U.S. patent application number 15/379061 was filed with the patent office on 2017-03-30 for drug-delivery device for use with ablation device.
The applicant listed for this patent is COVIDIEN LP. Invention is credited to RUPAL AYER, PHILLIP D. BLASKOVICH, PAUL DICARLO, CLIFFORD J. HERMAN, WENXING HUANG, LES HULL, WILLIAM H. NAU, JR., RACHIT OHRI, LAN PHAM, FRANCESCA ROSSETTO, ALLISON WALLER, STEPHEN H. WU.
Application Number | 20170087345 15/379061 |
Document ID | / |
Family ID | 49671108 |
Filed Date | 2017-03-30 |
United States Patent
Application |
20170087345 |
Kind Code |
A1 |
OHRI; RACHIT ; et
al. |
March 30, 2017 |
DRUG-DELIVERY DEVICE FOR USE WITH ABLATION DEVICE
Abstract
A drug-delivery device includes a body configured for attachment
to a handle of an ablation device, a shaft portion defining a
passageway therein, and a delivery lumen to provide for drug
delivery to tissue. The body includes a proximal portion, a distal
portion, and a contoured portion disposed therebetween. The
contoured portion is configured for engagement with a contoured
portion of the handle of the ablation device. The shaft portion
includes a proximal end and a distal end. The proximal end of the
shaft engages with an opening defined in the distal end of the
body. The passageway of the shaft portion is configured to receive
the delivery lumen slideably moveably therein. The delivery lumen
includes a proximal portion and a distal portion. The drug-delivery
device also includes a knob member coupled to the proximal portion
of the delivery lumen.
Inventors: |
OHRI; RACHIT; (WOBURN,
MA) ; PHAM; LAN; (NASHUA, NH) ; BLASKOVICH;
PHILLIP D.; (SALEM, MA) ; HULL; LES;
(SANDWICH, MA) ; AYER; RUPAL; (BOULDER, CO)
; WU; STEPHEN H.; (CHESTERFIELD, MO) ; HERMAN;
CLIFFORD J.; (SAINT LOUIS, MO) ; NAU, JR.; WILLIAM
H.; (LONGMONT, CO) ; ROSSETTO; FRANCESCA;
(LONGMONT, CO) ; WALLER; ALLISON; (BLACKSTONE,
MA) ; HUANG; WENXING; (SHANGHAI, CN) ;
DICARLO; PAUL; (MIDDELBORO, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
COVIDIEN LP |
Mansfield |
MA |
US |
|
|
Family ID: |
49671108 |
Appl. No.: |
15/379061 |
Filed: |
December 14, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14011438 |
Aug 27, 2013 |
9526568 |
|
|
15379061 |
|
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/0428 20130101;
A61B 2018/143 20130101; A61B 18/1815 20130101; A61M 37/00 20130101;
A61N 5/045 20130101; A61B 2218/002 20130101; A61M 5/007 20130101;
A61B 2018/00029 20130101; A61B 2018/00011 20130101; A61B 2018/1475
20130101; A61M 2037/0007 20130101; A61M 5/48 20130101; A61B
2034/2065 20160201; A61B 18/18 20130101; A61M 2205/055 20130101;
A61N 1/306 20130101; A61B 2018/00946 20130101; A61B 2018/1869
20130101; A61B 2018/00577 20130101; A61M 5/158 20130101; A61M
2205/0266 20130101; A61B 18/1477 20130101; A61B 10/0233 20130101;
A61B 10/06 20130101; A61N 5/022 20130101 |
International
Class: |
A61M 37/00 20060101
A61M037/00; A61M 5/00 20060101 A61M005/00; A61N 5/04 20060101
A61N005/04; A61N 1/04 20060101 A61N001/04; A61N 1/30 20060101
A61N001/30; A61N 5/02 20060101 A61N005/02; A61B 18/14 20060101
A61B018/14; A61M 5/158 20060101 A61M005/158 |
Claims
1-8. (canceled)
9. A method for treating tissue comprising: attaching a fluid
delivery device to an ablation device, the fluid delivery device
including a first contoured portion configured to engage a second
contoured portion of the ablation device; inserting a shaft coupled
to the fluid delivery device and an ablation electrode coupled to
the ablation device into tissue; and inserting a delivery lumen
into the tissue through the shaft.
10. The method according to claim 9, further comprising: supplying
a fluid through the delivery lumen into the tissue.
11. The method according to claim 10, wherein supplying a fluid
through the delivery lumen includes supplying a drug agent into the
tissue.
12. The method according to claim 10, wherein supplying a fluid
through the delivery lumen includes supplying a contrast agent into
the tissue.
13. The method according to claim 9, further comprising: adjusting
longitudinal position of the delivery lumen relative to the
shaft.
14. The method according to claim 13, wherein adjusting
longitudinal position of the delivery lumen includes longitudinally
moving an actuator coupled to the delivery lumen.
15. The method according to claim 9, further comprising: adjusting
rotational position of the delivery lumen relative to the
shaft.
16. The method according to claim 15, wherein adjusting rotational
position of the delivery lumen includes rotating an actuator
coupled to the delivery lumen.
17. The method according to claim 9, further comprising: imaging
the tissue to obtain an image of the tissue; and controlling the
delivery lumen based on the image of the tissue.
18. The method according to claim 9, further comprising: bending
the delivery lumen.
19. The method according to claim 18, wherein bending the delivery
lumen includes adjusting temperature of the delivery lumen to bend
the delivery lumen that is formed from a shape-memory material.
20. A method for treating tissue comprising: attaching a fluid
delivery device to an ablation device, the fluid delivery device
including a first contoured portion configured to engage a second
contoured portion of the ablation device; inserting a shaft coupled
to the fluid delivery device and an ablation electrode coupled to
the ablation device into tissue; inserting a plurality of delivery
lumens into the tissue through the shaft; and supplying a fluid
through each of the plurality of delivery lumens into the
tissue.
21. The method according to claim 20, wherein supplying the fluid
through each of the plurality of delivery lumens includes supplying
a drug agent into the tissue.
22. The method according to claim 20, wherein supplying the fluid
through each of the plurality of delivery lumens includes supplying
a contrast agent into the tissue.
23. The method according to claim 20, further comprising: adjusting
longitudinal position of each of the plurality of delivery lumens
relative to the shaft.
24. The method according to claim 23, wherein adjusting
longitudinal position of each of the plurality of delivery lumens
includes longitudinally moving an actuator coupled to the plurality
of delivery lumens.
25. The method according to claim 20, further comprising: adjusting
rotational position of each of the plurality of delivery lumens
relative to the shaft.
26. The method according to claim 25, wherein adjusting rotational
position of each of the plurality of delivery lumens includes
rotating an actuator coupled to the plurality of delivery
lumens.
27. The method according to claim 20, further comprising: imaging
the tissue to obtain an image of the tissue; and controlling the
plurality of delivery lumens based on the image of the tissue.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. patent
application Ser. No. 14/011,438, file Aug. 27, 2013, the entire
disclosure of which is incorporated by reference herein.
BACKGROUND
[0002] 1. Technical Field
[0003] The present disclosure relates to electrosurgical systems
and devices for performing medical procedures. The present
disclosure relates to the administration of beneficial agents in
general, which include any physiologically, pharmacologically
active and/or psychotropic substance(s). More particularly, the
present disclosure relates to drug-delivery devices for use with
ablation devices and electrosurgical systems including the
same.
[0004] 2. Discussion of Related Art
[0005] Electrosurgical instruments have become widely used by
surgeons. Electrosurgery involves the application of thermal and/or
electrical energy to cut, dissect, ablate, coagulate, cauterize,
seal or otherwise treat biological tissue during a surgical
procedure. Electrosurgery is typically performed using a handpiece
including a surgical instrument (e.g., end effector, ablation
probe, or electrode) adapted to transmit energy to a tissue site
during electrosurgical procedures, an electrosurgical generator
operable to output energy, and a cable assembly operatively
connecting the surgical instrument to the generator.
[0006] Treatment of certain diseases requires the destruction of
malignant tissue growths, e.g., tumors. Electromagnetic radiation
can be used to heat and destroy tumor cells. Treatment may involve
inserting ablation probes into tissues where cancerous tumors have
been identified. Once the probes are positioned, electromagnetic
energy is passed through the probes into surrounding tissue.
[0007] In the treatment of diseases such as cancer, certain types
of tumor cells have been found to denature at elevated temperatures
that are slightly lower than temperatures normally injurious to
healthy cells. Known treatment methods, such as hyperthermia
therapy, heat diseased cells to temperatures above 41.degree. C.
while maintaining adjacent healthy cells below the temperature at
which irreversible cell destruction occurs. These methods involve
applying various forms of energy (e.g., electromagnetic,
ultrasonic, etc.) to heat, ablate and/or coagulate tissue.
Microwave or radio-frequency energy is sometimes utilized to
perform these methods. Radio-frequency (RF) and microwave (MW)
energy are electromagnetic radiation in the frequency ranges of 3
kilohertz (kHz) to 300 Megahertz (MHz), and 300 MHz to 300
gigahertz (GHz), respectively. Other procedures utilizing
electromagnetic radiation to heat tissue also include coagulation,
cutting and/or ablation of tissue.
[0008] Electrosurgical devices utilizing electromagnetic radiation
have been developed for a variety of uses and applications. A
number of devices are available that can be used to provide high
bursts of energy for short periods of time to achieve cutting and
coagulative effects on various tissues. There are a number of
different types of apparatus that can be used to perform ablation
procedures. Typically, microwave apparatus for use in ablation
procedures include a microwave generator that functions as an
energy source, and a microwave surgical instrument (e.g., microwave
ablation probe) having an antenna assembly for directing the energy
to the target tissue. The microwave generator and surgical
instrument are typically operatively coupled by a cable assembly
having a plurality of conductors for transmitting microwave energy
from the generator to the instrument, and for communicating
control, feedback and identification signals between the instrument
and the generator.
[0009] The basic purpose of both monopolar and bipolar
electrosurgery is to produce heat to achieve the desired
tissue/clinical effect. In monopolar electrosurgery, devices use an
instrument with a single, active electrode to deliver energy from
an electrosurgical generator to tissue, and a patient return
electrode (usually a plate positioned on the patient's thigh or
back) as the means to complete the electrical circuit between the
electrosurgical generator and the patient. In bipolar
electrosurgery, the electrosurgical device includes two electrodes
that are located in proximity to one another for the application of
current between their surfaces. Bipolar electrosurgical current
travels from one electrode, through the intervening tissue to the
other electrode to complete the electrical circuit.
[0010] The benefits provided by controlled delivery of active
agents for the treatment of injury or disease are well recognized
in the art and various approaches have been taken to realize the
goal of delivering active agents at desired rates over
predetermined periods of time. Various different implantable
controlled delivery formulations are known in the art, and various
different mechanisms have been employed for delivering active agent
from implantable formulations at a controlled rate over time.
[0011] Medical imaging has become a significant component in the
clinical setting and in basic physiology and biology research,
e.g., due to enhanced spatial resolution, accuracy and contrast
mechanisms that have been made widely available. Medical imaging
now incorporates a wide variety of modalities, e.g., computed
tomography (CT) and magnetic resonance imaging (MRI), that
noninvasively capture the structure and/or function of the human
body. Such images are acquired and used in many different ways
including medical images for diagnosis, staging and therapeutic
management of malignant disease.
[0012] Medical image processing, analysis and visualization play an
increasingly useful role in disease diagnosis and monitoring as
well as, among other things, surgical planning and monitoring of
therapeutic procedures. A contrast agent may be used for
enhancement of the contrast of structures or fluids within the body
(or region of interest) in medical imaging to allow visualization
and evaluation of lesions seen minimally, if at all, with imaging
alone. There is a continuing need for devices capable of dispensing
a contrast agent to enhance the visualization of the lesion during
the procedure.
[0013] Despite advancements in the use of electrosurgical devices
for treating biological tissue, there are still concerns for tumor
reoccurrence. A continuing need exists for devices capable of
dispensing a controlled delivery formulation of a desired active
agent, which may help to reduce or eliminate tumor
reoccurrence.
SUMMARY
[0014] There is a need for drug-delivery devices configured for
attachment to ablation devices to provide the capability of
dispensing a controlled delivery formulation of a desired active
agent (and/or contrast agent). There is a need for drug-delivery
devices configured for attachment to energy-delivery devices to
provide the capability of dispensing therapeutic agents, e.g.,
visualization agents, radioactive agents, and/or
radiation-protective agents. The combination of ablation (e.g., RF
ablation and/or microwave ablation) and drug delivery may help to
reduce or eliminate tumor reoccurrence. The combination of ablation
and contrast agent introduction may help to enhance the
visualization of the lesion during the treatment procedure. There
is a need for drug-delivery devices configured for attachment to
ablation devices to provide the capability of dispensing a
therapeutic agent and/or an active agent in a controlled delivery
formulation and/or non-active agent (e.g., contrast agent) before,
during and/or after ablation, e.g., without the need for further
manipulation of the device.
[0015] Electromagnetic energy is generally classified by increasing
energy or decreasing wavelength into radio waves, microwaves,
infrared, visible light, ultraviolet, X-rays and gamma-rays. As it
is used in this description, "ablation procedure" generally refers
to any ablation procedure, such as, for example, microwave
ablation, radio frequency (RF) ablation or microwave
ablation-assisted resection.
[0016] As it is used in this description, "energy-delivery device"
generally refers to any device that can be used to transfer energy
from a power generating source, such as a microwave or RF
electrosurgical generator, to tissue. For the purposes herein, the
term "ablation device" is interchangeable with the term
"energy-delivery device." As it is used in this description,
"transmission line" generally refers to any transmission medium
that can be used for the propagation of signals from one point to
another.
[0017] For the purposes of this description, the terms "drug,"
"drug agent," "implantable drug agent," "active agent," "beneficial
agent," "therapeutic agent," "therapeutic molecule," and the like
are used interchangeably herein, and may include, for example,
small molecules, proteins, enzymes, hormones, polynucleotides,
nucleoproteins, polysaccharides, glycoproteins, lipoproteins,
polypeptides, steroids, analgesics, local anesthetics, antibiotic
agents, anti-inflammatory corticosteroids, ocular drugs and
synthetic analogs of these species. Some examples of drug agents
that may be delivered by devices according to embodiments of the
present disclosure are provided later in this description.
[0018] According to an aspect of the present disclosure, a
drug-delivery device is provided. The drug-delivery device includes
a body configured for attachment to a handle of an ablation device,
a shaft portion defining a passageway therein, and a delivery lumen
to provide for drug delivery to tissue. The body includes a
proximal portion, a distal portion, and a contoured portion
disposed therebetween. The contoured portion is configured for
engagement with a contoured portion of the handle of the ablation
device. The shaft portion includes a proximal end and a distal end.
The proximal end of the shaft engages with an opening defined in
the distal end of the body. The passageway of the shaft portion is
configured to receive the delivery lumen slideably moveably
therein. The delivery lumen includes a proximal portion and a
distal portion. The drug-delivery device also includes a knob
member coupled to the proximal portion of the delivery lumen.
[0019] According to an aspect of the present disclosure, an
electrosurgical system is provided. The electrosurgical system
includes an ablation device and a drug-delivery device. The
ablation device includes a handle portion and a plurality of
ablation electrodes operatively connected to the handle portion.
The handle portion includes a contoured portion. The drug-delivery
device includes a body, a delivery lumen to provide for drug
delivery to tissue, and a knob member. The body is configured for
attachment to the handle portion of the ablation device. The body
includes a proximal portion, a distal portion, and a contoured
portion disposed therebetween. The contoured portion of the body is
configured for engagement with the contoured portion of the handle
portion of the ablation device. The shaft portion defines a
passageway therein. The shaft portion includes a proximal end and a
distal end. The proximal end of the shaft engages with an opening
defined in the distal end of the body. The delivery lumen includes
a proximal portion and a distal portion. The knob member is coupled
to the proximal portion of the delivery lumen. The passageway of
the shaft portion is configured to receive the delivery lumen
slideably moveably therein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] Objects and features of the presently-disclosed
drug-delivery devices for use with ablation devices and
electrosurgical systems including the same will become apparent to
those of ordinary skill in the art when descriptions of various
embodiments thereof are read with reference to the accompanying
drawings, of which:
[0021] FIG. 1 is a schematic view of a drug-delivery device in an
aligned position with respect to an energy-delivery device, spaced
apart therefrom, the drug-delivery device including a drug-delivery
lumen, a knob member coupled thereto, and a body configured to be
attachable to the energy-delivery device, in accordance with an
embodiment of the present disclosure;
[0022] FIG. 2 is a schematic view of the drug-delivery device of
FIG. 1 coupled to an energy-delivery device, such as the
energy-delivery device of FIG. 1, showing the drug-delivery device
in a first configuration in which the knob member thereof is
disposed in a proximal position, wherein the drug-delivery lumen is
configured in a retracted position, in accordance with an
embodiment of the present disclosure;
[0023] FIG. 3 is a schematic view of the drug-delivery device of
FIG. 1 coupled to an energy-delivery device, such as the
energy-delivery device of FIG. 1, showing the drug-delivery device
in a first configuration in which the knob member thereof is
disposed in the distal-most position, wherein the drug-delivery
lumen is configured in an extended position, in accordance with an
embodiment of the present disclosure;
[0024] FIG. 4 is a bottom, perspective view of the drug-delivery
device of FIG. 2 coupled to an energy-delivery device, in
accordance with an embodiment of the present disclosure;
[0025] FIG. 5 is a rear, schematic view of the drug-delivery device
of FIG. 2 coupled to an energy-delivery device, in accordance with
an embodiment of the present disclosure;
[0026] FIG. 6 is a side, perspective view of the drug-delivery
device of FIG. 2 coupled to an energy-delivery device, including
the drug-delivery lumen shown in an extended position, in
accordance with an embodiment of the present disclosure;
[0027] FIG. 7 is a side, perspective view of the energy-delivery
device and the drug-delivery device of FIG. 1, illustrating an
alternative embodiment of the drug-delivery lumen thereof, shown in
an extended position, in accordance with the present
disclosure;
[0028] FIG. 8 is an enlarged view of the distal portion of the
drug-delivery lumen of the drug-delivery device of FIG. 7 shown
extending outwardly from the distal end of the shaft; and
[0029] FIG. 9 is a schematic view of the drug-delivery device of
FIG. 1 in an aligned position with respect to another embodiment of
an energy-delivery device, spaced apart therefrom, in accordance
with an embodiment of the present disclosure.
DETAILED DESCRIPTION
[0030] Hereinafter, embodiments of the presently-disclosed
drug-delivery devices for use with ablation devices, and
electrosurgical systems including the same of the present
disclosure are described with reference to the accompanying
drawings. Like reference numerals may refer to similar or identical
elements throughout the description of the figures. As shown in the
drawings and as used in this description, and as is traditional
when referring to relative positioning on an object, the term
"proximal" refers to that portion of the device, or component
thereof, closer to the user and the term "distal" refers to that
portion of the device, or component thereof, farther from the
user.
[0031] This description may use the phrases "in an embodiment," "in
embodiments," "in some embodiments," or "in other embodiments,"
which may each refer to one or more of the same or different
embodiments in accordance with the present disclosure.
[0032] Various embodiments of the present disclosure provide
drug-delivery devices configured to be attachable to
energy-delivery devices. Embodiments may be suitable for use with
Cool-Tip.TM. RF ablation devices. Embodiments may be suitable for
use with microwave ablation devices. Embodiments may be suitable
for utilization with endoscopic and laparoscopic surgical
procedures. Embodiments may be implemented using electromagnetic
radiation at microwave frequencies, RF frequencies or at other
frequencies.
[0033] Various embodiments of the present disclosure provide
electrosurgical system including a drug-delivery device configured
to be attachable to an energy-delivery. Various embodiments of the
presently-disclosed drug-delivery device include an elongated shaft
portion configured to facilitate delivery of one or more drug
agents and/or therapeutic agents, which may be temperature
sensitive, into tissue. Any suitable number of the same or
different drugs may be utilized, e.g., depending upon a particular
purpose and/or to achieve a desired surgical outcome. The
presently-disclosed drug-delivery device embodiments may be
configured for visualization, e.g., configured to allow for
delivery of a miniaturized camera system at the distal end of the
delivery lumen. The presently-disclosed drug-delivery device
embodiments may be configured to allow for delivery of pill-sized
cameras.
[0034] Drug agents which may be delivered by devices according to
embodiments of the present disclosure include drugs which act on
the peripheral nerves, adrenergic receptors, cholinergic receptors,
the skeletal muscles, the cardiovascular system, smooth muscles,
the blood circulatory system, synoptic sites, neuroeffector
junctional sites, endocrine and hormone systems, the immunological
system, the reproductive system, the skeletal system, autacoid
systems, the alimentary and excretory systems, the histamine system
and the central nervous system. Some examples of implantable drug
agents which may be delivered by devices according to embodiments
of the present disclosure are provided later in this description.
Therapeutic agents which may be delivered by devices according to
embodiments of the present disclosure include visualization agents,
radio-active agents, and radiation-protective agents. Therapeutic
agents need not necessarily be in molecular form (e.g., ethanol may
be preferred over molecular therapeutics to induce cytotoxicity for
the tumorous tissue). The therapeutic agent and/or formulation may
or may not have controlled-release or sustained-release, and may
instead be delivered as a bolus.
[0035] Various embodiments of the present disclosure provide a
"clip-on" component for drug-delivery suitable for use with an
ablation device, wherein the device architecture, configuration,
and manufacturing process for the ablation device does not need to
be modified. Various embodiments of the presently-disclosed
"clip-on" component for drug-delivery provide the capability to
deliver localized drugs or other payload for therapeutic and/or
visualization purposes.
[0036] FIG. 1 shows a drug-delivery device (shown generally as 10)
in accordance with an embodiment of the present disclosure and an
electrosurgical system (shown generally as 100) including an
ablation device 101. Drug-delivery device 10, which is described in
more detail later in this description, is adapted to allow the user
to selectively position a delivery lumen 70, e.g., for the delivery
of therapeutic agents, active pharmaceutical ingredients (APIs),
and/or contrast agent, in tissue. The delivery lumen 70 may be
either disposable or reusable.
[0037] Ablation device 101 includes an electrode array "E" and a
handle assembly 130. Electrode array "E" may include one or more
ablation electrodes 110. In some embodiments, as shown in FIG. 1,
the electrode array "E" includes three ablation electrodes 110
supported on and/or operatively connected to the handle assembly
130. The shape, size and number of ablation electrodes 110 of the
electrode array "E" may be varied from the configuration depicted
in FIG. 1.
[0038] Ablation device 101 is operatively connected via a
transmission line 150 to an electrosurgical power generating source
28, e.g., a microwave or radio frequency (RF) electrosurgical
generator. Power generating source 28 may be any generator suitable
for use with electrosurgical devices and may be configured to
provide various frequencies of energy. In some embodiments,
ablation device 101 is disposed in fluid communication with a
coolant source (not shown). Ablation device 101 may include first
and second conduits 151 and 152, respectively, to provide a first
fluid-flow path, e.g., leading to the ablation electrodes 110, and
a second fluid-flow path, e.g., leading away from the ablation
electrodes 110, configured to provide fluid flow of a coolant fluid
e.g., deionized water, or other suitable cooling medium, for
cooling at least the distal end portion 113 of the ablation
electrodes 110. Ablation device 101 may include additional, fewer,
or different components than shown in FIG. 1, depending upon a
particular purpose or to achieve a desired result.
[0039] In some embodiments, electrosurgical system 100 (also
referred to herein as ablation system 100) may include a controller
26 for controlling and/or monitoring the operating parameters of
the ablation system 100. In some embodiments, as shown in FIG. 1,
the controller 26 is communicatively-coupled to the electrosurgical
power generating source 28. Controller 26 may include any type of
computing device, computational circuit, or any type of processor
or processing circuit capable of executing a series of instructions
that are stored in a memory (not shown) associated with the
controller 26. Functions of the controller 26 may be integrated
with those of the electrosurgical power generating source 28 and/or
may be integrated with other components of the electrosurgical
system 100.
[0040] In some embodiments, a drug and/or contrast agent supply
line (not shown) may be provided to fluidly-couple the
drug-delivery device 10 to a source of the drug and/or contrast
agent delivery supply for supplying drugs and/or contrast agent to
the delivery lumen 70. A fluid-movement device may be fluidly
coupled between the source of the drug (and/or contrast agent) and
the delivery lumen 70, and the controller 26 may be
communicatively-coupled to the fluid-movement device. In some
embodiments, the controller 26 may be configured to control
operation(s) of the fluid-movement device, e.g., during an ablation
procedure based on one or more operating parameters of the
electrosurgical power generating source 28. Electrosurgical system
100 may additionally, or alternatively, include an imaging system
(not shown) capable of generating image data, and the controller 26
may be communicatively-coupled to the imaging system. In some
embodiments, the controller 26 may be configured to control
operation(s) of the fluid-movement device based, at least in part,
on data captured by the imaging system.
[0041] Drug-delivery device 10 includes an elongated, substantially
cylindrically-shaped shaft portion 12 defining a passageway 11 of
generally tubular shape configured to receive the delivery lumen 70
slideably moveably therein. Shaft portion 12 generally includes a
distal end portion 14 and a proximal end portion 16. A port 15 is
located at the distal-most tip of the distal end portion 14. The
proximal end portion 16 of the shaft portion 12 engages with an
opening 35 defined in the distal portion 34 of the body 30.
Although the passageway 11 is generally tubular-shaped, other
shapes can be used depending on the configuration of the shaft
portion 12. Shaft portion 12 may be formed of any suitable rigid
material, and may be either disposable or reusable.
[0042] Drug-delivery device 10 includes an actuator 40 operatively
coupled to the delivery lumen 70. In some embodiments, the actuator
40 includes a knob member 42. In some embodiments, as seen in FIGS.
1 and 5, the knob member 42 defines a channel 41 configured to
receive the delivery lumen 70 therethrough. As shown in FIG. 1, the
delivery lumen 70 is rotatable about a longitudinal axis "A-A"
defined through shaft 12, either manually or otherwise, by the
rotatable knob member 42. Actuator 40 may additionally, or
alternatively, include a device, e.g., an electric motor, capable
of reciprocally moving the delivery lumen 70. In some embodiments,
the controller 26 may be configured to control operation(s) of the
device, e.g., during an ablation procedure based on one or more
operating parameters of the electrosurgical power generating source
28.
[0043] Drug-delivery device 10 is configured to allow the user to
selectively position the delivery lumen 70, or portion thereof,
from within the shaft portion 12 of the drug-delivery device 10 to
outside the shaft portion 12. For ease of explanation and
understanding, the delivery lumen 70 is described below as
selectively positionable with respect to fixed structures, or
portions thereof, of the ablation device 101, e.g., in relation to
the distal end portion 113 of the ablation electrodes 110, and/or
in relation to the distal end 14 of the shaft portion 12 of the
drug-delivery device 10.
[0044] Delivery lumen 70 may be formed of any suitable material,
and may include one or more portions formed of a flexible material.
In some embodiments, as shown in FIGS. 3 and 6, the distal portion
74 of the delivery lumen 70 is formed of a flexible material
configured to bend in a curvilinear fashion. The curved or "bent"
distal portion 74 of the delivery lumen 70 allows for
maneuverability and access in and around the tumor and/or the
tumor-margin in a manner suitable for drug-delivery through the
delivery lumen 70. In some procedures, the distal portion 74 of the
delivery lumen 70 is that portion of the delivery lumen 70 intended
to be inserted into the tumor. The dimensions and/or the angle of
the bend at the distal portion 74 of the delivery lumen 70, which
is rotatably moveable about a longitudinal axis "A-A" (FIG. 1)
defined by the shaft portion 12 (shown in FIG. 1), may be selected
to enhance the maneuverability of the distal end of the delivery
lumen 70. In some embodiments, the distal portion 74 of the
delivery lumen 70 may be formed of a shape-memory material. For
example, shape-memory alloys may be used to induce a certain angle
of the bend at body temperature when delivery lumen 70 is
deployed.
[0045] In some embodiments, where the delivery lumen 70 is
disposable, replaceable and/or interchangeable, different
configurations of the delivery lumen 70 (e.g., varied dimensions
and angles for the distal end) may be used depending upon the needs
of the procedure and/or the preference of the surgeon.
[0046] In some embodiments, as shown in FIGS. 2 and 3, the
drug-delivery device 10 is adapted to allow the user to selectively
position the distal portion 74 of the delivery lumen 70 from at
least a first configuration, wherein the distal portion 74 of the
delivery lumen 70 is positioned proximal to the distal end portion
113 of the ablation electrodes 110, to at least a second
configuration, wherein at least a portion of the distal portion 74
of the delivery lumen 70 is positioned distally beyond the distal
end portion 113 of the ablation electrodes 110.
[0047] As shown in FIGS. 2 and 3, knob member 42 is selectively
moveable from at least a first configuration, wherein the distal
portion 74 of the delivery lumen 70 is positioned proximal to the
distal end 14 of the shaft portion 12 (FIG. 2), to at least a
second configuration, wherein at least a portion of the distal
portion 74 of the delivery lumen 70 is positioned distally beyond
the distal end 14 of the shaft portion 12 (FIG. 3).
[0048] Drug-delivery device 10 includes a body 30 configured to be
attachable to an energy-delivery device (e.g., ablation device 101
shown in FIG. 1). Body 30 may have various configurations. As seen
in FIGS. 1 and 4, body 30 includes a proximal portion 31, a distal
portion 34, and a contoured portion 33 disposed between the
proximal and distal portions 31 and 34, respectively. As best seen
in FIG. 4, the contoured portion 33 of the body 30 is configured to
engage with a contoured portion 133 of the ablation device 101.
[0049] Body 30 defines a body chamber 37 therein (FIG. 4) having an
interior space configured to accommodate one or more components of
the ablation device 101, e.g., a handle (e.g., handle assembly 130
shown in FIG. 1) or portion thereof. In some embodiments, the body
30 may include one or more internal walls (not shown) configured to
partition the body chamber 37 into one or more compartments. Body
30 may additionally, or alternatively, include an actuator (not
shown), such as a slideably moveable member, e.g., thumb-slide
actuator, adapted to allow the user to selectively
initiate/activate the delivery of drug and/or contrast agent
through the delivery lumen 70 to the tissue site.
[0050] Body 30 may be formed of any suitable material or
combination of materials by any suitable process. In some
embodiments, the drug-delivery device 10 may be adapted to be a
reusable device. Autoclavable materials may be used to form the
body 30, and/or other components of the drug-delivery device 10, to
provide for a sterilizable device. Body 30, or portions thereof,
may be formed from two housing halves (not shown). Each half of the
housing may include a series of mechanical interfacing components
(not shown) configured to matingly engage with a corresponding
series of mechanical interfaces (not shown) to align the two
housing halves to define therein the body chamber 37. It is
contemplated that the housing halves (as well as other components
described herein) may be assembled together with the aid of
alignment pins, snap-like interfaces, tongue and groove interfaces,
locking tabs, adhesive ports, etc., utilized either alone or in
combination for assembly purposes.
[0051] In some embodiments, as shown in FIG. 6, the body 30 is
configured to provide support for the shaft portion 12 wherein the
shaft portion 12 extends distally from the body 30 at a
predetermined angle, e.g., relative to a longitudinal axis of the
body 30, whereby the distal end 14 of the shaft portion 12 is
disposed within the perimeter defined by the distal end portion 113
of the three ablation electrodes 110.
[0052] FIG. 7 shows the drug-delivery device 30 of FIG. 1 including
an alternative embodiment of the drug-delivery lumen (shown as 70
in FIG. 1), shown in an extended position. The drug-delivery lumen
770 shown in FIGS. 7 and 8 includes a multi-lumen configuration. As
best seen in FIG. 8, the drug-delivery lumen 770 includes five
lumens 785, shown extending outwardly of the distal end 14 of the
shaft portion 12. The shape, size and number of lumens 785 of the
drug-delivery lumen 770 may be varied from the configuration
depicted in FIGS. 7 and 8.
[0053] FIG. 9 shows the drug-delivery device 10 of FIG. 1 and an
ablation device 900. Ablation device 900 includes a microwave probe
910 and a handle assembly 930. Ablation device 900 is configured to
be operatively connected via a transmission line 15 to an
electrosurgical power generating source (not shown in FIG. 9),
e.g., a microwave electrosurgical generator.
[0054] Drug-delivery device 10 includes a body 30 configured to be
attachable to an energy-delivery device (e.g., ablation device 900
shown in FIG. 9, or ablation device 101 shown in FIG. 1). As seen
in FIG. 9, the contoured portion 33 of the body 30 of the
drug-delivery device 10 is configured to engage with a contoured
portion 933 of the handle assembly 930 of the ablation device 900.
Body 30 may have various configurations, e.g., depending upon the
configuration of the handle assembly of the energy-delivery
device.
[0055] A variety of drug agents may be delivered by devices
according to embodiments of the present disclosure. Some examples
of drug agents which may be delivered by devices according to
embodiments of the present disclosure include chemotherapeutic
agents such as without limitation cisplatin, paclitaxel,
doxorubicin, fluorouracil, as well as other compounds such as
without limitation prochlorperzine edisylate, ferrous sulfate,
aminocaproic acid, mecamylamine hydrochloride, procainamide
hydrochloride, amphetamine sulfate, methamphetamine hydrochloride,
benzamphetamine hydrochloride, isoproterenol sulfate, phenmetrazine
hydrochloride, bethanechol chloride, methacholine chloride,
pilocarpine hydrochloride, atropine sulfate, scopolamine bromide,
isopropaniide iodide, tridihexethyl chloride, phenformin
hydrochloride, methylphenidate hydrochloride, theophylline
cholinate, cephalexin hydrochloride, diphenidol, meclizine
hydrochloride, prochlorperazine maleate, phenoxybenzamine,
thiethylperzine maleate, anisindone, diphenadione erythrityl
tetranitrate, digoxin, isofluorophate, acetazolamide,
methazolamide, bendroflumethiazide, chloropromaide, tolazamide,
chlormadinone acetate, phenaglycodol, allopurinol, aluminum
aspirin, methotrexate, acetyl sulfisoxazole, erythromycin,
hydrocortisone, hydrocorticosterone acetate, cortisone acetate,
dexamethasone and its derivatives such as betamethasone,
triamcinolone, methyltestosterone, 17-S-estradiol, ethinyl
estradiol, ethinyl estradiol 3-methyl ether, prednisolone,
17-oc-hydroxyprogesterone acetate, 19-nor-progesterone, norgestrel,
norethindrone, norethisterone, norethiederone, progesterone,
norgesterone, norethynodrel, aspirin, indornethacin, naproxen,
fenoprofen, sulindac, indoprofen, nitroglycerin, isosorbide
dinitrate, propranolol, timolol, atenolol, aiprenolol, cimetidine,
clonidine, imipramine, levodopa, chlorpromazine, methyldopa,
dihydroxyphenylalanine, theophylline, calcium gluconate,
ketoprofen, ibuprofen, cephalexin, erythromycin, haloperidol,
zomepirac, ferrous lactate, vincamine, diazepam, phenoxybenzamine,
diltiazem, mitrinone, capropril, mandol, quanbenz,
hydrochlorothiazide, ranitidine, flurbiprofen, fenufen, fluprofen,
tolmetin, alciofenac, mefenamic, flufenamic, difiuinal, nimodipine,
nitrendipine, nisoldipine, nicardipine, felodipine, lidoflazine,
tiapamil, gallopamul, amlodipine, mioflazine, lisinoipril,
enalapril, enalaprilat, captopril, ramipril, famotidine,
nizatidine, sucralfate, etintidine, tetratolol, minoxidil,
chlordazepoxide, diazepam, amitriptyline, and imipramine; opioids
such as meperidine, hydrocodone, oxycodone, and semi-synthetic
opioids such as oxymorphone, hydromorphone, opiates such as
morphine and codeine, opioid antagonists such as without limitation
naltrexone, nalbuphine, naloxone as well as opioid
agonist/antagonist compounds such as buprenorphine, and synthetic
analgesics such as methadone, tramadol, fentanyl and
sufentanil.
[0056] Some other examples of drug agents which may be delivered by
devices according to embodiments of the present disclosure include
vitamin and supplements such as vitamins B-12 (cyanocobalamin) and
D2, anti-virals such as without limitation acyclorvir and
zidovudine; proteins and peptides such as without limitation
insulin, colchicine, glucagon, thyroid stimulating hormone,
parathyroid and pituitary hormones, calcitonin, renin, prolactin,
corticotrdphin, thyrotropic hormone, follicle stimulating hormone,
chorionic gonadotropin, gonadotropin releasing hormone, bovine
somatotropin, porcine somatotropin, oxytocin, vasopressin, GRE,
prolactin, somatostatin, lypressin, pancreozymin, luteinizing
hormone, LHRH, LHRH agonists and antagonists, leuprolide,
interferons, interleukins, growth hormones such as human growth
hormone, bovine growth hormone and porcine growth hormone,
fertility inhibitors such as the prostaglandins, fertility
promoters, growth factors, coagulation factors, human pancreas
hormone releasing factor, analogs and derivatives of these
compounds, and pharmaceutically acceptable salts of these
compounds, or their analogs or derivatives. On the molecular level,
the various forms of the beneficial agent may include uncharged
molecules, molecular complexes, and pharmaceutically acceptable
acid addition and base addition salts such as hydrochlorides,
hydrobromides, acetate, sulfate, laurylate, oleate, and salicylate.
Examples of acidic compounds which may be delivered by devices
according to embodiments of the present disclosure include salts of
metals, amines or organic cations. Derivatives such as esters,
ethers and amides may also be used.
[0057] A drug agent for delivery by devices according to
embodiments of the present disclosure may be used alone or mixed
with other agents. A drug agent for delivery by the
presently-disclosed devices may include pharmaceutically acceptable
excipients, polymeric carriers and/or additional ingredients, such
as antioxidants, stabilizing agents, permeation enhancers,
polysaccharides, proteins, nucleotides like aptamers, and fatty
acids, etc., and fabricated into different forms, such as solution,
suspension, gel, colloidal dispersion like liposome, or micro- and
nano-particles for controlled delivery of the drug agent. A drug
agent for delivery by the presently-disclosed devices may include a
thermo-sensitive metal depositor or any such compound that
increases the sensitivity of the target tissue, e.g., tumor, to
ablation.
[0058] A drug agent for delivery by the presently-disclosed devices
may include a cryoablation agent, e.g., liquid nitrogen, and may
prove complementary to thermal ablation that uses electrosurgical
energy at RF or microwave frequencies.
[0059] The above-described devices provide to the capability to
operate with two or more different modalities (e.g., ablation and
drug delivery), without any fundamental change to the device
architecture, manufacturing process etc. for the ablation
device.
[0060] The above-described systems and drug-delivery devices
coupled to ablation devices may offer improved anti-cancer efficacy
with RF ablation (or microwave ablation) and localized drug
delivery capabilities integrated into a dual medical device. In
accordance with the above-described systems and ablation devices,
an approach is taken to deliver drug formulation(s) locally when
the anatomical access has already been obtained for the purpose of
RF or microwave ablation, which, in turn, presents the prospect of
reduced side-effects associated with systemic administration of the
same drug molecule(s).
[0061] In accordance with the above-described systems and ablation
devices, heat activated drugs may be delivered to the periphery of
the tumor, which may not get as hot as the center of the tumor, to
ensure adequate margins. The above-described systems and ablation
devices may be used to kill tumors from the inside out, wherein the
temperature at the periphery may not be high enough to destroy the
tumor through ablation (e.g., in some cases, requiring temperatures
of at least 55.degree. C.), but at high enough temperature (e.g.,
in some cases, temperatures of about 45.degree. C.) to activate one
or more drugs delivered by the above-described ablation devices,
which may take care of killing the tumor edges.
[0062] Although embodiments have been described in detail with
reference to the accompanying drawings for the purpose of
illustration and description, it is to be understood that the
inventive processes and apparatus are not to be construed as
limited thereby. It will be apparent to those of ordinary skill in
the art that various modifications to the foregoing embodiments may
be made without departing from the scope of the disclosure.
* * * * *