U.S. patent application number 16/599382 was filed with the patent office on 2020-02-13 for body-inserted tube cleaning.
The applicant listed for this patent is ENDOCLEAR LLC. Invention is credited to Arthur Bertolero, James M. Gracy, Brad E. Vazales, Ken Watson.
Application Number | 20200046453 16/599382 |
Document ID | / |
Family ID | 42539143 |
Filed Date | 2020-02-13 |
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United States Patent
Application |
20200046453 |
Kind Code |
A1 |
Vazales; Brad E. ; et
al. |
February 13, 2020 |
BODY-INSERTED TUBE CLEANING
Abstract
Systems, devices, and methods are disclosed for the cleaning of
an endotracheal tube while a patient is being supported by a
ventilator connected to the endotracheal tube for the purpose of
increasing the available space for airflow or to prevent the build
up of materials that may constrict airflow or be a potential nidus
for infection. In one embodiment, a method for cleaning
endotracheal tubes comprises inserting a cleaning device within an
endotracheal tube while a cleaning member is in a compressed
position, radially expanding the cleaning member to an expanded
position within the endotracheal tube, and withdrawing the cleaning
device from the endotracheal tube with the cleaning member in the
expanded position.
Inventors: |
Vazales; Brad E.; (Petoskey,
MI) ; Bertolero; Arthur; (New York, NY) ;
Watson; Ken; (Milwaukee, WI) ; Gracy; James M.;
(Harbor Springs, MI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ENDOCLEAR LLC |
San Ramon |
CA |
US |
|
|
Family ID: |
42539143 |
Appl. No.: |
16/599382 |
Filed: |
October 11, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15971449 |
May 4, 2018 |
10441380 |
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16599382 |
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14816356 |
Aug 3, 2015 |
9962233 |
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15971449 |
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14100321 |
Dec 9, 2013 |
9095286 |
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14816356 |
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13775024 |
Feb 22, 2013 |
8601633 |
|
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14100321 |
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12701421 |
Feb 5, 2010 |
8382908 |
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13775024 |
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61150456 |
Feb 6, 2009 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 1/06 20130101; A61M
25/0097 20130101; A61B 1/2676 20130101; A61B 1/04 20130101; A61M
16/04 20130101; A61M 25/1002 20130101; A61M 39/16 20130101; A61B
1/267 20130101; A61M 2202/203 20130101; A61B 2090/701 20160201;
A61B 1/00096 20130101; A61M 16/0486 20140204; A61B 1/00082
20130101; A61B 1/122 20130101; A61B 1/126 20130101; B08B 9/0436
20130101; A61B 90/70 20160201; A61M 2209/10 20130101; A61M 16/0833
20140204; A61M 16/0434 20130101; A61M 16/0463 20130101 |
International
Class: |
A61B 90/70 20060101
A61B090/70; A61M 39/16 20060101 A61M039/16; A61M 25/10 20060101
A61M025/10; A61M 25/00 20060101 A61M025/00; A61B 1/06 20060101
A61B001/06; A61B 1/04 20060101 A61B001/04; A61B 1/00 20060101
A61B001/00; B08B 9/043 20060101 B08B009/043; A61B 1/12 20060101
A61B001/12; A61B 1/267 20060101 A61B001/267; A61M 16/04 20060101
A61M016/04; A61M 16/08 20060101 A61M016/08 |
Claims
1. (canceled)
2. A cleaning device for removing biofilm from a body-inserted
medical tube comprising: an elongate body comprising a distal end
and a proximal end; a cleaning member positioned along the elongate
body, wherein the cleaning member is selectively movable between a
radially-collapsed configuration and a radially-expanded
configuration, wherein at least a portion of the cleaning member 1s
configured to circumferentially contact an interior surface of the
medical tube when in the radially-expanded configuration, wherein
the cleaning member, when m the radially-expanded configuration, is
configured to remove biofilm from the medical tube as the elongate
body is withdrawn from the medical tube; and a suction channel
extending along an interior of the elongate body, the suction
channel comprising at least one port.
3. The cleaning device of claim 2, wherein the cleaning member
comprises an inflatable balloon.
4. The cleaning device of claim 2, further comprising a light and a
camera.
5. The cleaning device of claim 2, wherein the at least one port is
located at a location along a length of the elongate body.
6. The cleaning device of claim 2, further comprising a
visualization channel extending along a portion of the elongate
body, the visualization channel having a window at a distal end of
the visualization channel, and the visualization channel being
configured to facilitate visualization of the interior of the
medical tube.
7. The cleaning device of claim 2, in combination with a multi-port
adapter comprising a first port configured to couple to a
ventilator, a second port configured for insertion of the cleaning
device, and a third port configured to couple to the medical
tube.
8. The cleaning device of claim 2, wherein the at least one port is
located along the cleaning member.
9. The combination of claim 7, wherein the second port comprises an
elastomeric diaphragm configured to prevent loss of ventilator
tidal volume.
10. The cleaning device of claim 2, wherein the distal end of the
elongate body comprises a closed distal tip.
11. A cleaning device for removing biofilm from a body-inserted
medical tube comprising: an elongate body comprising a distal end
and a proximal end; a cleaning member positioned along the elongate
body, wherein the cleaning member is selectively movable between a
collapsed configuration and an expanded configuration, wherein at
least a portion of the cleaning member is configured to
circumferentially contact an interior surface of the medical tube
when in the expanded configuration, wherein the cleaning member,
when in the expanded configuration, is configured to remove biofilm
from the medical tube as the elongate body is withdrawn from the
medical tube; and a suction channel extending along at least a
portion of the elongate body, the suction channel comprising at
least one port.
12. The cleaning device of claim 11, wherein the cleaning member
comprises an inflatable balloon.
13. The cleaning device of claim 11, wherein the at least one port
is located at a location along a length of the elongate body.
14. The cleaning device of claim 11, wherein the at least one port
is located along the cleaning member.
15. The cleaning device of claim 11, further comprising a
visualization channel extending along a portion of the elongate
body, the visualization channel having a window at a distal end of
the visualization channel, and the visualization channel being
configured to facilitate visualization of the interior of the
medical tube.
16. A cleaning device for removing biofilm from a body-inserted
medical tube, the cleaning device comprising: an elongate body
comprising a distal end and a proximal end; a cleaning member
positioned along the elongate body, wherein the cleaning member is
selectively movable between a collapsed configuration and an
expanded configuration, wherein at least a portion of the cleaning
member is configured to contact an interior surface of a medical
tube when in the expanded configuration, wherein the cleaning
member, when in the expanded configuration, is configured to remove
biofilm from the medical tube as the elongate body is withdrawn
from the medical tube; and a suction channel extending along at
least a portion of the elongate body.
17. The cleaning device of claim 16, wherein the cleaning member
comprises an inflatable balloon.
18. The cleaning device of claim 16, wherein the suction channel
comprises an opening located at a location along a length of the
elongate body.
19. The cleaning device of claim 16, wherein the suction channel
comprises an opening located along the cleaning member.
20. The cleaning device of claim 16, further comprising a
visualization channel extending along a portion of the elongate
body, the visualization channel having a window at a distal end of
the visualization channel, and the visualization channel being
configured to facilitate visualization of the interior of the
medical tube.
21. The cleaning device of claim 16, further comprising a light and
a camera.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 14/816,356, filed Aug. 3, 2015, which is a
continuation of U.S. patent application Ser. No. 14/100,321, filed
Dec. 9, 2013, now U.S. Pat. No. 9,095,286, which is a continuation
of U.S. patent application Ser. No. 13/775,024, filed Feb. 22,
2013, now U.S. Pat. No. 8,601,633, which is a continuation of U.S.
patent application Ser. No. 12/701,421, filed Feb. 5, 2010, now
U.S. Pat. No. 8,382,908, which claims the priority benefit under 35
U.S.C. .sctn. 119(e) of U.S. Provisional Application No.
61/150,456, filed Feb. 6, 2009, the entirety of each of which is
hereby incorporated by reference herein.
BACKGROUND
Field
[0002] This application relates generally to the cleaning of
body-inserted tubes and, more specifically, to devices, systems,
and methods for removing fluids, secretions and/or other materials
from a lumen of an endotracheal tube.
Description of the Related Art
[0003] An endotracheal tube is used in patient care to provide a
clear airway through the mouth, pharynx, and trachea into the
tracheobronchial tree. Use of an endotracheal tube is appropriate
when the integrity of the airway is, or may become, challenged due
to trauma or pathology, or if a patient cannot otherwise breathe
unaided. Often the endotracheal tube is coupled to a mechanical
ventilator to aid the patient's respiration, and can be expected to
remain in situ for an extended time until the patient is once again
able to breathe on his own.
[0004] Endotracheal tubes are used in millions of patients around
the world to support life after major surgery, trauma, or the
development of certain severe medical conditions such as pneumonia
and sepsis. Patients with endotracheal tubes may be supported by
the ventilator for days, weeks or months.
[0005] In certain circumstances, secretions and debris (biofilm)
begin to accumulate on the inside wall of the endotracheal tubes
shortly after (e.g., within 24 hours) of initial intubation. The
biofilm can contain harmful bacteria (e.g., gram-negative
organisms) that, if not removed in a timely and efficient manner,
can be a potential nidus for infection. Endotracheal intubation is
the single most important risk factor for hospital-acquired
pneumonia. Intubated patients experience a much greater risk of
developing hospital-acquired pneumonia than patients who are not
ventilated. Further, ventilator-acquired pneumonia (VAP) is the
leading cause of morbidity and mortality in the intensive care unit
(ICU), and once present, can double the expected mortality for
affected patients.
[0006] In certain circumstances. VAP significantly increases the
cost of hospitalization. Tracheostomy can further increase the cost
of dealing with such conditions. As these are typically classified
as hospital-acquired infections, health insurance providers may
stop reimbursement for VAP. Because VAP is so prevalent for
intubated patients, this could vastly increase the cost to health
care providers.
SUMMARY
[0007] There remains a need for systems, methods and devices for
the cleaning of endotracheal tubes that are effective and efficient
so that the tube cleanings can be reasonably carried out on a
regular and preventative basis, rather than only when a particular
problem arises. There also remains a need for systems, methods and
devices for the cleaning of endotracheal tubes that prevent the
build up of materials, perform the cleaning quickly, and that
permit sufficient airflow through the endotracheal tube during
use.
[0008] Frequently, it is not practical or clinically acceptable to
change out the endotracheal tube when there is a buildup of biofilm
in order to remove the endotracheal tube for cleaning. Removal and
reinsertion of the endotracheal tube can be uncomfortable for the
patient, can cause injury to the native airway, and can put
reliable control of the airway at risk. Thus, several embodiments
of the invention permit the cleaning of an endotracheal tube
without the need to remove the endotracheal tube from the
patient.
[0009] Some embodiments of the invention are particularly
advantageous because it avoids the need for "blind" suctioning of
the biofilm with a suction catheter. Thus, in several embodiments,
the invention minimizes patient discomfort and avoids long periods
of breathing interruption.
[0010] Some embodiments of the invention are advantageous because
they do not employ a balloon or other seal as a cleaning member.
Thus, in some embodiments, the invention facilitates airflow
through the endotracheal tube during cleaning. In addition,
problems associated with rupture of the balloon or the inability to
adequately deflate the balloon are avoided in some embodiments. In
some embodiments, the invention comprises a cleaning device that
can be operated by a single user. In one embodiment, the invention
comprises a cleaning device that can be operated by a single user
using one hand. Thus, several embodiments are particularly
advantageous because of the simplicity of one-handed operation and
the reduced time needed for mechanically actuating the device (as
opposed to inflating a balloon). In one embodiment, the cleaning
device does not require multiple passes to clean the endotracheal
tube, although the device is suitable for repeated closure and
expansion if desired.
[0011] In some embodiments, the cleaning device removes harmful
bacteria from the endotracheal tube by removing biofilm. In several
embodiments, the cleaning device comprises a scaffold (e.g., mesh
scaffold), or other collection member, for trapping the harmful
biofilm, thereby reducing the vaporization or travel of harmful
bacteria during the cleaning process.
[0012] In some embodiments, the removal of biofilm not only removes
a source of harmful bacteria, but also enhances airflow and
respiration. Biofilm can accumulate over time to a level that
impairs ventilation by significantly reducing the cross-sectional
area of the lumen of the endotracheal tube. For example, a 1 mm
thick layer of biofilm in an endotracheal tube having an 8 mm
inside diameter can reduce the cross-sectional area available for
air flow by approximately 50%. Progressive airway occlusion within
the endotracheal tube can make weaning and extubating the patient
difficult or impossible, and may lead to the need for a
tracheostomy.
[0013] In several embodiments, the devices described herein are
inserted to a variable, predetermined depth inside the endotracheal
tube and when the cleaning member is deployed to engage the inner
surface of the endotracheal tube, air exchange through the deployed
cleaning member can still occur. In some embodiments, the
endotracheal tube cleaning device has a lockable, adjustable
insertion stop that prevents the device from being inserted too far
into the patient's ET tube, thereby avoiding potential injury to
the patient's airway.
[0014] In some embodiments, the endotracheal tube cleaning devices
described herein can accommodate a viewing element in an internal
channel or lumen for training purposes, to assess the inside
surface of an endotracheal tube, and/or to determine the position
of the tip of the endotracheal tube in relation to the patient's
carina.
[0015] In some embodiments, the endotracheal tube cleaning devices
have a simple expansion mechanism and can be manufactured from
inexpensive and/or disposable materials to keep costs low. By
reducing patient care costs, the endotracheal tube cleaning device
can be used on a regular and preventative basis and not just when
trouble arises.
[0016] A cleaning device according to some embodiments of the
invention has a cleaning member that can be rapidly deployed, the
tube cleaned of build up, and the cleaning device removed in a
manner such that the patient can continue to be supported by a
ventilator with only the briefest interruption.
[0017] According to some embodiments, a mechanically-actuated
non-inflatable cleaning device for scraping debris (e.g., biofilm)
from an interior wall of a conduit is provided. In one embodiment,
the cleaning device comprises an elongated member having a proximal
end and a distal end and a mechanically-expandable scaffold (e.g.,
mesh scaffold, struts, etc.) positioned along the distal end of the
elongated member. The mechanically-expandable scaffold is adapted
to move between a radially-collapsed position and a
radially-expanded position. Further, in one embodiment, the
scaffold comprises one or more removal members (e.g., O-ring,
wiper, piston ring, etc.) extending outwardly (e.g., radially) from
an outer surface of the scaffold. In some embodiments, the removal
member is configured to engage an interior surface of a conduit
when the scaffold is in the radially-expanded position. In other
embodiments, expansion of the scaffold can be configured so that
the removal member does not contact the inside surface of the
conduit. In other embodiments, the expansion and collapse of the
scaffold can be selectively regulated to easily modify the radial
expansion of the removal member coupled to the scaffold. In some
embodiments, the removal member is configured to scrape, shear,
dislodge, loosen or otherwise remove debris collected on an
interior surface of the conduit when said cleaning device is moved
relative to the conduit. In several embodiments, the scaffold
comprises pores (e.g., mesh structure), other orifices or openings
and/or the like that are configured to trap the scraped debris. The
cleaning device additionally includes an actuation assembly coupled
to the proximal end of the elongated member. In some embodiments,
the scaffold is configured to move between the radially-collapsed
position and the radially-expanded position (e.g., a fully
radially-collapsed position, a fully radially-expanded position, a
partially radially-collapsed position, a partially
radially-expanded position, etc.) by manipulation of the actuation
assembly (e.g., trigger, handle, lever, etc.). In some embodiments,
the expansion and collapse of the scaffold occurs mechanically. In
some embodiments, the actuation assembly provides single action
expansion and single action collapse of the scaffold.
[0018] In one embodiment, the removal member (e.g., one or more
O-rings, wipers, etc.), scaffold (e.g., mesh scaffold), struts,
ribs, the collection member and/or any other portion of the
cleaning device or system are configured to be actively
mechanically actuated between an expanded configuration and a
collapsed configuration. In some embodiments, the removal member,
scaffold, struts, ribs, the collection member and/or any other
portion of the cleaning device or system are actively mechanically
actuated without the use of a sheath, sleeve, covering or similar
member. In another embodiment, the removal member, scaffold,
struts, ribs, the collection member and/or any other portion of the
cleaning device or system are non-bristled, non-inflatable and/or
non-sheathed.
[0019] According to some embodiments, a non-inflatable,
mechanically-actuated cleaning device for removing biofilm from an
interior wall of an endotracheal tube or other conduit comprises an
elongate body having a distal end, a proximal end, a longitudinal
axis and a diameter in the range of about 1 mm to about 5 mm. The
cleaning device further comprises a scaffold (e.g., mesh scaffold)
positioned at the distal end of the elongate body. In some
embodiments, the scaffold is positioned near the proximal end of
the elongate body or at any other location along the elongate body.
In one embodiment, the cleaning device comprises one or more
O-rings or other removal members coupled to the scaffold (e.g.,
mesh scaffold) and a non-inflatable actuation assembly coupled to
the proximal end of the elongate body for mechanically-actuating
the expansion of the scaffold. In some embodiments, the scaffold is
radially expandable between a collapsed position and an expanded
position by manipulation of the actuation assembly. In one
embodiment, the level of expansion and/or collapse can be precisely
controlled between fully-expanded and fully-collapsed positions. In
several embodiments, the O-ring or other removal member is
configured to engage an interior surface of an endotracheal tube
when the scaffold is in the expanded position. In some embodiments,
the O-ring is configured to remove biofilm collected on the
interior surface of an endotracheal tube when said O-ring is moved
along the longitudinal axis of the elongate body. In one
embodiment, the scaffold comprises a porous architecture configured
for facilitating the in-flow of said biofilm into an interior of
the scaffold, thereby trapping at least a portion of the biofilm
within the scaffold. In other embodiments, one or more portions of
the scaffold are non-porous or substantially non-porous so as to
prevent or reduce the likelihood of biofilm and/or other materials
from passing therethrough. In several embodiments, the scaffold
(e.g., mesh scaffold) is configured to allow airflow through the
endotracheal tube in the collapsed position and the expanded
position. In some embodiments, the actuation assembly is configured
for one-handed manipulation of the cleaning device during a
cleaning procedure.
[0020] In some embodiments, the conduit to be cleaned is a gun
barrel, and the cleaning device or system comprises one or more
removal members that are configured to remove oil, grease,
oxidation, rust, mineral deposits, scale, other types of deposits,
gun powder residue, other types of combustion residue and/or the
like. In other embodiments, the conduit to be cleaned is a pipe,
duct, flue (e.g., boiler flue), exhaust conduit or tubing, and the
cleaning device or system comprises one or more removal members
that are configured to remove sludge, mineral deposits, rust, other
oxidation, grease, oil, soot, biofilm, scum, scale and/or the
like.
[0021] According to some embodiments, a non-inflatable,
mechanically-actuated cleaning device for removing biofilm from an
interior wall of an endotracheal tube comprises an elongate body
having a distal end, a proximal end and a longitudinal axis, and a
cleaning member positioned at or near the distal end of the
elongate body. In some embodiments, the cleaning member is
positioned near the proximal end of the elongate body, generally
between the distal and proximal ends of the elongate body and/or at
any other location along the elongate body. In one embodiment, the
distal end of the elongate body comprises a tip. In some
embodiments, the cleaning member comprises a removal member and a
collection member, such that the removal member is selectively
movable between a radially-collapsed position and a
radially-expanded position. In several embodiments, the removal
member is configured to engage an interior surface of an
endotracheal tube when in the radially-expanded position. In other
embodiments, the removal member is configured to engage at least a
portion of a biofilm layer positioned along the interior surface of
an endotracheal tube when in the radially-expanded position. In
some embodiments, the removal member is configured to be expanded
to any one of a plurality of possible expanded positions. In one
embodiment, the possible expanded positions for the removal member
are generally between a fully collapsed and a fully expanded
position.
[0022] According to several embodiments, the removal member is
configured to remove biofilm collected on the interior surface of
an endotracheal tube when the removal member is moved along the
longitudinal axis of the elongate body. In other embodiments, the
removal member is configured to remove biofilm when it is moved
relative to the endotracheal tube. In some embodiments, the
non-inflatable, mechanically-actuated cleaning device further
comprises one or more collection members configured to collect at
least a portion of removed biofilm. In several embodiments, the
collection member is configured to allow airflow through the
endotracheal tube. In other embodiments, the cleaning device
additionally comprises a non-inflatable actuation assembly coupled
to the elongate body. In one embodiment, the actuation assembly is
located at or near the proximal end of the elongate body. According
to some embodiments, the removal member is movable between the
radially-collapsed position and the radially-expanded position by
manipulation of the actuation assembly. In another embodiment, the
expansion and collapse of the removal member occurs mechanically
and not using inflation balloons and/or other hydraulic devices or
features.
[0023] In some embodiments, the outside diameter of the elongate
body of the cleaning device is about 0.05 mm to about 10 mm (e.g.,
from about 1 mm to about 5 mm, about 2 mm to about 4.5 mm, about
2.5 mm to about 3.5 mm, about 5 mm to about 8 mm, about 8 mm to
about 10 mm, or greater, and overlapping ranges thereof). In some
embodiments, the length of the elongate body is about 10 cm to
about 70 cm, or greater. (e.g., from about 10 cm to about 20 cm,
about 20 cm to about 30 cm, about 30 cm to about 40 cm, about 40 cm
to about 50 cm, about 50 cm to about 70 cm, and overlapping ranges
thereof). In one embodiment, the length of the elongate body is
about 29 cm to about 45 cm.
[0024] In some embodiments, the cleaning member is positioned at,
near or proximate to the distal end of the elongate body. In other
embodiments, the cleaning member is positioned anywhere along the
elongate body. In several embodiments, the collection member
comprises an expandable scaffold configured to expand the removal
member into the radially-expanded position. According to some
embodiments, the collection member comprises a mesh or another
member having a plurality of pores, orifices or other openings. In
some embodiments, the actuation assembly is configured to permit a
user to modify radial expansion of the removal member in order to
modify a pressure exerted by the removal member on an inside
surface of an endotracheal tube or on a biofilm deposited thereon.
In one embodiment, the expansion of the removal member can be
varied along a spectrum or range generally defined between a
fully-collapsed positioned and a fully-expanded position.
[0025] According to some embodiments, the non-inflatable,
mechanically-actuated cleaning device for removing biofilm from an
interior wall of an endotracheal tube includes a cleaning device
having an elongate body which comprises an inner shaft and an outer
shaft, such that movement of the inner shaft relative to the outer
shaft causes the removal member to move between collapsed and
expanded radial positions. In some embodiments, the removal member
is moved between a radially-collapsed position and a
radially-expanded position by deployment of at least one strut or
similar member located at or near the cleaning member. In other
embodiments, the removal member of the cleaning device comprises
one or more expandable wiper members.
[0026] According to some embodiments, the cleaning member of the
cleaning device comprises an expandable spring or an expandable
collet. In several embodiments, the removal member comprises a
generally smooth outer surface. In other embodiments, the elongate
body of the cleaning device comprises at least one interior lumen
that extends at least partially along the length of the elongate
body. In some embodiments, the cleaning device additionally
comprises one or more ports in the elongate body and/or the
actuation assembly that provides access to the interior lumen of
the elongate body.
[0027] In some embodiments, the distal tip of the elongate body
comprises a viewing window or other feature or portion through
which visualization can occur. In one embodiment, the elongate body
of the cleaning device comprises one or more interior lumens,
channels or other openings to provide access to a location along an
exterior of the elongate body. In other embodiments, the removal
member can have one or more openings that provide access to a
location along an exterior of the cleaning device. In some
embodiments, the openings along the elongate body and/or the
removal member allow for the aspiration and/or irrigation of fluids
or other materials. In several embodiments, an interior lumen or
other opening of the elongate body is configured to receive at
least one of a visualization scope, an aspiration conduit, an
irrigation conduit, a light therapy source or a ventilation
conduit. In some embodiments, catheters or other instruments
configured to be positioned through one or more lumens of the
elongate body or other portion of the cleaning device comprise
ultrasonic catheters, radio frequency (RF) catheters, irrigation
catheters, aspiration catheters, drug delivery catheters, catheters
for delivering light for photodynamic or other light-based therapy,
other types of catheters or devices, and/or combinations thereof.
In one embodiment, the elongate body comprises one or more openings
at or near the distal tip. In other embodiments, the elongate body
comprises one or more openings near its proximal end and/or at any
other location along the length of the elongate body.
[0028] According to some embodiments, the actuation assembly is
configured for one-handed manipulation of the cleaning device
during a cleaning procedure. In other embodiments, the cleaning
device is configured for single pass cleaning. In other
embodiments, the cleaning device is configured for multiple pass
cleaning. In certain embodiments, the cleaning device is used to
clean endotracheal tubes having a variety of diameters and lengths.
In some embodiments, the removal member is positioned along an
exterior surface of the collection member. In one embodiment, the
removal member is positioned, at least partially, along an interior
portion of the collection member.
[0029] In other embodiments, the removal member generally divides
the collection member into a first portion and a second portion,
such that the first portion is situated at a location proximal to
the removal member and the second portion is situated at a location
distal to the removal member. In some embodiments, the first
portion is configured to generally allow biofilm to pass
therethrough and the second portion is configured to generally
prevent biofilm from passing therethrough, such that biofilm is
collected and trapped within a cavity of the collection member as
the cleaning device is moved relative to an endotracheal tube. In
some embodiments, the first portion comprises a plurality of pores
or openings that are larger in cross-sectional shape than second
pores or openings of the second portion.
[0030] According to some embodiments, the removal member is
positioned along an exterior surface of the collection member so as
to generally divide the collection member into a first portion and
a second portion. The first portion is situated proximal to the
removal member and the second portion is situated distal to the
removal member. In one embodiment, the first and second portions
form a generally convex, concave or any other shape when the
removal member is in a radially expanded position. According to
some embodiments, the removal member and the collection member are
separate items that are permanently or removably attached to each
other. In other embodiments, the removal member and the collection
member are integrally formed as part of a unitary structure.
[0031] According to several embodiments, a cleaning system for
clearing debris from an interior wall of a medical tube (e.g.,
endotracheal tube, catheters, probes, body lumens, arteries, veins,
other vasculature, grafts, aspiration conduits, ventilation tubes,
etc.) includes an elongated member having a proximal end and a tip
along its distal end. In one embodiment, the elongated member
comprises one or more lumens or other channels extending within its
interior. In some embodiments, the cleaning system additionally
comprises a mechanically-expandable scaffold positioned along the
elongated member. In one embodiment, the scaffold is adapted to be
selectively moved between a radially-collapsed position and a
radially-expanded position. In several embodiments, the scaffold is
moved between fully-expanded and fully collapsed radial positions.
In other embodiments, the scaffold is configured to be moved to any
partially-expanded or partially-collapsed position that is
generally between the fully-expanded and fully-collapsed radial
positions. In some embodiments, the scaffold is configured to be
moved between the radially-collapsed position and the radially
expanded-position using one or more self-expanding members,
expanding members releasably positioned within a sheath,
umbrella-type members and/or the like.
[0032] In some embodiments, the scaffold (e.g., mesh scaffold)
comprises one or more removal members (e.g., O-rings, wipers,
squeegees, piston rings, etc.) extending outwardly (e.g., radially)
from an outer surface of the scaffold. In other embodiments, the
removal member is at least partially positioned within or through
the scaffold. In several embodiments, the removal member is
configured to engage an interior surface of a medical tube and/or
at least a portion of the biofilm situated within the medical tube
when the scaffold is in the radially-expanded position. In another
embodiment, the removal member is configured to contact and remove
debris collected on an interior surface of a medical tube when the
mechanically-expandable scaffold is moved relative to the medical
tube. The cleaning system additionally comprises an actuation
assembly coupled to the proximal end of the elongated member. In
some embodiments, the scaffold (e.g., mesh scaffold) is configured
to move between the radially-collapsed position and the radially
expanded-position by manipulation of the actuation assembly (e.g.,
trigger, handle, other mechanical actuator, button, other
controller, etc.). In some embodiments, expansion and collapse of
the scaffold occurs mechanically and not hydraulically (e.g.,
without the use of a balloon or other inflatable member).
[0033] In several embodiments, the cleaning system further
comprises a visualization element configured for insertion into a
lumen of the elongated member for visualizing the interior of the
medical tube.
[0034] According to some embodiments, the cleaning system comprises
a collection member configured to collect at least a portion of
removed biofilm. In one embodiment, the scaffold comprises at least
one layer of mesh. In some embodiments, the scaffold comprises one
or more struts, ribs and/or other members that are configured to be
selectively moved. In some embodiments, the scaffold comprises an
umbrella-type structure. In some embodiments, the actuation
assembly is configured to permit a user to selectively expand or
collapse the scaffold in order to modify a pressure exerted by the
at least one removal member on an inside surface of an endotracheal
tube. In several embodiments, the elongated member comprises an
inner shaft and an outer shaft, such that movement of the inner
shaft relative to the outer shaft causes the scaffold to move
between radially collapsed and expanded positions.
[0035] In some embodiments, the removal member comprises one or
more O-rings. In some embodiments, the O-ring has a partial or full
circular, oval, X-shaped, rounded, curvate, or irregular shape, or
combinations thereof. Other suitable shapes may also be used as
desired and/or required. In one embodiment, the removal member
comprises one or more rounded portions or sections. In several
embodiments, the removal member comprises one or more flat,
sharp-edged or cornered portions or sections. In yet other
embodiments, the removal member comprises both rounded and flat or
cornered portions or sections. In certain embodiments, the removal
member comprises one or more wipers. In some embodiments, the
removal member comprises one or more squeegees. In other
embodiments, the removal member comprises one or more blades, sharp
edges, blades and/or the any other type of edge or surface. In
several embodiments, the removal member comprises a helical spring,
another type of coiled spring and/or another type of resilient
member. In one embodiment, the removal member comprises a spring or
other resilient member that normally moves from a
radially-collapsed position to a radially-expanded position when
forces are exerted on it. In other embodiments, the removal member
comprises a spring or other resilient member that normally moves
from a radially-expanded position to a radially-collapsed position
when forces are exerted on it. In other embodiments, the scaffold
comprises an expandable spring or an expandable collet.
[0036] According to several embodiments, the cleaning system
further includes one or more ports in the elongated member, the
actuation assembly and/or any other location. In some embodiments,
the port provides access to the interior lumen of the elongated
member. In other embodiments, the tip of the elongated member
comprises a viewing window, viewing strip, viewing region, other
transparent or translucent region and/or the like. In other
embodiments, the elongated member comprises at least one lumen or
other opening to provide access to a location along an exterior of
the cleaning device. In one embodiment, the actuation assembly is
configured for one-handed manipulation of the cleaning system
during a cleaning procedure. In other embodiments, the cleaning
device is configured for single pass cleaning. In some embodiments,
the cleaning system is suitable for use with endotracheal tubes of
varying diameters and lengths.
[0037] Several embodiments of the invention comprise a method of
removing debris from the inside of a conduit. In some embodiments,
the conduit is a medical tube. In some embodiments, the conduit is
an endotracheal tube. According to some embodiments, methods for
removing biofilm from an interior wall of an endotracheal tube or
other conduit using the cleaning devices described herein are
provided.
[0038] In one embodiment, the method comprises providing a
non-inflatable, mechanically-actuated cleaning device configured to
remove biofilm from an interior wall of an endotracheal tube and/or
the vicinity thereof. In several embodiments, the endotracheal tube
is inserted into the native airway of a patient and coupled to an
external ventilator. In some embodiments, the cleaning device is
not balloon inflatable. In several embodiments, the cleaning device
comprises an elongate body, a mesh scaffold or other type of
scaffold, one or more removal members and an actuation assembly. In
one embodiment, the elongate body comprises a distal end, a
proximal end and a longitudinal axis. In some embodiments, the
scaffold is positioned at the distal end of the elongate body. In
one embodiment, the scaffold is positioned at or near a tip of the
elongate body. In other embodiments, the scaffold is positioned at
any along the elongate body. In some embodiments, the removal
member is coupled to the scaffold. In several embodiments, the
removal member is a separate member from the scaffold that is
permanently or removably attached to the scaffold. In other
embodiments, the removal member and the mesh are integrally formed
as a unitary structure.
[0039] According to several embodiments, the method additionally
comprises decoupling the endotracheal tube from an external
ventilator, inserting the distal end of the cleaning device into
the endotracheal tube while the scaffold is in a collapsed position
and mechanically actuating the mesh scaffold using the actuation
assembly to expand the mesh scaffold from the collapsed position to
an expanded position, thereby expanding the removal member to
contact the biofilm and/or an inside surface of the endotracheal
tube. The method further comprises withdrawing the cleaning device
from the endotracheal tube while maintaining contact between the
removal member and the biofilm and/or an interior surface of the
endotracheal tube in order to dislodge at least a portion of
biofilm. In some embodiments, the method further comprises
collecting some or all of the dislodged biofilm within the mesh
scaffold and removing the cleaning device from the patient. In
several embodiments, the method additionally comprises coupling the
endotracheal tube to the external ventilator.
[0040] According to some embodiments, the removal member of the
cleaning device used in the biofilm removal method comprises a
smooth outer periphery. In some embodiments, the removal member
comprises a blunt outer surface. In other embodiments, the removal
member comprises a non-smooth and/or a non-blunt outer periphery or
surface. In some embodiments, the cleaning device comprises two or
more removal members. In another embodiment, the removal member
comprises one or more O-rings. In some embodiments, the O-ring has
a circular, oval. X-shaped, rounded, curvate, irregular and/or any
other shape, or a portion thereof. In another embodiment, the
removal member comprises one or more rounded portions or sections.
In other embodiments, the removal member comprises one or more
flat, sharp-edged or cornered portions or sections. In yet other
embodiments, the removal member comprises both rounded and flat or
cornered portions or sections. In certain embodiments, the removal
member comprises one or more wipers. In some embodiments, the
removal member comprises one or more squeegees. In other
embodiments, the removal member comprises one or more blades, sharp
edges, blades and/or the any other type of edge or surface. In
several embodiments, the removal member comprises a helical spring,
another type of coiled spring and/or another type of resilient
member. In one embodiment, the removal member comprises a spring or
other resilient member that normally moves from a
radially-collapsed position to a radially-expanded position when
forces are exerted on it. In other embodiments, the removal member
comprises a spring or other resilient member that normally moves
from a radially-expanded position to a radially-collapsed position
when forces are exerted on it.
[0041] According to some embodiments, the one or more removal
members are coupled to the scaffold using one or more adhesives,
stitches, welds, hot melt connections, braided connections,
fasteners and/or any other attachment method or device. In some
embodiments, the removal member is positioned, at least partially,
along the outside of the scaffold. In other embodiments, the
removal member is positioned, at least partially, within the
interior of the scaffold member and/or through the scaffold member.
In yet other embodiments, the removal member is routed through
exterior and interior portions or sections of the scaffold.
According to some embodiments, the removal member is positioned
along a single plane or generally within a single plane that is
generally perpendicular to the longitudinal axis of the elongate
body. In other embodiments, the removal member comprises a
sinusoidal, undulating, curvy, curly and/or wavy shape or design.
In some embodiments, the removal member comprises one or more
elastomeric and/or polymeric materials. In other embodiments, the
removal member comprises a metal, an alloy and/or any other rigid,
semi-rigid and/or flexible material.
[0042] According to several embodiments, the scaffold of the
cleaning device is configured to allow airflow through the
endotracheal tube while the scaffold is in an expanded position. In
some embodiments, the scaffold of the cleaning device is configured
to allow airflow through the endotracheal tube regardless if the
scaffold is in a collapsed or expanded position. In one embodiment,
the scaffold of the cleaning device comprises mesh, one or more
pores, orifices and/or other openings through which air or other
fluids can pass. In some embodiments, the actuation assembly of the
cleaning device is configured for one-handed manipulation of the
cleaning device during a cleaning procedure. In other embodiments,
the actuation assembly of the cleaning device is configured for
two-handed manipulation of the cleaning device during a cleaning
procedure. In one embodiment, the biofilm removal method comprises
only a single pass of the cleaning device through the interior of
the endotracheal tube to achieve an adequate level of cleaning. In
other embodiments, the cleaning device is configured for repeated
expansion and collapse of the scaffold and the removal member,
thereby allowing the same cleaning device to be used more than once
during a biofilm removal method or procedure.
[0043] According to several embodiments, the scaffold comprises a
porous architecture configured to facilitate the collection of
biofilm, debris and/or other materials present within or near the
interior of an endotracheal tube. In some embodiments, the scaffold
comprises a mesh scaffold. In other embodiments, the scaffold
comprises a first section that generally permits biofilm to pass
therethrough and a second section that generally prevents biofilm
from passing therethrough. In one embodiment, the scaffold of the
cleaning device includes an interior cavity or region into which
the removed biofilm and/or other materials are collected and
trapped. In some embodiments, the mesh size, pore size or opening
size of the first section of the scaffold is generally greater than
that of the second section.
[0044] According to some embodiments, the method of removing
biofilm from an endotracheal tube additionally includes providing a
visualization element or device for viewing at least a portion of
the interior wall of the endotracheal tube, a patient's trachea,
tracheobronchial tree and/or any other portion within a patient's
anatomy. In one embodiment, the visualization element comprises an
endoscope, a borescope, another type of visualization scope and/or
any type of viewing element configured to provide visual feedback
to a clinician during a biofilm removal method or procedure. In
several embodiments, the visualization element is inserted through
a lumen of the elongate body. In some embodiments, the elongate
body of the cleaning member comprises one, two or more lumens or
channels through which a visualization element, another type of
catheter or scope and/or other devices can be inserted.
[0045] In some embodiments, the method of removing biofilm from the
inside of an endotracheal tube additionally comprises aspirating
biofilm and/or other materials from an interior of the endotracheal
tube using a suction catheter or other aspiration device. In one
embodiment, aspiration of biofilm occurs prior to inserting the
distal end of the cleaning device into the endotracheal tube.
However, in other embodiments, aspiration of biofilm and/or other
materials occurs while the cleaning device is being inserted into
the endotracheal tube, while the endotracheal tube is being removed
from the endotracheal tube, after the cleaning device has been
removed from the endotracheal tube and/or combinations thereof.
[0046] According to several embodiments, the method of removing
biofilm from an endotracheal tube further comprises irrigating at
least a portion of the interior wall of the endotracheal tube with
a drug, a medicament, a treatment fluid, another type of liquid,
gas, other fluid, solid, gel, paste and/or other materials. In some
embodiments, irrigation fluids and/or other materials are adapted
to disinfect, decontaminate, sterilize and/or otherwise treat the
endotracheal tube. In some embodiments, irrigation fluids and/or
other materials are configured to loosen, break up, penetrate,
degrade, disperse, dissolve and/or otherwise undermine or affect
biofilm deposited on the inside wall or other surface of the
endotracheal tube. In some embodiments, irrigation of the interior
wall of the endotracheal tube is performed using one or more
irrigation catheters or other devices inserted through a lumen or
other channel of the elongate body. In other embodiments,
irrigation comprises delivering a fluid and/or other substances
through a catheter or other conduit that is not routed through an
interior of the elongate body or the cleaning device.
[0047] In several embodiments, a method of removing biofilm from an
endotracheal tube comprises the introduction of one or more
diagnostic and/or therapeutic catheters or other instruments within
one or more lumens or other channels of elongate body. In some
embodiments, catheters or other instruments configured to be
positioned through a lumen of the elongate body or other portion of
the cleaning device comprise ultrasonic catheters, radio frequency
(RF) catheters, irrigation catheters, aspiration catheters, drug
delivery catheters, catheters for delivering light for photodynamic
or other light-based therapy, other types of catheters or devices,
and/or combinations thereof.
[0048] According to some embodiments, a method for cleaning an
inside surface of an endotracheal tube without removing the
endotracheal tube from a native airway of a patient comprises
positioning the patient in a semi-upright position, delivering
concentrated oxygen or oxygen-containing fluid through the
endotracheal tube using a ventilator for a predetermined time
period and aspirating an interior of the endotracheal tube using an
aspiration instrument. In one embodiment, positioning the patient
in a semi-upright position comprises elevating the head of the bed
on which the patient is situated to at least approximately 20 to 40
degrees, (e.g., 30 degrees) relative to horizontal. In some
embodiments, the concentrated oxygen or oxygen-containing fluid
that is delivered to the patient comprises pure oxygen (e.g., 100%
oxygen) or nearly 100% oxygen. In other embodiments, the
concentration of oxygen in the fluid delivered through the
endotracheal tube is less than 100% oxygen, e.g., 95-100%, 90-95%,
80-90%, 70-80% oxygen, air comprising less than 70% oxygen and/or
the like. In some embodiments, the oxygen or oxygen containing
fluid is delivered to the patient for about 10 minutes. In other
embodiments, oxygen or oxygen containing fluid is delivered to the
patient for less than about 10 minutes or longer than about 10
minutes.
[0049] In some embodiments, a method for cleaning an inside surface
of an endotracheal tube without removing the endotracheal tube from
a native airway of a patient additionally includes providing an
endotracheal tube cleaning device having a radially expandable
cleaning member. According to several embodiments, the cleaning
member comprises a removal member. In several embodiments, the
method additionally comprises determining a deployment depth for
the endotracheal tube cleaning device based at least in part on the
length of the endotracheal tube and locking a movable stop on the
endotracheal tube cleaning device at an axial position that causes
deployment of the cleaning member at the determined deployment
location. In some embodiments, the method for cleaning an
endotracheal tube comprises disconnecting the ventilator from the
endotracheal tube.
[0050] According to several embodiments, the method for cleaning an
inside surface of an endotracheal tube without removing the
endotracheal tube from a native airway of a patient additionally
comprises inserting the cleaning device into the endotracheal tube
according to a determined deployment depth and mechanically
actuating the cleaning member from a radially-collapsed position to
a radially-expanded position by manipulating an actuation assembly
of the endotracheal tube cleaning member. In some embodiments,
mechanically actuating the cleaning member causes the removal
member to engage an interior wall of the endotracheal tube and/or a
biofilm layer or other debris located along the interior of the
endotracheal tube. In certain embodiments, the method additionally
includes withdrawing the cleaning device from the endotracheal tube
so as to remove biofilm accumulated on the interior wall of the
endotracheal tube. In one embodiment, the method additionally
includes reconnecting the ventilator to the endotracheal tube after
the cleaning device has been withdrawn or otherwise removed from
the endotracheal tube.
[0051] In some embodiments, the removal member of the cleaning
device comprises a smooth outer periphery or surface. In other
embodiments, the removal member comprises a non-smooth outer
periphery or surface. In one embodiment, the removal member
comprises one or more O-rings, wipers, squeegees, piston rings,
and/or other members. In other embodiments, the cleaning member
comprises a mechanically-expandable mesh scaffold.
[0052] In other embodiments, a method for cleaning an inside
surface of an endotracheal tube without removing the endotracheal
tube from a native airway of a patient additionally includes
providing a visualization element for viewing the interior wall of
the endotracheal tube. In several embodiments, the method comprises
the introduction of one or more diagnostic and/or therapeutic
catheters or other instruments within one or more lumens or other
channels of the cleaning member. In some embodiments, catheters or
other instruments configured to be positioned through the cleaning
member comprise ultrasonic catheters, radio frequency (RF)
catheters, irrigation catheters, aspiration catheters, drug
delivery catheters, catheters for delivering light for photodynamic
or other light-based therapy, other types of catheters or devices,
and/or combinations thereof.
[0053] According to some embodiments, a method for removing biofilm
from an interior wall of an endotracheal tube comprises providing a
non-inflatable, mechanically-actuated cleaning device configured to
remove biofilm from an interior wall of an endotracheal tube. In
one embodiment, the endotracheal tube is inserted into the native
airway of a patient and coupled to an external ventilator. In
several embodiments, the method comprises providing a visualization
element for viewing the interior wall of the endotracheal tube. In
some embodiments, the cleaning device comprises an elongate body, a
scaffold (e.g., mesh scaffold), a removal member and an actuation
assembly. In several embodiments, the elongate body comprises a
distal end, a proximal end and a longitudinal axis. According to
some embodiments, the scaffold is positioned at the distal end of
the elongate body. However, in alternative embodiments, the
scaffold is located along any other portion of the elongate body.
In some embodiments, the removal member is coupled to the
scaffold.
[0054] According to some embodiments, the method for removing
biofilm from an interior wall of an endotracheal tube additionally
comprises decoupling the endotracheal tube from the external
ventilator, inserting the distal end of the cleaning device into
the endotracheal tube while the scaffold is in a collapsed
position, mechanically actuating the scaffold using the actuation
assembly to expand the scaffold from the collapsed position to an
expanded position, thereby expanding the removal member to contact
the biofilm, and withdrawing the cleaning device from the
endotracheal tube while maintaining contact between the removal
member and the biofilm and/or the interior wall of the endotracheal
tube to dislodge biofilm. In some embodiments, the method further
comprises collecting at least a portion of the dislodged biofilm
within the scaffold. In one embodiment, collection of dislodged
biofilm comprises allowing biofilm to pass through a plurality of
openings of the scaffold into an interior space of the scaffold,
and preventing at least a portion of said biofilm from leaving the
interior space of the scaffold. The method additionally comprises
removing the cleaning device from the patient.
[0055] In some embodiments, the method for removing biofilm from an
interior wall of an endotracheal tube additionally comprises
coupling the endotracheal tube to the external ventilator. In one
embodiment, the removal member comprises a smooth outer periphery.
In alternative embodiments, the removal member comprises an outer
surface or periphery that is generally blunt. In other embodiments,
the removal member comprises a non-smooth outer periphery or
surface. In several embodiments, the visualization element is
provided through a lumen of the elongate body of the cleaning
device. In one embodiment, the method additionally includes viewing
the interior wall of the endotracheal tube during insertion and/or
withdrawal removal of the cleaning device.
[0056] According to some embodiments, a method of manufacturing a
device configured to remove biofilm and/or other materials from the
interior of a conduit comprises providing an elongate tube,
securing a mechanically-expandable scaffold on the elongate tube
and mechanically coupling the scaffold to an actuation assembly. In
some embodiments, the device comprises one or more removal members
along a periphery or other surface of the scaffold. The removal
members (e.g., O-rings, wipers, squeegees, piston rings, etc.) are
configured to engage and remove biofilm and/or other materials
collected within an interior wall of the conduit when the scaffold
is in a radially expanded position and the device is withdrawn from
the conduit. In some embodiments, the elongate tube and the removal
member comprise one or more polymeric and/or elastomeric materials.
In several embodiments, the removal member is coupled to the
scaffold using adhesives, stitches, welds, hot melt connections,
braided connections, fasteners and/or any other attachment method
or device.
BRIEF DESCRIPTION OF THE DRAWINGS
[0057] FIG. 1 illustrates a partial cross-sectional view of an
endotracheal tube accounting to one embodiment.
[0058] FIGS. 2A and 2B illustrate perspective and cross-sectional
views, respectively, of an embodiment of an endotracheal tube
cleaning device.
[0059] FIGS. 3A and 3B illustrate partial-sectional views of
embodiments of the endotracheal tube cleaning device of FIG. 2
inserted into the endotracheal tube of FIG. 1.
[0060] FIG. 3C illustrates a distal end of the endotracheal tube of
FIG. 1.
[0061] FIGS. 3D and 3E illustrate collapsed and expanded
configurations, respectively, of a cleaning member of the
endotracheal tube cleaning device of FIG. 2.
[0062] FIG. 4 illustrates an embodiment of an endotracheal tube
cleaning device having a side port.
[0063] FIG. 5 illustrates the proximal end of the endotracheal tube
of FIG. 1 and the proximal end of the endotracheal tube cleaning
device of FIG. 2.
[0064] FIG. 6 illustrates a detailed partial cross-sectional view
of the endotracheal tube cleaning device of FIG. 2.
[0065] FIG. 7 illustrates an embodiment of a collection member of
an endotracheal tube cleaning device.
[0066] FIG. 8 illustrates an embodiment of a collection member
comprising a double-layer mesh scaffold.
[0067] FIGS. 9A-9D illustrate embodiments of a collection member
having a convex distal section and a concave proximal section.
[0068] FIGS. 10A-10H and FIG. 11A illustrate various embodiments of
a removal member of an endotracheal tube cleaning device.
[0069] FIG. 11B illustrates a cleaning member having multiple
removal members.
[0070] FIG. 12 illustrates an embodiment of an endotracheal tube
cleaning device having multiple cleaning members.
[0071] FIGS. 13A-13C illustrate various embodiments of scraping
edges of a removal member of an endotracheal tube cleaning
device.
[0072] FIG. 14 illustrates an embodiment of an endotracheal tube
cleaning device.
[0073] FIG. 15A illustrates a "fish-net" embodiment of a cleaning
member of an endotracheal tube cleaning device.
[0074] FIGS. 15B and 15C illustrate another embodiment of an
endotracheal tube cleaning device comprising deployment struts for
mechanical expansion of a cleaning member.
[0075] FIGS. 16A-16D illustrate various embodiments of mechanisms
for mechanical expansion of a cleaning member of an endotracheal
tube cleaning device.
[0076] FIGS. 17A and 17B illustrate an embodiment of a vented tube
design.
[0077] FIGS. 18A-18C illustrate various embodiments of a helical
spring wireform for mechanical expansion of the cleaning member of
an endotracheal tube cleaning device.
[0078] FIGS. 19A and 19B illustrate an embodiment of a
mechanically-expandable cleaning member.
[0079] FIG. 20 illustrates a perspective view of an actuation
assembly of an endotracheal tube cleaning device.
[0080] FIGS. 21A-21D illustrate perspective views of the components
of the actuation assembly of FIG. 20.
[0081] FIG. 22 illustrates an embodiment of an endotracheal tube
cleaning device having a movable stop and visible depth
markings.
[0082] FIGS. 23A-23E illustrate various embodiments of a movable
stop.
[0083] FIGS. 24A and 24B illustrate two embodiments of an
introduction adapter.
[0084] FIG. 25 illustrates an endotracheal tube cleaning device
inserted within an endotracheal tube positioned within a native
airway of a human patient.
[0085] FIG. 26 is a flow chart illustrating an embodiment of a
process for cleaning an inside surface of an endotracheal tube
while a patient is supported by function of the endotracheal
tube.
[0086] FIG. 27 illustrates an embodiment of a daily extubation
process in which an endotracheal tube cleaning device can be
utilized.
[0087] FIG. 28 illustrates an embodiment of a process for
preventing buildup of biofilm within an endotracheal tube.
DETAILED DESCRIPTION
[0088] The discussion and the figures illustrated and referenced
herein describe various embodiments of a body-inserted tube
cleaning system and device, as well as methods related thereto. A
number of these embodiments of tube cleaning systems, devices and
methods are particularly well suited to remove biofilm from an
interior surface of an endotracheal tube. However, the various
devices, systems, methods and other features of the embodiments
disclosed herein may be utilized or applied to other types of
apparatuses, systems, procedures, and/or methods, whether
medically-related or not. For example, the embodiments disclosed
herein can be utilized for, but are not limited to, cleaning
bronchoscopes, chest drainage tubes, gastrostomy drainage tubes,
abdominal drainage tubes, other body drainage tubes, feeding tubes,
endoscopes, percutaneous dialysis catheters, and any other
percutaneous or per as catheters or body-inserted tubes. In
addition, as discussed in greater detail herein, the various
embodiments disclosed herein can be used to clean conduits, such
as, for example, pipes, tubing, guns, other barreled instruments,
exhausts and/or other devices with lumens or other interior
openings.
[0089] For example, in one embodiment, the conduit to be cleaned is
a gun barrel, and the cleaning device or system is configured to
remove oil, grease, oxidation, rust, mineral deposits, scale, other
types of deposits, gun powder residue, other types of combustion
residue and/or the like. In other embodiments, the conduit to be
cleaned is a pipe, duct, flue (e.g., boiler flue), exhaust conduit
or tubing, and the cleaning device or system is configured to
remove sludge, mineral deposits, rust, other oxidation, grease,
oil, soot, biofilm, scum, scale and/or the like.
[0090] The materials used for the various components of the
endotracheal tube cleaning devices and systems described herein can
advantageously comprise one or more biocompatible materials.
[0091] The term "biofilm" as used herein shall be given its
ordinary meaning and shall include, without limitation, biological
fluids, solids, gels, deposits, films, debris, and/or secretions,
such as mucosal secretions, blood, bacteria, viruses, other
microorganisms, protein, feces, urine, albumin and/or any other
biological or biologically-related materials.
[0092] The term "scaffold" as used herein shall be given its
ordinary meaning and shall include, without limitation, support
members, collapsible members, expandable members, distensible
members, solid structures, mesh structures, braided devices, porous
structures, struts, polymeric structures, membranes, bladders,
stents, umbrella-type devices, ribs, spokes, frames, and the like,
and combinations thereof. Scaffolds may be fully or partially
covered or may be uncovered. Covered scaffolds may comprise
skeletons that are partially or fully covered by membranes,
fabrics, films, multiple layers, and/or coated. Scaffolds may
function as the cleaning member and/or may be used for supporting a
cleaning member. Scaffolds can be mechanically actuated,
self-actuated, inflated, and/or combinations thereof.
I. General System
[0093] A. Endotracheal Tube
[0094] FIG. 1 illustrates an example of an endotracheal tube 100
having a proximal end 102 and a distal end 104. The endotracheal
tube 100 includes a hollow, central lumen 106 extending through the
endotracheal tube 100 from the proximal end 102 to the distal end
104. In some embodiments, the endotracheal tube 100 includes a hole
(not shown) at the tip 108 of its distal end 104 and a hole 110 on
a side of the endotracheal tube 100 near the tip 108 of the distal
end 104 known as a Murphy eye. In other embodiments, an
endotracheal tube can include more or fewer holes or openings.
[0095] With continued reference to the embodiment illustrated in
FIG. 1, the endotracheal tube 100 can include one or more balloon
cuffs 112 at or near the distal end 104 of the endotracheal tube
100. The balloon cuff 112 is inflated during mechanical ventilation
to prevent air leaks back around the endotracheal tube 100. In some
embodiments, the proximal end 102 can include a coupling element
114 for connection with a mechanical ventilator. The inner diameter
of the endotracheal tube 100 can range from about 1 mm to about 20
mm or from about 5 mm to about 10 mm. The length of the
endotracheal tube 100 can range from about 10 cm to about 40 cm;
however, endotracheal tubes of any length can be cleansed by the
cleaning devices described herein. The endotracheal tube 100 can be
manufactured to have a slight curve or pre-bend for facilitating
insertion into a patient's native airway (e.g., trachea).
[0096] The endotracheal tube 100 can be configured to be inserted
within a patient temporarily or permanently. In some embodiments,
the endotracheal tube 100 is inserted within a patient orally or
nasally via an intubation procedure. In other embodiments, the
endotracheal tube 100 is inserted via a tracheotomy or tracheostomy
procedure.
[0097] As shown in FIG. 1, biofilm 116 can build up on the interior
surface of the endotracheal tube 100 over time. If not removed,
biofilm 116 can restrict the airflow through the endotracheal tube
100. In addition, biofilm 116 can harbor harmful bacteria that can
eventually lead to the development of pneumonia and/or other
ailments or conditions. The layer of biofilm 116 on the interior
surface of the endotracheal tube 100 can be substantially uniform
or can vary substantially in thickness (e.g., peaks and valleys)
along the length of the endotracheal tube 100.
[0098] The biofilm 116 can be present anywhere along the interior
surface of the endotracheal tube 100. In some embodiments, the
majority of the biofilm 116 collects in a main collection region
118 that extends from a point proximal to the Murphy eye 110 (e.g.,
about 2.5 cm from the tip 108 of the distal end 104) and for
approximately another 15 cm toward the proximal end 102. In some
embodiments, approximately 80% of the total biofilm found in the
endotracheal tube 100 is found within this main collection region
118. The remaining biofilm can be found from the proximal end of
the main collection region 118 to the ventilator coupling element
114. The biofilm 116 can have the consistency of rubber cement or
nasal secretions. The amount of biofilm 116 present in the
endotracheal tube 100 can range anywhere from zero to about thirty
cubic centimeters or more at the time of cleaning, depending on the
dimensions and/or properties of the endotracheal tube, patient
conditions or factors, the length of time within the body before
cleaning, and/or other factors. In some embodiments, the internal
surface of the endotracheal tube cleaning device 120 can be coated
with a bactericide before insertion within a patient to help
prevent or reduce the likelihood of bacterial growth within the
biofilm 116.
[0099] B. Endotracheal Tube Cleaning Device
[0100] FIG. 2A illustrates an embodiment of an endotracheal tube
cleaning device 120. As shown, the endotracheal tube cleaning
device 120 can include an elongate body 122, an actuation assembly
124 at the proximal end of the elongate body 122, and a cleaning
member 126 generally at the distal end of the elongate body 122. In
other embodiments, the cleaning member 126 is positioned anywhere
along the length of the elongate body 122 (e.g., near the proximal
end of the elongate body, generally between the distal and proximal
ends of the elongate body, etc.). In some embodiments, the
actuation assembly 124 is a syringe-like mechanism that actuates
expansion, or deployment, of the cleaning member 126. The actuation
assembly 124 can be configured to provide single action deployment
of the cleaning member 126. As discussed in greater detail herein,
the cleaning member 126 can be configured to remove and collect or
trap some or all of the biofilm 116 lining the endotracheal tube
100.
[0101] The endotracheal tube cleaning device 120 can be sized,
shaped, or otherwise adapted so as to be inserted within any
commercially available endotracheal tube (e.g., the endotracheal
tube 100) or other body-inserted tube for cleaning. In some
embodiments, the endotracheal tube cleaning device 120 can be
sized, shaped, or otherwise adapted so as to be inserted within a
specially-designed, proprietary endotracheal tube. In some
embodiments, the outside diameter of the elongate body 122 of the
endotracheal tube cleaning device 120 ranges from about 0.05 mm to
about 10 mm, e.g., from about 1 mm to about 5 mm, about 2 mm to
about 4.5 mm, about 2.5 mm to about 3.5 mm, about 5 mm to about 8
mm, about 8 mm to about 10 mm, or greater, and overlapping ranges
thereof. The length of the elongate body 122 distal to the
actuation assembly 124 can range from about 10 cm to about 70 cm,
or greater, e.g., from about 10 cm to about 20 cm, about 20 cm to
about 30 cm, about 30 cm to about 40 cm, about 40 cm to about 50
cm, about 50 cm to about 70 cm, and overlapping ranges thereof. In
one embodiment, the length of the elongate body is about 29 cm to
about 45 cm. The dimensions can be adjusted to accommodate various
uses or various body-inserted tubes without departing from the
spirit and/or scope of the disclosure.
[0102] In some embodiments, the endotracheal tube cleaning device
120 is manufactured with a slight curve to match or substantially
conform to the curve of commercially available endotracheal tubes.
The curvature of the endotracheal tube cleaning device 120 can
advantageously reduce the friction between the outer surface of the
endotracheal tube cleaning device 120 and the inner surface of the
endotracheal tube 100 and can avoid disruption of the biofilm 116
during insertion of the endotracheal tube cleaning device 120. The
curvature of the endotracheal tube cleaning device 120 can range
from about a 5 cm to a 50 cm radius or from about a 10 cm to about
a 30 cm radius. In one embodiment, the radius of the curvature of
the endotracheal tube cleaning device 120 is approximately 17.5 cm.
However, in other embodiments, the radius of curvature of the
endotracheal tube cleaning device 120 can be greater or smaller
than disclosed herein without departing from the spirit and/or
scope of the disclosure.
[0103] FIG. 2B illustrates a cross-sectional view of the distal end
of the endotracheal tube cleaning device 120. The elongate body 122
of the endotracheal tube cleaning device 120 includes an inner
shaft or sheath 128 and an outer shaft or sheath 129. In some
embodiments, the inner shaft 128 and the outer shaft 129 connect
the actuation assembly 124 (not shown) to the cleaning member 126.
The inner shaft 128 is coupled to the distal end of the cleaning
member 126 and is configured to transmit the motive force necessary
to expand the cleaning member 126 by compressing the distal end of
the cleaning member 126. The outer shaft 129 is coupled to the
proximal end of the cleaning member 126 and holds the proximal end
of the cleaning member 126 in place while the distal end is
compressed or deployed. In this manner, the cleaning member 126 can
be selectively expanded radially so as to impart a radial force
against the inside wall of the endotracheal tube 100 and/or biofilm
collected thereon. This and other embodiments of the expansion
mechanism of the cleaning member 126 will be described in further
detail below.
[0104] C. Endotracheal Tube Cleaning System and General
Operation
[0105] FIGS. 3A and 38 illustrate partial-sectional views of
embodiments of the endotracheal tube cleaning device 120 inserted
into the endotracheal tube 100. In some embodiments, the
endotracheal tube 100 is disconnected from a ventilator and a
distal tip 130 of the endotracheal tube cleaning device 120 is
inserted through the ventilator coupling member 114. The distal tip
130 of the cleaning device 120 can be advanced until the distal tip
130 is positioned within, or just distal of, the Murphy eye 110. In
other embodiments, the ventilator coupling member 114 is removed
before insertion of the endotracheal tube cleaning device 120.
[0106] As shown in FIGS. 3A and 3B, the cleaning member 126 can
include a removal member 132 and a collection member 134. In some
embodiments, the cleaning member includes more than one removal
member and/or more than one collection member. The removal member
132 can be configured to contact or engage the inside wall of the
endotracheal tube 100 upon radial expansion of the cleaning member
126. With reference to FIG. 3C, the removal member 132 can be
positioned within a region 135 just proximal of the Murphy eye 110
(e.g., within about 0.5 cm to about 2 cm). However, the removal
member 132 can be positioned at any position within the
endotracheal tube 100 depending upon a determination of where the
biofilm accumulation begins (e.g., via the visualization means
described herein) and/or any other factor. Mechanisms for
controlling the depth of insertion will be further described
below.
[0107] In some embodiments, the conduit 100 to be cleaned is a gun
barrel, and the cleaning device 120 or system comprises one or more
removal members 132 that are configured to remove oil, grease,
oxidation, rust, mineral deposits, scale, other types of deposits,
gun powder residue, other types of combustion residue and/or the
like. In other embodiments, the conduit 100 to be cleaned is a
pipe, duct, flue (e.g., boiler flue), exhaust conduit or tubing,
and the cleaning device 120 or system comprises one or more removal
members 132 that are configured to remove sludge, mineral deposits,
rust, other oxidation, grease, oil, soot, biofilm, scum, scale
and/or the like.
[0108] After proper positioning of the endotracheal tube cleaning
device 120 within the endotracheal tube 100, the cleaning member
126 is expanded by the actuation assembly 124 such that the removal
member 132 contacts the inside wall of the endotracheal tube 100
and/or the biofilm layer situated thereon. FIGS. 3D and 3E
illustrate the collapsed and expanded configurations, respectively,
of the cleaning member 126. After expansion of the cleaning member
126 by the actuation assembly 124, the endotracheal tube cleaning
device 120 can be withdrawn from the endotracheal tube 100 by a
clinician. As the endotracheal tube cleaning device 120 is
withdrawn from the interior of the endotracheal tube 100, the
removal member 132 removes biofilm 116 from the inside of the
endotracheal tube 100, and the collection member 134 advantageously
traps and collects the removed biofilm. Upon completion of a
cleaning procedure or as otherwise desired, the clinician can
manipulate the actuation assembly of the cleaning device to return
the cleaning member 126 to its collapsed configuration. Additional
details regarding the expansion and collapse of the cleaning
member, as well as the manner in which the collection member traps
and collects removed biofilm, are provided below.
[0109] D. Side Port
[0110] FIG. 4 illustrates an embodiment of an endotracheal tube
cleaning device 120 having a side port 140 coupled to the proximal
end of the endotracheal tube cleaning device 120. As shown in the
embodiment of FIG. 4, the side port 140 branches off from the main
body of the actuation assembly 124. The side port 140 can branch
off of at any location along generally the proximal end of the
endotracheal tube cleaning device 120. For example, in other
embodiments, the side port 140 can branch off of the elongate body
122 at a location distal to the actuation assembly 124.
[0111] The side port 140 can be constructed without sharp edges and
corners to enhance safety and/or to provide one or more other
benefits. The length of the side port 140 can be sufficiently long
so as to prevent contamination of the scopes, probes, catheters,
and/or other instruments inserted therein due to contact or
exposure to the endotracheal tube 100 or the biofilm 116 removed
from the endotracheal tube 100. The length of the side port 140 can
be just a few inches to avoid patient contact or as much as ten
feet to avoid proximity to the patient. In some embodiments, the
length of the side port 140 ranges from about 0.5 inches to about
24 inches.
[0112] In some embodiments, the side port 140 includes an
elastomeric diaphragm to reduce or eliminate airflow bypass. The
elastomeric diaphragm can have a slit, valve, or flap to allow
insertion of scopes, catheters, and/or other instruments. The
elastomeric diaphragm can comprise any suitable material, such as,
for example, latex, silicone, urethane, other elastomeric or
polymeric materials and/or the like. The thickness of the diaphragm
can range from about 0.001 inches to about 0.1 inches or from about
0.005 inches to about 0.020 inches.
[0113] As shown, the side port 140 can be used for the introduction
of a visualization scope 142. In some embodiments, the
visualization scope 142 comprises an endoscope or borescope.
However, the visualization scope 142 can include any other scope or
viewing element configured to provide visual feedback to the
clinician or other user of the cleaning device. The visualization
scope 142 can include one or more light delivery elements (e.g.,
light fibers) and an imaging or visualization element (e.g., an
ultrasound probe, a fiberoptic camera, a CCD camera), thereby
providing a clinician with simultaneous illumination and viewing of
selected portions within the endotracheal tube 100, such as, for
example, the biofilm 116 along the endotracheal tube walls,
possible tube obstructions, and/or the like. Accordingly, such a
visualization scope or similar tools can assist in the proper
placement of the endotracheal tube cleaning device 120 within the
endotracheal tube 100.
[0114] In some embodiments, the visualization scope 142 includes a
bundle of fiberoptic cables, with at least some of the fibers
configured to provide light and at least some of the fibers
configured to provide viewing capabilities. In some embodiments,
the light fibers can extend around the periphery of the
visualization scope 142 (e.g., along the inner wall) and the
viewing fibers can extend through the central portion of the
visualization scope 142. In some embodiments, the light fibers are
coupled to a light source and the viewing fibers are coupled to a
direct camera connection and/or to an optical connector. The
visualization scope 142 can advantageously provide the clinician
with an assurance that the endotracheal tube cleaning device 120 is
placed properly and does not unintentionally disrupt the biofilm.
In some embodiments, the visualization scope 142 is configured to
extend beyond the distal end 104 of the endotracheal tube 100.
[0115] The visualization scope 142 can include an integral or
removable sheath, sleeve, or jacket that extends along all or a
portion of its length and that is configured to prevent against
contamination and to allow relatively easy reuse of the
visualization scope 142 for multiple patients and/or procedures. In
some embodiments, the visualization scope 142 and/or its sheath is
pre-curved to assist in positioning the visualization scope 142
within the endotracheal tube cleaning device 120.
[0116] In some embodiments, the visualization scope 142 and/or its
sheath includes a stopper (fixed or adjustable) that is configured
to help position the distal tip of the visualization scope 142 at a
predetermined or adjustable position within the endotracheal tube
cleaning device 120 (e.g., in a viewing window at the distal tip
130 of the endotracheal tube cleaning device). The stopper can be
configured to abut against the proximal end of the side port 140.
The side port 140 can have visible markings that correspond to
markings on the visualization scope 142 to aid in the positioning
of the distal end of the visualization scope 142 and/or to aid in
the application of the stopper. The visible markings or indicia can
comprise lines, numbers, and/or text labels.
[0117] The thickness of the sheath of the visualization scope 142
can range from about 0.05 mm to about 0.5 mm, such as, for example,
about 0.1 mm. The outer diameter of the visualization scope 142 can
range from about 0.5 mm to about 2 mm, depending on the size of a
lumen or channel of the endotracheal tube cleaning device 120, as
described in further detail below.
[0118] As schematically illustrated in FIG. 4, the visualization
scope 142 can be coupled to a visualization unit 144 (e.g., via a
coupling element of a camera head). In some embodiments, the
visualization unit 144 includes a light source for delivery of
light to the endotracheal tube, the endotracheal tube cleaning
device, and/or the patient's native airway via light delivery
elements. The light delivery elements can provide illumination,
activation of drugs delivered within the endotracheal tube (e.g.,
in conjunction with photodynamic therapy) and/or other
capabilities. In other embodiments, the visualization unit 144
includes a display 146 for enhanced viewing. For example, the
display 146 can include a monitor capable of displaying
high-quality, high-resolution images. In other embodiments, the
visualization unit 144 can include one or more other types of
output devices. Moreover, the visualization unit 144 can be
configured to store in memory (temporarily and/or permanently)
images obtained by a scope during a cleaning procedure. In some
embodiments, the visualization unit 144 can transmit the images
over a network (wired or wireless) to remote storage, display,
and/or processing devices. These embodiments advantageously enable
a supervising physician to observe and monitor the cleaning
procedure and direct further intervention or treatments from a
remote location (for example, outside the ICU).
[0119] In other embodiments, the side port 140 can be used for the
introduction of diagnostic and/or therapeutic catheters or other
instruments. Example catheters include, but are not limited to,
ultrasonic catheters, radio frequency (RF) catheters, irrigation
catheters, aspiration catheters, drug delivery catheters, catheters
for delivering light for photodynamic or other light-based therapy,
and/or the like. In yet other embodiments, diagnostic and/or
therapeutic catheters can be introduced in conjunction with the
endotracheal tube cleaning methods, procedures, and/or devices
described herein but are not inserted within the endotracheal tube
cleaning device 120 itself. Visualization and other facilitative
and/or supplementary modalities will be described in further detail
below.
II. Structural Components and Connection Interfaces
[0120] A. Actuation Assembly
[0121] FIG. 5 illustrates the proximal ends of the endotracheal
tube 100 and an embodiment of an endotracheal tube cleaning device
120 situated therein. As shown, the actuation assembly 124 includes
a handle 150 and a trigger 152. The distal end of the handle 150
can be coupled to the outer shaft 129 of the endotracheal tube
cleaning device 120 using any mechanical fastener, adhesive, and/or
other coupling device or method, including, for example,
interference fits, ultrasonic welding, UV cure adhesives, epoxy,
and/or the like. In the depicted embodiment, the proximal end of
the handle 150 includes a grip 153 that is sized, shaped, or
otherwise adapted to receive an operator's thumb or other finger.
In some embodiments, the distal end of the handle 150 is integral
with the outer shaft 129.
[0122] The distal end of the trigger 152 can be coupled to the
inner shaft 128 using any mechanical fastener, adhesives, and/or
other coupling device or method, including, for example,
interference fits, ultrasonic welding, UV cure adhesives, epoxy,
and/or the like. In some embodiments, the distal end of the trigger
152 is integral with the inner shaft 128. In the illustrated
embodiment, the proximal end of the trigger 152 includes two grips
154, 155 that may be symmetrically positioned about the
longitudinal axis of the handle 150. Each of the two grips 154, 155
can be sized, shaped, or otherwise adapted to receive an operator's
finger.
[0123] Materials for the handle 150 and trigger 152 can include any
suitable materials, such as, for example,
acrylonitrile-butadiene-styrene (ABS), polycarbonate, K-RESIN,
other polymeric or elastomeric resins and/or the like. In some
embodiments, the materials are tough, non-brittle,
injection-moldable, plastic resins. In other embodiments, the
materials include one or more modifiers to improve stiffness and/or
other physical properties so that actuation of the trigger 152
and/or other functionality of the endotracheal tube cleaning device
120 is not compromised. The modifiers can include glass fiber,
calcium carbonate, titanium oxide, carbon, combinations of the
same, and/or the like. In some embodiments, the handle 150 and the
trigger 152 include internal ribs to improve stiffness.
[0124] The actuation assembly 124 advantageously allows for single
person, single-handed operation of the endotracheal tube cleaning
device 120. The trigger 152 is shown in a position that keeps the
cleaning member 126 in a collapsed configuration (see FIG. 3D). In
order to actuate the endotracheal tube cleaning device 120 so that
the cleaning member 126 transitions from the collapsed
configuration into a desired deployed configuration (see FIG. 3E),
manual force can be applied to the trigger 152 and handle 150 to
move the trigger 152 proximally with respect to the handle 150
(shown in phantom). As the trigger 152 moves with respect to the
handle 150, the inner shaft 128 and the outer shaft 129 are driven
to move relative to one another. Accordingly, the relative movement
of the inner and outer shafts 128, 129 can apply compressive and
tensile forces to the cleaning member 126 to selectively expand and
collapse, respectively, the cleaning member 126. As discussed in
greater detail below, the extent of expansion of the cleaning
member 126 can be advantageously controlled by the actuation member
124. In some embodiments, the actuation assembly 124 enables
single-hand operation and/or single action deployment of the
cleaning member 126.
[0125] B. Main Elongate Body
[0126] FIG. 6 illustrates a detailed cross-sectional view of the
distal and proximal ends of the endotracheal tube cleaning device
120. As described above, the main elongate body 122 of the
endotracheal tube cleaning device 120 can include an inner shaft
128 and an outer shaft 129.
[0127] 1. Outer Shaft
[0128] In some embodiments, the outer shaft 129 of the main
elongate body 122 extends from the handle 150 of the actuation
assembly 124 to the proximal end of the cleaning member 126. As
shown in FIG. 6, the proximal end of the outer shaft 129 can be
assembled into an opening located at the distal end of the handle
150. As described above, the outer shaft 129 can be coupled to the
handle 150 by any suitable mechanical and/or adhesive method or
device, such as interference fits, mechanical fasteners, ultrasonic
welding, UV cure adhesives, epoxy, and/or the like. The distal end
of the outer sheath 129 can be coupled to the proximal end of the
cleaning member 126 by any suitable attachment method or device,
including, but not limited to, adhesives, crush ribs, heat shrink
tubing, other low-profile mechanical fasteners, other attachment
methods or devices, ultrasonic bonding, interference fits, and/or
the like.
[0129] With continued reference to the embodiment illustrated in
FIG. 6, the outer shaft 129 comprises a central lumen or channel in
which the inner shaft 128 is slidably retained. In some
embodiments, the cross-section of the outer shaft 129 can be
circular, substantially circular, elliptical, oval and/or any other
shape. In some embodiments, the outer diameter of the outer shaft
129 ranges from about 1.5 mm to about 4 mm; however the outer
diameter of the outer shaft 129 can be smaller than 1.5 mm or
larger than 4 mm, as desired and/or required. In some embodiments,
the outer shaft 129 is an extrusion comprising polyolefin and/or
one or more other plastic materials, such as, for example,
polypropylene. PEPAX, polyester, nylon, polyimide, polyethylene
terephthalate (PET), polyethylene terephthalate glycol (PETG),
and/or the like.
[0130] 2. Inner Shaft
[0131] In some embodiments, the inner shaft 128 is located within
an inner lumen of the outer shaft 129 and is configured to move
with respect to the outer shaft 129 in a direction along the
longitudinal axis of the outer shaft 129. In some embodiments, the
inner shaft 128 extends from the trigger 152 to the distal tip 130
of the endotracheal tube cleaning device 120. The inner shaft 128
can be coupled to the distal tip 130 by any suitable attachment
method or device, such as, for example, adhesives, crush ribs, heat
shrink tubing, mechanical fasteners, other mechanical devices or
methods, low-profile mechanical connection means, ultrasonic
bonding, interference fits, and/or the like. As shown, the inner
shaft 128 can be coupled to the distal tip 130 and to the cleaning
member 126 with heat shrink tubing 160. In other embodiments, the
inner shaft 128 and the distal tip 130 are integrally formed as a
single molded component.
[0132] In some embodiments, the inner shaft 128 is a hollow sheath
or tube. In some embodiments, the outer diameter of the inner shaft
128 is less than 4 mm and the inner diameter of the inner shaft 128
is greater than 1 mm; however, the inner shaft 128 can have any
other diameter, as desired and/or required. For example, the outer
diameter of the inner shaft 128 can range from about 0.85 mm to
about 2 mm and the inner diameter of the inner shaft 128 can range
from about 0.5 mm to about 1.25 mm. The inner shaft 128 can include
a central lumen or channel 162 for the introduction of a
visualization scope and/or one or more diagnostic or therapeutic
catheters or other instruments. In some embodiments, a
visualization element (e.g., fiber optic camera) of a visualization
scope (e.g., visualization scope 142) can be inserted into the
central lumen or channel 162. The central lumen or channel 162 can
have a diameter ranging from about 0.5 mm to about 1.5 mm (e.g.,
about 1 mm). However, the diameter of the central lumen or channel
162 can be smaller than 0.5 mm or larger than 1.5 mm as desired
and/or required by the dimensions of the inner shaft 128. A depth
stop 166 can be included to position a visualization scope for
desired or required optical characteristics, thereby resulting in
maximum viewing potential.
[0133] In other embodiments, the inner shaft 128 includes one or
more internal and/or external channels adapted to selectively
receive scopes and/or other instruments or devices for
visualization and/or any other purpose. For example, the one or
more channels can be used for light delivery, photodynamic therapy,
fluid delivery (e.g., air, therapeutic agents, saline), irrigation,
aspiration, and/or the like. In some embodiments, the one or more
channels can comprise an equilibrium channel to reduce or alleviate
the any negative pressure or suction effect created distal to the
expandable cleaning member as the endotracheal tube cleaning device
120 is being withdrawn from the endotracheal tube 100. The channels
can extend through any length of the inner shaft. For example, one
or more channels can extend from generally the proximal end to
generally the distal end of the endotracheal tube cleaning device
120. In some embodiments, the one or more channels can include an
inlet in communication with the side port 140 and one or more
outlets in the distal tip 130, in or adjacent to the removal member
132, in the side wall of the endotracheal tube cleaning device 120.
In other embodiments, the one or more channels can include inlets
or outlets at other locations of the endotracheal tube cleaning
device 120.
[0134] In other embodiments, the inner shaft 128 is a solid,
central rod. The inner shaft 128 can have a circular, substantially
circular, elliptical, oval, and/or any other cross-sectional shape.
In some embodiments, the inner shaft 128 comprises an extrusion
having polyolefin and/or other plastic materials, such as, for
example, polypropylene. PEPAX, polyester, nylon, polyimide,
polyethylene terephthalate (PET), polyethylene terephthalate glycol
(PETG), and/or the like.
[0135] 3. Distal Tip
[0136] In some embodiments, the distal tip 130 is a closed tip to
prevent against exposure of the internal structure of the
endotracheal tube cleaning device 120, and any instruments or
devices inserted therein, to the biofilm 116 or other potential
contaminants within the patient's body. The distal tip 130 of the
endotracheal tube cleaning device 120 can comprise one or more
injection-moldable plastics, polymeric resins, including, but not
limited to, polycarbonate, PET, PETG, nylon, polypropylene.
K-RESIN, and/or the like. In some embodiments, at least a portion
of the distal tip 130 can comprise a clear, transparent or
semi-transparent material to form a viewing "window." The injection
mold of the distal tip 130 can be polished (e.g., using an SPE/SPI
A1 "high polish" finish of the injection mold) such that at least
the distal end of the distal tip 130 is optically transparent or
partially optically transparent. In some embodiments, the
transparent material can be configured to enable a "fish eye" view
for enhanced viewing of the endotracheal tube 100 itself, any
biofilm that could be accumulating in the tube, and/or the
like.
[0137] In some embodiments, the viewing window can have optical
properties to provide magnification and/or angular correction to
correct for the natural tendency for the device to follow the outer
bend of the endotracheal tube. For example, the optical properties
can enable the scope to provide a view of the lumen in the middle
of the endotracheal tube and not a view of the side of the
visualization scope or the biofilm itself. The viewing window can
also comprise a filter, coating, layer and/or other mechanism to
reduce glare of flashback from a light delivery element (e.g., an
endoscope light).
[0138] In some embodiments, the distal end of the distal tip 130 is
sized, shaped, and/or otherwise adapted to facilitate introduction
into the biofilm 116. For example, the distal end of the distal tip
130 can have a radius from about 0.010R to about 0.050R, or from
about 1 mm to about 15 mm. The distal tip 130 can be radiused using
a radio frequency tool, by injection molding and/or any other
suitable forming technologies. In arrangements wherein a
visualization scope is to be used in conjunction with the
endotracheal tube cleaning device 120, the optically clear distal
end of the distal tip 130 can be relatively thin (for example, from
about 0.010 inches to about 0.20 inches thick) to improve the
optical qualities of the distal tip 130 for enhanced visualization.
In other embodiments, the optical properties of the clear,
transparent or semi-transparent materials used to form the distal
tip 130 (e.g., an extrudable grade of clear polypropylene) may help
reduce or eliminate the need of the relatively thin tip.
[0139] In some embodiments, the distal tip 130 can include one or
more outlets or ports (not shown) to provide access to the interior
of the endotracheal tube and/or to the patient's airway (e.g., the
tracheobronchial tree) through the endotracheal tube cleaning
device 120. For example, an outlet can be in communication with an
inner lumen or channel of the endotracheal tube cleaning device 120
into which diagnostic and/or therapeutic instruments (e.g.,
aspiration, irrigation, and/or drug delivery mechanisms) can be
inserted. In some embodiments, the one or more outlets can permit
the escape of a fluid, such as air or therapeutic agents, from the
endotracheal tube cleaning device 120. In other embodiments, the
one or more outlets can permit the escape of a catheter or conduit
inserted through an internal channel of the endotracheal tube
cleaning device 120. The outlet can include a diaphragm, slit,
one-way valve and/or the like to substantially seal off the inner
lumen or channel, thereby preventing or reducing the likelihood of
contamination of the interior of the endotracheal tube cleaning
device 120 and/or the therapeutic and/or diagnostic instruments
inserted therein.
[0140] C. Cleaning Member
[0141] With continued reference to FIG. 6, an embodiment of the
cleaning member 126 is illustrated. As described above, the
cleaning member 126 can include a removal member 132 and a
collection member 134. In some embodiments, the removal member 132
and the collection member 134 can be two separate members. In other
embodiments, a single, integral removal/collection member can
perform removal and collection of accumulated biofilm. In yet other
embodiments, the cleaning member 126 may not include a removal
member 132 (e.g., an O-ring, wiper, etc), as depicted in the
embodiments illustrated in FIGS. 2A and 28, for example. In some
embodiments, the cleaning member 126 comprises a distensible
scaffold that removes and collects the deposited biofilm.
[0142] According to some embodiments, the removal member 132 and/or
any other portion of the cleaning member is configured to be
actively mechanically actuated between an expanded configuration
and a collapsed configuration. In several embodiments, the removal
member 132 and/or any other portion of the cleaning member 134 are
actively mechanically actuated without the use of a sheath, sleeve,
covering and/or the like. In another embodiment, the removal member
and/or any other portion of the cleaning member are non-bristled
and/or non-sheathed.
[0143] In some embodiments, the removal member 132 and/or the
collection member 134 of the cleaning member 126 can elute and/or
be coated with a fluid, drug, therapeutic agent, and/or other
medicament or substance that is configured to clean, disinfect,
decontaminate, sterilize, and/or prevent future contamination of
the endotracheal tube 100 and/or to degrade, disperse, and/or
dissolve biofilm deposited along the interior surface of the
endotracheal tube. Such materials can include, for example, an
anti-bacterial agent, a mucolytic agent, a saline solution, a
sterilant, an enzymatic cleaner, a germicide, and antiviral drug,
an antimicrobial drug, and/or a detergent. A coated removal member
and/or collection member can be configured to deliver the fluid,
drug, therapeutic agent, and/or other materials upon contact with
the inside wall of the endotracheal tube 100. A coating of the
cleaning member 136 can also comprise one or more absorbent
materials, such as, for example, super-absorbent polymers (e.g.,
polyacrylamide and/or the like).
[0144] 1. Collection Member
[0145] As described above, the collection member 134 can be adapted
to collect and/or trap biofilm removed by the removal member 132.
In some embodiments, the collection member 134 effectuates
expansion of the removal member 132 as it is expanded by the
relative movement between the inner and outer shafts 128, 129.
However, any other method of selectively expanding and contracting
the removal member 132 can be used. The collection member 134 can
advantageously be constructed to allow sufficient airflow through
the endotracheal tube 100 during use. For example, the air flow
rates can range from about 1 liter per minute to about 10 liters
per minute or from about 2 liters per minute to about 5 liters per
minute.
[0146] In some embodiments, the collection member 134 comprises a
distensible scaffold that can be mechanically actuated (e.g.,
actively mechanically actuated) between an expanded configuration
and a collapsed configuration. In some embodiments, the scaffold
comprises a mesh or braided scaffold (see FIG. 6). In several
embodiments, the scaffold is non-sheathed and/or non-bristled. The
scaffold can comprise a woven tubular braided material. The fibers
of the braid can range in diameter (or other cross-sectional
dimension) from about 0.001 inches to about 0.04 inches, or
greater, e.g., about 0.001 inches to about 0.005 inches, about
0.005 inches to about 0.010, about 0.010 inches to about 0.020
inches, and overlapping ranges thereof. However, the diameter or
other cross-sectional dimension of the fibers can be smaller than
0.001 inches or greater than 0.040 inches, as desired or required.
The braided material can be comprised of PET, nylon, polyester,
polypropylene and other extrudable plastic resins that are flexible
in the extruded state. The pick count of the braided material can
range from 5 to 25 picks per inch, or greater, e.g., from about 5
to 8 picks per inch, about 8 to 12 picks per inch, about 12 to 14
picks per inch, about 14 to 16 picks per inch, about 16 to 18 picks
per inch, about 18 to 20 picks per inch, about 20 to 25 picks per
inch, and overlapping ranges thereof.
[0147] According to some embodiments, the scaffold, the collection
member and/or any other portion of the cleaning device is
configured to be actively mechanically actuated between an expanded
configuration and a collapsed configuration. In several
embodiments, the scaffold, the collection member and/or any other
portion of the cleaning device are actively mechanically actuated
without the use of a sheath, sleeve, covering and/or the like. In
another embodiment, the scaffold, the collection member and/or any
other portion of the cleaning device are non-bristled and/or
non-sheathed.
[0148] In other embodiments, the collection member 134 is a
scaffold comprising a porous elastomeric polymer material, such as
silicone, urethane, and/or latex, or a porous foam material. FIG. 7
illustrates an embodiment of the collection member 134 comprising a
porous elastomeric polymer material.
[0149] In some embodiments, the collection member 134 has a
generally uniform construction from one end to the other end. In
other embodiments, the collection member 134 can have varying
constructions for different portions of the collection member 134
to serve different purposes. For example, a distal section of the
collection member 134 can have a construction just large enough to
allow air flow (e.g., high pick count, fine weave, small pore size,
etc.), which advantageously results in the efficient trapping and
storage of biofilm 116, and the proximal section of the collection
member 134 can have a construction with larger openings (e.g., low
pick count, loose weave, large pore size, etc.) to facilitate
collection of the biofilm 116 while still allowing expansion of the
removal member 132. FIGS. 9A-9D, which are described below,
illustrate embodiments of collection members having proximal and
distal sections of varying porosity. In some embodiments, the pick
count of the distal section of the collection member 134 can range
from about 10 to about 25 picks per inch and the pick count for the
proximal section can range from about 5 to about 10 picks per inch.
In some embodiments, the distal section can have a construction
that is impermeable or substantially impermeable to fluids or
permeable so as to allow fluids to filter through while catching
solid and semi-solid debris.
[0150] In some embodiments, the collection member 134 comprises two
or more layers of braided or mesh material. The two or more layers
can have varying pore size or pick count constructions. For
example, FIG. 8 illustrates an embodiment of the collection member
134 comprising a double-layer mesh scaffold. In some embodiments,
the proximal section of the collection member 134 comprises a first
mesh layer having a relatively large pore size (e.g., greater than
about 0.1 inch opening) and the distal section of the collection
member 134 comprises the first mesh layer having the relatively
large pore size as an inner mesh layer and a second outer mesh
layer having a relatively small pore size (e.g., about 0.05 inch
opening). The inner mesh layer and outer mesh layer can be
ultrasonically welded or otherwise coupled together at various
locations (e.g., the proximal and distal ends of the outer mesh
tube). For example, the distal ends of the two mesh layers can be
coupled together and/or to the inner shaft 128 using heat seal or
heat shrink band clamps 160. In other embodiments, the two mesh
layers are coupled by sutures, epoxy, adhesive, other low-profile
attachment devices, and/or the like. The outer mesh layer can
include an outer mesh ring 182 having the relatively large pore
size that is ultrasonically welded or otherwise connected to the
inner mesh layer at one or more locations adjacent to the removal
member 132. The outer mesh ring can have a conical or substantially
conical shape. In some embodiments, both the proximal section and
the distal section of the collection member 134 comprise two or
more mesh layers.
[0151] In some embodiments, the length of the collection member
ranges from about 0.2 inches to about 1 inch. In one embodiment,
the length of the collection member is about 0.4 inches. In some
embodiments, the length is selected to effectuate a "tent-like"
configuration when deployed instead of a "sausage-like"
configuration. The "tent-like" configuration advantageously focuses
the radial force along a perpendicular plane through the removal
member 132.
[0152] In some embodiments, the collection member 134 is expanded
generally uniformly across its length. For example, in its expanded
configuration, the collection member 134 can exhibit a "tent-like"
form, wherein the distal half and the proximal half have a convex
shape (as shown in FIG. 6). In other embodiments, a proximal
portion (e.g., the proximal half) of the collection member 134 can
be configured to expand in a concave fashion and a distal portion
(e.g., the distal half) of the collection member 134 can be
configured to expand in a convex fashion. The proximal and distal
portions can be integral or separate.
[0153] FIGS. 9A and 9B illustrate embodiments of the collection
member 134 having a convex distal section and a concave proximal
section. The concave profile of the proximal portion can
advantageously keep the surface of the collection member 134 away
from the inner wall of the endotracheal tube 100, thereby ensuring
that the outer surface of the removal member 132 is the only
surface that comes in contact with the inner wall of the
endotracheal tube 100. In some embodiments, the concave profile
advantageously results in more efficient biofilm collection than
the convex profile. For example, the concave profile can create
more surface area and volume for collection of biofilm. In some
embodiments, the collection member 134 is formed of two separate
elements. The slight wave pattern of the removal member 132 in FIG.
9B can advantageously improve radial deployment of the collection
member 134, can improve collection due to its greater surface area,
and/or can increase the expandability of the removal member
132.
[0154] With reference to FIGS. 9C and 9D, the concave profile of
the proximal section of the collection member 134 can be effected
by attaching one or more rings 192 about the proximal section of
the collection member 134 to constrain the expansion. If multiple
rings are used, the rings 192 can be spaced apart and can be
configured to expand to different diameters to effectuate a desired
profile. In some embodiments, the length of the collection member
134 can be increased with the inclusion of the rings 192 to
constrain the expansion of the proximal section of the collection
member 134. For example, the length of the collection member 134
can range from about 0.4 inches to about 2 inches. The collection
member 134 can be constructed to have a capacity of about 15 cubic
centimeters (ccs) of biofilm or other material; however a capacity
of less than or more than 15 ccs can be used as desired and/or
required.
[0155] 2. Removal Member
[0156] In general, the removal member 132 is configured to be
expanded during use to come in contact with the interior surface of
the endotracheal tube 100 (or other conduit) and to remove the
deposited debris (e.g., biofilm) therefrom as the cleaning device
120 is withdrawn from the endotracheal tube 100. In some
embodiments, the removal member 132 is configured to engage the
interior surface of the endotracheal tube 100 with a smooth,
regular outer surface. In other embodiments, the surface profile of
the removal member 132 can have an irregular shape. In one
embodiment, the removal member is flush with the outside periphery
of the scaffold (which, in some embodiments can serve as a
collection member). In other embodiments, the removal member
protrudes beyond the outside periphery of scaffold by about 0.05 mm
to about 4 mm, such that, in some embodiments, only the removal
member contacts the interior surface of the endotracheal tube (or
other conduit).
[0157] In some embodiments, the removal member 132 comprises one or
more soft, flexible, expandable materials, such as, for example,
silicone, UV curable silicone, ethylene vinyl acetate (EVA),
thermoplastic elastomer (TPE), KRATON polymers, polyisoprene,
urethane, silicone rubber, other suitable flexible and low-tear
materials, and/or the like.
[0158] In some embodiments, the removal member 132 has a material
softness that enables optimum deployment of the collection member
134 and reduces or prevents "hydroplaning" of the removal member
132 as it is withdrawn, thereby ensuring that the biofilm is
removed in an efficient manner. If the material is too soft, the
removal member 132 can gradually tear or pull away from the
collection member 134 over time.
[0159] In some embodiments, the use of materials that are too hard
can retard the deployment of the collection member 134, because the
removal member 132 exerts a backward force on the collection member
134 as it is expanded. Failure to adequately deploy the removal
member 132 can prevent the removal member 132 from adequately
engaging the inside wall of the endotracheal tube 100 with
sufficient radial force to effectively remove biofilm. In other
embodiments, if the material is too soft, then the removal member
132 "hydroplanes," thereby failing to adequately remove the biofilm
as the endotracheal tube device 120 is withdrawn.
[0160] The softness of the removal member 132, as measured on a
durometer scale, can range from 20 Shore A to 60 Shore A when
silicone is used or from about 0 Shore A to about 40 Shore A when
urethane or other materials are used. In one embodiment, the
softness of the removal member 132 is 30 Shore A when silicone or a
similar material is used. The removal member 132 can be configured
to expand to approximately 200 to 250 percent of its nominal
diameter. In some embodiments, the removal member 132 can be
configured to expand to accommodate endotracheal tubes having a
diameter between about 1 to about 10 mm.
[0161] The removal member 132 can be removably or integrally
coupled to the collection member 134 using any suitable attachment
method or device, including but not limited to, adhesive, epoxy,
suture, welding, casting, mechanically connected interference fit,
overmolding, and/or the like. In one embodiment, such as when the
removal member 132 comprises urethane material, the removal member
132 becomes chemically bonded to the collection member 134 (e.g., a
PE T braid scaffold) when overmolded. In some embodiments, the
removal member 132 is coupled to the outer surface of the
collection member 134. In other embodiments, the removal member 132
is coupled to the inner surface of the collection member 134. In
yet other embodiments, the removal member 132 is detachable or
separable from the collection member 134. In still other
embodiments, the removal member 132 is integral with the collection
member 134. In one embodiment, an integral well is formed
underneath and through the collection member 134 when the removal
member is overmolded or formed with an applicator. The integral
well design can advantageously prevent or reduce the likelihood of
the removal member 132 being sheared from the collection member 134
during operation.
[0162] In one embodiment, the removal member 132 comprises an
expandable O-ring wiper that generally circumscribes the collection
member 134. The O-ring wiper can be circular, substantially
circular, elliptical, oval, and/or any other shape. The O-ring
wiper can be a single, smooth, regular, continuous bead that is in
a perpendicular plane to the collection member 134. In another
embodiment, the removal member 132 comprises a wavy, or undulating,
pattern (as shown, for example, in FIGS. 9B and 9D). The peaks of
the wave pattern can vary from between about 0.05 inches to about
0.5 inches peak to peak, or e.g., about 0.1 inches to about 0.35
inches.
[0163] FIGS. 10A-10H illustrate cross-sectional profiles of various
alternative embodiments of the removal member 132 mounted on a
deployed collection member 134. In some embodiments, the portion of
the removal member 132 that contacts or engages the inner surface
of the endotracheal tube provides a smooth, regular contact
surface. In other embodiments, the contact portion of the removal
member 132 comprises an irregular contact surface. FIG. 10A
illustrates an O-ring having a substantially triangular cross
section. The concave slope and radius of the edges of the
substantially triangular O-ring can be varied as desired and/or
required. FIG. 10B illustrates an O-ring having a quarter-circle
cross section. The quarter-circle O-ring of FIG. 10B can be tapered
on the distal side for minimal disruption of biofilm on
introduction and optimal wiping of biofilm on removal of the
device. In some embodiments, the proximal side of the quarter
circle O-ring of FIG. 108 is concave, thus forming an O-ring having
a "wave-like" or "fin-like" cross section.
[0164] FIG. 10C illustrates an O-ring having a U-shaped cross
section. FIG. 10D) illustrates an O-ring having a half-circle or
half-moon shaped cross section. The radius of the half-circle can
range from about 0.001 inches to about 0.1 inches, or greater,
e.g., about 0.005 inches to about 0.01 inches, about 0.01 inches to
about 0.025 inches, about 0.025 inches to about 0.05 inches, about
0.05 inches to about 0.1 inches, and overlapping ranges thereof.
FIG. 10E illustrates an O-ring having a "squeegee-like" cross
section with a steep slope and a narrow wiping or scraping edge.
FIG. 10F illustrates an O-ring having a half-circle cross section
with a parting line. The parting line has been emphasized for
illustration and is not necessarily to scale. The parting line can
be a natural or intentional result of the molding process in
forming the O-ring. FIG. 10G illustrates an O-ring having a
squared-off contact portion. FIG. 10H illustrates an O-ring having
an X-shaped cross section.
[0165] The removal member 132 can be constructed of two or more
materials of an expandable nature. In some embodiments, the
majority of the body of the removal member 132 comprises a material
having a suitable durometer for expansion and the contact portion
comprises a more rigid material to provide sufficient strength and
rigidity for the effective wiping or removal of biofilm.
[0166] FIG. 11A illustrates an embodiment of a removal member 132
having a helical or "barber pole" configuration. Other embodiments
of removal member configurations include, but are not limited to, a
ribbed O-ring, an O-ring having a full circle cross-section, and an
O-ring having a varying cross-section about its circumference. In
still other embodiments, the removal member 132 can comprise
shaving members, bristles, or other protrusions. In various
embodiments, the removal member can comprise bumpy, ribbed,
saw-like, abrasive, rough, textured, slotted, and/or smooth or
substantially smooth materials. In some embodiments, the removal
member 132 can range from about 0.015 inches to about 0.050 inches
in height and from about 0.015 inches to about 0.1 inches in
width.
[0167] In some embodiments, the cleaning member 126 can include
multiple removal members 132, as illustrated in FIG. 11B. The
multiple removal members 132 can have the same or different
profiles. Different profiles can be used to accomplish various
purposes, as will be described in further detail below. In some
embodiments, the multiple removal members 132 include partial
O-rings that extend around a partial circumference of the
collection member 134 and are rotationally staggered.
[0168] In some embodiments, the removal member 132 can include
holes or apertures for fluid delivery, for suction, and/or for any
other purpose. The removal member 132 can be connected to a fluid
delivery channel or a suction/aspiration conduit within the
endotracheal tube cleaning device 120. For example, the removal
member 132 can be configured to deliver fluid and/or other
materials that help to disperse, degrade, or loosen hardened, more
adherent biofilm and/or to deliver drugs to the accumulated biofilm
and/or the internal surface of the endotracheal tube.
[0169] 3. Multiple Cleaning Members
[0170] In some embodiments, the endotracheal tube cleaning device
120 includes multiple cleaning members 126. The multiple cleaning
members 126 can be constructed to serve different purposes. For
example, the removal member 132 of each of the multiple cleaning
members 126 can be constructed with a different profile or cross
section. In other embodiments, each of the removal members 132 can
have the same profile or cross section. FIG. 12 illustrates an
embodiment of an endotracheal tube cleaning device 220 having three
cleaning members 226A-226C.
[0171] For example, the cleaning member 226A can include a round or
half-circle O-ring 232A for removing the mucous and other
easy-to-remove secretions deposited on the outer surface of the
biofilm layer. The cleaning member 226B can include an O-ring 232B
having a scraping edge 233 for removing the tenacious, more
adherent, older biofilm deposits. With reference to FIGS. 13A-13C,
various alternative embodiments of scraping edges 233 are
illustrated. Other scraping edge profiles can be used without
departing from the spirit and/or scope of the disclosure. Referring
back to FIG. 12, the cleaning member 226C can include a round,
half-circle, or quarter-circle O-ring 232C configured to remove and
collect any remaining biofilm. As described above, the O-ring
removal members 232 can be constructed of more than one material to
enhance the scraping or wiping action of the O-rings. The O-rings
232 of the cleaning members 226 can have any of the cross-sectional
profiles illustrated in FIGS. 10A-10H or any other cross-sectional
profiles as desired and/or required.
[0172] Each of the cleaning members 226 can include a collection
member 234 (e.g., braided or mesh scaffold) for collecting biofilm
while still allowing sufficient airflow through the endotracheal
tube 100. The multiple cleaning members 226 can be separated by a
non-expandable attachment device or method, such as, for example, a
heat shrink clamp band, sutures, adhesives, epoxy, welding, other
low-profile mechanical attachment methods or devices, and/or the
like. For example, as shown in FIG. 12, the multiple cleaning
members 226 are separated by clamp bands 235 that constrain the
expansion of the mesh collection members but are not attached to
the inner shaft 128, thereby allowing for simultaneous deployment
of the multiple cleaning members 226.
[0173] 4. Separate Collection Member
[0174] FIG. 14 illustrates another embodiment of an endotracheal
tube cleaning device 240. The endotracheal tube cleaning device 240
includes a removal member 242 and a collection member 244. The
removal member 242 includes an O-ring wiper 246 and a scaffold 248
(e.g., mesh scaffold) for selectively effectuating deployment of
the O-ring wiper 246. In the depicted embodiment, the collection
member 244 comprises a biofilm collection basket. The collection
member 244 can be spaced proximally from the removal member 242 at
a distance ranging from about 0.1 inches to about 0.5 inches;
however other separation distances can be used as desired and/or
required.
[0175] The collection member 244 can comprise a mesh or other
porous material having openings that are small enough to collect
solid or semi-solid biofilm deposits but large enough to allow for
sufficient airflow through the collection member. In some
embodiments, the maximum cross-sectional dimension of the openings
ranges from about 0.010 inches to about 0.050 inches. The
collection member 244 can be sized and shaped to hold up to about
20 ccs of biofilm. The collection member 244 can advantageously
have a width or diameter that is less than the diameter of the
endotracheal tube 100 so as not to contact the inner wall of the
endotracheal tube 100. As shown in FIG. 14, the endotracheal tube
cleaning device 240 can include an internal channel 249 for
insertion of scopes (e.g., a visualization scope), catheters,
probes, and/or other instruments, as described in greater detail
herein. The endotracheal tube cleaning device 240 can include an
inner shaft and outer shaft, as well as other structural features
not shown in FIG. 14, but described with respect to the other
embodiments herein.
III. Mechanical Expansion
[0176] As described above, according to some embodiments, the
cleaning member 126 can be configured to transition from a
collapsed configuration (see FIG. 3D) to an expanded configuration
(see FIG. 3E) by the relative movement of inner and outer members
(e.g., inner shaft 128 and outer shaft 129). In some embodiments,
the inner member moves axially while the outer member remains
stationary. In other embodiments, the outer member moves axially
while the inner member remains stationary. In yet other
embodiments, the inner and outer members are both configured to
move axially.
[0177] A. Mechanical Struts
[0178] In some embodiments, the cleaning member 126 can be
mechanically expanded by multiple deploying struts. FIG. 15A
illustrates a "fish-net" embodiment of the collection member 134.
The proximal section of the collection member 134 comprises
multiple "umbrella-like" deploying struts 252 to effectuate radial
expansion of the removal member 132 and the distal section of the
collection member 134 comprises a mesh scaffold, or collection
basket, constructed to collect and trap biofilm removed by the
removal member 132. The deploying struts 252 can be coined to
provide flexibility for a desired expansion angle. The expansion
angle can range from about 5 degrees to about 45 degrees or from
about 20 degrees to about 35 degrees. As shown, the deploying
struts 252 can extend from the outer shaft 129 to the removal
member 132. The deploying struts 252 can be mechanically coupled
and/or adhered to the outer shaft 129 and the removal member 132 by
any suitable coupling and/or adhesive device or method, such as
interference fits, ultrasonic welding, heat shrink tubing,
adhesive, epoxy, other low-profile mechanical attachment means,
and/or the like. As shown, the deploying struts 252 are coupled to
the outer shaft 129 by a heat shrink band clamp 254. The deploying
struts 252 can comprise one or more metallic and/or plastic
materials. Nitinol may be used in several embodiments to form
expanding components, such as the struts, scaffold, removal member,
etc.
[0179] FIGS. 15B and 15C illustrate another embodiment of a "living
hinge" endotracheal tube cleaning device 250 comprising deployment
struts for mechanical expansion of a cleaning member 251. The
cleaning member 251 illustrated in FIGS. 15B and 15C comprises a
scaffold having deployment struts 256 and longitudinal slits 258
and an O-ring wiper 259. In some embodiments, the distal tip 130 of
the endotracheal tube cleaning device 120 is integrally formed with
distal end of the cleaning member 251. The distal tip 130 of the
endotracheal tube cleaning device 120 can be coupled to the inner
shaft 128 and the proximal end of the cleaning member 251 can be
coupled to the outer shaft 129 by any suitable coupling and/or
adhesive device or method, such as interference fits, ultrasonic
welding, heat shrink tubing, adhesive, epoxy, other low-profile
mechanical attachment means, and/or the like. In some embodiments,
the connections between the distal end of the cleaning member 241
and the distal tip 130 or inner sheath 128 and/or the connection
between the proximal end of the cleaning member 241 and the outer
sheath 129 form living hinges about which the deployment struts
expand. The O-ring wiper 259 can be coupled and/or adhered to the
deploying struts 258 by overmolding, interference fits, ultrasonic
welding, adhesive, sutures, epoxy, other low-profile mechanical
attachment means, and/or the like. In some embodiments, movement of
the inner shaft in a proximal direction causes the deploying struts
258 to flex or bend outward, thereby radially expanding the O-ring
wiper 259. The deploying struts can comprise a substantially rigid
elastomeric material to prevent collapse due to the return force of
the O-ring wiper 259.
[0180] B. Expanding Collet Assemblies
[0181] FIGS. 16A-16D illustrate other mechanisms for mechanical
expansion of a removal member (e.g., an O-ring) of an endotracheal
tube cleaning device. FIGS. 16A and 16B illustrate an embodiment of
a collet expansion assembly 210 in an unexpanded and expanded
configuration, respectively. The collet expansion assembly 210
includes an expanding collet 212 that can be radially expanded by a
ram 214.
[0182] The expandable collet 212 can comprise elastomeric material,
such as polypropylene, polyethylene, nylon, polycarbonate, and/or
the like. The elastomeric material can advantageously provide
living hinge capability. The expandable collet 212 comprises
multiple (e.g., four or more) struts, or leaves, 216 and multiple
longitudinal openings, or slits, 217 to allow for radial
expansion.
[0183] The ram 214 can be fixedly attached to the outer shaft 129,
thereby remaining stationary. The ram 214 can have a circular,
substantially circular, elliptical and/or other shaped cross
section. The ram 214 can have a uniform cross-sectional diameter
across its length or a varying cross-sectional diameter. The distal
end of the ram 214 can have a tapered edge so as to reduce the
likelihood that the expandable collet 212 is snagged on the ram
214. The distal end of the expandable collet 212 can be connected
to and/or can be integral with the distal tip 130 of the
endotracheal tube cleaning device and the inner sheath 128 can be
connected to the distal tip 130.
[0184] As the inner shaft 128 is pulled proximally, the expandable
collet 212 can be pulled toward the ram 214. As the inner surface
of the struts 216 engage and move over the ram 214, they can be
expanded radially by the ram 214 about living hinges 218 formed
between the distal ends of the struts 216 and the distal tip 130.
As the struts 216 of the expandable collet 212 expand, the removal
member 132 can also expand. FIG. 16B illustrates the collet
expansion assembly 210 in an expanded position. As shown in FIG.
16B, upon expansion, the open proximal side of the expandable
collet 212 can function as a collector of biofilm as the
endotracheal tube cleaning device is withdrawn from the
endotracheal tube. In some embodiments, a mesh or other porous
material can be coupled to the expandable collet 212 to facilitate
collection of biofilm while still allowing airflow through the
endotracheal tube cleaning device. In other embodiments, the ram
214 can move with respect to the expandable collet 212.
[0185] The removal member 132 can be overmolded, applicated,
assembled, adhered, and/or otherwise coupled to the expandable
collet 212. In some embodiments, the removal member 132 sits within
a circumferential groove of the expandable collet 212. The removal
member 212 can be an O-ring comprised of TPE, silicone, urethane,
ethylene-vinyl acetate (EVA), polyisoprene, a KRATON polymer,
and/or the like. The durometer of the O-ring can range from about
30 Shore A to about 90 Shore A. In other embodiments, the removal
member 132 is not included.
[0186] FIG. 16C illustrates a collet expansion assembly 260 of an
embodiment of the endotracheal tube cleaning device 120 and the
endotracheal tube 100. In the depicted embodiment, the collet
expansion assembly 260 includes a center rod 262, a molded collet
264, a split tubing 266, an expanding netting 268, and a molded
adhesion band 269. FIG. 16D illustrates the assembled collet
expansion assembly 260 in its expanded configuration within the
endotracheal tube 100. In some embodiments, the center rod 262
replaces the inner shaft 128, the split tubing 266 replaces the
outer shaft 129, and the expanding netting 268 replaces the
collection member 134. As shown in FIG. 16D, the molded collet 264
is inserted over and attached to the center rod 262, which in turn
is inserted within the split tubing 266, the expanding netting 268
is placed over the split tubing 266, and the molded adhesion band
269 is overmolded on the distal end of the expanding netting 268.
The expanding netting 268 can be connected to the center rod 262 by
the molded adhesion band 269. As the center rod 262 moves
proximally, the increasing diameter of the molded collet 264 causes
the split tubing 266 to expand radially, thereby bringing the
expanding netting 268 into contact with the inner wall of the
endotracheal tube. As the center rod 262 is withdrawn, biofilm
removed by the expanding netting 268 can collect within the
expanding netting 268, similar to the collection members described
herein.
[0187] C. Vented Tube Design
[0188] FIGS. 17A and 17B illustrate an embodiment of a vented tube
assembly 270. The vented tube assembly 270 includes a center rod
272, a vented tube 273, and a vented tip 275. As shown in FIG. 17B,
the center rod 272 is inserted within the vented tube 273. The
vented tip 275 can be attached to the distal end of the center rod
272. The distal tip of the vented tube 273 can be tapered such that
when the center rod 272 is moved proximally with respect to the
vented tube 273, the rounded proximal edge of the vented tip 275
slides over the tapered distal tip of the vented tube 273, and
expands radially with the increasing diameter of the vented tube
273. The vents in the vented tube 273 can allow the vented tube 273
to expand. In some embodiments, the proximal edge of the vented
tube 273 comprises a circumferential ridge or protrusion configured
to engage the inner surface of the endotracheal tube 100 and to
remove biofilm deposited thereon as the center rod 272 is withdrawn
from the endotracheal tube 100. In other embodiments, an O-ring can
be overmolded or otherwise coupled about the circumference of the
vented tube 273.
[0189] In some embodiments, the vented tip 275 can be expanded by
infusion of air and/or liquid through the vented tube 273. In some
embodiments, therapeutic agents, drugs, and/or gases can be
delivered through the vented tip 275 and/or biofilm can be
aspirated out of the endotracheal tube 100 through the vented tube
273. The vented tip 275 can comprise one or more durable
elastomeric materials, such as silicone, urethane, polypropylene,
polyethylene, and/or the like.
[0190] D. Helical Spring Assembly
[0191] FIGS. 18A-18C illustrate other embodiments of mechanical
expansion mechanisms using helical springs. With reference to the
embodiments illustrated in FIGS. 18A-18C, the distal end of the
helical spring wireform 180 is attached to the inner sheath 128 and
the proximal end of the helical spring wireform is attached to the
outer sheath 129. The helical spring wireform 180 can be attached
to the inner sheath 128 and the outer sheath 129 by any suitable
attachment method or device, such as, for example, heat shrink
tubing, adhesive, epoxy, interference fits, other low-profile
mechanical attachment methods and/or the like.
[0192] In some embodiments, as shown in FIG. 18A, the helical
spring wireform 180 is wound or otherwise manufactured such that
the middle portion 182 comprises a slightly unstable, naturally
unfurled configuration. When the inner shaft 128 is engaged by the
trigger 152 (thereby moving the inner sheath 128 in a proximal
direction, the inner sheath 128 compresses or draws the helical
spring wireform 180 proximally, and the middle portion 182 is
distended radially. In other embodiments, as shown in FIG. 18B, the
helical spring wireform 180 is wound or otherwise manufactured such
that the middle portion 182 comprises a naturally distended
configuration. Before insertion of the endotracheal tube cleaning
device of FIG. 18B, the actuation assembly 124 can be configured to
move the outer sheath 129 proximally to draw the middle portion 182
of the helical spring wireform 180 to an unfurled configuration.
Once the middle portion 182 has been properly positioned within the
endotracheal tube, the trigger 152 can be released to return the
middle portion 182 to its distended configuration for engaging the
inner surface of the endotracheal tube 100.
[0193] The helical springs 180 of FIGS. 18A-18C can comprise one or
more metallic and/or plastic materials, such as, for example,
stainless steel, spring steel, Nitinol, injection-molded
polycarbonate and/or any other injection-molded plastic material
that is capable of retaining spring qualities. In some embodiments,
the diameter of the spring wire can range from about 0.001 inches
to about 0.05 inches in diameter, or from about 0.005 inches to
about 0.025 inches in diameter. The middle portion 182 can comprise
from about 1 to about 3 turns (e.g., 11/8 to about 13/4 turns). In
some embodiments, at least the outermost loop 185 of the distended
middle portion 182 is coated with plastisol, silicone, other
suitable elastomers, and/or the like, to aid in wiping and
collecting biofilm as the endotracheal tube cleaning device 120 is
withdrawn from the endotracheal tube 100.
[0194] In some embodiments, as illustrated in FIG. 18C, a thin,
flexible funnel 186 extends from the distal end of the inner shaft
128 or the distal tip 130 of the endotracheal tube cleaning device
120 to the middle spring 185 of the middle portion 182 of the
helical spring wireform 180. The funnel 186 can advantageously
serve as a collector of biofilm when the endotracheal tube device
120 is withdrawn from the endotracheal tube 100. The funnel 186 can
be attached to the inner shaft 128 or the distal tip 130 and to the
helical spring wireform 180 by any suitable attachment method or
device, such as, for example, heat shrink tubing, adhesive, wound
wire, suture, epoxy, other low-profile mechanical attachment method
or device, and/or the like. The funnel can be attached to the
helical spring wireform 180 continuously or intermittently (e.g.,
at selected attachment locations) using any attachment method or
device, such as adhesive, flexibly epoxy, sutures, and/or the like.
The funnel 186 can comprise latex, thin braid material, silicone,
and/or other elastomeric or polymeric materials, flaccid materials
and/or the like. The funnel can be draped over the helical spring
wireform 180 with enough spare material to allow for expansion of
the helical spring to the distended configuration without
substantially retarding or otherwise hindering deployment of the
helical spring. In other embodiments, the helical spring 180 can
serve as its own collector without the funnel 186.
[0195] E. Self-Expanding
[0196] In some embodiments, the collection member 126 can include
one or more "self-expanding" materials that are configured to
radially expand when a compressive force is exerted upon the
materials in a longitudinal direction by the movement of the inner
shaft 128. The radial expansion of the collection member 126 causes
the radial expansion of the removal member 132. The term
"self-expanding" as used herein shall be given its ordinary meaning
and shall mean, without limitation, that no additional mechanical
structure (such as struts, collets, springs, pistons, and/or the
like) other than the physical characteristics or properties of the
materials of the collection member (e.g., scaffold), is used to
expand the collection member. For example, self-expanding materials
can simply expand with the relative movement of the inner shaft 128
with respect to the outer shaft 129. In some embodiments,
self-expanding materials comprise Nitinol, other shape-memory
metals, alloys or other materials and/or the like.
[0197] FIGS. 19A and 19B illustrate another embodiment of a
mechanically-expandable cleaning member 290. FIG. 19A illustrates a
perspective view of the mechanically-expandable cleaning member 290
and FIG. 19B illustrates a cross-sectional view of the
mechanically-expandable cleaning member 290. FIGS. 19A and 19B
illustrate the mechanically-expandable cleaning member 290 in the
expanded configuration. As shown, the cleaning member 290 can
include an expandable collection member or scaffold 292 and a
removal member 294 having an angled rim 295 for contacting the
internal surface of the endotracheal tube 100. The angled rim 295
can be angled about 2 to about 40 degrees (e.g., 5 to 25 degrees)
from a vertical orientation.
[0198] The expandable collection member 292 can comprise an outer
scaffold member 296 and an inner scaffold member 298. In the
depicted embodiment, the inner scaffold member is folded in on
itself and forms a hinge about which it expands. In the depicted
embodiment, the distal end of the outer scaffold member 296 is
connected to the distal tip 130 of the endotracheal tube cleaning
device 120. The distal end of the outer scaffold member 296 can be
connected to the distal tip 130 using heat shrink tubing, an
interference fit, other fasteners, or other suitable low-profile
mechanical devices and/or any other attachment method or device.
The inner sheath 128 can be assembled to or be formed integral with
the distal tip 130. Likewise, a first end of the inner scaffold
member 298 can be connected to the distal end of the outer shaft
129 using any attachment device or method, including, for example,
an interference fit, heat shrink tubing, adhesive, epoxy, molding,
welding and/or the like. The second end of the inner scaffold
member 298 and the proximal end of the outer scaffold member 296
can be connected to the removal member using any attachment device
or method, including, for example, an interference fit, heat shrink
tubing, adhesive, epoxy, molding, welding and/or the like.
[0199] With continued reference to the embodiment illustrated in
FIGS. 19A and 19B, when the inner shaft 128 is pulled back (i.e.,
moved proximally with respect to the outer shaft 129), a force can
be exerted on the outer scaffold member 296 by the inner shaft 128
and the inner scaffold member 298 that causes the angled rim 295 of
the removal member 294 to distend radially against the inner wall
of the endotracheal tube 100. In some embodiments, the inner
scaffold member 298 of the expandable collection member 292 can
also exert a radial expansion force on the removal member 294 as
the inner sheath 128 moves in a proximal direction. The expandable
collection member 292 includes a collection area within the
interior of the outer scaffold member 296 and/or the inner scaffold
member 298 for collection of biofilm as the endotracheal tube
cleaning device 120 is withdrawn from the endotracheal tube. The
scaffold of the expandable collection member 292 can comprise one
or more braid materials, elastomeric or polymeric materials, such
as, for example, polyisoprene, TPE, silicone, urethane, and/or any
other suitable material that has the desired or required softness
and/or other characteristics (e.g., a softness of about 15 to about
40 Shore A durometer). The inner scaffold member 298 of the
expandable collection member 292 can comprise strengthening
materials to provide sufficient rigidity (e.g., larger diameter
braided fibers or stiff porous elastomeric material).
[0200] The outer scaffold member 296 and the inner scaffold member
298 can be configured to have varying porosity to facilitate
expansion and/or collection of biofilm. For example, in embodiments
where braided material is used for the expandable collection member
292, a lower pick count (e.g., about 5 to about 10 picks per inch)
can be used for the proximal side, while a higher pick count (e.g.,
about 10 to about 25 picks per inch) can be used for the distal
side. In some embodiments, the diameters (or other cross-sectional
dimensions) of the braid fibers vary from about 0.005 inches to
about 0.010 inches. However, in alternative embodiments, such
diameters or other cross-sectional dimension is less than about
0.005 inches or greater than 0.010 inches, as desired or required.
In some embodiments, the expandable collection member 292 comprises
two or more layers of braid material. In some embodiments, the
proximal portion and the distal portion of the braided collection
member 292 can be ultrasonically welded or otherwise attached to
form a regular smooth continuous rim and the removal member 294 is
not included.
[0201] In embodiments where elastomeric material is used for the
expandable collection member 292, the expandable collection member
292 can be molded in a transfer press, an injection molding press,
a compression molding press, a thermoforming press and/or using any
other manufacturing device, system or method.
IV. Alternate Modes of Expansion
[0202] In some embodiments, the collection member 134 (e.g.,
scaffold) can comprise one or more shape memory materials that
automatically expand from a compressed configuration maintained
during insertion of the endotracheal tube cleaning device 120 by a
sheath to an expanded configuration when the sheath is withdrawn or
the collection member 134 is pushed out of the sheath. The shape
memory material can include nickel titanium alloys and/or other
shape memory materials. In some embodiments, the shape memory
material can be temperature-activated, light-activated, and/or
activated by liquid.
[0203] In other embodiments, the collection member 134 can be
expanded using inflation. For example, the removal member 132 can
comprise an inflatable O-ring, which when inflated, causes the
collection member 134 to expand. The inflatable O-ring can be on
the inside of the collection member 134 (e.g., similar to an
innertube) or on the outside of the collection member 134. In some
embodiments, an inflatable balloon or other member is configured to
selectively expand the cleaning member 126 and/or any other portion
of the cleaning device. In one embodiment, the removal member
comprises a smooth or textured inflatable balloon or bladder.
V. Controlled Expansion
[0204] In some embodiments, the endotracheal tube cleaning device
120 can provide for variable expansion of the cleaning member 126,
depending on the tube's inside diameter, the amount of biofilm
deposited on the internal surface of the endotracheal tube 100
and/or one or more other factors or considerations. In other
embodiments, the endotracheal tube cleaning device 120 can
selectively deploy the cleaning member 126 with variable pressure
depending on the endotracheal tube's inside diameter, the amount of
biofilm deposited on the internal surface of the endotracheal tube
100 and/or one or more other factors or considerations. In some
embodiments, the actuation assembly 124 is configured to expand the
cleaning member 126 about 0.1 mm to about 2 mm larger than the
inside diameter of the endotracheal tube (e.g., from about 0.1 mm
to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2
mm, and overlapping ranges thereof).
[0205] In some embodiments, the actuation assembly 124 includes
features that provide for incremental expansion of the cleaning
member 126. FIG. 20) illustrates an assembled actuation assembly
124 configured to provide controlled, incremental expansion of the
cleaning member 126. FIGS. 21A-21D illustrate various perspective
views of components of one embodiment of an actuation assembly 124.
For example, FIGS. 21A and 21 B illustrate a detent half 312 and
FIG. 21C illustrates a thumb handle half 314 of the handle 150. As
shown in FIG. 21A, the detent half 312 can include multiple detents
315 incrementally spaced along its length. The detents 315 can be
formed as notches, slits, recesses, and/or the like within the
molded material of the detent half 312. As shown in FIG. 21B, the
detent half 312 can include visible markings or indicia 313. The
visible markings can aid the clinician in setting the initial
position of the trigger 152 with respect to the handle 150
depending on the diameter of the endotracheal tube to be cleaned.
The visible markings 313 can also provide visible feedback to the
clinician as to what diameter the cleaning member is currently
expanded to. The visible markings can include color or pattern
variations, text, varying line sizes or widths, numbers, and/or the
like. In some embodiments, the visible markings provide tactile
feedback to the clinician.
[0206] FIG. 21D illustrates one embodiment of a trigger 152 for an
actuation assembly. As shown, the trigger 152 can include one or
more bumps, ridges, projections 316 and/or the like. In some
embodiments, the bump 316 is sized, shaped, or otherwise adapted to
engage with, or be at least partially received by, the detents 315
of the handle 150. In some embodiments, the trigger 152 includes
multiple bumps 316 or similar features. The trigger 152 can be
captured by the assembly of the handle halves 312, 314. Further,
the handle halves 312, 314 can be coupled to each other or
otherwise assembled using adhesives, crush ribs, snap fit
connections, other mechanical fasteners, ultrasonic welding, and/or
any other suitable attachment method or device.
[0207] The detents 315 can serve to provide a hard stop and gauge
for the size of the endotracheal tube being to be cleaned.
Accordingly, a single cleaning device can be used to clean
endotracheal tubes having any of a range of inner diameters. For
example, and not by way of limitation, the detents 315 can allow
for cleaning of endotracheal tubes having an inner diameter between
about 5 mm and about 10 mm. In other embodiments, the detents 315
can permit for cleaning of endotracheal tubes for any other medical
or non-medical tube) with inner diameter below 5 mm or above 10 mm,
as desired or required. The detents 315 can be spaced to provide
for incremental expansion in 0.5 mm or 1 mm increments. However,
any other incremental expansion may be used. Engaging the
appropriate detent for each endotracheal tube size can
advantageously allow for the appropriate amount of scaffold
deployment based on the inner diameter of the endotracheal
tube.
[0208] The detent and bump profiles can be modified for smooth
operation and reentry. For example, the edges and tips of the
detents 315 can be radiused such that the bumps 316 do not hang up
or otherwise serve as an obstruction. In some embodiments, the
edges and tips of the detents 315 are generally smooth in order to
reduce friction. In some embodiments, the handle 150 can include
visible indicia on the outside surface to indicate the
correspondence between the detents 315 and the inner diameter
dimensions. Accordingly, a clinician can make sure that the
cleaning member 126 is appropriately expanded for the particular
endotracheal tube being cleaned. In some embodiments, the radiusing
of the detent tips and slight play in the trigger 152 allows for
"fine tuning" of the expansion during removal of the endotracheal
tube cleaning device 120.
[0209] In other embodiments, the actuation assembly 124 can be
configured to provide for continuous expansion of the cleaning
member 126, such as a rotatable thumbwheel assembly.
[0210] Under some circumstances, the failure to contact the biofilm
or inside wall of the endotracheal tube with the appropriate
pressure can potentially result in invagination or cavitation.
Accordingly, in some embodiments, the endotracheal tube cleaning
device 120 is configured to allow for manual fine tuning or
adjustment of the expansion of the cleaning member 126. In some
embodiments, the clinician can adjust the expansion of the cleaning
member 126 based upon an actual or estimated biofilm thickness
(e.g., maximum biofilm thickness, average biofilm thickness, etc.)
within the endotracheal tube 100 and the known inner diameter of
the endotracheal tube 100. For example, the estimated maximum
biofilm thickness can be determined based on the endotracheal tube
length, the inner diameter of the endotracheal tube, the reason for
ventilation, one or more patient risk factors, the amount of
biofilm removed at particular time intervals (e.g., 3, 8, 12, 24
hours, other time intervals, etc.).
[0211] In other embodiments, the clinician can adjust the expansion
of the cleaning member based on, at least in part, a pressure
sensor of the endotracheal tube cleaning device 120, tactile
feedback, visualization of the biofilm using a visualization scope
and/or one or more other factors or indicators.
[0212] In embodiments wherein a pressure sensor is used, the
pressure sensor can be an electrical or nanotechnology sensor
configured to sense the optimal pressure against the wall of the
endotracheal tube 100. Thus, the clinician can selectively adjust
the expansion of the cleaning member 126 based upon the measured
pressure and/or one or more other inputs. In other embodiments, the
pressure sensor can be connected to a feedback mechanism to provide
for automatic adjustment (e.g., expansion or contraction) of the
cleaning member.
[0213] In some embodiments that incorporate visualization,
expansion of the cleaning member can be manually or automatically
set or adjusted based on an analysis of the diameter of the
endotracheal tube 100, the amount of biofilm 116 present in the
endotracheal tube 100 and/or one or more other factors or
considerations.
[0214] In some embodiments, the removal member 132 comprises one or
more materials that automatically expand to independently apply
pressure to the wall of the endotracheal tube, thereby providing
automatic "fine-tuning" of the extent of expansion after a "rough"
mechanical expansion of the actuation assembly 124 and the
collection member 134.
VI. Depth Control
[0215] The endotracheal tube cleaning device 120 can include
features configured to control the depth of insertion of the
endotracheal tube cleaning device 120 within the endotracheal tube
100. In some embodiments, the endotracheal tube cleaning device 120
includes visible indicia along the length of the outer shaft 129 to
indicate the depth of the endotracheal tube cleaning device 120 in
the endotracheal tube 120. In some embodiments, a lockable, movable
stop is coupled to the outer shaft 129 to prevent against
over-insertion of the endotracheal tube cleaning device 120 beyond
the distal tip 108 of the endotracheal tube 100. In other
embodiments, the endotracheal tube cleaning device 120 includes a
visualization channel or lumen in which a visualization scope can
be inserted to determine the exact positioning of the endotracheal
tube cleaning device 120 within the endotracheal tube 100. In still
other embodiments, radiopaque markers can be used in combination
with imaging modalities to determine the depth of insertion.
[0216] A. Mechanical Control
[0217] FIG. 22 illustrates an embodiment of the endotracheal tube
cleaning device 120 having a movable stop 322 and visible depth
markings 323. In some embodiments, the visible depth markings 323
can be configured to align with corresponding depth measurements on
the outside of the endotracheal tube 100. For example, if the
endotracheal tube cleaning device 120 is being inserted into an
endotracheal tube having a length of 26 cm, the endotracheal tube
cleaning device 120 can be inserted until the 26 cm mark on the
endotracheal tube cleaning device 120 is aligned with the 26 cm
mark on the endotracheal tube. The visible depth markings 323 can
be calculated such that when the corresponding depth marks are
aligned, the distal tip of the endotracheal tube cleaning device
120 is at the desired depth within the endotracheal tube 100 (e.g.,
1.5 cm proximal of the distal tip 108). Once the visible depth
markings 323 are aligned with the corresponding markings on the
endotracheal tube, the movable stop 322 can be locked in place at
the proximal end 102 of the endotracheal tube 104, thereby
providing a positive check on the insertion of the endotracheal
tube cleaning device 120 within the endotracheal tube 100 and
advantageously preventing against or reducing the likelihood of
inadvertent over-insertion.
[0218] FIGS. 23A-23E illustrate various alternative embodiments of
a movable stop 322 configured for use with an endotracheal tube
cleaning device. FIG. 23A illustrates a locking clip design 330. In
the unlocked configuration (shown in FIG. 23A), the locking clip
can slide freely along the length of the outer shaft 129. When the
locking clip is moved to the correct position, as determined by the
visible depth markings 323, the locking clip can be squeezed or
otherwise manipulated to actuate the living hinge feature and
engage the locking feature. Accordingly, the locking clip can be
maintained in a fixed position. The locking clip design 330
advantageously provides one-handed operation, a one-piece design,
and a secure fastening feature. The materials for the locking clip
design can comprise materials capable of providing "living hinge"
capability, such as, for example, nylon, polypropylene,
polycarbonate, and/or the like. In some embodiments the materials
for the locking clip design 330 can comprise flexible materials,
such as, for example, urethane, silicone, and/or the like.
[0219] FIG. 23B illustrates an internal oval design 331. The
internal oval design 331 provides a constant "lock" due to the
interference of the internal oval opening with the radius of the
outer shaft 129. In some embodiments, in order to temporarily
"unlock" the movable stop and move the internal oval stop, manual
force is used to overcome the friction fit connection of the
internal oval design 331. The internal oval of the internal oval
design 331 can become substantially circular as it is moved along
the outer shaft 129. Once in position, the internal oval can return
to a substantially oval shape. In some embodiments, the internal
oval design 331 advantageously provides one-handed operation, a
one-piece design, and a secure fastening feature. The materials for
the internal oval design 331 can comprise materials having desired
or required physical and other properties, such as, for example,
toughness, flexibility, short term creep resistance, and/or the
like. Such materials can include, for example, urethane,
polyisoprene. TPE, other polymeric or elastomeric materials and/or
the like.
[0220] FIG. 23C illustrates one embodiment of a spring lock design
332 that is similar to the locking clips used on sweatshirt strings
or drawstring bags. The bore or aperture 333 of the illustrated
spring lock can have a diameter slightly larger than the diameter
of the outer shaft 129. The spring lock is maintained in a locking
position by a spring-loaded feature. According to some embodiments,
in order to unlock the device to move to a new position, the
spring-loaded feature is compressed by pressing on the compression
element 334. When the spring lock is positioned in the desired
position, the compression element 334 can be released, thereby
releasing the spring-loaded feature to re-lock the spring lock. In
other embodiments, the cylindrical features of the spring lock
design 332 can be substituted with flat, rectangular features. In
some embodiments, the spring lock design 332 advantageously
provides one-handed operation. The spring lock design 332 can
comprise one or more materials including, but not limited to, ABS,
polypropylene, nylon, filled polypropylene, polycarbonate,
polyethylene, other suitable injection-moldable grade resins, other
polymeric or elastomeric materials, and/or the like.
[0221] FIG. 23D illustrates one embodiment of a double wing design
335. The double wing design 335 includes a D-shaped opening 336 and
two symmetrical wings 337. In some embodiments, the flat-section of
the D-shaped opening 336 is configured to match a corresponding
flat section of the cross-section of the outer shaft 129. When the
corresponding flat sections are aligned, the double wing stop can
move freely along the outer shaft 129. In one embodiment, in order
to set the maximum depth, the double wing stop is turned either
clockwise or counterclockwise using the wings 337 so that the flat
section of the D-shaped opening 336 interferes with the radius of
the outer shaft 129. The double wing design 335 can advantageously
provide one-handed operation and a one-piece design. The double
wing design 332 can comprise one or more materials such as, for
example, ABS, polypropylene, nylon, filled polypropylene,
polycarbonate, polyethylene, other suitable injection-moldable
grade resins, other polymeric or elastomeric materials, and/or the
like.
[0222] FIG. 23E illustrates one embodiment of an oval design 338.
According to some embodiments, the oval design 338 includes a
D-shaped opening 339 and operates in a similar manner to the double
wing design 335. The oval design 338 can advantageously provide
one-handed operation and a one-piece design. The oval design 338
can comprise one or more materials such as, for example, ABS,
polypropylene, nylon, filled polypropylene, polycarbonate,
polyethylene, other suitable injection-moldable grade resins, other
polymeric or elastomeric materials, and/or the like.
[0223] In some embodiments, an elastomeric bag can be attached to
the movable stop 322 for containment of the collected biofilm after
removal from the endotracheal tube 100. The elastomeric bag can be
attached in a furled or rolled-up configuration. The movable stop
322 with the attached elastomeric sheath can be moved along the
outer shaft 129 in proximity to the biofilm that has been collected
on the cleaning member 126. The elastomeric sheath can then be
rolled out, or unfurled, over the cleaning member 126, thereby
containing the collected biofilm until it has been safely deposited
into a biohazardous container. The elastomeric bag can comprise one
or more materials, such as silicone, latex, other elastomeric or
polymeric materials, and/or the like.
[0224] B. Visualization
[0225] According to some embodiments, mechanical depth control can
be enhanced, supplemented, or replaced with the help of one or more
visualization features. As described above, an endotracheal tube
cleaning device 120 can include a visualization channel or lumen
configured to receive a visualization element (e.g., visualization
scope 142). The visualization element can utilize ultrasound,
infrared, CCD, fiberoptic and/or any other type of imaging
technology. For example, the visualization scope can comprise a
fiber optic camera on the end of an endoscope. As discussed herein,
the distal tip 130 of the endotracheal tube cleaning device 120 can
include a transparent viewing "window" and/or other viewing area or
region. The transparent viewing window or area of the visualization
channel can advantageously enable a clinician to position the
distal tip 130 of the endotracheal tube cleaning device at a
selected location with respect to the endotracheal tube 100.
[0226] In some embodiments, the proximal end of the visualization
channel is constructed with a introducer sheath area suitable for
preventing or reducing the likelihood of contamination of the
visualization element, thereby enabling reuse of the visualization
element from one patient to another without concern for
cross-contamination.
[0227] In some embodiments, the visualization element can
facilitate, optimize, and/or document the endotracheal tube
cleaning procedures. In some embodiments, the images received from
the visualization element scope can be transferred to remote
locations over a network, as described above, to permit remote
observation. In some embodiments, an endotracheal tube cleaning
system comprises a visualization scope (e.g., endoscope with a
fiber optic camera), an external camera for viewing the nurse and
the patient from a control room outside the ICU environment. The
images from the visualization scope and external camera can be
transmitted, along with clinical test and/or patient data, such as
oxygen saturation, heart rate, respiration rate, and/or the like,
to facilitate the remote treatment of the ICU patient.
VII. Supplementary and Preventative Modalities/Capabilities
[0228] In some embodiments, the endotracheal tube cleaning device
120 can have one or more channels or lumens for visualization,
aspiration or suction, ventilation, irrigation/infusion, light
delivery, and/or the like. In some embodiments, the endotracheal
tube cleaning device 120 can have a single channel (e.g., a central
lumen) for insertion of multiple catheters, probes, scopes, and/or
other instruments. In other embodiments, the endotracheal tube
cleaning device 120 includes two or more channels. For instance, an
endotracheal tube cleaning device 120 can comprise a visualization
channel, a suction channel, and an irrigation/infusion channel.
[0229] In arrangements including a side port 140, one or more
channels or lumens of the endotracheal tube cleaning device 120 can
be in communication with such a side port 140. In some embodiments,
the channels or lumens of the cleaning device can be sheathed to
prevent contamination of the catheters, probes, scopes, and/or
other instruments inserted therein.
[0230] The additional catheters, probes, scopes, and/or instruments
providing additional features to supplement and/or facilitate the
cleaning of the endotracheal tube can be configured for
single-handed operation. The single-handed operation can be
facilitated with the use of fibers, cables, conduits, and/or lines
of sufficient length such that the bulky components of the
additional diagnostic, visualization, and/or therapeutic
instruments or systems are positioned remote from the patient. In
some embodiment, user controls for the additional instruments or
systems are located adjacent to the patient or adjacent to the
actuation assembly 124 of the endotracheal tube cleaning device 120
to enable the single-handed operation by the user. The various
mechanisms can be controlled by pressing one or more user input
controls with a single finger. In some embodiments, a different
finger can be used for each respective action (e.g., one finger for
aspiration and another finger on the same hand for irrigation or
drug delivery). In other embodiments, the additional instruments
and/or capabilities can be controlled by multiple hands and/or
multiple persons.
[0231] In some embodiments, the additional instruments and
capabilities can be controlled by the clinician concurrently with
cleaning of the endotracheal tube with the endotracheal tube
cleaning device 120. In other embodiments, the additional
instruments and capabilities can be activated before, concurrently
with, and/or after the cleaning with the endotracheal tube cleaning
device 120. In some embodiments, two or more instruments can be
activated simultaneously (for example, for broncho-alveolar
lavage).
[0232] A. Suction/Aspiration
[0233] In some embodiments, a suction or aspiration catheter,
conduit, or line can be inserted into a channel of the endotracheal
tube cleaning device 120. The suction catheter can be used to
perform an initial pre-cleaning suctioning of the tracheobronchial
tree, the endotracheal tube 100 and/or any other item or region of
the anatomy. The suction catheter can also be used to aspirate
biofilm removed by the cleaning member 126 of the endotracheal tube
cleaning device 120. The aspiration catheter can be used for
sampling and analysis of the biofilm within the endotracheal tube
of a patient to determine the bacterial content or nature of the
biofilm. The clinician can then implement more effective treatment,
antibiotics and safeguards against cross-contamination based at
least in part on the determination of the bacterial content,
thereby advantageously reducing infections, conditions, and/or
other ailments, including but not limited to VAP, and reducing the
length of stay of the ICU patient. In some embodiments, the
endotracheal tube cleaning device 120 has a proximal seal at the
entry of the tube for generally sealing the region during the
application of suction, thereby helping to enhance the removal of
material.
[0234] In some embodiments, the removal member 132 (e.g., O-ring)
can include one or more openings or ports spaced continuously or
intermittently around its circumference or other outer region to
facilitate in the aspiration of biofilm and/or other materials. The
suction catheter, conduit, or line can provide suction to the
removal member 132 to facilitate removal of small amounts of
biofilm that are not completely removed (e.g., wiped) from the
inside surface of the endotracheal tube 100.
[0235] B. Irrigation/Fluid Delivery
[0236] In some embodiments, a delivery catheter can be inserted
into a channel of the endotracheal tube cleaning device 120.
Accordingly, the delivery catheter can be used to selectively
deliver one or more fluids and/or other materials to a target
region. In some embodiments, such fluids and/or other materials are
adapted to disinfect, decontaminate, or sterilize the endotracheal
tube. In some embodiments, such fluids and/or other materials are
configured to loosen, break up, penetrate, degrade, disperse,
dissolve and/or otherwise undermine or affect the biofilm 116
deposited on the inside surface of the endotracheal tube 100. In
some embodiments, such fluids and/or other materials can aid in
removal of the biofilm 116 and/or aid in the prevention of the
future accumulation of biofilm. The delivery catheter can be
configured and positioned to deliver one or more fluids and/or
other materials to the inside wall of the endotracheal tube 100,
tracheobronchial tree and/or any other region within a person's
anatomy.
[0237] In some embodiments, fluids and/or other materials that are
selectively delivered through a channel or lumen of the cleaning
device include, without limitation: antibacterial agents,
bactericides, antiviral agents, mucolytic agents, saline solution,
sterilant, enzymatic cleaner, germicide, antimicrobial fluid,
detergent, combinations of the same, and/or the like. In some
embodiments, the antiviral agents can be configured to prevent or
treat ventilator assisted pneumonia or other maladies or
conditions.
[0238] In some embodiments, an irrigation channel or lumen can
deliver drugs, fluids and/or other materials via the removal member
132 (e.g., O-ring), the collection member 134 (e.g., mesh
scaffold), a deployment member (e.g., struts) and/or any other
component or portion of the cleaning device. In some embodiments,
the irrigation channel or lumen includes multiple outlets that are
in communication with the outside of the endotracheal tube cleaning
device 120 along the length of the channel. Accordingly, such
embodiments can be used to selectively deliver fluids and/or other
materials (e.g., antibiotics, antiviral substances, other
pharmaceuticals, antiseptics, therapeutic agents, and/or the like)
to the biofilm 116. In other embodiments, the irrigation channel or
lumen includes a single outlet, either at the distal end of the
endotracheal tube cleaning device 120 (e.g., in the distal tip 130)
or at any other location along the length of the device, in order
to selectively deliver the desired fluids, agents, and/or other
materials to the biofilm 116. The one or more outlets can comprise
a one-way valve, slit, and/or diaphragm to substantially seal the
outlet, thereby preventing or reducing the likelihood of
contamination due to an influx of bacteria or materials from inside
the patient.
[0239] In some embodiments, an irrigation channel or lumen can be
used to deliver drugs in a spray pattern that will deliver the
drugs in an acceptable amount or rate to the wall of the
endotracheal tube 100. In some embodiments, a drug delivery
catheter can deliver a "mist" of a prescribed amount of a
therapeutic agent, other pharmaceutical or drug and/or other
substance to at least partially coat the inside wall of the
endotracheal tube 100 and/or the biofilm attached thereto. In some
embodiments, a drug delivery catheter can include a diffusing tip
to enhance the spray of drugs to the wall of the endotracheal tube
100. For example, such tips or nozzles can help to more evenly
diffuse the materials along a target region of the endotracheal
tube or biofilm layer.
[0240] In other embodiments, an irrigation channel has a distal
outlet directed at the "window," or distal tip, of the
visualization channel to help clear debris and other materials away
from the viewing window. Accordingly, the visualization features
described herein can be improved.
[0241] C. Ventilation
[0242] In some embodiments, the endotracheal tube cleaning device
120 has an internal lumen that facilitates or enables the continued
delivery of air, pure oxygen and/or other gases to the patient
while the endotracheal tube cleaning device 120 is in place. This
can help ensure that the patient's blood oxygen level is maintained
above a threshold level during a particular procedure. However, in
other embodiments, the cleaning device does not require
supplemental oxygen or other gases to be delivered to a patient
during a procedure. In some embodiments, the delivered gas or gases
can be heated to a temperature of between about 120 degrees to
about 180 degrees Fahrenheit.
[0243] D. Other Therapeutic Modalities
[0244] In some embodiments, one or more channels of the
endotracheal tube cleaning device 120 can be used to deliver
therapeutic modalities, such as sonication, vibration, radiation,
photodynamic therapy, light, electrical stimulation and/or the
like.
[0245] For example, photodynamic therapy can be used to treat
specific bacteria identified as being present within the
endotracheal tube 100 or within the tracheobronchial tree. In some
embodiments, one or more drugs can be delivered through a channel
(e.g., a drug delivery or infusion channel) of the endotracheal
tube cleaning device 120 or by a separate drug delivery catheter to
the inner wall of the endotracheal tube. Then, one or more light
delivery elements (e.g., LEDs, lasers) can be inserted within the
same channel or a different channel to deliver light at an
appropriate wavelength (e.g., visible, infrared, UV wavelengths) to
activate the one or more drugs delivered to the inner surface of
the endotracheal tube. For example, UV-C light can reduce surface
bacteria count within a matter of seconds. In certain embodiments,
the drugs and light can be delivered concurrently. In embodiments
where the light is delivered through the distal tip 130, the distal
tip can be configured to disperse and/or diffuse the light (e.g.,
using a diffuser, a deflector, and/or the tissue optics properties
of the tip itself) such that the appropriate wavelength, intensity,
and/or quantity of light can be delivered to activate a specific
drug. A control unit can be programmed and/or controlled to vary
the wavelength, intensity, pulse width and duty cycle (if pulsed
light is used), exposure time, and/or the like of the light.
[0246] As another example, sound waves can be delivered through
using a sonication device. Such sound waves can advantageously have
an inhibiting effect on the sustainability and/or growth of
biofilm. Vibrations produced by the sonication device can loosen
the tenacious or more adherent biofilm. In some embodiments, one or
more sensors or electrodes can be introduced on a probe or catheter
to detect one or more physiological conditions or parameters of the
patient.
VIII. Introduction Connector
[0247] In some embodiments, an endotracheal tube cleaning system
includes an adapter or introduction connector that advantageously
enables the patient to remain connected to a mechanical ventilator,
thereby maintaining ventilator airflow, during cleaning of the
endotracheal tube.
[0248] FIGS. 24A and 24B illustrate two embodiments of adapter
configurations to facilitate introduction of a tube cleaning device
120 in an endotracheal tube during a procedure, in some
embodiments, the distal end of the adapter 340 is configured to
removably couple (e.g., directly or indirectly) to the proximal end
102 of the endotracheal tube 100 after removal of the ventilator
coupling element 114. In some embodiments, the distal end of the
adapter 340 is sized and configured to be inserted within the lumen
106 of the endotracheal tube 100 (as shown in FIG. 24A). In other
embodiments, the distal end of the adapter 340 is sized and
configured to fit around the outside surface of the endotracheal
tube 100 (as shown in FIG. 248), thereby reducing the likelihood of
the cleaning member of the endotracheal tube cleaning device 120
being snagged on a ridge introduced by the thickness of the
inserted adapter 340 during removal from the endotracheal tube
100.
[0249] In some embodiments, the adapter 340 includes a ventilation
port 342 and a device insertion port 344. The ventilator coupling
element 114 can be coupled to the ventilation port 342 for
connection to the ventilator. The device insertion port 344 can be
used to insert the endotracheal tube cleaning device 120 and/or
other devices (e.g., catheters, probes, scopes). In one embodiment,
the device insertion port 344 includes an elastomeric diaphragm 346
to help prevent loss of ventilator tidal volume. The elastomeric
diaphragm 346 can comprise a slit, a one-way valve and/or any other
device or feature to substantially seal around the inserted device.
This can advantageously help prevent the escape of ventilator tidal
volume. The elastomeric diaphragm 346 can comprise one or more
elastomeric materials, such as, for example, urethane, latex,
silicone, other polymeric or elastomeric materials, and/or the
like. The thickness of the diaphragm 346 can range from about 0.002
inches to about 0.030 inches. In some embodiments, the thickness of
the diaphragm 346 is about 0.005 inches to about 0.20 inches.
However, in other embodiments, the diaphragm thickness is greater
than 0.030 inches or smaller than 0.002 inches, as desired or
required.
[0250] The device insertion port 344 can be sufficiently long such
that the entire distal end of the endotracheal tube cleaning device
120 is located proximal to the distal end of the adapter 340 when
the adapter 340 is removed. For example, the length of the device
insertion port 344 can range from about 30 cm to about 60 cm. The
diameter of the device insertion port 344 can range from about 4 mm
to about 7 mm. The inner diameter of the ventilation port can be
sized to be slightly larger than the outer diameter of the
ventilator coupling element 114. The length of the adapter 340 can
range from about 4 cm to about 10 cm. Other dimensions for the
adapter 340 can be used as desired and/or required.
[0251] As shown in FIG. 24A, the adapter 340A can be Y-shaped, with
the ventilation port 342 located at the proximal end of the adapter
and the device insertion port 344 extending from the side of the
adapter at an acute angle. The embodiment of the adapter 340B
illustrated in FIG. 24B is generally T-shaped, with the device
insertion port 344 located at the proximal end of the adapter 340B
and the ventilation port 342 extending from the side of the adapter
340B at a right angle. In other embodiments, the adapter 340B can
be Y-shaped, with the ventilation port 342 extending from the side
of the adapter 340B at an acute angle. The adapter 3408 of FIG. 24B
advantageously provides a straight insertion path for the
endotracheal tube cleaning device 120 or other devices. In other
embodiments, the adapters 340 can have a different shape or
configuration than discussed and illustrated herein.
[0252] The adapters 240 can include distance markings from the
connection to the proximal end of the endotracheal tube to the
opening of the device insertion port 344 to aid in positioning the
endotracheal tube cleaning device 120 and the locking of the
movable stop 322. In some embodiments, the distance from the
endotracheal tube connection to the opening of the device insertion
port can range from about 4 cm to about 8 cm; however, other
lengths can be used as desired and/or required.
[0253] According to some embodiments, kits of adapters 340 can be
provided to accommodate endotracheal tubes having various
diameters. The adapters 340 can include markings indicating the
tube diameter(s) for which they can be used. In other embodiments,
the adapters 340 comprise one-size-fits-all (or one-size-fits-most)
adapters that can be used to fit endotracheal tubes of various
diameters. For example, the adapter 340B of FIG. 24B has three
varying cross-sectional diameters so as to enable the adapter 3408
to fit endotracheal tubes of three different outer diameters (e.g.,
7 mm, 8 mm, or 9 mm).
[0254] In some embodiments, adapters 340 can also be used to at
least partially contain biofilm that has been removed by the
cleaning member 126. For example, when an adapter 340 is
disconnected from the endotracheal tube 100 and ventilator, the
distal end of the adapter can be slid over the cleaning member 126,
thereby providing a protective covering over the removed biofilm to
prevent contamination.
IX. Use
[0255] A. General Use
[0256] As generally described herein, the endotracheal tube
cleaning devices and systems described herein can be used to clean
endotracheal tubes while a patient is being supported by a
ventilator connected to the endotracheal tube. This cleaning is
useful for increasing the available space for airflow in the
endotracheal tube and for reducing or preventing the build up of
materials that would otherwise constrict airflow through the
endotracheal tube and potentially be a nidus for infection.
[0257] FIG. 25 illustrates an embodiment of the endotracheal tube
cleaning device 120 inserted within an endotracheal tube 100 within
a native airway 500 of a patient. The endotracheal tube cleaning
device 120 can advantageously be used to clean the endotracheal
tube 100 while the endotracheal tube 100 remains inside the
patient.
[0258] B. Indications
[0259] According to some embodiments, an endotracheal tube cleaning
device 120 can be used for a variety of indications. For example,
the endotracheal tube cleaning device 120 can be used for
preventative indications, for daily use indications, and/or for
near total occlusion indications. In some embodiments, the
endotracheal tube cleaning device 120 can be used at least once a
day to prevent any extensive buildup of biofilm, as biofilm has
been shown to start building up as early as within 24 hours of
intubation. Daily utilization can coincide with ICU protocols for
daily extubation attempts for all patients. In other embodiments,
the frequency of endotracheal tube cleaning can vary, depending on
patient, the patient's health and other conditions, a desired
cleaning protocol and/or the like.
[0260] For example, in some embodiments, the endotracheal tube
cleaning device 120 can be used multiple times a day for high risk
patients. High risk patients can include older patients, smokers,
patients with chronic obstructive pulmonary disease (COPD),
patients intubated as part of their treatment for respiratory
insufficiency related to pneumonia, patients with an indwelling
endotracheal tube for longer than 24 to 48 hours and/or others. The
frequency of use can be determined by clinical evaluation and
observation of the degree of secretions being produced by an
individual patient. However, the frequency of cleaning can depend
on one or more other features, as desired or required.
[0261] The endotracheal tube cleaning device 120 can advantageously
be used on intubated patients with ongoing bloody secretions or
frank hemoptysis in order to prevent clots from obstructing the
endotracheal tube lumen. The endotracheal tube cleaning device 120
can also be used on patients who fail weaning and extubation trials
before tracheostomy is performed. The endotracheal tube cleaning
device 120 can advantageously be used on intubated patients who
experience an acute unexplained change in their respiratory or
ventilatory status in order to rule out mucous plugging or clotting
within the endotracheal tube as a cause of the sudden
deterioration.
[0262] The amount of biofilm to be removed in the various
indications can vary greatly. By way of example, for a prevention
indication, the endotracheal tube cleaning device 120 can collect
about 1 cc to about 5 ccs of biofilm. By contrast, in daily use
indications, the endotracheal tube cleaning device can collect
about 5 ccs to about 15 ccs of biofilm. Further, for near total
occlusion indications, the endotracheal tube cleaning device can
collect more than about 15 ccs of biofilm.
[0263] In one embodiment, the cleaning member can be radially
expanded or otherwise radially deployed in a manner that sufficient
contacting force is maintained between a contact surface of the
cleaning member and the internal wall of the endotracheal tube
and/or the biofilm accumulated thereon. This can advantageously
permit the cleaning member to shear, wipe, or otherwise remove the
biofilm, while preventing or reducing the risk of hydroplaning,
cavitation, and/or invagination.
[0264] In several embodiments, the pull-out force used to withdraw
the endotracheal tube cleaning devices can be provided by a
clinician using a single hand without significant strain. In one
embodiment, the cleaning device comprises a mesh scaffold coupled
to a silicone O-ring having a softness of 40 Shore A durometer with
a pull-out force that is comparable to the mesh scaffold alone. In
one embodiment, the removal members do not appreciably increase the
pull-out force used to withdraw the endotracheal tube cleaning
devices when such devices are being used to remove biofilm
deposited on the internal wall of an endotracheal tube in a single
pass.
[0265] C. Cleaning Processes
[0266] FIG. 26 is a flow chart illustrating an embodiment of a
process 2600 for cleaning an inside surface of an endotracheal tube
(e.g., endotracheal tube 100) while such an endotracheal tube 100
is inserted within a patient. The cleaning process 2600 starts at
block 2610, where the head of the bed is positioned at
approximately 300 relative to horizontal. In other embodiments, the
head of the bed can be positioned at angles larger or smaller than
30.degree. relative to horizontal as desired and/or required.
According to some embodiments, information related to the patient's
heart rate, heart rhythm, blood pressure, O.sub.2 saturation, other
vital signs and/or other desired data can be detected and
advantageously displayed to the clinician performing the cleaning
procedure. In some embodiments, oxygen at 100% FiO.sub.2 or nearly
100% FiO.sub.2 is delivered to the patient for ten minutes or
another desired time period via a ventilator attached to the
patient's endotracheal tube 100, as illustrated at block 2615. A
disposable chux, pad and/or support member can be placed under the
endotracheal tube 100 and ventilation connection, and may be spread
out over the patient's chest.
[0267] Next, in some embodiments, routine endotracheal suction is
performed, and the endotracheal tube 100 is checked to confirm that
it is properly secured to the patient's face and/or mouth, as
illustrated at block 2620. The exact length from the visible
proximal end of the endotracheal tube 100 to its tip within the
patient can then be determined from visible markings on the
endotracheal tube 100, as illustrated at block 2625. According to
some embodiments, the endotracheal tube cleaning device 120 is
visualized and the movable locking stop 322 that prohibits
over-insertion of the endotracheal tube cleaning device 120 is
locked to an axial position that deploys the cleaning member 126 no
closer than 1.5 cm from the distal tip of the endotracheal tube
100, as illustrated at block 2630. In other embodiments, the
movable stop on the endotracheal tube cleaning device 120 is set to
the position corresponding to the length of the endotracheal
tube.
[0268] In some embodiments, the ventilator is temporarily
disconnected from the endotracheal tube 100 at block 2635 and the
endotracheal tube cleaning device 120 is inserted into the
endotracheal tube up to the locking stop 322 at block 2640. In some
embodiments, disconnecting the ventilator at block 2635 includes
loosening the ventilator coupling element 114 for one hand removal
and then removing the ventilator coupling element with one hand
while standing at the patient's side at chest level after the
ventilator is disconnected. The endotracheal tube cleaning device
120 can be inserted at block 2640 in a single-hand operation using
the other hand (the hand not used to remove the ventilator coupling
element 114).
[0269] The cleaning member 126 can then be deployed at block 2645
(e.g., with a one-hand activation of the actuation assembly 124)
and the endotracheal tube cleaning device 120 can then be withdrawn
from the endotracheal tube 100 while applying counter-traction to
the endotracheal tube 100 itself at block 2650. The endotracheal
tube cleaning device 120 can be withdrawn over a one to three
second time period. In other embodiments, withdrawal of the
cleaning device can be faster than one second or longer than three
second, as desired, required or permitted for a particular
application or use. The removed endotracheal tube cleaning device
120 can be placed on a chux and wrapped up for biohazard disposal
or reinserted into the original peel pouch and placed in a
biohazard collection unit. In one embodiment, the patient is then
reconnected to the ventilator at block 2655 after reconnecting the
ventilator coupling element 114.
[0270] The steps of the endotracheal tube cleaning process 2600
described above can be repeated multiple times as necessary at a
single treatment with the endotracheal tube cleaning device 120, so
long as the patient's heart rate, heart rhythm, blood pressure, and
O.sub.2 saturation remain stable. The endotracheal tube cleaning
process 2600 can be performed by a single person or by multiple
persons. For example, a first person (e.g., nurse or respiratory
therapist) can perform the cleaning with the endotracheal tube
cleaning device and a second person (e.g., an ICU technician) can
disconnect and reconnect the ventilator, remove the endotracheal
tube cleaning device from its packaging, and dispose of the used
endotracheal tube cleaning device.
[0271] In some embodiments, endotracheal tube cleaning methods can
be performed during a daily extubation attempt. FIG. 27 illustrates
one embodiment of a daily extubation process 2700) in which the
endotracheal tube cleaning device 120 can be utilized.
[0272] With reference to the embodiment of a daily extubation
process 2700 illustrated by the flowchart in FIG. 27, the clinician
performs an initial assessment 2705 to ensure that the patient is
in a stable condition. The clinician can ensure that no hemodynamic
or respiration system acute clinical changes exist that would make
that system a priority. Next, the clinician discontinues or
reverses sedating medications 2710 that may interfere with
spontaneous ventilation and/or medications that may produce a
paralytic effect.
[0273] With continued reference to the procedure illustrated in
FIG. 27, at block 2715, the clinician performs a neurological
examination to be sure that the patient is alert and able to follow
commands. As indicated at block 2720, the patient can be positioned
semi-upright (e.g., the head of the bed is elevated to at least
approximately 30 degrees relative to horizontal). In some
embodiments, the patient is then oxygenated at 100% FiO.sub.2 or
nearly 100% FiO.sub.2 for approximately ten minutes at block 2725
(pre-cleaning ventilation). In other embodiments, the patient is
oxygenated for more or less than ten minutes as desired and/or
required.
[0274] In some embodiments, as illustrated at block 2730, the
ventilator coupling element 114 is removed and an introduction
connector (e.g., adapter 340) is placed between the endotracheal
tube 100 and the ventilator. At block 2735, endotracheal auctioning
can be performed to aspirate pooled secretions from the major
segments of the tracheobronchial tree. According to some
embodiments, the patient is then oxygenated again at 100% FiO.sub.2
or nearly 100% FiO.sub.2 for ten minutes, as illustrated at block
2740. In other embodiments, the patient is oxygenated for more or
less than ten minutes as desired and/or required.
[0275] According to some embodiments, as illustrated at block 2745,
the clinician can insert the endotracheal tube cleaning device 120
through the introduction connector after setting a maximum
insertion depth with the movable stop 322 based on the length of
the