U.S. patent application number 14/272786 was filed with the patent office on 2015-11-12 for therapeutic energy delivery device with rotational mechanism.
This patent application is currently assigned to AngioDynamics, Inc.. The applicant listed for this patent is Valerie L. Douglass, Meir H. Moshe, Kevin L. Moss, Robert M. Pearson. Invention is credited to Valerie L. Douglass, Meir H. Moshe, Kevin L. Moss, Robert M. Pearson.
Application Number | 20150320488 14/272786 |
Document ID | / |
Family ID | 42354764 |
Filed Date | 2015-11-12 |
United States Patent
Application |
20150320488 |
Kind Code |
A1 |
Moshe; Meir H. ; et
al. |
November 12, 2015 |
THERAPEUTIC ENERGY DELIVERY DEVICE WITH ROTATIONAL MECHANISM
Abstract
A device for delivering therapeutic energy to tissue is
provided. The device includes a housing and a rotating device
coupled to the housing. The device includes a plurality of
electrodes, each electrode including: (i) a proximal section
longitudinally extending from within the housing to an exterior of
the housing and having a longitudinal axis; (ii) an intermediate
section extending from the proximal section; and (iii) a distal
section extending longitudinally from the intermediate section. The
rotating device is coupled to the proximal sections of the
plurality of electrodes and adapted to rotate the distal section of
the electrodes so that distance between at least two electrodes
changes, so that the electrodes can be placed in a compact
configuration or an expanded configuration to provide for a
treatment region larger than the size of the opening for
insertion.
Inventors: |
Moshe; Meir H.; (El
Sobrante, CA) ; Douglass; Valerie L.; (Sunnyvale,
CA) ; Moss; Kevin L.; (Tracy, CA) ; Pearson;
Robert M.; (San Jose, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Moshe; Meir H.
Douglass; Valerie L.
Moss; Kevin L.
Pearson; Robert M. |
El Sobrante
Sunnyvale
Tracy
San Jose |
CA
CA
CA
CA |
US
US
US
US |
|
|
Assignee: |
AngioDynamics, Inc.
Queensbury
NY
|
Family ID: |
42354764 |
Appl. No.: |
14/272786 |
Filed: |
May 8, 2014 |
Current U.S.
Class: |
606/41 |
Current CPC
Class: |
A61B 18/1477 20130101;
A61B 2018/00202 20130101; A61B 2018/143 20130101; A61B 2018/00613
20130101; A61B 2018/00607 20130101; A61B 2018/1475 20130101; A61B
18/1815 20130101; A61B 2018/1861 20130101; A61B 2018/00577
20130101; A61B 2018/126 20130101; A61B 2018/1467 20130101; A61B
2018/1266 20130101 |
International
Class: |
A61B 18/14 20060101
A61B018/14 |
Claims
1. A device for delivering therapeutic energy to tissue,
comprising: a housing; a plurality of electrodes, each electrode
including: a proximal section longitudinally extending from within
the housing and having a longitudinal axis; an intermediate section
extending from the proximal section; a distal section extending
longitudinally from the intermediate section; a rotating device
coupled to the proximal sections of the plurality of electrodes and
adapted to rotate the plurality of electrodes by rotating the
proximal section of each electrode about its longitudinal axis to
move the distal sections of the electrodes from a first radial
state to a second radial state.
2. The device of claim 1, wherein the distal sections of the
electrodes are arranged substantially parallel to each other.
3. The device of claim 1, wherein the distal sections of the
electrodes are uniformly spaced from each other.
4. The device of claim 1, wherein in the first radial state, at
least a portion of the intermediate section of at least one
electrode overlaps at least a portion of the intermediate section
of an adjacent electrode.
5. The device of claim 1, wherein the intermediate section includes
at least one bend to allow at least a portion of the electrodes to
overlap each other when in the first radial state.
6. The device of claim 1, wherein the intermediate sections of the
plurality of electrodes extend in a generally radial direction, and
wherein the intermediate sections and distal sections of each
electrode together form a generally L-shaped configuration.
7. The device of claim 1, wherein the proximal section has a
proximal end and a distal end, and wherein each proximal section of
the electrode includes a "U-shaped" section positioned at the
proximal end.
8. The device of claim 1, wherein the plurality of electrodes is
selected from a group consisting of: four and six electrodes.
9. The device of claim 8, wherein at least a portion of at least
one of the plurality of electrodes is surrounded by an insulation
layer.
10. The device of claim 1, further comprising an elongated shaft
having a proximal end, a distal end, an outer surface, and a
longitudinal axis, wherein the proximal end of the elongated shaft
is coupled to at least a portion of the housing.
11. The device of claim 10, wherein at least a portion of the
plurality of electrodes extends longitudinally within the elongate
shaft.
12. The device of claim 11, wherein at least one electrode of the
plurality of electrodes is located substantially at the center of
the longitudinal axis of the elongated shaft.
13. The device of claim 10, wherein when the rotating device is
rotated, the distal section moves from a first radial state
radially outward to a second radial state at least to a point
outside the perimeter of a longitudinal cross-section of the
elongated shaft.
14. The device of claim 13, wherein the rotating device is a
rotating collar, and wherein the rotating collar is coupled to the
housing and the proximal sections of the plurality of the
electrodes.
15. The device of claim 10, further comprising a sleeve, wherein
the sleeve can be moved and wherein the sleeve surrounds at least a
portion of and is slidably disposed around at least a portion of
the outer surface of the shaft.
16. The device of claim 15, further comprising a slide, wherein the
slide is coupled to the sleeve, wherein when the slide is moved
from a first position to a second position, the sleeve
substantially surrounds at least one electrode of the plurality of
electrodes, such that the plurality of electrodes is locked in
position.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional
Application Ser. No. 61/146,984, filed Jan. 23, 2009, which is
incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to a medical device and method
for the ablation of diseased tissue. More particularly, the present
application relates to a device for delivering therapeutic energy
to tissue, and methods for using the same.
BACKGROUND OF THE INVENTION
[0003] Conventional devices for delivering therapeutic energy to
tissue include a handle and a probe coupled to the handle. The
probe contains at least one electrode to which an electrical power
source is coupled. The power source allows the electrode to deliver
the therapeutic energy to a targeted tissue, thereby causing
ablation of the tissue.
[0004] In certain applications, it is desirable to provide a probe
having a relatively small cross-section, for example 1 cm in
diameter or less, wherein the electrodes are moved to a compact
state to a configuration where the distance between the distal
section of any two electrodes is smallest, so as to be placeable
within a position inside of the outermost dimension of the probe.
Prior art devices have utilized flexible materials having shape
memory (such as nickel titanium, also known as "Nitinol") for the
electrodes in order to accomplish this. However as the distal
sections of the electrodes are moved from a compact position to a
more expanded position where the distance between at least distal
sections of two electrodes becomes greater, it is difficult to keep
such electrodes in proper alignment if they are composed of
flexible materials. Further, it is often difficult or sometimes not
possible to place the electrodes in the correct location of the
tissue to be ablated.
[0005] Applications of a probe that could be utilized as described
ideally would involve the emerging technology of Irreversible
Electroporation (IRE). Irreversible electroporation (IRE) involves
the use of electrical pulses to target tumor tissue in the range of
microseconds to milliseconds that can lead to non-thermally
produced defects in the cell membrane that are nanoscale in size.
These defects can lead to a disruption of homeostasis of the cell
membrane, thereby causing irreversible cell membrane
permeabilization which induces cell necrosis, without raising the
temperature of the tumor ablation zone. During IRE ablation,
connective tissue and scaffolding structures are spared, thus
allowing the surrounding bile ducts, blood vessels, and connective
tissue to remain intact. With nonthermal IRE (hereinafter also
called non-thermal IRE), cell death is mediated through a
nonthermal mechanism, so the heat sink problem associated with many
ablation techniques is nullified. Therefore the advantages of IRE
to allow focused treatment with tissue sparing and without thermal
effects can be used effectively in conjunction with thermal
treatment such as RF that has been proven effective to prevent
track seeding; this will also allow (in this example embodiment)
the user to utilize determined RF levels (or long-DC pulses)
leading to in some cases ablation and in some cases coagulation of
blood vessels of all sizes encountered during treatment. IRE can be
utilized effectively with known techniques of thermal damage
including mediating tumor cell death and bringing about coagulation
along a tissue track.
[0006] Therefore, it would be desirable to provide a device and
method which includes electrodes that can be placed within a
relatively small diameter by being placed in a compact position to
a more expanded position where the distance between at least distal
sections of two electrodes becomes greater, and then returned to
the compact position while the distal sections of the electrodes
remain in parallel with each other. With some therapies, parallel
electrodes are needed; parallel embodiments are in certain cases
better than curved flexible electrodes such as in use with hard
surfaces, tumors, or cancers. Maintaining a parallel orientation
can be critical to treatment success. Additionally, this device
could be used to mediate irreversible electroporation separately or
in conjunction with reversible electroporation, long-DC pulses, and
Radio-Frequency (RF) technologies which provides additional
advantages of treatment when used in conjunction with features such
as the parallel electrode orientation.
SUMMARY
[0007] Throughout the present teachings, any and all of the one,
two, or more features and/or components disclosed or suggested
herein, explicitly or implicitly, may be practiced and/or
implemented in any combinations of two, three, or more thereof,
whenever and wherever appropriate as understood by one of ordinary
skill in the art. The various features and/or components disclosed
herein are all illustrative for the underlying concepts, and thus
are non-limiting to their actual descriptions. Any means for
achieving substantially the same functions are considered as
foreseeable alternatives and equivalents, and are thus fully
described in writing and fully enabled. The various examples,
illustrations, and embodiments described herein are by no means, in
any degree or extent, limiting the broadest scopes of the claimed
inventions presented herein or in any future applications claiming
priority to the instant application.
[0008] Disclosed herein are devices for delivering therapeutic
energy for destruction and/or removal of undesirable living
biological tissues and methods of using such, particularly for
treatment. In particular, according to the principles of the
present invention, a device for delivering therapeutic energy to
tissue is provided. The device includes a housing and a rotating
device coupled to the housing. The device includes a plurality of
electrodes, each electrode including: (i) a proximal section
longitudinally extending from the within the housing and having a
longitudinal axis; (ii) an intermediate section extending from the
proximal section; and (iii) a distal section extending
longitudinally from the intermediate section. The rotating device
is coupled to the proximal sections of the plurality of electrodes
and adapted to rotate the electrodes to move the distal section of
the electrodes so that distance between at least two electrodes
changes, so that the electrodes can be placed in a compact position
or an expanded position or can be placed at any configuration,
referring to any radial state between fully compacted and fully
expanded.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0009] FIG. 1A is an isometric view of a therapeutic energy
delivery device of the present invention shown with the electrodes
moved to a configuration where the distance between the distal
section of any two electrodes is smallest and wherein the distal
section of the electrodes are covered with the sleeve.
[0010] FIG. 1B is an enlarged partial isometric view of the distal
portion of the therapeutic energy delivery device of FIG. 1A
designated as Section A-A.
[0011] FIG. 2A is an isometric view of the therapeutic energy
delivery device of the present invention shown with the electrodes
in a configuration where the distance between the distal section of
any two electrodes is smallest and wherein the sleeve has been
moved to a position to uncover the distal sections of the
electrodes.
[0012] FIG. 2B is an enlarged partial isometric view of the
therapeutic energy delivery device of FIG. 2A designated as Section
B-B.
[0013] FIG. 3A is an isometric view of the therapeutic energy
delivery device of the present invention shown with the electrodes
in an expanded state where the distance between the distal section
of any two electrodes is greatest, and with the sleeve in a
position so as to uncover the distal section of the electrodes.
[0014] FIG. 3B is an enlarged partial isometric view of the
therapeutic energy delivery device of FIG. 3A designated as Section
C-C.
[0015] FIG. 4 is a partial cut-out perspective view of the hand
piece of the therapeutic energy delivery device of FIG. 2A.
[0016] FIG. 5A-5B show a single electrode of the present invention
where FIG. 5A is a plan view of an electrode of the therapeutic
energy delivery device of FIG. 1-3A and FIG. 5B is a distal end
view.
[0017] FIG. 6A is an enlarged isometric view of the electrodes and
rotational cam showing the electrodes in a configuration where the
distance between the distal section of any two electrodes is
smallest.
[0018] FIG. 6B is an enlarged isometric view of the electrodes and
rotational cam subassembly showing the electrodes in a intermediate
diameter configuration.
[0019] FIG. 6C is an enlarged isometric view of the electrodes and
rotational cam subassembly showing the electrodes in a fully
expanded position where the distance between the distal section of
any two electrodes is greatest
[0020] FIG. 7 is an exploded perspective view of the therapeutic
energy delivery device of FIG. 1A illustrating the assembly
components.
[0021] FIG. 8A is a plan view of the stabilizer component of the
therapeutic energy delivery device of FIG. 1A, and FIG. 8B shows a
distal end view of the stabilizer.
[0022] FIG. 9 is an exploded side view of the components of the
slide mechanism of the therapeutic energy delivery device of FIG.
1A controlling the position of the sleeve.
[0023] FIG. 10 is an exploded isometric view of components of an
alternative embodiment of the slide mechanism of FIG. 9 showing the
slide mechanism of the therapeutic energy delivery device of FIG.
1A controlling the position of the sleeve.
[0024] FIG. 11A is an isometric view of the rotational subassembly
and electrodes expanded to a configuration where the distance
between the distal section of any two electrodes is greatest.
[0025] FIG. 11B isometric view of the rotating cam subassembly with
electrodes showing the rotational cam and the electrodes in a
configuration where the distance between the distal section of any
two electrodes is smallest.
[0026] FIGS. 12A-D are distal end views of the therapeutic device
10 showing respectively the position of the electrodes as the
electrodes are moved from a configuration where the distance
between the distal section of any two electrodes is smallest (12A)
to the configuration where the between the distal section of any
two electrodes is greatest (12D). Two intermediate positions (FIGS.
12B-C) are also shown.
[0027] FIGS. 13A-13B are partial isometric views of the therapeutic
energy delivery device showing a stabilizer and electrodes for an
alternative embodiment of the device having six electrodes. FIG.
13A shows the electrodes in configuration where the distance
between the distal section of any two electrodes is smallest and
FIG. 13B shows the electrodes in a configuration where the distance
between the distal section of any two electrodes is greatest.
[0028] FIGS. 14A-C are distal end views of the therapeutic energy
delivery device of FIG. 13A-B having six electrodes showing
respectively the position of the electrodes as the electrodes are
moved from a configuration where the distance between the distal
section of any two electrodes is smallest (FIG. 14A) to a
configuration where the distance between the distal section of any
two electrodes is greatest (FIG. 14C). An intermediate
configuration (FIG. 14B) is also shown.
[0029] FIG. 15 is an partial isometric view of the distal segment
of an alternative embodiment of the therapeutic energy delivery
device having four electrodes having insulation placed through
tubes wherein a mechanism at the proximal end of the device can be
used to move the electrodes proximally and distally within the
tubes. In addition, the insulation can be slid proximally and
distally to ensure that electrodes coming in close contact are
electrically separated; the insulation can extend to the end of the
intermediate section 33 of the electrodes an in certain embodiments
can extend into at least a portion of the distal section 32 of the
electrodes. Please confirm that the electrodes can be advanced and
retracted rather than the insulation. I don't understand how this
would work. Insulation extends in a distal direction to encompass
the intermediate sections 33 of the electrodes to prevent
cross-conductivity of electrodes in close proximity. The insulation
can be made slideable through a controller at the proximal end of
the device.
[0030] FIG. 16 is a flowchart illustrating a method of treatment
using the therapeutic energy delivery device.
[0031] FIG. 17 is a partial cut-away view of the side of a patient
torso depicting the method of treatment using the therapeutic
energy delivery device to treat a liver tumor.
DETAILED DESCRIPTION
[0032] "Therapeutic energy" and "TE", used interchangeably herein
and in the contexts of "therapeutic energy delivery" and "TED",
refer to the energy output from the treatment member(s) of the
devices or portions thereof (e.g., distal segment(s) of the
treatment member(s)) to its immediate surroundings, such as the
target tissue(s) when present. Non-limiting examples of therapeutic
energy include electromagnetic energy such as radio frequency
energy, radiant thermal energy, radiation energy, acoustic energy
(e.g., ultrasonic energy), and high voltage DC current creating
electrical pulses. Also, the treatment can include therapies for
irreversible electroporation as well as reversible electroporation
(separately or in combination and with any of the previous energies
or therapies indicated).
[0033] "Operator" refers to a person or a robotic assembly who uses
the devices for treatments, particularly in patients (e.g.,
coagulation, ablation). The operator may be a physician, including
interventional radiologists, oncologists, and surgeons.
[0034] The term "distal" is understood to mean away from a medical
practitioner and towards the body site at which the procedure is
performed, and "proximal" means towards the medical practitioner
and away from the body site.
[0035] The present invention is illustrated in FIGS. 1 through 17.
FIG. 1A is an isometric view of a therapeutic energy delivery
device 10 of the present invention with the electrodes 74 protected
by a sleeve 21 for an embodiment having four individual electrodes.
Shown in FIG. 1A is the therapeutic energy delivery device 10,
having a housing 40 (also called a hand piece) as well as a
stabilizer 20 (also called an elongated shaft). A coupling 56 for
the therapeutic energy delivery device provides coupling with a
power source or energy source (not shown). Also shown in FIG. 1A is
the distal section 32 of the electrodes of the therapeutic energy
delivery device 10 as well as a sleeve 21 covering the distal
section 32 of the electrodes. Shown attached to the housing 40 is a
rotational cam 42 (also called a rotating collar) that functions to
rotate the electrodes such that the overall diameter of the
electrode group can be increased or decreased. When rotated to a
compact configuration, the distal sections of 32 of the electrode
group have the advantage of insertion of the electrodes into a
small diameter opening wherein upon rotation of the electrodes move
into an expanded radial state where the distance between the distal
section of any two electrodes becomes greater, allowing for a
larger treatment area than the size of the opening. In one
embodiment, the elongated shaft 20 has a diameter of about 1 cm or
less. The elongated shaft 20 is capable of being inserted into a
lumen of a laparoscopic trocar (not shown) during use. Also shown
in FIG. 1 is a slide 41 that allows for the sleeve to be moved
distally or proximally to respectively cover or uncover the
electrodes. Collar 46 is a structural component that the retractor
43 rests against in embodiments where the retractor 43 is
immobilized, and a component that the retractor 43 abuts in
embodiments where the retractor 43 is moveable when retractor 43 is
moved to a most proximal position. This provides stability for the
subassembly of the device in rapid electrode state changes. Also, a
plurality of tabs 27 lock the cap 25 position and prevent twisting
of the cap 25 when the radial state is adjusted, altering the
distance between distal sections 32 of the electrodes.
[0036] Still referring to FIG. 1A, the slide 41 can be coupled to
an assembly or subassembly that may include a retractor 43 having
sections known in the art to allow for the electrodes to be locked
in place such that no rotation is possible when the sleeve 21 is
moved to a distal position to cover the distal section of the
electrodes. The slide can be located on the top, side, or bottom of
the device and can be a trigger, knob, switch, or other mechanical
or electrical device known in the art to provide for movement of
the sleeve 21. In certain embodiments a knob coupled to the handle
rotates and the sleeve can be moved proximally and distally.
[0037] FIG. 1B is an enlarged isometric view of the distal portion
of the therapeutic energy delivery device of FIG. 1A designated as
Section A-A. Shown is the stabilizer 20, the distal section 32 of
the electrodes in a configuration where the distance between the
distal section of any two electrodes is smallest, and wherein the
distal sections 32 of the electrodes are covered by a sleeve 21
that has been moved distally to cover as well as to protect the
distal sections of the electrodes. Also shown is an intermediate
section 33. For completeness a tab 27 and cap 25 are shown. A
plurality of tabs 27 lock the cap 25 position and prevent twisting
of the cap 25 when the radial state is adjusted, altering the
distance between distal sections 32 of the electrodes.
[0038] The therapeutic device has electrodes that extend through an
elongated shaft and extend out of the distal end of the elongated
shaft. The electrodes are capable of rotation from a controller
such as a rotating device coupled to the handle of the therapeutic
device such that the electrodes can be placed in multiple
positions; the electrodes can be overlapped at the intermediate
section to form a compact, minimum diameter position wherein the
electrodes fit within the longitudinal cross-sectional perimeter of
the elongated shaft, and the electrodes can also be rotated in the
opposite direction so as to extend out to a point that reaches to
or even beyond the perimeter of the cross-section of the
longitudinal shaft. The electrodes can be positioned at any
overlapping position between fully overlapped and fully extended
and can be operable so as to deliver voltage for treatment at any
position. In certain embodiments the rotation in either direction
changes the diameter between the distal sections of at least two
electrodes and in various embodiments there is no elongated shaft.
In certain embodiments the position of the distal section of the
electrodes is called a radial state and the device can be set to
have any radial state between a minimum and maximum position and be
capable of delivering voltage for treatment. For example, one
radial state would be when the distal section of the electrodes are
moved to a configuration where the distance between the distal
section of any two electrodes is smallest, while another radial
state would be a configuration where the distance between the
distal section of any two electrodes was greatest. This would
represent a compact shape and an expanded state respectively and at
each radial state the distal sections of the electrodes would be
capable of delivering voltage for treatment. Also, any radial state
between those two configurations also would allow for the
capability of treatment. In various embodiments of the present
invention, the user has indicators that show the radial state, the
potential ablation zone, the distance between any two electrodes,
and any other factors significant for preparing for ablation. The
indicators can be mechanical, electrical, or software-mediated
indicators on the rotational cam 42 or the elongated shaft 20 so
that the user knows at any given time the ablation to be carried
out by used voltage. The indicators can also include the insulation
position or amount of exposed or active electrodes. Also, software
can keep track of and show through a 3D model or through numbers on
a computer screen how compact or expanded the radial state is for
use (including the numbers described such as distance between
electrodes. The ends of the electrodes can also have indicators
that allow better actual visualization for any scans of the
body.
[0039] The electrodes can in certain embodiments be covered by a
sleeve that can be moved by a controller at the handle to either
move the sheath to a position where the electrodes are covered or
move the sleeve so the distal section of the electrodes are
uncovered. When the electrodes are covered the electrodes are
protected. When the electrodes are covered, in certain embodiments,
the electrodes in various embodiments become locked in place and
cannot be rotated.
[0040] In various embodiments the elongated shaft 20 includes a
sleeve 21 that surrounds and protects the distal sections 32 of the
electrodes while the device is being inserted into a body through
the lumen of a laparoscopic trocar. A "body" can refer to a human
or mammal or other non-mammal or organism requiring treatment. The
sleeve 21 is in certain embodiments attached to a retractor 43 to
form a subassembly. A slide 41 controls advancement of the sleeve
and in certain embodiments controls the retraction of the retractor
43 (The retractor embodiment in FIG. 1 cannot move).
[0041] In various embodiments a rotating device or rotating collar
42 is coupled to the hand piece 40. The rotating collar 42 will be
described in further detail in subsequent figures such as FIG.
4.
[0042] Referring to FIG. 1B, a plurality of electrodes extend
within the elongated shaft 20. The number of electrodes can be one
or more. The distal sections 32 of the electrodes and the proximal
sections 31 of the electrodes (the proximal sections are not shown
in FIG. 1B though this is clearly shown in FIG. 5) are in parallel
with each other in all distal electrode configurations possible
upon rotation. Preferably, the electrodes are rigid which helps to
ensure that the orientation of the electrodes relative to each
other is constant (for example, ensuring that the electrodes remain
in a parallel configuration to each other). In one embodiment, the
electrodes are approximately 0.040'' in diameter and are made of
stainless steel The sleeve 21, when advanced to its most distal
position, has been extended out from the elongated shaft 20. In
certain embodiments the shaft or portions of the shaft include in
whole or in part sections made of biologically compatible materials
(e.g., stainless steel, titanium, alloys thereof), and in certain
embodiments is comprised of a solid core and in other embodiments
has a plurality of channels for receiving the proximal sections 31
of the electrodes. The electrodes are isolated from the metal shaft
through moveable or immovable insulation that extends distally
through the proximal sections 33 of the electrodes. A cap 25 is in
certain embodiments positioned at the distal end of the elongated
shaft 20. In certain embodiments a seal is optionally provided
between the cap 25 and the stabilizer. The distal sections 32 of
the electrodes extend out of the cap 25 for delivering the
therapeutic energy to the tissue. A plurality of tabs can 27 lock
the cap 25 position and prevent twisting of the cap 25 during use
of the device. The tips 35 of the electrodes can be sharp for
piercing tissue.
[0043] Each electrode can be insulated (insulation layer not
shown). The Insulation preferably runs up to about 2.5 cm from the
distal tip 35. although the electrodes may have an exposable
longitudinal length of 0.5 cm or greater and/or 10 cm or less, such
as 1 cm, 2 cm, 2.5 cm, 3 cm, 4 cm, 5 cm, 6 cm, 8 cm, or a range
between any two of such values. The uninsulated or exposed
electrode length defines the treatment section of the electrodes.
It is preferred that the Insulation layer covers the electrodes at
any location where overlap with another electrode is possible, such
as along the intermediate sections 33 of the electrodes. The
insulation layer can run along the entire length of the proximal
section of each electrode. The insulation layer can be variable or
it can be fixed. If the insulation layer is fixed, it at least
covers the Intermediate section 33 of the electrode, but the
insulation layer may also extend to surround a portion of the
distal section 32 of the electrode. The insulation layer can be
sprayed on, formed as shrink tubing, formed as a dipped material,
or extruded as an outer layer. The electrodes can be non-insulated
or insulated with a fixed or slidable insulation layer.
[0044] FIG. 2A is an isometric view of the therapeutic energy
delivery device of the present invention being shown with the
electrodes in a configuration where the distance between the distal
section of any two electrodes is smallest. FIG. 2B is an enlarged
isometric view of the therapeutic energy delivery device of FIG. 2A
designated as Section B-B.
[0045] FIGS. 2A and 2B depict the same embodiment as FIGS. 1A-B,
where the slide 41 has been moved proximally so as to pull back the
sleeve 41 to a proximal position so that the distal sections 32 of
the electrodes are uncovered. The sleeve 41 can be placed over the
distal sections of the electrodes as in FIGS. 1A-B during insertion
into a target region so as to protect the electrodes and to protect
organs from inadvertent puncture by electrode tips, and the sleeve
41 can be moved proximally to expose the distal sections of the
electrodes for treatment, as shown in FIGS. 2A-B. The treatment can
be performed at any level or position of distal electrode
configuration, referring to any radial state.
[0046] The distal sections 32 of the electrodes are fully exposed
and are in a parallel arrangement with each other. The electrodes
overlap each other at intermediate sections of the electrodes 33.
The intermediate sections of the electrodes 33 can include a shape
that allows for the overlap with multiple electrodes as shown in
FIG. 2B and FIG. 5. For example, the intermediate sections of the
electrodes 33 can include a bend or bends to allow the electrodes
to overlap each other. Alternatively, the intermediate sections 33
of the electrodes do not include any bends, but instead the distal
sections 32 of the electrodes have different lengths in order to
accommodate the overlapping arrangement.
[0047] FIG. 3A is an isometric view of the therapeutic energy
delivery device of the present invention shown with the electrodes
in a maximum expanded state where the distance between the distal
section of any two electrodes is greatest, and with the sleeve in a
position so as to uncover the distal section of the electrodes.
[0048] FIG. 3B is an enlarged isometric view of the therapeutic
energy delivery device of FIG. 3A designated as Section C-C.
[0049] In certain embodiments the distance between any electrode is
greater than the diameter of the stabilizer.
[0050] Referring to FIGS. 3A-3B, as the distal portions of the
electrodes are moved to an expanded configuration from the compact
configuration shown in FIGS. 2A-B, each of the electrodes undergoes
identical angular rotation, such that all electrodes remain in a
parallel configuration, spiraling in the form of an expanding
cylinder. Preferably, the total amount of rotation that is possible
is about 180 degrees from a compact configuration shown in FIGS.
2A-B to the expanded configuration that is the radial state shown
in FIGS. 3A-B. It is preferred that the distal sections of the
electrodes 32 remain in a parallel configuration through all
possible configurations. This is particularly advantageous because
it allows a predictable orientation of electrodes upon rotation.
Further, it is important that the distal sections of the electrodes
32 remain in a parallel configuration when the therapeutic energy
is delivered between the electrodes.
[0051] The distal sections 32 of the electrodes deliver therapeutic
energy to tissue. In one embodiment the distal sections 32 of the
electrodes deliver electrical energy to achieve IRE irreversible
electroporation (IRE) energy in order to permanently open the cell
membranes leading to tissue death. In another embodiment,
radiofrequency energy can be applied to the electrodes. The energy
source (not shown) is connected to the therapeutic device and
delivers the energy to the electrodes. In one embodiment, the
electrodes are mono-polar electrodes and only two electrodes
deliver energy at any given moment wherein one electrode is
positive and one electrode is negative. The operator may program
the energy source according to a predetermined energy delivery
pattern as disclosed, for example, in U.S. Pat. No. 5,674,267
issued to Mir et al., which is incorporated herein by reference. As
an example, if the device includes four electrodes (electrodes 1-4)
as shown in FIG. 3B, and assuming that the electrodes are numbered
1 through 4 in a circumferential direction, the electrode firing
sequence may be (1) electrode 1 (+)-electrode 2 (-); (2) electrode
2 (+)-electrode 3 (-); (3) electrode 3 (+)-electrode 4 (-); (4)
electrode 4 (+)-electrode 1 (-); (5) electrode 1 (+)-electrode 3
(-); and (6) electrode 2 (+)-electrode 4 (-). In another
embodiment, each electrode is a bipolar electrode. In one
embodiment, both pairs of electrodes can fire simultaneously rather
than sequential firing of individual pairs.
[0052] FIG. 4 is a partial cut-out perspective view of the hand
piece of the therapeutic energy delivery device of FIG. 2A, and
parts of FIG. 2A. Shown is the half-handle 68 of the hand piece,
with a proximal handle protrusion 66 shown that can be used to
hold, snap-fit, or be part of a mechanism to adhere or hold the
handle parts or halves together. Also shown is the proximal end 34
of each electrode placed through supporting member 52 (also called
bearing block). The support member 52 can lock into a support plate
51 that is attached to or is part of the housing to prevent
unintentional movement of the distal sections 32 of the electrodes
to a different radial state. In various embodiments the supporting
member 52 interlocks with support plate 51 when the slide 41 is in
its most distal position, when the sleeve is covering the distal
section of the electrodes. Alternative embodiments allow locking in
place when the sleeve is moved to a position where the distal
section of the electrodes are uncovered. Also shown in FIG. 4 are:
apertures 50 that are adapted to receive the proximal ends of each
electrode 34, as well as the rotating collar 42 with slots 45
within the rotating collar (clearly depicted in FIGS. 6A-C), the
stabilizer 20 that in this pictured embodiment is shown with a
trocar 78 of the therapeutic energy device surrounding the
stabilizer 20, and the proximal sections 31 of the electrodes just
proximal to the intermediate sections of the electrodes (not
shown). For completeness, the way the slide snaps in when it is in
a distal position are now described since these parts are shown in
FIG. 4. Slide 42 when moved distally can lock in place when
snap-fit 114 mechanically slides into place into detent with pocket
for snap-fit 64. When force is put on the slide to move it in a
proximal direction, the slide moves proximally as snap-fit 114
slides out of pocket for snap-fit 64. In other words when the slide
moved distally it snaps in place and when moved proximally it
mechanically slides out of snap-fit 64 and can be moved
proximally.
[0053] Still referring to FIG. 4, FIG. 4 shows certain components
housed partially or fully in the half-handle 68 of the hand piece
40 (not shown) of FIGS. 1A and 2A. Hand piece 40 may be composed of
separately molded left and right pieces that are coupled together
by adhesives or screws. A rotating collar 42 is coupled to the hand
piece 40. The rotating collar 42 is positioned so that it can
rotate about its axis which runs parallel to the elongated shaft
20. The rotating collar 42 in various embodiments includes a
plurality of ridges along its outer surface for providing a
gripping surface. At least a portion of the outer surface of the
rotating collar 42 is exposed outside of the hand piece 40. The
rotating collar 42 includes a plurality of slots 45 along its inner
surface (more clearly depicted in FIGS. 6A-6C). Each proximal
section of the electrode includes a "U-shaped" section 38 (depicted
in FIG. 5) near the proximal end. The longitudinally extending
bottom portion of each "U shaped" section 38 of each electrode runs
through each corresponding slot 45. Though section 38 forms a "U
shaped" section shown in FIG. 5, the shape can be defined as any
shape known in the art so as to allow rotation of the electrodes
when the rotating collar is moved. This could include electrodes
with V-shapes or squares, or even single or multiple bends of zero
to ninety degrees or more, or an electrode with undulations, among
other configurations.
[0054] FIG. 4. also shows that the proximal ends of the electrodes
31 extend proximally through a supporting member 52 (also depicted
in FIG. 9) within the handle that is for anchoring, supporting, and
securing the position of the electrodes; this supporting member can
be a single piece, molded or formed or created via any method known
in the art. In FIG. 4 this supporting member is shown as two
approximate rectangles and a rounded middle portion. In certain
embodiments the supporting member comprises a pair of retaining
plates that form a recess therebetween. The recess receives a
support plate 51 (also depicted in FIG. 7) that extends from at
least one side of the inner surface of the hand piece 40. The
supporting member thereby is attached to the support plate 51 to
form a secure fit in order to anchor the supporting member in a
fixed position. The supporting member includes a plurality of
apertures 50 that are adapted to receive the proximal ends of each
electrode 34. As shown in FIG. 4, the apertures 50 of the
supporting member thereby provide a fixed axis for the rotation of
the proximal section of each electrode (the proximal ends of which,
34, can be seen clearly in the FIG. 4).
[0055] FIG. 5A-5B show a single electrode of the present invention
where FIG. 5A is a plan view of an electrode of the therapeutic
energy delivery device of FIG. 1-3A and FIG. 5B is a distal end
view.
[0056] Still referring to FIGS. 5A-B, FIG. 5A-5B show a single
electrode 74 of the present invention. 5B is a distal end view of
the electrode and 5B is a side view rotated 45.degree. from end
view 5B to more clearly illustrate both offset sections 32 and 38.
The electrode is comprised of a conductive material such as
stainless steel, nitinol, or other metals or conductive plastics
known in the art, and may have a uniform cross-sectional outer
diameter of from 0.001'' to 0.080'' along its length. In one
embodiment the overall length of electrode 74 is approximately 19
inches. The electrode includes: (i) a proximal section 31
longitudinally extending from the housing surface (not shown) and
having a first longitudinal axis X; (ii) an intermediate section 33
extending from the proximal section 31 extending radially outward
from the first longitudinal axis X; and (iii) a distal section 32
extending longitudinally from the intermediate section 33 on a
second longitudinal axis parallel to axis X. The proximal section
31 extends from proximal electrode end 34 for approximately 17.5''
to intermediate section 33. Although not shown, electrode end 34 is
coupled to an electrical wire or other element which extends
through coupling 56 of FIG. 1A for transmission of energy from the
energy source to the electrode. Intermediate section 33 further
includes a "U-shaped" section 38 having a longitudinal length of
approximately 0.65 inches. Section 33 is outwardly off-set from
longitudinal axis X by approximately 0.25'' at a 90.degree. angle
relative to section 38, as shown in FIG. 5B. Intermediate section
33 is comprised of a stepped section consisting of two bends. The
stepped profile of Intermediate section 33 functions to provide a
nested overlap of the electrodes when in a minimum diameter
position, as will be described in more detail below. Distal section
32 of electrode 74 extends for approximately 1.3 Inches from
intermediate section 33 to sharpened distal tip 35. Distal section
32 is outwardly off-set from longitudinal axis X by approximately
0.32 Inches. An insulative covering, not shown, is coaxially
arranged around electrode 74 and extends from proximal end 34 to
distal end section 32 where it terminates proximal to the distal
end 35.
[0057] FIGS. 6A-6C show enlarged isometric views of the electrodes
and rotational cam showing the electrodes first in a compact
configuration where the distance between the distal section of any
two electrodes is smallest (FIG. 6A), a second configuration in
which the electrodes are at greater but not maximum distance
relative to each other (FIG. 6B) and, a third configuration where
the distance between the distal section of any two electrodes is
greatest (FIG. 6C). FIGS. 6A-6C show the rotating collar 42, slots
45 within the rotating collar, as well as the "U-shaped" sections
38 of the electrodes, the proximal sections 31 of the electrodes,
the intermediate sections 33 and the distal sections 32 of the
electrodes. Arrow 76 shows the rotation direction as the rotating
collar 42 is rotated from FIG. 6A to 6B to 6C respectively.
[0058] When the rotating collar 42 is rotated, the "U-shaped"
sections 38 of the electrodes also move because they are captured
within the slots 45. Therefore, as the rotating collar 42 is
rotated the proximal section 31 of each electrode is caused to
rotate about the longitudinal axis of the device thereby
simultaneously causing the distal sections of the electrodes 32 to
move radially outward as shown in FIG. 3A-B. Because the
longitudinal axis of each proximal section 31 of each electrode is
not centered within the rotating collar 42, the "U shaped" portion
will slide radially within the slot 45 as the rotating collar 42 is
rotated. Each slot 45 is property sized so that the rotating collar
42 can rotate for a predetermined number of degrees (for example
about 180 degrees) which in turn causes simultaneous rotation of
the electrodes. For example, in certain embodiments when the
electrodes are in a configuration where the distance between the
distal section of any two electrodes is smallest (FIGS. 2A-B) the
"U-shaped" section 38 is positioned near the innermost surface of
the slot 45. As the rotating collar 42 is rotated about 90 degrees,
the "U-shaped" section 38 moves radially to the outermost surface
of the slot 45, as shown in FIG. 4. As the rotating collar 42 is
continued to rotate for about another 90 degrees (for a total of
about 180 degrees), the "U-shaped" section 38 moves radially back
again near the innermost surface of the slot 45, at which point the
electrodes are in a configuration where the distance between the
distal section of any two electrodes is greatest (FIG. 3). In one
embodiment, the slot 45 is sealed at both ends for preventing the
"U-shaped" section 38 from inadvertently exiting the slot 45.
[0059] FIG. 7 is an exploded perspective view of the therapeutic
energy delivery device of FIG. 1A. Shown are: the half-handle 68 of
the hand piece with a proximal handle protrusion 66, the support
plate 51 this supporting member 52, the spring 58, the lock shaft
72, the lock sleeve 60 with the lock pin 62, the alternative
embodiment of the retractor 430, the slide 41, the stabilizer 20,
the trocar 78, and the full electrodes 74. FIG. 7. FIG. 7 is a
holistic figure showing many parts of the device; there are four
main sections shown, including the distal portions such as the
electrodes 74 with the trocar 78 and stabilizer 20, the more
proximal portions including those responsible for moving the sleeve
forward and back via the slide 41 and retractor 430. Also shown are
the parts responsible for rotation and locking of rotation when the
slide is moved distally, such as the rotational cam 42 and the cam
wheel lock element of rotational lock component 75 and the barrel
portion of the rotational lock component 73 and the post section of
rotation lock component 192. Also shown are the handle portions
that are most proximal and that provide stability.
[0060] FIG. 8A is a plan view of the stabilizer 20 component of the
therapeutic energy delivery device of FIG. 1A, and FIG. 8B shows a
distal end view of the stabilizer 20. In one embodiment, stabilizer
20 has an outer diameter of 0.34'' with a central through channel
197 of approximately 0.185''. Stabilizer 30 is preferably comprised
of a medical grade stainless steel or other metal and includes a
plurality of longitudinal electrode channels 190 in the outer
surface of the stabilizer which extend the entire length of the
stabilizer. Electrode channels 190 are approximately 0.050'' in
depth so as to accommodate the electrodes 74 completely within the
channel 190. When the cam wheel 42 is rotated, electrodes 74 each
rotate about their longitudinal axis (X in FIG. 5) within their
respective channels 190. Stabilizer 30 with channels 190 function
to ensure that during rotational movement of the electrodes around
their X axis, the electrodes remain restricted within channels 190
preventing any horizontal or other movement.
[0061] FIG. 9 is an exploded isometric view of components of the
slide mechanism of that controls the movement of sleeve 21, as well
as locking the cam while 42 in position so as to prevent any
inadvertent radial expansion of the electrode group while covered
by sleeve 21. The slide mechanism subassembly includes thumb slide
41 which is attached to retractor 430 by post 81 which fits into
mating recess (not shown) in slide 41. Stabilizer 20 is coaxially
arranged within the through lumen of retractor 430 allowing for
longitudinal movement of the retractor when the thumb slide 41 is
advanced or retracted. Trocar 78 (not shown), sleeve 21 and the
plurality of electrodes 74 which are also positioned within the
lumen of the retractor have been removed from FIG. 9 for clarity.
Although not shown, sleeve 21 is fixably attached to retractor 430,
so that longitudinal movement of thumb slide 41 causes a
corresponding longitudinal movement of sleeve 21. Retractor 430
includes a plurality of longitudinally upper extending prongs of
the retractor 193 which when slid proximally comes to abut up
against lug 198 of lock sleeve 60, preventing any further
longitudinal movement. Lock sleeve 60 is attached to stabilizer 20
by pin 62 which is received within hole 85 in the side wall of lock
sleeve 60. Pin 62 is also aligned within through slot 195 (see FIG.
8A) of stabilizer 20 and pin 62 moves longitudinally within slot
195 of the stabilizer 20 in response to movement of the thumb
slide. Longitudinal travel is limited to the length dimension of
slot 195 which is approximately 0.1 inch in one embodiment (where
the radius of either end is 0.05 inches). Also shown in FIG. 9 is
rotational lock component 72 which includes a barrel portion 73,
cam wheel lock element 75 and post section 76. When assembled,
proximal barrel portion 73 is positioned within channel 88 of
stabilizer 20 (refer to FIG. 8A-B). Cam wheel lock element 75
functions to lock the cam wheel 42 (not shown) preventing any
inadvertent radial expansion of the distal sections 32 of the
electrodes to a different radial state while protected by sleeve
21. When the thumb slide 41 is moved distally to advance the sleeve
21 over the distal sections 32 of the electrodes, cam wheel lock
element 75 of rotational lock component 72 moves longitudinally to
become seated within the cavity of cam wheel 42 (see FIG. 7).
Because rotational lock component 72 is prevented from rotational
movement along its longitudinal axis, the cam wheel lock 75 becomes
immobilized and cannot be rotated. The lock 72 is prevented from
any rotational movement by post section 76 which is inserted and
through into bearing block 52. Bearing lock 52 includes openings
through which the proximal segment of the electrodes are positioned
and a single square central opening for receiving post section 76
of rotational lock component 72. Referring again to FIG. 7, bearing
block 52 is positioned within and permanently mounted to handle 68
by tabs 51. Bearing block component 52 thus functions to prevent
rotation of the rotational lock component as well as providing a
mounting area for the proximal ends 34 of the of electrodes. For
completeness, upper extending prongs of the retractor 193 are also
shown in FIG. 9.
[0062] FIG. 10 is an exploded isometric view of components of an
alternative embodiment of the slide mechanism of FIG. 9 that
control the movement of sleeve 21, as well as locking the cam while
42 in position so as to prevent any inadvertent radial expansion of
the electrode group while covered by sleeve 21. This embodiment
differs from FIG. 9 in that there is an additional part called a
rotational cam insert 104, and the lock sleeve has been altered
such that there is not a lock pin 62 but rather a distal lock
sleeve tab 110. When the slide is in its most distal position so as
to cover the distal sections 32 of the electrodes, the lock sleeve
60 moves forward and the distal lock sleeve tabs 110 slide into a
section of handle 68 (not show). When this occurs, rotation of the
distal sections 32 of the electrodes is prevented. To more clearly
understand the interrelation of the parts, the following
description is provided to show how the parts must fit together in
an assembly: the slide 41 moves the lower extending prongs of the
retractor 108 into contact with the lock sleeve 60, which presses
against the spring 58 that then contacts the rotational cam insert
104. The lock sleeve tabs 112 interlock with the rotational cam
insert grooves 106 of the rotational cam insert 104. The spring 58
fits inside of the inner diameter of the lock sleeve 60. In certain
embodiments additional protective coverings can be placed on the
exterior of the elongated shaft 20 and FIG. 10 shows a protective
covering 122. When the slide 41 is in a distal position to cover
the distal sections 32 of the electrodes, the spring 58 is in its
relaxed position. When the slide 41 moves proximally, the distal
lock sleeve tab 110 slides out of the handle part that it fits
within (not shown) and releases such that the distal sections 32 of
the electrodes can be changed to an altered radial state via
movement of the rotational cam 42.
[0063] FIG. 11A is an isometric view of the rotating cam
subassembly with electrodes showing the rotational cam and the
electrodes in a configuration where the distance between the distal
section of any two electrodes is greatest (FIG. 11A), and FIG. 11B
is an isometric view of the rotational cam showing the electrodes
in a configuration where the distance between the distal section of
any two electrodes is smallest. FIGS. 11A-11B show the rotating
collar 42, the proximal section 31 of the electrodes, the distal
section of the electrode 32, the proximal ends 34 of the
electrodes, and the supporting member 52. FIG. 10A also designates
the intermediate sections 33 of the electrodes. When the rotating
collar 42 is turned, the proximal electrode 31 section turns and
this alters the radial state of the distal section 32 of the
electrodes. FIGS. 6A-C show that there is a U-shaped section of the
proximal section 31 of the electrode that actually turns within
slots 45 as the rotational cam 42 is turned, but this is not shown
in FIGS. 11A-B.
[0064] FIGS. 12A-D are distal end views of the therapeutic energy
delivery device 10 showing respectively the position of the
electrodes as the electrodes are moved from a minimum outer
diameter configuration to a maximum outer diameter configuration.
For clarity, only the trocar 78, stabilizer 20 and electrodes 74
are shown. FIG. 12A illustrates the electrodes positioned such that
the outer diameter of the combined electrode group is smaller than
the outer diameter of stabilizer 20 as well as the inner diameter
of trocar 78. In one embodiment the outer diameter of the electrode
group in its minimum configuration is approximately 0.35''. In this
minimum diameter position, protective sleeve 21 which has an inner
diameter of approximately 0.395'' may be advanced over the distal
ends 35 into a protective position as shown in FIG. 1B. The sleeve
21 may also be retracted to expose the electrode group as shown in
FIG. 28. For completeness, the distance between any two adjacent
electrodes in FIG. 12A to FIG. 12D respectively is 0.208, 0.326,
0.453, and 0.618 inches. In other words the distance between each
electrode in FIG. 12A is 0.208 inches, and between each electrode
in FIG. 12B is 0.326 inches, showing that electrodes are in their
most compact state in FIG. 12A. For perspective, the channel in
stabilizer 197 is also shown as is the electrode channel 190 in
stabilizer.
[0065] To expand the initial outer diameter of the combined
electrode group, cam wheel 42 is rotated counterclockwise. This
action moves the U-shaped section 38 of each electrode (see FIG.
6A) in the direction of the cam rotation, which in turn causes each
electrode to rotate on its own axis. As a result of this rotation,
the intermediate section 33 of each electrode pivots outwardly from
the central axis of the device as shown in FIG. 12B. In one
embodiment, the electrodes pivot between 45-90.degree. with an
outer electrode group diameter of approximately of 0.50''. Further
rotation of cam 42 causes the electrodes to move to yet a larger
overall diameter of approximately 0.71'' as shown in FIG. 12C. At
its largest diameter, shown in FIG. 12D, each electrode has rotated
approximately 180.degree. from its original minimum diameter
position. In the embodiment shown, the maximum outer diameter of
the electrode group is approximately 1 inch.
[0066] In a key aspect of the invention, therapeutic device 10
having a minimum diameter may be inserted into a patient through a
laparoscopic device or other access means. The minimum outer
diameter configuration may represent an operatable treatment
diameter for smaller ablation zones. Alternatively, for a larger
ablation zone, the electrodes may be rotated outwardly using the
cam wheel to provide a larger electrode group diameter. Thus, the
invention described herein provides the operator with the ability
to customize the overall diameter of the electrode group to
correspond with the desired ablation volume. The device may also be
used as a combination resection/ablation device. As an example, the
operator position the device at a maximum diameter to ablate a 2-4
cm. tumor and then adjust the device to a minimum diameter to
thermally coagulate a line of tissue in preparation for liver
resection.
[0067] FIGS. 13A-13B are partial isometric views of the therapeutic
energy delivery device showing a stabilizer and electrodes for an
alternative embodiment of the device having six electrodes. FIG.
12A shows the electrodes in shows the electrodes in a configuration
where the distance between the distal sections of any two
electrodes is smallest and FIG. 12B shows the electrodes in a
configuration where the distance between the distal sections of any
two electrodes is greatest. Shown are the distal sections 32 of the
electrodes and the tip of each electrode 35, as well as the
stabilizer 20. In this embodiment the distal section 32 of a
central electrode 201 is also shown. Electrode 201 is aligned with
the central axis of the device and does not rotate in response to
the rotation of the cam wheel. Having a central electrode allows
for larger ablation volumes by providing for more optimal coverage
of ablation areas through more equal spacing of the electrodes for
complete ablation coverage of a targeted region.
[0068] FIGS. 14A-C illustrate distal end views of the therapeutic
energy delivery device 10 of FIG. 13 having a six-electrode
configuration and showing respectively the position of the
electrodes as the electrodes are moved from a minimum outer
diameter configuration to a maximum outer diameter configuration.
For clarity, only the trocar 78, stabilizer 20 and electrodes 74
are shown. FIG. 13A illustrates the electrodes positioned such that
the outer diameter of the combined electrode group is smaller than
the outer diameter of stabilizer 20 as well as the inner diameter
of trocar 78. Central, non-rotating electrode 201 is positioned on
the center longitudinal axis of the stabilizer and does not include
any bends. The intermediate sections of the remaining electrodes
are positioned in an overlapping relationship forming star-like
configuration. In one embodiment the outer diameter of the
electrode group in its minimum configuration is approximately
0.35''. To expand the initial outer diameter of the combined
electrode group, cam wheel 42 is rotated counterclockwise. This
action moves the U-shaped section 38 of each electrode (see FIG.
6A) in the direction of the cam rotation, which in turn causes each
electrode to rotate on its own axis. As a result of this rotation,
the intermediate section 33 of each electrode pivots outwardly from
the central axis approximately 45.degree. Further rotation of cam
42 causes the electrodes to move to yet a larger overall diameter
which extends radially outward from the outer diameter of the
stabilizer 20 and trocar 78. At its largest diameter, shown in FIG.
12C, each electrode has rotated approximately 160.degree. from its
original minimum diameter position. For the six-electrode model,
certain embodiments involve a largest radial state with: an
ablation diameter of up to 45 millimeters, with a distance from the
distal section 32 of the center electrode to the distal section of
a non-center electrode being 18 millimeters, and with the distance
between any two non-central electrodes being 22 millimeters. In
certain embodiments a 15 millimeter length trocar is used. These
particular embodiments contrast with the 4 electrode model, where
the trocar can be 10 millimeters in diameter, there can be in
certain embodiments up to a 3 cm ablation diameter, adjacent
electrodes can be up to 17 millimeters apart, and diagonally
electrodes can be spaced up to 24 millimeters apart. Also, in
certain embodiments a 5-electrode model can be used, wherein there
is a central electrode with four surrounding electrodes; in that
model the trocar can be 12 millimeters long, there can be up to a
36 millimeter ablation, each adjacent electrode can be 20
millimeters apart, and the non-central electrodes can be spaced
diagonally apart up to 24 millimeters. Having a central electrode
allows for larger ablation volumes by providing for more optimal
coverage of ablation areas through more equal spacing of the
electrodes for complete ablation coverage of a targeted region.
[0069] FIG. 15 is an isometric view of the distal end of an
alternative embodiment of the therapeutic energy delivery device
having four electrodes placed through tubes wherein the length of
the exposed electrode can be set. Shown are the distal sections 32
of the electrodes, the tip 35 of each electrode, tubes 36 through
which the electrodes can be placed, and the sleeve 21. In this
embodiment the electrodes are inserted through tubes 36 such that
the distal sections 32 of the electrodes extend in a distal
direction from the tubes 36. The insulation can also be moved
proximally or distally and will extend distally beyond the
intermediate sections 33 of the electrodes to protect the
electrodes from touching. The tips of the tubes 36 are sharp and in
certain embodiments can be placed through tissue prior to placing
the electrodes through the end of the tubes. This embodiment is
particularly useful for treating intra-mural tissue which is below
a tissue surface. The surface of the tissue can first be pierced by
the tips of the tubes 36, and then the amount of exposed electrode
can be adjusted within the tissue. Alternatively, the tissue can be
pierced by the electrodes themselves. In this embodiment, a set
depth below the tissue surface can be achieved where the treatment
energy does not extend all the way to the tissue surface. Such a
device and method is particularly useful for treating the liver or
other large organs, where intra-mural tissue treatment is
required.
[0070] In another related embodiment, the tubes 36 can be connected
to a slide mechanism 41 such that the amount of exposed electrode
can be adjusted by controlling the position of the insulative tubes
36 relative to the electrodes which remain in a fixed position.
[0071] FIG. 16 is a flowchart illustrating a method of treatment
using the therapeutic energy delivery device so as to ensure safety
and provide for the option of placing the electrodes, that are in a
configuration where the distance between the distal section of any
two electrodes is smallest, covered with a protective sleeve to be
inserted into a target area and then to uncover the distal section
of the electrodes by moving the sleeve and treat the patient with
electrodes placed in a configuration where the distance between the
distal sections of any two electrodes is greatest. The procedure is
started 80, the target tissue is located 82, and the probe is
inserted 84 into the tissue with electrodes in a compact position
and protected by the sleeve. The term probe here refers to the
sections of the therapeutic energy deliver device distal to the
most distal section of the handle, and can include the electrodes
sections capable ablation and the portions of the stabilizer and
trocar of the therapeutic energy delivery device distal to the most
distal part of the handle. In certain cases a part of the probe
will be inserted into the patient, and in various cases this will
be performed through laparoscopy. In various embodiments the device
can be used for treatment of a target region where the treatment is
for irreversible electroporation and then the device can be
withdrawn and energy applied for radiofrequency (RF) treatment so
that track ablation can occurprevent seeding and in various cases
to cause coagulation. In other embodiments RF treatment can precede
IRE treatment in a target region. The combination of IRE and RF
treatment can be performed using multiple generators or a generator
with software or controls to alter the settings. In other words a
probe can be coupled to a first generator and, once the probe is
placed into a target region, the target region can be treated with
IRE. Subsequently the probe can be uncoupled from the first
generator and coupled to a second generator meant for RF treatment
and the treatment can continue, either on the target region or on a
track as the probe is withdrawn so as to apply thermal treatment of
the track. Or a single generator can be used where a mechanical or
electrical switch was used to change from one setting to another so
as to allow IRE treatment or RF treatment or both, in any
combination through probe insertion, treatment, and withdrawal. The
sleeve is moved to uncover the electrodes 86, the radial state is
set 126 to adjust the distance between the distal electrode 32
sections the tissue is treated 88, and then the probe is placed in
a compact configuration and the sleeve is used to cover the distal
sections of the electrodes 90, and the procedure is ended 92. In
certain cases the electrodes or device will be moved, replaced, or
reinserted to perform more than one treatment or ablation as needed
for therapeutic benefit, wherein the procedure is repeated.
[0072] FIG. 17 is a partial cut-away view of the side of a patient
torso depicting the method of treatment using the therapeutic
energy delivery device to treat a liver tumor or other portion of
undesirable tissue within a liver. Shown is the therapeutic device
10 where the elongated shaft 20 has been placed through the skin,
fat, and muscle layers of the surface of the patient 110 and has
been placed so that the distal sections 32 of the electrodes are
touching a zone to be ablated 120 within a liver 114. For
perspective also shown are a stomach 116, intestine 118, and
visualization device 124. This figure shows how the device can be
placed with precision within or adjacent to undesirable tissue and
that the electrodes can be placed to the desired depth for
ablation. The active electrode length can be altered by movement of
slideable insulation (not shown), and the amount of ablation can be
tailored not only by the active electrode length but by the radial
state as well. Regarding the movement of the insulation, the
section of the distal portion 32 of the electrodes that does not
have an insulation covering is said to be the electrically exposed
portion. This portion is electrically active. This length can be
essentially any length up to the length of the distal sections 32
of the electrodes.
[0073] TED devices 10 of the present invention and components
therein may be able to withstand exposure to 2.times. ethylene
oxide sterilization without incurring functional failures. TED
devices and components therein may be substantially
biocompatible.
[0074] TED devices 10 disclosed herein may be used in monopolar
configurations and/or bipolar configurations. The geometry of
resulting ablation/resection volumes may depend at least in part on
the configuration of the distal sections 32 of the electrodes. For
example, with a linear arrangement of two or more electrodes, the
ablation volume may have a minimum diameter of 1 mm to 2 mm, such
as 1.8 mm. With a two-dimension arrangement of four or more
electrodes, the ablation volume may have a major cross-section, at
a minimum, of 5.times.5 mm to 10.times.10 mm, such as 8.times.8 mm.
TED devices may be activated by switch through depression of switch
actuator on the hand piece 40. Alternatively or in combination, TED
devices may be activated by one or more foot pedals.
[0075] The combination of the sleeve 21 and the rotating device 42
allows the distal sections 32 of the electrodes to be initially
inserted through a small opening (such as the lumen of a
laparoscopic trocar) without the risk of damage to the distal
sections 32. The device can also be inserted into a lumen of a
laparoscope. Once the device 10 has been inserted through the
opening (such as the lumen of the laparoscopic trocar), the sleeve
21 is moved and the distal sections 32 of the electrodes are
exposed. The rotating device 42 is then rotated to cause the distal
sections 32 of the electrodes to move radially outward. Preferably,
as the distal sections 32 of the electrodes are rotated so that the
distance between the distal sections of any two electrodes becomes
greater, the distal sections 32 of the electrodes are moved
radially outward at least to a point outside the perimeter of the
elongated shaft 20. The amount of radial movement of the distal
sections 32 of the electrodes is controlled by the amount of
rotation of the rotating collar 42. Such degree of freedom allows
an operator to position the distal sections 32 of the electrodes of
the device 10 into predetermined target tissues during use.
Therefore, the size of the treatment area being defined by the
distal sections of the electrodes is controlled by the amount of
rotation of the rotating collar 42. This minimizes the need for
repeated treatment.
[0076] Software on a computer-readable medium may be used to
control certain aspects of using the devices, such as controlling
power (e.g., amplitude, pulse frequency) to the device, analyzing
feedback signals from electrodes (e.g., thermal readings,
impedance, visual signals), and providing signals for actions
(e.g., readiness, stand-by, power-on, power-off, warnings, failure
signals). For example, a software package stored or installed on a
computer-readable medium may be used for facilitating and/or
enabling the methods and/or processes of using the TED devices 10.
The device can be coupled to software enabling capturing data from
the distal sections 32 of the electrodes such that there are
feedback loops such that the software can visually demonstrate (or
additionally through audio) to the user that the treatment is
proceeding as planned or that there are difficulties or errors in
the treatment or in the orientation or configuration of the
electrodes or the position of the device. The user can use the
feedback to change the treatment including the orientation of the
probe, the position of the probe, the electrode configuration or
orientation, the exposed electrodes, the active electrode, the
insulation position, or other features to ensure proper
treatment.
[0077] Methods and processes of using the devices disclosed herein
may involve one, two, or more of the following actions: at least a
portion of the therapeutic device 10 is inserted into a body
cavity, rotating the plurality of electrodes thereby causing the
distal sections to move radially outward, positioning the distal
sections near the tissue, and delivering therapeutic energy through
the electrodes to treat the tissue. The therapeutic device 10 has a
housing 40 having a surface. The therapeutic device 10 has a
plurality of electrodes 75, wherein each electrode includes: (i) a
proximal section 31 longitudinally extending from the housing 40
and having a longitudinal axis; (ii) an intermediate section 33
extending from the proximal section 31; and (iii) a distal section
32 extending longitudinally from the intermediate section 33. The
plurality of electrodes are rotated thereby causing the distal
sections 32 to move radially outward relative to the elongated
shaft 20. The distal sections 32 can be positioned in the tissue.
Therapeutic energy can be delivered through the electrodes to treat
the tissue. In one embodiment of the method, the tissue that is
treated is pancreatic cancer tissue. The method can be carried out
during a laparoscopic procedure, wherein the therapeutic device 10
is inserted into a lumen of a laparoscopic trocar. In various
embodiments the treated tissue can be physiologically normal or
tissue of a pathology, and can include tumors or cancers.
Treatments can involve normal organ systems or parts of organ
systems including digestive, skeletal, muscular, nervous,
endocrine, circulatory, reproductive, integumentary, lymphatic,
urinary tissue or organs, or other soft tissue or organs where
selective ablation is desired.
[0078] The method results in at least one resection, excision,
coagulation, disruption, denaturation, or ablation of the target
tissue. The method can be used for laparoscopic coagulation prior
to tissue resection as is commonly known in liver surgeries.
Following the treatment and before removing the device from the
body, the rotating device can be rotated in a direction to cause
the distal sections of the electrodes 32 to move radially inward
towards the center of the elongated shaft 20. Sleeve 21 may be
moved to cover and protect the distal sections 32 of the
electrodes. Treatment device 10 may then be safely removed from the
patient without causing unintended effects.
[0079] This device can be used to ablate tissue or coagulate tissue
for resection, or be used for a combination of these functions. The
device can be used to tailor the type or size of the area to be
treated. The tips of the electrodes can be used to deliver voltage
or the entire length of the distal section of the electrodes can be
used. In addition, the radial state of the distal electrode section
of the current device can be set to ensure ablation to match the
size of the targeted area, so that one device can be used for
treatment of multiple conditions and target tissues whereas
previously multiple devices would have been necessary. The device
can be used to coagulate tissue, thus preventing bleeding. The
parameters can be changed manually or electronically to move from
an ablation setting to parameters such that bleeding is controlled;
this can be changed either through use of software or by the manual
actions of the probe user. The device can also be used for
coagulation for resection and this function can be performed
through use of the probe at andy radial state of the distal
sections 32 of the electrodes.
[0080] TED devices disclosed herein are designed for tissue
destruction in general, such as resection, excision, coagulation,
disruption, denaturation, and ablation, and are applicable in a
variety of surgical procedures, including but not limited to open
surgeries, minimally invasive surgeries (e.g., laparoscopic
surgeries, endoscopic surgeries, surgeries through natural body
orifices), thermal ablation surgeries, nonthermal surgeries, as
well as other procedures known to one of ordinary skill in the art.
The devices may be designed as disposables or for repeated
uses.
[0081] In certain embodiments the elongated shaft 20 can involve an
articulating region that can allow a greater range of motion. The
articulating region may include a hinge which allows for the distal
section of the elongated shaft to articulate or bend with respect
to the longitudinal axis of the shaft. (An articulating probe is
described in patent application Ser. No. 12/26,730, Articulatable
Device for Delivering Therapeutic Energy to Tissue, filed Nov. 7,
2008, herein incorporated by reference.) This allows for insertion
of the distal electrodes 32 into a body, and allows for a range of
motion so that difficult areas can be reached. The articulation can
include a single area of articulation or multiple areas of
articulation and can be controlled via any mechanism known in the
art from a device coupled to the handle housing 40. In certain
embodiments the angle of articulation of the distal portion of the
probe is 30 0 degrees to 90 degrees relative to the longitudinal
axis of the device.
[0082] In various embodiments a portion of the proximal sections 31
of the electrodes at the point of the rotational cam are placed
very close together so that in certain embodiment the electrodes
are separated only by insulation when at the point of the bearing
block 52. In such embodiments there is no U-shape 38 section of the
proximal section 32 of the electrode. Instead when moving from the
proximal ends 34 of the electrodes distally along the proximal
section 31 of the electrodes, the electrodes 74 angle away from
each other. In certain embodiments the proximal electrodes become
parallel to each other proximal to the intermediate sections 33 of
the electrodes. Such embodiments allow easier assembly. The
elongated shaft 20 is not necessary in such models as the
electrodes rotate together along the center axis of the trocar (or
along the center axis of the center electrode in embodiments having
a center electrode). This is in contrast to having each electrode
rotate around its own axis as is the case in certain
embodiments.
[0083] In certain embodiments of those mentioned above, where a
portion of the proximal sections 31 of the electrodes at the point
of the rotational cam are placed very close together so that in
certain embodiment the electrodes are separated only by insulation
when at the point of the bearing block 52, there am no slots 45
within the rotating collar (clearly depicted in FIGS. 6A-C);
rather, these slots have been replaced by holes through which at
least a portion of the proximal sections 31 of the electrodes are
positioned such that the electrodes can rotate as a group in a
small diameter. The electrodes do not slide back and forth within
the slots but rather rotate and do so as a group. The holes can be
dimensioned substantially the same diameter as the electrodes but
so as to allow rotation. The holes can also be cut so that they are
angled so as to accept non-parallel electrodes as they angle out
from proximal to distal moving away from bearing block 52.
[0084] As indicated, in certain embodiments IRE treatment will be
utilized. More particularly, in one aspect, the total number of
pulses and pulse trains in various embodiments can be varied based
on the desired treatment outcome and the effectiveness of the
treatment for a given tissue. During delivery of non-thermal IRE
energy to target tissue, a voltage can be generated that is
configured to successfully ablate tissue. In one aspect, certain
embodiments can involve pulses between about 5 microseconds and
about 62,000 milliseconds, while others can involve pulses of about
75 microseconds and about 20,000 milliseconds. In yet another
embodiment, the ablation pulse applied to the target tissue 47 can
be between about 20 microseconds and 100 microseconds. In one
aspect, the at least one energy source can be configured to release
at least one pulse of energy for between about 100 microseconds to
about 100 seconds and can be adjustable at 10 microsecond
intervals. In certain embodiments the electrodes described herein
can provide a voltage of about 100 volts per centimeter (V/cm) to
about 7,000 V/cm to the target tissue 47. In other exemplary
embodiments, the voltage can be about 200 V/cm to about 2000 V/cm
as well as from about 300 V/cm to about 1000 V/cm. Other exemplary
embodiments can involve voltages of about 2,000 V/cm to about
20,000 V/cm. In one exemplary aspect, the bipolar probe 100 can be
used at a voltage of up to about 2700 volts. As indicated, in
various embodiments IRE treatment can be used in conjunction with
reversible electroporation or other thermal treatments such as
RF.
[0085] In one exemplary embodiment thermal energy can be applied
such that it produces fluctuations in temperature to effect
treatment. In one aspect, the thermal energy provided to the tissue
can heat the target tissue to between about 50.degree. C. and about
105.degree. C. to bring about cell death. In one aspect the
temperature can be adjusted such that it can be lesser or greater
than this temperature range, depending on the exact rate of speed
of removal of the energy delivery device from the target tissue 47.
In one embodiment the temperature used is between about 105.degree.
C. and about 110.degree. C., although one of ordinary skill would
recognize that temperatures above about 105.degree. C. can cause
tissue vaporization.
[0086] The above disclosure is intended to be illustrative and not
exhaustive. This description will suggest many modifications,
variations, and alternatives may be made by ordinary skill in this
art without departing from the scope of the invention. Those
familiar with the art may recognize other equivalents to the
specific embodiments described herein. Accordingly, the scope of
the invention is not limited to the foregoing specification.
* * * * *