U.S. patent application number 14/689373 was filed with the patent office on 2016-02-11 for tissue contact detection prior to and during an ablation procedure.
This patent application is currently assigned to Advanced Cardiac Therapeutics, Inc.. The applicant listed for this patent is Advanced Cardiac Therapeutics, Inc.. Invention is credited to Robert C. Allison, Eric R. Kanowsky, Timothy J. Lenihan, John F. McCarthy.
Application Number | 20160038229 14/689373 |
Document ID | / |
Family ID | 49671128 |
Filed Date | 2016-02-11 |
United States Patent
Application |
20160038229 |
Kind Code |
A1 |
McCarthy; John F. ; et
al. |
February 11, 2016 |
TISSUE CONTACT DETECTION PRIOR TO AND DURING AN ABLATION
PROCEDURE
Abstract
The present invention provides systems and methods for
radiometrically measuring temperature and detecting tissue contact
during ablation. An interface module includes a first input/output
(I/O) port for receiving radiometer and thermocouple signals from
an integrated catheter tip (ICT) that includes a radiometer; a
second I/O port for receiving ablative energy from an
electrosurgical generator; a temperature display; a patient relay;
a computer-readable medium storing radiometer and thermocouple
parameters and instructions for causing the processor to: calculate
a temperature adjacent to the ICT based on the radiometer and
thermocouple signals and the parameters; causing the temperature
display to display the calculated temperature; closing the patient
relay to pass ablative energy from the second to the first I/O
port; determining whether the ICT is in contact with tissue based
on the radiometer signal. An output device indicates whether the
ICT is determined to be in contact with the tissue.
Inventors: |
McCarthy; John F.; (Newbury,
NH) ; Lenihan; Timothy J.; (Hradec Kralove, CZ)
; Kanowsky; Eric R.; (Santa Barbara, CA) ;
Allison; Robert C.; (Rancho Palos Verdes, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Advanced Cardiac Therapeutics, Inc. |
Santa Clara |
CA |
US |
|
|
Assignee: |
Advanced Cardiac Therapeutics,
Inc.
Santa Clara
CA
Meridian Medical Systems, LLC
Portland
ME
|
Family ID: |
49671128 |
Appl. No.: |
14/689373 |
Filed: |
April 17, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14274438 |
May 9, 2014 |
9014814 |
|
|
14689373 |
|
|
|
|
13486889 |
Jun 1, 2012 |
8954161 |
|
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14274438 |
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Current U.S.
Class: |
606/34 |
Current CPC
Class: |
A61B 2018/0066 20130101;
A61B 5/6886 20130101; A61B 5/1405 20130101; A61B 2018/00708
20130101; A61B 5/150022 20130101; A61B 18/1492 20130101; A61B 18/12
20130101; A61B 2017/0007 20130101; A61B 2018/1467 20130101; A61B
2018/00702 20130101; A61B 2018/00898 20130101; A61B 2018/00821
20130101; A61B 2017/00057 20130101; A61B 2018/00351 20130101; A61B
2018/1861 20130101; A61B 2018/00791 20130101; A61B 2018/00672
20130101; A61B 2018/00642 20130101; A61B 5/01 20130101; A61B 5/0422
20130101; A61B 2018/00678 20130101; A61B 5/7405 20130101; A61B
2090/065 20160201; A61B 2018/00577 20130101; A61B 2018/0212
20130101; A61B 5/6852 20130101; A61B 18/1233 20130101 |
International
Class: |
A61B 18/14 20060101
A61B018/14; A61B 18/12 20060101 A61B018/12 |
Claims
1. A method of using an interface module with an ablation energy
generator and an integrated catheter tip (ICT), the ICT including a
radiometer, an ablative tip, and a thermocouple, the method of
using the interface module comprising the steps of: (a) receiving
at a first I/O port of the interface module a radiometer signal and
a thermocouple signal from the ICT; (b) receiving at a second I/O
port of the interface module ablative energy from the ablation
energy generator; (c) calculating at the interface module a
temperature adjacent to the ICT based on the radiometer signal, the
thermocouple signal, and the operation parameters; (d) determining
at the interface module whether the ICT is in contact with tissue
based on the radiometer signal; (e) outputting with an output
device an indication of the interface module's determination of
whether the ICT is in contact with the tissue; (f) displaying on a
temperature display of the interface module the calculated
temperature; and (g) after step (e), passing ablative energy
received on the second I/O port to the first I/O port by closing a
patient relay of the ablation module.
2. The method of claim 1, wherein step (d) comprises: (i)
identifying a change in the radiometer signal; (ii) comparing the
change in the radiometer signal to a threshold value; (iii) if the
change is greater than the threshold value, transmitting a signal
to the output device.
3. The method of claim 2, wherein the output device comprises a
visual display device configured to visually represent tissue
contact responsive to the signal.
4. The method of claim 2, wherein the output device comprises an
audio device configured to audibly represent tissue contact
responsive to the signal.
5. The method of claim 1, further comprising the steps of: (h)
storing at the interface module a safety cutoff temperature; (i) at
the interface module, comparing the calculated temperature to the
safety cutoff temperature while the patient relay is closes; and
(j) if the calculated temperature exceeds the safety cutoff
temperature, opening the patient relay and closing a load relay of
the ablation module such that the load relay passes ablative energy
received on the second I/O port to a dummy load of the ablation
module.
6. The method of claim 1, wherein the patient relay is maintained
in a normally closed state and opened upon detection of an unsafe
condition.
7. The method of claim 1, further comprising the steps of: (h)
initially calculating at the interface module a temperature
adjacent to the ICT based on the thermocouple signal and the
operation parameters but not the radiometer signal; (i) displaying
on the temperature display the initially calculated temperature;
and (j) if the temperature calculated in step (h) is in the range
of 35.degree. C. to 39.degree. C., and if the second I/O port is
receiving ablative energy from the ablation energy generator, then
performing steps (c)-(g).
8. The method of claim 1, further comprising the steps of: (h)
receiving at a third I/O port of the ablation energy generator a
signal from an indifferent electrode; and (i) providing at a fourth
I/O port the signal from the indifferent electrode to the ablation
energy generator.
9. The method of claim 1, wherein the ablative energy is selected
from the group consisting of RF energy, microwave energy,
cryoablation energy, and high frequency ultrasound energy.
10. The method of claim 1, wherein the ablative energy is RF
energy.
11. A system for facilitating detection of contact with a target
region of a subject, comprising: a processor, wherein the processor
is configured to receive a signal from a radiometer carried by a
medical instrument and to provide an output indicative of contact
between a portion of the medical instrument and a target region of
a subject based upon, at least in part, properties determined from
the signal received from the radiometer.
12. The system of claim 11, wherein the processor is configured to
regulate operation of an energy delivery member of the medical
instrument based on the output indicative of the contact between
the portion of the medical instrument and the target region of the
subject.
13. The system of claim 11, wherein the system is configured to
provide to a user of the system confirmation of contact between the
portion of the medical instrument and the target region of the
subject.
14. The system of claim 11, wherein the medical instrument
comprises a catheter comprising an irrigation pump in fluid
communication with a fluid passage of the catheter, wherein the
irrigation pump is configured to selectively deliver irrigation
fluid through the fluid passage of the catheter and at least one
irrigation fluid port of the catheter in fluid communication with
the fluid passage of the catheter during use.
15. The system of claim 11, further comprising the medical
instrument, wherein the medical instrument comprises an ablation
catheter configured to deliver energy sufficient to ablate the
target region upon being activated by an ablation energy source
after the output indicative of contact is provided by the
processor.
16. The system of claim 11, further comprising the medical
instrument, wherein the medical instrument comprises an energy
delivery catheter configured to deliver energy to the target region
upon being activated by an energy source after the output
indicative of contact is provided by the processor.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation application of U.S.
patent application Ser. No. 14/274,438, filed May 9, 2014, which is
a continuation application of U.S. patent application Ser. No.
13/486,889, filed on Jun. 1, 2012, the entirety of each of which is
hereby incorporated by reference herein.
FIELD
[0002] This application generally relates to systems and methods
for measuring temperature and detecting tissue contact prior to and
during tissue ablation.
BACKGROUND
[0003] Tissue ablation may be used to treat a variety of clinical
disorders. For example, tissue ablation may be used to treat
cardiac arrhythmias by destroying aberrant pathways that would
otherwise conduct abnormal electrical signals to the heart muscle.
Several ablation techniques have been developed, including
cryoablation, microwave ablation, radio frequency (RF) ablation,
and high frequency ultrasound ablation. For cardiac applications,
such techniques are typically performed by a clinician who
introduces a catheter having an ablative tip to the endocardium via
the venous vasculature, positions the ablative tip adjacent to what
the clinician believes to be an appropriate region of the
endocardium based on tactile feedback, mapping electrocardiogram
(ECG) signals, anatomy, and/or fluoroscopic imaging, actuates flow
of an irrigant to cool the surface of the selected region, and then
actuates the ablative tip for a period of time and at a power
believed sufficient to destroy tissue in the selected region.
[0004] Although commercially available ablative tips may include
thermocouples for providing temperature feedback via a digital
display, such thermocouples typically do not provide meaningful
temperature feedback during irrigated ablation. For example, the
thermocouple only measures surface temperature, whereas the heating
or cooling of the tissue that results in tissue ablation may occur
at some depth below the tissue surface. Moreover, for procedures in
which the surface of the tissue is cooled with an irrigant, the
thermocouple will measure the temperature of the irrigant, thus
further obscuring any useful information about the temperature of
the tissue, particularly at depth. As such, the clinician has no
useful feedback regarding the temperature of the tissue as it is
being ablated or whether the time period of the ablation is
sufficient.
[0005] Moreover, during an ablation procedure it is important that
the clinician position the ablative tip directly against the
cardiac surface (e.g., makes good contact) before activating the
ablation energy source and attempting to ablate the tissue. If the
clinician does not have good tissue contact, ablation energy may
heat the blood instead of the tissue, leading to the formation of
an edema, e.g., a fluid-filled pocket or blister on the tissue
surface. Such an edema may inhibit adequate destruction of aberrant
nerve pathways in the tissue. For example, edemas may physically
interfere with the clinician's ability to contact a desired region
of tissue with the ablative tip, and thus may interfere with
destruction of a desired nerve pathway. Additionally, partial
lesions or lesions in undesired locations have been found after the
clinician completes the procedure and the edema dissipates.
Formation of such partial or undesired lesions are thought to be
caused by reduced contact between the ablative tip and the tissue,
resulting in a tissue temperature insufficient to cause tissue
necrosis. Edemas and partially formed lesions also may make it more
difficult to create an effective lesion in the future, for example
during a touch-up ablation within the same procedure or later on
during a secondary procedure.
[0006] Accordingly, it may only be revealed after the procedure is
completed--for example, if the patient continues to experience
cardiac arrhythmias--that the targeted aberrant pathway was not
adequately interrupted. In such a circumstance, the clinician may
not know whether the procedure failed because the incorrect region
of tissue was ablated, because the ablative tip was not actuated
for a sufficient period of time to destroy the aberrant pathway,
because the ablative tip was not touching or not sufficiently
touching the tissue, because the power of the ablative energy was
insufficient, or some combination of the above. Upon repeating the
ablation procedure so as to again attempt to treat the arrhythmia,
the clinician may have as little feedback as during the first
procedure, and thus potentially may again fail to destroy the
aberrant pathway. Additionally, there may be some risk that the
clinician would re-treat a previously ablated region of the
endocardium and not only ablate the conduction pathway, but damage
adjacent tissues.
[0007] In some circumstances, to avoid having to repeat the
ablation procedure as such, the clinician may ablate a series of
regions of the endocardium along which the aberrant pathway is
believed to lie, so as to improve the chance of interrupting
conduction along that pathway. However, there is again insufficient
feedback to assist the clinician in determining whether any of
those ablated regions are sufficiently destroyed.
[0008] U.S. Pat. No. 4,190,053 to Sterzer describes a hyperthermia
treatment apparatus in which a microwave source is used to deposit
energy in living tissue to effect hyperthermia. The apparatus
includes a radiometer for measuring temperature at depth within the
tissue, and includes a controller that feeds back a control signal
from the radiometer, corresponding to the measured temperature, to
control the application of energy from the microwave source. The
apparatus alternates between delivering microwave energy from the
microwave source and measuring the radiant energy with the
radiometer to measure the temperature. As a consequence of this
time division multiplexing of energy application and temperature
measurement, temperature values reported by the radiometer are not
simultaneous with energy delivery.
[0009] U.S. Pat. No. 7,769,469 to Carr et al. describes an
integrated heating and sensing catheter apparatus for treating
arrhythmias, tumors and the like, having a diplexer that permits
near simultaneous heating and temperature measurement. This patent
too describes that temperature measured by the radiometer may be
used to control the application of energy, e.g., to maintain a
selected heating profile.
[0010] Despite the promise of precise temperature measurement
sensitivity and control offered by the use of radiometry, there
have been few successful commercial medical applications of this
technology. One drawback of previously-known systems has been an
inability to obtain highly reproducible results due to slight
variations in the construction of the microwave antenna used in the
radiometer, which can lead to significant differences in measured
temperature from one catheter to another. Problems also have arisen
with respect to orienting the radiometer antenna on the catheter to
adequately capture the radiant energy emitted by the tissue, and
with respect to shielding high frequency microwave components in
the surgical environment so as to prevent interference between the
radiometer components and other devices in the surgical field.
[0011] Acceptance of microwave-based hyperthermia treatments and
temperature measurement techniques also has been impeded by the
capital costs associated with implementing radiometric temperature
control schemes. Radiofrequency ablation techniques have developed
a substantial following in the medical community, even though such
systems can have severe limitations, such as the inability to
accurately measure tissue temperature at depth, e.g., where
irrigation is employed. However, the widespread acceptance of RF
ablation systems, extensive knowledge base of the medical community
with such systems, and the significant cost required to changeover
to, and train for, newer technologies has dramatically retarded the
widespread adoption of radiometry.
[0012] In view of the foregoing, it would be desirable to provide
apparatus and methods that permit radiometric measurement of
temperature at depth in tissue, and permit use of such measurements
to control the application of ablation energy in an ablation
treatment, e.g., a hyperthermia or hypothermia treatment,
particularly in which contact between the ablative tip and the
tissue readily may be assessed.
[0013] It further would be desirable to provide apparatus and
methods that employ microwave radiometer components that can be
readily constructed and calibrated to provide a high degree of
measurement reproducibility and reliability.
[0014] It also would be desirable to provide apparatus and methods
that permit radiometric temperature measurement and control
techniques to be introduced in a manner that is readily accessible
to clinicians trained in the use of previously-known RF ablation
catheters, with a minimum of retraining, and that provide readily
understandable signals to the clinicians as to whether the ablative
tip is in contact with tissue.
[0015] It still further would be desirable to provide apparatus and
methods that permit radiometric temperature measurement and control
techniques to be readily employed with previously-known RF
electrosurgical generators, thereby reducing the capital costs
needed to implement such new techniques.
SUMMARY
[0016] In view of the foregoing, it would be desirable to provide
apparatus and methods for treating living tissue that employs a
radiometer for temperature measurement and control. In accordance
with one aspect of the invention, systems and methods are provided
for radiometrically measuring temperature and detecting tissue
contact prior to and during RF ablation, i.e., calculating
temperature and detecting tissue contact based on signal(s) from a
radiometer. Unlike standard thermocouple techniques used in
existing commercial ablation systems, a radiometer may provide
useful information about tissue temperature at depth--where the
tissue ablation occurs--and thus provide feedback to the clinician
about the extent of tissue damage as the clinician ablates a
selected region of the tissue. Additionally, the radiometer may
provide useful information about whether an ablative tip is in
contact with tissue, and thus provide feedback to assist the
clinician in properly contacting and ablating the tissue.
[0017] In one embodiment, the present invention comprises an
interface module (system) that may be coupled to a previously-known
commercially available ablation energy generator, e.g., an
electrosurgical generator, thereby enabling radiometric techniques
to be employed with reduced capital outlay. In this manner, the
conventional electrosurgical generator can be used to supply
ablative energy to an "integrated catheter tip" (ICT) that includes
an ablative tip, a thermocouple, and a radiometer for detecting the
volumetric temperature of tissue subjected to ablation. The
interface module is configured to be coupled between the
conventional electrosurgical generator and the ICT, and to
coordinate signals therebetween. The interface module thereby
provides the electrosurgical generator with the information
required for operation, transmits ablative energy to the ICT under
the control of the clinician, displays via a temperature display
the temperature at depth of tissue as it is being ablated, and
outputs a visible or audible indication of tissue contact for use
by the clinician. The displayed temperature and determination of
tissue contact may be calculated based on signal(s) measured by the
radiometer using algorithms such as discussed further below.
[0018] In an exemplary embodiment, the interface module includes a
first input/output (I/O) port that is configured to receive a
digital radiometer signal and a digital thermocouple signal from
the ICT, and a second I/O port that is configured to receive
ablative energy from the electrosurgical generator. The interface
module also includes a processor, a patient relay in communication
with the processor and the first and second I/O ports, and a
persistent computer-readable medium. The computer-readable medium
stores operation parameters for the radiometer and the
thermocouple, as well as instructions for the processor to use in
coordinating operation of the ICT and the electrosurgical
generator.
[0019] The computer-readable medium preferably stores instructions
that cause the processor to execute the step of calculating a
temperature adjacent to the ICT based on the digital radiometer
signal, the digital thermocouple signal, and the operation
parameters. This temperature is expected to provide significantly
more accurate information about lesion quality and temperature at
depth in the tissue than would a temperature based solely on a
thermocouple readout. The computer-readable medium may further
store instructions for causing the processor to cause the
temperature display to display the calculated temperature, for
example so that the clinician may control the time period for
ablation responsive to the displayed temperature. The
computer-readable medium may further store instructions for causing
the processor to close the patient relay, such that the patient
relay passes ablative energy received on the second I/O port, from
the electrosurgical generator, to the first I/O port, to the ICT.
Note that the instructions may cause the processor to maintain the
patient relay in a normally closed state, and to open the patient
relay upon detection of unsafe conditions.
[0020] The computer-readable medium preferably also stores
instructions that cause the processor to execute the step of
determining whether the ICT is in contact with tissue, based on the
digital radiometer signal. For example, because blood and tissue
have different dielectric constants, the digital radiometer signal
may change when the ICT is brought into or out of contact with the
tissue. The instructions may cause the processor to monitor the
digital radiometer signal for changes. Any such changes may be
compared to a predetermined threshold value (also stored on the
computer-readable medium). If the change is determined to be
greater than the threshold value, then the processor outputs a
signal to an output device that, responsive to the signal,
indicates whether the ICT is in contact with tissue. The output
device may be, for example, a visual display device that visually
represents the tissue contact, e.g., a light that illuminates when
there is tissue contact, or an audio device that audibly represents
the tissue contact, e.g., a speaker that generates a tone when
there is tissue contact. Preferably, the processor determines
whether the ICT is in contact with the tissue before passing
ablation energy to the ICT.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] FIG. 1A is a schematic illustration of a first embodiment of
an arrangement including an interface module with tissue contact
indicator according to one aspect of the present invention,
including a display of the front and back panels of, and exemplary
connections between, the interface module, a previously known
ablation energy generator, e.g., electrosurgical generator, and an
integrated catheter tip (ICT).
[0022] FIG. 1B is a schematic illustrating exemplary connections to
and from the interface module of FIG. 1A, as well as connections
among other components that may be used with the interface
module.
[0023] FIG. 2A is a schematic illustrating internal components of
the interface module of FIGS. 1A-1B.
[0024] FIG. 2B schematically illustrates additional internal
components of the interface module of FIG. 2A, as well as selected
connections to and from the interface module.
[0025] FIG. 3A illustrates steps in a method of using the interface
module of FIGS. 1A-2B during tissue ablation.
[0026] FIG. 3B illustrates steps in a method of calculating
radiometric temperature using digital signals from a radiometer and
a thermocouple and operation parameters.
[0027] FIG. 3C illustrates steps in a method of controlling an
ablation procedure using a temperature calculated based on
signal(s) from a radiometer using the interface module of FIGS.
1A-2B.
[0028] FIG. 4A illustrates data obtained during an exemplary tissue
contact measurement procedure performed using the interface module
of FIGS. 1A-2B.
[0029] FIGS. 4B-4E illustrate data obtained during exemplary
ablation procedures performed using the interface module of FIGS.
1A-2B.
[0030] FIG. 5A illustrates a plan view of an exemplary patient
interface module (PIM) associated with an integrated catheter tip
(ICT) for use with the interface module of FIGS. 1A-2B.
[0031] FIG. 5B schematically illustrates selected internal
components of the PIM of FIG. 5A, according to some embodiments of
the present invention.
[0032] FIGS. 6A-6B respectively illustrate perspective and exploded
views of an exemplary integrated catheter tip (ICT) for use with
the interface module of FIGS. 1A-2B and the PIM of FIGS. 5A-5B,
according to some embodiments of the present invention.
DETAILED DESCRIPTION
[0033] Embodiments of the present invention provide systems and
methods for radiometrically measuring temperature and detecting
tissue contact prior to and during ablation, in particular cardiac
ablation. As noted above, commercially available systems for
cardiac ablation may include thermocouples for measuring
temperature, but such thermocouples may not adequately provide the
clinician with information about tissue temperature or tissue
contact. Thus, the clinician may need to make an "educated guess"
about whether an ablative tip is in contact with tissue, as well as
whether a given region of tissue has been sufficiently ablated to
achieve the desired effect. By comparison, calculating a
temperature based on signal(s) from a radiometer is expected to
provide accurate information to the clinician about the temperature
of tissue at depth, even during an irrigated procedure. Moreover,
the signal(s) from the radiometer may be used to determine whether
the ablative tip is in sufficient contact with tissue before
attempting to ablate the tissue, so as to reduce the likelihood of
forming edemas such as described above and improve the likelihood
of creating effective transmural lesions. The present invention
provides a "retrofit" solution that includes an interface module
that works with existing, commercially available ablation energy
generators, such as electrosurgical generators. In accordance with
one aspect of the present invention, the interface module displays
a tissue temperature and provides an indication of tissue contact
based on signal(s) measured by a radiometer, that a clinician may
use to perform ablation procedures with significantly better
accuracy than can be achieved using only a thermocouple for
temperature measurement.
[0034] First, high level overviews of the interface module,
including tissue contact indicator, and connections thereto are
provided. Then, further detail on the internal components of the
interface module, and exemplary methods of calculating radiometric
temperature, determining tissue contact, and controlling an
ablation procedure based on same, are provided. Data obtained
during experimental procedures also is presented. Lastly, further
detail on components that may be used with the interface module is
provided.
[0035] FIG. 1A illustrates plan views of front panel 111, back
panel 112, and connections to and from exemplary interface module
110, constructed in accordance with the principles of the present
invention. As illustrated in FIG. 1A, front panel 111 of interface
module 110 may be connected to a catheter 120 that includes patient
interface module (PIM) 121 and integrated catheter tip (ICT) 122.
Catheter 120 optionally is steerable, or may be non-steerable and
used in conjunction with a robotic positioning system or a
third-party steerable sheath (not shown). ICT 122 is positioned by
a clinician (optionally with mechanical assistance such as noted
above), during a procedure, within subject 101 lying on grounded
table 102. ICT 122 may include, among other things, an ablative
tip, a thermocouple, and a radiometer for detecting the volumetric
temperature of tissue subjected to ablation. The ICT 122 optionally
includes one or more irrigation ports, which in one embodiment may
be connected directly to a commercially available irrigant
pump.
[0036] In embodiments in which the ablation energy is
radiofrequency (RF) energy, the ablative tip may include an
irrigated ablation electrode, such as described in greater detail
below with reference to FIGS. 6A-6B. ICT 122 further may include
one or more electrocardiogram (ECG) electrodes for use in
monitoring electrical activity of the heart of subject 101.
Interface module 110 receives signals from the thermocouple,
radiometer, and optional ECG electrodes of ICT 122 via PIM 121.
Interface module 110 provides to ICT 122, via PIM 121, power for
the operation of the PIM and the sensors (thermocouple, radiometer,
and ECG electrodes), and ablation energy to be applied to subject
101 via the ablative tip.
[0037] Front panel 111 includes tissue contact indicator 170, which
is an output device configured to indicate whether ICT 122 is in
contact with tissue, e.g., which interface module 110 determines
based on signal(s) from the radiometer as described in greater
detail below. Tissue contact indicator 170 may include a visual
display device that visually represents interface module 110's
determination of whether ICT 122 is in contact with tissue. For
example, tissue contact indicator 170 may include a light that
illuminates when interface module 110 determines that ICT 122 is in
contact with tissue, and is dark when interface module 110
determines that ICT 122 is out of contact with tissue.
Alternatively, tissue contact indicator 170 may be an audio device
that audibly represents interface module 110's determination of
whether ICT 122 is in contact with tissue. For example, tissue
contact indicator 170 may include a speaker that generates a tone
when interface module 110 determines that ICT 122 is in contact
with tissue, and is silent when interface module 110 determines
that ICT 122 is out of contact with tissue. Tissue contact
indicator 170 may continuously generate a tone throughout the
duration of the contact, and cease generating the tone when contact
is lost, so as to facilitate the clinician's ability to determine
whether tissue contact has been lost. Alternatively, tissue contact
indicator 170 may generate a brief tone at a first frequency when
contact is made, and may generate a second tone at a second
frequency when contact is lost. Optionally, tissue contact
indicator 170 includes a visual display device and an audio device
for providing the clinician with both visible and audible
indications of tissue contact.
[0038] Back panel 112 of interface module 110 may be connected via
connection cable 135 to a commercially available previously-known
ablation energy generator 130, for example an electrosurgical
generator 130, such as a Stockert EP-Shuttle 100 Generator
(Stockert GmbH, Freiburg Germany) or Stockert 70 RF Generator
(Biosense Webster, Diamond Bar, Calif.). In embodiments where the
electrosurgical generator 130 is a Stockert EP-Shuttle or 70 RF
Generator, generator 130 includes display device 131 for displaying
temperature and the impedance and time associated with application
of a dose of RF ablation energy; power control knob 132 for
allowing a clinician to manually adjust the power of RF ablative
energy delivered to subject 101; and start/stop/mode input 133 for
allowing a clinician to initiate or terminate the delivery of RF
ablation energy. Start/stop/mode input 133 also may be configured
to control the mode of energy delivery, e.g., whether the energy is
to be cut off after a given period of time.
[0039] Although generator 130 may be configured to display
temperature on display device 131, that temperature is based on
readings from a standard thermocouple. As noted above, however,
that reported temperature may be inaccurate while irrigant and
ablative energy are being applied to tissue. Interface module 110
provides to generator 130, via connection cable 135, a thermocouple
signal for use in displaying such a temperature, and signals from
the ECG electrodes; and provides via indifferent electrode cable
134 a pass-through connection to indifferent electrode 140.
Interface module 110 receives from generator 130, via connection
cable 135, RF ablation energy that module 110 controllably provides
to ICT 122 for use in ablating tissue of subject 101.
[0040] As will be familiar to those skilled in the art, for a
monopolar RF ablation procedure, a clinician may position an
indifferent electrode (IE) 140 on the back of subject 101 so as to
provide a voltage differential that enables transmission of RF
energy into the tissue of the subject. In the illustrated
embodiment, IE 140 is connected to interface module 110 via first
indifferent electrode cable 141. Interface module 110 passes
through the IE signal to second indifferent electrode cable 134,
which is connected to an indifferent electrode input port on
electrosurgical generator 130. Alternatively, IE 140 may be
connected directly to that port of the electrosurgical generator
130 via appropriate cabling (not shown).
[0041] It should be understood that electrosurgical generators
other than the Stockert EP-Shuttle or 70 RF Generator suitably may
be used, e.g., other makes or models of RF electrosurgical
generators. Alternatively, generators that produce other types of
ablation energy, such as microwave generators, cryosurgical
sources, or high frequency ultrasound generators, may be used.
Ablation energy generator 130 need not necessarily be commercially
available, although as noted above it may be convenient to use one
that is. It should also be appreciated that the connections
described herein may be provided on any desired face or panel of
interface module 110, and that the functionalities of different
connectors and input/output (I/O) ports may be combined or
otherwise suitably modified.
[0042] Front panel 111 of interface module 110 includes temperature
display 113, e.g., a digital two or three-digit display device
configured to display a temperature calculated by a processor
internal to interface module 110, e.g., as described in greater
detail below with reference to FIGS. 2A-2B and 3A. Other types of
temperature displays, such multicolor liquid crystal displays
(LCDs), alternatively may be used. In one embodiment, the
functionalities of temperature display 113 and tissue contact
indicator 170 are provided by a single display device configured
both to display temperature and to provide an indication of
interface module 110's determination of whether ICT 122 is in
contact with tissue. For example, the background of temperature
display 113 may be configured to change from one color to another
(e.g., from red to green) when interface module 110 determines that
ICT 122 is in contact with tissue. In such an embodiment, a
separate, audible tissue contact indicator 170 such as described
above optionally may be provided as well. Front panel 111 also
includes connectors (not labeled) through which interface module
110 is connected to ICT 122 via PIM 121, and to IE 140 via
indifferent electrode cable 141.
[0043] Back panel 112 of interface module 110 includes connectors
(not labeled) through which interface module 110 is connected to
electrosurgical generator 130, via indifferent electrode cable 134
and connection cable 135. Back panel 112 of interface module 110
also includes data ports 114 configured to output one or more
signals to a suitably programmed personal computer or other remote
device, for example an EP monitoring/recording system such as the
LABSYSTEM.TM. PRO EP Recording System (C.R. Bard, Inc., Lowell,
Mass.). Such signals may, for example, include signals generated by
the thermocouple, radiometer, and/or ECG electrodes of the ICT, the
tissue temperature calculated by interface module 110, and the
like.
[0044] Referring now to FIG. 1B, exemplary connections to and from
interface module 110 of FIG. 1A, as well as connections among other
components, are described. In FIG. 1B, interface module 110 is in
operable communication with catheter 120 having a patient interface
module (PIM) 121 and an integrated catheter tip (ICT) 122 that
includes a radiometer, ablative tip, a thermocouple (TC), and
optionally also includes ECG electrodes and/or irrigation ports(s).
Interface module 110 is also in operable communication with
electrosurgical generator 130 and indifferent electrode 140.
[0045] Electrosurgical generator 130 optionally is in operable
communication with electrophysiology (EP) monitoring/recording
system 160 via appropriate cabling 161, or alternatively via data
ports 114 of interface module 110 and appropriate cabling (not
shown). EP monitoring/recording system 160 may include, for
example, various monitors, processors, and the like that display
pertinent information about an ablation procedure to a clinician,
such as the subject's heart rate and blood pressure, the
temperature recorded by the thermocouple on the catheter tip, the
ablation power and time period over which it is applied,
fluoroscopic images, and the like. EP monitoring/recording systems
are commercially available, e.g., the MEDELEC.TM. Synergy
T-EP-EMG/EP Monitoring System (CareFusion, San Diego, Calif.), or
the LABSYSTEM.TM. PRO EP Recording System (C.R. Bard, Inc., Lowell,
Mass.).
[0046] If ICT 122 includes irrigation port(s), then one convenient
means of providing irrigant to such ports is irrigation pump 140
associated with electrosurgical generator 130, which pump is in
operable communication with the generator and in fluidic
communication with the ICT 122 via connector 151. For example, the
Stockert 70 RF Generator is designed for use with a CoolFlow.TM.
Irrigation pump, also manufactured by Biosense Webster.
Specifically, the Stockert 70 RF Generator and the CoolFlow.TM.
pump may be connected to one another by a commercially available
interface cable, so as to operate as an integrated system that
works in substantially the same way as it would with a standard,
commercially available catheter tip. For example, prior to
positioning ICT 122 in the body, the clinician instructs the pump
to provide a low flow rate of irrigant to the ICT, as it would to a
standard catheter tip; the ICT is then positioned in the body.
Then, when the clinician presses the "start" button on the face of
generator 130, the generator may instruct pump 150 to provide a
high flow rate of irrigant for a predetermined period (e.g., 5
seconds) before providing RF ablation energy, again as it would for
a standard catheter tip. After the RF ablation energy application
is terminated, then pump 150 returns to a low flow rate until the
clinician removes the ICT 122 from the body and manually turns off
the pump.
[0047] Referring now to FIGS. 2A-2B, further details of internal
components of interface module 110 of FIGS. 1A-1B are provided.
[0048] FIG. 2A schematically illustrates internal components of one
embodiment of interface module 110. Interface module 110 includes
first, second, third, and fourth ports 201-204 by which it
communicates with external components. Specifically, first port 201
is an input/output (I/O) port configured to be connected to
catheter 120 via PIM 121, as illustrated in FIG. 1A. Port 201
receives as input from catheter 120 digital radiometer and digital
thermocouple (TC) signals, and optionally ECG signals, generated by
ICT 122, and provides as output to catheter 120 RF ablation energy,
as well as power for circuitry within the ICT 122 and the PIM 121.
Second port 202 is also an I/O port, configured to be connected to
electrosurgical generator 130 via connection cable 135 illustrated
in FIG. 1A, and receives as input from generator 130 RF ablation
energy, and provides as output to generator 130 a reconstituted
analog thermocouple (TC) signal and raw ECG signal(s). Third port
203 is an input port configured to be connected to indifferent
electrode (IE) 140 via indifferent electrode cable 134 illustrated
in FIG. 1A, and fourth port 204 is an output port configured to be
connected to generator 130 via indifferent electrode cable 141
illustrated in FIG. 1A. As shown in FIG. 2A, interface module 110
acts as a pass-through for the IE signal from IE 140 to generator
130, and simply receives IE signal on third port 203 and provides
the IE signal to generator 130 on fourth port 204.
[0049] Interface module 110 also includes processor 210 coupled to
non-volatile (persistent) computer-readable memory 230, user
interface 280, load relay 260, and patient relay 250. Memory 230
stores programming that causes processor 210 to perform steps
described further below with respect to FIGS. 3A-3C, thereby
controlling the functionality of interface module 110. Memory 230
also stores parameters used by processor 210. For example, memory
230 may store a set of operation parameters 231 for the
thermocouple and radiometer, as well as a temperature calculation
module 233, that processor 210 uses to calculate the radiometric
temperature based on the digital TC and radiometer signals received
on first I/O port 201, as described in greater detail below with
respect to FIG. 3B. The operation parameters 231 may be obtained
through calibration, or may be fixed. Memory 230 also stores a set
of safety parameters 232 that processor 210 uses to maintain safe
conditions during an ablation procedure, as described further below
with respect to FIG. 3C. Memory 230 further stores decision module
234 that processor 210 uses to control the opening and closing of
patient relay 250 and load relay 260 based on its determinations of
temperature and safety conditions, as described further below with
reference to FIGS. 3A-3C. When closed, patient relay 250 passes
ablative energy from the second I/O port 202 to the first I/O port
201. When closed, load relay 260 returns ablative energy to the IE
140 via dummy load D (resistor, e.g., of 120.OMEGA. resistance) and
fourth I/O port 204. Memory 230 further stores predetermined
threshold 235 value and tissue contact module 236 that processor
210 uses to determine whether ICT 122 is in contact with tissue,
and to provide output indicative of such contact to the clinician,
such as described further below with reference to FIG. 3A.
[0050] As illustrated in FIG. 2A, interface module 110 further
includes user interface 280 by which a user may receive information
about the temperature adjacent ICT 122 as calculated by processor
210, as well as other potentially useful information. In the
illustrated embodiment, user interface 280 includes digital
temperature display 113, which displays the instantaneous
temperature calculated by processor 210. In other embodiments (not
shown), display 113 may be an LCD device that, in addition to
displaying the instantaneous temperature calculated by processor
210, also graphically display changes in the temperature over time
for use by the clinician during the ablation procedure. User
interface 280 further may include data ports 114, which may be
connected to a computer or EP monitoring/recording system by
appropriate cabling as noted above, and which may output digital or
analog signals being received or generated by interface module 110,
e.g., radiometer signal(s), a thermocouple signal, and/or the
temperature calculated by processor 210. Preferably, user interface
280 also includes tissue contact indicator 170, which is configured
display the processor 210's determination as to whether ICT 122 is
in contact with tissue based on predetermined threshold value 235
and tissue contact module 236 stored in memory 230, e.g., as
described in further detail below with reference to FIG. 3A.
[0051] So as to inhibit potential degradations in the performance
of processor 210, memory 230, or user interface 280 resulting from
electrical contact with RF energy, interface module 110 may include
opto-electronics 299 that communicate information to and from
processor 210, but that substantially inhibit transmission of RF
energy to processor 210, memory 230, or user interface 280. This
isolation is designated by the dashed line in FIG. 2A. For example,
opto-electronics 299 may include circuitry that is in operable
communication with first I/O port 201 so as to receive the digital
TC and radiometer signals from first I/O port 201, and that
converts such digital signals into optical digital signals.
Opto-electronics 299 also may include an optical transmitter in
operable communication with such circuitry, that transmits those
optical digital signals to processor 210 through free space.
Opto-electronics 299 further may include an optical receiver in
operable communication with processor 210, that receives such
optical digital signals, and circuitry that converts the optical
digital signals into digital signals for use by processor 210. The
opto-electronic circuitry in communication with the processor also
may be in operable communication with a second optical transmitter,
and may receive signals from processor 210 to be transmitted across
free space to an optical receiver in communication with the
circuitry that receives and processes the digital TC and radiometer
signals. For example, processor 210 may transmit to such circuitry,
via an optical signal, a signal that causes the circuitry to
generate an analog version of the TC signal and to provide that
analog signal to the second I/O port. Because opto-electronic
circuitry, transmitters, and receivers are known in the art, its
specific components are not illustrated in FIG. 2A.
[0052] With respect to FIG. 2B, additional internal components of
interface module 110 of FIG. 2A are described, as well as selected
connections to and from the interface module. FIG. 2B is an
exemplary schematic for a grounding and power supply scheme
suitable for using interface module 110 with an RF electrosurgical
generator, e.g., a Stockert EP-Shuttle or 70 RF Generator. Other
grounding and power supply schemes suitably may be used with other
types, makes, or models of electrosurgical generators, as will be
appreciated by those skilled in the art.
[0053] As illustrated in FIG. 2B, interface module 110 includes
isolated main power supply 205 that may be connected to standard
three-prong A/C power outlet 1, which is grounded to mains ground
G. Interface module 110 also includes several internal grounds,
designated A, B, C, and I. Internal ground A is coupled to the
external mains ground G via a relatively small capacitance
capacitor (e.g., a 10 pF capacitor) and a relatively high
resistance resistor (e.g., a 20 NE/resistor) that substantially
prevents internal ground A from floating. Internal ground B is
coupled to internal ground A via a low resistance pathway (e.g., a
pathway or resistor(s) providing less than 1000.OMEGA. resistance,
e.g., about 0.OMEGA. resistance). Similarly, internal ground C is
coupled to internal ground B via another low resistance pathway.
Internal ground I is an isolated ground that is coupled to internal
ground C via a relatively small capacitance capacitor (e.g., a 10
pF capacitor) and a relatively high resistance resistor (e.g., a 20
M.OMEGA. resistor) that substantially prevents isolated ground I
from floating.
[0054] Isolated main power supply 205 is coupled to internal ground
A via a low resistance pathway. Isolated main power supply 205 is
also coupled to, and provides power (e.g., .+-.12V) to, one or more
internal isolated power supplies that in turn provide power to
components internal to interface module 110. Such components
include, but are not limited to components illustrated in FIG. 2A.
For example, interface module 110 may include one or more isolated
power supplies 220 that provide power (e.g., .+-.4V) to processor
210, memory 230, and analog circuitry 240. Analog circuitry 240 may
include components of user interface 280, including temperature
display 113 and circuitry that appropriately prepares signals for
output on data ports 114. Data ports 114, as well as analog
circuitry 240, are coupled to internal ground B via low resistance
pathways, while processor and memory 210, 230 are coupled to
internal ground C via low resistance pathways. Interface module
also may include one or more isolated power supplies 270 that
provide power (e.g., .+-.4V) to ICT 122, PIM 121, and RF circuitry
290.
[0055] RF circuitry 290 may include patient and load relays 250,
260, as well as circuitry that receives the radiometer and
thermocouple signals and provides such signals to the processor via
optoelectronic coupling, and circuitry that generates a clock
signal to be provided to the ICT as described further below with
reference to FIG. 5B. RF circuitry 290, ICT 122, and PIM 121 are
coupled to isolated internal ground I via low resistance
pathways.
[0056] As shown in FIG. 2B, power supply 139 of RF electrosurgical
generator 130, which may be external to generator 130 as in FIG. 2B
or may be internal to generator 130, is connected to standard two-
or three-prong A/C power outlet 2. However, generator power supply
139 is not connected to the ground of the outlet, and thus not
connected to the mains ground G, as is the isolated main power
supply. Instead, generator power supply 139 and RF electrosurgical
generator 130 are grounded to internal isolated ground I of
interface module 110 via low resistance pathways between generator
130 and PIM 121 and ICT 122, and low resistance pathways between
PIM 121 and ICT 122 and internal isolated ground I. As such, RF
circuitry 290, PIM 121, IE 140, and generator 130 are all
"grounded" to an internal isolated ground I that has essentially
the same potential as does ICT 122. Thus, when RF energy is applied
to ICT 122 from generator 130 through interface module 110, the
ground of RF circuitry 290, PIM 121, ICT 122, IE 140, and generator
130 all essentially float with the RF energy amplitude, which may
be a sine wave of 50-100V at 500 kHz.
[0057] As further illustrated in FIG. 2B, the .+-.12V of power that
isolated main power supply 205 provides to isolated
processor/memory/analog power supply 220 and to isolated ICT/RF
power supply 270 may be coupled by parasitic capacitance (pc,
approximately 13 pF) to A/C power outlet 1, as may be the .+-.4V of
power that such power supplies provide to their respective
components. Such parasitic coupling will be familiar to those
skilled in the art. Note also that the particular resistances,
capacitances, and voltages described with reference to FIG. 2B are
purely exemplary and may be suitably varied as appropriate to
different configurations.
[0058] Referring now to FIG. 3A, method 300 of using interface
module 110 of FIGS. 1A-2B during a tissue ablation procedure is
described. The clinician couples the integrated catheter tip (ICT)
122 and indifferent electrode (IE) 140 to respective I/O ports of
interface module 110 (step 301). For example, as shown in FIG. 1A,
ICT 122 may be coupled to a first connector on front panel 111 of
interface module 110 via patient interface module (PIM) 121, and IE
140 may be coupled to a third connector on front panel 111 via
indifferent electrode cable 141. The first connector is in operable
communication with first I/O port 201 (see FIG. 2A) and the third
connector is in operable communication with third I/O port 203 (see
FIG. 2A).
[0059] In method 300 of FIG. 3A, the clinician may couple
electrosurgical generator 130 to I/O port(s) of interface module
110 (step 302). For example, as illustrated in FIG. 1A,
electrosurgical generator 130 may be coupled to a second connector
on back panel 112 of interface module 110 via connection cable 135,
and also may be coupled to a fourth connector on back panel 112 via
indifferent electrode cable 134. The second connector is in
operable communication with second I/O port 202 (see FIG. 2A), and
the fourth connector is in operable communication with fourth I/O
port 204 (see FIG. 2A).
[0060] In method 300 of FIG. 3A, the clinician initiates flow of
irrigant, positions ICT 122 within the subject, e.g., in the
subject's heart, and positions IE 140 in contact with the subject,
e.g., on the subject's back (step 303). Those skilled in the art
will be familiar with methods of appropriately positioning catheter
tips relative to the heart of a subject in an ablation procedure,
for example via the peripheral arterial or venous vasculature.
[0061] In method 300 of FIG. 3A, interface module 110 receives
digital radiometer, digital thermocouple, and/or analog ECG signals
from the ICT, and receives ablation energy from generator 130 (step
304), for example using the connections, ports, and pathways
described above with references to FIGS. 1A-2B. Preferably,
generator 130 may provide such ablation energy to the interface
module responsive to the clinician pressing "start" using inputs
133 on the front face of generator 130 (see FIG. 1A).
[0062] In method 300 of FIG. 3A, interface module 110 calculates
and displays the temperature adjacent to ICT 122, based on the
radiometer and thermocouple signals (step 305). This calculation
may be performed, for example, by processor 210 based on
instructions in temperature calculation module 233 stored in memory
230 (see FIG. 2A). Exemplary methods of performing such a
calculation are described in greater detail below with respect to
FIG. 3B.
[0063] In method 300 of FIG. 3A, interface module 110 determines
whether ICT 122 is in contact with tissue based on the digital
radiometer signal (step 306). For example, tissue contact module
236 stored in memory 230 may cause processor 210 of interface
module 110 first to identify a change in the radiometer signal.
Specifically, the magnitude of the radiometer signal is a function
of, among other things, the temperature of the material(s) near the
radiometer and the dielectric constants of the material(s). Blood
and tissue have different dielectric constants from one another.
Therefore, as the clinician brings ICT 122 into or out of contact
with the tissue, that is, into or out of contact with a material
having a different dielectric constant than the blood, the
radiometer signal varies correspondingly. If the tissue and the
blood are at the same temperature as one another, then any changes
to the radiometer signal may be attributed to ICT 122 coming into
or out of contact with the tissue. Such changes may be viewed as a
change in the magnitude (e.g., voltage) of the radiometer signal
over baseline, or as a percent change in the radiometer signal over
baseline, in which baseline is the magnitude of the signal when ICT
122 is in the blood and away from the tissue.
[0064] Tissue contact module 236 then may cause processor 210 of
interface module 110 to compare the change in the radiometer signal
to a predetermined threshold value, e.g., predetermined threshold
value 235 stored in memory 230. The predetermined threshold value
preferably is selected such that changes in the radiometer signal
caused by non-contact sources such as noise fall below the
threshold value, while changes in the radiometer caused by tissue
contact fall above the threshold value. As such, threshold values
may vary from system to system, depending on the particular noise
characteristics and sensitivity of the radiometer. For example, at
baseline, the radiometer signal may have a noise level of about
.+-.0.1 V. It may be determined via calibration that the radiometer
signal increases to about 0.3 V above baseline when ICT 122 is
brought into contact with tissue. As such, predetermined threshold
value 135 suitably may be set to an intermediate magnitude between
the upper end of the noise level and the average value when ICT 122
is in contact with tissue, e.g., a value in the range of about
0.11-0.29 V in the above example, e.g., 0.15 V, 0.2 V, or 0.25 V.
Alternatively, the noise level of the radiometer is .+-.10% of
baseline, and it may be determined via calibration that the
radiometer signal increases by about 30% when ICT 122 is brought
into contact with tissue. As such, predetermined threshold value
135 suitably may be set to an intermediate percentage between the
upper end of the noise level and the average value when ICT 122 is
in contact with tissue, e.g., in the range of 11-29% in the above
example, e.g., 15%, 20%, or 25% in the above example.
[0065] If processor 210 of interface module 110 determines that the
change in the radiometer signal is greater than stored
predetermined threshold value 235, then the processor causes tissue
contact indicator 170 to indicate that there is contact between ICT
122 and the tissue. For example, processor 210 may transmit a
signal to tissue contact indicator 170 that indicates that ICT 122
is in contact with tissue. Responsive to the signal, tissue contact
indicator 170 generates an appropriate indicator that the clinician
may perceive as meaning that ICT 122 has been brought into contact
with tissue. For example, tissue contact indicator 170 may include
a light that illuminates when there is tissue contact, and/or may
include a speaker that generates a tone when there is tissue
contact, or otherwise signal contact such as described above with
reference to FIG. 1A.
[0066] In method 300 illustrated in FIG. 3A, interface module 110
also actuates patient relay 250 so as to provide ablation energy to
ICT 122 for use in tissue ablation (step 307). For example,
processor 210 may maintain patient relay 250 illustrated in FIG. 2A
in a normally closed state during operation, such that ablation
energy flows from electrosurgical generator 130 to ICT 122 through
interface module 110 without delay upon the clinician's actuation
of the generator, and may open patient relay 250 only upon
detection of unsafe conditions such as described below with respect
to FIG. 3C. In an alternative embodiment, processor 210 may
maintain patient relay 250 in a normally open state during
operation, and may determine based on instructions in decision
module 234 and on the temperature calculated in step 305 that it is
safe to proceed with the tissue ablation, and then close patient
relay so as to pass ablation energy to the ICT. In either case,
after a time period defined using input 133 on the front face of
generator 130, the supply of ablation energy ceases or the
clinician manually turns off the supply of ablation energy.
Preferably, step 307 is executed after step 306. That is, processor
210 preferably determines that there is tissue contact, and causes
tissue contact indicator to provide an indication of such contact
to the clinician, before allowing ablation energy to be provided to
ICT 122 via patient relay 250.
[0067] Interface module 110 also generates an analog version of the
thermocouple signal, and provides the ECG and analog thermocouple
signals to generator 130 (step 308). Preferably, step 308 is
performed continuously by the interface module throughout steps 303
through 307, rather than just at the end of the ablation procedure.
For example, as will be familiar to those skilled in the art, the
Stockert EP-Shuttle or 70 RF Generator may "expect" certain signals
to function properly, e.g., those signals that the generator would
receive during a standard ablation procedure that did not include
use of interface module 110. The Stockert EP-Shuttle or 70 RF
generator requires as input an analog thermocouple signal, and
optionally may accept analog ECG signal(s). The interface module
110 thus may pass through the ECG signal(s) generated by the ICT to
the Stockert EP-shuttle or 70 RF generator via second I/O port 202.
However, as described above with reference to FIG. 2A, interface
module 110 receives a digital thermocouple signal from ICT 122. In
its standard configuration, the Stockert EP-Shuttle or 70 RF
generator is not configured to receive or interpret a digital
thermocouple signal. As such, interface module 110 includes the
functionality of reconstituting an analog version of the
thermocouple signal, for example using processor 210 and
opto-electronics 299, and providing that analog signal to generator
130 via second I/O port 202.
[0068] Turning to FIG. 3B, the steps of method 350 of calculating
radiometric temperature using digital signals from a radiometer and
a thermocouple and operation parameters is described. The steps of
the method may be executed by processor 210 based on temperature
calculation module 233 stored in memory 230 (see FIG. 2A). While
some of the signals and operation parameters discussed below are
particular to a PIM and ICT configured for use with RF ablation
energy, other signals and operation parameters may be suitable for
use with a PIM and ICT configured for use with other types of
ablation energy. Those skilled in the art will be able to modify
the systems and methods provided herein for use with other types of
ablation energy.
[0069] In FIG. 3B, processor 210 obtains from memory 230 of
interface module 110 the operation parameters for the thermocouple
(TC) and the radiometer (step 351). These operation parameters may
include, for example, TCSlope, which is the slope of the TC
response with respect to temperature; TCOffset, which is the offset
of the TC response with respect to temperature; RadSlope, which is
the slope of the radiometer response with respect to temperature;
TrefSlope, which is the slope of a reference temperature signal
generated by the radiometer with respect to temperature; and F,
which is a scaling factor.
[0070] Processor 210 then obtains via first I/O port 201 and
opto-electronics 299 the raw digital signal from the thermocouple,
TCRaw (step 352), and calculates the thermocouple temperature, TCT,
based on TCRaw using the following equation (step 353):
T C T = TCRaw TCSlope - TCOffset ##EQU00001##
[0071] Then, processor 210 causes temperature display 113 to
display TCT until both of the following conditions are satisfied:
TCT is in the range of 35.degree. C. to 39.degree. C., and ablation
energy is being provided to the ICT (e.g., until step 307 of FIG.
3A). There are several reasons to display only the thermocouple
temperature TCT, as opposed to the temperature calculated based on
signal(s) from the radiometer, until both of these conditions are
satisfied. For example, if the temperature TCT measured by the
thermocouple is less than 35.degree. C., then based on instructions
in decision module 234 the processor 210 interprets that
temperature as meaning that ICT 122 is not positioned within a
living human body, which would have a temperature of approximately
37.degree. C. If ICT 122 is positioned in the body, power safely
may be provided to the radiometer circuitry so as to obtain
radiometer signal(s) that processor 210 may use to determine
whether ICT 122 is in contact with tissue (e.g., step 306 of FIG.
3A).
[0072] As illustrated in FIG. 3B, processor 210 then provides
ablation energy to ICT 122, e.g., in accordance with step 307
described above, and receives via second I/O port 202 two raw
digital signals from the radiometer: Vrad, which is a voltage
generated by the radiometer based on the temperature adjacent the
ICT; and Vref, which is a reference voltage generated by the
radiometer (step 355). Note that Vrad and Vref also may be provided
from the radiometer at times other than when ablation energy is
being provided to ICT 122, and that Vrad and/or Vref may constitute
the radiometer signal(s) used by processor 210 to determine whether
ICT 122 is in contact with tissue (e.g., step 306 of FIG. 3A).
[0073] As illustrated in FIG. 3B, processor 210 calculates the
reference temperature Tref based on Vref using the following
equation (step 356):
Tref = Vref TrefSlope + TrefOffset ##EQU00002##
[0074] Processor 210 also calculates the radiometric temperature
Trad based on Vrad and Tref using the following equation (step
357):
Trad = Vrad RadSlope - RadOffset + Tref ##EQU00003##
[0075] During operation of interface module 110, processor 210 may
continuously calculate TCT, and also may continuously calculate
Tref and Trad during times when ablation power is provided to the
ICT (which is subject to several conditions discussed further
herein). Processor 210 may store in memory 230 these values at
specific times and/or continuously, and use the stored values to
perform further temperature calculations. For example, processor
210 may store in memory 230 TCT, Tref, and Trad at baseline, as the
respective values TCBase, TrefBase, and TradBase. The processor
then re-calculates the current radiometric temperature TradCurrent
based on the current Vrad received on second I/O port 202, but
instead with reference to the baseline reference temperature
TrefBase, using the following equation (step 358):
TradCurrent = Vrad RadSlope - RadOffset + TrefBase ##EQU00004##
[0076] Processor 210 then calculates and causes temperature display
113 to display a scaled radiometric temperature TSrad for use by
the clinician based on the baseline thermocouple temperature
TCBase, the baseline radiometer temperature TradBase, and the
current radiometer temperature TradCurrent, using the following
equation (step 359):
TSrad=TCBase+(TradCurrent-TradBase).times.F
[0077] In this manner, interface module 110 displays for the
clinician's use a temperature calculated based on signal(s) from
the radiometer that is based not only on voltages generated by the
radiometer and its internal reference, described further below with
reference to FIGS. 6A-6B, but also on temperature measured by the
thermocouple.
[0078] With respect to FIG. 3C, method 360 of controlling an
ablation procedure based on a temperature calculated based on
signal(s) from a radiometer, e.g., as calculated using method 350
of FIG. 3B, and also based on safety parameters 232 and decision
module 234 stored in memory 230 is described.
[0079] In method 360 of FIG. 3C, a slow flow of irrigant is
initiated through the ICT and the ICT is then positioned within the
subject (step 361). For example, in embodiments for use with a
Stockert 70 RF Generator, the generator may automatically initiate
slow irrigant flow to the catheter tip by sending appropriate
signals to a CoolFlow irrigant pumping system associated with the
generator, responsive to actuation of the generator by the
clinician.
[0080] After confirming that the ICT is in contact with tissue
based on an indication by tissue contact indicator 170 such as
described above, the clinician presses a button on the generator to
start the flow of ablation energy to the ICT; this may cause the
generator to initiate a high flow of irrigant to the ICT and
generation of ablation energy following a 5 second delay (step
362). The interface module passes the ablation energy to the ICT
via the patient relay, as described above with respect to step 306
of FIG. 3A.
[0081] Based on the calculated and displayed radiometric
temperature (see methods 300 and 350 described above with respect
to FIGS. 3A-3B), the clinician determines the temperature of the
tissue volume that is being ablated by the ablation energy (step
363). By comparison, temperature measured by a thermocouple alone
would provide little to no useful information during this stage of
the procedure.
[0082] Interface module 110 may use the calculated radiometric
temperature to determine whether the ablation procedure is being
performed within safety parameters. For example, processor 210 may
obtain safety parameters 232 from memory 230. Among other things,
these safety parameters may include a cutoff temperature above
which the ablation procedure is considered to be "unsafe" because
it may result in perforation of the cardiac tissue being ablated,
with potentially dire consequences. The cutoff temperature may be
any suitable temperature below which one or more unsafe conditions
may not occur, for example "popping" such as described below with
respect to FIGS. 4D-4E, or tissue burning, but at which the tissue
still may be sufficiently heated. One example of a suitable cutoff
temperature is 85.degree. C., although higher or lower cutoff
temperatures may be used, e.g., 65.degree. C., 70.degree. C.,
75.degree. C., 80.degree. C., 90.degree. C., or 95.degree. C.
Instructions in decision module 234, also stored in memory 230,
cause processor 210 to continuously compare the calculated
radiometric temperature to the cutoff temperature, and if the
radiometric temperature exceeds the cutoff temperature, the
processor may set an alarm, open the patient relay, and close the
load relay so as to return power to the IE via I/O port 204,
thereby cutting off flow of ablation energy to the ICT (step 364 of
FIG. 3C). Otherwise, the processor may allow the ablation procedure
to proceed (step 364).
[0083] The ablation procedure terminates (step 365), for example,
when the clinician presses the appropriate button on generator 130,
or when the generator 130 automatically cuts of ablation energy at
the end of a predetermined period of time.
[0084] Referring now to FIGS. 4A-4E, illustrative data obtained
during experiments using an interface module constructed in
accordance with the present invention is described. This data was
obtained using an unmodified Stockert EP Shuttle Generator with
integrated irrigation pump, and a catheter including the PIM 121
and ICT 122 described further below with reference to FIGS. 5A-6B
coupled to interface module 110.
[0085] FIG. 4A illustrates the change over time in various signals
collected during a procedure in which the ablative tip of ICT 122
was immersed into a tank of saline containing a tissue sample that
were maintained at a constant temperature of about 49.5.degree. C.
and had dielectric constants similar to that of living blood and
tissue, respectively. The ablative tip of ICT 122 was manually
brought into and out of contact with the tissue several times.
Signal 401 illustrated in FIG. 4A corresponds to radiometer signal
Vrad (having units of Volts, right side y-axis of graph) signal 402
corresponds to the thermocouple temperature (having units of
.degree. C., left side y-axis of graph), and signal 403 corresponds
to display temperature Tdisplay (also having units of .degree. C.,
left side y-axis of graph). Signals 401, 402, and 403 were
collected without actuating the Stockert EP Shuttle Generator, so
that changes in Vrad as ICT 122 was brought into contact with the
tissue could be attributed to the difference between the dielectric
constants of the saline and the tissue, rather than to changes in
temperature.
[0086] As can be seen in FIG. 4A, radiometer signal 401 begins at a
baseline 404 around 2.95 V; the particular value of this baseline
depends, among other things, on the dielectric constant and
temperature of the saline in which ICT 122 is immersed, and the
sensitivity of the radiometer. Radiometer signal 401 has a noise
level 405 of about .+-.0.05 V about baseline 404, which may be
attributed to random noise in the radiometer electronics. During
the time periods between about 20-32 seconds, 40-52 seconds, 60-72
seconds, and 80-92 seconds, radiometer signal 401 may be seen to
rapidly increase from baseline 404 to a higher level 406 around
3.37 V. Because the tissue is at the same temperature as the
saline, the change in radiometer signal 401 to level 406 may be
attributed to the different dielectric constant of the tissue as
compared to the saline. As such, contact between ICT 122 and the
tissue in the tank readily may be identified based on changes in
radiometer signal from baseline 404 to level 406. Additionally,
based on such observations a predetermined threshold value 407 may
be defined that lies between the upper end of noise 405 and level
406 indicative of tissue contact, and that may be stored in memory
230 and used by processor 210 of interface module 110 at a later
time to determine whether ICT 122 is in contact with tissue. Thus,
in essence, such a procedure calibrates the ICT 122 with regards to
tissue contact. Preferably, the temperature and the dielectric
constants of the materials used during such a calibration are
selected to be relatively similar to those of blood and tissue of a
human, so that baseline 404, level 406, and predetermined threshold
value 407 are based on the expected temperatures and dielectric
constants measured by the radiometer during an actual ablation
procedure.
[0087] FIG. 4B illustrates the change over time in various signals
collected during an ablation procedure in which ICT 122 was placed
against exposed thigh tissue of a living dog, and the Stockert EP
Shuttle generator actuated so as to apply 20 W of RF energy for 60
seconds. A Luxtron probe was also inserted at a depth of 3 mm into
the dog's thigh. Luxtron probes are considered to provide accurate
temperature information, but are impractical for normal use in
cardiac ablation procedures because such probes cannot be placed in
the heart of a living being.
[0088] FIG. 4B illustrates the change over time in various signals
collected during the ablation procedure. Signal 410 corresponds to
scaled radiometric temperature TSrad; signal 420 corresponds to the
thermocouple temperature; signal 430 corresponds to a temperature
measured by the Luxtron probe; and signal 440 corresponds to the
power generated by the Stockert EP Shuttle Generator.
[0089] As can be seen from FIG. 4B, power signal 440 indicates that
RF power was applied to the subject's tissue beginning at a time of
about 40 seconds and ending at a time of about 100 seconds.
Radiometric temperature signal 410 indicates a sharp rise in
temperature beginning at about 40 seconds, from a baseline in
region 411 of about 28.degree. C. to a maximum in region 412 of
about 67.degree. C., followed by a gradual fall in region 413
beginning around 100 seconds. The features of radiometric
temperature signal 410 are similar to those of Luxtron probe signal
430, which similarly shows a temperature increase beginning around
40 seconds to a maximum value just before 100 seconds, and then a
temperature decrease beginning around 100 seconds. This similarity
indicates that the radiometric temperature has similar accuracy to
that of the Luxtron probe. By comparison, thermocouple signal 420
shows a significantly smaller temperature increase beginning around
40 seconds, followed by a low-level plateau in the 40-100 second
region, and then a decrease beginning around 100 seconds. The
relatively weak response of the thermocouple, and the relatively
strong and accurate response of the Luxtron thermocouple, indicate
that an unmodified Stockert EP Shuttle Generator successfully may
be retrofit using interface module 110 constructed in accordance
with the principles of the present invention to provide a clinician
with useful radiometric temperature information for use in an
ablation procedure.
[0090] FIG. 4C illustrates signals obtained during a similar
experimental procedure, but in which two Luxtron probes were
implanted into the animal's tissue, the first at a depth of 3 mm
and the second at a depth of 7 mm. The Stockert EP Shuttle
generator was activated, and the RF power was manually modulated
between 5 and 50 W using the power control knob on the front panel
of the generator. In FIG. 4C, the radiometer signal is designated
460, the 3 mm Luxtron designated 470, and the 7 mm Luxtron
designated 480. The radiometer and 3 mm Luxtron signals 460, 470
may be seen to have relatively similar changes in amplitude to one
another resulting from the periodic heating of the tissue by RF
energy. The 7 mm Luxtron signal 480 may be seen to have a slight
periodicity, but far less modulation than do the radiometer and 3
mm Luxtron signals 460, 470. This is because the 7 mm Luxtron is
sufficiently deep within the tissue that ablation energy
substantially does not directly penetrate at that depth. Instead,
the tissue at 7 mm may be seen to slowly warm as a function of
time, as heat deposited in shallower portions of the tissue
gradually diffuses to a depth of 7 mm.
[0091] A series of cardiac ablation procedures were also performed
in living humans using the experimental setup described above with
respect to FIGS. 4B-4C, but omitting the Luxtron probes. The humans
all suffered from atrial flutter, were scheduled for conventional
cardiac ablation procedures for the treatment of same, and
consented to the clinician's use of the interface box and ICT
during the procedures. The procedures were performed by a clinician
who introduced the ICT into the individuals' endocardia using
conventional methods. During the procedures, the clinician was not
allowed to view the temperature calculated by the interface module.
As such, the clinician performed the procedures in the same manner
as they would have done with a system including a conventional RF
ablation catheter directly connected to a Stockert EP-Shuttle
generator. The temperature calculated by the interface module
during the various procedures was made available for the clinician
to review at a later time. The clinician performed a total of 113
ablation procedures on five humans using the above-noted
experimental setup.
[0092] FIGS. 4D-4E illustrate data obtained during sequential
ablation procedures performed on a single individual using the
experimental setup. Specifically, FIG. 4D illustrates the change
over time in the signal 415 corresponding to the scaled radiometric
temperature TSrad, as well as the change over time in the signal
421 corresponding to the thermocouple temperature, during the tenth
ablation procedure performed on the individual. During the
procedure, about 40 W of RF power was applied to the individual's
cardiac tissue for 60 seconds (between about 20 seconds and 80
seconds in FIG. 4D), and the clinician had a target temperature 445
of 55.degree. C. to which it was desired to heat the cardiac tissue
so as to sufficiently interrupt an aberrant pathway causing the
individual's atrial flutter. It can be seen that the scaled
radiometric temperature signal 415, which was subjected to data
smoothing in FIG. 4D, varied between about 40.degree. C. and
51.degree. C. while RF power was applied. By comparison, as
expected, the thermocouple temperature 421 provided essentially no
useful information about the tissue temperature during the
procedure. Notably, the clinician's target temperature 445 of
55.degree. C. was never reached during the procedure, even though
the clinician believed based on his or her perceptions of the
procedure that such temperature had been reached. Because the
target temperature 445 was not reached, the tissue was
insufficiently heated during the procedure to interrupt an aberrant
pathway. The failure to reach the target temperature may be
attributed to insufficient contact or force between the ablative
tip of the ICT and the individual's cardiac tissue, the condition
of the cardiac surface, insufficient power, and the like.
[0093] FIG. 4E illustrates the change over time in signal 416
corresponding to TSrad, as well as the change over time in the
signal 422 corresponding to the thermocouple temperature, during
the eleventh ablation procedure performed on the same individual as
in FIG. 4D. During this procedure, again about 40 W of RF power was
applied to the individual's cardiac tissue for 60 seconds (between
about 20 seconds and 80 seconds in FIG. 4E), and the clinician
again had a target temperature 445 of 55.degree. C. It can be seen
that the scaled radiometric signal 416, again subject to data
smoothing, varied between about 55.degree. C. and 70.degree. C.
while RF power was applied, while the thermocouple temperature 421
again provided essentially no useful information. Here, the
clinician attributed the higher temperature tissue temperature
achieved during the ablation to better contact between the ablative
tip of the ICT and the individual's cardiac tissue. However, it can
be seen that even while RF power was being applied to the tissue,
the temperature varied relatively rapidly over time, e.g., from
about 70.degree. C. at about 35 seconds, to about 56.degree. C. at
40 seconds, which may be attributed to variations in the quality of
contact between the ICT and the individual's cardiac tissue.
[0094] The results of the ablation procedures performed on the five
individuals are summarized in the following table:
TABLE-US-00001 Total % of Total Ablation Number of patients 5
Number of ablations 113 Number of ablations that did not reach 50
44% target temperature of 55.degree. C. Number of ablations that
reached high 13 12% temperature cutoff of 95.degree. C. Number of
pops 3 3% Number of successful treatments of 5 100% atrial
flutter
[0095] As can be seen from the above table, 44% of the ablation
procedures did not reach the clinician's target tissue temperature
of 55.degree. C. As such, it is likely that this percentage of the
procedures resulted in insufficient tissue heating to interrupt
aberrant pathway(s). However, although many of the ablation
procedures failed, the clinician repeated the ablation procedures a
sufficient number of times to achieve 100% treatment of the
individuals' atrial flutter. It is believed that displaying the
calculated temperature to the clinician during ablation procedures
would enable the clinician to far more accurately assess the
quality of contact between the ablative tip of the ICT and the
individual's cardiac tissue, and thus to sufficiently heat the
tissue above the target temperature for a desired period of time,
and thus reduce the clinicians' need to repeatedly perform numerous
ablation procedures on the same subject so as to achieve the
desired treatment.
[0096] As shown in the above table, 12% of the ablation procedures
triggered the high temperature cutoff such as illustrated in FIG.
3C. Here, the cutoff temperature was defined to be 95.degree. C.
However, it was observed that at this cutoff temperature, "pops"
formed during three of the ablation procedures. A "pop" occurs when
the blood boils because of excessive localized heating caused by
ablation energy, which results in formation of a rapidly expanding
bubble of hot gas that may cause catastrophic damage to the cardiac
tissue. It is believed that a lower cutoff temperature, e.g.,
85.degree. C., may inhibit formation of such "pops."
[0097] Additional components that may be used in conjunction with
interface module 110 of the present invention, e.g., PIM 121 and
ICT 122 of catheter 120, are now briefly described with reference
to FIGS. 5A-6B.
[0098] In FIG. 5A, patient interface module (PIM) 121 that may be
associated with the integrated catheter tip (ICT) described further
below with respect to FIGS. 6A-6B is described. PIM 121 includes
interface module connector 501 that may be connected to front panel
111 of interface module 110, as described with reference to FIG.
1A; PIM circuitry 502, which will be described in greater detail
below with reference to FIG. 5B; ICT connector 503 that may be
connected to catheter 120; and PIM cable 504 that extends between
interface module connector 501 and PIM circuitry 502. PIM 121 is
preferably, but not necessarily, designed to remain outside the
sterile field during the ablation procedure, and optionally is
reusable with multiple ICT's.
[0099] FIG. 5B schematically illustrates internal components of PIM
circuitry 502, and includes first I/O port 505 configured to be
coupled to catheter 120, e.g., via ICT connector 503, and second
I/O port 506 configured to be coupled to interface module 110,
e.g., via PIM cable 504 and interface module connector 501.
[0100] PIM circuitry 502 receives on first I/O port 505 an analog
thermocouple (TC) signal, raw analog radiometer signals, and analog
ECG signals from catheter 120. PIM circuitry 502 includes TC signal
analog-to-digital (A/D) converter 540 that is configured to convert
the analog TC signal to a digital TC signal, and provide the
digital TC signal to interface module 110 via second I/O port 506.
PIM circuitry 502 includes a series of components configured to
convert the raw analog radiometer signals into a usable digital
form. For example, PIM circuitry may include radiometric signal
filter 510 configured to filter residual RF energy from the raw
analog radiometer signals; radiometric signal decoder 520
configured to decode the filtered signals into analog versions of
the Vref and Vrad signals mentioned above with reference to FIG.
3B; and radiometric signal A/D converter 530 configured to convert
the analog Vref, Vrad signals into digital Vref, Vrad signals and
to provide those digital signals to second I/O port for
transmission to interface module 110. PIM circuitry 502 also passes
through the ECG signals to second I/O port 506 for transmission to
interface module 110.
[0101] On second I/O port 506, PIM circuitry 502 receives RF
ablation energy from generator 130 (e.g., a Stockert EP-Shuttle or
70 RF Generator) via interface module 110. PIM circuitry 502 passes
that RF ablation energy through to catheter 120 via first I/O port
505. PIM circuitry 502 also receives on second I/O port 506 a clock
signal generated by RF circuitry within interface module 110, as
described further above with reference to FIG. 2B, and passes
through the clock signal to first I/O port 505 for use in
controlling microwave circuitry in ICT 122, as described below.
[0102] Referring now to FIGS. 6A-6B, an exemplary integrated
catheter tip (ICT) 122 for use with the interface module 110 of
FIGS. 1A-2B and the PIM of FIGS. 5A-5B is described. Further detail
on components of ICT 122 may be found in U.S. Pat. No. 7,769,469 to
Carr, the entire contents of which are incorporated herein by
reference, as well as in U.S. Patent Publication No. 2010/0076424,
also to Carr ("the Carr publication"), the entire contents of which
are incorporated herein by reference. The device described in the
aforementioned patent and publication do not include a thermocouple
or ECG electrodes, which preferably are included in ICT 122
configured for use with interface module 110.
[0103] As described in the Carr publication and as depicted in
FIGS. 6A-6B, ICT 122 includes an inner or center conductor 103
supported by a conductive carrier or insert 104. Carrier 104 may be
formed from a cylindrical metal body having an axial passage 106
that receives conductor 103. Upper and lower sectors of that body
extending inward from the ends may be milled away to expose passage
106 and conductor 103 therein and to form upper and lower
substantially parallel flats 108a and 108b. Flat 108a may include
coplanar rectangular areas 108aa spaced on opposite sides of
conductor 103 near the top thereof. Likewise, flat 108b may include
two coplanar rectangular areas 108bb spaced on opposite sides of
conductor 103 near the bottom thereof. Thus, carrier 104 may
include center segment 104a containing the flats and distal and
proximal end segments 104b and 104c, respectively, which remain
cylindrical, except that a vertical groove 107 may be formed in
proximal segment 104c.
[0104] Center conductor 103 may be fixed coaxially within passage
106 by means of an electrically insulating collar or bushing 109,
e.g. of PTFE, press fit into passage 106 at distal end segment 104b
of the carrier and by a weld to the passage wall or by an
electrically conductive collar or bushing (not shown) at the
carrier proximal segment 104c. This causes a short circuit between
conductor 103 and carrier 104 at the proximal end of the carrier,
while an open circuit may be present therebetween at the distal end
of the carrier. In the carrier center segment 104a, the walls 106a
of passage 106 may be spaced from center conductor 103. This forms
a quarter wave stub S, as described in greater detail in U.S. Pat.
No. 7,769,469 and U.S. Patent Publication No. 2010/0076424.
Conductor 103 includes distal end segment 103a which extends beyond
the distal end of carrier 104 a selected distance, and a proximal
end segment 103b which extends from the proximal end of ICT 122 and
connects to the center conductor of cable 105 configured to connect
to PIM 121.
[0105] As illustrated in FIG. 6B, mounted to the upper and lower
flats 108a and 108b of carrier 104 is a pair of opposed, parallel,
mirror-image, generally rectangular plates 115a and 115b. Each
plate 115a, 115b may include a thin, e.g. 0.005 in., substrate 116
formed of an electrically insulating material having a high
dielectric constant. Printed, plated or otherwise formed on the
opposing or facing surfaces of substrates 116 are axially centered,
lengthwise conductive strips 117, preferably 0.013-0.016 mm wide,
which extend the entire lengths of substrates 116. Also, the
opposite or away-facing surfaces of substrates 116 are plated with
conductive layers 118, e.g. of gold. The side edges of layers 118
wrap around the side edges of the substrates.
[0106] When the ICT is being assembled, plate 115a may be seated on
the upper flat 108a of carrier 104 and the lower plate 115b is
likewise seated on the lower flat 108b so that the center conductor
103 is contacted from above and below by the conductive strips 117
of the upper and lower plates and the layer 118 side edges of those
plates contact carrier segment 104a. A suitable conductive epoxy or
cement may be applied between those contacting surfaces to secure
the plates in place.
[0107] At least one of the plates, e.g. plate 115a, functions also
as a support surface for one or more monolithic integrated circuit
chips (M_MICs), e.g. chips 122 and 124. The chip(s) may include a
coupling capacitor connected by a lead (not shown) to center
conductor 103 and the usual components of a radiometer such as a
Dicke switch, a noise source to provide a reference temperature,
amplifier stages, a band pass filter to establish the radiometer
bandwidth, additional gain stages if needed, a detector and buffer
amplifier. Due to the relatively small profile of the present ICT
122, the above circuit components may be arranged in a string of
four chips. The chip(s) may be secured to the metal layer 118 of
plate 115a by a suitable conductive adhesive so that that layer
which, as described above, is grounded to the insert 104 may
function as a ground plane for those chips. The plates also conduct
heat away from the chips to conductor 103 and carrier 104. Various
leads (not shown) connect the chips to each other and other leads
125b extend through carrier slot 107 and connect the last chip 124
in the string, i.e. the radiometer output, to corresponding
conductors of cable 105 leading to PIM 121.
[0108] A tubular outer conductor 126 may be slid onto carrier 104
from an end thereof so that it snugly engages around the carrier
with its proximal and distal ends coinciding with the corresponding
ends of the carrier (not shown). The conductor 126 may be fixed in
place by a conductive epoxy or cement applied around the carrier
segments 104b and 104c.
[0109] ICT 122 also may include an annular dielectric spacer 137,
e.g. of PTFE, which is centered on the distal end of carrier 104
and surrounds the conductor segment 103a. The spacer may have a
slit 137a enabling it to be engaged around that conductor segment
from the side thereof. The spacer 137 may be held in place by a
conductive collar 136 which encircles the spacer and is long enough
to slidably engage over a distal end segment of outer conductor
126. The collar 136 may be press fit around that conductor and
carrier segment 104b to hold it in place and to electrically
connect all those elements.
[0110] The distal end of the ICT 122 may be closed off by
conductive tip 142 which, in axial section, may be T shaped. That
is, the tip 142 may have discoid head 142a that forms the distal
end of the ICT and an axially extending tubular neck 142b. The
conductor segment 103a is sufficiently long to extend beyond the
distal end of the spacer 137 into the axial passage in neck 104b.
The tip may be secured in place by conductive adhesive applied
around the distal end of conductor segment 103a and at the distal
end or edge of collar 136. When the tip is in place, the conductor
segment 103a and tip 104 form a radiometric receiving antenna, as
described in greater detail in U.S. Pat. No. 7,769,469 and U.S.
Patent Publication No. 2010/0076424.
[0111] ICT 122 may further include dielectric sheath 144 which may
be engaged over the rear end of outer conductor 126 and slid
forwardly until its distal end 144a is spaced a selected distance
behind the distal end of tip 142. The conductors 103 and 126 of ICT
122 form an RF transmission line terminated by the tip 104. When
the ICT 122 is operative, the transmission line may radiate energy
for heating tissue only from the uninsulated segment of the probe
between tip 104 and the distal end 144a of the sheath 144. That
segment thus constitutes an RF ablation antenna.
[0112] The proximal ends of the center conductor segment 103b,
outer conductor 126 and sheath 144 may be connected, respectively,
to the inner and outer conductors and outer sheath of cable 105
that leads to PIM 121. Alternatively, those elements may be
extensions of the corresponding components of cable 105. In any
event, that cable 105 connects the center conductor 103 to the
output of a transmitter which transmits a RF heating signal at a
selected heating frequency, e.g. 500 GHz, to the RF ablation
antenna.
[0113] As illustrated in FIG. 6A, ICT 122 further may include
first, second, and third ECG electrodes 190 disposed on the outside
of sheath 144, as well as a thermocouple 191 positioned so as to
detect the temperature of blood or tissue in contact with ICT 122.
Signals generated by electrodes 190 and thermocouple 191 may be
provided along cable 105 connected to PIM 121.
[0114] If desired, cable 105 further may include probe steering
wire 145 whose leading end 145a may be secured to the wall of a
passage 146 in carrier segment 104c.
[0115] Preferably, helical through slot 147 is provided in collar
136 as shown in FIGS. 6A-6B. The collar material left between the
slot turns essentially forms helical wire 148 that bridges spacer
137. Wire 148 is found to improve the microwave antenna pattern of
the radiometric receiving antenna without materially degrading the
RF heating pattern of the RF ablation antenna.
[0116] The inner or center conductor 103 may be a solid wire, or
preferably is formed as a tube that enables conductor 103 to carry
an irrigation fluid or coolant to the interior of probe tip 142 for
distribution therefrom through radial passages 155 in tip head 142a
that communicate with the distal end of the axial passage in tip
neck 142b.
[0117] When plates 115a and 115b are seated on and secured to the
upper and lower flats 108a and 108b, respectively, of carrier 104,
conductive strips 117, 117 of those members may be electrically
connected to center conductor 103 at the top and bottom thereof so
that conductor 103 forms the center conducts for of a slab-type
transmission line whose ground plane includes layers 118, 118.
[0118] When ablation energy is provided to ICT 122, a microwave
field exists within the substrate 116 and is concentrated between
the center conductor 103 and layers 118, 118. Preferably, as noted
here, conductive epoxy is applied between conductor 103 and strips
117 to ensure that no air gaps exist there because such a gap would
have a significant effect on the impedance of the transmission line
as the highest field parts are closest to conductor 103.
[0119] Plates 115a, 115b and conductor 103 segment together with
carrier 104 form a quarter wave (.lamda..sub.R/4) stub S that may
be tuned to the frequency of radiometer circuit 124, e.g. 4 GHz.
The quarter wave stub S may be tuned to the center frequency of the
radiometer circuit along with components in chips 122, 124 to form
a low pass filter in the signal transmitting path to the RF
ablation antenna, while other components of the chips form a high
pass or band pass filter in the signal receiving path from the
antenna to the radiometer. The combination forms a passive diplexer
D which prevents the lower frequency transmitter signals on the
signal transmitting path from antenna T from reaching the
radiometer, while isolating the path to the transmitter from the
higher frequency signals on the signal receiving path from the
antenna.
[0120] The impedance of the quarter wave stub S depends upon the K
value and thickness t of substrates 116 of the two plates 115a,
115b and the spacing of center conductor 103 from the walls 106a,
106a of passage 106 in the carrier center segment 104a. Because the
center conductor 103 is not surrounded by a ceramic sleeve, those
walls can be moved closer to the center conductor, enabling
accurate tuning of the suspended substrate transmission line
impedance while minimizing the overall diameter of the ICT 122. As
noted above, the length of the stub S may also be reduced by making
substrate 116 of a dielectric material which has a relatively high
K value.
[0121] In one working embodiment of the ICT 122, which is only
about 0.43 in. long and about 0.08 in. in diameter, the components
of the ICT have the following dimensions:
TABLE-US-00002 Component Dimension (inches) Conductor 103 0.020
outer diameter 0.016 inner diameter (if hollow) Substrate 116 (K =
9.8) 0.065 wide; thickness t = 0.005 Strips 117 0.015 wide Air gap
between 103 and each 106a 0.015
[0122] Thus, the overall length and diameter of the ICT 122 may be
relatively small, which is a useful feature for devices configured
for percutaneous use.
[0123] While various illustrative embodiments of the invention are
described above, it will be apparent to one skilled in the art that
various changes and modifications may be made herein without
departing from the invention. For example, although the interface
module has primarily been described with reference for use with an
RF electrosurgical generator and the PIM and ICT illustrated in
FIGS. 5A-6B, it should be understood that the interface module
suitably may be adapted for use with other sources of ablation
energy and other types of radiometers. Moreover, the radiometer may
have components in the ICT and/or the PIM, and need not necessarily
be located entirely in the ICT. Furthermore, the functionality of
the radiometer, ICT, and/or PIM optionally may be included in the
interface module. The appended claims are intended to cover all
such changes and modifications that fall within the true spirit and
scope of the invention.
* * * * *