U.S. patent application number 16/170653 was filed with the patent office on 2019-02-28 for bronchoscope adapter and methods for using the same.
The applicant listed for this patent is Jeffrey Dinghua Lei, Michael Yuchen Lei, Thomas Dinghua Lei. Invention is credited to Jeffrey Dinghua Lei, Michael Yuchen Lei, Thomas Dinghua Lei.
Application Number | 20190059708 16/170653 |
Document ID | / |
Family ID | 54555179 |
Filed Date | 2019-02-28 |
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United States Patent
Application |
20190059708 |
Kind Code |
A1 |
Lei; Thomas Dinghua ; et
al. |
February 28, 2019 |
Bronchoscope Adapter and Methods for Using the Same
Abstract
Bronchoscope adapters and methods of using the same are
provided. Aspects of the adaptors include a body having a
passageway, a mechanical ventilator access port, a bronchoscope
access port configured to receive a bronchoscope into the
passageway, and an exit port. The bronchoscope access port
comprises a reversibly adjustable inner diameter component that
provides locking of the bronchoscope at desired position. The
adaptors find use in a variety of different applications.
Inventors: |
Lei; Thomas Dinghua;
(Mountain View, CA) ; Lei; Michael Yuchen;
(Mountain View, CA) ; Lei; Jeffrey Dinghua;
(Mountain View, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Lei; Thomas Dinghua
Lei; Michael Yuchen
Lei; Jeffrey Dinghua |
Mountain View
Mountain View
Mountain View |
CA
CA
CA |
US
US
US |
|
|
Family ID: |
54555179 |
Appl. No.: |
16/170653 |
Filed: |
October 25, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14714938 |
May 18, 2015 |
|
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16170653 |
|
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62002081 |
May 22, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 16/0463 20130101;
A61B 1/2676 20130101; A61M 16/04 20130101; A61M 39/22 20130101;
A61B 1/00128 20130101; A61B 1/00119 20130101; A61B 1/00112
20130101; A61M 16/0816 20130101; A61B 1/00137 20130101; A61B 1/018
20130101; A61B 1/01 20130101 |
International
Class: |
A61B 1/018 20060101
A61B001/018; A61M 16/04 20060101 A61M016/04; A61B 1/01 20060101
A61B001/01; A61B 1/00 20060101 A61B001/00; A61M 16/08 20060101
A61M016/08; A61B 1/267 20060101 A61B001/267 |
Claims
1-23. (canceled)
24. A system comprising: (a) an adaptor comprising: a body having a
passageway; a mechanical ventilator access port configured to
operatively couple a mechanical ventilator to the passageway; a
bronchoscope access port configured to receive a bronchoscope into
the passageway, wherein the bronchoscope access port comprises a
reversibly adjustable inner diameter component; and an exit port
configured to operatively connect the passageway to an endo
tracheal tube; and (b) a bronchoscope present in the
passageway.
25. The system according to claim 24, wherein the bronchoscope
access port comprises an actuator configured to provide for
mechanical adjustment of the reversibly adjustable inner diameter
component.
26. The system according to claim 25, wherein the actuator
comprises a rotatable member.
27. The system according to claim 26, wherein the rotatable member
is configured to rotate about the longitudinal axis of the
bronchoscope access port.
28. The system according to claim 24, wherein the reversibly
adjustable inner diameter component comprises a compressible
member.
29. The system according to claim 28, wherein the compressible
member is a compressible tube.
30. The system according to claim 29, wherein the compressible
member comprises a polymeric material.
31. The system according to claim 30, wherein the polymeric
material comprises a silicone or thermoplastic elastomer (TPE).
32. The system according to claim 24, wherein the reversibly
adjustable inner diameter component is configured to provide a
magnitude of diameter change ranging from 1 to 3.5 mm.
33. The system according to claim 32, wherein the reversibly
adjustable inner diameter has an adjustable diameter that ranges
from 3.5 to 7 mm.
34. The system according to claim 24, wherein the passageway ranges
in length from 40 to 50 mm.
35. The system according to claim 24, wherein the bronchoscope
access port and exit port are coaxial with the longitudinal axis of
the passageway.
36. The system according to claim 35, wherein the mechanical
ventilator port has a longitudinal access that is orthogonal to the
longitudinal access of the passageway.
37. The adaptor according to claim 24, wherein the adaptor is
configured to be operatively employed with a mammal.
38. The adaptor according to claim 37, wherein the mammal is a
human.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] Pursuant to 35 U.S.C. .sctn. 119(e), this application claims
priority to the filing date of U.S. Provisional Application Ser.
No. 62/002,081 filed May 22, 2014, the disclosure of which is
herein incorporated by reference.
INTRODUCTION
[0002] Bronchoscopy is one of the most common surgical procedures
performed by pulmonologists, thoracic surgeons and other trained
medical professionals. A fibrotic bronchoscope consists of a long,
flexible tube containing several elements: an illumination device
for the field distal to the tip of bronchoscope; an image-capturing
system delivering a live-video feed with the capability of taking
still photos, all through a flexible optical fiber connected to an
external light source; and a working channel, via which, both
diagnostic and therapeutic instruments, and agents (such as biopsy
forceps, aspiration needle, brushes, laser, cryo, radiofrequency
probe, fiducial markers, medications, etc.) are inserted or
instilled. The distal tip of bronchoscope is steerable on one plane
by flipping a lever up and down, and on another plane by rotating
the handle of bronchoscope left and right to reach the intended
targets.
[0003] Bronchoscopies are performed routinely in the diagnosis and
treatment of various lung diseases such as pulmonary nodule, lung
mass, lung cancer, pneumonia, atelectasis, emphysema and foreign
body retrieving. Bronchoscopies are usually performed by
pulmonologists, thoracic surgeons, or other trained medical
professionals, also known as a bronchoscopist.
[0004] One of greatest achievements in pulmonary/chest medicine is
the recent development of the electromagnetic navigational
bronchoscopy (ENB). The ENB provides tools of high precision in
both diagnosis and treatment of pulmonary nodules and lung cancer.
The ENB utilizes computer technology in digitalizing the collected
image data of a patient's lung anatomy acquired from a chest
computerized tomography (CT) scan. It then reconstructs the
patient's lung anatomy in a three dimensional model and through an
electromagnetic field allows for the physician to locate the
intended target (e.g. tumor, nodule, etc.). This new technology,
the ENB, revolutionizes the diagnosis and treatment of certain lung
diseases. It enables physicians to enter a new frontier of human
lung space; it makes it possible to reach peripheral, distal and
tiny lesions with high precision in a minimally invasive way
compared to conventional bronchoscopy; and it replaces other
invasive surgical procedures, such as transthoracic needle biopsy,
open lung biopsy, etc.
[0005] The nature of the ENB procedure demands high precision, and
typically the
[0006] ENB is performed under general anesthesia. It necessitates
the intubation of the patient, an insertion of an endotracheal tube
inside the patient's respiratory system while simultaneously
placing the patient inside a defined magnetic field. Currently, the
ENB requires a minimum staff of four or more: the bronchoscopist,
an anesthesiologist, one or more scrub nurses, and a circulating
nurse meant solely for the purpose of managing documentations.
[0007] During a typical ENB procedure after a patient is intubated
and fully anesthetized, the bronchoscopist inserts the bronchoscope
into the endotracheal tube via an adapter of three ports, one port
for the bronchoscope, one port for the mechanical ventilator, and
an exit port for connection to a tracheal tube, e.g., an
endotracheal tube. Examples of such adaptors are described in
various United States patents, including U.S. Pat. No. 5,158,569 to
Strickland, et al.; U.S. Pat. No. 4,683,879 to Tudor; U.S. Pat. No.
4,416,273 to Grimes, et al. After insertion, the procedure moves
onto an examination of the general structures of the lungs.
Navigation through the lung space is achieved by movement of the
bronchoscope handle. The bronchoscope can be pulled up, pushed
down, rotated left and right, and flipped by a deflection lever up
and down, eventually driving the bronchoscope to the intended
target(s). Once the bronchoscope tip reaches its furthest point
(either limited by the diameter of the patient's bronchial tree
and/or the angle of the bronchial tree branch), an extended working
channel/catheter (EWC) along with locatable guide (LG) in place is
introduced through the bronchoscope work channel. This EWC and LG
have much smaller diameters and far more flexible tips, allowing
the physician to overcome the size and angular limitations of the
bronchoscope. The EWC and LG extend the physician's reach to the
much more distal portions of the bronchial tree and its smaller
lesions where the target of interest typically resides. This
predetermined navigational path is chosen by a combination of
computer software and the expertise of the bronchoscopist. The
navigation is accomplished by viewing both live and visual images
in a three-dimensional space. Once the tip of LG reaches its
intended target, the LG is removed and the tools of choice (biopsy
forceps, aspiration needle, needle brush, fiducial or such), will
be inserted through the EWC to accomplish intended tasks (such as a
biopsies of the lesion or the placement of the fiducial, etc.). The
EWC is being held steady and locked at the orifice of the working
channel on the bronchoscope by existing devices and methods, such
as described in "System of accessories for use with bronchoscope"
to Greenberg, Bet al., U.S. Pat. Nos. 8,663,088; 8,317,149 to
Greenburg B. et al. and PCT patent application no, WO 03/086498
entitled "Endoscope Structure and Techniques for Navigation in
Branched Structure" to Gilboa.
SUMMARY
[0008] Bronchoscope adapters and methods of using the same are
provided. Aspects of the adaptors include a body having a
passageway, a mechanical ventilator access port, a bronchoscope
access port configured to receive a bronchoscope into the
passageway, and an exit port configured to connect to an
endotracheal tube. The bronchoscope access port comprises a
reversibly adjustable inner diameter component. The adaptors find
use in a variety of different applications.
[0009] The current invention compliments and completes the existing
applications, such as described in the introduction section above,
to achieve a complete control and lock down of a bronchoscope along
with an EWC at the intended target position by a single operator,
i.e., the bronchoscopist. While the current devices and methods
described by Gilboa and Greenburg are able to lock the EWC with/on
bronchoscope, the bronchoscope itself still remains a moving
object, due to the respiration of the patient, the respiration of
the bronchoscopist and the repeated maneuvers at the orifice of the
EWC; such as changes of instruments, repeated sampling. All these
disturbances displace the EWC tip several millimeters or even
centimeters away from the intended target due to the subtle moving
up and down of the bronchoscope along/relative to the endotracheal
tube. This undesired and inevitable movement of bronchoscope
relative to the endotracheal tube with the existing devices, could
move the EWC tip far away from the intended target, and completely
negates the tremendous effort made to navigate to and then lock the
EWC tip at the intended target. This undesired movement causes
several problems: missing the target without awareness of operator,
resulting in poor precision leading to reduction of the diagnostic
yield, or requiring repeated navigation to the same target,
increasing in the operational time. This intrinsic imperfection of
existing devices is currently remedied by requiring additional
personnel to hold the bronchoscope at the junction of endotracheal
tube periodically.
[0010] The existing practice increases the complexity of an already
complicated multi-person procedure that requires delicate
coordination between the bronchoscopist and the assistants. Current
conditions greatly add to the cost of the operation and more so,
often result in missing the intended targets of the procedure that
depend on the high precision of the operators.
[0011] The current invention, the device and its mechanisms
described here, allow for the adjustable locking of the
bronchoscope to the endotracheal tube. Embodiments of the invention
provide and maintain an airtight sealing of the ventilator system,
reduce additional personnel, and give the bronchoscopist total
control of navigation, targeting, locking and adjusting the
bronchoscope as desired. Embodiments of the invention facilitate
and secure the locking of the EWC tip to the intended target
leading to greater precision in accomplishing the intended tasks.
Embodiments of the current invention also expand and accommodate
various size ranges of bronchoscopes as compared with current
adapters. Embodiments of the current invention, in combination of
existing ENB technology, add a new arsenal in the field of the
diagnosis and treatment of pulmonary nodules, particularly early
lung cancer. Furthermore, embodiments of the invention aid in the
reduction of human error, increase the precision of the
bronchoscopic surgical procedures, improve the diagnostic yield of
bronchoscopic biopsies, deliver any therapeutic modality, such as
fiducial, laser to a more precise target location, and greatly
reduce the existing operation cost.
[0012] Aspects of the invention include an apparatus and related
mechanisms, which secure a bronchoscope at a desired position of
choice, and allow for the adjustment and security at new positions
at will through a single operator, i.e., the bronchoscopist, and
further facilitate the securing of EWC or such at target position
as intended.
[0013] Adaptors according to embodiments of the invention are
configured to protect the delicacy of the fiber optic material used
in the flexible fiber optic bronchoscope, while providing secure
locking of the bronchoscope. The locking is adjustable and
controlled by single operator, the bronchoscopist, and achieved by
providing a direct contact of the delicate bronchoscope only with
an elastomeric material, such as polymeric material, e.g., a
silicone or thermoplastic elastomer (TPE) material. The locking
mechanism is accomplished through the manipulation of a cylindrical
conduit of the elastomeric material, caused by vertical force
controlled by the bronchoscopist.
[0014] Embodiments of the current invention are configured to
maintain the integrity of the airtight ventilator system while
bronchoscopic surgical procedures are being performed. Because of
the adjustable nature of the current invention, the size range of
bronchoscopes able to be used with a single adaptor is greatly
expanded, allowing for smaller pediatric bronchoscopes to be
employed with an adaptor also configured to be used with adult
sized bronchoscopes.
[0015] Embodiments of the current invention provide for the
substitution of personnel currently required, to reduce human
error, and to streamline the complicated operation. By doing so,
embodiments of the current invention significantly reduce the cost
of bronchoscopic procedures, e.g., as compared to existing
practice.
[0016] Embodiments of the current invention provide for an airtight
ventilator system at the end of bronchoscopic intervention, by
simply plugging the bronchoscope access port using the attached
plug at the end of procedure when the bronchoscope is removed from
the endotracheal tube, before the patient is successfully
extubated. Embodiments of the current invention significantly
increase the precision and accuracy of the intended
operation--leading to higher diagnostic yields, better therapeutic
results through reduction of the variables of human error.
Embodiments of the current invention expand the arsenal of tools
available to the health care professional in the field of diagnosis
and treatment of pulmonary nodule, particularly early lung
cancer.
BRIEF DESCRIPTION OF THE FIGURES
[0017] FIGS. 1 to 6 depict various views of a device according to
an embodiment of the invention.
DETAILED DESCRIPTION
[0018] Bronchoscope adapters and methods of using the same are
provided. Aspects of the adaptors include a body having a
passageway, a mechanical ventilator access port, a bronchoscope
access port configured to receive a bronchoscope into the
passageway, and an exit port configured to connect to an
endotracheal tube. The bronchoscope access port comprises a
reversibly adjustable inner diameter component. The adaptors find
use in a variety of different applications.
[0019] Before the present invention is described in greater detail,
it is to be understood that this invention is not limited to
particular embodiments described, as such may, of course, vary. It
is also to be understood that the terminology used herein is for
the purpose of describing particular embodiments only, and is not
intended to be limiting, since the scope of the present invention
will be limited only by the appended claims.
[0020] Where a range of values is provided, it is understood that
each intervening value, to the tenth of the unit of the lower limit
unless the context clearly dictates otherwise, between the upper
and lower limit of that range and any other stated or intervening
value in that stated range, is encompassed within the invention.
The upper and lower limits of these smaller ranges may
independently be included in the smaller ranges and are also
encompassed within the invention, subject to any specifically
excluded limit in the stated range. Where the stated range includes
one or both of the limits, ranges excluding either or both of those
included limits are also included in the invention.
[0021] Certain ranges are presented herein with numerical values
being preceded by the term "about." The term "about" is used herein
to provide literal support for the exact number that it precedes,
as well as a number that is near to or approximately the number
that the term precedes. In determining whether a number is near to
or approximately a specifically recited number, the near or
approximating un-recited number may be a number which, in the
context in which it is presented, provides the substantial
equivalent of the specifically recited number.
[0022] Unless defined otherwise, all technical and scientific terms
used herein have the same meaning as commonly understood by one of
ordinary skill in the art to which this invention belongs. Although
any methods and materials similar or equivalent to those described
herein can also be used in the practice or testing of the present
invention, representative illustrative methods and materials are
now described.
[0023] All publications and patents cited in this specification are
herein incorporated by reference as if each individual publication
or patent were specifically and individually indicated to be
incorporated by reference and are incorporated herein by reference
to disclose and describe the methods and/or materials in connection
with which the publications are cited. The citation of any
publication is for its disclosure prior to the filing date and
should not be construed as an admission that the present invention
is not entitled to antedate such publication by virtue of prior
invention. Further, the dates of publication provided may be
different from the actual publication dates which may need to be
independently confirmed.
[0024] It is noted that, as used herein and in the appended claims,
the singular forms "a", "an", and "the" include plural referents
unless the context clearly dictates otherwise. It is further noted
that the claims may be drafted to exclude any optional element. As
such, this statement is intended to serve as antecedent basis for
use of such exclusive terminology as "solely," "only" and the like
in connection with the recitation of claim elements, or use of a
"negative" limitation.
[0025] As will be apparent to those of skill in the art upon
reading this disclosure, each of the individual embodiments
described and illustrated herein has discrete components and
features which may be readily separated from or combined with the
features of any of the other several embodiments without departing
from the scope or spirit of the present invention. Any recited
method can be carried out in the order of events recited or in any
other order which is logically possible.
Bronchoscopy Adaptors
[0026] As summarized above, aspects of the invention include a
bronchoscopy/mechanical ventilation adaptor. The adaptor is a
device that may be viewed as a manifold configured to operationally
combine a mechanical ventilator, a bronchoscope and a tracheal tube
when these elements are employed in a bronchoscopic procedure.
Adaptors as described herein include an elongated body having an
internal passageway. The adaptors are dimensioned to be placed on
an endotracheal tube that has been placed in the oral cavity of a
mammal, such as a human. In some instances, the adaptors have a
length ranging from 40 mm to 50 mm, and a width ranging from 35 mm
to 55 mm. While the cross-sectional shape of the adaptors may vary,
e.g., ranging from square to rectangular to triangular to
curvilinear, e.g., circular, in some embodiments the adaptors are
tubular in structure. Where the adaptors are tubular in structure,
the inner and outer diameters of the adaptors may vary. In some
instances, the tubular adaptors have an outer diameter ranging from
12 mm to 25 mm; and an inner diameter ranging from 9 mm to 15 mm.
Of course, the dimensions, e.g., inner and/or outer diameters, may
vary or be constant in a given adaptor, as desired.
[0027] Adaptors of the invention include a bronchoscope access port
configured to receive a bronchoscope into the passageway of the
adaptor. The bronchoscope access port may be positioned on the body
at any convenient location, and in certain embodiments is
positioned at one end of the body, e.g., the proximal end of the
body of the adaptor. The bronchoscope access port has an inner
diameter that is configured to provide access of a bronchoscope
into the passageway of the adaptor. While the inner diameter of the
bronchoscope access port may vary, in some instances the inner
diameter ranges from 3.5 mm to 7 mm, such as 4 to 7 mm. The
bronchoscope access port may have a length that varies, ranging in
some instances from 10 to 20 mm. While the angle of the
longitudinal axis relative to the longitudinal access of the
passageway may vary, in some instances ranging from 0 to
15.degree., in some instances the longitudinal axis of the
bronchoscope access port is coaxial with the longitudinal access of
the passageway.
[0028] Aspects of the adaptors described herein include a
reversibly adjustable inner diameter component associated with the
bronchoscope access port. A reversibly adjustable inner diameter
component is a sub-device of the adaptor that is configured to
provide for a reversible change in the inner diameter of the
bronchoscope access port. As the change in the inner diameter is
reversible, it can be adjusted as desired to accommodate the size
of the bronchoscope being used with the adaptor, e.g., to provide a
sealing relationship with the bronchoscope and yet not damage the
bronchoscope. The reversibly adjustable inner diameter component
may be configured to provide a variety of inner diameters, and in
some instances is configured to provide a magnitude of diameter
change between its most open and most constricted settings that
ranges 1 to 3.5 mm, such as 1 to 3.5 mm. The reversibly adjustable
inner diameter may be configured to provide for a variety of
different inner diameters in the access port, and in some instances
has an adjustable diameter that ranges from 4 to 8 mm, such as 3.5
to 7 mm.
[0029] The bronchoscope access port comprises may include an
actuator that is configured to provide for mechanical adjustment of
the reversibly adjustable inner diameter component. Any convenient
actuator may be present, so long as it provides for adjustment of
the inner diameter of the adjustable component, as desired. An
example of an actuator of interest is a compressible member that
may be turned in a manner that changes the inner diameter of the
adjustable component. In some instances the compressible member,
e.g., in the form of a knob or dial, is configured to deform about
the longitudinal axis of the bronchoscope access port along a
thread so that it moves along the longitudinal axis of the access
port and, in doing so, compresses a compressible member, e.g., as
described in greater detail below.
[0030] The adjustable inner diameter component may include a
compressible member configured so that the compression of the
compressible member results in a decrease in the inner diameter of
the adjustable component. While such a compressible member may have
a variety of configurations, in some instances it is configured as
a tubular member that rests inside of and is coaxial with the
longitudinal axis of the access port. When the compressible member
is a tubular member, the dimensions of the compressible member may
vary in the compressed and uncompressed states. In some instances,
the compressible member in the uncompressed state has a height
ranging from 5 to 10 mm, an inner diameter ranging from 5 to 8 mm,
such as 3.5 to 7 mm, and an outer diameter that remains constant
due to the hard casing enclosing the compressible member. An
example of a reversibly adjustable inner diameter component is such
a compressible which is operatively coupled or even structurally
embedded to a rotatable member, e.g., dial, where rotation of the
dial, e.g., along a suitable thread, causes the dial to compress or
un-compress the compressible member.
[0031] The compressible member of such embodiments may be
fabricated from any convenient materials. Materials of interest
include elastomeric materials, i.e., materials that are able to
resume their original shape when a deforming force is removed.
Materials of interest include, but are not limited to, polymeric
materials, such as naturally occurring or synthetic rubbers,
thermoplastic elastomer (TPE), silicones, etc.
[0032] In some instances, the bronchoscope access port may include
a sealing mechanism that is configured to seal the access port and
passage way connected thereto from the outside environment when a
bronchoscope is not present in the access port. The sealing
mechanism may vary, and in some instances is configured to provide
an airtight seal. Sealing mechanisms of interest include, but are
not limited to: plugs, valves, etc., where the sealing mechanism
may conveniently be attached to the adaptor whether or not it is
sealing the port, if desired.
[0033] In addition to the bronchoscope access port, e.g., as
described above, adaptors of the invention include a mechanical
ventilator access port configured to operatively couple a
mechanical ventilator to the passageway of the adaptor. The
configuration of the mechanical ventilator access port may vary, so
long as it can operatively couple a mechanical ventilator tube to
the passageway of the adaptor, e.g., provide for gaseous
communication between the interior of the ventilator tube and the
passageway of the adaptor. The location of the mechanical
ventilator access port may vary on the device, and in some
instances is located between the proximal and distal end, e.g.,
within 15 to 20 mm of the proximal end. In some instances, the
mechanical ventilator access port has an inner diameter ranging
from 5 to 10 mm, such as 9 to 10 mm. The mechanical ventilator
access port may have a length that varies, ranging in some
instances from 20 to 25 mm. While the angle of the longitudinal
axis of the mechanical ventilator access port relative to the
longitudinal access of the passageway may vary, in some instances
ranging from 90 to 145, such as 100 to 110.degree., in some
instances the longitudinal axis of the mechanical ventilator access
port is orthogonal to the longitudinal access of the passageway.
The mechanical ventilator access port may include an attachment
element configured to stably associate a ventilator tube with the
adaptor, e.g., rotatable in a sealing relationship.
[0034] Adaptors of the invention further include an exit port
configured to operatively connect the passageway to an endotracheal
tube. The configuration of the exit port may vary, so long as it
can operatively couple the endotracheal tube to the passageway of
the adaptor, e.g., provide for gaseous communication between the
passageway of the adaptor and the endotracheal tube and rotatable
around the endotracheal tube. The location of the exit port may
vary on the device, and in some instances is located at an end of
the adaptor, e.g., the distal end. In some instances, the exit port
has an inner diameter ranging from 10 to 15, such as 12 to 15 mm.
The exit port may have a length that varies, ranging in some
instances from 15 to 20 mm. While the angle of the longitudinal
axis of the exit port relative to the longitudinal access of the
passageway may vary, in some instances ranging from 0 to
15.degree., in some instances the longitudinal axis of the exit
port is coaxial with the longitudinal access of the passageway. The
exit port may include an attachment element configured to stably
associate a tracheal tube with the adaptor, e.g., in a sealing
relationship. The adaptor may be configured to be used with a
variety of tracheal tubes, including but not limited to: an
endotracheal tube, a tracheostomy tube, etc.
[0035] The adaptor may be fabricated from any convenient material.
Suitable materials include, but are not limited to: medical grade
plastics, thermoplastic elastomer (TPE) or silicones, as well as
metals. In some instances, the adaptor is configured as a one time
use adaptor, where the material is from which it is fabricated is
chosen in terms of suitability for placement close to the oral
cavity and outside body (in vitro) of a patient and yet be
inexpensive enough to provide for one time use.
[0036] The adaptor is a sterile single-use disposable device. Any
other similar system using different material and techniques for
attaching and locking bronchoscope to endotracheal tube to achieve
the similar goal also falls within the scope and spirit of the
current invention. Although the current invention is described in
the context of electromagnetic navigational bronchoscopy (ENB) in
conjunction with mechanic ventilation, endotracheal tube, it
applies to any other applications using a bronchoscope with or
without involved in endotracheal tube requiring locking the
bronchoscope at an adjustable, desired position.
[0037] The adaptor having been generally described above, a
detailed description of an adaptor according to the embodiment
shown in FIG. 1 to FIG. 6 is now provided. It is to be understood
that the embodiments shown in FIG. 1 is merely exemplary of the
invention which may be embodied in various forms, size using
different material. Therefore, the structure and functional
specifics, details presented here are not to be interpreted as
limiting and excluding, but merely as the basis for the claims, and
as representative basis, while the spirit of the current invention
could be employed in various forms and shapes, with appropriate
structure details.
[0038] As shown in the FIG. 1 to FIG. 6, the depicted
multifunctional bronchoscope/endotracheal tube adapter/manifold is
a cylindrical, tubular body, having three ports, i.e., port A, port
B and port C. Port B, which is the ventilator port, is at a
substantially angular relationship to the longitude body, with
outer swivel connecting ventilator machine (not shown). As depicted
in FIG. 1, port B includes a one way snap on swivel 6 and
ventilator tubing access 7. Port C, which is an endotracheal tube
port, includes an inner swivel snap on piece 9 containing an O-ring
8 (as shown in FIG. 4) for seal, connecting an endotracheal tube
via access 10 (ETT shown FIG. 5). Port A is the bronchoscope access
port. Port A has rigid housing, in which resides an elastomeric,
cylindrical compressible member 4 (made of silicone or
thermoplastic elastomer TPE) with a through hole fitting various
sizes of bronchoscopes. The locking and accommodating mechanism is
accomplished through changing this through hole inner diameter by
deformation of this silicone/TPE piece 4. Deformation of the piece
4 produces circular pressure against bronchoscope, so to lock it at
desired the position. The deformation, i.e., the inner diameter, is
adjusted by applying and releasing the vertical force from a
cylindrical cap/dial 1 containing a through channel, by screwing or
torqueing the cap up and down along the thread 3 (FIG. 4). The
through channel 2 on the access port can be plugged before or after
the bronchoscopic procedures using a removable plug 5, in order to
maintain the integrity of ventilator circuit.
Methods of Use
[0039] Also provided are methods of using adaptors in bronchoscopic
procedures, e.g., as described generally above and exemplified in
the experimental section, below. In methods of invention, and
adaptor having a bronchoscope access port with an adjustable inner
diameter component, e.g., as described above, is operatively
associated with a tracheal tube that intubates a patient, as well
as a mechanical ventilator tube, such that the mechanical
ventilator tube is operatively connected to the tracheal tube via
the passageway of the adaptor. As desired, a bronchoscope may be
introduced into the passageway and then the tracheal tube through
the bronchoscope access port, e.g., after removal of a sealing
element (such as a plug) from the bronchoscope access port. When
desired, the inner diameter of the adjustable inner diameter
component may be narrowed, e.g., through compression, to stably
associate the bronchoscope with the adaptor, such that the two
components do not move relative to other. After any bronchoscope
procedure, the inner diameter may be broadened, e.g., through
decompression, to release the bronchoscope such that it may be
moved with ease relative to the adaptor.
[0040] The subject adaptors and methods may be used in a variety of
subjects, including humans, e.g., as described above. In certain
embodiments, the subjects or patients are humans, ranging from
neonates to adults.
Kits
[0041] As summarized above, also provided are kits for use in
practicing the subject methods. The kits at least include an
adaptor, e.g., as described above. The kits may include one or more
additional components that may find use in an application where the
adaptor is employed, where such additional components include, but
are not limited to: extra plugs. The adaptor (and other components
when present) of the kits may be present in a suitable container,
such as a sterile container, e.g., a sterile pouch.
[0042] In addition to the above components, the subject kits may
further include (in certain embodiments) instructions for
practicing the subject methods. These instructions may be present
in the subject kits in a variety of forms, one or more of which may
be present in the kit. One form in which these instructions may be
present is as printed information on a suitable medium or
substrate, e.g., a piece or pieces of paper on which the
information is printed, in the packaging of the kit, in a package
insert, etc. Yet another form of these instructions is a computer
readable medium, e.g., diskette, compact disk (CD), Hard Drive
etc., on which the information has been recorded. Yet another form
of these instructions that may be present is a website address
which may be used via the internet to access the information at a
removed site.
[0043] The following examples are put forth so as to provide those
of ordinary skill in the art with a complete disclosure and
description of how to make and use the present invention, and are
not intended to limit the scope of what the inventors regard as
their invention nor are they intended to represent that the
experiments below are all or the only experiments performed.
Experimental
I. Electromagnetic Navigational Bronchoscopy (ENB) Procedure Using
BETLA (Bronchoscope Endotracheal Tube Lock/Adapter)
[0044] Patient JD is a 68 years old male with diagnosis of lung
nodule/mass, possible early lung cancer. He has two lung nodules,
one nodule at right upper lobe, another one at right middle lobe. A
diagnostic electromagnetic navigational bronchoscopy is performed
on JD as follows. After registration, the patient is transferred
from the pre-surgical department to an operating room. An
anesthesiologist starts induction of general anesthesia using
either inhaled anesthetics, intravenous anesthetics or both if
needed. Once the patient is fully sedated, the anesthesiologist
intubates the patient by placing of an endotracheal tube into the
patient's trachea and connects the endotracheal tube to a
mechanical ventilator directly to start mechanical ventilation. The
anesthesiologist secures the endotracheal tube by taping it to the
patient. Throughout the operation process, the patient's
respiration is fully provided by a mechanical ventilator and his
vital signs are monitored closely. Once the operation team is ready
to start, the anesthesiologist unwraps a single use BETLA, e.g., as
depicted in FIG. 1. The anesthesiologist attaches port B, the
ventilator port of the BETLA, to a mechanical ventilator. The
anesthesiologist attached port C, the endotracheal tube
port/connector, to the endotracheal tube, while keeping port A, the
bronchoscope port of the BETLA, plugged, awaiting the
bronchoscopist to start.
[0045] After unplugging port A, a bronchoscopist inserts a
bronchoscope into the endotracheal tube via port A of the BETLA.
(Because of the inner diameter of port A is adjustable, rather than
being fixed as in all current analogous adaptors, the BETLA can
accommodate various sizes of bronchoscopes depending on the
intended procedures and patients' anatomy). As part of the
procedure, the bronchoscopist examines the general structures of
patient's lungs, cleans up visible secretions if any, and takes
photos for the record. The bronchoscopist navigates along the
bronchial tree as if on enclosed highways inside the lung space by
performing a variety of manipulations, such as pulling up, pushing
down, rotating left and right of the bronchoscope, and flipping the
bronchoscope tip by a deflection of the lever up and down,
eventually driving the bronchoscope to the nearest point of the
intended target(s). The bronchoscopist starts with the right upper
lobe lesion, navigates to positions the bronchoscope tip to the
nearest point of the intended target(s) according to pre-planned
navigational path. This predetermined navigational path is planned
and chosen by combining of computer software mapping of airways,
targets and the expertise of the bronchoscopist. The navigation
process is accomplished with viewing both live and visual images in
a three-dimensional fashion. Once the bronchoscope tip reaches its
furthest point allowed (either limited by the diameter of the
patient's bronchial airway tree and/or the angle of the bronchial
tree branch), the bronchoscopist introduces an extended working
channel (EWC) with a locatable guide (LG) in place through the
bronchoscope work channel. This EWC and LG have much smaller
diameters and far more flexible tips, allowing the bronchoscopist
to overcome the size and angular limitations of the bronchoscope
itself. By using the EWC and LG the bronchoscopist reaches to the
smaller, more distal portions of the bronchial tree where the
target of interest resides. Once the tip of LG arrives the chosen
target, the bronchoscopist locks the bronchoscope at the
endotracheal tube by turning the screw/dial on BETLA until the
bronchoscope is locked at the desired position, then locks the EWC
at the orifice of the working channel on the bronchoscope by
existing devices and methods (described in "System of accessories
for use with bronchoscope" to Greenberg, Bet al., U.S. Pat. Nos.
8,663,088; 8,317,149 to Greenburg B. et al. and PCT patent
application no, WO 03/086498 entitled "Endoscope Structure and
Techniques for Navigation in Branched Structure" to Gilboa). The
bronchoscopist then removes the LG and inserts the tools of choice
(biopsy forceps, aspiration needle, needle brush, fiducial or
such), through the EWC to accomplish intended tasks (such as a
biopsies of the lesion or the placement of the fiducial, etc.).
After finishing up the lesion at right upper lobe, the
bronchoscopist unlocks both BETLA and EWC/LG, repositions the
bronchoscope to navigate to a new target at right middle lobe. This
is achieved by loosening up the grip of bronchoscope, and by
adjusting the screw/dial on BETLA. A smooth driving up and down
till the bronchoscopist reaches the nearest point the bronchoscope
allowed to the new target, and repeats the above navigational
process with EWC/LG and places the LG tip to the closest point
either near or on the new target, completes the intended tasks,
e.g., biopsy of the lesion, placing of a fiducial mark. In case
there is a need to remove the bronchoscope from the BETLA during
procedure or at the end of operation, the bronchoscopist can plug
port A of the BETLA to maintain the airtight integrity of
ventilation system, to continue providing mechanical ventilation
until the patient is awake, and it is safe for the patient to be
extubated to breathe on his own.
[0046] Using the BETLA is complimentary to existing devices, as the
bronchoscopist is able to achieve complete control and maneuver of
bronchoscope and EWC, LG through the whole process without the
assistance of others, i.e., the bronchoscopist can perform all of
these tasks: navigation, positioning, locking of bronchoscope by
himself/herself, except passing and receiving tools from supporting
staffs. Using the BETLA, the bronchoscopist overcomes a number of
sources of mechanical disturbance, such as the respiration of the
patient, the respiration of the bronchoscopist and the repeated
maneuvers at the orifice of the EWC: changes of instruments,
repeated sampling, etc. These undesired and inevitable disturbances
and their resulting unintended movements of the bronchoscope,
movements or displacements of the EWC tip away from the intended
target, etc., can be either completely stopped or significantly
minimized by using the BETLA.
[0047] Using the BETLA provides and maintains an airtight seal of
the ventilator system during and after the operation, reduces the
number of personnel required, reduces human errors and gives the
bronchoscopist the total control of navigation, targeting, locking
and adjusting the bronchoscope, and locking and adjusting the EWC
and LG as desired. Use of the BETLA leads to a greater precision in
accomplishing the intended tasks, improves the diagnostic yield of
bronchoscopic biopsies, delivers therapeutic modality, such as
fiducial, laser to a more precise target location, and cuts down
the existing operation cost.
[0048] Although the foregoing invention has been described in some
detail by way of illustration and example for purposes of clarity
of understanding, it is readily apparent to those of ordinary skill
in the art in light of the teachings of this invention that certain
changes and modifications may be made thereto without departing
from the spirit or scope of the appended claims.
[0049] Accordingly, the preceding merely illustrates the principles
of the invention. It will be appreciated that those skilled in the
art will be able to devise various arrangements which, although not
explicitly described or shown herein, embody the principles of the
invention and are included within its spirit and scope.
Furthermore, all examples and conditional language recited herein
are principally intended to aid the reader in understanding the
principles of the invention and the concepts contributed by the
inventors to furthering the art, and are to be construed as being
without limitation to such specifically recited examples and
conditions. Moreover, all statements herein reciting principles,
aspects, and embodiments of the invention as well as specific
examples thereof, are intended to encompass both structural and
functional equivalents thereof. Additionally, it is intended that
such equivalents include both currently known equivalents and
equivalents developed in the future, i.e., any elements developed
that perform the same function, regardless of structure. The scope
of the present invention, therefore, is not intended to be limited
to the exemplary embodiments shown and described herein. Rather,
the scope and spirit of present invention is embodied by the
appended claims.
* * * * *