U.S. patent application number 13/181918 was filed with the patent office on 2013-01-17 for system for indicating catheter deflection.
The applicant listed for this patent is Doron Moshe Ludwin. Invention is credited to Doron Moshe Ludwin.
Application Number | 20130018306 13/181918 |
Document ID | / |
Family ID | 46551383 |
Filed Date | 2013-01-17 |
United States Patent
Application |
20130018306 |
Kind Code |
A1 |
Ludwin; Doron Moshe |
January 17, 2013 |
SYSTEM FOR INDICATING CATHETER DEFLECTION
Abstract
Apparatus, consisting of a probe, having a proximal end and a
distal end, which is deflectable in first and second directions.
The apparatus includes a probe manipulator, which is coupled to the
proximal end of the probe and has first and second tactile control
elements. The elements are operable by a user of the probe to
deflect the distal end in the first and second directions,
respectively, and are tactilely distinguishable one from the
other.
Inventors: |
Ludwin; Doron Moshe; (Haifa,
IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Ludwin; Doron Moshe |
Haifa |
|
IL |
|
|
Family ID: |
46551383 |
Appl. No.: |
13/181918 |
Filed: |
July 13, 2011 |
Current U.S.
Class: |
604/95.04 |
Current CPC
Class: |
A61M 25/0136 20130101;
A61M 25/0133 20130101; A61B 1/0052 20130101; A61B 1/0057 20130101;
A61B 1/0005 20130101; A61M 2209/01 20130101 |
Class at
Publication: |
604/95.04 |
International
Class: |
A61M 25/092 20060101
A61M025/092 |
Claims
1. Apparatus, comprising: a probe, comprising a proximal end and a
distal end, which is deflectable in first and second directions;
and a probe manipulator, which is coupled to the proximal end of
the probe and comprises first and second tactile control elements,
which are operable by a user of the probe to deflect the distal end
in the first and second directions, respectively, and which are
tactilely distinguishable one from the other.
2. The apparatus according to claim 1, wherein the first and second
tactile control elements have respective first and second shapes,
wherein the first and second shapes are different one from the
other.
3. The apparatus according to claim 1, wherein the first and second
tactile control elements have respective first and second congruent
shapes, wherein the first and second shapes are oriented
differently.
4. The apparatus according to claim 1, wherein the first and second
tactile control elements have respective surfaces which are
tactilely distinguishable one from the other.
5. The apparatus according to claim 1, and wherein the first and
second tactile control elements are configured to have respective
visible characteristics different one from the other.
6. The apparatus according to claim 1, and comprising a screen
configured to display respective different graphic symbols in
response to deflection of the distal end in the first direction and
in the second direction.
7. The apparatus according to claim 6, wherein the first and second
tactile control elements are configured to have respective visible
characteristics different one from the other, and wherein the
respective graphic symbols comprise the respective visible
characteristics.
8. The apparatus according to claim 6, wherein the screen is
configured to display a further graphic symbol in response to the
distal end being in an un-deflected state.
9. The apparatus according to claim 1, wherein the first and second
tactile control elements are related by 2-fold rotational
symmetry.
10. A method, comprising: configuring a probe, comprising a
proximal end, and a distal end that is deflectable in first and
second directions; and coupling a probe manipulator to the proximal
end of the probe, the manipulator comprising first and second
tactile control elements, which are operable by a user of the probe
to deflect the distal end in the first and second directions,
respectively, and which are tactilely distinguishable one from the
other.
11. The method according to claim 10, wherein the first and second
tactile control elements have respective first and second shapes,
wherein the first and second shapes are different one from the
other.
12. The method according to claim 10, wherein the first and second
tactile control elements have respective first and second congruent
shapes, wherein the first and second shapes are oriented
differently.
13. The method according to claim 10, wherein the first and second
tactile control elements have respective surfaces which are
tactilely distinguishable one from the other.
14. The method according to claim 10, and wherein the first and
second tactile control elements are configured to have respective
visible characteristics different one from the other.
15. The method according to claim 10, and comprising displaying
respective different graphic symbols in response to deflection of
the distal end in the first direction and in the second
direction.
16. The method according to claim 15, wherein the first and second
tactile control elements are configured to have respective visible
characteristics different one from the other, and wherein the
respective graphic symbols comprise the respective visible
characteristics.
17. The method according to claim 15, and comprising displaying a
further graphic symbol in response to the distal end being in an
un-deflected state.
18. The method according to claim 9, wherein the first and second
tactile control elements are related by 2-fold rotational symmetry.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to catheter probes,
and specifically to manipulation of the probes by an operator.
BACKGROUND OF THE INVENTION
[0002] Probes such as catheters may be inserted into the body of a
patient during a medical procedure that is performed on the
patient. The probes may be used for a variety of purposes, such as
an internal inspection of the patient, or ablation of an organ of
the patient.
[0003] The insertion of the probe into the patient is typically a
delicate procedure, which needs to be performed carefully.
[0004] Documents incorporated by reference in the present patent
application are to be considered an integral part of the
application except that to the extent any terms are defined in
these incorporated documents in a manner that conflicts with the
definitions made explicitly or implicitly in the present
specification, only the definitions in the present specification
should be considered.
SUMMARY OF THE INVENTION
[0005] An embodiment of the present invention provides apparatus,
including:
[0006] a probe, having a proximal end and a distal end, which is
deflectable in first and second directions; and
[0007] a probe manipulator, which is coupled to the proximal end of
the probe and includes first and second tactile control elements,
which are operable by a user of the probe to deflect the distal end
in the first and second directions, respectively, and which are
tactilely distinguishable one from the other.
[0008] Typically, the first and second tactile control elements
have respective first and second shapes, wherein the first and
second shapes are different one from the other.
[0009] In a disclosed embodiment the first and second tactile
control elements have respective first and second congruent shapes,
wherein the first and second shapes are oriented differently.
[0010] In a further disclosed embodiment the first and second
tactile control elements have respective surfaces which are
tactilely distinguishable one from the other.
[0011] In a yet further disclosed embodiment the first and second
tactile control elements are configured to have respective visible
characteristics different one from the other.
[0012] In an alternative embodiment the apparatus includes a screen
configured to display respective different graphic symbols in
response to deflection of the distal end in the first direction and
in the second direction. Typically, the first and second tactile
control elements are configured to have respective visible
characteristics different one from the other, and wherein the
respective graphic symbols comprise the respective visible
characteristics. The screen may be configured to display a further
graphic symbol in response to the distal end being in an
un-deflected state.
[0013] In a further alternative embodiment the first and second
tactile control elements are related by 2-fold rotational
symmetry.
[0014] There is further provided, according to an embodiment of the
present invention, a method, including:
[0015] configuring a probe, having a proximal end, and a distal end
that is deflectable in first and second directions; and
[0016] coupling a probe manipulator to the proximal end of the
probe, the manipulator including first and second tactile control
elements, which are operable by a user of the probe to deflect the
distal end in the first and second directions, respectively, and
which are tactilely distinguishable one from the other.
[0017] The present disclosure will be more fully understood from
the following detailed description of the embodiments thereof,
taken together with the drawings, in which:
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1 is a schematic illustration of a system for
indicating the deflection direction of a probe, according to an
embodiment of the present invention;
[0019] FIG. 2 is a schematic figure illustrating internal elements
of a probe manipulator of the system, according to an embodiment of
the present invention;
[0020] FIG. 3 is a schematic figure illustrating internal elements
of a probe of the system, according to and embodiment of the
present invention;
[0021] FIG. 4 is a schematic figure illustrating the probe
manipulator in an assembled state, according to an embodiment of
the present invention;
[0022] FIG. 5 is a schematic figure illustrating the manipulator in
an assembled state, and rotated from the orientation of FIG. 4,
according to an embodiment of the present invention; and
[0023] FIG. 6 is a schematic figure of a display of graphic
symbols, according to an embodiment of the present invention.
DETAILED DESCRIPTION OF EMBODIMENTS
Overview
[0024] Embodiments of the present invention provide a system that
facilitates the manipulation of a probe having a distal end which
is deflectable in two directions. Typically the two directions are
opposite to each other, so that, for example, the distal end may be
deflected to the left or to the right. A probe manipulator is
coupled to the proximal end of the probe, and the manipulator is
configured to have two control elements. Operation of one of the
control elements deflects the distal end in one direction;
operation of the other control element deflects the distal end in
the other direction.
[0025] Typically, an operator using the manipulator to insert the
probe into the body of a patient may need to twist the manipulator
during or after the insertion, for example to locate the distal end
in a desired position. Such a twist may cause the operator to
confuse which control element causes which type of deflection,
since the operator may typically rely on visible cues, such as the
position of the control elements, to select which element to
operate.
[0026] Embodiments of the present invention overcome this confusion
by forming the control elements to be tactilely distinguishable
from each other, so that the operator is able to select the
required control element on the basis of touch or feel, rather than
on the basis of visual cues.
System Description
[0027] Reference is now made to FIG. 1, which is a schematic
illustration of a system 20 for indicating the deflection direction
of a probe, according to an embodiment of the present invention.
System 20 comprises a catheter probe 22 which is inserted into the
body of a patient 24 during a medical procedure. The procedure is
performed by an operator 26, typically a medical professional. By
way of example, the procedure assumed in the description herein
comprises insertion of a distal end 28 of the probe into a heart 30
of the patient. However, it will be understood that embodiments of
the present invention are not limited to such a procedure, but
rather may be used for any procedure requiring or using knowledge
of the deflection direction of a probe.
[0028] Probe 22 typically comprises tracking elements in distal end
28 which enable system 20 to track the position and orientation of
the distal end. For example, the position and orientation may be
measured using coils in the distal end which detect levels of
magnetic fields generated by magnetic field transmitters external
to patient 24. Such a technique for measuring the position and
location of the distal end is used in Carto system probes produced
by Biosense Webster of Diamond Bar, Calif. Other techniques for
tracking the position and orientation of the distal end, such as by
using impedance measurements between electrodes on the distal end
and one or more electrodes on the skin of patient 24, are known in
the art. System 20 is assumed to use one or more of these
techniques in order to measure the position and orientation of
distal end 28. For simplicity and clarity, tracking elements within
the distal end that are used to track the position and orientation
are not shown in the diagram.
[0029] Signals from the tracking elements are processed by a system
controller 32, comprising a processing unit 34 communicating with a
memory 36. The signals transfer via a cable 38, connecting the
tracking elements of probe 22, as well as other elements of the
probe such as electrodes incorporated in the distal end, to the
controller. The controller, under overall control of operator 26,
uses software stored in memory 36 for analyzing the signals from
the tracking elements, as well as to perform other functions
related to the operation of system 20. Results of the operations
performed by controller 32 are presented to the operator on a
screen 39, which typically displays a graphic user interface to the
operator, and/or an image of heart 30. The software may be
downloaded to controller 32 in electronic form, over a network, for
example, or it may, alternatively or additionally, be provided
and/or stored on non-transitory tangible media, such as magnetic,
optical, or electronic memory.
[0030] Probe 22 is configured so that operator 26 is able to
deflect distal end 28 of the probe, while the probe is inserted
into patient 24, in one of two directions. Such a bi-directionally
deflectable probe and its operation is described in US Patent
Applications 2005/0277875 and 2008/0255540, both to Selkee, which
are incorporated herein by reference. A bi-directionally
deflectable probe system is also produced, as an EZ Steer
Bi-Directional Catheter, by Biosense Webster. For clarity, in the
description herein probe 22 is assumed to be constructed generally
as described for the probe described in US Patent Application
2008/0255540.
[0031] Probe 22 comprises a probe manipulator 40 which is
mechanically connected to the proximal end of the probe. Operator
26 holds the manipulator and uses it in order to control entry and
exit of the probe into and out of the patient, as well as to
deflect the probe.
[0032] FIG. 2 is a schematic figure illustrating internal elements
of manipulator 40, and FIG. 3 is a schematic figure illustrating
internal elements of probe 22, according to embodiments of the
present invention. For the following description with reference to
FIGS. 2 and 3, a set of right handed orthogonal xyz axes are
assumed to be attached to manipulator 40, probe 22 is assumed to
extend in a positive y-direction from the manipulator, and the
probe and the manipulator are assumed to lie generally in an x-y
plane defined by the axes. It will be appreciated that the
description herein applying the xyz axes described above is for the
purposes of explanation only, and those having ordinary skill in
the art will be able to adapt the explanation for other
orientations of the probe and the manipulator.
[0033] Diagrams 42, 44, and 46 in FIG. 2 illustrate the probe
manipulator when probe 22 is respectively deflected left,
un-deflected, and deflected right. Diagrams 48, 50, and 52 in FIG.
3 respectively illustrate distal end 28 when it is deflected left,
un-deflected, and deflected right. The deflection is in an x-y
plane, and is assumed to be measured with respect to the y-axis. As
shown in FIG. 3, probe 22 comprises a puller wire 54 and a puller
wire 56 which are anchored at distal end 28 by respective anchors
58, 60. Wires 54 and 56 are constrained by respective generally
parallel lumens 62, 64 within probe 22, the wires being able to
slide within the lumens. Lumens 62 and 64 are typically
approximately equidistant from, and symmetrically disposed with
respect to, a central axis 66 of probe 22, and the axis and the
lumens lie in, and may be considered to define, an x-y plane.
[0034] As shown in FIG. 2, wires 54 and 56 extend to a steering
assembly 68 connected to manipulator 40. Steering assembly
comprises a lever 70, which is able to rotate around an axis 72
parallel to the z-axis. Lever 70 comprises two pulleys 74, 76,
around which wires 54 and respectively pass. After passing their
respective pulleys, wires 54 and 56 traverse respective stops 78,
80, before being attached at their ends 82, 84 to springs 86 and
88.
[0035] In the un-deflected state, illustrated in diagrams 44 and
50, the lengths of wires 54 and 56 within probe 22, i.e., extending
from a distal end 90 of manipulator 40, are approximately equal so
that distal end 28 is not deflected from the y-axis. In the
un-deflected state ends 82 and 84 are against their respective
stops 78 and 80.
[0036] As illustrated in diagrams 42 and 48, distal end 28 has been
deflected left. The left deflection is achieved by lever 70
rotating counter-clockwise from the system's un-deflected state.
The rotation causes the length of wire 54 within probe 22, i.e.,
from end 90 to end 28, to be shorter than in the un-deflected
state, since end 82 maintains contact with stop 78. The
counter-clockwise rotation causes pulley 76 to move towards distal
end 90, allowing the length of wire 56 within probe 22 to be longer
than in the un-deflected state. (The movement of pulley 76 also
allows spring 88 to retract wire 56, so that end 84 moves from its
stop 80.) The combination within probe 22 of the reduction in
length of wire 54, and the extension in length of wire 56, causes
distal end 28 to deflect left.
[0037] Diagrams 46 and 52 illustrate distal end 28 deflected right,
caused by lever 70 rotating clockwise from the system's
un-deflected state. The lever rotation causes, within probe 22,
wire 54 to be extended in length and wire 56 to be reduced in
length. The combination of the two length changes causes distal end
28 to deflect right.
[0038] FIG. 4 is a schematic figure illustrating manipulator 40 in
an assembled state, according to an embodiment of the present
invention. In the assembled state, the internal elements of the
manipulator are typically enclosed in a housing 92, so that the
elements are not exposed. In addition, a control 94 is fixedly
connected to lever 70 so that axis 72 is common to both the control
and the lever. Control 94 is above housing 92. Operator 26 holds
housing 92, and rotates lever 70 by pushing (or pulling) on end
tactile control elements 96 or 98 of control 94.
[0039] A diagram 91 illustrates distal end 28 in an un-deflected
state, and diagrams 93 and 95 show the distal end in a deflected
state. Thus, as shown in diagram 93, rotating control 94 about axis
72 in the direction shown by arrow 97 deflects distal end 28 to the
left. As shown in diagram 95, rotating control 94 about axis 72 in
the direction shown by arrow 99 deflects the distal end to the
right. From the point of view of an operator looking down on the
manipulator, i.e., an operator above the plane of the paper,
rotating control 94 in the direction shown in this view by arrow
97, i.e., counterclockwise, deflects the distal end to the left.
Similarly, rotating control 94 shown in this view by arrow 99,
i.e., clockwise, deflects the distal end to the right.
[0040] FIG. 5 is a schematic figure illustrating manipulator 40 in
an assembled state, and rotated from the orientation of FIG. 4,
according to an embodiment of the present invention. Typically,
while operator 26 operates probe 22 with manipulator 40, the
operator may rotate the manipulator, for example around the y-axis.
Such a rotation typically does not cause a corresponding rotation
of probe 22, but rather generates a twist in the probe. Diagrams
111, 113, and 115 respectively correspond to diagrams 91, 93, and
95 (FIG. 4), and show the manipulator rotated by approximately
180.degree. about the y-axis. In this case control 94 is below
housing 92.
[0041] As is illustrated in diagram 115, in this view arrow now
shows that control 94 needs to rotate counterclockwise to deflect
the distal end to the right. Similarly, as shown in diagram 113, in
this view arrow 97 now shows that control 94 needs to rotate
clockwise to deflect the distal end to the left. Comparing the
situations illustrated in FIGS. 4 and 5, it is apparent that
rotation of manipulator 40 may confuse the operator as to the
directions of deflection of the distal end caused by rotation of
the left and right elements of control 94.
[0042] Embodiments of the present invention eliminate the confusion
by causing the control elements to be tactilely distinguishable
from each other. In other words, operator 26 is able to distinguish
between the elements by touching the elements, and by perceiving
from the sense of touch that the elements are different. The
operator is thus able to identify each of the elements by touch
alone. By way of example, element 96 is assumed to have a groove
100 inset in the edge of the element and a protuberance 102
projecting from the edge of the element. As shown in the diagrams
of FIGS. 4 and 5, in element 96 groove 100 has a greater y-value
than protuberance 102. Also by way of example, element 98 is
assumed to have a groove 104 inset in the edge of the element and a
protuberance 106 projecting from the edge of the element. As shown
in the diagrams, in element 98 groove 104 has a smaller y-value
than protuberance 106. The different arrangements of grooves and
protuberances in the two control elements provide different tactile
feedback to operator 26 when the operator feels or touches the
elements.
[0043] Typically, elements 96 and 98 are implemented to be
tactilely distinguishable by arranging that the shapes of the
elements are different, as in the example described above and
illustrated in FIGS. 4 and 5. As another example, one tactile
control element may have a smooth continuously curved edge with no
sharp corners, and the other tactile control element may have a
discontinuous smooth curved edge, with at least one sharp corner.
Other differences in shapes for the two elements, enabling operator
26 to distinguish the elements on the basis of touch or feel, will
be apparent to those having ordinary skill in the art. Such
differences include, but are not limited to, the elements having
congruent shapes, but being oriented differently, so that the
different orientation is perceptible to operator 26 when the
operator touches the elements.
[0044] In some embodiments, the tactile difference between the two
elements may comprise implementing the surfaces of the elements to
be different. For example, the surface of element 96 may be formed
as a smooth surface, and the surface of element 98 may be rough. In
this case the shapes and orientations of the two elements may be
the same, and the tactile difference between the two elements is
implemented by selecting one or more characteristics of the
surface, such as the surface's roughness, elasticity, and/or
thermal conductivity, to be different, so that the operator is able
to detect the difference on touching the surfaces. In some
embodiments, the shape and the surface of the two elements may be
different.
[0045] In some embodiments, as well as forming elements 96 and 98
to be tactilely distinguishable, the elements are constructed so
that they are visually distinguishable. For example, element 96 may
have at least part of its surface colored blue, and element 98 may
have at least part of its surface colored yellow. In some
embodiments the visible differences between the elements may be
implemented by selecting visual characteristics other than color of
the elements to be different, such as by making one element
transparent and one element opaque.
[0046] In some embodiments, the tactile differences between the two
elements are configured to be related by 2-fold rotational
symmetry. Such a configuration is shown in FIGS. 4 and 5, which
illustrate that control 94 has 2-fold rotational symmetry about
axis 72. With such 2-fold symmetry a tactile difference
relationship within each of the control elements can be used as a
"global" command for distal tip deflection. For example, as is
demonstrated in the figures, the tactile difference relationship
between the protuberances and the grooves means that following the
instruction "rotate the protuberance towards the groove" deflects
distal tip 28 right no matter how the manipulator is oriented. Such
a global command may be provided to the operator in terms of a
convenient mnemonic. E.g., if grooves 100 and 104 are termed
dimples, and if protuberances 102 and 106 are termed pimples, then
the mnemonic "rotate the pimple (protuberance) towards the dimple
(groove) to deflect the tip right" applies regardless of the
orientation of the manipulator, and regardless of which control
element is considered.
[0047] FIG. 6 is a schematic figure of graphic symbols, according
to an embodiment of the present invention. Typically, the location
and orientation of distal end 28 within heart 30 is displayed on
screen 39 using respective images 28' and 30'. In addition, graphic
symbols representing the state of the distal end i.e., if it is
deflected or un-deflected, may be presented on the screen in order
to assist operator in manipulating the probe and its end. The
graphic symbols provide a visual confirmation to the operator of
the deflected or un-deflected state of end 28, as generated by the
operator using manipulator 40. Diagrams 120, 122, and 124
illustrate symbols 126, 128, and 130 displayed on screen in the
case of the distal end respectively being deflected left, being
un-deflected, and being deflected right. Diagram 120, with symbol
126, corresponds to diagrams 113 and 93; diagram 122, with symbol
128, corresponds to diagrams 111 and 91; and diagram 124, with
symbol 130, corresponds to diagrams 115 and 95 (FIGS. 4 and 5).
[0048] In the case of embodiments where the tactile control
elements of control 94 have a visual characteristic, a
corresponding visual characteristic may be applied to symbols 126,
128, and 130. For example, if at least part of element 96 is
colored blue, then symbol 130 may be colored blue; and if at least
part of element 98 is colored yellow, then symbol 126 may be
colored yellow. Alternatively or additionally, the corresponding
visual characteristic applied to symbols 126, 128, and 130 may
comprise other visible qualities applied to the symbols, such as
different types of shading, as exemplified in FIG. 6.
[0049] The description above has assumed a probe manipulator with
one control for deflecting the probe, the control having separate
tactile control elements which may be formed as part of a single
integrated control. It will be understood that this is one example
of a probe manipulator, and other manipulators may have tactile
control elements which are separated from one another, and which
are not formed as part of a single integrated control. It will also
be understood that probe manipulators according to embodiments of
the present invention do not need to be of the generally planar
form exemplified above, but may comprise other geometric forms,
such as a trackball or a joystick. All such manipulators are
included within the scope of the present invention.
[0050] It will thus be appreciated that the embodiments described
above are cited by way of example, and 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 subcombinations of the various features
described hereinabove, as well as variations and modifications
thereof which would occur to persons skilled in the art upon
reading the foregoing description and which are not disclosed in
the prior art.
* * * * *