U.S. patent application number 17/328530 was filed with the patent office on 2021-09-09 for screen sphere tissue ablation devices and methods.
The applicant listed for this patent is Innoblative Designs, Inc.. Invention is credited to Ryan M. Bean, Robert F. Rioux.
Application Number | 20210275244 17/328530 |
Document ID | / |
Family ID | 1000005599116 |
Filed Date | 2021-09-09 |
United States Patent
Application |
20210275244 |
Kind Code |
A1 |
Rioux; Robert F. ; et
al. |
September 9, 2021 |
SCREEN SPHERE TISSUE ABLATION DEVICES AND METHODS
Abstract
The present invention is an ablation device having a screen
sphere configuration for the ablation of marginal tissue
surrounding a tissue cavity. The device includes a probe having a
nonconductive elongated shaft including at least one lumen
therethrough and a nonconductive distal portion extending from the
shaft. The nonconductive distal portion includes a plurality distal
ports and a plurality of proximal ports in communication with the
at least one lumen of the shaft. The device further includes an
electrode array including a plurality of independent conductive
wires extending through the lumen and positioned along an external
surface of the nonconductive distal portion, each of the plurality
of wires passes through at least an associated one of the proximal
ports and through at least a corresponding one of the distal
ports.
Inventors: |
Rioux; Robert F.; (Ashland,
MA) ; Bean; Ryan M.; (Groton, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Innoblative Designs, Inc. |
Chicago |
IL |
US |
|
|
Family ID: |
1000005599116 |
Appl. No.: |
17/328530 |
Filed: |
May 24, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15828941 |
Dec 1, 2017 |
11013550 |
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17328530 |
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15624327 |
Jun 15, 2017 |
9839472 |
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15828941 |
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15337334 |
Oct 28, 2016 |
9848936 |
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15624327 |
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62275984 |
Jan 7, 2016 |
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62248157 |
Oct 29, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 18/1206 20130101;
A61B 2018/00577 20130101; A61B 2018/00529 20130101; A61B 2018/00541
20130101; A61B 2018/1467 20130101; A61B 2018/144 20130101; A61B
2018/1472 20130101; A61B 2218/002 20130101; A61B 2018/00452
20130101; A61B 2018/00238 20130101; A61B 2018/0022 20130101; A61B
2018/00333 20130101; A61B 18/148 20130101; A61B 18/14 20130101;
A61B 18/1482 20130101; A61B 2018/00547 20130101; A61B 2018/00559
20130101 |
International
Class: |
A61B 18/14 20060101
A61B018/14; A61B 18/12 20060101 A61B018/12 |
Claims
1. A medical device comprising: a distal portion defining an
interior chamber and also defining a plurality of ports; a
hydrophilic member disposed within the interior chamber of the body
and configured to receive and distribute a conductive fluid to the
plurality of ports; and a conductive wire disposed along at least a
portion of an exterior surface of the distal portion.
2. The medical device of claim 1, further comprising handle
including a lumen for receiving the conductive fluid, wherein the
lumen is in fluid communication with the interior chamber of the
distal portion.
3. The medical device of claim 1, wherein one or more of the
plurality of ports is configured allow passage of the conductive
fluid to an exterior surface of the distal portion.
4. The medical device of claim 3, wherein, upon receipt, of an
electric current, the conductive wire is configured to conduct
radiofrequency (RF) energy to be carried by the conductive fluid
passing through one or more of the plurality of ports for ablation
of a tissue.
5. The medical device of claim 3, wherein the plurality of ports
comprises one or more medial ports for allowing passage of the
conductive fluid.
6. The medical device of claim 1, further comprising a spacing
member disposed within the interior chamber of the distal portion,
wherein the hydrophilic member is disposed between an exterior
surface of the spacing member and an interior surface of the distal
portion.
7. The medical device of claim 1, wherein the conductive wire is
substantially aligned with least one of the plurality of ports.
8. The medical device of claim 1, wherein the plurality of ports
comprises a plurality of proximal ports and distal ports, wherein
the conductive wire passes through at least one of the proximal
ports and through a corresponding one of the distal ports such that
a portion of the conductive wire has a length that extends along
the exterior surface of the distal portion between the
corresponding proximal and distal ports.
9. The medical device of claim 8, wherein the conductive wire is
one of a plurality of conductive wires, each of the plurality of
conductive wires is disposed along at least a portion of the
exterior surface of the distal portion.
10. The medical device of claim 9, wherein each of the plurality of
conductive wires passes through at least one of the proximal ports
and through a corresponding one of the distal ports, wherein each
of the plurality of proximal ports corresponds to a separate one of
the plurality of distal ports such that a portion of a conductive
wire passing through a set of corresponding proximal and distal
ports has a length that extends along the exterior surface of the
distal portion between the corresponding proximal and distal
ports.
11. A medical device comprising: a distal portion comprising a
rigid body of a fixed diameter, the rigid body defining an interior
chamber and also defining a plurality of ports; and a conductive
wire disposed along at least a portion of an exterior surface of
the rigid body and configured to conduct energy to be carried by a
conductive fluid passing through one or more of the plurality of
ports.
12. The medical device of claim 11, further comprising handle
including a lumen for receiving the conductive fluid, wherein the
lumen is in fluid communication with the interior chamber of the
distal portion.
13. The medical device of claim 11, wherein one or more of the
plurality of ports is configured to allow passage of the conductive
fluid to an exterior surface of the distal portion.
14. The medical device of claim 13, wherein, upon receipt of an
electric current, the conductive wire is configured to conduct
radiofrequency (RF) energy to be carried by the conductive fluid
passing through one or more of the plurality of ports for ablation
of a tissue.
15. The medical device of claim 13, wherein the plurality of ports
comprises one or more medial ports for allowing passage of the
conductive fluid.
16. The medical device of claim 11, wherein the conductive i
axially translates along a longitudinal axis of the device.
17. The medical device of claim 11, wherein the conductive wire is
substantially aligned with at least one of the plurality of ports.
1$. The medical device of claim 11, wherein the plurality of ports
comprises a plurality of proximal ports and distal ports, wherein
the conductive wire passes through at least one of the proximal
ports and through a corresponding one of the distal ports such that
a portion of the conductive wire has a length that extends along
the exterior surface of the distal portion between the
corresponding proximal and distal ports.
19. The medical device of claim 18, wherein the conductive wire is
one of a plurality of conductive wires, each of the plurality of
conductive wires is disposed along at least a portion of the
exterior surface of the distal portion.
20. The medical device of claim 19, wherein each of the plurality
of conductive wires passes through at least one of the proximal
ports and through a corresponding one of the distal ports, wherein
each of the plurality of proximal ports corresponds to a separate
one of the plurality of distal ports such that, a portion of a
conductive wire passing through a set of corresponding proximal and
distal ports has a length that extends along the exterior surface
of the distal portion between the corresponding proximal and distal
ports.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. Non-Provisional
application Ser. No. 15/624,327, filed Jun. 15, 2017, which is a
continuation of U.S. Non-Provisional application Ser. No.
15/337,334, filed Oct. 28, 2016, which claims the benefit of, and
priority to, U.S. Provisional Application No. 62/248,157, filed
Oct. 29, 2015, and U.S. Provisional Application No. 62/275,984,
filed Jan. 7, 2016, the contents of each of which are hereby
incorporated by reference herein in their entirety.
FIELD
[0002] The present disclosure relates generally to medical devices,
and, more particularly, to screen sphere tissue ablation devices
and methods for ablation of marginal tissue surrounding a tissue
cavity.
BACKGROUND
[0003] Cancer is a group of diseases involving abnormal cell growth
with the potential to invade or spread to other parts of the body.
Cancer generally manifests into abnormal growths of tissue in the
form of a tumor that may be localized to a particular area of a
patient's body (e.g., associated with a specific body part or
organ) or may be spread throughout. Tumors, both benign and
malignant, are commonly treated and removed via surgical
intervention, as surgery often offers the greatest chance for
complete removal and cure, especially if the cancer has not spread
to other parts of the body. Electrosurgical methods, for example,
can be used to destroy these abnormal tissue growths. However, in
some instances, surgery alone is insufficient to adequately remove
all cancerous tissue from a local environment.
[0004] For example, treatment of early stage breast cancer
typically involves a combination of surgery and adjuvant
irradiation. Unlike a mastectomy, a lumpectomy removes only the
tumor and a small rim (area) of the normal tissue around it.
Radiation therapy is given after lumpectomy in an attempt to
eradicate cancer cells that may remain in the local environment
around the removed tumor, so as to lower the chances of the cancer
returning. However, radiation therapy as a post-operative treatment
suffers various shortcomings. For example, radiation techniques can
be costly and time consuming, and typically involve multiple
treatments over weeks and sometimes months. Furthermore, radiation
often results in unintended damage to the tissue outside the target
zone. Thus, rather than affecting the likely residual tissue,
typically near the original tumor location, radiation techniques
often adversely affect healthy tissue, such as short and long-term
complications affecting the skin, lungs, and heart.
[0005] Accordingly, such risks, when combined with the burden of
weeks of daily radiation, may drive some patients to choose
mastectomy instead of lumpectomy. Furthermore, some women (e.g., up
to thirty percent (30%)) who undergo lumpectomy stop therapy before
completing the full treatment due to the drawbacks of radiation
treatment. This may be especially true in rural areas, or other
areas in which patients may have limited access to radiation
facilities.
SUMMARY
[0006] Tumors, both benign and malignant, are commonly treated and
destroyed via surgical intervention, as surgery often offers the
greatest chance for complete removal and cure, especially if the
cancer has not metastasized. However, after the tumor is destroyed,
a hollow cavity may remain, wherein tissue surrounding this cavity
and surrounding the original tumor site can still leave abnormal or
potentially cancerous cells that the surgeon fails, or is unable,
to excise. This surrounding tissue is commonly referred to as
"margin tissue" or "marginal tissue", and is the location within a
patient where a reoccurrence of the tumor may most likely
occur.
[0007] The systems and methods described herein can be used during
an ablation procedure to destroy a thin rim of normal tissue around
the cavity in an effort to manage residual disease in the local
environment that has been treated. This technique can help to
ensure that all microscopic disease in the local environment has
been treated. This is especially true in the treatment of tumors
that have a tendency to recur. Applications of such a method of
intra-operatively extending tumor margins are applicable to many
areas of the body including the liver and especially the
breast.
[0008] In particular, the present disclosure is generally directed
to a cavitary tissue ablation system including an ablation device
to be delivered into a tissue cavity and emit non-ionizing
radiation, such as radiofrequency (RF) energy, to treat the
marginal tissue around the tissue cavity. The tissue ablation
device of the present invention generally includes a probe
including an elongated shaft configured as a handle and adapted for
manual manipulation and a nonconductive distal portion coupled to
the shaft. The nonconductive distal portion includes an electrode
array positioned along an external surface thereof. The distal
portion, including the electrode array, can be delivered to and
maneuvered within a tissue cavity (e.g., formed from tumor removal)
and configured to ablate marginal tissue (via RF energy)
immediately surrounding the tissue cavity in order to minimize
recurrence of the tumor.
[0009] In one aspect, the electrode array is composed of a
plurality of conductive members (e.g., conductive wires)
electrically isolated and independent from one another. Thus, in
some embodiments, each of the plurality of conductive wires, or one
or more sets of a combination of conductive wires, is configured to
independently receive an electrical current from an energy source
(e.g., ablation generator) and independently conduct energy, the
energy including RF energy. This allows energy to be selectively
delivered to a designated conductive wire or combination of
conductive wires. This design also enables the ablation device to
function in a bipolar mode because a first conductive wire (or
combination of conductive wires) can deliver energy to the
surrounding tissue through its electrical connection with an
ablation generator while a second conductive wire (or combination
of conductive wires) can function as a ground or neutral conductive
member.
[0010] The independent, control of each wire or sets of wires
allows for activation (e.g., emission of RF energy) of
corresponding portions of the electrode array. For example, the
electrode array may be partitioned into specific portions which may
correspond to clinical axes or sides of the distal portion of the
device. In one embodiment, the electrode array may include at least
four distinct portions (i.e., individual or sets of conductive
wires) corresponding to four clinical axes or sides of the distal
portion (e.g, four sides or quadrants around spheroid body).
[0011] In some embodiments, the ablation device is configured to
provide RF ablation via a virtual electrode arrangement, which
includes distribution of a fluid along an exterior surface of the
distal tip and, upon activation of the electrode array, the fluid
may carry, or otherwise promote, energy emitted from the electrode
array to the surrounding tissue. For example, the nonconductive
distal portion of the ablation device includes an interior chamber
retaining at least a spacing member (e.g., spacer ball) and a
hydrophilic insert surrounding a spacing member. The interior
chamber of the distal portion is configured to receive and retain a
fluid (e.g., saline) therein from a fluid source. The hydrophilic
insert is configured receive and evenly distribute the fluid
through the distal tip by wicking the saline against gravity. The
distal portion may generally include a plurality of ports or
apertures configured to allow the fluid to pass therethrough, or
weep, from the interior chamber to an external surface of the
distal portion. The spacer member is shaped and sized so as to
maintain the hydrophilic insert in contact with the interior
surface of the distal tip wail, and specifically in contact with
the one or more perforations, such that the hydrophilic insert
provides uniformity of saline distribution to the perforations.
Accordingly, upon positioning the distal portion within a target
site (e.g., tissue cavity to be ablated), the electrode array can
be activated. The fluid weeping through the perforations to the
outer surface of the distal portion is able to carry energy from
electrode array, thereby creating a virtual electrode. Accordingly,
upon the fluid weeping through the perforations, a pool or thin
film of fluid is formed on the exterior surface of the distal
portion and. is configured to ablate surrounding tissue via the RF
energy carried from the electrode array.
[0012] It should be noted the devices and methods of the present
disclosure are not limited to such post-surgical treatments and, as
used herein, the phrase "body cavity" may include non-surgically
created cavities, such as natural body cavities and passages, such
as the ureter (e.g. for prostate treatment), the uterus (e.g. for
uterine ablation or fibroid treatment), fallopian tubes (e.g. for
sterilization), and the like. Additionally, or alternatively,
tissue ablation devices of the present disclosure may be used for
the ablation of marginal tissue in various parts of the body and
organs (e.g., lungs, liver, pancreas, etc.) and is not limited to
treatment of breast cancer.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] Features and advantages of the claimed subject matter will
be apparent from the following detailed description of embodiments
consistent therewith, which description should be considered with
reference to the accompanying drawings, wherein:
[0014] FIG. 1 is a schematic illustration of an ablation system
consistent with the present disclosure;
[0015] FIG. 2 is a perspective view of an ablation device tip of
the ablation system of FIG. 1;
[0016] FIGS. 3A, 3B and 3C are perspective views of the ablation
device tip of FIG. 2 in greater detail;
[0017] FIGS. 4A and 4B schematically illustrate the ablation device
tip of the ablation device of FIG. 1 with and without the
nonconductive distal portion, respectively;
[0018] FIG. 5A is a side view and FIG. 5B is a cross-sectional view
of one embodiment of a deployable distal portion of the ablation
device illustrating transitioning of the distal portion from a
delivery configuration to a deployed configuration;
[0019] FIG. 6 illustrates a method of deploying the distal portion
of FIGS. 5A and 5B into an expanded configuration for delivery of
RF energy to a target site for ablation of marginal tissue;
[0020] FIG. 7 is a cross-sectional view of the deployable distal
portion of FIGS. 5A and 5B illustrating the inclusion of an
internal balloon member within an interior chamber of the distal
portion. The internal balloon is configured to receive a fluid from
a fluid source and thereby expand, which, in turn, causes the
distal portion to transition from the delivery configuration to the
deployed configuration, and further supply the fluid to an exterior
surface of the distal portion, via weeping of the fluid through one
or more perforations on the distal portion wall, to create a
virtual electrode arrangement with the electrode array;
[0021] FIG. 8 is an exploded view of an ablation device consistent
with the present disclosure, including a hydrophilic insert
provided within an interior chamber of the distal portion and
configured to receive a fluid from a fluid source and evenly
distribute the fluid to an exterior an exterior surface of the
distal portion, via weeping of the fluid through one or more
perforations on the distal portion wall, to create a virtual
electrode arrangement with the electrode array;
[0022] FIG. 9 is an exploded view of the ablation device of FIG. 8
illustrating the hydrophilic insert in more detail;
[0023] FIGS. 10A-10E are perspective views of a distal tip of the
ablation device of FIG. 1 illustrating various electrode array
configurations;
[0024] FIG. 11 is a side view of the distal tip of the ablation
device of FIG. 1 including several clinical axes or sides. Each
clinical axis or side includes one or more independently connected
electrodes, which enables differential function and current
independent drives and/or measurements;
[0025] FIGS. 12A-12D are side and perspective views of the distal
tip of the application device illustrating the different clinical
axes or sides of FIG. 11;
[0026] FIGS. 13 and 14 are perspective and exploded perspective
views, respectively, of one embodiment of a device controller
consistent with the present disclosure;
[0027] FIG. 15 is an exploded perspective view of another
embodiment of an ablation device consistent with the present
disclosure;
[0028] FIG. 16 is a plan view of the ablation device of FIG. 15
illustrating the two halves of the device separated front one
another and showing the external surface of each;
[0029] FIG. 17 is a plan view of the ablation device of FIG. 15
illustrating the two halves of the device separated from one
another and showing the interior surface of each;
[0030] FIGS. 18A and 18B are enlarged views of the spheroid body of
the first halve of the device showing the exterior and interior
surfaces, respectively, and further illustrating the particular
arrangement of first and second conductive wires extending through
proximal and distal ports of the spheroid body;
[0031] FIGS. 19A and 19B are enlarged views of the spheroid body of
the second halve of the device showing the exterior and interior
surfaces, respectively, and further illustrating the particular
arrangement of third and fourth conductive wires extending through
proximal and distal ports of the spheroid body;
[0032] FIG. 20 is a schematic illustration of the ablation device
of FIG. 15 illustrating delivery of fluid from the irrigation pump,
as controlled by the controller, to the hydrophilic insert within
the interior chamber of the distal portion of the device, wherein
the fluid can be subsequently distributed to an exterior surface of
the distal portion resulting in a virtual electrode arrangement
upon activation of one or more portions of the electrode array;
[0033] FIG. 21 is a perspective view of a detachable mount for
holding a temperature probe (or any other separate monitoring
device) at a desired position relative to the distal portion of the
ablation device for the collection of temperature data during an RF
ablation procedure; and
[0034] FIG. 22 is a plan view of the detachable mount holding the
temperature probe relative to the distal portion of the ablation
device.
[0035] For a thorough understanding of the present disclosure,
reference should be made to the following detailed description,
including the appended claims, in connection with the
above-described drawings. Although the present disclosure is
described in connection with exemplary embodiments, the disclosure
is not intended to be limited to the specific forms set forth
herein. It is understood that various omissions and substitutions
of equivalents are contemplated as circumstances may suggest or
render expedient.
DETAILED DESCRIPTION
[0036] By way of overview, the present disclosure is generally
directed to a tissue ablation device having a deployable applicator
head configured to be delivered into a tissue cavity and ablate
marginal tissue surrounding the tissue cavity.
[0037] A tissue ablation system consistent with the present
disclosure may be well suited for treating hollow body cavities,
such as irregularly-shaped cavities in breast tissue created by a
lumpectomy procedure. For example, once a tumor has been removed, a
tissue cavity remains. The tissue surrounding this cavity is the
location within a patient where a reoccurrence of the tumor may
most likely occur. Consequently, after a tumor has been removed, it
is desirable to destroy the surrounding tissue (also referred
herein as the "margin tissue" or "marginal tissue").
[0038] The tissue ablation system of the present disclosure can be
used during an ablation procedure to destroy the thin rim of
marginal tissue around the cavity in a targeted manner. In
particular, the present disclosure is generally directed to a
cavitary tissue ablation system including an ablation device to be
delivered into a tissue cavity and configured to emit non-ionizing
radiation, such as radiofrequency (RF) energy, in a desired shape
or pattern so as to deliver treatment for the ablation and
destruction of a targeted portion of marginal tissue around the
tissue cavity.
[0039] The tissue ablation device of the present invention
generally includes a probe including an elongated shaft configured
as a handle and adapted for manual manipulation and a nonconductive
distal portion coupled to the shaft. The nonconductive distal
portion includes: an electrode array positioned along an external
surface thereof. The distal portion, including the electrode array,
can be delivered to and maneuvered within a tissue cavity (e.g.,
formed from tumor removal) and configured to ablate marginal tissue
(via RF energy) immediately surrounding the tissue cavity in order
to minimize recurrence of the tumor. The tissue ablation device of
the present disclosure is configured to allow surgeons, or other
medical professionals, to deliver precise, measured doses of RF
energy at controlled depths to the marginal tissue surrounding the
cavity.
[0040] Accordingly, a tissue ablation device consistent with the
present disclosure may be well suited for treating hollow body
cavities, such as irregularly-shaped cavities in breast tissue
created by a lumpectomy procedure. It should be noted, however,
that the devices of the present disclosure are not limited to such
post-surgical treatments and, as used herein, the phrase "body
cavity" may include non-surgically created cavities, such as
natural body cavities and passages, such as the ureter (e.g. for
prostate treatment), the uterus (e.g. for uterine ablation or
fibroid treatment), fallopian tubes (e.g. for sterilization), and
the like. Additionally, or alternatively, tissue ablation devices
of the present disclosure may be used for the ablation of marginal
tissue in various parts of the body and organs (e.g., skin, lungs,
liver, pancreas, etc.) and is not limited to treatment of breast
cancer.
[0041] FIG. 1 is a schematic illustration of an ablation system 10
for providing targeted ablation of marginal tissue during a tumor
removal procedure in a patient 12. The ablation system 10 generally
includes an ablation device 14, which includes a probe having a
distal tip or portion 16 and an elongated catheter shaft 17 to
which the distal tip 16 is connected. The catheter shaft 17 may
generally include a nonconductive elongated member including a
fluid delivery lumen. The ablation device 14 may further be coupled
to a device controller 18 and an ablation generator 20 over an
electrical connection (electrical line 34 shown in FIG. 2), and an
irrigation pump or drip 22 over a fluid connection (fluid line 38
shown in FIG. 2). The ablation generator 20 may also connected to a
return electrode 15 that is attached to the skin of the patient
12.
[0042] As will be described in greater detail herein, the device
controller 18 may be used to control the emission of energy from
one or more conductive members of the device 14 to result in
ablation, as well as controlling the delivery of fluid to the
applicator head 16 so as to control subsequent weeping of fluid
from the head 16 during an RF ablation procedure. In some cases,
the device controller 18 may be housed within the ablation device
14. The ablation generator 20 may also connected to a return
electrode 15 that is attached to the skin of the patient 12.
[0043] As will be described in greater detail herein, during an
ablation treatment, the ablation generator 20 may generally provide
RF energy (e.g., electrical energy in the radiofrequency (RF) range
(e.g., 350-800 kHz)) to an electrode array of the ablation device
14, as controlled by the device controller 18. At the same time,
saline may also be released from the head 16. The RF energy travels
through the blood and tissue of the patient 12 to the return
electrode 15 and, in the process, ablates the region(s) of tissues
adjacent to portions of the electrode array that have been
activated.
[0044] FIG. 2 is a perspective view of the distal portion or tip 16
of the ablation device 14. The distal tip 16 may include a neck
portion 24 and a generally spheroid body 26 extending distally from
the neck 24. It should be noted that, in some embodiments, the
spheroid body 26 may be generally rigid and may maintain a default
shape. However, in some embodiments, the spheroid body 26 may be
configured to transition between a collapsed state and an expanded
state, as will be described in greater detail herein, particular
with respect to FIGS. 5A-5B and 6-7. For example, the spheroid body
26 may be collapsible to a delivery configuration having a reduced
size (e.g., equatorial diameter) relative to the deployed
configuration size (e.g., equatorial diameter) of the spheroid body
26.
[0045] In some examples, the spheroid body 26 includes a
non-conductive material (e.g., a polyamide) as a layer on at least
a portion of an internal surface, an external surface, or both an
external and internal surface. In other examples, the spheroid body
26 is formed from a non-conductive material. Additionally or
alternatively, the spheroid body 26 material can include an
elastomeric material or a shape memory material.
[0046] In some examples, the spheroid body 26 has a diameter (e.g.,
an equatorial diameter) of about 80 mm or less. In certain
implementations, the spheroid body 26 of the distal tip, in a
deployed configuration, has an equatorial diameter of 2.0 mm to 60
mm (e.g., 5 mm, 10 mm, 12 mm, 16 mm, 25 mm, 30 mm, 35 mm, 40 mm, 50
mm, and 60 mm). Based on the surgical procedure, the collapsibility
of the spheroid body 26 can enable the distal tip to be delivered
using standard sheaths (e.g., an 8 F introducer sheath). However,
the spheroid body 26 need not be collapsible in some procedures,
and thus has a relatively rigid body and maintains the default
shape.
[0047] The distal tip 16 of the ablation device 14 further includes
an electrode array positioned thereon. The electrode array includes
at least one conductive member 28. As illustrated in the figures,
the electrode array may includes at least eight conductive members
28. Accordingly, the electrode array may include a plurality of
conductive members 28. The plurality of conductive members 28
extend within the distal tip 16, through a channel 32 and along an
external surface of the spheroid body 26. The conductive members 28
extend along the longitudinal length of the distal tip 16 and are
radially spaced apart (e.g., equidistantly spaced apart) from each
other. These conductive members transmit RF energy from the
ablation generator and can be formed of any suitable conductive
material (e.g., a metal such as stainless steel, nitinol, or
aluminum). In some examples, the conductive members 28 are metal
wires. Accordingly, for ease of description, the conductive
member(s) will be referred to hereinafter as "conductive wire(s)
28".
[0048] As illustrated, one or more of the conductive wires 28 can
be electrically isolated from one or more of the remaining
conductive wires 28. This electrical isolation enables various
operation modes for the ablation device 14. For example, ablation
energy may be supplied to one or more conductive wires 28 in a
bipolar mode, a unipolar mode, or a combination bipolar and
unipolar mode. In the unipolar mode, ablation energy is delivered
between one or more conductive wires 28 on the ablation device 14
and the return electrode 15, as described with reference to FIG. 1.
In bipolar mode, energy is delivered between at least two of the
conductive wires 28, while at least one conductive wire 28 remains
neutral. In other words, at least, one conductive wire functions as
a grounded conductive wire (e.g., electrode) by not delivering
energy over at least one conductive wire 28.
[0049] The electrode array may further include one or more
stabilizing members 30 configured to provide support for the
plurality of conductive wires 28. The one or more stabilizing
member 30 generally extend along a surface (e.g., external or
internal) of the distal tip 16 so as to circumscribe the spheroid
body 26. The stabilizing members 30 can, in some examples,
electrically connect to one or more conductive wires 28. In other
examples, the stabilizing members 30 are non-conductive. The
stabilizing members 30 can be formed of a suitably stiff material
(e.g., metal such as stainless steel, nitinol, or aluminum). In
some implementations, the stabilizing members 30 can be integral
with a portion of the spheroid body 26 (e.g., as a rib). While, the
distal tip 16 is generally shown with one or more stabilizing
members, in some implementations, the distal tip 16 is free of
stabilizing members.
[0050] To further aid in illustrating the arrangement of the
conductive wires 28 and the non-conductive spheroid body 26. FIG.
4A shows the conductive wires 28 positioned over the non-conductive
spheroid body 26 while FIG. 4B shows the electrode array of the
ablation device without the non-conductive spheroid body 26.
[0051] As shown, the distal tip 16 may be coupled to the ablation
generator 20 and/or irrigation pump 22 via an electrical line 34
and a fluid line 38, respectively. Each of the electrical line 34
and fluid line 38 may include an adaptor end 36, 40, respectively,
configured to couple the associated lines with a respective
interface on the ablation generator 20 and irrigation pump 22. In
some examples, the ablation device 14 may further include a user
switch or interface 19 which may serve as the device controller 18
and thus, may be in electrical communication with the ablation
generator 20 and the ablation device 14, as well as the irrigation
pump 22 for controlling the amount of fluid to be delivered to the
tip 16.
[0052] The switch 19 can provide a user with various options with
respect to controlling the ablation output of the device 14, as
will be described in greater detail herein. For example, the switch
19, which may serve as the device controller 18, may include a
timer circuit, or the like, to enable the conductive wires 28 to be
energized for a pre-selected or desired amount of time. After the
pre-selected or desired amount of time elapses, the electrical
connection can be automatically terminated to stop energy delivery
to the patient. In some cases, the switch 19 may be connected to
individual conductive wires 28. For example, in some embodiments,
the switch 19 may be configured to control energy delivery from the
ablation generator 20 so that one or more individual conductive
wires, or a designated combination of conductive wires, are
energized for a pre-selected, or desired, duration.
[0053] FIGS. 3A, 3B, and 3C are perspective views of the distal tip
16 of FIG. 2 in greater detail. As shown in FIGS. 2 and 3A-3C, the
conductive wires 28 extend through a lumen 42 within the distal tip
16. For example, each of the conductive wires 28 enters the lumen
42 of the neck 27 and extends through the distal tip portion 16
before exiting the distal tip through either a center channel 32 at
a distal most portion of the distal tip or one of a plurality of
proximal ports 44. In some examples, a plurality of distal ports 46
extending through a wall of the distal tip 16 is positioned around
the channel 32. A plurality of proximal ports 44 can also extend
through a wall of the distal tip 16. These proximal ports 44 can be
positioned around the distal tip 16 in close proximity (e.g.,
within at least 5 mm, within at least 3 mm, within at least 1 mm,
within 0.5 mm, within 0.4 mm, or within 0.2 mm) to the junction
between the spheroidal body 26 and the neck 24 of the distal tip
16. In some cases, the number of proximal ports 44 and distal ports
46 is equal to the number of conductive wires 28.
[0054] In some examples, each conductive wire 28 can extend through
a different distal port 46, which allows the conductive wires 28 to
remain electrically isolated from one another. In other examples,
one or more conductive wires can extend through the same distal
port 46.
[0055] Upon passing through a distal port 46, each conductive wire
28 can extend along an external surface of the distal tip 16. In
some examples, the length of the conductive wire 28 extending along
the external surface is at least 20% (e.g., at least, 50%, 60%,
75%, 85%, 90%, or 99%) of the length of the spheroid body 26. The
conductive wire 28 can then re-enter the lumen 42 of the distal tip
16 through a corresponding proximal port 44. For example, as shown
in FIG. 3C, conductive wire 28(1) passes through distal port 46(1),
extends along a length of the external surface of the distal tip
16, and passes through an associated proximal port 44(1) into the
lumen 42 of the distal tip 16, while conductive wire 28(2) is
electrically isolated from conductive wire 28(1) in that it passes
through associated proximal and distal ports 44(2), 46(2),
respectively.
[0056] In some examples, each conductive wire 28 can extend through
a different associated proximal port 44, which allows the
conductive wires 28 to remain electrically isolated from one
another. In other examples, one or more conductive wires can extend
through the same proximal port. Yet still, as will be described in
greater detail herein, particularly with reference to the device
14a illustrated in FIGS. 18A-18B and 19A-19B, an individual
conductive wire can extend through multiple proximal and distal
ports.
[0057] In some embodiments, the spheroid body 26 may be configured
to transition between a collapsed state and an expanded state,
which may allow for a surgeon to introduce the distal portion 26
into certain areas of the body that may have reduced openings and
could be difficult to access with when the spheroid body is in the
default shape. FIG. 5A is a side view and FIG. 5B is a
cross-sectional view of one embodiment of a deployable distal
portion 26 of the ablation device 14 illustrating transitioning of
the distal portion 26 from a delivery configuration to a deployed
configuration.
[0058] As shown, when in a delivery configuration, the spheroid
body 26 may generally have a prolate-spheroid shape, thereby having
a reduced size (e.g., equatorial diameter) relative to the deployed
configuration size (e.g., equatorial diameter). In some
embodiments, the spheroid body 26 may be configured to transition
between the delivery and deployed configurations via manipulation
of one or more of the conductive wires. For example, as shown in
FIG. 5B, at least one conductive wire 28 may be configured to
translate axially along a longitudinal axis of the distal tip 16,
which, in turn, can exert a force an at least a region of the
distal tip 16 that causes or partially causes the spheroid body 26
to transition or deform between a delivery configuration to a
deployed configuration. For example, axial translation of the
conductive wire 28 along an axial direction exerts a force on the
distal tip 16, which causes spheroid body 26 to assume a more
spherical configuration for deployment. In other words, axially
translating the conductive wire 28 causes the spheroid body 26 to
transition from a delivery configuration in which the spheroid body
26 exhibits a prolate-spheroid shape to a deployment configuration
in which the spheroid body 26 exhibits an oblate-spheroid
shape.
[0059] FIG. 6 illustrates a method of deploying the distal portion
16 into an expanded configuration for delivery of RF energy to a
target site for ablation of marginal tissue. As shown, the catheter
shaft 17 of the ablation device 14 can optionally include a
dedicated control wire connected to a knob or control mechanism
accessible on the catheter shaft. In this example, one or more
control wires or other components may be coupled to the conductive
wires to control the retraction and expansion (e.g., via pushing
along direction 48 and pulling along direction 50) of the distal
tip 105 from the catheter shaft 107. In addition, other components
(e.g., electrical wiring for electrically coupling the conductive
element and RF generator) can also be housed within the, at least,
one lumen of the catheter shaft 17 of the ablation device 14.
[0060] In some implementations, the catheter shaft 17 can be
configured as a handle adapted for manual manipulation. In some
examples, the catheter shaft 17 is additionally or alternatively
configured for connection to and/or interface with a surgical
robot, such as the Da Vinci.RTM. surgical robot available from
Intuitive Surgical, Inc., Sunnyvale, Calif. The catheter shaft 17
may be configured to be held in place by a shape lock or other
deployment and suspension system of the type that is anchored to a
patient bed and which holds the device in place while the ablation
or other procedure takes place, eliminating the need for a user to
manually hold the device for the duration of the treatment.
[0061] FIG. 7 is a cross-sectional view of the deployable distal
portion of FIGS. 5A and 5B illustrating the inclusion of an
internal balloon member within an interior chamber of the distal
portion 26. The internal balloon is configured to receive a fluid
from a fluid source and thereby expand, which, in turn, causes the
distal portion to transition from the delivery configuration to the
deployed configuration, and further supply the fluid to an exterior
surface of the distal portion, via weeping of the fluid through one
or more perforations on the distal portion wall (e.g., distal port
46), to create a virtual electrode arrangement with the electrode
array. For example, the inner balloon may include a plurality of
perforations, holes, or micropores in the balloon wall so as to
allow a fluid provided within the balloon (e.g., saline) to pass
therethrough, or weep, from the balloon when the balloon is
inflated. The perforations may be sized, shaped, and/or arranged in
such a pattern so as to allow a volume of fluid to pass from the
interior volume of the balloon into the interior chamber of the
distal portion 26 and then to pass through one or more
perforations, holes, or micropores formed in the distal portion
wall o an exterior surface of the tip at a controlled rate so as to
allow the balloon to remain inflated and maintain its shape.
[0062] FIG. 8 is an exploded view of an ablation device 14
consistent with the present disclosure. As shown, in some
implementations, the ablation device 14, specifically the distal
tip 16, may be formed from two or more pieces (tip halves 16a and
16b) configured to be coupled to one another to form the unitary
distal tip 16. Each half 16a and 16b includes cooperating neck
portions 24a, 24b and spheroid bodies 26a, 26b, as well as a cap 52
to be coupled to both halves 16a and 16b so as to fully enclose the
interior of the distal tip 16. As further illustrated, an
electrical line 34 may be provided for coupling the conductive
wires 28 to the controller 18 and ablation generator 20 and a fluid
line 38 may be provided for providing a fluid connection between
the irrigation pump or drip 22 to the distal tip 16 so as to
provide a conductive fluid (e.g., saline) to the tip 16. The
electrical line 34 and/or the fluid delivery line 38 can be
supported by a stabilizing element 62 within the device lumen. In
some cases, the stabilizing element 62 may be integral with the
neck 24 of the distal tip 16.
[0063] As previously described, conductive members 28 extend
through a first port (e.g., the distal port 44), run along an
external surface of the spheroid body 26 (e.g. within the groove
47) before re-entering the lumen of the distal tip 16 through
another port (e.g., the proximal port 46). A conductive fluid, such
as saline, may be provided to the distal tip 16 via the fluid line
38, wherein the saline may be distributed through the ports (e.g.,
to the distal ports 44, the proximal ports 46, and/or medial ports
45). The saline weeping through the ports and to an outer surface
of the distal tip 16 is able to carry electrical current from
electrode array, such that energy is promoted from the electrode
array to the tissue by way of the saline weeping from the ports,
thereby creating a virtual electrode. Accordingly, upon the fluid
weeping through the ports, a pool or thin film of fluid is formed
on the exterior surface of the distal tip 16 and is configured to
ablate surrounding tissue via the electrical current carried from
the electrode array.
[0064] As shown, the ablation device 14 may further include
hydrophilic insert 54 aligned with the fluid delivery line 38 and
positioned within the interior chamber formed between the two
halves 16a, 16b. The hydrophilic insert 40 is configured to
distribute fluid (e.g., saline) delivered from the fluid line 38
through the distal tip 16 by, for example, wicking the saline
against gravity. This wicking action improves the uniformity of
saline distribution to the device ports (e.g., to the proximal
ports 44, the distal ports 46, and/or a medial ports 45). The
hydrophilic insert 40 can be formed from a hydrophilic foam
material (e.g., hydrophilic polyurethane).
[0065] As shown in FIG. 9, for example, a conductive wire 28 passes
within a lumen 64 of the hydrophilic insert 40 and along an
external surface thereof. Similar to the conductive wires 28, the
conductive wire 28 passing through the hydrophilic insert 54 is
also electrically connected to the ablation generator 20. In some
embodiments, the conductive member 28 is also configured to deploy
the hydrophilic insert 40 from a delivery configuration to a
deployed configuration (e.g., deployed as shown). For example,
during use, the conductive member 28 can also contract or expand
the hydrophilic insert 40 to modify the saline fluid flow as
desired. For example, a control wire 58 may pass within the lumen
of the tip 16, and may be grouped with other control wires (not
shown) into a control line 56 that extends through the device lumen
alongside the fluid delivery line 38. The control wires 58 can be
connected to the conductive members 28 by a conductive link 60.
[0066] FIGS. 10A-10E are perspective views of a distal tip of the
ablation device of FIG. 1 illustrating various electrode array
configurations. In addition, while the conductive wires 28 have
been described as extending along an external surface of the distal
tip 16 in a direction that is parallel to the longitudinal axis of
the device (as shown in a longitudinal configuration of conductive
wires 28a in FIG. 10A), other configurations are possible. For
example, one or more conductive wires 28b could extend along the
external surface of the distal tip 16 in a direction that is
perpendicular to the longitudinal axis of the device (as shown in a
circumferential configuration in FIG. 10B). In other examples, one
or more conductive wires 28c can extend from along the external
surface of the distal tip 16 at an angle (e.g., non-parallel to the
longitudinal axis of the device), as shown in an angled
configuration in FIG. 10C. One or more conductive wires 28d, 28e,
and 28f can also form a pattern along the external surface in which
the conductive wires extend in various directions, as shown in a
combined configuration in FIG. 10D. Additionally or alternatively,
one or more conductive wires 28g can extend a reduced length of the
external surface an alternative configuration in FIG. 10E.
[0067] While various conductive wires 28 have generally been
described such that individual conductive members are energized or
that the desired combination of conductive members is energized for
a pre-selected or desired duration, in some cases, the desired
combination of conductive members can be based on desired contact
region of the distal tip 16.
[0068] FIG. 11 is a side view of the distal tip 16 of the ablation
device 14 of FIG. 1 including several clinical axes or sides. Each
clinical axis or side includes one or more independently connected
electrodes, which enables differential function and current
independent drives and/or measurements. For example, referring to
FIG. 11, the distal tip 16 can be divided into clinical axes or
sides 66, 68, 70, 72, 74, and 75 (not shown). In other words, the
distal tip 16 may include six clinical axes or sides of the distal
portion (e.g, four sides or quadrants around spheroid body 70, 72,
74, and 75, and a top axis/side 66, and a bottom axis/side 68).
[0069] FIGS. 12A-12D are side and perspective views of the distal
tip of the application device illustrating the different clinical
axes or sides of FIG. 9. As shown in FIGS. 12A-12D, each clinical
axis can include multiple independently connected conductive wires.
For example, clinical axis/side 66 can include three independently
connected conductive wires 76, clinical axis/side 68 can include
three independently connected conductive wires 78, clinical
axis/side 70 can include three independently controlled conductive
wires 80, clinical axis/side 72 can include three independently
connected conductive wires 82, clinical axis/side 74 can include
three independently controlled conductive wires 84, and clinical
axis/side 75 can include three independently controlled conductive
wires 86. The independently connected conductive wires within each
clinical axis or side allows for differential function and
independent energy delivery and/or measurements. While FIGS.
12A-12D generally show three conductive wires for each clinical
axis or side, other combinations are possible. For example, each of
the clinical axes or sides can include a combination of conductive
wires ranging from one conductive wire to ten or more conductive
members.
[0070] FIGS. 13 and 14 are perspective and exploded perspective
views, respectively, of one embodiment of a device controller 19
consistent with the present disclosure. As shown, the controller 19
may include a first halve or shell 88a and a second halve or shell
88b for housing a PC board 90 within, the PC board 90 comprising
circuitry and hardware for controlling various parameters of the
device 14 during an ablation procedure. The controller 19 further
includes a display 92, such as an LCD or LED display for providing
a visual representation of one or more parameters associated with
the device 14, including, but not limited to, device status (e.g.,
power on/off, ablation on/off, fluid delivery on/off) as well as
one or more parameters associated with the RF ablation (e.g.,
energy output, elapsed time, timer, temperature, conductivity,
etc.). The controller 19 may further include a top membrane 94
affixed over the PC board 92 and configured to provide user input
(by way of buttons or other controls) with which a user (e.g.,
surgeon or medical professional) may interact with a user interface
provided on the display 92. The controller 19 may be configured to
control at least the amount of electrical current applied to one or
more of the conductive wires 28 from the ablation generator 20 and
the amount of fluid to be delivered to the device 14 from the
irrigation pump/drip 22.
[0071] FIG. 15 is an exploded perspective view of another
embodiment of an ablation device 14a consistent with the present
disclosure. The device 14a is similarly configured as device 14
illustrated in FIG. 8, and includes similar elements. For example,
the device 14a includes the distal tip 16 formed from two or more
pieces (tip halves 16a and 16b) configured to be coupled to one
another to form the unitary distal tip 16. Each half 16a and 16b
includes cooperating neck portions 24a, 24b and spheroid bodies
26a, 26b, as well as a cap 52 to be coupled to both halves 16a and
16b so as to fully enclose the interior of the distal tip 16. As
further illustrated, an electrical line 34 may be provided for
coupling the conductive wires 28 to the controller 18 and ablation
generator 20 and a fluid line 38 may be provided for providing a
fluid connection between the irrigation pump or drip 22 to the
distal tip 16 so as to provide a conductive fluid (e.g., saline) to
the tip 16. The electrical line 34 and/or the fluid delivery line
38 can be supported by a stabilizing element 62 within the device
lumen. In some cases, the stabilizing element 62 may be integral
with the neck 24 of the distal tip 16.
[0072] The device 14a is configured to provide RF ablation via a
virtual electrode arrangement, which includes distribution of a
fluid along an exterior surface of the distal tip 16 and, upon
activation of the electrode array, the fluid may carry, or
otherwise promote, energy emitted from the electrode array to the
surrounding tissue. For example, the nonconductive spheroid body 26
includes an interior chamber (when the first and second halves 26a,
26b are coupled to one another) for retaining at least a spacing
member 96 (also referred to herein as "spacer ball") and one or
more hydrophilic inserts 98a, 98b surrounding the spacing member
96. The interior chamber of the distal tip 16 is configured to
receive and retain a fluid (e.g., saline) therein from a fluid
source. The hydrophilic inserts 98a, 98b are configured receive and
evenly distribute the fluid through the distal tip 16 by wicking
the saline against gravity. The hydrophilic inserts 98a and 98b can
be formed from a hydrophilic foam material (e.g., hydrophilic
polyurethane).
[0073] As previously described, the distal tip 16 may generally
include a plurality of ports or apertures configured to allow the
fluid to pass therethrough, or weep, from the interior chamber to
an external surface of the distal tip 16. Accordingly, in some
embodiments, all of the ports (e.g., proximal ports 44, medial
ports 45, and distal ports 46) may be configured to allow for
passage of fluid from the inserts 98a, 98b to the exterior surface
of the distal tip 16. However, in some embodiments, only the medial
ports 45 may allow for fluid passage, while the proximal and distal
ports 44, 46 may be blocked via a heat shrink or other occlusive
material.
[0074] The spacer member 96 may formed from a nonconductive
material and may be shaped and sized so as to, maintain the
hydrophilic inserts 98a, 98b in sufficient contact with the
interior surface of the distal tip wall, and specifically in
contact with the one or more ports, such that the hydrophilic
inserts 98a, 98b provides uniformity of saline distribution to the
ports. In some embodiments, the spacer member 96 may have a
generally spherical body, corresponding to the interior contour of
the chamber of the spheroid body 26.
[0075] Accordingly, upon positioning the distal tip 16 within a
target site (e.g., tissue cavity to be ablated), the electrode
array can be activated and fluid delivery can be initiated. The
fluid weeping through the ports to the exterior surface of the
distal tip is able to carry energy from electrode array, thereby
creating a virtual electrode. Accordingly, upon the fluid weeping
through the port, a pool or thin film of fluid is formed on the
exterior surface of the distal portion and is configured to ablate
surrounding tissue via the RF energy carried from the electrode
array.
[0076] As previously described herein, conductive wires 28 may
generally extend through a first port (e.g., the distal port 44),
run along an external surface of the spheroid body 26 before
re-entering the lumen of the distal tip 16 through another port
(e.g., the proximal port 46). FIGS. 16, 17, 18A-18B, and 19A-19B
illustrate another arrangement of conductive wires 28, in which at
least four different conductive wires are provided, two of which
serve as supply electrodes and the other two serve as return
electrodes. Each of the four different conductive wires generally
pass through at least two different proximal ports and two
different distal ports, while remaining isolated from one another.
FIG. 16 is a plan view of the ablation device 14a illustrating the
two halves of the device tip 16a, 16b separated from one another
and showing the external surface each, while FIG. 17 shows the
interior surface of each.
[0077] FIGS. 18A and 18B are enlarged views of the spheroid body of
the first halve 16a of the device 14a showing the exterior and
interior surfaces, respectively, and further illustrating the
particular arrangement of first and second conductive wires 28(1)
and 28(2), partly in phantom, extending through proximal and distal
ports 44, 46 of the spheroid body 26a. The following description of
the first and second conductive wires 28(1) and 28(2) provides a
general pathway of each wire, including passages through ports and
extensions along lengths of the interior and exterior surfaces of
the tip 16. In the illustrated embodiment, a first conductive wire
28(1) may serve as a return electrode while a second conductive
wire 28(2) may serve as a supply electrode.
[0078] As shown, the first conductive wire 28(1) extends within the
lumen of the tip 16a and passes through proximal port 44(1),
extends along the exterior surface of the spheroid body 26a towards
the distal ports (generally parallel to longitudinal axis of
device), passes through distal port 46(1), extends along the
interior surface of the body 26a towards adjacent distal ports
(generally transverse to longitudinal axis of the device), passes
through distal port 46(2), extends along the exterior surface of
the spheroid body 26a back towards the proximal ports, passes
through proximal port 44(2), extends along the interior surface of
body 26a towards adjacent proximal ports, passes through proximal
port 44(5), extends along the exterior surface of the spheroid body
26a back towards the distal ports, passes through distal port
46(5), extends along the interior surface of the body 26a towards
adjacent distal ports, passes through distal port 46(6), extends
along the exterior surface of the spheroid body 26a back towards
the proximal ports, passes through proximal port 44(6), and extends
back through lumen of the tip 16a. Accordingly, the first
conductive wire 28(1) has at least four portions that extend along
the exterior surface of the spheroid body 26a.
[0079] The second conductive wire 28(2) extends within the lumen of
the tip 16a and passes through distal port 44(3), extends along the
exterior surface of the spheroid body 26a towards the distal ports
(generally parallel to longitudinal axis of device), passes through
distal port 46(3), extends along the interior surface of the body
26a towards adjacent distal ports (generally transverse to
longitudinal axis of the device), passes through distal port 46(4),
extends along the exterior surface of the spheroid body 26a back
towards the proximal ports, passes through proximal port 44(4), and
extends back through lumen of the tip 16a. Accordingly, the second
conductive wire 28(2) has at least two portions that extend along
the exterior surface of the spheroid body 26a.
[0080] FIGS. 19A and 18B are enlarged views of the spheroid body of
the second halve 16b of the device 14a showing the exterior and
interior surfaces, respectively, and further illustrating the
particular arrangement of third and fourth conductive wires 28(3)
and 28(4) extending through proximal and distal ports of the
spheroid body 26b. The following description of the third and
fourth conductive wires 28(3) and 28(4) provides a general pathway
of each wire, including passages through ports and extensions along
lengths of the interior and exterior surfaces of the tip 16. In the
illustrated embodiment, a third conductive wire 28(3) may serve as
a return electrode while a second conductive wire 28(4) may serve
as a supply electrode.
[0081] As shown, the third conductive wire 28(3) extends within the
lumen of the tip 16a and passes through proximal port 44(9),
extends along the exterior surface of the spheroid body 26b towards
the distal ports (generally parallel to longitudinal axis of
device), passes through distal port 46(9), extends along the
interior surface of the body 26b towards adjacent distal ports
(generally transverse to longitudinal axis of the device), passes
through distal port 46(10), extends along the exterior surface of
the spheroid body 26b back towards the proximal ports, passes
through proximal port 44(10), and extends back through lumen of the
tip 16a. Accordingly, the third conductive wire 28(3) has at least
two portions that extend along the exterior surface of the spheroid
body 26b.
[0082] The fourth conductive wire 28(4) extends within the lumen of
the tip 16b and passes through proximal port 44(7), extends along
the exterior surface of the spheroid body 26b towards the distal
ports (generally parallel to longitudinal axis of device), passes
through distal port 46(7), extends along the interior surface of
the body 26b towards adjacent distal ports (generally transverse to
longitudinal axis of the device), passes through distal port 46(8),
extends along the exterior surface of the spheroid body 26b back
towards the proximal ports, passes through proximal port 44(8),
extends along the interior surface of body 26b towards adjacent
proximal ports, passes through proximal port 44(11), extends along
the exterior surface of the spheroid body 26b hack towards the
distal ports, passes through distal port 46(11), extends along the
interior surface of the body 26b towards adjacent distal ports,
passes through distal port 46(12), extends along the exterior
surface of the spheroid body 26b back towards the proximal ports,
passes through proximal port 44(12), and extends back through lumen
of the tip 16a. Accordingly, the fourth conductive wire 28(4) has
at least four portions that extend along the exterior surface of
the spheroid body 26b.
[0083] Furthermore, each of the four conductive wires 28(1)-28(4)
remain electrically isolated and independent from one another such
that, each, or one or more sets of a combination of, the conductive
wires, can independently receive an electrical current from the
ablation generator and independently conduct energy, the energy
including RF energy. This allows energy to be selectively delivered
to a designated conductive wire or combination of conductive wires.
This design also enables the ablation device to function in a
bipolar mode because a first conductive wire (or combination of
conductive wires) can deliver energy to the surrounding tissue
through its electrical connection with an ablation generator while
a second conductive wire (or combination of conductive wires) can
function as a ground or neutral conductive member.
[0084] The independent control of each wire or sets of wires allows
for activation (e.g., emission of RF energy) of corresponding
portions of the electrode array. For example, the electrode array
may be partitioned into specific portions which may correspond to
clinical axes or sides of the distal portion of the device. In one
embodiment, the electrode array may include at least four distinct
portions (i.e., individual or sets of conductive wires)
corresponding to four clinical axes or sides of the distal portion
(e.g, four sides or quadrants around spheroid body).
[0085] FIG. 20 is a schematic illustration of the ablation device
14a illustrating delivery of fluid from the irrigation pump 22, as
controlled by the controller 19, to the hydrophilic inserts 98a,
98b within the interior chamber of the distal tip 16, wherein the
fluid can be subsequently distributed to an exterior surface of the
spheroid body 26 resulting in a virtual electrode arrangement upon
activation of one or more portions of the electrode array. As
shown, the saline may be distributed through at least the medial
ports 45, such that the weeping saline is able to carry electrical
cumin from electrode array, such that energy is transmitted from
the electrode array to the tissue by way of the saline weeping from
the ports, thereby creating a virtual electrode. Accordingly, upon
the fluid weeping through the medial port, a pool or thin film of
fluid is formed on the exterior surface of the spheroid body 26 and
is configured to ablate surrounding tissue via the electrical
current carried from the electrode array.
[0086] FIGS. 21 and 22 are perspective and plan views of a
detachable mount 100 for holding and maintaining a temperature
probe 102 (or any other separate monitoring device) at a desired
position, as indicated by arrow 106, relative to the spheroid body
26 of the distal tip of the ablation device 14. In particular, the
mount 100 allows for an operator (e.g., surgeon) to releasably
couple a temperature probe 102, or other measurement device, to the
ablation device 14a and further position the working end 104 of the
probe 102 in close proximity to the spheroid body 2 for the
collection of temperature data during an RF ablation procedure.
[0087] As previously described herein, the controller 18, 19 may be
configured to provide a surgeon with the ability to control
ablation, such as controlling the supply of power to one or more
conductive wires as well as control the delivery of fluid to the
device tip 16. Furthermore, the controller 18, 19 may provide
device status (e.g., power on/off, ablation on/off, fluid delivery
on/off) as well as one or more parameters associated with the RF
ablation (e.g., energy output, elapsed time, timer, temperature,
conductivity, etc.). Thus, in some instances, it may be important
to monitor at least the temperature adjacent to the device tip 16
during the ablation procedure, as well as pre-ablation and
post-ablation, as temperature may be indicative of the status of
surrounding tissue that is being, or is intended to be, ablated.
Furthermore, it may be important to monitor the temperature at
certain distances from the device tip 14 and at certain angles.
Current devices may include a thermocouple mechanism integrated
into the device. However, such configurations lack the ability to
obtain temperature measurement at specific distances and angles
relative to the ablation tip. The mount 100 is configured to
provide a surgeon with the ability to adjacent the angle at which
the temperature probe is positioned relative to the device tip 16
as well as the distance from the device tip 16, thereby overcoming
the drawbacks of integrated thermocouples.
[0088] As shown, the mount 100 generally includes a body having a
first end 108 configured to be releasably coupled to at least the
proximal end of the device 14 by way of a clamping mechanism or
latch-type engagement. The first end 108 includes a top guard
member 110 configured to partially enclose at least the proximal
end of the device 14, to further enhance securement of the mount
100 to the device 14. The mount 100 further includes an arm member
112 extending from the first end 108 and providing a second end 114
positioned a distance from the first end 108. The second end 114 is
configured to hold the temperature probe 102 at a desired position,
including a desired distance from the spheroid body 26 and a
desired angle .theta. relative to the longitudinal axis of the
ablation device. For example, in one embodiment, the second end 114
may include a bore or channel configured to receive and retain a
portion of the temperature probe 102 within. The second end 114 may
further allow for the temperature probe 102 to translate along the
bore or channel, as indicated by arrow 116, to thereby adjust the
distance of the temperature probe tip 104 relative to the spheroid
body of the device tip. In some embodiments, the arm 112 and/or
second end 114 may articulate relative to one another and/or the
first end 108. Accordingly, the angle of the temperature probe 102
may also be adjusted as desired.
[0089] Accordingly, a tissue ablation devices, particularly the
applicator heads described herein, may be well suited for treating
hollow body cavities, such as cavities in breast tissue created by
a lumpectomy procedure. The devices, systems, and methods of the
present disclosure can help to ensure that all microscopic disease
in the local environment has been treated. This is especially true
in the treatment of tumors that have a tendency to recur.
[0090] As used in any embodiment herein, the term "controller",
"module", "subsystem", or the like, may refer to software, firmware
and/or circuitry configured to perform any of the aforementioned
operations. Software may be embodied as a software package, code,
instructions, instruction sets and/or data recorded on
non-transitory computer readable storage medium. Firmware may be
embodied as code, instructions or instruction sets and/or data that
are hard-coded (e.g., nonvolatile) in memory devices. "Circuitry",
as used in any embodiment herein, may comprise, for example, singly
or in any combination, hardwired circuitry, programmable circuitry
such as computer processors comprising one or more individual
instruction processing cores, state machine circuitry, and/or
firmware that stores instructions executed by programmable
circuitry. The controller or subsystem may, collectively or
individually, be embodied as circuitry that forms part of a larger
system, for example, an integrated circuit (IC), system on-chip
(SoC), desktop computers, laptop computers, tablet computers,
servers, smart phones, etc.
[0091] Any of the operations described herein may be implemented in
a system that includes one or more storage mediums having stored
thereon, individually or in combination, instructions that when
executed by one or more processors perform the methods. Here, the
processor may include, for example, a server CPU, a mobile device
CPU, and/or other programmable circuitry.
[0092] Also, it is intended that operations described herein may be
distributed across a plurality of physical devices, such as
processing structures at more than one different physical location.
The storage medium may include any type of tangible medium, for
example, any type of disk including hard disks, floppy disks,
optical disks, compact disk read-only memories (CD-ROMs), compact
disk rewritables (CD-RWs), and magneto-optical disks, semiconductor
devices such as read-only memories (ROMs), random access memories
(RAMs) such as dynamic and static RAMs, erasable programmable
read-only memories (EPROMs), electrically erasable programmable
read-only memories (EEPROMs), flash memories, Solid State Disks
(SSDs), magnetic or optical cards, or any type of media suitable
for storing electronic instructions. Other embodiments may be
implemented as software modules executed a programmable control
device. The storage medium may be non-transitory.
[0093] As described herein, various embodiments may be implemented
using hardware elements, software elements, or any combination
thereof. Examples of hardware elements may include processors,
microprocessors, circuits, circuit elements (e.g., transistors,
resistors, capacitors, inductors, and so forth), integrated
circuits, application specific integrated circuits (ASIC),
programmable logic devices (PLD), digital signal processors (DSP),
field programmable gate array (FPGA), logic gates, registers,
semiconductor device, chips, microchips, chip sets, and so
forth.
[0094] Reference throughout this specification to "one embodiment"
or "an embodiment" means that a particular feature, structure, or
characteristic described in connection with the embodiment is
included in at least one embodiment. Thus, appearances of the
phrases "in one embodiment" or "in an embodiment" in various places
throughout this specification are not necessarily all referring to
the same embodiment. Furthermore, the particular features,
structures, or characteristics may be combined in any suitable
manner in one or more embodiments.
[0095] The terms and expressions which have been employed herein
are used as terms of description and not of limitation, and there
is no intention, in the use of such terms and expressions, of
excluding any equivalents of the features shown and described (or
portions thereof), and it is recognized that various modifications
are possible within the scope of the claims. Accordingly, the
claims are intended to cover ail such equivalents.
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