U.S. patent application number 11/319250 was filed with the patent office on 2006-05-11 for method and system for atrial defibrillation.
This patent application is currently assigned to BIOSENSE WEBSTER, INC.. Invention is credited to Kristine B. Fuimaono, Shahram Moaddeb.
Application Number | 20060100669 11/319250 |
Document ID | / |
Family ID | 21914035 |
Filed Date | 2006-05-11 |
United States Patent
Application |
20060100669 |
Kind Code |
A1 |
Fuimaono; Kristine B. ; et
al. |
May 11, 2006 |
Method and system for atrial defibrillation
Abstract
A method and system for atrial defibrillation in a patient are
provided. The method comprises introducing into the patient a
catheter comprising an elongated catheter body having proximal and
distal ends and at least one lumen therethrough, and a
basket-shaped electrode assembly at the distal end of the catheter
body. The electrode assembly has proximal and distal ends and
comprises a plurality of spines connected at their proximal and
distal ends, each spine comprising an elongated spine electrode
along its length. The electrode assembly has an expanded
arrangement wherein the spines bow radially outwardly and a
collapsed arrangement wherein the spines are arranged generally
along the axis of the catheter body. The method further comprises
introducing the electrode assembly into the heart of the patient
and applying defibrillation energy to the tissue through one or
more of the elongated electrodes. The system comprises a catheter
as described above in combination with an external defibrillator
electrically connected to the catheter.
Inventors: |
Fuimaono; Kristine B.;
(Covina, CA) ; Moaddeb; Shahram; (Irvine,
CA) |
Correspondence
Address: |
CHRISTIE, PARKER & HALE, LLP
PO BOX 7068
PASADENA
CA
91109-7068
US
|
Assignee: |
BIOSENSE WEBSTER, INC.
|
Family ID: |
21914035 |
Appl. No.: |
11/319250 |
Filed: |
December 27, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10040977 |
Dec 31, 2001 |
6980858 |
|
|
11319250 |
Dec 27, 2005 |
|
|
|
Current U.S.
Class: |
607/4 ;
607/122 |
Current CPC
Class: |
A61N 1/0563
20130101 |
Class at
Publication: |
607/004 ;
607/122 |
International
Class: |
A61N 1/39 20060101
A61N001/39 |
Claims
1. A method for atrial defibrillation in a patient in need thereof
comprising: introducing into the patient a catheter comprising: an
elongated catheter body having proximal and distal ends and at
least one lumen therethrough, and a basket-shaped electrode
assembly at the distal end of the catheter body, the electrode
assembly having proximal and distal ends and comprising a plurality
of spines connected at their proximal and distal ends, each spine
comprising an elongated spine electrode along its length, the
electrode assembly having an expanded arrangement wherein the
spines bow radially outwardly and a collapsed arrangement wherein
the spines are arranged generally along the axis of the catheter
body; introducing the electrode assembly into the heart of the
patient; and applying defibrillation energy to the tissue through
one or more of the elongated electrodes.
2. The method of claim 1, wherein each elongated spine electrode
has a length ranging from about 10 mm to about 100 mm.
3. The method of claim 1, wherein each elongated spine electrode
has a length ranging from about 30 mm to about 80 mm.
4. The method of claim 1, wherein each elongated spine electrode
has a length ranging from about 50 to about 60 mm.
5. The method of claim 1, wherein each spine comprises a flexible
wire having proximal and distal ends, wherein at least a portion of
the flexible wire forms the elongated electrode.
6. The method of claim 5, wherein each spine comprises
non-conductive coverings over the proximal and distal ends of the
flexible wire.
7. The method of claim 1, wherein the catheter further comprises a
tip electrode mounted at the distal end of the electrode
assembly.
8. The method of claim 1, wherein the catheter further comprises
one or more ring electrodes mounted at or near the distal end of
the catheter body.
9. The method of claim 1, wherein the electrode assembly comprises
at least three spines.
10. The method of claim 1, wherein the electrode assembly comprises
at least five spines.
11. The method of claim 1, wherein the electrode assembly further
comprises an expander having a distal end attached to the distal
ends of the spines and a proximal end attached to a control handle
mounted to the proximal end of the catheter body, whereby
manipulation of the control handle results in longitudinal movement
of the expander relative to the catheter body to thereby expand and
contract the electrode assembly.
12. The method of claim 11, wherein the expander has at least one
lumen extending therethrough.
13. The method of claim 1, wherein the catheter has a length of at
least about 90 cm.
14. The method of claim 1, wherein the catheter has a length
ranging from about 100 cm to about 120 cm.
15. The method of claim 1, wherein the total amount of
defibrillation energy delivered ranges from about 0.5 to about 20
joules.
16. The method of claim 1, wherein the total amount of
defibrillation energy delivered ranges from about 1 to about 10
joules.
17. The method of claim 1, wherein the total amount of
defibrillation energy delivered ranges from about 1 to about 4
joules.
18. The method of claim 1, wherein defibrillation energy is
delivered to the heart tissue through all of the spine
electrodes.
19. The method of claim 18, wherein all of the spine electrodes are
shorted together.
20. The method of claim 18, wherein the total amount of
defibrillation energy delivered ranges from about 0.5 to about 20
joules.
21. The method of claim 18, wherein the total amount of
defibrillation energy delivered ranges from about 1 to about 4
joules.
22. The method of claim 18, wherein the catheter further comprises
one or more ring electrodes at or near the distal end of the
catheter body, wherein the one or more ring electrodes are shorted
together and function as a return electrode for the defibrillation
energy.
23. The method of claim 18, further comprising providing a patch
electrode on the outside of the patient, wherein the patch
electrode functions as a return electrode for the defibrillation
energy.
24. The method of claim 1, wherein defibrillation energy is
delivered to the heart tissue through only a portion of the spine
electrodes, leaving one or more spine electrodes through which
defibrillation energy is not delivered to the heart tissue.
25. The method of claim 24, wherein defibrillation energy is
delivered to the heart tissue through at least half of the spine
electrodes.
26. The method of claim 24, wherein the spine electrodes through
which defibrillation energy is delivered are shorted together.
27. The method of claim 26, wherein the one or more spine
electrodes through which defibrillation energy is not delivered to
the heart tissue are shorted together and function as a return
electrode for the defibrillation energy.
28. The method of claim 1, further comprising detecting electrical
signals in the heart before, during or after the delivery of
defibrillation energy using one or more ring electrodes mounted at
or near the distal end of the catheter body.
29. The method of claim 1, further comprising delivering pacing
energy to the heart tissue using a tip electrode mounted at the
distal end of the electrode assembly.
30. A system for atrial defibrillation in a patient comprising: a
catheter comprising: an elongated catheter body having proximal and
distal ends and at least one lumen therethrough, and a
basket-shaped electrode assembly at the distal end of the catheter
body, the electrode assembly having proximal and distal ends and
comprising a plurality of spines connected at their proximal and
distal ends, each spine comprising an elongated spine electrode
along its length, the electrode assembly having an expanded
arrangement wherein the spines bow radially outwardly and a
collapsed arrangement wherein the spines are arranged generally
along the axis of the catheter body; and an external defibrillator
electrically connected to the catheter.
31. The system of claim 30, further comprising an interface switch
box that connects the external defibrillator to the catheter and
that permits the selection of spine electrodes through which
defibrillation energy is to be delivered.
32. The system of claim 31, further comprising an ECG recorder
electrically connected to the catheter through the interface switch
box.
33. The system of claim 32, wherein the catheter further comprises
one or more ring electrodes mounted at or near the distal end of
the catheter body.
34. The system of claim 31, further comprising an external pacer
electrically connected to the catheter through the interface switch
box.
35. The system of claim 34, wherein the catheter further comprises
a tip electrode mounted at the distal end of the electrode
assembly.
36. The system of claim 31, wherein each elongated spine electrode
has a length ranging from about 10 mm to about 100 mm.
37. The system of claim 31, wherein the elongated spine electrode
has a length ranging from about 30 mm to about 80 mm.
38. The system of claim 31, wherein the elongated spine electrode
has a length ranging from about 50 to about 60 mm.
39. The system of claim 31, wherein each spine comprises a flexible
wire having proximal and distal ends, wherein at least a portion of
the flexible wire forms the elongated electrode.
40. The system of claim 31, wherein the electrode assembly
comprises at least three spines.
41. The system of claim 31, wherein the electrode assembly
comprises at least five spines.
42. The system of claim 31, wherein the catheter has a length of at
least about 90 cm.
43. A system for atrial defibrillation in a patient comprising: a
catheter comprising: an elongated catheter body having proximal and
distal ends, a length of at least about 90 cm, and at least one
lumen therethrough, the catheter body having one or more ring
electrodes mounted at or near its distal end, and a basket-shaped
electrode assembly at the distal end of the catheter body, the
electrode assembly having proximal and distal ends and comprising
at least three spines connected at their proximal and distal ends,
each spine comprising an elongated spine electrode along its
length, wherein each spine electrode has a length ranging from
about 30 mm to about 80 mm., the electrode assembly having an
expanded arrangement wherein the spines bow radially outwardly and
a collapsed arrangement wherein the spines are arranged generally
along the axis of the catheter body, the electrode assembly having
a tip electrode mounted at its distal end; an external
defibrillator electrically connected to the catheter; an interface
switch box that connects the external defibrillator to the catheter
and that permits the selection of spine electrodes through which
defibrillation energy is to be delivered; an ECG recorder
electrically connected to the catheter through the interface switch
box.; and an external pacer electrically connected to the catheter
through the interface switch box.
Description
CROSS-REFERENCE TO RELATED APPLICATION(S)
[0001] This application is a continuation of U.S. application Ser.
No. 10/040,977, filed Dec. 31, 2001, now U.S. Pat. No. 6,980,858,
issued Dec. 27, 2005, the entire contents of which are incorporated
herein by reference.
BACKGROUND OF THE INVENTION
[0002] Atrial fibrillation (also called "AF" or "A Fib") is the
most common abnormal heart rhythm. It is a very fast, uncontrolled
heart rhythm caused when the upper changes of the heart (the atria)
quiver instead of beating. During atrial fibrillation, the upper
chambers of the heart beat between 350 and 600 times per minute,
causing the pumping function of the upper chambers to not work
properly. As a result, blood is not completely emptied from the
heart's chambers, causing it to pool and sometimes clot. In about 5
percent of patients with atrial fibrillation, clotted blood
dislodges from the atria and results in a stroke. The American
Heart Association estimates that, in the United States, atrial
fibrillation is responsible for over 70,000 strokes each year.
[0003] Various methods exist for treating atrial fibrillation. One
such method is cardiac ablation, which is a medical procedure
performed to prevent abnormal electrical impulses from ever
beginning in the first place. In an ablation procedure, the
electrophysiologist first pinpoints the precise area in the heart
at which the abnormal signals start through a mapping procedure.
The electrophysiologist then eliminates the small area of tissue
that is causing the arrhythmia by ablating that tissue. With a
procedure known as AV nodal ablation, the electrophysiologist
ablates the AV node, keeping the abnormal impulses from traveling
to the heart's lower chambers. A pacemaker is used to regulate the
heartbeat after this therapy.
[0004] Another method for treating atrial fibrillation is AF
suppression. With this method, an implanted pacemaker stimulates
the heart in a way that preempts any irregular rhythms. In about
half of the atrial fibrillation cases, medication can be effective
in controlling the rate at which the upper and lower chambers of
the heart beat. Standard medications used for atrial fibrillation
include beta-blockers (such as carvedilol and propanolol) and
calcium-channel clockers (like verapamil and diltiazem), which slow
the heart rate. Digoxin, which slows the heart rate through the AV
node, thereby decreasing the rate at which the electrical impulses
conduct from the upper to lower chambers, can also be used. Other
medications, such as disopyramide, flecainide, procainamide and
sotalol, are used to chemically convert AF back to normal rhythm.
In many cases, anticoagulants, such as heparin, are also used to
"thin" the blood to reduce the risk of clot formation.
[0005] Cardioversion can also be used to treat atrial fibrillation.
Cardioversion involves changing an abnormal heart rate back to a
normal one. Cardioversion can be done using medication or
electricity. In electrical cardioversion, energy is applied to the
heart to "jolt" it out of atrial fibrillation. Two types of
electrical cardioversion exist, external and internal. For external
cardioversion, two external paddles are placed on the patient's
chest or on the chest and back. A high-energy electrical shock is
sent through the patches and through the body to the heart. The
energy shocks the heart out of atrial fibrillation and back into
normal rhythm.
[0006] Internal cardioversion uses a similar approach, but instead
of paddles being placed on the outside of the body, a catheter is
inserted through a vein to the heart. The electrical energy is
delivered through the catheter to the inside of the heart to stop
the atrial fibrillation. Internal cardioversion has met with high
success and provides a desirable alternative to external
cardioversion. Notably, internal cardioversion requires far lower
energy levels than external cardioversion and thus can provide a
more comfortable procedure for patients by eliminating the trauma,
discomfort and risk associated with high-energy external
cardioversion.
[0007] Electrophysiologists are developing clinical techniques
targeted toward the use of catheter-based ablation as a therapeutic
alternative in the treatment of focally induced atrial
fibrillation. An important component of these efforts are methods
for quickly and reliably inducing and converting the AF arrhythmia
while the patient is in the electrophysiology lab.
SUMMARY OF THE INVENTION
[0008] The present invention is directed to an method and system
for performing internal cardioversion utilizing a catheter having a
basket-shaped electrode assembly.
[0009] In one embodiment, the invention is directed to a method for
atrial defibrillation in a patient in need thereof comprising
introducing into the patient a catheter. The catheter comprises an
elongated catheter body having proximal and distal ends and at
least one lumen therethrough, and a basket-shaped electrode
assembly at the distal end of the catheter body. The electrode
assembly has proximal and distal ends and comprises a plurality of
spines connected at their proximal and distal ends, each spine
comprising an elongated spine electrode along its length. The
electrode assembly has an expanded arrangement wherein the spines
bow radially outwardly and a collapsed arrangement wherein the
spines are arranged generally along the axis of the catheter body.
The method further comprises introducing the electrode assembly
into the heart of the patient and applying defibrillation energy to
the tissue through one or more of the elongated electrodes.
[0010] In another embodiment, the invention is directed to a system
for atrial defibrillation in a patient. The system comprises a
catheter as described above in combination with an external
defibrillator electrically connected to the catheter.
[0011] In a particularly preferred embodiment, the invention is
directed to a system for atrial defibrillation in a patient
comprising a catheter. The catheter comprises an elongated catheter
body having proximal and distal ends, a length of at least about 90
cm, and at least one lumen therethrough. The catheter body has one
or more ring electrodes mounted at or near its distal end. The
catheter further comprises a basket-shaped electrode assembly at
the distal end of the catheter body, the electrode assembly having
proximal and distal ends and comprising at least three spines
connected at their proximal and distal ends. Each spine comprises
an elongated spine electrode along its length, wherein each spine
electrode has a length ranging from about 30 mm to about 80 mm. The
electrode assembly has an expanded arrangement wherein the spines
bow radially outwardly and a collapsed arrangement wherein the
spines are arranged generally along the axis of the catheter body.
The electrode assembly has a tip electrode mounted at its distal
end. The system further comprises an external defibrillator
electrically connected to the catheter, an interface switch box
that connects the external defibrillator to the catheter and that
permits the selection of spine electrodes through which
defibrillation energy is to be delivered, an ECG recorder
electrically connected to the catheter through the interface switch
box, and an external pacer electrically connected to the catheter
through the interface switch box.
[0012] The inventive method and system offer several advantages
over existing methods and systems. First, the basket-shaped
electrode assembly has a larger surface area than conventional
catheters and permits better current distribution to cover a
majority of both atria during treatment. The larger surface area
also reduces the impedance and energy requirements. The ability of
the electrode assembly to expand and contract permits adjustability
of the electrodes and better contact with tissue. The electrode
assembly can also be placed within the pulmonary artery for better
current distribution in the left atrium.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] These and other features and advantages of the present
invention will be better understood by reference to the following
detailed description when considered in conjunction with the
accompanying drawings wherein:
[0014] FIG. 1 is a perspective view of a catheter according to the
invention.
[0015] FIG. 2 is a close-up perspective view of the basket-shaped
electrode assembly and the distal end of the catheter body of the
catheter shown in FIG. 1.
[0016] FIG. 3 is a side cross-sectional view of the control handle
of the catheter shown in FIG. 1.
[0017] FIG. 4 is a perspective view of an alternative basket-shaped
electrode assembly in accordance with the invention.
[0018] FIG. 5 is a schematic diagram of a system in accordance with
the invention.
[0019] FIG. 6 is a side cross-sectional view of the distal end of a
catheter according to the invention showing an exemplary steering
mechanism.
DETAILED DESCRIPTION OF THE INVENTION
[0020] The invention is directed to a method and system for atrial
defibrillation using a catheter having a basket-shaped electrode
array at its distal end. As shown in FIG. 1, the catheter 10
comprises an elongated catheter body 12 having proximal and distal
ends, a connector 15 and a control handle 16 at the proximal end of
the catheter body, and a basket-shaped electrode assembly 18
mounted at the distal end of the catheter body 12.
[0021] In accordance with the invention, the catheter body 12
comprises an elongated tubular construction having a single, axial
or central lumen (not shown), but can optionally have multiple
lumens if desired. The catheter body 12 is flexible, i.e.,
bendable, but substantially non-compressible along its length. The
catheter body 12 can be of any suitable construction and made of
any suitable material. A presently preferred construction comprises
an outer wall made of polyurethane or PEBAX.RTM. (polyether block
amide). The outer wall comprises an imbedded braided mesh of
stainless steel or the like to increase torsional stiffness of the
catheter body 12 so that, when the control handle 16 is rotated,
the distal end of the catheter body will rotate in a corresponding
manner.
[0022] The length of the catheter, i.e, the catheter body 12 and
mapping assembly 18 excluding the connector 15 and control handle
16, is preferably at least about 90 cm, more preferably from about
110 cm to about 120 cm, still more preferably about 115 cm. The
outer diameter of the catheter body 12 is not critical, but is
preferably no more than about 8 french, more preferably 7 french.
Likewise the thickness of the outer wall is not critical, but is
preferably thin enough so that the central lumen can accommodate a
puller wire, lead wires, sensor cables and any other wires, cables
or tubes. An example of a catheter body construction suitable for
use in connection with the present invention is described and
depicted in U.S. Pat. No. 6,064,905, the entire disclosure of which
is incorporated herein by reference.
[0023] The basket-shaped electrode assembly 18 is mounted to the
distal end of the catheter body 12. As shown in FIGS. 1 and 2, the
basket-shaped electrode assembly 18 comprises five spines 20 or
arms. The spines 20 are all attached, directly or indirectly, to
each other at their proximal and distal ends, and to the catheter
body 12 at their proximal ends. The basket-shaped electrode
assembly 18 is moveable between an expanded position and a
contracted position, so that, in the expanded position the spines
20 are bowed outwardly and in the contracted position the spines
are generally straight and arranged generally along the axis of the
catheter body. As will be recognized by one skilled in the art, the
number of spines 20 can vary as desired depending on the particular
application, so that the assembly has at least two spines,
preferably at least three spines, more preferably at least five
spines, and as many as eight or more spines.
[0024] Expansion and contraction of the electrode assembly 18 can
be accomplished by any suitable means. For example, as shown in
FIG. 2, the assembly 18 includes an expander 22 attached at its
distal end to the distal ends of the spines 20 with the spines
mounted, preferably generally evenly-spaced, around the expander so
that the expander forms the axis of the electrode assembly. The
expander 22 is generally coaxial with the catheter body 12. The
expander 22 extends through the catheter body and out the proximal
end of the catheter body, preferably into a suitable control handle
16, as discussed further below. The expander 22 is not connected to
the catheter body 12, so that longitudinal movement of the expander
relative to the catheter body results in expansion and contraction
of the electrode assembly 18.
[0025] The expander 22 can comprise a wire, such as a Nitinol wire,
that optionally extends through a non-conductive tubing (not shown)
outside of the catheter body 12. Alternatively, the expander 22 can
comprise a flexible tubing having a lumen (not shown) extending
through its entire length. The lumen permits a guidewire to extend
through the entire length of the catheter for introduction of the
catheter into the body and so that the electrode assembly 18 can be
removed and later reintroduced to the same position, if desired. In
a preferred embodiment, the expander 22 comprises braided polyimide
tubing, i.e., tubing having inner and outer layers of polyimide
with a braided stainless steel mesh therebetween, as is generally
known in the art. A more detailed description of a catheter having
a basket-shaped electrode assembly with such an expander is
disclosed in copending application entitled "BASKET CATHETER WITH
MULTIPLE LOCATION SENSORS," filed on Dec. 14, 2001, the disclosure
of which is incorporated herein by reference.
[0026] Each spine 20 comprises a flexible wire 24 that forms an
elongated spine electrode 25 along at least a portion of its
length. The elongated electrode 25 preferably has a length ranging
from about 10 mm to about 100 mm, more preferably from about 30 mm
to about 80 mm, still more preferably from about 50 to about 60 mm.
In a preferred embodiment, the flexible wires 24 each comprise a
flat or round Nitinol wire. The flexible wires 24 are insulated
from one another at their proximal and distal ends. In the depicted
embodiment, each wire 24 has non-conductive coverings 26 at its
proximal and distal ends, with the remainder being exposed to form
the spine electrode 25. As would be recognized by one skilled in
the art, the elongated spine electrodes 25 could have other
suitable designs such that the are of sufficient length. For
example, the flexible wires 24 could be covered along their entire
length with a non-conductive covering 26, with an elongated
electrode then placed over the non-conductive covering.
[0027] In a preferred embodiment, the distal ends of the spines 20
are connected and covered by a plastic, preferably polyurethane,
cap 28. If desired, the distal ends of the spines 20 can be held in
place within the cap 28 using polyurethane glue or the like. A tip
electrode 30 is mounted on the distal end of the plastic cap 28,
preferably for use as a pacing electrode, as discussed in more
detail below. Alternatively, the tip electrode 30 can be used as a
mapping electrode. The tip electrode 30 can comprise any suitable
conductive metal, such as gold or platinum, and preferably an alloy
of platinum and iridium.
[0028] Each of the spine electrodes 25 and tip electrode 30 is
electrically connected to a suitable source of energy, as discussed
further below, by an electrode lead wire 32. An electrode lead wire
32 can be attached to the spine electrodes 25 and tip electrode 30
by any suitable means, preferably by solder of the like. Each
electrode lead wire 32 attached to a spine electrode 25 is attached
to the proximal end of the corresponding electrode, extends through
a lumen in the catheter body 12 and is attached to the connector
17. The lead wire 32 for the tip electrode 30 is attached to the
tip electrode 30, extends through a lumen in the expander 22,
extends through the catheter body 12, and is attached at its
proximal end to the connector 17. Each lead wire 32 is attached to
its corresponding spine electrode 25 or tip electrode 30 by any
suitable method, preferably solder or the like.
[0029] In the depicted embodiment, four ring electrodes 34 are
mounted along the distal end of the catheter body 12. Each ring
electrode 34 preferably comprises a ring of platinum, gold or a
combination of platinum and iridium. The ring electrodes 34 can be
used for pacing, for detecting electrical signals before, during or
after defibrillation [please confirm], or for a return electrode
for defibrillation, as discussed further below. As would be
recognized by one skilled in the art, the presence and number of
ring electrodes 34 can vary depending on the particular
application.
[0030] An electrode lead wire 32 is attached to each ring electrode
34 by any suitable method. A preferred method for attaching a lead
wire 32 to a ring electrode 34 involves first making a small hole
through the outer wall of the catheter body 12. Such a hole can be
created, for example, by inserting a needle through the wall of the
catheter body 12 and heating the needle sufficiently to form a
permanent hole. The lead wire 32 is then drawn through the hole by
using a microhook or the like. The end of the lead wire 32 is then
stripped of any coating and welded to the underside of the ring
electrode 34, which is then slid into position over the hole and
fixed in place with polyurethane glue or the like. Alternatively,
each ring electrode 34 may be formed by wrapping the lead wire 32
around the catheter body 12 a number of times and stripping the
lead wire of its own non-conductive coating on its outwardly facing
surfaces.
[0031] Longitudinal movement of the expander 22 relative to the
catheter body 12, which results in expansion of the electrode
assembly 18, is accomplished by manipulation of the control handle
16. As shown in FIG. 3, the control handle 16 comprises a
generally-hollow handle housing 54 and a piston 56 slidably mounted
within the distal end of the handle housing. The proximal end of
the catheter body 12 is fixedly attached to the distal end of the
piston 56 by a shrink sleeve (not shown), as is generally known in
the art, or by any other suitable method.
[0032] Within the control handle 16, the proximal end of the
expander 22 extends through a passage 57 in the piston 56, through
the handle housing 54 and into a support tube 58, preferably made
of braided polyimide or PEBAX.RTM.. The support tube 58 extends out
the proximal end of the control handle 16 and terminates in a luer
hub 60. The support tube 58 and expander 22 are together fixedly
attached to the handle housing 54 by any suitable method,
preferably with polyurethane glue or the like. If the expander 22
does not have a lumen, e.g., is in the form of a puller wire or the
like, the expander can be attached to the handle housing 54 without
the use of the support tube 58 and luer hub 60, as is generally
known for handles for steerable catheters. Examples of such handle
designs are disclosed in U.S. Pat. Nos. Re 34,502 and 5,897,529,
the disclosures of which are incorporated herein by reference.
[0033] If desired, the expander can be eliminated. With such a
design, the basket-shaped mapping assembly 18 may be expanded and
contracted by moving a guiding sheath proximally off the basket and
distally over the basket, respectively, so that the catheter itself
does not need to include a means for expanding and contracting the
basket. In this embodiment, as shown in FIG. 4, the mapping
assembly 18 include five spines, but only four of the spines 20a
form electrodes 25. The fifth spine 20b comprises a flexible wire
24 having a non-conductive covering 26 over its entire length. The
electrode lead wire 32 for the tip electrode extends along the
fifth spine 20b within the non-conductive covering 26 and then into
the catheter body 12, as generally described above with respect to
the embodiment shown in FIG. 2.
[0034] If desired, the catheter can include one or more location
sensors (not shown) for providing location information about the
electrode assembly 18. Such a design is particularly useful if the
an electrical map of the heart has been produced by a mapping
catheter having one or more location sensors. The
electrophysiologist can then use the location sensors to determine
the proper placement of the electrode assembly 18. A catheter
having a basket-shaped electrode assembly with location sensors is
described in copending application entitled "BASKET CATHETER WITH
MULTIPLE LOCATION SENSORS," filed on Dec. 14, 2001.
[0035] As shown generally in FIG. 5, the catheter of the invention
is used in connection with a suitable external defibrillator 110,
an external pacer 112, and an ECG recorder 114, which are all
connected via an interface switch box 116. Any suitable external
defibrillator, external pacer and ECG recorder known in the art can
be used in connection with the invention. The interface switch box
116 provides a centralized connection to the other system
components while also facilitating electrode selection.
[0036] Specifically, cardioversion can be achieved using various
electrode arrangements. For example, cardioversion can be achieved
internally by shorting together all of the spine electrodes 25 so
that they can together be used as a single shocking electrode.
Shorting of the spine electrodes 25 is achieved using the interface
switch box, as is generally known in the art. In such an
embodiment, one or more of the ring electrodes 34 on the catheter
body 12 and/or the tip electrode 30 mounted on the electrode
assembly 18 can be used as the return electrode, and preferably
multiple ring electrodes are shorted together to form a return
electrode. With this embodiment, a large shocking electrode surface
is formed with the five spine electrodes 25.
[0037] Cardioversion can also be achieved internally by using less
than all of the spine electrodes 25 as a shocking electrode and
using the remaining spine electrodes as a return electrode. For
example, with the embodiment shown in FIG. 4, two of the spine
electrodes 25 can be shorted together to form a shocking electrode,
with the two remaining spine electrodes shorted together to form
the return electrode. In this embodiment, a relatively large
shocking electrode surface is formed using two spine
electrodes.
[0038] Alternatively, cardioversion can be achieved with a
combination of internal and external electrodes. For example, one
or more of the spine electrodes 25 can be used as the shocking
electrode, as generally described above. An electrode patch (not
shown) is provided on the outside of the patient's body and
electrically connected to the external defibrillator 110 through
the interface switch box 116. The electrode patch serves as the
return electrode for defibrillation.
[0039] As shown in FIG. 5, the external defibrillator 110 has two
electrical connections to the interface switch box 116, namely, a
shocking connection 118 through which electrical energy to the one
or more shocking electrodes is delivered, and a return connection
120 through which electrical energy passes to the defibrillator
from the return electrodes. The defibrillator delivers sufficient
energy to achieve defibrillation, preferably from about 0.5 to
about 20 joules, more preferably from about 1 to about 10 joules,
still more preferably from about 1 to 4 joules. The energy is
preferably delivered over a period of time ranging from about 2 to
about 10 msec, more preferably about 6 msec. The shape of the
energy delivered can be uniphasic, biphasic, or multiphasic.
[0040] The external pacer 112 is electrically connected to the
interface switch box 116 by one or more pacer connections 122
depending on the number of pacing electrodes on the catheter. In
the depicted embodiment, the catheter includes one tip electrode 30
and four ring electrodes 34 that can be use for pacing, and thus
the system includes five pacer connections 122.
[0041] The ECG recorder 114 is similarly connected to the interface
switch box 116 by one or more recorder connections 124 depending on
the number of electrodes available for obtaining ECG information.
In the depicted embodiment, the catheter includes one tip electrode
30 and four ring electrodes 34 that can be used for obtaining
electrical information, and thus the system includes five recording
connections 124.
[0042] To use the catheter of the invention, an electrophysiologist
introduces a guiding sheath, guidewire and dilator into the
patient, as is generally known in the art. A suitable guiding
sheath for use in connection with the inventive catheter is the
PREFACE.TM. Braided Guiding Sheath (commercially available from
Biosense Webster, Inc., Diamond Bar, Calif.). The dilator is
removed, and the catheter is introduced through the guiding sheath
whereby the guidewire lumen in the expander 22 permits the catheter
to pass over the guidewire. The guiding sheath covers the spines 20
of the electrode assembly 18 internally in a collapsed position so
that the entire catheter can be passed through a vein or artery to
a desired location. Once the distal end of the catheter reaches the
desired location, the guiding sheath is withdrawn. The expander 22
is then manipulated so that the spines 20 of the electrode assembly
18 flex outwardly into an expanded arrangement. In such an
arrangement the spines 20 (and thus spine electrodes 25) contact
the tissue of the heart. As will be recognized by one skilled in
the art, the electrode assembly 18 can be fully or partially
expanded in a variety of configurations depending on the precise
configuration of the region of the heart in which the assembly is
positioned.
[0043] Once the electrode assembly 18 is in the desired position,
the system is set up. The catheter 10 is electrically connected to
the interface switch box 116 via the electrode lead wires 32, which
can be done before or after insertion of the catheter. The
interface switch box 116 is also electrically connected to the
external defibrillator 110, external pacer 112, and ECG recorder
114, as described above. The electrode impedance is verified
through the external defibrillator 110 and/or external pacer 112.
The intercardiac ECG amplitude is also verified to assure that the
electrodes are working properly and in good contact with the heart
tissue. The electrophysiologist then selects the electrode,
defibrillation and pacing modes, as well as the defibrillation
parameters (such as energy and pulse width) to be delivered through
the external defibrillator.
[0044] After the electrode assembly 18 is in the desired position
and the system set up, the electrophysiologist can then introduce
into the patient's heart a suitable treatment catheter, such as an
ablation catheter for ablating lines of block. The
electrophysiologist performs the ablation or other atrial
fibrillation treatment, as is generally known in the art. It is not
uncommon for the patient's heart to stop beating during such
procedures. Accordingly, to the extent this occurs, the
electrophysiologist uses the basket catheter of the invention to
deliver shocking energy to the heart. To do so, the
electrophysiologist synchronizes cardioversion with the R-wave and
then delivers the defibrillation energy to the heart. The
electrophysiologist then verifies capture, and if there is not
capture, he redelivers the defibrillation energy.
[0045] As noted above, because the basket-shaped electrode assembly
has a larger surface area than conventional catheters, the
impedance and energy requirements are reduced, thereby causing less
pain to the patient than with conventional defibrillation methods.
Moreover, the ability of the electrode assembly to expand and
contract permits adjustability of the electrodes and better contact
with tissue. After the patients achieves a regular heartbeat, the
electrophysiologist can resume the ablation or other treatment
procedure. Additionally, the basket catheter of the invention can
be used for pacing during the ablation or other treatment procedure
using the tip electrode and/or ring electrodes.
[0046] Although the inventive methods and systems have been
described with respect to a particularly preferred basket catheter
configuration, other similar basket catheter configurations can
also be used. Examples of such configurations are generally
described in U.S. Pat. Nos. 6,262,695, 5,782,239, 5,772,590,
5,628,313, and 5,411,025, the disclosures of which are incorporated
herein by reference.
[0047] If desired, the catheter can include a steering mechanism
for deflection of the distal end of the catheter body 12. With such
a design, the distal end of the catheter body 12 preferably
includes a tip section 14 comprising a short length of tubing,
e.g., 2 to 4 inches, that is more flexible than the remainder of
the catheter body, as shown in FIG. 6. The tip section 14 can be
attached to the catheter body 12 by any suitable method, such as by
polyurethane glue or the like, as described in more detail in U.S.
patent application Ser. No. 09/796,198, entitled "Catheter Having
Continuous Braided Electrode," the entire disclosure of which is
incorporated herein by reference.
[0048] The steering mechanism comprises a puller wire 34 that
extends from a proximal end in the handle through the catheter body
and into an off axis lumen 36 in the tip section 14. The tip
section 14 comprises a primary lumen 38, which can be an off-axis
lumen or an axial lumen, into which the expander 22, electrode lead
wires 32 and the proximal ends of the spines 20 extend. Within the
catheter body 12, the puller wire preferably extends through a
closely wound coil (not shown) that is bendable but substantially
compressible, as generally described in U.S. patent application
Ser. No. 09/796,198, entitled "Catheter Having Continuous Braided
Electrode," the entire disclosure of which is incorporated herein
by reference. Preferably the coil is fixed near the proximal and
distal ends of the catheter body to prevent deflection of the
catheter body. The distal end of the puller wire 34 is anchored in
the tip section 14 proximal to the proximal end of the electrode
assembly 18 by any suitable means. In the depicted embodiment, the
puller wire 34 is anchored to the distal end of the tip section 14
with a T-shaped anchor 37, as generally described in U.S. patent
application Ser. No. 09/796,198, entitled "Catheter Having
Continuous Braided Electrode," the entire disclosure of which is
incorporated herein by reference. As described in U.S. patent
application Ser. No. 09/796,198, the T-shaped anchor can also be
used to attach the puller wire to the side wall of the tip
section.
[0049] The proximal end of the puller wire 34 is anchored to a
movable member in the control handle 16 that can be moved relative
to the catheter body 12. If the catheter does not include an
expander 22, the above-described control handle 16 can be used for
manipulating the puller wire 34 in place of the expander, as would
be recognized by one skilled in the art. In other words, the
proximal end of the puller wire 34 is attached, directly or
indirectly, to the handle housing 54 so that proximal movement of
the handle housing relative to the piston 56 and catheter body 12
results in longitudinal movement of the puller wire 34 relative to
the catheter body, thereby deflecting the tip section 14. If a
steering mechanism is included in addition to an expander 22, the
control handle 16 may be of any suitable construction for
manipulating two wires, in this case, the expander 22 and the
puller wire 34. Preferably the handle has a pair of movable members
to which the expander and puller wire attach, such as handles
typically used for bidirectional and multidirectional catheters.
Examples of such handles are disclosed in U.S. Pat. Nos. 6,210,407,
6,198,974, 6,183,463, 6,183,435, 6,171,277, and 6,123,699, the
disclosures of which are incorporated herein by reference.
[0050] The preceding description has been presented with references
to presently preferred embodiments of the invention. Persons
skilled in the art and technology to which this invention pertains
will appreciate that alterations and changes in the described
structures and methods can be practiced without meaningfully
departing from the principle, spirit and scope of this invention.
Accordingly, the foregoing description should not be read as
pertaining only to the precise structures and methods described and
shown in the accompanying drawings, but rather should be read as
consistent with and as support for the following claims, which are
to have their fullest and fairest scope.
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