U.S. patent application number 16/521707 was filed with the patent office on 2019-11-14 for sheath visualization method by means of impedance localization and magnetic information.
The applicant listed for this patent is BIOSENSE WEBSTER (ISRAEL) LTD.. Invention is credited to Dror Berman, Assaf Pressman, Shaul Haim Raz, Avigdor Rosenberg.
Application Number | 20190343423 16/521707 |
Document ID | / |
Family ID | 57570387 |
Filed Date | 2019-11-14 |
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United States Patent
Application |
20190343423 |
Kind Code |
A1 |
Pressman; Assaf ; et
al. |
November 14, 2019 |
SHEATH VISUALIZATION METHOD BY MEANS OF IMPEDANCE LOCALIZATION AND
MAGNETIC INFORMATION
Abstract
Catheterization is carried out by inserting a sheath into a
human patient and moving a catheter having an electrode through the
sheath lumen. A variation between a first threshold value and a
second threshold value in electrical current through the electrode
is identified. Responsively to the variation, it is reported that a
portion of the catheter has transitioned between an in-sheath
condition and an out-of-sheath condition. The sheath is defined and
identified by the historical data of the readings of the magnetic
sensor during its movements.
Inventors: |
Pressman; Assaf; (Pardes
hanna-Karkur, IL) ; Raz; Shaul Haim; (Shimshit,
IL) ; Rosenberg; Avigdor; (Kiryat Tivon, IL) ;
Berman; Dror; (Haifa, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
BIOSENSE WEBSTER (ISRAEL) LTD. |
Yokneam |
|
IL |
|
|
Family ID: |
57570387 |
Appl. No.: |
16/521707 |
Filed: |
July 25, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14974878 |
Dec 18, 2015 |
10398347 |
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16521707 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/0422 20130101;
A61B 5/6885 20130101; A61B 5/0432 20130101; A61B 5/746 20130101;
A61M 25/0127 20130101; A61B 5/062 20130101; A61M 2025/0166
20130101; A61M 2025/0681 20130101; A61B 5/6852 20130101; A61B 5/063
20130101 |
International
Class: |
A61B 5/06 20060101
A61B005/06; A61B 5/0432 20060101 A61B005/0432; A61M 25/01 20060101
A61M025/01; A61B 5/042 20060101 A61B005/042 |
Claims
1. (canceled)
2. (canceled)
3. (canceled)
4. (canceled)
5. (canceled)
6. (canceled)
7. (canceled)
8. (canceled)
9. (canceled)
10. (canceled)
11. An apparatus, comprising: a plurality of body surface
electrodes, which are adapted to be fixed to a surface of a body at
respective locations; a controller having current-measuring
circuitry, which is adapted to be coupled to a catheter having a
distal portion and at least one catheter electrode disposed on the
distal portion and to body surface electrodes, the controller being
operative for passing electrical current through the body between
the at least one catheter electrode and the body surface
electrodes, and for determining position coordinates of the
catheter by measuring respective characteristics of the electrical
current passing through the body surface electrodes; a memory; a
processor, having access to the memory and cooperative with the
controller to perform the steps of: while the catheter is being
moved in a human patient through a sheath having a lumen and a
distal end, measuring the electrical current through the at least
one catheter electrode with the current-measuring circuitry;
identifying a variation in the electrical current between a first
threshold value and a second threshold value; and responsively to
the variation, reporting that a portion of the catheter has
transitioned between an in-sheath condition and an out-of-sheath
condition.
12. The apparatus according to claim 11, wherein the
current-measuring circuitry is a component of an impedance
measuring system and wherein measuring the electrical current
comprises measuring an impedance of a heart of the human
patient.
13. The apparatus according to claim 11, wherein the sheath has an
outer wall, the outer wall having a perforation formed
therethrough, wherein identifying a variation is performed while
the catheter electrode is passing by the perforation.
14. The apparatus according to claim 13, wherein the at least one
catheter electrode comprises a plurality of catheter electrodes:
while the catheter is being moved, concurrently measuring the
electrical current in the plurality of catheter electrodes,
respectively, wherein identifying a variation comprises recognizing
a transient decrease in current flow in one of the catheter
electrodes that does not fall below a lower threshold; and
concluding that a position of the one catheter electrode opposes
the perforation during the transient decrease.
15. The apparatus according to claim 14, wherein the processor and
the controller are operative responsively to identifying a
variation determining a location of the distal end of the catheter
relative to the perforation.
16. The apparatus according to claim 13, wherein the portion of the
catheter is the distal end of the catheter.
17. The apparatus according to claim 13, wherein the portion of the
catheter is another electrode.
18. The apparatus according to claim 11 wherein the memory contains
a database of sheath-catheter combinations.
19. The apparatus according to claim 11, further comprising a
position processing system operative for reading signals from a
magnetic sensor disposed in the catheter at a predetermined
distance from the distal end of the catheter and reporting a
location of the distal end of the catheter from the reading.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
[0001] This invention relates to instruments for performing medical
examinations of the interior of cavities. More particularly, this
invention relates to instruments employing magnetic fields and
impedance measurements for determining a position of a probe in the
interior of a cavity.
2. Description of the Related Art
[0002] The meanings of certain acronyms and abbreviations used
herein are given in Table 1.
TABLE-US-00001 TABLE 1 Acronyms and Abbreviations ACL Active
Current Location CPM Current Position Map
[0003] In a number of medical procedures a probe is inserted into a
patient through a sheath. Typically, the sheath acts to guide the
probe during its insertion, as well as to maintain the probe in a
desired alignment. Once the probe and the sheath have been inserted
into the patient, their distal ends are not visible, so that an
operator performing the procedure may be unaware of the
relationship of the sheath's distal end relative to the probe's
distal end. It is possible to use fluoroscopy to locate the sheath,
but at the cost of exposing, which exposes the subject to
radiation.
[0004] Impedance-based position sensing is one method used to guide
the tip of the catheter to the target position in which the medical
procedure is to be performed. Commonly assigned U.S. Patent
Application Publication No. 20150126895, which is herein
incorporated by reference, describes a sheath having an outer wall
that surrounds an inner lumen and has multiple holes along the tube
penetrating the outer wall. Multiple electrically conducting
elements are inserted in the respective holes, so as to allow
transmission of electrical current between the inner lumen and an
exterior of the outer wall.
SUMMARY OF THE INVENTION
[0005] In one cardiac catheterization technique, the operator first
inserts a sheath having ACL electrodes percutaneously into the
patient's body and guides the sheath's distal end to the target
region. The operator then inserts a hybrid catheter having magnetic
and ACL sensors into the lumen of the sheath and guides the tip of
the catheter through the sheath. When the catheter has exited the
sheath, a current position map is eventually built as part of the
medical procedure.
[0006] According to disclosed embodiments of the invention, data
from magnetic sensors is used to trace the location of the catheter
through the sheath. Once the distal portion of the catheter emerges
from the sheath, the magnetic data is augmented by data from using
the ACL sensors of the catheter. However, the ACL data is not valid
while the catheter tip is still within the sheath. By evaluating
the currents in the ACL sensors of the catheter it is possible to
detect the emergence of the catheter through the tip of the sheath.
The combined magnetic and ACL data then locates the sheath tip
prior to construction of the map.
[0007] There is provided according to embodiments of the invention
a method, which is carried out by inserting a sheath into a human
patient and moving a catheter through the lumen of the sheath,
wherein the catheter has at least one electrode disposed on its
distal portion. The method is further carried out by measuring
electrical current through the electrode with current-measuring
circuitry, identifying a variation in the electrical current
between a first threshold value and a second threshold value, and
responsively to the variation, reporting that a portion of the
catheter has transitioned between an in-sheath condition and an
out-of-sheath condition.
[0008] According to a further aspect of the method, the electrode
and the current-measuring circuitry are components of an impedance
measuring system and wherein the electrical current is a measure of
an impedance of a heart.
[0009] According to yet another aspect of the method, the sheath
has a perforation formed through its outer wall, and identifying a
variation occurs while the electrode is passing by the
perforation.
[0010] A plurality of electrodes may be disposed on the catheter.
The method is further carried out by concurrently measuring
respective electrical current in the plurality of electrodes,
recognizing a transient decrease in current flow in one of the
electrodes that does not fall below a lower threshold, and
concluding that a position of the one electrode opposes the
perforation during the transient decrease.
[0011] Responsively to identifying a variation the method is
further carried out by determining a location of the distal end of
the catheter relative to the perforation.
[0012] According to still another aspect of the method, the portion
of the catheter is the distal end of the catheter.
[0013] According to an additional aspect of the method, the portion
of the catheter is another electrode.
[0014] According to another aspect of the method, the at least one
electrode includes a proximal electrode and a distal electrode. The
method is further carried out by defining an upper threshold and a
lower threshold, wherein moving the catheter includes iteratively
advancing the catheter in the sheath while the electrical current
through the distal electrode does not exceed the upper threshold,
retracting the catheter in the sheath until the electrical current
through the proximal electrode no longer exceeds the lower
threshold, and thereafter reporting that the distal electrode is in
the out-of-sheath condition and the proximal electrode is in the
in-sheath condition.
[0015] According to yet another aspect of the method, defining an
upper threshold and a lower threshold includes accessing a database
of sheath-catheter combinations.
[0016] According to still another aspect of the method, a magnetic
sensor is disposed in the catheter at a predetermined distance from
the distal end, and reporting includes reading the magnetic sensor,
and reporting a location of the distal end of the catheter from the
reading.
[0017] There is further provided according to embodiments of the
invention an apparatus, including a plurality of body surface
electrodes, which are adapted to be fixed to a surface of a body at
respective locations and a controller having current-measuring
circuitry. The controller is adapted to be coupled to a catheter
having at least one catheter electrode disposed on its distal
portion and to the body surface electrodes. The controller is
operative for passing electrical current through the body between
the at least one catheter electrode and the body surface
electrodes, and for determining position coordinates of the
catheter by measuring respective characteristics of the electrical
current passing through the body surface electrodes, The apparatus
further includes a memory and a processor with access to the
memory, the processor being cooperative with the controller for
measuring the electrical current through the at least one catheter
electrode with the current-measuring circuitry, identifying a
variation in the electrical current between a first threshold value
and a second threshold value, and responsively to the variation,
reporting that a portion of the catheter has transitioned between
an in-sheath condition and an out-of-sheath condition.
[0018] The apparatus may include a position processing system
operative for reading signals from a magnetic sensor disposed in
the catheter at a predetermined distance from the distal end of the
catheter and reporting a location of the distal end of the catheter
from the reading using the predetermined distance as an offset.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0019] For a better understanding of the present invention,
reference is made to the detailed description of the invention, by
way of example, which is to be read in conjunction with the
following drawings, wherein like elements are given like reference
numerals, and wherein:
[0020] FIG. 1 is a pictorial illustration of a system for
performing catheterization procedures on a heart in accordance with
a disclosed embodiment of the invention;
[0021] FIG. 2 is a schematic pictorial view of catheter within a
sheath in accordance with an embodiment of the invention;
[0022] FIG. 3 is a schematic diagram illustrating a catheter having
ACL electrodes and a sheath in accordance with an embodiment of the
invention;
[0023] FIG. 4 is a schematic diagram illustrating a catheter lying
partially within a sheath in accordance with an embodiment of the
invention;
[0024] FIG. 5 is an electrical schematic of a circuit modeling the
impedance and current of an ACL electrode in accordance with an
embodiment of the invention;
[0025] FIG. 6 is a plot of ACL electrode current obtained while an
electrode transitions from an in-sheath to an out-of-sheath status
accordance with an embodiment of the invention;
[0026] FIG. 7 is a plot showing a distribution of out-of-sheath
currents in accordance with an embodiment of the invention;
[0027] FIG. 8 is a plot of ACL electrode current as a function of
penetration into a sheath in accordance with an embodiment of the
invention;
[0028] FIG. 9 is a plot of ACL electrode current as a function of
penetration into a sheath in accordance with an embodiment of the
invention;
[0029] FIG. 10 is a graph comparing the data of FIG. 8 and FIG. 9
in accordance with an embodiment of the invention;
[0030] FIG. 11 displays two plots relating currents through a
proximal electrode of a multi-electrode catheter to movement of the
electrode into a perforated sheath in accordance with an embodiment
of the invention;
[0031] FIG. 12 is a schematic illustration of a test arrangement
for determination of electrode currents in ACL electrodes in
accordance with an embodiment of the invention;
[0032] FIG. 13 is a schematic diagram of a lasso catheter, which
has been inserted through a sheath in accordance with an embodiment
of the invention; and
[0033] FIG. 14 is a flow chart for determining an optimum location
of a catheter being inserted through a sheath in accordance with an
embodiment of the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0034] In the following description, numerous specific details are
set forth in order to provide a thorough understanding of the
various principles of the present invention. It will be apparent to
one skilled in the art, however, that not all these details are
necessarily needed for practicing the present invention. In this
instance, well-known circuits, control logic, and the details of
computer program instructions for conventional algorithms and
processes have not been shown in detail in order not to obscure the
general concepts unnecessarily.
[0035] Documents incorporated by reference herein are to be
considered an integral part of the application except that, to the
extent that any terms are defined in these incorporated documents
in a manner that conflicts with definitions made explicitly or
implicitly in the present specification, only the definitions in
the present specification should be considered.
System Overview.
[0036] Turning now to the drawings, reference is initially made to
FIG. 1, which is a pictorial illustration of a system 10 for
evaluating electrical activity and performing ablative procedures
on a heart 12 of a living subject, which is constructed and
operative in accordance with a disclosed embodiment of the
invention. The system comprises a catheter 14, which is
percutaneously inserted by an operator 16 through the patient's
vascular system into a chamber or vascular structure of the heart
12. The operator 16, who is typically a physician, brings the
catheter's distal tip 18 into contact with the heart wall, for
example, at an ablation target site. Electrical activation maps may
be prepared, according to the methods disclosed in U.S. Pat. Nos.
6,226,542, and 6,301,496, and in commonly assigned U.S. Pat. No.
6,892,091, whose disclosures are herein incorporated by reference.
One commercial product embodying elements of the system 10 is
available as the CARTO.RTM. 3 System, available from Biosense
Webster, Inc., 3333 Diamond Canyon Road, Diamond Bar, Calif. 91765.
This system may be modified by those skilled in the art to embody
the principles of the invention described herein.
[0037] Areas determined to be abnormal, for example by evaluation
of the electrical activation maps, can be ablated by application of
thermal energy, e.g., by passage of radiofrequency electrical
current through wires in the catheter to one or more electrodes at
the distal tip 18, which apply the radiofrequency energy to the
myocardium. The energy is absorbed in the tissue, heating it to a
point (typically about 60.degree. C.) at which it permanently loses
its electrical excitability. When successful, this procedure
creates non-conducting lesions in the cardiac tissue, which disrupt
the abnormal electrical pathway causing the arrhythmia. The
principles of the invention can be applied to different heart
chambers to diagnose and treat many different cardiac
arrhythmias.
[0038] The catheter 14 typically comprises a handle 20, having
suitable controls on the handle to enable the operator 16 to steer,
position and orient the distal end of the catheter as desired for
the ablation. To aid the operator 16, the distal portion of the
catheter 14 contains position sensors (not shown) that provide
signals to a processor 22, located in a console 24. The processor
22 may fulfill several processing functions as described below.
[0039] Ablation energy and electrical signals can be conveyed to
and from the heart 12 through one or more ablation electrodes 32
located at or near the distal tip 18 via cable 34 to the console
24. Pacing signals and other control signals may be conveyed from
the console 24 through the cable 34 and the electrodes 32 to the
heart 12. Sensing electrodes 33, also connected to the console 24
are disposed between the ablation electrodes 32 and have
connections to the cable 34.
[0040] Wire connections 35 link the console 24 with body surface
electrodes 30 and other components of a positioning sub-system for
measuring location and orientation coordinates of the catheter 14.
The processor 22 or another processor (not shown) may be an element
of the positioning subsystem. The electrodes 32 and the body
surface electrodes 30 may be used to measure tissue impedance at
the ablation site as taught in U.S. Pat. No. 7,536,218, issued to
Govari et al., which is herein incorporated by reference. A
temperature sensor (not shown), typically a thermocouple or
thermistor, may be mounted on or near each of the electrodes
32.
[0041] The console 24 typically contains one or more ablation power
generators 25. The catheter 14 may be adapted to conduct ablative
energy to the heart using any known ablation technique, e.g.,
radiofrequency energy, ultrasound energy, and laser-produced light
energy. Such methods are disclosed in commonly assigned U.S. Pat.
Nos. 6,814,733, 6,997,924, and 7,156,816, which are herein
incorporated by reference.
[0042] In one embodiment, the positioning subsystem comprises a
magnetic position tracking arrangement that determines the position
and orientation of the catheter 14 by generating magnetic fields in
a predefined working volume and sensing these fields at the
catheter, using field generating coils 28. The positioning
subsystem is described in U.S. Pat. No. 7,756,576, which is hereby
incorporated by reference, and in the above-noted U.S. Pat. No.
7,536,218.
[0043] As noted above, the catheter 14 is coupled to the console
24, which enables the operator 16 to observe and regulate the
functions of the catheter 14. Console 24 includes a position
processor 27, preferably a computer with appropriate signal
processing circuits. The processor is coupled to drive a monitor
29. The signal processing circuits typically receive, amplify,
filter and digitize signals from the catheter 14, including signals
generated by sensors such as electrical, temperature and contact
force sensors, and a plurality of location sensing electrodes (not
shown) located distally in the catheter 14. The digitized signals
are received and used by the console 24 and the positioning system
to compute the position and orientation of the catheter 14, and to
analyze the electrical signals from the electrodes.
[0044] In order to generate electroanatomic maps, the processor 22
typically comprises an electroanatomic map generator, an image
registration program, an image or data analysis program and a
graphical user interface configured to present graphical
information on the monitor 29.
[0045] Typically, the system 10 includes other elements, which are
not shown in the figures for the sake of simplicity. For example,
the system 10 may include an electrocardiogram (ECG) monitor,
coupled to receive signals from one or more body surface
electrodes, in order to provide an ECG synchronization signal to
the console 24. As mentioned above, the system 10 typically also
includes a reference position sensor, either on an
externally-applied reference patch attached to the exterior of the
subject's body, or on an internally-placed catheter, which is
inserted into the heart 12 maintained in a fixed position relative
to the heart 12. Conventional pumps and lines for circulating
liquids through the catheter 14 for cooling the ablation site are
provided. The system 10 may receive image data from an external
imaging modality, such as an MRI unit or the like and includes
image processors that can be incorporated in or invoked by the
processor 22 for generating and displaying images.
[0046] Reference is now made to FIG. 2, which is a schematic
pictorial view of catheter 14 in sheath 40, according to an
embodiment of the invention. The catheter 14 is typically a hybrid
type, having electrodes 31 for impedance-based position sensing and
a tri-coil magnetic sensor 58. Proximal end 46 of the catheter 14
and a proximal end 48 of the sheath 40 are both able to be
manipulated by operator 16 (FIG. 1). By manipulation of their
proximal ends, operator 16 is able adjust the position of sheath
tip 45 relative to distal end 52 of the catheter 14, so that the
sheath 40 encloses a portion of the catheter 14.
[0047] In one mode of operation, the operator first inserts sheath
40 percutaneously into the patient body and guides sheath tip 45 to
the target region. The operator then inserts the catheter 14 into
the lumen of the sheath 40 and guides distal end 52 through the
sheath 40 to the target region (not shown). The sheath 40 may be
provided with electrodes 42 for impedance-based position sensing.
In such impedance-based systems, a processor in the console 24
generates and then measures a plurality of currents between at
least of the electrodes 42 and a plurality of body surface
electrodes, fixed at respective locations on a surface of the
patient body. The processor then computes a plurality of impedances
based on the measured currents and detects the position of the
sheath using the computed impedances as taught in the above-noted
U.S. Pat. No. 7,536,218.
[0048] While the catheter 14 is en route through the sheath 40, the
sheath tip 45 may be conventionally located using imaging
modalities, such as fluoroscopy, although such procedures may
expose the patient to radiation.
[0049] After navigating the distal end 52 of the catheter 14
through the sheath 40, a current position map (CPM) is generated
during the catheterization session during the catheterization
session using impedance measurements obtained via the catheter
electrodes 31 and readings from the magnetic sensor 58. One method
for generation of a CPM is described in commonly assigned U.S. Pat.
No. 8,478,383 to Bar-Tal et al., which is herein incorporated by
reference.
[0050] In catheters having a magnetic sensor and multiple ACL
electrodes, with known inter-electrode distances and offsets from
the sensor, the location of all the catheter ACL electrodes can be
evaluated at any time during insertion of the catheter. However, as
to the sheath, until the CPM is available the impedance information
provided by the sheath ACL electrodes 42 is insufficient to define
the location of the sheath tip 45 with respect to physical
landmarks in the heart with the precision required by a typical
medical procedure. However, stability of distal portion 60 of the
sheath can be assessed by monitoring readings of the sheath ACL
electrodes.
[0051] It is helpful to know the precise position of sheath tip 45
in the heart. As noted above, an out-of-sheath status is required
for construction of a CPM. Conventionally, however, without the
CPM, it is necessary to resort to fluoroscopy or other imaging in
order to obtain the position and conform the out-of-sheath status.
It is desirable for the operator to have an indication of the
position of catheter tip 56 relative to sheath tip 45 in order to
avoid evaluating possibly invalid ACL data while the catheter is
still inside the sheath as well as to acquire valid CPM data once
the operator is assured that the catheter has exited the
sheath.
[0052] Reference is now made to FIG. 3, which is a schematic
diagram illustrating a catheter 62 having electrodes extending
through a sheath 64 in accordance with an embodiment of the
invention. The catheter 62 in this example has three ACL electrodes
66, 68, 70 and a tip electrode 72 that is used for ablation. The
catheter 62 may be provided with additional ACL electrodes (not
shown). The tip electrode 72 and the electrodes 66, 68, 70 have all
been extended beyond sheath tip 74, and in this configuration a CPM
may be validly constructed.
[0053] Reference is now made to FIG. 4, which is a schematic
diagram illustrating catheter 62 lying partially within sheath 64
and indicating the position of catheter tip 76 relative to sheath
tip 74 in accordance with an embodiment of the invention. During
ablation, the physical stiffness of the sheath 64 is needed for
better catheter maneuverability. In such a situation the operator
may keep one or two of the most proximal ACL electrodes 66, 68 in
the sheath, while the distal ACL electrode 70 and any other distal
ACL electrodes (not shown) are out of the sheath. The position of
the distal end of the catheter, here occupied by tip electrode 72,
can be computed based on the known offsets from any of the
electrodes 66, 68, 70. The presence of a short portion 78 of the
catheter 62 out of the sheath enhances catheter maneuverability and
stability because the sheath 64 is more rigid than the catheter 62.
At the same time maintain the portion 78 outside the sheath 64
guarantees that the tip electrode 72 is also out of the sheath 64
and does not transfer energy into the sheath 64. When manipulating
the catheter 62, the operator may view an indication on the monitor
29 (FIG. 1) in order to achieve the desired configuration.
[0054] The inventors have found that values of the catheter ACL
electrodes currents provide discrimination between an in-sheath and
an out-of-sheath status of the catheter. Several parameters
influence the values: [0055] Electrical Impedance of human heart;
[0056] Impedance measuring circuitry, e.g., the ACL electrical
circuitry of the CARTO 3 system; [0057] Sheath material (including
its insulative properties); and [0058] Sheath structure: Diameter;
presence or absence of perforations; placement of perforations
relative to the sheath end.
[0059] The heart may be treated as an ambient with resistance of
100-150 ohms. Under such resistance the ACL circuits yield a
nominal current of 500 microamperes. When the electrode experiences
a higher resistance while in a known position within the sheath, it
may be assumed that some of the current is leaking via other
pathways.
[0060] Without being bound by a particular theory, it would seem
that when the electrode is inserted into the sheath, it is
surrounded by insulative material, i.e., the sheath, and by
conductive fluid but with relatively little blood. The conductive
fluid can be considered to form a cylinder around the catheter. An
electrical description of the model includes parasitic impedance
from the sheath and from the electrical circuitry of the system. As
the catheter is taken deeper into the sheath, the proportion of
blood relative to the conductive fluid increases, and the parasitic
impedance begins to approach the impedance of the ambient blood.
Thus, some current leaks via the parasitic impedance path of the
ACL electrical circuitry. Finally, as the catheter is taken even
farther into the sheath, the current reading from the catheter ACL
electrodes does not change as all the current follows the parasitic
impedance path.
[0061] Reference is now made to FIG. 5, which is an electrical
schematic of a circuit 80 modeling the impedance and current of an
ACL electrode in accordance with an embodiment of the invention.
The circuit 80 comprises an alternating current generator 82 that
produces a voltage V. The load of the generator 82 is a capacitor
84 having an impedance Z.sub.p in parallel with a resistor 86
having an impedance Z.sub.e.
[0062] The impedance of the in-sheath electrode is given by:
Z e = .rho. l .pi. ( R 1 2 - R 2 2 ) , 0 < l < l 0 ; .rho. l
0 .pi. ( R 1 2 - R 2 2 ) + .rho. ( l - l 0 ) .pi. ( R 1 2 ) , l 0
< l ; Z = ( 1 Z e + 1 Z p ) - 1 ; I = V Z ##EQU00001##
where
[0063] R.sub.1 is the sheath radius;
[0064] R.sub.2 is the catheter radius;
[0065] .rho. is the specific impedance of the heart;
[0066] I is the distance of the electrode from the sheath end;
[0067] I.sub.0 is the distance from the electrode to the most
distal electrode;
[0068] Z is the total system impedance;
[0069] Z.sub.e is the ACL electrode impedance; and
[0070] Z.sub.P is the parasitic impedance of the system.
Example 1
[0071] Experiments were performed by measuring the in-sheath and
out-of-sheath currents. An aquarium was used to as a
patient-simulant. The tests employed Navistar.RTM. and
Thermocool.RTM. SF (7.5 F) catheters in Agilis.TM. (8.5 F) and
MobiCath.TM. (8 F) sheaths. The catheters were moved in and out of
the sheath in a controlled manner and the respective currents were
recorded.
[0072] Reference is now made to FIG. 6, which is a plot of ACL
electrode current obtained while the electrode transitions from an
in-sheath to an out-of-sheath status accordance with an embodiment
of the invention. The plot shows three zones of interest: (1) an
in-sheath condition; (2) a transient position, in which the
electrode is at the end of the sheath or partially out of the
sheath; and (3) an out-of-sheath condition, in which the electrode
is fully out of the sheath. Thus, the sheath is defined and
identified by the historical data of the readings of the magnetic
sensor during its movements.
[0073] A threshold value of 400 microamperes differentiates an
in-sheath form an out-of-sheath condition, based on an accumulated
database of recordings. Reference is now made to FIG. 7, which is a
plot showing a distribution of out-of-sheath currents, in
accordance with an embodiment of the invention. Each bar stands for
the lowest value for all catheter electrodes while the electrodes
are out-of-sheath. The current distribution can be fitted to a half
Gaussian form (the nominal value is around 500 microamperes.).
There is a non-zero probability in the Gaussian tail (not shown in
FIG. 7) that currents as low as 400 microamperes and somewhat lower
still represent out of sheath currents.
[0074] In the following examples a perforation or hole in the wall
of the sheath serves as a zero point, as the hole, being a break in
the insulation of the sheath, provides a highly conductive path for
the electrode current. One function of the hole is to maintain the
sheath clear of obstruction. Passage of an electrode by the hole
produces current readings almost as high as those in an
out-of-sheath condition. Nevertheless, because the distance between
the hole and the sheath tip, and the offsets of the catheter tip
from the electrodes are all known, the changes in current readings
when the catheter electrode is abeam of the hole can be exploited
to localize the catheter tip with respect to the sheath tip.
[0075] Reference is now made to FIG. 8, which is a plot of ACL
electrode current as a function of retraction of the catheter from
an out-of-sheath condition to an in-sheath condition into a sheath
in accordance with an embodiment of the invention. In this
experiment a Thermocool SF (7.5 F) catheter was navigated through
two different Agilis (8.5 F) sheaths. The two sets of data that
were acquired are shown as open and closed triangles.
[0076] Reference is now made to FIG. 9, which is a plot similar to
FIG. 8, in accordance with an embodiment of the invention. In this
example a Thermocool SF (7.5 F) catheter was navigated through a
MobiCath (8 F) sheath. Two sets of data were acquired. It is
evident that the observations are highly reproducible.
[0077] Reference is now made to FIG. 10, which is a plot comparing
the results of the experiments using the Agilis (8.5 F) sheath
(FIG. 8) and the MobiCath (8 F) (FIG. 9) in accordance with an
embodiment of the invention. In all cases there is a relatively
rapid decline (.gtoreq.50%) in the first 10 mm. The decline is more
rapid in the narrower MobiCath (8 F) sheath. The measurements
showed good agreement with the model represented by the impedance
equations given above. The different sheath-catheter combinations
produce characteristic curves. Analysis of the curves by known
discrimination techniques define thresholds that optimally
discriminate among in-sheath and out-of-sheath conditions and the
transition zone noted above. A database of such sheath-catheter
combinations may be accumulated and referenced at patient
sessions.
[0078] Reference is now made to FIG. 11, which are two plots taken
from multi-electrode catheters (Navistar1; Navistar2) as the
proximal electrode is retracted into a sheath having a perforation
5 mm proximal to its distal end. The tracings show a decline at the
2 mm mark. Allowing for the width of the proximal electrode, the
edge of the electrode is at 4 mm, at which point the effect of the
perforation begins to be seen. Beyond the 5 mm mark the current
declines. By 6 mm the electrode has passed the hole and the current
has declined more than 100 pa from the baseline. At 6 mm a
pre-defined threshold (400 .mu.a) will have been crossed, after
which there is a true in-sheath indication. The current decline at
2 mm can be differentiated from a true transition between an
in-sheath and an out-of-sheath condition by (1) its transient
nature and (2) by the level of the minimum, which exceeds the
threshold value.
Example 2
[0079] Reference is now made to FIG. 12, which is a schematic
illustration of a test arrangement for determination of electrode
currents in ACL electrodes in accordance with an embodiment of the
invention. In an initial position, tip 90 of catheter 92 lies at
distal end 94 of sheath 96. A hole 98 in the sheath 96 is placed 4
mm from its distal end 94. The catheter 92 has four electrodes 100,
102, 104, 106, which are 1 mm wide.
[0080] The hole 98 enables conductive fluid, blood or salt water in
the case of the test arrangement, to be in contact with the
electrodes 100, 102, 104, 106 when they are within the sheath and
generally opposite the hole 98. The electrodes 100, 102, 104, 106
are positioned such that in the tests, a true in-sheath indication
occurs only when the distal edge 108 of electrode 100, i.e., the
most proximal of the electrodes 100, 102, 104, 106, is at least 1
mm from the hole 98 in the proximal direction. As that point the
current in the electrode 100 begins to rise above or is falling
below the in-sheath threshold, according to whether the electrode
100 is approaching or receding from the hole 98, respectively. The
electrodes 100, 102, 104, 106 are positioned on the catheter 92
such that, the most proximal electrode, electrode 100, functions as
a guard: During retraction of the catheter 92, when electrode 100
passes by the hole 98 and its current begins to decline, an
out-of-sheath condition cannot no longer be confirmed. Similarly,
when advancing the catheter 92, a transient decline in current in
the distal electrode 106 indicates that an in-sheath condition is
no longer certain, as the offset between the electrode 106 and the
tip 90 is such that the tip 90 is beginning to protrude through the
distal end 94 of the sheath 96. At this time the location of the
tip 90 and hence the location of the distal end 94 of the sheath 96
can be determined using the information from a magnetic sensor
(e.g., magnetic sensor 58 as shown in FIG. 2) of the catheter
92.
[0081] In a perforated sheath, during movement of a catheter
electrode into the sheath, a definitive drop in electrode current
from a baseline (an out-of-sheath indication) occurs only after the
electrode has crossed the hole.
[0082] In summary, in a perforated sheath, where the location of
the hole is known, two points on the sheath can be determined for
each catheter electrode: [0083] the sheath end where the current
rises to the steady out-of-sheath state and remains steady
regardless of further distal movement of the electrode; and [0084]
the location of the hole when retracting the catheter when the
electrode crosses the hole, and current has declined below the
in-sheath threshold.
[0085] Further inside the sheath, the electrode location can be
calculated based on the above-described reference points. In the
example of FIG. 12, there is a 4 mm interval of relative
uncertainty between the sheath end and the hole regarding the
location of a catheter electrode. However, such an electrode can
still be located based on information obtained from other
electrodes.
[0086] Reference is now made to FIG. 13, which is a schematic
diagram of a lasso catheter 110, which has been inserted through a
sheath 112 in accordance with an embodiment of the invention. The
lasso catheter 110 is provided with mapping electrodes 114 for
building the CPM. A proximal guard electrode 116 and a distal guard
electrode 118 are located on the stem of the lasso catheter 110. If
it is desired only to build a CPM, It is only necessary to advance
the catheter such that both the proximal and distal electrodes are
positioned outside the sheath by reference only to a threshold
current value. The catheter is advanced until an out-of-sheath
condition is signified by the current levels in both guard
electrodes 116, 118.
[0087] It will be recalled that mechanical stability of the
catheter is important when ablation is to be performed. The
following procedure may be applied, mutatis mutandis, to perforated
and non-perforated sheaths by appropriate positioning of the ACL
electrodes. Reference is now made to FIG. 14, which is a flow chart
for determining an optimum location of a catheter being inserted
through a sheath in accordance with an embodiment of the invention.
In this embodiment the guard electrode 118 is in an out-of-sheath
condition, while the guard electrode 116 remains within the shield.
Once positioned, the catheter is to be used for ablation of a
target. The method is presented with reference to the example of
FIG. 13.
[0088] At initial step 120 the sheath is placed conventionally into
the heart. Upper and lower threshold current values are chosen
according to data previously accumulated for the particular sheath
and catheter being used. For example, the upper and lower threshold
current values could be 400 and 250 microamperes, respectively.
These values discriminate between definite in-sheath and
out-of-sheath conditions and define a transitional zone
therebetween.
[0089] During the following procedure, when current in a suitably
positioned ACL electrode exceeds the upper threshold, the electrode
is determined to be outside the sheath. Otherwise the electrode may
be inside the sheath or in a transitional zone, as explained above.
When the ACL electrode current is below the lower threshold, the
electrode is determined to be inside the sheath. In this and
subsequent flow charts some steps may be performed in different
orders and not all illustrated process steps may be required to
implement the method.
[0090] Next, at step 122 the catheter is advanced within the
sheath. Typically, this is done in small increments when the
catheter approaches the distal end of the sheath.
[0091] At decision step 124, it is determined if the current in the
distal electrode (guard electrode 118; FIG. 13) exceeds the upper
threshold. If the determination is negative, then the distal
electrode has not yet exited the sheath. Control returns to step
122.
[0092] If the determination at decision step 124 is affirmative,
then at decision step 126, it is determined if the current in the
proximal electrode (guard electrode 116; FIG. 13) has risen above
the lower threshold. If the determination is affirmative, then the
catheter was advanced too far in the last performance of step 122.
Control then proceeds to step 128. The catheter is retracted
somewhat, typically less than its last advancement in step 122.
Control returns to decision step 124 to redetermine its
position.
[0093] If the determination at decision step 126 is negative, then
the proximal electrode remains within the sheath while the distal
electrode is outside the sheath. This configuration is appropriate
for performing ablation. Control proceeds to final step 130, and
the procedure ends.
[0094] The method of FIG. 14 may be modified for application to a
multi-electrode catheter when determining an optimum location of a
catheter tip with respect to the sheath tip. For some ablation
procedures the tolerances must be tightly controlled. For example
when using a SmartTouch.TM. catheter, which has a contact force
sensor, ACL electrodes are appropriately located with respect to
the sensor in order to adjust the catheter's position such that the
spring of the sensor is fully out of the sheath, while the proximal
electrode is at a marginal position that still gives an in-sheath
indication. For such applications a value of the upper threshold,
such as 400 microamperes, may be chosen.
[0095] The procedure is performed by measuring the currents in all
the electrodes concurrently, and adjusting the position of the
catheter such that the current in a selected electrode, having a
known offset to the tip of the catheter, is within the dynamic
segment of the curve, while the current in more distal electrodes
provide an out-of-sheath indication and more proximal electrodes
provide an in-sheath indication. For example, referring to FIG. 8,
the current value in the selected electrode should be between 250
and 400 .mu.a in order to guarantee that the tip of the catheter
protrudes through the sheath, but not more than a specified
distance.
[0096] It will be appreciated by persons skilled in the art that
the present invention is not limited to what has been particularly
shown and described hereinabove. Rather, the scope of the present
invention includes both combinations and sub-combinations of the
various features described hereinabove, as well as variations and
modifications thereof that are not in the prior art, which would
occur to persons skilled in the art upon reading the foregoing
description.
* * * * *