U.S. patent application number 13/050833 was filed with the patent office on 2011-07-07 for method of delivering energy to a lung airway using markers.
This patent application is currently assigned to Asthmatx, Inc.. Invention is credited to Timothy R. Dalbec, Noah Webster, William J. Wizeman.
Application Number | 20110166565 13/050833 |
Document ID | / |
Family ID | 39318966 |
Filed Date | 2011-07-07 |
United States Patent
Application |
20110166565 |
Kind Code |
A1 |
Wizeman; William J. ; et
al. |
July 7, 2011 |
METHOD OF DELIVERING ENERGY TO A LUNG AIRWAY USING MARKERS
Abstract
An energy delivery device for treating tissue regions in a body
conduit, such as a lung airway, may utilize one or more markers,
rings, bands, or other visual indicators along an outer surface of
the device body. The one or more visual indicators facilitate
guidance of the device to effectively and efficiently treat the
tissue according to a predetermined axial treatment as well as
measure extension of a distal portion of the device, tissue length,
and/or treatment length. The predetermined axial treatment may be
contiguous, overlapping, or intermittently spaced apart as
determined by the marker spacing distance.
Inventors: |
Wizeman; William J.; (Menlo
Park, CA) ; Dalbec; Timothy R.; (Saratoga, CA)
; Webster; Noah; (San Francisco, CA) |
Assignee: |
Asthmatx, Inc.
Sunnyvale
CA
|
Family ID: |
39318966 |
Appl. No.: |
13/050833 |
Filed: |
March 17, 2011 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
11551639 |
Oct 20, 2006 |
7931647 |
|
|
13050833 |
|
|
|
|
Current U.S.
Class: |
606/33 ;
606/41 |
Current CPC
Class: |
A61B 2018/00267
20130101; A61B 18/14 20130101; A61B 2090/3937 20160201; A61B
2018/00214 20130101; A61B 18/1492 20130101; A61B 2018/00541
20130101 |
Class at
Publication: |
606/33 ;
606/41 |
International
Class: |
A61B 18/18 20060101
A61B018/18; A61B 18/00 20060101 A61B018/00 |
Claims
1. An energy delivery device for use in a body conduit or cavity,
the device comprising: an elongate body having a proximal portion
with a proximal end and a distal portion with a distal end; an
energy delivery element disposed at the distal end of the elongate
body; and a plurality of visual indicators disposed on the distal
portion of the elongate body, wherein the visual indicators are
separated by a predetermined spacing distance so as to provide a
predetermined axial treatment in a body conduit or cavity.
2. The energy delivery device of claim 1, wherein the predetermined
axial treatment comprises contiguous, overlapping, intermittent, or
combination treatment thereof of the body conduit or cavity with
the energy delivery element.
3. The energy delivery device of claim 1, wherein the energy
delivery element comprises an electrode, wherein the predetermined
spacing distance comprises an active electrode length.
4. The energy delivery device of claim 1, wherein the predetermined
spacing comprises a distance in a range from about 3 mm to about 30
mm.
5. The energy delivery device of claim 1, wherein the predetermined
spacing comprises a distance of about 5 mm.
6. The energy delivery device of claim 1, wherein the plurality of
visual indicators comprise two circular bands or rings.
7. The energy delivery device of claim 1, wherein the plurality of
visual indicators comprise four circular bands or rings.
8. The energy delivery device of claim 1, wherein the plurality of
visual indicators comprise two identical markers.
9. The energy delivery device of claim 1, wherein the plurality of
visual indicators comprise two markers having different colors or
non-uniform configurations.
10. The energy delivery device of claim 1, wherein the elongate
body comprises a tubular sheath or shaft.
11. The energy delivery device of claim 1, further comprising a
proximal marker disposed on the proximal portion of the elongate
body.
12. A radio frequency energy delivery device for use in a lung
airway so as to treat asthma, the device comprising: an elongate
body having a proximal portion with a proximal end and a distal
portion with a distal end; a radio frequency electrode disposed at
the distal end of the elongate body; and a plurality of visual
indicators disposed on the distal portion of the elongate body,
wherein the visual indicators are separated by a predetermined
spacing distance so as to provide a predetermined axial treatment
in a lung airway so as to treat asthma.
13-27. (canceled)
Description
BACKGROUND OF THE INVENTION
[0001] Asthma is a disease in which bronchoconstriction, excessive
mucus production, and inflammation and swelling of airways occur.
This causes widespread variable airflow obstruction which makes it
difficult for an asthma sufferer to breathe. Asthma is a chronic
disorder, primarily characterized by persistent airway
inflammation. Asthma is further characterized by acute episodes of
additional airway narrowing via contraction of hyper-responsive
airway smooth muscle.
[0002] Asthma is traditionally managed pharmacologically by: (1)
long term control through use of anti-inflammatories and
long-acting bronchodilators and (2) short term management of acute
exacerbations through use of short-acting bronchodilators. Both of
these approaches require repeated and regular use of prescribed
drugs, which often present difficulties in patient compliance. High
doses of corticosteroid anti-inflammatory drugs can have serious
side effects that require careful management. In addition, some
patients are resistant to steroid treatment. The difficulty of
avoiding stimulus that triggers asthma is also a common barrier to
successful asthma management. As such, current management
techniques are neither completely successful nor free from side
effects.
[0003] Presently, a new treatment for asthma is showing promise.
This treatment comprises the application of energy to the airway
tissue. This treatment is described in more detail in commonly
assigned U.S. Pat. Nos. 6,411,852; 6,634,363; 7,027,869; 7,104,987
and U.S. Publication No. 2005/0010270, each of which is
incorporated herein by reference.
[0004] The application of energy to airway tissue, when performed
via insertion of a treatment device into the bronchial passageways,
requires navigation through tortuous anatomy as well as the ability
to treat a variety of sizes of bronchial passageways. As discussed
in the above referenced patents and applications, use of a radio
frequency (RF) energy delivery device provides one mechanism for
treating tissue within the bronchial passageways.
[0005] FIG. 1 illustrates a bronchial tree 90. As noted herein,
devices treating areas of the lungs desirably have a construction
that enables navigation through the tortuous passages. As shown,
the various bronchioles 92 decrease in size and have many branching
segments 96 as they extend into the right and left bronchi 94.
Accordingly, an efficient treatment utilizes devices that are able
to treat airways of varying sizes as well as function properly when
repeatedly deployed after navigating through the tortuous
anatomy.
[0006] In addition to considerations of navigation and site access,
there exists the matter of device orientation at the treatment
site. The treatment devices generally make contact or are placed in
close proximity to the target tissue. However, in utilizing the
treatment devices in a patient, visibility of the energy delivery
element, particularly depth perception, within the lung airways may
be relatively limited as viewed from an imaging lens of an access
device, such as a bronchoscope or endoscope. Limited visibility
combined with a variety of other factors, including airway movement
due to patient breathing, coughing, and/or wheezing (tidal motion)
as well as movement of the access device, may make it difficult to
ensure desired axial treatment of the lung airways with the energy
delivery device.
[0007] For example, in procedures where a relatively long region of
tissue is to be treated (e.g., longer than a length of the energy
delivery element), difficulty in ascertaining the amount of tissue
being treated may result in over-treatment of the same region or
non-treatment of the target region. In particular, as the energy
delivery element is translated from a first region to a second
region and so on, portions of the target tissue may be over-treated
or skipped entirely. Additionally, such conditions may result in
slower procedures that increase total procedure time and patient
discomfort.
[0008] In view of the above, methods and devices are desired for
treating tortuous anatomy such as the bronchial passages which
enable a user to effectively and efficiently treat tissue and
relocate an energy delivery device along one or more portions of
the tissue.
SUMMARY OF THE INVENTION
[0009] In treating tissue regions, such as within the lungs, a
treatment device may utilize an elongate sheath or shaft having a
plurality of markers, rings, bands, or other visual indicators
along an outer surface thereof so as to facilitate guidance of the
device to effectively and efficiently treat the tissue according to
a predetermined axial treatment. The predetermined axial treatment
may be contiguous (adjacent), overlapping, intermittently spaced
apart (gapping), or a combination thereof as determined by the
marker spacing, and as desired. The visual indicators may also
serve as a mechanism for measuring a depth of the treatment device,
the tissue length, and/or treatment length, as further described
below.
[0010] In one aspect of the present invention, an energy delivery
device such as an RF electrode basket may be advanced within a
working channel of an access device, such as a bronchoscope or
endoscope, until a final proximal marker, e.g., a fourth mark, is
extended outside the access device, such that the electrode basket,
or at least a proximal insulation thereof, and the markers are
visible via an imaging lens in the access device. The electrode
basket may be deployed into contact against the tissue to be
treated and then activated. The treatment device may then be pulled
proximally until the next adjacent mark, e.g., a third mark, is
reached. This process of activation and pulling proximally may be
repeated until a last mark is reached providing for a contiguous
and/or continuous axial treatment length of the tissue.
[0011] In another aspect of the present invention, the treatment
device which may be used in a body conduit, cavity, passageway, or
lumen, such as a lung airway, may generally comprise an elongate
body, an energy delivery element, and one or more visual
indicators. The elongate body comprises a proximal portion with a
proximal end and a distal portion with a distal end. The energy
delivery element may be disposed at the distal end of the elongate
body. The one or more visual indicators may be disposed on the
distal portion of the elongate body. Significantly, the visual
indicators are separated by a predetermined spacing distance so as
to provide the desired predetermined axial treatment in the body
conduit or cavity.
[0012] In yet another aspect of the prevent invention, the
treatment device may comprise a radio frequency energy delivery
device for use in a lung airway so as to treat asthma. The device
comprises an elongate body having a proximal portion with a
proximal end and a distal portion with a distal end. A RF electrode
is disposed at the distal end of the elongate body. A plurality of
visual indicators are disposed on the distal portion of the
elongate body, wherein the visual indicators are separated by a
predetermined spacing distance so as to provide a predetermined
axial treatment in a lung airway so as to treat asthma.
[0013] In a further aspect of the present invention, one method for
using the treatment device to deliver energy may generally comprise
positioning the access device having a visualization element within
a lung airway so as to access airways that are typically 3 mm (or
smaller) to 10 mm (or larger) in diameter, as can be properly
viewed with direct real-time visualization. The access device may
then be stabilized or anchored. The energy delivery device is
advanced within the access device so that at least one visual
indicator disposed on a distal portion of the energy delivery
device and proximal an energy element delivery element disposed on
a distal end of the energy delivery device is positioned outside
the access device as verified with the visualization element. The
visual indicators in turn will provide the desired predetermined
axial treatment in the lung airway with the energy delivery element
relative to the access device.
[0014] A further understanding of the nature and advantages of the
present invention will become apparent by reference to the
remaining portions of the specification and drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The following drawings should be read with reference to the
detailed description. Like numbers in different drawings refer to
like elements. The drawings, which are not necessarily to scale,
illustratively depict embodiments of the present invention and are
not intended to limit the scope of the invention.
[0016] FIG. 1 is an illustration of the airways within a human
lung.
[0017] FIG. 2 illustrates a schematic view of a treatment system
for delivering energy to tissue utilizing an expandable electrode
basket.
[0018] FIG. 3A illustrates a side view of the treatment device of
FIG. 2 extending distally from a bronchoscope, wherein the device
has an active distal end for treating tissue using energy
delivery.
[0019] FIG. 3B illustrates a variation of a treatment device
comprising an expandable body, such as a balloon, having one or
more electrodes disposed along its surface.
[0020] FIG. 4 illustrates an exemplary schematic view of an
expandable electrode basket projecting distally from an elongate
sheath having one or more markers delineated along its length and a
representative image on a monitor corresponding to an image as
viewed from the bronchoscope, wherein the spacing distance between
each adjacent marker corresponds to a length of the electrodes
located on the treatment device.
[0021] FIG. 5 illustrates the energy delivery device of FIG. 4
advanced into a bronchial airway and positioned for treatment upon
the tissue.
[0022] FIGS. 6A and 6B illustrates the treatment device advanced
distally within an airway lumen for treating the tissue and the
corresponding image from a bronchoscope on a monitor showing the
markers along the sheath.
[0023] FIGS. 7A and 7B illustrate the treatment device pulled
proximally along the tissue by a length corresponding to a length
between markers along the sheath such that the treatment device is
aligned to an adjacent region of tissue to be treated.
[0024] FIGS. 8A and 8B illustrate the treatment device pulled
further proximally along the tissue by a length corresponding to a
length between markers along the sheath such that the treatment
device is aligned to another adjacent region of tissue to be
treated.
[0025] FIG. 9A illustrates a variation of the sheath utilizing
dashed markers.
[0026] FIG. 9B illustrates another variation of the sheath
utilizing non-uniform markers.
[0027] FIG. 9C illustrates another variation of the sheath
utilizing markers which have a length between adjacent markers
which is less than a length of the electrodes on the treatment
device such that overlapping regions of tissue may be treated.
[0028] FIG. 9D illustrates yet another variation of the sheath
utilizing markers having graduated measurements therealong to
provide a visual indication of tissue or treatment length and/or
electrode basket depth.
[0029] FIG. 9E illustrates yet another variation of the sheath
utilizing markers having alternative colors, such as a green marker
to indicate treatment device deployment or a red marker to indicate
a maximum length of sheath extension.
[0030] FIG. 9F illustrates still another variation of the sheath
utilizing markers which have a length between adjacent markers
which is greater than a length of the electrodes on the treatment
device such that intermittent regions of tissue may be treated.
DETAILED DESCRIPTION OF THE INVENTION
[0031] It will be appreciated that the examples below discuss uses
in the airways of the lungs. However, unless specifically noted,
the devices and methods described herein are not limited to use in
the bronchial passageways. Instead, such devices and methods may
have applicability in various parts of the body, such as the upper
respiratory tract, trachea, esophagus, urethra, ureter, digestive
tract, cardiovascular system, circulatory system, arthroscopic,
brain, liver, etc. Moreover, the present invention may be used in
various procedures where the benefits of the device are
desired.
[0032] Generally, in treating tissue regions within the lungs, the
treatment device may utilize an elongate body, such as tubular
sheath, shaft, or catheter, having a plurality of markers, rings,
bands, or other visual indicators (e.g., circular or otherwise)
along an outer surface thereof. The plurality of visual indicators
facilitate guidance of the device to effectively and efficiently
treat the tissue according to a predetermined axial treatment. The
predetermined axial treatment may be contiguous, overlapping, or
intermittently spaced apart treatment of the lung airway walls with
the energy delivery element(s). The plurality of visual indicators
may also serve as a mechanism to measure a depth of the device,
tissue length, airway segment length, and/or treatment length.
[0033] In one example of operation, the treatment device, such as
an RF electrode basket assembly, may be advanced within a working
channel of an access device, such as a bronchoscope, until a final
proximal marker is extended distally from the access device while
under direct real-time visualization. With the treatment device and
the markers visible through the access device, the electrode basket
assembly may be deployed against the tissue to be treated and
activated. The treatment device may then be pulled proximally
relative to the access device until the next adjacent marker is
reached. The treatment device may then be activated to treat the
portion of tissue adjacent to the previously treated portion
without overlap (i.e., over-treatment of the same region) or
separation (i.e., non-treatment of target tissue) between the
adjacent portions of treated tissue. This process of activation and
pulling proximally may be repeated until the last mark is reached
providing for a continuous axial treatment where the target tissue
regions are neither over-treated nor skipped.
[0034] Referring now to FIG. 2, a schematic diagram of one example
of a treatment system 10 for delivering therapeutic energy to
tissue of a patient is illustrated. The system 10 comprises a power
supply having an energy generator 12, a controller 14 coupled to
the energy generator 12, and a user interface surface 16 in
communication with the controller 14. The system 10 further
includes an energy delivery device 20, a return electrode 40 (if
the system 10 employs a mono-polar RF configuration), and foot
actuation pedal(s) 42. It will be appreciated that the above
depictions are for illustrative purposes only and do not
necessarily reflect the actual shape, size, or dimensions of the
system 10 or device 20. This applies to all depictions
hereinafter.
[0035] The system 10 depicted in FIG. 2 shows the user interface
portion 16 having one or more connections 36, 44, 46 for the device
20, the return electrode 40 (optional), and the actuation pedal(s)
42 (optional) respectively. The user interface 16 may also include
visual prompts 48, 50, 52, 54 for user feedback regarding setup or
operation of the system 10. The user interface 16 may also employ
graphical representations of components of the system 10, audio
tone generators, as well as other features to assist the user with
system operation.
[0036] The controller 14 may be configured to deliver RF energy in
either a mono-polar or bi-polar configuration. In many variations
of the system 10, the controller 14 may include a processor 38 that
is generally configured to accept information from the system and
system components, and process the information according to various
algorithms to produce control signals for controlling the energy
generator 12. The processor 38 may also accept information from the
system 10 and system components, process the information according
to various algorithms and produce information signals that may be
directed to the visual indicators, digital display or audio tone
generator of the user interface in order to inform the user of the
system status, component status, procedure status or any other
useful information that is being monitored by the system. The
processor 38 of the controller 14 may be a digital IC processor,
analog processor, or any other suitable logic or control system
that carries out the control algorithms.
[0037] Detailed descriptions on the processor 38, user interface
16, and safety algorithms that are useful for the treatment of
asthma as discussed above may be found in commonly assigned U.S.
patent application Ser. No. 11/408,688, filed Apr. 21, 2006,
entitled CONTROL METHODS AND DEVICES FOR ENERGY DELIVERY, which is
incorporated herein by reference.
[0038] It is understood that the device 20 of the present invention
may be used with a variety of systems 10, having the same or
different components as described in FIG. 2. For example, although
the device 20 is described with reference to RF energy delivery
systems 10, variations of the device and system may include light
energy sources, laser systems, resistive heating systems, infrared
heating elements, microwave energy systems, focused ultrasound,
cryo-ablation, radiation, electrical stimulation, or any other
energy delivery system or configuration.
[0039] The energy delivery device 20 may include a flexible tubular
sheath 22, an elongate shaft 24 (in this example, the shaft 24
extends out from the distal end of the sheath 22), and a handle or
other optional operator interface 26 secured to a proximal end of
the sheath 22. The distal portion of the device 20 includes an
energy transfer element 28 for applying energy to the tissue of
interest. The energy transfer element 28, such as an expandable
electrode basket, may be advanced into and through the patient body
in an atraumatic low profile configuration. Upon reaching the
designed tissue region to be treated, the energy transfer element
28 may be expanded or reconfigured into a treatment configuration
which facilitates contact of the element 28 against the tissue to
be treated. In one example, the energy transfer element 28 may be
reconfigured via a pull wire 21 routed proximally through elongate
shaft 24 and/or flexible sheath 22 and affixed to a handle 26 and
actuated with a slide mechanism 34.
[0040] Additionally, the device 20 may includes a connector 30
common to such energy delivery devices. The connector 30 may be
integral to the end of a cable 32 coupled to the handle 26 or the
connector 30 may be fitted to receive a separate cable 32. In any
case, the device 20 is configured for attachment to the power
supply via some type of connector or adaptor plug 30. The elongate
shaft 24 and/or flexible sheath 22 may also be configured and sized
to permit passage through a working channel of a commercially
available bronchoscope or endoscope. However, the device 20 may
also be advanced into a body conduit or cavity with or without a
steerable catheter, in a minimally invasive procedure, in an open
surgical procedure, or with or without the guidance of various
vision or imaging systems.
[0041] The devices 20 of the present invention will have a
sufficient length and/or diameter and/or flexibility to access the
tissue targeted for treatment. For example, treating airways as
small as 3 mm in diameter may utilize the flexible sheath 22 and/or
elongate shaft 24 which is sufficiently long and sized in diameter
to reach deep into the lungs to treat the airways. Generally the
device shaft 24 and/or sheath 22 will have a length in range from
about 0.5 feet to about 8.0 feet and an expanded basket diameter 28
in a range from about 1 mm to about 25 mm, more preferably from
about 3 mm to about 10 mm. However, it is noted that this example
is merely illustrative and is not limiting in dimension or
flexibility.
[0042] Referring now to FIG. 3A, an example of an energy transfer
device 28 is illustrated as an expandable electrode basket. The
device 28 has one or more legs 60 configured in the form of a
basket 62 converging to an atraumatic common distal tip 68. The
basket 62 may reconfigure from an atraumatic low profile shape to
an expanded or deployed configuration to facilitate contact against
the tissue walls of a body conduit, cavity, passageway, or lumen,
such as a lung airway wall. Examples of such devices are described
in greater detail in commonly assigned U.S. Publication No.
2003/0233099, which is incorporated herein by reference.
[0043] The one or more legs 60 may be configured into the basket
shape 62 such that the legs 60 may expand radially during operation
to a working diameter as described above that will achieve contact
between the legs 60 having active electrode regions 64 and the
airway walls. The legs 60 may also include temperature sensors for
tissue temperature feedback to the controller 14. In this
configuration, four legs 60 are shown, however any number of legs
60 may be utilized to form the basket 62 (e.g., 2, 3, 4, 5, 6, 7,
8, 9, 10, etc.).
[0044] As illustrated in FIG. 3A, a pull wire 66 may extend through
a lumen of the elongate shaft body 24, to which the basket 62 may
be directly mounted. Pull wire 66 may be utilized to deliver energy
to the active electrodes 64 and/or assist basket 62 in expanding
into its deployed treatment configuration. The treatment device 62
may optionally be delivered to a treatment site directly through
the elongate delivery sheath or sleeve body 22. In still other
embodiments, pull wire 66 may be omitted entirely in which case
basket 62 may be expanded or deployed by utilizing one or more legs
60 which are fabricated as elastic, super-elastic, or shape memory
alloys (e.g., nickel-titanium alloys) which may self-expand from a
compressed configuration when removed from the elongate sheath 22.
In summary, basket 62 may expand upon activation by the user or it
may automatically expand when advanced out of a restraining sheath
22 or when the sheath 22 is withdrawn proximally from the basket
62.
[0045] The energy transfer device 28 is shown in association with a
bronchoscope access device 70. The elongate shaft 24 and flexible
sheath 22 are received within a working channel 72 of the
bronchoscope 70. Accordingly, the energy transfer device 28 may be
utilized along with an imaging lumen 76 and/or light optical fibers
74 of the bronchoscope 70. The imaging lumen 76 may utilize
visualization elements, such as CCD imaging or a camera lens. The
bronchoscope 70 may additionally comprise an aspiration lumen (not
shown).
[0046] Referring now to FIG. 3B, an alternative configuration of
the energy transfer device 80 is illustrated. The active member 80
is configured as a body 82 having a set diameter and length. One or
more electrodes 84 are shown secured to the body 82 through holes
86 or adhesives or other attachment mechanisms. The electrodes 84
may be oriented axially relative to the body 82 to optimize contact
along the tissue walls during treatment. The diameter of active
member 80 is set to correspond to that desired for treating a given
body lumen or passageway, such as lung airway. Accordingly, body 82
may be configured as an inflatable balloon member, an expandable
scaffold member, and the like, where the electrodes 84 will move
outward upon body 82 expansion.
[0047] Energy delivery devices 28, 80 of wire frames and/or basket
configurations will generally have its members (e.g., electrodes)
symmetrically deployed. This shape may be round, rounded, or
polygonal in cross section. These and other configurations,
including asymmetrical active member configurations, are described
in detail in U.S. patent application Ser. Nos. 11/255,796, filed
Oct. 21, 2005, entitled IMPROVED ENERGY DELIVERY DEVICES AND
METHODS and 11/420,438, filed. May 25, 2006, entitled MEDICAL
DEVICE WITH PROCEDURE IMPROVEMENT FEATURES, each of which is
incorporated herein by reference.
[0048] Referring now to FIG. 4, one variation of an exemplary
treatment device is shown which facilitates guidance of the
expandable electrode basket 62 so as to effectively and efficiently
treat tissue as desired, particularly relatively long portions of
tissue (e.g., regions of tissue longer than a length of the
electrode 64). In this embodiment, the basket 62 is disposed at the
distal end of the elongate sheath 22 which in turn is shown
projecting distally outward from the bronchoscope 70. One or more
visual indicators 100 are disposed along a length of the elongate
sheath 22 (or shaft 24), preferably on a distal portion of the
sheath 22 and proximal to the basket 62. Visual indicators 100 may
generally comprise one or more markers, rings, bands, and the like.
For example, a first marker 102 may be positioned proximally of
basket 62, a second marker 104 may be positioned proximally of
first marker 102, a third marker 106 may be positioned proximally
of second marker 104, and a fourth marker 108 may be positioned
proximally of third marker 106. In another variation, at least two
circular bands or rings may be utilized and in other variations,
four circular bands or rings may be utilized. It will be
appreciated that any number, type, and/or combination of markers,
rings or bands may be utilized in the present invention (e.g., 2,
3, 4, 5, 6, 7, 8, 9, 10, etc.).
[0049] Each marker 102, 104, 106, 108 may be uniformly spaced apart
from one another with each spacing matching the length of the
active electrodes 64 of basket 62. Thus, each spacing between
markers 102, 104, 106, 108 may be set to correspond to a length of
a active electrode 64 located centrally between proximal and distal
insulation regions 61, 63 of the basket leg 60. For instance,
active electrodes 64 having a length of 5 mm along basket 62 may
provide for a length of 5 mm between markers 102, 104, 106, 108. It
will be appreciated that the active electrode length 64 and
corresponding marker spacing of 5 mm is illustrative and other
lengths fewer than 5 mm or greater than 5 mm may also be utilized
as desired. For example, the predetermined spacing distance may
range anywhere from about 3 mm to about 30 mm, more preferably in a
range from about 5 mm to about 15 mm, depending on the active
electrode length, basket leg length, electrode array length
parallel to a longitudinal axis of the airway lumen, treatment
temperature, time, power, current, voltage, and/or energy settings,
and/or polarity configuration.
[0050] As mentioned above, in one variation the spacing between
these markers 102, 104, 106, 108 may each correspond to a length LE
of the active electrodes 64 on basket 62. For instance, a first
marker distance LS1 between first marker 102 and second marker 104,
a second marker distance LS2 between second marker 104 and third
marker 106, and a third marker distance LS3 between third marker
106 and fourth marker 108 may each correspond in length to the
length LE of active electrodes 64 on basket 62. Moreover, although
four markers are illustrated in this example, fewer than four or
more than four markers, as desired, may be utilized along the
length of elongate sheath 22 in alternative variations.
[0051] Bronchoscope 70 may be electrically coupled 110 to a monitor
112 and/or processor configured to display images 114 received from
imaging lumen 76. As represented on monitor 112, the displayed
image corresponds to an image as viewed from the perspective of
lumen 76 showing basket 62 projected from the elongate sheath 22.
Also illustrated are the visual markings 100 positioned along the
sheath 22.
[0052] Advantageously, the embodiment of FIG. 4 allows for the
amount of tissue being treated by the basket 62 to be easily
ascertained with reference to the visual markers 100. In
particular, markers 100 improve visibility and/or navigation of
locating and placing the treatment electrodes 64 so as to reliably
and uniformly apply predetermined axial treatments (e.g.,
continuous activation treatments). This in turn may reduce
physician effort or fatigue (e.g., less surgical technique
sensitive), total treatment procedure time, and/or patient
discomfort and improve procedure efficacy.
[0053] Referring now to FIGS. 5 through 8B, the basket 62 and
elongate sheath 22 may be deployed from bronchoscope 70 and
positioned distally of bronchoscope 70 along the tissue wall of a
bifurcated airway 96. In one example of use, basket 62 may be
deployed from bronchoscope 70 and advanced distally relative to
bronchoscope working channel 72, as shown in FIG. 6A, while
visualizing the passage of markers 102, 104, 106, 108 in monitor
112 directly in real-time, as illustrated in FIG. 6B. With basket
62 positioned, it may be expanded into contact against the
surrounding tissue wall 96 and the active electrodes 64 may be
activated to heat the airway tissue 120 along a treatment length
LE3. The treated tissue length LE3, extending between tissue
borders 122, 124, may correspond in length to third marker spacing
distance LS3 on elongate sheath 22.
[0054] Once the treatment is completed along tissue length LE3,
basket 62 may be retracted and withdrawn proximally relative to
bronchoscope 70 while visualizing on monitor 112 by one marker
length until the fourth marker 108 is no longer visible and third
marker 106 is verified as visible in the monitor 112, as shown in
FIG. 7B. Moving elongate sheath 22 by such a distance also
translates basket 62 proximally by one marker length LS3 and
correspondingly translates the active electrodes 64 to an adjacent
tissue region proximal to the previously treated tissue length LE3.
Once desirably positioned, basket 62 may then again be actuated so
as to deploy against the airway wall 96 and activated to heat the
airway tissue 121 along a treatment length LE2 which borders
treated tissue length LE3 contiguously without overlapping or
leaving any gap between the two treated tissue lengths, as shown in
FIG. 7A.
[0055] Once the tissue along tissue length LE2 has been treated,
basket 62 may once again be retracted and withdrawn proximally
relative to bronchoscope 70 by another marker length such that
third marker 106 is no longer visible and second marker 104 is
verified as visible on the monitor 112, as shown in FIG. 8B.
Accordingly, basket 62 is translated proximally by a corresponding
distance along the tissue such that the active electrodes 64 are
aligned between tissue borders 126 and 128. The basket 62 may then
be activated to treat the tissue region 123 along tissue length LE1
which borders treated tissue length LE2, as illustrated in FIG. 8A.
This process of deploying, activating, retracting, and pulling
proximally may be repeated, as desired, until first marker 102 is
reached or by pulling the bronchoscope 70 proximally with respect
to the sheath markers 100 and following the above steps relative to
the stationary bronchoscope 70. Thus, longer portions of the tissue
may be treated as desired.
[0056] The resulting treated tissue may be thus formed into a
contiguous length of treated tissue (e.g., LE1, LE2, LE3) which
avoids over-treating the tissue by avoiding overlapping regions and
avoids the formation of gaps between adjacent tissue lengths. Once
the treatment is completed, the basket 62 may be withdrawn
proximally into the bronchoscope working channel 72 for withdrawal
from the patient or advancement into another region of tissue to be
treated. Thus, if the length of the active electrode 64 is 5 mm and
the corresponding marker lengths LS1, LS2, LS3 are each 5 mm in
length, the tissue may be treated in increments of 5, 10, 15, 20 mm
or more in a contiguous manner depending upon the desired length of
tissue to be treated. The predetermined axial treatment (e.g., LE1,
LE2, LE3) may comprise treatment of the lung airways for a length
of at least 10 mm, preferably in a range from about 10 mm to about
75 mm, more preferably in a range from about 20 mm to about 30
mm.
[0057] It will be appreciated that there are several ways to use
the device of the present invention, and as such is not limited by
the above example. In an alternative method of use, elongate sheath
22 may be translated distally relative to bronchoscope 70 such that
the initial treatment is initiated when first marker 102 is
visualized. Accordingly, subsequent portions of tissue may be
treated by advancing the basket 62 distally relative to
bronchoscope 70 while viewing advancement of the markers on monitor
112. In yet another variation, the elongate sheath 22 and basket 62
may be initially advanced distally until the first marker 102,
second marker 104, or third marker 106 is exposed rather than being
fully advanced until the fourth marker 108 is exposed. Thus,
shorter portions of the tissue may be treated as desired.
[0058] Referring now to FIGS. 9A through 9F, although markers 100
may be identical, it will be appreciated that they may also be
varied in any number of configurations. For example, FIG. 9A
illustrates one variation where the markers 130, 132, 134, 136 may
be dashed rather than solid. Another variation is shown in FIG. 9B
where the markers may be non-uniform in width, or alternating in
width. For instance, markers 140, 144 may have a first width while
alternating markers 142, 146 may have a second width larger than
the first width.
[0059] In yet another variation, the markers 150, 152, 154, 156 may
be aligned to correspond to the active electrode length, as
described above. Additional half markers 158, 160, 162 may be
marked at, e.g., intermediate positions between markers 150, 152,
154, 156, to denote positions where portions of tissue may be
treated by overlapping the treatment regions, as shown in FIG.
9C.
[0060] Another variation is illustrated in FIG. 9D where markers
170, 172, 174, 176 may be graduated with length measurements, e.g.,
5 mm, 10 mm, 15 mm, 20 mm, etc., much like an endoscope to
facilitate measurement of basket 62 insertion depth or to
facilitate measurement of the tissue region (e.g., length of the
lung airway). In this manner, a portion of tissue or the depth in
which the treatment device is advanced may be ascertained by
directly visualizing the elongate sheath 22 extending from the
stationary bronchoscope 70. Although the measurement values are
illustrated in 5 mm increments corresponding to the length of the
active electrode 64 on the electrode basket 62, any number of
incremental values may be marked and delineated either in a
corresponding or even non-corresponding manner with respect to the
active electrodes, if so desired.
[0061] Referring now to FIG. 9E, an elongate sheath 22 having
markers which are in various colors to denote particular features
associated with that particular marking is illustrated. Although
the markers may be colored in the same color (e.g., black), various
colors may be utilized, particularly to indicate predetermined
device states. For example, marker 180 may comprise a first color
(e.g., green) to indicate that once marker 180 is visible,
electrode basket 62 is sufficiently advanced relative to the
bronchoscope 70 for expansion and/or activation. Additional markers
182, 184 may also comprise various colors as well while the
proximal marker 186 may also be colored in yet another color (e.g.,
red) as a visual indication that the elongate sheath 22 should not
be advanced any further distal into the airway lung.
[0062] In yet another variation, markers 171, 173, 175 (with
graduations 7 mm, 14 mm, 21 mm) may have a length between adjacent
markers which is greater than a length of the active electrodes 64
of the treatment device so that intermittent regions of tissue may
be treated, as shown in FIG. 9F. Still further, the sheath may have
a second set of markers 177, 179, 181, 183 that have a different
spacing distance, e.g., set to the active electrode 64 length, so
that a user may utilize a particular marker set based on a
particular anatomy section to be treated.
[0063] In these and other variations described herein, each of the
markers may be marked on the elongate sheath 22 in various
increments and are not limited to just the length of the active
electrodes 64, as described above in detail. Moreover, additional
markers may be utilized or as few as a single marker may be
utilized depending upon the desired visual indications.
[0064] The markers may also serve as a safety feature to discourage
the pre-mature deployment of the electrode basket 62 within the
bronchoscope 70. For example, the first proximal marker may serve
this purpose so as to prevent against any electrical discharge from
flowing proximally along the sheath 22, shaft 24 and/or
bronchoscope 70, which could potentially result in injury or harm
to the patient or user. Additionally, the final proximal marker,
which may be positioned along sheath 22 up to 75 mm or more, more
preferably up to 50 mm or 30 mm, from the electrode basket 62, may
also serve as a visual safety feature to ensure against advancing
the electrode basket 62 too deep into the patient body (i.e.,
beyond bronchoscopic vision), which in turn prevents against any
patient harm, such as puncturing of the airway wall into the
parenchyma, pneumothorax, pneumomediastinum, etc.
[0065] In yet another alternative, at least one of the markers may
also be aligned with an anatomical landmark within the lung airway
to provide not only for alignment of the device but also to
facilitate measurement of the lung airway, if so desired. For
example, a marker may be aligned with a particular airway
bifurcation, colored tissue, cartilage ring, tissue nodule, and the
like, so as to ensure against user disorientation due to tidal
motion or movement of the access device.
[0066] Referring back to FIG. 8B, it will be further appreciated
that the markers 102 further allow for user differentiation of the
sheath 22 from the insulated electrodes 61, 63, particularly the
proximal insulation regions of the basket legs 60. This
visualization is important to ensure proper deployment of the
basket electrode 62.
[0067] Although certain exemplary embodiments and methods have been
described in some detail, for clarity of understanding and by way
of example, it will be apparent from the foregoing disclosure to
those skilled in the art that variations, modifications, changes,
and adaptations of such embodiments and methods may be made without
departing from the true spirit and scope of the invention. For
example, the plurality of visual indicators may be located on the
device shaft, the energy delivery device may comprise a non-RF
source, and/or the expandable energy device may comprise an
inflatable balloon member. Still further, the markers of the
present invention may be positioned alternatively or additionally
on a proximal portion of the sheath or shaft that extends at least
partially outside the access device and patient. Proximal makers
may also facilitate quicker and more confident introduction of the
shaft into the access device by indicating a measurement of the
shaft within the access device. Reference to a singular element,
includes the possibility that there are plural of the same elements
present. More specifically, as used herein and in the appended
claims, the singular forms "a," "an," "said," and "the" include
plural referents unless the context clearly dictates otherwise.
Therefore, the above description should not be taken as limiting
the scope of the invention which is defined by the appended
claims.
* * * * *