U.S. patent application number 15/483634 was filed with the patent office on 2017-09-28 for controlled irrigated catheter ablation systems and methods thereof.
The applicant listed for this patent is ST. JUDE MEDICAL, ATRIAL FIBRILLATION DIVISION, INC.. Invention is credited to Huisun Wang.
Application Number | 20170273739 15/483634 |
Document ID | / |
Family ID | 41818786 |
Filed Date | 2017-09-28 |
United States Patent
Application |
20170273739 |
Kind Code |
A1 |
Wang; Huisun |
September 28, 2017 |
CONTROLLED IRRIGATED CATHETER ABLATION SYSTEMS AND METHODS
THEREOF
Abstract
The present invention relates to open irrigated catheter
ablation systems and methods used in connection with open irrigated
catheter systems. The systems and related methods can control
irrigation fluid flow to obtain temperature responses indicative of
temperatures associated with an ablation procedure. Embodiments of
the present invention provide irrigated catheter ablation systems
having controlled irrigation fluid flow that can be directed at
target areas where coagulation is more likely to occur to help
minimize blood coagulation and associated problems. The irrigated
fluid flow may be regulated in connection with an established or
predetermined temperature threshold to improve or better optimize
cooling and ablation properties of the system. In embodiments,
irrigation flow may be either delayed or intermitted.
Inventors: |
Wang; Huisun; (Maple Grove,
MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ST. JUDE MEDICAL, ATRIAL FIBRILLATION DIVISION, INC. |
St. Paul |
MN |
US |
|
|
Family ID: |
41818786 |
Appl. No.: |
15/483634 |
Filed: |
April 10, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12345975 |
Dec 30, 2008 |
9629678 |
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15483634 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 18/1492 20130101;
A61B 2017/00084 20130101; A61B 2018/00029 20130101; A61B 2218/002
20130101 |
International
Class: |
A61B 18/14 20060101
A61B018/14 |
Claims
1.-25. (canceled)
26. An irrigated catheter ablation system comprising: an irrigated
ablation catheter assembly including: an irrigated electrode, and a
catheter shaft, wherein a distal end of the catheter shaft is
coupled to a proximal portion of the irrigated electrode; a fluid
source fluidly coupled with the catheter assembly; an energy source
electrically coupled with the catheter assembly; and an irrigation
temperature control mechanism in communication with the fluid
source and the energy source, wherein the irrigation temperature
control mechanism is configured to control a flow rate of
irrigation from the fluid source, and wherein the fluid source is
configured to output a first flow rate of irrigant, a second flow
rate of irrigant, and a third flow rate of irrigant in response to
the irrigation temperature control mechanism.
27. The system of claim 26, wherein the first flow rate of irrigant
is zero cc/min.
28. The system of claim 26, wherein the temperature control
mechanism is configured to receive data relating to a temperature
of the irrigated electrode.
29. The system of claim 26, wherein the irrigated electrode
comprises a thermal sensor and wherein the temperature control
mechanism is configured to receive data from the thermal
sensor.
30. The system of claim 29, wherein the thermal sensor is
positioned within a distal portion of the irrigated electrode.
31. The system of claim 26, wherein the irrigated electrode
comprises a plurality of thermal sensors and wherein the
temperature control mechanism is configured to receive data from
the plurality of thermal sensors.
32. The system of claim 26, wherein the flow rate output by the
fluid source changes from the first flow rate to the second flow
rate based on a pre-set temperature threshold.
33. The system of claim 26, wherein the flow rate output by the
fluid source changes from the second flow rate to the third flow
rate based on a pre-set temperature threshold.
34. The system of claim 26, wherein the flow rate output by the
fluid source changes from the third flow rate to the second flow
rate based on a pre-set temperature threshold.
35. The system of claim 26, wherein the temperature sensor is
positioned within the distal portion of the electrode.
36. The system of claim 26, wherein the irrigation temperature
control mechanism is coupled to the energy source.
37. The system of claim 26, wherein the fluid source includes a
saline pump.
38. The system of claim 26, wherein the irrigation temperature
control mechanism includes a controller.
39. A method of irrigating biological tissue comprising: receiving
information from an irrigated catheter ablation system, wherein the
irrigated catheter ablation system comprises an irrigated ablation
catheter assembly, a fluid source connected to the catheter
assembly, an energy source connected to the catheter assembly,
wherein the information is received by an irrigation temperature
control mechanism in communication with the fluid source and energy
source, wherein the irrigated ablation catheter assembly includes a
catheter shaft, and an irrigated electrode having a proximal
portion coupled to a distal end of the catheter shaft; controlling
a flow rate of an irrigation flow from the fluid source through the
irrigated electrode, wherein the irrigation temperature control
mechanism is configured to control the flow rate, and wherein the
fluid source is configured to output a first flow rate of irrigant,
a second flow rate of irrigant, and a third flow rate of irrigant
in response to the irrigation temperature control mechanism.
40. The method of claim 39, wherein the first flow rate of irrigant
is zero cc/min.
41. The method of claim 39, wherein the irrigated electrode
comprises a thermal sensor and wherein the temperature control
mechanism is configured to receive data from the thermal
sensor.
42. The method of claim 39, wherein the irrigated electrode
comprises a plurality of thermal sensors and wherein the
temperature control mechanism is configured to receive data from
the plurality of thermal sensors.
43. The method of claim 39, wherein the flow rate output by the
fluid source changes from the first flow rate to the second flow
rate based on a pre-set temperature threshold.
44. The method of claim 39, wherein the flow rate output by the
fluid source changes from the second flow rate to the third flow
rate based on a pre-set temperature threshold.
45. The method of claim 39, further comprising presetting or
establishing a temperature threshold for the irrigated catheter
ablation system that regulates irrigation fluid flow from the
passageway of the catheter assembly.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 12/345,975, filed 30 Dec. 2008 (the '975 application). The '975
application is hereby incorporated by reference as though fully set
forth herein.
BACKGROUND OF THE INVENTION
[0002] a. Field of the Invention
[0003] The present invention relates to irrigated catheter assembly
systems and methods for ablating tissue using controlled irrigation
flow. The present invention further relates to open irrigated
catheter ablation systems having irrigation fluid flow that may be
regulated in connection with a predetermined temperature
threshold.
[0004] b. Background Art
[0005] Electrophysiology catheters are used for an ever-increasing
number of procedures. For example, catheters are used for
diagnostic, therapeutic, and ablative procedures, to name just a
few procedures. Typically, a catheter is manipulated through the
patient's vasculature to an intended site, for example, a site
within the patient's heart. The catheter commonly carries one or
more electrodes, which may be used for ablation, diagnosis, and/or
other treatments.
[0006] There are a number of methods used for ablation of desired
areas, including for example, radiofrequency (RF) ablation. RF
ablation is accomplished by transmission of radiofrequency energy
to a desired target area through an electrode assembly to ablate
tissue at a target site. Because RF ablation may generate
significant heat, which if not controlled could result in tissue
damage, such as steam pop, tissue charring, and the like, it is
often desirable to include a mechanism to irrigate the target area
and the device with biocompatible fluids, such as saline solution.
The use of fluid irrigated ablation catheters can also prevent the
formation of soft thrombus and/or blood coagulation.
[0007] Generally, there are two classes of irrigated electrode
catheters, open and closed irrigation catheters. Closed ablation
catheters can circulate a cooling fluid within the inner cavity of
the ablation electrode. Open ablation catheters can deliver the
cooling fluid through open outlets or openings on the surface of
the electrode. Open ablation catheters use the inner cavity of the
electrode, or distal member, as a manifold to distribute saline
solution (or other irrigation fluids known to those skilled in the
art) to one or more passageways that lead to openings/outlets
provided on the surface of the electrode. The saline thus flows
directly through the outlets of the passageways onto or about the
distal electrode member. This direct flow through the distal
electrode tip lowers the temperature of the distal tip during
operation, which may make accurate monitoring and control of the
ablation process somewhat more challenging.
[0008] While open irrigated ablation catheters may improve the
safety of RF catheter ablation by preventing protein aggregation
and blood coagulation through the dissipation of heat by providing
fluid to the site during the ablation procedure, direct contacting
fluid irrigation has the tendency to cool the electrode temperature
dramatically during ablation procedures. The irrigation fluid flow
ultimately cuts off the electrode temperature from rising, which
may result in increased (and possibly more than desirable) ablation
in a target area. As such, it can be desirable to control and more
accurately monitor the temperature of an electrode performing
ablation.
BRIEF SUMMARY OF THE INVENTION
[0009] The present invention is directed to improved open irrigated
catheter ablation systems and methods used in connection with open
irrigated catheter systems. Among other things, systems and related
methods are provided that can control irrigation fluid flow and
obtain an effective temperature response with respect to an
ablation procedure. Embodiments of the present invention provide an
irrigated catheter ablation system having controlled irrigation
fluid flow directed at target areas, for example, where coagulation
is more likely to occur so as to minimize blood coagulation and
associated problems. The irrigated fluid flow may be regulated in
connection with a predetermined temperature threshold to improve or
better optimize cooling and ablation properties associated with the
system.
[0010] The present invention provides an ablation system having an
open irrigated ablation electrode coupled to or connected with a
catheter shaft forming an open irrigated catheter assembly in
connection with a fluid source, an energy source, and a temperature
control mechanism for regulating irrigation fluid flow within the
catheter shaft assembly.
[0011] The present invention further discloses an ablation system
having an open irrigated ablation catheter assembly including an
open irrigated ablation electrode coupled to or connected to a
catheter shaft forming the open irrigated catheter assembly in
connection with a fluid source, an energy source, such as, for
example, radio frequency (RF) generator, and a processor for
regulating the temperature control of the electrode performing the
ablation.
[0012] The present invention provides a method of controlling the
irrigation of biological tissue. The method includes the steps of
providing an irrigated catheter ablation system including an
irrigated ablation catheter assembly, a fluid source connected to
the catheter assembly, an energy source connected to the catheter
assembly; and an irrigation temperature control mechanism in
communication with the fluid source and energy source; presetting a
temperature threshold for the system that regulates irrigation
fluid flow from the passageway of the catheter assembly;
positioning the irrigated electrode of the irrigated ablation
catheter assembly at a target location; applying energy from the
energy source to the target location through the irrigated
electrode; collecting temperature measurements from a thermal
sensor disposed within the irrigated electrode; irrigating the
ablation electrode forming an irrigation flow through the
passageway of the electrode; and completing the application of
energy to the target location to form an ablation lesion.
[0013] The invention further contemplates alternate methods for
irrigating biological tissue, including a delayed irrigation method
and an intermitted irrigation method. The delayed irrigation method
involves collecting temperature measurements of the open irrigation
electrode until the collected temperature measurements of the
electrode reach a predetermined upper temperature threshold. Once
the upper temperature threshold is met, the irrigation fluid flow
from the passageways of the open irrigation electrode increases
from a maintenance flow rate to an amplified irrigation flow rate.
The increased irrigation flow continues until the ablation is
completed. In comparison, during the intermitted irrigation method,
once the irrigation fluid flow from the passageways of the open
irrigation electrode is increased, the intermitted method further
includes collecting temperature measurements of the electrode until
the temperature measurements of the electrode reach a predetermined
lower temperature threshold. Once the electrode temperature
measurements reach the lower threshold level, the irrigation flow
is reduced to the maintenance flow level through the passageway of
the electrode. Once the irrigation flow is reduced, temperature
measurements continue to be collected from a thermal sensor
disposed within the irrigated electrode until the temperature
measurements once again return to the predetermined upper
temperature threshold. The irrigation fluid flow is then increased
again through the passageway of the electrode therein creating an
intermitted irrigation cycle. Accordingly, the irrigation flow is
reduced periodically during the intermitted irrigation cycle in
response to the temperature. The intermitted irrigation cycle is
continued until the ablation is complete. The intermitted
irrigation method further provides that the irrigation may be
turned off periodically during the ablation procedure to check the
temperature response of the electrode until the ablation is
completely.
[0014] The foregoing and other aspects, features, details,
utilities, and advantages of the present invention will be apparent
from reading the following description and claims, and from
reviewing the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1 is an isometric view of an ablation electrode
according to an embodiment of the present invention;
[0016] FIG. 2 is a cross-sectional view of an ablation electrode of
the type generally shown in FIG. 1;
[0017] FIG. 3 is a cross-sectional view of an ablation electrode
according to another embodiment of the present invention;
[0018] FIG. 4 is an isometric view of an ablation catheter system
according to an embodiment of the present invention, the
illustrated system including an irrigated catheter assembly
operably connected to an energy source and a fluid source;
[0019] FIG. 5 is an isometric view of an ablation catheter system
according to another embodiment of the present invention, the
illustrated system including an irrigated catheter assembly
operably connected to an energy source, a fluid source, and a
processor;
[0020] FIG. 6 is a graphical representation of a conventional tip
electrode temperature response and irrigation flow according to the
prior art;
[0021] FIG. 7 is a graphical representation of the tip electrode
temperature response and delayed irrigation flow rate according to
an embodiment of the present invention; and
[0022] FIG. 8 is an graphical representation of the tip electrode
temperature response and intermitted irrigation flow according to
an embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0023] In general, the instant invention relates to irrigated
catheter ablation systems and to methods of using irrigated
catheter ablation systems. For purposes of this description,
similar aspects among the various embodiments described herein will
generally be referred to by the same reference number. As will be
appreciated, however, the structure of the various aspects may
differ among various embodiments.
[0024] Open irrigated catheter ablation systems of the present
invention include an irrigated ablation catheter assembly 10, as
generally shown in FIG. 1. The illustrated irrigated ablation
catheter assembly 10 includes an ablation electrode 12. While
embodiments of the invention disclosed herein may describe RF
ablation catheter assemblies and related systems, the invention is
not so limited, and the invention may include or involve other
types of ablation electrodes and assemblies in which the
temperature of the device and a targeted tissue area may be factors
during the procedure. FIGS. 2 and 3, discussed in further detail
below, illustrate specific open irrigated ablation electrodes 10
according to alternate embodiments associated with the present
invention. Moreover, FIGS. 4 and 5, discussed in further detail
below, illustrate catheter ablation systems embodying features
associated with the present invention.
[0025] Embodiments of open irrigated catheter ablation systems in
accordance with the present invention include an open irrigated
catheter assembly 10 having an open irrigated electrode 12
configured to control the flow of irrigation fluid to an ablation
site. The present invention encompasses irrigated catheter assembly
systems that control and regulate the irrigation fluid flow to an
ablation site, for example, to improve or optimized ablation on a
tissue while irrigating the surface of the tissue. The system may
be configured and/or regulated to provide either intermitted
irrigation fluid flow throughout the ablation procedure or a
delayed onset of irrigation to ensure good physical contact of
electrode 12 with the ablation site. In embodiments, temperature
feedback may be used in combination with responsive irrigation flow
to improve or optimize tissue ablation when using convention open
irrigated ablation catheters to perform an ablation procedure or
technique on biological tissue. Such conventional irrigation
catheters include, but are not limited to, those such as IBI
Therapy.TM. Cool Path.TM. Ablation Catheter available from Irvine
Biomedical, Inc.
[0026] In particular, one embodiment of the present invention
provides a system and related method for performing RF ablation
that includes the delayed onset of the irrigation fluid flow to
electrode 12. The onset of therapeutic irrigation fluid flow may be
controllably delayed until electrode 12 reaches a predetermined
temperature threshold, such as, without limitation, about 65
degrees Celsius. With such embodiments, after electrode 12 reaches
the temperature threshold level, the irrigation fluid flow can be
started to provide cooling to the electrode. The delayed onset of
the irrigation flow better ensures that an accurate temperature
reading of the electrode may be obtained during the initial
ablation procedure, which further helps ensure improved physical
contact between electrode 12 and a targeted site (e.g., targeted
tissue). On the other hand, if the temperature threshold is not met
upon the application of the ablation energy or shortly thereafter,
electrode 12 may need to be repositioned to ensure sufficient or
proper physical contact with targeted tissue. Since the temperature
threshold is generally set below an associated safety limit, e.g.,
about 65 degrees C., heat related coagulum that is present can be
eliminated in connection with the ablation.
[0027] An alternate embodiment of the present invention provides a
system and related method for performing ablation, such as RF
ablation, that includes intermitted fluid irrigation flow such that
irrigation fluid may be regulated (i.e., increased and decreased)
in response to the temperature of electrode 12. More particularly,
the intermitted fluid irrigation flow may be controlled by a
predetermined temperature threshold, such as, for example, about 65
degrees. Accordingly, the irrigation fluid flow may be increased
when the electrodes reaches about 65 degrees and is then decreased
once a reduced temperature threshold is reached, such as, for
example about 40 degrees. The irrigation fluid flow may be provided
for a fixed intermitted duration (i.e., for example, a fixed period
of time), a variable intermitted duration that is based solely on
temperature threshold levels, or some combination of the
foregoing.
[0028] As noted, open irrigated catheter assemblies may be used for
a variety of treatments and procedures. FIG. 1 is an isometric view
of part of an embodiment of an irrigated ablation catheter assembly
10. The irrigated ablation catheter assembly 10 includes an open
irrigated ablation electrode 12 connected to a catheter shaft 14
having at least one fluid delivery tube 16 therein. The ablation
electrode 12 includes an outer body portion 18 having an outer
surface 20, and includes a proximal portion 22 and a distal portion
24. As further illustrated in FIGS. 2 and 3, electrode 12 of the
catheter assembly 10 may further include an inner cavity 26 that
may be coupled to or is in fluid communication with fluid delivery
tube 16. The open irrigated electrode 12 further includes at least
one fluid or irrigation passageway 28 that extends from inner
cavity 26 to outer surface 20 of electrode 12.
[0029] Electrode 12 may be comprised of any electrically, and
potentially thermally, conductive material known to those of
ordinary skill in the art for delivery of ablative energy to target
tissue areas. Examples of electrically conductive materials include
gold, platinum, iridium, palladium, stainless steel, and mixtures
thereof. A portion of electrode 12 may be configured to connect to
(or be received by) catheter shaft 14 of catheter assembly 10
therein coupling electrode 12 to form an embodiment of a catheter
assembly 10. It is noted that alternate configurations may be
employed with other embodiments in which an electrode may be
comprised of multiple members that connect or fit together to form
the electrode. Various materials may be used in the formation of
such electrodes, including a combination of electrically conductive
materials and materials that are less thermally conductive.
[0030] In the illustrated embodiment, outer body portion 18 of
electrode 20, which includes outer surface 20, is generally
cylindrical in shape and terminates in a hemispherical end.
However, outer body portion 18 may be provided in alternate
configurations that may be directed to the design of the catheter
assembly and/or the procedures being performed. Proximal portion 22
of electrode 12 is generally adjacent to catheter shaft 14, and may
be disposed on the distal end of catheter shaft 14. Distal portion
24 of electrode 12 is generally more remote from catheter shaft 14
and includes the portion of electrode 12 intended to come into
operative contact with tissue. Distal portion 24 further includes a
distal end 36 which may be generally hemispherical, although other
shapes and configurations are also contemplated by the present
invention.
[0031] Proximal portion 22 of electrode 12 may further include a
mounting portion, such as mounting shaft 34 that is provided on or
in connection with the proximal end 30 of electrode 12. Mounting
shaft 34 may be connected to or an integral part of proximal end 30
of proximal portion 22 of electrode 12 and may be received within
or otherwise connected to catheter shaft 14 of assembly 12. In an
embodiment, coupling member 32 is disposed between mounting shaft
34 and catheter shaft 14. A coupling member 32, such as a seal or
adhesive, is provided to ensure that electrode 12 is connected to
catheter shaft 14. Coupling member 32 is generally known in the art
and includes any type of material known for such a purpose to those
of ordinary skill in the art. Moreover, coupling member 32 may have
alternate configurations or arrangements to connect electrode 12
with catheter shaft 14.
[0032] Electrode 12 may further include a temperature or thermal
sensor 40 (generally represented in FIGS. 2 and 3) positioned
within distal portion 24 of electrode 12. Thermal sensor 40 may be
configured and positioned to provide improved or optimized accurate
temperature sensing by electrode 12 as ablative energy is applied
by catheter assembly 10. A lead wire 42 may be coupled to thermal
sensor 40 and may extend along the catheter assembly 12 such that
the temperature of electrode 12 may be communicated to a processor
or controller within the catheter assembly system to help control
overall system operation and regulation of the irrigation fluid
flow and ablation performed by the catheter assembly system. The
configuration of thermal sensor 40 may be modified to work with
various designs of open irrigation catheter assemblies. Moreover,
more than one thermal sensor 40 may be provided in connection with
an electrode. In embodiments in which a plurality of sensors 40 are
provided, the sensors may be used in combination to provide
temperature readings associated with an electrode 12.
[0033] With reference to FIGS. 2 and 3, inner cavity 26 of
electrode 12 includes a central longitudinal axis 38 that extends
along the length of electrode 12. Inner cavity 26 may have a
generally tubular configuration, although alternate embodiments of
the inner cavity are also contemplated. In the illustrated
embodiment, inner cavity 26 extends through proximal portion 22 and
into distal portion 24 of electrode 12.
[0034] As shown in FIGS. 2 and 3, an open irrigation electrode 12
includes at least one fluid passageway 28--such as, without
limitation, passageways 28a and/or 28b shown in FIG. 2). Such
passageway(s) 28 may include and be referred to as conduit(s),
irrigation port(s), irrigation hole(s), channel(s), or other types
of structures employed by those of skill in the art. In general,
passageway 28 extends from internal cavity 26 to an outer surface
20 of electrode 12. Moreover, some open irrigation electrodes, such
as those illustrated in FIGS. 2 and 3, may include at least one
passageway 28a that is perpendicular, or substantially
perpendicular, to the central longitudinal axis 38 of electrode 12.
In addition, as generally shown in FIG. 2, passageway 28b may be
provided that extends along central longitudinal axis 38 from inner
cavity 26 to distal end 36 to provide irrigation at distal portion
24 of electrode 12.
[0035] In addition to those configurations reflected in FIGS. 2 and
3, various alternative embodiments of fluid passageways may be
incorporated within electrode 12, such as those described in
currently pending applications assigned U.S. patent application
Ser. Nos. 11/939,195 and 11/939,206, both of which are herein fully
incorporated by reference. Furthermore, passageways 28 are disposed
circumferentially around electrode 12. In embodiments, the
passageways may be provided so that they are generally equidistant
from one another, although alternate configurations and placements
of passageway 28 may be used depending on the design or desired
performance (e.g., to cover a given volume of fluid flow) of
electrode 12.
[0036] Accordingly, the design of the passageways 28 may be
modified to obtain a desired flow rate of the irrigation fluid
based on a temperature threshold set by the overall system. The
size and configuration of passageway 28 (such as 28a and/or 28b)
may be varied depending on the size and design of an associated
electrode 12. In an embodiment, the diameter of passageway 28 may
range from 10-20 thousandths of an inch. In another embodiment, the
diameter of the passageway 28 may range from 12-16 thousandths of
an inch. Moreover, the flow rate and/or volume of fluid flow may
range from 13-20 ml/min. The diameter size of passageway 28 may be
configured to permit a given flow volume or rate, and further may
be varied in connection with the number of passageways provided by
electrode 12, as well as the length of the electrode, or with other
features associated with the electrode or catheter assemblies.
[0037] In addition to various passageway networks and
configurations, electrode 12 may include additional components,
such as those typically used by ablation electrodes, including but
not limited to pressure sensors, power wires, or other features or
components traditionally integrated with catheter assemblies.
[0038] An open irrigation catheter assembly 12, such as generally
described above, may be integrated into alternate embodiments of
catheter assembly system 50s, for example, as shown in FIGS. 4 and
5. System 50, 50' may be configured to control and regulate the
flow of irrigation fluid such that the relative positioning of the
electrode and establishment of sufficient or improved physical
contact is, at least in part, facilitated by a temperature feedback
provided by electrode 12.
[0039] As generally shown in the embodiment illustrated in FIG. 4,
catheter assembly 10 may be operably connected to a fluid source 52
(e.g., a pump assembly) and an energy source 54 (e.g., an RF
generator assembly), together comprising an embodiment of a
catheter system 50. The fluid source 52 and energy source 54 may
serve to facilitate operation of ablation procedures and may
involve monitoring any number of chosen variables (e.g.,
temperature of ablation electrode, ablation energy, and/or position
of the assembly), assisting in manipulation of the assembly during
the use, and providing the requisite energy from a source that is
delivered to the electrode 12. Furthermore, additional components
may be integrated into the system. By way of example, without
limitation, such additional components may include visualization,
mapping and navigation components known in the art, including St.
Jude Medical, Inc.'s NavX.RTM. system or other related systems.
[0040] As generally represented in FIG. 4, fluid source 52 and
energy source 54 may be provided in combination with a catheter
assembly 10 to comprise a system 50. Fluid source 52 can comprise
various known fluid sources, including fixed volume rolling pumps,
variable volume syringe pumps, and various other pump assemblies
known to those skilled in the art. Moreover, the fluid provided by
fluid source 52, may comprise a suitable biocompatible fluid, such
as saline. The energy source 54 may comprise, for example and
without limitation, an IBI-1500T RF Cardiac Ablation Generator
available from Irvine Biomedical, Inc. The energy source can also
comprise various other known energy sources. In order to obtain
controlled/regulated fluid flow within the system , energy source
54 may also, if desired, be configured with a temperature threshold
setting and pump control switch (not shown). In an embodiment,
energy source 54 (i.e., generator) may monitor and detect the
temperature of electrode 12 of catheter assembly 10 and, once an
established temperature threshold is met, activate fluid source 52,
therein either increasing/decreasing fluid flow or turning the pump
completely on or off. Accordingly, FIG. 4 generally illustrates a
system having a closed control loop to control the flow of
irrigation fluid, e.g., saline, based on the temperature feedback
provided by catheter assembly 10.
[0041] FIG. 5 generally illustrates another embodiment of the
invention wherein system 50' integrates a controller 56, such as,
for example, a computer or other type of processor or signal
control device. Controller 56 may be configured to receive input
from energy source 54. Input received by controller 56 may further
include temperature readings obtained from catheter assembly 10
(such as those provided in connection with a thermal sensor 40 of
electrode 12). Controller 56 can process temperature readings and
make comparisons/calculations with respect to specified temperature
threshold levels. Once a desired temperature threshold levels is
established or obtained, controller 56 can output a signal to pump
52, which can in turn control irrigation fluid flow supplied to
catheter assembly 12. Continued (periodic or continuous)
temperature readings from catheter assembly 10 may be provided to
controller 56 and based on changes in the temperature readings of
catheter assembly 10, controller 56 may modify its signal (e.g.,
instructions) to pump 52, which can increase or decrease the
associated fluid flow. Various data, such as, for example,
irrigation fluid flow (cc/min), temperature measurements, duration
of fluid flow, and electrode temperature response may be processed
by controller 56. In an embodiment, controller 56 may also help
assess (e.g., chart) various data or parameters, which may be
reviewed by a user. Moreover, the system 50 can provide for dynamic
assessment and review.
[0042] As represented in FIGS. 6-8, temperature readings of an
electrode 10 of catheter assembly 12 and the provision of
irrigation fluid have a direct correlation with one another. As
generally shown in FIG. 6, the conventional method of introducing
irrigation fluid upon the onset of the ablation procedure results
in the electrode temperature only reaching approximately 40 degrees
Celsius. However, this can result in less effective ablation with
respect to a target area and there may be some regulation
difficulties if the ablation electrode is in direct contact with
the target tissue. In comparison, FIGS. 7 and 8, without
limitation, illustrate delayed and intermitted irrigation,
respectively, in accordance with embodiments of the present
invention.
[0043] As generally shown in FIG. 7, irrigation fluid flow may
initially be delayed following application of ablation energy. The
delay in irrigation fluid flow may either be obtained through a
fixed delay or a variable delay. The fixed delay may occur, for
example, when irrigation flow is delayed for a fixed or
predetermined period of time, such as, for example, 10-30 seconds
after the start of the ablation energy. After a fixed period of
time has passed, the irrigation fluid may be provided to the
catheter assembly. In contrast, a variable delay may occur, for
example, when irrigation flow is controlled by a predetermined
temperature threshold. In a particular embodiment, the variable
delay may occur and continue until a temperature threshold level,
e.g., 65 degrees Celsius, is reached and then a constant irrigation
fluid flow can be provided and maintained for the duration of the
ablation procedure.
[0044] FIG. 8 illustrates an embodiment of an intermitted
irrigation fluid flow and a correlation between irrigated fluid
flow and resulting electrode temperature response. The intermitted
irrigation flow may occur for either a fixed intermitted duration
or for a variable intermitted duration. The fixed intermitted
duration may, for example, occur for a predefined period of time,
e.g., approximately 10-20 seconds, and then return back to a
maintenance flow level (e.g., 2 cc/min). This flow control can
occur for and throughout an entire ablation procedure. In other
embodiments, a variable intermitted duration may be controlled by
an upper predetermined electrode temperature threshold level (e.g.,
ranging from 50-70 degrees Celsius) and a lower predetermined
electrode temperature threshold level (e.g., ranging from 37-45
degrees Celsius). Accordingly, only a maintenance irrigation flow
level may be initially present (e.g., 2 cc/min), until an upper
predetermined threshold level is reached and then irrigation fluid
flow may be initiated. The irrigation fluid flow can be configured
to continue until a lower predetermined electrode temperature
threshold level is reached, at which point the irrigation fluid
flow may be decreased to return to a maintenance flow level. The
foregoing can continue in the form of a cycle or loop, which can
result in an intermitted fluid flow throughout an entire ablation
procedure. Alternately, the irrigation flow may be turned off
periodically during the ablation procedure to check the temperature
response of the electrode until the ablation is completely.
[0045] In accordance with the embodiments of the present invention,
and performing ablation of biological tissue through the use of
open irrigated catheter assemblies, a temperature threshold may be
preset in connection with a generator 54. In embodiments, the
temperature threshold level may range from 50-70 degrees Celsius,
and for some embodiments may preferably be about 65 degrees
Celsius. After a temperature threshold level is set or otherwise
established, an open irrigated ablation catheter assembly 10 can be
maneuvered to a target location (such as, for example, the surface
of the heart). Once electrode 12 of catheter assembly 10 is
provided at a desired target position, energy can be applied by
generator 54 to electrode 10.
[0046] The present invention further provides a method of
irrigating biological tissue. The method can be initiated by
providing an irrigated catheter ablation system 50, 50'. The system
50, 50' can include an irrigated ablation catheter assembly, a
fluid source connected to the catheter assembly, an energy source
connected to the catheter assembly, and an irrigation temperature
control mechanism in communication with the fluid source and energy
source. The irrigated ablation catheter assembly 10 may be in
accordance with teachings previously described. The method may
include a step of establishing or presetting a temperature
threshold for the system that regulates irrigation fluid flow from
the passageway of the catheter assembly. The irrigated electrode of
the irrigated ablation catheter assembly may be operatively
positioned at a target location. Energy may then applied to the
target location via an irrigated electrode. Temperature
measurements associated with an electrode may be continuously
collected. The temperature measurements can be continuously taken
by a thermal sensor disposed within an irrigated electrode. After
either a fixed period of time (fixed delay) or upon the temperature
measurement reaching a temperature threshold level (variable
delay), irrigation flow may be initiated or increased (if an
original (e.g., maintenance flow was already present) to cool the
electrode. Irrigation may continue until ablation is discontinued.
As previously described, an application of fixed delay irrigation
may cause the irrigation flow to be initiated, for example, about
10 to approximately 30 seconds after the application of the
ablation energy was applied. In comparison, if variable delay
irrigation is performed, the irrigation may be initiated after an
upper temperature threshold level is reached, e.g., at about 50-70
degrees Celsius.
[0047] Another embodiment further includes a method of irrigating
biological tissue involving an intermitted irrigation flow. In
addition to the steps discussed above, additional temperature
measurements of the irrigated electrode can be collected until a
predetermined lower threshold is reached. Once a predetermined
lower threshold level is reached, the irrigation flow may be
discontinued. Temperatures can continued to be monitored and
collected. If temperature measurements reach an upper temperature
threshold level again, irrigation flow can be initiated or
re-initiated, as the case may be. Such an intermitted irrigation
cycle can continue until the ablation is formed. Alternately, the
irrigation flow may be turned off periodically during the ablation
procedure to check the temperature response of the electrode until
the ablation is completely.
[0048] Although a number of embodiments of this invention have been
described above with a certain degree of particularity, those
skilled in the art could make numerous alterations to the disclosed
embodiments without departing from the spirit or scope of this
invention. All directional references (e.g., upper, lower, upward,
downward, left, right, leftward, rightward, top, bottom, above,
below, vertical, horizontal, clockwise, and counterclockwise) are
only used for identification purposes to aid the reader's
understanding of the present invention, and do not create
limitations, particularly as to the position, orientation, or use
of the invention. Joinder references (e.g., attached, coupled,
connected, and the like) are to be construed broadly and may
include intermediate members between a connection of elements and
relative movement between elements. As such, joinder references do
not necessarily infer that two elements are directly connected and
in fixed relation to each other. It is intended that all matter
contained in the above description or shown in the accompanying
drawings shall be interpreted as illustrative only and not
limiting. Changes in detail or structure may be made without
departing from the spirit of the invention as defined in the
appended claims.
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