U.S. patent application number 11/858068 was filed with the patent office on 2008-09-04 for medical device control system.
This patent application is currently assigned to BOSTON SCIENTIFIC SCIMED, INC.. Invention is credited to Robert F. Bencini, Richard Lardner, Katie Messing, Miriam H. Taimisto, Jon Wohlgemuth.
Application Number | 20080215046 11/858068 |
Document ID | / |
Family ID | 28039410 |
Filed Date | 2008-09-04 |
United States Patent
Application |
20080215046 |
Kind Code |
A1 |
Messing; Katie ; et
al. |
September 4, 2008 |
MEDICAL DEVICE CONTROL SYSTEM
Abstract
A medical device for use by an operator to perform a medical
procedure in a body includes a handle to be held by the operator, a
shaft attached to the handle and an actuating assembly to control
functions associated with the medical procedure. The shaft includes
an operative distal portion to perform a medical procedure in the
body. The medical device may be part of an ablation catheter system
that is programmed to correlate one or more functions with the
actuation of the actuating assembly. Multiple actuating assemblies
may be provided. Each actuating assembly may be a button. Other
types of actuating assemblies may also be used, such as switches or
a trackball. The actuating assembly may also be provided on a
sleeve that may be selectively attached to the handle of the
catheter or the physician operating the catheter, for example.
Inventors: |
Messing; Katie; (San Jose,
CA) ; Wohlgemuth; Jon; (Morgan Hill, CA) ;
Bencini; Robert F.; (Sunnyvale, CA) ; Taimisto;
Miriam H.; (San Jose, CA) ; Lardner; Richard;
(Oakland, CA) |
Correspondence
Address: |
Vista IP Law Group LLP
2040 MAIN STREET, 9TH FLOOR
IRVINE
CA
92614
US
|
Assignee: |
BOSTON SCIENTIFIC SCIMED,
INC.
Maple Grove
CA
|
Family ID: |
28039410 |
Appl. No.: |
11/858068 |
Filed: |
September 19, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10098661 |
Mar 15, 2002 |
7285117 |
|
|
11858068 |
|
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Current U.S.
Class: |
606/41 ;
606/1 |
Current CPC
Class: |
A61B 34/25 20160201;
A61B 18/00 20130101; A61B 2017/00367 20130101; A61B 18/1492
20130101; A61B 2018/00916 20130101; A61B 2017/00199 20130101 |
Class at
Publication: |
606/41 ;
606/1 |
International
Class: |
A61B 18/14 20060101
A61B018/14 |
Claims
1. A system for performing a medical procedure on a patient,
comprising: a medical device comprising: a holding portion; a shaft
associated with said holding portion and having a distal portion of
performing a medical procedure on a patient; and an actuating
assembly located proximal to said holding portion; and a processing
device coupled to said actuating assembly, said processing device
being user programmable to initiate at least one of a plurality of
functions in response to actuation of said actuating assembly.
2-43. (canceled)
Description
FIELD OF THE INVENTION
[0001] The present invention relates to medical devices, and more
particularly, to control systems for medical devices.
BACKGROUND OF THE INVENTION
[0002] Catheters are often used in medical procedures to provide
access to remote locations within a patient. A catheter can be
inserted into the patient's body through a small incision and
threaded through a blood vessel or other narrow passageway to reach
the intended location. Dilatation catheters have been used to open
blockages in blood vessels in percutaneous transluminal coronary
angioplasty procedures, for example. Various types of catheters are
also used in electrophysiology therapies to locate and treat
cardiac arrhythmias. For example, one or more catheters may be used
to pace, map and ablate cardiac tissue to block the passage of
aberrant electrical signals.
[0003] Steering mechanisms have been developed to facilitate the
transit of catheters through body lumens such as the vascular
system. These mechanisms typically require that a physician or
other trained medical professional hold and rotate the catheter to
navigate the twists and branches of the body lumen. Movement of the
steering assembly bends or deflects a distal portion of the
catheter, allowing the physician to steer the catheter through the
body lumen. In many applications, the ability to steer the catheter
is critical to the success of the diagnostic or therapeutic
protocol and may affect the risk of trauma to the patient as well.
Moreover, the ability to precisely steer the catheter impacts the
speed and ease by which the physician can properly position the
distal portion of the catheter. Steering mechanisms are described
in U.S. Pat. No. 6,163,716, which is incorporated by reference,
herein, for example. Steering mechanisms are also described in U.S.
Pat. No. 6,064,902, which is also incorporated by reference herein.
Steering mechanisms have also been developed to control a catheter
once it reaches its final destination. For example, steering
mechanisms can be used to precisely position a catheter within the
chambers of the patient's heart.
[0004] In a typical cardiac ablation procedure, electrical signals
are applied to the cardiac tissue by a pacing catheter to induce
arrhythmia. A mapping catheter is then used to locate aberrant
electrical pathways and currents emanating within the heart. The
mapping catheter records the actuation times, the distribution and
the waveforms of the electrical charges or potentials that trigger
the pumping action of the heart muscle. The mapping catheter may be
a "basket" catheter with a mapping basket at its distal end. The
basket may comprise eight arms constructed of ribbons of a shape
memory material, such as Nitinol. Each arm carries a plurality of
mapping electrodes that detect the electrical activity of
underlying cardiac tissue. A plurality of ultrasound receiving
transducers are also mounted to each arm. Pacing and mapping
catheters are described in U.S. Pat. No. 6,216,027 B1, for example,
which is incorporated by reference herein.
[0005] After the aberrant electrical signals and pathways are
located, lesions are formed in the cardiac tissue by an ablation
catheter, to block the propagation of the aberrant electrical
signals. The ablation catheter includes one or more energy
transmitting elements, such as electrodes of gold, tantalum or
platinum, to transmit energy, such as RF energy, to ablate the
tissue to form the lesions. Ablation catheters are described in
U.S. Pat. No. 6,241,724 B1, U.S. Pat. No. 6,216,027 B1, and U.S.
Pat. No. 6,004,269, for example, which are assigned to the assignee
of the present invention and are incorporated by reference herein.
Two or more functions (pacing, mapping and/or ablation) may be
provided on the same catheter, as described in U.S. Pat. No.
6,163,716, which is incorporated by reference herein.
[0006] Cardiac ablation systems typically include an imaging system
to display the position of the one or more catheters used in the
procedure. Ultrasound, magnetic, x-ray, or other imaging techniques
known in the art may be used.
[0007] Cardiac Pathways Corporation, Sunnyvale, Calif., provides an
Arrhythmia Mapping System with Realtime Position Management.TM.
Tracking Technology that enables the user to record, view and
analyze intracardiac electrogram and EKG signals, as well as to
view a real-time graphic representation of the catheters being used
in the procedure. The views of the catheters may be rotated in
three dimensions. A "time of flight" principle is used in
combination with geometrical triangulation to establish a
three-dimensional coordinate system using reference ultrasonic
transducers on one or more reference catheters. Other catheters
used in the procedure, such as the ablation catheter, include
transducers to detect the ultrasound signals emitted by the
reference transducers. Once the coordinate system is established,
the three-dimensional location of the other catheters may be
established by using the time of flight method to determine the
distance between the catheter and the reference catheters. The
coordinates of the catheter may then be established by basic
algebra and the law of cosines, through triangulation. Operation of
the Cardiac Pathways Arrhythmia Mapping System is described in more
detail in U.S. Pat. No. 6,216,027 B1, which is incorporated by
reference herein. Cardiac Pathways Corporation has merged with
Boston Scientific EP Technologies, Inc. San Jose, Calif.
[0008] It is often desirable to identify and store information
concerning the procedure and the areas of the patient's heart that
had been ablated or are currently being ablated. This information
can include certain characteristics of the ablation procedure such
as the temperature of the ablation electrode during the ablation
procedure and the type of lesions that are formed. The date of the
procedure may be recorded, as well. Some advanced ablation systems,
such as the Cardiac Pathways system described above, are capable of
identifying and storing this information.
[0009] Some ablation systems have the capability to color code
certain information about a procedure. For example, cardiac tissue
ablated in prior procedures may be identified by one color, such as
yellow, while cardiac tissue ablated in the current procedure may
be identified by a second color, such as green. In this way, the
physician can readily distinguish between current ablation sites
and earlier ablation sites. Likewise, the physician can assign
color based on the power of the electrodes during the ablation
process and is then capable of distinguishing between these
ablation areas based on the color. The use of several colors may
also assist the physician in his performance of an ablation
procedure. For example, the use of two colors contrasts the
different procedures. This can assist the physician by ensuring
that the ablation areas of two different ablation procedures at
least partially coincide with each other when such result is
desired.
[0010] One drawback of conventional catheters, including catheters
used in ablation procedures, is that they may require both of the
physician's hands to hold the catheter and manipulate the steering
assembly. In electrophysiology procedures, the initiation and
completion of the pacing, mapping and ablation procedures, as well
as color coding, for example, require input to a control device by
an input device, such as a keyboard. Since the physician does not
have a free hand to operate the keyboard or other such input
device, the physician must verbally instruct others to operate the
input device to initiate and complete these and other functions.
Verbal instructions may be misunderstood and, in some instances,
may be hard to communicate. In addition, there is a time delay
between the giving of the verbal instruction and the performance of
the request. At least one extra person may be required in the
operating room to carry out the physician's instructions,
increasing the costs of the procedure and increasing the likelihood
of error.
[0011] Certain prior art ablation catheters include a handle with
one or more buttons to control the powering up and powering down of
an RF generator to provide energy to the one or more electrodes
near the distal end of the catheter. See, for example, U.S. Pat.
No. 6,142,994, which is incorporated by reference, herein. These
buttons provide the physician with the ability to directly initiate
ablation of cardiac tissue while holding the catheter. Other
functions are not directly controlled by the physician conducting
the ablation procedure, but by an assistant operating an input
device, as discussed above.
SUMMARY OF THE INVENTION
[0012] It would be advantageous to enable a physician operating a
medical device, such as an ablation catheter, to directly control
other functions of the physician's choosing, as well.
[0013] In accordance with one embodiment of the invention, a system
for performing a medical procedure comprises a device having a
holding portion, a shaft associated with the holding portion and an
actuating assembly proximal to the holding portion. The shaft has a
distal portion that is operable to perform a medical procedure. A
user programmable processing device is coupled to the actuating
assembly. The processing device is programmable by the user, such
as the physician, to initiate at least one of a plurality of
functions in response to actuation of the actuating assembly. The
actuating assembly may comprise a button, a switch, a trackball, a
joystick, a disk, a sliding element or a rotatable sleeve, for
example. One actuating assembly can control multiple functions.
Multiple actuating assemblies may also be provided to control
multiple functions. By providing the actuating assembly proximate
the holding portion, a physician can steer and/or otherwise
manipulate the catheter while initiating these other functions. The
catheter system may also be programmed to initiate one of set
predetermined functions in sequence in response to each actuation
of the assembly.
[0014] Another aspect of the invention relates to a removable
actuating assembly that is capable of attachment to the handle of a
catheter, other objects close to the physician or to the
physician's body. The removable actuating assembly can also be used
with a catheter without buttons to add functionality to the
catheter system.
[0015] Another aspect of the invention relates to the use of an
actuating assembly near the catheter handle to navigate and select
from a list or menu of options displayed on a visual display.
Examples of suitable actuating assemblies include a push button
assembly, a rotating or sliding disk or lever, and a pointing or
navigation device. The visual display provides the physician with a
plurality of options that the physician can select and perform by
actuating one or more of the actuating assemblies near the catheter
handle. For example, a menu or list of options can be displayed to
the physician and, through the actuating of the actuating assembly,
the physician can select and/or initiate one of the displayed
options.
[0016] In another aspect of the invention, a system for conducting
a medical procedure is programmed to respond to the manner in which
an actuating assembly on the handle of the catheter is actuated.
For example, the catheter system can initiate a first function with
a response to a single triggering of the actuating assembly and may
initiate a second, different function in response to a quick,
repetitive triggering of the actuating assembly.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 is a perspective view of an ablation catheter system
including a push button assembly on a catheter handle according to
an embodiment of the present invention.
[0018] FIG. 2 is a cross-sectional representation of a catheter
handle with a single push button assembly.
[0019] FIG. 3 is a top view of a catheter handle with push button
assembly surrounded by protrusions to prevent accidental triggering
of the push button.
[0020] FIG. 4 is a perspective view of the catheter system similar
to the system of FIG. 1, including an expandable basket on a distal
end of the catheter.
[0021] FIG. 5A is an example of a menu displayed on a visual
display.
[0022] FIG. 5B is another example of a menu displayed on a visual
display, where the menu is in the form of a tool bar.
[0023] FIGS. 6A-6B are two partial views of a rotating scroll wheel
having an additional actuation feature incorporated therein.
[0024] FIGS. 7A-7B are two partial views of a catheter handle
having a rotatable disk as an actuating assembly.
[0025] FIG. 8 is a perspective view of the catheter system having
six actuating button assemblies.
[0026] FIG. 9A-9C are cross sectional representations of a catheter
handle having three rotatable switches as actuating assemblies.
[0027] FIGS. 10A-10C are three cross sectional representations of a
rotatable switch having a relaxed position.
[0028] FIGS. 11A-11C are three cross sectional representations of
another rotatable switch having a relaxed position.
[0029] FIGS. 12A-12B are two cross sectional representations of a
two position button assembly.
[0030] FIG. 13 is a cross sectional representation of catheter
handle with five button assemblies in a 1-3-1 arrangement.
[0031] FIG. 14A-14B are partial cross-sectional representations of
a push button assembly having five depression areas.
[0032] FIGS. 15-16 are two partial cross-sectional representation
of alternative button assemblies having depression areas.
[0033] FIG. 17A is a perspective view of a catheter handle with a
rotating sleeve.
[0034] FIG. 17B is a partial cross-sectional representation of the
rotating sleeve of FIG. 17A.
[0035] FIG. 18A-18C are three cross-sectional representations of
sliding element actuating assembly.
[0036] FIGS. 19A-19B are two views of a catheter handle having a
miniature trackball to navigate and point.
[0037] FIG. 20 is a cross-sectional representation of a catheter
handle having a joystick pointing feature.
[0038] FIGS. 21-23 are perspective views of removably attachable
button assemblies attached to various parts of the catheter and/or
physician.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0039] FIG. 1 illustrates an embodiment of a push button ablation
catheter system 10 in accordance with an embodiment of the present
invention. The system 10 includes a catheter 20 having a catheter
body or shaft 30 and a catheter handle 40. The catheter handle 40
has a distal portion 50, a proximal portion 60, an actuating
assembly 70, and a steering assembly 80. The actuating assembly 70
in this embodiment is a push button assembly 70 enabling a
physician manipulating the catheter 20 to also directly control
other functions of the system, as discussed further below.
[0040] The steering assembly 80 is used to control a distal portion
90 of the catheter body 30 as it is guided through the body's
vascular system. The steering assembly 80 is attached to steering
wires that extend through an interior lumen of the catheter handle
40 and the catheter body 30. The steering wires are secured to
circumferentially spaced elements of the distal portion 90 of the
catheter body 30 such that rotation of the steering assembly 80 to
the right or left causes corresponding right or left deflection of
the distal portion 90. In an alternative embodiment, the steering
mechanism may be a unidirectional steering mechanism with a single
steering wire that connects with the distal portion 90 for
deflection of the distal portion 90 in only one direction. Steering
mechanisms are described in more detail in U.S. Pat. No. 6,163,716,
for example, which is incorporated by reference herein. Steering
mechanisms are also described in U.S. Pat. No. 6,064,902, for
example, which is also incorporated by reference, herein.
[0041] The ablation catheter system 10 includes an ultrasound
imaging and control system 110, such as the Arrhythmia Mapping
System with Realtime Position Management.TM. Tracking Technology,
available from Cardiac Pathways Corporation, Sunnyvale, Calif. The
imaging and control system 110 enables the user to record, view and
analyze intracardiac electrogram and EKG signals, as well as to
view a real-time graphic representation of the catheters being
used, as discussed above. Operation of the Cardiac Pathways
Arrhythmia Mapping System is described in more detail in U.S. Pat.
No. 6,216,027 B1, assigned to the assignee of the present invention
and incorporated by reference herein. The imaging and control
system 110 comprises an RF generator, a computer or other
processing device, and memory or other storage device.
Alternatively, the processing device and the storage device can be
one or more separate units. As discussed above and in U.S. Pat. No.
6,216,02781, the imaging and control system 110 receives signals
from a plurality of ultrasound transducers carried by reference
catheters (not shown) located within the interior lumen or on the
catheter body 30. A connector 120 electrically couples the catheter
20 and its components to the control and imaging system 110. Real
time cross-sectional images of a patient's vasculature are
generated and displayed on one more visual displays 112 of the
control and imaging system 110, based on signals received from the
transducers and processed by the processing device. The transducers
may also be used to locate the catheter 20 within a patient's body
and display the location of the catheter 20 as an image on the
visual display 112. A physician can thereby determine the position
of the distal portion 90 and the electrodes 100 relative to the
cardiac tissue in real time on the imaging and control system 110.
This information can be stored in the memory so that the physician
can reposition the distal portion 90 of the catheter 20 at the
stored location at a later time.
[0042] The Cardiac Pathways system includes three displays
112a-112c. One of the displays 112a is a Monitor Window, which
displays up to 16 user-selected signals, such as EKG signals, in
real time. Another of the displays 112b is a Tracking Window, which
displays a real-time graphical representation of the reference
catheters and one or more other catheters, such as an ablation
catheter. The past position of a catheter can also be displayed.
The third display 112c is a Review Window, which displays signals
from the Monitor Window 112a for measurement, annotation and
comparison.
[0043] Another example of a system capable of identifying a
location of a catheter within a patient's body using ultrasound is
described in U.S. Pat. No. 5,131,397, which is also assigned to the
assignee of the present invention and is incorporated by reference
herein.
[0044] The catheter 20 contains a plurality of electrodes 100 for
mapping and/or ablating cardiac tissue. The electrodes 100 are
powered via the generator of the imaging and control system 110.
The imaging and control system 110 may also process electrical
mapping signals picked up from the electrodes 100 and/or supply RF
energy to the electrodes 100 for ablating cardiac tissue. Similar
ultrasound/electrophysiology catheters are described in U.S. Pat.
No. 6,241,724 B1, U.S. Pat. No. 6,216,027 B1, U.S. Pat. No.
6,163,716, and U.S. Pat. No. 6,004,269, for example, which are
incorporated by reference herein.
[0045] Also included in the catheter system 10 is an input device
115, such as a keyboard or mouse, for programming the catheter
system 10 and for controlling certain functions of the catheter
system 10. These functions may include the powering up of the RF
generator to supply energy to one or more of the electrodes 100 for
ablating cardiac tissue, for example. In accordance with the
invention, the input device 115 may also be used by the physician
to pre-program the catheter system 10 before a procedure so that
the system 10 will perform a pre-determined function in response to
an actuation of the push button assembly 70, as discussed further
below.
[0046] During use of the catheter system 10, a physician positions
the distal portion 90 of the catheter 20 by using the steering
assembly 80 to maneuver the catheter body 30 through the vascular
system to the heart. Left rotation of the steering assembly 80
causes the distal portion 90 to bend to the left to position 160,
for example, and right rotation of the steering assembly 80 causes
the distal portion 90 to bend to the right to position 170, for
example. While maneuvering around turns and bends, the physician
can observe the progress of the distal portion 90 on the Tracking
Window 112c of the display 112b.
[0047] FIG. 2 is a cross-sectional side view of the handle 40,
showing a generally flat top section 230 that carries the steering
assembly 80 and the push button assembly 70. The push button
assembly 70 is electrically connected to the control system 10 via
the connector 120. In the alternative, the push button assembly 70
can be coupled to the control system 110 by an RF transmitter and
receiver or by other means known in the art.
[0048] Preferably, the push button assembly 70 is secured to the
flat top section 230 on the distal portion 50 of the handle 40,
directly above a tension screw assembly 260. Attaching the push
button assembly 70 above the tension screw assembly 260 may be cost
efficient because a recess 270 to receive the push button 70 may be
easily created by removing a transparent window (not shown), which
is commonly secured to the flat top section 230 above the tension
screw assembly 260. This location is also convenient for operation
of the push button assembly 70 with the physician's thumb,
regardless of which hand the physician uses to hold the catheter
handle 40. Alternatively, the push button assembly 70 can be housed
at any number of alternative locations along the handle 40, such as
on the proximal portion 60 of the handle 40, on a side of the
handle 40, or circumferentially opposite the steering assembly
80.
[0049] The tension screw assembly 260 includes a tension adjustment
screw 280 and a tension adjustment hex nut 290. Adjustment of the
tension screw assembly 260 permits fine-tuning of the tension of
the distal end 90 of catheter 20 during assembly. The transparent
window covers the tension adjustment screw 280 and the tension
adjustment nut 290. The transparent window and recess 270 may be
oval-shaped, or may, alternatively, be any number of other shapes,
such as rectangular, circular or square, for example.
[0050] The transparent window may be replaced by a button backing
310 that is dimensioned to fit within the recess 270. The button
backing 310 carries the push button assembly 70 and includes a base
320 surrounded by a pair of arcuate protective ridges 330. As best
seen in FIG. 2, the push button assembly 70 is preferably recessed
within arcuate protective ridges 330 to avoid being accidentally
depressed by the physician during normal use of the handle 40 or
when the handle is laid down with the button 70 face down against a
flat surface. Alternatively, the resilient push button 70 may be
surrounded by a plurality of hard, inflexible protective raised
bumps 332, which are the functional equivalent of the protective
ridges 330, as shown in FIG. 3.
[0051] Returning to FIG. 2, the button backing 310 further includes
an aperture 340 dimensioned to allow passage of electrical leads
350, which electrically couple the push button 70 to the imaging
and control system 110 or other procedure-related operative
equipment adapted to carry out a procedure-related task by pressing
the push button 70. In the illustrated embodiment, the aperture 340
is a vertical, circular passageway; however, in an alternative
embodiment, the aperture may be angled to avoid unnecessary bending
of the electrical leads 350.
[0052] One example of the push button assembly 70 is a membrane
switch, such as a tactile switch. A tactile switch provides a
positive snap action response to one's thumb or finger when
depressed. The snap action response can be achieved through the use
of stainless steel domes embedded in the membrane switch.
[0053] The push button assembly 70 is positioned to be readily
accessible to the physician so that the physician can pay the
necessary attention to holding and steering the catheter 20. The
button assembly 70 also provides the physician with the capability
of performing other procedure-related tasks. The imaging and
control system 10 is programmable such that the actuation of the
push button assembly 70 can initiate one or more functions or
activities.
[0054] In one example, the imaging and control system 110 can be
programmed to add an identification mark on the Tracking Window of
the display 112 when the push button assembly 70 is pressed. The
imaging and control system 110 preferably displays cross-sectional
or three dimensional images of the catheter or catheters being
used. An identification mark gives the physician the ability to
identify particular areas of interest within the heart and vascular
system. The particular areas of interest can be stored in the
storage device for later retrieval and use. In another example of
the invention, the imaging and control system 110 can be programmed
to identify and store information concerning the relative location
and position of the distal portion 90 of the catheter body 30
relative to the patient's body, when the button assembly 70 is
depressed. These functions may be particularly helpful to a
physician to discuss or identify areas of interest at a later time
or to return to a particular location to perform a procedure in the
future. In another example of the invention, the push button
assembly 70 can be used to store images displayed on the imaging
system 110 for later retrieval or for printing these images from an
attached printer (not shown). Through the actuation of the push
button assembly 70, stored images can be retrieved from the storage
device for display on the visual display 112. These stored images
can then be compared by the physician to real time images of the
patient.
[0055] In another example, the imaging and control system 110 can
be programmed to deliver a dose of drugs to the patient
percutaneously through a lumen in the catheter 20 upon actuation of
the assembly 70. In a similar manner, the push button 70 can
control the release of a supply of saline or an anti-coagulation
drug through the catheter body 30 to prevent blood clotting.
[0056] Other examples of functions or tasks that the imaging and
control system 110 can be programmed to initiate through the
actuation of the push button assembly 70 include measuring the
heart rate and measuring of the time duration between portions of a
single heart beat. These procedures are carried out by sensing the
heart beat, processing the information through the imaging and
control system 110, and displaying the result on the visual display
112.
[0057] Yet another example includes programming the imaging and
control system 110 to modify images on the visual display 112 in
response to actuating the push button assembly 70. For example, the
system 10 may be programmed such that depression of the push button
assembly 70 magnifies an image or a certain area of interest of an
image displayed on the visual display 112, or displays an
alternative view of real time images. The imaging and control
system 110 can also be programmed such that depression of the push
button assembly 70 causes toggling between several images or views
or modifies the layout of images on the visual display 112.
[0058] Another example includes programming the imaging and control
system 110 to display colors on the visual display 112. As
discussed in more detail above, the use of colors can provide the
physician with helpful information concerning areas of the
patient's that have been ablated. Such information can include the
location, date or time of the previous ablation as well as the
certain other characteristics of the ablation, such as the lesion
pattern and the arrhythmia type.
[0059] Other functions that can be controlled by the button
assembly 70 include the selection of different settings of the RF
generator. The button assembly 70 can be used to select the
temperature, duration, and power settings of the generator, for
example.
[0060] In an ablation system 10a of FIG. 4, the distal portion 90
of the catheter 20 supports an expandable basket 130 with a
plurality of splines 140. Each of the splines 140 carries one or
more mapping electrodes 150. The imaging and control system 110 may
be programmed so that the expandable basket 130 is deployed out of
an opening in the distal portion 90 in response to a depression in
the push button assembly 70. Such deployable electrode mapping
assemblies are described in greater detail in U.S. Pat. No.
6,163,716, which is incorporated by reference herein. The system
110 can also be programmed to collapse the basket 130 in response
to a depression of the same push button assembly 70.
[0061] In accordance with the invention, the system 10 may be
programmed to associate any one of the functions described above,
or other functions desired by the physician, through actuation of
the button assembly 70. The system 10 may also be programmed to
associate multiple functions with actuation of the button assembly
70, as desired by a physician.
[0062] One way a physician can control multiple functions of the
catheter system 10 through the use of a push button assembly 70 is
by varying the manner in which the push button assembly 70 is
actuated. For example, the catheter system 10 can be programmed to
perform one function (e.g. power up ablation electrodes) when the
push button assembly 70 is pressed once and perform another
function (e.g. power down ablation electrodes) when the push button
assembly 70 is pressed twice within a short, predetermined time
period. Alternatively, the imaging and control system 110 can be
programmed to respond differently when it receives three quick
presses of the button assembly 70 or one relatively long press.
[0063] In yet another alternative, the system 110 can be programmed
to respond to a first press of the button assembly 70 by initiating
a first programmed function and to a subsequent press of the button
assembly 70 by stopping the programmed function. For example, a
first press can power up the RF generator and a second press can
power down the RF generator.
[0064] The catheter system 10 can also be programmed to respond to
the release of a depressed button assembly 70 as well as the
depression of the button assembly 70. The response to the release
may be the opposite of the response to the depression. For example,
if the catheter system 10 is programmed to respond to a depression
of the button assembly 70 by powering up the RF generator 112 that
supplies power to one or more ablating electrodes, the system 10
can also be programmed to respond to the release of the button
assembly 70 by powering down the RF generator. In this way, the
physician can control the duration of ablation by pressing and
holding the button assembly 70 down.
[0065] Programming may be performed by a physician through the use
of keyboard 115, or other input device, such as a mouse, prior to
the start of the ablation procedure. Preferably, a graphical user
interface ("GUI") is provided on the visual display 112 to
facilitate the programming process. For example, the physician
could choose from a list the available programmable functions
displayed on the GUI and assign a corresponding manner in which the
button assembly can be actuated to each of the desired functions by
pointing and clicking a mouse.
[0066] The imaging and control system 110 can also be programmed to
respond to a press of the button assembly 70 according to a
predetermined sequence each time a physician actuates the push
button assembly 70. For example, in a sequence useful for cardiac
mapping and ablation, the system 10 can be programmed to respond as
follows. After the physician navigates the distal end of the
catheter 20 into the patient's heart, the physician actuates the
push button assembly 70 a first time to initiate the pacing step of
the procedure. In the pacing step, one or more of the electrodes
100 in the distal portion 90 sends an electric current into the
cardiac tissue of a patient at a predetermined rate for a
predetermined length of time. The electric current forces the
patient's cardiac tissue into arrhythmia.
[0067] Pressing the push button assembly 70 a second time initiates
the mapping step. During the mapping step, the catheter system 10
detects and processes electrical signals from the cardiac tissue.
Signals may be analyzed to identify, among other things, a flutter
in the cardiac tissue. The processed signals are displayed in a
suitable format on the visual display 112 of the imaging and
control system 110. In the Cardiac Pathways system, the signals may
be displayed on the monitor window 112a. The trained physician can
view the processed signals and navigate the distal portion 90 to a
desired position in the heart for ablation.
[0068] A third press of the push button assembly 70 initiates the
ablation step. The generator of the imaging and control system 110
then powers one or more of the electrodes 100 to be used to ablate
the cardiac tissue. Energy delivery characteristics, such as the
number of electrodes to be energized, the power and duration of the
energy delivery, and/or the temperature of the electrodes during
ablation, for example, can also be controlled by the user through
the button assembly 70.
[0069] A fourth press of the button assembly 70 powers down the
generator to stop the ablation step. A fifth press of the button
assembly 70 initiates the mapping step again. A sixth press
initiates the ablation step again. A seventh press powers down the
generator. This process of mapping, ablating, and powering down
recycles indefinitely with subsequent depressions of the button
assembly 70 until a termination signal is received by the control
system 110.
[0070] Two examples of termination signals include two quick
presses of the button assembly 70 within a relatively short period
of time and a single press and hold of the button assembly 70 for a
relatively long period of time. The catheter system 10 may also be
programmed to stop the programmed sequence in response to actuation
of a separate actuator assembly located on the catheter handle 40.
The use of multiple actuating assemblies is discussed further
below. After the catheter system 10 receives the ending signal, the
programmed sequence is reset to the beginning. The procedure can
then be restarted from the beginning.
[0071] The following is another example of a programmable sequence
that may be useful for mapping a heart using a catheter with basket
assembly, as shown in FIG. 4. A first press of the button assembly
70 expands the basket 130 located near the distal portion 90 of the
catheter body 30. The expandable basket 130 may be expanded within
a chamber of the patient's heart. A second press of the button
assembly 70 initiates the mapping step. The mapping electrodes 150
detect electrical signals, the signals are processed by the control
system 110, and the result is displayed on the visual display 112.
A third press of the button assembly 70 stops the mapping step and
collapses the expandable basket 130. A fourth press expands the
basket 130 again. This sequence is repeated until a termination
signal is received. Just as with the previously described example
of a programmable sequence, the catheter system 10 is programmed to
stop the sequence upon receipt of a termination signal.
[0072] The catheter system 10 may also display the progress of a
programmed sequence by listing all the steps of the programmed
sequence on a display 112 and highlighting the current step in
progress, for example. This provides the physician with information
on the current status of the procedure and what to expect from the
catheter system 10 the next time the push button assembly 70 is
actuated.
[0073] The imaging and control system 110 can also be programmed to
provide feedback to the physician concerning the current operation
of the system 10 or the next function programmed to be initiated in
response to actuation of the button assembly 70. In the case of
ablation catheters, a signal may be provided to the physician that
ablation electrodes at the distal portion 90 are currently powered
up and ablating tissue. For example, the push button assembly 70
can vibrate when the ablation electrodes are powered. In the
alternative, the catheter handle 40 may have a light that flashes
when the ablation step is in progress. Alternatively, a signal can
be provided to inform the physician of a potential risk if the
button assembly 70 is actuated. For example, a light on the handle
can flash when the catheter system 10 is in a state where the next
press of the push button assembly 10 will power up the ablation
electrodes. This signal can warn the physician so that the
physician does not mistakenly press the button assembly 70 thinking
that a different function will be carried out.
[0074] In the Cardiac Pathways system, various functions and
displays are controllable by a physician's assistant by menus. In
accordance with the invention, the menu driven features may be
controlled with the push button assembly 70. This provides the
physician with the ability to navigate and select features from a
menu displayed on the visual display 112 of the imaging and control
system 110.
[0075] FIGS. 5A-5B show two examples of menus that can be used in
connection with the system 10. In the example of FIG. 5A, a menu
600 is shown as displayed on a visual display 112. The menu 600
contains a list of various functions that can be performed by the
catheter system 10. In this example, the menu 600 is made of two
levels, Level 1 and Level 2. As discussed in greater detail below,
the physician has the ability to navigate through the menu 600 and
select an operation by pressing the button assembly 70.
[0076] The menu 600 displays a list of first level options in Level
1. In this example, the Level 1 options include "basket assembly,"
"ablation electrode," and "begin pacing." The option "basket
assembly" controls the deployment and collapse of a basket assembly
at the distal portion 90. The option "ablation electrode" controls
the powering of one or more ablation electrodes. The option "begin
pacing" controls the application of electrical current to cardiac
tissue to pace the heart. A single, quick depression of the button
assembly 70 advances the current selection, which is highlighted,
to the next available selection. In the example of FIG. 5A, if the
selection "basket assembly" is highlighted, a single press of the
button assembly 70 will highlight the selection "ablation
electrode," as shown. A quick, double press of the push button 70
selects and may activate the highlighted selection. In some cases,
a selection may bring up another set of options in Level 2. In the
alternative, the list of options in Level 2 may be displayed
automatically upon the highlighting of the Level 1 selection. In
this example, a selection of "ablation electrode" brings up four
options related to the powering up and powering down of two
electrodes E1/E2 located on the distal portion 90 of the catheter
body 30. As with the case of the options of Level 1, one of the
options of Level 2 is highlighted. Navigation through the list in
Level 2 is accomplished in the same manner.
[0077] FIG. 5B illustrates another exemplary depiction of a display
screen of the imaging and control system 110. A toolbar 601 having
various options related to the display of information is pictured
on the left side of the display 112. In the center of the display
112 is a real time graphical representation of positions of
reference and tracking catheters in the patient's heart. The upper
right portion of the display is dedicated to the display of EKG
signals received from mapping electrodes. These signals are useful
for detecting arrhythmia and provides a physician with information
to determine a suitable location of the patient's heart to
ablate.
[0078] Navigation through the options of the toolbar 601 is
achieved in a manner similar to the example of FIG. 5A. A single
press of the push button assembly 70 advances through the list of
highlightable selections, and a double click of the push button
assembly 70 activates the selection. In the illustrated example, if
the highlighted selection is "Reference," a single click will
advance to the selection "View." A double click on the "View"
selection will provide the physician with the capability of
choosing from the list of options within the "View" subcategory.
This list includes various options for operating the system and
controlling the displayed view.
[0079] In the alternative, the catheter handle 40 may also have two
actuators, one actuator for scrolling through the options and a
second actuator for making the selection. The actuators may be
buttons or switches, for example.
[0080] In an another alternative, the catheter handle 40 may have a
rotating disk for scrolling through the listed options. The use of
a rotating disk to navigate through a list of options may be
preferable because it provides the physician with the capability of
scrolling through the list of options in two directions, forward
and backwards. FIGS. 6A-6B illustrate one example of a rotating
disk 73, and FIGS. 7A-7B illustrate another example of a rotating
disk 74. Both of the disks 73,74 rotate about an axis of rotation
76, 77, respectively.
[0081] Referring now to FIG. 8, in another embodiment of the
invention, a catheter 465 has six buttons assemblies 470a-470f
located near its holding portion. The button assemblies 470 are
arranged in three rows of two pairs each, wherein each pair of
button assemblies 470 controls different aspects of the operation
of a particular function. For example, the imaging and control
system 110 may be programmed so that the two button assemblies
closest to the holding portion of the catheter 470a, 470d initiate
the deployment and collapse of an expandable basket near the distal
end of the catheter, respectively. Actuation of the two center
button assemblies 470b, 470e may cause the commencement and
completion of the sending of electrical pulses into the patient's
tissue to pace the heart, respectively. The two button assemblies
furthest from the handle portion 470c, 470f may initiate and stop
the mapping step, respectively. While a preferred correlation of
the buttons 470 is described, the buttons 470 can be programmed to
control other functions and can be arranged in numerous alternative
configurations, as well.
[0082] The button assemblies 470 may be embossed or otherwise
marked with a distinctive symbol to provide the physician with
information concerning the programmed function that is correlated
with each of the buttons 470. In the alternative, the button
assemblies 470 can be shaped to provide this information. The
physician can be trained to associate a distinctive feature of the
button assemblies with the programmed function or the programmed
function can be obvious from the feature.
[0083] As mentioned above, switches may be provided instead of
buttons. In FIGS. 9A-9C, a catheter 473 is provided with three
switches 475a-475c instead of the six buttons of the embodiment of
FIG. 8. Each of the switches 475 includes a protruding member 478,
which is engageable and rotatable about an axis of rotation 479.
The switches 475 have two positions, an A position and a B
position. The switches are advanced from one position to the other
by engaging the switches 475 with a thumb or finger and rotating
the protruding portion 478 with respect to the axis of rotation
479.
[0084] The use of two position switches can be advantageous in
certain applications. A single, double-position switch may provide
the functionality of two button assemblies and thus may occupy less
space on the handle of the catheter. Another benefit is that the
operator can view the positions of the switches 475 to confirm that
the system is in the intended configuration. As in the embodiment
of FIG. 8, the imaging and control system 473 can be programmed to
perform, or cease performance of, an operation in response to the
position of the switches 475.
[0085] FIGS. 10A-10C and FIGS. 11A-11C illustrate two additional
examples of switches 375, 376 suitable for use with a catheter. The
switches 375, 376 are resilient in that they return to its
original, relaxed position upon release. FIGS. 10A and 11A
illustrate the switches 375, 376 in their relaxed position.
Protruding portions 377, 378 of the switches 375, 376 are in its
neutral position. The switches 375, 376 can be rotated by the
physician about an axis to position. A (illustrated in FIGS. 10B
and 11B) or to position B (illustrated in FIGS. 10C and 11C). The
physician can move the switches 375, 376 to position A to initiate
one function of the catheter system and can move the switches 375,
376 to position B to initiate another function. In this way, the
catheter assembly is capable of performing more than one function
in response to actuation of one actuating device.
[0086] Alternatively, the switch 375, 376 can be sliding switches.
The sliding switches 375, 376 are confined within slots and can be
pushed by the physician along the slots in two directions. The
switches can also return to a neutral or relaxed position upon
release of the switches by the physician.
[0087] Referring now to FIGS. 12A-12B, two partial cross sectional
representations of a double position button assembly 480 are shown
in its depressed position and a released position, respectively.
The button assembly 480 is capable of being locked in the depressed
and released positions and toggles between the positions in
response to pressure by the operator. As in the example of FIGS.
9A-9C, one double-position button assembly 480 can replace two
single position button assemblies. Protrusions 485 preferably are
shaped to surround the button assembly 480 to reduce the chance
that an operator will inadvertently trigger a function of the
catheter system.
[0088] In an alternative embodiment illustrated in FIG. 13, a
system 500 has a catheter 505 with five button assemblies 510a-510e
located on a relatively flat portion of its handle 520. As in the
example of FIG. 1, the system 500 provides option selection through
the use of menus. The visual display 112 displays the menu or list
of options to the physician. The physician navigates through, and
selects options from, the menus through the button assemblies 510.
More than one of the button assemblies 510 may be used to navigate
through the menus. For example, the center button assembly 510e can
be assigned to select an option and the remaining button assemblies
510a-510d can be assigned to scroll through each of the
options.
[0089] Examples of other functions of the button assemblies 510
include the navigation of a pointer on one or more of the visual
displays 112a-112c. One benefit of controlling a pointer is that it
provides the physician with the ability to identify certain areas
of interest of the patient's vascular system and magnify portions
of images displayed on the visual display 112. The button
assemblies 510 can also be used with a visual pointer to mark or
highlight certain areas of interest on the visual display 112.
These areas of interest may include, for example, blockage in the
arteries of the patient, areas of the heart in which ablation
procedures have already been performed, and precise locations on
which the operator intends to perform a procedure. The imaging and
control system 110 may be programmed to magnify the area of
interest on the same visual display or on a separate visual display
associated with system 110.
[0090] Referring now to FIGS. 14A-14B, in an embodiment similar to
the embodiment of FIG. 13, a catheter handle has a button 501
shaped to have five recesses or depression areas 502a-502e. The
button assembly 501 has the same functionality of the button
assemblies 510 of FIG. 13. The button assembly 501 can be pressed
by the physician in one of the five depression areas 502a-502e
Infrared sensors, pressure contacts or other types of sensors
beneath the button 501 assembly are provided to detect depression
of a particular area 502a-502e. Other examples of button assemblies
are illustrated in FIGS. 15 and 16. The button assemblies 525, 528
each have depression areas 526, 529, respectively.
[0091] FIGS. 17A-17B illustrate another example of a catheter
system 575 similar to the embodiment of FIG. 13. The system 575
includes a catheter 550 with a movable and rotatable sleeve 555.
The rotatable sleeve 555 rotates around an axis in the axial
direction of the catheter 550. The rotating aspect can be useful to
navigate or scroll through menus displayed on an imaging system or
display, as discussed above. The rotatable sleeve 555 is also
capable of adjusting the magnification of images displayed on the
visual display with the catheter system being programmed to
increase the magnification when the sleeve 555 is rotated in one
direction and decrease the magnification when rotated in the
opposite direction. The rotating sleeve 555 is also movable in the
axial direction. The axial movement of the sleeve 555 provides a
second dimension to the capabilities of the catheter 550. The
ability of the sleeve 555 to move in two dimensions provides the
physician with the capability of navigating a pointer on the
imaging system.
[0092] Additional examples of functional actuating assemblies that
can be placed on a handle of the catheter are illustrated in FIGS.
18A-18B and FIGS. 19A-19B. FIG. 18B-18C are cross sectional,
schematic representations of a sliding element 600 that can be
incorporated in a handle 603 of a catheter 604. The sliding element
600 is configured to slide along a linear recess 605. For example,
the sliding element can control a 200m function of the display of
an image. The imaging and control system 110 may be programmed to
initiate, terminate or modulate a function in response to the
linear movement of the sliding element. For example, the sliding
element 600 can control a zoom function of the display of an image
to magnify and reduce the image. Optionally, the sliding element
600 can also be adapted to be pressed into the body of the handle
603, to add additional functionality.
[0093] FIGS. 19A-19B illustrate another example of an actuation
assembly. A catheter 620 includes a miniature trackball 625
embedded in its body. A physician can navigate through menus
displayed on the visual display 112 or navigate a pointer on the
visual display 112 by rolling the trackball 625, for example. The
physician can also make a selection from the menu or can utilize
other features of the catheter system by pressing the trackball 625
into the body of the catheter 620. Alternatively, the physician can
actuate one of the two buttons assemblies 628. Sensors, such as
light emitting diodes (not shown), can be incorporated within the
handle to monitor the movement of the track ball 625.
[0094] In another embodiment, FIG. 20 depicts a catheter handle
having a pointing or navigation assembly 650. The pointing assembly
650 has pressure sensors for sensing the magnitude and direction of
a force placed upon a contact portion 653 of the pointing assembly
650. The control and imaging system 110 is capable of processing
signals received from the sensors to navigate a pointer on the
visual display 112. The processing of the signals is accomplished
in a manner similar to the eraser head, TrackPoint pointing
apparatus found in the center of keyboards of many laptop
computers. A more detailed explanation of an exemplary pointing
device is described in U.S. Pat. No. 6,271,834, which is
incorporated by reference herein.
[0095] In accordance with another embodiment, a push button or
other such actuating assembly may be removably attachable to a
catheter handle 400 or the physician's wrist or finger. FIG. 21
shows a push button assembly 410 including a sleeve 420.
Preferably, the sleeve 420 is elastic. Due to its elastic nature,
the sleeve 420 can be attached at an infinite number of locations
along the longitudinal axis of the catheter handle 400 by
stretching it out and allowing it to contract around the handle 400
at a desired location. Electrical leads 430 couple the push button
assembly 410 to the control and imaging system 110 or other
procedure-related operative equipment adapted to carry out a
procedure-related task by actuating the push button assembly 410.
The push button assembly 410 preferably includes a membrane switch
such as the tactile switch described above with respect to FIG.
1.
[0096] The sleeve 420 may be slid over a catheter body 432, and a
distal portion 440 of the catheter handle 400, toward a proximal
portion 450 of the catheter handle 400, for mounting the push
button assembly 410 to the handle 400. Mounting the push button 410
just distal of a steering assembly 460, with the top of the push
button 410 facing in the same direction as the top of the steering
assembly 460, eases actuation of the push button assembly 410 by a
physician's thumb, regardless of which hand the physician uses to
hold the catheter handle 400.
[0097] Although the sleeve 420 is shown positioned around the
distal portion 440 of the handle 400, in alternative embodiments,
the sleeve 420 may be positioned in any number of locations along
the handle 400, including around the proximal portion 450 of the
handle 400. The sleeve member 420 can be made of any flexible
material including, but not limited to, plastic, rubber or any
elastomer.
[0098] Alternatively, as shown in FIG. 22, a sleeve 420a can be a
fabric material with VELCRO.TM. sections 421, i.e., a single strap
with an opposing hook section and loop section at opposite ends,
for simple attachment and detachment around the user's finger, for
example. In FIG. 23, the sleeve 420a is shown attached to the
operator's wrist. The sleeve 420a could also be attached to the
handle 400 and the sleeve 420 of FIG. 21 could be attached to the
operator, by suitable adjustment of the dimensions of the
respective sleeve.
[0099] While the embodiments described above relate to catheters
used in cardiac ablation systems, the invention may be incorporated
in other types of catheters, as well. For example, a push button
assembly may be provided on a dilatation catheter for performing
angioplasty. The angioplasty system may be programmed to deploy a
dilatation balloon near the distal portion of the catheter in
response to a depression of the push button assembly and collapse
the balloon in response to a subsequent depression of the button,
for example. The system could also be programmed to deliver drugs
upon depression of the button assembly.
[0100] Furthermore, while the invention is particularly useful with
catheters having at least one steering mechanism for controlling a
distal end of the catheter, the invention may be useful with
non-steerable catheters, as well.
[0101] In addition, the invention may be used with catheters for
ablation procedures in other parts of the body, such as in the
remainder of the circulatory system, other soft tissue, such as the
liver, the kidneys, the brain, the pancreas, the lungs, the
prostate and in the soft tissue of the bones, for example.
[0102] The invention may also be used with laparoscopic probes
which provide minimally invasive direct access for introducing
ablation elements or other therapeutic or diagnostic devices at a
distal end of the probe into interior body regions through body
cavity walls. Functions of laparascopic probe systems can be user
programmed and controlled in a similar manner as described above.
In the specification and claims, the term "catheter" is meant to
encompass hand held probes of any type, as well.
[0103] In addition, while the embodiments have been described with
respect to the Cardiac Pathways Arrhythmia Mapping System, other
imaging and control systems may be used. For example, a
fluoroscopic imaging system may be used, in which case, in addition
to the functions described above, the actuating assembly may be
used to inject contrast for improved visualization of the site of
interest. Magnetic and x-ray based imaging systems can also be
used.
[0104] Although the disclosed examples illustrate button assemblies
in certain location on the handle, the invention is not
specifically limited to those locations. Any type of actuatable
device, including pointing and navigating devices may be provided,
in any suitable location near the handle, as well.
[0105] It will evident to those skilled in the art that the
invention is not limited to the details of the foregoing
illustrative examples and that the present invention may be
embodied in other specific forms without departing from the scope
of the invention, which is defined by the following claims.
* * * * *