one embodiment, once the distal end
of the delivery catheter is adjacent the myocardium, an angled bend
is created in the catheter by actuating expandable steering guides
mounted to the catheter which cooperate with the walls of the blood
vessel to cause the catheter to turn. Then, a guidewire is advanced
through the delivery catheter and into the myocardium. In another
embodiment, a tip-deflecting pull wire extends from the distal end
of the delivery catheter which may be actuated to turn towards and
then inserted into the myocardium. In another embodiment, an exit
port facing the insertion site is provided within the catheter or a
balloon mounted on the catheter so that a guidewire may be directed
through a lumen and out the exit port into the myocardium. Once the
guidewire punctures into the myocardium, the guidewire is anchored
using barbs, balloons or other actuatable members to secure the
guidewire to the myocardium. Subsequently, using a push-pull
mechanism, stents and other medical devices can be advanced over
the guidewire into the myocardium.
Inventors: |
Hall, Todd A.; (Goshen,
KY) ; Furnish, Greg R.; (Louisville, KY) ;
Furnish, Simon M.; (Louisville, KY) ; Wolf, Scott
J.; (Minneapolis, MN) ; Wilk, Peter J.; (New
York, NY) ; Phelps, David Y.; (Louisville, KY)
; Pompili, Vincent; (Chagrin Falls, OH) |
Correspondence
Address: |
FINNEGAN, HENDERSON, FARABOW, GARRETT &
DUNNER LLP
1300 I STREET, NW
WASHINGTON
DC
20005
US
|
Assignee: |
Percardia, Inc.
|
Family ID: |
23453100 |
Appl. No.: |
09/796590 |
Filed: |
March 2, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09796590 |
Mar 2, 2001 |
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09368868 |
Aug 4, 1999 |
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6261304 |
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09368868 |
Aug 4, 1999 |
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09150181 |
Sep 10, 1998 |
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6196230 |
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Current U.S.
Class: |
623/1.11 ;
606/108 |
Current CPC
Class: |
A61B 2017/22054
20130101; A61B 2018/00392 20130101; A61F 2/95 20130101; A61F 2/86
20130101; A61B 2017/22071 20130101; A61M 25/10 20130101; A61F 2/958
20130101; A61M 2210/125 20130101; A61M 25/0194 20130101; A61M
25/0155 20130101; A61B 2017/00252 20130101; A61B 2017/22095
20130101; A61M 25/0147 20130101; A61M 2025/1095 20130101; A61M
2025/1097 20130101; A61B 2017/00247 20130101; A61M 25/0152
20130101; A61M 25/1011 20130101; A61M 2025/0096 20130101; A61M
2025/0197 20130101; A61M 25/1006 20130101; A61F 2/2493
20130101 |
Class at
Publication: |
623/1.11 ;
606/108 |
International
Class: |
A61F 002/06 |
Claims
What is claimed is:
1. A method for delivering a medical device into the heart wall of
a patient, comprising: delivering a guidewire into the patient, the
guidewire once delivered having a proximal end extending out of the
patient and a distal end positioned adjacent the heart wall;
inserting the distal end of the guidewire into the heart wall;
anchoring the guidewire to the heart wall; and advancing an
introducer catheter carrying the medical device over the guidewire
to deliver the device into the heart wall.
2. The method of claim 1, wherein the guidewire is delivered
percutaneously into the patient.
3. The method of claim 2, wherein the distal end of the guidewire
is advanced through a blockage in a coronary artery.
4. The method of claim 2, wherein the distal end of the guidewire
is advanced through a coronary vein.
5. The method of claim 2, wherein the distal end of the guidewire
is advanced into the left ventricle.
6. The method of claim 1, further comprising advancing a delivery
catheter into the patient prior to delivering the guidewire, the
delivery catheter comprising a tubular body having a proximal end
and a distal end and a lumen extending at least partially
therethrough, until the distal end of the delivery catheter is
positioned adjacent the heart wall.
7. The method of claim 6, further comprising turning the distal end
of the guidewire toward the heart wall prior to inserting the
distal end of the guidewire, by: actuating an anchoring member
mounted on the distal end of the delivery catheter to secure the
delivery catheter within the patient; and actuating a steering
member mounted on the distal end of the tubular body at a position
distal to that of the anchoring member to turn the distal end of
the delivery catheter toward the heart wall; and advancing the
guidewire through the lumen in the delivery catheter and out the
distal end of the delivery catheter.
8. The method of claim 1, wherein the guidewire is a tip-deflecting
wire, and further comprising turning the distal end of the
guidewire toward the heart wall prior to inserting the distal end
of the guidewire by actuating the tip-deflecting wire.
9. The method of claim 1, further comprising: providing a
passageway adjacent the heart wall having a proximal opening for
receiving the distal end of the guidewire and a side port exit
facing the heart wall; wherein delivering the guidewire comprises
advancing the distal end of the guidewire through the passageway
toward the heart wall.
10. The method of claim 9, wherein the passageway is provided
through a lumen in a delivery catheter.
11. The method of claim 9, wherein the passageway is provided
through an anchoring member mounted to a distal end of a delivery
catheter.
12. The method of claim 1, wherein anchoring the guidewire to the
heart wall comprises providing at least one barb attached to the
distal end of the guidewire, the barb having a shape that
facilitates advancement of the guidewire distally through the heart
wall but prevents retraction of the guidewire proximally.
13. The method of claim 1, wherein inserting the distal end of the
guidewire into the heart wall comprises advancing the guidewire
from a coronary blood vessel until the distal end extends into the
left ventricle.
14. The method of claim 1, wherein anchoring the guidewire further
comprises expanding an anchoring member mounted on the distal end
of the guidewire within the left ventricle.
15. The method of claim 14, wherein the anchoring member is an
inflatable balloon.
16. The method of claim 1, wherein advancing the introducer
catheter carrying a medical device further comprises: pulling
proximally on the guidewire anchored to the heart wall; and pushing
the introducer catheter over the guidewire into the heart wall.
17. A method for delivering a conduit into a heart wall to bypass a
blockage formed in a coronary artery, comprising: creating a
channel from a position proximal to the blockage in the coronary
artery to a position distal to the blockage in the coronary artery;
advancing a guidewire through the channel until a distal end of the
guidewire is adjacent the heart wall; inserting the guidewire into
the heart wall; and advancing a conduit over the guidewire into the
heart wall.
18. The method of claim 17, wherein the channel is a tunnel formed
through the myocardium.
19. The method of claim 17, wherein the conduit is a stent.
20. A method for creating a bypass around a blockage in a blood
vessel, comprising: delivering a guidewire along a pathway from a
location in the blood vessel proximal to the blockage to a location
in the blood vessel distal to the blockage; and creating a channel
along the pathway formed by the guidewire.
21. The method of claim 20, wherein the blockage occurs in a
coronary artery.
22. The method of claim 21, wherein the guidewire is delivered
through the heart wall.
23. The method of claim 22, wherein creating the channel comprises
dilating the pathway formed by the guidewire.
24. The method of claim 23, further comprising implanting a shunt
in the dilated pathway.
25. The method of claim 21, wherein the guidewire is delivered
through the pericardial space, and further comprising providing a
shunt over the guidewire.
26. The method of claim 20, wherein the guidewire has eyes for
navigation.
27. A method for creating a bypass around a blockage in a coronary
artery, adjacent a heart wall, comprising: inserting a needle into
a patient into the heart wall, the needle having a lumen extending
therethrough; advancing the needle through the heart wall and into
the coronary artery distal to the blockage; advancing a guidewire
through the lumen in the needle, the guidewire once advanced
extending through the coronary artery proximal to the blockage,
through the heart wall, and into the coronary artery distal to the
blockage; removing the needle from the patient while leaving the
guidewire in place; advancing a shunt over the guidewire, the shunt
once advanced having a distal end in the coronary artery distal to
the blockage.
28. The method of claim 27, wherein prior to inserting the needle
into the heart wall, the needle is inserted into the coronary
artery from the pericardial space through the anterior wall of the
coronary artery at a location proximal to the blockage.
29. The method of claim 27, wherein the shunt once delivered has a
proximal end in the coronary artery proximal to the blockage.
30. The method of claim 27, wherein the needle is advanced through
the heart wall into the left ventricle and back into the heart
wall.
31. The method of claim 30, wherein the shunt once delivered has a
proximal end opening toward the left ventricle.
32. The method of claim 27, wherein the needle is pre-shaped in a
carved configuration.
33. A method for creating a bypass through the heart wall of a
patient to bypass a blockage formed in a coronary artery,
comprising: creating a first tunnel through the heart wall having a
proximal end and a distal end, the proximal end opening into the
coronary artery proximal to the blockage, and the distal end
positioned within the heart wall; creating a second tunnel through
the heart wall, the second tunnel having a first branch extending
from the distal end of the first tunnel and opening into the
coronary artery at a position distal to the blockage, and a second
branch extending from the distal end of the first channel and
opening into a heart chamber; and disposing a conduit in the second
tunnel to provide a passageway therethrough.
34. The method of claim 33, wherein the conduit is a stent.
35. The method of claim 33, further comprising closing off the
first tunnel at the distal end thereof.
36. The method of claim 33, further comprising closing off the
first tunnel at the proximal end thereof.
37. A delivery catheter, comprising: an elongate tubular body
having a proximal end and a distal end and a lumen extending
therethrough; a first steering member mounted on the distal end of
the tubular body; and a second steering member mounted on the
distal end of the tubular body at a position distal to that of the
anchoring member.
38. The catheter of claim 37, wherein the first steering member is
an expandable anchoring member which, when actuated, is sized to
press against a wall of the body lumen to secure the catheter
within the lumen.
39. The catheter of claim 38, wherein the second steering member is
an expandable member which, when actuated, cooperates with a wall
of the body lumen to turn the distal end of the catheter.
40. The catheter of claim 39, wherein the second steering member is
capable of turning the distal end of the catheter greater than 90
degrees.
41. The catheter of claim 37, wherein the anchoring member and
steering member are inflatable balloons.
42. The catheter of claim 37, wherein the anchoring member is
mounted to one side of the tubular body and the steering member is
mounted to an opposite side of the tubular body.
43. A method for turning a distal end of a catheter within a body
lumen, the catheter comprising an elongate tubular body having a
proximal end and a distal end, the method comprising: actuating an
anchoring member mounted on the distal end of the tubular body to
secure the catheter against the body lumen; and actuating a
steering member mounted on the distal end of the tubular body at a
position distal to that of the anchoring member, wherein the
steering member when actuated cooperates with the body lumen to
turn the distal end of the catheter.
44. The method of claim 43, wherein the anchoring member and the
steering member are inflatable balloons.
45. A method for delivering a medical device to a delivery site
within a patient comprising: providing a delivery catheter having a
proximal end and a distal end and a lumen extending therethrough
into a body lumen of the patient; securing the delivery catheter
within the body lumen; turning the distal end of the catheter by
actuating a steering member mounted on the distal end of the
catheter which pushes off against a wall of the body lumen; and
advancing the medical device through the lumen of the delivery
catheter and out the distal end.
46. The method of claim 45, wherein the steering member when
actuated pushes off a wall of the body lumen to turn the distal end
of the catheter.
47. The method of claim 45, wherein securing the delivery catheter
comprises actuating an anchoring member mounted on the distal end
of the catheter against the wall of the body lumen.
48. The method of claim 47, wherein actuating the anchoring member
comprises inflating a balloon against the wall of the body
lumen.
49. The method of claim 45, wherein actuating the steering member
comprises inflating a balloon against the wall of the body
lumen.
50. A catheter, comprising: an elongate tubular body having a
proximal end and a distal end and a lumen extending at least
partially therethrough; and means for turning the distal end of the
catheter mounted on the distal end of the tubular body.
51. The catheter of claim 50, wherein the means for turning the
distal end of the catheter includes means for anchoring the
catheter to a body lumen.
52. A method for delivering a conduit into the heart wall of a
patient, comprising: advancing a delivery catheter into the
vasculature of the patient, the delivery catheter having a proximal
end and a distal end and a lumen extending therethreough, until the
distal end is adjacent the heart wall; actuating a pull wire
extending from the distal end of the delivery catheter to turn the
pull wire toward the heart wall; advancing the pull wire from the
distal end of the delivery catheter into the heart wall; and
delivering the conduit over the pull wire into the heart wall.
53. The method of claim 52, wherein the conduit is a stent.
54. A method for delivering a conduit into the heart wall of a
patient, comprising: advancing a delivery catheter into the
vasculature of the patient, the catheter having a proximal end and
a distal end and a lumen extending from the proximal end to a side
port near the distal end, until the side port faces the heart wall;
inserting a guidewire having a proximal end and a distal end into
the lumen; advancing the distal end of the guidewire through the
lumen and out the side port; advancing the guidewire into the heart
wall; and delivering the conduit over the guidewire into the heart
wall.
55. The method of claim 54, further comprising anchoring the
delivery catheter within the vasculature.
56. The method of claim 54, wherein anchoring of the delivery
catheter comprises expanding an anchoring member mounted to the
distal end of the delivery catheter.
57. The method of claim 56, wherein the anchoring member is an
inflatable balloon.
58. The method of claim 56, further comprising perfusing blood
through at least one channel in the anchoring member.
59. The method of claim 54, wherein the distal end of the guidewire
is advanced out the side port at an angle greater than about 90
degrees relative to the direction the guidewire is advanced through
the lumen.
60. A method for delivering a conduit into the heart wall of a
patient, comprising: advancing a delivery catheter into the
vasculature of a patient, the catheter having a proximal end and a
distal end, until the distal end is adjacent the heart wall;
expanding an anchoring member mounted on the distal end of the
catheter to secure the delivery catheter within the vasculature;
inserting a guidewire having a proximal end and a distal end
through a lumen in the expanded anchoring member, the lumen
extending from a proximal end of the anchoring member to a side
port facing the heart wall, so that the distal end of the guidewire
exits through the side port; advancing the guidewire into the heart
wall; and advancing the conduit over the guidewire into the heart
wall.
61. The method of claim 60, wherein expanding the anchoring member
comprises inflating a balloon.
62. The method of claim 60, further comprising perfusing blood
through at least one channel in the expanded anchoring member.
63. A delivery catheter, comprising: an elongate body having a
proximal end and a distal end; an expandable member mounted on the
distal end of the tubular body, the expandable member having a
proximal end and a distal end and an exterior surface; and a guide
lumen extending from the proximal end of the expandable member to a
side port on the exterior surface of the expandable member for
directing a medical device therethrough.
64. The delivery catheter of claim 63, wherein the guide lumen
extends through the elongate body from the side port to the
proximal end of the elongate body.
65. The delivery catheter of claim 63, wherein the guide lumen is
separate from the elongate body.
66. The delivery catheter of claim 63, wherein the guide lumen
curves up to about 90 degrees.
67. The delivery catheter of claim 63, wherein the expandable
member is an inflatable balloon.
68. The delivery catheter of claim 63, further comprising a
perfusion channel to allow blood to flow therethrough.
69. The delivery catheter of claim 68, wherein the perfusion
channel extends through the expandable member.
70. A delivery catheter, comprising: an elongate body having a
proximal end and a distal end defining a generally longitudinally
axis therebetween; a guidewire lumen extending at least partially
between the proximal end and the distal end of the elongate body
and having a proximal end and a distal end; an exit port at the
distal end of the guidewire lumen creating a curve of between about
0 and 180 degrees relative to the longitudinal axis of the elongate
body for directing a guidewire out of the lumen.
71. The delivery catheter of claim 70, wherein the exit port is a
side port formed proximal to the distal end of the elongate
body.
72. The delivery catheter of claim 71, further comprising an
expandable member mounted proximal to the side exit port.
73. The delivery catheter of claim 71, further comprising an
expandable member mounted distal to the side exit port.
74. The delivery catheter of claim 70, wherein the guidewire lumen
extends between the proximal end and the distal end of the elongate
body, and the exit port is located at the distal end of the
elongate body.
75. The delivery catheter of claim 74, further comprising a
narrowing passageway between the guidewire lumen and the exit
port.
76. A catheter, comprising: an elongate tubular body having a
proximal end and a distal end and a lumen extending at least
partially therethrough; means provided near the distal end of the
tubular body for directing a guidewire at an angle into a body
tissue.
77. A method for treating an aneurysm, comprising: advancing a
catheter having a proximal end and a distal end to the site of the
aneurysm; actuating an expandable member mounted on the distal end
of the catheter to substantially enclose the aneurysm; and
inserting an embolic element into the aneurysm.
78. The method of claim 77, wherein the embolic element is inserted
through a lumen in the expandable member.
79. The method of claim 77, wherein actuating the expandable member
comprises inflating a balloon.
80. The method of claim 77, further comprising perfusing blood
through at least one channel in the expandable member.
81. The method of claim 77, wherein the embolic element is a
wire.
82. A method for treating an aneurysm, comprising: enclosing the
aneurysm; and inserting an embolic element into the aneurysm while
the aneurysm is closed.
83. The method of claim 82, wherein the embolic element is inserted
into the aneurysm by delivering wire through a catheter.
84. The method of claim 82, wherein the aneurysm is enclosed with
an inflatable balloon.
85. The method of claim 84, wherein the embolic element is inserted
into the aneurysm by delivering wire through the balloon.
86. An assembly for delivering a medical device into a heart wall
of a patient, comprising: an insertion tube having a proximal end
and a distal end and a delivery channel extending therethrough; a
tubular member having a proximal end and a distal end and a lumen
extending therethrough, the tubular member having a distal portion
provided with an internal spring bias tending to form said distal
portion into an arcuate configuration in the absence of an external
straightening force on said distal portion, the tubular member
being longitudinally slidable in said delivery channel, and wherein
said distal portion may be alternately maintained in a relatively
straightened configuration in the distal end of said channel and
moved outside of said channel to assume said arcuate configuration;
and a guidewire longitudinally slidable within the lumen of the
tubular member.
87. A method for delivering a guidewire at an angle into a desired
insertion site in the body, the method comprising: delivering an
insertion tube into the vasculature of a patient, the insertion
tube having a delivery channel extending therethrough and once
delivered having a proximal end located outside of the patient and
a distal end located adjacent a desired insertion site; delivering
a delivery catheter through the delivery channel, the delivery
catheter having a guidewire lumen extending therethrough, the
delivery catheter once delivered having a proximal end outside of
the patient and a distal end within the delivery channel; ejecting
the distal end of the delivery catheter out of the delivery channel
at the distal end of the insertion tube, the ejection of the
delivery catheter from the delivery channel causing the distal end
of the delivery catheter to turn toward the insertion site; and
advancing a guidewire through the guidewire lumen into the
insertion site.
88. The method of claim 87, wherein the delivery catheter comprises
a tubular member having a distal portion provided with an internal
spring bias tending to form said distal portion into an arcuate
configuration in the absence of an external straightening force on
said distal portion.
89. A method for delivering a guidewire into the heart wall,
comprising: inserting a guidewire into a lumen of a delivery
catheter, the guidewire having a proximal section and a distal
section, the distal section of the guidewire being folded back over
the proximal section while inside the delivery catheter lumen;
delivering the delivery catheter into a patient, the delivery
catheter once delivered having a proximal end outside of the
patient and a distal end adjacent a desired insertion site in the
heart wall; ejecting the distal section of the guidewire out of the
lumen of the delivery catheter at its distal end; and pulling
proximally on the guidewire such that the distal section punctures
into the heart wall at an obtuse angle relative to the direction
that the guidewire is ejected out of the lumen of the delivery
catheter at its distal end.
90. The method of claim 89, further comprising, prior to pulling
proximally on the guidewire, turning the guidewire so that the
distal section faces the heart wall.
91. A method for delivering a guidewire into an insertion site in
the body, comprising: advancing a delivery catheter having a
proximal end and a distal end and a lumen extending therethrough
into the body, the distal end of the delivery catheter once
advanced being located adjacent the insertion site; turning the
distal end of the delivery catheter toward the insertion site; and
advancing a guidewire through the lumen in the delivery catheter
from the proximal end toward the distal end; and guiding the
guidewire out the distal end and into the insertion site through a
narrowing passageway formed in the lumen.
92. A medical guidewire, comprising: an elongate body having a
proximal end and a distal end; and a tip on the distal end having a
screw configuration.
93. A method for delivering a medical device into a body tissue of
a patient comprising: inserting a guidewire having a proximal end
and a distal end into the heart wall from a coronary blood vessel;
anchoring the guidewire to the body tissue; pushing the medical
device over the guidewire into the body tissue; and pulling on the
proximal end of the guidewire while advancing the medical device
through the body tissue.
94. The method of claim 93, wherein anchoring the guidewire
comprises actuating an expandable member.
95. The method of claim 94, wherein the expandable member is an
inflatable balloon.
96. The method of claim 93, further comprising providing at least
one barb on the distal end of the guidewire to anchor the guidewire
to the heart wall.
97. A delivery system for directing a medical treatment at least
partially into the heart wall, comprising: a guidewire having a
proximal end and a distal end; means for turning the distal end of
the guidewire toward the heart wall; means for anchoring the
guidewire to the heart wall; and a catheter carrying the medical
treatment having a lumen extending therethrough for receiving the
guidewire and advancing the catheter into the heart wall.
98. A method for delivering a conduit into the heart wall of a
patient to bypass a blockage formed in a coronary artery,
comprising: advancing a catheter having a proximal end and a distal
end and a lumen extending at least partially therethrough from the
proximal end to a distal opening through the coronary artery of the
patient until the distal opening is past the blockage; turning the
catheter so that the distal opening faces the heart wall; extending
a wire having a proximal end and a distal end through the distal
opening such that the distal end punctures into the heart wall;
anchoring the distal end of the wire to the heart wall; delivering
a dilation catheter over the wire, the catheter carrying a dilation
balloon on a distal end thereof, until the balloon is within the
heart wall; inflating the dilation balloon to create an opening in
the heart wall; deflating the dilation balloon and removing the
dilation catheter from the wire; delivering a conduit introducer
catheter over the wire, the conduit introducer catheter carrying a
conduit on a distal end thereof, until the conduit is located
within the opening in the heart wall, and deploying the conduit
within the opening in the heart wall.
99. The method of claim 98, wherein the conduit is a stent.
100. A method for delivering medical treatment into the heart wall
of a patient, comprising: delivering a tubular wire having a lumen
extending therethrough into the patient, the wire once delivered
having a proximal end extending out of the patient and a distal end
positioned adjacent the heart wall; providing a means for turning
the distal end of the wire towards the heart wall; inserting the
distal end of the wire into the heart wall; and delivering the
medical treatment through the lumen in the wire into the heart
wall.
101. The method of claim 100, wherein delivering medical treatment
through the lumen comprises providing drug fluid into the lumen at
the proximal end.
102. The method of claim 100, wherein the distal end of the wire
further comprises at least one exit port.
103. The method of claim 100, wherein the means for turning the
distal end comprises delivering the wire through a delivery
catheter.
104. The method of claim 103, wherein the means for turning the
distal end further comprises: actuating an anchoring member mounted
on a distal end of the delivery catheter to secure the delivery
catheter within the patient; and actuating a steering member
mounted on the distal end of the tubular body at a position distal
to that of the anchoring member to turn the distal end of the
delivery catheter toward the heart wall.
105. The method of claim 100, wherein the tubular wire is a pull
wire, and the means for turning the distal end comprises actuating
the pull wire.
106. The method of claim 100, wherein the means for turning the
distal end comprises: providing a curved passageway adjacent the
heart wall having a proximal opening for receiving the distal end
of the tubular wire and a side port exit facing the heart wall; and
delivering the tubular wire through the curved passageway.
107. The method of claim 106, wherein the passageway is provided
through a lumen in a delivery catheter.
108. The method of claim 106, wherein the passageway is provided
through an anchoring member mounted to a distal end of a delivery
catheter.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation-in-part of application
Ser. No. 09/150,181, filed Sep. 10, 1998, the entirety of which is
hereby incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to the delivery of a stent or
conduit and other devices into the myocardium of a patient, and
more particularly, to a stent or conduit delivery system to provide
a bypass through the myocardium from the left ventricle into a
coronary artery.
[0004] 2. Description of the Related Art
[0005] Coronary arteries as well as other vessels frequently become
clogged with plaque that at the very least impairs the efficiency
of the heart's pumping action and can lead to heart attack and
death. One conventional treatment for clogged coronary or other
arteries is a bypass operation wherein one or more venous segments
are inserted between the aorta and the coronary artery. The
inserted venous segments or transplants act as a bypass of the
clogged portion of the coronary artery and thus provide for a free
or unobstructed flow of blood to the heart.
[0006] Such coronary artery bypass surgery, however, is expensive,
time-consuming and traumatic to the patient. Hospital stays
subsequent to the surgery and convalescence are prolonged.
[0007] A new coronary artery bypass technique is disclosed in U.S.
Pat. No. 5,429,144. That technique utilizes a stent made of a
biocompatible material and comprises steps of moving the stent in a
collapsed configuration through a blood vessel of a patient's
vascular system to the patient's heart, inserting the stent in the
patient's myocardium, and upon disposition of the stent in the
myocardium, expanding the stent from the collapsed configuration to
a substantially tubular expanded configuration so that a blood flow
path is formed at least partially through the myocardium.
[0008] One problem with the coronary artery bypass method providing
a stent through the myocardium of the heart is how to get the stent
into the myocardium. U.S. Pat. No. 5,429,144 describes a
percutaneous approach wherein the stent is brought to the
myocardium through the patient's vasculature on the distal end of a
catheter, and advanced into the myocardium over a guidewire. One
particular challenge is how to make an angled bend in the guidewire
to puncture through the wall of the vessel and into the myocardium.
This challenge is exacerbated when it is desired to penetrate the
guidewire through the myocardium at an obtuse angle relative to the
direction that the guidewire is advanced through the
vasculature.
[0009] Another problem with this approach is that catheters
delivering the guidewire, stent or other devices to be provided
into the myocardium are conventionally guided to the puncture point
through the blockage in the coronary artery. However, when the
blockage is too large, a delivery catheter cannot access the
desired insertion site.
[0010] In addition, it is often difficult to advance devices into
the myocardium because of the traction and force necessary to push
through the myocardium. This problem arises not only for delivery
of the stent, but also for the delivery of dilation catheters used
to expand the cross-section of the passageway through the
myocardium, and other devices.
[0011] Accordingly, what is needed is a method and apparatus for
delivering guidewires, stents and other devices into the
myocardium. In particular, what is needed is a delivery system that
can deliver these devices at an angled bend for transverse
insertion into the myocardium. Moreover, what is needed is a
delivery method and apparatus for advancing a delivery catheter to
a puncture site in a coronary vessel when the blockage in the
vessel is too large to permit passage of a catheter therethrough.
What is also needed is a method and apparatus for advancement of a
stent, dilation catheter or other device into and through the
myocardium.
SUMMARY OF THE INVENTION
[0012] Briefly stated, the present invention addresses the above
needs by providing various methods and apparatuses for delivering
stents or conduits and other devices into the heart wall or
myocardium of a patient. One preferred stent delivery system
provides access to the insertion site in the myocardium by
advancing a delivery catheter through a blockage in a coronary
artery, or around the blockage through a coronary vein or through a
channel or tunnel formed around the blockage. In one embodiment,
once the distal end of the delivery catheter is adjacent the
myocardium, an angled bend is created in the catheter by actuating
expandable steering guides mounted to the catheter which cooperate
with the walls of the blood vessel to cause the catheter to turn.
Then, a guidewire is advanced through the delivery catheter and
into the myocardium. In another embodiment, a tip-deflecting pull
wire extends from the distal end of the delivery catheter which may
be actuated to turn towards and then inserted into the myocardium.
In another embodiment, an exit port facing the insertion site is
provided within the catheter or a balloon mounted on the catheter
so that a guidewire may be directed through a lumen and out the
exit port into the myocardium. Once the guidewire punctures into
the myocardium, the guidewire is anchored using barbs, balloons or
other actuatable members to secure the guidewire to the myocardium.
Subsequently, using a push-pull mechanism, stents and other medical
devices can be advanced over the guidewire into the myocardium.
[0013] In one aspect of the present invention, a guidewire is
delivered into the patient such that the proximal end of the
guidewire extends out of the patient, while the distal end of the
guidewire is positioned adjacent the heart wall. The distal end of
the guidewire is inserted into the heart wall, and the guidewire is
then anchored to the heart wall. An introducer catheter carrying a
medical device is advanced over the guidewire to deliver the device
into the heart wall.
[0014] In another aspect of the present invention, a method for
delivering a conduit into a heart wall to bypass a blockage formed
in a coronary artery is provided. A channel is created from a
position proximal to the blockage in the coronary artery to a
position distal to the blockage in the coronary artery. A guidewire
is advanced through the channel until a distal end of the guidewire
is adjacent the heart wall. The guidewire is inserted into the
heart wall, and a conduit is advanced over the guidewire into the
heart wall.
[0015] In another aspect of the present invention, a bypass around
a blockage in a blood vessel is formed by delivering a guidewire
along a pathway from a location in the blood vessel proximal to the
blockage to a location in the blood vessel distal to the blockage.
A channel is created along the pathway formed by the guidewire.
This pathway may preferably be created either through the heart
wall or through the pericardial space. The channel may be dilated
and shunted along the pathway defined by the guidewire.
[0016] In another aspect of the present invention, a method is
provided for creating a bypass around a blockage in a coronary
artery, adjacent a heart wall. A needle is inserted into a patient
into the heart wall, the needle having a lumen extending
therethrough. The needle is advanced through the heart wall and
into the coronary artery distal to the blockage. A guidewire is
advanced through the lumen in the needle, the guidewire once
advanced extending through the coronary artery proximal to the
blockage, through the heart wall, and into the coronary artery
distal to the blockage. The needle is removed from the patient
while leaving the guidewire in place. A shunt is advanced over the
guidewire, the shunt once advanced having a distal end in the
coronary artery distal to the blockage.
[0017] In another aspect of the present invention, a method is
provided for creating a bypass through the heart wall of a patient
to bypass a blockage formed in a coronary artery. A first tunnel is
created through the heart wall having a proximal end and a distal
end. The proximal end of the tunnel opens into the coronary artery
proximal to the blockage. The distal end of the tunnel is
positioned within the heart wall. A second tunnel is created
through the heart wall, the second tunnel having a first branch
extending from the distal end of the first tunnel and opening into
the coronary artery at a position distal to the blockage. A second
branch of the second tunnel extends from the distal end of the
first channel and opens into a heart chamber. A conduit is disposed
in the second tunnel to provide a passageway therethrough.
[0018] In another aspect of the present invention, a delivery
catheter is provided. This delivery catheter comprises an elongate
tubular body having a proximal end and a distal end and a lumen
extending therethrough. A first steering member is mounted on the
distal end of the tubular body, and a second steering member is
mounted on the distal end of the tubular body at a position distal
to that of the anchoring member.
[0019] In another aspect of the present invention, a method for
turning a distal end of a catheter within a body lumen is provided.
The catheter comprises an elongate tubular body having a proximal
end and a distal end. An anchoring member mounted to the distal end
is actuated to secure the catheter against the body lumen. A
steering member is mounted to the distal end of the of the
guidewire at a position distal to that of the anchoring member.
When actuated, the steering member cooperates with the body lumen
to turn the distal end of the catheter.
[0020] In another aspect of the present invention, a method is
provided for delivering a medical device to a delivery site within
a patient. This method comprises providing a delivery catheter
having a proximal end and a distal end and a lumen extending
therethrough into a body lumen of the patient. The delivery
catheter is secured within the body lumen. The distal end of the
catheter is turned by actuating a steering member mounted on the
distal end of the catheter which pushes off against a wall of the
body lumen. The medical device is advanced through the lumen of the
delivery catheter and out the distal end.
[0021] In another aspect of the present invention, a method for
delivering a conduit into the heart wall of a patient is provided.
A delivery catheter is advanced into the vasculature of the
patient, the delivery catheter having a proximal end and a distal
end and a lumen extending therethrough, until the distal end is
adjacent the heart wall. A pull wire extending from the distal end
of the delivery catheter is actuated to turn the pull wire toward
the heart wall. The pull wire is advanced from the distal end of
the delivery catheter into the heart wall. The conduit is delivered
over the pull wire into the heart wall.
[0022] In another aspect of the present invention, a method for
delivering a conduit into the heart wall of a patient is provided.
A delivery catheter is advanced into the vasculature of the
patient, the catheter having a proximal end and a distal end and a
lumen extending from the proximal end to a side port near the
distal end, until the side port faces the heart wall. A guidewire
having a proximal end and a distal end is inserted into the lumen.
The distal end of the guidewire is advanced through the lumen and
out the side port. The guidewire advances into the heart wall, and
the conduit is delivered over the guidewire into the heart
wall.
[0023] In another aspect of the present invention, a method for
delivering a conduit into the heart wall of a patient is provided.
A delivery catheter is advanced into the vasculature of a patient,
the catheter having a proximal end and a distal end, until the
distal end is adjacent the heart wall. An anchoring member mounted
on the distal end of the catheter is expanded to secure the
delivery catheter within the vasculature. A guidewire having a
proximal end and a distal end is inserted through a lumen in the
expanded anchoring member, the lumen extending from a proximal end
of the anchoring member to a side port facing the heart wall, so
that the distal end of the guidewire exits through the side port.
The guidewire advances into the heart wall, and the conduit is
advanced over the guidewire into the heart wall.
[0024] In another aspect of the present invention, a delivery
catheter is provided. The catheter comprises an elongate body
having a proximal end and a distal end. An expandable member is
mounted on the distal end of the tubular body, the expandable
member having a proximal end and a distal end and an exterior
surface. A guide lumen extends from the proximal end of the balloon
to a side port on the exterior surface of the expandable member for
directing a medical device therethrough.
[0025] In another aspect of the present invention, a delivery
catheter is provided comprising an elongate body having a proximal
end and a distal end defining a generally longitudinally axis
therebetween. A guidewire lumen extends at least partially between
the proximal end and the distal end of the elongate body, having a
proximal end and a distal end. An exit port at the distal end of
the guidewire lumen creates a curve of between about 0 and 180
degrees relative to the longitudinal axis of the elongate body for
directing a guidewire out of the lumen. In one embodiment, the exit
port is a side port formed proximal to the distal end of the
elongate body. In another embodiment, the exit port is at the
distal end of the elongate body, and comprises a narrowing
passageway between the guidewire lumen and the exit port.
[0026] In another aspect of the present invention, a method for
treating an aneurysm is provided. A catheter having a proximal end
and a distal end is advanced to the site of the aneurysm. An
expandable member mounted on the distal end of the catheter is
actuated to substantially enclose the aneurysm. An embolic element
is inserted into the aneurysm.
[0027] In another aspect of the present invention, an assembly for
delivering a medical device into the heart wall of a patient is
provided. The assembly comprises an insertion tube having a
proximal end and a distal end and a delivery channel extending
therethrough. A tubular member is provided having a proximal end
and a distal end and a lumen extending therethrough, the tubular
member having a distal portion provided with an internal spring
bias tending to form the distal portion into an arcuate
configuration in the absence of an external straightening force on
the distal portion. The tubular member is longitudinally slidable
in the delivery channel. The distal portion may be alternately
maintained in a relatively straightened configuration in the distal
end of the channel and moved outside of the channel to assume the
arcuate configuration. A guidewire is longitudinally slidable
within the lumen of the tubular member.
[0028] In another aspect of the present invention, a method is
provided for delivering a guidewire at an angle into a desired
insertion site in the body. The method comprises delivering an
insertion tube into the vasculature of a patient, the insertion
tube having a delivery channel extending therethrough and once
delivered having a proximal end located outside of the patient and
a distal end located adjacent a desired insertion site. A delivery
catheter is delivered through the delivery channel, the delivery
catheter having a guidewire lumen extending therethrough. The
delivery catheter once delivered has a proximal end outside of the
patient and a distal end within the delivery channel. The distal
end of the delivery catheter is ejected out of the delivery channel
at the distal end of the insertion tube. The ejection of the
delivery catheter from the delivery channel causes the distal end
of the delivery catheter to turn toward the insertion site. A
guidewire is advanced through the guidewire lumen into the
insertion site.
[0029] In another aspect of the present invention, a method is
provided for delivering a guidewire into the heart wall. A
guidewire is inserted into a lumen of a delivery catheter, the
guidewire having a proximal section and a distal section. The
distal section of the guidewire is folded back over the proximal
section while inside the delivery catheter lumen. The delivery
catheter is delivered into a patient, the delivery catheter once
delivered having a proximal end outside of the patient and a distal
end adjacent a desired insertion site in the myocardium. The distal
section of the guidewire is ejected out of the lumen of the
delivery catheter at its distal end. The guidewire is pulled
proximally such that the distal section punctures into the heart
wall at an obtuse angle relative to the direction that the
guidewire is ejected out of the lumen of the delivery catheter at
its distal end.
[0030] In another aspect of the present invention, a method for
delivering a guidewire into an insertion site in the body is
provided. A delivery catheter having a proximal end and a distal
end and a lumen extending therethrough is advanced into the body.
The distal end of the delivery catheter once advanced is located
adjacent the insertion site. The distal end of the delivery
catheter is turned toward the insertion site. A guidewire is
advanced through the lumen in the delivery catheter from the
proximal end toward the distal end. The guidewire is guided out the
distal end and into the insertion site through a narrowing
passageway formed in the lumen.
[0031] In another aspect of the present invention, a method for
delivering a medical device into a body tissue of a patient is
provided. The method comprises inserting a guidewire having a
proximal end and a distal end into the myocardium from a coronary
blood vessel. The guidewire is anchored to the body tissue, and the
medical device is pushed over the guidewire into the body tissue.
The proximal end of the guidewire is correspondingly pulled
proximally while the medical device is pushed distally in order to
assist advancing the medical device through the body tissue.
[0032] In another aspect of the present invention, a delivery
system for directing medical treatment at least partially into a
heart wall is provided. The delivery system comprises a guidewire
having a proximal end and a distal end, means for turning the
distal end of the guidewire toward the heart wall, means for
anchoring the guidewire to the heart wall, and a catheter carrying
the medical treatment having a lumen extending therethrough for
receiving the guidewire and advancing the catheter into the heart
wall.
[0033] In another aspect of the present invention, a method for
delivering a conduit into the heart wall of a patient to bypass a
blockage formed in a coronary artery is provided. The method
comprises advancing a catheter having a proximal end and a distal
end and a lumen extending at least partially therethrough from the
proximal end to a distal opening through the coronary artery of the
patient until the distal opening is past the blockage. The catheter
is turned so that the distal opening faces the heart wall. A wire
having a proximal end and a distal end is extended through the
distal opening such that the distal end punctures into the heart
wall. The distal end of the wire is anchored to the heart wall. A
dilation catheter is delivered over the wire, the catheter carrying
a dilation balloon on a distal end thereof, until the balloon is
within the heart wall. The dilation balloon is inflated to create
an opening in the heart wall. The dilation balloon is then deflated
and the dilation catheter removed from the wire. A conduit
introducer catheter is delivered over the wire, the conduit
introducer catheter carrying a conduit on a distal end thereof,
until the conduit is located within the opening in the heart wall.
The conduit is deployed within the opening in the myocardium.
[0034] In another aspect of the present invention, a method for
delivering medical treatment into the heart wall of a patient is
provided. A tubular wire is delivered into the patient, the wire
having a lumen extending therethrough. The wire once delivered has
a proximal end extending out of the patient and a distal end
positioned adjacent the heart wall. Means for turning the distal
end of the wire towards the heart wall are provided. Then, the
distal end of the wire is inserted into the heart wall. Medical
treatment is delivered through the lumen in the wire into the heart
wall.
BRIEF DESCRIPTION OF THE DRAWINGS
[0035] FIG. 1A is a schematic, cross-sectional view of a human
heart, showing a stent in the myocardium of the heart for forming a
bypass shunt between the left ventricle and a coronary artery.
[0036] FIG. 1B is an enlarged view of the bypass shunt of FIG.
1A.
[0037] FIG. 2 is a schematic, partial cross-sectional view of a
human heart, showing a stent extending partially into the
myocardium from the left ventricle.
[0038] FIG. 3A is a schematic, partial cross-sectional view of a
coronary artery adjacent the left ventricle, showing a delivery
catheter being advanced through a blockage in the coronary
artery.
[0039] FIG. 3B is a schematic, partial cross-sectional view of a
coronary artery adjacent the left ventricle, showing a delivery
catheter being advanced into the left ventricle.
[0040] FIG. 4A is a schematic side view of a venous access route
through a patient's heart.
[0041] FIG. 4B is a schematic, partial cross-sectional view of the
venous access route of FIG. 4A between a coronary vein and a
coronary artery, showing a delivery catheter being advanced through
the coronary vein into the coronary artery.
[0042] FIG. 5 is a schematic, partial cross-sectional view of a
coronary artery adjacent the left ventricle, showing a tunnel
formed through the myocardium to bypass a blockage in the coronary
artery.
[0043] FIG. 6 is a schematic, partial cross-sectional view of a
coronary artery adjacent the left ventricle, showing a delivery
catheter being advanced through a tunnel formed through the
myocardium.
[0044] FIGS. 7A-7G are schematic, partial cross-sectional views of
a coronary artery with a blockage therein, showing a guidewire
method for forming a bypass or access channel through the
myocardium around the blockage.
[0045] FIGS. 8A-8F are schematic, partial cross-sectional views of
a coronary artery with a blockage therein, showing a method for
forming a bypass or access channel into the pericardial space
around the blockage.
[0046] FIGS. 9A-9E are schematic, partial cross-sectional views of
a coronary artery with a blockage therein, showing another method
for forming a bypass or access channel around the blockage.
[0047] FIGS. 10A-10E are schematic, partial cross-sectional views
of a coronary artery with a blockage therein, showing yet another
method for forming a bypass or access channel around the
blockage.
[0048] FIGS. 11A-11F are schematic, partial cross-sectional views
of a coronary artery adjacent the left ventricle, showing a
guidewire method for forming a left ventricular conduit.
[0049] FIG. 12 is a schematic, partial cross-sectional view of a
coronary artery adjacent the left ventricle, showing a Y-shaped
tunnel formed through the myocardium to bypass a blockage in the
coronary artery.
[0050] FIG. 13 is a partial cross-sectional view of the Y-shaped
tunnel of FIG. 12, showing a stent provided therein.
[0051] FIG. 14 is a side view of a delivery catheter carrying two
uninflated steering balloons in a blocked coronary artery, with the
artery shown partially cut away.
[0052] FIG. 15 is a side view of the delivery catheter of FIG. 14,
showing the two balloons partially inflated.
[0053] FIG. 16 is a side view of the delivery catheter of FIG. 14,
showing the two balloons fully inflated and a guidewire extending
from the distal end of the delivery catheter.
[0054] FIG. 17 is a side view of the delivery catheter of FIG. 14,
showing the two balloons fully inflated and a guidewire extending
from the distal end of the delivery catheter at a back angle.
[0055] FIG. 18 is a side view of a delivery catheter with a tip
deflecting wire in a blocked coronary artery, with the artery shown
partially cut away.
[0056] FIG. 19A is a side view of a delivery catheter having a side
port proximal to an inflatable balloon in a blocked coronary
artery, with the artery shown partially cut away.
[0057] FIG. 19B is a cross-sectional view of the delivery catheter
of FIG. 19A, further showing a guidewire extending
therethrough.
[0058] FIG. 20A is a side view of a delivery catheter having a side
port distal to an inflatable balloon in a blocked coronary artery,
with the artery shown partially cut away.
[0059] FIG. 20B is a cross-sectional view of the delivery catheter
of FIG. 20A, further showing a guidewire extending
therethrough.
[0060] FIG. 20C is a cross-sectional view of a delivery catheter
having a side port for delivering a guidewire at a back angle.
[0061] FIG. 21A is a side view of a delivery catheter having a side
port within an inflatable balloon in a blocked coronary artery,
with the artery shown partially cut away.
[0062] FIG. 21B is a cross-sectional view of the delivery catheter
of FIG. 21A, further showing a guidewire extending through the
balloon.
[0063] FIG. 21C is a side view of an alternative embodiment of a
delivery catheter having a side port within an inflatable balloon
in a blocked coronary artery, with the artery shown partially cut
away.
[0064] FIG. 21D is a cross-sectional view of the delivery catheter
of FIG. 21C, further showing a guidewire extending through the
balloon.
[0065] FIG. 22A is a side view of a delivery catheter having a side
port within an inflatable balloon used for treating an aneurysm in
a blood vessel, with the vessel shown partially cut away.
[0066] FIG. 22B is a partial cross-sectional view of a delivery
catheter having a side port within an inflatable balloon used for
treating an aneurysm in a blood vessel, with the vessel shown
partially cut away.
[0067] FIG. 23 is a side view of a delivery catheter having a
curved distal end.
[0068] FIGS. 24A-24C are partial side views of the device of FIG.
23, illustrating the increasing emergence of the delivery catheter
from the distal end of a channel.
[0069] FIGS. 25A-25C are side views showing delivery of the device
of FIG. 23 in a coronary artery adjacent the myocardium, with the
artery and myocardium shown partially cut away.
[0070] FIGS. 26A-26C are schematic, partial cross-sectional views
of a coronary artery adjacent a left ventricle, showing delivery of
a folded guidewire into the myocardium.
[0071] FIG. 27 is a schematic, partial cross-sectional view of a
coronary artery adjacent a left ventricle, showing delivery of a
guidewire through a delivery catheter at a back angle.
[0072] FIG. 28 is a side view of an anchoring guidewire extending
through the myocardium, with the myocardium shown partially cut
away.
[0073] FIG. 29A is a side view of a guidewire carrying an
inflatable balloon on its distal end extending through the
myocardium, with the myocardium shown partially cut away.
[0074] FIG. 29B is a side view of the guidewire of FIG. 29A,
showing the balloon inflated to anchor the guidewire against the
myocardium.
[0075] FIGS. 30A-30C are side views of an alternative embodiment of
a guidewire anchored to the inner wall of the myocardium, with the
myocardium shown partially cut away.
[0076] FIG. 31 is a perspective view of a guidewire with a screw
tip.
[0077] FIG. 32 is a side view of a dilation catheter in a coronary
artery advanced over a guidewire extending into the myocardium,
with the artery and the myocardium shown partially cut away.
[0078] FIG. 33 is a side view of the dilation catheter of FIG. 32
advanced into the myocardium.
[0079] FIG. 34 is a side view of a stent introducer catheter in a
coronary artery advanced over a guidewire extending into the
myocardium, with the artery and myocardium shown partially cut
away.
[0080] FIG. 35 is a side view of the stent introducer catheter of
FIG. 34 advanced into the myocardium.
[0081] FIG. 36 is a side view of a drug delivery wire advanced
through a coronary artery into the myocardium, with the artery and
the myocardium shown partially cut away.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0082] The preferred embodiments described hereinbelow depict
methods and apparatuses for delivering a stent or conduit into the
myocardium to create a passageway between the left ventricle and
coronary artery. It should be appreciated, however, that these
embodiments may also be applied to the delivery of stents or
conduits and other medical devices into other body tissues and
vessels, and are particularly applicable for delivering devices at
an angle relative to the axis of blood flow. In addition, the
delivery methods and apparatuses described herein pertain to the
placement of stents or conduits and other devices partially through
the myocardium, as well as for drug delivery and similar
applications.
[0083] The principles of the present invention are not limited to
left ventricular conduits, and include conduits for communicating
bodily fluids from any space within a patient to another space
within a patient, including any mammal. Furthermore, such fluid
communication through the conduits is not limited to any particular
direction of flow and can be antegrade or retrograde with respect
to the normal flow of fluid. Moreover, the conduits may communicate
between a bodily space and a vessel or from one vessel to another
vessel (such as an artery to a vein or vice versa). Moreover, the
conduits can reside in a single bodily space so as to communicate
fluids from one portion of the space to another. For example, the
conduits can be used to achieve a bypass within a single vessel,
such as communicating blood from a proximal portion of an occluded
coronary artery to a more distal portion of that same coronary
artery.
[0084] In addition, the conduits and related methods can preferably
traverse various intermediate destinations and are not limited to
any particular flow sequence. Preferred embodiments are disclosed,
including direct transmyocardial communication from a left
ventricle, through the myocardium and into the coronary artery. The
term "transmyocardial" should not be narrowly construed in
connection with the preferred fluid communication conduits, and
other non-myocardial and even non-cardiac fluid communication are
preferred as well. With respect to the walls of the heart (and more
specifically the term "heart wall"), the preferred conduits and
related methods are capable of fluid communication through all such
walls including, without limitation, the pericardium, epicardium,
myocardium, endocardium, septum, etc.
[0085] The bypass which is achieved with certain preferred
embodiments and related methods is not limited to a complete bypass
of bodily fluid flow, but can also include a partial bypass which
advantageously supplements the normal bodily blood flow. Moreover,
the occlusions which are bypassed may be of a partial or complete
nature, and therefore the terminology "bypass" or "occlusion"
should not be construed to be limited to a complete bypass or a
complete occlusion but can include partial bypass and partial
occlusion as described.
[0086] The preferred conduits and related methods disclosed herein
can also provide complete passages or partial passages through
bodily tissues. In this regard, the conduits can comprise stents,
shunts, or the like, and therefore provide a passageway or opening
for bodily fluid such as blood. Thus, although many of the
preferred embodiments describe stents or shunts, it will be
appreciated that other types of conduits may be used as well.
Moreover, the conduits are not necessarily stented or lined with a
device but can comprise mere tunnels or openings formed in the
tissues of the patient.
[0087] The conduits of the present invention preferably comprise
both integral or one-piece conduits as well as plural sections
joined together to form a continuous conduit. The present conduits
can be deployed in a variety of methods consistent with sound
medical practice including vascular or surgical deliveries,
including minimally invasive techniques, as described below. For
example, various preferred embodiments of delivery rods and
associated methods may be used. In one embodiment, the delivery rod
is solid and trocar-like. It may be rigid or semi-rigid and capable
of penetrating the tissues of the patient and thereby form the
conduit, in whole or in part, for purposes of fluid communication.
In other preferred embodiments, the delivery rods may be hollow so
as to form the conduits themselves (e.g., the conduits are
preferably self-implanting or self-inserting) or have a conduit
mounted thereon (e.g., the delivery rod is preferably withdrawn
leaving the conduit installed). Thus, the preferred conduit device
and method for installation is preferably determined by appropriate
patient indications in accordance with sound medical practices.
[0088] As illustrated in FIGS. 1A and 1B, a coronary artery bypass
is accomplished by disposing a stent 10 in a heart wall or
myocardium MYO of a patient's heart PH. The stent 10 preferably
extends from the left ventricle LV of heart PH to a clogged
coronary artery CA at a point downstream of a blockage BL to create
a shunt 12 therethrough. Stent 10 is preferably made of a
biocompatible material such as stainless steel or nitinol, although
other materials such as Ti, Ti alloys, Ni alloys, Co alloys and
biocompatible polymers may also be used. In one embodiment, stent
10 has a one way valve 14 to allow blood to flow from the left
ventricle LV to the coronary artery CA. Although the stent 10 may
elastically deform under the contractive pressure of the heart
muscle during systole, the stent remains open to allow blood to
pass from the patient's left ventricle LV into the coronary artery
CA. During diastole, the blood pumped into coronary artery through
shunt 12 is blocked by one-way valve 14 from returning to left
ventricle LV. Further details are disclosed in U.S. Pat. No.
5,429,144, the entirety of which is hereby incorporated by
reference. Various types of conduits or stents and medical devices
and their methods of delivery, may also be used in accordance with
the preferred embodiments described herein, such as described in
copending applications entitled DESIGNS FOR LEFT VENTRICULAR
CONDUIT [Attorney Docket No. PERCAR.013A], application Ser. No. ,
filed the same date herewith, LEFT VENTRICULAR CONDUITS WITH BLOOD
VESSEL GRAFT [Attorney Docket No. PERCAR.005A], application Ser.
No. , filed the same date herewith, VALVE DESIGNS FOR LEFT
VENTRICULAR CONDUIT [Attorney Docket No. PERCAR.006A], application
Ser. No. , filed the same date herewith, LEFT VENTRICULAR CONDUITS
TO CORONARY ARTERIES AND METHODS FOR CORONARY BYPASS [Attorney
Docket No. PERCAR.033CP1], application Ser. No. , filed the same
date herewith, and BLOOD FLOW CONDUIT DELIVERY SYSTEM AND METHOD OF
USE [Attorney Docket No. PERCAR.040A], application Ser. No. , filed
the same date herewith, and U.S. Pat. No. 5,662,124, all of which
are hereby incorporated by reference in their entirety.
[0089] FIG. 2 illustrates another application for which it is
desirable to dispose a stent into the myocardium of a patient. In
this application, a stent 10 is provided partially through the
myocardium MYO from the left ventricle LV. The stent 10 guides
blood directly into the myocardium MYO from the left ventricle to
replenish oxygen-deprived heart muscle. Further details are
disclosed in the above-referenced U.S. Pat. No. 5,429,144. Other
applications providing a stent in the myocardium, extending either
partially or entirely therethrough and accessed from either the
coronary artery or the left ventricle, are also contemplated by the
present invention.
[0090] To achieve some or all of the objects of the present
invention, in particular creating a myocardial passageway between
the left ventricle LV and the coronary artery CA for disposition of
a stent therein, requires a delivery system capable of directing
the necessary devices to and into the myocardium. As described in
further detail below, the suitable delivery system: (1) provides
access to the insertion site adjacent the myocardium; (2) creates
an angled bend for transverse insertion of devices into the
myocardium; and (3) directs devices into the myocardium for
creation of the myocardial passageway.
[0091] I. Access To The Myocardium
[0092] The delivery system described herein preferably comprises
one or more catheters or guidewires inserted percutaneously into
the body, such as through the femoral artery and advanced in the
patient's vasculature through the aorta AO, shown in FIG. 1A. It
should be appreciated that the percutaneous approach is not
essential to achieve many of the objects of the invention, and
therefore, an open-chest or other approach may also be used.
Furthermore, access to a treatment site using a saphenous vein
graft (SVG) is also contemplated, as disclosed in assignee's
copending application entitled VASCULAR GRAFT BYPASS [Attorney
Docket No. PERCAR.041A], application Ser. No. , filed the same date
herewith, the entirety of which is hereby incorporated by
reference.
[0093] As shown in FIG. 3A, an exemplary delivery catheter or
guidewire 20 which has been advanced percutaneously, for example,
through the femoral artery and through aorta AO is advanced through
the blockage BL in the coronary artery CA. The distal tip 22 of the
catheter is delivered past the blockage so that it is positioned
adjacent to a desired insertion point into the myocardium MYO. FIG.
3B shows an alternative access method wherein the catheter 20 is
delivered to a position adjacent the myocardium through the left
ventricle LV.
[0094] FIGS. 4A and 4B depict an alternative access route used when
a blockage in the coronary artery is too large for the catheter to
be passed therethrough. In this alternate embodiment, a delivery
catheter 20 enters the body through an access point preferably in
the femoral vein (not shown). The catheter is advanced up the vein
to the vena cava VC and into the right atrium RA, as shown in FIG.
4A. Then, the catheter 20 is directed into the coronary sinus CS,
and then to the coronary vein CV which runs adjacent to the
coronary artery CA.
[0095] As shown in FIG. 4B, after the distal tip 22 of catheter 20
is past the blockage BL in the adjacent coronary vein, the delivery
catheter 20 is inserted through the vessel wall VW separating the
coronary vein CV from the coronary artery CA. Steering of catheter
20 between coronary vein CV and coronary artery CA may be
accomplished using the methods and apparatus for turning catheters
discussed in further detail below, or other suitable methods. As
described in further detail below, the delivery catheter is turned
toward the myocardium MYO either for insertion into the myocardium
or for directing a guidewire to puncture therethrough. Access to
the insertion point may also be accomplished by steering the
delivery catheter through the coronary artery CA to a point
proximal to the blockage, directing the catheter into the coronary
vein to bypass the blockage, and reinserting the catheter from the
coronary vein into the coronary artery past the blockage, as shown
in FIG. 4B.
[0096] An alternative method of accessing the myocardium MYO when
the blockage BL is too large to pass a catheter therethrough
employs creating a channel around the blockage. As illustrated in
FIG. 5, a tunnel 24 is created from the coronary artery CA into the
myocardium MYO at a point proximal to the blockage BL. The tunnel
may be created using radiation, lasers, or a surgical drill, or any
other suitable methods for creating a tunnel. The tunnel 24 extends
underneath the blockage BL and connects with the coronary artery CA
at a point distal to the blockage BL. As shown in FIG. 6, a
delivery catheter 20 is advanced through the coronary artery CA,
into the tunnel 24, and back into the coronary artery CA past the
blockage BL. It will be appreciated that other methods for
diverting a delivery catheter around a blockage may be used, such
as directing the catheter through a shunt into the pericardial
space outside the coronary artery, as described below. Furthermore,
the tunnel 24 may be stented with a shunt to keep the tunnel 24
open, and to provide a bypass around the blockage, as described
below.
[0097] While the tunnel 24 shown in FIG. 6 is described as
providing access to a myocardial insertion point for a coronary
bypass, it should also be appreciated that this tunneling technique
may be useful for obliteration of the blockage BL. In particular,
conventional methods for ablating a blockage only permit access to
the blockage from one side. By employing the tunneling method shown
in FIG. 6, however, a blockage BL can be treated not only from its
proximal end, but also from its distal end simultaneously.
[0098] FIGS. 7A-7G illustrate a preferred guidewire method for
forming a channel through the myocardium. As shown in FIG. 7A, in
this method, a delivery catheter 200 is delivered into the coronary
artery CA proximal to the blockage BL. The delivery catheter 200
has a proximal end 202 (not shown) and a distal end 204 and a lumen
206 (not shown) extending therethrough. Using any of the methods
described below, or other suitable methods, the distal end 204 of
the delivery catheter 200 is turned toward the myocardium MYO.
Then, as shown in FIG. 7B, a guidewire 208 exits from the lumen 206
at the distal end 204 of the delivery catheter 200 into the
myocardium. This guidewire 208 may be formed of a shape memory
alloy material such as nitinol, having a preestablished curved
shape that allows the guidewire to curve beneath the blockage BL
and out of the myocardium MYO into the coronary artery CA distal to
the blockage, as shown in FIG. 7C.
[0099] The myocardium MYO is then preferably dilated along the path
formed by the guidewire 208 in the myocardium. FIG. 7D illustrates
that the myocardium may be dilated by inserting a catheter 210 over
the guidewire 208, the catheter 210 effectively forming a pathway
through the myocardium. It will be appreciated that other methods
for dilating the pathway, including balloons, radiation, drills and
lasers, may also be used. Once dilated, a myocardial tract 212
extends from proximal the blockage to distal the blockage, as shown
in FIG. 7E.
[0100] The myocardial tract 212 allows for access to the coronary
artery distal to the blockage BL. FIG. 7F further illustrates that
this tract 212 may also receive a shunt 220 to keep the tract open.
As shown in FIG. 7F, the shunt 220 is preferably delivered through
delivery catheter 200, and may be delivered over the guidewire 208.
As shown in FIG. 7G, the shunt 220 has a proximal end 222 and a
distal end 224 and a lumen 226 (not shown) extending therethrough.
In one embodiment, as shown in FIG. 7G, once the shunt is
delivered, the proximal end 222 and the distal end 224 both extend
out into the flow path of the coronary artery CA. This enables
easier guidance of stents and other medical devices through the
shunt 220 because devices delivered through the coronary artery
need not necessarily be turned into the myocardium MYO.
Furthermore, the lumen 226 connecting the proximal end 222 to the
distal end 224 may also serve as a blood flow path providing a
bypass around the blockage BL.
[0101] FIGS. 8A-8F depict another method wherein a bypass or access
channel is formed through the pericardial space PS around a
blockage BL. FIG. 8A illustrates a blockage in a coronary artery CA
adjacent the myocardium MYO. A delivery catheter 200, such as
described above, is advanced to a point proximal to the blockage in
the coronary artery CA. The distal end 204 of the catheter 200 is
turned toward the anterior wall AW of the coronary artery, as shown
in FIG. 8A. A guidewire 208 extending through the lumen 206 (not
shown) of the delivery catheter 200 is advanced out of the distal
end 204 and punctures through the anterior wall.
[0102] As shown in FIGS. 8B-8C, the guidewire 208 navigates through
the pericardial space PS around the blockage BL. The guidewire 208
may be provided with a mini-endoscope to aid in navigation through
the pericardial space PS. Turning of the guidewire around the
blockage may be accomplished by using a guidewire 208 made of a
shape memory alloy material, and providing the guidewire 208 with a
preestablished curved shape that will turn the guidewire back into
coronary artery CA distal to the blockage. The guidewire may also
be turned by using forceps to move the guidewire in the pericardial
space.
[0103] As shown in FIG. 8D, the guidewire 208 reenters the coronary
artery CA distal to the blockage BL. A shunt 220, illustrated in
FIG. 8E, is then delivered through the coronary artery proximal to
the blockage BL, over the guidewire, into the pericardial space PS,
and back into the coronary artery distal to the blockage. Once
delivered, the shunt 220 has a proximal end 222 and a distal end
224 extending into the flow path of the coronary artery as shown in
FIG. 8F. A lumen 226 (not shown) extends between the two ends that
provides an access channel to deliver devices to a point distal the
blockage in the coronary artery CA. This lumen 226 also may serve
as a blood flow conduit to provide a bypass around the
blockage.
[0104] FIGS. 9A-9E illustrate another embodiment for delivering a
shunt to create a bypass or access channel around a blockage BL. As
shown in FIG. 9A, a needle 228 punctures the anterior wall AW of
coronary artery CA from the pericardial space PS. The needle is
preferably preshaped in a curved configuration such that when
needle 228 is advanced, it punctures the lower wall LW facing
myocardium MYO, advances underneath the blockage BL through the
myocardium MYO, and curves back out of the myocardium MYO through
lower wall LW. The needle 228 then preferably punctures through
anterior wall AW into pericardial space PS, as shown in FIG. 9B.
The needle 228 is preferably hollow, and allows a guidewire 208 to
pass therethrough, as shown in FIG. 9C once the needle has been
removed. A shunt 220 is then advanced over the guidewire 208 until
a proximal end 222 of the shunt is in the pericardial space PS
proximal to the blockage, and a distal end 224 of the shunt is in
the pericardial space PS distal to the blockage, as shown in FIG.
9D. The shunt 220 may be collapsible, and inserted through a
delivery tube over the guidewire, or by other methods known to one
of skill in the art. As shown in FIG. 9E, the guidewire 208 is
removed, and the proximal and distal ends 222 and 224,
respectively, of the shunt are moved into the coronary artery CA to
complete the blood flow conduit around the block BL. The openings
formed in the anterior wall due to puncturing by the shunt is
preferably closed with sutures 229 or by other closure means.
[0105] FIGS. 10A-10E illustrate a similar technique for creating a
conduit around a blockage, except as shown in FIG. 10B, the needle
228 is advanced until its distal tip is in the coronary artery
rather than out in the pericardial space PS. Then, after the
guidewire 208 is advanced and the needle is removed (FIG. 10C), the
shunt 220 is advanced such that distal end 224 is placed in the
coronary artery CA. As shown in FIG. 10E, only proximal end 222
then need be moved out of the pericardial space PS into the
coronary artery CA, with sutures 229 preferably closing the
artery.
[0106] FIGS. 11A-11F illustrate a method and apparatus for
delivering a shunt directly from the left ventricle to the coronary
artery. As shown in FIG. 11A, a needle 228 is inserted into the
myocardium MYO, preferably adjacent to the coronary artery CA, at a
position generally proximal to a blockage BL in the coronary artery
CA. As shown in FIG. 11B, the needle 228 is preferably curved in a
manner that as it is advanced through the myocardium MYO, it enters
the left ventricle LV, and then reenters the myocardium MYO toward
the coronary artery CA. In one embodiment, shown in FIG. 11B,
needle 228 enters the coronary artery CA and punctures the anterior
wall into pericardial space PS. In another embodiment, shown in
FIG. 11C, needle 228 only advances until it is within coronary
artery CA.
[0107] Needle 228 is preferably hollow to allow a guidewire 208 to
pass therethrough. This guidewire 208 is shown in FIG. 11D after
the needle 228 has been removed. It will be appreciated that
although FIG. 11D illustrates the embodiment wherein the needle 228
does not puncture through anterior wall AW, the guidewire 208 may
also be provided through the anterior wall into pericardial space
PS through the needle of FIG. 11C. As shown in FIG. 11E, a shunt
220 is delivered over the guidewire, preferably using a pushing
rod, delivery catheter, or other method known to one of skill in
the art, such that its proximal end 222 opens into the left
ventricle LV and its distal end 224 opens into the coronary artery
CA, as shown in FIG. 11F. Once the guidewire 208 is removed, the
shunt 220 provides a left ventricular conduit to the coronary
artery CA. This shunt is preferably angled to provide downstream
flow of blood from out of the conduit into the coronary artery
CA.
[0108] In another embodiment, a tunnel is created through the
myocardium MYO from a point proximal to a blockage in the coronary
artery into the left ventricle. As shown in FIG. 12, where a
blockage BL substantially occludes a coronary artery CA, a first
tunnel 26 is formed proximally of the blockage BL extending into
the myocardium MYO beneath the blockage BL. The tunnel 26 has a
proximal end 28 which opens into the coronary artery CA proximal to
the blockage BL, and a distal end 30 within the myocardium MYO
beneath the blockage BL. A second tunnel 32 extends from the distal
end 30 of the first tunnel, with a first branch 34 opening a
channel to the coronary artery CA past the location of the blockage
BL. A second branch 36 of the second tunnel 32 extends downward
from the distal end 30 and opens into the left ventricle LV. As
illustrated in FIG. 12, a substantially Y-shaped passageway is
thereby created through the myocardium MYO to bypass the blockage
BL.
[0109] As shown in FIG. 13, after formation of the Y-shaped
passageway in the myocardium MYO, one or more stents 10 are
provided in the second tunnel 32 extending between the left
ventricle LV and the coronary artery CA. This stent 10 opens the
myocardial passageway which provides the bypass past blockage BL.
Positioning of stent 10 in the tunnel 32 is preferably accomplished
by advancing a guidewire through the first tunnel 26 and into each
branch 34 and 36 of the second tunnel 32, and then advancing the
stent over the guidewire in the manner described below. After
placement of the stent, the tunnel 26 between the coronary artery
CA and stent 14 is preferably closed at least at distal end 30, and
more preferably, also at proximal end 28. Closure of the tunnel may
be accomplished by inserting plugs or other blocking means 38, or
by sealing the tunnel with sutures or similar methods. Other
suitable closure means include occlusion coils and balloons,
adhesives such as cyanoacrylate, and plugs such as sold under the
trade name GELFOAM. Alternatively, the tunnel may be closed due to
the natural contraction of the openings 28 and 30 over time.
[0110] It will be appreciated that while the above embodiments
describe forming a channels, either through the myocardium or
through the pericardial space, the channel may also be formed by
other pathways exiting the blood vessel proximal to a blockage and
reentering the vessel distal to the blockage. With respect to the
above described embodiments, it will be appreciated that prior to
delivering the stent over the guidewire, the passageway may be
dilated using the methods described below. Furthermore, the
guidewire 208 may be anchored to the myocardium as described
below.
[0111] II. The Delivery Catheter
[0112] Once access to the desired insertion site is achieved, an
appropriate delivery system is brought to the site. The preferred
embodiments described hereinbelow are directed to a delivery system
for inserting stents and other medical devices into the myocardium
at an angle relative to the axis of blood flow. It should be
appreciated that the angle of insertion may be adjusted between 0
and 180 degrees depending on the desired application. Furthermore,
while the delivery systems below describe insertion of devices into
the myocardium, these systems also enable angled delivery of
medical devices into and through other body lumens and tissues.
[0113] A. Dual Balloon Delivery System
[0114] In one embodiment, the stent delivery system comprises a
catheter which creates an angled bend for insertion of devices into
the myocardium MYO. FIG. 14 illustrates a delivery catheter 40
which has been advanced into the coronary artery CA past the
blockage BL. Catheter 40 is an elongate tubular body 42 having a
lumen 44 (not shown) extending from a proximal end 46 (not shown)
to a distal end 48. The catheter 40 is preferably formed from a
flexible biocompatible material such as polymers, stainless steel
or nitinol.
[0115] Mounted adjacent distal end 48 of catheter 40 are two
steering guides, which are preferably expandable members such as
inflatable balloons 50 and 52. As illustrated in FIG. 14, a
steering member, such as balloon 52, is preferably located distally
of an anchoring member, such as balloon 50, such that steering
balloon 52 is disposed near or at the very distal tip 48 of the
catheter 40. Balloons 50 and 52 are each preferably mounted on
opposite sides of the catheter tubular body 42, such that anchoring
balloon 50 is mounted facing lower wall LW adjacent the myocardium
MYO, and steering balloon 52 is mounted facing upper wall UW
opposite lower wall LW. Alternatively, the anchoring balloon 50 may
be mounted concentrically around the tubular body 42 so that
inflation of the balloon expands against both the upper and lower
walls. It will be appreciated that other devices, such as filters,
posts and other expandable members may be used for the anchoring
and/or steering members.
[0116] As shown in FIG. 14, as the catheter 40 is advanced into
position adjacent the myocardium MYO, the balloons 50 and 52 remain
uninflated. As illustrated in FIG. 15, once the distal tip 48 of
the catheter 40 is positioned adjacent the desired insertion site
into the myocardium MYO, the balloons 50 and 52 are inflated.
Inflation causes the balloons 50 and 52 to cooperate with the walls
of the blood vessel to turn the distal end of the catheter. More
particularly, in an intermediate state, anchoring balloon 50
inflates against the lower wall LW of the coronary artery CA, while
steering balloon 40 presses against the upper wall UW.
[0117] As illustrated in FIG. 16, anchoring balloon 50 acts to
secure the tubular body 42 within the coronary artery CA. Inflation
of balloon 50 also preferably causes the catheter 40 to displace in
a direction opposite lower wall LW, thereby placing the catheter
into a better position for transverse insertion of the distal end
48 into the myocardium MYO. Steering balloon 52 is further
inflated, causing the distal tip 48 of the tubular body 32 to turn
downward towards lower wall LW and myocardium MYO due to the
resistance provided by upper wall UW against the balloon. FIG. 16
also illustrates the effect that the dual balloon inflation may
have on the upper and lower walls of the coronary artery CA. When
balloons 50 and 52 are fully inflated, forces created on the lower
wall LW and upper wall UW, respectively, may cause the walls to
shift at least slightly in the direction of balloon inflation. In
particular, the lower wall LW may have a tendency to bend upwards
distally of the balloon 50 toward the distal end 48 of delivery
catheter 40 to assist in angling of the catheter.
[0118] Due to the turning action of catheter 40 caused by inflation
of balloons 50 and 52, as well as the bending of lower wall LW
toward distal end 48, once inflation of the balloons 50 and 52 is
complete, the distal tip 48 of catheter 30 is positioned at a
substantially transverse angle to the lower wall LW of the coronary
artery CA and the myocardium MYO. From this position, the catheter
40 may serve as a guide for the delivery of devices used in
creating a myocardial passageway. For example, as shown in FIG. 16
and described in further detail below, a puncture wire or guidewire
100 is advanced through the lumen 44 of tubular body 42, and then
ejected out the distal tip 48 of the catheter 40 to puncture the
lower wall LW into the myocardium MYO.
[0119] The dual balloon delivery system described above is also
advantageous in that it allows turning of the catheter 40 at angles
greater than 90 degrees relative to the direction of blood flow
through the coronary artery CA. Thus, as shown in FIG. 17, the
balloons 50 and 52 may be inflated to angle the distal end 48 of
the catheter 40 at a back angle toward the myocardium.
[0120] B. Pull Wire Actuator
[0121] FIG. 18 illustrates another embodiment for delivering
devices transversely into the myocardium MYO of a patient's heart.
A catheter 54 is shown extending through the coronary artery CA
past a blockage BL. Catheter 54 comprises an elongate tubular body
56 with a lumen 58 (not shown) extending therethrough from a
proximal end 60 (not shown) to a distal end 62. A tip-deflecting
puncture wire or pull wire 64 extends from the distal end 62 of the
catheter 54. The wire 64 is actuated at the proximal end (not
shown) so that it deflects to form a near 90 degree angle relative
to the catheter 54. It will be appreciated that the wire 64 may
also be actuated to form angles of less than or greater than 90
degrees. The distal tip 66 of wire 64 is turned so that it is
provided adjacent the myocardium MYO. This shape can be locked and
the wire 64 is pushed forward through the coronary artery CA and
into the wall of the myocardium MYO. As described in further detail
below, with the wire 64 in place medical devices are delivered over
the wire into the myocardium.
[0122] C. Side Port
[0123] In another embodiment, a delivery catheter is provided with
a side port which allows a puncture wire to exit therethrough. As
shown in FIGS. 19A and 20A, delivery catheter 70 comprises an
elongate tubular body 72 having a proximal end 76 (not shown) and a
distal end 78 and a lumen 74 (not shown) extending at least
partially therethrough. Preferably, mounted on distal end 78 is an
expandable or anchoring member such as inflatable balloon 80, which
is inflated to maintain the position of the catheter 70 within the
artery. The balloon 80 is preferably a perfusion type balloon
having a channel 86 to allow blood flow through the artery during
the procedure. Alternatively, filters or other devices which allow
blood flow through the artery while anchoring the catheter 70 may
also be utilized. Perfusion may also be provided through a lumen in
the tubular body 72. A distal opening or side port exit 82 is
provided through the wall of tubular body 72 near the distal end of
the catheter extending from lumen 74. The side port 82 may be
located either proximal to the balloon 80, as in FIG. 19A, or
distal to the balloon 80, as in FIG. 20A. Catheter 70 is delivered
through the vasculature until the side port exit 82 is past the
location of the blockage BL. Prior to balloon inflation, the
catheter 70 is turned about its longitudinal axis so that the
opening 82 faces the myocardium.
[0124] FIGS. 19B and 20B illustrate the pathway for a guidewire 100
to pass through the lumen 74 of catheter 70. In FIG. 19B, guidewire
100 extends through the lumen 74 toward the distal end 78 of the
catheter. Proximal to balloon 80, the lumen 74 turns downward
toward side port exit 82. Thus, before guidewire 100 reaches the
proximal end of balloon 80, the guidewire 100 is directed out of
the side port 82 toward the lower wall LW of the coronary artery
CA. A second lumen 84 is also provided within catheter 70 to direct
inflation fluid to balloon 80.
[0125] FIG. 20B shows substantially the same configuration except
that the lumen 74 extends through the balloon 80 such that the side
port exit 82 is located distal to the balloon 80. Guidewire 100
therefore extends through lumen 74 and out side port exit 82 toward
the lower wall LW. As with FIG. 19B, a second lumen 84 is provided
through tubular body 72 to direct inflation fluid into the balloon
80.
[0126] In another embodiment, as shown in FIG. 21A, the side port
82 is located on an exterior surface of the balloon 80. After the
catheter 70 is delivered to a location past the blockage BL,
balloon 80 is inflated. As shown in the cross-sectional view of
FIG. 21B, balloon 80 preferably comprises a perfusion channel 86
extending from the proximal end to the distal end of the balloon 80
to allow blood to flow through the vessel. A lumen 74 is provided
through the catheter 70 which extends into balloon 80 and turns
downward into side port exit 82. The catheter 70 also has a lumen
84 for inflation of balloon 80. Guidewire 100 is advanced through
lumen 74 and out side port exit 82 into the myocardium MYO.
[0127] FIGS. 21C and 21D illustrate yet another embodiment of a
delivery catheter with a side port exit. The catheter 70 comprises
an elongate tubular body 72 having a lumen 74 extending from a
proximal end 76 (not shown) to distal end 78. This lumen 74 is in
fluid communication with balloon 80 to provide inflation of the
balloon. When inflated, balloon 80 has a perfusion lumen 86 which
allows blood to perfuse therethrough. The balloon 80 also has a
guide lumen 88 extending therethrough which, when inflated, extends
from a proximal end of the balloon to the lower wall LW. A
guidewire 100 may then be inserted through the guide lumen 88 and
out side port exit 82 into the myocardium MYO.
[0128] Although the side port exit 82 as illustrated in FIGS.
19A-21D is shown to cause the guidewire 100 to exit at an
approximately 90 degree angle, it will be appreciated that the side
port exit 82 can cause the guidewire 100 to exit at angles less
than or greater than 90 degrees as well. This may be accomplished
by creating a turn within the lumen 74 near the exit 82 to direct
the guidewire in the desired direction. A lumen 74 creating this
desired angle is shown in FIG. 20C. More particularly, because of
the path formed by the lumen 74 at the side port exit 82, guidewire
100 may exit at an obtuse angle relative to the insertion direction
of the catheter 70. It will be appreciated that the lumens 74 in
FIGS. 19B and 21B and the lumen 88 in FIG. 21D may be turned to
vary the angle the guidewire 100 exits the side port 82 anywhere
from about 0 to 180 degrees.
[0129] The delivery catheters described and shown in FIGS. 21A-21D
are useful not only for disposing a stent into the myocardium but
also for the treatment of aneurysms. Aneurysms are typically
treated by introducing embolic elements to fill the aneurysm. When
the aneurysm opens substantially into the blood vessel, it becomes
difficult to retain the embolic elements within the aneurysm while
the aneurysm is being filled. FIG. 22A illustrates a method for
solving this problem using the delivery catheter 70 described above
with respect to FIGS. 21C and 21D. In a blood vessel 90 with an
aneurysm 92, a catheter 70 carrying inflatable balloon 80 is
advanced such that the balloon 80 is adjacent the aneurysm 92. The
balloon 80 is inflated to substantially enclose the aneurysm 92. A
wire 94 or other embolic element is advanced through the guide
lumen 88 of balloon 80 and out side port 82. The wire 94 fills up
the aneurysm 92, and is maintained in the aneurysm due to the fact
that the balloon 80 encloses the aneurysm to prevent wire 94 from
extending into the vessel. It should be appreciated that the wire
94 or other embolic element may also be delivered through a lumen
74, as shown with respect to the embodiment in FIG. 21B. After the
aneurysm 92 is filled with wire 94, the wire 94 is cut, the balloon
80 is deflated, and the catheter 70 is removed from the vessel.
[0130] FIG. 22B illustrates another embodiment of the balloon 80 as
described above for treating an aneurysm 92. The balloon 80 is
mounted on catheter 70 which has an inflation lumen (not shown)
extending therethrough for inflating the balloon. Perfusion lumen
86 extends through the balloon 80 as shown when the balloon is
inflated, to allow blood to flow from proximal of the balloon to
distal of the balloon. Guide lumen 88 extends from the proximal end
of the balloon to the side of the balloon facing the aneurysm,
terminating in an exit port 82. The guide lumen 88 is preferably
funnel-shaped or tapered, having an opening 81 at the proximal end
of the balloon that is larger than the opening of the side port
exit 82. This enables wire 94 to more easily be directed through
the balloon 80 into the aneurysm 92. Because blood may also flow
into the guide lumen 88 into the aneurysm, an outflow lumen 83 is
provided in the balloon 80, creating fluid communication between
the aneurysm and the distal end of the balloon to allow blood to
flow out of the aneurysm 92.
[0131] It will be appreciated that insertion of the embolic element
need not be through the balloon 80. For instance, a separate
catheter may be used to deliver wire or other embolic elements into
the aneurysm, while a balloon 80 such as described above encloses
the aneurysm. In one embodiment, a catheter delivering a wire may
be inserted into the aneurysm prior to inflating a balloon 80 such
as described above. The balloon is then inflated, and the aneurysm
is filled with wire exiting from the catheter. It will also be
appreciated that devices other than balloons may be used to enclose
the aneurysm while embolic elements are delivered into the
aneurysm.
[0132] D. Delivery Catheter Turning Guide
[0133] FIGS. 23-24C illustrate another method for delivering a
guidewire at an angle into the myocardium. As illustrated in FIG.
23, a delivery catheter 300 comprises a tubular member 302 having a
proximal end 304 and a distal end 306 and a lumen 308 extending
therethrough. A distal portion 310 is provided with a spring bias
or memory tending to form the distal end portion into an arcuate
configuration, e.g., a substantially U-shaped configuration. At
proximal end 304, tubular member 302 is preferably provided with a
flange or other hand grip 312 for facilitating use of the device as
described in detail hereinafter.
[0134] As illustrated in FIGS. 24A-24C, tubular member 302 is
insertable through a delivery channel 314 of an insertion tube or
catheter 316. Tubular member 302 is longitudinally slidable in
channel 314. Accordingly, distal end portion 310 of tubular member
302 may be maintained in a relatively straightened configuration in
a distal end section of channel 314 during insertion and removal of
tube 316 from a patient. Upon the arrival of the distal end of
insertion tube 316 at a desired insertion site, tubular member 302
is shifted in the distal direction through channel 314 until a part
of distal end portion 310 emerges from the channel and bends under
the action of the internal spring force built into tubular member
302.
[0135] As illustrated in FIGS. 24A-24C, the degree of bending of
distal end portion 310 of tubular member 302 is determined by
controlling the degree of ejection of distal end portion 310 from
channel 314. The more tubular member 302 is pushed in the distal
direction, the greater the angle a.sub.1 that a tip 306 of tubular
member 302 bears with respect to a longitudinal axis of channel
314. The angle a.sub.1 may thus be adjusted anywhere from about 0
to 180 degrees.
[0136] As illustrated in FIG. 25A, to deliver the delivery catheter
300 to a location adjacent the myocardium, the insertion tube 316
may be advanced percutaneously using any of the methods described
above until its distal end 318 is adjacent to the insertion site.
The delivery catheter 300, as shown in FIG. 25B, is ejected from
the distal end 318 until the desired angle is attained relative to
the myocardium MYO. As shown in FIG. 25C, a guidewire 100 is then
inserted through the lumen in the delivery catheter into the
myocardium MYO at the desired angle.
[0137] Further details regarding this method are disclosed in U.S.
Pat. No. 5,386,818, the entirety of which is hereby incorporated by
reference.
[0138] E. Reverse Guidewire
[0139] FIGS. 26A-26C illustrate another method for delivering a
guidewire at a back angle into the myocardium. As shown in FIG.
26A, a delivery tube 400 is advanced into the coronary artery CA
adjacent the myocardium MYO using any of the methods described
above. A guidewire 100 is delivered through the lumen 404 of the
delivery tube toward the distal end 402 of the delivery tube.
Preferably, before insertion of the guidewire 100 into the lumen
404, the guidewire is folded such that it has a distal section 116
that folds back over the proximal section 114. The length of the
distal section 116 from the fold 118 to the distal end 104 of
guidewire 100 is preferably selected to be greater than the length
that the guidewire is to be inserted through the myocardium MYO.
The guidewire once located inside the lumen 404 at the distal end
402 of the delivery tube 400 is preferably turned so that the
distal section 116 is closest to the myocardium MYO.
[0140] In one embodiment, the guidewire 100 is made of a shape
memory alloy material such as nitinol. In this embodiment, the
shape of the folded guidewire may be set by a memory imparting heat
treatment, as would be known to one skilled in the art. More
particularly, the angle of the fold may be set before insertion of
the guidewire into the lumen 404 to correspond with the desired
angle of insertion of the guidewire into the myocardium relative to
the axis of the delivery tube. Then, when the guidewire 100 is
inserted into the lumen 404, the angle of the fold decreases to
accommodate insertion, but not to such an extent as to cause
permanent deformation of the guidewire.
[0141] As shown in FIG. 26B, the guidewire 100 is ejected from the
distal end 402 of the delivery tube 400 such that the distal
section 116 is completely outside of the lumen 404. Once outside
the lumen 404, the distal section 116 still remains folded relative
to the proximal section 114, though preferably, the angle of the
fold returns to its original shape-set configuration. As shown in
FIG. 26C, after the distal section 116 is outside of the lumen 404,
the guidewire can be pulled back proximally, causing the distal tip
104 of the guidewire to puncture into the myocardium MYO at a
desired insertion point. The guidewire 100 continues to be pulled
back proximally until the distal tip 104 has punctured through the
myocardium MYO into the left ventricle LV. After placement of the
guidewire 100, a stent may be delivered into the myocardium as
described below.
[0142] F. Reverse Catheter
[0143] FIG. 27 illustrates another embodiment for delivering a
guidewire at a back angle into the myocardium. In this embodiment,
a delivery catheter 500 is preferably delivered to an insertion
site adjacent the myocardium MYO and turned toward the myocardium
using any of the methods described above. The delivery catheter is
specially constructed to have a lumen 506 that tapers inwardly
toward the distal end 504. In other words, the walls of the
catheter 500 increase in thickness toward distal end 504 to provide
a narrowing passageway 508. A guidewire 100 is inserted through the
lumen 506 at the proximal end 502 (not shown) of the delivery
catheter and is guided through the narrowing passageway 508 and out
of the distal end 504 in a desired direction at the insertion site.
As illustrated in FIG. 27, by the combination of turning the distal
end of the delivery catheter and providing the narrowing passageway
506, the guidewire 100 preferably exits the delivery catheter at a
back angle into the myocardium.
[0144] III. Anchoring Guidewire
[0145] The embodiments described above are directed primarily to
providing a guidewire 100 into the patient's myocardium. As
described in further detail below, this guidewire is used for
delivering medical devices into the myocardium. However, it should
be appreciated that many of the embodiments described above may
also be used in conjunction with other methods for creating a
passageway through the myocardium. For instance, a delivery
catheter, such as described above, may be used for delivering a
surgical drill or other tissue penetrating device ejected from the
distal end thereof. This approach would be useful, for instance, in
creating a tunnel through the myocardium as described above.
Alternatively, a Seldinger wire may be ejected from the distal end
of the delivery catheter. Further details are described in the
above-referenced U.S. Pat. No. 5,429,144.
[0146] As shown in FIG. 28, a puncture device such as guidewire 100
is directed into the myocardium 100 using any of the preferred
methods described above. Guidewire 100 preferably has a proximal
end 102 (not shown) which remains outside the patient's body, and a
distal end 104 which is inserted through a delivery catheter as
described above. Where the delivery catheter is provided through
the coronary artery, the guidewire is advanced in one embodiment
until the distal end 104 of the guidewire enters the left
ventricle. Alternatively, where it is desired that a stent or other
device extend only partially into the myocardium, the guidewire 100
need not extend all the way through to the left ventricle. The
distal tip 104 of the guidewire 100 is preferably made of a
radiopaque material that can be visualized by the physician by an
available method, such as fluoroscopy.
[0147] The distal end of the guidewire 100 is preferably formed
such that it is easily advanced but is difficult to pull back
through the tissue. As shown in FIG. 28, one embodiment of the
distal tip 104 comprises one or more barbs 106 extending from the
tip in a type of "multi-winged arrowhead" configuration. These
barbs allow the guidewire to be advanced distally into the
myocardium but require more force to pull the guidewire 100
proximally out of the myocardium, thus creating an effective
anchor.
[0148] FIG. 29A shows another embodiment wherein a guidewire 100
carries an expandable member such as balloon 110 on its distal end.
Use of an expandable member reduces damage to the myocardium during
subsequent retraction of the wire 100. As illustrated in FIG. 29B,
once the balloon 110 reaches the left ventricle LV, the balloon 110
is inflated. The balloon is then preferably pulled proximally back
to the ventricle wall to anchor and secure the guidewire 100 in
place.
[0149] Alternatively, FIGS. 30A-30C show an expandable guidewire
100 extending through and actuated to anchor the guidewire within
the myocardium MYO. In FIG. 30A, a guidewire 100 is shown advanced
through the myocardium MYO. Guidewire 100 is provided with an
expandable device 112 on distal end 104 which may be actuated by an
operator at the proximal end of the guidewire outside of the
patient. Actuating of the device may be accomplished by using a
shape memory material such as nitinol and heating the material
above its transformation temperature. Alternatively, the guidewire
may be mechanically actuated to assume the desired shape. FIG. 30B
shows the guidewire 100 partially actuated at its distal end 104 to
expand the device 112 into an anchorable shape. FIG. 30C shows the
expandable device 112 fully actuated to anchor the guidewire 100
against the ventricle wall. Other types of anchoring and expandable
members may also be used to secure the guidewire 100.
[0150] FIG. 31 illustrates a specially constructed guidewire 100
having a screw tip 119. More particularly, the distal end 104 of
the guidewire 100 is shaped in a screw configuration to assist in
puncturing through the myocardium.
[0151] Once the guidewire 100 is anchored in place, the delivery
catheter may be removed without displacing the guidewire inserted
through the myocardium. Then, with the guidewire 100 anchored in
place, catheters used in creating and stenting the passageway or
other medical devices may be provided into the myocardium.
Alternatively, the delivery catheter may remain within the blood
vessel and other catheters or medical devices may be advanced over
the guidewire and through the delivery catheter. Furthermore, an
expandable member such as a balloon may be provided on the delivery
catheter or on the guidewire 100 to anchor the catheter or
guidewire to the wall of the blood vessel to provide for more
secure deployment of medical devices into the myocardium.
[0152] IV. Delivery Over the Guidewire
[0153] The anchoring of the guidewire 100 within or to the
myocardium MYO allows for the delivery of devices into the
myocardium for creation of a myocardial passageway. In particular,
the anchoring of the guidewire 100 facilitates advancement of
over-the-wire catheters such as introducer catheters into the
myocardium by employing a push-pull mechanism. When it is desired
to push a catheter over the guidewire 100, the guidewire 100 may be
pulled proximally by an operator from outside of the body. The
anchoring member at the distal end of the guidewire, whether a
balloon, barb, or other member, prevents the guidewire 100 from
exiting the myocardium MYO. Meanwhile, a delivery catheter or other
over-the-wire device may be pushed into the myocardium MYO,
assisted by the pulling force of the anchoring member toward the
catheter. The anchoring member also assists in placement of an
over-the-wire catheter in the myocardium by preventing the catheter
from extending beyond the location of the anchoring member.
[0154] As illustrated in FIG. 32, to create a myocardial
passageway, a catheter 120 having a dilation balloon 122 is
advanced over guidewire 100, into the myocardium MYO, as shown in
FIG. 33. The anchored balloon 110 acts as a barrier to advancement
of balloon 122, which is subsequently inflated within myocardium
MYO to expand a myocardial passageway. The balloon 122 is then
deflated and the catheter 120 removed. The process may be repeated
with successively larger dilation balloons to form a passageway of
desired size.
[0155] After inflation of the largest desired dilation balloon, the
catheter 120 is withdrawn and a stent introducer catheter 130 is
advanced over wire 100, as shown in FIG. 34. The catheter 130 has
an inflatable balloon 132 mounted on its distal end for deploying a
stent 134 carried by balloon 132. Upon the positioning of balloon
132 inside the myocardium MYO, balloon 132 is inflated, as shown in
FIG. 35, to assist in an initial expansion of stent 134 in
opposition to the compressive forces of the heart muscle. Upon the
desired disposition of stent 134, balloon 132 is deflated and
catheter 130 and wire 100 are withdrawn, leaving stent 134 in place
to provide a coronary bypass between ventricle LV and artery
CA.
[0156] It will be appreciated that the stent 134 can be delivered
by other methods, such as described in the above-referenced
application entitled STENT DESIGNS [Attorney Docket No.
PERCAR.013A]. It will also be appreciated that the anchoring of the
guidewire may also be used in other applications, such as
delivering a shunt between two locations in the body as described
above.
[0157] V. Drug Delivery
[0158] The guidewire such as described above delivered into the
myocardium MYO may also be used for delivering drugs into the
myocardium. As shown in FIG. 36, a guidewire 140 is advanced
partially into the myocardium using any of the methods described
above. The guidewire 140 comprises a tubular body 142 having a
lumen 148 (not shown) extending from a proximal end 144 (not shown)
to a distal end 146. The guidewire may be angled using the turning
methods described above to provide the distal end of the guidewire
at a desired position within the myocardium for drug delivery. Drug
delivery fluids 150 are ejected from the distal and 146 into the
myocardium. Although the guidewire 140 shown in FIG. 36 is not
anchored to the myocardium MYO, anchoring means as described above
may be provided. Furthermore, the guidewire 140 may contain a
plurality of ports 152 along the tubular body 142 near the distal
end 146.
[0159] The embodiments illustrated and described above are provided
merely as examples of certain preferred embodiments of the present
invention. Other changes and modifications can be made from the
embodiments presented herein by those skilled in the art without
departure from the spirit and scope of the invention, as defined by
the appended claims.
* * * * *