U.S. patent application number 11/791985 was filed with the patent office on 2008-10-16 for add-on for invasive probe.
Invention is credited to Ron Hadani.
Application Number | 20080255441 11/791985 |
Document ID | / |
Family ID | 36087635 |
Filed Date | 2008-10-16 |
United States Patent
Application |
20080255441 |
Kind Code |
A1 |
Hadani; Ron |
October 16, 2008 |
Add-On For Invasive Probe
Abstract
An invasive probe assembly including an invasive probe having a
surface area and a tool carrier removably mounted on the invasive
probe, including a substrate having an area smaller than 25% of the
surface area of the probe and at least one tool mounted on the
substrate. The layout of the substrate or of one or more of the at
least one tool is optionally substantially different in different
sectors of the circumference of the probe.
Inventors: |
Hadani; Ron; (Cresskill,
NJ) |
Correspondence
Address: |
Martin D. Moynihan;PRTSI
P.O.Box 16446
Arlington
VA
22215
US
|
Family ID: |
36087635 |
Appl. No.: |
11/791985 |
Filed: |
December 1, 2005 |
PCT Filed: |
December 1, 2005 |
PCT NO: |
PCT/US2005/043274 |
371 Date: |
March 3, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60632739 |
Dec 1, 2004 |
|
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|
60653135 |
Feb 16, 2005 |
|
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60669007 |
Apr 7, 2005 |
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Current U.S.
Class: |
600/373 |
Current CPC
Class: |
A61N 1/3918 20130101;
A61N 1/05 20130101; A61B 1/00135 20130101; A61B 1/05 20130101; A61B
1/00105 20130101; A61N 1/0517 20130101; A61B 1/00142 20130101; A61N
1/3621 20130101; A61N 1/3625 20130101; A61B 2018/1495 20130101 |
Class at
Publication: |
600/373 |
International
Class: |
A61B 5/042 20060101
A61B005/042 |
Claims
1. An invasive probe assembly, comprising: an invasive probe having
a surface area; and a tool carrier removably mounted on the
invasive probe, including a substrate having an area smaller than
25% of the surface area of the probe and at least one tool mounted
on the substrate, wherein the layout of the substrate, or of one or
more of the at least one tool is substantially different in
different sectors of the circumference of the probe.
2. An assembly according to claim 1, wherein the substrate has a
width shorter than 3 cm, measured in an axial dimension of the
invasive probe.
3. An assembly according to claim 2, wherein the substrate has a
width shorter than 1 cm.
4. An assembly according to claim 1, wherein the substrate
substantially entirely surrounds the circumference of the
probe.
5. An assembly according to claim 1, wherein the substrate is
attached to the probe by an adhesive.
6. An assembly according to claim 1, wherein the substrate includes
a protective electrical or heat isolating layer, which is located
between the tool and the probe.
7. An assembly according to claim 1, wherein the at least one tool
comprises an electrode.
8. An assembly according to claim 7, wherein the substrate is
electrically conductive, serving as a part of the electrode.
9. An assembly according to claim 7, wherein the at least one tool
comprises only a single electrode.
10. An assembly according to claim 1, wherein the substrate is
electrically isolative.
11. An assembly according to claim 1, wherein the at least one tool
comprises at least one sensor and at least one electrode.
12. An assembly according to claim 1, comprising a protective
sheath that covers the probe and wherein the substrate is mounted
on the protective sheath.
13. An assembly according to claim 1, wherein the substrate does
not cover a distal 5 mm portion of the probe.
14. An assembly according to claim 1, wherein over most of the
length of the substrate, the substrate covers less than 20% of the
circumference of the probe.
15. An assembly according to claim 1, wherein the tool comprises a
flat electrode and wherein attaching the electrode to the probe
increases the cross-section diameter of the probe by less than 2
millimeters.
16. An assembly according to claim 1 wherein the tool comprises an
electrode which conforms to the shape of the probe.
17. An assembly according to claim 1, wherein the tool carrier is
flexible.
18. An assembly according to claim 17, wherein the tool carrier is
more flexible than the invasive probe.
19. An assembly according to claim 1, wherein the tool carrier
includes a wire electrically coupled to the tool and extending to a
proximal end of the probe.
20. An assembly according to claim 19, comprising the wire is
fastened to the probe using a ring at a proximal side of the
probe.
21-76. (canceled)
Description
RELATED APPLICATIONS
[0001] This application claims the benefit under 119(e) of U.S.
provisional patent application 60/632,739, titled "Add on Electrode
for Endoscope", filed Dec. 1, 2004, U.S. provisional patent
application 60/653,135, titled "Endoscopic Sheath with Illumination
System", filed Feb. 16, 2005, and U.S. provisional patent
application 60/669,007, filed Apr. 7, 2005, titled "Emergency
Electrode on Medical Tube". The disclosures of all of these
applications are incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to apparatus for minimally
invasive procedures and particularly to electrodes to be used in
such procedures.
BACKGROUND OF THE INVENTION
[0003] Endoscopes and other invasive probes are used to view
internal tissue of humans, and for many other tasks.
[0004] U.S. Pat. No. 4,354,502 to Colley et al., the disclosure of
which is incorporated herein by reference, describes a catheter
having an ultrasound transducer and an ECG electrode built into the
catheter.
[0005] Not all catheters and endoscopes are constructed with an
integral electrode. In some cases it is desired to add an electrode
to an existing endoscope or probe.
[0006] U.S. Pat. No. 6,394,949 to Crowley et al., the disclosure of
which is incorporated herein by reference, describes a removably
attachable electrode housing for mounting on a distal end of an
endoscope. Electrodes of the housing are used for ablation. The
U.S. Pat. No. 6,394,949 refers to prior art attempts to mount
electrodes on expandable surfaces, such as balloons, delivered
through an accessory channel of the endoscope.
[0007] U.S. patent publication 2002/0177847 to Long, the disclosure
of which is incorporated herein by reference, describes an ablation
cap for mounting on the distal end of an endoscope. The ablation
cap includes two electrodes which are positioned along the side of
the endoscope at its distal end. The electrodes are connected to
the proximal end of the endoscope via wires which are wrapped
around the endoscope or are attached along its length using
connectors.
[0008] U.S. patent publication 2002/0198583 to Rock et al., the
disclosure of which is incorporated herein by reference, describes
a disposable sheath for a transesophageal electrocardiography (TEE)
ultrasound probe or for an endoscope, which has a conductor
integrated into the sheath, so as to be located along the axial
length of the probe.
[0009] U.S. Pat. No. 5,588,432 to Crowley, the disclosure of which
is incorporated herein by reference, describes ring ablation
electrodes mounted on a disposable catheter sheath.
[0010] U.S. Pat. No. 5,830,146 to Skaldnev et al., the disclosure
of which is incorporated herein by reference, describes a sheath
cover of a diagnostic probe that includes electrodes in its distal
tip.
[0011] U.S. Pat. No. 6,517,530 to Kleven, the disclosure of which
is incorporated herein by reference, describes a sleeve for adding
an auxiliary element (e.g., an electrode) to an endoscope. The
sleeve surrounds the endoscope over a substantial part of its
length and carries on it the auxiliary element.
[0012] These sheaths are relatively large and may interfere with
the insertion of the endoscope into the patient and/or its use
therein.
[0013] U.S. Pat. Nos. 5,191,885 to Bilof et al. and 5,069,215 to
Jadvar et al., the disclosures of which are incorporated herein by
reference, describe a single use disposable esophageal electrode
structure in the form of a sheet to be wrapped around an esophageal
probe. The sheet is described as having a length dimension of the
order of between 50-200 millimeters and a width dimension of the
order of 40 millimeters.
[0014] PCT publication WO 2004/021867, titled "Endoscopic Accessory
Mounting Adapter", the disclosure of which is incorporated herein
by reference, describes an adapter for releaseably securing tools
to the distal end of an endoscope.
[0015] U.S. patent publication 2003/0036681 to Aviv et al., the
disclosure of which is incorporated herein by reference, describes
an optical transesophageal echocardiography probe which has an
optical fiber running along its circumference.
SUMMARY OF THE INVENTION
[0016] An aspect of some embodiments of the present invention
relates to a compact electrode carrier for mounting on an endoscope
or other elongate invasive probe, such as a trans-esophageal
ultrasound probe, without covering the distal end of the probe. The
electrode carrier occupies a small portion of the axial extent of
the endoscope or probe. Optionally, the electrode carrier occupies
less than 25% or even less than 15% of the surface area of the
portion of the probe suitable for insertion into the patient. In an
exemplary embodiment of the invention, the electrode carrier has an
area of less than 1500 square millimeters or even less than 800
square millimeters. In some cases, using a compact electrode
carrier is simpler and cheaper than using a large electrode carrier
sheath or sheet which covers most (or a large portion) of the
endoscope. Optionally, the electrode carrier comprises a substrate
(e.g., an isolating material) with one or more electrodes mounted
thereon.
[0017] The electrode is optionally very thin (flat), so as not to
substantially affect the cross-section area of the probe.
Optionally, the attachment of the electrode increases the
cross-section diameter of the probe by less than 2 millimeters, or
even less than one millimeter. In an exemplary embodiment of the
invention, the electrode increases the cross-section diameter of
the probe by less than half a millimeter.
[0018] In some embodiments of the invention, the substrate and/or
electrodes have layouts that are different over the circumference
of the probe, such that, for example, even if the substrate and/or
electrode need to be wide in one or more sectors of the
circumference, they may be narrower or even none existent in other
sectors of the circumference. Thus, the electrode carrier is made
compact by having different substrate and/or electrode layouts
cover different sectors of the circumference of the probe.
Optionally, the entire length of a sector of the circumference of
the probe is not covered by the substrate and/or by any of the one
or more electrodes of the electrode carrier. In some embodiments of
the invention, the sector of the probe not covered by the substrate
and/or any electrodes includes at least a third, a half or even two
thirds of the probe. When the electrode carrier is mounted on an
ultrasound probe, the electrode carrier is optionally mounted onto
the probe oriented such that the electrode or electrodes are
directed in the same direction as an ultrasound sensor of the
probe.
[0019] Optionally, in order to keep the electrode carrier to a
small size, the electrode covers most of the area of the substrate.
In some embodiments of the invention, the electrode covers more
than 70%, 80% or even 90% of the surface area of the substrate.
[0020] In some embodiments of the invention, the substrate has
different widths on different sectors of the circumference of the
probe. Optionally, the substrate is wide in a sector on which the
electrode is placed and is narrow on the remaining sectors of the
circumference where the substrate serves as a strap for holding the
electrode in place.
[0021] In some embodiments of the invention, the electrode carrier
occupies less than 10% or even 5% of the length of the endoscope.
Optionally, in these embodiments, the electrode carrier has an area
of less than 400 or even less than 200 square millimeters. In an
exemplary embodiment of the invention, the electrode carrier has an
area of less than 100 square millimeters.
[0022] Alternatively or additionally, the electrode carrier
occupies less than 30% or even less than 15% of the circumference
of the probe over most, i.e., at least 50% or even 80%, of the
length of the probe, over which the electrode carrier is placed. In
accordance with this alternative, the electrode carrier is
optionally attached to the probe using an adhesive and/or one or
more attachment straps.
[0023] The electrode carrier may include a plurality of electrodes
or, for compactness (e.g., when only a single electrode is
required), may include only a single electrode.
[0024] In some embodiments of the invention, the electrode carrier
includes a substrate which surrounds the entire circumference of
the probe. Alternatively, the electrode carrier covers only a
portion of the circumference of the probe. In some embodiments of
the invention, the electrode carrier includes an adhesive which is
used to connect the electrode carrier to the probe or endoscope.
Optionally, the electrode carrier is removably attached to the
endoscope or probe, so that it is easily removed after completion
of a medical procedure in which the one or more electrodes on the
electrode carrier are used. The adhesive is optionally a temporary
adhesive which allows complete removal of the electrode, without
damaging the probe and/or without leaving remnants on the
probe.
[0025] In some embodiments of the invention, the electrode carrier
includes a protective layer, which separates the probe from the
electrode (or electrodes), in order to prevent damage to the probe
from the electrical currents and/or heat in the electrode.
[0026] One or more functional units other than an electrode, such
as an optical fiber or a pH sensor, may be integrated with, or
introduced through, the electrode carrier.
[0027] An aspect of some embodiments of the present invention
relates to a compact electrode carrier with an adhesive substrate
for mounting on an endoscope or other elongate invasive probe.
Using an adhesive for attachment of the electrode carrier to the
probe, instead of mechanical attachment makes the attachment of the
electrode carrier simpler and usable with a large range of
probes.
[0028] An aspect of some embodiments of the present invention
relates to a single-electrode carrier for mounting on an endoscope
or other elongate invasive probe. The use of a single electrode,
rather than a plurality of electrodes, may simplify the electrode
carrier.
[0029] An aspect of some embodiments of the present invention
relates to a compact electrode carrier for mounting on an elongate
invasive probe. One or more flat electrodes are carried by the
compact electrode carrier. The flat electrodes are optionally
thinner than 2.5 millimeters, preferably thinner than 1 millimeter,
over substantially the entire area of contact between the
electrodes and the electrode carrier and/or of the intended contact
area between the electrode and human tissue.
[0030] In some embodiments of the invention, the flat electrode is
a straight electrode included in a single plane. Alternatively, the
flat electrode has any other surface area shape, for example a wavy
shape, optionally in order to conform to the shape of a probe on
which it is mounted.
[0031] There is therefore provided in accordance with an exemplary
embodiment of the invention, a method of adding at least one
electrode to an invasive probe, comprising providing an invasive
probe having a surface area, providing an electrode carrier
including a substrate adapted for attaching to the probe, the
substrate having an area smaller than 25% of the surface area of
the probe and at least one electrode mounted on the substrate; and
attaching the substrate to the probe, such that the layout of the
substrate or of one or more of the at least one electrodes is
substantially different in different sectors of the circumference
of the probe.
[0032] Optionally, the substrate has a width shorter than 3 cm or
even less than 1 cm, measured in an axial dimension of the invasive
probe. Optionally, the substrate has a length measured along a
circumference of the probe, sufficient to surround the
circumference of the probe. Optionally, the substrate includes an
adhesive on a surface opposite a surface of the substrate on which
the electrode is mounted. Optionally, the substrate includes a
protective electrical or heat isolating layer, which is located
between the electrode and the probe.
[0033] Optionally, the protective isolating layer has a thickness
of at least 0.1 mm. Optionally, the substrate is electrically
conductive, serving as a part of the electrode. Optionally, the
substrate is electrically isolative. Optionally, the electrode
carrier includes at least one sensor additional to the electrode.
Optionally, the probe comprises a protective sheath that covers the
probe and wherein attaching the substrate to the probe comprises
attaching the substrate to the protective sheath. Optionally,
attaching the substrate to the probe comprises attaching without
covering a distal 5 mm portion of the probe. Optionally, the at
least one electrode comprises only a single electrode. Optionally,
attaching the substrate to the probe comprises attaching such that
over most of the length of the substrate, the substrate covers less
than 20% of the circumference of the probe. Optionally, the
electrode comprises a flat electrode and attaching the electrode to
the probe comprises attaching along the length of the probe so as
to increase the cross-section diameter of the probe by less than 2
millimeters.
[0034] Optionally, attaching the substrate to the probe comprises
attaching such that the electrode conforms to the shape of the
probe. Optionally, the electrode carrier is flexible. Optionally,
the electrode carrier is more flexible than the invasive probe.
Optionally, the electrode carrier includes a wire electrically
coupled to the electrode and extending to a proximal end of the
probe. Optionally, the method includes fastening the wire to the
probe using a ring at a proximal side of the probe.
[0035] Optionally, the ring includes an electrical connector
connecting the wire to an external electrical wire. Optionally, the
electrode carrier includes a circuit for wirelessly receiving
power. Optionally, providing the invasive probe comprises providing
a probe previously used on one or more patients. Optionally, the
method includes inserting the probe to the patient within an hour
after attaching the substrate to the probe.
[0036] Optionally, attaching the substrate to the probe is
performed within a medical treatment clinic. Optionally, providing
the invasive probe comprises providing a probe whose production was
completed. Optionally, providing the electrode carrier comprises
providing the electrode carrier in a sterilized package.
Optionally, the substrate has an area smaller than 10% of the
surface area of the probe that is suitable for insertion into the
patient. Optionally, attaching the substrate to the probe is
performed such that the entire length of a sector of the
circumference of the probe is not covered by the at least one
electrode. Optionally, attaching the substrate to the probe is
performed such that the entire length of at least half of the
circumference of the probe is not covered by the at least one
electrode.
[0037] Optionally, attaching the substrate to the probe comprises
attaching such that the electrode is placed on less than 30% the
circumference of the probe. Optionally, attaching the substrate to
the probe is performed such that the entire length of a sector of
the circumference of the probe is not covered by the substrate.
Optionally, attaching the substrate to the probe is performed such
that the substrate covers substantially different widths along the
length of the probe in different sectors of the circumference of
the probe.
[0038] Optionally, the substrate has an area smaller than 15 or
even smaller than 5 square centimeters. Optionally, the at least
one electrode covers more than 50% or even 75% of the substrate.
Optionally, attaching the substrate to the probe comprises wrapping
the substrate around at least a portion of the circumference of the
probe. Optionally, attaching the substrate to the probe comprises
attaching such that the substrate does not extend beyond the distal
end of the probe. Optionally, attaching the substrate to the probe
comprises attaching such that the substrate does not cover the
distal end of the probe.
[0039] There is further provided in accordance with an exemplary
embodiment of the invention, a method of adding an electrode to an
invasive probe, comprising providing an invasive probe having a
surface area, providing an electrode carrier including a substrate
for attaching to the probe, the substrate having an area smaller
than 25% of the surface area of the probe and a single electrode
mounted on the substrate and attaching the substrate to the
probe.
[0040] Optionally, the method includes an adhesive mounted on the
substrate. Optionally, the adhesive is mounted on an opposite side
of the substrate from the electrode. Optionally, the substrate has
a width shorter than 3 cm, measured in an axial dimension of the
invasive probe.
[0041] Optionally, the substrate has a length measured along a
circumference of the probe, sufficient to surround the
circumference of the probe. Optionally, the substrate includes a
protective electrical or heat isolating layer, which is located
between the electrode and the probe. Optionally, the electrode
carrier includes at least one sensor additional to the electrode.
Optionally, the electrode carrier includes a wire electrically
coupled to the electrode and extending to a proximal end of the
probe.
[0042] Optionally, the adhesive is such that pulling the electrode
carrier off the probe removes the adhesive, such that substantially
no adhesive remnants remain on the probe.
[0043] Optionally, the substrate has an area smaller than 1500
square millimeters.
[0044] There is further provided in accordance with an exemplary
embodiment of the invention, a method of adding at least one
electrode to an invasive probe, comprising providing an invasive
probe having a surface area, providing an electrode carrier
including a substrate for attaching to the probe, the substrate
having an area smaller than 20% of the surface area of the probe
and at least one electrode mounted on the substrate and attaching
the substrate to the probe, such that the electrode does not extend
beyond the surface of the probe by more than 2 mm.
[0045] Optionally, the electrode does not extend beyond the surface
of the probe by more than 1 mm. Optionally, attaching the substrate
to the probe comprises attaching without covering a distal 5 mm
portion of the probe. Optionally, the at least one electrode
comprises only a single electrode. Optionally, attaching the
substrate to the probe comprises attaching such that over most of
the length of the substrate, the substrate covers less than 30% of
the circumference of the probe.
[0046] There is further provided in accordance with an exemplary
embodiment of the invention, a method of adding at least one
electrode to an invasive probe, comprising providing an invasive
probe having a surface area, providing an electrode carrier
including a substrate for attaching to the probe, the substrate
having an area smaller than 25% of the surface area of the probe
and at least one electrode mounted on the substrate, covering most
of the surface area of the substrate and attaching the substrate to
the probe.
[0047] Optionally, attaching the substrate to the probe comprises
attaching without covering a distal 5 mm portion of the probe.
[0048] There is further provided in accordance with an exemplary
embodiment of the invention, an electrode carrier kit for
attachment of an electrode to an invasive probe having a given
length and a given diameter, comprising an electrode carrier
including a substrate having a surface area of less than 1500
square millimeters, adapted to be placed on an invasive probe, at
least one electrode mounted on the substrate and an adhesive on the
substrate and a package encompassing the electrode carrier.
[0049] Optionally, the at least one electrode has an area smaller
than 75 square millimeters or even smaller than 40 square
millimeters. Optionally, the substrate is adapted to be placed on
the invasive probe in a specific orientation. Optionally, the
electrode carrier includes a wire electrically coupled to the
electrode and extending over at least 10 centimeters. Optionally,
the wire extends over a sufficient length to connect to a proximal
end of the probe, if the substrate is attached close to a distal
end of the probe.
[0050] Optionally, the substrate has a surface area of less than
500 square millimeters or even less than 200 square millimeters.
Optionally, the substrate has a ring shape and/or is elastic.
[0051] Optionally, the substrate comprises a "C" shape clip,
adapted to be placed on the invasive probe. Optionally, the
substrate has a length with mating fastening units at opposite
ends. Optionally, the mating fastening units comprise wire
ties.
[0052] Optionally, the mating fastening units comprise an adhesive
surface and a surface adapted to attach to the adhesive surface.
Optionally, the substrate is adapted to be placed on the probe with
a width along the length of the probe shorter than the length along
the circumference. Optionally, the substrate is adapted to be
placed on the probe with a width along the length of the probe
shorter than 4 centimeters.
[0053] Optionally, the substrate is adapted to be placed on the
probe in a specific orientation by having a length of at least 30
millimeters.
[0054] Optionally, the substrate is adapted to be placed on the
probe in an orientation in which over most of the length of the
probe the substrate covers less than 20% of the circumference of
the probe.
[0055] Optionally, the substrate is adapted to be placed on the
probe in an orientation in which over most of the length of the
probe the substrate covers less than 0.5 centimeters of the
circumference of the probe. Optionally, the electrode carrier
includes a single electrode. Optionally, the substrate is
conductive and serves as part of the electrode. Optionally, the kit
includes at least one C-clip or even two C-clips for attaching a
wire attached associated with the electrode to the probe.
Optionally, the package comprises a sterile package.
[0056] There is further provided in accordance with an exemplary
embodiment of the invention, an invasive probe assembly, comprising
an invasive probe having a surface area, and a tool carrier
removably mounted on the invasive probe, including a substrate
having an area smaller than 25% of the surface area of the probe
and at least one tool mounted on the substrate, the layout of the
substrate or of one or more of the at least one tool is
substantially different in different sectors of the circumference
of the probe.
[0057] Optionally, the substrate has a width shorter than 3 cm or
even shorter than 1 cm, measured in an axial dimension of the
invasive probe. Optionally, the substrate substantially entirely
surrounds the circumference of the probe. Optionally, the substrate
is attached to the probe by an adhesive. Optionally, the substrate
includes a protective electrical or heat isolating layer, which is
located between the tool and the probe. Optionally, the at least
one tool comprises an electrode. Optionally, the substrate is
electrically conductive, serving as a part of the electrode.
[0058] Optionally, the at least one tool comprises only a single
electrode. Optionally, the substrate is electrically isolative.
Optionally, the at least one tool comprises at least one sensor and
at least one electrode. Optionally, the assembly includes a
protective sheath that covers the probe and wherein the substrate
is mounted on the protective sheath. Optionally, the substrate does
not cover a distal 5 mm portion of the probe.
[0059] Optionally, over most of the length of the substrate, the
substrate covers less than 20% of the circumference of the probe.
Optionally, the tool comprises a flat electrode and wherein
attaching the electrode to the probe increases the cross-section
diameter of the probe by less than 2 millimeters. Optionally, the
tool comprises an electrode which conforms to the shape of the
probe. Optionally, the tool carrier is flexible. Optionally, the
tool carrier is more flexible than the invasive probe. Optionally,
the tool carrier includes a wire electrically coupled to the tool
and extending to a proximal end of the probe. In some embodiments
of the invention, the tool comprises a camera. Optionally, the wire
is fastened to the probe using a ring at a proximal side of the
probe.
[0060] Optionally, the ring includes an electrical connector
connecting the wire to an external electrical wire. Optionally, the
tool carrier includes a circuit for wirelessly receiving power.
[0061] Optionally, the probe is adapted for use in a plurality of
patients. Optionally, the substrate has an area smaller than 10% of
the surface area of the probe that is suitable for insertion into
the patient. Optionally, the entire length of a sector of the
circumference of the probe is not covered by the at least one tool.
Optionally, the entire length of at least half of the circumference
of the probe is not covered by the at least one tool. Optionally,
the tool covers less than 30% the circumference of the probe.
Optionally, the entire length of a sector of the circumference of
the probe is not covered by the substrate. Optionally, the
substrate covers substantially different widths along the length of
the probe in different sectors of the circumference of the probe.
Optionally, the substrate has an area smaller than 15 square
centimeters or even less than 5 square centimeters. Optionally, the
at least one tool covers more than 50% or even 75% of the
substrate. Optionally, the substrate does not extend beyond the
distal end of the probe and/or does not cover the distal end of the
probe.
BRIEF DESCRIPTION OF THE DRAWINGS
[0062] Exemplary non-limiting embodiments of the invention will be
described with reference to the following description of the
embodiments, in conjunction with the figures. Identical structures,
elements or parts which appear in more than one figure are
preferably labeled with the same or similar number in all the
figures in which they appear, and in which:
[0063] FIG. 1 is a schematic side view of an ultrasound probe with
an electrode carrier band mounted thereon, in accordance with an
exemplary embodiment of the present invention;
[0064] FIG. 2 is a schematic illustration of an electrode carrier
band, in accordance with an exemplary embodiment of the
invention;
[0065] FIG. 3 is a flowchart of acts performed by a physician in
employing an electrode carrier, in accordance with an exemplary
embodiment of the invention;
[0066] FIG. 4 is a schematic illustration of a probe with a
proximal wire port, in accordance with an exemplary embodiment of
the invention;
[0067] FIG. 5 is a schematic illustration of a combined electrode
and optical fiber attachment, in accordance with an exemplary
embodiment of the invention;
[0068] FIG. 6 is a schematic illustration of an electrode add-on
strip on a probe, in accordance with an exemplary embodiment of the
invention;
[0069] FIG. 7 is a schematic illustration of a wireless ablation
electrode carrier, for attachment to invasive probes, in accordance
with an exemplary embodiment of the invention; and
[0070] FIG. 8 is a schematic illustration of a wireless ablation
electrode carrier, for attachment to invasive probes, in accordance
with another exemplary embodiment of the invention.
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0071] FIG. 1 is a schematic side view of an ultrasound probe 100
with an electrode carrier band 130 mounted thereon, in accordance
with an exemplary embodiment of the present invention. Probe 100
includes an echocardiography sensor 107 and an elongate insertion
tube 105. Probe 100 is optionally used for transesophageal
echocardiography. By adding electrode carrier band 130 with an
electrode 132 thereon to probe 100, probe 100 can be used for
transesophageal cardioversion or cardiac pacing during a same
procedure as the echocardiography.
[0072] FIG. 2 is a schematic illustration of electrode carrier band
130, in accordance with an exemplary embodiment of the invention.
Carrier band 130 includes an electrode 132 and a wire 134 (or a
group of wires), which electrically connects the electrode to a
power generator, sensor, controller or other apparatus, at a
proximal end of probe 100. Electrode 132 is optionally mounted on a
substrate 136, which serves to attach the electrode to probe 100.
In some embodiments of the invention, substrate 136 is covered with
an adhesive on a surface opposite electrode 132, which surface is
attached to probe 100. Optionally, substrate 136 is provided with a
peel off sheet (not shown), which covers the adhesive before
attaching substrate 136 to probe 100. Before using probe 100, the
peel off sheet is removed and substrate 136 is attached to probe
100.
[0073] In some embodiments of the invention, substrate 136 is
removably attached to probe 100. The adhesive optionally has
sufficient strength required to prevent substrate 136 from
inadvertently falling off of probe 100, while passing through body
lumens. On the other hand, the adhesive is optionally not too
strong, allowing purposeful removal of substrate 136 from probe 100
by a physician, without requiring large forces and/or extensive
cleaning of the probe after removal of the electrode.
[0074] In some embodiments of the invention, substrate 136
comprises one or more protective layers, which protect probe 100
and the equipment within it, from the electrical energy passed
through electrode 132. The protective layers optionally include an
electrically isolative material, such as silicone,
polyvinylchloride, polyurethane or any other suitable isolative
material. The protective layer optionally has a thickness of at
least 0.1 mm or even 0.25 mm, in order to provide sufficient
isolation. In some embodiments of the invention, the protective
layer is thinner than 0.3 mm or even thinner than 0.15 mm, in order
to limit the enlargement of the cross-section of the probe, when
substrate 136 is attached to the probe. Alternatively, a substrate
136 is not included in carrier band 130 and electrode 132 is
directly mounted on probe 100 (i.e., a portion of electrode 132
serves as the substrate).
[0075] The substrate together with the electrode are optionally
sufficiently flexible to take the form of the probe surface on
which they are mounted. In some embodiments of the invention, the
substrate together with the electrode is more flexible than the
probe 100, at least the area of the probe on which substrate 136 is
mounted.
[0076] Electrode 132 optionally comprises a bio-compatible metal,
such as titanium, silver, stainless steel or gold. Alternatively,
the electrode comprises an alloy of metals, optionally including
one or more of the above materials. In some embodiments of the
invention, electrode 132 includes a highly conductive outer film.
The conductive film is optionally used to cover a material base
with a lower electrical conductance.
[0077] In some embodiments of the invention, electrode 132 is used
for sensing electrical signals from the patient. Alternatively or
additionally, electrode 132 is used for stimulating tissue. Further
alternatively or additionally, electrode 132 is used for any other
task requiring an electrode, for example serving as a ground
electrode. Electrode 132 may be used for substantially any type of
ablation known in the art, including heat ablation, current
ablation and RF ablation.
Size
[0078] Substrate 136 optionally has a width (w) of between about
5-20 mm, e.g., 10-13 mm, for placing along the length of probe 100.
Thus, less than 10% or even 5% of the length of probe 100 is
covered by electrode carrier band 130. In some embodiments of the
invention, less than 1% of probe 100 is covered by electrode
carrier band 130.
[0079] In some embodiments of the invention, the length (l) of
substrate 136 is sufficient to surround the entire circumference of
probe 100. For example, for a probe of a diameter of 2.5
centimeters, substrate 136 optionally has a length (l) of between
about 7.8-8.5 centimeters. At its ends, substrate 136 optionally
has mating fastening elements and/or an adhesive strip, as
described below. In some embodiments of the invention, substrate
136 is elastic so that it can be stretched along its length (l),
for example if necessary to surround probe 100.
[0080] Alternatively to substrate 136 being larger than electrode
132, substrate 136 is substantially the size of a required
electrode, in order to limit the addition to the circumference size
of probe 100 from mounting electrode 132 on the probe. As shown,
electrode 132 is much smaller than substrate 136. In other
embodiments of the invention, electrode 132 covers most (optionally
more than 75%), or even substantially all, of substrate 136. In an
exemplary embodiment of the invention, electrode 132 has a largest
dimension smaller than 1.5 centimeters or even smaller than 1
centimeter. Optionally, electrode 132 has an area smaller than 80
square millimeters, 60 square millimeters or even smaller than 40
square millimeters.
[0081] Further alternatively, electrode 132 is larger than
substrate 136, such that while some areas of electrode 132 are
separated from probe 100 by substrate 136, while other areas of
electrode 132 are in direct contact with the probe and/or areas of
electrode 132 are above areas of probe 100, without substrate 136
separating between electrode 132 and the probe.
[0082] Electrode 132 optionally has a thickness as measured from
its contact points with substrate 136, of less than 1 millimeter or
even less than 0.5 millimeters. In an exemplary embodiment of the
invention, the thickness of electrode 132 is less than 0.25
millimeters.
[0083] In some embodiments of the invention, substrate 136 and
electrode 132 together are very thin, such that the transition from
an area of the probe without substrate 136 to an area of the probe
with substrate 136 is smooth. Optionally, the edges of substrate
136 are tapered so that there is virtually no step between the
substrate and its surroundings. Alternatively, substrate 136 and
electrode 132 are together relatively thick, such that a finger
passed over the probe will feel the transition to the area
including substrate 136.
Other Attachment Methods
[0084] Alternatively or additionally to an adhesive on the surface
of substrate 136 opposite electrode 132, substrate 136 has an
adhesive strip 138 at its end 142. When substrate 136 is wrapped
around probe 100, adhesive strip 138 attaches to an opposite end
140 of the substrate, thus forming a ring around probe 100. This
may be advantageous to avoid applying adhesive directly to the
probe, which could pose cleaning problems.
[0085] In some embodiments of the invention, the surface opposite
electrode 132, which is attached to probe 100, uses friction to
prevent slipping of electrode carrier band 130 along the probe or
from totally falling off. In some embodiments of the invention,
carrier band 130 is stretched on probe 100 in a manner which
enhances the friction. Carrier band 130 is optionally elastic in a
manner which allows the stretching. In some embodiments of the
invention, substrate 136 is connected to electrode 132 at a limited
number of points in a manner which allows stretching of the
substrate without applying strong forces to the electrode.
Alternatively or additionally, the surface opposite electrode 132
is roughened to enhance the friction.
[0086] In other embodiments of the invention, ends 140 and 142 of
substrate 136 include matching mechanical connectors. Optionally,
the connectors allow fastening around probes of different
circumference sizes. In some embodiments of the invention, the
mechanical connectors include wire ties, although any other
mechanical connectors may be used.
[0087] Alternatively, the connectors are set for a predetermined
probe circumference size. For example, the connectors may include
one or more snaps.
[0088] Further alternatively or additionally, substrate 136
comprises a "C-shaped" clip that snaps on to the circumference of
probe 100. Alternatively or additionally, one or more rings formed
of a heat shrinking material are used. The rings or first loaded
onto the probe 100 and are then heated to shrink and firmly hold
electrode carrier 130 in place. In other embodiments of the
invention, substrate 136 comprises a complete ring that is slid on
to probe 100. In these embodiments, substrate 136 optionally
comprises an elastic band, which is stretched by a physician in
order to slide it onto probe 100. When the band is at a desired
position along the length of probe 100, the band is released by the
physician so that it snugly contracts onto probe 100. Optionally,
the band is slid onto probe 100 from the distal end of the probe,
down to a desired position distanced from the distal end of the
probe. Alternatively, for example with probes redesigned to have
small handles or with probes having detachable handles, the band is
slid onto probe 100 from its proximal end.
Placement
[0089] Electrode 132 may optionally be mounted at substantially any
required location along probe 100. In some embodiments of the
invention, electrode 132 is distanced from echocardiography sensor
107 (FIG. 1) by at least 4-6 mm, in order to prevent interference
to sensor 107 from electrode 132. Substrate 136 optionally does not
extend beyond the distal end of the probe and/or does not cover the
distal end of the probe, in order not to interfere with the
insertion of the probe into the patient and/or so that the
electrode is not harmed, due to its insertion without firm backing
of the probe.
[0090] In some embodiments of the invention, electrode 132 may be
mounted on a sheath that covers probe 100, after the sheath already
covers the probe. For example, probe 100 may be covered by a
protective sheath that isolates the probe from body fluids and
prevents contamination of the probe. The attachment means used to
connect electrode 132 to probe 100 are optionally suitable for
connecting to the sheath and/or for connecting to the probe while
the sheath covers the probe. For example, when adhesive strip 138
is used, the adhesive is optionally suitable for bonding to the
sheath materials. It is noted that when electrode 132 is mounted on
a disposable sheath, there is no need to clean adhesive remnants
off the sheath, after removal of the electrode. Optionally, the
protective layers of substrate 136, if used, are devised according
to the material of the sheath with which electrode 132 is planned
to be used.
[0091] In some embodiments of the invention, a sheath is preplanned
for use with electrode carrier band 130. Optionally, the sheath has
a marking indicating a location at which the electrode 132 is to be
mounted. Alternatively or additionally, the sheath has a slot
adapted to receive substrate 136. The slot is optionally formed by
two folds in the sheath that are spaced from each other by the
width of substrate 136. In other embodiments of the invention, the
sheath includes two pockets that receive the ends 140 and 142 of
the substrate. Alternatively or additionally, the sheath is adapted
for receiving wire 134, for example in accordance with any of the
wire placements described below.
[0092] Producing a sheath that is only adapted for receiving an
electrode, rather than including the electrode, is useful in cases
when the sheath is meant for use both with and without an
electrode. A sheath prepared for mounting an electrode is generally
cheaper and/or better fit for use than a sheath that has an
electrode, which electrode may not be used in many medical
procedures.
[0093] Preparation of Probe for Use
[0094] FIG. 3 is a flowchart of acts performed by a physician in
employing electrode 132, in accordance with an exemplary embodiment
of the invention. Optionally, electrode 132 is provided in a kit or
assembly having the electrode in a package, optionally a sterile
package. The physician optionally removes (302) the electrode from
its package. The electrode is optionally placed (304) on the probe
in a desired position and orientation, as discussed above with
relation to FIG. 2. The electrode is attached (306) to the probe
using any of the attachment methods described above and/or any
other suitable attachment method. For example, the physician may
remove a peel off sheet from substrate 136 and connect an adhesive
on the substrate to the probe.
[0095] Wire 134 is then optionally fixed (308) along the probe, so
that it does not interfere with the insertion of the probe into the
patient. In some embodiments of the invention, a proximal collar is
mounted (310) on a proximal end of probe 100, so as to hold wire
134 in place. An exemplary embodiment of a collar is described
below with reference to FIG. 4. The proximal end of wire 134 is
connected (312) to a generator or other control apparatus.
Wire Placement
[0096] Referring in more detail to fixing (308) wire 134 along the
probe, in some embodiments of the invention, the wire is wrapped
around the probe in a helical manner, as shown in FIG. 1.
Optionally, wire 134 is wrapped around the probe at most 5 rounds,
so as not to require a long wire segment for the wrapping.
Alternatively, wire 134 is wrapped around the probe more than 5, 10
or even 20 rounds, so as to keep the wire in place. Wire 134
optionally has a length corresponding to a recommended number of
wire wrapping turns around the length of the probe. In some
embodiments of the invention, the wire has a length of at least 5,
10 or even 20 centimeters, beyond the length of the probe.
Optionally, the wire has a length of at least 120 centimeters.
[0097] In some embodiments of the invention, after mounting
electrode carrier band 130 on probe 100, the probe is covered by a
sheath. The sheath optionally has a window above electrode 132
and/or extends from the proximal end of probe 100 only up to (not
including) the location of electrode carrier band 130. The sheath
optionally serves to hold wire 134 in place. Alternatively or
additionally, bands, C-shaped clips and/or hooks may be used to
keep wire 134 adjacent to probe 100.
[0098] FIG. 4 is a schematic illustration of probe 100 with a
proximal wire port 160, in accordance with an exemplary embodiment
of the invention. Port 160 is optionally mounted on probe 100 close
to the proximal end of the probe, for example, within the proximal
10% or even the proximal 5% of the probe. Port 160 includes a
collar 162 with a locking ring 164 which is used to fasten collar
162 to the probe. A socket 166, electrically coupled to wire 134,
is mounted on collar 162. The socket is adapted to receive a
corresponding plug 170 of an electrical cable that leads, for
example, to a power generator.
[0099] Port 160 optionally provides a stronger attachment than the
connection of wire 134 to probe 100. The strong connection prevents
inadvertent pulling of the wires out of place.
[0100] Locking ring 164 optionally includes a latch, so that collar
162 can be used with substantially any probe size. Alternatively or
additionally, any other attachment mechanism may be used, for
example any of those described above with relation to electrode
substrate 136.
[0101] In some embodiments of the invention, electrode carrier band
130 includes at least one additional functional sensor or tool,
which adds to the functionality of probe 100. Such an additional
sensor may include, for example, one or more of an acidity (pH)
sensor, a position sensor, an active beacon, illumination LEDs
and/or an optical fiber. In some embodiments of the invention,
carrier band 130 includes a miniature camera (e.g., CCD, CMOS),
which is used to acquire images within body cavities. Carrier band
130 optionally includes a thin lens (e.g., having a 1 millimeter
thickness), which covers the miniature camera and focuses light
onto the camera.
[0102] Additional wires parallel to wire 134 of electrode 132 may
be used for sensors or tools requiring access wires. The additional
wires may be packaged together with wire 134, for example the wires
may be woven together or they may be bundled in a single unit.
Alternatively, the wires may be packaged separately.
[0103] FIG. 5 is a schematic illustration of a combined electrode
and optical fiber attachment 200, in accordance with an exemplary
embodiment of the invention. Attachment 200 is similar to electrode
carrier band 130 but additionally includes an optical fiber 202 (or
bundle of fibers), which is used to illuminate and/or view the
vicinity in front of a probe on which attachment 200 is mounted,
while the probe is inserted into a patient. The distal end 204 of
optical fiber 202 optionally extends a predetermined distance
beyond substrate 136, such that when the distal end 204 of fiber
202 is suitably positioned for viewing, electrode 132 is at an
optimal position for ablation and/or for any other task for which
it is utilized. Alternatively, fiber 202 is movable axially
relative to substrate 136, so as to accommodate different probes
100. In some embodiments of the invention, fiber 202 is only
allowed to move along a limited extent for which adjustment is
expected to be required, for example of less than 12 mm or even
less than 8 mm. Optionally, fiber 202 has two notches 206,
separated by the maximal movement extent allowed, which limit axial
movement of the fiber. Alternatively, any other method of limiting
the movement extent is used. In some embodiments of the invention,
fiber 202 is allowed to move only in a single direction relative to
substrate 136, for example, fiber 202 may only be allowed to
retract. Fiber 202 and/or substrate 132 optionally include markings
that are to be aligned for specific types of probes, thus aiding
the physician in setting the relative orientation of the fiber and
substrate. The markings may be visible markings and/or indents
which can be felt by the user.
[0104] As shown, fiber 202 is distanced from wire 134. This
embodiment may be used, for example, when it is desired to wrap
wire 134 around the probe, while laying fiber 202 substantially
straight on the probe or when it is otherwise desired that fiber
202 and wire 134 run along separate paths. In other embodiments of
the invention, wire 134 runs along fiber 202, making attachment 200
more compact.
[0105] FIG. 6 is a schematic illustration of an electrode add-on
strip 350 on a probe 100, in accordance with an exemplary
embodiment of the invention. Unlike the above described
embodiments, strip 350 may extend over a large percentage of the
length of probe 100. Strip 350, however, only covers a small
percentage, for example less than 20% or even less than 10%, of the
circumference of probe 100. Strip 350 is optionally attached to
probe 100 (or to a sheath covering the probe) using an adhesive.
The adhesive may be spread substantially over the entire length
and/or area of strip 350 or may be concentrated at several (e.g.,
3-10) points along the length of the substrate. Alternatively or
additionally, strip 350 includes one or more lateral bands 352 that
fit around probe 100 and hold strip 350 against the probe. As
shown, strip 350 includes three electrodes 354. It is noted,
however, that strip 350 can include more electrodes or fewer
electrodes. In an exemplary embodiment of the invention, strip 350
mounts only a single electrode 354.
[0106] In some embodiments of the invention, strip 350 is placed on
probe 100 along most of its length, from its proximal end to the
location of the most distal electrode. Optionally, wires connecting
probe 100 to an external unit are mounted on strip 350 and/or are
embedded within strip 350.
[0107] FIG. 7 is a schematic illustration of a wireless ablation
electrode carrier 700, for attachment to invasive probes, in
accordance with an exemplary embodiment of the invention. Electrode
carrier 700 optionally carries a coil for receiving electrical
energy through magnetic coupling. The current received by coil 702
passes through a resistor 704 which converts the electrical current
into heat. The heat is passed to a heat transfer electrode 706 that
contacts tissue and performs the ablation. Alternatively to a
resistor, electrode carrier 700 may include an RF antenna that
generates RF waves for ablation, from the electrical power received
by coil 702. Electrode carrier 700 is optionally relatively thin,
of the order of 0.1-0.7 millimeters. Suitable production methods of
miniature electrical elements for electrode carrier 700 are well
known, for example in the field of smart cards.
[0108] FIG. 8 is a schematic illustration of a wireless ablation
element carrier 750, for attachment to invasive probes, in
accordance with an exemplary embodiment of the invention. Carrier
750 includes a flat surface ablation element 752, which is
sufficiently large and has a suitable resistance to allow inducing
of eddy currents therein. The eddy currents in ablation element 752
optionally heat body tissue for ablation.
[0109] Carriers 700 and 750 may be attached to probe 100 using any
of the methods described above relating to carrier band 130.
[0110] Alternatively or additionally, wireless transfer of power to
an element mounted on the probe may be performed using any other
wireless power transfer method, including, for example, using a
piezo-electric power receiver.
[0111] The present invention is not limited to attachment carriers
carrying electrodes. Rather, attachment carriers for attachment to
invasive probes may carry other tools, such as an ablation unit, a
camera, sensors (e.g., acidity sensor) and/or LEDs.
[0112] It will be appreciated that the above-described apparatus
and methods may be varied in many ways, including, changing the
order of steps of the employing of the electrode, and/or performing
a plurality of steps concurrently. It should also be appreciated
that the above described description of methods and apparatus are
to be interpreted as including apparatus for carrying out the
methods, and methods of using the apparatus.
[0113] The present invention has been described using non-limiting
detailed descriptions of embodiments thereof that are provided by
way of example and are not intended to limit the scope of the
invention. It should be understood that features and/or steps
described with respect to one embodiment may be used with other
embodiments and that not all embodiments of the invention have all
of the features and/or steps shown in a particular figure or
described with respect to one of the embodiments. For example,
carrier band 130 and/or attachment 200 may be used with an invasive
tool with two sheaths. An inner sheath may be used for example to
prevent contamination, while an outer sheath is used to hold wire
134 and/or fiber 202 in place. Variations of embodiments described
will occur to persons of the art. Furthermore, the terms
"comprise," "include," "have" and their conjugates, shall mean,
when used in the claims, "including but not necessarily limited
to."
[0114] It is noted that some of the above described embodiments may
describe the best mode contemplated by the inventors and therefore
may include structure, acts or details of structures and acts that
may not be essential to the invention and which are described as
examples. Structure and acts described herein are replaceable by
equivalents which perform the same function, even if the structure
or acts are different, as known in the art. Therefore, the scope of
the invention is limited only by the elements and limitations as
used in the claims.
* * * * *