U.S. patent application number 10/461299 was filed with the patent office on 2003-10-23 for catheter distal assembly with pull wires.
Invention is credited to Fleischman, Sidney D., Koblish, Josef V., Levin, Steven E., Thompson, Russell B., Whayne, James G..
Application Number | 20030199817 10/461299 |
Document ID | / |
Family ID | 27737701 |
Filed Date | 2003-10-23 |
United States Patent
Application |
20030199817 |
Kind Code |
A1 |
Thompson, Russell B. ; et
al. |
October 23, 2003 |
Catheter distal assembly with pull wires
Abstract
A catheter assembly having a sheath, which includes a side wall
enclosing an interior bore, and a distal region. The assembly also
has a bendable catheter tube, which is carried for sliding movement
in the interior bore. A pull wire also runs through the interior
bore of the sheath, preferably within a lumen. The catheter tube
has a distal portion with a coupling which joins the distal portion
of the catheter tube and the distal portion of the pull wire.
Relative movement of the pull wire and the sheath causes bending of
the catheter tube outwardly through the opening, in response to
sliding movement of the catheter tube within the interior bore
toward the distal region of the sheath.
Inventors: |
Thompson, Russell B.; (Los
Altos, CA) ; Fleischman, Sidney D.; (Menlo Park,
CA) ; Koblish, Josef V.; (Sunnyvale, CA) ;
Whayne, James G.; (Saratoga, CA) ; Levin, Steven
E.; (Mountain View, CA) |
Correspondence
Address: |
HENRICKS SLAVIN AND HOLMES LLP
SUITE 200
840 APOLLO STREET
EL SEGUNDO
CA
90245
|
Family ID: |
27737701 |
Appl. No.: |
10/461299 |
Filed: |
June 13, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10461299 |
Jun 13, 2003 |
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09497541 |
Feb 3, 2000 |
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6607505 |
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09497541 |
Feb 3, 2000 |
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08960902 |
Oct 30, 1997 |
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6048329 |
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08960902 |
Oct 30, 1997 |
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08769856 |
Dec 19, 1996 |
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6332880 |
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Current U.S.
Class: |
604/95.01 ;
604/264 |
Current CPC
Class: |
A61B 2018/1407 20130101;
A61B 2018/1467 20130101; C08L 2201/12 20130101; A61M 25/0147
20130101; A61M 25/0152 20130101; A61B 18/1492 20130101; A61M
2025/0163 20130101; A61M 25/0043 20130101; A61M 2025/015 20130101;
A61B 2018/00577 20130101; A61M 25/01 20130101; A61M 25/0144
20130101; A61B 2018/142 20130101; A61B 2017/00867 20130101; A61B
2018/00553 20130101; A61B 2018/1861 20130101; A61M 2025/0161
20130101; A61B 2018/00065 20130101; A61B 2018/00797 20130101; A61M
25/0141 20130101 |
Class at
Publication: |
604/95.01 ;
604/264 |
International
Class: |
A61M 031/00; A61M
025/00 |
Claims
We claim:
1. A probe assembly, comprising: an outer member including a wall
defining an interior bore having a distal end and a proximal end;
an elongate body, defining a distal portion, a distal end, a
proximal end and an exterior, carried within the outer member, the
distal portion of the elongate body including at least one
operative element, the elongate body further including a flexible
spline extending from adjacent the distal end toward the proximal
end, the flexible spline defining a first stiffness; and a control
element defining a distal portion extending into the distal end of
the elongate body and operably connected to the flexible spline,
and a proximal portion extending along the exterior of the elongate
body within the outer member toward the proximal end of the outer
member, at least the portion of the control element aligned with
the distal end of the elongate body defining a second stiffness,
the second stiffness being less than the first stiffness.
2. A probe assembly as claimed in claim 1, wherein the outer member
comprises a tubular sheath.
3. A probe assembly as claimed in claim 1, wherein the outer member
defines a third stiffness and the third stiffness is greater than
the first stiffness.
4. A probe assembly as claimed in claim 1, wherein the control
element comprises a pull wire.
5. A probe assembly as claimed in claim 4, wherein the pull wire
comprises multiple strands.
6. A probe assembly as claimed in claim 4, wherein the pull wire
comprises a central stand and at least one surrounding strand.
7. A probe assembly as claimed in claim 1, wherein the flexible
spline comprises a solid core wire.
8. A probe assembly as claimed in claim 1, wherein the flexible
spline defines a first cross-sectional shape over a substantial
portion thereof and a second cross-sectional shape over a
relatively small portion thereof.
9. A probe assembly as claimed in claim 8, wherein the first
cross-sectional shape is substantially circular and the second
cross-sectional shape is substantially flat.
10. A probe assembly as claimed in claim 9, wherein the
substantially flat portion of the flexible spline is prebent.
11. A probe assembly as claimed in claim 8, wherein the flexible
spline defines a distal end and the relatively small portion of the
flexible spline is substantially adjacent to the distal end of the
flexible spline.
12. A probe assembly as claimed in claim 1, wherein the flexible
spline defines a longitudinal axis, the distal portion of the
control element defines a longitudinal axis and the flexible spline
and distal portion of the control element are substantially
coaxial.
13. A probe assembly as claimed in claim 1, wherein the control
element is operably connected to the flexible spline by a crimp
tube.
14. A probe assembly as claimed in claim 12, wherein the crimp tube
includes flexible spline crimps and control element crimps and the
flexible spline crimps are offset from the control element crimps
by approximately 90 degrees.
15. A probe assembly as claimed in claim 1, wherein the elongate
body comprises a catheter tube.
16. A probe assembly as claimed in claim 1, further comprising: a
tip member associated with the distal end of the elongate body, the
tip member defining a bore through which the control element
extends, the bore defining a distal end, a proximal end and a bore
diameter which increases at least in the area adjacent to the
distal end of the bore.
17. A probe assembly as claimed in claim 16, wherein the bore is
substantially frusto-conically shaped.
18. A probe assembly as claimed in claim 16, wherein the bore
curves outwardly.
19. A probe assembly as claimed in claim 1, further comprising: a
tip member associated with the distal end of the elongate body, the
tip member including an elastomeric member defining a bore through
which the control element extends.
20. A probe assembly as claimed in claim 19, wherein the tip member
further includes a shape retainer ring around at least a portion of
the elastomeric member.
21. A probe assembly as claimed in claim 1, wherein the operative
element comprises an electrode.
22. A probe assembly as claimed in claim 1, further comprising: an
apparatus adapted to fix the proximal portion of the control
element with respect to the proximal portion of the elongate
body.
23. A probe assembly as claimed in claim 1, wherein movement of the
elongate member relative to the control element causes the distal
end of the elongate member to form a loop.
24. A probe assembly as claimed in claim 1, further comprising:
means for displaying the magnitude of relative movement between the
outer member and the elongate body.
25. A probe assembly as claimed in claim 1, wherein the flexible
spline and control element comprise an integrally formed
structure.
26. A probe assembly as claimed in claim 1, wherein the elongate
body defines a longitudinal axis and the distal portion of the
control element is arranged at a non-zero angle with respect to the
longitudinal axis.
27. A probe assembly, comprising: an outer member including a wall
defining an interior bore having a distal end and a proximal end;
an elongate body, defining a distal portion, a distal end, a
proximal end and an exterior, carried within the outer member, the
distal portion of the elongate body including at least one
operative element; a control element defining a distal portion
operably connected to at least one of the distal end and the distal
portion of the elongate body, and a proximal portion extending
along the exterior of the elongate body within the outer member
toward the proximal end of the outer member; and a tip member
associated with the distal end of the elongate body and defining an
aperture through which the control element extends, the tip member
including stress reducing-means for reducing bending stress on the
control element.
28. A probe assembly as claimed in claim 27, wherein the stress
reducing means comprises a bore through which the control element
extends, the bore defining a distal end, a proximal end and a bore
diameter which increases at least in the area adjacent to the
distal end of the bore.
29. A probe assembly as claimed in claim 28, wherein the bore is
substantially frusto-conically shaped.
30. A probe assembly as claimed in claim 28, wherein the bore
curves outwardly.
31. A probe assembly as claimed in claim 27, wherein the stress
reducing means comprises an elastomeric member defining a bore
through which the control element extends.
32. A probe assembly as claimed in claim 31, wherein the stress
reducing means further comprises a shape retainer ring around at
least a portion of the elastomeric member.
33. A probe assembly as claimed in claim 27, wherein the elongate
body comprises a catheter tube.
34. A probe assembly as claimed in claim 27, wherein the outer
member comprises a sheath.
35. A probe assembly as claimed in claim 27, wherein the control
element comprises a pull wire.
36. A probe assembly as claimed in claim 27, wherein the control
element extends into the distal end of the elongate body.
37. A probe assembly as claimed in claim 36, wherein the distal
portion of the elongate body includes a flexible spline and the
control element is operably connected to the flexible spline.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of co-pending
U.S. application Ser. No. 08/769,856, filed Dec. 19, 1996, which is
incorporated herein by reference thereto.
BACKGROUND OF THE INVENTION
[0002] 1. Field of Invention
[0003] The invention generally relates to the field of medical
surgical instruments, specifically structures for supporting one or
more diagnostic or therapeutic elements in contact with body
tissue. In a more particular sense, the invention relates to
structures well suited for supporting one or more electrode
elements within the heart.
[0004] 2. Description of the Related Art
[0005] There are many instances where diagnostic and therapeutic
elements must be inserted into the body. One instance involves the
treatment of cardiac conditions such as atrial fibrillation and
atrial flutter which lead to an unpleasant, irregular heart beat,
called arrhythmia. The treatment of cardiac arrhythmia requires
electrodes capable of creating tissue lesions having a diversity of
different geometries and characteristics, depending upon the
particular physiology of the arrhythmia to be treated.
[0006] For example, it is believed that the treatment of atrial
fibrillation and flutter requires the formation of continuous
lesions of different lengths and curvilinear shapes in heart
tissue. These lesion patterns require the deployment within the
heart of flexible ablating elements having multiple ablating
regions. The formation of these lesions by ablation can provide the
same therapeutic benefits that the complex incision patterns that
the surgical maze procedure presently provides, but without
invasive, open heart surgery.
[0007] The task is made more difficult because heart chambers vary
in size from individual to individual. They also vary according to
the condition of the patient. One common effect of heart disease is
the enlargement of the heart chambers. For example, in a heart
experiencing atrial fibrillation, the size of the atrium can be up
to three times that of a normal atrium.
[0008] A need exists for electrode support structures that can
create lesions of different geometries and characteristics, and
which can readily adopt to different contours and geometries within
a body region, e.g., the heart.
SUMMARY OF THE INVENTION
[0009] The invention provides structures for supporting operative
therapeutic or diagnostic elements within an interior body region,
like the heart. The structures possess the requisite flexibility
and maneuverability permitting safe and easy introduction into the
body region. Once deployed in the body region, the structures
possess the capability to exert force against tissue thereby
deforming the tissue resulting in conformance between tissue and
elements.
[0010] A probe assembly in accordance with one embodiment of the
invention includes an outer member including a wall defining an
interior bore having a distal end and a proximal end, and an
elongate body, defining a distal end, a proximal end and an
exterior, carried within the outer member. The distal end of the
elongate body includes at least one operative element. The elongate
body further includes a flexible spline extending from adjacent the
distal end toward the proximal end which has a first stiffness. The
assembly also includes a control element defining a distal portion
extending into the distal end of the elongate body and operably
connected to the flexible spline, and a proximal portion extending
along the exterior of the elongate body within the outer member
toward the proximal end of the outer member. At least the portion
of the control element aligned with the distal end of the elongate
body has a second stiffness which is less than the first
stiffness.
[0011] There are many advantages associated with this embodiment of
the present invention. For example, this embodiment is more compact
than conventional probes. Additionally, the relatively flexible
control element is less likely to cause tissue damage than the
control elements in conventional probes.
[0012] An assembly in accordance with another embodiment of the
present invention includes an elongate catheter body, and a control
element defining a distal portion operably connected to the distal
portion of the catheter body and a proximal portion associated
with, and extending along, the exterior surface of the catheter
body to an area adjacent the proximal end of the catheter body. The
assembly also includes an apparatus, associated with the catheter
body and the control element, that is adapted to secure the control
element in predetermined relation to the catheter body.
[0013] There are many advantages associated with this embodiment of
the present invention. For example, the control element, which is
typically a pull wire, is less likely to wrap around the catheter
body than is the control element in a conventional device. As a
result, when the present assembly is used in conjunction with a
sheath, the catheter is less likely to become stuck within the
sheath.
[0014] A probe assembly in accordance with another embodiment of
the invention includes an outer member including a wall defining an
interior bore, and an elongate body carried within the outer
member. The distal portion of the elongate body includes at least
one operative element. The elongate body also includes a flexible
spline extending from adjacent the distal end toward the proximal
end. The flexible spline defines a first cross-sectional shape over
a substantial portion thereof and a second cross-sectional shape
over a relatively small portion thereof. The assembly also includes
a control element defining a distal portion operably connected to
at least one of the distal end and distal portion of the elongate
body, and a proximal portion extending along the exterior of the
elongate body within the outer member toward the proximal end of
the outer member.
[0015] There are many advantages associated with this embodiment of
the present invention. For example, the second cross-sectional
shape may be a relatively flat shape. As compared to conventional
probe assemblies, the flat shape provides increased predictability
and consistency in the deflection direction of the elongate body
and, therefore, better control of the movement of the elongate
body. This is especially true when the elongate body is used to
form loops.
[0016] The above described and many other features and attendant
advantages of the present invention will become apparent as the
invention becomes better understood by reference to the following
detailed description when considered in conjunction with the
accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] Detailed description of preferred embodiments of the
invention will be made with reference to the accompanying
drawings.
[0018] FIG. 1 is a perspective view of a probe, which carries on
its distal region a multiple electrode support structure that
embodies features of the invention;
[0019] FIG. 2A is an enlarged side view, with portions broken away
and in section, of the distal region of the probe shown in FIG.
1;
[0020] FIG. 2B is a side view of the multiple electrode structure
shown in FIG. 1, in which stiffness is varied using a slidable,
tapered spline;
[0021] FIG. 3A is an enlarged side view of an embodiment of the
distal region of the probe shown in FIG. 1;
[0022] FIG. 3B is a section view of the embodiment of the distal
region shown in FIG. 3A;
[0023] FIG. 4A is a side view of the distal region shown in FIG.
3A, in which the catheter tube is stiffer than the sheath, and in
which the catheter tube has been rotated within the sheath and
flipped over upon itself;
[0024] FIG. 4B is a side view of the distal region shown in FIG.
3A, in which the catheter tube is not as stiff as the sheath, and
in which the catheter tube has been rotated within the sheath to
form an orthogonal bend in the loop;
[0025] FIG. 5 is a side view of an embodiment of the distal region
shown in FIG. 3A, in which a pre-stressed spline within the looped
structure alters the geometry of the structure;
[0026] FIG. 6 is a side view of an embodiment of the distal region
shown in FIG. 3A, with the catheter tube having a pre-bent geometry
orthogonal to the looped structure;
[0027] FIG. 7 is a side view of an embodiment of the distal region
shown in FIG. 6, with the sheath advanced forward to straighten the
pre-bent geometry;
[0028] FIG. 8A is a section view of the catheter tube within the
sheath, in which the geometries of the sheath and catheter tube are
extruded to prevent relative rotation;
[0029] FIG. 8B is a section view of the catheter tube within the
sheath, in which the geometries of the sheath and catheter tube are
extruded to permit limited relative rotation;
[0030] FIGS. 9, 10, and 11, are side sectional views, largely
diagrammatic, showing an embodiment of the distal region shown in
FIG. 1, in which the electrode array is movable;
[0031] FIGS. 12A and 12B are views of the distal region shown in
FIG. 1;
[0032] FIG. 13 is an enlarged side view of a pull wire loop
configuration of the device depicted in FIG. 1;
[0033] FIG. 14 is an enlarged cross-sectional view of the distal
end portion of the device depicted in FIG. 13;
[0034] FIG. 15 is an enlarged cross-sectional view, similar to that
shown in FIG. 14, depicting an alternative distal tip embodiment of
the present invention;
[0035] FIG. 16 is a cross-sectional view depicting an alternative,
continuous core wire and pull wire embodiment of the present
invention;
[0036] FIG. 16A is yet another alternative embodiment of the
present invention;
[0037] FIG. 17 is an enlarged side view of an alternative
embodiment of the distal region of the probe shown in FIG. 1, with
the associated sheath withdrawn and with no rearward force applied
to the associated pull wire;
[0038] FIG. 18 is an enlarged side view of the distal region of the
probe shown in FIG. 17, with the associated sheath advanced;
[0039] FIG. 19 is an enlarged side view of distal region of the
probe shown in FIG. 17, with the associated sheath withdrawn and
with rearward force applied to the associated pull wire to form a
looped structure;
[0040] FIG. 20 is an enlarged side view of an alternative
embodiment of the distal region shown in FIG. 17, with a slotted
end connection;
[0041] FIG. 21 is a cross sectional view of a pull wire according
to the present invention;
[0042] FIG. 22 is a side cut away view of an alternate embodiment
of a catheter end tip according to the present invention;
[0043] FIG. 23 is a side cut away view of a catheter end tip such
as has been described in relation to FIG. 1, showing a stress point
thereon;
[0044] FIG. 24 is a side cut away view of a catheter end tip such
as has been described in relation to FIG. 22, showing a stress
point thereon;
[0045] FIG. 25 is a side cut away view of an alternate catheter end
tip having a protective plug therein;
[0046] FIG. 26 is a side view of another embodiment of a catheter
end tip protective plug;
[0047] FIG. 27 is a side cut away view of the catheter end tip with
the protective plug shown in FIG. 26;
[0048] FIG. 28 is a cross sectional view of an atrial wall with the
inventive probe 10 deployed therein;
[0049] FIG. 29 is a cross sectional view of an electrode structure
showing an optional mask thereon;
[0050] FIG. 30 is a view of the distal end of the catheter sleeve
showing optional features thereof;
[0051] FIG. 31 is a side view of a probe, like that shown in FIG.
1, that includes indicia for marking the extent of movement of the
catheter tube relative to the associated sheath;
[0052] FIG. 32 is a side view of an alternative embodiment of a
probe, of the type shown in FIG. 1, showing indicia for marking the
extent of movement of the catheter tube relative to the associated
sheath;
[0053] FIG. 33 is a diagrammatic depiction of the location of the
major anatomic landmarks for lesion formation in the left
atrium;
[0054] FIGS. 34A to 34D show representative lesion patterns in the
left atrium, which rely, at least in part, upon anchoring a
structure with respect to a pulmonary vein;
[0055] FIGS. 35A to 35C show representative lesion patterns in the
right atrium, which rely, at least in part, upon anchoring a
structure with respect to the superior vena cava, the inferior vena
cava, or the coronary sinus;
[0056] FIG. 36 shows a looped structure of the type shown in FIG.
3A, which carries a porous ablation element;
[0057] FIG. 37 is a side section view of the porous ablation
element taken generally along line 37-37 in FIG. 36;
[0058] FIG. 38 is a side section view of an alternative embodiment
of the porous ablation element, showing segmented ablation regions,
taken generally along line 38-38 in FIG. 39;
[0059] FIG. 39 is an exterior side view of the segmented ablation
regions shown in section in FIG. 38;
[0060] FIG. 40 is a side section view of an alternative embodiment
of a porous electrode element of the type shown in FIG. 38;
[0061] FIG. 41 is a partial side view of a probe in accordance with
another embodiment of the present invention;
[0062] FIG. 42 is a partial side view of a probe in accordance with
still another embodiment of the present invention;
[0063] FIG. 43 is side view of a gripping mechanism in accordance
with yet another embodiment of the present invention;
[0064] FIG. 44 is a partial side view of a probe in accordance with
another embodiment of the present invention;
[0065] FIG. 45 is a section view taken along line 45-45 in FIG. 44;
and FIG. 46 is a section view taken along line 46-46 in FIG.
45.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0066] The following is a detailed description of the best
presently known mode of carrying out the invention. This
description is not to be taken in a limiting sense, but is made
merely for the purpose of illustrating the general principles of
the invention. The scope of the invention is defined solely by the
appended claims.
[0067] This Specification discloses various multiple electrode
structures in the context of catheter-based cardiac ablation. That
is because the structures are well suited for use in the field of
cardiac ablation. Still, it should be appreciated that the
disclosed structures are applicable for use in other applications.
For example, the various aspects of the invention have application
in procedures requiring access to other regions of the body, such
as, for example, the prostate, brain, gall bladder, and uterus. The
structures are also adaptable for use with systems that are not
necessarily catheter-based.
[0068] The detailed description of the preferred embodiments is
organized as follows:
[0069] I. Probe Structures
[0070] II. Loop Size Marking
[0071] Ill. Deployment and Use of Multiple Electrode Structures
[0072] IV. Flexible Electrode Structures
[0073] V. Structures For Preventing the Pull Wire From Wrapping
Around the Catheter Tube
[0074] The section titles and overall organization of the present
detailed description are for the purpose of convenience only and
are not intended to limit the present invention.
[0075] I. Probe Structures
[0076] FIG. 1 shows a multiple electrode probe 10 having a flexible
catheter tube 12 with a proximal end 14 and a distal end 16. The
proximal end 14 has an attached handle 18. A multiple electrode
structure 20 is attached to the distal end 16 of the catheter tube
12 (see FIG. 2A). It should be noted that the probe 10, as depicted
in FIG. 1, is not substantially different from a probe which has
been disclosed and claimed in co-pending U.S. application Ser. No.
08/769,856. Differences between the present inventive probe and
that previously disclosed will be discussed in relation to
subsequent figures, herein.
[0077] Electrode elements 22 on the multiple electrode structure 20
can serve different purposes. For example, the electrode elements
22 can be used to sense electrical events in heart tissue.
Alternatively, or in addition, the electrode elements 22 can serve
to transmit electrical pulses to measure the impedance of heart
tissue, to pace heart tissue, or to assess tissue contact. In the
illustrated embodiment, the principal use of the electrode elements
22 is to transmit electrical energy, and, more particularly,
electromagnetic radio frequency energy, to ablate heart tissue.
[0078] The electrode elements 22 are electrically coupled to
individual wires (not shown in FIG. 1, but which will be discussed
in greater detail below) to conduct ablating energy to them. The
wires from the structure 20 are passed in conventional fashion
through a lumen in the catheter tube 12 and into the handle 18,
where they are electrically coupled to a connector 24 (see FIG. 1).
The connector 24 plugs into a source of RF ablation energy (not
shown).
[0079] As FIG. 2A shows, the support structure 20 has a flexible
spline 26 (which may comprise a core wire, as will be discussed in
more detail hereinafter) surrounded by a flexible, electrically
nonconductive distal tubing 28. The multiple electrodes 22 are
carried by the distal tubing 28.
[0080] The spline 26 is preferably made from resilient, inert wire,
like Nickel Titanium (commercially available as Nitinol material)
or 17-7 stainless steel. However, resilient injection molded
plastic can also be used. Preferably, the spline 26 comprises a
thin, rectilinear strip of resilient metal or plastic material.
Still, other cross sectional configurations can be used.
[0081] The spline 26 can decrease in cross sectional area in a
distal direction, by varying, e.g., thickness or width or diameter
(if round), to provide variable stiffness along its length.
Variable stiffness can also be imparted by composition changes in
materials or by different material processing techniques.
[0082] As FIG. 2B shows, the stiffness of the support structure 20
can be dynamically varied on the fly by providing a tapered wire 30
that is slidably movable within a lumen 32 in the structure 20.
Movement of the tapered wire 30 (arrows 34 in FIG. 2B) adjusts the
region of stiffness along the support structure 20 during use.
[0083] The distal tubing 28 is made of, for example, a polymeric,
electrically nonconductive material, like polyethylene or
polyurethane or PEBAX.RTM. material (polyether block amide) as,
generally, are such comparable components as are discussed herein
in relation to other embodiments of the invention. The signal wires
for the electrodes 22 preferably extend within the distal tubing
28.
[0084] The electrode elements 22 can be assembled in various ways.
They can, for example, comprise multiple, generally rigid electrode
elements arranged in a spaced apart, segmented relationship along
the distal tubing 28. The segmented electrodes 22 can each comprise
solid rings of conductive material, like platinum, which makes an
interference fit about the distal tubing 28. Alternatively, the
electrode segments can comprise a conductive material, like
platinum-iridium or gold, coated upon the distal tubing 28 using
conventional coating techniques or an ion beam assisted deposition
(IBAD) process.
[0085] Alternatively, the electrode elements 22 can comprise spaced
apart lengths of closely wound, spiral coils wrapped about the
distal tubing 28 to form an array of generally flexible electrode
elements 22. The coils are made of electrically conducting
material, like copper alloy, platinum, or stainless steel, or
compositions such as drawn-filled tubing. The electrically
conducting material of the coils can be further coated with
platinum-iridium or gold to improve its conduction properties and
biocompatibility. The electrode elements 22 can also comprise
porous materials, which transmit ablation energy through an ionic
medium.
[0086] The electrode elements 22 can be operated in a uni-polar
mode, in which the ablation energy emitted by the electrode
elements 22 is returned through an indifferent patch electrode (not
shown) externally attached to the skin of the patient.
Alternatively, the elements 22 can be operated in a bi-polar mode,
in which ablation energy emitted by one or more electrode element
22 is returned through another of the electrode elements 22 on the
structure 20.
[0087] The diameter of the support structure 20 (including the
electrode elements 22, flexible distal tubing 28, and the spline
26) can vary from about 2 French to about 10 French.
[0088] The support structure 20 must make and maintain intimate
contact between the electrode elements 22 and the endocardium or
other bodily structure. Furthermore, the support structure 20 must
be capable of assuming a relatively low profile for steering and
introduction into the body.
[0089] To accomplish these objectives, the probe 10 is inserted
through a sheath 36 (FIG. 2a). A distal section 38 of the sheath 36
extends about the multiple electrode structure 20 (see FIGS. 1 and
2A). In the embodiment shown in FIG. 1, a proximal section 40 of
the sheath 36 terminates short of the handle 18 and includes a
raised gripping surface 42. The proximal section 40 also includes a
homeostatic valve and side port (not shown) for fluid infusion.
Preferably the homeostatic valve locks about the catheter tube
12.
[0090] FIGS. 2A and 2B show the structure 20 carrying multiple
electrode elements 22 having had added thereto certain elements
particular to the illustrated embodiment, as will be discussed
hereinafter. As previously discussed herein, the structure 20 is
intended, in use, to be carried at the distal end 16 of the
flexible catheter tube 12, as a part of the probe 10, as shown in
FIG. 1. As has been discussed in relation to FIG. 2, the support
structure 20 has the flexible spline 26 surrounded by the flexible,
electrically nonconductive distal tubing 28. The multiple
electrodes 22 are carried by the distal tubing 28. The distal
section 38 of the sheath 36 extends about the multiple electrode
structure 20.
[0091] In accordance with another aspect of the present invention,
and as shown by way of example in FIG. 2A, the support structure 20
may also be provided with a support tube 25 that is located between
the distal tubing 28 and the flexible spline 26. The support tube
25 is preferably formed from TEFLON.RTM. and is approximately three
inches in length. Other materials, such as polyester or silicon,
can also be used.
[0092] The support tube 25 provides a number of benefits. Most
importantly, the support tube 25 prevents the formation of kinks in
the distal end of the distal tubing 28 when the support structure
20 is pulled into a relatively tight loop, i.e. a loop with a
radius on the order of 0.5 inch. Such kinks can develop between the
electrode elements 22, which results in a flat section in the
distal tubing 28 between the electrode elements 22. This can lead
to the exposure of the edges of the electrode elements 22 and the
exposed edges can become caught on the sheath 36 or pinch
tissue.
[0093] Generally speaking, kinks are less likely to be formed in
the proximal end of the distal tubing 28 because there are many
more wires passing between the flexible spline 26 and the distal
tubing 28 at the proximal end of the distal tubing 28 (such as the
wires associated with the electrode elements 22 and the temperature
sensors), then there are at the distal end. Absent such wiring and
the present support tube 25, there will be a space between the
flexible spline 26 and the distal tubing 28 which allows kinks to
form when the distal tubing 28 is deflected into a relatively tight
loop. The support tube 25 occupies this space, holds the distal
tubing 28 open and, therefore, prevents the formation of kinks.
[0094] The support tube 25 also increases the stiffness of the
support structure 20, thereby helping to ensure electrode/tissue
contact.
[0095] As shown by way of example in FIG. 3A, a wire 60 extends
through the sheath 36 to a stop/handle 62 located proximal to the
gripping surface 42 of the sheath 36. Holding the handle 62
stationary, the physician deploys a looped structure 64 (which is
the multiple electrode support structure 20 formed into the shape
of a loop) by advancing the catheter tube 12 through the sheath 36
(arrow 66). Once the looped structure 64 has been formed, the
physician can pull on the wire 60 (arrow 68) to decrease its
exposed length beyond the distal sheath section 38, to minimize
tissue trauma. Further adjustments to the loop are made by
advancing or retracting the catheter tube 12 within the sheath 36.
The wire 60 unattached to the sheath 36 allows the physician to
interchangeably use the structure 64 With essentially any
alternative sheath (not shown).
[0096] Alternatively, as FIG. 3B shows, an alternative sheath 36a
can include a lumen 70 through which the wire 60 passes. Unlike the
embodiment depicted in FIG. 3A, however, the alternative sheath 36a
and the wire 60 comprise one integrated unit and cannot be
interchanged.
[0097] A wire engagement assembly 72 (FIGS. 2A and 3A) provides an
anchor point for attaching the distal end of the structure 20 to
the wire 60 and will be discussed in greater detail
hereinafter.
[0098] The catheter tube 12 is slidable within the sheath in a
forward and rearward direction, as indicated by arrows 80 and 82 in
FIG. 1. By grasping the raised gripping surface 42 at the proximal
end of the sheath 36, and pushing the catheter tube 12 in the
forward direction (arrow 80) through the sheath 36 (see FIG. 3A),
the structure 20, secured to the catheter tube 12 and to the wire
60, and further constrained to the end 38 of the sheath 36, bends
outwardly to form the looped structure 64.
[0099] The physician can alter the diameter of the looped structure
64 from large to small, by incrementally moving the catheter tube
12 in the forward and rearward directions (arrows 66 and 68)
through the sheath 36. In this way, the physician can manipulate
the looped structure 64 to achieve the desired degree of contact
between tissue and the electrode elements 22.
[0100] If desired, the physician can, while grasping the raised
gripping surface 42 (FIG. 1), rotate the catheter tube 12 within
the sheath 36. As FIG. 4A shows, the relative rotation (arrow 86)
which shows rotation of the catheter tube 12, flips the looped
structure 64 over upon itself (compare FIGS. 3A and 4A), to place
the electrode elements 22 in a different orientation for anatomic
location and/or for tissue contact.
[0101] By grasping the raised gripping surface 42 and pulling the
catheter tube 12 in the rearward direction (arrow 82 of FIG. 1),
the physician draws the multiple electrode structure 20 back into
the sheath 36, as shown in FIG. 2A. When the multiple electrode
structure 20 is housed within the sheath 36, the combination forms
a generally straight, low profile geometry for introduction into
and out of a targeted body region.
[0102] The sheath 36 is made from a material having a greater
inherent stiffness than the support structure 20 itself.
Preferably, the sheath material is relatively thin (e.g., with a
wall thickness of about 0.013 inch) so as not to significantly
increase the overall diameter of the distal region of the probe 10
itself. The selected material for the sheath 36 is preferably also
lubricious, to reduce friction during relative movement of the
catheter tube 12 within the sheath 36. For example, materials made
from polytetrafluoroethylene (PTFE) can be used for the sheath 36.
Alternatively, a lubricious coating can be applied. Optional
features of the distal end of the sheath 36 which are presently
preferred by the inventors will be discussed hereinafter in
relation to FIG. 30.
[0103] Additional stiffness can be imparted by lining the sheath 36
with a braided material coated with PEBAX.TM. material. Increasing
the sheath stiffness imparts a more pronounced D-shape geometry to
the formed looped structure 64. Other compositions made from PTFE
braided with a stiff outer layer and other lubricious materials can
be used. Steps are taken to keep remnants of braided materials away
from the exposed distal end 38 of the sheath 36.
[0104] As FIG. 5 shows, a region 90 of the spline 26 within the
structure 20' away from the electrode elements 22 can be preformed
with elastic memory to bow radially away from the electrode
elements 22 when advanced from the sheath 36. The radially outward
bow of the preformed region 90 forms a more symmetric looped
structure 20', in contrast to the more asymmetric tear drop shaped
loop 20 shown in FIG. 3A. When in contact with tissue, the
preformed, outwardly bowed region 90 generates a back pressure
that, in combination with the loop stress maintained by the wire
60, establishes greater contact pressure between electrode elements
22 and tissue.
[0105] In FIG. 5, the region 90 is preformed with a generally
uniform bend in a single plane. The region 90 can be preformed with
complex, serpentine bends along a single plane, or with bends that
extend in multiple planes. Further details of representative looped
structures having complex, curvilinear geometries will be described
in greater detail later.
[0106] Additional tissue contact forces can be generated by
mounting a bendable spring 94 in the distal end 16 of the catheter
tube 12 (see FIG. 2A). One or more steering wires 96 are bonded
(e.g., soldered, spot welded, etc.) to the bendable spring 94
extend back to a steering mechanism 98 in the handle 18 (see FIG.
1). Details of steering mechanisms that can be used for this
purpose are shown in Lundquist and Thompson U.S. Pat. No.
5,254,088, which is incorporated into this Specification by
reference. Operation of the steering mechanism 98 pulls on the
steering wires 96 to apply bending forces to the spring 94. Bending
of the spring 94 bends the distal end 16 of the catheter tube 12,
as shown in phantom lines in FIG. 1.
[0107] The plane of bending depends upon the cross section of the
spring 94 and the attachment points of the wires 96. If the spring
94 is generally cylindrical in cross section, bending in different
planes is possible. If the spring 94 is generally rectilinear in
cross section, anisotropic bending occurs perpendicular to the top
and bottom surfaces of the spring 94, but not perpendicular to the
side surfaces of the spring 94.
[0108] Alternatively, or in combination with the manually bendable
spring 94, the distal end 16 of the catheter tube 12 can be
pre-bent to form a preshaped section 100 (see FIG. 6) generally
orthogonal or at some other selected angle to the looped structure
20. In the illustrated embodiment, a preformed wire 102 is secured,
e.g., by soldering, spot welding, or with adhesive, to the end 16
of the catheter tube 12. The preformed wire 102 is biased to
normally curve. The preformed wire 102 may be made from stainless
steel 17/7, nickel titanium, or other elastic material. It may be
configured as a wire or as a tube with circular, elliptical, or
other cross-sectional geometry.
[0109] The wire 102 normally imparts its curve to the catheter tube
distal end 16, thereby normally bending the distal end 16 in the
direction of the curve. The direction of the normal bend can vary,
according to the functional characteristics desired. In the
preferred mode of operation, the catheter tube 12 and wire 102
slide (note arrow 106) along the interior of the sheath 104 between
a rearward position where the sheath 104 overlies the wire 102
(FIG. 7) and a forward position where the wire 102 is beyond the
distal end of the sheath 104 (FIG. 6). The sheath 104 is only moved
to reposition the entire system within the body. When the catheter
tube 12 is in the rearward position, the sheath 104 retains the
catheter tube distal end 16 in a straightened configuration against
the normal bias of the wire 102 (FIG. 7). The sheath 104 may
include spirally or helically wound fibers to enhance the torsional
stiffness of the sheath 104. Upon movement of the catheter tube 12
to its forward position (FIG. 6), the distal end 16 yields to the
wire 102 and assumes its normally biased bent position. The
slidable sheath 104 may also include a suitable gripping surface
(not shown), like the gripping surface 42 of the sheath 36 (note
FIG. 1), to enable the physician to prevent movement of the sheath
104 as the catheter tube 12 and wire 102 are moved. In accordance
with other modes of operation, the sheath 104 can be moved relative
to the catheter tube 12 and wire 102, or all three elements may be
moved, to effect the bending of the distal end 16 shown in FIGS. 6
and 7.
[0110] As discussed previously herein, FIG. 4A shows the multiple
element structure 20 flipped upon itself by rotation of the looped
structure 64 within the sheath 36. The rotation is allowed, because
both the electrode structure 20 which makes up the looped structure
64 and sheath 36 possess generally cylindrical cross sections. If
it is desired to prevent relative rotation of the structure 20 and
catheter tube 12 within the sheath 36, the outer geometry of the
structure 20 and the interior geometry of the sheath 36 can be
formed as an ellipse, as FIG. 8A shows. The interference
(elliptically keyed) arrangement in FIG. 8A prevents rotation of
the structure 20 and also provides improved torque response and
maintains the electrode elements 22 is a fixed orientation with
respect to the sheath 36. By matching the outer geometry of the
structure 20 and the interior geometry of the sheath 36 (see FIG.
8B), a prescribed range of relative rotation can be allowed before
interference occurs. In FIG. 8B, the elliptical distal tubing 28'
will rotate until it contacts the butterfly shaped key way within
the sheath 36'.
[0111] In at least one preferred embodiment of the present
invention, the sheath 36 is made from a material (or combination of
materials) having a greater inherent stiffness than the support
structure 20. One exemplary sheath construction is a PEBAX and
stainless steel braid composite construction. The selected material
for the sheath 36 is preferably also lubricious. For example,
materials made from polytetrafluoroethylene (PTFE) can be used for
the sheath 36.
[0112] The wire 60 comprises a flexible, inert cable constructed
from strands of metal wire material, like Nickel Titanium or 17-7
stainless steel. Alternatively, the wire 60 can comprise a
flexible, inert stranded or molded plastic material. The wire 60 in
FIG. 3A is shown to be round in cross section, although other cross
sectional configurations can be used.
[0113] As shown by way of example in FIG. 30, the distal section 38
of the sheath preferably has a distal end that is perpendicular to
the longitudinal axis of the sheath. This makes transseptal
introduction into the left atrium easier because there is
relatively little opportunity for the distal end of the sheath to
catch on the septal wall and tear the septal wall. Alternatively,
and as illustrated for example in FIG. 3A, the distal end of the
distal sheath section 38 may be cut at an angle and tapered in a
transverse direction relative to the longitudinal axis of the
sheath 36. The angled linear cut on the distal sheath section 38
might also be a contoured elongated opening, or the like, to make
the initiation of the loop formation easier. The angle cut on the
sheath 36 helps deploy the structure 20. It is a consideration in
the configuration of the distal end of the sheath 38 that the
sheath 36 also serves to shield the wire as much as possible from
direct surface contact with tissue. The possibility of cutting
tissue due to contact with the wire 60 is thereby minimized.
[0114] The embodiment shown in schematic form in FIGS. 9, 10, and
11 offers additional options for adjusting the nature and extent of
contact between the electrode elements 22 and tissue. As FIG. 9
shows, a flexible spline 124 extends from an external push-pull
control 126 through the sheath 130 and is looped back to a point of
attachment 128 within the sheath 130. A multiple electrode
structure 20, made of an electrically insulated material, is
slidable along the spline 124, both within and outside the sheath
130. The multiple electrode structure 20 carries the electrode
elements 22. The proximal end of the multiple electrode structure
20 is attached to a push-pull control 132 exposed outside the
sheath 130.
[0115] By pushing both controls 126 and 132 simultaneously (arrows
134 in FIG. 10), both the spline 124 and the multiple electrode
structure 20 are deployed beyond the distal end of the sheath 130.
Together, the spline and multiple electrode structure 20 form a
looped structure 136 to present the electrode elements 22 for
contact with tissue, in much the same way as the multiple electrode
structure 20 previously described.
[0116] In addition, by holding the spline control 126 stationary
while pushing or pulling the control 132 (arrows 134 and 136 in
FIG. 11), the physician is able to slide the multiple electrode
structure 20 and thus the electrode elements 22 themselves along
the spline 124 (as shown by arrows 138 and 140 in FIG. 11). The
physician is thereby able to adjustably locate the region and
extent of the electrode elements 22 for tissue contact.
[0117] Furthermore, by holding the control 132 stationary while
pushing or pulling upon the spline control 126, the physician is
able to adjust the length of the spline 124 exposed beyond the
distal end of the sheath 130. The physician is thereby able to
incrementally adjust the radius of curvature in generally the same
fashion previously described in the context of FIG 3.
[0118] By pulling both controls 126 and 132 simultaneously (arrows
142 in FIG. 9) both the spline 124 and the multiple electrode
structure 20 are moved to a position close to or within the distal
end of the sheath 130 for introduction into a body region.
[0119] Accordingly, the exemplary arrangement shown in FIGS. 9, 10
and 11 provides a wide range of adjustment options for establishing
the desired degree of contact between tissue and the electrode
elements 22 carried by the looped structure 136.
[0120] The geometry of the looped structure 64 can be altered by
varying the stiffness of the flexible wire 60. As FIG. 12A shows,
the flexible wire 60' can be tapered, to provide a cross section
that decreases in the distal direction. The tapered cross section
provides varying stiffness, which is greatest next to the sheath 36
and decreases with proximity to the distal end of the structure
20.
[0121] The stiffness can also be changed by changing the thickness
of the flexible spline 26 in a step fashion. FIG. 12B shows the
flexible spline 26 decreasing in a step fashion leading up to its
junction with the wire 60. Changing the thickness of the flexible
spline 26 can be done by rolling the wire in steps, or by pressing
it, or by chemical etching.
[0122] Referring now to FIG. 13, there is depicted a side elevation
view of the support structure 20 shown in FIG. 3A deformed into a
loop configuration 64. In a preferred embodiment, the distal end
assembly 20 includes fourteen (14) ablation electrodes 22
(although, as throughout this disclosure, this quantity is not
limiting as to the invention) each being approximately 12.5 mm in
length. The first of said electrodes 22 is positioned approximately
5 mm from the distal tip 140 of the electrode structure 20, with
the remaining electrodes 22 being equally spaced approximately two
(2) mm apart down the support structure 20 toward the catheter
handle 18 (FIG. 1). Additionally, referring to FIGS. 1 and 3A, to
achieve a desired loop configuration of the distal end assembly 20
during normal use of the catheter 10, the user can pull back the
sheath 36 relative to the distal assembly 20, causing a desired
length of distal assembly 20 to be exposed. Then, holding catheter
tube 12 and sheath 36 in place relative to the pull wire 60, the
user pulls back on the pull wire handle 62, causing the pull wire
60 to pull back and deflect the distal assembly 20 back toward the
sheath end 38 to create the looped structure 64.
[0123] Referring now to FIG. 14, there is depicted an enlarged
cross-section view of distal assembly/multiple electrode structure
20, showing in detail the pull wire engagement assembly 72 of the
present invention. The flexible spline 26 made of solid Nitinol
core wire having a preferred diameter approximately of 0.23" is
positioned inside of and passes within the length of the catheter
tube assembly 12 to the handle 18 (FIG. 1). The proximal end of
flexible spline 26 is preferably fixedly engaged to catheter handle
18 by a crimp (not shown) or it is flattened and fastened by other
common means (not shown), all as is generally shown in FIG. 1. The
distal end 144 of the flexible spline 26 is fixedly engaged in an
in-line manner to the distal end 146 of the stranded Nitinol pull
wire 60 by utilizing a stainless steel crimp tube 148. The in-line
connection of core wire flexible spline 26 and pull wire 60 allows
for a reduction in the overall diameter of distal assembly 20 and
therefore sheath 36 (FIG. 13) to within clinical norms. This
provides a significant clinical advantage over devices having side
by side pull wire connections which create a larger diameter
device. Pull wire 60 is preferably approximately 0.012 inch to
0.018 inch in diameter providing increased flexibility over a solid
wire and thereby reducing the risk of collateral tissue damage
during loop manipulation. The pull wire 60 passes through a pull
wire bore 150 formed axially through a catheter tip 152, and the
tip 152 is fixedly engaged, such as by silver solder, adhesive or
spot welding, with a distal end 154 of crimp tube 148. The flexible
spline 26 is preferably electrically insulated using a thin walled
polyester heat shrink tube 156, and a distal end 158 of structure
20 is fixedly engaged by use of an adhesive to the catheter tip
152.
[0124] With further reference to FIG. 14, the flexible spline 26
preferably includes at least one flattened portion 160 which causes
the distal tip 140 to deflect in a plane defined by the arrows 162,
with a lesser degree of force transmitted from pull wire 60 than
would be required without flattened portion 160. The in-line
assembly of the flexible spline 26 and pull wire 60, as described
above, along with the flattened portion 160 provides increased
predictability and consistency in the direction of deflection, and
therefore increased control of the movement of the structure 20 and
shape of the looped structure 64 during normal use. Additional
flattened sections (not shown) of the flexible spline 26 can be
included so as to permit the structure 20 to be consistently
manipulated into varying loop profile shapes such as ovals, circles
and teardrops.
[0125] The pull wire engagement assembly 72 may be constructed as
follows. First, the flexible spline 26 (which is preferably a solid
core wire) is cut to a preferred length of approximately 130
centimeters. Second, an approximately 2 inch portion 160 of the
distal portion of flexible spline 26 is flattened to a width of
approximately 0.030". Third, the stainless steel crimp tube 148 is
fixedly engaged to the round distal end 144 of the flexible spline
26. Fourth, the distal end 146 of an approximately 130 centimeter
long stranded Nitinol pull wire 60 is fixedly engaged to the crimp
tube 148 that has been engaged to the flexible spline 26. Fifth,
the pull wire 60 is positioned through the pull wire bore 150 on
the tip 152, and the distal end 154 of the crimp tube 148 is
soldered within a crimp sleeve bore 164 formed within the tip 152.
Sixth, the polyester heat shrink tube 156 is inserted around the
crimp tube 148, enclosing the core and pull wire ends 144 and 146,
the flattened portion 160 of the flexible spline 26, and the
flexible spline 26 in sufficient length (approximately 12 inches
from the tip 152) to insulate the assembly from any possible
electrical short circuit of electrical current flowing from lead
wires 166 leading from the electrodes 22 to the catheter handle 18
(FIG. 1). Seventh and lastly, the multiple electrode structure 20
is positioned over the crimp tube 148 and fixedly engaged by
adhesive to the tip 152. It can be readily understood by one
skilled in the art that steps three and four as described above
could be switched in sequence without deviating from the spirit and
scope of the construction of the distal tip assembly 140 of the
invention.
[0126] Referring now to FIG. 15, there is shown a second distal tip
assembly embodiment 170 of the invention, wherein the tip 152 (FIG.
14) is replaced with an alternative tip 172. Alternative tip 172 is
fixedly engaged to the distal end 154 of the crimp tube 148 in the
same manner along linear axis X as has previously been described in
relation to tip 152 of FIG. 14. However, the alternative tip 172
includes a pull wire bore 174 having an axis Y which intersects the
axis X at an angle of approximately 45 degrees, so that pull wire
60 exits tip 172 in the direction of the pull wire bore axis Y.
Accordingly, when a pulling force is applied to the pull wire 60,
the structure 20 is deformed in the direction of arrow 176
providing increased directional control of the structure 20 in loop
formation and electrode positioning.
[0127] FIG. 16 depicts yet another embodiment of the present
invention wherein the flexible spline 26, pull wire 60 and crimp
tube 148 which comprise the distal tip assembly 140 as shown in
detail in FIG. 14, is replaced with a unitary core/pull wire 180.
Rather than join a stranded pull wire 60 (FIG. 14) to the flexible
spline 26, one continuous core wire/pull wire 180 is employed. The
diameter of the wire within the structure 20 as described above,
can range from approximately 0.020" to 0.050" as required to
maintain loop strength (stiffness) of the structure 20 when
deployed. A core wire section 182 distal to the flattened section
160 can be reduced in diameter by tapering, centerless grinding, or
by flattening portions of the wire. Then, the smaller diameter
section 182, ranging from approximately 0.005 inch to 0.012 inch,
can be positioned just distal of tip 152 or 172 (FIGS. 14 and 15,
respectively) for increased flexibility and durability in the
formation of various loop configurations 64.
[0128] FIG. 16A depicts yet another alternative embodiment of the
present invention. The distal portion of the flexible spline 26 is
fixedly engaged in an in-line manner to the proximal end of the
strand wire 385 by utilizing the crimp tube 148. As described above
with reference to FIG. 14, the strand wire 385 passes through a
pull wire bore 150 formed axially through the catheter tip 152. The
distal portion of the crimp tube 148 is fixedly engaged to the
catheter tip 152 by adhesive or soldering.
[0129] The strand wire 385 end farthest from the tip 152 is also
fixedly engaged in an in-line manner to the distal end of the
flexible wire 60, utilizing a secondary crimp tube 148. The
flexible wire 60 is in this case a solid wire which can be pushed
or pulled during the manipulation of the catheter distal section
20. In this version, the wire strand 385 is a spring like structure
and is flexible enough to reduce the likelihood of fatigue during
extreme bending during the introduction and the formation of the
loop.
[0130] The stranded wire 385, which is also shown in FIG. 21 in
more detail, can be made as previously described from Nitinol, 17-7
or resilient plastic.
[0131] FIG. 17 shows an alternate embodiment of the present
invention having an alternate multiple electrode support structure
200 formed from a spline 26 covered with an electrically insulating
distal tubing 28. The electrode elements 22 are carried by the
distal tubing 28. The structure 200 is carried at the distal end 16
of a catheter tube 12, and comprises the distal part of a probe 10,
in the manner shown in FIG. 1. In these respects, the structure 200
is like the structure 20, previously described, and the same
materials as previously described can be used in making the
structure 200.
[0132] The sheath 36 is intended to be held stationary while the
catheter tube 12 is moved to deploy the structure 200. Movement of
the catheter tube 12 moves the structure 200 between a rearward
position (FIG. 18), where the sheath 36 covers the structure 200
for introduction into a body region, and a forward position (FIGS.
17 and 19), where the structure 200 is exposed for use. The sheath
36 will be moved only to reposition the entire apparatus within the
body. Alternatively, the sheath 36 may be moved relative to the
catheter tube 12, or the sheath 36 and catheter tube 12 may both be
moved, to achieve the same results.
[0133] A pull wire 60 extends from the distal end 158 of the
structure 200. In the illustrated embodiment, the pull wire 60 is
an extension of the spline 26, thereby eliminating the need for an
additional distal hub component to join the wire 60 to the distal
structure end 158, although the alternative means for attachment of
the wire 60 to the spline 26 would be applicable to this present
embodiment, as well.
[0134] In the presently described embodiment, the catheter tube 12
includes an interior lumen 71, which accommodates sliding passage
of the pull wire 60. The pull wire 60 passes through the lumen 71
to an accessible push-pull control stop/handle 62, e.g., mounted on
a handle 18 as shown in FIG. 1. When the structure 200 is free of
the rearwardly withdrawn sheath 36, the physician pulls back on the
wire 60 (arrow 202 in FIG. 19) to bend the structure 200 into a
loop.
[0135] As FIGS. 17 and 19 show, the wire 60 may optionally include
a preformed region 204 adjacent to the distal structure end 158,
wound into one or more loops, forming a spring. The region 204
imparts a spring characteristic to the wire 60 when bending the
structure 200 into a loop. The region 204 mediates against extreme
bending or buckling of the wire 60 during formation of a loop in
the structure 200. The region 204 thereby reduces the likelihood of
fatigue failure arising after numerous flex cycles.
[0136] FIG. 20 shows an alternative embodiment for the structure
200. In this embodiment, the distal structure end 158 includes a
slotted passage 206, which extends across the distal structure end
158. In FIG. 20, the slotted passage 206 extends transverse of the
longitudinal axis "A" of the structure 200. Alternatively, the
slotted passage 206 could extend at other angles relative to the
main axis.
[0137] Unlike the embodiment shown in FIGS. 17 to 19, the wire 60
in FIG. 20 is not an extension of the spline 26 of the structure
200. Instead, the wire 60 comprises a separate element, which
carries a ball 208 at its distal end. The ball 208 is engaged for
sliding movement within the slotted passage 206. The ball 208 also
allows rotation of the wire 60 relative to the structure 200. The
ball 208 and slotted passage 206 form a sliding joint, which, like
the spring region 204 of the embodiment shown in FIGS. 17 to 19,
reduces the likelihood of fatigue failure arising after numerous
flex cycles.
[0138] As before described in the context of the structure 20,
additional tissue contact forces between the structure 200 and
tissue can be generated by mounting a bendable spring 94 in the
distal end 16 of the catheter tube (see FIG. 17). Alternatively, or
in combination with the manually bendable spring 94, the distal end
16 of the catheter tube 12 can be pre-bent to form a preshaped
section generally orthogonal or at some other selected angle to the
loop formed by the structure 200.
[0139] FIG. 21 is a cross sectional view of one embodiment of the
pull wire 60. The pull wire 60 of this embodiment has a central
strand 210 and a plurality (six in this example) of surrounding
strands 212. In this embodiment, the surrounding strands 212 are
twisted, although a linear, or a braided construction would also be
possible. The pull wire 60 has been successfully constructed with
each of the strands 210 and 212 being made from the materials
previously described herein in relation to the pull wire 60. The
central strand 210 of the pull wire 60 may, alternatively, be made
from platinum. In this embodiment, the diameter of each of the
strands 210 and 212 is 0.004 to 0.010 inch, and the approximate
total diameter of the stranded pull wire 60 is 0.012 to 0.018 inch.
The pull wire 60 may also be formed from a monofilament fiber, such
as KEVLAR.RTM. or nylon, or a multiple filament fiber. Such fibers
may be arranged in the central strand/surrounding strands
configuration discussed above, or may simply be a single mono (or
multiple) filament strand.
[0140] The inventors herein have determined that there may be some
instances where it is desirable to reduce the stress that the pull
wire 60 will experience during use as well as the likelihood that
the pull wire will fray or break due to fatigue at the point where
the pull wire 60 exits the catheter tip. A variety of exemplary
stress-reducing structures are illustrated in FIGS. 22-27.
[0141] FIG. 22 is a side cross sectional view of an alternate
catheter tip 220 which is, in many respects, similar to the
catheter tip 152 previously discussed herein in relation to the
embodiment depicted in FIG. 14. Shown also in the view of FIG. 22
are the flexible spline 26, the pull wire 60, and the crimp tube
148. As can be seen in the view of FIG. 22, unlike embodiments
previously discussed herein, the alternate catheter tip has a
rounded nose portion 222. The rounded nose portion 222 reduces the
stress, as compared to a more squared nose portion, that the pull
wire 60 will experience when it is pulled distally back along the
catheter tube 12. It should be noted that, in the exemplary
embodiment shown in FIG. 22, the crimp tube 148 is affixed to the
catheter tip 220 by solder 226.
[0142] Also, as can be seen in the view of FIG. 22, an optional
protective sleeve 224 may be added to the preferred embodiment
which includes the tip 220 having the rounded nose portion 222. The
sleeve 224, which is formed from conventional polyester shrink
tubing or other types of tubing such as TEFLON.RTM. tubing, covers
that portion of the pull wire 60 which might be susceptible to wear
at the junction of the pull wire 60 and the catheter tip 220.
Preferably, the length of the protective sleeve 224 is
approximately 1.0 inch, although shorter protective sleeves have
been found to perform adequately.
[0143] In accordance with another exemplary embodiment of the
invention, the protective sleeve 224 may also be used with a
catheter tip, such as the catheter tip 152 shown in FIG. 14, to
prevent fatigue failure.
[0144] Further regarding the alternate catheter tip 220 shown in
FIG. 22, the inventors have found that the shape of the rounded
nose portion 222 is a concern. To illustrate this point and by way
of comparison, FIG. 23 is a cross sectional view of the catheter
tip 152 and surrounding portions of the probe 10 showing a stress
point 230 where the pull wire 60 is forced against the tip 152 when
the pull wire 60 is retracted fully into the sheath 36. By
comparison, FIG. 24 is a side cross sectional view of the
alternative catheter tip having the chamfered nose portion 222 as
introduced in relation to FIG. 22. It should be noted that, while
stress is much relieved by the rounded nose portion 22, a stress
point 242 remains in this configuration.
[0145] FIG. 25 is a side cross sectional view of a second alternate
catheter tip 250 having a protective plug 254 inserted in the
distal end of the second alternate catheter tip 250. The protective
plug 254 is made from an elastomeric material such that stress is
alleviated where there otherwise might be a stress point. In the
second alternate catheter tip 250, the protective plug 254 is made
from polyurethane, although other elastomers such as silicone or
other thermoplastic material can also be used. The protective plug
254 is preferably held within the catheter tip 250 with an
adhesive.
[0146] As shown by way of example in FIGS. 26A and 26B, a third
alternate catheter tip 260 has a protective plug 264. Instead of
using adhesive, the protective plug 264 is mechanically interlocked
with the catheter tip 260. More specifically, the catheter tip 260
includes a pair of holes 265 and the protective plug 264 includes a
corresponding pair of radially extending members 266 which are
located within the holes 265.
[0147] A fourth alternate catheter tip 270, which has a protective
plug 274, is shown in FIG. 27. Here, the protective plug 274
extends to the radial edge of the catheter tip 270. It should be
noted that the protective plug 274 should be made from a slightly
harder (higher durometer) material than the protective plugs 254
and 264.
[0148] Referring now to FIG. 28, which is a diagrammatic cross
sectional view of a portion of atrial wall 280 with the looped
structure 64 (as described in relation to FIG. 3) deployed therein.
Two of the electrodes 22 of the structure 20 can be seen in the
view of FIG. 28 in cross section. It can be seen in the view of
FIG. 28 that an ablated portion 282 of the atrial wall 280 (which
is that portion of the atrial wall 280 which is in contact with the
electrode 22 and will, thus, be ablated by energy dissipated into
the atrial wall 280 from the electrode 22) is actually somewhat
wider than the diameter of the electrode 22, since the atrial wall
280 is somewhat elastic and tends to conform around the structure
20 when the looped structure 64 is pressed against the atrial wall
280. This is a generally undesirable condition, since it is usually
desired to make only narrow contiguous lesions in the atrial wall
280 when tissue is ablated by the electrodes 22.
[0149] FIG. 29 is a cross sectional view of a masked electrode
structure 290. The masked electrode structure 290 is much like the
first introduced electrode structure 20, having a plurality of
electrodes 20 (only one of which can be seen in the cross sectional
view of FIG. 29) with the flexible spline 26 (a flattened portion
thereof being visible in the view of FIG. 29) and distal tubing 28.
Also shown in the example of FIG. 29 is a temperature sensor 292
such as may be used in conjunction with the present invention. The
masked electrode structure 290 has a mask 294 for protecting a
portion of the atrial wall 280 from being heated by the electrode
22 such that the width of the ablated portion 282 of the atrial
wall 280 is minimized as desired. It is anticipated by the
inventors that an unmasked portion 296 of the electrode 22 will be
from approximately 90.degree. to somewhat less than 180.degree. of
the cross sectional circumference of the electrodes 22. It is
within the scope of the invention that other configurations of the
electrodes 22 for minimizing the width of lesions could be used.
For example, a resistive electrode element (not shown) could be
printed on the multiple electrode structure 20 of FIG. 2a such that
the resistive electrode element would cover only a portion of the
circumference of the multiple electrode structure.
[0150] FIG. 30 is a more detailed view of the distal end of the
sheath 38. It should be noted that a sheath tip 320 is preferably
made of a soft material. The soft sheath tip 320 can, optionally,
be made of a different material than the sheath tubing such that
the sheath tip 320 will be softer than the sheath 38. In the
preferred embodiment, the soft sheath tip 320 does not have any
braid and the distal end thereof is rounded as illustrated in FIG.
30. The soft sheath tip 320 has been found to help decrease the
possibility of displacing the electrodes when the multiple
electrode structure 20 is brought back into the sheath 38.
[0151] As can also be seen in the view of FIG. 30, the distal end
of the sheath 38 is preferably provided with radiopaque marker 321
as shown. The radiopaque marker 321 is used to help the clinician
orient the distal end of the sheath 38 within the heart. For
example, the radiopaque marker 321 is needed if the sheath is
placed into the left atrium, through the septal wall. It is very
important that the sheath stay in the left atrium while the loop is
being used, so that the septum is not unnecessarily stressed. The
radiopaque marker 321 near the tip of the sheath 38 will also help
identify the location of the catheter tip 152 (FIG. 16) with
respect to the distal end of the sheath 38.
[0152] Various access techniques can be used to introduce the
previously described multiple electrode structures into a desired
region of the body. As has been discussed in more detail in the
co-pending U.S. application Ser. No. 08/769,856, during
introduction, the electrode structure 20 is enclosed in a
straightened condition within its associated outer sheath 36 at the
end 16 of the catheter tube 12. To enter the right atrium of the
heart, the physician directs the catheter tube 12 through a
conventional vascular introduce into, e.g., the femoral vein. For
entry into the left atrium, the physician can direct the catheter
tube 12 through a conventional vascular introducer retrograde
through the aortic and mitral valves, or can use a transseptal
approach from the right atrium.
[0153] Once the distal end 16 of the catheter tube 12 is located
within the selected chamber, the physician deploys the structure 20
in the manners previously described.
[0154] It should be appreciated that the electrode structure 20
discussed above in the context of intracardiac use, can also be
directly applied to the epicardium through conventional thoracotomy
or thoracostomy techniques.
[0155] The various structures heretofore described, which exhibit
compound or orthogonal bends (which will be referred to here
collectively as compound bend assemblies) also make it possible to
locate the ablation electrodes 22 at any location within a complex
body cavity, like the heart. With prior conventional catheter
designs, various awkward manipulation techniques were required to
position the distal region, such as prolapsing the catheter to form
a loop within the atrium, or using anatomical barriers such as the
atrial appendage or veins to support one end of the catheter while
manipulating the other end, or torquing the catheter body. While
these techniques can still be used in association with the compound
bend assemblies mentioned above, the compound bend assemblies
significantly simplify placing electrode(s) at the desired location
and thereafter maintaining intimate contact between the
electrode(s) and the tissue surface. The compound bend assemblies
make it possible to obtain better tissue contact and to access
previously unobtainable sites, especially when positioning multiple
electrode arrays.
[0156] Compound bend assemblies which provide a proximal curved
section orthogonal to the distal steering or loop geometry plane
allow the physician to access sites which are otherwise difficult
and often impossible to effectively access with conventional
catheter configurations, even when using an anatomic barrier as a
support structure. For example, to place electrodes between the
tricuspid annulus and the cristae terminalis perpendicular to the
inferior vena cava and superior vena cava line, the distal tip of a
conventional the catheter must be lodged in the right ventricle
while the catheter is torqued and looped to contact the anterior
wall of the right atrium. Compound bend assemblies which can
provide a proximal curved section orthogonal to the distal steering
or loop geometry plane greatly simplify positioning of electrodes
in this orientation. Compound bend assemblies which provide a
proximal curved section orthogonal to the distal steering or loop
geometry plane also maintain intimate contact with tissue in this
position, so that therapeutic lesions contiguous in the
subepicardial plane and extending the desired length, superiorly
and/or inferiorly oriented, can be accomplished to organize and
help cure atrial fibrillation.
[0157] A transseptal approach will most likely be used to create
left atrial lesions. In a transseptal approach, an introducing
sheath is inserted into the right atrium through the use of a
dilator. Once the dilator/sheath combination is placed near the
fossa ovalis under fluoroscopic guidance, a needle is inserted
through the dilator and is advanced through the fossa ovalis. Once
the needle has been confirmed to reside in the left atrium by
fluoroscopic observation of radiopaque contrast material injected
through the needle lumen, the dilator/sheath combination is
advanced over the needle and into the left atrium. At this point,
the dilator is removed leaving the sheath in the left atrium.
[0158] A left atrial lesion proposed to help cure atrial
fibrillation originates on the roof of the left atrium, bisects the
pulmonary veins left to right and extends posteriorly to the mitral
annulus. Since the lesion described above is perpendicular to the
transseptal sheath axis, a catheter which can place the distal
steering or loop geometry plane perpendicular to the sheath axis
and parallel to the axis of the desired lesion greatly enhances the
ability to accurately place the ablation and/or mapping element(s)
and ensures intimate tissue contact with the element(s). To create
such lesions using conventional catheters requires a retrograde
procedure. The catheter is advanced through the femoral artery and
aorta, past the aortic valve, into the left ventricle, up through
the mitral valve, and into the left atrium. This approach orients
the catheter up through the mitral valve. The catheter must then be
torqued to orient the steering or loop geometry plane parallel to
the stated lesion and its distal region must be looped over the
roof of the left atrium to position the ablation and/or mapping
element(s) bisecting the left and right pulmonary veins and
extending to the mitral annulus.
[0159] Preformed guiding sheaths have also been employed to change
catheter steering planes. However, preformed guiding sheaths have
been observed to straighten in use, making the resulting angle
different than the desired angle, depending on the stiffness of the
catheter. Furthermore, a guiding sheath requires a larger puncture
site for a separate introducing sheath, if the guiding sheath is
going to be continuously inserted and removed. Additional
transseptal punctures increase the likelihood for complications,
such as pericardial effusion and tamponade
[0160] II. Loop Size Marking
[0161] FIG. 31 shows a probe 310 having an alternate catheter tube
312 carrying a sheath 36 of the type previously described and
shown, e.g., in FIG. 1. The catheter tube 312 includes proximal
handle 18 and a distal multiple electrode array 20. The multiple
electrode array 20 is deployed as a looped structure from the
sheath 36, in the manner previously described and shown. The
exemplary probe 310 depicted in FIG. 31 includes indicia 315 on the
catheter tube 312 that provides the physician with feedback on the
size of the formed looped structure. In FIG. 31, the indicia 315 is
in the form of markings 316 on the region of the catheter tube 312
extending through the proximal end of the sheath 36. The markings
316 indicate how much of the catheter tube 312 has been advanced
through the sheath 36, which thereby indicates the size of the
formed looped structure.
[0162] The markings 316 can be made in various ways. They can, for
example, be placed on the catheter tube 312 by laser etching, or by
printing on the catheter tube 312 using bio-compatible ink, or by
the attachment of one or more premarked, heat shrink bands about
the catheter tube 312.
[0163] In FIG. 32, the sleeve 36 is attached to an alternate handle
320 of the probe 311. The catheter tube is advanced and retracted
through the sheath 36 by a push-pull control 322 on the handle 320.
In this embodiment, indicia 313, which also provides feedback as to
the size of the formed looped structure includes markings 314 on
the handle 320 that are arranged along the path of travel of the
push-pull control 322. The markings 314, which can be applied to
the handle 320, e.g., by laser etching or printing, indicate how
much of the catheter tube has been advanced through the sheath
36.
[0164] It should be noted that self anchoring techniques, similar
to those described in relation to the catheters described and
claimed in the co-pending U.S. application Ser. No. 08/769,856,
could be readily applied by one skilled in the art to the present
invention. The distal end of the structure 20 can be used, as
described herein, in conjunction with the anchoring techniques to
be discussed hereinafter. Alternative, one skilled in the art will
recognize that an elongated portion of the catheter tube 12 could
be provided distal to the most distal electrode 22, where such
could be used to advantage in conjunction with the below described
deployment techniques.
[0165] III Deployment and Use of Multiple Electrode Structures
[0166] A. Left Atrium
[0167] The multiple electrode structures 20 described above can be
deployed into the left atrium to create lesions between the
pulmonary veins and the mitral valve annulus. Tissue nearby these
anatomic structures are recognized to develop arrhythmia substrates
causing atrial fibrillation. Lesions in these tissue regions block
reentry paths or destroy active pacemaker sites, and thereby
prevent the arrhythmia from occurring. FIG. 33 shows (from outside
the heart H) the location of the major anatomic landmarks for
lesion formation in the left atrium. The landmarks include the
right inferior pulmonary vein (RIPV), the right superior pulmonary
vein (RSPV), the left superior pulmonary vein (LSPV), the left
inferior pulmonary vein (LIPV); and the mitral valve annulus (MVA).
FIGS. 34A to 34D show representative lesion patterns formed inside
the left atrium based upon these landmarks.
[0168] In FIG. 34A, the lesion pattern comprises a first leg L1
between the right inferior pulmonary vein (RIPV) and the right
superior pulmonary vein (RSPV); a second leg L2 between the RSPV
and the left superior pulmonary vein (LSPV); a third leg L3 between
the left superior pulmonary vein (LSPV) and the left inferior
pulmonary vein (LIPV); and a fourth leg L4 leading between the LIPV
and the mitral valve annulus (MVA).
[0169] FIG. 34B shows an intersecting lesion pattern comprising
horizontal leg L1 extending between the RSPV-LSPV on one side and
the RIPV-LIPV on the other size, intersected by vertical leg L2
extending between the RSPV-RIPV on one side and the LSPV-LIPV on
the other side. The second leg L2 also extends to the MVA.
[0170] FIG. 34C shows a crisscross-crossing lesion pattern
comprising a first leg extending between the RSPV and LIPV; a
second leg L2 extending between the LSPV and RIPV; and a third leg
L3 extending from the LIPV to the MVA.
[0171] FIG. 34D shows a circular lesion pattern comprising a leg L1
that extends from the LSPV, and encircles to RSPV, RIPV, and LIPV,
leading back to the LSPV.
[0172] The linear lesion patterns shown in FIGS. 34A, 34B, and 34C
can be formed, e.g., using the structure 20 shown in FIGS. 1 and 2,
by placing the distal end of the electrode structure 20 in a
selected one of the pulmonary veins to stabilize the position of
the electrodes 22, and then maneuvering the electrodes 22 to
sequentially locate them along the desired legs of the lesion
pattern. It may be necessary to relocate the electrodes 22 in a
different pulmonary vein to facilitate maneuvering of the
electrodes 22 to establish all legs of the pattern.
[0173] The circular lesion pattern shown in FIG. 34D can be formed
using the distal end of the catheter tube 20. The distal end of the
catheter tube 20 is located within a selected one of the pulmonary
veins (the-LSPV in FIG. 34D), and the looped structure 20 is
advanced from the sheath 36 to circumscribe the remaining pulmonary
veins. As with other looped structures, the looped structure tend
to seek the largest diameter and occupy it. Most of the structures
are suitable for being torqued or rotated into other planes and
thereby occupy smaller regions. To access the left atrium, any of
these structures can be introduced in the manner shown in FIG. 44
through the inferior vena cava (IVC) into the right atrium, and
then into the left atrium through a conventional transseptal
approach. Alternatively, a retrograde approach can be employed
through the aorta into the left ventricle, and then through the
mitral valve into the left atrium.
[0174] B. Right Atrium
[0175] FIG. 33 shows (from outside the heart H) the location of the
major anatomic landmarks for lesion formation in the right atrium.
These landmarks include the superior vena cava (SVC), the tricuspid
valve annulus (TVA), the inferior vena cava (IVC), and the coronary
sinus (CS). Tissue nearby these anatomic structures have been
identified as developing arrhythmia substrates causing atrial
fibrillation. Lesions in these tissue regions block reentry paths
or destroy active pacemaker sites and thereby prevent the
arrhythmia from occurring.
[0176] FIGS. 35A to 35C show representative lesion patterns formed
inside the right atrium based upon these landmarks. More
specifically, FIG. 35A shows a representative lesion pattern L that
extends between the superior vena cava (SVC) and the tricuspid
valve annulus (TVA). FIG. 35B shows a representative lesion pattern
that extends between the interior vena cava (IVC) and the TVA. FIG.
35C shows a representative lesion pattern L that extends between
the coronary sinus (CS) and the tricuspid valve annulus (TVA).
[0177] The multiple electrode structures described above can be
deployed into the right atrium to create these lesions. For
example, the structure 20 can be used, by placing the distal tip
thereof in the SVC or IVC to stabilize the position of the
electrodes 22, and then maneuvering the electrodes to locate them
along the desired path of the lesion pattern. Any of these
structures can be introduced through the inferior vena cava (IVC)
into the right atrium.
[0178] C. Surgical Use
[0179] Many of the above structures suited for intracardiac
deployment, as discussed above, can be directly applied to the
epicardium or endocardium through conventional thoracotomy or
thoracostomy techniques.
[0180] IV. Flexible Electrode Structures
[0181] A. Spacing of Electrode Elements
[0182] In the illustrated embodiments, the size and spacing of the
electrode elements 22 on the various structures can vary.
[0183] 1. Long Lesion Patterns
[0184] For example, the electrode elements 22 can be spaced and
sized for creating continuous, long lesion patterns in tissue.
Long, continuous lesion patterns are beneficial to the treatment of
atrial fibrillation. Such patterns are formed due to additive
heating effects, which cause the lesion patterns to span adjacent,
spaced apart electrode 22, creating the desired elongated, long
geometry.
[0185] The additive heating effects occur when the electrode
elements 22 are operated simultaneously in a bi-polar mode between
electrode elements 22. Furthermore, the additive heating effects
also arise when the electrode elements 22 are operated
simultaneously in a unipolar mode, transmitting energy to an
indifferent electrode (not shown).
[0186] More particularly, when the spacing between the electrodes
22 is equal to or less than about 3 times the smallest of the
diameters of the electrodes 22, the simultaneous emission of energy
by the electrodes 22, either bi-polar between the segments or
unipolar to the indifferent electrode, creates an elongated
continuous lesion pattern in the contacted tissue area due to the
additive heating effects.
[0187] Alternatively, when the spacing between the electrodes 22
along the contacted tissue area is equal to or less than about 2
times the longest of the lengths of the electrodes 22, the
simultaneous application of energy by the electrodes 22, either
bi-polar between electrodes 22 or unipolar to the indifferent
electrode, also creates an elongated continuous lesion pattern in
the contacted tissue area due to additive heating effects.
[0188] Further details of the formation of continuous, long lesion
patterns are found in co-pending U.S. patent application Ser. No.
08/287,192, filed Aug. 8, 1994, entitled "Systems and Methods for
Forming Elongated Lesion Patterns in Body Tissue Using Straight or
Curvilinear Electrode Elements," which is incorporated herein by
reference.
[0189] Alternatively, long continuous lesion patterns can be
achieved using an elongated electrode element made from a porous
material. By way of illustration, FIG. 36 shows an alternate loop
electrode structure 360, similar to that shown in FIG. 2A, but
having an electrode body 362 which includes a porous material 364
to transfer ablation energy by ionic transport.
[0190] As best shown in FIG. 37, the electrode body 362 includes a
center support lumen 370 enveloped by the porous material 364. The
lumen 370 carries spaced-apart electrodes 372 along its length. The
lumen 370 also includes spaced-apart apertures 374 along its
length.
[0191] The lumen 370 includes a proximal end 376, which
communicates with a source of ionic fluid 378. The lumen 370
conveys the ionic fluid. The ionic fluid passes through the
apertures 374 and fills the space between the lumen 370 and the
surrounding porous material 364. The fluid also serves to expand
the diameter of the structure 360. The structure 360 therefore
possesses a low profile geometry, when no fluid is present, for
introduction within the targeted body region. Once advanced from
the sheath 36 (FIG. 36) and formed into the looped structure 360,
fluid can be introduced to expand the structure 360 for use.
[0192] The porous material 364 has pores capable of allowing
transport of ions contained in the fluid through the material 364
and into-contact with tissue. As FIG. 37 also shows, the electrodes
372 are coupled to a source 380 of radio frequency energy. The
electrodes 372 transmit the radio frequency energy into the ionic
fluid. The ionic fluid establishes an electrically conductive path.
The pores of the porous material 364 establish ionic transport of
ablation energy from the electrodes 372, through the fluid, to
tissue outside the electrode body 362.
[0193] Preferably, the fluid possesses a low resistivity to
decrease ohmic loses, and thus ohmic heating effects, within the
body 362. The composition of the electrically conductive fluid can
vary. In the illustrated embodiment, the fluid comprises a
hypertonic saline solution, having a sodium chloride concentration
at or near saturation, which is about 5% to about 25% weight by
volume. Hypertonic saline solution has a low resistivity of only
about 5 ohm/cm, compared to blood resistivity of about150 ohm/cm
and myocardial tissue resistivity of about 500 ohm/cm.
[0194] Alternatively, the composition of the electrically
conductive fluid can comprise a hypertonic potassium chloride
solution. This medium, while promoting the desired ionic transfer,
requires closer monitoring of the rate at which ionic transport
occurs through the pores of the material 364, to prevent potassium
overload. When hypertonic potassium chloride solution is used, it
is preferred to keep the ionic transport rate below about 10
mEq/min.
[0195] Regenerated cellulose membrane materials, typically used for
blood oxygenation, dialysis, or ultrafiltration, can be used as the
porous material 364. Regenerated cellulose is electrically
non-conductive; however, the pores of this material (typically
having a diameter smaller than about 0.1 micrometer) allow
effective ionic transport in response to the applied RF field. At
the same time, the relatively small pores prevent transfer of
macromolecules through the material 364, so that pressure driven
liquid perfusion is less likely to accompany the ionic transport,
unless relatively high pressure conditions develop within the body
362.
[0196] Other porous materials can be used as the porous material
364. Candidate materials having pore sizes larger than regenerated
cellulose material, such as nylon, polycarbonate, polyvinylidene
fluoride (PTFE), polyethersulfone, modified acrylic copolymers, and
cellulose acetate, are typically used for blood microfiltration and
oxygenation. Porous or microporous materials may also be fabricated
by weaving a material (such as nylon, polyester, polyethylene,
polypropylene, fluorocarbon, fine diameter stainless steel, or
other fiber) into a mesh having the desired pore size and porosity.
These materials permit effective passage of ions in response to the
applied RF field. However, as many of these materials possess
larger pore diameters, pressure driven liquid perfusion, and the
attendant transport of macromolecules through the pores, are also
more likely to occur at normal inflation pressures for the body
362. Considerations of overall porosity, perfusion rates, and
lodgment of blood cells within the pores of the body 362 must be
taken more into account as pore size increase.
[0197] Low or essentially no liquid perfusion through the porous
body 362 is preferred. Limited or essentially no liquid perfusion
through the porous body 362 is beneficial for several reasons.
First, it limits salt or water overloading, caused by transport of
the hypertonic solution into the blood pool. This is especially
true, should the hypertonic solution include potassium chloride, as
observed above. Furthermore, limited or essentially no liquid
perfusion through the porous body 362 allows ionic transport to
occur without disruption. When undisturbed by attendant liquid
perfusion, ionic transport creates a continuous virtual electrode
at the electrode body-tissue interface. The virtual electrode
efficiently transfers RF energy without need for an electrically
conductive metal surface.
[0198] FIGS. 38 and 39 show an embodiment of the porous electrode
body 362 which includes spaced-apart external rings 382, which form
porous electrode segments 376. It is believed that, as the expanded
dimension of the body 362 approaches the dimension of the interior
electrodes 372, the need to segment the electrode body 362
diminishes.
[0199] Alternatively, as FIG. 40 shows, instead of a lumen 370
within the body, a foam cylinder 384 coupled in communication with
the source of ionic fluid 378 could be used to carry the electrodes
372 and perfuse the ionic fluid.
[0200] 2. Interrupted Lesion Patterns
[0201] The electrode elements 22 can be sized and spaced to form
interrupted, or segmented lesion patterns. Alternatively,
spaced-apart electrode elements 22 which are capable of providing
long relatively uninterrupted lesion patterns can be operated with
some electrode elements 22 energized and others not, to provide an
interrupted lesion pattern.
[0202] When the spacing between the electrodes 22 is greater than
about 5 times the smallest of the diameters of the electrodes 22,
the simultaneous emission of energy by the electrodes 22, either
bi-polar between segments or unipolar to an indifferent electrode,
does not generate additive heating effects. Instead, the
simultaneous emission of energy by the electrodes 22 creates an
elongated segmented, or interrupted, lesion pattern in the
contacted tissue area.
[0203] Alternatively, when the spacing between the electrodes 22
along the contacted tissue area is greater than about 3 times the
longest of the lengths of the electrodes 22, the simultaneous
application of energy, either bi-polar between electrodes 22 or
unipolar to the indifferent electrode, creates an elongated
segmented, or interrupted, lesion pattern.
[0204] 3. Flexibility
[0205] When the electrode elements 22 are flexible, each element 22
can be as long as 50 mm. Thus, if desired, a single coil electrode
element 22 can extend uninterrupted along the entire length of the
support structure. However, a segmented pattern of spaced apart,
shorter electrode elements 22 is preferred.
[0206] If rigid electrode elements 22 are used, the length of the
each electrode segment can vary from about 2 mm to about 10 mm.
Using multiple rigid electrode elements 22 longer than about 10 mm
each adversely effects the overall flexibility of the element.
Generally speaking, adjacent electrode elements 22 having lengths
of less than about 2 mm do not consistently form the desired
continuous lesion patterns..
[0207] 4. Temperature Sensing
[0208] As previously discussed herein, each electrode element 22
can carry at least one and, preferably, at least two, temperature
sensing elements (for example the temperature sensors 292 of FIG.
29). The multiple temperature sensing elements 292 measure
temperatures along the length of the electrode element 22. The
temperature sensing elements 292 can comprise thermistors or
thermocouples. If thermocouples are used, a cold junction can be
carried on-the same structure as the electrode elements 22.
[0209] An external temperature processing element (not shown)
receives and analyses the signals from the multiple temperature
sensing elements 292 in prescribed ways to govern the application
of ablating energy to the electrode element 22. The ablating energy
is applied to maintain generally uniform temperature conditions
along the length of the element 22.
[0210] Further details of the use of multiple temperature sensing
elements in tissue ablation can be found in co-pending U.S. patent
application Ser. No. 08/286,930, filed Aug. 8, 1994, entitled
"Systems and Methods for Controlling Tissue Ablation Using Multiple
Temperature Sensing Elements," which is incorporated herein by
reference.
[0211] V. Structures for Preventing the Pull Wire from Wrapping
Around the Catheter Tube
[0212] In accordance with another aspect of the present invention,
the pull wire 60 may be prevented from wrapping around the catheter
tube 12 by the exemplary mechanisms illustrated in FIGS. 41-46.
Such mechanisms may be used in conjunction with the probes
discussed above, or other probes.
[0213] As illustrated in FIG. 41, the handle 18 of the exemplary
probe 400 is provided with a nose cone 19 and strain relief element
21. In order to prevent the pull wire 60 from wrapping around the
catheter tube 12, probe 400 includes an anchoring element 402 which
secures the pull wire 60 to the proximal end of the catheter tube
12. Here, the anchoring element 402 is in the form of a length of
shrink tubing. Alternatively, the pull wire 60 in the exemplary
probe 404 shown in FIG. 42 is secured to the handle 18 by an
anchoring element 406, which is also in the form of shrink tubing.
The pull wire 60 could also be passed through a lumen (not shown)
in the handle 18.
[0214] Turning to FIG. 43, the pull wire 60 may be secured relative
to the catheter shaft 12 by an exemplary gripping mechanism 408
which can be fixed in place on the catheter shaft 12. The gripping
mechanism 408 includes a main body 410 and tubular members 412 and
414 which respectively ride on the pull wire 60 and catheter tube
12. The tubular member 412 supports a rotatable vice 416, while the
tubular member 414 supports a rotatable vice 418. Preferably, the
vices 416 and 418 operate in accordance with the same principles as
a pin vice or collet and are operably connected to one another by a
mechanical linkage (not shown) to insure that they rotate in
unison.
[0215] Another probe, which is generally represented by reference
numeral 420, and which is shown by way of example in FIGS. 44-46,
is provided with a gripping mechanism 422. The gripping mechanism
422 includes a main body 424 having an aperture 426 that forms an
interference fit with the catheter tube 12 such that the gripping
mechanism 422 will not rotate relative to the catheter tube 12.
Alternatively, the catheter tube 12 and main body aperture 426 may
be keyed by, for example, making the aperture 426 and at least a
portion of the catheter tube 12 an oval shape. The pull wire 60 is
held in place by a locking button 428 that is biased by a spring
430. The button 428 includes an aperture 432 through which the pull
wire 60 passes. The spring 430 biases the button 428 to the
orientation best seen in FIG. 46, thereby forcing the side of the
aperture 432 against the pull wire 60. Pressing the button 428 will
release the pull wire 60 and allow the pull wire 60 to be moved
relative to the gripping mechanism 422. It is also noteworthy that
wires 434, such as those connected to the electrodes and
temperature sensors, are visible in FIG. 45.
[0216] The inventors herein have determined that there are many
reasons for preventing the pull wire 60 from wrapping around the
catheter tube 12. For example, one reason is to prevent the
catheter tube 12 from becoming stuck (or locked) within the sheath
36, which hinders the introduction and/or withdrawal of the
catheter tube 12 from the sheath 36. Such locking may occur if the
pull wire 60 wraps around the catheter tube 12 many times over a
short section of the catheter tube 12. This increases the maximum
outer diameter of the catheter (which includes the catheter tube
12, the multiple electrode support structure 20 and the pull wire
60) to a level which prevents movement within the sheath 36. A
wrapped pull wire 60 can also catch the electrodes 22 positioned on
the deployed loop structure and either dislodge the electrodes 22,
or prevent the operator form collapsing the loop.
[0217] When the pull wire 60 is secured proximal to the sheath 36
homeostatic valve, rotation of the catheter tube 12 will cause the
pull wire 60 to revolve around the catheter tube 12 in the same
direction both at the distal end and proximal end of the catheter
tube 12. Accordingly, if enough tension were exerted on the pull
wire 60 in this configuration, it would straighten within the
sheath 36. The catheter tube 12 may be rotated several times and,
when withdrawn, the pull wire 60 will straighten, thus decreasing
the potential for the pull wire 60 to overlap and catch on the
electrodes 22. Additionally, this mechanism enables the operator to
observe the direction that the catheter tube 12 has been rotated.
Therefore, if the catheter 12 is locked in the sheath 36, the
operator can unwind the catheter tube 12 by simply reversing the
direction relative to the direction in which the proximal end of
the pull wire 60 has revolved around the catheter tube 12. This
will straighten the pull wire 60 and unlock the catheter tube 12
from the sheath 36.
[0218] Although the present invention has been described in terms
of the preferred embodiments above, numerous modifications and/or
additions to the above-described preferred embodiments would be
readily apparent to one skilled in the art. It is intended that the
scope of the present invention extends to all such modifications
and/or additions and that the scope of the present invention is
limited solely by the claims set forth below.
[0219] Additionally, this specification discloses multiple
electrode structures in the context of cardiac ablation because the
structures are well suited for use in the field of cardiac
ablation. Nevertheless, it should be appreciated that the disclosed
structures are applicable for use in other applications. For
example, various aspects of the invention have applications and
procedures concerning other regions of the body such as the
prostate, brain, gall bladder and uterus.
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