U.S. patent application number 14/538930 was filed with the patent office on 2015-05-21 for thoracoscopic methods for treatment of bronchial disease.
The applicant listed for this patent is Ethicon, Inc.. Invention is credited to Kevin Shaun Weadock.
Application Number | 20150141810 14/538930 |
Document ID | / |
Family ID | 52004070 |
Filed Date | 2015-05-21 |
United States Patent
Application |
20150141810 |
Kind Code |
A1 |
Weadock; Kevin Shaun |
May 21, 2015 |
Thoracoscopic Methods for Treatment of Bronchial Disease
Abstract
A method and apparatus for treatment of pulmonary conditions,
including a device having an end effector sized and shaped to
contact a nerve component on the exterior of a bronchial segment
and apply energy to that nerve component.
Inventors: |
Weadock; Kevin Shaun;
(Hillsborough, NJ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Ethicon, Inc. |
Somerville |
NJ |
US |
|
|
Family ID: |
52004070 |
Appl. No.: |
14/538930 |
Filed: |
November 12, 2014 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
61905971 |
Nov 19, 2013 |
|
|
|
Current U.S.
Class: |
600/424 ; 600/3;
606/14; 606/169; 606/27; 606/28; 606/33; 606/41; 606/49 |
Current CPC
Class: |
A61B 2018/1422 20130101;
A61B 2018/142 20130101; A61B 18/18 20130101; A61B 2018/144
20130101; A61B 18/1445 20130101; A61B 18/1815 20130101; A61B
2018/044 20130101; A61B 18/20 20130101; A61N 2007/003 20130101;
A61B 18/085 20130101; A61N 5/1014 20130101; A61B 90/361 20160201;
A61B 2018/00642 20130101; A61B 2018/00541 20130101; A61B 18/04
20130101; A61B 2018/00613 20130101; A61N 7/02 20130101; A61B
2018/00434 20130101; A61B 2018/1435 20130101; A61B 2018/1861
20130101 |
Class at
Publication: |
600/424 ; 606/41;
606/28; 606/27; 606/169; 606/49; 606/33; 606/14; 600/3 |
International
Class: |
A61B 18/14 20060101
A61B018/14; A61N 7/00 20060101 A61N007/00; A61N 5/10 20060101
A61N005/10; A61B 18/18 20060101 A61B018/18; A61B 19/00 20060101
A61B019/00; A61B 18/04 20060101 A61B018/04; A61B 18/20 20060101
A61B018/20 |
Claims
1. A method of treating pulmonary disease comprising the steps of:
a. inserting an apparatus into a thoracic cavity of a patient by
passing at least a portion of its length in a location selected
from: through adjacent ribs, above the sternum, or through the
chest wall of the patient, said apparatus having an end effector
and a source of energy secured thereto; aligning said end effector
proximal to or in contact with a nerve component present on a
bronchial segment; and, applying energy from said source of energy
through said end effector to said nerve component.
2. The method of claim 1, wherein said end effector has two
semi-circular shapes that align to form a central pathway and sized
to contain a bronchi therewithin.
3. The method of claim 1, wherein said end effector includes two
components moveable with respect to each other which may be
configured to contact an outer surface of a bronchial segment
therebetween.
4. The method of claim 1, wherein said end effector is deformable
or pliable so as to be wrapped about at least a portion of the
bronchial segment.
5. The method of claim 1, wherein said end effector comprises a
material on its surface to conform to the surface of a bronchial
segment.
6. The method of claim 1, further comprising the step of inserting
said apparatus into the body of a patient through a trocar or
through a delivery port.
7. The method of claim 6, wherein said end effector is compressed
to a reduced diameter when inserted through said catheter or
delivery port, and expands upon exit from said catheter or delivery
port.
8. The method of claim 1, wherein said method comprises video
assisted thoracoscopic surgery techniques.
9. The method of claim 1, wherein said end effector substantially
surrounds said bronchial segment.
10. The method of claim 1, wherein said end effector applies energy
in the form of heated elements or electrodes, heated fluid such as
gas or liquid, ultrasonic energy, including low-energy ultrasound
or high intensity focused ultrasound, harmonic energy, direct
current or cauterization exposure, electromagnetic energy,
radiofrequency energy, microwaves, plasma energy, infrared,
non-ionizing optical energy such as laser treatment, including
pulsed laser, fractional laser, or high energy laser exposure,
other radiation energy including alpha, beta, gamma, x-ray, proton,
neutron, or ionic radiation.
11. The method of claim 1, wherein said application of energy
results in increased temperature, and said temperature is about
65.degree. C. or higher.
12. An apparatus for treating pulmonary disease comprising: a. an
extended body having a proximal end and distal end; b. an end
effector at the distal end; c. An energy source to provide energy
to said end effector; wherein said end effector is sized and shaped
to be passed into the thoracic cavity of a patient and to contact a
nerve component located on at least a portion of a bronchial
segment and apply energy to the exterior surface of said bronchial
segment to treat said nerve component.
13. The apparatus of claim 12, wherein said end effector has at
least one semi-circular shape sized to contain bronchial segment
therein.
14. The apparatus of claim 12, wherein said end effector includes
two components moveable with respect to each other which may be
configured to contact an outer surface of a bronchial segment
therebetween.
15. The apparatus of claim 12, wherein said end effector is
deformable or pliable so as to be wrapped about at least a portion
of the bronchial segment.
16. The apparatus of claim 12, wherein said end effector comprises
a material on its surface to conform to the surface of the
bronchial segment.
17. The apparatus of claim 12, wherein said apparatus may be
compressed so as to be inserted into the body of a patient through
a catheter or delivery port.
18. The apparatus of claim 12, wherein said end effector applies
energy in the form of heated elements or electrodes, heated fluid
such as gas or liquid, ultrasonic energy, including low-energy
ultrasound or high intensity focused ultrasound, harmonic energy,
direct current or cauterization exposure, electromagnetic energy,
radiofrequency energy, microwaves, plasma energy, infrared,
non-ionizing optical energy such as laser treatment, including
pulsed laser, fractional laser, or high energy laser exposure,
other radiation energy including alpha, beta, gamma, x-ray, proton,
neutron, or ionic radiation.
19. The apparatus of claim 12, wherein said energy may be applied
through a plurality of electrodes in said end effector.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to methods and devices for
treatment of bronchial diseases, including asthma or chronic
bronchitis. The invention more directly relates to methods of
providing energy to one or more nerves on or near the bronchi and
more particularly, application of energy to these nerves through
thoracoscopic means.
BACKGROUND
[0002] Obstructive pulmonary disease affects millions of
individuals in the United States, limiting enjoyment of life and
costing billions of dollars to treat. One such disease is asthma,
which is a complex inflammatory disorder of the airways
characterized by airway hyperresponsiveness and variable airflow
obstruction. According to recent estimates, the annual cost of
asthma alone is estimated to be nearly $18 billion. Direct costs
accounted for nearly $10 billion (hospitalizations being the single
largest portion of direct cost) and indirect costs of $8 billion
(lost earnings due to illness or death). For adults, asthma is the
fourth leading cause of work absenteeism, resulting in nearly 15
million missed workdays each year (this accounts for nearly $3
billion of the "indirect costs" shown above). Among children ages 5
to 17, asthma is the leading cause of school absences from a
chronic illness. It accounts for an annual loss of more than 14
million school days per year (approximately 8 days for each student
with asthma) and more hospitalizations than any other childhood
disease. A person suffering from an asthma "attack" experiences an
acute constriction of the smooth muscles lining the bronchi (the
passageway for air to get into the lungs), reducing the airway and
limiting air flow. Asthma has traditionally been treated through
the use of bronchodilation medication, which opens the airway by
dilating the bronchi. This, of course, is a short-term solution to
a chronic problem. Other pulmonary diseases include, for example,
emphysema and chronic bronchitis, which are both considered Chronic
Obstructive Pulmonary Diseases (COPD).
[0003] Constriction of the bronchial airway is often caused by the
firing or activity of nerves, such as in response to an external
stimulus or allergen. These nerves are part of the autonomic
nervous system, and the nerves to the lungs derive from the vagus
nerves near the pulmonary plexuses. The vagus nerves generally run
roughly parallel to or lateral to the esophagus and trachea, while
the plexuses are in turn further lateral than the vagus nerves. The
plexuses lie on or near the main bronchi near their bifurcation,
and the nerves follow the branching of the bronchial tree within
the lung parenchyma.
[0004] Medications have been provided to treat bronchial
constriction, but unfortunately these medications are only
short-term solutions and may be difficult for children and elderly
individuals to take. In addition to medication, other therapies
have been attempted. One such therapy includes implanting a signal
generator to block signals to the bronchus, which inhibits nerve
traffic and relieves contraction. This, however, includes the use
of an implantable device, which may have complications with
implantation and maintenance, among other issues. Bronchial
thermoplasty is another therapy that has recently been explored.
Bronchial thermoplasty targets the airway smooth muscles or nerves
by inserting a bronchoscope into the patient's airway and
delivering radiofrequency (RF) energy to the airway wall, thereby
reducing the amount of smooth muscle associated with asthmatic
constriction. Since it is difficult to control the deposition of
energy to a particular layer of the bronchial wall, attempts to
deliver RF energy specifically to the smooth muscle cell layer may
inadvertently damage the mucosa or nerves on the surface of the
bronchi.
[0005] Breathing is automatic, and is controlled by the central
nervous system. The peripheral nervous system, in contrast,
includes both sensory and motor components. The peripheral nervous
system conveys and integrates signals from the environment to the
central nervous system. The neurons of the peripheral nervous
system transmit signals from the periphery to the central nervous
system. The lung, for example, is innervated by the peripheral
nervous system, which is under central nervous system control. One
particular type of stimulation is of the parasympathetic system
(constriction). Stimulation of the parasympathetic system leads to
airway constriction, blood vessel dilation, and increased glandular
secretion. The parasympathetic innervation of the lung originates
from the medulla in the brain via the vagus nerve. The vagus nerve
descends and forms ganglia at and around the bronchi.
Postganglionic fibers from the ganglia then complete the network by
innervating smooth muscle cells, blood vessels, and bronchial
epithelial cells. Parasympathetic stimulation through the vagus
nerve is responsible for the slightly constricted smooth muscle
tone in the normal resting lung.
[0006] Stimulation of the parasympathetic system causes bronchi or
bronchial tubes to constrict, whereas stimulating the sympathetic
nervous system produces the opposite reaction (dilation). Disposed
around the outer surface of the bronchi are a series of
parasympathetic nerves, which gather into a ganglion or plexus.
These plexuses lie on or near the main bronchi near their
bifurcation, and the nerves follow the branching of the bronchial
tree within the lung parenchyma. These bronchial nerves are
associated with the vagus nerve, and cause the swelling and
inflammation associated with an asthmatic response. Vagal
stimulation can also lead to an increase in the activity of the
parasympathetic reflex control of the airways, which contributes to
greater mucus secretion and bronchial smooth muscle contraction.
Thus methods and devices that inhibit or prevent such stimulation
may have an additional beneficial effect of reducing symptoms
associated with asthma and chronic bronchitis.
[0007] It follows that attempts to bronchoscopically apply RF
energy to nerves on the external surface of the bronchi may
unintentionally damage the mucosa and smooth muscle cells as well.
Therefore, even in seemingly successful bronchial thermoplasty
treatments, the patient's recovery time is extended due to the
damages to the mucosal wall of the bronchi. In fact, patients
undergoing this procedure frequently experience several weeks of
discomfort before they may experience relief. The present invention
seeks to treat pulmonary diseases such as asthma and chronic
bronchitis through the use of procedures and devices that apply
energy to nerves on the external surface of the bronchi through
thoracoscopic methods.
SUMMARY
[0008] In one embodiment of the present invention, there is
provided an apparatus for treating pulmonary disease including, the
apparatus including an extended body having a proximal end and
distal end; an end effector at the distal end; and an energy source
to provide energy to the end effector; where the end effector is
sized and shaped to contact a nerve located on at least a portion
of a bronchial segment and to apply energy to a nerve on the
exterior surface of the bronchial segment.
[0009] In another embodiment of the invention, there is provided a
method of treating pulmonary disease including the steps of:
thoracoscopically inserting an apparatus into the thoracic cavity
of a patient, the apparatus coupled to an energy source and having
an end effector secured thereto; aligning the end effector proximal
to or in contact with a nerve component present on or near an
exterior surface of a bronchial segment; and, applying energy
through the end effector to the nerve component.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 shows the cross-section of a bronchus.
[0011] FIG. 2 is a depiction of the autonomic nervous system as it
affects the bronchi.
[0012] FIG. 3 is a depiction of one embodiment of an
energy-applying apparatus of the invention.
[0013] FIGS. 4A, 4B and 4C are alternate embodiments of an
energy-applying apparatus of the invention.
[0014] FIG. 5 is a depiction of the pulmonary system of a
human.
[0015] FIG. 6 is a depiction of a surgical procedure using the
energy-applying apparatus of the invention.
[0016] FIGS. 7A-7B show an alternate embodiment of the present
invention including a wrappable end effector applying microwave
energy to a nerve on an external surface of a bronchus.
[0017] FIGS. 8-8A show an alternate embodiment of the present
invention including a wrappable end effector applying
radiofrequency energy to a nerve on an external surface of a
bronchus.
[0018] FIG. 9 is an exemplary external powered device useful in the
present invention.
DETAILED DESCRIPTION
[0019] FIG. 1 shows a cross-sectional view of a bronchus, with a
number of its features labeled for reference. The open inner
channel (having diameter labeled as D in the Figure) forms the
pathway for air to travel from a person's mouth or nose to the
lungs. As can be seen, the walls of the bronchus include a number
of components, such as the epithelium, blood vessels, smooth muscle
tissue, mucous glands, nerve fibers, stroma and cartilage. The
nerves or nerve components to be treated through the present
invention are located towards the outer surface of the bronchial
wall (e.g., away from its open inner channel).
[0020] FIG. 2 is a depiction of the autonomic nervous system as it
controls the pulmonary system of a person. Extending from the brain
is the Vagus nerve, which synapses with parasympathetic ganglion on
the bronchi surface. There is a series of parasympathetic nerve
components forming a parasympathetic ganglion on the surface of the
bronchi, which include post-ganglionic fibers.
[0021] The present invention seeks to treat the undesirable and
dangerous constriction of muscles of the bronchi that may occur in
patients with asthma or chronic bronchitis by disruption, ablation
or severing of at least one bronchial nerve component. As used
herein, a nerve component is any portion of a nerve that is sought
to be treated, and may include a nerve, a ganglion or plexus
present on or near the external surface of the bronchi. Most
desirably, the nerve component to be treated is a plexus, and
particularly the plexus located around the periphery of one
bronchi. Since there is more than one nerve component surrounding
the outer surface of a bronchi, the treatment may include
application of energy around a region of the surface of the
bronchi, and may include treatment to a region completely covering
a circumference of a bronchi. The treatment may include application
of energy to one nerve, multiple nerve components, or all nerve
components around a circumference of a region of a bronchi.
[0022] As used herein, the terms "proximal" and "distal" are used
with reference to a clinician manipulating one end of an instrument
used to treat the bronchial diseases. The term "proximal" refers to
the portion of the instrument closest to the clinician and the term
"distal" refers to the portion located furthest from the clinician.
It will be further appreciated that for conciseness and clarity,
spatial terms such as "vertical," "horizontal," "up," and "down"
may be used herein with respect to the drawings. However, surgical
instruments may be used in many orientations and positions, and
these terms are not intended to be limiting and absolute.
[0023] As will be discussed below, the invention provides a method
and apparatus for treatment of asthma and other related respiratory
disorders, e.g., chronic bronchitis. The apparatus includes an
elongated device, having a proximal end and a distal end, where
there is an end effector located at or near the distal end of the
elongated device. The end effector is designed to provide energy to
a surface in which it is in contact, such as the outer surface of
the bronchi. The proximal end may optionally include a handle or
other control means, as will be discussed below. The inventive
energy-providing device is intended to be inserted into the body of
the patient such that the end effector is in contact with the outer
surface of the bronchi, allowing the end effector to contact one or
more bronchial nerves and apply energy to the one or more bronchial
nerves. This energy may be sufficient to ablate, disrupt, achieve
cell necrosis, or simply sever the bronchial nerves.
[0024] Nerves are sensitive to heat and mechanical vibration, so
various energy types may be used to achieve the desired result. For
example, application of heat through a heated element, such as a
heated tip or instrument, or use of a bladder filled with heated
fluid may be used. In addition, mechanical vibration such as
ultrasonic energy or radiofrequency energy may be used to provide
the desired result. Radiation, such as infrared, microwave, or
other levels of radiant energy may also be used. In general, any
desired energy type may be applied to the surface of at least one
nerve, ganglion or plexus. Non-limiting types of energy to be
applied include heated elements or electrodes, heated fluid such as
gas or liquid, ultrasonic energy, including low-energy ultrasound
or high intensity focused ultrasound (HIFU), harmonic energy,
direct current (DC) or cauterization exposure, electromagnetic
energy, radiofrequency energy, microwaves, plasma energy, infrared,
non-ionizing optical energy such as laser treatment, including
pulsed laser, fractional laser, or high-energy laser exposure,
other radiation energy including alpha, beta, gamma, x-ray, proton,
neutron, or ionic radiation. The temperature level applied to the
nerve component to be treated should be such that the nerve
component is treated but that adjacent tissue is not damaged, or at
least that the damage level is minimized. In some embodiments, the
energy that is applied by the end effector is sufficient to heat
the nerve to about 65.degree. C. The energy application methods may
alternatively include exposure to cold temperatures, such as
cryosurgical methods. Energy may also include simple mechanical
energy such as the use of a blade or blades positioned on or near
the end effectors to cut the nerve or nerves. Targeted application
of energy effectively treats the nerves, ganglions or plexuses with
minimal damage to other structures such as vessels, tissue,
muscles, or mucosa.
[0025] In some embodiments, the methods of treatment included
herein may include the introduction or deposition of certain
materials to the target area, including, for example, neurotoxins
or other similar nerve-damaging materials. One such material that
can be delivered to the target nerve component is
onabotulinumtoxinA (commonly known as BOTOX.RTM.). Through the use
of controlled delivery means such as those described herein for the
delivery of energy, delivery of such neurotoxins can be useful in
treating the intended nerve component(s). Delivery of such
materials can be achieved through use of devices and methods
described herein.
[0026] The present invention and methods of controlled application
of energy to the outer surface of the bronchi, applying targeted
energy to the nerve, ganglion, or plexus desired provides a number
of benefits to the user. First and foremost, the application of
energy is highly targeted and precise due to the visual ability of
users to view the instruments and nerves on the bronchi through
thoracoscopic means as opposed to the lack of visual ability
through the use of bronchoscopic methods. Further, due to the
ability to apply energy directly to the desired nerve segment, as
opposed to traveling through the bronchi and its various branches
and then having to deliver the energy across different tissue
layers within the bronchial wall (mucosa, muscle, etc.), there is
much less collateral damage to other tissues and bodily components.
This provides for a much quicker and less painful recovery
process.
[0027] The present invention provides an apparatus and method that
can treat pulmonary conditions through contacting the exterior
surface of the bronchi, as opposed to previously used methods that
insert an apparatus through the patient's airway. As such, the
inventive methods may be performed through the use of novel
thoracoscopic devices adapted to engage the exterior bronchial
wall. In such methods, at least one elongated device is inserted
through the chest of the patient, and more particularly through a
pair of the patient's ribs or in a notch above the sternum. In some
embodiments, the apparatus to be inserted may be inserted through a
trocar, while in other embodiments, the device may be inserted into
the patient's body without the use of a trocar other loading
device. The thoracoscopic methods used herein may include the
insertion of multiple elongated devices, and may incorporate the
techniques known as video assisted thoracoscopic surgery (VATS) or
mediastinoscopy. The use of such thoracoscopic methods allows for a
user or users to be able to visually see the interior of the
patient's thoracic cavity, giving a significantly more targeted and
precise surgical technique. As explained above, this allows a user
to apply energy or other agents to the nerves, ganglion or plexus
around the outside of the bronchi. More than one elongated device
may be inserted into the patient during the procedure, including
the inventive device having an energy-providing end effector, a
camera, atraumatic retractors to help move and/or manipulate lungs,
and other devices that may help with identification of the nerve to
be treated.
[0028] In a VATS technique, each device to be inserted may have an
elongated profile with a length and diameter suitable to meet the
needs of its use. For example, the method may incorporate the use
of an endoscope. Depending on its use and medical discipline, an
endoscope may be between 4 cm and 200 cm long. Endoscopes may be
rigid or flexible and may have a diameter of from about 2
millimeters to about 15 millimeters, and more particularly about
3-5 millimeters. The elongated devices should have a small enough
diameter so as to be insertable through the patient's ribs or chest
wall, and to prevent significant trauma to the nerves that travel
along the bottom edge of each rib. In addition, each device may
have enough flexibility so as to allow maximum mobility inside the
chest without putting pressure on the ribs. Thoracosurgical methods
allow for smaller incisions into the patient's body, which results
in reduced post-operative pain, speed recovery, and provide a
superior cosmetic result.
[0029] With the patient sedated or anesthetized, and lying
comfortably on his or her side, a small incision may be made near
the tip of the scapula, or wing bone, on the back. Into this
incision, an elongated device may be inserted. For example, a
catheter or trocar may be inserted, into which the inventive
energy-providing device may be inserted, or alternatively, an
introducer may be placed into the chest cavity and air may be
introduced into the space around the lung. Although not required,
by introducing air, the space around the lung is enlarged, making
the lung smaller and allowing for easier treatment. As the lung
becomes smaller inside the chest, the surgeon can see more of the
structures on and around the lung, including the bronchi. When an
adequate space has developed, a small incision is made below the
armpit of the patient, and device may be placed into the patient's
body. In addition, another incision may be made on the lower chest
wall in order to insert surgical devices and/or a drain into the
body of a patient. The use of multiple incisions and insertion of
multiple elongated devices allows for proper treatment and gives
sufficient vision to the surgeon(s) treating the patient. In one
embodiment, an endoscope may be inserted through a port near the
tip of the scapula, allowing the surgeon to see the apex of the
lung. A grasper may be inserted below the armpit, to grasp the apex
of the lung. The inventive energy-providing device may be inserted
into any desired incision point that gives access to the desired
nerve plexus. As noted above, any of the devices may be used and
inserted into any desired location on the body, including through a
notch formed above the sternum, between ribs, into the back or
shoulder, or through any other bodily location.
[0030] The location, number, and size of small incisions may vary,
which depends upon the number of devices to be inserted into the
body of the patient.
[0031] The energy-applying device of the present invention may take
various shapes and configurations. In some embodiments, the device
may include an end effector that has a semi-circular configuration
designed to contact the outer surface of a bronchus within its
semi-circular opening. In some embodiments, the end effector may
include two end components that are movable with respect to each
other so as to contact the outer surface of the bronchi
therebetween. Such configurations may, for example, include two
opposing c-shaped ends, which are each articulatable about a hinge
and come together to form a circular or elliptical opening. In
other embodiments, the device's end may be pliable or deformable so
as to wrap about the outer surface of the bronchi, such as in a
helical or other configuration, whereby the surface of the wrapped
end contacts the outer surface of the bronchi. In any embodiment,
at least a portion of the end effector of the device is in
substantial contact with the outer surface of the bronchi and is
capable of delivering energy to the surface of the bronchi and, in
turn, to the nerve component(s) to be treated thereon. In some
embodiments, the device has articulation means located at at least
one location along its shaft to facilitate reaching the targeted
nerve or ganglion on the bronchi. For example, the device may
include a region or regions allowing for rotation and/or
articulation, as will be described below.
[0032] With reference to FIG. 3, one embodiment of an
energy-applying device of the present invention is depicted. As can
be seen, the device 100 includes an elongated shaft 110, which may
have any cross-sectional configuration, including a circular or
elliptical cross-section. The shaft 110 extends for any desired
length, but preferably between 0.5 and 2 feet long, from a proximal
end 120 to distal end 130. The length of the shaft 110 should be
sufficient to allow for insertion of the distal end 130 into the
body of a patient so as to contact the targeted nerve on a bronchi,
while still leaving a sufficient length of the shaft outside of the
patient's body for control and manipulation by the clinician. The
distal end 130 of the device 100 includes an end effector 140,
which will be described in greater detail below. The device 100 may
include a region 150 or multiple regions along the shaft 110 which
may articulate or rotate, if desired. Further, the shaft 110 may be
substantially rigid in a curved or straight configuration. In one
embodiment, at least a portion of the shaft 110 may be flexible. In
this embodiment, the end effector 140 has at least one electrode
associated in or on the end effector that is coupled through the
shaft 110 and out the handle 125 of the device 100 to a power
supply (not shown). The device may include an on-off switch or
button 135, or it may include other means of powering on and off
the device, if desired.
[0033] The shaft 110 of the device 100 may also be configured and
sized to permit passage through the working lumen of a commercially
available endoscope. However, the device may also be advanced into
the body without an endoscope in a minimally invasive procedure or
in an open surgical procedure, and with or without the guidance of
various vision or imaging systems.
[0034] FIGS. 4A and 4B show two different embodiments of end
effectors (end effector 140 in FIG. 4A, end effector 145 in FIG.
4B), depending upon the type of energy used to treat the targeted
nerve on the surface of the bronchi. It will be appreciated that
these embodiments are two possible shapes, sizes, and types, and
that alternate shapes, sizes and configurations are within the
scope of the present invention. In one embodiment, the end
effectors may be rotatable about the point R, such as seen in the
various embodiments depicted in FIGS. 4A and 4B. For example, as
seen in FIG. 4A, the end effector itself may be rotatable about the
point R, and in FIG. 4B, the individual contact components may be
independently rotatable.
[0035] The device 100 includes a shaft 110 and an end effector 140
(or end effector 145 in FIG. 4B) at its distal end 130. In both
FIGS. 4A and 4B, the end effector 140, 145 includes a first contact
component 160A and second contact component 160B, which are
depicted as being substantially C-shaped or semi-circular
components, but other shapes and configurations may be used. The
first and second contact components 160A and 160B are movable with
respect to each other and capable of being compressed such that
they form a substantially circular or elliptical shape. In one
embodiment, one of the first or second contact components is fixed
with respect to the shaft 110 and the other contact component is
movable with respect to the shaft or the other contact component.
The device 100 may include a hinge 165, for example, which allows
the contact components 160A or 160B to be articulated with respect
to each other. It will be noted that when the two contact
components 160A and 160B are moved toward each other, they form an
open interior into which a bodily lumen, such as bronchi, can be
engaged. Each contact component 160A and 160B includes a contact
surface, which is intended to substantially contact the outer
surface of the bronchi for treatment of the nerve component(s)
thereon.
[0036] In some embodiments, the energy-applying devices described
herein may utilize electrodes to provide electrical energy to the
nerve component(s) to be treated. In electrical-energy-applying
devices, the end effector may include a series of electrodes having
an electrically conductive portion (e.g., medical grade stainless
steel) and may be coupled to an energy source. The device may
include sharpened edges that contact the outer surface of the
bronchi and, more particularly, contact one or more nerve component
to be treated. These sharp edges may be configured to deliver a hot
cut when energy, such as radiofrequency energy, is applied.
[0037] Once the electrodes are positioned proximal to the treatment
region, an energizing potential is applied to the electrodes to
deliver electric current to the treatment region to treat the nerve
components. The electric current may be supplied by an external
energy source having a control unit or generator. Energy sources
such as those described in U.S. Pat. No. 7,200,445, the content of
which is incorporated herein in its entirety, may be used. The
energizing potential (and the resulting electric current) may be
characterized by a particular waveform in terms of frequency,
amplitude, pulse width, and polarity. The electrode may be
configured as either an anode (+) or a cathode (-) or may comprise
a plurality of electrodes with at least one configured as an anode
(+) and the at least one another one configured as the cathode (-).
Regardless of the initial configuration, the polarity of the
electrodes may be reversed by reversing the polarity of the output
of the energy source. The electrodes may be energized with DC
voltages and conduct currents at various frequencies, amplitudes,
pulse widths, and polarities. The electrodes also may be energized
with time-varying voltages and currents at amplitudes and
frequencies suitable for rendering the desired therapy. A suitable
energy source may comprise an electrical waveform generator adapted
to deliver DC and/or time-varying energizing potentials
characterized by frequency, amplitude, pulse width, and/or polarity
to the electrodes. The electric current flows between the
electrodes and through the target nerve component(s) proportionally
to the potential (e.g., voltage) applied to the electrodes. In one
embodiment, the energy source may comprise a wireless transmitter
to deliver energy to the electrodes via one or more antennas.
[0038] In one embodiment, the energy source may be configured to
produce pulsed or cyclical electrical signals to electrically treat
nerve component(s) with the energy-applying device. In one
embodiment, a timing circuit may be used to interrupt the output of
the energy source and generate a pulsed output signal. The timing
circuit may comprise one or more suitable switching elements to
produce the pulsed output signal. For example, the energy source
may produce a series of n pulses (where n is any integer) suitable
to treat the nerve component(s) when the pulsed energy is applied
to the electrodes in the end effector. The pulses may have a fixed
or variable pulse width and may be delivered at any suitable
frequency.
[0039] In one embodiment, the energy source may be configured to
produce electrical output waveforms at predetermined frequencies,
amplitudes, polarities, and/or pulse widths to electrically treat
the nerve component(s) with the energy-applying device. When the
electrical output waveforms are applied to the electrodes, the
resulting electric potentials cause currents to flow through the
distal end of the device (at end effector) to treat nerve
component(s).
[0040] In one embodiment, the energy source may be configured to
produce radio frequency (RF) waveforms at predetermined
frequencies, amplitudes, polarities, and pulse widths to
electrically treat nerve component(s) with the energy-applying
device. The energy source may comprise a commercially available
conventional, bipolar/monopolar electrosurgical RF generator such
as Model Number ICC 350, available from Erbe, GmbH.
[0041] In FIG. 4A, the end effector 140 includes electrical contact
surfaces 170A and 170B. A first contact surface 170A is located on
the interior surface of first contact component (160A). A second
contact surface 170B is located on the interior surface of second
contact component (160B). The size of the contact surface may be
modified to allow for the desired amount of contact with the
bronchial wall. In one embodiment, the electrical contact surfaces
170A and 170B are electrodes of opposite polarity so that bipolar
RF energy can be delivered to the target nerve or ganglion. In one
embodiment, the electrical contact surfaces 170A and 170B are
electrodes of similar polarity, i.e., they form an active
electrode. A return electrode in the form of a grounding pad placed
on the surface of the patients skin is coupled to the power supply
so that monopolar RF energy can be applied to the targeted nerve or
ganglion. In one embodiment, the electrical contact surfaces 170A
and 170B are resistive elements that enable resistive heating of
the targeted nerve or ganglion.
[0042] In FIG. 4B, an end effector 145 includes bladder contact
surfaces 175A and 175B into which heated fluid such as water, air,
or other liquid or gas may be introduced. In this figure, both
surfaces 175A and 175B are bladder contact surfaces, but it is
understood that it may be useful if only one surface is a bladder
contact surface, and the other surface is not a bladder surface.
Introduction of heated media such as gas, water, steam, or oil is
accomplished by way of conduits which are fluidly coupled from the
bladder to a source of heated media coupled to the proximal end of
the device. In one embodiment, coupling and delivery of fluid or
other media is accomplished by connection of the bladder contact
surfaces 175A and 175B with a tube 185 housed within the shaft 110
of the device, the tube 185 ending at a port 186 on the proximal
end of the device. The port 186 can be in the form of a luer lock
fitting or other quick connect means known to those skilled in the
art of coupling fluids through tubes and other compartments. The
size of the contact surfaces 175A and 175B may be modified to allow
for the desired amount of contact with the bronchial wall. In an
embodiment including bladder contact surface(s), at least one
opening is present on the surface of the bladder contacting
surfaces 175A and 175B to allow for elution of neurotoxins from the
contacting surfaces. A source of neurotoxin is coupled to the
proximal end of the device and the toxin can be injected through
the tube and into the bladder where it can leave the bladder and
treat the targeted nerve or ganglion.
[0043] FIG. 4C illustrates another embodiment of the present
invention in which contact surfaces 195A and 195B include at least
one blade 197 capable of transecting the nerve targeted for
treatment. In one embodiment the blades are embedded in a rigid
polymeric backing 196. The blade or blades 197 may be made of any
material, including, for example, stainless steel. The blade or
blades 197 may have a height, relative to the surface of the
polymer backing, of between 1 and 3 mm. The opposing surface may
include an anvil 198 or other component against which the blade 197
may contact, and may include a second blade or blades if
desired.
[0044] The device 100 may optionally include a handle 190 or other
control means at its proximal end 120, which may include a control
mechanism to manipulate the device 100 and the end effector 140.
For example, a trigger may be provided that is coupled to a
ratcheting mechanism or cable driven mechanism to move one or more
contact components 160A or 160B with respect to each other once in
place or may include mechanisms to wrap the end effector about the
bronchi. Wires 195 may extend through the proximal end 120 and
optionally through the handle 190 so as to provide energy to the
end effector 140. A power supply is not shown but known power
supply sources may be used in the present invention including those
described in U.S. Pat. No. 7,200,445, incorporated by reference
above. In one embodiment, the power supply includes an energy
generator, a controller coupled to the energy generator, and a user
interface surface in communication with the controller. Although
variations of the device shall be described as RF energy delivery
devices, variations of the device may include resistive heating
systems, infrared heating elements, microwave energy systems,
focused ultrasound, cryoablation, or any other energy delivery
system. Additionally, the device may include a connector common to
such energy delivery devices. The connector may be integral to the
end of a cable as shown, or the connector may be fitted to receive
a separate cable. In any case, the device may be configured for
attachment to the power supply via some type connector. The power
supply may have connections for the device, return electrode (if
the system employs a monopolar RF configuration), and optionally an
actuation pedal(s). The power supply and controller may also be
configured to deliver RF energy to an end effector having
electrodes configured for bipolar RF energy delivery. The user
interface may also include visual prompts for user feedback
regarding setup or operation of the system. The user interface may
also employ graphical representations of components of the system,
audio tone generators, as well as other features to assist the user
with system use. A wireless energy supply may be provided through
the use of one or more antennas in the device 100 or an internal
energy supply source may be used.
[0045] Referring again to FIGS. 4A-4C, the end effector 140 may
include only one contact component 160A and may have only one
contact surface 170A (or 175A, for example). The end effector 140
may have a substantially C-shaped or semi-circular contact
component 160A, or it may have any desired shape.
[0046] The end effector 140 may be collapsible, so as to provide
the device 100 with a narrow profile and therefore aid in insertion
of the device through a trocar and into the body of the patient.
For example, the end effector 140 may be spring-loaded, such that
it may be compressed when the distal end 130 is inserted into a
trocar, and may spring open when it exits through the distal end of
the trocar. Conversely, the end effector may collapse when being
pulled back through the trocar and then expand again upon exiting
the patient. In one embodiment, one or both of the end effectors
may include a shape memory alloy, such as nitinol. The end
effectors could then have a first configuration and a second
configuration.
[0047] The contact surfaces 170A and 170B illustrated in FIG. 4A or
175A and 175B in FIG. 4B may include a soft or pliable surface, if
desired. The use of a soft or pliable surface may be useful in
protecting against unintentional squeezing or crushing of the
bronchi within the interior of the end effector 140. Thus, the
contact surface of end effector may be configured to have an
atraumatic engagement with the bronchi and simultaneously ensure
sufficient energy is applied to the nerve components to be treated.
As noted above, the device 100 may be inserted into the body of a
patient and manipulated by the surgeon so that the bronchi are
aligned between the contact surfaces 170A and 170B of FIG. 4A or
175A and 175B in FIG. 4B.
[0048] In one embodiment, the device may include a means for
feedback, such as tactile or haptic feedback, when in use. For
example, although the device is intended to be used in concert with
other endoscopic instruments such as an endoscope with a light
source and camera, the device may give some sensation in the form
of feedback when an object is contacted by one or more surfaces
170A or 170B. Using a feedback system may allow for controlled
closure of the end effector 140 and protect against undesired
crushing or collapsing of the bronchi disposed therein.
[0049] FIGS. 5 and 6 show the pulmonary system of an individual and
an example of the surgical procedure useful herein, respectively.
The system includes the lungs 210, trachea 215, mainstem or primary
bronchi 220, and secondary bronchi 225. The trachea divides into
the two primary bronchi at the level of the sternal angle and of
the fifth thoracic vertebra or up to two vertebrae higher or lower,
depending on breathing, at the anatomical point the carina of
trachea. The right main bronchus is wider, shorter, and more
vertical than the left main bronchus. It enters the right lung at
approximately the fifth thoracic vertebra. The right main bronchus
subdivides into three secondary bronchi which deliver air to the
three lobes of the right lung: the superior, middle and inferior
lobe. The left main bronchus is smaller in caliber but longer than
the right, being approximately 5 cm long. It enters the root of the
left lung opposite the sixth thoracic vertebra.
[0050] The present invention is useful for treatment, including to
treat nerves or ganglion that exist on the either or both of the
mainstem bronchi 220. As noted above, the surface of the bronchi
220 includes a number of components, including nerves and the nerve
components to be treated through the present invention. FIG. 6
illustrates the body of a patient 200, showing the left lung 210
and its mainstem or primary bronchus 220. A number of instruments
may be partially inserted into the body 200 of the patient, and in
the depiction shown in FIG. 6, two elongated instruments are
inserted. One is the shaft 225 of the inventive device 230, having
end effector 240, and the other is a manipulation device 250, which
may be used to physically move and manipulate portions of the lung
210 during the procedure. In one embodiment, the device is used in
concert with an endoscope having a light source and camera (not
shown). The inventive device 230 is inserted into the patient's
body by the methods described herein, such that the end effector
240 is substantially in contact with the primary bronchus 220 at a
desired location. Once the end effector 240 is in contact with the
intended location at the bronchus 220, energy may be applied to the
end effector 240, and thus energy is provided to the bronchus 220.
Depending on the configuration and design of the end effector, the
energy may include electrical energy, radiofrequency energy, direct
current energy, mechanical energy, microwave energy, and ultrasonic
energy.
[0051] FIGS. 7A, 7B and 8, 8A depict alternate embodiments of the
end effector of the present invention, in particular, a
wrapping-type end effector. As discussed above, any configuration
of device may be used such that the end effector contacts at least
a portion of the outer surface of the bronchi to be targeted and
more desirably contacts a substantial portion of the circumference
of the bronchi. In FIGS. 7B and 8A, an end effector is depicted
that wraps around the outer surface of the bronchi, as opposed to
being clamped or clasped around the outer surface of the bronchi
(as in FIGS. 4A-4B). FIGS. 7A-7B show a wrapping-type end effector
using microwave energy, while FIGS. 8-8A show a wrapping type end
effector using radiofrequency energy. It is understood that any
energy form may be used, and FIGS. 7A, 7B, 8, and 8A only depict
two potential energy forms.
[0052] Since the introduction of anatomic lung resection by
video-assisted thoracoscopic surgery (VATS) was introduced, VATS
has experienced major advances in both equipment and technique,
introducing a technical challenge in the surgical treatment of both
benign and malignant lung disease. The demonstrated safety,
decreased morbidity, and equivalent efficacy of this minimally
invasive technique have led to the acceptance of VATS as a standard
surgical modality. The present invention can be used during VATS to
treat the targeted nerves so that symptoms of asthma or chronic
bronchitis can be reduced.
[0053] FIG. 7A illustrates the chest wall 300 of a patient, into
which a loading device 310 (such as catheter, port, or trocar) may
be inserted. The loading device 310 has a central lumen 320, into
which the elongated energy applying device 330 of the present
invention is inserted. Proximate the distal end 345 of the device
330 is the end effector 340 of the device 330. Along a substantial
portion of the device 330, and particularly at or near the end
effector 340 of the device 330 is a microwave energy emitting
device 350. FIG. 7A shows the end effector 340 of the device 330 as
it is being pushed or advanced by the surgeon. It exists as a first
straightened state while in the lumen of the trocar, and may be
capable of curving after it exits the trocar, either through
self-curving methods or by enacting force on the device to cause
curving. In the embodiment of FIG. 7A, the device remains straight
until a force causes curving, but it is understood that the device
may automatically begin to curve after it leaves the trocar and
force is not acted on it.
[0054] In one embodiment, the distal end of the device of FIG. 7A
includes flexible and configurable materials, such as nitinol or
another deformable material. The deformation should be controllable
from external means, such as a proximal handle or by other devices
insertable into the body. Control can also be accomplished, in the
case of a distal end including nitinol, by simply advancing or
retracting the distal end of the device into or out of the lumen in
the trocar. The distal end, once outside the trocar and in the
patient's thoracic cavity, is free to assume a second
configuration. This second configuration may be a curved C shape, a
coil, a semi-circle, or a spiral so as to enable the surgeon to
place the energy delivering component of the device on the target
nerve or ganglion. Further, the end effectors of these embodiments
may include means for alerting the clinician when wrapping is
achieved, or to warn the clinician when excess or insufficient
pressure is exerted on the bronchi. Visual means may be
particularly useful in using a wrapping-style of end effector. FIG.
7B illustrates the device 330 in a second state, in which the end
effector 340 of the device 330 is at least partially wrapped around
the outer surface of a bronchus 360. As can be seen in FIG. 7B, a
nerve 370 is disposed along the outer surface of the bronchi 360,
and by wrapping the end effector 340 around the bronchi 360, at
least a portion of the nerve 370 is in contact with the end
effector 340. FIG. 7B shows the end effector 340 wrapped around the
bronchi 360 in a helical configuration covering 360 degrees of the
outer surface, but it will be understood that the end effector 340
may be disposed in any configuration and may cover any desired
portion of the outer surface of the bronchi 360. Once in position
as in FIG. 7B, energy may be provided by a power supply described
previously herein. In one embodiment, the power supply is comprised
of a microwave generator. Thus, the energy emitting component 350
is activated so that the appropriate energy can be applied to the
targeted nerve 370 or ganglion on the bronchi.
[0055] FIGS. 8 and 8A illustrate one embodiment of the present
invention used to apply radiofrequency (RF) energy to a target
nerve or ganglion. FIG. 8 illustrates a chest wall 400 of a
patient, a loading device 410, which has a central lumen 420, and
the energy emitting device 430 of the present invention
(terminating in distal end 445). Device 430 and its end effector
440 include an energy source, in this embodiment including first
electrode 450 and second electrode 460 of opposite polarity so that
bipolar RF energy can be applied across the electrodes and
proximate the target nerve or ganglion. In another embodiment, the
electrodes are of similar polarity and the return electrode exists
as a grounding pad on the patient's skin so that monopolar RF
energy can be applied. In either embodiment, as can be seen in FIG.
8A, the end effector 440 is brought into contact with the outer
surface of the bronchi 470, where it is in substantial contact with
at least a portion of a nerve 480. The end effector 440 may be
brought into contact with the outer surface of the bronchi 470 in
any configuration or to any extent, such that it contacts at least
a portion of the nerve component 480 to be treated. The first and
second electrodes 450/460 are powered by a separate energy source,
which may be secured to the device 430 by wires or may be an
internal source such as a battery located within the handle of the
device, or may be wireless transmission of power.
[0056] The devices 330 and 430 of FIGS. 7A-7B and 8-8A may be
enabled have a pre-determined curvature by employing the use of a
nitinol shaft (not shown) within the core of the device. The
curvature of the nitinol core is predetermined and is constrained
while being passed through the trocar. In one embodiment, the
nitinol core extends along the entire length of the device. In
another embodiment, the shaft of the device may have a smaller
diameter metal other than nitinol. This metal core can be bent or
deformed into any configuration the surgeon desires so as to
customize the curvature, and thus help bring the electrodes in
close contact with the nerve or ganglion. In this method of use, a
trocar may or may not be used, depending on whether the desired
shape of the device's shaft can fit through the trocar. The
deformation may be controllable from external means, such as other
devices typically used by endoscopic surgeons, endoscopic clamps,
forceps, etc. that are insertable into other trocars and then
brought into contact with the shaft so as to bend or curve it into
the desired configuration that can contact the exterior bronchial
wall. Further, the end effectors of these embodiments may include
means for alerting the clinician when wrapping is achieved, or to
warn the clinician when excess or insufficient pressure is exerted
on the bronchi. In some embodiments, the energy applied may be
sufficient to cause irreversible electroporation (IRE), which is
the process of killing cells by applying large destabilizing
electrical potentials across the cell membranes for a long period
of time. IRE provides an effective method for destroying cells
while avoiding some of the negative complications of heat-inducing
therapies. In particular, IRE destroys cells without the use of
heat and does not destroy the extracellular matrix. Large
destabilizing IRE electric potentials may be in the range of about
several hundred to about several thousand volts applied across
biological membranes over a distance of about several millimeters,
for example, for a relatively long period of time. The
destabilizing electric potential forms pores in the cell membrane
when the potential across the cell membrane exceeds its dielectric
strength causing the cell to die by processes known as apoptosis
and/or necrosis.
[0057] In one embodiment, irreversible electroporation (IRE) energy
may be in the form of bipolar or monopolar pulsed direct current
(DC) output signals to electrically treat nerve component(s) with
the energy-applying device. The energy source may comprise a
commercially available conventional, bipolar or monopolar Pulsed DC
generator such as Model Number ECM 830, available from BTX
Molecular Delivery Systems Boston, Mass. In bipolar mode a first
electrode may be electrically coupled to a first polarity and a
second electrode may be electrically coupled to a second (e.g.,
opposite) polarity. Bipolar or monopolar pulsed DC output signals
(e.g., DC pulses) may be produced at a variety of frequencies,
amplitudes, pulse widths, and polarities. For example, the energy
source may be configured to produce DC pulses at frequencies in the
range of about 1 Hz to about 1000 Hz, amplitudes in the range of
about +/-100 to about +/-3000 voltage direct current (VDC), and
pulse widths (e.g., pulse durations) in the range of about 1 .mu.s
to about 100 ms to electrically treat the intended nerve
component(s). The polarity of the energy delivered to the
electrodes may be reversed during the therapy. For example, the
polarity of the DC pulses initially delivered at amplitudes in the
range of about +100 to about +3000 VDC may be reversed to
amplitudes of about -100 to about -3000 VDC. In some embodiments,
the nerve component(s) may be treated with DC pulses at frequencies
of about 10 Hz to about 100 Hz, amplitudes in the range of about
+700 to about +1500 VDC, and pulse widths of about 10 .mu.s to
about 50 .mu.s.
[0058] Once the energy-applying device is positioned such that the
end effector is at least partially in contact with the nerve
component(s) to be treated, and the electrical connections are
completed, the nerve component(s) may be treated with energy
supplied by the energy source. As explained above, the energy may
include any of the energy forms previously described. Following the
application of energy, the energy-applying device may be removed
from the patient, however, if subsequent application of energy is
necessary to completely treat the nerve component(s) or to treat
additional nerve component(s), the energy applying device may be
reinserted into the body of the patient, through either the same
incision location or through a different incision location. The
treated nerve component(s) may be monitored over time (e.g., days,
weeks, or months) to observe any follow-on activity.
[0059] The energy source, regardless of the type of energy to be
applied, may energize the end effector through a wired or a
wireless connection. In a wired connection, the energy source is
coupled to the end effector by way of one or more electrically
conductive wires through the body. In a wireless connection, the
energy source may be coupled to the end effector by way of one or
more antennas, thus eliminating the need to have a wired connection
running through the body of the energy-applying device, or the
energy source may be disposed internal of the energy-applying
device. In a wireless embodiment, an internal cable may be replaced
by an antenna, for example. The antenna may be coupled to the end
effector by an electrically conductive wire (not shown).
[0060] The end effector may additional include a light-emitting
means to assist in targeted and precise delivery of the energy. The
end effector may also include a means to provide feedback, such as
tactile or haptic feedback, to the user. The feedback may give the
user a warning that the device is inserted too shallow or deep, or
that the device is in contact with other bodily organs. In
addition, as the end effector is applied around the circumference
of the bronchi, the device may provide feedback that alerts the
user to the pressure being applied to the outer surface of the
bronchi. In some embodiments, the exact diameter of the bronchi to
be treated is known, and the end effector can be set to alert the
user when the end effector has reached the intended or desired
diameter. The feedback can thus prevent the user from exerting an
undesirable level of pressure onto the bronchi.
[0061] The device may be capable of providing energy to the target
site so as to generate a range of temperatures and, in some
embodiments, the method of use may include starting at a lower
energy and raising the energy levels to arrive at an increased
temperature. In addition, the device may include one or more
instruments that are capable of determining the temperature of the
treated bronchial surface or the current applied, and may be
configured to stop application of energy if necessary. For example,
the device may include one or more thermocouples configured to
measure the temperature at the site of treatment and protect
against overheating. In addition, the device may include a
mechanism to cool the target site if needed, for example, through
the use of a cooled water jacket or other cooling methods. This is
an additional safety or control mechanism that reduces or
eliminates the risk for damage to the patient, such as through
overheating or uncontrolled temperature application. The device may
include or utilize a number of algorithms to adjust energy
delivery, to compensate for device failures, to compensate for
excess current, to compensate for improper use or insufficient
contact, or to compensate for tissue inhomogeneities or variations
in the nerve component(s) targeted.
[0062] A controller and power supply may be used, where the power
supply may be internal of the device or may be external and
connected to the device, such as through the use of wires or
connectors. An exemplary external powered device is seen in FIG. 9,
which includes an energy generator 500, a controller 510 (including
processor 520), and power supply 530. The power supply 530 should
be configured to deliver energy for a sufficient duration and in
the manner desired. The power supply 530 may include programmable
information such as a timer. The power supply 530 may also employ a
number of algorithms to adjust the energy delivery before or during
treatment, if desired. Further, the power supply 530 may be capable
of monitoring the various parameters of energy transfer, including,
for example, voltage, current, power, impedance, and may use this
monitored information to control the output. The level of power may
be increased or decreased either by a user or automatically in
response to one or more monitored levels. A return electrode 540
may be connected to the power supply 530, and optionally an
actuator 550 may also be included. The device is connected via
appropriate wiring 560 to the device 570, which includes end
effectors, such as those described above (e.g., 580A, 580B). In
some embodiments, end effectors may be capable of being removed
and/or replaced, such as through the use of a modular device. Any
engagement means may be used to secure an end effector to the
device, including friction fits, snap on-snap off tooling, screw
fit, and the like. The invention may include a kit, which contains
the body of the device and a plurality of modular end
effectors.
[0063] The present invention provides methods of controlled and
targeted application of energy to a nerve, ganglion or plexus,
particularly those located on the outer surface of an individual's
bronchi. The invention includes the use of an energy-applying
device, such as that described above. In one useful method of
application of energy, a user (typically a surgeon) makes at least
one small incision into the body of a patient. The incision is
located at or near the thoracic position of the patient and in
particular should be at a point between two adjacent ribs of the
patient. Once the incision is complete, the user inserts the distal
end of the energy-applying device into the body of the patient. In
some embodiments, a port or trocar may be placed in the incision
site. The insertion of the energy-applying device is such that the
distal end of the device, which includes an end effector described
above, can substantially contact at least a portion of the outer
surface of a bronchi.
[0064] If desired, additional devices to allow for a VATS technique
may be used, including, for example, devices to move or manipulate
lungs, lobes of lungs, and bronchi. In addition, video devices may
be inserted through additional incision locations in the patient's
body. Other tools may be inserted to help visualize the interior of
the body, or to help manipulate and/or place the end effector in
the proper location.
[0065] Once the desired devices are inserted into the body of the
patient, the end effector of the energy-applying device is moved
into a position at or near one of the bronchi. The end effector is
then placed into substantial contact with the outer surface of the
desired bronchi, where it contacts at least one nerve component to
be treated. The end effector may include a clamp-type effector
(such as in FIGS. 4A-4C) or it may include a wrapped end effector
(such as in FIGS. 7A-8), or may be any other configuration in which
at least a portion of the outer surface of the bronchi is contacted
by a contact surface of the end effector. Most desirably, the
contact surface of an end effector contacts the bronchi at least a
portion of the circumference, preferably 45 degrees to 360 degrees.
The end effector is opened such the energy-applying surface of the
end effector is positioned so as to contact the outer surface of
the bronchi. The nerve component, ganglion or plexus is placed into
contact with the energy-applying surface of the end effector and,
if desired, the end effector can be closed around at least a
portion of the circumference of the bronchi, where the nerve
components to be treated are located. Energy may be applied to one
or more nerve components simultaneously. Thus, the application of
energy may be provided to a small region, including one nerve
component, or may be applied to a plurality of regions covering at
least a portion of the circumference of bronchi to be treated. In
some embodiments, the end effector is disposed around an entire
circumference of the bronchi, allowing application of energy to all
nerve components disposed in that region of the bronchi. The end
effector may have any size desired so as to cover as much or as
little of the surface of the bronchi to be treated. Multiple
regions may be treated on one bronchi or bronchial segments.
[0066] Once the nerve component (ganglion or plexus) to be treated
is in contact with at least one energy applying surface of the end
effector, the user can introduce energy to the end effector and
treat the nerve component to be treated. The energy application is
sufficient such that the intended effect is achieved, such as
severing or ablation of the nerve component. In some embodiments,
the energy applying surface of the end effector may have a
conformable surface such that when the end effector is placed into
position about the bronchi, there is minimal, if any, compression
of the bronchi. In some embodiments, the energy applying surface of
the end effector includes at least one blades or sharp edge, and
the application of mechanical energy includes severing the nerve
component to be treated.
[0067] Once the desired energy is applied to the nerve component or
components to be treated, the energy applying device may be
removed. If other devices such as light sources, cameras, or other
endoscopic tools were inserted, they may also be removed. The
treated bronchial site may be given additional treatment, including
application of drugs or other medication, or may be wrapped or
coated with a material to promote healing and/or to restrict
regrowth or rejoinder of the severed or ablated nerve
components.
[0068] As noted above, the present invention uses the application
of energy to the exterior surface of the bronchi, giving targeted
and precise treatment to one or more of the nerve components
located on the exterior surface of the bronchi. This method and
apparatus for achieving the method provides a number of benefits
over previous methods, the previous methods including, for example,
intra-bronchial methods (bronchoscopic methods) and methods that
attach or implant a device to the bronchi. The invention provides a
method of treating pulmonary conditions through targeted means,
giving a less painful recovery and quicker recovery time, while
also avoiding the need to implant a device in the body. Further,
through thoracoscopic methods such as that described herein, visual
methods may be used to provide targeted treatment of the intended
nerve component(s).
* * * * *