U.S. patent application number 09/795713 was filed with the patent office on 2001-08-09 for systems and methods for conducting electrophysiological testing using high-voltage energy pulses to stun tissue.
Invention is credited to Swanson, David K..
Application Number | 20010012918 09/795713 |
Document ID | / |
Family ID | 27414381 |
Filed Date | 2001-08-09 |
United States Patent
Application |
20010012918 |
Kind Code |
A1 |
Swanson, David K. |
August 9, 2001 |
Systems and methods for conducting electrophysiological testing
using high-voltage energy pulses to stun tissue
Abstract
Systems and methods for diagnosing and treating tissue transmit
an electrical energy pulse that temporarily stuns a zone of tissue,
temporarily rendering it electrically unresponsive. The systems and
methods sense an electrophysiological effect due to the transmitted
pulse. The systems and methods alter an electrophysiological
property of tissue in or near the zone based, at least in part,
upon the sensed electrophysiological effect. The alteration of the
electrophysiological property can be accomplished, for example, by
tissue ablation or by the administration of medication. In a
preferred implementation, radio frequency energy is used to both
temporarily stun tissue and to ablate tissue through a common
electrode.
Inventors: |
Swanson, David K.; (Mountain
View, CA) |
Correspondence
Address: |
HENRICKS SLAVIN AND HOLMES LLP
SUITE 200
840 APOLLO STREET
EL SEGUNDO
CA
90245
|
Family ID: |
27414381 |
Appl. No.: |
09/795713 |
Filed: |
February 28, 2001 |
Related U.S. Patent Documents
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Application
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Filing Date |
Patent Number |
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09795713 |
Feb 28, 2001 |
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09430835 |
Nov 1, 1999 |
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6212426 |
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09430835 |
Nov 1, 1999 |
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09084065 |
May 22, 1998 |
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6023638 |
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09084065 |
May 22, 1998 |
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08914860 |
Aug 19, 1997 |
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5759158 |
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08914860 |
Aug 19, 1997 |
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08791625 |
Jan 31, 1997 |
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08791625 |
Jan 31, 1997 |
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08508750 |
Jul 28, 1995 |
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Current U.S.
Class: |
600/510 |
Current CPC
Class: |
A61B 2018/00577
20130101; A61B 2018/0016 20130101; A61B 2562/046 20130101; A61B
18/12 20130101; A61N 1/36185 20130101; A61B 2018/00107 20130101;
A61N 1/3686 20130101; A61B 2017/003 20130101; A61N 1/3622 20130101;
A61N 1/3702 20130101; A61B 5/6855 20130101; A61B 2018/00267
20130101; A61B 2018/1286 20130101; A61B 2018/00041 20130101; A61B
2018/00214 20130101; A61B 18/1485 20130101; A61B 2018/1465
20130101; A61B 5/6853 20130101; A61B 5/6858 20130101; A61B 18/1492
20130101; A61B 2018/00148 20130101; A61B 2017/00101 20130101; A61B
2018/0022 20130101; A61B 5/6859 20130101; A61B 2018/00136 20130101;
A61B 2018/1472 20130101; A61B 2562/043 20130101; A61B 5/287
20210101; A61B 2562/0215 20170801; A61B 2018/00065 20130101; A61B
2090/065 20160201; A61B 5/6856 20130101 |
Class at
Publication: |
600/510 |
International
Class: |
A61B 005/04 |
Claims
We claim:
1. An electrophysiological method, comprising the steps of:
transmitting an electrical energy pulse that temporarily renders a
zone of tissue electrically unresponsive for at least one second;
and sensing an electrophysiological effect due to the transmitted
pulse.
2. A method as claimed in claim 1, further comprising the step of:
altering an electrophysiological property of the tissue in or near
the zone based, at least in part, upon the sensed
electrophysiological effect.
3. A method as claimed in claim 2, wherein the step of altering an
electrophysiological property comprises ablating the tissue in or
near the zone.
4. A method as claimed in claim 3, wherein the step of ablating
tissue comprises applying electrical energy to the tissue in or
near the zone.
5. A method as claimed in claim 1, wherein the transmitted
electrical energy pulse comprises a radio frequency energy
waveform.
6. A method as claimed in claim 1, further comprising the step of:
modifying the tissue in or near the zone based, at least in part,
upon the sensed electrophysiological effect.
7. A method as claimed in claim 1, wherein the zone comprises an
elongate continuous zone.
8. A method as claimed in claim 1, wherein the transmitted
electrical energy pulse comprises a plurality of electrical energy
pulses transmitted at spaced locations.
9. An electrophysiological method, comprising the steps of; sensing
at least one electrical event in a region of tissue; transmitting
into an area of the region an electrical energy pulse that
temporarily renders tissue in the area electrically unresponsive
for at least one second; and sensing a change in the electrical
event while the tissue in the area is electrically
unresponsive.
10. A method as claimed in claim 9, further comprising the step of;
altering an electrophysiological property of the tissue in or near
the area based, at least in part, upon the sensed
electrophysiological effect.
11. A method as claimed in claim 10, wherein the step of altering
an electrophysiological property comprises ablating the tissue in
or near the area.
12. A method as claimed in claim 11, wherein the step of ablating
tissue comprises applying electrical energy to the tissue in or
near the area.
13. A method as claimed in claim 9, wherein the transmitted
electrical energy pulse comprises a radio frequency energy
waveform.
14. A method as claimed in claim 9, further comprising the step of:
modifying the tissue in or near the zone based, at least in part,
upon the sensed electrophysiological effect.
15. A method as claimed in claim 9, wherein the area comprises an
elongate continuous area.
16. A method as claimed in claim 1, wherein the transmitted
electrical energy pulse comprises a plurality of electrical energy
pulses transmitted at spaced locations.
17. An electrophysiological system, comprising an energy
transmission device; and an energy source, coupled to the energy
transmission device, adapted to transmit an energy pulse through
the energy transmission device that temporarily renders a zone of
tissue electrically unresponsive for at least one second.
18. A system as claimed in claim 17, further comprising: a sensing
device adapted to sense an electrophysiological effect due to the
transmitted pulse.
19. A system as claimed in claim 17, wherein the energy source is
adapted to transmit energy through the energy transmission device
that alters an electrophysiological property of the tissue in or
near the zone.
20. A system as claimed in claim 17, wherein the energy pulse
comprises an electrical energy pulse.
21. A system as claimed in claim 17, wherein the energy pulse
comprises a frequency energy waveform.
22. A system as claimed in claim 17, wherein the energy
transmission device comprises an electrode.
23. A system as claimed in claim 17, wherein the energy
transmission device comprises a plurality of spaced electrodes.
24. A system as claimed in claim 23, wherein the plurality of
electrodes define spacing therebetween such that the zone of
electrically unresponsive tissue is a continuous zone that spans
the area between the electrodes.
25. A system as claimed in claim 24, wherein the energy pulse
comprises a plurality of energy pulse transmitted sequentially
through respective electrodes in the plurality of spaced
electrodes.
27. A system as claimed in claim 17, wherein the energy
transmission device comprises a porous electrode.
28. A system as claimed in claim 17, further comprising: a
relatively short shaft defining a distal end and a proximal end,
the distal end supporting the energy transmission device; a handle
associated with the proximal end of the relatively short shaft.
29. A system as claimed in claim 26, wherein the relatively short
shaft is malleable.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S.
application Ser. No. 08/914,860, filed Aug. 19, 1997, which is a
continuation of U.S. which is a continuation of U.S. application
Ser. No. 08/508,750, filed Jul. 28, 1995, now abandoned, each of
which is incorporated herein by reference.
BACKGROUND OF THE INVENTIONS
[0002] 1. Field of the Inventions
[0003] The inventions generally relate to systems and methods for
diagnosing or treating medical conditions.
[0004] 2. Description of the Related Art
[0005] There are many medical treatments which involve instances of
cutting, ablating, coagulating, destroying, or otherwise changing
the physiological properties of tissue (collectively referred to
herein as "tissue modification"). For example, tissue modification
can be used to change the electrophysiological properties of
tissue. Although treatments that include tissue modification are
beneficial, the physiological changes to the tissue are often
irreversible and the modification of tissue other than the intended
tissue can disable or even kill a patient. Accordingly, physicians
must carefully select the tissue that is to be treated in this
manner.
[0006] One area of medical treatment which involves tissue
modification is the ablation of cardiac tissue to cure various
cardiac conditions. Normal sinus rhythm of the heart begins with
the sinoatrial node (or "SA node") generating a depolarization wave
front. The impulse causes adjacent myocardial tissue cells in the
atria to depolarize, which in turn causes adjacent myocardial
tissue cells to depolarize. The depolarization propagates across
the atria, causing the atria to contract and empty blood from the
atria into the ventricles. The impulse is next delivered via the
atrioventricular node (or "AV node") and the bundle of HIS (or "HIS
bundle") to myocardial tissue cells of the ventricles. The
depolarization of these cells propagates across the ventricles,
causing the ventricles to contract. This conduction system results
in the described, organized sequence of myocardial contraction
leading to a normal heartbeat.
[0007] Sometimes aberrant conductive pathways develop in heart
tissue, which disrupt the normal path of depolarization events. For
example, anatomical obstacles in the atria or ventricles can
disrupt the normal propagation of electrical impulses. These
anatomical obstacles (called "conduction blocks") can cause the
electrical impulse to degenerate into several circular wavelets
that circulate about the obstacles. These wavelets, called "reentry
circuits," disrupt the normal activation of the atria or
ventricles. As a further example, localized regions of ischemic
myocardial tissue may propagate depolarization events slower than
normal myocardial tissue. The ischemic region, also called a "slow
conduction zone," creates errant, circular propagation patterns,
called "circus motion." The circus motion also disrupts the normal
depolarization patterns, thereby disrupting the normal contraction
of heart tissue.
[0008] The aberrant conductive pathways create abnormal, irregular,
and sometimes life-threatening heart rhythms, called arrhythmias.
An arrhythmia can take place in the atria, for example, as in
atrial tachycardia (AT), atrial fibrillation (AFIB) or atrial
flutter (AF). The arrhythmia can also take place in the ventricle,
for example, as in ventricular tachycardia (VT).
[0009] In treating VT and certain other arrhythmias, it is
essential that the location of the sources of the aberrant pathways
(called substrates) be located. Once located, the tissue in the
substrates can be destroyed, or ablated, by heat, chemicals, or
other means of creating a lesion in the tissue. Ablation can remove
the aberrant conductive pathway, restoring normal myocardial
contraction. The lesions used to treat VT are typically relatively
deep and have a large surface area. However, there are some
instances where shallower lesions will successfully eliminate
VT.
[0010] The lesions used to treat AFIB, on the other hand, are
typically long and thin and are carefully placed to interrupt the
conduction routes of the most common reentry circuits. More
specifically, the long thin lesions are used to create a maze
pattern which creates a convoluted path for electrical propagation
within the left and right atria. The lesions direct the electrical
impulse from the SA node along a specified route through all
regions of both atria, causing uniform contraction required for
normal atrial transport function.
[0011] The lesions finally direct the impulse to the AV node to
activate the ventricles, restoring normal atrioventricular
synchrony.
[0012] Prior to modifying the electrophysiological properties of
cardiac tissue by ablation, or by other means of destroying tissue
to create lesions, physicians must carefully determine exactly
where the lesions should be placed. Otherwise, tissue will be
unnecessarily destroyed. In addition, the heart is in close
proximity to nerves and other nervous tissue and the destruction of
this tissue will result in severe harm to the patient.
[0013] With respect to the treatment of VT, physicians examine the
propagation of electrical impulses in heart tissue to locate
aberrant conductive pathways. The techniques used to analyze these
pathways, commonly called "mapping," identify regions (or
substrates) in the heart tissue which can be ablated to treat the
arrhythmia. One form of conventional cardiac tissue mapping
techniques uses multiple electrodes positioned in contact with
epicardial heart tissue to obtain multiple electrograms. The
physician stimulates myocardial tissue by introducing pacing
signals and visually observes the morphologies of the electrograms
recorded during pacing, which this Specification will refer to as
"paced electrograms." The physician visually compares the patterns
of paced electrograms to those previously recorded during an
arrhythmia episode to locate tissue regions appropriate for
ablation. These conventional techniques require invasive open heart
surgical techniques to position the electrodes on the epicardial
surface of the heart.
[0014] Conventional epicardial electrogram processing techniques
used for detecting local electrical events in heart tissue are
often unable to interpret electrograms with multiple morphologies.
Such electrograms are encountered, for example, when mapping a
heart undergoing ventricular tachycardia (VT). For this and other
reasons, consistently high correct identification rates (CIR)
cannot be achieved with current multi-electrode mapping
technologies. In treating VT using conventional open-heart
procedures, the physician may temporarily render a localized region
of myocardial tissue electrically unresponsive during an induced or
spontaneous VT episode. This technique, called "stunning," is
accomplished by cooling the tissue. If stunning the localize region
interrupts an ongoing VT, or suppresses a subsequent attempt to
induce VT, the physician ablates the localized tissue region.
However, in conventional practice, cooling a significant volume of
tissue to achieve a consistent stunning effect is clinically
difficult to achieve.
[0015] Another form of conventional cardiac tissue mapping
technique, called pace mapping, uses a roving electrode in a heart
chamber for pacing the heart at various endocardial locations. In
searching for the VT substrates, the physician must visually
compare all paced electrocardiograms (recorded by twelve lead body
surface electrocardiograms (ECG's)) to those previously recorded
during an induced VT. The physician must constantly relocate the
roving electrode to a new location to systematically map the
endocardium.
[0016] These techniques are complicated and time consuming. They
require repeated manipulation and movement of the pacing
electrodes. At the same time, they require the physician to
visually assimilate and interpret the electrocardiograms. Because
the lesions created to treat VT typically have a large volume, the
creation of lesions that are improperly located results in a large
amount of tissue being destroyed, or otherwise modified,
unnecessarily. Additionally, because these techniques do not
distinguish between VTs that require a deep lesion, and VTs that
can be treated with a more shallow lesion, tissue will be
unnecessarily modified when a deep lesion is made to treat VTs that
only require a more shallow lesion.
[0017] Turning to the treatment of AFIB, anatomical methods are
used to locate the areas to be ablated or otherwise modified. In
other words, the physician locates key structures such as the
mitral valve annulus and the pulmonary veins. Lesions are typically
formed that block propagations near these structures. Additional
lesions are then formed which connect these lesions and complete
the so-called "maze pattern." However, the exact lesion pattern,
and number of lesions created, can vary from patient to patient.
This can lead to tissue being unnecessarily destroyed in patients
who need fewer lesions than the typical maze pattern.
[0018] Another issue that often arises in the treatment of AFIB is
atrial flutters which remain after the physician finishes the maze
procedure. Such flutters are the result of gaps in the lesions that
form the maze pattern. The gaps in the lesions must be located so
that additional tissue modification procedures may be performed to
fill in the gaps. Present method of locating these gaps are,
however, difficult and time consuming.
[0019] There thus remains a real need for systems and procedures
that simplify the process of locating tissue that is intended for
cutting, ablating, coagulating, destroying, or otherwise changing
its physiological properties.
SUMMARY OF THE INVENTIONS
[0020] One aspect of a present invention provides systems and
methods for conducting diagnostic testing of tissue. The systems
and methods transmit an electrical energy pulse that temporarily
renders a zone of tissue electrically unresponsive. The systems and
methods may also sense an electrophysiological effect due to the
transmitted pulse. Based at least in part upon the sensing of the
electrophysiological effect, the physician can determine whether
the temporarily unresponsive tissue is in fact the tissue that is
intended for modification. Thus, the present invention allows the
physician to easily identify the tissue that is intended for
modification, as well as tissue that is not.
[0021] In the area of cardiac treatment, for example, temporarily
rendering localized zones of myocardial tissue electrically
unresponsive allows the physician to locate potential pacemaker
sites, slow conduction zones and other sources of aberrant pathways
associated with arrhythmia. Using the same process, the physician
can selectively alter conduction properties in the localized zone,
without changing electrophysiological properties of tissue outside
the zone. With respect to the treatment of VT, the present
invention allows a physician to temporarily create a large, deep
area of electrically unresponsive tissue and then determine whether
such tissue should be made permanently electrically unresponsive by
performing tests which show whether or not the VT has been
eliminated. When treating AFIB, the physician can create continuous
long, thin areas of electrically unresponsive tissue and then
perform testing if required to insure that the permanent
modification of the temporarily unresponsive tissue would create
the desired therapeutic effect. Similar techniques may also be used
to precisely locate the sources of AF.
[0022] Once it is determined that the temporarily unresponsive
tissue is the tissue that should be permanently modified to cure
the VT, AFIB or other arrhythmia, the physician can alter an
electrophysiological property of the myocardial tissue in or near
the diagnosed zone. The electrophysiological property of myocardial
tissue can be altered, for example, by ablating myocardial tissue
in or near the zone. The physician will not ablate the tissue if
the zone does not meet preestablished criteria for ablation.
[0023] During procedures that are performed in and around neural
tissue, physicians can render the tissue temporarily unresponsive
prior to permanent modification. Tests can then be performed to
determine whether unwanted paralysis is present. If it is not, the
physician can proceed with modification.
[0024] In a preferred embodiment, the systems and methods use radio
frequency energy to both temporarily render tissue electrically
unresponsive as well as modify the tissue, should the established
criteria be met. The same electrode (or series of electrodes) may
be used to transmit the radio frequency energy, which, in one mode,
temporarily renders the tissue electrically unresponsive and which,
in a second mode, ablates or otherwise modifies the tissue.
[0025] Another one of the present inventions is an electrical
energy generating device. A preferred embodiment of the device
includes a first element that, when activated, generates for
transmission by an electrode (or series of electrodes) coupled to
the device an electrical energy pulse that temporarily renders
tissue electrically unresponsive. The device also comprises a
second element that, when activated, generates for transmission by
an electrode (or series of electrodes) coupled to the device
electrical energy to modify tissue by, for example, ablating the
tissue. A switch may be provided which selects for activation
either the first element or the second element.
[0026] The above described and many other features and attendant
advantages of the present inventions 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
[0027] Detailed description of preferred embodiments of the
inventions will be made with reference to the accompanying
drawings.
[0028] FIG. 1 is a diagrammatic view of a system for accessing a
targeted tissue region in the body for diagnostic or therapeutic
purposes in accordance with one embodiment of a present
invention.
[0029] FIG. 2 is an enlarged perspective view of a
multiple-electrode structure that may be used in association with
the system shown in FIG. 1.
[0030] FIG. 3 is an enlarged view of a tissue modification device
that may be used in association with the system shown in FIG.
1.
[0031] FIG. 4 is a schematic view of a slow conduction zone in
myocardial tissue and the circular propagation patterns (called
circus motion) it creates.
[0032] FIG. 5 is a diagrammatic view of a representative switching
element in accordance with a preferred embodiment of a present
invention that may be used in association with a radio frequency
energy generator to switch between a stunning mode and an ablation
(or other tissue modification) mode.
[0033] FIG. 6 is a perspective view of a flexible probe that
includes a plurality of flexible electrodes in accordance with one
embodiment of a present invention.
[0034] FIG. 7 is a side view of a flexible probe that includes a
flexible electrode and a tip electrode in accordance with one
embodiment of a present invention.
[0035] FIG. 8 is a side, partial section view of an exemplary
flexible electrode in accordance with one embodiment of a present
invention.
[0036] FIG. 9 is a side section view of the interior of the heart
with a probe in accordance with one embodiment of a present
invention positioned transeptally against the septal wall of the
left atrium.
[0037] FIG. 10 is an end view of the probe shown in FIG. 9.
[0038] FIG. 11 is a side section view of the interior of the heart
with the probe shown in FIG. 9 positioned against the septal wall
of the right atrium.
[0039] FIG. 12A is a side view of a probe including a high density
array of electrodes.
[0040] FIG. 12B is a side view of the probe shown in FIG. 12A with
the array of electrodes in a generally flat orientation.
[0041] FIG. 13A is a side view of an exemplary asymmetric electrode
support device.
[0042] FIG. 13B is an end view of the exemplary asymmetric
electrode support device shown in FIG. 13A.
[0043] FIG. 14 is a plan view of a system for stunning and/or
modifying tissue which includes an expandable porous electrode
structure in accordance with one embodiment of a present
invention.
[0044] FIG. 15 is side view, with portions broken away, of a porous
electrode structure in accordance with one embodiment of a present
invention in an expanded state.
[0045] FIG. 16 is side view of the porous electrode structure shown
in FIG. 15 in a collapsed state.
[0046] FIG. 17 is an enlarged side view, with portions broken away,
of the porous electrode structure shown in FIG. 15.
[0047] FIG. 18 is a side view, with portions broken away, of a
porous electrode structure in accordance with another embodiment of
a present invention.
[0048] FIG. 19 is side, section view of the porous electrode
structure shown in FIG. 18 in a collapsed state.
[0049] FIG. 20 is a section view taken generally along line 20-20
in FIG. 17.
[0050] FIG. 21 is a side view of a porous electrode structure in
accordance with another embodiment of a present invention.
[0051] FIG. 22 is side view, with portions broken away, of a porous
electrode structure in accordance with still another embodiment of
a present invention.
[0052] FIG. 23 is a side view of a surgical device for positioning
an operative element within a patient in accordance with a
preferred embodiment of a present invention.
[0053] FIG. 24 is a side, partial section view of a portion of the
surgical device shown in FIG. 23.
[0054] FIGS. 25 and 26 are front views of a spline assembly in
accordance with one embodiment of a present invention.
[0055] FIG. 27 is a partial front, partial section view of a
surgical device for positioning an operative element within a
patient in accordance with a preferred embodiment of a present
invention.
[0056] FIG. 28 is a side view of a surgical device for positioning
an operative element within a patient in accordance with another
preferred embodiment of a present invention.
[0057] FIG. 29 is a side, partial section view of an alternate tip
that may be used in conjunction with the device shown in FIG.
28.
[0058] FIG. 30 is a section view of the distal portion of the
device shown in FIG. 28 taken along line 30-30 in FIG. 28.
[0059] FIG. 31 a section view of an alternate distal portion for
the device shown in FIG. 30.
[0060] FIG. 32 is a section view taken along line 32-32 in FIG.
28.
[0061] FIG. 33 is a section view showing an electrode coated with
regenerated cellulose.
[0062] FIG. 34 is a section view showing a partially masked
electrode.
[0063] FIG. 35 is a section view showing an alternative electrode
configuration.
[0064] FIG. 36 is a diagram showing one embodiment of a power
supply circuit in accordance with the present invention.
[0065] FIG. 37A is a diagram showing where an additional switching
device may be added to the circuit shown in FIG. 36.
[0066] FIG. 37B is a detailed diagram of the switching device shown
in FIG. 37A.
[0067] FIG. 38 is a schematic view of an exemplary graphical user
interface-based system including various diagnostic and therapeutic
instruments.
[0068] FIG. 39 is a schematic view of an exemplary graphical user
interface-based system including various diagnostic and therapeutic
instruments.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0069] The following is a detailed description of the best
presently known modes of carrying out the inventions. 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.
[0070] The detailed description of the preferred embodiments is
organized as follows:
[0071] I. Mapping and Stunning-Modification Systems
[0072] A. Mapping Devices
[0073] B. Process Controller
[0074] C. Stunning-Modification Device
[0075] D. Power Supply
[0076] E. Electrode Selecting Device
[0077] F. Graphical User Interface-Based System
[0078] II. Additional Devices That May be Used in a
Stunning-Modification System
[0079] A. Multiple Electrode Stunning-Modification Devices
[0080] B. Structures For Positioning Electrodes in a
Three-Dimensional Array
[0081] C. Expandable-CollapsiblePorous Electrode Structures
[0082] D. Surgical Probes
[0083] E. Regenerated Cellulose Coating
[0084] F. Temperature Sensors
[0085] III. Modes of Operation
[0086] A. Stunning Mode
[0087] B. Power Considerations Associated With Stunning
[0088] C. Modification Mode
[0089] D. Roving Pacing Mode
[0090] E. Electrophysiological Diagnosis Mode
[0091] IV. Bypass and Non-Bypass Environment Considerations
[0092] 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.
[0093] I. Mapping and Stunning-Modification System
[0094] FIG. 1 shows an exemplary system 10 for analyzing
endocardial electrical events, using catheter-based, vascular
access techniques in accordance with one embodiment of a present
invention. The system 10 examines the depolarization of heart
tissue that is subject to an arrhythmia and locates a potential
tissue site for ablation or other modification.
[0095] The exemplary system 10 shown in FIG. 1 includes a mapping
probe 14 and a multi-purpose stunning-modification probe 16. Each
probe is separately introduced into the selected heart region 12
through a vein or artery (typically the femoral vein or artery)
through suitable percutaneous access. The mapping probe 14 and
multi-purpose stunning-modification probe 16 can be assembled in an
integrated structure for simultaneous introduction and deployment
in the heart region 12. Further details of the deployment and
structures of the probes 14 and 16 are set forth in U.S. Pat. No.
5,636,634, entitled "Systems and Methods Using Guide Sheaths for
Introducing, Deploying, and Stabilizing Cardiac Mapping and
Ablation Probes," which is incorporated herein by reference.
[0096] Other types of catheter-based mapping and
stunning-modification probes may also be used. Additionally, the
mapping and/or stunning-modification probes do not have to be
catheter-based and can be in the form of probes that are inserted
into the heart through a thoracotomy, thoracostomy or median
sternotomy. Examples of such structures are discussed in Section
II-D below.
[0097] A. Mapping Devices
[0098] Exemplary mapping device 14 has a flexible catheter body 18.
The distal end of the catheter body 18 carries a three-dimensional
multiple-electrode structure 20. In the illustrated embodiment, the
structure 20 takes the form of a basket defining an open interior
space 22 (see FIG. 2). It should be appreciated that other
three-dimensional structures could be used.
[0099] As FIG. 2 shows, the illustrated basket structure 20
comprises a base member 26 and an end cap 28. Generally flexible
splines 30 extend in a circumferentially spaced relationship
between the base member 26 and the end cap 28.
[0100] The splines 30 are preferably made of a resilient,
biologically inert material, like Nitinol metal or silicone rubber.
The splines 30 are connected between the base member 26 and the end
cap 28 in a resilient, pretensed, radially expanded condition, to
bend and conform to the endocardial tissue surface they contact. In
the illustrated embodiment (see FIG. 2), eight splines 30 form the
basket structure 20. Additional or fewer splines 30 could be
used.
[0101] The splines 30 carry an array of electrodes 24. In the
illustrated embodiment, each spline 30 carries eight electrodes 24.
Of course, additional or fewer electrodes 24 can be used.
[0102] A slidable sheath 19 is movable along the axis of the
catheter body 18 (shown by arrows in FIG. 2). Moving the sheath 19
forward causes it to move over the basket structure 20, collapsing
it into a compact, low profile condition for introducing into the
heart region 12. Moving the sheath 19 rearward frees the basket
structure 20, allowing it to spring open and assume the pretensed,
radially expanded position shown in FIG. 2. The electrodes are
urged into contact against the surrounding heart tissue.
[0103] Further details of a suitable basket structure are disclosed
in U.S. patent application Ser. No. 08/206,414, filed Mar. 4, 1994,
and PCT Publication No. WO 9421166, both entitled "Multiple
Electrode Support Structures."
[0104] In use, the electrodes 24 sense electrical events in
myocardial tissue for the creation of electrograms. The electrodes
24 are electrically coupled to a process controller 32 (see FIG.
1). A signal wire (not shown) is electrically coupled to each
electrode 24. The wires extend through the body 18 of the device 14
into a handle 21 (see FIG. 2), in which they are coupled to an
external multiple pin connector 23. The connector 23 electrically
couples the electrodes to the process controller 32.
[0105] Alternatively, multiple electrode structures can be located
epicardially using a set of catheters individually introduced
through the coronary vasculature (e.g., retrograde through the
aorta or coronary sinus), as disclosed in PCT Publication No. WO
9416619, entitled "Multiple Intravascular Sensing Devices for
Electrical Activity."
[0106] B. Process Controller
[0107] In the illustrated embodiment, the process controller 32
induces electrical events in heart tissue by transmitting pacing
signals into heart tissue. The process controller 32 senses these
electrical events in heart tissue to process and analyze them to
locate a potential ablation site.
[0108] More particularly (see FIG. 1), the process controller 32 is
electrically coupled by a bus 47 to a pacing module 48, which paces
the heart sequentially through individual or pairs of electrodes to
induce depolarization. Details of the process controller 32 and
pacing module 48 are described in U.S. Pat. No. 5,494,042, entitled
"Systems and Methods for Deriving Electrical Characteristics of
Cardiac Tissue for Output in Iso-Characteristic Displays."
[0109] The process controller 32 is also electrically coupled by a
bus 49 to a signal processing module 50. The processing module 50
processes cardiac signals into electrograms. A Model TMS 320C31
processor available from Spectrum Signal Processing, Inc. can be
used for this purpose.
[0110] The process controller 32 is further electrically coupled by
a bus 51 to a host processor 52, which processes the input from the
electrogram processing module 50. The output of the host processor
32 can be selectively displayed for viewing by the physician on an
associated display device 54. The host processor 32 can be a
Pentium.TM.-type or other suitable microprocessor. The exemplary
process controller 32 operates in two functional modes, called the
sampling mode and the matching mode.
[0111] Representative matching techniques to find potential
ablation sites are described in U.S. patent application Ser. No.
08/390,559, filed Feb. 17, 1995, and PCT Publication No. WO
9625094, both entitled "Systems and Methods for Analyzing
Biopotential Morphologies in Body Tissue."
[0112] C. Stunning-Modification Device
[0113] The exemplary multi-purpose stunning-modification device 16
shown in FIG. 3 includes a flexible catheter body 34 that carries
an electrode 36 at the distal tip. The electrode is suitable for
ablation and other tissue modification procedures. A handle 38 is
attached to the proximal end of the catheter body 34. The handle 38
and catheter body 34 carry a steering mechanism 40 for selectively
bending or flexing the catheter body 34 along its length, as the
arrows in FIG. 3 show. The steering mechanism 40 can vary. For
example, the steering mechanism can be as shown in U.S. Pat. No.
5,254,088, which is incorporated herein by reference.
[0114] A wire (not shown) electrically connected to the electrode
36 extends through the catheter body 34 into the handle 38, where
it is electrically coupled to an external connector 45. The
connector 45 connects the electrode 36 to a generator 46, which
supplies electromagnetic radio frequency energy to the electrode
36. As used in this Specification, the term "radio frequency
energy" refers to electrical energy with frequencies in the range
of between about 10 kHz to about 3 GHz (3.times.10.sup.9 Hz). When
operated in a uni-polar mode, an external patch electrode (not
shown) constitutes the radio frequency energy return line. When
operated in a bi-polar mode, an electrode carried on the catheter
body 34, or an electrode carried on a nearby catheter, constitutes
the radio frequency energy return line. The generator 46 is
operable through an associated switching element 80 in two modes,
called the stunning mode and the modification mode.
[0115] D. Power Supply
[0116] FIG. 36 illustrates one preferred embodiment of a power
supply circuit 500 for delivering controlled high voltage RF pulses
to tissue. In the exemplary circuit, which is a full-wave bridge
rectifier and transformer circuit, a stepped up AC voltage from a
variably controllable power source 502 is rectified into
substantially unidirectional (rectified) pulse waveforms for
application to body tissue in a safe and controllable manner.
[0117] The circuit includes a first isolation and step-up
transformer T1 (preferably having a turns ratio of 10:1) through
which power is input from the AC power source 502, and four diodes
D1, D2, D3 and D4, with output to the input terminal end of a RC
circuit. The RC circuit has at least one shunting capacitor C1, in
parallel with resistors R1, R2 and R3 (resistors R1 and R2 are in
series with one another and in parallel with resistor R3). The
output terminal end of the RC circuit is the voltage drop across
the capacitor C1. The RC circuit, which also includes switching
devices S1 and S2, can be thought of as resonant-type circuit that
stores energy supplied by the AC power supply through the full-wave
bridge rectifier, until such time that the RC circuit is
selectively discharged through the primary coils of a second
isolation and step-up transformer T2 by operation of switching
device S1. The switching device S1 connects the transformer T2 with
the output voltage drop at capacitor C1. Output from transformer T2
is applied to a load, which is the body of the patient in the
stunning and modification systems disclosed herein.
[0118] Inputting the AC power from AC power source 502 through the
first isolation and step-up transformer T1 provides at least two
advantages. First, it allows the AC source voltage to be stepped up
(or stepped down) as needed. Second, it isolates the AC power
source 502 from the remaining circuit, as shown with dashed lines
in FIG. 36, thereby reducing the shock hazard to a patient. A
similar function is provided by the second step-up and isolation
transformer T2. Accordingly, the isolation and step-up transformers
T1 and T2 electrically isolate the portion of the circuit circled
with dotted lines from the patient and other circuits.
[0119] Step-up transformer T2 provides additional safety protection
for the patent, should switching device S1 fail in either the open
or closed positions. If switching device S1 fails in the open
position, no power is delivered, since no current flows through the
primary coils of transformer T2. If the switching device S1 fails
in the closed position, substantially rectified voltage waveforms
of long duration (predominately DC voltage waveforms) will flow
through the primary coils of transformer T2, and only minor
variations in current will be reflected at the secondary coils.
Thus, the patient is only exposed to RF pulsed voltage waveforms
when S1 is properly working and rapidly being switched ON and
OFF.
[0120] Operation of the exemplary full-wave bridge rectifier shown
in FIG. 36 allows for substantial rectification of AC waveforms
into substantially rectified or unidirectional pulsed waveforms
(allowing for the usual non-ideal behavior of actual circuits,
ripple voltage, and the like). The secondary voltage of transformer
T1, seen at the output of transformer T1, equals the turns ratio
times the primary voltage, e.g.,
V.sub.sec=(N.sub.sec/N.sub.pri)V.sub.pri. When the input cycle
voltage waveform is positive, diodes D1 and D4 are forward-biased
and conduct current in the direction from node A to node B, and
from node D to node C (node D can be connected to ground), with the
portions of the circuit between nodes A to D and nodes B to C being
an open circuit by nature of diodes D2 and D3 being reverse biased.
When the input cycle is negative, diodes D2 and D3 are
forward-biased and conduct current in the direction from node C to
node B and from node D to node A, with the portions of the circuit
between nodes D to C and nodes A to B being an open circuit, by
nature of diodes D1 and D4 being reverse biased. A substantially
full-wave rectified output voltage appears across node 1 of the
circuit and as seen by the RC circuit to the right of node 1.
[0121] Diodes D1-D4, which may be Zener diodes, must have reverse
breakdown voltages that exceed the maximum voltage to which the
capacitor C1 can be charged. In one preferred embodiment, the
diodes D1-D4 have a breakdown voltage of 300 V, and carry a maximum
current flow of less than or equal to 0.2 amperes RMS, while
capacitor C1 has a value of 10,000 .mu.F, and is a high-voltage
electrolytic capacitor, such as the kind commonly used for flash
cameras. Capacitor C1 can be repeatedly charged to 350-400 V, and
may be connected in parallel with similar capacitors to achieve the
necessary storage capacitance. When charged to 300 volts, capacitor
C1 stores about 600 J of energy.
[0122] The input AC power is preferably about 5 W and 500 W.
However, it should be noted that relatively low levels of input
power will reduce the overall flexibility of the system. For
example, a 5 W input power source would require at least 2 minutes
to fully charge capacitor C1 to the preferred level of about 600 J.
Although a smaller capacitor or lower stored voltages would enable
more rapid charging, the techniques disclosed herein require the
storage of a significant amount of energy as well as rapid delivery
to be effective. With respect to the upper preferred limit, power
levels higher than about 500 W increase the potential for patient
injury in the event of component failure.
[0123] The delivered power requirements for stunning targeted
tissue using the circuit shown in FIG. 36 is high. In some
instances 800 V must be delivered into a 50 .OMEGA. load, requiring
12 kW of power. As noted in Section III-B with respect to the
electrodes used in a three-dimensional structure, a RF pulse having
an amplitude of 150 volts and a duration of about 10 ms will stun
tissue to a depth of 5 mm, while a 800 volt RF pulse at 500 kHz
frequency and a duration of 10 ms will stun a tissue to a depth of
10 mm. Delivery of this high level of power must be carefully
controlled, since that level of power can severely injure a
patient.
[0124] In some special circumstances, voltages as low as 100 V can
electrically stun tissue. On the other hand, a short burst of very
high voltages (about 4000 V) are often required to kill tissue by
dielectric breakdown of cell membranes. In order to account for
these situations, the voltage outputs from transformer T1 should
range from about 100 V to about 4000 V.
[0125] In the preferred embodiment, the AC power supply 502 will
deliver up to 50 W of power and have a maximum peak-to-peak voltage
of 30 V, operating at a frequency of 10-100 kHz. The resistors R1
and R2 may have values of 10 .OMEGA. and 100 .OMEGA., respectively,
resulting in a decay time constant of about 2 minutes and an
expected monitoring voltage of 0-3 V across R2. R3 is a power
resistor with a resistance value of about 100 .OMEGA., which
enables a more rapid adjustment of the voltage across capacitor C1,
such as when the operator selects a lower stunning voltage. Thus,
when switching device S2 is closed, the capacitor C1 is discharged,
with a time constant of 1.4 sec.
[0126] Switching devices S1 and S2 may be switched ON and OFF to
produce a plurality of various amplitude and pulse width duration
RF pulses. Switching devices S1 and S2 may be any suitable
switching device, whether mechanical, electrical or
electromechanical, and are preferably solid state or power
semiconductor switches such as an SCR, gate turn-off thyristor
(GTO), power MOSFET, transistor, thyristor, or hybrid devices with
FET input and a bipolar output stage. The switching devices S1 are
S2 are preferably controlled by a processor 504 (which may be part
of process controller 32 shown in FIG. 1 or a separate component),
and/or with suitable computation circuits, where applicable, to
produce in conjunction with the circuit shown in FIG. 36 a
plurality or train of waveform pulses of RF frequency at the output
2-2 of the circuit. These voltage pulses are stepped up by
transformer T2, having a turns ratio of 4:1, for application to the
patient.
[0127] Shunting resistors R1 and R2 can serve two purposes. First,
when the AC power from power supply 502 is shut off, the resistors
drain charge and reduce power from capacitor C1. Second, the
voltage across resistor R2 is measured by the controller 504 and is
used to control the AC power supply 502. The AC power supply can be
controlled by the controller 504 to vary its output power and
frequency.
[0128] To further provide for isolation, the voltage measurement of
resistor R2 by controller 504 may be made by optical isolation, or
other isolation measuring techniques such as magnetic isolation or
telemetry.
[0129] The circuit of FIG. 36 controls the cycle length of the
rectified RF pulse, the amplitude of the pulse, and the total
duration of the pulse thorough selective discharge of the capacitor
through the selective switching of the switching device S2, which
discharges the capacitor through shunting resistor R3, and
selective switching of switching device S1, which creates a
plurality of rectified RF pulse waveforms that feed through step-up
transformer T2. This produces a RF voltage pulse train for
application to the tissue in the patient's body. The duty cycle of
the RF voltage pulse train may also be controlled by the selective
switching ON and OFF of switching device S1. The center frequency
for the pulse waveform is preferably between about 100 kHz and 1
MHz, with the waveform generated using ON/OFF duty cycles of from
10% to 50%. Frequencies above about 100 Mhz are not effective in a
voltage stunning mode because dielectric absorption results in high
heating rates in the tissue, while frequencies below about 100 kHz
can directly stimulate tissue, which is not desirable.
[0130] In one preferred embodiment, the switching device S1 is
turned ON and OFF with a cycle length of 2 .mu.sec and a duty cycle
of 50%, for a total pulse duration of 10 ms. To produce this pulse
train, a train of 5,000 1.0 .mu.sec long pulses turn switching
device S1 to the ON state, to create a 10 msec long 500 kHz pulse
waveform at the output 2-2 of FIG. 36, which are then suitably
stepped up in voltage in a 4:1 ratio by transformer T2 for output
to the tissue.
[0131] The rectified AC waveform produced by turning switching
device S1 ON and OFF at a 500 kHz repetition rate would, in the
absence of filtering, produce a nearly square wave. However, finite
switching times for the switching device S1 and the transformer T2,
which acts as a bandpass filter, strongly filter out the higher
harmonics of the base frequency of the pulse waveform, resulting in
a stunning waveform as applied to tissue that can be made to be
somewhat sinusoidal. Should a more perfect sinusoidal waveform be
desired, using the teachings of the present invention one could
produce a more perfect sinusoidal waveform by the tuning of the
output transformer T2 to the center frequency of the pulse waveform
used to stun tissue.
[0132] Energy outputted to the patient can be reduced by limiting
the power provided by the AC power supply 502 and the energy stored
in capacitor C1. For one preferred embodiment of the invention,
stored energy at the capacitor C1 is 600 J and the AC power supply
used to charge C1 is limited to 50 W. Under maximum transfer rates,
C1 is discharged with a time constant of 77 msec. After several
hundred msec, C1 is largely discharged, and the power delivery rate
will drop to less than 30 W. Plateau power delivery rates to the
patient are decreased from 50 W at the AC power supply input to 30
W at the output due to power losses, such as losses in transformers
T1 and T2.
[0133] It should be noted that the exemplary power supply circuit
is susceptible to many variations. The only requirement is that
power be supplied to a storage device and discharged from the
storage device by way of a switching device that produces the
desired pulses. For example, should it be found that their
functionality is not required in a particular application, the
resistors in the RC circuit could be eliminated. Storage devices
other than capacitors may be employed. The AC power supply and
rectifier arrangement illustrated in FIG. 36 may be replaced by a
battery (or plurality of batteries in series) and a suitable ON/OFF
switch. Also, the transformer T2 can be replaced by another type of
inductive device.
[0134] E. Electrode Selecting Device
[0135] As discussed in Section III-A, a sequence of stunning pulses
can be applied with different electrodes in a multiple electrode
structure (such as those discussed in Section II and shown in FIGS.
10-13B) to create a complex pattern of temporarily unresponsive
tissue. One example of an electrode selecting device that may be
used to switch from one (or more) electrodes to another (or more)
electrodes in, for example the circuit shown in FIG. 36, is shown
in FIGS. 37A and 37B. Exemplary switching device S3 includes a
plurality of mechanical or electromechanical switches
SW.sub.1-SW.sub.N. Preferably, each switch SW.sub.1-SW.sub.N is
associated with an individual electrode E.sub.1-E.sub.N. Thus, the
state of the switch SW determines whether the associated electrode
will deliver the stunning voltage.
[0136] Relay or mechanical switches are preferred because these
switches can have very low coupling capacitances across the switch,
as compared to single solid state power switches. The switches
should normally be open in order to promote patient safety and
minimize the switching power requirements.
[0137] Should relatively fast switching times be desired, four or
more switches with relatively low ON resistances could be used in
series, thereby decreasing the effective capacitance across the
switch. Here, the switch SW may be formed from multiple solid state
switches in series. It should be noted, however, that such an
arrangement will greatly complicate the switch drive circuitry.
[0138] F. Graphical User Interface-Based System
[0139] One example of a graphical user interface-based system that
may be used to sequentially apply either a single high voltage
pulse or a series of high voltage pulses to tissue is illustrated
in FIGS. 38 and 39. In the illustrated embodiment, the system 310
includes an instrument 312 (such as a catheter or surgical probe)
having an array of electrodes 318, as well as instruments 314 and
316, which include operative elements usable for diagnostic or
therapeutic purposes. One exemplary operative element is a device
for imaging body tissue, such as an ultrasound transducer or an
array of ultrasound transducers, an optic fiber element, or a CT or
MRI scanner. Other exemplary operative elements include device to
deliver drugs or therapeutic material to body tissue, or electrodes
for sensing a physiological characteristic in tissue or
transmitting energy to stimulate or ablate tissue.
[0140] The exemplary system 310 includes one or more instrument
controllers (designated 320, 322, and 324) which, in use, condition
the associated instrument 312, 314, and 316 to perform its
respective diagnostic or therapeutic function. To aid in
coordinating signal and data flow among the controllers 320, 322,
and 324 and their linked instruments, the system 310 includes an
interface 326 (or "master switching unit) that establishes
electrical flow paths and processes the various diagnostic or
therapeutic data and signals in an organized and efficient fashion.
A suitable interface is disclosed in U.S. application Ser. No.
08/770,971, entitled "Unified Switching System for
Electrophysiological Stimulation and Signal Recording and
Analysis," filed Dec. 12, 1996, and incorporated herein by
reference.
[0141] The exemplary system 310 also includes a main processing
unit (MPU) 328, which is preferably a Pentium.TM. microprocessor.
The MPU 328 includes an input/output (I/O) device 330, which
controls and monitors signal and data flow to and from the MPU 328.
The I/O device 330 can, for example, consist of one or more
parallel port links and one or more conventional serial RS-232C
port links or Ethernetm communication links. The I/O device 330 is
coupled to a data storage module or hard drive 332, as well as to
the instrument interface 326 and a printer 334. An operator
interface module 336, which is coupled to the I/O device 330,
includes a graphics display monitor 338, a keyboard input 340, and
a pointing input device 342, such as a mouse or trackball. The
graphics display monitor 338 can also provide for touch screen
(finger or stylus) input. An operating system 344 for the MPU 328
may, for example, reside as process software on the hard drive 332,
which is down loaded to the MPU 328 during system initialization
and startup. In the illustrated embodiment, the operating system
344 executes through the operator interface 336 a graphical user
interface (GUI) 346.
[0142] The operating system 344 administers the activation of a
library 348 of control applications, which are designated, for
purpose of illustration, as A1 to A7 in FIG. 38. In the illustrated
embodiment, the control applications A1 to A7 all reside in storage
354 as process software on the hard drive 332 and are down loaded
and run based upon operator input through the GUI 346. Each control
application A1 to A7 prescribes procedures for carrying out given
functional tasks. Of course, the number and functions of the
applications A1 to A7 can vary. Exemplary functions include
clinical procedures, specialized navigation applications, and
utility applications.
[0143] Clinical procedure applications contain the steps to carry
out a prescribed clinical procedure, such as the sequential
application of stunning pulses to predetermined electrodes in a two
or three-dimensional array. A number of such applications may be
stored, each corresponding to an area, or areas, of stunned tissue
having various shapes and sizes. That way, the physician need only
select the desired shape with the GUI 346 to form the desired area
of temporarily unresponsive tissue. Similar application programs
may be used to form areas of permanently unresponsive tissue using
the high voltage pulse-based modification techniques described in
Section III-C below.
[0144] The navigation applications allow the operator to visualize
on the GUI 346 the orientation of the multiple electrode array 312
and instruments 314 and 316, thereby assisting the operator in
manipulating and positioning the array and instruments. For
example, one navigation application may construct an ideal or
virtual image of the deployed array and the instruments, while the
other displays an actual, real-time image of each.
[0145] Utility applications carry out system testing, system
servicing, printing, and other system support functions affecting
the applications.
[0146] When run by the operating system 344, each application
generates prescribed command signals, which the I/O device 330
distributes via the instrument interface 326 to condition the
instrument controllers 320, 322, and 324 to perform a desired task
using the instruments 312, 314, and 316. The I/O device 326 also
receives data from the instrument controllers 320, 322, and 324 via
the instrument interface 326 for processing by the procedure
application being run. The GUI 346 presents to the operator, in a
graphical format, various outputs generated by the procedure
application run by the operating system 344 and allows the user to
alter or modify specified processing parameters in real time.
[0147] The operating system 344 also includes one or more specialty
functions (designated F1 and F2 in FIG. 38), which run in the
background during execution of the various applications A1 to A7.
For example, one function F1 can serve to establish and maintain an
event log 350 which keeps time track of specified important system
events as they occur during the course of a procedure. Another
function F2 can serve to enable the operator, using the GUI 346, to
down load patient specific information generated by the various
applications A1 to A7 to the hard drive 332 as data base items, for
storage, processing, and retrieval, thereby making possible the
establishment and maintenance of a patient data base 352 for the
system 310.
[0148] As illustrated in FIG. 39, the exemplary multiple electrode
array is a three-dimensional basket structure 358 carried at the
distal end 356 of a catheter or surgical probe. The exemplary
basket structure includes eight spaced apart spline elements
(alphabetically designated A to H in FIG. 39) assembled together by
a distal hub 360 and a proximal base 362. Each spline carries eight
electrodes which are numerically designated on each spline from the
most proximal to the most distal electrode as 1 to 8. The basket
structure 358 thus supports a total of sixty-four electrodes. Of
course, a greater or lesser number of spline elements and/or
electrodes can be present. Each of the electrodes is electrically
connected to an individual conductor in a multiple conductor cable
364. The splines can either be arranged symmetrically, as shown in
FIG. 39, or asymmetrically as shown in FIGS. 13A and 13B to provide
a high density electrode array. A stunning energy source 380 can
also be coupled to the electrodes, either through the instrument
interface 326 (as shown in solid lines in FIG. 39), or through its
own instrument interface 326" (shown in phantom lines in FIG. 39)
coupled to the MPU 328.
[0149] Instrument 314 may be carried at the distal end 366 of a
catheter or surgical probe. In the illustrated embodiment,
instrument 314 includes an electrode 368 for sensing electrical
activity in tissue, as well as to transmitting energy to stimulate
or ablate tissue. The electrode 368 is electrically connected by a
cable 370 to the instrument interface 326. A generator 378 for
transmitting radio frequency ablation energy can also be coupled to
the electrode 368, either through the instrument interface 326 (as
shown in solid lines in FIG. 39), or through its own instrument
interface 326' (shown in phantom lines in FIG. 39) coupled to the
MPU 328. Instrument 316, which may be carried at the distal end of
a catheter or surgical probe, includes an imaging device 372 which
operates using a visualizing technique such as fluoroscopy,
ultrasound, CT, or MRI, to create a real-time image of a body
region. A cable 376 conveys signals from the imaging device 372 to
the instrument interface 326.
[0150] Clinical procedure applications can also be designed and
implemented during a procedure using the GUI 346. Based on the
images provided by the navigation applications of the electrode
support structure, the physician can select the electrodes that
will produce the desired area, or areas, of permanently or
temporarily unresponsive tissue. The image of the electrode support
structure will preferably appear as it does in FIG. 39, i.e. with
the spline letters and electrodes numbers visible. The desired
electrodes can be selected using the keypad by typing the spline
element letters and electrode number. For example, A5, B5 and C5
can be selected to produce an area which spans spline elements, or
A3, A4 and A5 can be selected to produce an area which extends
along a single spline element. Alternatively, the electrodes may be
selected by way of the touch screen or pointing device.
[0151] Unless otherwise desired, the pulses will occur in the order
that the electrodes are selected. Other information, such as pulse
length, time between pulses, pulse magnitude, etc. can also be
input via the GUI 346. Instead of delivering energy sequentially,
the system can be configured such that a plurality of electrodes
transmit energy simultaneously. Such simultaneous transmission may
be part of a sequence that includes other electrodes transmitting
energy simultaneously or individually. This feature may also be
selected on the GUI 346.
[0152] Additional information concerning the GUI-based system
illustrated in FIGS. 38 and 39 may be found in U.S. application
Ser. No. 09/048,629, entitled "Interactive Systems and Methods For
Controlling the Use of Diagnostic or Therapeutic Instruments in
Interior Body Regions," filed Mar. 26, 1998, and incorporated
herein by reference.
[0153] II. Additional Devices That May be Used in a
Stunning-Modification System
[0154] A. Multiple Electrode Stunning-Modification Probes
[0155] Probe configurations employing multiple electrodes may also
be used to form continuous, elongate areas of modified or
temporarily electrically unresponsive (i.e. "stunned") tissue. Such
areas may be either straight or curvilinear. Examples of such
multiple electrode probes are shown in U.S. Pat. Nos. 5,545,193 and
5,582,609, both of which are incorporated herein by reference.
[0156] As shown by way of example in FIG. 6, an exemplary multiple
element probe 100 includes a plurality of segmented, generally
flexible electrodes 102 carried on a flexible body 104. The
flexible body 104 is made of a polymeric, electrically
nonconductive material, like polyethylene or polyurethane, and
preferably carries within it a resilient bendable wire or spring
with attached steering wires so it can be flexed to assume various
curvilinear shapes. The electrodes 102 are preferably spaced apart
lengths of closely wound, spiral coils made of electrically
conducting material, like copper alloy, platinum, or stainless
steel. The electrically conducting material can be coated with
platinum-iridium or gold to improve its conduction properties,
radiopacity and biocompatibility. Instead of a single length of
wound wire, one or more of the electrodes 102 may be formed from
multiple, counter wound layers of wire. The electrodes may also be
formed from a hypotube that is machined into a coil. Additionally,
the other electrode structures disclosed in the present
specification may also be used in combination with this
embodiment.
[0157] Alternatively, a ribbon of electrically conductive material
can be wrapped about the flexible body 104 to form a flexible
electrode. Flexible electrodes may also be applied on the flexible
body by coating the body with a conductive material, like
platinum-iridium or gold, using conventional coating techniques or
an ion beam assisted deposition (IBAD) process. For better
adherence, an undercoating of nickel or titanium can be
applied.
[0158] In another preferred embodiment, and as shown by way of
example in FIG. 7, a generally rigid tip electrode 106 may be
combined with the generally flexible electrodes. Of course, the tip
electrode 106 could be a generally flexible electrode structure
made of a closely wound coil or other flexible material.
Temperature sensing elements 298, such as thermocouples or
thermistors, may also be provided. Temperature sensing is discussed
in detail in Section II-F below.
[0159] The flexible body 104 can be remotely steered to flex it
into a desired shape, or it can possess a preformed shape. In the
latter situation, removing a constraint (such as a sheath, not
shown), enables the operator to change the segment from straight to
curvilinear. The probe body may also be formed from a malleable
material, which is especially useful when the probe is part of a
surgical probe that is not catheter-based. Such probes are
discussed in Section II-D below.
[0160] The number of electrodes and the spacing between them, can
vary, according to the particular objectives of the therapeutic
procedure. For example, the probe shown in FIG. 6 is well suited
for creating continuous, elongated lesion patterns (or patterns of
tissue modified in other ways) as well as continuous, elongated
areas of stunned tissue, provided that the electrodes are
adjacently spaced close enough together to create additive
heating/stunning effects when energy is transmitted simultaneously
to the adjacent electrodes. The additive heating effects between
close, adjacent electrodes intensifies the desired effect on the
tissue contacted by the electrodes. The additive heating effects
occur when the electrodes are operated simultaneously in a bipolar
mode between electrodes or when the electrodes are operated
simultaneously in a unipolar mode, transmitting energy to an
indifferent electrode.
[0161] More particularly, when the spacing between the electrodes
is equal to or less than about 3 times the smaller of the diameters
of the electrodes, the simultaneous emission of energy by the
electrodes creates an elongated continuous lesion pattern, or area
of stunned tissue, in the contacted tissue area due to the additive
effects. Similar effects are obtained when the spacing between the
electrodes is equal to or less than about 2 times the longest of
the lengths of the electrodes.
[0162] To consistently form long, thin, continuous curvilinear
lesion patterns or areas of electrically unresponsive tissue,
additional spatial relationships among the electrodes must be
observed. When the length of each electrode is equal to or less
than about 5 times the diameter of the respective electrode, the
curvilinear path that the probe takes should create a distance
across the contacted tissue area that is greater than about 8 times
the smaller of the diameters of the electrodes. The simultaneous
application of energy will form a continuous elongate lesion
pattern, or area of stunned tissue, that follows the curved
periphery contacted by the probe, but does not span across the
contacted tissue area. The same effect will be obtained when the
length of each electrode is greater than about 5 times the diameter
of the respective electrode, and the curvilinear path that support
element takes should create a radius of curvature that is greater
than about 4 times the smallest the electrode diameters. Of course,
the spacing between the electrodes must be such that additive
heating effects are created.
[0163] Taking the above considerations into account, it has been
found that adjacent electrode segments having lengths of less than
about 2 mm do not consistently form the desired continuous lesions.
Such constraints do not apply to areas of stunned tissue.
Techniques to stun tissue to 5 mm to 10 mm in depth using small
electrodes are discussed in Section III-B. For ablation purposes,
flexible electrode elements can range from 2 mm to 50 mm in length
and are preferably 12.5 mm in length with 2 to 3 mm spacing. The
diameter of the electrodes and underlying flexible body can vary
from about 4 French to about 10 French in catheter-type probes. The
tip electrode is preferably from 4 mm to 10 mm in length.
[0164] The flexibility of the coil electrodes can be increased by
spacing the individual coil windings, which increases the ability
of the windings to closely conform to irregular anatomical
surfaces. The windings of electrodes should be spread apart by a
distance that is at least 1/5 of the width of the material that
makes up the individual coils. Preferably, the distance is 1/2 of
the width. Referring to FIG. 8, the distance D can also vary along
the length of the electrode. Here, the electrode 110 includes a
first zone 112 of windings that are spaced apart and two second
zones 114 of windings that are closely adjacent to one another. The
closely spaced zones provide a support structure for temperature
sensing elements, which as discussed below in Section II-F, may be
advantageously placed at the longitudinal ends of the electrode.
Although the exemplary electrode shown in FIG. 8 has a rectangular
cross-section, other configurations, such as a round cross-section,
can also be employed.
[0165] Power can be supplied to the electrodes individually or, as
described above, the power can be simultaneously supplied to more
than one or even all of the electrodes. The supply of power to the
electrodes can be controlled in the manner disclosed in U.S. Pat.
No. 5,545,193.
[0166] B. Structures For Positioning Electrodes in a
Three-Dimensional Array
[0167] There are many instances where it is advantageous to
position electrodes in a three-dimensional array. For example, the
interatrial septum (identified by the letter S in FIG. 9) has been
shown to be a junction for the propagation of atrial fibrillation
wavelets. FIGS. 9 and 10 show a device 116 adapted to locate
multiple electrodes 118 against a large area of the interatrial
septum (S). The device 116 may be used in the same manner as the
mapping device 14 shown in FIG. 2. The device may also be used to
deliver RF energy to ablate tissue. For example, a subset of the
electrodes on the array can be used to simultaneously deliver RF
energy to the tissue contacting the electrodes. The subset is
chosen based on the geometry and dimensions of the region to be
ablated. The region may be a long, continuous line used to treat
AFIB, a large circular area used to treat the subendocardial
substrates that cause VT, or any other geometry necessary to ablate
the substrate(s) causing a particular physiologic event.
[0168] Although device 116 is shown as part of a catheter-based
device, it may also be employed in a surgical probe that is not
catheter-based. Such probes are discussed in Section II-D
below.
[0169] The device 116 includes an array of spline elements 120 that
radiate in a star-like pattern from the distal end 122 of a
catheter tube 124 (as the end view in FIG. 10 best shows). Each
spline element 120 carries multiple electrodes 118. As shown by way
of example in FIG. 9, the catheter tube 124 is deployed through a
conventional transeptal sheath 126 into the left atrium. During
introduction, the sheath 126 encloses the device 116, maintaining
the device in a collapsed condition. Once located in the left
atrium, the sheath 126 is pulled back past the septum S, and the
spline elements 120, freed of the sheath 126, spring open. The
physician pulls the catheter tube 124 back to bring the electrodes
118 into contact against the septal wall within the left
atrium.
[0170] Turning to FIG. 11, the device 116 can be deployed in the
right atrium by introduction through the sheath 126. Retraction of
the sheath 126 allows the spline elements 120 to spring open. The
physician pushes the catheter tube 124 toward the septum S to place
the electrodes 118 into contact against the septal wall within the
right atrium.
[0171] Another device, generally represented by reference numeral
128 in FIGS. 12A and 12B, includes a high density array of
electrodes 130 that can be placed against the septal wall in the
right atrium, or against another region anywhere within the heart.
The device 128 includes an array of spline elements 132 constrained
between a proximal anchor 134 and a distal hub 136. The device 128
is attached to the distal end 138 of a catheter tube 140. However,
it may also be employed in a surgical probe that is not
catheter-based.
[0172] The spline elements 132 carry the electrodes 130 such that
they are concentrated in a high density pattern about the distal
hub 136. Away from the distal hub 136, the spline elements 132 are
free of electrodes 130.
[0173] A stylet 142 extends through the catheter tube bore 144 and
is attached at its distal end to the distal hub 136. The proximal
end of the stylet 142 is attached to a push-pull control mechanism
146 in the catheter tube handle 148. As FIG. 12B shows, pulling
back on the mechanism 146 (arrow 147) draws the distal hub 136
toward the proximal anchor 134. The distal region of the spline
elements 132 bend and deform outward, to form a generally planar
surface 150 radiating about the distal hub 136, on which the
electrodes 130 are located. The surface 150 presents the high
density pattern of electrodes 130 for intimate surface contact with
a large region of heart tissue. The distal hub 136 can be made of
an energy transmitting material and serve as an electrode to
increase the electrode density.
[0174] FIGS. 13A and 13B show another example of a device (or
"support assembly") that may be used to position a high density
array of electrodes against a bodily structure. The support
assembly 129 can be attached to the distal end of a catheter or
surgical probe and includes an array of flexible spline elements
131 extending longitudinally between a distal hub 133 and a base
135. The geometry of the assembly 129 is asymmetric in a radial
sense. That is, when viewed from distal hub 133, as FIG. 13B shows,
the spline elements 131 do not radiate from the main axis at
generally equal circumferential intervals. Instead, there are at
least some adjacent spline elements 131 that are circumferentially
spaced apart more than other adjacent spline elements 131. The
largest angle measured between two adjacent spline elements in the
assembly (designated angle .alpha. in FIG. 13B) preferably exceeds
the smallest angle measured between two other adjacent spline
elements (designated angle .beta. in FIG. 1 3B).
[0175] Due to the radial asymmetry of the assembly 129, not all the
spline elements 131 need to carry electrodes 137. The geometry of
the assembly 129 is symmetric in an axial sense. The proximal
region 139 and the distal region 141 of each spline are, or capable
of being, occupied by electrodes 137.
[0176] The exemplary embodiment shown in FIGS. 13A and 13B includes
ten spline elements 131, designated S1 to S10. The exemplary
asymmetric arrangement includes a first discrete group 145 of five
adjacent spline elements 131 (S1 to S5) and a second discrete group
149 (S6 to S10). The groups 145 and 149 are shown to be
diametrically arranged, and each group 145 and 149 occupies an arc
of about 90.degree.. Within each group, the adjacent spline
elements S1 to S5 and S6 to S10 are circumferentially spaced apart
in equal intervals of about 22.degree. (which comprises angle
.beta.). However, the spline elements S1/S10 and S5/S6, marking the
boundaries between the groups 145 and 149, are circumferentially
spaced farther apart, at about 90.degree. (which comprises angle
.alpha.). This non-uniform circumferential spacing of the spline
elements 131 exemplifies one type of radially asymmetric
structure.
[0177] Preferably, the distance between electrode s on different
spline elements within a group of spline elements (such as S1 to
S5) is equal to the distance between electrodes on a spline element
within the group. In other words, the distance between two adjacent
electrodes on a spline element is the same as the distance between
two adjacent electrodes respectively located on adjacent spline
elements. Such an arrangement simplifies the process of forming
complex two-dimensional patterns (or large areas) of stunned or
permanently modified tissue.
[0178] Other types of asymmetric structures for positioning
electrodes in a three-dimensional array, such as axially asymmetric
structures, are disclosed in U.S. patent application Ser. No.
08/742,569, entitled "Asymmetric Multiple Electrode Support
Structures," filed Oct. 28, 1996, which is incorporated herein by
reference.
[0179] C. Expandable-Collapsible Porous Electrode Structures
[0180] Device configurations employing expandable-collapsible
porous electrode structures can be used to form areas of modified
or temporarily unresponsive tissue that are either large and deep,
small and shallow, or large and shallow. Examples of such devices
are shown in FIGS. 15-22. These devices may be used in the same
manner as the device shown in FIGS. 1 and 3. Additionally, although
the devices shown in FIGS. 15-22 are part of catheter-based devices
(such as that shown in FIG. 14), the features of the devices may be
employed in surgical probes that are not catheter-based. Such
probes are discussed in Section II-D below.
[0181] Additional information concerning expandable-collapsible
porous electrode structures, which are preferably formed from
regenerated cellulose, can be found in U.S. patent application Ser.
No. 08/631,575, entitled "Tissue Heating and Ablation Systems and
Methods Using Porous Electrode Structures," which is incorporated
herein by reference.
[0182] 1. Expandable-Collapsible Porous Electrode Structure
Configurations
[0183] FIG. 14 shows a tissue modification-stunning system 152 that
includes a flexible catheter tube 154 with a proximal end 156 and a
distal end 158. The proximal end 156 carries a handle 160. The
distal end 158 carries an electrode structure 162. As shown by way
of example in FIGS. 15 and 20, the electrode structure 162 includes
an expandable-collapsible body 164. The geometry of the body 164
can be altered between a collapsed geometry (FIG. 16) and an
enlarged, or expanded, geometry (FIG. 15). In the illustrated
embodiments, liquid pressure is used to inflate and maintain the
expandable-collapsible body 164 in the expanded geometry.
[0184] As illustrated for example in FIGS. 14-16, the catheter tube
154 carries an interior lumen 166 along its length. The distal end
of the lumen 166 opens into the hollow interior of the
expandable-collapsible body 164. The proximal end of the lumen 166
communicates with a port 168 on the handle 160. The liquid
inflation medium 170 is conveyed under positive pressure through
the port 168 and into the lumen 166. The liquid medium 170 fills
the interior of the expandable-collapsible body 164. The liquid
medium 170 exerts interior pressure to urge the
expandable-collapsible body 164 from its collapsed geometry to the
enlarged geometry.
[0185] This characteristic allows the expandable-collapsible body
164 to assume a collapsed, low profile (ideally, less than 8 French
diameter, i.e., less than about 0.267 cm) when introduced into the
vasculature. Once located in the desired position, the
expandable-collapsible body 164 can be urged into a significantly
expanded geometry of, for example, approximately 5 mm to 20 mm.
Expandable-collapsible bodies with larger profiles may be used in
conjunction with probes that are not catheter-based.
[0186] As shown by way of example in FIGS. 18 and 19, the structure
162 can include, if desired, a normally open, yet collapsible,
interior support structure 172 to apply internal force to augment
or replace the force of liquid medium pressure to maintain the body
164 in the expanded geometry. The form of the interior support
structure 172 can vary. It can, for example, comprise an assemblage
of flexible spline elements 174, as shown in FIG. 18, or an
interior porous, interwoven mesh or an open porous foam
structure.
[0187] The exemplary internally supported expandable-collapsible
body 164 is brought to a collapsed geometry, after the removal of
the inflation medium, by outside compression applied by an outer
sheath 178 (see FIG. 19), which slides along the catheter tube 154.
Forward movement of the sheath 178 advances it over the expanded
expandable-collapsible body 164. The expandable-collapsible body
164 collapses into its low profile geometry within the sheath 178.
Rearward movement of the sheath 178 retracts it away from the
expandable-collapsible body 164. Free from the confines of the
sheath 178, the interior support structure 172 springs open to
return the expandable-collapsible body 164 to its expanded geometry
to receive the liquid medium.
[0188] As illustrated for example in FIG. 18, the structure 162
further includes an interior electrode 180 formed of an
electrically conductive material carried within the interior of the
body 164. The material of the interior electrode 180 has both a
relatively high electrical conductivity and a relatively high
thermal conductivity. Materials possessing these characteristics
include gold, platinum, platinum/iridium, among others. Noble
metals are preferred. An insulated signal wire 182 is coupled to
the electrode 180. The signal wire 182 extends from the electrode
180, through the catheter tube 154, to an external connector 185 on
the handle 160. The connector 185 electrically couples the
electrode 180 to a radio frequency generator.
[0189] In accordance with the exemplary embodiments, the liquid
medium 170 used to fill the body 164 includes an electrically
conductive liquid. The liquid 170 establishes an electrically
conductive path, which conveys radio frequency energy from the
electrode 180. In conjunction, the body 164 comprises an
electrically non-conductive thermoplastic or elastomeric material
that contains pores 184 on at least a portion of its surface. The
pores 184 of the body 164 (shown diagrammatically in enlarged form
for the purpose of illustration) establishes ionic transport of the
tissue stunning or modification energy from the electrode 180,
through the electrically conductive medium 170, to tissue outside
the body. Preferably, the liquid 170 possesses a low resistivity to
decrease ohmic loses, and thus ohmic heating effects, within the
body 164. In the illustrated and preferred embodiment, the liquid
170 also serves the additional function as the inflation medium for
the body, at least in part.
[0190] The composition of the electrically conductive liquid 170
can vary. In the illustrated and preferred embodiment, the liquid
170 comprises a hypertonic saline solution, having a sodium
chloride concentration at or near saturation, which is about 20%
weight by volume. Hypertonic saline solution has a low resistivity
of only about 5 ohm.cm, compared to blood resistivity of about 150
ohm.cm and myocardial tissue resistivity of about 500 ohm.cm.
Alternatively, the composition of the electrically conductive
liquid medium 170 can comprise a hypertonic potassium chloride
solution. This medium, while promoting the desired ionic transfer,
requires closer monitoring of rate at which ionic transport occurs
through the pores 184, to prevent potassium overload. When
hypertonic potassium chloride solution is used, it is preferred
keep the ionic transport rate below about 1 mEq/min.
[0191] Due largely to mass concentration differentials across the
pores 184, ions in the medium 170 will pass into the pores 184,
because of concentration differential-driven diffusion. Ion
diffusion through the pores 184 will continue as long as a
concentration gradient is maintained across the body 164. The ions
contained in the pores 184 provide the means to conduct current
across the body 164.
[0192] When radio frequency energy is conveyed from a generator to
the electrode 180, electric current is carried by the ions within
the pores 184. The RF currents provided by the ions result in no
net diffusion of ions, as would occur if a DC voltage were applied,
although the ions do move slightly back and forth during the RF
frequency application. This ionic movement (and current flow) in
response to the applied RF field does not require perfusion of
liquid in the medium 170 through the pores 184. The ions convey
radio frequency energy through the pores 184 into tissue to a
return electrode, which is typically an external patch electrode
(forming a unipolar arrangement). Alternatively, the transmitted
energy can pass through tissue to an adjacent electrode (forming a
bipolar arrangement). The radio frequency energy may be used to
heat tissue (mostly ohmically) to form a lesion, or to render
tissue temporarily unresponsive.
[0193] The preferred geometry of the expandable-collapsible body is
essentially spherical and symmetric, with a distal spherical
contour. However, nonsymmetric or nonspherical geometries can be
used. For example, the expandable-collapsible body may be formed
with a flattened distal contour, which gradually curves or necks
inwardly for attachment with the catheter tube. Elongated,
cylindrical geometries can also be used.
[0194] The exemplary segmented porous zones 198 shown in FIG. 21
are well suited for use in association with folding
expandable-collapsible bodies 164. In this arrangement, the regions
that are free of pores comprise creased or folding regions 204. It
should be appreciated that the foldable body 164 shown in FIG. 21
can also be used for other patterns of porous regions. The creased
regions 204 can also be provided with pores, if desired.
[0195] 2. Pore Patterns
[0196] The pattern of pores 184 that define the porous region of
the body may vary. As shown by way of example in FIGS. 15 and 16,
the region of at least the proximal 1/3 surface of the
expandable-collapsible body 164 is free of pores 184 and the porous
region is in the form of a continuous cap on the distal 1/3 to 1/2
of the body. This configuration is useful when it is expected that
ablation will occur with the distal region of body 164 oriented in
end-on contact with tissue. Alternatively, the electrically
conductive porous region may be segmented into separate energy
transmission zones arranged in a concentric "bulls eye" pattern
about the distal tip of the body 164. When it is expected that
tissue stunning or modification will occur with the side region of
the body 164 oriented in contact with tissue, the porous region is
preferably segmented into axially elongated energy transmission
zones, which are circumferentially spaced about the body.
[0197] 3. Non-porous Conductive and Marking Regions
[0198] FIG. 22 shows an embodiment of an expandable-collapsible
electrode structure 206 that includes one or more nonporous,
electrically conductive regions 208 on the surface of the body 164.
In the illustrated embodiment, the nonporous conductive regions 208
comprise metal, such as gold, platinum, platinum/iridium, among
others, deposited upon the expandable-collapsible body 164 by
sputtering, vapor deposition, ion beam deposition, electroplating
over a deposited seed layer, or a combination of these processes.
Alternatively, the nonporous conductive regions 208 can comprise
thin foil affixed to the surface of the body. Still alternatively,
the nonporous conductive regions can comprise solid fixtures
carried by the porous body 164 at or more locations. Signal wires
(not shown) within the body are electrically coupled to the
nonporous regions. The signal wires traverse the catheter tube 154
for coupling to the connectors 185 carried by the handle 160.
[0199] Various ways for attaching nonporous electrodes 208 and
associated signal wires to an expandable-collapsible electrode body
164 are described in U.S. patent application Ser. No. 08/629,363,
entitled "Enhanced Electrical Connections for Electrode
Structures," which is incorporated herein by reference.
[0200] The nonporous regions 208 can be used to sense electrical
activity in myocardial tissue. The sensed electrical activity is
conveyed to an external controller, which processes the potentials
for analysis by the physician. The processing can create a map of
electrical potentials or depolarization events for the purpose of
locating potential arrhythmia substrates. Once located with the
nonporous regions 208, the porous regions 198 can be used to convey
radio frequency energy as previously described to ablate the
substrates. Alternatively, or in combination with sensing
electrical activities, the nonporous regions 208 can be used to
convey pacing signals. In this way, the nonporous regions can carry
out pace mapping or entrainment mapping.
[0201] Opaque markers may be deposited on the interior surface of
the body 164 so that the physician can guide the device under
fluoroscopy to the targeted site. Any high-atomic weight material
is suitable for this purpose. For example, platinum,
platinum-iridium. can be used to build the markers. Preferred
placements of these markers are at the distal tip and center of the
structure 164.
[0202] The expandable-collapsible structure 206 shown in FIG. 22
thereby combines the use of "solid" nonporous electrodes 208 with
"liquid" or porous electrodes 198. The expandable-collapsible
structure makes possible the mapping of myocardial tissue for
therapeutic purposes using one electrode function, and the stunning
or modification of tissue for therapeutic purposes using a
different electrode function.
[0203] 4. Electrical Resistivity of the Expandable-Collapsible
Body
[0204] The electrical resistivity of the body 164 has a significant
influence on the lesion geometry and controllability. It has been
discovered that ablation with devices that have a low-resistivity
body 164 (below about 500 ohm.cm) requires more RF power and
results in deeper lesions. On the other hand, devices that have a
high-resistivity body 164 (at or above about 500 ohm.cm) generate
more uniform heating, therefore, improve the controllability of the
lesion. Because of the additional heat generated by the increased
body resistivity, less RF power is required to reach similar tissue
temperatures after the same interval of time. Consequently, lesions
generated with high-resistivity bodies 164 usually have smaller
depth. The electrical resistivity of the body 164 can be controlled
by specifying the pore size of the material, the porosity of the
material, and the water adsorption characteristics (hydrophilic
versus hydrophobic) of the material. A detailed discussion of these
characteristics, as well as the formation of the
expandable-collapsible body, can be found in the aforementioned
U.S. application Ser. No. 08/631,575, entitled "Tissue heating and
Ablation Systems and Methods Using Porous Electrode
Structures."
[0205] Generally speaking, pore diameters smaller than about 0.1
.mu.m retain macromolecules, but allow ionic transfer through the
pores in response to the applied RF field. With smaller pore
diameters, pressure driven liquid perfusion through the pores 184
is less likely to accompany the ionic transport, unless relatively
high pressure conditions develop within the body 164. Larger pore
diameters (less than 8 .mu.m) prevent most blood cells from
crossing the membrane, but permit passage of ions in response to
the applied RF field. With larger pore diameters, pressure driven
liquid perfusion, and the attendant transport of macromolecules
through the pores 184, is also more likely to occur at normal
inflation pressures for the body 164.
[0206] Low or essentially no liquid perfusion through the pores 184
is preferred because it limits salt or water overloading, caused by
transport of the hypertonic solution into the blood pool and it
allows ionic transport to occur without disruption. When
undisturbed by attendant liquid perfusion, ionic transport creates
a continuous virtual electrode 186 (see FIG. 20) at the body
164-tissue interface. The virtual electrode 186 efficiently
transfers RF energy without need for an electrically conductive
metal surface.
[0207] With respect to porosity, the placement of the pores 184 and
the size of the pores 184 determine the porosity of the body 164.
The porosity represents the space on the body 164 that does not
contain material, or is empty, or is composed of pores 184.
Expressed as a percentage, porosity represents the percent volume
of the body 164 that is not occupied by the body material. The
magnitude of the porosity affects the liquid flow resistance of the
body 164, as discussed above. The equivalent electrical resistivity
of the body 164 also depends on its porosity. Low-porosity
materials have high electrical resistivity, whereas high-porosity
materials have low electrical resistivity. For example, a material
with 3% porosity, when exposed to 9% hypertonic solution
(resistivity of 5 ohm.cm), may have an electrical resistivity
comparable to that of blood or tissue (between 150 and 450
ohm.cm).
[0208] For a given a porosity value, an array of numerous smaller
pores 184 is typically preferred, instead of an array of fewer but
larger pores, because the presence of numerous small pores 184
distributes current density so that the current density at each
pore 184 is less. With current density lessened, the ionic flow of
electrical energy to tissue occurs with minimal diminution due to
resistive heat loss. An array of numerous smaller pores 184 is also
preferred because it further helps to impose favorably large liquid
flow resistance. It is also preferable that the porous body 164
possess consistent pore size and porosity throughout the desired
ablation region to avoid localized regions of higher current
density and the formation of lesions that are not therapeutic
because they do not extend to the desired depth or length.
[0209] A dynamic change in resistance across a body 164 can be
brought about by changing the diameter of the body 164 made from a
porous elastic material, such as silicone. In this arrangement, the
elastic body 164 is made porous by drilling pores of the same size
in the elastic material when in a relaxed state, creating a given
porosity. As the elastic body 164 is inflated, its porosity remains
essentially constant, but the wall thickness of the body 164 will
decrease. Thus, with increasing diameter of the body 164, the
resistance across the body 164 decreases, due to decreasing wall
thickness and increasing surface area of the body 164. The desired
lesion geometry may be specified according to the geometry of the
body 164. This enables use of the same porous body 164 to form
small lesions, shallow and wide lesions, or wide and deep lesions,
by controlling the geometry of the body 164.
[0210] Turning to water absorption characteristics, hydrophilic
materials are generally preferable because they possess a greater
capacity to provide ionic transfer of RF energy without significant
liquid flow through the material.
[0211] D. Surgical Probes
[0212] As noted above, the present inventions are not limited to
catheter-based devices and may be incorporated into surgical probes
which are not catheter-based. Such probes allow the physician to
directly apply the electrode or other operative element to tissue.
Additional information concerning such probes, and uses thereof,
may be found in U.S. patent application Ser. No. 08/949,117,
entitled "Systems and Methods for Positioning a Diagnostic or
Therapeutic Element Within the Body," which is incorporated herein
by reference.
[0213] As illustrated for example in FIGS. 23 and 24, a surgical
device (or "probe") 210 for positioning an operative element 214
within a patient includes a relatively short shaft 216 and a
substantially triangularly shaped spline assembly 234. The
relatively short shaft may be between approximately 4 and 18 inches
in length, and is preferably 8 inches in long, while the outer
diameter of the shaft is preferably between approximately 6 and 24
French. The operative element preferably consists of a plurality of
electrode elements 250. The spline assembly 234 consists of first
and second side legs 236 and 238 and a distal leg 240. The distal
leg 240, which is preferably non-linear from end to end and
approximately 10 to 12 cm in length, includes first and second
linear portions 242 and 244 and a bent portion 246 located mid-way
between the ends. This spline configuration provides a spring force
against the selected bodily surface during use (such as the atrium
wall in a cardiac procedure) and the bend in the distal leg 240
optimizes the contact between the operative element 214 and the
selected surface. The surgical probe 210 also includes a first
handle 228 and a second handle 229.
[0214] The spline assembly 234 will collapse in the manner shown in
FIG. 24 when a tubular member 226 (such as a sheath) is advanced
thereover and will return to the orientation shown in FIG. 23 when
the tubular member is retracted. The tubular member 226 preferably
includes a raised gripping surface 230.
[0215] During use of the exemplary surgical device shown in FIGS.
23 and 24, the handle 229 is grasped by the physician and force is
applied through the shaft 216 and side legs 236 and 238 to the
operative element supporting distal leg 240. The shaft 216 and side
legs 236 and 238 may be configured such that they collapse and form
a semicircle with the distal leg 240 when force is applied to the
shaft. Here, the operative element should be appropriately masked
in one of the manners described below to limit contact of the
operative element to the intended bodily structure.
[0216] The exemplary embodiment illustrated in FIGS. 23 and 24 may
also be provided without the tubular member 226. Such devices are
especially useful in surgical procedures associated with a
thoracotomy or a median sternotomy, where the spline assemblies can
be easily collapsed and advanced to the desired location, or
advanced into the desired location without being collapsed. Here,
the spline assemblies can be malleable, if desired, as opposed to
simply being bendable.
[0217] The spline assemblies illustrated in FIGS. 23 and 24 are
preferably made from resilient, inert wire, like nickel titanium
(commercially available as Nitinol material) or 17-7 stainless
steel. However, resilient injection molded inert plastic can also
be used. The wire or molded plastic is covered by suitable
biocompatible thermoplastic or elastomeric material such as
PEBAX.RTM. or pellethane. Preferably, the various portions of the
spline assemblies comprises a thin, rectilinear strips of resilient
metal or plastic material. Still, other cross-sectional and
longitudinal configurations can be used. For example, the spline
legs 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. The distal leg 240 may be
configured such that the leg is flat at the distal end, but becomes
more semicircular in cross-section as the leg becomes more proximal
in order to taper the stiffness profile and prevent lateral
movement of the spline assembly. The curvature of the spline legs
may also be varied and the lateral ends of the distal leg may be
reinforced in order to provide more lateral stability.
[0218] As shown by way of example in FIGS. 25-27, the spline
assembly of the probe shown in FIGS. 23 and 24 may be replaced by a
curved spline assembly 252. Here, the spline assembly includes a
flat, inert wire 254 (preferably formed from Nitinol) that acts as
a spring and an outer portion 256 (preferably formed from
PEBAX.RTM. or pellethane). Viewed in cross-section, the flat wire
254 has a long side and a short side. As such, the spline assembly
252 will deflect in the manner shown in FIG. 26 when "in plane"
forces F are applied to the spline assembly. Conversely, the
assembly will resist bending when "out of plane" forces are
applied. As such, it may be used to form an arcuate lesion during,
for example, a procedure where a lesion is formed around the
pulmonary vein.
[0219] It should be noted here that the wire 254 does not have to
be rectangular in cross-section. Other cross-sectional shapes where
the length is greater than the width can also be used. The wire 254
can also be made from a malleable material such as partially or
fully annealed stainless steel instead of the spring-like material
discussed above. The malleable embodiments will enable the operator
to form fit the ablation element support structure to irregular
anatomical structures.
[0220] As shown in FIG. 27, exemplary spline assembly 252 may
include first and second steering wires 251a and 251b that are
secured to the spring-like flat wire 254 by, for example, welding
or adhesive bonding. The proximal ends of the steering wires 251a
and 251b are operably connected to a knob 255 on a handle 248 by
way of a cam (not shown). The handle 248 also includes provisions
for the steering wires 251a and 251b. Rotation of the knob 255 will
cause the spline assembly to move side to side. Thus, in addition
to simply moving the handle, the physician will be able to move the
operative element 214 within the patient by rotating the knob 255.
Such movement is useful when the physician is attempting to
precisely locate the operative element within the patient and/or
control the contact force between the operative element and the
tissue surface. This is especially true when the handle and or
shaft 216 cannot be moved, due to anatomical or surgical
constraints.
[0221] In the exemplary embodiment shown in FIG. 27, the steering
wires 251a and 251b are both secured at about the midpoint of the
flat wire loop. Other configurations are possible depending on the
configuration of the loop that is desired after the knob 255 is
rotated. For example, one wire could be secured closer to the top
of the loop than the other. The shape of the cam may also be
varied. More detailed discussions of the use of steering wires,
albeit in conventional catheter settings, can be found in commonly
assigned U.S. Pat. Nos. 5,195,968, 5,257,451, and 5,582,609, which
are incorporated herein by reference.
[0222] The shaft 216 is preferably relatively stiff. As used herein
the phrase "relatively stiff" means that the shaft (or other
structural element) is either rigid, malleable, or somewhat
flexible. A rigid shaft cannot be bent. A malleable shaft is a
shaft that can be readily bent by the physician to a desired shape,
without springing back when released, so that it will remain in
that shape during the surgical procedure. Thus, the stiffness of a
malleable shaft must be low enough to allow the shaft to be bent,
but high enough to resist bending when the forces associated with a
surgical procedure are applied to the shaft. A somewhat flexible
shaft will bend and spring back when released. However, the force
required to bend the shaft must be substantial. Rigid and somewhat
flexible shafts are preferably formed from stainless steel, while
malleable shafts are formed from annealed stainless steel.
[0223] One method of quantifying the flexibility of a shaft, be it
shafts in accordance with the present invention or the shafts of
conventional catheters, is to look at the deflection of the shaft
when one end is fixed in cantilever fashion and a force normal to
the longitudinal axis of the shaft is applied somewhere between the
ends. Such deflection (.sigma.) is expressed as follows:
.sigma.=WX.sup.2(3L-X)/6EI
[0224] where:
[0225] W is the force applied normal to the longitudinal axis of
the shaft,
[0226] L is the length of the shaft,
[0227] X is the distance between the fixed end of the shaft and the
applied force,
[0228] E is the modulous of elasticity, and
[0229] I is the moment of inertia of the shaft.
[0230] When the force is applied to the free end of the shaft,
deflection can be expressed as follows:
.sigma.=WL.sup.3/3EI
[0231] Assuming that W and L are equal when comparing different
shafts, the respective E and I values will determine how much the
shafts will bend. In other words, the stiffness of a shaft is a
function of the product of E and I. This product is referred to
herein as the "bending modulus." E is a property of the material
that forms the shaft, while I is a function of shaft geometry, wall
thickness, etc. Therefore, a shaft formed from relatively soft
material can have the same bending modulus as a shaft formed from
relatively hard material, if the moment of inertia of the softer
shaft is sufficiently greater than that of the harder shaft.
[0232] For example, a relatively stiff 2 inch shaft (either
malleable or somewhat flexible) would have a bending modulus of at
least approximately 1 lb.-in..sup.2 Preferably, a relatively stiff
2 inch shaft will have a bending modulus of between approximately 3
lb.-in..sup.2 and approximately 50 lb.-in..sup.2. By comparison, 2
inch piece of a conventional catheter shaft, which must be flexible
enough to travel through veins, typically has bending modulus
between approximately 0.1 lb.-in..sup.2 and approximately 0.3
lb.-in..sup.2. It should be noted that the bending modulus ranges
discussed here are primarily associated with initial deflection. In
other words, the bending modulus ranges are based on the amount of
force, applied at and normal to the free of the longitudinal axis
of the shaft, that is needed to produce 1 inch of deflection from
an at rest (or no deflection) position.
[0233] As noted above, the deflection of a shaft depends on the
composition of the shaft as well as its moment of inertia. The
shaft could be made of elastic material, plastic material,
elasto-plastic material or a combination thereof. By designing the
shaft 216 to be relatively stiff (and preferably malleable), the
surgical tool is better adapted to the constraints encountered
during the surgical procedure. The force required to bend a
relatively stiff 2 inch long shaft should be in the range of
approximately 1.5 lbs. to approximately 12 lbs. By comparison, the
force required to bend a 2 inch piece of conventional catheter
shaft should be between approximately 0.2 lb. to 0.25 lb. Again,
such force values concern the amount of force, applied at and
normal to the free of the longitudinal axis of the shaft, that is
needed to produce 1 inch of deflection from an at rest (or no
deflection) position.
[0234] Ductile materials are preferable in many applications
because such materials can deform plastically before failure due to
fracturing. Materials are classified as either ductile or brittle,
based upon the percentage of elongation when the fracture occurs. A
material with more than 5 percent elongation prior to fracture is
generally considered ductile, while a material with less than 5
percent elongation prior to fracture is generally considered
brittle. Material ductility can be based on a comparison of the
cross sectional area at fracture relative to the original cross
area. This characteristic is not dependent on the elastic
properties of the material.
[0235] Alternatively, the shaft could be a mechanical component
similar to shielded (metal spiral wind jacket) conduit or flexible
Loc-Line.RTM., which is a linear set of interlocking ball and
socket linkages that can have a center lumen. These would be
hinge-like segmented sections linearly assembled to make the
shaft.
[0236] The exemplary tubular member 226 illustrated in FIGS. 23 and
24 is preferably in the form of a relatively thin cylindrical
sheath (e.g., with a wall thickness of about 0.005 inch) and has an
outer diameter which is preferably less than 0.180 inch. The sheath
material is preferably also lubricious, to reduce friction during
movement of the sheath relative to the shaft 216 and spline
assembly 234. For example, materials made from
polytetrafluoroethylene (PTFE) can be used for the sheath. The
distal end of the sheath should be relatively flexible to prevent
injury. If necessary, additional stiffness can be imparted to the
remaining portion of the sheath by lining the sheath with a braided
material coated with PEBAX.RTM. material (comprising polyethel
block amide related to nylon). Other compositions made from PTFE
braided with a stiff outer layer and other lubricious materials can
be used.
[0237] Alternatively, the tubular member 226 may be relatively
stiff and formed from the materials described above with respect to
the shaft 216.
[0238] As shown by way of example in FIG. 28, a surgical probe 260
in accordance with another embodiment of a present invention
includes a relatively stiff shaft 262, a handle 264 and a distal
section 266. The shaft 262 consists of a hypotube 268, which is
either rigid or relatively stiff, and an outer polymer tubing 270
over the hypotube. A relatively stiff tube, either malleable or
somewhat flexible, will preferably have a bending modulus of
between approximately 3 lb.-in..sup.2 and approximately 50
lb.-in..sup.2. The handle 264 is similar to the handle 228
discussed above in that it includes a PC board 272 for connecting
the operative elements on the distal portion of the probe to a
power source. The handle 264 preferably consists of two molded
handle halves and is also provided with strain relief element 274.
An operative element 214 (here, in the form of a plurality of
electrode elements 54) is provided on the distal section 266. This
embodiment is particularly useful because it can be easily inserted
into the patient through an introducing port such as a trocar.
[0239] In those instances where a malleable shaft 262 is desired,
the hypotube 268 may be the heat treated malleable hypotube 268
shown in FIGS. 28 and 32. By selectively heat treating certain
portions of the hypotube, one section of the hypotube (preferably
the distal section) can be made more malleable than the other. This
will alleviate any discontinuity between the distal section 266 and
the shaft 262 when the distal section is malleable.
[0240] The distal section 266 can be either somewhat flexible, in
that it will conform to a surface against which it is pressed and
then spring back to its original shape when removed from the
surface or, as noted above, malleable. A bending modulus of between
3 lb.-in..sup.2 and 50 lb.-n..sup.2 is preferred. As shown by way
of example in FIG. 30, a somewhat flexible distal section 266 may
include a spring member 280, which is preferably either a solid
flat wire spring (as shown) or a three leaf flat wire Nitinol
spring, that is connected to the distal end of the hypotube 268.
Other spring members, formed from materials such as 17-7 or
carpenter's steel, may also be used. A series of lead wires 282 and
284 connect the electrode elements 250 and temperature sensor
elements (discussed below), respectively, to the PC board 272. The
spring member 280 and leads wires 282 and 284 are enclosed in a
flexible body 286, preferably formed from PEBAX.RTM. material,
polyurethane, or other suitable materials. The spring member 280
may also be pre-stressed so that the distal tip is pre-bent in the
manner shown in FIG. 28. Also, an insulating sleeve 281 may be
placed between the spring member 280 and the lead wires 282 and
284.
[0241] In those instances where a malleable distal section 266 is
desired, the spring member 280 may be replaced by a mandrel 287
made of suitably malleable material such as annealed stainless
steel or beryllium copper, as illustrated for example in FIG. 31.
The mandrel will ideally be fixed to the distal tip of the device
(by, for example, soldering, spot welding or adhesives) and run
through the shaft into the handle where it will also be fixed to
insure good torque transmission and stability of the distal tip.
Alternatively, the malleable mandrel may be fixed directly within
the distal end of the shaft's hypotube 268 and secured by, for
example, soldering, spot welding or adhesives.
[0242] The distal section 266 may also be formed by a hypotube that
is simply a continuation of the shaft hypotube 268. However, the
distal end hypotube can be a separate element connected to the
shaft hypotube 268, if it is desired that the distal end hypotube
have different stiffness (or bending) properties than the shaft
hypotube.
[0243] The shaft 262 may be from 4 inches to 18 inches in length
and is preferably 6 to 8 inches. The distal section 266 may be from
1 inch to 10 inches in length and is preferably 2 to 3 inches. The
length of the electrode elements may range from approximately 4 mm
to approximately 20 mm. To facilitate the formation of long
continuous lesions or areas or temporarily unresponsive tissue, the
distal section 266 preferably includes six electrode elements 250
that are approximately 12 mm in length and approximately 2 to 3 mm
apart. This aspect of the inventions is discussed in Section II-A
above with reference to FIGS. 6-8. The number and length of the
electrode elements 250 can, of course, be varied to suit particular
applications.
[0244] In accordance with some embodiments of the invention, and as
shown by way of example in FIG. 29, the distal section 266 may be
provided with a distal (or tip) electrode. The distal electrode 276
may be a solid electrode with a through hole for one or more
temperature sensors. Distal electrodes have a variety of
applications. For example, a distal electrode may be dragged along
an anatomical surface to create a long lesion. The distal electrode
may also be used to touch up lesions or areas of unresponsive
tissue (straight or curvilinear) created by electrode elements 250
if, for example, the distal section 266 does not exactly conform to
the anatomical surface, and to continue lesions and areas of
temporarily unresponsive tissue formed by the electrode elements.
The distal electrode may also be used to create lesions and areas
of temporarily unresponsive tissue in anatomical ridges that are
shaped such that the integrity of the surgical device would be
compromised if the distal section 266 were bent to conform to the
ridge.
[0245] In the exemplary embodiments illustrated in FIGS. 23-35, the
operative element 214 is made up of a plurality of electrode
elements 250 which can serve a variety of different purposes. The
operative elements may also be devices such as lumens for chemical
ablation, laser arrays, ultrasonic transducers, microwave
electrodes, and D.C. hot wires. Such devices may also be
incorporated into the other embodiments disclosed in the present
specification as appropriate.
[0246] In the illustrated embodiments, the principal use of the
electrode elements 250 is to transmit electrical energy and, more
particularly, RF energy, to modify or stun heart and other tissue.
However, the electrode elements 250 can also be used to sense
electrical events in heart and other tissue. Alternatively, or in
addition, the electrode elements 250 can serve to transmit
electrical pulses to measure the impedance of heart tissue, to pace
heart tissue, or to assess tissue contact.
[0247] The electrode elements 250 are electrically coupled to
individual wires (see reference numeral 288 FIG. 35 and reference
numeral 282 in FIGS. 30 and 31) to conduct energy to them. The
wires are passed in conventional fashion through a lumen extending
through one of the spline legs and the shaft 216 into a PC board in
the handle, where they are electrically coupled to a connector
which is received in a port in the handle. The connector can be
used to plug into a source of energy, such as RF ablation or tissue
stunning, energy. A plurality of temperature sensing elements (not
shown), such as theremocouples or thermistors, may also be provided
on the spline assemblies shown herein. Such temperature sensing
elements may be located on, under, abutting the edges of, or in
between, the electrode elements 250. The temperature sensing
elements, and the placement thereof, is discussed in detail below
in Section II-F. For temperature control purposes, signals from the
temperature sensor elements are transmitted to the source of energy
by way of wires (see reference numeral 294 FIG. 35 and reference
numeral 284 in FIGS. 30 and 31) which are also connected to the PC
board. The respective numbers of wires will, of course, depend on
the numbers of sensors and electrodes used in a particular
application.
[0248] The electrode elements 250, as well as the other electrodes
discussed in the present specification, can be assembled in various
ways. They can, for example, comprise multiple, generally rigid
electrode elements arranged in a spaced apart, segmented
relationship. The segmented electrodes can each comprise solid
rings of conductive material, like platinum, which makes an
interference fit about the annular spline member. Alternatively,
the electrode segments can comprise a conductive material, like
platinum-iridium or gold, coated upon the device using conventional
coating techniques or an ion beam assisted deposition (IBAD)
process. The electrodes can also be in the form of helical
ribbons.
[0249] Alternatively, the electrode elements 250, as well as the
other electrodes discussed in the present specification, can
comprise spaced apart lengths of closely wound, spiral coils
wrapped on the device which form an array of generally flexible
electrode elements, as discussed in Section Il-A above with
reference to FIGS. 6-8. The coils are made of electrically
conducting material, like copper alloy, platinum, or stainless
steel, or compositions such as drawn-filled tubing (e.g. a copper
core with a platinum jacket). The electrically conducting material
of the coils can be further coated with platinum-iridium or gold to
improve its conduction properties and biocompatibility.
[0250] Electrode elements 250, as well as the other electrodes
discussed in the present specification, can be formed with a
conductive ink compound that is pad printed onto a non-conductive
tubular body. A preferred conductive ink compound is a silver-based
flexible adhesive conductive ink (polyurethane binder), however
other metal-based adhesive conductive inks such as platinum-based,
gold-based, copper-based, etc., may also be used to form
electrodes. Such inks are more flexible than epoxy-based inks.
[0251] E. Regenerated Cellulose Coating
[0252] As illustrated for example in FIG. 33, the electrode
elements 250, as well as the other electrodes disclosed in the
present specification, can include a porous material coating 296,
which transmits ablation energy through an electrified ionic
medium. For example, as disclosed in U.S. patent application Ser.
No. 08/879,343, filed Jun. 20, 1997, entitled "Surface Coatings For
Catheters, Direct Contacting Diagnostic and Therapeutic Devices,"
which is incorporated herein by reference, electrode elements and
temperature sensor elements may be coated with regenerated
cellulose, hydrogel or plastic having electrically conductive
components. With respect to regenerated cellulose, the coating acts
as a mechanical barrier between the surgical device components,
such as electrodes, preventing ingress of blood cells, infectious
agents, such as viruses and bacteria, and large biological
molecules such as proteins, while providing electrical contact to
the human body. The regenerated cellulose coating also acts as a
biocompatible barrier between the device components and the human
body, whereby the components can now be made from materials that
are somewhat toxic (such as silver or copper).
[0253] For applications in which the ablation electrode is in
contact with flowing blood as well as tissue, such as when the
patient is not on bypass, coating electrodes with regenerated
cellulose decreases the effect of convective cooling on the
electrode because regenerated cellulose is a poor thermal conductor
as compared to metal. Thus, the effect of convective cooling by
blood flowing past the regenerated cellulose coated electrodes is
diminished. This provides better control for a lesion-generating
process because the hottest tissue temperature is closer to the
ablation electrode.
[0254] Furthermore, the regenerated cellulose coating decreases the
edge effects attributed to delivering RF energy to an electrode
having a sharp transition between the conductive electrode and
insulating material. The current density along the electrode and
power density within tissue are more uniform, which reduces the
incidence and severity of char and/or coagulum formation. The more
uniform current density along the axis of the device also results
in a more uniform temperature distribution at the electrode, which
decreases the requirement for precise placements of the temperature
sensors at the ablation electrodes. Additionally, by coating a
device with regenerated cellulose to create the outer surface, less
labor-intensive methods of forming electrodes and bonding wires to
electrode surfaces can be used.
[0255] F. Temperature Control
[0256] Temperature sensing elements 298, such as thermistors or
thermocouples, may be used in conjunction with any of the
electrodes (or other operative elements) disclosed in the present
specification. Preferably, the temperature sensing elements 298 are
located at the side edges of the electrodes where the electrodes
abut the underlying, non-electrically conductive support body, such
as the support body 104 shown in FIGS. 6 and 8 or the polymer outer
tubing 270 shown in FIG. 28. RF current densities are high at the
edges because the edges are regions where electrical conductivity
is discontinuous. The resultant rise in current density at the
electrode edges generates localized regions of increased power
density and, therefore, regions where higher temperatures exist.
Nevertheless, the temperature sensing elements may also be located
on, under, or in between, the electrode elements in any of the
exemplary devices disclosed herein.
[0257] In the preferred -embodiment illustrated in FIG. 8, a thin
strip of electrically insulating material 295 (such as an
electrically non-conducting adhesive) is applied to the support
body near the closely spaced regions in order to minimize the
presence of edge current effects. Additionally, the temperature
sensing elements can be mounted either on the inside surface of the
electrodes or on the outside surface encapsulated in an epoxy or
PTFE coating 297.
[0258] As illustrated for example in FIG. 15, the porous electrode
structure 162 can carry one or more temperature sensing elements
298. The sensing elements 298 are in thermal conductive contact
with the exterior of the electrode structure 162 to sense
conditions in tissue outside the structure 162. Temperatures sensed
by the temperature sensing elements 298 are processed by a
controller. Based upon temperature input, the controller adjusts
the time and power level of radio frequency energy transmissions by
the electrode 180, to achieve the desired therapeutic objectives.
Various ways for attaching temperature sensing elements to an
expandable-collapsible electrode body are described in U.S. patent
application Ser. No. 08/629,363, entitled "Enhanced Electrical
Connections for Electrode Structures," which is incorporated herein
by reference.
[0259] Additionally, a reference temperature sensing element may be
provided. For example, a reference temperature sensing element 299
may be provided on or near the distal tip of the device shown in
FIG. 28. The reference temperature sensor may, alternatively, be
located in the handle so that room temperature will be used as the
reference. Another alternative is to use an electronic circuit to
function as the reference temperature sensor. A reference
temperature sensor can also be placed on the patient or in the
operating room and the physician can simply input the reference
temperature into the power control device. It should be noted that
the accuracy of the reference temperature sensor is less important
in applications where the patient is on bypass because the
convective cooling effects of blood flowing past the electrodes is
substantially reduced. Also, the present surgical devices provide
better tissue contact than conventional catheter-based devices,
which provides more accurate temperature monitoring.
[0260] Suitable power controllers which control power to an
electrode based on a sensed temperature are disclosed in U.S. Pat.
Nos. 5,456,682 and 5,582,609, and the aforementioned U.S. patent
application Ser. No. 08/949,117, each of which are incorporated
herein by reference.
[0261] III. Modes of Operation
[0262] The operating modes are discussed in the context of cardiac
treatment. Nevertheless, and as noted above, the present inventions
may be used to treat other types of tissue.
[0263] A. Stunning Mode
[0264] Referring to FIGS. 1 and 5, in the stunning (or first) mode,
the generator 46 transmits via the switching element 80 one or more
high voltage pulses through one or more of the electrode(s)
discussed above into a local tissue region contacting or otherwise
near the electrode(s). Operation of the switching element 80 is
discussed in Section III-C. The electrode configuration may be in
the form of a single electrode, a series of spaced electrodes, or
an expandable-collapsible electrode structure. Thus, references to
"electrode(s)" in this section are references to all of the
electrode configurations disclosed in the present specification.
Each pulse has a prescribed waveform shape and duration that
temporarily "stuns" tissue in the local region without field
stimulating tissue in regions farther away from the electrode(s).
The temporary stunning creates a likewise temporary electrical
conduction block in the local region, rendering the tissue region
electrically unresponsive to spontaneous or induced depolarization
events. By observing the effect of the local conduction block upon
ongoing cardiac events, the physician obtains diagnostic
information helpful in locating and confirming potential tissue
modification sites.
[0265] By purposeful operation of the electrode(s) in the stunning
mode in regions where the process controller 32 has assigned a
potential ablation site, the system 10 is able to confirm and
cross-check the location output of the process controller 32 to
verify the location of a potentially efficacious modification site
before actually modifying tissue.
[0266] By way of example, the site appropriate for ablation to cure
VT typically constitutes a slow conduction zone, designated SCZ in
FIG. 4. Depolarization wave fronts (designated DWF in FIG. 4)
entering the slow conduction zone SCZ (at site A in FIG. 4) break
into errant, circular propagation patterns (designated B and C in
FIG. 4), called "circus motion." The circus motions disrupt the
normal depolarization patterns, thereby disrupting the normal
contraction of heart tissue to cause the cardiac event.
[0267] The event-specific templates T(i) generated by the process
controller 32 record these disrupted depolarization patterns. When
a pacing signal is applied to a slow conduction zone, the pacing
signal gets caught in the same circus motion (i.e., paths B and C
in FIG. 4) that triggers the targeted cardiac event. A large
proportion of the associated pacing morphologies P(i) at the
sensing electrodes E(i) will therefore match the morphologies
recorded during the targeted cardiac event.
[0268] However, when a pacing signal is applied outside a slow
conduction zone, the pacing signal does not get caught in the same
circus motion. It propagates free of circus motion to induce a
significantly different propagation pattern than the one recorded
during the targeted cardiac event. A large proportion of the pacing
morphologies P(i) at the sensing electrodes E(i) therefore do not
match those recorded during the targeted cardiac event. The
difference in propagation patterns between pacing inside and
outside a slow conduction zone is particularly pronounced during
entrainment pacing. For this reason, entrainment pacing is
preferred.
[0269] Ablating or otherwise modifying tissue in or close to the
slow conduction zone (designated SCZ in FIG. 4) prevents subsequent
depolarization. The destroyed tissue is thereby "closed" as a
possible path of propagation. Depolarization events bypass the
ablated region and no longer become caught in circus motion. In
this way, ablation can restore normal heart function in the
treatment of VT. In treating VT, the physician therefore places the
electrode(s) in a located tissue region where the process
controller 32 identifies potential efficacious ablation site. The
process controller 32 can include a homing module 70 to aid the
physician in guiding the electrode(s) in the located region.
Systems and methods for operating the homing module 70 are
disclosed in U.S. Pat. No. 5,722,402, and entitled "Systems and
Methods for Guiding Movable Electrode Elements Within Multiple
Electrode Structures", which is incorporated herein by
reference.
[0270] With the electrode(s) in position, and before transmitting
ablation energy, the physician conditions the generator 46 through
the switching element 80 for operation in the stunning mode. The
physician also conditions the process controller 32 to induce the
cardiac event to be treated, which in this example is VT, unless
the cardiac event is otherwise spontaneously occurring. As the
cardiac event occurs, the electrode(s) transmits one or more
stunning pulses into the tissue region nearest to it. The stunning
pulses are timed to the local electrogram to be transmitted when
local depolarization occurs.
[0271] When the selected pulse stuns tissue laying in the
modification-targeted zone, the temporarily rendering of this zone
electrically unresponsive will temporarily interrupt the cardiac
episode, just as ablation in the zone will permanently stop the
cardiac episode. In this respect, stunning serves as a temporary
preview of the intended permanent modification.
[0272] Should the stunning interrupt the cardiac episode, the
physician waits for the temporary conduction block to resolve.
Typically, this will take about 30 seconds. When a cardiac episode
is interrupted, some arrhythmias will not spontaneously recur
immediately after the temporary conduction block has resolved.
Here, the episode must be re-induced by conventional programmed
stimulation, burst pacing, or other induction methods. After the
physician confirms the similarity of the episode to the previous
targeted event, the physician may repeat the transmission of one or
more stunning pulses to confirm the interruption of the episode.
Such a procedure confirms that the substrate which is causing the
event, and which is targeted for ablation, is near the
electrode(s).
[0273] If the episode continues uninterrupted despite the
transmission of one or more stunning pulses, the physician knows
that the stunned tissue does not include the targeted slow
conduction zone. In this circumstance, the physician repositions
the electrode(s) to a different location geometrically near to the
last stunned site. The physician transmits one or more stunning
pulses into tissue at the new site and observes the effect upon the
spontaneous or induced episode.
[0274] The physician repeats these steps, operating the
electrode(s) in the stunning mode in the vicinity of all tissue
regions the process controller 34 assigns a potential ablation
site, until a site where stunning consistently interrupts the
arrhythmia or other condition is located.
[0275] When the stunning pulse or pulses repeatedly interrupt the
spontaneous or induced episode at a given site, the physician
targets the site for ablation. The physician can titrate the volume
of tissue comprising the slow conduction zone by varying the
amplitude of the stunning pulse and observing the effect. Having
targeted the modification site and titrated its volume, the
physician, without altering the position of the electrode(s),
conditions the generator 46 through the switching element 80 for
operation in the modification mode.
[0276] As noted above, some cases of VT can be cured with lesions
that are somewhat shallower than those typically used to cure VT.
In accordance with a present invention, the electrode(s) can be
used to stun tissue to a relatively shallow depth. A relatively
shallow lesion will be created if the relatively shallow area of
unresponsive tissue prevents VT. Otherwise, progressively deeper
areas of tissue can be stunned and tested until the VT is
eliminated. This way, the depth of the permanently modified tissue
will be no greater than necessary.
[0277] Another method of identifying appropriate ablation sites in
the VT treatment context involves the identification of
fractionated electrograms. Fractionated electrograms, in normal
sinus rhythm or during VT, are usually seen at sites where ablation
or other suitable tissue modification will cure VT. However, they
are also seen at sites where ablation does not cure VT. In
accordance with a present invention, once fractionated electrogram
sites are identified, VT can be induced and stunning voltages
applied. Sites that interrupt VT are good candidates for ablation.
Nevertheless, testing at a given site should be repeated because
spontaneous interruption of VT commonly occurs.
[0278] The three-dimensional electrode arrays shown by way of
example in FIGS. 2 and 9-13B are particularly useful here. Stunning
voltages can be sequentially applied to all sites at which
fractionated electrograms are observed. In most patients, fewer
than 20 electrode pairs exhibit this morphologic feature. Even if
only one stunning pulse were delivered per second to these sites,
which is a relatively slow pace, a likely ablation site could be
identified in only 20 seconds. A sequential stunning exercise could
be performed in less that 20 seconds. If a patient is in VT when
the sequence is initiated, one stunning pulse could be delivered
for each heart beat. As VT heart rates are usually faster than 180
beats/minute (or 3/sec), all potential ablation sites could be
stunned in less than 10 seconds. A record showing which stunning
pulse was effective in terminating VT could also be recorded.
[0279] Turning to the treatment of AFIB, the physician can create
continuous long, thin areas of electrically unresponsive tissue and
then perform testing to insure that the permanent modification of
the temporarily unresponsive tissue would create the desired
therapeutic effect. For example, the physician can perform the
portions of a maze procedure that are common to most patients and
then observe the surface ECG to determine whether or not AFIB is
continuing. In surgical cases, the atrial rhythm can be directly
observed, and reading the ECG is not required. If the patient has
spontaneously converted to normal sinus rhythm or atrial flutter,
then the physician can attempt to reinduce atrial fibrillation by
burst pacing the atrium at several different sites. When AFIB
persists or is inducible, the physician can use the electrode(s) to
temporarily form one or more areas of electrically unresponsive
tissue. The testing is then repeated and, if AFIB is no longer
present, those areas of tissue can be made permanently electrically
unresponsive. If AFIB continues to persist, the physician can
continue to render areas both permanently and temporarily
unresponsive until a suitable combination of lesions is
completed.
[0280] In accordance with another aspect of this invention,
three-dimensional structures (or baskets) such as those shown in
U.S. Pat. No. 5,545,193 can be used to create an entire maze
pattern of temporarily electrically unresponsive tissue. If
subsequent testing does not show that AFIB has been eliminated,
baskets that produce slightly different maze patterns can be
employed until the proper pattern is identified. The tissue can
then be permanently modified with the same three-dimensional
structure that was used to form the partial or complete maze
pattern of stunned tissue, provided that the electrodes on the
structure are configured for permanent tissue modification. If it
is not configured for ablation or other modification, the three
dimensional structure can be removed or left in the body to provide
a map of the eventual modification sites.
[0281] In accordance with another aspect of this invention,
three-dimensional structures (or baskets), such as those shown in
U.S. Pat. No. 5,647,870, can be used to create an entire maze
pattern of temporarily electrically unresponsive tissue. If
subsequent testing does not show that AFIB has been eliminated,
then a different set of electrodes can be used to create a
different maze pattern of temporarily electrically unresponsive
tissue and the testing can be repeated. This process can be
continued until a proper maze pattern has been identified. Then,
with the diagnostic basket still in place, therapeutic catheter(s)
or probes can be manipulated to create the maze pattern identified
by the diagnostic stunning procedure described above. Guidance of
therapeutic catheters to the desired locations near the basket
stunning sites can be facilitated using the locating and guiding
techniques described in U.S. Pat. No. 5,722,416. Alternatively, the
same three-dimensional structures may be used to create therapeutic
lesions by employing the high-voltage tissue modification
techniques disclosed in Section III-C below.
[0282] The effect of a stunning pulse lasts much longer than the
amount of time required to deliver the stunning pulse. Typically,
the effect lasts more than 100 times longer. Thus, a series of
pulses delivered in rapid sequence can be used to create a complex
pattern of temporarily unresponsive tissue. Electrode support
structures and energy delivery systems such as those shown in FIGS.
10-13B, 38 and 39 may be used to deliver a series of stunning
pulses. For example, a sequence of 10 msec stunning pulses, with 10
msecs between each pulse, could be applied with 50 different
electrodes in one second to create an entire set of intersecting
linear regions of temporarily unresponsive tissue. In other words,
a temporary maze pattern that would block transmission of a
excitation waveform could be created in one second, or less if the
pattern requires fewer electrodes. If the temporary maze pattern
successfully terminates AF, then the physician will know that a
curative lesion set for the patient may have been identified.
Because stunning is reversible, the successful pattern can be
repeated to confirm that the proposed pattern will be therapeutic
for the patient.
[0283] Arrhythmias can appear when there are gaps in the long
lesions formed to treat AFIB or when there is a gap between a
lesion and the anatomical barrier that the lesion should extend to.
For example, during the treatment of AFIB, lesions are created
between the pulmonary veins and between the pulmonary veins and the
mitral valve annulus. The inventors herein have determined that
gaps in lesions at the mitral valve annulus are common because the
myocardium is thicker at this site and because anatomical
structures at the mitral valve annulus make it difficult to obtain
tissue contact that will result in a continuous lesion, even in
patients with easily induced AF or those in chronic AF.
[0284] These gaps are very difficult to locate and treat using
conventional roving catheter or probe technology partly because the
process of defining the location and extent of the rotor circuit is
time consuming and laborious. With such technologies, location of
the appropriate ablation site commonly requires 2-4 hours of
procedure time. Use of a three-dimensional structure (or basket),
such as those shown in U.S. Pat. No. 5,547,870, can dramatically
reduce the time required to identify a potential ablation site.
However, even with this technology, the mapping information does
not provide a definitive site for curing the arrhythmia using
tissue modification methods.
[0285] The electrical stunning techniques described herein provide
an effective method of determining whether ablation at a potential
site will cure an arrhythmia. If the flutter is eliminated, the
suspected gap areas can be rendered permanently electrically
unresponsive by ablation or other suitable means.
[0286] In certain situations, an alternative strategy whereby
tissue is stunned at known anatomical positions is more efficient.
The approximate positions of the areas of electrically unresponsive
tissue to be created by the therapeutic catheters can be identified
with fluoroscopic or ultrasonic imaging. Stunning pulses are then
applied to sites that are known to be probable gap locations based
on prior experience. For example, unwanted gaps between a line of
block and an anatomical barrier are somewhat common, especially at
the mitral valve, tricuspid annulus and pulmonary veins. If a
stunning pulse applied to the suspected gap area eliminates the
flutter, then the area can be permanently rendered electrically
unresponsive by ablation or other suitable means.
[0287] In an alternative embodiment, the physician stuns the
selected local region and then operates the process controller 34
to induce the desired cardiac event. In this embodiment, the
physician observes whether stunning the selected local region
suppresses the undesired cardiac event. When stunning a given
selected region consistently suppresses the undesired cardiac
event, which in the absence of stunning occurs, the physician
targets the given region for ablation or other modification.
[0288] It should be appreciated that the use of high voltage
stunning can be carried out in association with conventional
electrocardiogram analysis, without the use of a multiple electrode
mapping probe described above. The use of a multiple electrode
mapping probe is preferred, as it provides a more accurate
indication where stunning should be applied than conventional
techniques.
[0289] It should also be appreciated that the stunning pulses can
alternatively comprise DC or AC energy transmitted by the electrode
36 from a source separate from the generator 46.
[0290] B. Power Considerations Associated With Stunning
[0291] The waveform pattern, duration, and amplitude of the
stunning pulses effective to stun an efficacious volume of
myocardium can be empirically determined by in vivo or in vitro
tests and/or computer modeling.
[0292] The character of the stunning pulse is expressed in terms of
its waveform shape, its duration, and its amplitude. The duration
and amplitude are selected so as to create a temporary electrical
conduction block without damage to the tissue. For the purpose of
this Specification, the term "temporary" refers to a time period
less than about five minutes.
[0293] The duration of the pulse can vary from microseconds up to
several seconds, depending upon the waveform (DC or AC) of the
pulse, amplitude of the pulse, and the electrode configuration.
There is a strength-duration relationship between pulse duration
and amplitude, with short pulse patterns requiring somewhat higher
voltages to stun, but not kill, tissue. Short pulse durations not
exceeding about 100 milliseconds are preferred. Also, because the
purpose of stunning is to simulate the effect of permanent tissue
modification, it is important to note that shallow lesions (about 5
mm) are effective in treating AFIB and some other arrhythmias,
while larger and deeper lesions (up to and exceeding 1 cm) are
generally required when treating VT.
[0294] The pulse amplitude, S.sub.AMP, selected depends upon the
voltage gradient, the configuration of the electrode(s), the depth
of tissue penetration desired, and the impedance of the system,
expressed as follows: 1 S AMP = ( S V L ) .times. ( A ) .times.
R
[0295] where:
[0296] S.sub.V/L represents the local voltage gradient,
[0297] A is the cross-sectional area of the voltage gradient,
[0298] .rho. is the resistivity of the tissue to be stunned,
and
[0299] R is the impedance of the delivery system and electrode that
transmits the pulse.
[0300] With respect to the local voltage gradient S.sub.V/L, as a
benchmark, DC voltage gradients of between about 70 volts/cm and
200 volts/cm that are about 10 milliseconds in duration, when
delivered by defibrillation catheters, have been shown to
temporarily stun chicken embryo myocardial tissue in vitro,
rendering it electrically unresponsive. The stunning in these
instances extends about 1 cm from the electrode when a 800 volt
(DC) shock is delivered. Higher voltage gradients increase the risk
of killing myocardial tissue. The duration of unresponsiveness of
stunned tissue varies from 1 to 60 seconds and more, depending upon
the local voltage gradient. The effective volume of the local
conduction block shrinks with time, as tissue exposed to lower
voltage gradients at the edges of the stunned tissue volume
recovers faster than tissue exposed to higher voltage gradients at
the center of the stunned tissue volume. See, e.g. Jones et al.,
"Microlesion Formation in Myocardial Cells by High Intensity
Electric Field Stimulation," the American Physiological Society
(1987), pp. H480-H486; Jones et al., "Determination of Safety
Factor for Defibrillator Waveforms in Cultured Cell Hearts," the
American Physiological Society (1982), pp. H662-H670. Based upon
the foregoing in vitro benchmarks, it is believed that a nominal
voltage gradient of about 125 volts/cm can be safely selected.
Voltage gradients about four times higher, i.e. 500 volts/cm, are
believed to kill about 50% of the cells and unintentional
application of such voltage gradients should be avoided.
[0301] The cross-sectional area A of the voltage gradient depends
upon the shape of the electrode(s). For example, the portions of
the electrode 36 shown in FIGS. 1 and 3 and the porous electrodes
shown in FIGS. 15-20 and 22 in contact with tissue are assumed to
be a spherical section with a radius r measured from the center of
the electrode body to the tissue where stunning occurs. The
spherical model is also useful for the relatively small electrodes
that are sometimes used in the exemplary three-dimensional arrays
shown in FIGS. 2 and 9-13B. For example, for r=1 cm, the quantity A
(assumed to be the surface area of a 1/2 of a sphere with radius r
of 1 cm) is 2.pi.r.sup.2 or about 6 cm.sup.2. This assumption can
be made with respect to a porous electrode when the distal half is
non-conductive.
[0302] The coil electrodes shown in FIGS. 6-8 and 23-28 form
continuous cylindrically shaped transmission areas. The quantity A
of the generally cylindrical coil is 2.pi.rl (where l is the length
of the coil). When the patient is on bypass, and one half of the
electrode is exposed to air, the quantity A is .pi.rl.
[0303] Turning to the resistivity .rho. of the tissue to be
stunned, for an electrode exposed to both blood and myocardial
tissue, .rho. is believed to be about 200 ohm.cm, while the
resistivity of myocardial tissue when blood is not present (such as
when the patient is on bypass) is about 400 to 500 ohm.cm.
[0304] It is also noteworthy that larger electrodes (greater than
about 4 mm) require somewhat lower voltages to achieve the same
stunning effect. This is primarily because of decreased losses in
near-field tissue because of decreased current densities at the
surface of larger electrodes.
[0305] The waveform shape and period is selected so that the pulse
will not field stimulate tissue at sites distant from the
electrode(s). A stunning pulse that causes far field stimulation
can cardiovert (i.e., stop) the entire cardiac event for reasons
other than a temporary, localized conduction block. Cardioversion
therefore can overshadow the desired, more discrete specificity of
the stunning effect. The character of the stunning pulse is
selected to induce only a temporary conduction block in a discrete,
relatively small volume of tissue generally equal to the volume of
tissue to be ablated or otherwise modified. A biphasic or uniphasic
square wave (DC) transmitted for a short duration (about 100
microseconds) will achieve this effect. A sinusoidal (AC) signal at
frequencies above about 10 kHz for durations of about 10
milliseconds will also achieve this effect. The DC pulse or short
duration AC signal can be transmitted either unipolar (as the
illustrated embodiment shows) or in a bipolar mode.
[0306] Based upon the foregoing considerations, and assuming that
blood is present so that the effective tissue resistivity is 200
ohm.cm, for an electrode such as that shown in FIGS. 1 and 3 with a
diameter of about 4 mm, a radio frequency pulse having an amplitude
of about 100 volts (at 500 kHz) and a duration of about 10
milliseconds will stun tissue to a depth of about 5 mm (which is
sufficient when treating AFIB and supra-ventricular tachycardia
(SVT)). With the same 4 mm electrode, a larger pulse amplitude of
about 400 volts (at 500 kHz) at a duration of about 10 milliseconds
will stun tissue to a deeper depth of about 1 cm (which is required
for treating VT). Thus, taking typical electrode configurations and
typical ranges of stunning depths into account, the radio frequency
pulse amplitude (at 500 kHz) will range from about 100 volts up to
about 800 volts (at 500 kHz), with durations less than about 100
milliseconds.
[0307] When the patient is on bypass with no blood present (and the
tissue resistivity is about 400 to 500 ohm-cm), a radio frequency
pulse having an amplitude of about 50 volts (at 500 kHz) and a
duration of about 10 milliseconds will stun tissue to a depth of
about 5 mm, and a pulse having an amplitude of about 250 volts (at
500 kHz) and a duration of about 10 milliseconds will stun tissue
to a depth of about 1 cm.
[0308] Turning to porous electrode structures, and assuming that
the distal half of the porous electrode is non-conductive so that
current flows primarily into the myocardial tissue and not into
blood, whether the patient is on bypass or not, the tissue
resistivity will be about 400 to 500 ohm-cm. For a 1.2 cm balloon,
stunning tissue to a depth of 5 mm requires a radio frequency pulse
having an amplitude of about 100 volts (at 500 kHz) and a duration
of about 10 milliseconds, further assuming a system impedance of 70
ohms. At 500 kHz, stunning tissue to a depth of 1 cm will require a
pulse of about 200 volts for about 10 milliseconds, stunning tissue
to a depth of 1.5 cm requires a pulse of about 360 volts for about
10 milliseconds, and stunning tissue to a 2 cm depth will require a
pulse of about 600 volts for about 10 milliseconds. The 600 volt
pulse may, however, kill 1-2 mm of tissue near the electrode
because of the very large voltage gradients at the surface of the
porous electrode.
[0309] The power requirement calculations for the electrodes shown
in FIGS. 6-8 and 23-28, which are especially useful in AFIB
treatment, have been made with the following assumptions: the
modification/stunning electrodes are 12.5 mm long coils, the coils
are exposed to blood (effective tissue resistivity of 200 ohm.cm),
the current spreads in cylindrical manner, the cylinder is 2 cm
long (to compensate for not including the ends of the cylinder in
the model), and the system impedance is 70 ohms when stunning
through a single electrode. With a cylindrical electrode, the
voltage gradient drops as a function of 1/r. When the tissue
surface is about 2 mm from the center of the coil, a radio
frequency pulse having an amplitude of about 300 volts (500 kHz)
and a duration of about 10 milliseconds will to stun tissue to a
depth of 3 mm. Stunning to a depth of 8 mm requires an amplitude of
about 600 volts (500 kHz) and duration of about 10 milliseconds.
Beyond 8 mm, the cylindrical model will not produce accurate
approximations of the geometry of the system, and voltage
requirements rise rapidly.
[0310] The three-dimensional electrode supporting structures shown
in FIGS. 2 and 9-13B are also used to stun tissue. Depending upon
electrode size and spacing, they are generally capable of creating
lines of temporarily unresponsive tissue along a spline or between
splines. When such structures are incorporated into a
catheter-based device, the wires to the electrodes are typically
only about 42 gauge. Although size limits their ability to carry
high currents for extended periods of time, the wires are capable
of carrying the 4 amperes of current required to stun tissue for at
least 10 ms.
[0311] The current requirements for the electrodes in the three
dimensional arrays are about the same as that required for the
conventional 4 mm electrode discussed above with reference to FIGS.
1 and 3, but the driving voltage requirements are higher due to the
higher system impedance. The higher system impedance is caused by
the resistance of the wires connecting the connector pins to the
electrodes (about 20 ohms) and the high current density at the
electrodes. Assuming that tissue resistivity is 200 ohm-cm (the
combined resistivity of tissue and blood in a non-bypass
environment), a system impedance of about 200 ohms (we measured
this in animals), and the aforementioned spherical model, a radio
frequency pulse having an amplitude of about 800 volts (500 kHz)
and a duration of about 10 milliseconds will to stun tissue to a
depth of 1 cm. A pulse with an amplitude of about 150 volts and a
duration of about 10 milliseconds will stun tissue to a depth of 5
mm. It should be noted, however, that the destruction of about 1
mm.sup.3 of tissue is almost unavoidable using presently available
electrodes.
[0312] Three-dimensional arrays, such as those discussed in Section
II-B, can be used in conjunction with surgical probes, preferably
when the patient is on bypass. The stunning voltage requirements
for electrodes in the three-dimensional arrays are much lower when
patients are on bypass. No blood is present and the effective
tissue resistivity is about 400-500 ohm-cm. The effective area of
the voltage gradient is also about one-half of the voltage gradient
area when blood is present because virtually no current flows in
air. The system impedance is, however, increased to about 350 ohms.
The net effect is to decrease, by about a factor of two, the
amplitude of the voltage pulse required to stun tissue to a given
depth. For example, only about 400 volts would be required to stun
tissue to a depth of 1 cm. In addition, the dimensional constraints
placed on a device that must be introduced percutaneously are
considerably relaxed for arrays that are inserted into patients on
bypass. Electrode area could easily be doubled for devices designed
for introduction into heart chambers via an atriaotomy during
cardiopulmonary bypass. Use of these larger electrodes would
decrease the amplitude of the voltage stunning pulse by an
additional factor of one and one-half, primarily because the system
impedance is lower with the larger electrodes.
[0313] It should be appreciated that the relatively high power
required to stun tissue will also heat the tissue. As compared to
the time required to redistribute heat in the body, stunning pulses
are very short in duration. Thus, a stunning pulse causes an
increase in the temperature of the affected tissue based solely on
the energy dissipated in the affected tissue during the stunning
pulse. Typically, a stunning pulse will directly heat 2 or more
grams of tissue. The maximum power required will be up to about
12,000 Watts, with a pulse duration of 1-10 msec. Therefore, the
stunning pulse could deliver as much as 120 Joules to the tissue
(or about 30 calories), which would immediately raise the
temperature of the affected tissue to about 50.degree. C.
[0314] 50.degree. C. is very close to the temperature that can kill
tissue. Therefore, unless the goal is to actually destroy tissue
(high voltage tissue modification is discussed in Section III-B),
the pulse duration should be limited to prevent ohmic heating to
such an extent that the affected tissue is destroyed. For example,
a 1 msec long pulse is nearly as effective at stunning tissue as is
a 10 msec long pulse, but the temperature rise with the 1 msec long
pulse is {fraction (1/10)} as large as with a 10 msec long
pulse.
[0315] C. The Modification Mode
[0316] 1. Low Voltage Modification
[0317] In the low voltage modification mode, the generator 46
transmits lower voltage radio frequency energy into a selected
tissue region through either the same electrode(s) that are used to
stun tissue, or different electrodes when the electrodes used to
stun the tissue are not suitable for tissue modification. The radio
frequency energy may, for example, have a waveform shape and
duration that electrically heats and kills tissue in the selected
region. When used in cardiac ablation, for example, the generator
46 is conditioned to deliver up to 150 watts of power for about 10
to 120 seconds at a radio frequency of 500 kHz. By destroying the
tissue, the radio frequency energy forms a permanent electrical
conduction block in the tissue region.
[0318] FIG. 5 shows a representative implementation for the
switching element 80 associated with the generator 46 to change
operation between the stunning mode and the modification mode. In
this embodiment, the switching element input 82 (comprising supply
and return lines) is coupled to the generator 46, which delivers
radio frequency energy (500 kHz) at a prescribed energy input level
suitable for stunning, as previously described. The switching
element output 84 (also comprising supply and return lines) is
coupled to the transmitting electrode(s) and to the return line
electrode, designated E.sub.r in FIG. 5.
[0319] The switching element 80 includes an electronic switch 92
defining a first switch path 86 and a second switch path 90.
[0320] The first switch path 86 conditions the generator 46 for
operation in the stunning mode. The first switch path 86 includes a
first isolation transformer 88. The isolation transformer 88, shown
in FIG. 5 as a 1:1 transformer, directs the stunning energy through
the electrode(s) without amplitude modification for stunning tissue
in the manner described. In the stunning mode, the electronic
switch 92 transmits stunning energy through the first switch path
86 in short cycle intervals to deliver the energy in preset
stunning pulses, as already described.
[0321] The switching element 80 also includes a second switch path
90, which conditions the generator 46 for operation in the
modification mode. The second switch path 90 includes a second
step-down isolation transformer 92, which is shown for the purpose
of illustration having a step-down ratio of 3:1. The transformer 92
decreases the amplitude of the energy transmitted to the
electrode(s) to lower levels suitable for ablating or otherwise
modifying tissue. In the modification mode, the electronic switch
92 transmits energy through the second switch path 90 for longer
cycle intervals conducive to tissue modification.
[0322] 2. High Voltage Modification
[0323] High voltage energy pulses (such as RF pulses) can be used
to kill or otherwise modify tissue in at least three ways. For
example, the creation of high voltage gradients within the tissue
dielectrically breaks down tissue structures. In addition,
ohmically heating tissue will coagulate tissue structures, while
ohmically heating to very high temperatures will vaporize
tissue.
[0324] When voltage gradients at or above 500 volts/cm are induced
in tissue, relatively short pulse durations can be used to destroy
the tissue. Although voltage amplitudes 4 to 6 times higher than
those used to stun tissue are required, the pulse duration
requirements are on the order of 0.1 msec. As a result, the total
pulse energy requirements for tissue destruction is similar to that
used for stunning. In one preferred method, stunning pulses are
delivered to identify tissue that is to be destroyed or otherwise
modified. After the target tissue is identified, a
tissue-destroying RF energy pulse could be delivered.
[0325] Turning to heating, a high voltage RF pulse (about 500 to
1200 volts in magnitude and about 50 to 100 msec in duration)
delivers relatively high power to tissue, thereby enabling very
rapid heating. Because the tissue is heated rapidly, there is
essentially no convective heat loss during power application. These
factors allow the thermal impulse response of the system to be
measured based on the application of a stunning pulse, and the
subsequent measurement of temperature at one or more locations on
the electrode. From a power control standpoint, the impulse
response of the system provides very important information as to
the plant to be controlled. Short bursts of high voltage RF power,
or more conventional continuous RF modification methods, may be
used to thermally destroy tissue using feedback control algorithms
that are optimized with the plant characterization obtained while
applying a stunning pulse.
[0326] Tissue vaporization can be performed through the use of high
voltage energy pulses with a pulse duration of about 250 msec to 1
sec. There are a number of therapeutic applications for this type
of tissue vaporization. For example, percutaneous myocardial
revascularization (PMR), which is currently performed using laser
tissue vaporization, can be performed by using high voltage pulses
to vaporize tissue. High voltage pulse-based tissue vaporization
techniques may also be useful in certain cancer therapies and to
channelize a vessel that has recently clotted off.
[0327] High voltage pulse-based tissue vaporization techniques can
further be used to create a channel in soft tissue in order to gain
access to the interior of a solid organ while maintaining
hemostasis. The channel in the soft tissue would enable a
diagnostic or therapeutic function (such as the formation of an
area of modified tissue) to be performed on the selected organ.
[0328] D. Roving Pacing Mode
[0329] In an alternative embodiment, any of the multi-purpose
stunning-modification probes discussed above can also be
conditioned for use by the process controller 34 as a roving pacing
probe, usable in tandem with the basket structure 20 to generate
and verify the location output during the above described sampling
and matching modes.
[0330] In this arrangement, the probe 16 is deployed in the heart
region 12 while the multiple electrode structure 20 occupies the
region 12. In this mode, the electrode(s) is electrically coupled
to the pacing module 48 (as shown in phantom lines in FIG. 1) to
emit pacing signals.
[0331] In use, once the process controller 32 generates the output
location or locations using the electrodes 24 to pace the heart,
the physician positions the probe within the localized region near
the output location electrode or electrodes 24. As above described,
the process controller 32 preferably includes the homing module 70
to aid the physician in guiding the probe 16 in the localized
region within the structure 20.
[0332] The process controller 32 conditions the pacing module 48 to
emit pacing signals through the probe electrode(s) to pace the
heart in the localized region, while the electrodes 24 record the
resulting electrograms. By pacing this localized region with the
probe 16, while comparing the paced electrograms with the
templates, the process controller 32 provides the capability of
pacing and comparing at any location within the structure 20. In
this way, the process controller 32 generates as output a location
indicator that locates a site as close to a potential ablation site
as possible.
[0333] Due to the often convoluted and complex contours of the
inside surface of the heart, the basket structure 20 cannot contact
the entire wall of a given heart chamber. The system 10 therefore
can deploy the probe 16 outside the structure 20 to pace the heart
in those wall regions not in contact with the electrodes 24. The
probe 16 can also be deployed while the basket structure-20
occupies-the region 12 to pace the heart in a different region or
chamber. In either situation, the electrodes 24 on the structure 20
record the resulting paced electrograms for comparison by the
process controller 32 to the templates. The process controller 32
is thus able to generate an output identifying a location close to
a potential ablation site, even when the site lies outside the
structure 20 or outside the chamber that the structure 20
occupies.
[0334] E. Electrophysiologic Diagnosis Mode
[0335] The generator 46 can be operated in the stunning mode in
association with the probe 16 to conduct diagnostic
electrophysiological testing of tissue, such as myocardial tissue,
in place of or in tandem with the mapping probe 14.
[0336] In this mode of operation, the physician conditions the
generator 46 to transmit through the probe electrode(s) an
electrical energy pulse, as previously described, which temporarily
renders a zone of tissue electrically unresponsive. By sensing an
electrophysiological effect due to the transmitted pulse, the
physician can make diagnoses.
[0337] Such sensing is useful in the myocardial area where it can
be used to diagnose the cause of cardiac events. For example, by
temporarily rendering zones of myocardial tissue electrically
unresponsive using an electrical energy pulse, and sensing the
resulting electrophysiological effect, the physician can, without
using the mapping probe 14, locate sites of automaticity, also
called pacemaker sites, where arrhythmia originates. Likewise, the
physician can, without using the mapping probe 14, locate the path
or paths that maintain arrhythmia, previously referred to as the
areas of slow conduction. Furthermore, by temporarily rendering
zones of myocardial tissue electrically unresponsive using the
electrical energy pulse, the physician can selectively alter the
conduction properties of the heart within the localized zone
without otherwise changing electrophysiological properties outside
the zone. For example, the physician can create a temporary AV
block by operating the generator 46 in the stunning mode, as
previously described.
[0338] Based at least in part upon these diagnostic tests conducted
in the stunning mode, the physician can proceed to altering an
electrophysiological property of tissue in or near a diagnosed
zone. For example, the physician can alter the electrophysiological
property by ablating tissue in or near the diagnosed zone, as above
described, using radio frequency electrical energy, or laser light
energy, or an ablation fluid. The physician can also treat the
diagnosed cardiac disorder without ablating tissue, using drugs
such as quinidine, digitalis, and lidocaine.
[0339] IV. Bypass and Non-Bypass Environment Considerations
[0340] In many of the exemplary embodiments, the electrodes are
exposed around their entire peripheries. These embodiments are
particularly useful when the heart is on bypass and there is no
blood flow within the heart. Here, air acts as an insulator and
produces only modest convective cooling effects, as compared to a
flowing blood pool that has a higher convection coefficient than
virtually static air. Energy transmission is, therefore,
essentially limited to the RF energy that is transmitted from the
portion of the electrode surface that is in contact with the tissue
to either a ground electrode, or another electrode within the group
of electrode elements. Also, as noted above, the overall impedance
of the system will increase (as compared to a situation where blood
is present). This is due to the smaller effective surface area
between the electrode and tissue.
[0341] Both of these conditions, focused RF energy and low heat
dissipation into the air, will impact the ablation because they
result in a high current density. When creating long lesions with a
conventional catheter, char can be created as the tip is dragged
because of the high current density and the difficulty in
monitoring tissue temperature and controlling power that is
inherent in the dragging process. Many of the present inventions,
however, can take advantage of the high current density because the
electrodes are not being dragged. For example, a number of
electrodes can be used to ablate simultaneously because the
effective (tissue contacting) surface area between all of the
ablating electrodes is smaller and the convective cooling effects
are reduced, as compared to situations where blood is present. This
reduces the power requirements of the system. In addition, by using
electrodes with lower thermal mass (as compared to a conventional
solid tip electrode), less heat will be retained by the electrode
and better temperature sensing can be made at the tissue surface.
This will speed up the creation of the lesions and enable better
lesion creation control.
[0342] In instances where the patient will not be on bypass and
blood will be flowing past the electrodes, the portion of the
electrode elements (or other operative elements) not intended to
contact tissue may be masked through a variety of techniques. For
example, a layer of UV adhesive (or another adhesive) may be
painted on preselected portions of the electrode elements to
insulate the portions of the elements not intended to contact
tissue. Alternatively, a slotted sheath may be positioned over the
portion of the electrode elements not intended to contact tissue.
Deposition techniques may also be implemented to position a
conductive surface only on those portions of the spline assembly
intended to contact tissue.
[0343] As shown by way of example in FIG. 34, a polymer layer 293
may be thermally fused over an electrode, such as electrode 250, to
mask desired portions of the electrodes. An exemplary process for
applying the polymer layer is as follows. A segment of shaft tubing
is cut long enough to cover the desired electrodes, and is then
split in half (or other desired angle) along the axis. One half is
placed over the assembled distal section so that it covers the side
of the electrodes that are to be masked. A piece of polymeric
shrink tubing, preferably RNF-100 or irradiated LDPE, is then
carefully slid over the catheter distal end, so that the mask
tubing is not moved from its placement over the electrodes and so
that it stops approximately 2 cm beyond the end of the tubing half.
The distal end is then heated in a controlled heat source at
approximately 400.degree. F. so that the mask tubing fuses into the
distal shaft tubing along its length, and so that all of its edges
are well fused into the shaft tubing, but not fused so much that
the covered electrodes begin to poke through. Finally, the
polymeric shrink tubing is split on one end and the assembly is
heated at approximately 225.degree. F. while the polymeric shrink
tubing is slowly peeled off of the fused catheter shaft.
[0344] Additionally, as illustrated in FIG. 35, the shape of an
electrode 250' may be such that the metallic material in the region
not intended to contact tissue is eliminated.
[0345] The masking techniques described in the preceding paragraph
improve the efficiency of, for example, an ablation procedure by
decreasing the surface area of the electrodes and, therefore, the
energy required to heat tissue. The masking can be used to form a
narrow electrode which is sometimes desirable, even when the
patient will be on bypass. The convective cooling effects of blood
flowing by the electrode are also reduced. In addition, the
transmission of RF energy to unintended anatomic structures is
prevented. This is especially important in epicardial applications
when the ablation electrode elements may be sandwiched between
multiple anatomic structures including, for example, the aorta and
pulmonary artery.
[0346] It is also noteworthy that masking can be useful during
bypass because tissue can partially wrap around the electrodes when
the distal end of the device is pressed against the tissue. Such
masking can also be used to control lesion thickness.
[0347] Although the present invention has been described in terms
of the preferred embodiment above, numerous modifications and/or
additions to the above-described preferred embodiments would be
readily apparent to one skilled in the art. By way of example, but
not limitation, methodologies of ablating tissue other than those
described above can be used. Laser energy can be transmitted to
ablate tissue and fluids like alcohol (ethanol), collagen, phenol,
carbon dioxide, can also be injected into tissue to ablate it (see,
for example, U.S. Pat. No. 5,385,148). It is intended that the
scope of the present invention extends to all such modifications
and/or additions.
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