U.S. patent application number 14/662975 was filed with the patent office on 2015-10-01 for system and method for predictable deployment of a medical device.
The applicant listed for this patent is Spiration, Inc., d.b.a. Olympus Respiratory America. Invention is credited to David H. Dillard, Hugo Xavier Gonzalez, Brandon J. Shuman.
Application Number | 20150272662 14/662975 |
Document ID | / |
Family ID | 52808187 |
Filed Date | 2015-10-01 |
United States Patent
Application |
20150272662 |
Kind Code |
A1 |
Shuman; Brandon J. ; et
al. |
October 1, 2015 |
SYSTEM AND METHOD FOR PREDICTABLE DEPLOYMENT OF A MEDICAL
DEVICE
Abstract
A medical device system for the delivery of energy to a region
of a patient's anatomy is provided. An introducer tube defines a
lumen therein and bears a first electrode. A second electrode is
movable within the lumen between a retracted position and an
extended position. In the retracted position, the second electrode
is substantially disposed within the lumen. In the extended
position, the second electrode extends at least partially beyond
the distal end of the introducer tube. In one form, the introducer
tube is configured to substantially hold the second electrode
within the lumen in a predetermined orientation in the extended
position, and the introducer tube prevents the second electrode
from substantially rotating within the lumen of the introducer tube
during movement into the extended position. In one form, the
introducer tube is more flexible in a first plane than in a second
plane. A method is also provided.
Inventors: |
Shuman; Brandon J.;
(Kirkland, WA) ; Gonzalez; Hugo Xavier;
(Woodinville, WA) ; Dillard; David H.; (Grapeview,
WA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Spiration, Inc., d.b.a. Olympus Respiratory America |
Redmond |
WA |
US |
|
|
Family ID: |
52808187 |
Appl. No.: |
14/662975 |
Filed: |
March 19, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61972090 |
Mar 28, 2014 |
|
|
|
Current U.S.
Class: |
606/41 |
Current CPC
Class: |
A61B 2017/00809
20130101; A61B 2018/1435 20130101; A61B 1/2676 20130101; A61B
18/1477 20130101; A61B 18/14 20130101; A61B 2018/00982 20130101;
A61B 2018/1405 20130101; A61B 18/1492 20130101; A61B 2018/00577
20130101; A61B 2018/1475 20130101; A61B 2018/00541 20130101 |
International
Class: |
A61B 18/14 20060101
A61B018/14 |
Claims
1. A medical device system for the delivery of energy to a region
of a patient's anatomy, the medical device system comprising: an
introducer tube defining a lumen therein, the introducer tube being
configured to be inserted into the patient's anatomy, the
introducer tube being a first electrode; and a second electrode
being movable within the lumen of the introducer tube between a
retracted position and an extended position, wherein in the
retracted position, the second electrode is substantially disposed
within the lumen, and wherein in the extended position, the second
electrode extends at least partially beyond the distal end of the
introducer tube, the first and second electrodes being configured
to deliver an energy to a tissue, the introducer tube being
configured to substantially hold the second electrode within the
lumen in a predetermined orientation in the extended position, the
introducer tube preventing the second electrode from substantially
rotating within the lumen of the introducer tube during movement
into the extended position.
2. The medical device system of claim 1, the second electrode being
a coil having a collapsed straightened configuration in the
retracted position and an expanded helix configuration in the
extended position.
3. The medical device system of claim 2, the coil having a
substantially flat cross-sectional shape.
4. The medical device system of claim 3, the first electrode
comprising a piercing tip disposed at the distal end of the first
electrode, the piercing tip being configured to pierce through a
tissue.
5. The medical device system of claim 4, the coil being a first
coil, the retracted position being a first retracted position, and
the extended position being a first extended position, the medical
device system further comprising a second coil disposed within the
lumen of the introducer tube in a second retracted position, the
second coil being movable within the introducer tube between the
second retracted position and a second extended position, wherein
in the second extended position, the second coil extends at least
partially beyond the distal end of the introducer tube, the second
coil having a collapsed straightened configuration in the second
retracted position and a helix expanded configuration in the second
extended position.
6. The medical device system of claim 4, further comprising a
bronchoscope having a curved section disposed at a bronchoscope
distal end, the bronchoscope defining a bronchoscope lumen therein,
the introducer tube being at least partially disposed in the
bronchoscope lumen and axially movable therein, the first electrode
being more flexible in a first plane than in a second plane, the
second plane being perpendicular to the first plane, wherein a
bending orientation of the first electrode aligns with a bend in
the curved section of the bronchoscope.
7. The medical device system of claim 4, the coil having an outer
perimeter, a height, and a width in the collapsed straightened
configuration, the height and the width being non-equal, the first
electrode having a form-fitting inner perimeter defining the lumen,
the form-fitting inner perimeter corresponding to the outer
perimeter of the coil.
8. The medical device system of claim 7, wherein the first
electrode has a hollow, rectangular cross-section with first,
second, third, and fourth sides, the first and third sides being
longer than the second and fourth sides, the coil being prevented
from substantially rotating within the lumen by at least one of the
first, second, third, and fourth sides.
9. The medical device system of claim 2, wherein the first
electrode has a hollow, ovular cross-section.
10. The medical device system of claim 7, the first electrode
having an outer sheath and an inner sheath disposed in the outer
sheath, the outer sheath having a round, circular cross-section,
the inner sheath defining the lumen.
11. A medical device system for the delivery of energy to a region
of a patient's anatomy, the medical device system comprising: an
introducer tube defining an introducer tube lumen therein, the
introducer tube being configured to be inserted into the patient's
anatomy, the introducer tube being a first electrode; a second
electrode being movable within the introducer tube lumen between a
retracted position and an extended position, wherein in the
retracted position, the second electrode is substantially disposed
within the introducer tube lumen, and wherein in the extended
position, the second electrode extends at least partially beyond
the distal end of the introducer tube, the first and second
electrodes being configured to deliver an energy to a tissue, the
introducer tube being more flexible in a first plane than in a
second plane, wherein the first plane is perpendicular to the
second plane.
12. The medical device system of claim 11, wherein the second
electrode is more flexible in the first plane than in the second
plane.
13. The medical device system of claim 12, the first electrode
having an outer side having an open channel defined therein, the
open channel extending at least partially along a length of the
introducer tube.
14. The medical device system of claim 13, the second electrode
being a coil having a collapsed straightened configuration in the
retracted position and an expanded helix configuration in the
extended position, the coil having a substantially flat
cross-sectional shape, the first electrode comprising a piercing
tip disposed at the distal end of the introducer tube, the piercing
tip being configured to pierce through a tissue, the medical device
system further comprising an endoscope having a curved section
disposed at an endoscope distal end, the endoscope defining an
endoscope lumen therein, the introducer tube being at least
partially disposed in the endoscope lumen and axially movable
therein.
15. The medical device system of claim 14, the introducer tube
being configured to substantially hold the second electrode within
the introducer tube lumen in a predetermined orientation in the
extended position, the introducer tube preventing the second
electrode from substantially rotating within the introducer tube
lumen during movement into the extended position.
16. A method of delivering energy to a patient's anatomy, the
method comprising: piercing a hollow needle into a tissue in the
patient's anatomy, the hollow needle being a first electrode, the
hollow needle defining a needle lumen therein having an opening at
a distal end; extending a second electrode from the distal end of
the hollow needle a first time; activating the first electrode and
a second electrode to deliver a first energy to the tissue through
the first electrode and the second electrode; retracting the second
electrode into the needle lumen; rotating the hollow needle by a
predetermined number of degrees about a central axis of the distal
end of the hollow needle, thus causing the second electrode within
the needle lumen to also rotate by substantially the same
predetermined number of degrees about the central axis; extending
the second electrode from the distal end of the hollow needle a
second time; and activating the first and second electrodes to
deliver a second energy to the tissue through the first and second
electrodes.
17. The method of claim 16, further comprising substantially
preventing the second electrode from rotating with respect to the
hollow needle when the second electrode is retracted within or
extended from the needle lumen.
18. The method of claim 17, further comprising inserting the hollow
needle through an endoscope, the step of rotating the hollow needle
by a predetermined number of degrees about a central axis of the
distal end of the hollow needle including rotating the endoscope by
the predetermined number of degrees about the central axis, thus
causing the hollow needle to also rotate by substantially the same
predetermined number of degrees about the central axis.
Description
RELATED APPLICATION
[0001] This application claims the benefit of U.S. Provisional
Patent Application No. 61/972,090, filed on Mar. 28, 2014, the
entire contents of which are incorporated herein by reference.
FIELD
[0002] The present disclosure relates to medical device systems and
methods, and more particularly, to medical device systems, methods,
and devices for predictable deployment into a patient's
anatomy.
BACKGROUND
[0003] The statements in this section merely provide background
information related to the present disclosure and may or may not
constitute prior art.
[0004] Lung nodules, lesions, tumors, and other cancerous or
pre-cancerous regions of tissue in the lung may be difficult to
treat with invasive surgical techniques, with attendant
complications such as excessive bleeding, infection risk, air
leaks, pneumothorax, and other such issues. In particular, regions
deep in the lung may be difficult to access using conventional
methods, further increasing the difficulty of treatment.
[0005] Electrical ablation, in particular radiofrequency electrical
ablation, has been used in the treatment of tumors and other masses
present in solid tissues such as the liver. Use of such techniques,
however, entails some attendant complications and difficulties.
First, the use of conventional electrical ablation probes in the
lungs, requires piercing into the thoracic cavity and into the
lung, with a consequent high likelihood of pneumothorax, excessive
bleeding and other complications. Moreover, these transthoracic
ablation probes are rigid and may not be able to reach certain
areas around the pulmonary artery.
[0006] While there have been some attempts to pursue radiofrequency
electrical ablation via bronchoscopes inserted into airways, these
attempts are limited by the confines of the airway passage and the
reach of the bronchoscope and accordingly may not be able to
position the probes and/or deliver sufficient energy to treat
tissue such as lung nodules adequately.
[0007] In addition, visualization and localization of the tissue
region to be treated may present challenges, especially for tissue
regions deep in the lung. Likewise, such visualization within the
body may present challenges for procedures in tissue in other areas
of the body outside of the lung region. Ultrasound techniques do
not always provide for sufficient viewing of the medical devices
used. As a result, in ablation procedures, surgeons may be unsure
of whether an ablation device has been properly placed and whether
adequate ablation has occurred.
SUMMARY
[0008] The present disclosure provides systems, methods, and
devices for the predictable deployment of medical devices into a
patient's anatomy. Predictable deployment may allow for optimal
positioning for treatment. The medical device, along with an
introducer needle, may have features that cause the medical device
to deploy in a predictable direction from the introducer needle. In
some versions, the introducer needle may have features that cause
the introducer needle to orient in a predictable direction from a
surrounding endoscope, such as a bronchoscope.
[0009] Accordingly, pursuant to one aspect of the invention, there
is contemplated a medical device system for the delivery of energy
to a region of a patient's anatomy. The medical device system
includes an introducer tube defining a lumen therein. The
introducer tube is configured to be inserted into the patient's
anatomy. The introducer tube bears a first electrode. A second
electrode is movable within the lumen of the introducer tube
between a retracted position and an extended position. In the
retracted position, the second electrode is substantially disposed
within the lumen. In the extended position, the second electrode
extends at least partially beyond the distal end of the introducer
tube. The first and second electrodes are configured to deliver an
energy to a tissue. The introducer tube is configured to
substantially hold the second electrode within the lumen in a
predetermined orientation in the extended position. The introducer
tube prevents the second electrode from substantially rotating
within the lumen of the introducer tube during movement into the
extended position.
[0010] Accordingly, pursuant to another aspect of the invention,
there is contemplated a medical device system for the delivery of
energy to a region of a patient's anatomy. The medical device
system includes an introducer tube defining an introducer tube
lumen therein. The introducer tube is configured to be inserted
into the patient's anatomy, and the introducer tube bears a first
electrode. A second electrode is movable within the introducer tube
lumen between a retracted position and an extended position. In the
retracted position, the second electrode is substantially disposed
within the introducer tube lumen. In the extended position, the
second electrode extends at least partially beyond the distal end
of the introducer tube. The first and second electrodes are
configured to deliver an energy to a tissue. The introducer tube is
more flexible in a first plane than in a second plane, wherein the
first plane is perpendicular to the second plane.
[0011] Accordingly, pursuant to yet another aspect of the
invention, there is contemplated a method of delivering energy to a
patient's anatomy. The method includes piercing a hollow needle
into a tissue in the patient's anatomy, wherein the hollow needle
is a first electrode and the hollow needle defines a needle lumen
therein having an opening at a distal end. The method also includes
extending a second electrode from the distal end of the hollow
needle a first time. The method further includes activating the
first and second electrodes to deliver a first energy to the tissue
through the first electrode and the second electrode. Additionally,
the method includes retracting the second electrode into the needle
lumen. Further, the method includes rotating the hollow needle by a
predetermined number of degrees about a central axis of the distal
end of the hollow needle, thus causing the second electrode within
the needle lumen to also rotate by substantially the same
predetermined number of degrees about the central axis. The method
also includes extending the second electrode from the distal end of
the hollow needle a second time. In addition, the method includes
activating the first and second electrodes to deliver a second
energy to the tissue through the first and second electrodes.
[0012] The invention may be further characterized by one or any
combination of the features described herein, such as: the second
electrode being a coil having a collapsed straightened
configuration in the retracted position and an expanded helix
configuration in the extended position; the coil having a
substantially flat cross-sectional shape; the first electrode
comprising a piercing tip disposed at the distal end of the first
electrode; the piercing tip being configured to pierce through a
tissue; the coil being a first coil, the retracted position being a
first retracted position, and the extended position being a first
extended position, the medical device system further comprising a
second coil disposed within the lumen of the introducer tube in a
second retracted position; the second coil being movable within the
introducer tube between the second retracted position and a second
extended position, wherein in the second extended position, the
second coil extends at least partially beyond the distal end of the
introducer tube; the second coil having a collapsed straightened
configuration in the second retracted position and a helix expanded
configuration in the second extended position; further comprising a
bronchoscope having a curved section disposed at a bronchoscope
distal end; the bronchoscope defining a bronchoscope lumen therein;
the introducer tube being at least partially disposed in the
bronchoscope lumen and axially movable therein; the first electrode
being more flexible in a first plane than in a second plane; the
second plane being perpendicular to the first plane; wherein a
bending orientation of the first electrode aligns with a bend in
the curved section of the bronchoscope; the coil having an outer
perimeter, a height, and a width in the collapsed straightened
configuration; the height and the width being non-equal; the first
electrode having a form-fitting inner perimeter defining the lumen;
the form-fitting inner perimeter corresponding to the outer
perimeter of the coil; the first electrode having a hollow,
rectangular cross-section with first, second, third, and fourth
sides; the first and third sides being longer than the second and
fourth sides; the coil being prevented from substantially rotating
within the lumen by at least one of the first, second, third, and
fourth sides; the first electrode having a hollow, ovular
cross-section; the first electrode having an outer sheath and an
inner sheath disposed in the outer sheath; the outer sheath having
a round, circular cross-section and the inner sheath defining the
lumen; the second electrode being more flexible in the first plane
than in the second plane; the first electrode having an outer side
having an open channel defined therein; the open channel extending
at least partially along a length of the introducer tube; the
medical device system further comprising an endoscope having a
curved section disposed at an endoscope distal end; the endoscope
defining an endoscope lumen therein; the introducer tube being at
least partially disposed in the endoscope lumen and axially movable
therein; the introducer tube being configured to substantially hold
the second electrode within the introducer tube lumen in a
predetermined orientation in the extended position, the introducer
tube preventing the second electrode from substantially rotating
within the introducer tube lumen during movement into the extended
position; the method further comprising substantially preventing
the second electrode from rotating with respect to the hollow
needle when the second electrode is retracted within or extended
from the needle lumen; and the method further comprising inserting
the hollow needle through an endoscope, the step of rotating the
hollow needle by a predetermined number of degrees about a central
axis of the distal end of the hollow needle including rotating the
endoscope by the predetermined number of degrees about the central
axis, thus causing the hollow needle to also rotate by
substantially the same predetermined number of degrees about the
central axis.
[0013] Further aspects, advantages and areas of applicability will
become apparent from the description provided herein. It should be
understood that the description and specific examples are intended
for purposes of illustration only and are not intended to limit the
scope of the present disclosure.
DRAWINGS
[0014] The drawings described herein are for illustration purposes
only and are not intended to limit the scope of the present
disclosure in any way.
[0015] FIG. 1A is a side perspective view of a medical device
system including an electrode movably disposed in a retracted
position, in accordance with the principles of the present
disclosure;
[0016] FIG. 1B is a side perspective view of the medical device
system of FIG. 1A, the electrode being disposed in an extended
position, in accordance with the principles of the present
disclosure;
[0017] FIG. 1C is a cross-sectional view of the medical device
system of FIGS. 1A-1B, taken along the line 1C-1C in FIG. 1B, in
accordance with the principles of the present disclosure;
[0018] FIG. 2 is a perspective view of another medical device
system, in accordance with the principles of the present
disclosure;
[0019] FIG. 3 is a perspective view of an introducer tube, in
accordance with the principles of the present disclosure;
[0020] FIG. 4 is a perspective view of yet another medical device
system, in accordance with the principles of the present
disclosure;
[0021] FIG. 5 is a perspective view of still another medical device
system, in accordance with the principles of the present
disclosure;
[0022] FIG. 6 is a perspective view of yet another introducer tube,
in accordance with the principles of the present disclosure;
[0023] FIG. 7 is a side view of still another medical device
system, the medical device system being deployed in an airway
through a bronchoscope, in accordance with the principles of the
present disclosure;
[0024] FIG. 8 is a block diagram illustrating a method of
delivering energy to a patient's anatomy, in accordance with the
principles of the present disclosure;
[0025] FIG. 9A is a perspective view of the medical device system
of FIG. 2 performing a variation of the method of FIG. 8 in a first
deployment position, in accordance with the principles of the
present disclosure;
[0026] FIG. 9B is a perspective view of the medical device system
of FIGS. 2 and 9A performing the variation of the method of FIG. 8
started in FIG. 9A in a second deployment position, in accordance
with the principles of the present disclosure;
[0027] FIG. 10A is a schematic side view of the medical device
system of FIG. 2 performing another variation of the method of FIG.
8 in a first deployment position, in accordance with the principles
of the present disclosure;
[0028] FIG. 10B is a schematic side view of the medical device
system of FIGS. 2 and 10A performing the variation of the method of
FIG. 8 started in FIG. 10A in a second deployment position, in
accordance with the principles of the present disclosure;
[0029] FIG. 10C is a schematic side view of the medical device
system of FIGS. 2, 10A, and 10B performing the variation of the
method of FIG. 8 started in FIG. 10A in a third deployment
position, in accordance with the principles of the present
disclosure;
[0030] FIG. 10D is a schematic side view of the medical device
system of FIGS. 2 and 10A-10C performing the variation of the
method of FIG. 8 started in FIG. 10A in a fourth deployment
position, in accordance with the principles of the present
disclosure;
[0031] FIG. 11A is a schematic side view of a yet another medical
device system, in accordance with the principles of the present
disclosure;
[0032] FIG. 11B is a schematic top view of the medical device
system of FIG. 11A, in accordance with the principles of the
present disclosure;
[0033] FIG. 12 is a schematic side view of an electrode, in
accordance with the principles of the present disclosure; and
[0034] FIGS. 13A-13D are schematic side views of the electrode of
FIG. 12 shown with a medical device system during deployment of the
electrode, in accordance with the principles of the present
disclosure.
DETAILED DESCRIPTION
[0035] The following description is merely exemplary in nature and
is not intended to limit the present disclosure, application, or
uses.
[0036] The present disclosure provides a system and method for the
predictable deployment of a medical device into a patient's
anatomy. Predictable deployment may allow for optimal positioning
for treatment. The medical device, along with an introducer needle,
may have features that cause the medical device to deploy in a
predictable direction from the introducer needle. In some versions,
the introducer needle may have features that cause the introducer
needle to orient in a predictable direction from a surrounding
endoscope, such as a bronchoscope.
[0037] With reference to the figures, wherein like numerals
indicate like components, and specifically with reference to FIGS.
1A-1C, an example of a medical device system in accordance with the
principles of the present disclosure is illustrated and generally
designated at 20. The medical device system 20 is configured to be
inserted into a patient's anatomy, for example, for treatment of
tissue, such as pulmonary tissue. The medical device system 20 may
be configured to be used in bronchoscopic, thoracoscopic,
laparoscopic, transcutaneous, and/or percutaneous procedures, by
way of example. In some variations, the medical device system 20
may be inserted into a bronchoscope, such as a BF-P180 bronchoscope
manufactured by Olympus and/or an EBUS.RTM. scope manufactured by
Olympus. In some configurations, the medical device system 20 may
be inserted into an airway so that the medical device system 20
reaches or is placed proximate a region of tissue to be
treated.
[0038] The medical device system 20 may include an introducer tube
22, which defines a lumen 24 therein. The introducer tube 22 bears
a first electrode 26. As such, the introducer tube 22 may itself be
the first electrode 26, as shown in FIGS. 1A-1C, or the first
electrode 26 may be attached to the introducer tube 22. The
introducer tube 22 defines an opening 28 at a distal end 30 of the
introducer tube 22. The introducer tube 22 may be in the form of a
hollow needle having a piercing tip 32. The piercing tip 32 may be
used to pierce through an airway wall, a tumor, or other tissue,
for example, but without limitation. As such, the piercing tip 32
may have a sharp edge or end that may pierce, perforate, or
penetrate into or through tissue.
[0039] A second electrode 34 is movably disposed in the lumen 24 of
the introducer tube 22. FIG. 1A illustrates a retracted position of
the second electrode 34. In the retracted position, the second
electrode 34 is disposed, or substantially disposed, within the
lumen 24 of the introducer tube 22. The second electrode 34 is
movable within the introducer tube 22 between the retracted
position and an extended position (illustrated in FIG. 1B). When it
is desired to extend the second electrode 34 from the introducer
tube 22, the second electrode 34 may be pushed or otherwise moved
through lumen 24 and out of the opening 28 of the distal end 30 of
the introducer tube 22. In the extended position (see FIG. 1B), the
second electrode 34 extends at least partially beyond the distal
end 30 of the introducer tube 22.
[0040] Each of the first and second electrodes 26, 34 has its own
electrical lead (not shown) to connect the respective electrode 26,
34 to a power source (not shown). The power source may be connected
to the leads via wires and the like. As such, the power source is
operable to deliver power to the first electrode 26 and/or the
second electrode 34 through the leads (not shown). Thus, the power
source may be configured to deliver energy to a region of tissue
via the medical device system 20, which includes one or more of the
first and second electrodes 26, 34.
[0041] In some configurations, the power source (not shown)
comprises a source of electric or electromagnetic power. Other
sources of energy, alone or in combination, can be used and energy
can be delivered to the tissue via the power source (not shown)
and/or the medical device system 20. Such power sources can include
electric current treatment, cryo treatment (including
cryoablation), microwave, laser, and/or photodynamic treatment, by
way of example.
[0042] In some configurations, the power source may be configured
to deliver electric power at varied frequencies. In some
configurations, the power source may be configured to deliver
radiofrequency (RF) energy in a range of between about 3 KHz and
about 300 GHz. In some configurations, the range may be between
about 100 KHz and about 500 KHz. In some configurations, the range
may be between about 300 KHz and about 400 KHz. In some
configurations, the power source may be configured to deliver power
in a range of between about 5 watts and about 40 watts, or between
about 7 watts and about 25 watts, or between about 8 watts and
about 13 watts, by way of example.
[0043] In some configurations, the power level may be set by the
user or operator, and the resulting voltage and current will vary
with that setting. In some configurations, the voltage and current
may vary between the ranges of about 20 VAC and about 60 VAC and
between about 0.1 ampere and about 1 ampere. In some
configurations, the energy delivered to a 1 cm diameter volume
treatment site may be between about 8 KJ and about 13 KJ, depending
on the type of tissue.
[0044] In some configurations, the medical device system 20 may act
to heat or ablate tissue via RF energy. Tissues such as tumors
(especially lung nodules) or other tissue masses may be treated
with energy so as to heat the cells therein to ablate, kill, burn,
heat, or denature the cells. The tissue may not necessarily need to
be heated so as to kill the component cells, but may be heated
enough to modify the cells so as to become non-malignant or
otherwise benign. This may also be achieved by cooling, such as by
cryoablation.
[0045] In some configurations, energy such as RF energy may be
delivered by a single electrode, for example, only one of the
electrodes 26, 34. In such configurations, the electrical field may
emanate away from the electrode as a single point source. A surface
pad may serve as a second electrode. In other configurations,
energy may be delivered via a bipolar electrode assembly. In such
configurations, the electrical field may emanate between two
respective poles formed by the first and second electrodes 26, 34.
Thus, the first and second electrodes 26, 34 are configured to
apply a current, or deliver an energy, to a tissue.
[0046] Additional electrodes may be used for multipolar electrode
treatment. In the illustrated example, the needle tip serves as the
first electrode 26, however, in other configurations, more than two
electrodes may be disposed at or near the distal end 30 of the
introducer tube 22. In other configurations, multiple medical
device systems 20 may be used.
[0047] When the second electrode 34 is disposed within the first
electrode 26, only the introducer tube 22 may need to be
sufficiently strong to pierce through an airway wall (e.g., with
the piercing tip 32), rather than needing two separate electrodes
possessing sufficient strength or rigidity or being provided with
piercing tips arranged to puncture the airway wall. On the other
hand, in some configurations, the second electrode 34 may be
provided with, or attached to, a piercing end (not shown in FIGS.
1A-1C, see FIG. 2). The piercing end can be used to penetrate into
tissue being treated (e.g., a lung nodule). In some configurations,
the piercing end may be sheathed by the first electrode 26. In some
configurations, the piercing end may be exposed when the second
electrode 34 is extended from the first electrode 26.
[0048] When the second electrode 34 is extended from the introducer
tube 22 and into the extended position, the second electrode 34 may
curve or form a spiral, coil, or helix. Such a configuration may be
desirable because it may induce an eddy current into the tissue
being treated, in addition to the joule heating resulting from a
resistance of the tissue being treated. In some configurations, the
second electrode 34 is flexible, and adapts a helical, spiral, or
coiled configuration once extended away from the distal end 30 of
the introducer tube 22. In some configurations, the second
electrode 34 may comprise a superelastic material (e.g., Nitinol)
and the second electrode 34 can change shapes. Other materials may
also be used, including, without limitation, conductive polymers
and bundles of multiple wires (such as a cable), which may in some
configurations provide for greater elasticity.
[0049] As explained above, in some configurations, the second
electrode 34 can be manufactured at least in part from a
shape-memory material, such as Nitinol. In some such
configurations, the second electrode 34 may have an austenite
configuration above body temperature that forms a coil or bend. The
second electrode 34 may be loaded into the introducer tube 22 in
the martensite configuration and in a straighter form, such that
heating of the second electrode 34 (e.g., due to electric current
passing through the second electrode 34 or by contact of the second
electrode 34 with warmer body tissue) causes the second electrode
34 to convert to the austenite configuration and form a bend or
coil. In some configurations, the second electrode 34 may be
deployed into tissue while still straight, followed by subsequent
heating to cause it to change shape. In some configurations, the
second electrode 34 may be heated as it is inserted into the tissue
(e.g., as it exits the opening 28 of the distal end 30 of the
introducer tube 22) so that the second electrode 34 begins to bend
or coil as it is deployed. In still other configurations, the
second electrode 34 may simply return to a coil shape once deployed
by virtue of a spring force in its superelastic material.
[0050] It is contemplated that deployment of the second electrode
34 into a bent or coiled configuration may result in the electrode
assembly entering a tissue locking position such that a distal end
of the second electrode 34 is maintained in position with respect
to the treatment area of interest. Such a locking position may be
maintained during breathing or heat treatment. It is contemplated
that the second electrode 34 may go through multiple deployments
from the introducer tube 22 without moving the introducer tube 22,
in some variations. The introducer tube 22 may also be formed at
least in part of a shape memory material, such as Nitinol, if
desired.
[0051] Preferably, the second electrode 34 may be shaped as a coil
with a pitch in a range of between about 0.1 mm to about 2 mm, and
preferably about 1 mm, by way of example. The major diameter of the
coil may measure between about 2 mm and about 10 mm, and preferably
between about 3 mm and about 4 mm. The coil may also comprise
between about 0.5 total helical turns and about 5 total helical
turns, and preferably between about 1.5 total helical turns and
about 3 total helical turns. The wire diameter that may be used to
manufacture the coil may measure between about 0.010 inches and
about 0.020 inches, and preferably about 0.015 inches. In the
illustrated example, the second electrode 34 forms a coil once
deployed within the patient's anatomy. The second electrode 34 has
a flat, ribbon shape and defines a plurality of helical turns 35.
In this example, three helical turns 35 are illustrated, however, a
greater or lower number of helical turns 35 could be used
alternatively.
[0052] In some configurations, at least one of the first electrode
26 and the second electrode 34 includes an insulating layer (not
shown). In some configurations, for example, an insulating layer
can be positioned between the first electrode 26 and the second
electrode 34, formed on an inner surface of the first electrode 26
and/or on an outer surface of the second electrode 34. Such a
placement of the insulating layer(s) can serve to reduce the
likelihood of short circuiting between the electrodes 26, 34 while
improving the use of bipolar or multipolar ablation
configurations.
[0053] In some configurations, insulating materials may be
lubricious. Lubricious insulating materials can improve the ability
of the electrodes 26, 34 to move relative to each other. Any
suitable insulating material may be used to overlay at least a
portion of the one or more electrodes 26, 34. In some
configurations, the insulating material may comprise a polymeric
material. For example, PTFE, fluorinated ethylene propylene, high
density polyethylene, polyethylene, and/or other suitable
insulating materials may be used. In some embodiments, the use of
saline (e.g., saline conductive gel) can reduce friction between
the electrodes 26, 34. In some embodiments, one or more surfaces of
the electrodes 26, 34 can be coated with a ceramic powder.
[0054] When using bipolar or multipolar electrical ablation, in
particular RF ablation, the first and second electrodes 26, 34 can
be used to concentrate the energy being delivered to the
surrounding tissue into a zone roughly bounded by these electrodes
26, 34. The degree of extension of the second electrode 34 into the
tissue permits the user to modulate the amount and area of energy
being directed into the surrounding tissue. In some configurations,
the first and second electrodes 26, 34 can be configured to limit
the range of relative extension. For example, the range of relative
extension between the first and second electrodes 26, 34 can be
predetermined based upon the size of the nodule or other area of
interest to be treated. In some embodiments, the deployed distance
between the first and second electrodes 26, 34 is configured to be
approximately equal to the depth of the nodule or other area of
interest into which the first and/or second electrodes 26, 34 are
deployed. In some configurations, the extent to which the first and
second electrodes 26, 34 can move relative to each other in the
distal and/or proximal directions is approximately equal to the
distance required to move the proximal end of the second electrode
34 from the stored position (retracted position) to the deployed
position (extended position). In some embodiments, the extent to
which the first and second electrodes 26, 34 can move relative to
each other in the distal and/or proximal directions is greater than
the deployed distance between the first and second electrodes 26,
34 due, for example, to the second electrode 34 being stored in a
relative straight configuration within the lumen 24 of the
introducer tube 22 prior to deployment into the extended
position.
[0055] The introducer tube 22 is configured to substantially hold
the second electrode 34 within the lumen 24 in a predetermined
orientation in the extended position. A proximal part 36 of the
second electrode 34 remains within the lumen 24 in the extended
position, and the introducer tube 22 holds the proximal part 36 in
a predetermined angular orientation to prevent the second electrode
34 from substantially rotating within the lumen 24 of the
introducer tube 22 during movement into the extended position and
when the second electrode 34 is in the extended position as shown
in FIG. 1B.
[0056] For example, referring to FIG. 1C, in the medical device
system 20 of FIGS. 1A-1C, the introducer tube 22 has a rectangular
hollow cross-section, and the second electrode 34 has a flat,
rectangular cross-section. As such, the second electrode 34 is
keyed to the introducer tube 22 at least at the distal end 30 of
the introducer tube 22. This is because the inner perimeter 38 of
the introducer tube 22 corresponds to the outer perimeter 40 of the
second electrode 34. Each has a rectangular shape, in this example,
and the inner perimeter 38 of the introducer tube 22 is
form-fitting, with a sliding fit, over the outer perimeter 40 of
the second electrode 34. As such, the portion of the second
electrode 34 that is disposed in the lumen 24 is prevented from
substantially rotating with respect to the introducer tube 22. In
other words, if the second electrode 34 began to rotate within the
lumen 24, the second electrode 34 would contact one of the inner
sides 42, 44, 46, 48 of the introducer tube 22, which would prevent
the second electrode 34 from further rotation.
[0057] In the illustrated example, the second electrode 34
cross-section has a height h and a width w, wherein the height h
and the width w are non-identical, because the second electrode has
an oblong rectangular (non-square rectangular) cross-section.
Likewise, the first and third inner sides 42, 46 of the introducer
tube 22 are longer than the second and fourth inner sides 44, 48 of
the introducer tube 22, creating a hollow rectangular inner
cross-section of the introducer tube 22. Thus, the oblong
rectangular second electrode 34 fits into the hollow rectangular
lumen 24 with a keyed fit that does not substantially rotate. The
fit is referred to as a "keyed" fit based on the fact that second
electrode 34 has an outer shape that corresponds to, or
compliments, the inner perimeter shape of the introducer tube 22,
thus preventing substantial rotation therebetween. This causes the
second electrode 34 to deploy in a known direction, because it is
known how the second electrode 34 is disposed at the distal end 30
of the introducer tube 22. At least the distal end 30 of the
introducer tube 22 has the oblong rectangular cross-section, in
this example. In some examples, the oblong rectangular
cross-section may extend along the length of the introducer tube,
while in other examples, the oblong rectangular cross-section may
exist only at the distal end 30.
[0058] Referring now to FIG. 2, another example of a medical device
system 120 is illustrated. It should be understood that the medical
device system 120 may be used similarly to the medical device
system 20 described above, if desired. In addition, the medical
device system 120 may serve as an electrode assembly, as described
above. All other details not described with respect to FIG. 2 may
be similar or the same as the features described with respect to
the example in FIGS. 1A-1B.
[0059] The medical device system 120 has an introducer tube 122,
which defines a lumen 124 therein. The introducer tube 122 bears a
first electrode 126. As such, the introducer tube 122 may itself be
the first electrode 126, as shown in FIGS. 1A-1C, or the first
electrode 126 may be attached to the introducer tube 122. The
introducer tube 122 defines an opening 128 at a distal end 130 of
the introducer tube 122. The introducer tube 122 may be in the form
of a hollow needle having a piercing tip 132.
[0060] A second electrode 134 is movably disposed in the lumen 124
of the introducer tube 122. FIG. 2 illustrates an extended position
of the second electrode 134, though it should be understood that
the second electrode 134 may be retracted into a retracted position
similar to that shown in FIG. 1A. In the retracted position, the
second electrode 134 is disposed, or substantially disposed, within
the lumen 124 of the introducer tube 122. The second electrode 134
is movable within the introducer tube 122 between the retracted
position (similar to FIG. 1A) and the extended position
(illustrated in FIG. 2). When it is desired to extend the second
electrode 134 from the introducer tube 122, the second electrode
134 may be pushed or otherwise moved through lumen 124 and out of
the opening 128 of the distal end 130 of the introducer tube 122.
In the extended position (FIG. 2), the second electrode 134 extends
at least partially beyond the distal end 130 of the introducer tube
122.
[0061] When the second electrode 134 is disposed within the first
electrode 126, only the introducer tube 122 may need to be
sufficiently strong to pierce through an airway wall (e.g., with
the piercing tip 132), rather than needing two separate electrodes
possessing sufficient strength or rigidity or being provided with
piercing tips arranged to puncture the airway wall. On the other
hand, in some configurations, the second electrode 134 may be
provided with, or attached to, a piercing end 150. The piercing end
150 can be used to penetrate into tissue being treated (e.g., a
lung nodule). In some configurations, the piercing end 150 may be
sheathed by the first electrode 126. In some configurations, the
piercing end 150 may be exposed when the second electrode 134 is
extended from the first electrode 126.
[0062] When the second electrode 134 is extended from the
introducer tube 122 and into the extended position, the second
electrode 134 may curve or form a spiral, coil, or helix. As
described above with respect to FIGS. 1A-1C, the second electrode
134 may comprise a superelastic material (e.g., Nitinol), though
other materials may also be used. In the illustrated example, the
second electrode 134 forms a coil once deployed within the
patient's anatomy. The second electrode 134 may have, for example,
a flat, ribbon shape or an ovular shape. The second electrode 134
defines a plurality of helical turns 135. In this example, three
helical turns 135 are illustrated, however, a greater or lower
number of helical turns 135 could be used alternatively.
[0063] The introducer tube 122 is configured to substantially hold
the second electrode 134 within the lumen 124 in a predetermined
orientation in the extended position. A proximal part 136 of the
second electrode 134 remains within the lumen 124 in the extended
position, and the introducer tube 122 holds the proximal part 136
in a predetermined angular orientation to prevent the second
electrode 134 from substantially rotating within the lumen 124 of
the introducer tube 122 during movement into the extended position
and when the second electrode 134 is in the extended position as
shown in FIG. 2.
[0064] For example, in the medical device system 120 of FIG. 2, the
introducer tube 122 has a neck portion 152 having an ovular hollow
cross-section. The second electrode 134 may have a corresponding
ovular cross-section that fits through the neck portion 152, or the
second electrode may have a flat, oblong rectangular cross-section
that still fits snugly within the neck portion 152. As such, the
second electrode 134 is "keyed" to the introducer tube 122 at least
at the distal end 130 of the introducer tube 122. This is because
the inner perimeter of the neck portion 152 of the introducer tube
122 corresponds to the outer perimeter of the second electrode 134.
The inner perimeter of the introducer tube 122 is form-fitting or
nearly form-fitting with the outer perimeter of the second
electrode 134, whether the second electrode 134 has an oblong
rectangular or ovular cross-section. In other words, an ovular
cross-section of the second electrode 134 would be more
form-fitting than a rectangular cross-section of the second
electrode 134 to correspond with the inner perimeter of the neck
portion 152. Thus, the portion of the second electrode 134 that is
disposed in the lumen 124 is prevented from substantially rotating
with respect to the introducer tube 122. In other words, if the
second electrode 134 began to rotate within the lumen 124, the
second electrode 134 would contact an inner wall in the neck
portion 152 of the introducer tube 122, which would prevent the
second electrode 134 from further rotation.
[0065] In the illustrated example, the second electrode 134
cross-section has a height h and a width w, wherein the height h
and the width w are non-identical, because the second electrode 134
has an oblong rectangular or ovular cross-section. Likewise, the
inner side of the neck portion 152 of the introducer tube 122 has a
longer diameter in one direction than in a perpendicular direction,
creating a hollow ovular inner cross-section of the introducer tube
122. Thus, the second electrode 134 fits into the hollow ovular
lumen 124 with a keyed fit that does not substantially rotate. This
causes the second electrode 134 to deploy in a known direction,
because it is known how the second electrode 134 is disposed at the
distal end 130 of the introducer tube 122. At least the neck
portion 152 of the introducer tube 122 has the ovular
cross-section, in this example. In some examples, the ovular
cross-section may extend along the length of the introducer tube
122, while in other examples, the ovular cross-section may exist
only at the neck portion 152.
[0066] Referring now to FIG. 3, another example of an introducer
tube 222 for use in a medical device system and with a second
electrode is illustrated. It should be understood that the medical
device system using the introducer tube 222 may include one of the
second electrodes 34, 134 described above, or another suitable
second electrode. The introducer tube 222 may be used similarly to
those described above, if desired. In addition, the medical device
system using the introducer tube 222 may serve as an electrode
assembly, as described above. All other details not described with
respect to FIG. 3 may be similar or the same as the features
described with respect to the example in FIGS. 1A-2.
[0067] The introducer tube 222 defines a lumen 224 therein. The
introducer tube 222 bears a first electrode 226. In this example,
the first electrode 226 is formed from the outer sheath 254. The
introducer tube 222 defines an opening 228 at a distal end 230 of
the introducer tube 222. The introducer tube 222 may be in the form
of a hollow needle having a piercing tip 232.
[0068] As described above, a second electrode (not shown) may be
movably disposed in the lumen 224 of the introducer tube 222, the
second electrode being movable between a retracted position and an
extended position.
[0069] The introducer tube 222 is configured to substantially hold
the second electrode (not shown) within the lumen 224 in a
predetermined orientation in the extended position. The introducer
tube 222 holds the second electrode in a predetermined angular
orientation within the lumen 224 to prevent the second electrode
from substantially rotating within the lumen 224 of the introducer
tube 222 during movement of the second electrode into the extended
position and when the second electrode is in the extended
position.
[0070] For example, the introducer tube 222 may define the lumen
224 as having an oblong rectangular or ovular cross-section, by way
of example. The second electrode may have a corresponding
cross-section that fits within the cross-section of the lumen 224
at the distal end 230. As such, the second electrode is "keyed" to
the introducer tube 222 at least at the distal end 230 of the
introducer tube 222. This is because the inner perimeter of the
introducer tube 222 corresponds to the outer perimeter of the
second electrode. The inner perimeter of the introducer tube 222 is
form-fitting or nearly form-fitting with the outer perimeter of the
second electrode, whether the second electrode 134 has an oblong
rectangular or ovular cross-section, by way of example. Thus, the
portion of the second electrode that is disposed in the lumen 224
is prevented from substantially rotating with respect to the
introducer tube 222. In other words, if the second electrode began
to rotate within the lumen 224, the second electrode would contact
an inner wall of the introducer tube 222, which would prevent the
second electrode from further rotation.
[0071] In the illustrated example, the introducer tube 222 has an
inner sheath 256 surrounded by the outer sheath 254, the inner
sheath 256 being disposed in the outer sheath 254. The outer sheath
254 has a round, circular cross-section, in this example, and may
be formed of a metal, by way of example. The inner sheath 256
defines the lumen 224, and thus, the inner sheath 256 may have a
non-circular inner hollow cross-section defined by an inner wall
258 or walls, in order to key the second electrode within the lumen
224. The inner sheath 256 may be a plastic extrusion, such as from
a polyether ether ketone (PEEK) material. The inner sheath 256 may
be fixedly attached to the outer sheath 254, for example, by a
non-moving form fit.
[0072] Referring now to FIG. 4, another example of a medical device
system 320 is illustrated. It should be understood that the medical
device system 320 may be used similarly to the medical device
systems 120, 20 described above, if desired. In addition, the
medical device system 320 may serve as an electrode assembly, as
described above. All other details not described with respect to
FIG. 4 may be similar or the same as the features described with
respect to the example in FIGS. 1A-3.
[0073] The medical device system 320 has an introducer tube 322,
which defines a lumen 324 therein. The introducer tube 322 bears a
first electrode 326. As such, the introducer tube 322 may itself be
the first electrode 326, as shown in FIG. 4, or the first electrode
326 may be attached to the introducer tube 322. The first electrode
326 defines an opening 328 at a distal end 330 of the first
electrode 362. The first electrode 326 may be in the form of a
hollow needle having a piercing tip 332.
[0074] A second electrode 334 is movably disposed in the lumen 324
of the first electrode 326, and a third electrode 360 is movably
disposed in the lumen 324 of the introducer tube 322. FIG. 4
illustrates extended positions of the second electrode 334 and the
third electrode 360, though it should be understood that the second
and third electrodes 334, 360 may be retracted into retracted
positions similar to that shown in FIG. 1A. In the retracted
positions, the second and third electrodes 334, 360 are disposed,
or substantially disposed, within the lumen 324 of the introducer
tube 322. The second and third electrodes 334, 360 are movable
within the first electrode 326 and the introducer tube 322 between
the retracted positions (similar to FIG. 1A) and the extended
positions (illustrated in FIG. 4). When it is desired to extend the
second and third electrodes 334, 360 from the first electrode 326,
the second and third electrodes 334, 360 may be pushed or otherwise
moved through lumen 324 and out of the opening 328 of the distal
end 330 of the introducer tube 322. In the extended position (FIG.
4), the second and third electrodes 334, 360 extend at least
partially beyond the distal end 330 of the first electrode 326. The
second and third electrodes 334, 360 may have piercing ends
350.
[0075] When the second and third electrodes 334, 360 are extended
from the introducer tube 322 and into the extended positions, the
second and third electrodes 334, 360 may curve or form a spiral,
coil, or helix. As described above with respect to FIGS. 1A-1C, the
second and third electrodes 334, 360 may comprise a superelastic
material (e.g., Nitinol), though other materials may also be used.
In the illustrated example, the second and third electrodes 334,
360 each form a coil once deployed within the patient's anatomy.
The second and third electrodes 334, 360 may have, for example, a
flat, ribbon shape or an ovular shape. Each of the second and third
electrodes 334, 360 define a plurality of helical turns 335. In
this example, each electrode 334, 360 has three helical turns 335,
however, a greater or lower number of helical turns 335 could be
used alternatively.
[0076] The introducer tube 322 is configured to substantially hold
the second and third electrodes 334 within the lumen 324 in
predetermined orientations in the extended positions. In this
example, the second electrode 334 extends upwardly from the first
electrode 326 in the orientation of FIG. 4, and the third electrode
360 extends downwardly from the first electrode 326 in the
orientation of FIG. 4; thus, each electrode 334, 360 reaches a
different part of tissue. Proximal parts 336 of the second and
third electrode 334, 360 remain within the lumen 324 in the
extended positions, and the introducer tube 322 holds the proximal
parts 336 in a predetermined angular orientation to prevent the
second and third electrodes 334, 360 from substantially rotating
within the lumen 324 of the introducer tube 322 during movement
into the extended positions and when the second and third
electrodes 334, 360 are in the extended positions as shown in FIG.
4.
[0077] For example, in the medical device system 320 of FIG. 4, the
introducer tube 322 has a neck portion 352 having an ovular hollow
cross-section. Each of the second and third electrodes 334, 360 may
have corresponding cross-sections that fit together through the
neck portion 352, such as ovular or flat cross-sections. As such,
the second and third electrodes 334, 360 are keyed to the
introducer tube 322 at least at the distal end 330 of the
introducer tube 322. This is because the inner perimeter of the
neck portion 352 of the introducer tube 322 corresponds to part of
the outer perimeters of the second and third electrodes 334, 360.
Thus, the portions of the second and third electrodes 334, 360 that
are disposed in the lumen 324 are prevented from substantially
rotating with respect to the introducer tube 322. In other words,
if the second and third electrodes 334, 360 began to rotate within
the lumen 324, the second and third electrodes 334, 360 would
contact an inner wall in the neck portion 352 of the introducer
tube 322, which would prevent the second and third electrodes 334,
360 from further rotation.
[0078] The first, second, and third electrodes 326, 334, 360 may be
used for multipolar electrode treatment. For example, electricity
may pass between the second and third electrodes 334, 360, the
second and third electrodes 334, 360 and the first electrode 326,
or any combination thereof.
[0079] Referring now to FIG. 5, another example of a medical device
system 420 is illustrated. It should be understood that the medical
device system 420 may be used similarly to the medical device
system 20 described above, if desired. In addition, the medical
device system 420 may serve as an electrode assembly, as described
above. All other details not described with respect to FIG. 5 may
be similar or the same as the features described with respect to
the examples in FIGS. 1A-4.
[0080] The medical device system 420 has an introducer tube 422,
which defines a lumen 424 therein. The introducer tube 422 bears a
first electrode 426. As such, the introducer tube 422 may itself be
the first electrode 426, as shown in FIG. 5, or the first electrode
426 may be attached to the introducer tube 422. The introducer tube
422 defines an opening 428 at a distal end 430 of the introducer
tube 422. The introducer tube 422 may be in the form of a hollow
needle having a piercing tip (not shown).
[0081] A second electrode 434 is movably disposed in the lumen 424
of the introducer tube 422. FIG. 5 illustrates a retracted position
of the second electrode 434, though it should be understood that
the second electrode 434 may be extended from the first electrode
426 into an extended position similar to that shown in FIG. 1B. In
the retracted position, the second electrode 434 is disposed, or
substantially disposed, within the lumen 424 of the introducer tube
422. The second electrode 434 is movable within the introducer tube
422 between the retracted position (illustrated in FIG. 5) and the
extended position (may be similar to FIG. 1B). When it is desired
to extend the second electrode 434 from the introducer tube 422,
the second electrode 434 may be pushed or otherwise moved through
lumen 424 and out of the opening 428 of the distal end 430 of the
introducer tube 422. In the extended position, the second electrode
434 will extend at least partially beyond the distal end 430 of the
introducer tube 422.
[0082] When the second electrode 434 is extended from the
introducer tube 422 and into the extended position, the second
electrode 434 may curve or form a spiral, coil, or helix, as shown
above in FIGS. 1B, 2, and 4. As described above with respect to
FIGS. 1A-1C, the second electrode 434 may comprise a superelastic
material (e.g., Nitinol), though other materials may also be used.
In the illustrated example, the second electrode 434 forms a coil
once deployed within the patient's anatomy. The second electrode
434 may have, for example, a flat, ribbon shape as shown, or
another suitable shape. Once deployed, the second electrode 434
defines a plurality of helical turns (not shown).
[0083] The introducer tube 422 is configured to substantially hold
the second electrode 434 within the lumen 424 in a predetermined
orientation in the extended and the retract positions, in this
variation. The introducer tube 422 holds the second electrode 434
in a predetermined angular orientation to prevent the second
electrode 434 from substantially rotating within the lumen 424 of
the introducer tube 422 during movement into the extended position
and when the second electrode 434 is in the retracted position (as
shown in FIG. 5) and the extended position (not shown).
[0084] For example, in the medical device system 420 of FIG. 5, the
introducer tube 422 has a rectangular hollow cross-section, and the
second electrode 434 has a flat, rectangular cross-section, similar
to the cross-sections described in FIG. 1C, and discussion with
respect to FIG. 1C is herein incorporated by reference into this
section. As such, the second electrode 434 is keyed to the
introducer tube 422 at least at the distal end 430 of the
introducer tube 422.
[0085] In the illustrated example, the introducer tube 422 is more
flexible in a first plane than in a second plane, wherein the first
plane is perpendicular to the second plane. More specifically, per
convention, X-Y-Z coordinates are illustrated with the Y-direction
extending to the left and right in the orientation of FIG. 5, the
Z-direction extending up and down in the orientation of FIG. 5, and
the X-direction extending out of and into the page in the
orientation of FIG. 5. The first electrode 426 is more flexible in
the X-Z plane, or in the positive and negative Z-directions, than
in the Y-Z plane or in the positive and negative Y-directions.
[0086] Likewise, the second electrode 434 may be more flexible in
the first plane than in the second plane. Thus, in this example,
the second electrode 434 is more flexible in the X-Z plane, or in
the positive and negative Z-directions, than in the Y-Z plane or in
the positive and negative Y-directions. Accordingly, the second
electrode 434 is keyed to the first electrode 426 by virtue of the
second electrode 434 being bendable in one plane (the X-Z plane
here), while being substantially unbendable in other planes. Thus,
the second electrode 434 will tend to only bend in the plane in
which it is bendable. If the first electrode 426 is bent around a
curve, which will be described in further detail below, the second
electrode 434 will only bend along its bendable plane around the
curve, and thus, an operator will know which direction the second
electrode 434 is deployed.
[0087] Referring now to FIG. 6, another example of an introducer
tube 522 for use in a medical device system and with a second
electrode is illustrated. It should be understood that the medical
device system using the introducer tube 522 may include one of the
second electrodes 34, 134, 434 described above, or another suitable
second electrode. The introducer tube 522 may be used similarly to
those described above, if desired. In addition, the medical device
system using the introducer tube 522 may serve as an electrode
assembly, as described above. All other details not described with
respect to FIG. 6 may be similar or the same as the features
described with respect to the examples in FIGS. 1A-5.
[0088] The introducer tube 522 defines a lumen 524 therein. The
introducer tube 522 bears a first electrode 526. In this example,
the first electrode 526 is the introducer tube 522 itself. The
introducer tube 522 defines an opening 528 at a distal end 530 of
the introducer tube 522. The introducer tube 522 may be in the form
of a hollow needle having a piercing tip 532.
[0089] As described above, a second electrode (not shown) may be
movably disposed in the lumen 524 of the introducer tube 522
between a retracted position and an extended position.
[0090] The introducer tube 522 is configured to substantially hold
the second electrode (not shown) within the lumen 524 in a
predetermined orientation in the extended position. The introducer
tube 522 holds the second electrode in a predetermined angular
orientation within the lumen 524 to prevent the second electrode
from substantially rotating within the lumen 524 of the introducer
tube 522 during movement of the second electrode into the extended
position and when the second electrode is in the extended
position.
[0091] The introducer tube 522 has an open channel 562 defined in
outer side 564 of the introducer tube 522. The open channel 562 may
extend entirely through the outer side 564 of the introducer tube
522, or the open channel 562 may be a groove, cavity, or score mark
in the outer side 564 without extending completely through the
outer side 564 and into the lumen 524. The open channel 562 renders
the introducer tube 522 more bendable along a first plane than
along a second plane that is perpendicular to the first plane. More
specifically, per convention, X-Y-Z coordinates are illustrated
with the Y-direction extending to the left and right in the
orientation of FIG. 6, the Z-direction extending up and down in the
orientation of FIG. 6, and the X-direction extending out of and
into the page in the orientation of FIG. 6. The first electrode 526
is more flexible in the X-Z plane, or in the positive and negative
Z-directions, than in the Y-Z plane, or in the positive and
negative Y-directions.
[0092] Likewise, the second electrode (not shown) may be more
flexible in the first plane than in the second plane. The second
electrode (not shown) could also have an open channel, groove,
cavity, or score formed therein. Accordingly, the second electrode
could be keyed to the first electrode 526 by virtue of the second
electrode being bendable in one plane (the X-Z plane here), while
being substantially unbendable in other planes. Thus, the second
electrode will tend to only bend in the plane in which it is
bendable.
[0093] The open channel 562 may also serve as a keyway to orient
the second electrode (not shown) within the first electrode 526, in
some variations.
[0094] FIG. 7 illustrates an embodiment of a medical device system
620 disposed within a bronchoscope 668 provided with a side-facing
ultrasound probe 669 placed within an airway 670. An example of
such a bronchoscope 668 is the EBUS.RTM. scope manufactured by
Olympus. Preferably, the bronchoscope 668 is provided with at least
one lateral port 672 extending from the bronchoscope working
channel or lumen 676; this permits the introducer tube 622 (bearing
the first electrode 626) to extend through the port 672. The
bronchoscope 668 has a curved section 673 defining a bend 674
therein. The curved section 673 is disposed at or near a distal end
675 of the bronchoscope, which terminates in the port 672. The
introducer tube 622 is at least partially disposed in the
bronchoscope lumen 676 and axially movable therein.
[0095] In some configurations, the first electrode 626 is bendable
and flexible. In some configurations, the first electrode 626 may
be bendable at an angle of at least 10.degree., preferably about
20.degree., about 30.degree., about 45.degree., about 55.degree.,
about 65.degree., about 75.degree., and even more preferably at
least about 90.degree., relative to the longitudinal axis of the
axial length of the airway. As such, when a region of lung tissue
to be treated is located, the first electrode 626 can be extended
at least partially into that region of lung tissue by piercing
through the airway 670. As described above in reference to previous
embodiments, a second electrode 634 in the form of a coil is
movable from a retracted position into an extended position as
shown.
[0096] Like the examples in FIGS. 5-6 (which may be used in FIG.
7), the introducer tube 622 is more flexible in a first plane than
in a second plane, wherein the first plane is perpendicular to the
second plane. Accordingly, as the medical device system 620 is
moved around the bend 674 in the bronchoscope 668 (or other
endoscope for other applications), the introducer tube 622
automatically orients itself in the direction in which the
introducer tube 622 is most flexible to go around the bend 674. In
some variations, a bend may be located in the port 672. Thus, a
bending orientation of the first electrode 626 aligns with the bend
674 in the curved section 673 of the bronchoscope 668, or with a
bend located in the port 672 in other embodiments. Accordingly, an
operator can then know the orientation in which the medical device
system 620 is extending from the port 672 of the bronchoscope 668.
If the second electrode 634 is keyed within the first electrode 626
(in any of the manners described above, for example), then the
operator will also know the orientation in which the second
electrode 634 will deploy from the first electrode 626.
[0097] Referring now to FIG. 8 and FIGS. 9A-9B, a method of
delivering energy to a patient's anatomy is illustrated and
generally designated at 700. The method 700 includes a first step
702 of piercing a hollow needle into a tissue in the patient's
anatomy, wherein the hollow needle is a first electrode and the
hollow needle defines a needle lumen therein having an opening at a
distal end. Any of the medical device systems 20, 120, 320, 420,
620 and/or introducer tubes 22, 122, 222, 322, 422, 522, 622
hereinbefore shown and described, or another suitable medical
device system, may be used in the method 700. For illustration
purposes, however, FIGS. 9A and 9B show the medical device assembly
120 hereinbefore described with respect to FIG. 2 being used to
perform the method 700. Thus, referring to FIG. 9A, the hollow
needle, or introducer tube 122, is pierced into a tissue 178. The
introducer tube 122 bears the first electrode 126 at a distal end
130, and the introducer tube 122 defines a lumen 124 therein having
an opening 128 at the distal end 130.
[0098] The method 700 also includes a step 704 of extending a
second electrode from the distal end of the hollow needle a first
time. Thus, as shown in FIG. 9A, the second electrode 134 is pushed
out of the opening 128 to extend from the distal end 130 of the
hollow needle, or electrode 126 and introducer tube 122, a first
time. Note that the second electrode 134 extends in a downward
direction D from a central axis C in the orientation of FIG. 9A
upon being deployed from the first electrode 126 the first time.
Such orientation is predictable, based on the second electrode 134
being keyed to the first electrode 126, as described above.
[0099] The method 700 further includes a step 706 of activating the
first electrode 126 and the second electrode 134 to deliver a first
energy to the tissue 178 through the first electrode 126 and the
second electrode 134. Accordingly, the electrodes 126, 134 will
ablate the tissue 178 in an area near the first and second
electrodes 126, 134, which is shown in a first region 180 of the
tissue 178 in FIG. 9A. The method 700 then includes a step 708 of
retracting the second electrode 134 into the needle lumen 124,
which may be into a retracted position similar to that illustrated
in FIG. 1A.
[0100] The method 700 includes a step 710 of rotating the hollow
needle 122 by a predetermined number of degrees about the central
axis C of the distal end 130 of the hollow needle 122. Such
rotation of the hollow needle, or introducer tube 122, causes the
second electrode 134 within the needle lumen 124 to also rotate by
substantially the same predetermined number of degrees about the
central axis C by virtue of the fact that the second electrode 134
is keyed in the lumen 124, for example, in one or more of the ways
described above. In this case, the rotation occurs from the
orientation of FIG. 9A to the orientation of FIG. 9B. As can be
seen, the introducer tube 122 and first electrode 126 have been
rotated about 180.degree. about the central axis C. Thus, the
method 700 may include substantially preventing the second
electrode 134 from rotating with respect to the hollow needle 122
when the second electrode 134 is retracted within or extended from
the needle lumen 124.
[0101] Referring to FIGS. 8 and 9B, the method 700 further includes
a step 712 of extending the second electrode 134 from the distal
end 130 of the hollow needle 122 a second time. Since the second
electrode 134 was held to the orientation of the first electrode
126, when the first electrode 126 was rotated about 180.degree.,
the second electrode 134 was also rotated about 180.degree. with
the first electrode 126. Thus, when the second electrode 134 is
extended from the distal end 130 a second time, the second
electrode 134 then extends in an upward direction U from the
central axis C, in the orientation of FIG. 9B.
[0102] The method 700 includes a step 714 of activating the first
and second electrodes 126, 134 to deliver a second energy to the
tissue 178 through the first and second electrodes 126, 134.
Accordingly, the electrodes 126, 134 will ablate the tissue 178 in
an area near the first and second electrodes 126, 134, which is
shown in a second region 182 of the tissue 178 in FIG. 9B.
[0103] The method 700 could also include inserting the hollow
needle through an endoscope, such as the bronchoscope 668 of FIG.
7. In such a variation, the step 710 of rotating the hollow needle
122 by a predetermined number of degrees about the central axis C
of the distal end 130 of the hollow needle 122 may include rotating
the endoscope (in this example, bronchoscope 668) by the
predetermined number of degrees about the central axis C, thus
causing the hollow needle 122 to also rotate by substantially the
same predetermined number of degrees about the central axis C. In
other words, in this variation, bronchoscope 668 or other endoscope
is rotated by the physician, while both the introducer tube 122 and
the second electrode 134 merely rotate by virtue of the fact that
they are ultimately keyed to the bronchoscope 668.
[0104] Referring now to FIGS. 10A-10D, the method 700 is shown
implemented with additional steps and with the second electrode 134
deployed in additional orientations. In FIG. 10A, the medical
device system 120 is inserted into a tissue 184, and the second
electrode 134 is extended from the first electrode 126. A first
ablation is performed, including activating the first and second
electrodes 126, 134, and as such, the medical device system 120
ablates an area denoted by the first lighter circle 186.
[0105] After the first ablation, the second electrode 134 may be
retracted into the first electrode 126, for example, as in FIG. 1A.
The first electrode 126 is then rotated about 90.degree. to the
orientation shown in FIG. 10B. The second electrode 134
automatically rotates with the first electrode 126, being keyed
together, for example, in one of the ways described above. The
second electrode 134 is then extended from the first electrode 126
a second time in a second direction. A second ablation is
performed, including activating the first and second electrodes
126, 134, and as such, the medical device system 120 ablates an
area denoted by the second lighter circle 188. FIG. 10B illustrates
that areas 186 and 188 have thus far been ablated.
[0106] After the second ablation, the second electrode 134 may be
retracted into the first electrode 126, for example, as in FIG. 1A.
The first electrode 126 is then rotated about 90.degree. to the
orientation shown in FIG. 10C. The second electrode 134
automatically rotates with the first electrode 126, being keyed
together, for example, in one of the ways described above. The
second electrode 134 is then extended from the first electrode 126
a third time in a third direction. A third ablation is performed,
including activating the first and second electrodes 126, 134, and
as such, the medical device system 120 ablates an area denoted by
the third lighter circle 190. FIG. 10C illustrates that areas 186,
188, and 190 have thus far been ablated.
[0107] After the third ablation, the second electrode 134 may be
retracted into the first electrode 126, for example, as in FIG. 1A.
The first electrode 126 is then rotated about 90.degree. to the
orientation shown in FIG. 10D. The second electrode 134
automatically rotates with the first electrode 126, being keyed
together, for example, in one of the ways described above. The
second electrode 134 is then extended from the first electrode 126
a fourth time in a fourth direction. A fourth ablation is
performed, including activating the first and second electrodes
126, 134, and as such, the medical device system 120 ablates an
area denoted by the fourth lighter circle 192. FIG. 10D illustrates
that areas 186, 188, 190, and 192 have now been ablated. Areas 186,
188, 190, 192 cover the entire area of the target tissue 184, and
therefore, the method resulted in the full ablation of the target
tissue 184.
[0108] Turning now to FIGS. 11A and 11B, another example of a
medical device system 800 is illustrated. It should be understood
that the medical device system 800 may be used similarly to the
medical device systems 120, 20, 320 and 420, as well as the
introducer tubes 222 and 522, described above, if desired. In
addition, the medical device system 800 may serve as an electrode
assembly, as described above. All other details not described with
respect to FIGS. 11A and 11B may be similar or the same as the
features described with respect to the example in FIGS. 1A-6.
[0109] The medical device system 800 has an introducer tube 822,
which defines a lumen 824 therein. The introducer tube 822 bears a
first electrode 826. As such, the introducer tube 822 may itself be
the first electrode 826, as shown in FIGS. 11A and 11B, or the
first electrode 826 may be attached to the introducer tube 822. The
first electrode 826 defines an opening 828 at a distal end 830 of
the first electrode 826. The first electrode 826 may be in the form
of a hollow needle having a piercing tip 832.
[0110] A second electrode 834 is movably disposed in the lumen 824
of the introducer tube 822, and a third electrode 860 is movably
disposed in the lumen 824 of the introducer tube 822. FIGS. 11A and
11B illustrate extended positions of the second electrode 834 and
the third electrode 860, though it should be understood that the
second and third electrodes 834, 860 may be retracted into
retracted positions similar to that shown in FIG. 1A. In the
retracted positions, the second and third electrodes 834, 860 are
disposed, or substantially disposed, within the lumen 824 of the
introducer tube 822. The second and third electrodes 834, 860 are
movable within the first electrode 826 and the introducer tube 822
between the retracted positions (similar to FIG. 1A) and the
extended positions (illustrated in FIGS. 11A and 11B). When it is
desired to extend the second and third electrodes 834, 860 from the
first electrode 826, the second and third electrodes 834, 860 may
be pushed or otherwise moved through lumen 824 and out of the
opening 828 of the distal end 830 of the introducer tube 822. In
the extended position (FIGS. 11A and 11B), the second and third
electrodes 834, 860 extend at least partially beyond the distal end
830 of the first electrode 826. The second and third electrodes
834, 860 may have piercing ends 850.
[0111] When the second and third electrodes 834, 860 are extended
from the introducer tube 822 and into the extended positions, the
second and third electrodes 834, 860 may curve or form a spiral,
coil, or helix. As described above with respect to FIGS. 1A-1C, the
second and third electrodes 834, 860 may comprise a superelastic
material (e.g., Nitinol), though other materials may also be used.
In the illustrated example, the second and third electrodes 834,
860 each form a coil once deployed within the patient's anatomy.
The second and third electrodes 834, 860 may have, for example, a
flat, ribbon shape or an ovular shape. Each of the second and third
electrodes 834, 860 define one or more helical turns 835. In this
example, each electrode 834, 860 has one helical turn 835, however,
a greater number of helical turns 835 could be used alternatively.
In the arrangement shown in FIGS. 11A and 11B, each electrode 834,
860 extends a shorter distance into tissue as compared to some of
the other previously described electrodes. The combination of the
two electrodes provides sufficient surface area to transmit a
desired current to the tissue. And since each of the electrodes
834, 860 turns into the tissue with fewer turns than some of the
other above described electrodes, each of the electrodes 834, 860
does not have to be as stiff as the previously described
electrodes.
[0112] The introducer tube 822 is configured to substantially hold
the second and third electrodes 834, 860 within the lumen 824 in
predetermined orientations in the extended positions. In this
example, the second electrode 834 extends upwardly from the first
electrode 826 in the orientation of FIGS. 11A and 11B, and the
third electrode 860 extends downwardly from the first electrode 826
in the orientation of FIGS. 11A and 11B; thus, each electrode 834,
860 reaches a different part of tissue. Proximal parts 836 of the
second and third electrode 834, 860 remain within the lumen 824 in
the extended positions, and the introducer tube 822 may be keyed to
hold the proximal parts 836 in a predetermined angular orientation
to prevent the second and third electrodes 834, 860 from
substantially rotating within the lumen 824 of the introducer tube
822 during movement into the extended positions and when the second
and third electrodes 834, 860 are in the extended positions as
shown in FIGS. 11A and 11B.
[0113] For example, in the medical device system 800 of FIGS. 11A
and 11B, the introducer tube 822 may have a neck portion with an
ovular hollow cross-section. Each of the second and third
electrodes 834, 860 may have corresponding cross-sections that fit
together through the neck portion, such as ovular or flat
cross-sections. As such, the second and third electrodes 834, 860
are keyed to the introducer tube 822 at least at the distal end 830
of the introducer tube 822. This is because the inner perimeter of
the neck portion of the introducer tube 822 corresponds to part of
the outer perimeters of the second and third electrodes 834, 860.
Thus, the portions of the second and third electrodes 834, 860 that
are disposed in the lumen 824 are prevented from substantially
rotating with respect to the introducer tube 822. In other words,
if the second and third electrodes 834, 860 began to rotate within
the lumen 824, the second and third electrodes 834, 860 would
contact an inner wall in the neck portion 852 of the introducer
tube 822 which may be provided with a keying feature and which may
prevent the second and third electrodes 834, 860 from further
rotation.
[0114] The first, second, and third electrodes 826, 834, 860 may be
used for multipolar electrode treatment. For example, electricity
may pass between the second and third electrodes 834, 860, the
second and third electrodes 834, 860 and the first electrode 826,
or any combination thereof. It is contemplated that more than two
electrodes may pass through an outer electrode and pass through a
keyhole and be correspondingly keyed such that they exit the distal
most end at a desired angle or set of angles.
[0115] Turning now to FIGS. 12 and 13A-13D, another example of a
coil 900 employed with a medical device system 920 is illustrated.
It should be understood that the medical device system 920 may be
used similarly to the medical device systems 120, 20, 320, 420 and
800, as well as the introducer tubes 222 and 522, described above,
if desired. In addition, the medical device system 920 may serve as
an electrode assembly, as described above. All other details not
described with respect to FIGS. 11A and 11B may be similar or the
same as the features described with respect to the examples in
FIGS. 1A-6 and 11A and 11B.
[0116] The medical device system 920 has an introducer tube 922,
which defines a lumen 924 therein. The introducer tube 922 bears a
first electrode 926. As such, the introducer tube 922 may itself be
the first electrode 926, as shown in FIGS. 13A-13D, or the first
electrode 926 may be attached to the introducer tube 922. The first
electrode 926 defines an opening 928 at a distal end 930 of the
first electrode 926. The first electrode 926 may be in the form of
a hollow needle having a piercing tip 932.
[0117] The coil 900 forms a second electrode 934 that is movably
disposed in the lumen 924 of the first electrode 926. FIGS. 13A-13D
illustrate extended positions of the second electrode 934, though
it should be understood that the second electrode 934 may be
retracted into retracted positions similar to that shown in FIG.
1A. In the retracted positions, the second electrode 934 is
disposed, or substantially disposed, within the lumen 924 of the
introducer tube 922. The portion of the second electrode 934
disposed in the lumen 924 includes an extended axial portion 938
with one or more twists 940. The second electrode 934 is movable
within the first electrode 926 and the introducer tube 922 between
the retracted positions (similar to FIG. 1A) and the extended
positions (illustrated in FIGS. 13A-13D). When it is desired to
extend the second electrode 934 from the first electrode 926, the
second electrode 934 may be pushed or otherwise moved through lumen
924 and out of the opening 928 of the distal end 930 of the
introducer tube 922. In the extended positions (FIGS. 13A-13D), the
second electrode 934 extends at least partially beyond the distal
end 930 of the first electrode 926. The second electrode 934 may
have a piercing end 950.
[0118] When the second electrode 934 is extended from the
introducer tube 922 and into the extended positions, the second
electrode 934 may curve or form a spiral, coil, or helix. As
described above with respect to FIGS. 1A-1C, the second electrode
934 may comprise a superelastic material (e.g., Nitinol), though
other materials may also be used. In the illustrated example, the
second electrode 934 forms a coil once deployed within the
patient's anatomy. The second electrode 934 may have, for example,
a flat, ribbon shape or an ovular shape. The second electrode 934
defines one or more helical turns 935. In this example, the second
electrode 934 has three helical turns 935 when extended as shown in
FIG. 13D, however, a greater number or smaller number of helical
turns 935 could be used alternatively.
[0119] The introducer tube 922 is configured to substantially hold
the second electrode 934 within the lumen 924 in predetermined
orientations in the extended positions. A proximal part 936 of the
second electrode 934 remains within the lumen 924 in the extended
most position (FIG. 13D), and the introducer tube 922 holds the
proximal part 936 in a predetermined angular orientation to prevent
the second electrode 934 from substantially rotating within the
lumen 924 of the introducer tube 922 during movement into the
extended positions and when the second electrode is in the extended
positions as shown in FIGS. 13A-13D.
[0120] In the configuration shown in FIGS. 13A-13D, the introducer
tube 922 has a keyway 952 positioned within the lumen 924 near the
distal end 930 of the introducer tube 922. As the second electrode
934 is pushed distally through the lumen 924, the coil 900 passes
through a keyhole in the keyway 952. Accordingly, as the twists 940
of the extended axial portion 938 pass through the keyhole, the
twists 940 form into helical turns 935 such that the second
electrode 934 deploys axially about its longitudinal axis as the
second electrode 934 turns into tissue.
[0121] The description of the invention is merely exemplary in
nature and variations that do not depart from the gist of the
invention are intended to be within the scope of the invention.
Such variations are not to be regarded as a departure from the
spirit and scope of the invention. For example, variations in the
various figures can be combined with each without departing from
the spirit and scope of the present disclosure.
[0122] For example, it should be understood that the embodiments
disclosed herein are merely examples, and variations may occur
without departing from the spirit and scope of the invention, as
defined by the claims. The specific illustrations are examples and
are not meant to limit the invention in any way.
[0123] The preferred embodiment of the present invention has been
disclosed. A person of ordinary skill in the art would realize,
however, that certain modifications would come within the teachings
of this invention. Therefore, the following claims should be
studied to determine the true scope and content of the
invention.
[0124] Any numerical values recited in the above application
include all values from the lower value to the upper value in
increments of one unit provided that there is a separation of at
least 2 units between any lower value and any higher value. As an
example, if it is stated that the amount of a component or a value
of a process variable such as, for example, temperature, pressure,
time and the like is, for example, from 1 to 90, preferably from 20
to 80, more preferably from 30 to 70, it is intended that values
such as 15 to 85, 22 to 68, 43 to 51, 30 to 32 etc. are expressly
enumerated in this specification. For values which are less than
one, one unit is considered to be 0.0001, 0.001, 0.01 or 0.1 as
appropriate. These are only examples of what is specifically
intended and all possible combinations of numerical values between
the lowest value and the highest value enumerated are to be
considered to be expressly stated in this application in a similar
manner.
[0125] Unless otherwise stated, all ranges include both endpoints
and all numbers between the endpoints, the use of "about" or
"approximately" in connection with a range apply to both ends of
the range. Thus, "about 20 to 30" is intended to cover "about 20 to
about 30", inclusive of at least the specified endpoints.
[0126] The disclosures of all articles and references, including
patent applications and publications, are incorporated by reference
for all purposes.
[0127] The term "consisting essentially of" to describe a
combination shall include the elements, ingredients, components or
steps identified, and such other elements ingredients, components
or steps that do not materially affect the basic and novel
characteristics of the combination.
[0128] The use of the terms "comprising" or "including" describing
combinations of elements, ingredients, components or steps herein
also contemplates embodiments that consist essentially of the
elements, ingredients, components or steps.
* * * * *