U.S. patent application number 17/545109 was filed with the patent office on 2022-03-31 for medical devices and related methods.
This patent application is currently assigned to Boston Scientific Scimed, Inc.. The applicant listed for this patent is Boston Scientific Scimed, Inc.. Invention is credited to Niklas ANDERSSON, Ramon ESTEVEZ, Allyn JENSRUD, Gary JORDAN, Aidan McGLINCHEY, Paul SMITH, Mingxiang XU.
Application Number | 20220096154 17/545109 |
Document ID | / |
Family ID | 1000006013694 |
Filed Date | 2022-03-31 |
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United States Patent
Application |
20220096154 |
Kind Code |
A1 |
SMITH; Paul ; et
al. |
March 31, 2022 |
MEDICAL DEVICES AND RELATED METHODS
Abstract
A medical device includes a shaft including a lumen configured
to direct a flow of fluid through the shaft and an electrode. A
proximal end of the electrode and a distal end of the shaft form a
coupling configured to releasably couple the proximal end of the
electrode with the distal end of the shaft. When the proximal end
of the electrode is coupled to the distal end of the shaft, fluid
delivered through the lumen is emitted from the electrode.
Inventors: |
SMITH; Paul; (Smithfield,
RI) ; McGLINCHEY; Aidan; (Dallas, TX) ;
JENSRUD; Allyn; (Brookline, MA) ; ESTEVEZ; Ramon;
(Lowell, MA) ; XU; Mingxiang; (Wayland, MA)
; ANDERSSON; Niklas; (Wayland, MA) ; JORDAN;
Gary; (Litchfield, NH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Boston Scientific Scimed, Inc. |
Maple Grove |
MN |
US |
|
|
Assignee: |
Boston Scientific Scimed,
Inc.
Maple Grove
MN
|
Family ID: |
1000006013694 |
Appl. No.: |
17/545109 |
Filed: |
December 8, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
16111818 |
Aug 24, 2018 |
11224480 |
|
|
17545109 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 25/0082 20130101;
A61B 18/1492 20130101; A61M 2205/054 20130101; A61B 2218/002
20130101 |
International
Class: |
A61B 18/14 20060101
A61B018/14; A61M 25/00 20060101 A61M025/00 |
Claims
1-18. (canceled)
19. A method, comprising: coupling a first electrode with a first
structure to a distal end of a medical device shaft, wherein the
coupling includes releasably coupling an internal component of the
medical device shaft to a portion of the first electrode;
uncoupling the first electrode from the distal end; and coupling a
second electrode with a second structure to the distal end, wherein
the second structure is different than the first structure.
20. The method of claim 19, wherein uncoupling the first electrode
includes an action on a medical device handle coupled to a proximal
end of the shaft, wherein the action on the medical device handle
retracts one or more arms causing the one or more arms to expand
and uncouple the arms from a proximal portion of the first
electrode.
21. The method of claim 20, wherein the one or more arms are biased
radially outward.
22. The method of claim 19, wherein the first electrode includes a
first fluid flow path, and wherein the second electrode includes a
second fluid flow path having a shape different from a shape of the
first fluid flow path.
23. The method of claim 22, wherein the first fluid flow path
includes a radial flow path, and wherein the second fluid flow path
extends at an acute angle relative a central longitudinal axis of
the distal end of the medical device shaft.
24. The method of claim 19, wherein the first electrode includes a
first insulation pattern, and wherein the second electrode includes
a second insulation pattern different from the first insulation
pattern.
25. The method of claim 24, wherein the first insulation pattern
includes a rounded annular insulation pattern on a distal end face
of the first electrode, and wherein the second insulation pattern
includes a dotted insulation pattern on a distal end face of the
second electrode.
26. The method of claim 19, wherein uncoupling the first electrode
from the distal end includes an action on a medical device handle,
and wherein coupling the second electrode to the distal end
includes inserting the distal end of the medical device shaft into
an opening of a cartridge, wherein the opening of the cartridge
retains the second electrode.
27. The method of claim 26, wherein the cartridge includes a
plurality of openings, with each opening retaining a different
electrode with a different fluid flow path and/or a different
insulation pattern.
28. The method of claim 19, further comprising, before uncoupling
the first electrode from the distal end, energizing at least a
portion of the first electrode.
29. The method of claim 28, wherein energizing at least a portion
of the first electrode includes an action on a switch on a
handle.
30. The method of claim 29, wherein the switch is a slide switch
that is movable between different positions, wherein the different
positions of the slide switch correspond to different operational
states of the first electrode.
31. The method of claim 30, wherein the first electrode includes a
first conductive member and a second conductive member, wherein the
different operational states include a first operational state in
which neither the first conductive member nor the second conductive
member of the first electrode is energized, a second operational
state in which the first conductive member of the first electrode
is energized and the second conductive member of the first
electrode is not energized, a third operational state in which the
second conductive member of the first electrode is energized and
the first conductive member of the first electrode is not
energized, and a fourth operational state in which both the first
conductive member and the second conductive member of the first
electrode are energized.
32. A method, comprising: coupling a first electrode with a first
structure to a distal end of a medical device shaft, wherein the
coupling includes releasably coupling an internal component of the
medical device shaft to a portion of the first electrode;
uncoupling the first electrode from the distal end; and coupling a
second electrode with a second structure to the distal end, wherein
the second structure includes a shape of a fluid flow path and/or
an insulation pattern that is different from a shape of a fluid
flow path and/or an insulation pattern than the first
structure.
33. The method of claim 32, wherein uncoupling the first electrode
includes an action on a medical device handle coupled to a proximal
end of the medical device shaft, wherein the action on the medical
device handle retracts a plurality of arms causing the plurality of
arms to expand and uncouple the plurality of arms from a proximal
portion of the first electrode, and wherein the plurality of arms
are biased radially outward.
34. The method of claim 32, wherein the first electrode includes a
radial flow path, and wherein the second electrode includes a fluid
flow path that extends at an acute angle relative a central
longitudinal axis of the distal end of the medical device shaft
35. The method of claim 34, wherein the first electrode includes a
rounded annular insulation pattern on a distal end face of the
first electrode, and wherein the second electrode includes a dotted
insulation pattern on a distal end face of the second
electrode.
36. The method of claim 35, further comprising, before uncoupling
the first electrode from the distal end, energizing at least a
portion of the first electrode, and after coupling the second
electrode to the distal end, energizing at least a portion of the
second electrode.
37. A method, comprising: coupling a first electrode with a first
structure to a distal end of a medical device shaft, wherein the
coupling includes releasably coupling one or more radially biased
arms of the medical device shaft to a portion of the first
electrode; energizing at least a portion of the first electrode;
and uncoupling the first electrode from the distal end by
retracting the one or more radially biased arms.
38. The method of claim 37, further comprising: coupling a second
electrode with a second structure to the distal end via the one or
more radially biased arms, wherein the second structure is
different than the first structure; and energizing at least a
portion of the second electrode, wherein the first electrode
includes a rounded annular insulation pattern on a distal end face
of the first electrode, and wherein the second electrode includes a
dotted insulation pattern on a distal end face of the second
electrode.
Description
TECHNICAL FIELD
[0001] Aspects of the present disclosure generally relate to
medical devices and related methods. In particular, aspects of the
present disclosure relate to medical devices and related methods
configured for the treatment of tissue by delivering electrical
energy to or into tissue, and injecting fluid into and/or under
tissue, with one or more electrodes.
BACKGROUND
[0002] Medical devices, such as endoscopes or other suitable
insertion devices, are employed for a variety of types of
diagnostic and surgical procedures, such as endoscopy, laparoscopy,
arthroscopy, gynoscopy, thoracoscopy, cystoscopy, etc. Many of
these procedures involve delivering energy to tissue of an organ or
a gland to treat tumors, infections, and the like. Examples of such
procedures include Endoscopic Mucosal Resection (EMR), Endoscopic
Sub-mucosal Resection (ESR), Endoscopic Sub-mucosal Dissection
(ESD), polypectomy, mucosectomy, etc. In particular, such
procedures may be carried out by inserting an insertion device into
a subject's body through a surgical incision, or via a natural
anatomical orifice (e.g., mouth, vagina, or rectum), and performing
the procedure or operation at a target site with an auxiliary
device inserted through the insertion device.
[0003] At times, during a medical procedure, a user may use an
injection needle and an energy delivery device for purposes of
raising, separating, flushing, cutting, dissecting, ablating,
marking, coagulating, cauterizing, or otherwise treating tissue.
The injection and energy delivery may be performed separately. For
example, in order to deliver energy to the tissue, the user may be
required to remove the injection needle from the insertion device
and deliver the energy delivery device through the insertion device
to the tissue being targeted, and vice versa. During the procedure,
the user may alternate using the injection needle and the energy
delivery device, and exchange of devices may increase the duration
and risks of the medical procedure. Additionally, instances may
arise where the type of injection needle needed may change. Also,
in some instances, the type of energy delivery device needed may
change. This may further increase the duration of the medical
procedure and/or limit the types of procedures that may be
performed.
[0004] The devices and methods of the current disclosure may
rectify some of the deficiencies described above or address other
aspects of the prior art.
SUMMARY
[0005] Examples of the present disclosure relate to, among other
things, medical devices configured for treating tissue by
delivering electrical energy to the tissue, and configured for
delivering fluid into and/or under the tissue. The devices may
involve the use of different electrodes, for example, ones with
different fluid flow paths, insulation patterns, and/or other
characteristics. The present disclosure also relates to methods of
assembling the devices, operating the devices, and/or performing
procedures with the devices. Each of the examples disclosed herein
may include one or more of the features described in connection
with any of the other disclosed examples.
[0006] In one example, a medical device may include a shaft
including a lumen configured to direct a flow of fluid through the
shaft and an electrode. A proximal end of the electrode and a
distal end of the shaft may form a coupling configured to
releasably couple the proximal end of the electrode with the distal
end of the shaft. When the proximal end of the electrode is coupled
to the distal end of the shaft, fluid delivered through the lumen
may be emitted from the electrode.
[0007] The medical device may further include one or more of the
following features. The coupling may include one or more arms
positioned within the distal end of the shaft. Each of the one or
more arms may include a protrusion. Each of the one or more arms
may further include at least one of an angled portion at a proximal
end of the protrusion and an angled portion at a distal end of the
protrusion, and the at least one angled portion may be angled
relative to a central longitudinal axis of the distal end of the
shaft. The electrode may include one or more receivers configured
to receive the one or more arms. The one or more receivers may be
radially wider than a portion of the electrode distal to the one or
more receivers, and/or than a portion of the electrode proximal to
the one or more receivers. The medical device may further include
one or more seals configured to form a fluid tight seal between the
electrode and the shaft. With the electrode coupled to the one or
more arms, the one or more seals may sealingly engage surfaces of
the electrode and the shaft to direct fluid from the lumen to the
electrode.
[0008] The distal end of the shaft may include one or more arms.
The one or more arms may be biased to move radially outwardly, and
the one or more arms may be longitudinally movable within the
distal end. The medical device may further include at least one
biasing member configured to bias the arms distally within the
distal end of the shaft. The distal end of the shaft may include a
central passage with an angled portion that narrows distally. The
angled portion may be configured to force the one or more arms
radially inwardly as the one or more arms move distally within the
distal end of the shaft. The shaft may include a coupling tube with
a distal coupling portion configured for securing to the proximal
end of the electrode. The distal coupling portion may comprise an
elastomeric polymer material configured to couple the coupling tube
to the electrode, and to form a seal between coupling tube and the
electrode that facilitates fluid flow from the lumen to the
electrode. The electrode may include an insulator that only
partially covers a distal end face of the electrode. The electrode
may include an outlet in the distal end face, and the insulator may
include a plurality of protrusions projecting from the distal end
face about the outlet. The electrode may include a first conductive
member and a second conductive member. The first conductive member
and the second conductive member may be electrically separated by
an insulating member. The medical device may include a conductor
that is longitudinally movable to contact and deliver energy to the
first conductive member or to the second conductive member.
[0009] In another example, a medical device kit may include a
medical device including a handle, and a shaft extending distally
from the handle, wherein the shaft includes a lumen. The medical
device kit may also include a plurality of electrodes. The shaft
may include a distal end having a mechanism therein configured for
securing one of the plurality of electrodes to the distal end of
the shaft, releasing the one of the electrodes from the distal end
of the shaft, and securing another of the electrodes to the distal
end of the shaft.
[0010] The medical device kit may further include one or more of
the following features. At least two of the electrodes may differ
in structure, and coupling different electrodes of the plurality of
electrodes to the shaft may change a fluid flowpath of the medical
device. When one of the at least two electrodes is coupled to the
distal end of the shaft, fluid delivered through the central lumen
may be delivered through the coupled electrode, movement of a
portion of the handle may control movement of the coupled
electrode, and electrical energy delivered through the shaft may be
delivered to tissue through the coupled electrode. The distal end
of the shaft may include one or more arms each including a
protrusion, an angled portion proximal to the protrusion, and an
angled portion distal to the protrusion. Each of the plurality of
electrodes may include a receiver portion that is radially wider
than a portion of the electrode distal to the receiver portion and
a portion of the electrode proximal to the receiver portion. The
protrusion may engage the receiver portion.
[0011] In a further example, a method may include coupling a first
electrode with a first structure to a distal end of a medical
device shaft, and the coupling may include releasably coupling an
internal component of the medical device shaft to a portion of the
first electrode. The method may further include uncoupling the
first electrode from the distal end, and coupling a second
electrode with a second structure to the distal end, where the
second structure is different than the first structure.
[0012] The method may further include one or more of the following
features. Uncoupling the first electrode may include an action on a
medical device handle coupled to a proximal end of the shaft. The
action on the medical device handle may retract one or more arms
causing the one or more arms to expand and uncouple the arms from a
proximal portion of the first electrode.
[0013] It may be understood that both the foregoing general
description and the following detailed description are exemplary
and explanatory only and are not restrictive of the disclosure, as
claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] The accompanying drawings, which are incorporated in and
constitute a part of this specification, illustrate exemplary
aspects of the present disclosure and together with the
description, serve to explain the principles of the disclosure.
[0015] FIG. 1A illustrates an exemplary medical device, and FIG. 1B
illustrates a cross-sectional view of the medical device, according
to aspects of this disclosure.
[0016] FIGS. 2A and 2B illustrate views of a distal portion of the
medical device of FIG. 1A in different operational states,
according to aspects of the present disclosure.
[0017] FIGS. 3A-3D illustrate cross-sectional views of various
electrodes of the distal portion of the medical device, according
to aspects of the present disclosure.
[0018] FIG. 4 illustrates a cross-sectional view of an exemplary
coupling arrangement configured for releasably coupling electrodes
of the distal portion of the medical device, according to aspects
of the present disclosure.
[0019] FIGS. 5A and 5B illustrate partially cutaway views of
another exemplary coupling arrangement configured for releasably
coupling electrodes of the distal portion of the medical device,
according to aspects of the present disclosure.
[0020] FIGS. 6A and 6B illustrate a perspective view and a
cross-sectional view, respectively, of an exemplary electrode,
according to aspects of the present disclosure.
[0021] FIGS. 7A and 7B illustrate a perspective view and a
cross-sectional view, respectively, of another exemplary electrode,
according to aspects of the present disclosure.
[0022] FIGS. 8A-8C illustrate perspective views of other exemplary
electrodes, according to further aspects of the present
disclosure.
[0023] FIGS. 9A and 9B illustrate a perspective view of an
exemplary distal portion of the medical device, and a
cross-sectional view of the electrode of the distal portion,
respectively, according to aspects of the present disclosure.
[0024] FIG. 10 illustrates a perspective view of an exemplary
cartridge that may store one or more exemplary electrodes,
according to further aspects of the present disclosure.
[0025] FIGS. 11A-11C illustrate exemplary steps to couple one or
more exemplary electrodes stored in an exemplary cartridge, similar
to the cartridge of FIG. 10, to a distal end of a medical device,
according to further aspects of the present disclosure.
[0026] FIGS. 12A and 12B illustrate a perspective and a
cross-sectional view of a further exemplary electrode, according to
further aspects of the present disclosure.
[0027] FIG. 13 illustrates a perspective view of a portion of a
further exemplary medical device, according to further aspects of
the present disclosure.
[0028] FIGS. 14A-14D illustrate various arrangements of an actuator
on the medical device of FIG. 13, and the corresponding
configurations of an exemplary electrode, according to further
aspects of the present disclosure.
[0029] FIGS. 15A and 15B illustrate perspective views of additional
electrode configurations, according to further aspects of the
present disclosure.
DETAILED DESCRIPTION
[0030] Examples of the present disclosure include devices and
methods for: facilitating and improving the efficacy, efficiency,
and safety of treating tissue when, for example, applying
electrical energy to tissue; and delivering fluid into and/or under
tissue during a medical procedure. For example, aspects of the
present disclosure may provide a user (e.g., physician, medical
technician, or other medical service provider) with the ability to
apply electrical energy or heat to tissue using a medical device
having an electrode, and to deliver fluid into and/or under tissue
with the same medical device. Additionally, aspects of the present
disclosure may provide the user with the ability to deliver fluid
through one or more outlets, with the fluid being diverted on its
way to the outlets (e.g., delivered at an angle relative to a
central longitudinal axis of the electrode), thereby changing the
fluid flowpath. Other aspects of the present disclosure may allow
the user to change the electrode to a different electrode, for
example, one with a different outlet position and/or arrangement,
thereby changing the flowpath of fluid from the medical device.
Additional aspects of the present disclosure may allow the user to
change the electrode to a different electrode with a different
insulation pattern, thereby changing the treatment effect on the
treated tissue. Additional aspects of the present disclosure may
allow the user to change the electrode to any other electrode
having at least one different characteristic, even if, for example,
the flowpath and/or insulation pattern is similar. Some aspects of
the present disclosure may be used in performing an endoscopic,
laparoscopic, arthroscopic, gynoscopic, thoracoscopic, cystoscopic,
or other type of procedure.
[0031] Reference will now be made in detail to examples of the
present disclosure described above and illustrated in the
accompanying drawings. Wherever possible, the same reference
numbers will be used throughout the drawings to refer to the same
or like parts.
[0032] The terms "proximal" and "distal" are used herein to refer
to the relative positions of the components of an exemplary medical
device. When used herein, "proximal" refers to a position
relatively closer to the exterior of the body of a subject or
closer to a user, such as a medical professional, holding or
otherwise using the medical device. In contrast, "distal" refers to
a position relatively further away from the medical professional or
other user holding or otherwise using the medical device, or closer
to the interior of the subject's body. As used herein, the terms
"comprises," "comprising," "having," "including," or other
variations thereof, are intended to cover a non-exclusive
inclusion, such that a device or method that comprises a list of
elements does not include only those elements, but may include
other elements not expressly listed or inherent thereto. Unless
stated otherwise, the term "exemplary" is used in the sense of
"example" rather than "ideal." As used herein, the terms "about,"
"substantially," and "approximately," indicate a range of values
within +/-10% of a stated value.
[0033] FIG. 1 depicts a medical device 10 that includes a handle
12, a shaft 14, and a distal end 16. Handle 12 may include a main
body 18 and a movable body 20. Handle 12 also may include a port 22
configured to receive fluid, and a hub 24 configured to receive
electrical energy similar to an electrical plug or socket. Distal
end 16 includes an electrode 26. Electrode 26 is electrically
connected to hub 24, and may include one or more lumens, passages,
recesses, or other surfaces (FIGS. 3A-3D) fluidly connected to, or
otherwise in fluid communication with, port 22. Medical device 10
may be inserted into a body lumen of a subject, either through an
insertion device (not shown) or alone, such that at least a portion
of shaft 14 may be within the subject, while handle 12 may remain
outside of the subject. From outside of the subject, a user can
manipulate handle 12. Movement of movable body 20 relative to main
body 18 in a first direction (e.g., the distal direction) may
extend electrode 26 relative to shaft 14 (e.g., move electrode 26
distally relative to a distal end of shaft 14), while movement of
movable body 20 relative to main body 18 in a second direction
(e.g., the proximal direction) may retract electrode 26 relative to
shaft 14 (e.g., move electrode 26 proximally relative to a distal
end of shaft 14).
[0034] Handle 12 may be coupled to a fluid source via port 22. Port
22 may be in fluid communication with electrode 26 via an internal
lumen 27 in shaft 14 (FIG. 1B). Internal lumen 27 may extend
longitudinally through main body 18 of handle 12, and port 22 may
include a port lumen 22A that extends through port 22 to fluidly
connect port 22 to internal lumen 27. Port 22 may be positioned on
a distal portion of main body 18. Alternatively, port 22 may be
positioned on movable body 20. Moreover, port 22 may include a
one-way valve 28, a luer, a seal, threading 30, and/or any
appropriate element to maintain a secure connection between handle
12 and the fluid source, minimize or prevent back-flow (e.g., fluid
flowing proximally out of port 22), and/or minimize or prevent
leakage. In one example, one-way valve 28 may include an outer
housing containing an inner elastomeric and/or gelatinous sealing
member (not shown).
[0035] Handle 12 may be coupled to an energy source through hub 24.
Hub 24 may be electrically coupled to electrode 26 via a conductive
element 33 in shaft 14. The energy source may be an electrocautery
source, a radio frequency generator, a heating source, a current
generator, etc. In one aspect, medical device 10 may be used for
monopolar electrosurgery, and may include a return electrode
positioned remotely from electrode 26 on the subject. In another
aspect, medical device 10 may be used for bipolar electrosurgery.
In that instance, electrode 26 may include an active electrode
portion, and a return electrode may be provided at or near another
portion of electrode 26 and/or shaft 14. In one example, two
conductive elements may run through shaft 14, where the conductive
elements may be electrically isolated from each other, allowing one
to conduct energy to the active electrode and the other to conduct
energy from a return electrode. Hub 24 may be positioned on movable
body 20 and may include one or more pins or prongs 32 to couple to
the energy source. Alternatively, hub 24 may be positioned on main
body 18.
[0036] In one aspect shown in FIG. 1B, prong 32 may extend through
hub 24 transverse to a longitudinal axis of handle 12, and may be
electrically and physically connected to conductive element 33,
such as a wire, a cable, and/or a braided sheath. Conductive
element 33 may be electrically conductive or include an
electrically conductive element, and conductive element 33 may
extend longitudinally through internal lumen 27 and through shaft
14. As shown in FIG. 1B, fluid delivered through port 22 may
surround at least a portion of conductive element 33. In another
aspect, the energy source may be a part of handle 12 (e.g., an
internal battery in handle 12). As alluded to above, a second
conductive element (not shown) may be provided as a return pathway
where medical device 10 has a bipolar configuration.
[0037] As mentioned, handle 12 may control the extension or
retraction of electrode 26 relative to the distal end 16 of shaft
14. For example, main body 18 may include a slot 34 and a thumb
ring 36. Movable body 20 may be slidably positioned within slot 34
and include one or more finger holes 38. Movable body 20 may be
lockable in one or more positions relative to main body 18. Movable
body 20 may be coupled to a drive element, and the drive element
may impart distal or proximal movement to at least a portion of
electrode 26 based on relative movement between main body 18 and
movable body 20. In one aspect, conductive element 33 may also act
as a drive wire, rod, cable, or the like, such that conductive
element 33 imparts distal or proximal movement to at least a
portion of electrode 26 while also coupling electrode 26 to hub 24,
e.g., the one or more prongs 32, to deliver the energy to (and/or
from) electrode 26.
[0038] As shown in FIGS. 1A and 1B, shaft 14 extends from a distal
portion of main body 18 to distal end 16, and may surround at least
a portion of electrode 26. Shaft 14 may be coupled to handle 12 via
a coupler 40, which may surround a portion of shaft 14 and screw
onto main body 18 to secure the elements. Shaft 14 may be a sheath
that surrounds at least a portion of one or more lumens (e.g.,
lumen 27) and the drive wire (e.g., conductive element 33). In
another aspect, shaft 14 may be an extrusion that includes one or
more lumens extending from handle 12 to distal end 16.
[0039] FIGS. 2A and 2B illustrate additional aspects of distal end
16. It is noted that FIGS. 2A and 2B illustrate the internal
components of distal end 16, without showing the distal portion of
shaft 14 that may radially surround at least a portion of distal
end 16. FIGS. 2A and 2B show perspective views of a portion of
distal end 16, with a portion of electrode 26 positioned within an
end cap 42 of distal end 16. End cap 42 may include a distal end
face 44 and graduated surfaces 46, 48, and 50. End cap 42 may be at
least partially electrically insulating. For example, end cap 42
may be formed of a ceramic material or another non-conductive
material. Alternatively, only distal end face 44 and an internal
portion of end cap 42 that contacts and/or surrounds electrode 26
may be electrically insulating. Distal end face 44 includes a
central opening 52 (FIG. 2B) through which electrode 26 may extend
and retract.
[0040] Electrode 26 may be coupled to a proximal support 54 of
distal end 16, which includes a cylindrical extension 56. Proximal
support 54 may be coupled to a portion of the drive wire (e.g.,
conductive element 33) via a wire receiving portion 57 (FIGS.
3A-3D). Cylindrical extension 56 may extend distally and may
receive at least a portion of electrode 26. As discussed in detail
below, electrode 26 and cylindrical extension 56 may be coupled via
a snap fit, friction fit, threading, an elastomeric and/or adhesive
material, or other suitable coupling. Cylindrical extension 56 may
allow for different electrodes 26 to be removably coupled to distal
end 16.
[0041] Electrode 26 and proximal support 54 may be movable relative
to end cap 42 in response to the relative movement of movable body
20 and main body 18 of handle 12. For example, with movable body 20
in a proximal position relative to main body 18, electrode 26 may
be substantially retracted within end cap 42 with only a distal
portion of electrode 26 extending distally beyond end cap 42 (FIG.
2A). Then, as movable body 20 is translated distally relative to
main body 18, electrode 26 and proximal support 54 translate
distally relative to end cap 42 such that a greater portion of
electrode 26 extends distally beyond end cap 42 through central
opening 52 (FIG. 2B).
[0042] Alternatively, although not shown in the figures, with
movable body 20 in the proximalmost position, electrode 26 may be
fully retracted within central opening 52 of end cap 42. It is
noted that while central opening 52 is shown in FIG. 2B as being
smaller than a portion of electrode 26, this disclosure is not so
limited, and central opening 52 and electrode 26 may include
various sizes and arrangements. For example, central opening 52 may
be wider than electrode 26 such that electrode 26 may be fully
retracted within central opening 52. Such a configuration may be
advantageous, for example, in versions of medical device 10 in
which fluid flows along the outer surface of electrode 26.
Alternatively, central opening 52 may be narrower than a distal
portion of electrode 26 such that the distal portion of electrode
26 may always remain partially extended from central opening
52.
[0043] In one aspect, electrode 26 is releasably coupled to the
rest of distal end 16. As shown in FIG. 3A, electrode 26A may be
snap-fit to an internal portion of distal end 16. For example,
distal end 16 may include one or more fastening portions 58
extending from and/or coupled to cylindrical extension 56. A
proximal portion of electrode 26A may include one or more reception
portions 60 including, for example, one or more distal widened
portions and/or one or more indentations, which may be shaped to
receive the one or more fastening portions 58. For instance, each
fastening portion 58 may include a distal angled portion 62 and a
protrusion 64. As electrode 26A is inserted into the rest of distal
end 16, a proximal portion of electrode 26A may contact distal
angled portions 62, and relative movement between the two may push
fastening portion(s) 58 radially outward, such that the proximal
portion of electrode 26A may be releasably received within or
between fastening portions 58. Further movement of electrode 26A
proximally (and/or the rest of distal end 16 distally) may bring
protrusions 64 into engagement with reception portion 60 of
electrode 26A, thereby securing electrode 26A. In one example, one
or more fastening portions 58 may include one or more cantilevered
arms extending distally from an annular base enveloping cylindrical
extension 56, such as a single cantilevered arm, a pair of
cantilevered arms projecting from opposite sides of the base, or
more than two cantilevered arms projecting from any suitable
location on the base. Alternatively, one or more fastening portions
58 may include a compliant sheath enveloping cylindrical extension
56, the sheath having a distal rim portion with distal angled
portions 62. It also is contemplated that one or more fastening
portions 58 may be integrally formed with proximal support 54.
[0044] Distal end 16 includes one or more seals 66 to help ensure
that fluid delivered through lumen 27 is directed through electrode
26A. In one aspect, distal end 16 may include a compressible and/or
expandable seal 66. For example, seal 66 may be a circular ring of
elastomeric material positioned on a distal end of cylindrical
extension 56 such that positioning electrode 26A within the one or
more fastening portions 58 ensures that electrode 26A abuts and/or
compresses seal 66. As such, fluid delivered via lumen 27 may be
delivered through an electrode lumen 70 and out of outlets 72 of
electrode 26A. In one aspect, proximal support 54, cylindrical
extension 56, and fastening portion 58 are conductive such that
electrical energy delivered via conductive element 33 may be
delivered to or into tissue via electrode 26A.
[0045] As mentioned, electrode 26A is removably coupled to distal
end 16. For example, pulling electrode 26A distally relative to the
rest of distal end 16, and/or pulling the rest of distal end 16
proximally relative to electrode 26A, may expand fastening portions
58 such that electrode 26A may be removed from distal end 16. For
example, fastening portions 58 may include proximal angled portions
at location(s) 68, and/or reception portions 60 may include distal
angled portions at location(s) 68, which may facilitate the
expansion of the one more fastening portions 58. The amount of
force required to expand fastening portions 58 may be greater than
(e.g., approximately two times greater than) the forces that may be
imparted to electrode 26A by tissue or other material within a
subject during a medical procedure. As such, fastening portions 58
may help to ensure that electrode 26A is only removed from the rest
of distal end 16 by a user or other medical professional when
distal end 16 is external to the subject.
[0046] Additionally, electrode 26A may be temporarily stored in a
delivery cartridge (FIG. 10) before coupling to distal end 16
and/or after uncoupling from distal end 16. For example, the
cartridge may surround at least the distal portion of electrode 26A
(and may surround an entirety of electrode 26A) and may help the
user to handle and/or store electrode 26A, for example, in
preparation for coupling electrode 26A to the rest of distal end
16. The cartridge may help the user align electrode 26A with
central opening 52 and position electrode 26A within the rest of
distal end 16 during coupling. As discussed with respect to FIG. 10
below, the cartridge may also store a plurality of electrodes,
which may be the same electrode configuration, or may include
different electrode configurations.
[0047] FIGS. 3A-3D illustrate various electrodes 26, 26A, 26B, 26C,
and 26D that may be coupled to and removed from distal end 16.
Electrode 26A includes an electrode lumen 70, two outlets 72, and a
channel 74 connecting electrode lumen 70 to outlets 72. As shown in
FIG. 3A, when electrode 26A is coupled to distal end 16, one or
more fluid paths 100A take a substantially radial flow path out of
outlets 72.
[0048] Electrode 26B includes an electrode lumen 70B, two outlets
72B, and a channel 74B connecting electrode lumen 70B to outlets
72B (FIG. 3B). Channel 74B may include two angled portions
connecting electrode lumen 70B to outlets 72B. When electrode 26B
is coupled to distal end 16, one or more fluid paths 100B take a
diverted flow path out of outlets 72B, at an acute angle relative
to, for example, a central longitudinal axis of distal end 16,
shaft 14, cap 42, and/or lumen 70B. Fluid flow path(s) 100B may be
angled relative to fluid flow path(s) 100A.
[0049] Electrode 26C includes an electrode lumen 70C extending to a
single outlet 72C (FIG. 3C). Outlet 72C is substantially aligned
with electrode lumen 70C. When electrode 26C is coupled to distal
end 16, a fluid path 100C forms a forward flow path out of outlet
72C, substantially aligned with the central longitudinal axis of
distal end 16, shaft 14, cap 42, and/or lumen 70C, and/or
substantially perpendicular to the distal face of electrode
26C.
[0050] Electrode 26D includes at least one side opening, channel,
passage, and/or hole 76 (FIG. 3D). Side opening 76 may extend from
the proximal portion of electrode 26D. Electrode 26D may not
include a central lumen. Electrode 26D may, for example, be solid
instead of hollow. With electrode 26D coupled to the rest of distal
end 16, side opening 76 may be in fluid communication with lumen
27. A fluid path 100D forms a flow path out of side opening 76 such
that fluid delivered through lumen 27 exits distal end 16 at a
position proximal to the distal tip of electrode 26D. For example,
the fluid may flow along an exterior surface of electrode 26D, via
a gap between the exterior surface of electrode 26D and the surface
forming opening 52. At least a portion of side opening 76 may be
radially inward of the sealing surfaces of seal 66.
[0051] As discussed above, electrodes 26A-26D may be releasably
coupled to and removed from the rest of distal end 16, such that a
user may couple one electrode, for example, electrode 26A, to
distal end 16, and may then remove electrode 26A and couple another
electrode, for example, electrode 26B, 26C, or 26D to distal end
16. For example, a user may couple electrode 26A to the rest of
distal end 16 and deliver distal end 16 to an internal lumen of a
subject for a first portion of a procedure, for example, where
fluid path 100A and/or the structural features of electrode 26A
is/are favorable or beneficial. The user may then remove distal end
16 from the subject, and uncouple electrode 26A from the rest of
distal end 16. The user may then couple electrode 26B, 26C, or 26D
to the rest of distal end 16, and deliver distal end 16 to the
internal lumen of the subject for a second portion of a procedure,
for example, where fluid path 100B, 100C, or 100D and/or the
structural features of electrode 26B, 26C, or 26D, is/are favorable
or beneficial. The swapping of electrodes may be repeated as many
times as necessary, allowing the user to modify the fluid flow path
and/or electrode structural characteristics while treating
tissue.
[0052] FIG. 4 illustrates a cross-sectional view of a ball and
socket configuration for coupling and removing electrodes,
according to one embodiment of this disclosure. For example, an
electrode 126 may include a reception portion 160, and a proximal
support 154 within distal end 116 may include fastening arms 180
extending from a radial extension portion 182. Fastening arms 180
may be inherently outwardly biased, such that fastening arms 180
may move radially outward away from each other in the absence of a
compressing or constraining force holding them in place. Proximal
support 154 may further include a biasing element or spring 184
positioned proximal of radial extension portion 182. Furthermore,
distal end 116 may include a central passage 186, and central
passage 186 may include an angled widened portion 188. Proximal
support 154 may be at least partially moveable longitudinally
within central passage 186 between the equilibrium position (as
shown) and a retracted position wherein radial extension portion
182 compresses spring 184 and fastening arms 180 expand in angled
widened portion 188.
[0053] In the retracted position, spring 184 biases radial
extension portion 182 distally. As radial extension portion 182
moves distally, angled widened portion 188 forces fastening arms
180 radially inward. As fastening arms 180 move radially inward,
fastening arms 180 may engage reception portion 160 of electrode
126. Similarly, a user may retract proximal support 154, for
example, via a mechanism on the handle (not shown), such that
fastening arms 180 may retract and expand, allowing a user to
uncouple electrode 126.
[0054] It is noted that, fastening arms 180 may form a circular, or
partially circular, socket configured to receive a portion of
electrode 126, for example, reception portion 160. Fastening arms
180 may be a plurality of individual arm members spaced apart in
the retracted and expanded configuration, or may be a single member
that is radially expanded in the retracted and expanded
configuration. Additionally, although not shown, the configuration
illustrated in FIG. 4 may include one or more seals in distal end
116 to maintain the fluidic connections between lumen 127 and the
electrode lumen when electrode 126 is coupled to distal end 116.
For example, one or more seals may be positioned radially within
fastening arms 180 such that, with electrode 126 coupled to the
rest of distal end 116, the seals are positioned between fastening
arms 180 and reception portion 160. The one or more seals may be
positioned at any one or more positions along the overlap of
fastening arms 180 and reception portion 160. Alternatively or
additionally, one or more seals may be positioned within distal end
116 distal to angled widened portion 188.
[0055] FIGS. 5A and 5B illustrate additional aspects of the
disclosure. FIGS. 5A and 5B are partial sectional views of another
exemplary mechanism to couple and remove electrodes. For example, a
distal end 216 may include a coupling tube 290 that is
longitudinally movable with proximal support 254. Coupling tube 290
includes a coupling portion 292 configured to contact the proximal
end of electrode 226 and couple electrode 226 to coupling tube 290.
Coupling tube 290 may be coupled to a distal end of the fluid lumen
and may include an inner lumen 293. Coupling tube 290 may include
an elastomeric polymer material that forms or is positioned within
coupling portion 292. For example, the elastomeric polymer material
may be neoprene, Santoprene.TM. (thermoplastic vulcanizate), Viton,
rubber, etc. Coupling tube 290 may be longitudinally movable
between at least a retracted position (FIG. 5A) and an extended
position (FIG. 5B). For example, a user may insert electrode 226
into distal end 216 (FIG. 5A), and may extend coupling tube 290
with proximal support 254 from the retracted position to the
extended position. Extending coupling tube 290 to the extended
position may bring coupling portion 292 into contact with the
proximal end of electrode 226. Further extension of coupling tube
290 moves a portion of coupling tube 290 onto and over the proximal
portion of electrode 226 such that the proximal portion of
electrode 226 is coupled within a portion of inner lumen 293, thus
coupling proximal support 254 with electrode 226 (FIG. 5B).
Proximal portion of electrode 226 may include one or more contours,
for example, a radially narrower portion that widens distally to
help in the coupling and/or stretching of coupling tube 290 over
the proximal portion of electrode 226. Coupling tube 290 and
electrode 226 may securely engage one another in a manner similar
to fastening portions 58 and electrodes 26A-26D, and/or similar to
fastening arms 180 and electrode 126.
[0056] Still further distal movement of coupling tube 290 from the
position shown in FIG. 5B may extend electrode 226 distally from
the rest of distal end 216. During this movement, coupling tube 290
may extend distally into a lumen or passage in an end cap of distal
end 216 (the end cap being similar to cap 42). The wall of coupling
tube 290 may be squeezed between the outer surface of electrode 226
and the inner surface of the end cap, thereby enhancing sealing of
coupling tube 290 around electrode 226 to facilitate fluid flow
through coupling tube 290 into electrode 226.
[0057] The elastomeric polymer material within coupling portion 292
may expand around the proximal end of electrode 226 and releasably
couple coupling portion 292 to the proximal end of electrode 226.
The elastomeric polymer material within coupling portion 292 may
also form a seal around the proximal end of electrode 226 such that
fluid may be delivered through coupling tube 290 and into electrode
226. Additionally, retracting coupling tube 290 proximally and/or
pulling electrode 226 distally may cause the elastomeric polymer
material within coupling portion 292 to disconnect from the
proximal end of electrode 226, allowing for the user to change
electrode 226, as discussed above. Although not shown, it is noted
that coupling tube 290 and proximal support 254 may be coupled to a
mechanism on the handle in order for a user to extend and/or
retract coupling tube 290.
[0058] Alternatively or additionally, electrodes 26, 26A, 26B, 26C,
26D, 126, 226, or any other suitable electrodes, may be coupled to
the rest of distal end 16 via another form of coupling. For
example, any of the electrodes may be screw-fit into the rest of
distal end 16 via corresponding (engaging) threading on the
proximal portion of electrode 26 and distal portion 56 of proximal
support 54. It also is contemplated that any of the electrodes may
be coupled to the rest of distal end 16 via a receptacle, and an
element to be received (and, in some instances, locked) within the
receptacle. For example, the coupling between any of the electrodes
and the rest of distal end 16 may include a post, a plug, a pin, a
spiral, a lever, a bayonet, etc. on one of the electrode(s) and
proximal support 54, and the receptacle may include a ring, an
orifice, or another correspondingly shaped connection element on
the other of the electrode(s) and proximal support 54. The lockable
coupling may further include a detent mechanism, an interference
element, and/or a quick connect mechanism. Furthermore, the
coupling may include a lever lock, a taper lock, a pin, and/or a
keying component, and the coupling may be operably and/or
releasably controlled via a mechanism in handle 12.
[0059] Other examples of electrodes are described in the paragraphs
below. It should be understood that any feature described in
connection with electrodes 26, 26A, 26B, 26C, 26D, 126, and/or 226
may be found in any of the other electrodes, and vice-versa.
Aspects of the other electrodes also may be shared between them. In
particular, any of the examples of electrodes discussed herein may
include any of the fluid paths and coupling mechanisms discussed
above. Similarly, any of the examples of electrodes discussed
herein may include any of the insulation patterns discussed
below.
[0060] FIGS. 6A and 6B depict perspective and cross-sectional
views, respectively, of another electrode 326 that may be
positioned and function within medical device 10. Electrode 326
includes an insulator 394, which may form a rounded annular
insulation pattern on a distal end face 396 of electrode 326. For
example, insulator 394 may be ring or donut shaped, and an outer
edge of insulator 394 may be flush with a radially outer edge of
electrode 326. As shown in FIG. 6B, electrode 326 may include an
annular cavity 398 extending proximally from distal end face 396,
and a proximal portion of insulator 394 may be received within
cavity 398. Although not illustrated, electrode 326 may include a
lumen and one or more outlets as discussed above, to facilitate
fluid flow through electrode 326. Alternatively, electrode 326 may
be solid as shown, and fluid may flow along its outer surface.
[0061] Insulator 394 may provide a buffer or stand off from distal
end face 396 and any tissue. In aspect, insulator 394 may abut
tissue such that electrode 326 may be energized while insulator 394
helps to insulate the tissue. Additionally, electrode 326 may be
advanced further distally and a portion of the abutted tissue may
contact the portion of distal end face 396 radially interior of
insulator 394 or otherwise not including insulator 394.
[0062] FIGS. 7A and 7B depict perspective and cross-sectional
views, respectively, of another electrode 426 that may be
positioned and function within medical device 10. Electrode 426
includes an insulator 401, which includes a dotted insulation
pattern. Insulator 401 may include substantially hemispherical
distal portions 401A and substantially cylindrical proximal
portions 401B (FIG. 7B) extending proximally of respective
hemispherical distal portions 401A. For example, insulator 401 may
include four hemispherical portions 401A positioned on a distal end
face 498 of electrode 426. Fewer or more hemispherical distal
portions 401A may be used. As shown in FIG. 7B, electrode 426 may
include cylindrical cavities 403, and the cylindrical proximal
portions 401B of insulator 401 may extend into cylindrical cavities
403. As illustrated, electrode 426 may include a lumen 470 and one
or more outlets 472 to deliver fluid, as discussed above. For
example, electrode 426 may include a central outlet 472 in distal
end face 498, and the hemispherical distal portions 401A of
insulator 401 may be positioned radially around outlet 472.
Electrode 326 may include a similar flow path for fluid.
[0063] FIGS. 8A-8C illustrate additional electrodes 526, 626, and
726. For example, as shown in FIG. 8A, electrode 526 may include a
cross-shaped insulator 505 on a distal end face 596. Electrode 526
may include an outlet 572 positioned within cross-shaped insulator
505, or may include one or more outlets as discussed above.
Furthermore, cross-shaped insulator 505 may be formed by
intersecting semicylindrical insulation portions. Other portions of
insulator 505 may be positioned within one or more cavities (not
shown) in distal end face 596. Alternatively, cross-shaped
insulator 505 may include intersecting polygonal (e.g.,
rectangular) insulation portions positioned on distal end face
596.
[0064] As shown in FIG. 8B, electrode 626 may include a line-shaped
insulator 607 on distal end face 696. Line-shaped insulator 607 may
bisect distal end face 696 (i.e., with ends of line-shaped
insulator 607 positioned 180 degrees apart). Alternatively,
line-shaped insulator 607 may be offset and/or not span distal end
face 607 (e.g., with ends of line-shaped insulator 607 positioned
approximately 150, 120, 90, etc. degrees apart). Although not
shown, electrode 626 may include an outlet positioned within
line-shaped insulator 607, or may include one or more outlets as
discussed above. Furthermore, line-shaped insulator 607 may be
formed by a semicylindrical insulation portion. Other portions of
insulator 607 may be positioned within one or more cavities (not
shown) in distal end face 696. Alternatively, insulator 607 may
include a polygonal (e.g., rectangular) insulation portion
positioned on distal end face 696.
[0065] As shown in FIG. 8C, electrode 726 may include an annular
insulator 709 at distal end face 796. Annular insulator 709 may be
substantially cylindrical with an open cylindrical middle portion.
Annular insulator 709 may include cylindrical inner and outer
walls. Annular insulator 709 may include a flat distal portion,
and/or may include a rounded radially exterior distal portion on
the distal face of annular insulator 709. As shown, the outer wall
of annular insulator 709 may be substantially aligned with (flush
with) the outer surface of a distal end portion of electrode 726.
Annular insulator 709 may extend proximally beyond distal end face
796. For example, electrode 726 may include a narrowed distalmost
portion extending proximal of distal end face 796, forming a ledge
for annular insulator 709. Annular insulator 709 may be coupled to
electrode 726 over the narrowed distalmost portion, with the
remainder of the distal portion of electrode 726 being uninsulated.
Although not shown, electrode 726 may include an outlet positioned
interior to annular insulator 709, or may include one or more
outlets as discussed above.
[0066] In the aforementioned aspects of this disclosure, the
various insulators may be formed by a ceramic, fluoropolymer,
polyether ether ketone (PEEK), or other heat resistant and
non-conductive material. The insulators provide one or more
standoffs of material raised from the distal end face of the
electrode. The various electrodes allows for a device that may be
used to both cut tissue and mark around an area of tissue. The
various electrodes also allow the device to provide hemostasis to
control small bleeds. Such electrodes include insulated portions
that allow for at least a portion of the distal end face to be
exposed to contact tissue. The insulated portions help to minimize
the risk of thermal damage and perforation of the tissue by still
allowing for the electrode to perform marking and providing
hemostasis.
[0067] The various electrodes discussed herein are capable of
modifying physical properties of tissue when in contact with tissue
by delivering energy (e.g., radio frequency energy). The energy
delivered may be monopolar or bipolar energy. The various
electrodes may be coupled to a shaft, with the shaft configured to
extend into a body lumen or cavity of a subject. The shaft includes
an electrical element traversing the shaft and connecting the
electrode to an energy source, for example, in the handle or
coupled to the handle.
[0068] The electrodes discussed above include at least two distinct
portions: (1) a cutting shaft with a primary axis that is
coincident or parallel to a longitudinal axis of the shaft, and (2)
a distal portion that includes a cross-sectional area greater than
the cutting shaft. The distal portion includes a distal face (e.g.,
distal end face 396) including a partially insulated portion and an
exposed portion. The insulated portions are positioned on the
distal end face of the electrode, such that the insulated portions
are not positioned along the cutting shaft. The exposed portion may
be used to provide energy to a portion of tissue. For example, the
electrode may be advanced toward tissue. With a first force applied
pushing the electrode distally, the partially insulated portion may
abut the portion of tissue but may prevent the exposed portion from
contacting the tissue. With a second force greater than the first
force applied pushing the electrode distally, the exposed portion
may contact a portion of the tissue. Additionally, the distal
portion of the electrode may include a length to allow a user to
use the greater cross-sectional area of the distal portion to
deliver energy to a portion of tissue to provide hemostasis.
[0069] The electrode may also be coupled to an actuation member,
for example, in the handle or coupled to the handle, that allows a
user to translate the electrode relative to the shaft. The
electrode may be translatable between at least a first position in
which the cutting shaft of the electrode is retracted within the
shaft (FIG. 2A), and a second position in which the cutting shaft
is extended beyond the shaft and exposed (FIG. 2B). In both the
first and second positions, the distal portion that includes the
insulated portions are extended and exposed beyond the shaft, and
not retracted within the shaft.
[0070] As such, a user may position the partially insulated distal
end face to abut tissue, and may apply energy via the distal end
face to mark. The user may position the radial exterior of the
distal portion to perform hemostasis to cauterize or coagulate
tissue. The user may also position the uninsulated electrode shaft
to abut or contact tissue and apply energy to cut, dissect, or
ablate tissue. Different insulators with different insulation
patterns may be appropriate for different medical procedures.
Therefore, each electrode may be releasably coupled to distal end
16 as discussed above. Moreover, the electrode may include one or
more distal outlets to provide any of the fluid flowpaths discussed
above with respect to FIGS. 1A-3D.
[0071] FIGS. 9A and 9B illustrate an additional example of an
electrode 826. As shown, electrode 826 may include an insulator 811
on a distal end portion 813 of electrode 826. In one aspect,
insulator 811 may be deposited on distal end portion 813 via
ceramic deposition. Insulator 811 may be annular, having a passage
therein for receiving distal end portion 813. Insulator 811 may be
substantially cylindrical.
[0072] Electrode 826 may include one or more outlets 868 fluidly
connected to electrode lumen 870, for example, as shown, electrode
826 may include a distal end outlet 868' and a side outlet 868''.
In one aspect, side outlet 868'' may be smaller than distal end
outlet 868' such that a majority of delivered fluid exits via
distal end outlet 868', However, if distal end outlet 868' is
blocked, for example, by abutting tissue, fluid may still exit
electrode lumen 870 via side outlet 868''. Electrode 826 may be
coupled to the rest of distal end 816 and may be movable relative
to an end cap 842 as discussed above. Furthermore, electrode 826
may be releasably coupled within distal end 816 with any of the
mechanisms discussed above.
[0073] Electrode 826 includes an electrode body 815, which may form
a cutting shaft for electrode 826. As shown in FIG. 9B, electrode
826 also includes a distal end portion 813, which has a reduced
cross-sectional area (reduced relative to electrode body 815).
Moreover, insulator 811 may be applied on the radial exterior of
distal end portion 813 such that the diameter of distal end portion
813 and insulator 811, together, is less than or equal to the
diameter of electrode body 815. In one example, the radially outer
surfaces of insulator 811 and electrode body by 815 are flush.
Although not shown, insulator 811 may also be provided
circumferentially around distal end face 896 of electrode 826 to
form an insulated distal end portion 813. In one example, the
distal faces of insulator 811 and distal end portion 813 are flush.
Alternatively, insulator 811 may narrow as it approaches the distal
face of distal end portion 813. In either aspect, distal end
portion 813 may be at least partially insulated, and electrode body
815 may be uninsulated. Accordingly, distal end portion 813 may be
nonconductive to avoid stray electrical energy being directed to
tissue, for example, when electrode 826 is retracted within the
rest of distal end 816, but distal end portion 813 remains outside
of the rest of distal end 816.
[0074] As such, electrode 826 may be coupled to an electrical
element and an actuation member, as discussed above, in order to
deliver energy and extend or retract electrode 826. Electrode body
815 includes a primary axis that is coincident to a longitudinal
axis of the shaft. As mentioned, distal end portion 813 includes a
cross-sectional area less than or equal to the cross-sectional area
of electrode body 815. Moreover, insulator 811 on distal end
portion 813 does not have the longest axis of a cross-section of
electrode 826, and insulator 811 does not extend over a majority of
electrode 826.
[0075] FIG. 10 illustrates an exemplary cartridge 911 with a
plurality of electrodes 913A-913E stored within a plurality of
openings 915. In this figure, different electrodes 913A-913E are
shown within the plurality of openings 915, but it also is
contemplated that any number of identical electrodes may be
contained in cartridge 911. Cartridge 911 may also include one or
more indications 917A-917E (e.g., text, diagrams, symbols, or the
like) substantially aligned with each opening 915 to indicate the
type or configuration of each of electrodes 913A-913E stored in the
respective openings 915. For example, electrodes 913A-913E may
include different shapes, conductive pathways, and/or fluid
flowpaths, and indications 917A-917E may include a shape,
silhouette, arrows, and/or an exemplary fluid flowpath of the
electrodes 913A-913E stored in the respective openings 915.
Although five electrodes 913A-913E and openings 915 are shown, this
disclosure is not so limited. Cartridge 911 may include any number
of electrodes stored in any number of respective openings, and the
electrodes may include any of the configurations disclosed
herein.
[0076] FIGS. 11A-11C illustrate steps that may be performed to
couple an exemplary electrode 913 (e.g., any of electrodes
913A-913E or other electrodes disclosed herein) stored within one
opening 915 of cartridge 911 to a distal end 916 of a shaft 914 of
a medical device. Distal end 916 may include any of the medical
device distal end aspects disclosed herein. As shown in FIG. 11A, a
proximal portion 919 of electrode 913 may include one or more
grooves and/or graduated portions, which may help secure the
physical, electrical, and fluid connections between electrode 913
and distal end 916, as discussed above with respect to FIGS. 3A-3D,
4, 5A, and 5B. Distal end 916 may be inserted into opening 915 and
may surround proximal portion 919 of electrode 913, as shown in
FIG. 11B. Opening 915 may be larger than a cross-sectional area of
distal end 916 to facilitate its entry into opening 915 and
positioning circumferentially around at least a portion of proximal
portion 919 of electrode 913, to couple electrode 913 to distal end
916. Distal end 916 may then be removed from opening 915, with
electrode 913 coupled to distal end 916, as shown in FIG. 11C.
[0077] In one aspect, cartridge 911 may be configured to retain
each electrode 913 in a specific position or arrangement. For
example, cartridge 911 may include one or more cavities or
protrusions within opening 915 that may engage with one or more
portions of electrode 913. The cavities and/or protrusions within
opening 915 may define a recess with a shape complementary to the
shape of electrode 913. Additionally, material that forms or is
within cavity 915 may be flexible to allow electrode 913 to be
inserted into opening 915 and withdrawn from opening 915. In one
aspect, cavity 915 and electrode 913 may be coupled via a friction
fit, a snap-fit, or another type of engagement. Cartridge 911 and
distal end 916 of medical device 910 may each include one or more
markings, protrusions, grooves, etc. that may help a user to align
electrode 913 in a proper orientation while coupling electrode 913
to the rest of distal end 916. For example, an inner wall of
opening 915 may include one or more protrusions that may align with
one or more grooves on an outer wall of distal end 916. In one
aspect, a width of opening 915 may be slightly larger than a width
of distal end 916, such that the interior walls of opening 915 may
abut or engage one or more exterior portions of distal end 916,
thereby ensuring that distal end 916 is properly aligned to receive
electrode 913. Additionally or alternatively, the walls forming
opening 915 may be tapered inwardly toward electrode 913, which may
help guide distal end 915 into alignment to receive electrode
913.
[0078] The user may insert distal end 916 into opening 915 to
surround at least a portion of proximal portion 919 of electrode
913 such that the coupling mechanism (e.g., one or more fastening
portions 58, FIGS. 3A-3D) within distal end 916 couples electrode
913 to the rest of distal end 916. The user may then remove
electrode 913 from cartridge 911 (FIG. 11C). For example, the force
necessary to uncouple electrode 913 from cartridge 911 may be
weaker than the force necessary to uncouple electrode 913 from the
coupling mechanism within distal end 916. Although not shown,
electrode 913 may be uncoupled from distal end 916 and repositioned
within opening 915 in cartridge 911 for storage, cleaning, and/or
later use. For example, distal end 916 may include a mechanism to
uncouple electrode 913 from distal end 916, as discussed with
respect to FIG. 4 above. Additionally, a different electrode 913
may then be coupled to distal end 916.
[0079] FIGS. 12A and 12B illustrate an additional exemplary
electrode 1021 coupled to a distal end 1016 of a shaft 1014.
Electrode 1021 may be coupled to distal end 1016 via any of the
mechanisms discussed herein, and may also include any of the shapes
and fluid flowpaths discussed herein. Furthermore, electrode 1021
may be used for monopolar or bipolar electrosurgery. Electrode 1021
may include at least a first conductive member 1023 and a second
conductive member 1025. First conductive member 1023 and second
conductive member 1025 may be electrically separated by an
insulating member 1027. Insulating member 1027 may include, for
example, an annular member at a distal end of first conductive
member 1023 that may be received in a recess in second conductive
member 1025. First conductive member 1023 may form a proximal
portion of electrode 1021, and second conductive member 1025 may
form a distal end portion of electrode 1021. First conductive
member 1023 and second conductive member 1025 may be formed of, for
example, titanium or another medically safe and conductive
material. Insulating member 1027 may be formed of a ceramic, for
example, aluminum oxide (Al.sub.2O.sub.3).
[0080] As shown in the cross-sectional view of FIG. 12B, electrode
1021 may include, or may receive, a first conductor 1029 and a
second conductor 1031. First conductor 1029 may be connected to
first conductive member 1023, and second conductor 1031 may be
connected to second conductive member 1025. Each conductor may be
either permanently coupled to its corresponding conductive member,
for example, by soldering, adhering, and/or mechanical fixing, or
may be selectively coupled, for example, by use of a plug and
socket arrangement or a pin(s) and hole(s) arrangement used for
mechanical and electrical coupling.
[0081] First conductor 1029 and second conductor 1031 may be
electrically insulated, and may each be connected to one or more
energy sources, for example, in a handle connected to shaft 1014 or
in an electrosurgical generator coupled to the handle. Each of
first conductive member 1023 and second conductive member 1025 may
be configured to receive energy in various modes, for example,
radio frequency energy in a cutting mode, a coagulation mode, etc.
First conductive member 1023 and second conductive member 1025 may
thus be separately energized in order to treat tissue selectively
with different portions of electrode 1021.
[0082] Although FIGS. 12A and 12B illustrate electrode 1021 having
first conductive member 1023 and second conductive member 1025,
this disclosure is not so limited. Electrode 1021 may include
three, four, five, or more separate conductive members that are
separated by insulating members. Additionally, the conductive
members may be longitudinally spaced on electrode 1021, may be
circumferentially spaced around electrode 1021, or may be both
longitudinally spaced and circumferentially spaced around electrode
1021. The respective conductive members may include respective
conductors to individually energize the conductive members.
[0083] Alternatively, one conductor may be longitudinally movable
within at least a portion of the electrode and controllable via the
handle or another proximally located element. For example, instead
of conductive members 1029 and 1031, a single moveable conductor
may extend from the handle to the electrode. The conductor may be
at least partially insulated such that energy is only delivered
from a distal end portion of the conductor. Movement of the handle
may control the position of the distal end of the single moveable
conductor such that the distal end of the single moveable conductor
may contact different portions of the electrode. The portions of
the electrode may be insulated from the other portions of the
electrodes. Therefore, a user may deliver energy through the
conductor, and the longitudinal position of the conductor relative
to the electrode may control which portion or portions of the
electrode are energized.
[0084] FIG. 13 illustrates an additional exemplary medical device
1110 with a handle 1112 and a shaft 1114. Although not shown, any
of the electrodes discussed herein may be coupled to a distal end
of shaft 1114. In one aspect, handle 1112 includes an activation
control 1133, for example, on a main body 1118 of handle 1112.
Activation control 1133 may include a plurality of buttons,
switches, or other user input mechanisms that control the delivery
of energy to one or more portions of the electrode coupled to shaft
1114. For example, activation control 1133 may include a slide
switch 1135 that may be positioned in a plurality of positions to
allow a user to control the energization of an electrode coupled to
medical device 1110.
[0085] FIGS. 14A-14D illustrate various positions for activation
control 1133 and the corresponding configurations of electrode
1021. For example, slide switch 1135 may be longitudinally movable
(e.g., slidable) within a portion of handle 1112, and the position
of slide switch 1135 corresponds to different operational states or
configurations of electrode 1021. Slide switch 1135 may include one
or more pads or protrusions 1137A-1137D, which may be electrically
conductive pads or protrusions, for setting and/or indicating a
configuration of electrode 1021. For example, slide switch 1135 may
include a first protrusion 1137A on a first side of slide switch.
Slide switch 1135 may include a second protrusion 11376 on a second
side of slide switch 1135. Slide switch 1135 may include a third
protrusion 1137C on the first side of slide switch 1135 and a
fourth protrusion 1137D, aligned with third protrusion 1137C, on
the second side of slide switch 1135. Each of protrusion
1137A-1137D may be electrically coupled to an electrosurgical
generator (not shown) via one or more conductive wires and/or
cables (not shown) running through handle 1112, and running from
handle 1112 to the electrosurgical generator.
[0086] Handle 1112 may include one or more arrows 1139A and 11396,
which may be positioned on the first and second sides of slide
switch 1135. Arrows 1139A and 11396 may indicate the locations of
pads or protrusions on or coupled to conductors 1029 and 1031,
respectively. When the pads or protrusions 1137A-1137D of slide
switch 1135 contact pads or protrusions at arrows 1139A and 1139B,
a circuit is completed that may direct electrosurgical energy to
one or more portions of electrode 1021.
[0087] FIG. 14A illustrates activation control 1133 in an inactive
configuration. For example, slide switch 1135 may be in a first
position where none of protrusions 1137A-1137D are aligned with
arrows 1139A and 11396. There is a break in a circuit between an
energy source (e.g., an electrosurgical generator) and electrode
1021 due to an air gap between pads or protrusions at arrows 1139A
and 11396, so current cannot flow to conductors 1029 and 1031.
Accordingly, electrode 1021 may be inactive, with no energy being
delivered to first conductive member 1023 or second conductive
member 1025.
[0088] FIG. 14B illustrates activation control 1133 in a first
active configuration. For example, slide switch 1135 may be in a
second position, with first protrusion 1137A aligned with arrow
1139A. In this first active configuration, a circuit is completed
between the energy source and electrode 1021 due to an electrical
connection between protrusion 1137A and arrow 1139A. Therefore,
energy may be delivered to first conductive member 1023, for
example, via first conductor 1029 (FIG. 12B), such that first
conductive member 1023 is energized. A circuit is not completed
between one of protrusions 1137A-1137D and arrow 1139B, so no
current is delivered to second conductive member 1025 via second
conductor 1031.
[0089] FIG. 14C illustrates activation control 1133 in a second
active configuration. For example, slide switch 1135 may be in a
third position, with second protrusion 1137B aligned with arrow
1139B. In this second active configuration, a circuit is completed
between the energy source and electrode 1021 due to an electrical
connection between protrusion 1137B and arrow 1139B. Therefore,
energy may be delivered to second conductive member 1025, for
example, via second conductor 1031 (FIG. 12B), such that second
conductive member 1025 is energized. A circuit is not completed
between one or protrusions 1137A-1137D and arrow 1139A, so no
current is delivered to first conductive member 1023 via first
conductor 1029.
[0090] FIG. 14D illustrates activation control 1133 in a third
active configuration. For example, slide switch 1135 may be a
fourth position, with both third protrusion 1137C and fourth
protrusion 1137D aligned with arrows 1139A and 1139B. In this third
active configuration, a circuit is completed between the energy
source and electrode 1021 due to an electrical connection between
protrusions 1137C and 1137D and arrows 1139A and 1139B. Therefore,
energy may be delivered to both first conductive member 1023 and
second conductive member 1025, for example, via first conductor
1029 and second conductor 1031 (FIG. 12B), such that both first
conductive member 1023 and second conductive member 1025 are
energized.
[0091] Although slide switch 1135 on handle 1112 is discussed
above, this disclosure is not so limited. In another aspect,
medical device 1110 may include a plurality of buttons, switches,
user interfaces, foot pedals, etc. that may be manipulated to
selectively energize different portions of electrode 1021. For
example, a first foot pedal may be depressed to energize first
conductive member 1023, and a second foot pedal may be depressed to
energize second conductive member 1025. A third foot pedal may be
depressed to energize both first conductive member 1023 and second
conductive member 1025, or simultaneously depressing both the first
and second foot pedals may energize both first conductive member
1023 and second conductive member 1025. In this aspect, depressing
one or more foot pedals may complete a circuit between an energy
source and the respective portions of electrode 1021.
[0092] In another aspect, medical device 1110 may be coupled to a
touch screen, and various user inputs on the touch screen may allow
a user to control the circuitry connections, and thus energy
delivery, to respective portions of electrode 1021. Furthermore,
medical device 1110 may be coupled to an electrosurgical generator,
and one or more switches may be positioned on the electrosurgical
generator and/or on handle 1112 to control the circuitry
connections and energy delivery to respective portions of electrode
1021. Conductors 1029 and 1031 may run all the way from electrode
1021 to electrosurgical generator or another energy source.
Electrode 1021 may include any number of regions, and any of the
control elements discussed herein may allow a user to selectively
energize individual regions or groups of regions of electrode 1021.
Moreover, any of the control elements may allow a user to energize
different electrode regions to varying degrees (e.g., by
controlling voltage, current, etc.) due to the use of separate
circuitry to each region and insulation between the regions of
electrode 1021.
[0093] Additionally or alternatively, slide switch 1135 may extend
from handle 1112 to a distal end of device 1110. In such a
configuration, pads or protrusions 1137A-1137D may be at the distal
end, while a proximal portion of slide switch 1135 may extend
proximally back to handle 1112, such that the user may still move
pads or protrusions 1137A-1137D from handle 112. One or more arrows
1139A and 1139B also may be positioned at the distal end of device
1110. In one example, one or more arrows 1139A and 11396 may be at,
or otherwise electrically coupled to, one or more portions of
electrode 1021. When the pads or protrusions 1137A-1137D of slide
switch 1135 contact pads or protrusions at arrows 1139A and 11396,
a circuit is completed that may direct electrosurgical energy to
one or more portions of electrode 1021. As noted above, the energy
may be selectively directed to a portion of electrode 1021 while
leaving another portion of electrode 1021 unenergized.
[0094] Energizing only the first conductive member 1023 may be
useful when cutting tissue, as only energizing the shaft of
electrode 1021 may help to reduce the risk of tissue perforation or
other thermal damage to tissue because the blunt distal end of
electrode 1021, which may be abutting tissue, is not energized.
Energizing the second conductive member 1025 may be useful during
an initial tissue marking, an incision, a hemostasis to increase
coagulation, etc. For example, energizing the second conductive
member 1025 may allow the energized distal end to deliver immediate
and effective thermal treatment of tissue without the need to
exchange electrode 1021 or the medical device, and may also
increase the accuracy of electrode 1021. Moreover, energizing only
a portion of electrode 1021 at a time may help to concentrate the
delivered energy or heat in one region, which may increase the
efficacy of the delivered energy or heat. As such, electrode 1021
may be used to perform various different procedures, reducing
procedure time and costs.
[0095] FIGS. 15A and 15B illustrate electrodes 1021A and 1021B
coupled to distal end 1016 of shaft 1014, according to further
aspects of this disclosure. Electrode 1021A includes a first
conductive member 1023A and a second conductive member 1025A spaced
apart by an insulating member 1027A. First conductive member 1023A
and second conductive member 1025A may be separately energized via
any of the mechanisms discussed herein to treat tissue.
Additionally, first conductive member 1023A includes one or more
first conductive regions 1041A. First conductive regions 1041A may
be metallic deposits on a ceramic or insulating base material to
form an integral first conductive member 1023A that has alternating
conductive and non-conductive regions. First conductive regions
1041A may be substantially parallel lines extending along the
longitudinal axis of electrode 1021A. First conductive regions
1041A may be evenly spaced. Alternatively, one side of electrode
1021A may include a denser concentration of first conductive
regions 1041A than another side, providing for different energy
delivering capabilities of the respective sides of electrode 1021A.
First conductive regions 1041A are coupled to conductor 1029, or
other similar conductors. Furthermore, all first conductive regions
1041A may be energized together, or one or more of first conductive
regions 1041A may be energized individually using any of the
above-described selection arrangements.
[0096] Second conductive member 1025A may include one or more
second conductive regions 1043A. For example, second conductive
regions 1043A may be metallic deposits on a ceramic or insulating
base material to form an integral second conductive member 1025A
that includes alternating conductive and non-conductive regions.
Second conductive regions 1043A may be radial extensions spaced
around a distal face of second conductive member 1025A. Second
conductive regions 1043A are coupled to conductor 1031, or other
similar conductors. Furthermore, all second conductive regions
1043A may be energized together, or one or more of second
conductive regions 1043A may be energized individually using any of
the above-described selection arrangements.
[0097] Electrode 1021B includes a first conductive member 1023B and
a second conductive member 1025B spaced apart by an insulating
member 1027B. First conductive member 1023B and second conductive
member 1025B may be separately energized via any of the mechanisms
discussed herein to treat tissue. Additionally, first conductive
member 1023B includes one or more first conductive regions 1041B,
which are coupled to conductor 1029 or similar conductors. First
conductive regions 1041B may be metallic deposits on a ceramic or
insulating base material to form an integral first conductive
member 1023B that has alternating conductive and non-conductive
regions. First conductive regions 1041B may be helical or spiral
lines positioned on an exterior of first conductive member 1023B.
First conductive regions 1041B may be evenly spaced. Alternatively,
one portion of electrode 1021B may include a denser concentration
of first conductive regions 1041B than another portion, providing
for different energy delivering capabilities of the respective
portions of electrode 1021B.
[0098] Furthermore, second conductive member 1025B may include one
or more second conductive regions 1043B, which may be coupled to
conductor 1031 or similar conductors. For example, second
conductive regions 1043B may be metallic deposits on a ceramic or
insulating base material to form an integral second conductive
member 1025B that has alternative conductive and non-conductive
regions. Second conductive regions 1043B may be circular lines
spaced around a distal face of second conductive member 1025B. As
such, the conductive and non-conductive regions may be annular, for
example, in the form of concentric rings. As discussed above with
respect to first conductive regions 1041A and second conductive
regions 1043A, first conductive regions 1041B and second conductive
regions 1043B may be energized together, or one or more of first
conductive regions 1041B or second conductive regions 1043B may be
energized individually using any of the above-described selection
arrangements.
[0099] Any of the aforementioned electrodes may be selectively
coupled to and uncoupled from a medical device. Similarly, once
coupled to the medical device, each electrode may include separate
portions that are insulated from one another, and the separate
portions of the electrode may be individually energized to treat
tissue.
[0100] The medical devices and methods discussed above allow a user
to treat tissue by delivering electrical energy into the tissue,
and delivering fluid, either simultaneously or sequentially.
Additionally, the user may select one of a plurality of electrodes,
including, for example, electrodes 26, 26A-26D, 126, 226, 326, 426,
526, 626, 727, 826, 913, 1021, 1021A and 1021B, to deliver the
electrical energy and/or fluid, with the electrodes each having
varying fluid flowpaths and/or insulators. It also is contemplated
that the user may select between electrodes having similar
flowpaths and/or insulation patterns, that differ in some other
way. For example, electrodes having different shapes, dimensions,
material properties, level(s) of use (e.g., newer versus older, or
replacing worn or damaged electrodes), and/or any other
characteristics. Similarly, the user may select between shafts
and/or handles having different characteristics, including shapes,
dimensions, material properties, level(s) of use, flexibility,
operation, and/or any other characteristics.
[0101] Distal ends 16, 116, 216, 816, 916, and 1016 may allow for
releasably coupling the electrodes, so a user may easily couple a
first electrode to the distal end to prepare for one portion of the
procedure, then remove it to prepare for another portion of the
procedure. For example, a user may couple a first electrode to the
distal end and deliver the distal end to an interior lumen of a
subject to deliver medical therapy in a first portion of a
procedure (e.g., mark, cauterize, or resect tissue). The user may
then remove the distal end from the interior lumen and uncouple the
first electrode from the distal end. The user may then couple a
second electrode to the distal end and deliver the distal end to
the lumen to deliver medical therapy for a second portion of the
procedure. The second electrode may include a different fluid
flowpath and/or insulation pattern than the first electrode, which
may be more suitable for the second portion of the procedure than
the first electrode. These steps may be repeated as many times as
necessary during the procedure, using as many different types of
electrodes as needed. Additionally, the user may use the same
medical device 10 to deliver the various types of medical therapy
by simply swapping and/or changing the electrodes coupled to distal
end 16. The various fluid flowpaths and/or insulation patterns may
help the user to more quickly and efficiently deliver the medical
therapy, for example, cut, dissect, ablate, mark, coagulate,
cauterize, or otherwise treat tissue.
[0102] Additionally or alternatively, the securing and/or removing
of electrodes may be performed prior to performing a medical
procedure, in preparation for performing the medical procedure. For
example, the securing and/or removing of electrodes may be
performed by an assembler of the medical device, and the device may
then be delivered to the user for performance of a medical
procedure.
[0103] Moreover, as discussed with respect to FIGS. 12-15B, a
single electrode 1021, 1021A, or 1021B may allow the user to
perform different tissue treatment procedures with the same
electrode coupled to the distal end 1016 of the medical device. For
example, a user may energize first conductive members 1023, 1023A,
and 1023B to perform a cutting procedure with a reduced risk of
tissue perforation because insulating members 1027, 1027A, and
1027B may help to prevent energy flowing through second conductive
member 1025, 1025A, and 1025B or the distal end of electrode 1021,
1021A, and 1021B. Similarly, a user may energize second conductive
members 1025, 1025A, and 1025B to perform a marking or hemostasis
procedure. Lastly, a user may energize the entirety of electrodes
1021, 1021A, and 1021B for another portion of a procedure. A
proximal control, for example, activation control 1133, a single
moveable conductor, a slide switch, one or more actuators or foot
pedals, etc, may allow the user to control the energization of
electrodes 1021, 1021A, and 1021B without removing the medical
device from the patient, which may help to reduce the costs and
duration of the procedure, also potentially reducing the risks to
the patient.
[0104] While principles of the present disclosure are described
herein with reference to illustrative aspects for particular
applications, it should be understood that the disclosure is not
limited thereto. Those having ordinary skill in the art and access
to the teachings provided herein will recognize additional
modifications, applications, aspects, and substitution of
equivalents all fall within the scope of the aspects described
herein. Accordingly, the disclosure is not to be considered as
limited by the foregoing description.
* * * * *