U.S. patent application number 12/246361 was filed with the patent office on 2009-05-07 for systems and methods for transeptal cardiac procedures, including tissue sealing members associated methods.
This patent application is currently assigned to CoAptus Medical Corporation. Invention is credited to David C. Auth, Joseph E. Eichinger, David A. Herrin, Ryan E. Kaveckis, Larry B. Kulesa, Robert S. Schwartz, Mark A. Tempel.
Application Number | 20090118726 12/246361 |
Document ID | / |
Family ID | 40523917 |
Filed Date | 2009-05-07 |
United States Patent
Application |
20090118726 |
Kind Code |
A1 |
Auth; David C. ; et
al. |
May 7, 2009 |
Systems and Methods for Transeptal Cardiac Procedures, Including
Tissue Sealing Members Associated Methods
Abstract
Systems and methods for transeptal cardiac procedures are
disclosed. A patient treatment device in accordance with a
particular embodiment includes a catheter having a proximal end, a
distal end, a working portion toward the distal end, and an
electrical energy path coupleable to a source of electrical energy.
The device can further include a tissue penetrating member carried
by the catheter and an electrode device carried by the working
portion of the catheter and movable along the tissue penetrating
member. The electrode device can include a collapsible stranded
conductive material coupled to the electrical signal path and being
changeable between a deployed position and a stowed position. The
conductive material can be elongated along a deployment axis when
in the stowed position, and can be contracted along the deployment
axis and expanded transverse to the deployment axis when in the
deployed position.
Inventors: |
Auth; David C.; (Kirkland,
WA) ; Kaveckis; Ryan E.; (Everett, WA) ;
Kulesa; Larry B.; (Bothell, WA) ; Eichinger; Joseph
E.; (Everett, WA) ; Herrin; David A.;
(Seattle, WA) ; Tempel; Mark A.; (Sammamish,
WA) ; Schwartz; Robert S.; (Inner Grove Heights,
MN) |
Correspondence
Address: |
PERKINS COIE LLP;PATENT-SEA
P.O. BOX 1247
SEATTLE
WA
98111-1247
US
|
Assignee: |
CoAptus Medical Corporation
Redmond
WA
|
Family ID: |
40523917 |
Appl. No.: |
12/246361 |
Filed: |
October 6, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60977837 |
Oct 5, 2007 |
|
|
|
Current U.S.
Class: |
606/33 ;
606/41 |
Current CPC
Class: |
A61B 18/1492 20130101;
A61B 17/0057 20130101; A61B 2018/00285 20130101; A61B 2017/00575
20130101; A61B 2018/00351 20130101; A61B 2018/00898 20130101; A61B
2018/144 20130101; A61B 2017/22038 20130101; A61B 2018/00214
20130101; A61B 2018/00279 20130101; A61B 2018/00208 20130101 |
Class at
Publication: |
606/33 ;
606/41 |
International
Class: |
A61B 18/18 20060101
A61B018/18; A61B 18/14 20060101 A61B018/14 |
Claims
1. A patient treatment device, comprising: a catheter having a
proximal end, a distal end, a working portion toward the distal
end, and an electrical energy path coupleable to a source of
electrical energy; a tissue penetrating member carried by the
catheter; and an electrode device carried by the working portion of
the catheter and movable along the tissue penetrating member, the
electrode device including: a collapsible, stranded conductive
material coupled to the electrical signal path and being changeable
between a deployed position and a stowed position, the conductive
material being elongated along a deployment axis when in the stowed
position, the conductive material being contracted along the
deployment axis and expanded transverse to the deployment axis when
in the deployed position.
2. The treatment device of claim 1, further comprising an
insulating material adjacent to a distal surface of the conductive
material.
3. The treatment device of claim 1 wherein the conductive material
has a distal surface, and wherein the distal surface includes no
insulating material.
4. The treatment device of claim 1 wherein the conductive material
tends toward the stowed position in the absence of an external
force.
5. The treatment device of claim 1 wherein the conductive material
tends toward the deployed position in the absence of an external
force.
6. The treatment device of claim 1 wherein the tissue penetrating
member includes an electrically conductive guidewire have an
RF-energy emitting tip.
7. The treatment device of claim 1 wherein the catheter includes an
electrode catheter, and wherein the treatment device further
comprises a delivery catheter having a lumen in which the electrode
catheter is slideably received.
8. The treatment device of claim 1 wherein the conductive material
includes a tubular braid of shape-memory material, and wherein the
conductive material is in a relaxed state when in the stowed
position, and in an actively compressed state when in the deployed
position.
9. The treatment device of claim 1 wherein the electrode device
includes an actuator coupled to the stranded conductive material,
and wherein the actuator is movable relative to the catheter to
move the conductive material between the stowed position and the
deployed position.
10. The treatment device of claim 1 wherein the conductive material
includes filaments arranged in a regular geometric pattern when the
conductive material is in the stowed position.
11. The treatment device of claim 10 wherein the conductive
material includes braided filaments.
12. The treatment device of claim 1 wherein the conductive material
includes filaments arranged in an irregular manner when the
conductive material is in the stowed position and the deployed
position.
13. The treatment device of claim 1 wherein the conductive material
has a generally ellipsoidal shape when in the deployed
position.
14. The treatment device of claim 13 wherein the conductive
material has a generally spheroidal shape when in the deployed
position.
15. The treatment device of claim 1 wherein the conductive material
includes a tubular braid of shape-memory material, and wherein the
conductive material is in a relaxed state when in the stowed
position, and in an actively compressed state when in the deployed
position, and wherein the conductive material has a generally
spheroidal shape when in the deployed position, and wherein the
electrode device includes an actuator coupled to the stranded
conductive material, and wherein the actuator is movable relative
to the catheter to move the conductive material between the stowed
position and the deployed position, and wherein the catheter
includes an electrode catheter, and wherein the treatment device
further comprises: a delivery catheter having a lumen in which the
electrode catheter is slideably received; and a return electrode
carried by the delivery catheter.
16. The treatment device of claim 1 wherein at least one of the
electrode device and the catheter includes fluid delivery ports
positioned to direct a fluid toward to conductive material.
17. The treatment device of claim 16 wherein the fluid delivery
ports are coupled to a supply of electrically conductive fluid.
18. The treatment device of claim 16 wherein the fluid delivery
ports are coupled to a supply of fluid that is generally
electrically non-conductive, and wherein in the fluid is configured
to flush clotting substances from the electrode device.
19. The treatment device of claim 16 wherein the fluid delivery
ports are coupled to a supply of fluid that is configured to flush
clotting substances from the electrode device.
20. The treatment device of claim 16, further comprising a
controller operatively coupled to the fluid delivery ports, the
controller being programmed with instructions to vary the flow of
fluid through the fluid delivery ports.
21. The treatment device of claim 20 wherein the controller is
programmed with instructions to pulse fluid through the fluid
delivery ports.
22. The treatment device of claim 20 wherein the controller is
programmed with instructions to vary the flow of fluid in a manner
that depends at least in part on a patient's cardiac rhythm.
23. The treatment device of claim 20 wherein the controller is
programmed with instructions to vary the flow of fluid in a manner
that depends at least in part on a pressure in the patient's
heart.
24. A patient treatment device, comprising: a catheter having a
proximal end, a distal end, a working portion toward the distal
end, and an electrical energy path coupleable to a source of
electrical energy; an electrode device carried by the working
portion of the catheter and movable along the tissue penetrating
member, the electrode device including a collapsible, stranded
conductive material coupled to the electrical signal path and being
changeable between a deployed position and a stowed position, the
conductive material being elongated along a deployment axis when in
the stowed position, the conductive material being contracted along
the deployment axis and expanded transverse to the deployment axis
so as to have a generally ellipsoidal shape when in the deployed
position; and a tissue penetrating member carried by the
catheter.
25. The treatment device of claim 24 wherein the conductive
material has a generally spheroidal shape when in the deployed
position.
26. The treatment device of claim 24 wherein the stranded,
conductive material is electrically uninsulated.
27. The treatment device of claim 24 wherein the conductive
material includes a tubular braid of shape-memory material, and
wherein the conductive material is in a relaxed state when in the
stowed position, and in an actively compressed state when in the
deployed position, and wherein the conductive material has a
generally spheroidal shape when in the deployed position, and
wherein the electrode device includes an actuator coupled to the
stranded conductive material, and wherein the actuator is movable
relative to the catheter to move the conductive material between
the stowed position and the deployed position, and wherein the
catheter includes an electrode catheter, and wherein the treatment
device further comprises: a delivery catheter having a lumen in
which the electrode catheter is slideably received; and a return
electrode carried by the delivery catheter.
28. A patient treatment device, comprising: a catheter having a
proximal end, a distal end, a working portion toward the distal
end, and an electrical signal path coupleable to a source of
electrical energy; a tissue penetrating member carried by the
catheter; and an electrode device carried by the working portion of
the catheter and movable along the tissue penetrating member, the
electrode device including: a collapsible support structure being
changeable between a deployed position and a stowed position; and a
flexible conductive sheet carried by the support structure, the
sheet being under tension when the collapsible support structure is
in the deployed position, the sheet being electrically connected to
the electrical energy path.
29. The treatment device of claim 28 wherein the sheet includes a
conductive fabric.
30. The treatment device of claim 28 wherein the sheet includes a
conductive membrane.
31. The treatment device of claim 28 wherein the support structure
includes multiple collapsible struts.
32. The treatment device of claim 31 wherein the struts fold
inwardly and distally from the deployed position to the stowed
position.
33. The treatment device of claim 31 wherein the struts fold
inwardly and proximally from the deployed position to the stowed
position.
34. The treatment device of claim 31 wherein the struts include a
shape memory metal material.
35. The treatment device of claim 28 wherein the flexible
conductive sheet forms a generally flat, single unfolded layer when
the collapsible support structure is in the deployed position.
36. The treatment device of claim 28 wherein the flexible
conductive sheet includes generally non-conductive, woven fibers
coated with a conductive material.
37. The treatment device of claim 36 wherein the fibers are
polyester fibers, and wherein the conductive material includes at
least one of gold and silver.
38. The treatment device of claim 28 wherein the collapsible
support structure includes a plurality of struts attached to the
electrode, and wherein the electrode device further includes an
actuator connected to the struts, the actuator being movable toward
the electrode to erect the electrode and being movable away from
the electrode to collapse the electrode.
39. The treatment device of claim 38 wherein the actuator moves
distally to erect the electrode.
40. The treatment device of claim 38 wherein the actuator moves
proximally to erect the electrode.
41. A patient treatment device, comprising: a catheter having a
proximal end, a distal end, a working portion toward the distal
end, and an electrical energy path coupleable to a source of
electrical energy; and an electrode device carried by the working
portion of the catheter, the electrode device including: a
collapsible electrode electrically connected to the electrical
signal path; and an inflatable member positioned proximate to the
electrode, the inflatable member and the electrode being movable
relative to each other, the inflatable member being changeable
between an inflated configuration and a deflated configuration,
with the inflatable member applying a force on the electrode when
in the inflated configuration.
42. The treatment device of claim 41 wherein the inflatable member
is in contact with the electrode when in the inflated
configuration.
43. The treatment device of claim 41 wherein the inflatable member
is spaced apart from the electrode when in the inflated
configuration.
44. The treatment device of claim 41, further comprising an
actuator carried by and movable relative to the catheter, and
wherein the electrode device and the inflatable member are carried
by the actuator.
45. The treatment device of claim 44 wherein the electrode is
coupled to the actuator with flexible lines, and wherein the
inflatable member is positioned to erect the electrode in a
direction transverse to the actuator and tension the lines when in
the inflated configuration.
46. The treatment device of claim 45 wherein the electrode is
coupled to the actuator at a first location, the flexible lines are
coupled to the actuator at a second location spaced apart from the
first location, and wherein the inflatable member is positioned
between the first and second locations.
47. The treatment device of claim 46 wherein the electrode is
coupled to the actuator at the first location with a sliding
coupling, and wherein the sliding coupling moves along the actuator
as the inflatable member changes between the inflated configuration
and the deflated configuration.
48. The treatment device of claim 46 wherein the flexible lines are
coupled to the actuator at the second location with a sliding
coupling, and wherein the sliding coupling moves along the actuator
as the inflatable member changes between the inflated configuration
and the deflated configuration.
49. The treatment device of claim 41 wherein the collapsible
electrode has a distal outwardly flared end.
50. The treatment device of claim 49 wherein the flared end
includes multiple outwardly flared fingers having a distal surface
and a proximal surface, the distal surface being in contact with
the inflatable member when the inflatable member is in the inflated
configuration.
51. The treatment device of claim 49 wherein the electrode includes
a tube having outwardly flared fingers.
52. The treatment device of claim 49 wherein the electrode includes
multiple filaments forming the flared end.
53. A method for treating a patient, comprising: deploying a
catheter in the patient's heart; forming an opening through septal
tissue between the patient's right atrium and left atrium;
advancing an electrode through the opening, the electrode being
formed at least in part from stranded conductive material;
deploying the electrode in the left atrium to arrange the stranded
conductive material into a generally ellipsoidal shape; and
delivering energy from the electrode to the septal tissue to at
least partially seal a PFO in the septal tissue.
54. The method of claim 53 wherein the electrode is a first
electrode and wherein the catheter includes a second, return
electrode, and wherein advancing the electrode includes advancing
the first electrode while the second electrode is positioned in the
right atrium, and wherein delivering energy includes delivering
energy in a bipolar manner between the first electrode in the left
atrium and the second electrode in the right atrium.
55. The method of claim 53, further comprising at least restricting
sticking between the electrode and the septal tissue by cooling the
electrode with left atrial blood passing through interstices
between neighboring strands of the electrode.
56. The method of claim 53, further comprising at least restricting
blood coagulation at the electrode by cooling the electrode with
left atrial blood passing through interstices between neighboring
strands of the electrode.
57. The method of claim 53, further comprising clamping the septal
tissue between the electrode and the catheter while delivering
energy from the electrode to the septal tissue.
58. The method of claim 57 wherein clamping the septal tissue
includes contacting the septal tissue with a first surface portion
of the electrode while a second surface portion of the electrode
spaced radially apart from the first portion is out of contact with
the septal tissue.
59. The method of claim 53, further comprising at least restricting
adhesion of materials to the stranded conductive material by
directing fluid to the conductive material from ports carried by at
least one of the catheter and the electrode.
60. The method of claim 59, further comprising selecting the fluid
to include 5% dextrose in water.
61. The method of claim 53, further comprising cooling a first
portion of the septal tissue exposed to left atrial blood at a
faster rate than a second portion of septal tissue at an interface
between the patient's primum and secundum by delivery energy at a
duty cycle of less than 100%.
62. A method for treating a patient, comprising: deploying a
catheter in the patient's heart; positioning an energy delivery
device carried by the catheter proximate to septal tissue located
between the patient's right atrium and left atrium, the septal
tissue including a primum, a secundum and a PFO between the primum
and the secundum; delivering energy to the septal tissue from the
energy delivery device at a first energy level during a first phase
to shrink, desiccate or both shrink and desiccate the septal
tissue; and delivering energy to the septal tissue from the energy
delivery device at a second energy level during a second phase to
at least partially seal the PFO, the second energy level being
higher than the first energy level.
63. The method of claim 62, further comprising: forming an opening
through the septal tissue advancing the electrode through the
opening, the electrode being formed at least in part from stranded
conductive material; deploying the electrode in the left atrium to
arrange the stranded conductive material into a generally
ellipsoidal shape; and delivering energy from the electrode to the
septal tissue while the electrode has the generally ellipsoidal
shape.
64. The method of claim 62 wherein delivering energy at a first
energy level includes delivering energy without at least partially
sealing the PFO.
65. The method of claim 62 wherein delivering energy at a first
energy level includes delivering energy at least until the septal
tissue has shrunk, desiccated or both shrunk and desiccated.
66. The method of claim 62 wherein delivering energy at a first
energy level includes delivering energy at least until a region of
the septal tissue sealed during the second phase is generally free
of water.
67. A method for treating a patient, comprising: deploying a
catheter in the patient's heart; advancing an electrode and an
inflatable member toward a target tissue in the heart, the
inflatable member being separable from the electrode during
inflation, deflation, or both; expanding the electrode by inflating
the inflatable member; and delivering energy from the electrode to
the target tissue while the electrode is expanded and the
inflatable member is inflated.
68. The method of claim 67, further comprising controlling an
amount by which the inflatable member is inflated based at least in
part on characteristics of the target tissue.
69. The method of claim 67 wherein inflating the inflatable member
includes contacting the inflatable member with the electrode.
70. The method of claim 67 wherein inflating the inflatable member
includes inflating the inflatable member without contact between
the inflatable member and the electrode.
71. The method of claim 67 wherein inflating the inflatable member
includes inflating the inflatable member without the electrode
being in intimate surface-to-surface contact with the inflatable
member during at least a portion of the inflation.
72. The method of claim 67 wherein inflating the inflatable member
includes applying tension, with the inflatable member, to flexible
lines connected to the electrode.
73. The method of claim 72 wherein the flexible lines are connected
between the electrode and an anchor, and wherein the method further
comprises moving at least one of the electrode and the anchor
toward the inflatable member as the inflatable member inflates.
74. The method of claim 67 wherein delivering electrical energy
includes delivering energy to a PFO to at least partially seal the
PFO.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The present application claims priority to U.S. Provisional
Application No. 60/977,837, filed Oct. 5, 2007 and incorporated
herein by reference.
TECHNICAL FIELD
[0002] The present disclosure is directed generally to systems and
methods for transeptal cardiac procedures, including separable
guidewires, tissue penetrating members, and tissue sealing
members.
BACKGROUND
[0003] The human heart is a complex organ that requires reliable,
fluid-tight seals to prevent de-oxygenated blood and other
constituents received from the body's tissues from mixing with
re-oxygenated blood delivered to the body's tissues. FIG. 1A
illustrates a human heart 100 having a right atrium 101, which
receives the de-oxygenated blood from the superior vena cava 116
and the inferior vena cava 104. The de-oxygenated blood passes to
the right ventricle 103, which pumps the de-oxygenated blood to the
lungs via the pulmonary artery 114. Re-oxygenated blood returns
from the lungs to the left atrium 102 and is pumped into the left
ventricle 105. From the left ventricle 105, the re-oxygenated blood
is pumped throughout the body via the aorta 115.
[0004] The right atrium 101 and the left atrium 102 are separated
by an interatrial septum 106. As shown in FIG. 1B, the interatrial
septum 106 includes a primum 107 and a secundum 108. Prior to
birth, the primum 107 and the secundum 108 are separated to form an
opening (the foramen ovale 109) that allows blood to flow from the
right atrium 101 to the left atrium 102 while the fetus receives
oxygenated blood from the mother. After birth, the primum 107
normally seals against the secundum 108 and forms an oval-shaped
depression, i.e., a fossa ovalis 110.
[0005] In some infants, the primum 107 never completely seals with
the secundum 108, as shown in cross-sectional view in FIG. 1C and
in a left side view in FIG. 1D. In these instances, a patency often
having the shape of a tunnel 112 forms between the primum 107 and
the secundum 108. This patency is typically referred to as a patent
foramen ovale or PFO 113. In most circumstances, the PFO 113 will
remain functionally closed and blood will not tend to flow through
the PFO 113, due to the normally higher pressures in the left
atrium 102 that secure the primum 107 against the secundum 108.
Nevertheless, during physical exertion or other instances when
pressures are greater in the right atrium 101 than in the left
atrium 102, blood can inappropriately pass directly from the right
atrium 101 to the left atrium 102 and can carry with it clots, gas
bubbles, or other vaso-active substances. Such constituents in the
atrial system can pose serious health risks including hemodynamic
problems, cryptogenic strokes, venous-to-atrial gas embolisms,
migraines, and in some cases even death.
[0006] Traditionally, open chest surgery was required to suture or
ligate a PFO 113. However, these procedures carry high attendant
risks, such as postoperative infection, long patient recovery, and
significant patient discomfort and trauma. Accordingly, less
invasive techniques have been developed. Most such techniques
include using transcatheter implantation of various mechanical
devices to close the PFO 113. Such devices include the Cardia.RTM.
PFO Closure Device, Amplatzer.RTM. PFO Occluder, and
CardioSEAL.RTM. Septal Occlusion Device. One potential drawback
with these devices is that they may not be well suited for the
long, tunnel-like shape of the PFO 113. As a result, the implanted
mechanical devices may become deformed or distorted and in some
cases may fail, migrate, or even dislodge. Furthermore, these
devices can irritate the cardiac tissue at or near the implantation
site, which in turn can potentially cause thromboembolic events,
palpitations, and arrhythmias. Other reported complications include
weakening, erosion, and tearing of the cardiac tissues around the
implanted devices.
[0007] Another potential drawback with the implanted mechanical
devices described above is that, in order to be completely
effective, the tissue around the devices must endothelize once the
devices are implanted. The endothelization process can be gradual
and can accordingly take several months or more to occur.
Accordingly, the foregoing techniques do not immediately solve the
problems caused by the PFO 113.
[0008] Still another drawback associated with the foregoing
techniques is that they can be technically complicated and
cumbersome. Accordingly, the techniques may require multiple
attempts before the mechanical device is appropriately positioned
and implanted. As a result, implanting these devices may require
long procedure times during which the patient must be kept under
conscious sedation, which can pose further risks to the
patient.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIGS. 1A-1D illustrate a human heart having a patent foramen
ovale (PFO) in accordance with the prior art.
[0010] FIG. 2 illustrates a catheter positioned proximate to a PFO
for treatment in accordance with several embodiments of the
disclosure.
[0011] FIGS. 3A-3J illustrate a process for closing a PFO in
accordance with an embodiment of the disclosure.
[0012] FIG. 4 is a partially schematic, isometric illustration of a
process for closing a PFO via a trans-primum procedure in
accordance with an embodiment of the disclosure.
[0013] FIGS. 5A-5D are schematic, isometric illustrations of a
process for closing a PFO using a trans-primum procedure in
accordance with another embodiment of the disclosure.
[0014] FIGS. 6A-6M illustrate guidewires configured to center in a
PFO tunnel in accordance with embodiments of the disclosure.
[0015] FIG. 7A is a flow diagram illustrating a process for
pre-loading a penetrating guidewire in accordance with an
embodiment of the disclosure.
[0016] FIG. 7B-7G illustrate devices suitable for applying a
pre-load to a penetrating guidewire in accordance with several
embodiments of the disclosure.
[0017] FIGS. 8A-8L illustrate electrode devices that include
conductive filaments in accordance with several embodiments of the
disclosure.
[0018] FIGS. 9A and 9B illustrate an electrode device that includes
a conductive sheet configured in accordance with an embodiment of
the disclosure.
[0019] FIGS. 10A and 10B illustrate an electrode device including a
conductive material that deploys in an "umbrella" fashion.
[0020] FIGS. 11A-11C illustrate an electrode device and an
inflatable member for deploying the electrode device.
[0021] FIGS. 12 and 13 illustrate electrode devices that are
deployed with inflatable members in accordance with further
embodiments of the disclosure.
[0022] FIG. 14 illustrates an electrode device that is deployed in
an umbrella-like fashion in accordance with another embodiment of
the disclosure.
[0023] FIGS. 15A-15B illustrate an electrode device that includes a
tubular portion and fingers configured in accordance with an
embodiment of the disclosure.
[0024] FIGS. 16A-16B illustrate an electrode device having nested
tubular portions with inner and outer fingers in accordance with
another embodiment of the disclosure.
[0025] FIGS. 17A-17B illustrate an electrode device having a spiral
wound tubular portion and associated flange in accordance with an
embodiment of the disclosure.
[0026] FIGS. 18A-18B illustrate an electrode device having a woven
tubular portion and associated flange in accordance with an
embodiment of the disclosure.
[0027] FIGS. 19A and 19B illustrate an electrode device having
knitted fibers forming a tubular portion and a flange in accordance
with another embodiment of the disclosure.
[0028] FIGS. 20A and 20B illustrate an electrode device having
fibers woven to form a tubular portion and a flange in accordance
with yet another embodiment of the disclosure.
[0029] FIG. 21 is a partially schematic, cross-sectional
illustration of a catheter arranged to apply a compressive force on
an electrode device in accordance with a particular embodiment of
the disclosure.
[0030] FIG. 22 is a partially schematic illustration of a threaded
device for applying a compressive force on an electrode device in
accordance with an embodiment of the disclosure.
[0031] FIG. 23 is a partially schematic, cross-sectional
illustration of an arrangement that includes a slider for applying
a compressive force on an electrode device in accordance with yet
another embodiment of the disclosure.
DETAILED DESCRIPTION
A. Introduction
[0032] Aspects of the present disclosure are directed generally to
methods and devices for drawing portions of cardiovascular tissue
together, sealing the portions to each other, and controlling the
performance of these tasks. Much of the discussion below is
provided in the context of sealing patent foremen ovales (PFOs).
However, in other embodiments, these techniques may be used to
treat other types of cardiac tissue and/or tissue defects. The
energy to seal the PFO is generally provided by an energy
transmitter. For purposes of discussion, much of the following
description is provided in the context of energy transmitters that
include electrodes configured to seal cardiac tissue by delivering
radio frequency (RF) energy. In other embodiments, the energy
transmitters can have other arrangements and can deliver other
types of energy, for example, microwave energy, laser energy or
ultrasound energy.
[0033] In general, many of the techniques and associated devices
described below include advancing a catheter into the right atrium
of the patient's heart, piercing the septum between the right
atrium and the left atrium, and placing an electrode or other
energy transmitter in the left atrium. The energy transmitter
applies energy to the septum to seal the PFO, optionally with the
assistance of a balloon or other inflatable member, and is then
drawn back through the septum. The catheter can then be withdrawn
from the patient's body, leaving no foreign objects behind. A
residual hole in the septum remaining after the electrode is
withdrawn from the left atrium to the right atrium is expected to
close over a short period of time as a result of the body's natural
healing response. Many techniques and devices described in detail
in one or more of the following sections may be combined with
techniques and/or devices described in the same section and/or
other sections. Several details describing devices or processes
that are well-known to those of ordinary skill in the relevant art
and often associated with such devices and processes are not set
forth in the following description for purposes of brevity. Those
of ordinary skill in the relevant art will understand that further
embodiments may include features not disclosed in the following
sections, and/or may eliminate some of the features described below
with reference to FIGS. 2-23.
[0034] FIG. 2 is a schematic, not-to-scale illustration of the
general components of a system 220 used to treat a patient in
accordance with several embodiments of the disclosure. The system
220 generally includes one or more patient treatment devices, a
term which, as used herein, includes devices that provide direct
therapeutic benefits, and/or associated functions, including but
not limited to, diagnostic functions, feedback functions, and/or
positioning functions. The system 220 can include one or more
guidewires 250 that are directed into the patient via an introducer
226, and are then threaded through the patient's vascular system to
the heart 100. In the illustrated embodiment, the guidewire 250
enters the right atrium 101 from the inferior vena cava 104, and in
other embodiments, the guidewire 250 can enter the right atrium 101
or other heart chamber from other vessels. One, or more guidewires
may also pass into the left atrium 102. One or more catheters 230
are then threaded along the guidewire 250 via corresponding lumens
to treat a PFO 113 (e.g., the PFO tunnel 112) located between the
primum 107 and the secundum 108 of the patient's septum 106. The
catheter lumen(s) can be flushed with saline or another appropriate
biocompatible fluid, either continuously at selected intervals, to
prevent clot formation and/or to lubricate the relative motion
between the catheter(s) and devices within the lumens.
[0035] The catheter 230 typically includes a distal end 232 within
the patient's body, a working portion 233 toward the distal end
232, and a proximal end 231 that extends outside the patient's
body. A controller 221 controls the functions carried out by the
catheter 230 and the rest of the system 220, and can include an
energy delivery controller 223 to control RF or other energy
transmitted to the patient, an inflatable member controller 222 to
control the operation of one or more inflatable members in the
patient, a sensor feedback unit 225 to receive diagnostic
information, and other controllers 224 to control other functions,
for example, the motion of various guidewires and/or other elements
of the system 220, and/or fluid delivery to elements of the system
220. A representative handheld controller configured for such
purposes is described in co-pending U.S. application Ser. No.
______ (attorney docket no. 57120.8022US), filed concurrently
herewith and incorporated herein by reference. When the energy
transmitter or delivery device includes an electrode, it may be
operated in a monopolar manner, in which case a return electrode
280a is located remotely from the PFO 113. For example, the return
electrode 280a can include a patient pad located at the back of the
patient's left shoulder. In other embodiments, the electrode can
operate in a bipolar manner, in which case the return electrode is
generally located at or close to the PFO 113.
[0036] For purposes of organization and ease of understanding, the
following discussion is arranged in five sections in addition to
the present Section A. Section B describes overall techniques and
tissue sealing devices for sealing a patient's PFO. Section C
describes self-centering guidewires used to position the tissue
sealing devices, and Section D describes systems and techniques for
penetrating the septal tissue. Section E describes electrodes
configured to seal the PFO, and Section F describes systems and
techniques for clamping the septal tissue as it is sealed. Similar
disclosures are included in the following U.S. Applications, filed
concurrently herewith and incorporated herein by reference: U.S.
application Ser. No. ______ (attorney docket no. 57120.8016US01);
U.S. application Ser. No. ______ (attorney docket no.
57120.8017US); and U.S. application Ser. No. ______ (attorney
docket no. 57120.8019US).
B. General Techniques and Systems for Treating a PFO
[0037] FIGS. 3A-3I are enlarged cross-sectional views of the heart
regions around a PFO, and illustrate representative techniques and
associated devices for sealing the PFO in accordance with a
particular embodiment. Beginning with FIG. 3A, a practitioner
passes a right atrial guidewire 250a into the right atrium 101 of
the patient's heart 100 in accordance with a particular embodiment.
Optionally, the practitioner can continue to advance the right
atrial guidewire 250a into the superior vena cava. The practitioner
then passes a left atrial guidewire 250b into the right atrium 101,
through the PFO tunnel 112 and into the left atrium 102.
Accordingly, the left atrial guidewire 250b is positioned in the
tunnel 112 between the primum 107 and the secundum 108. Suitable
imaging processes (e.g., transthoracic ultrasound or TTE,
intra-cardiac echo or ICE, transesophageal echo or TEE,
fluoroscopy, and/or others) known to those of ordinary skill in the
relevant art may be used to position the guidewires 250a, 250b
and/or other devices used during the procedure.
[0038] In another embodiment, the left atrial guidewire 250b is
routed as described above, but before the right atrial guidewire
250a is introduced. The right atrial guidewire 250a is instead
pre-loaded into a delivery catheter (described later with reference
to FIG. 3C), and the delivery catheter, with the right atrial
guidewire 250a on board, is threaded along the left atrial
guidewire 250b to the right atrium 101 (e.g., at or near the
junction between the right atrium 101 and the inferior vena cava).
Once the delivery catheter is in the right atrium 101, the right
atrial guidewire 250a can be deployed to the location shown in FIG.
3A.
[0039] In FIG. 3B, the practitioner has threaded a self-centering
guidewire 250c along the left atrial guidewire 250b and into the
tunnel 112. Alternatively, the self-centering guidewire 250c can be
pre-loaded into the delivery catheter (described later with
reference to FIG. 3C) and both can be advanced together along the
left atrial guidewire 250b. This latter arrangement, e.g., in
combination with pre-loading the right atrial guidewire 250a as
described above, can prevent the left atrial guidewire 250b and the
right atrial guidewire 250a from becoming twisted. In either
embodiment, the self-centering guidewire 250c can include a first
branch 251 and a second branch 252 positioned around an enclosed
region 249. In a particular aspect of this embodiment, the first
branch 251 is hollow so as to receive the left atrial guidewire
250b along which the self-centering guidewire 250c is passed. The
first and second branches 251, 252 can be at least somewhat
compliant and resilient and can accordingly spread or tighten the
primum 107 laterally, as indicated by arrow S, upon being
introduced into the tunnel 112. By stretching the primum 107, the
self-centering guidewire 250c can draw the primum 107 toward the
secundum 108. In addition, the branches 251, 252 can be symmetric
relative to a central axis C and can accordingly center the
self-centering guidewire 250c within the PFO tunnel 112.
Furthermore, the closed shape provided by the first and second
branches 251, 252 can provide the guidewire 250c with a degree of
lateral rigidity along the axis identified by arrow S. Accordingly,
when the guidewire 250c is placed in the tunnel 112, the resilience
provided by the primum 107 and/or the secundum 108 can force the
guidewire 250c to assume the orientation shown in FIG. 3B, e.g.,
with the generally flat plane of the enclosed region 249
"sandwiched" between and facing toward the primum 107 on one side
and the secundum 108 on the other. The lateral rigidity of the
self-centering guidewire 250c when it is deployed can also prevent
it from twisting, which in turn can make it easier for the
practitioner to accurately seal the tunnel 112.
[0040] Turning next to FIG. 3C, the practitioner has threaded a
delivery catheter 230a along the right atrial guidewire 250a and
the self-centering guidewire 250c, which is in turn threaded along
the left atrial guidewire 250b, as discussed above. Or, as
discussed above, the right atrial guidewire 250a and the
self-centering guidewire 250c can be pre-loaded into the delivery
catheter 230a and deployed once the delivery catheter 230a has been
threaded along the left atrial guidewire 250b until it is
positioned in the right atrium 101. In either embodiment, the
delivery catheter 230a can include a right atrial guidewire opening
234a that receives the right atrial guidewire 250a, and a left
atrial guidewire opening 234b that receives the self-centering
guidewire 250c and the left atrial guidewire 250b over which the
self-centering guidewire 250c is passed. In this embodiment, the
self-centering guidewire 250c has a generally elliptical
cross-sectional shape, and accordingly, the left atrial guidewire
opening 234b has a similar shape. With this arrangement, the
self-centering guidewire 250c is "keyed" to the delivery catheter
230a. Accordingly, the delivery catheter 230a has a known
orientation relative to the self-centering guidewire 250c when the
delivery catheter 230a reaches the position shown in FIG. 3C. The
upward progress of the delivery catheter 230a can be limited by a
"tree crotch effect" provided by the delivery catheter 230a
positioned on one side of the septal limbus 117, and the combined
left atrial guidewire 250b and self-centering guidewire 250c on the
other side of the limbus 117. In addition, radiopaque markers M can
be located at the left atrial guidewire opening 234b and the point
at which the branches 251, 252 bifurcate. In a particular
embodiment, the markers M can therefore be co-located or nearly
co-located when the delivery catheter 230a has been properly
advanced. Once the delivery catheter 230a has the position shown in
FIG. 3C, the right atrial guidewire 250a can optionally be
withdrawn, or it can remain in place for additional steps,
including for the remainder of the procedure.
[0041] As noted above with reference to FIG. 2, the overall system
can include a return electrode positioned close to the PFO. FIG. 3C
illustrates a return electrode 280b carried by the delivery
catheter 230a so as to operate in a bipolar manner with an
electrode delivered in accordance with an embodiment of the
disclosure. In a particular aspect of this embodiment, the return
electrode 280b can include an electrically conductive coating or
sleeve positioned at the outside of the delivery catheter 230a, and
coupled to an electrical return terminal (e.g., at the controller
221 shown in FIG. 2) via a lead wire (not visible in FIG. 3C). In
another embodiment, the return electrode 280b can have other
arrangements and/or configurations in which it is positioned close
to the primum 107 and/or the secondum 108.
[0042] In FIG. 3D, a positioning catheter 230b (which is housed
within and movable relative to the delivery catheter 230a) is
deployed from the delivery catheter 230a. In this embodiment, the
positioning catheter 230b is deployed by applying an axial force to
it, causing it to buckle or bend outwardly through a corresponding
slot (not visible in FIG. 3D) in the outer surface of the delivery
catheter 230a. Accordingly, the positioning catheter 230b can
assume the shape shown in FIG. 3D. In one arrangement, the distal
end of the positioning catheter 230b is eccentrically connected to
a pivot axle 235, which allows the positioning catheter 230b to
rotate as indicated by arrow R as it buckles. As the positioning
catheter 230b rotates, it can position the exit opening of a lumen
239 to face outwardly from the delivery catheter 230a.
[0043] The lumen 239 can also face directly toward the secundum
108, and can be aligned with the central axis C above the limbus
117, as a result of the features of the self-centering guidewire
250c, the delivery catheter 230a and the positioning catheter 230b.
In particular, the self-centering guidewire 250c can be centered
within the tunnel 112, with the plane defined by the enclosed
region 249 facing directly toward the secundum 108. Because the
self-centering guidewire 250c has a generally flat shape (and can
optionally stretch the primum 107), the primum 107 and the secundum
108 can tend to keep the self-centering guidewire 250c from
rotating or twisting about its lengthwise axis relative to the
tunnel 112. In addition, the branches 251, 252 of the
self-centering guidewire 250 can be secured to each other in a
manner that resists twisting. Because the self-centering guidewire
250c is keyed with the delivery catheter 230a, as discussed above
with reference to FIG. 3C, the delivery catheter 230a is prevented
or at least restricted from rotating about its lengthwise axis
relative to the tunnel 112. Accordingly, when the positioning
catheter 230b is deployed, the lumen 239 can face directly toward
the secundum 108, e.g., at an orientation of from about 80.degree.
to about 135.degree., and in a particular embodiment, about
105.degree.. It is expected that in at least some embodiments, an
orientation of about 105.degree. results in a subsequent tissue
penetration operation that effectively penetrates the secundum 108
and the primum 107 with a reduced likelihood for penetrating other
tissue in the left atrium. In addition, this orientation can
increase the likelihood of penetrating the primum 107, e.g., when
the tunnel 112 is relatively short. The lumen 239 can also be
located at the lateral center or approximate center of the tunnel
112 (e.g., measured laterally along a lateral axis L that is
generally transverse to the central axis C). The "tree-crotch
effect" described above can act to locate the lumen 239 above the
limbus 117, but not so high that the lumen 239 is above the primum
107.
[0044] In a particular embodiment, a limbus stop 236 is connected
to the positioning catheter 230b. As the positioning catheter 230b
rotates, the limbus stop 236 rotates outwardly to the position
shown in FIG. 3D. When the practitioner applies an axial (e.g.,
upward) force to the delivery catheter 230a, the limbus stop 236
can nudge up against the limbus 117. In other embodiments, the
limbus stop 236 can be eliminated. In still further embodiments,
the delivery catheter 230b can include a limbus marker 236a, in
addition to or in lieu of the limbus stop 236. The limbus marker
236a can be a pin or other element made from gold, platinum or
another radiopaque material. The limbus marker 236a can help guide
the operator to correctly position the delivery catheter 230a
relative to the limbus 117 before penetrating the secundum 108. The
limbus 117 itself may be illuminated with a contrast agent. In many
cases, the delivery catheter 230a and other components illustrated
in FIG. 3D may be formed from plastics or other materials that do
not readily appear during fluoroscopy processes. Accordingly, the
limbus marker 236a can provide a readily visible locater on the
delivery catheter 230a to aid the practitioner during a tissue
sealing procedure. The limbus marker 236a can be positioned at a
known location along the length of the delivery catheter 230a, for
example 4 mm below the axis along which a penetrating guidewire is
deployed. Further details of the penetrating guidewire are
described below with reference to FIG. 3E.
[0045] As shown in FIG. 3E, a penetrating guidewire 250d or other
penetrating device or member can be deployed from the positioning
catheter 230b. The penetrating guidewire 250d can include a
penetrating tip 253 that penetrates through the secundum 108 and
the primum 107, so as to cross the entire septum 106 into the left
atrium 102. In a particular embodiment, the penetrating tip 253 can
include an RF electrode that is advanced through the septum 106 in
a stepwise fashion described in further detail below with reference
to FIGS. 7A-7F. The electrode can have a generally spherical or
ball-type shape, with a diameter of up to about 1.0 mm. In other
embodiments, the penetrating tip 253 can have other shapes or
configurations, and/or can be advanced using other techniques,
and/or can employ other non-RF methods for penetrating the septum
106. Such configurations include, but are not limited to a
penetrating tip 253 having a sharp distal end that pierces the
septum 106. For example, the penetrating tip can include one or
more razor-like elements or blades that score the septum 106. The
blades can deploy laterally outwardly, and/or can be deployed from
an inflatable balloon. In other embodiments, the tip 253 can
include rotoblades, laser energy emitters, and/or ultrasound energy
emitters.
[0046] In FIG. 3F, the practitioner advances an electrode catheter
230c along the penetrating guidewire 250d from the right atrium 101
into the left atrium 102. The electrode catheter 230c can include a
dilator 237 that temporarily stretches the hole initially created
by the penetrating guidewire 250d to allow additional components to
pass into the left atrium 102. These components can include an
inflatable member 270 (shown collapsed) and an electrode device
280. In a particular embodiment, the penetrating guidewire 250d can
form a hole having a diameter of about one millimeter, and the
dilator 237 can have a diameter of about two millimeters to
temporarily stretch the hole to a diameter of about two
millimeters. When the electrode catheter 230c and the penetrating
guidewire 250d are later withdrawn, the hole can relax back to a
diameter of about one millimeter. In other embodiments, these
dimensions can have other values. In any of these embodiments, the
dilator 237 and/or the penetrating tip 253 can include radiopaque
markings for enhanced visibility during fluoroscopic
visualization.
[0047] In FIG. 3G, the practitioner has inflated the inflatable
member 270 (e.g., with saline or another suitable inflation medium)
in the left atrium 102, and has also deployed the electrode device
280. In a particular embodiment, the electrode device 280 includes
a conductive coating applied to a proximally facing surface of the
inflatable member 270. The inflatable member 270 can be formed from
a non-stretch material so that it maintains a predefined shape
(e.g., the cylindrical shape shown in FIG. 3G) when inflated. This
arrangement can also prevent or restrict the conductive coating
from delaminating, flaking, and/or otherwise detaching from the
inflatable member 270. Other suitable electrode shapes and
configurations are described later with reference to FIGS. 8A-20B
and in at least some of these embodiments, the inflatable member
270 is eliminated.
[0048] Prior to engaging the electrode device 280 with the septum
106, the practitioner can withdraw the self-centering guidewire
250c and the left atrial guidewire 250b by separating or opening
the first and second branches 251, 252 at a separation location
255, allowing them to pass downwardly around opposite sides of the
electrode catheter 230c and into the left atrial guidewire opening
234b. Further details of embodiments for performing this task are
described later with reference to FIGS. 6A-6K. In FIG. 3H, the
self-centering guidewire 250c (FIG. 3G) and the left atrial
guidewire 250b (FIG. 3G) have been removed, and the practitioner
has applied an axial force to the electrode catheter 230c in a
generally proximal direction P. The axial force draws the
inflatable member 270 and the electrode device 280 snugly up
against the primum 107. This force can also clamp the primum 107
against the secundum 108, and can clamp both the primum 107 and the
secundum 108 between the electrode device 280 and a backstop
surface 238. In an embodiment shown in FIG. 3H, the backstop
surface 238 includes the outwardly facing, conductive external
surface of the delivery catheter 230a, e.g., the return electrode
280b. Accordingly, the electrode device 280 can operate in a
bipolar manner via the return electrode 280b. In other embodiments,
the backstop surface 238 can have other locations and/or
arrangements. For example, the backstop surface 238 can be separate
from the delivery catheter 230a, and/or can be electrically
non-conductive, so that the electrode device 280 operates in a
monopolar manner.
[0049] With the electrode device 280 in the position shown in FIG.
3H, the practitioner can apply electrical energy (e.g., a varying
electrical current) to the electrode device 280. In representative
embodiments, electrical energy is applied to an electrode device
280 having a diameter in the range of about 3 mm to about 30 mm, at
a frequency in the range of about 100 KHz to about 5 MHz for a
period of up to 10 minutes (e.g., in a particular embodiment, from
about 30-120 seconds). The energy can be provided at a rate in the
range of from about 10 Watts to about 500 Watts, and in a
particular embodiment, in the range of from about 40 Watts to about
50 Watts. The foregoing ranges are suitable for the electrode
device 280 shown in FIG. 3H, and other electrodes as well,
including the electrode device 580f described later with reference
to FIG. 8J. Different sizes and shapes of the PFO (or other tissue
defect) will typically determine the particular electrode device
size and/or energy delivery parameters. For example, the electrode
device 280 can have a diameter of from about 7 mm to about 20 mm,
and in a particular embodiment, about 9 mm. In a particular
embodiment, the electrical energy can be applied to a 9 mm diameter
electrode device at a frequency of about 450 KHz, for about 5
seconds, at a rate of from about 300 Watts to about 400 Watts. The
electrical energy can be applied with a sinusoidal waveform, square
waveform, or another periodic waveform shape, generally with a
crest factor of from about one to about fifteen. RF energy provided
to the electrode device 280 is received by the adjacent tissue so
as to heat both the primum 107 and the secundum 108. The heat can
at least partially fuse, glue, cement, or otherwise seal, join or
connect the primum 107 and the secundum 108 together, forming a
seal 118 that partially or completely closes the PFO tunnel 112
between the left atrium 102 and the right atrium 101.
[0050] After the tissue fusing and/or sealing process has been
completed, the inflatable member 270 can be collapsed and the
electrode catheter 230c, the positioning catheter 230b and the
penetrating guidewire 250d can be withdrawn into the delivery
catheter 230a, as is shown in FIG. 3I. A residual opening 119 may
remain in the seal 118 as a result of withdrawing the electrode
catheter 230c and penetrating guidewire 250d (FIG. 3H) back through
the septum 106 from the left atrium 102 to the right atrium 101.
The residual opening 119 is typically very small (e.g., on the
order of one millimeter) and is expected to close quickly as a
result of the body's normal healing process. The practitioner then
withdraws the delivery catheter 230a from the patient's body. In
other cases in which the seal 118 may initially be incomplete for
other reasons, it is also expected that the seal will be sufficient
to allow the body's normal healing processes to complete the
closure, generally in a short period of time.
[0051] FIG. 3J is a partially schematic, cross-sectional
illustration of the delivery catheter 230a taken substantially
along line 3J-3J of FIG. 3I. As shown in FIG. 3J, the delivery
catheter 230a can include multiple lumens, including an electrode
catheter lumen 279 that carries the positioning catheter 230b (FIG.
3F) and the electrode catheter 230c (FIG. 3F) housed within it. The
delivery catheter 230a can also include a right atrial guidewire
lumen 278 that houses the right atrial guidewire 250a (FIG. 3C),
and a self-centering guidewire lumen 275 that houses the
self-centering guidewire 250c (FIG. 3C). A return electrode lumen
277 houses a return electrode lead 276 that is in turn coupled to
the return electrode 280b (FIG. 3C). Contrast agent can be
delivered to the PFO region via any of the foregoing lumens (e.g.,
the return electrode lumen 277), and/or via an interstitial region
274 between neighboring lumens.
[0052] In other embodiments, techniques similar at least in part to
those described above with reference FIGS. 3A-3I may be used to
form tissue seals in different manners. For example, referring now
to FIG. 4, the delivery catheter 230a can be located so that the
positioning catheter 230b is below the limbus 117 and facing the
primum 107, rather than above the limbus 117 and facing the
secundum 108, as described above with reference to FIGS. 3A-3I.
Accordingly, when the penetrating guidewire 250d and the electrode
catheter 230c are deployed, they pass through the primum 107 but
not the secundum 108. The resulting tissue seal 418 will typically
be smaller than the seal 118 described above with reference to FIG.
3I because a greater portion of the electrode device 280 is located
below the limbus 117 and does not face directly toward the secundum
108. However, this arrangement may be suitable where it is expected
that the smaller seal 418 will still have the desired effect on the
PFO tunnel 112 (e.g., tunnel sealing), and/or where it is
undesirable to penetrate the secundum 108.
[0053] FIGS. 5A-5D illustrate another arrangement for sealing the
PFO tunnel 112 without penetrating the secundum 108. As shown in
FIG. 5A, the right atrial guidewire 250a is positioned in the right
atrium 101, and the left atrial guidewire 250b and the
self-centering guidewire 250c are positioned in the tunnel 112 and
the left atrium 102. In FIG. 5B, a delivery catheter 530a is
threaded along the right atrial guidewire 250a and the
self-centering guidewire 250c. A right atrial guidewire opening
534a and a left atrial guidewire opening 534b are positioned so
that as the delivery catheter 530a is passed along the guidewires
250a-250c, it enters the PFO tunnel 112. A penetrating guidewire
550d, when deployed, accordingly penetrates only the primum 107 and
not the secundum 108.
[0054] After the penetrating guidewire 550d has passed through the
primum 107, the delivery catheter 530a is removed, as shown in FIG.
5C. The right atrial guidewire 550a is then also removed. In FIG.
5D, the practitioner threads a positioning catheter 530b along the
penetrating guidewire 550d, and deploys an electrode catheter 530c
from the positioning catheter 530b to pass through the primum 107.
The electrode catheter 530c can include an electrode device 280 and
an inflatable member 270 generally similar to those described above
with reference to FIG. 3G. When drawn up against the primum 107,
the electrode device 280 can clamp the primum 107 and the secundum
108 against a backstop surface 538 of the positioning catheter
530b. The resulting seal 518 has a shape and location generally
similar to the seal 418 described above with reference to FIG.
4.
C. Self-Centering Guidewires and Associated Systems and Methods
[0055] In many of the embodiments described above, a self-centering
intravenous guidewire can be used to locate the sides, edges and/or
lateral boundaries of the PFO tunnel 112, thus allowing the
practitioner to more precisely locate the tissue seal at the center
of the tunnel 112, e.g., along an axis transverse or generally
transverse to the flow axis of the tunnel 112. FIGS. 6A-6K
illustrate representative embodiments of guidewires, generally
referred to as self-centering guidewires, suitable for performing
this function. Beginning with FIG. 6A, a self-centering guidewire
650a (generally similar to the self-centering guidewire 250c
described above) includes a first branch 651a and a second branch
652a that are fixedly secured relative to each other at a first
location 654a. When the self-centering guidewire 250c is positioned
in a catheter, the first and second branches 651a, 652a are
squeezed toward each other. The first and second branches 651a,
652a can be formed from a flexible, resilient material, e.g.,
Nitinol or another material that tends to assume the shape shown in
FIG. 6A when the self-centering guidewire 650a is deployed. When in
the deployed position, the first and second branches 651a, 652a can
be located in the same generally flat plane. The first branch 651a
can have a hollow or tubular construction, which allows it to be
threaded along the left atrial guidewire 250b. The practitioner
advances the self-centering guidewire 650a along the left atrial
guidewire 250b by applying an axial force to a distal portion of
the self-centering guidewire 650a while the left atrial guidewire
250b is held in place. The delivery catheter 230a (FIG. 3C) is then
passed along the self-centering guidewire 650a.
[0056] The self-centering guidewire 650a can also include a
connector tube 656 at a second location 655a. The connector tube
656 can be fixedly attached to the second branch 652a, but not to
the first branch 651a. The left atrial guidewire 250b can pass
through both the tubular first branch 651a and the connector tube
656, so that the first branch 651a and the second branch 652a form
a generally closed shape around an enclosed region 649. The left
atrial guidewire 250b can accordingly prevent the branches 651a,
652a from separating at the second location 655a. The practitioner
then directs the penetrating guidewire 250d through the septum (as
described above with reference to FIG. 3E) and through the enclosed
region 649 between the first and second branches 651a, 652a. Next,
the practitioner can pass the electrode catheter 230c (a portion of
which is shown in FIG. 6A) over the penetrating guidewire 250d, as
was discussed above with reference to FIG. 3F, and through the
enclosed region 649.
[0057] To remove the self-centering guidewire 650a without
disturbing the electrode catheter 230c, the practitioner can
withdraw the left atrial guidewire 250b from the connector tube 656
by moving the left atrial guidewire 250b in a proximal direction P.
Without the left atrial guidewire 250b securing the first branch
651a to the connector tube 656, the first branch 651a can at least
disengage from the connector tube 656, and in a particular
embodiment, can spring away from the second branch 652a as
indicated by arrow E, and as shown in dashed lines in FIG. 6A.
Accordingly, the first branch 651a and the second branch 652a can
form an open shape having a gap 657. With this configuration, the
self-centering guidewire 650a can be withdrawn in a proximal
direction P so that the first branch 651a passes along one side of
the electrode catheter 230c and the second branch 652a, separated
from the first branch by the gap 657, passes along the opposite
side of the electrode catheter 230c. The practitioner can then
withdraw the self-centering guidewire 650a and the left atrial
guidewire 250b into the delivery catheter 230a (FIG. 3H) while the
electrode catheter 230a remains in position. In another embodiment,
the first branch 651a can disengage from the connector tube 656
without initially moving to form the gap 657. In this case, the
first branch 651a can contact the electrode catheter 230c as the
self-centering guidewire 650 is drawn proximally, causing the first
branch 651a to deflect away from and around the electrode catheter
230c.
[0058] In a particular embodiment, the first and second branches
651a, 652a can enclose a generally hexagonally-shaped enclosed
region 649 having rounded or arcuate corners. Accordingly, the
first and second branches 651a, 652a can move smoothly into and out
of the PFO tunnel 112 (FIG. 3H). The rounded or arcuate portions of
the first branch 651a can also accommodate the left atrial
guidewire 250b positioned within it without causing the left atrial
guidewire 250b to kink or bind. Each of the first and second
branches 651a, 651b can have generally parallel side portions 646
toward the center of the self-centering guidewire 650a, and
converging end portions 645 toward the first and second locations
654a, 655a. This arrangement can be particularly suitable when the
opposing edges of the PFO tunnel 112 are generally parallel. In
other embodiments, other shapes (e.g., elliptical shapes and/or
other arcuate shapes) can also be suitable for such tunnel
topologies. In still further embodiments, the enclosed region 649
can have other shapes, e.g., shapes with non-parallel side portions
646, depending on the particular patient's tunnel characteristics.
In any of these embodiments, the first and second locations 654a,
654b (and/or other locations of the self-centering guidewire 650a)
can include radiopaque markings for enhanced visibility during
fluoroscopic visualization.
[0059] FIG. 6B illustrates a self-centering guidewire 650b having a
central enclosed region 649 formed by a first branch 651b and a
second branch 652b, with the left atrial guidewire 250b passing
through, rather than around, the enclosed region 649, in accordance
with another embodiment. In a particular aspect of this embodiment,
the first and second branches 651b, 652b are fixedly secured
relative to each other at a first location 654b, and are releasably
secured relative to each other by the left atrial guidewire 250b at
a second location 655b. At the second location 655b, the first
branch 651b includes a first connector tube 656a, and the second
branch 652b includes a second connector tube 656b having two
portions 648a, 648b separated by a space 647 (e.g., in the form of
a slot or other receptacle 640). The first connector tube 656a is
removably received in the space 647, e.g., in a tab-and-slot
arrangement. In particular, the first connector tube 656a can
include a tab 641 having surfaces generally parallel to the plane
of the enclosed region 649, and the second connector tube 656b can
have receptacle or slot surfaces that are also generally parallel
to the plane of the enclosed region 649. Accordingly, the first and
second branches 651b, 652b can interlock at the second location
655b when the tab 641 is received in (e.g., snugly engaged with)
the receptacle 640. The tab-and-slot arrangement can restrict or
eliminate relative twisting between the two branches 651b, 652b,
thus maintaining the generally flat, planar shape of the enclosed
region 649. The left atrial guidewire 250b passes through both the
first and second connector tubes 656a, 656b when the self-centering
guidewire 650b forms the enclosed region 649. To remove the
self-centering guidewire 650b without disturbing the electrode
catheter 230c, the practitioner can withdraw the left atrial
guidewire 250b proximally (as indicated by arrow P) from the first
connector tube 656a, allowing the first branch 651b to release and,
in at least one embodiment, spring outwardly, as indicated by arrow
E. The first and second branches 651b, 652b can then be passed
around the electrode catheter 230a and out of the patient's body
without disturbing the electrode catheter 230c.
[0060] FIG. 6C illustrates a self-centering guidewire 650c
configured in accordance with another embodiment in which the
electrode catheter 230c is used to separate a first branch 651c
from a second branch 652c at a second location 655c. The
self-centering guidewire 650c can include a tube 656c that is
threaded along the left atrial guidewire 250b as the self-centering
guidewire 650c is advanced into the heart. Prior to separating the
first and second branches 651c, 652c, the first branch 651c extends
around most of the enclosed region 649 and is received in an
opening at the end of the second branch 652c, at the second
location 655c. When the self-centering guidewire 650c is moved in a
proximal direction P toward the electrode catheter 230c, a contact
portion 658 of the first branch 651c contacts the electrode
catheter 230c. As the practitioner applies an additional axial
force to the self-centering guidewire 650c, the electrode catheter
230c forces the end of the first branch 651c out of the opening at
the end of the second branch 652c, as indicated by arrow O, causing
the first branch 651c to disengage, and in at least one embodiment,
spring outwardly as indicated by arrow E. With the self-centering
guidewire 650c in this configuration, it can be removed from around
the electrode catheter 230c. In other embodiments, mechanisms other
than the opening at the end of the second branch 652c can be used
to releasably connect the first and second branches 651c, 652c at
the second location 655c. For example, magnets carried by each of
the first and second branches, 651c, 652c can be used to perform
this function.
[0061] FIG. 6D illustrates a self-centering guidewire 650d that is
similar in some respects to the self-centering guidewire 650c
described above with reference to FIG. 6C. In particular, an
embodiment of the self-centering guidewire 650d includes a first
branch 651d attached to a second branch 652d at a first location
654d. The first branch 651d includes an end that is removably
received in a tubular portion of the second branch 652d at a second
location 655d. A central tube 656d is threaded along the left
atrial guidewire 250c and extends generally across the enclosed
region 649, but is not attached to the first and second branches
651d, 652d, except at the first location 654d. The increased axial
length of the tube 656d can further guide and align the
self-centering guidewire 650d relative to the left atrial guidewire
250c. When the self-centering guidewire 650d is to be removed, the
practitioner can move it in a proximal direction P until a contact
portion 658 contacts the electrode catheter 230c. When the
practitioner moves the self-centering guidewire 650d by an
additional amount in the proximal direction P, the first branch
651d pulls out of the second branch 652d, separating and/or
springing open as indicated by arrow E and opening a gap 657
through which the electrode catheter 230c passes as the
self-centering guidewire 650d is removed.
[0062] FIG. 6E is a partially broken illustration of a
self-centering guidewire 650e configured in accordance with still
another embodiment. In one aspect of this embodiment, the guidewire
650e includes a first branch 651e and a second branch 652e that
each have a fixed position relative to the other at a first
location 654e and are removably secured relative to each other at a
second location 655e. At the first location 654e, the first and
second branches 654e, 655e can be connected to a ferrule 659 that
slideably receives a connector tube 656e which is in turn threaded
along the left atrial guidewire 250c. The connector tube 656e can
include a connector 673 toward its distal end. The connector 673
can include a first aperture 674a that receives the first branch
651e, and a second aperture 674b that receives the second branch
652e. Flat surfaces 675 on the ends of the branches 651e, 652e
snugly mate with corresponding surfaces within the connector 673 to
resist the tendency for the branches 651e, 652e to twist out of the
plane shown in FIG. 6E. When the self-centering guidewire 650e is
deployed into the patient's PFO, the connector tube 656e and the
attached connector 673 have a position that is proximal (as
indicated by arrow P) from the position shown in FIG. 6E, so that
the end of the first branch 651e is received in the first aperture
674a, and the end of the second branch 652e is received in the
second aperture 674b. Accordingly, the first and second branches
651e, 652e are temporarily secured in position relative to each
other at the second location 655e. When the self-centering
guidewire 650e is to be removed, the practitioner can slide the
connector tube 656e and the connector 673 in a distal direction
relative to the ferrule 659 and along the left atrial guidewire
650c (as indicated by arrow D) to disengage the connector 673 from
the first and second branches 651e, 652e. The self-centering
guidewire 650e can then be removed from the patient in a manner
generally similar to that described above.
[0063] FIGS. 6F-6J illustrate an overall arrangement for a
self-centering guidewire and a controller in accordance with a
particular embodiment of the disclosure. Aspects of the embodiment
can facilitate deploying the self-centering guidewire (and the
right atrial guidewire) from the delivery catheter once the
delivery catheter is located in the patient's heart to reduce or
eliminate the likelihood for these guidewires to interfere with
each other (e.g., twist together). This arrangement is also
expected to be less likely to disturb the position of the
self-centering guidewire once it is in the PFO because the
(stiffer) delivery catheter is advanced along the self-centering
guidewire for only a short distance, e.g., the distance between (a)
the entrance of the vena cava to the heart, and (b) the PFO tunnel.
Beginning with FIG. 6F, the self-centering guidewire 650f can
include a first branch 651f and a second branch 652f fixedly
secured relative to each other at a first location 654f. For
example, both branches 651f, 652f can be fixedly connected to a
shaft 685. The first and second branches 651f, 652f can be
releasably secured relative to each other at a second location 655f
by a connector 673. A deployment tube 686 is attached to the
connector 673 and slides within the shaft 685 to change the
configuration of the self-centering guidewire 650f from a stowed
position (shown in FIG. 6F) in which the guidewire 650f is
configured to be carried in a delivery catheter, to a deployed
position described in further detail below with reference to FIG.
6G.
[0064] The operation of the self-centering guidewire 650f can be
controlled by a guidewire controller 680 that includes a housing
681, a deployment knob 682, and a connector knob 683. The
deployment knob 682 is manipulated to change the self-centering
guidewire 650f from the stowed position shown in FIG. 6F to the
deployed position. The connector knob 683 is manipulated to release
the first and second branches 651f, 652f at the second location
655f. The shaft 685 and the guidewire controller 680 are threaded
over the left atrial guidewire 250b, and a lubricant fitting 684
can provide saline or another suitable, biocompatible lubricant to
facilitate relative motion between the various components of the
guidewire 650f and the guidewire controller 680. The guidewire is
typically threaded through a catheter (e.g., the delivery catheter
230a shown in FIG. 3C), but for purposes of clarity, the catheter
is not shown in FIGS. 6F-6K.
[0065] The housing 681 can include an L-shaped deployment slot 687
which receives a deployment pin 688 carried by the deployment knob
682. To deploy (e.g., expand) the self-centering guidewire 650f,
the operator rotates the deployment knob 682 as indicated by arrow
R1 so that the deployment pin 688 moves circumferentially within
the deployment slot 687. An internal spring then forces the
deployment knob 682 away from the housing 681 so that the
deployment pin 688 moves axially within the deployment slot 687.
The deployment knob 682 is connected to the deployment tube 686,
which is in turn connected to the connector 673. Accordingly, when
the deployment knob 682 moves axially as indicated by arrow T1, the
connector 673 moves axially as indicated by arrow T2.
[0066] FIG. 6G illustrates the self-centering guidewire 650f in its
deployed position, after the deployment knob 682 has been
manipulated in the manner described above with reference to FIG.
6F. The first and second branches 651f, 652f can be formed from a
shape-memory material (e.g., Nitinol) so as to bend toward the
shape shown in FIG. 6G in the absence of an external force. In this
configuration, the first and second branches 651f, 652f can spread
and/or tighten the tissue of the primum in a manner generally
similar to that described above, and an electrode can be moved
through the atrial septum into the left atrium so as to seal or at
least partially seal the PFO tunnel, also in a manner generally
similar to that described above.
[0067] One aspect of an embodiment shown in FIGS. 6F-6G is that the
deployment knob 683 is spring loaded and is not locked once it is
released. As a result, the self-centering guidewire 650f will
automatically adjust to PFO tunnels having different widths. For
example, if the tunnel is relatively narrow, the branches 651f,
652f may not spread apart to the fullest possible extent, and the
deployment knob 683 may not travel axially to the fullest possible
extent. In this manner, the self-centering guidewire can
automatically adjust to any tunnel having a width greater than or
equal to the spread of the branches 651f, 652f in the undeployed
position (FIG. 6F), and less than or equal to the spread of the
branches 651f, 652f in the fully deployed position (FIG. 6G).
[0068] After the electrode has been positioned for tissue sealing
(e.g., as discussed above with reference to FIG. 3H), the first and
second branches 651f, 652f can be released at the second location
655f to allow the self-centering guidewire 650f to be withdrawn
from the patient's body. To release the first and second branches
651f, 652f, the operator rotates the connector knob 683 as
indicated by arrow R2, causing a connector pin 690 (which depends
from the connector knob 683) to rotate circumferentially within a
corresponding C-shaped connector slot 689 carried by the deployment
knob 682. This motion can unlock the connector knob 683 and allow
it to move axially. The practitioner then moves the connector knob
683 axially relative to the deployment knob 682 and the housing
681, as indicated by arrow T3, against a resistance force provided
by an internal spring. The locking function provided by the
connector slot 689 and the resistance provided by the internal
spring can prevent the connector knob 683 from being operated
inadvertently. As the connector knob 683 is advanced axially, the
connector 673 moves axially away from the branches 651f, 652f, as
indicated by arrow T4. Once the connector knob 683 has been
advanced axially as indicated by arrow T3, it is rotated as
indicated by arrow R3 so as to move the connector pin 690
circumferentially clockwise within the connector slot 689. Once the
practitioner has rotated the connector knob 683 as indicated by
arrow R3, the connector 673 is secured in an unlocked position,
described below with reference to FIG. 6H.
[0069] FIG. 6H illustrates the self-centering guidewire 650f and
the guidewire controller 680 with the self-centering guidewire 650f
in an unlocked configuration. In this configuration, a connector
tube 656f, which is slideably housed within the deployment tube
686, and which is connected to the connector knob 683, has pushed
the connector 673 axially along the left atrial guidewire 250b to
release the first and second branches 651f, 652f at the second
location 655f. Once in this configuration, the entire
self-centering guidewire 650f can be removed from the patient's
body by moving the guidewire controller 680 as a unit in an axial
distal manner as indicated by arrows T5. Because the first and
second branches 651f, 652f are no longer secured at the second
location 655f, they can readily pass around the electrode catheter
230c, in a manner generally similar to that described above. The
branches 651f, 652f can then collapse as they are pulled proximally
through a catheter, e.g., the delivery catheter 230a shown in FIG.
3C.
[0070] FIG. 6I is a partially schematic, cross-sectional
illustration of the shaft 685, taken generally along lines 6I-6I of
FIG. 6H. As discussed above with reference to FIG. 3C, the shaft
can have an elliptical or other non-round cross-sectional shape so
as to maintain its orientation relative to the catheter from which
it extends (e.g., the delivery catheter 230a shown in FIG. 3C). The
shaft 685 can be formed from a flexible material (e.g., a plastic)
and can include multiple lumens that house corresponding components
of the self-centering guidewire 650f. For example, the shaft 685
can include a control lumen 691a that houses the deployment tube
686, the connector tube 656f, and the left atrial guidewire 250b in
a generally concentric, annular fashion. Each of these components
can move relative to the other within the control lumen 691a. The
shaft 685 can further include a first branch lumen 691b that houses
the first branch 651f of the self-centering guidewire 650f, and a
second branch lumen 691c that houses the second branch 652f. The
branches 651f, 652f can be secured to the inner surfaces of the
corresponding lumens 691b, 691c, so that they do not move relative
to the shaft 685.
[0071] FIG. 6J is a partially schematic, partially broken
illustration of the self-centering guidewire 650f illustrating
details of particular components. At the first location 654f, the
self-centering guidewire 650f includes a ferrule 695 that fixedly
secures the first and second branches 651f, 652f to each other,
e.g., via one or more spot welds. The generally rigid ferrule 695
abuts and/or is attached to the generally flexible shaft 685. The
deployment tube 686 can slide relative to the shaft 685 at the
first location 654f, and is connected to a pair of tabs 692 at the
second location 655f. The tabs 692 snugly engage with corresponding
flat surfaces 675 of the first and second branches 651f, 652f. The
connector tube 656f, which is slideably positioned within the
deployment tube 686, is attached to the connector 673, which in
turn includes a tip 693 and a sleeve 694. The tip has an opening
(e.g., a through-hole) to accommodate the left atrial guidewire
250b. The sleeve 694 fits around the distal ends of the first and
second branches 651f, 652f to keep the flat surfaces 675 engaged
with the tabs 692. This arrangement can significantly reduce the
tendency for the branches 651f, 652f to twist out of the plane of
FIG. 6J. When the deployment tube 686 is moved axially in either
direction indicated by arrow T6, the connector 673, the connector
tube 656f, and the first and second branches 651f, 652f at the
second location 655f move as a unit relative to the first location
654f. When the connector tube 656f is moved axially as indicated by
arrow T4, the sleeve 694 slides off the first and second branches
651f, 652f, allowing the first and second branches 651f, 652f to
disengage from the tabs 692 so that the self-centering guidewire
650f can be removed from around the electrode catheter 230c (FIG.
6H) and removed from the patient's body, as described above with
reference to FIG. 6H. In other embodiments, the self-centering
guidewire 650f can include other arrangements that selectively lock
the branches 651f, 652f at the second location 655f, and resist
twisting when locked, and that selectively unlock the branches
651f, 652f to allow the guidewire 650f to be withdrawn.
[0072] FIG. 6K is a partially schematic, cross-sectional
illustration of the guidewire controller 680. The housing 681 of
the guidewire controller 680 is rigidly attached to the shaft 685,
and both the guidewire controller 680 and the shaft 685 are
threaded over the left atrial guidewire 250b. The deployment tube
686 is attached to a first fitting 697a which is in turn forced by
a deployment knob spring 696a into engagement with the deployment
knob 682. Accordingly, the deployment knob spring 696a can
facilitate the axial motion of the deployment knob 682 as indicated
by arrow T1, and as described above with reference to FIG. 6F.
[0073] The connector tube 656f, which is slideably positioned
within the deployment tube 686, is connected to a second fitting
697b which is in turn connected to the connector knob 683. A
connector knob spring 696b forces the connector knob 683 to the
position shown in FIG. 6K, so that the practitioner must overcome
this force to move the connector tube 656f (and the associated
connector 673), as described above with reference to FIG. 6G.
[0074] One feature of at least some of the foregoing embodiments is
that they include a guidewire having two resilient separable
portions (e.g., branches). An advantage of this feature is that it
allows each portion to apply a relatively small, moderate, or
otherwise non-tearing force against opposite sides or edges of the
PFO tunnel, which can both stretch the tunnel and center the
guidewire. When the practitioner then penetrates the septum with
the penetrating guidewire and the electrode catheter, he or she can
do so with greater assurance that the electrode or other energy
delivery device is centered or approximately centered laterally in
the tunnel. Because the branches of the self-centering guidewire
are separable, the guidewire can be removed from its centered
position without disturbing the electrode catheter or the tissue
bond formed by the electrode catheter.
[0075] Another feature of at least some of the foregoing
embodiments is that the branches, when connected, can define a
generally planar enclosed shape. This shape can tend to sandwich
directly between the primum and the secundum, as discussed above
with reference to FIG. 3D, so that the guidewire tends not to
rotate or twist once in position in the PFO tunnel. This is unlike
existing guidewires having separate prongs, which may allow the
guidewire to twist once it is in the PFO tunnel. In addition, at
least some of the foregoing embodiments include connectors that
snugly yet releasably secure the distal ends of the branches
relative to each other. This is also unlike some existing
guidewires having prongs with distal ends that are partially
captured, but are not constrained in a manner that adequately
resists twisting. For example, the flat surfaces 675 securely mated
with the corresponding surfaces of the connector shown in FIG. 6E
are expected to significantly stiffen the guidewire 650f against
twisting about its major axis. The flat surfaces 675 and
corresponding tabs 692, in combination with the surrounding sleeve
694 are also expected to achieve this result. In addition, the
connector 673 can prevent the distal ends from inadvertently being
released as the guidewire 650f is moved axially, proximally and/or
distally, during a positioning procedure. Accordingly, embodiments
of the guidewire described above can allow the practitioner to more
accurately position additional devices, e.g., penetrating
guidewires and/or energy transmitters.
[0076] Another feature of at least some of the foregoing
embodiments is that the self-centering guidewire can automatically
align with the main axis of the tunnel (e.g., the axis running the
length of the tunnel, from entry to exit), even if the
cross-section of the tunnel varies. For example, FIG. 6L
illustrates a right atrial view of the self-centering guidewire
650f in a PFO tunnel 112 having diverging tunnel walls. The
flexible nature of the branches 651f, 652f allows them to conform
to the orientation of the diverging walls, while flat portions 654f
of the branches 651f, 652f maintain contact with the walls. Because
the flat portions 654f are pre-formed to be flat, they will
generally remain flat when the guidewire 650f assumes the shape
shown in FIG. 6L in a diverging tunnel. FIG. 6M illustrates a right
atrial view of the self-centering guidewire 650f in a PFO tunnel
having converging walls. Again, the flexible nature of the branches
651f, 652f can allow them to conform to the converging orientation
of the walls, while the flat portions 654f of the branches maintain
contact with the tunnel walls. In particular embodiments, the
branches 651f, 652f can include features that enhance this
capability. For example, the branches 651f, 652f can include bends
653f on either side of the flat portions 654f that preferentially
allow the flat portions 654f to pivot relative to the distal and
proximal portions of the branches 651f, 652f. The bends 653f can
include pivot joints, weaker (e.g., smaller diameter) regions of
the branches 651f, 652f, or other suitable arrangements.
D. Devices and Methods for Penetrating Tissue
[0077] In many of the foregoing embodiments, the self-centering
guidewire is used to locate the penetrating guidewire (or other
penetrating member) and the electrode catheter (or other energy
transmitter) relative to the PFO tunnel. In many cases, it is
desirable to advance the penetrating guidewire incrementally so as
to control the motion of the penetrating tip and the rate at which
the tip passes through the septum. Several embodiments are
described below in the context of penetrating guidewires that
deliver RF energy to perform tissue penetration. In other
embodiments, the penetrating guidewire can deliver other types of
energy, e.g., ultrasound energy, microwave energy, laser energy
and/or physical force (e.g., via a sharpened tip).
[0078] FIG. 7A illustrates a process 760 for performing this
technique in accordance with a particular embodiment. Process
portion 762 includes advancing the penetrating guidewire into the
right atrium. In process portion 764, one or more characteristics
of the right atrial blood are sensed. For example, in a particular
embodiment, process portion 764 includes sensing an impedance of an
electrical circuit that includes the penetrating guidewire and the
right atrial blood. The impedance value can then be used as a basis
for comparison to the circuit impedance when the penetrating
guidewire is (a) within the septal tissue and/or (b) through the
septal tissue.
[0079] In process portion 766, the penetrating guidewire is
advanced by a preselected or predetermined distance unit. In a
particular embodiment, the distance unit can be one millimeter, and
in other embodiments, the distance unit can have other values. In
any of these embodiments, the distance unit can be less (and in
some cases, significantly less) than the thickness of the tissue
through which the guidewire will pass. The distance unit can be
measured outside the patient's body, e.g., at the proximal end 231
of the catheter 230 shown in FIG. 2.
[0080] Process portion 768 includes sensing the environment
adjacent to the penetrating guidewire, and determining whether the
adjacent environment is tissue, rather than blood. This process can
include determining the impedance of the electrical circuit
described above, and comparing the impedance to a predetermined
value, for example, the impedance determined in process portion
764. In at least some cases, the penetrating guidewire will exit
the delivery catheter directly into the septal tissue, and so the
tissue will be sensed without advancing the penetrating guidewire
any further. However, if tissue is not sensed in process portion
768, the penetrating guidewire is advanced an additional distance
unit (process portion 766).
[0081] If tissue is sensed, then the penetrating guidewire is
advanced by a distance unit to place a designated preload on the
penetrating guidewire (process portion 770). For example, once the
penetrating guidewire has encountered tissue, advancing the
penetrating guidewire by an additional distance unit can cause the
wire to bow and/or stretch the tissue against which it is abutted.
In a particular embodiment, the distance unit by which the
penetrating guidewire is advanced can be the same, whether the
penetrating guidewire is passing through right atrial blood, or
through tissue. In other embodiments, the distance units can be
different, depending on whether the penetrating guidewire is
approaching the tissue, up against the tissue, or within the
tissue. For example, the distance unit can be greater when the
penetrating guidewire is approaching the tissue than when it is
against and/or within the tissue. The preload can have a value
selected based on parameters that include patient physiology and/or
characteristics of the penetrating guidewire. In particular
embodiments, the preload can have a value in the range of from
about 0.01 pounds to about 0.5 pounds. In a particular embodiment
in which the penetrating guidewire has a diameter of about 0.013
inch and a generally spherical tip with a diameter of about 0.030
inches, the preload can be about 0.15 pounds.
[0082] In process portion 772, an energy pulse or a series of
pulses is applied to the penetrating guidewire to ablate the tissue
against which the penetrating guidewire abuts. The pulses can
include a single pulse, a burst of pulses, and/or a series of pulse
bursts. The pulses can be RF energy pulses, or pulses of other
types of energy, for example, ultrasound energy. As the penetrating
guidewire advances into the ablated hole made in process portion
772, the preload placed upon the guidewire in process portion 770
is released. In process portion 774, the penetrating guidewire is
advanced an additional distance unit e.g., to place a new preload
on the guidewire prior to ablating additional tissue.
[0083] Process portion 776 includes determining whether a distance
limit has been reached, e.g., whether the guidewire has been
advanced by or to a target value. In particular embodiments, the
distance limit can correspond to a maximum expected thickness of
the septum, or a maximum lateral dimension of the left atrium.
Accordingly, process portion 786 can be used to prevent the
penetrating guidewire from passing through the left atrium and into
the left wall of the heart. If the distance limit has been reached,
the process 760 stops at process portion 780. If not, then process
portion 768 includes determining whether left atrial blood is
sensed, e.g., by sensing the impedance of the circuit described
above. If so, this indicates that the penetrating guidewire has
passed entirely through the septum. The penetrating guidewire can
then be advanced to the distance limit to provide room for
additional devices deployed along the penetrating guidewire in the
left atrium. Accordingly, the process 700 can return to process
portion 774. If left atrial blood is not sensed, then the process
returns to process portion 772, and additional tissue is ablated in
an incremental manner until left atrial blood is sensed.
[0084] FIG. 7B schematically illustrates a representative apparatus
suitable for advancing the penetrating guidewire in accordance with
an embodiment of a method described above with reference to FIG.
7A. The apparatus can include a guidewire advancer 710a that
incrementally advances the penetrating guidewire 250d into and
through the septum 106, e.g., through the primum, the secundum, or
both. The guidewire advancer 710a can include an actuator 711a that
is operatively coupled to the penetrating guidewire 250d. In a
particular arrangement, the actuator 711a can include a screw 719
that slides along an axial guide 729 (e.g., a keyway). The screw
719 is connected to a spring 722 which is in turn connected to the
guidewire 250d with a coupling 716. The coupling 716 can transmit
electrical energy to and/or from the guidewire 250d, and
accordingly can be connected to a connecting lead 715, which is in
turn connected to a power source 714 via a switch 717. The power
source 714 can have a relatively high output impedance (e.g.,
400-1000 ohms), which can allow the penetrating tip 753 to readily
begin a spark erosion process when in contact with the septal
tissue. This feature can also allow the tip 753 to rapidly quench
when in a blood pool. Still further, the high output impedance is
expected to reduce the likelihood for the tip 753 to arc when in a
blood pool, thus reducing the likelihood for forming a thrombus. A
sensor 726 (e.g., an impedance sensor) can detect a characteristic
of the environment in which a penetrating tip 753 of the guidewire
250d is positioned, as discussed above with reference to FIG.
7A.
[0085] In a particular aspect of the arrangement shown in FIG. 7B,
the actuator 711a further includes a rotatable knob 712 that
threadably engages the screw 719 and is restricted from axial
movement by a retainer 713. Accordingly, the operator can rotate
the knob 712 in a counterclockwise direction (indicated by arrow
R1), which causes the screw 719 to axially advance along the axial
guide 729 while the knob 712 is held in a fixed axial position by
the retainer 713. One or more detents 721 can control the motion of
the screw 719. For example the detents 721 can provide temporary
and/or intermediate stops for the screw 719 as it is advanced by
predetermined distances. A head 727 of the screw 719 can provide a
final stop by contacting the knob 712 when the maximum number of
distance units has been reached.
[0086] In a particular embodiment, the knob 712 can be rotated
manually by a practitioner. In other embodiments, a motor 720 or
other powered device can rotate the knob 712 to automate or at
least partially automate the process of advancing the penetrating
guidewire 250d. In such embodiments, the motor 720, the switch 717,
and the sensor 726 can be operatively coupled together (e.g., under
the direction of the controller 221 shown in FIG. 2) so that the
guidewire 250d can be automatically advanced until the tip 753
penetrates through the septum 106. In further embodiments the
actions of the knob 712 and the screw 719 can be reversed, e.g.,
the knob 712 can slide axially, and the screw 719 can rotate.
[0087] FIG. 7C illustrates the guidewire advancer 710a after the
screw 719 has been advanced by a representative distance unit D. At
this point, a preload has been applied to the guidewire 250d, for
example, by compressing the spring 722 and/or by deforming the
septum 106. The switch 717 can remain open while the preload is
applied to the guidewire 250d.
[0088] When the guidewire 250d has been advanced far enough to
contact the septum 106, as indicated in FIG. 7C, and as detected by
the sensor 726, the switch 717 can be closed, as shown in FIG. 7D.
As electrical power is provided to the tip 753, the tip 753 ablates
the septal tissue and advances by a distance unit D, relieving the
compressive force (e.g. the preload) on the tip 753 provided by the
septum 106 and/or the spring 722. The process shown in FIGS. 7B-7D
can be repeated until the septum 106 is penetrated and/or until the
head 727 engages the knob 712.
[0089] FIG. 7E illustrates a guidewire advancer 710b and associated
actuator 711b configured in accordance with another embodiment of
the disclosure. In one aspect of this embodiment, the actuator 711b
can include a slider 723 that is coupled to the spring 722 and the
guidewire 250d to advance the guidewire tip 753. The slider 723 can
be operated manually or via the motor 720. In either arrangement,
the guidewire advancer 710b can include one or more detents 721 to
control the motion of the slider 723. For example, the detents 721
can be positioned one distance unit apart to allow the guidewire
250d to be advanced incrementally into and through the septum
106.
[0090] FIG. 7F illustrates a guidewire advancer 710c configured for
automated operation in accordance with another embodiment of the
disclosure. The guidewire advancer 710c can include a constant
force spring 722 and/or a motor 720, operatively coupled to the
guidewire 250d. Before the tissue penetration feature of the
guidewire 250d is operated, a catch 728 is engaged with a wire stop
725 to prevent inadvertent movement of the penetrating tip 753. To
begin operation, the practitioner can press a start button 724
which both releases the wire stop 725 from the catch 728, and
closes an energy delivery "on" switch 717a. At this point, the
spring 722 and/or the motor 720 apply an axial force to the
penetrating guidewire 250d while the power source 714 (FIG. 7B)
applies an electrical current to the guidewire 250d. In a
particular embodiment, the tip 753 can be positioned against the
septum 106 before the start button 724 is engaged, but in other
embodiments, the tip 753 can be automatically advanced into contact
with the septum 106 using a feedback arrangement as was discussed
above with reference to FIGS. 7A-7B.
[0091] As the penetrating tip 753 presses against and ablates the
septal tissue, it advances into the septum 106 while the constant
force spring 722 and/or the motor 720 continue to apply an axial
force that moves the tip 753 forward. In a particular aspect of
this embodiment, the motion of the tip 753 can be generally
continuous until the tip 753 penetrates through the septum 106
and/or until the wire stop 725 engages an energy delivery "off"
switch 717b, e.g., after traveling a full travel distance T as
shown in FIG. 7F. In other embodiments, the motion of the tip 753
can be controlled to be stepwise or incremental, as discussed above
with reference to FIGS. 7A-7E. In still further embodiments,
devices other than a constant force spring can be used to apply a
generally constant force to the tip 753. Such devices include, but
are not limited to, pneumatic devices and hydraulic devices.
[0092] FIG. 7G is a detailed cross-sectional illustration of the
penetrating guidewire 250d in accordance with a particular
embodiment. The penetrating guidewire 250d can include a flexible,
electrically conductive core 744 enclosed by a sheath of flexible,
electrical insulation 743. The tip 753 is in electrical
communication with the conductive core 744. A collar 742 or other
electrically and thermally insulating member can be located between
the tip 753 and the flexible electrical insulation 743. In a
particular embodiment, the penetrating guidewire 250d can include
features to enhance fluoroscopic visualization (or other
visualization) during operation. For example, the penetrating
guidewire 250d can include one or more bands or other regions of
plating (e.g., a 7.mu. layer of gold plating) at points in a
proximal direction from the tip 753. In a particular embodiment,
the plating can be a continuous coating that extends from the tip
753 proximally by a distance of about two inches.
[0093] In operation, the penetrating guidewire 250d can perform as
a spark erosion or spark discharge device. Accordingly, sparking
produced at the tip 753 can produce microscopic explosive steam
vesicles that open a region in the tissue ahead of the tip 753 and
allow the guidewire 250d to penetrate. The materials for the
components of the penetrating guidewire 250d can be selected to
enhance this operation. For example, the tip 753 can include a
thermally refractory, radio-dense or radiopaque material, such as a
platinum-iridium alloy, that resists pitting and/or other types of
degradation that occur in metals with lower melting points, such as
steel and Nitinol. Platinum-iridium alloys are also readily
machineable and swageable, and can show up well during fluoroscopic
surveillance of the penetrating procedure. The conductive core 744
can be formed from a more flexible material, such as Nitinol, and
the insulation 743 can reduce or prevent the loss of electrical
energy along the length of the conductive core 744. The collar 742
can include a ceramic material that provides a thermal buffer
between the tip 753 and the electrical insulation 743, which might
otherwise suffer melting and/or other damage as a result of the
sparking action at the tip 753.
[0094] One feature of particular embodiments described above with
reference to FIGS. 7A-7G is that the penetrating guidewire is
advanced incrementally. Accordingly, the likelihood for
over-advancing the penetrating guidewire can be eliminated or
significantly reduced. Another advantage associated with particular
embodiments is that the process of advancing the penetrating
guidewire can include applying a compressive preload on the
guidewire. This arrangement can increase the efficiency with which
the guidewire penetrates the septal tissue. Still another advantage
associated with at least some of the foregoing embodiments is that
some or all aspects of the guidewire motion can be automated or
semi-automated. For example, the practitioner can manually place
the guidewire 250d at or close to the septum 106, and the automated
procedure can be used to penetrate the septum. This arrangement
can, in at least some cases, provide for increased consistency of
operation and/or increased penetration accuracy.
[0095] In at least some embodiments, selected aspects of the
penetrating guidewire can be modified or eliminated. For example,
in some embodiments, the final "stop" feature of the foregoing
embodiments can be included, but the discrete stepwise advancement
feature can be eliminated. Imaging/visualization techniques can
instead be used to determine the progress of the penetrating
guidewire and can optionally supplement the function of the final
stop.
[0096] Returning now to FIG. 3E, the penetrating guidewire 250d can
be operated in a bipolar manner, as indicated by field lines F,
independently of whether or not it is controlled in accordance with
the method described above with references to FIGS. 7A-7G. In
particular, electrical power can be provided to the electrode tip
253 shown in FIG. 3E, and the return electrode 280b can operate as
a return path for electrical current provided to both the tip 253
and a treatment electrode, e.g., the electrode 280 shown in FIG.
3F. In other embodiments, the penetrating guidewire 250d can use
other return electrodes, but in an aspect of the embodiment shown
in FIG. 3E, the shared return electrode 280b can reduce the overall
complexity of the system.
[0097] In a particular embodiment, power can be supplied to the
penetrating guidewire 250d at from about 150 volts rms to about 250
V.sub.rms (e.g., about 200 V.sub.rms) and a frequency of from about
100 KHz to about 5 MHz (e.g., about 480 KHz). The power can be
applied for about 2 seconds continuously in one embodiment, and
another embodiment, the power can be applied over a time period
that ranges from about 1 second to about 5 seconds. In still
further embodiments, the power can be applied for time periods of
less than 1 second. For example, from about 0.01 seconds to about
0.1 seconds.
[0098] In any of the foregoing embodiments, the motion of the
penetrating guidewire 250d can be constrained, for example, via a
stop device carried by the penetrating guidewire 250d and/or the
delivery catheter 230b. In particular embodiments, the motion of
the penetrating guidewire 250d can be constrained so that the tip
253 (at maximum displacement) is no further than five centimeters
from the return electrode 280b. In other embodiments, this distance
can be three centimeters or less. In any of these embodiments, the
distance between the tip 253 and the return electrode 280b is
relatively small, so that the electric field emanating from the tip
253 loops back to the return electrode 280b.
[0099] One feature of the foregoing bipolar arrangement for the
penetrating guidewire 250d is that it can improve patient safety
because the electric fields are more tightly constrained to the
region of interest (e.g., the septum 106). In addition, the bipolar
arrangement eliminates the need for a patient pad, which can
simplify the patient treatment procedure and provide for more
consistency from one patient to another. Further features of
bipolar electrode arrangements are described later with reference
to FIG. 6J.
E. Electrode Devices and Associated Methods
[0100] After the penetrating guidewire is inserted through the
septal tissue, an electrode device or other energy delivery device
can be passed along the penetrating guidewire to seal the PFO
tunnel. FIG. 8A is a partially schematic, cross-sectional
illustration of an electrode device 880a configured in accordance
with a particular embodiment of the disclosure. The electrode
device 880a can be carried by the electrode catheter 230c described
above, or by another catheter. The electrode device 880a can
include an electrically conductive material 881 formed from a
plurality of flexible fibers. In a particular embodiment, the
fibers are wrapped in a generally spiral and/or braided fashion
with first ends 888 connected to a support 887 (e.g., a distal end
of the electrode catheter 230c, or a ferrule carried at the distal
end), and second ends 889 attached to an actuator 883. The actuator
883 can include an actuator cap 885 connected to an actuator tube
884 that fits within the electrode catheter 230c and has an axial
opening through which the penetrating guidewire 250d passes. The
actuator cap 885 can be formed from an electrically insulating
material, e.g., a ceramic material or polymer. In some embodiments,
the actuator tube 884 can extend (as a tube) through the entire
electrode catheter 230c and outside the patient's body for
actuation. In other embodiments, the actuator tube 884 can extend
for a short distance and then connect to an actuator cable that
extends alongside the penetrating guidewire 250d and outside the
patients' body. In still further embodiments, the actuator tube 884
can be eliminated and replaced with a cable that attaches directly
to the actuator cap 885.
[0101] The conductive material 881 forming the electrode device
880a can include a Nitinol material, another shape memory material,
and/or another suitable fibrous electrically conductive material.
The electrode device 880a can include a suitable number of fibers
or strands (e.g., from about 16 to about 128), having a suitable
diameter (e.g., from about 0.001 inches to about 0.010 inches). In
a particular embodiment, the electrode device 880a can include 48
strands, each having a diameter of about 0.004 inches. In a
particular embodiment, the conductive material 881 has the
configuration shown in FIG. 8A when in its relaxed state. When the
actuator tube 884 (and/or cable) is withdrawn proximally into the
electrode catheter 230c, the actuator cap 885 draws the second ends
889 of the conductive material 881 toward the first ends 888,
causing the conductive material 881 to splay outwardly from the
penetrating guidewire 250d.
[0102] Electrical power is provided to the conductive material 881
via an electrical energy path 886. In a particular embodiment, the
actuator 883 itself can be electrically conductive and can provide
the electrical energy path 886 to the conductive material 881. In
other embodiments, a separate electrical lead or other conductive
member can provide the electrical energy path.
[0103] FIGS. 8B and 8C illustrate the electrode device 880a in its
deployed configuration. In this configuration, the conductive
material 881 can be flattened or partially flattened up against the
primum 107 (as shown in FIG. 8B), and can form a petal-like
configuration when seen in end view (as shown in FIG. 8C).
Accordingly, the electrode device 880a includes gaps or spaces
between the strands or filaments of conductive material 881. In
general, the electrode device 880a can have a diameter in the range
of from about 2 mm to about 30 mm (e.g., about 12 mm) when
deployed. The particular diameter selected by the practitioner can
depend on features that include the geometry of a given patient's
PFO.
[0104] Referring now to FIG. 8B, the distal-facing surfaces of the
conductive material 881 may be coated with an insulating material
882 in a particular embodiment to prevent or restrict electrical
signals from being directed distally into the blood in the left
atrium 102. Instead, the insulating material 882 can limit the
delivery of electrical energy so as to be delivered to the septum
106 rather than throughout the left atrial region, which would
otherwise provide an electrical pathway to ground. In another
embodiment, the insulating material 882 can be eliminated. It is
expected that eliminating the insulating material 882 may improve
the manufacturability of the electrode device 880a, and in many
cases may enhance the energy delivery to the primum 107 when
compared to an electrode device that includes the insulating
material 882. In particular, as the electrode device 880a directs
energy into the septum 106, the impedance of the tissue in the
septum 106 (e.g., in the primum 107) directly adjacent to the
electrode device 880a increases. Accordingly, the path of least
electrical resistance may move laterally away from this region. For
example, the path of least electrical resistance may be through the
blood located adjacent to the distal surface of the conductive
material 881 in the left atrium 102, and then back into a portion
of the septum located laterally from the electrode device 880a, as
indicated by arrows F in both FIGS. 8B and 8C. It is expected that
in at least some embodiments, the effect of the spreading current
path will be to increase the radial dimension of the seal 118
formed between the primum 107 and the secundum 108 in spite of the
increasing impedance of the tissue close to the conductive material
881. Accordingly, this arrangement can provide a more secure and/or
more complete tissue seal 118 between the primum 107 and the
secundum 108.
[0105] The foregoing effect (e.g., directing the electrical field
radially outwardly) can apply to the electrode device 880a as a
whole, as discussed above, and also to individual fibers or strands
of the electrode device 880a. For example, FIG. 8D is a
cross-sectional view of one of the fibers or strands of conductive
material 881 shown in FIG. 8C, positioned against the primum 107.
As energy is applied to the conductive material 881, a tissue
desiccation zone 816 typically forms in the primum 107 adjacent to
the conductive material 881, depending upon the density of the
current at the strand. The increased impedance in the tissue
desiccation zone 816 reduces current flow (and resultant heat
production) therein; however, the ongoing current flow in the
blood-to-tissue circuit continues, as shown by arrows F. Without
the ability of the current to flow from the distal-facing surfaces
of the electrode device filaments or strands (which are in contact
with circulating blood), the tissue may not reach temperatures
adequate to cause tissue sealing in the regions between individual
strands. Accordingly, making the distal surfaces uninsulated can
increase the amount of heated tissue between individual strands of
conductive material 881. This in turn can improve the uniformity of
the seal formed by the electrode device 880a even though it
includes individual strands rather than a continuous conductive
plate. This effect can be important, particularly for larger
electrode devices 880a (e.g., having a diameter of 12 mm and used
for sealing larger regions of tissue), for which there may exist
larger spaces between individual strands.
[0106] In particular embodiments, the entire distal surface of the
electrode device 880a can be uninsulated, and in other embodiments,
selected portions of the distal surface can be uninsulated, and
other portions can be insulated. For example, referring now to FIG.
8B, the lower or inferior portion of the distal surface can be
insulated and the upper or superior portion can be uninsulated. In
this manner, the heating effect produced by the electrode device
880a can preferentially be projected radially outwardly in the
superior direction. Because the primum 107 may overlap the secundum
108 to a greater extent in the superior region than in the inferior
region, this arrangement can concentrate the heating effect in the
region(s) where a tissue seal is most likely to form (e.g., the
superior region), while reducing power loss to the left atrial
blood in other regions (e.g., the inferior region). This result can
be particularly beneficial for larger electrode devices, e.g.,
those having a diameter in the range of from about 12 mm to about
18 mm.
[0107] In other embodiments, the distribution of insulation on the
distal surface of the electrode device may be selected in other
manners. For example, selected inferior portions of the electrode
device 880a may remain uninsulated to promote primum heating even
where the primum 107 does not overlap the secundum 108 so as to
shrink the primum in such regions. This arrangement can reduce
septal tissue "floppiness" and/or improve the tissue seal.
[0108] In particular embodiments, the practitioner may wish to
monitor the temperature in the region of the tissue seal.
Accordingly, the electrode device 880a can include a thermocouple
879 or other temperature sensor to provide feedback. The feedback
information can be used to update energy delivery parameters,
either with the practitioner "in the loop," or automatically in a
closed loop fashion.
[0109] As discussed above, embodiments of the electrode device 880a
include a filamentous, fibrous, stranded and/or otherwise porous
and/or fluid transmissible conductive material 881. As a result,
the filaments can be exposed to and cooled by blood circulating in
the left atrium 102. An expected advantage of this arrangement is
that the filaments can be less likely to overheat by virtue of heat
conduction from the adjacent cardiac tissue, which is in turn
heated by the RF energy produced by the electrode device 880a. This
arrangement can also be less likely to overheat the adjacent
cardiac tissue. Accordingly, the filaments can be less likely to
stick to the adjacent cardiac tissue, and the tendency for clot
formation can be reduced. Blood desiccation and/or coagulation
might otherwise adversely affect the uniformity and/or strength of
the electric field provided by the electrode device 880a. In
addition, this arrangement can allow the electrode device 880a to
be operated at higher powers and/or for longer periods of time
without coagulating, which gives the practitioner additional
flexibility and safety when performing procedures.
[0110] FIGS. 8E and 8F illustrate electrode devices having
filamentous and/or fibrous conductive material 881 arranged in
accordance with other embodiments of the disclosure. For example,
FIG. 8E illustrates an electrode device 880b having conductive
material arranged in a woven pattern and flattened in its relaxed
state. In a further aspect of this embodiment, the flattened sheet
of conductive material 881 can further be folded on itself, as
indicated by arrows G, so as to more easily fit within the
electrode catheter 230c. In an embodiment shown in FIG. 8F, an
electrode device 880c includes a filamentous electrically
conductive material 881 that is arranged more or less randomly,
rather than in a regular pattern. When deployed, the electrode
device 880c can form a shape (e.g., a "ball") that is more
three-dimensional than the generally flat, petal-shaped
configuration shown in FIG. 8C. An advantage of this arrangement is
that it may be easier to manufacture, and/or the level of care
required to place the electrode device 880c in the electrode
catheter 230c may be less than is required for the electrode device
880a shown in FIGS. 8A-8D.
[0111] FIG. 8G illustrates an electrode device 880d having
electrically conductive material 881 in the form of one or more
fibers arranged in a petal configuration. The conductive material
881 can have a preformed shape once the electrode device 880d has
been deployed, and in a particular embodiment, the preformed shape
can include a generally concave, disk-type shape, as shown in FIG.
8G. This shape can flatten out when the electrode device 880d is
pulled against the septal tissue. In particular embodiments,
depending for example on the flexibility of the conductive material
881, this arrangement can result in a more uniform distribution of
force on the septal tissue. The preformed shape can be formed in
any of a variety of suitable manners, including heat setting the
conductive material 881, permanently deforming the conductive
material fibers during the assembly process, varying the helix
angle of the braid along the length of the braid, and/or varying
the way the braid is constrained during the assembly process and/or
during the process of deploying the electrode device 880d.
[0112] FIG. 8H illustrates an electrode device 880e configured in
accordance with yet another embodiment of the disclosure. In this
embodiment, the conductive material 881 can have a petal
configuration positioned in a plane that is generally flat, as
shown in FIG. 8C, or concave, as shown in FIG. 8G, or shaped in
another manner. In any of these embodiments, the general plane in
which the conductive material 881 is positioned can be tilted
relative to the axis of the electrode catheter 230c at a
non-orthogonal angle. When the electrode device 880e is deployed at
the septum 106, as shown in FIG. 8I, the degree of tilt between the
plane of the electrode device 880e and the axis of the electrode
catheter 230c can help to ensure that the upper edge of the
electrode device 880e makes good contact with the primum 107 and
holds the primum 107 firmly against the secundum 108 in this area.
The tilt angle can be selected in concert with the tissue
penetration angle, which is about 105.degree. in FIG. 8I and was
discussed further above with reference to FIG. 3D. This arrangement
can align the electrode device 880e with the septum 106 and provide
good coaption between the primum 107 and the secundum 108. When the
electrode device 880e has an initially concave preformed shape, as
discussed above with reference to FIG. 8G, applying a proximal
force (as indicated by arrow P) on the electrode device 880e can
cause it to flatten and provide a generally uniform compression
force against the septum 106.
[0113] In other embodiments, the electrode devices can have shapes
and/or configurations other than those that are explicitly shown
and described above. In at least some cases, these electrode
devices are shaped and/or configured to increase the uniformity
with which coaption forces are applied to the septum 106, and in
other cases, these electrode devices are shaped and/or configured
to concentrate the coaption force in one or more areas of the
septum.
[0114] Another feature of an embodiment of the electrode device
880e shown in FIGS. 8H and 8I is that it can include fluid delivery
ports 890 that are in fluid communication with a fluid delivery
lumen internal to the electrode catheter 230c. In operation, an
electrolyte (e.g., an electrolytic fluid) can be delivered radially
outwardly through the fluid delivery ports 890 to cool the distal,
exposed surfaces of the electrode device 880e, and/or to prevent
the accumulation of proteins or other substances at these surfaces.
In another embodiment, the fluid delivery ports 890 can be
positioned at the proximal side of the conductive material 881 to
infuse the region between the electrode device 880e and the septum
106. In still a further embodiment, the fluid delivery ports 890
can be positioned axially between proximal and distal portions of
the conductive material 891, as described further with reference to
FIG. 8J. The fluid can be delivered manually or automatically. In
particular embodiments, the electrolyte can include a hypertonic
saline, or another biocompatible, electrically conductive fluid.
Accordingly, the fluid can both cool the septal tissue at the
interface with the electrode device 880e (e.g., to prevent or
restrict the septal tissue from sticking to the electrode device
880e), while still allowing electrical energy to pass deeper into
the septal tissue to heat the tissue and seal the PFO 112. In
particular embodiments, the fluid can be chilled (e.g. to a
suitable temperature below normal body temperature) to enhance the
cooling effect. Whether the fluid is chilled or not, it can pass
through a thermally insulated channel in the electrode catheter
230c so as to reduce or eliminate the likelihood that it will cool
the septum 106 (the secundum 108 and/or the primum 107) before
exiting through the delivery ports 890. Another approach is to
preheat the fluid (e.g., in a range of from about 40.degree. C. to
about 90.degree. C., or about 65.degree. C. to about 70.degree. C.)
so that it does not chill the septum 106. It is expected that in at
least some of the foregoing embodiments, the electrolytic fluid can
more readily cool and/or flush the electrode device/tissue
interface than can the blood in the left atrium.
[0115] In another embodiment, the fluid dispensed from the fluid
delivery ports 890 can have characteristics other than those
described above. For example, the fluid can include D5-W water
(e.g., 5% dextrose in water), or another electrically
non-conductive, or generally non-conductive, fluid that can provide
cooling for the electrode device 880e. In this embodiment, the
electrically non-conductive nature of the fluid can prevent the
loss of electrical power to the adjacent blood field. In either
embodiment, the fluid can act to prevent or reduce the accumulation
of clotting proteins at the electrode device 880e, via one or more
mechanisms. For example, the flow of fluid can flush such proteins
from the electrode device 880e. In addition to or in lieu of
flushing the proteins, the ability of the fluid to reduce the
temperature of the electrode device 880e can reduce or eliminate
protein accumulations. Still further, when the fluid is
electrically non-conductive, it can displace the electrically
conductive blood away from the electrode device 880a, so as to
create an electrically non-conductive region around the electrode
device 880e and preferentially direct current into the septal
tissue.
[0116] In any of the foregoing embodiments, the fluid can include
constituents that provide functions other than (e.g., in addition
to) those described above. For example, the fluid can include an
ultrasound contrast agent to allow the fluid to be visualized more
readily via ultrasound techniques. In any of the foregoing
embodiments, the fluid can be provided at a suitable rate through
suitably sized delivery ports 890. For example, the electrode
device 880e can include 8-16 ports 890 having diameters of 0.005
inches, and the fluid can be provided at a rate of from about 1
ml/minute to about 100 ml/minute. In particular embodiments, the
fluid can be pulsed. For example, the fluid flow can be active or
active at a first rate during portions of the cardiac cycle when
there is a low blood flow rate past the electrode device 880e, and
the fluid flow can be inactive or active at a second rate less than
the first rate during portions of the cardiac cycle when there is a
higher blood flow rate past the electrode device 880e. Changes in
the fluid flow rate can be based at least in part on changes in
left atrial and/or right atrial pressure, and/or based on EKG data.
In a particular embodiment, the system can include pressure
transducers positioned in both the left and right atria, and
coupled to a controller to vary the fluid flow rate in accordance
with changes in the left atrial pressure and/or changes in the
difference between left and right atrial pressures. Varying the
flow rate can reduce the volume of fluid injected into the patient,
while preserving a cooling effect on the electrode device 880e. Any
of the foregoing aspects of fluid delivery can be controlled by the
controller 221 as shown in FIG. 2, e.g., via programmed,
computer-based instructions
[0117] As discussed previously, it is believed that the mechanism
by which the interface between an electrode device 880e and the
adjacent septal tissue 106 heats up is not due to directly heating
the electrode device 880e as current is passed through it, but is
instead due to heat that is conductively transferred back to the
electrode device 880e from the adjacent septal tissue 106, which is
in turn heated by absorbing RF radiation from the electrode device
880e. Accordingly, embodiments of the disclosure are directed to
devices and techniques that facilitate cooling an electrode device
without unduly sacrificing heat applied to the septal tissue 106
for closing the PFO. For example, FIG. 8J illustrates an electrode
device 880f deployed relative to the primum 107 and the secundum
108 in accordance with a particular embodiment of the disclosure.
The electrode device 880f can include a filamentous electrically
conductive material 881 connected at one end to a support 887
(e.g., the end portion of the electrode catheter 230c) and at the
other end to an actuator cap 885. The actuator cap 885 is in turn
moved by an actuator tube 884 that slides within the electrode
catheter 230c. A stop tube 878 or other suitable device restricts
the axial motion of the actuator cap 885 toward the support 887.
Accordingly, when the actuator cap 885 is drawn proximately into
contact with the stop tube 878, the electrode device 880f assumes
an ellipsoid shape, generally as shown in FIG. 8J. The ellipsoid
can have any of a variety of aspect ratios. For example, in a
particular embodiment, the electrode device 880f can have a
generally spheroidal shape, with a diameter D1 approximately equal
to an overall length L1. In still further embodiments, D1 and L1
can have values of about 9 mm. In other embodiments, the electrode
device can have variations on this shape, as described later with
reference to FIGS. 8K and 8L. The electrode device 880f can
optionally include fluid delivery ports 890 (FIG. 8I) positioned
between the support 887 and the actuator cap 885. However, it is
expected that in at least some embodiments, the cooling effect
resulting from the shape and porous nature of the electrode device
880f will eliminate the need for fluid delivery ports.
[0118] In a particular aspect of the embodiment shown in FIG. 8J,
the electrode device 880f operates in a bipolar manner, for
example, via the return electrode 280b carried by the delivery
catheter 230a. Accordingly, electric field lines (shown as phantom
lines F in FIG. 8J) generated when current is applied to the
electrode device 880f tend to form a pattern that is directed back
toward the return electrode 280b. One expected result of this
arrangement is that more of the electrical current generated by the
electrode device 880f will be directed into the primum 107 and the
secundum 108, rather than distally into the adjacent blood field.
Another result is that the patient need not have a patient pad or
plate in contact with the patient's skin to provide a return
electrical path. This can simplify the system and reduce the number
of components the practitioner must track. In addition, in at least
some embodiments, this bipolar arrangement can increase the
predictability and repeatability of the tissue sealing procedure.
For example, it is expected that the patient-to-patient impedance
variations between the two bipolar electrodes will be less than the
variation between a monopolar electrode and a remote patient pad.
In particular, the electrode 880f can have a relatively low
impedance. If the impedance at the skin/pad interface varies
significantly, this can have a dramatic effect on the impedance of
the overall circuit, and therefore on the efficacy and/or
efficiency of the tissue sealing process.
[0119] One feature of the ellipsoid/spheroid shape of the electrode
device 880f is that it has fewer corners or edges than flat
electrode devices, for example the electrode device 880e described
above with reference to FIGS. 8H and 8I. As a result, it is
expected that the likelihood for current density concentrations at
such edges is significantly reduced or eliminated, producing a more
uniform electrical field within the septal tissue 106. Another
feature of this arrangement is that a relatively small portion of
the electrode device 880f is actually in contact with the primum
107. As a result, the electrode device 880f is expected to receive
less heat from the septal tissue 106 than is an electrode that is
placed flat up against the primum 107. Nevertheless, the
ellipsoidal (and in a particular embodiment, spheroidal) shape of
the electrode device 880f can not only contact the primum 107 and
provide a coapting force, but it can also conform the primum 107 to
have a concave shape, which can in turn stretch the primum 107 and
extend the radius of the coapting force between the primum 107 and
the secundum 108 beyond the region of the primum 107 that is in
direct contact with the electrode device 880f. In addition, this
arrangement, in combination with the overall porous nature of the
electrode device 880f provided by the filamentous conductive
material 881 allows for greater cooling by the adjacent blood. This
in turn reduces the likelihood for forming clots at the electrode
device 880f and/or causing the electrode device 880f to stick to
the primum 107. The bipolar electric field (which tends to direct
more energy to the septum 106 and less into the left atrial blood)
is also expected to reduce the likelihood for clotting. Optionally,
the electrode device 880f can include heparin or another
antithrombotic coating to reduce or prevent clot formation. At the
same time, the shape of the electrode device 880f is expected to
provide a coaption force sufficient to clamp the primum 107 and the
secundum 108 against each other between the electrode device 880f
and the delivery catheter 230a.
[0120] Still another feature of at least some embodiments of the
foregoing arrangement is that the shape and radius of the electrode
device 880f can be controlled by varying the movement of the
actuator tube 878. For example, the practitioner can deploy the
electrode device 880f by different amounts to produce corresponding
different shapes, including those described below with reference to
FIGS. 8K and 8L. The particular shape selected by the practitioner
can depend on size and/or geometry of a particular patient's
PFO.
[0121] When power is applied to the electrode device 880f (and/or
other electrode devices described herein), it can be applied in a
number of manners. For example, in one embodiment, the power can be
applied to the electrode device 880f as a generally continuous
high-frequency stream of pulses. In other embodiments, the power
can be modulated to achieve particular results. For example, in a
particular embodiment, the power can be provided at different
amplitudes during different phases of the tissue sealing process.
In particular, the power can be provided during a first phase at a
first power level and during a second phase at a second power level
higher than the first. During the first phase, the power applied to
the septal tissue 106 can produce one or both of the following
effects. First, it can pre-shrink the septal tissue 106 (e.g., the
primum 107 and/or the secundum 108) without sealing the tissue
together. More particularly, the power can be applied at an
amplitude high enough to heat the septal tissue 106 sufficiently to
cause it to shrink, but not so high as to cause it to seal. For
example, the tissue can reach a temperature of less than
100.degree. C. during the first phase. Second, applying heat to the
septal tissue 106 in this manner can pre-desiccate the tissue,
e.g., purge or at least partially purge the tissue of water before
the primum 107 is sealed to the secundum 108. During the second
phase, the pre-shrunk and/or pre-desiccated tissue is sealed by
applying power at a higher amplitude and heating the tissue to a
higher temperature (e.g., about 100.degree. C.).
[0122] In particular embodiments, the power can be selected in a
manner that depends upon patient-specific characteristics and/or
specific characteristics of the electrode device 880f and/or other
features of the overall system. For example, power can be applied
in the range of from about 10 watts to about 60 watts for a period
of about 2 seconds to about 120 seconds during the initial phase,
and can be applied at a higher power (e.g., 12 watts to about 100
watts for a period of about 2 seconds to about 180 seconds) to seal
the septal tissue during the second phase. Particular values
selected within the foregoing ranges can depend upon factors that
include whether the electrical power is provided in a monopolar
manner or a bipolar manner, the size and shape of the electrode
device, and/or the shape or characteristics of a particular
patient's secundum 108 and/or primum 107.
[0123] One expected advantage of the foregoing arrangement is that
pre-shrinking the septal tissue 106 can reduce the likelihood that
the tissue will shrink during the tissue sealing process.
Accordingly, the sealed tissue is expected to have fewer shear
stresses and is therefore expected to remain intact for a longer
period of time and/or (in the case of an initially incomplete seal)
it is expected to more quickly form a complete seal as a result of
the body's natural healing processes. By pre-desiccating the septal
tissue, embodiments of the foregoing process can reduce or
eliminate the presence of water in the septal tissue when higher
power is applied to the septal tissue for sealing. This in turn can
reduce the likelihood that such residual water will vaporize as the
tissue is sealed under higher amplitude power, thus reducing the
likelihood for disrupting the tissue seal as the vaporized water
attempts to escape from the sealed region.
[0124] In another embodiment, the power applied to the electrode
can be provided at a duty cycle of less than 100% (e.g., with the
power off during certain intervals) so as to increase the efficacy
of the process. For example, it has been observed that the surface
of the primum 107 exposed in the left atrium can cool much more
quickly than the tissue located at the interface between the primum
107 and the secundum 108, at least in part due to the enhanced
cooling effect provided by blood in the left atrium as it passes
directly adjacent to the exposed left atrial surface of the primum
107. By interrupting the power provided by the electrode device
880f to the septal tissue 106, the exposed surface of the primum
107 can cool relatively rapidly, while the temperature of the
tissue at the interface between the primum 107 and the secundum 108
remains relatively high. For example, in at least some cases, there
can exist a 30.degree.-45.degree. temperature difference between
the exposed left atrial surface of the primum 107 and the interface
between the primum 107 and the secundum 108. The ability to achieve
this temperature differential can be enhanced by using a duty cycle
of less than 100% Representative duty cycles include a 75% duty
cycle (with power on for 15 seconds and off for 5 seconds), a 67%
duty cycle (with power on for 14 seconds and off for 7 seconds),
and an 84% duty cycle (with power on for 5 seconds and off for 1
second). In other embodiments, the duty cycle can have other
characteristics with ranges of from about 50% to about 90%,
durations ranging from about 1 second to about 10 minutes, and the
total number of cycles ranging from 1 to about 1,000.
[0125] In other embodiments, electrodes having shapes similar at
least in part to those described above can be operated in a
generally similar manner to that described above with reference to
FIG. 8J. For example, as shown in FIG. 8K, an electrode device 880g
can have an aspect ratio D1/L1 of up to approximately 1.5 or more,
to form an oblate spheroidal shape. In a particular aspect of this
embodiment, D1 can have a value of about 10.6 mm. As shown in FIG.
8L, another electrode device 880h can have an aspect ratio D1/L1
that is less than 1.0 to form a generally prolate spheroid. In a
particular aspect of this embodiment, D1 can have a value of less
than 9 mm. In still further embodiments, the electrode device can
have shapes other than those specifically described above and shown
in the Figures.
[0126] FIG. 9A is a partially schematic, cross-sectional side view
of an electrode device 980 configured in accordance with another
embodiment of the disclosure. The electrode device 980 can include
a conductive sheet 981 carried by a support structure 990. In a
particular embodiment, the conductive sheet 981 can include a
conductive fabric, for example, a fabric woven from conductive
strands or fibers. The conductive fibers or strands can be fully
conductive (e.g., metal strands) or partially conductive (e.g.,
polyester or other non-conductive strands coated or deposited with
a conductive material). In another embodiment, the conductive sheet
981 can include a non-conductive substrate coated with a conductive
material, for example, a flexible polymer sheet coated with a
deposited conductive material, such as gold and/or silver. In a
particular aspect of this embodiment, the substrate material can be
flexible but generally not stretchable (e.g., Mylar.RTM.), so as to
reduce the likelihood for the conductive material to flake off.
[0127] The support structure 990 can include struts 991 (e.g.,
Nitinol struts) connected between the conductive sheet 981 and an
actuator 983. In a particular embodiment, the struts 991 are biased
or pre-formed to a position that is at least approximately
orthogonal relative to the penetrating guidewire 250d. When the
electrode device 980 is stowed, the struts 991 are folded within
the electrode catheter 230c and the conductive sheet 981 is furled.
When the electrode device 980 is deployed, the struts 991 can move
outwardly, as shown in FIG. 9B to unfurl the conductive sheet 981.
The electrode device 980 can be deployed to form the generally flat
shape shown in FIG. 9B, or it can include a stop (generally similar
to that described above with reference to FIG. 8J) so as to form a
pyramidal shape like that shown in FIG. 9A when fully deployed.
Such an arrangement can produce at least some of the beneficial
effects described above with reference to FIG. 8J.
[0128] FIGS. 10A and 10B illustrate an electrode device 1080
configured in accordance with another embodiment of the disclosure
to deploy in a manner somewhat similar to that described above with
reference to FIGS. 9A-9B. In a particular aspect of this
embodiment, the electrode device 1080 includes a flexible
conductive material 1081 electrically connected to an electrical
energy path 1086 (e.g., a leadwire) and attached to a support
structure 1090. The support structure 1090 can include flexible,
resilient struts 1091 having first ends attached to an actuator
1083 at an electrode attachment or anchor 1093. The second ends of
the struts 1091 can be connected to a slider 1092 (e.g., another
anchor) that slides axially along the actuator 1083. Each of the
struts 1091 can include a spring loop 1099 that tends to force the
struts 1091 into a triangular shape. When stowed, the struts 1091
are forced by the interior walls of the electrode catheter 230c to
be approximately parallel to the penetrating guidewire 250d. When
deployed, as shown in FIG. 10B, the actuator 1083 moves the
electrode device 1080 out of the catheter 230c. Once the electrode
device 1080 emerges from the catheter electrode 230c, the struts
1091 can assume a generally triangular shape. The electrode
attachment 1093 remains fixed, while the slider 1092 slides in a
proximal direction (indicated by arrow H) to accommodate the
radially expanded shape of the struts 1091.
[0129] FIGS. 11A-11C illustrate an electrode device 1180 that
includes a conductive material 1181 deployed, at least in part, by
an inflatable member 1170 in accordance with another embodiment.
The conductive material 1181 can be secured to an actuator 1183 at
an electrode attachment or anchor 1193. Flexible support lines 1191
extend in a distal direction from the conductive material 1181 to a
collar 1194 (e.g., another anchor) that is fixed relative to the
actuator 1183. A wire or other conductive element provides an
electrical energy path 1186 to the conductive material 1181. The
inflatable member 1170 can be inflated with saline, contrast, or
another suitable fluid. In a particular embodiment, the inflation
fluid can be circulated through the inflatable member 1170 via
supply and return conduits, and can accordingly provide functions
in addition to inflating the inflatable member 1170. Such functions
can include cooling the electrode device 1180.
[0130] When the actuator 1183 is moved in a distal direction
(indicated by arrow J), it moves the electrode device 1180 out of
the catheter 230c, as shown in FIG. 11B. As shown in FIG. 11C, the
inflatable member 1170 can then be inflated to unfurl the
conductive material 1181. The inflatable member 1170 can bear
outwardly on the electrode support lines 1191, placing the
electrode support lines 1191 under tension, which secures the
conductive material 1181 in the deployed or unfurled configuration.
In this embodiment, and in other embodiments that include an
inflatable member, (e.g., the inflatable member 270 shown in FIG.
3G) the practitioner may in some cases select the degree to which
the inflatable member is inflated based on the particular patient's
PFO physiology. For example, the inflatable member 1170 can be
partially inflated to allow the conductive material 1181 to assume
a convex shape when drawn against the septum, or it can be more
fully inflated so as to assume a flatter shape.
[0131] One aspect of an embodiment shown in FIGS. 11A-11C is that
the inflatable member 1170 and the electrode device 1180 need not
be intimately connected to each other, as is the case with an
electrode device that includes a conductive coating applied to, and
in continuous direct contact with, the exterior surface of the
inflatable member. Instead, the inflatable member 1170 and the
electrode device 1180 can be movable relative to each other. For
example, the inflatable member 1170 shown in FIGS. 11A-11C can
erect or deploy the electrode device 1180 by acting on the
electrode support lines 1191. When fully inflated, the inflatable
member 1170 can be in surface-to-surface contact with the electrode
device 1180 to provide shape and support to the electrode device
1180, but the inflatable member 1170 and the electrode device 1180
can collapse separately. An expected advantage of this feature is
that the material forming the electrode device 1180 need not be
bonded directly to the inflatable member 1170, and as a result, is
less likely to deteriorate, e.g., due to flaking off the inflatable
member 1170. An additional expected advantage is that this
arrangement can allow greater flexibility for the manufacturer when
choosing materials and configurations for both the electrode device
1180 and the inflatable member 1170.
[0132] FIG. 12 illustrates an electrode device 1280 having at least
some features generally similar to those of the electrode device
1180 described above, except that the conductive material 1181
slides relative to the actuator 1183 at a sliding interface 1292,
while the collar 1194 is fixed. When the electrode device 1280 is
moved out of the catheter 230c, and the inflatable member 1170 is
inflated, the conductive material 1181 can slide distally toward
the inflatable member 1170 along the actuator 1183, as indicated by
arrow H. It is expected that this arrangement can increase the
likelihood for the conductive material to have a generally flat
surface facing toward the primum 107 (FIG. 8A) when deployed. In
other embodiments, the inflatable member 1170 can have other shapes
(e.g., rounded, spheroid, or ellipsoid shapes) to produce
correspondingly shaped electrode device surfaces. In still further
embodiments, the shape of the inflatable member 1170 can be changed
(e.g., by varying the inflation pressure) to conform to an
individual patient's septal geometry.
[0133] FIG. 13 illustrates an electrode device 1380 that is
somewhat similar to the electrode device 1280 described above, but
instead of the conductive material 1181 sliding at a sliding
interface 1292, the electrode support lines 1191 are attached to a
slider 1392 so as to slide relative to the actuator 1183 when the
electrode device 1380 is deployed. In at least some cases, the
sliding action provided by the slider 1392 can allow the conductive
material 1181 to take on a flatter shape when deployed, as
discussed above with reference to FIG. 12.
[0134] FIG. 14 illustrates an electrode device 1480 that is similar
in some respects to the electrode device 980 described above with
reference to FIGS. 9A-9B, but that deploys and retracts in a sense
generally opposite to that described above with reference to FIGS.
9A-9B. For example, the electrode device 1480 can include a
conductive material 1481 attached to an actuator 1483 with a
support structure 1490 that includes multiple flexible struts 1491.
The conductive material 1481 can also be attached to a retractor
1495. The struts 1491 can be biased to the position shown in FIG.
14, and can lie generally parallel to the guidewire 250d when
stowed. When the electrode device 1480 is deployed from the
electrode catheter 230c as indicated by arrow K, the struts 1491
can spring outwardly to the position shown in FIG. 14, unfurling
the conductive material 1481. To retract the electrode device 1480,
the practitioner can draw the retractor 1495 in a proximal
direction P, pulling the conductive material 1481 and the struts
1491 inwardly toward the actuator 1483 and the guidewire 250d. Once
the struts 1491 are aligned with the guidewire 250d, the
practitioner can move the retractor 1495 and the actuator 1483 as a
unit in the proximal direction P to draw the electrode device 1480
into the electrode catheter 230c.
[0135] FIG. 15A is a partially schematic, cross-sectional side view
of an electrode device 1580 configured in accordance with another
embodiment of the disclosure. FIG. 15B is a partially schematic,
end view of a portion of the electrode device 1580 shown in FIG.
15A. With reference to FIG. 15A, the electrode device 1580 can
include a tubular portion 1596 connected to an electrode actuator
1583, and fingers 1597 that extend from the tubular portion 1596.
In a particular embodiment, the fingers 1597 can be manufactured by
slitting the tubular portion 1596, and bending the fingers 1597 in
an outward direction. When the electrode device 1580 is stowed, the
walls of the electrode catheter 230c can force the fingers 1597
into axial alignment with the guidewire 250d. When the electrode
device 1580 is deployed, the fingers 1597 can expand radially
outwardly as shown in FIG. 15A. An inflatable member 1570 (e.g., a
balloon) can be positioned adjacent to the electrode device 1580 to
provide support for the electrode device 1580 when the electrode
device 1580 is clamped against the adjacent septal tissue. The
inflatable member 1570 can include an inflatable member actuator
1571 that provides an inflation medium (e.g., saline) to the
inflatable member 1570, and that can be used to draw the inflatable
member 1570 proximally against the electrode device 1580. FIG. 15B
illustrates an end view of the electrode device 1580 (without the
inflatable member 1570), showing the fingers 1597 in the deployed
position.
[0136] FIGS. 16A-20B illustrate electrode devices having tubular
portions and outwardly splayed fingers or flanges in accordance
with further embodiments of the disclosure. For example, FIGS. 16A
and 16B illustrate side and end views, respectively, of an
electrode device 1680 that includes an outer tubular portion 1696a
having outer fingers 1697a and a nested inner tubular portion 1696b
positioned annularly inwardly from the outer tubular portion 1696a
and having inner fingers 1697b. The combination of the outer and
inner fingers 1697a, 1697b can increase the conductive surface area
presented to the septal tissue when the electrode device 1680 is
deployed.
[0137] FIGS. 17A and 17B illustrate side and end views,
respectively, of an electrode device 1780 formed by winding a
conductive filament 1781 into a tubular portion 1796 and a flange
1798. In this embodiment, the electrode device 1780 can include a
single filament of conductive material that is wound in a helical
fashion to form both the tubular portion 1796 and the flange 1798.
In other embodiments, filamentous conductive material can form
electrode devices having generally the same shape as is shown in
FIGS. 17A and 17B, with different construction techniques. For
example, FIGS. 18A and 18B illustrate an electrode device 1880
having a tubular portion 1896 and a flange 1898 formed by weaving
conductive filaments 1781. In FIGS. 19A-19B, the illustrated
electrode device 1980 includes a tubular portion 1996 and a flange
1998 formed by a knitting process. In FIGS. 20A-20B, the
illustrated electrode device 2080 includes a tubular portion 2096
and flange 2098 formed from a flat pattern rather than spiral weave
pattern.
F. Systems and Techniques for Clamping Tissue
[0138] In particular embodiments, the tissue sealed or fused by the
electrode or other energy transmission device can be clamped as it
is heated, so as to promote tissue sealing. FIG. 21 is a partially
schematic illustration of an embodiment of the system 220 that
includes a compression device 2160 for clamping the primum 107 and
the secundum 108 between an electrode device 2180 and the delivery
catheter 230a. The delivery catheter 230a can have a configuration
generally similar to that described above with reference to FIG. 3H
and can accordingly include a backstop surface 238 positioned
proximate to the secundum 108. The positioning catheter 230b can
then be positioned to deploy the electrode catheter 230c along the
penetrating guidewire 250d through the septum 106 (e.g., the
secundum 108 and the primum 107, or just the primum 107). An
electrode device 2180, shown schematically in FIG. 21, can then be
deployed in the right atrium 102.
[0139] The electrode device 2180 can have a generally flat,
not-cutting surface facing toward the primum 107, suitable for
tissue sealing and/or fusing. The compression device 2160 can be
operatively coupled between the electrode device 2180 and one of
the catheters 230a-230c (e.g., the delivery catheter 230a). For
example, the compression device 2160 can include an actuator 2183
(e.g., a cable) that is connected to the electrode 2180 and that
extends through the electrode catheter 230c, the positioning
catheter 230b, the delivery catheter 230a and is connected to a
compression member 2161. In a particular embodiment, the
compression member 2161 includes a spring connected to a cam 2162
that is operated via a cam handle 2163 and is accordingly located
outside the patient for manipulation by the practitioner. With the
electrode device 2180 deployed, the practitioner can rotate the cam
handle 2163, as indicated by arrow R, to stretch the compression
member 2161, thereby applying an axial tension to the actuator 2183
and compressing the septum 106 between the electrode device 2180
and the backstop surface 238.
[0140] The amount of force and/or pressure provided by the
compression device 2160 can be selected based on a variety of
factors, including the particular patient physiology and the
particular electrode device configuration. For example, in a
particular embodiment, the pressure applied to the septal tissue by
the compression device 2160 can be from about 0.1 psig to about 15
psig. In a particular embodiment, the pressure can be from about
0.5 psig to about 5 psig, and in a further particular embodiment,
about 8 psig. When the electrode device 2180 has a petal-shaped
configuration (as shown in FIG. 8C) with an overall diameter of
about 12 mm, the load applied to the electrode device 2180 can be
in the range of from about 0.5 pounds to about 2.0 pounds, and in a
particular embodiment, about 1.4 pounds.
[0141] One advantage of embodiments including the foregoing feature
is that they can improve the efficiency with which a seal is
created between the secundum 108 and the primum 107. For example,
clamping the tissue to be sealed can improve the strength of the
seal by (a) reducing the convective cooling provided by blood in
the tissue, (b) raising the boiling point of tissue water, (c)
raising the temperature for evolution of entrained tissue gases,
(d) improving thermal conductivity, and/or (e) increasing tissue
adhesion at the tissue interface. In addition, the primum 107
and/or the secundum 108 may shrink during the heating and fusing
process, and the compression device 2160 can maintain a compressive
force on these two tissues throughout the sealing process, even if
the tissues tend to shrink. For example, the compression device
2160 can apply a generally constant force over a distance several
times the thickness of the septum 106, e.g., over a distance of
about 20 mm. Accordingly, the compression device 2160 can maintain
a generally constant force on the tissue during at least some
phases of operation, and can be adjustable to vary the compressive
force applied to the tissue (e.g., between a first clamping force
and a second lesser or zero clamping force) during other phases of
operation. By applying a constant force over a particular range,
embodiments of the compression device can also be suitable for
sealing tissues (e.g., septal tissues) having a variety of
thicknesses. Accordingly, such devices can be used with a wide
variety of patient cardiac topologies.
[0142] In other embodiments, other devices and/or techniques can be
used to apply tension to the actuator 2183 and compression to the
secundum 108 and the primum 107. For example, the compression
device 2160 can be activated until the two tissues are "snugged"
against each other, and then further tightened or activated by
extending the spring a predetermined distance, corresponding to a
predetermined load. In other embodiments, the actuator 2183 itself
can be resilient, compliant, and/or stretchable, and can provide
the compressive force on the septum 106. Accordingly, the
compression device 2160 need not include a compression member 2161
in addition to the actuator 2183. In this and other embodiments, at
least part of the compression device can be located inside the
patient, e.g., at the working portion or other portions of the
catheter.
[0143] FIG. 22 illustrates a compression device 2260 that includes
a threaded shaft 2265 connected to the compression member 2161
(e.g., a spring) with a swivel joint 2264. The threaded shaft 2265
is connected to a handle 2263 and is received in a threaded opening
2266 of the delivery catheter 230a. When the practitioner rotates
the handle 2263 counterclockwise, the threaded shaft 2265 moves
outwardly from the delivery catheter 230a, applying a tension to
the compression member 2161 and the actuator 2183 so as to clamp
the primum 107 (FIG. 21) and the secundum 108 (FIG. 21). The
compressive force can be released by rotating the handle 2263 in
the opposite direction. As discussed above with reference to FIG.
21, the actuator 2183 can be made stretchable and the spring can be
eliminated in another embodiment. The compression device 2260 can
include detents and/or circumferential markings to indicate to the
practitioner how much force (or an equivalent, e.g., stretch
distance) is being applied to the actuator 2183.
[0144] FIG. 23 illustrates a compression device 2360 that in turn
includes a slider 2367 having a pawl 2369 that engages with one or
more teeth or notches 2368 carried by the delivery catheter 230a.
The compression device 2360 can further include a piston (e.g.
non-sealing piston) 2362 and a compression member 2361 (e.g., a
spring between the piston 2362 and the slider 2367). The piston
2362 can be attached to the actuator 2183, which passes through a
passageway in the slider 2367. The practitioner can move the slider
2367 in a proximal direction indicated by arrow P to compress the
compression member 2361, which applies a tension to the actuator
2183, which in turn compresses the primum 107 (FIG. 21) and
secundum 108 (FIG. 21). This arrangement can provide a stop (or
multiple stops) along the path of the slider 2367 to prevent the
practitioner from inadvertently clamping the tissue too tightly,
and/or to provide a final stop that prevents the practitioner from
over-compressing the septal tissue.
[0145] Any of the foregoing devices described above with reference
to FIGS. 21-23 can be configured as "two position" devices (e.g.,
having a "compressed" position and an "uncompressed" position), or
as a variable position device (e.g., having intermediate
positions). The actuation forces can be applied by devices other
than springs. For example, the actuation forces can be provided by
pneumatic or hydraulic actuators, which are suitable for applying a
constant force over a selected actuation distance.
[0146] From the foregoing, it will be appreciated that specific
embodiments of the disclosure have been described herein for
purposes of illustration, but that various modifications may be
made from these embodiments. For example, as discussed above, the
energy transmitter can include devices other than RF electrodes,
e.g., microwave devices. When the energy transmitter includes
electrodes, the electrodes can be arranged in a monopolar manner or
a bipolar manner as described above, or the electrodes can be
arranged in another multipolar manner (e.g., a quadrapolar manner).
For example, the spheroidal electrode shown in FIG. 8J can include
multiple neighboring portions (in a circumferential direction) that
are electrically insulated from each other. Certain aspects of the
foregoing embodiments may be applied to tissues other than septal
tissue (e.g., other target tissues), and/or in a manner to treat
patient conditions other than PFOs. For example, in some cases,
aspects of the foregoing embodiments can be used for procedures
other than sealing or closing a PFO, and/or procedures other than
tissue fusing. Representative procedures include percutaneous
aortic or mitral valve treatments and/or implants, left atrial
appendage closures, aortic aneurysm repair, artery or vein
treatment, and electrophysiology ablation therapies for correcting
EKG rhythm disorders.
[0147] Certain aspects of the disclosure described in the context
of particular embodiments may be combined or eliminated in other
embodiments. For example, a catheter system in accordance with
particular embodiments may include only some of the foregoing
devices and features, and other systems may include devices and
features in addition to those disclosed above. In a further
particular example, features of the guidewire advancers discussed
above with reference to FIGS. 7A-7F may be included in the
electrode clamping devices described with reference to FIGS. 21-23,
and/or vice versa. Electrode devices other than those shown in
FIGS. 8H-8I can include the fluid delivery ports shown in FIGS.
8H-8I. Further, while advantages associated with certain
embodiments have been described in the context of those
embodiments, other embodiments may also exhibit such advantages,
and not all embodiments need necessarily exhibit such advantages.
Accordingly, the disclosure can include other embodiments not shown
or described above.
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