U.S. patent application number 15/363782 was filed with the patent office on 2017-07-06 for closed suction system.
This patent application is currently assigned to AIRWAY MEDIX S.A.. The applicant listed for this patent is AIRWAY MEDIX S.A.. Invention is credited to Eizik AMAR, Yair RAMOT, Oron ZACHAR.
Application Number | 20170189589 15/363782 |
Document ID | / |
Family ID | 55406780 |
Filed Date | 2017-07-06 |
United States Patent
Application |
20170189589 |
Kind Code |
A1 |
ZACHAR; Oron ; et
al. |
July 6, 2017 |
CLOSED SUCTION SYSTEM
Abstract
A cleaning catheter insertable into a ventilation tube and an
input module are provided, the input module coupled to the cleaning
catheter and including (i) an inflation module, including an
inflation chamber and a one-way air inlet valve; (ii) a flow
regulator, configured to assume first and second fluid-control
states; and (iii) a mechanical user control element, which is
configured (a) to mechanically and non-electrically set the
fluid-control states, (b) to assume first and second
configurations, and (c) to mechanically and non-electrically
increase pressure in an interior of an inflation chamber of the
cleaning catheter during a transition of the mechanical user
control element from the first configuration to the second
configuration. The one-way air inlet valve is arranged to allow air
to flow into the inflation chamber during a transition of the
mechanical user control element from the second configuration to
the first configuration.
Inventors: |
ZACHAR; Oron; (Tel Aviv,
IL) ; RAMOT; Yair; (Kfar Maas, IL) ; AMAR;
Eizik; (Ashdod, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
AIRWAY MEDIX S.A. |
Warsaw |
|
PL |
|
|
Assignee: |
AIRWAY MEDIX S.A.
Warsaw
PL
|
Family ID: |
55406780 |
Appl. No.: |
15/363782 |
Filed: |
November 29, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62287223 |
Jan 26, 2016 |
|
|
|
62319640 |
Apr 7, 2016 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2025/0019 20130101;
A61M 25/10 20130101; A61M 39/22 20130101; A61M 1/0035 20140204;
A61M 1/0043 20130101; A61M 39/00 20130101; A61M 2205/581 20130101;
A61M 16/0463 20130101; A61M 1/0041 20130101; A61M 2205/183
20130101; A61M 16/00 20130101; A61M 39/24 20130101 |
International
Class: |
A61M 1/00 20060101
A61M001/00; A61M 16/04 20060101 A61M016/04; A61M 25/10 20060101
A61M025/10 |
Foreign Application Data
Date |
Code |
Application Number |
Jan 6, 2016 |
GB |
1600233.9 |
Claims
1. Apparatus for use with a tracheal ventilation tube and a suction
source, the apparatus comprising: (A) a cleaning catheter, which
(a) is insertable into the ventilation tube, (b) is shaped so as to
define one or more distal suction orifices, and (c) which
comprises: (i) an elongate, flexible, tubular catheter main body;
and (ii) an inflatable element, which is mounted to the catheter
main body at a location within 3 cm of at least one of the one or
more distal suction orifices; and (B) an input module, which is
coupled to the cleaning catheter, and comprises: (i) an inflation
module, which comprises (a) an inflation chamber separate from the
suction source, and (b) a one-way air inlet valve; (ii) a flow
regulator, which (a) is shaped so as to define a suction port
coupleable in fluid communication with the suction source, and (b)
is configured to assume at least first and second fluid-control
states; and (iii) a mechanical user control element, which is
configured (a) to mechanically and non-electrically set the
fluid-control states of the flow regulator, (b) to assume at least
first and second configurations, and (c) to mechanically and
non-electrically increase pressure in an interior of the inflation
chamber during at least a portion of a transition of the mechanical
user control element from the first configuration to the second
configuration, wherein the input module is arranged such that: at
least when the mechanical user control element is in the first
configuration, the flow regulator is in the first fluid-control
state, in which the flow regulator (a) blocks fluid communication
between the suction source and the distal suction orifices and (b)
connects the suction source and an interior of the inflatable
element in fluid communication to deflate the inflatable element,
at least when the mechanical user control element is in the second
configuration, the flow regulator is in the second fluid-control
state, in which the flow regulator (a) connects the suction source
and the distal suction orifices in fluid communication, (b)
connects the interior of the inflation chamber and an interior of
the inflatable element in fluid communication to inflate the
inflatable element, and (c) does not connect the suction source and
the interior of the inflatable element in fluid communication, and
the flow regulator is (a) not in the first fluid-control state when
the mechanical user control element is in the second configuration,
and (b) not in the second fluid-control state when the mechanical
user control element is in the first configuration, wherein the
one-way air inlet valve is arranged to allow air to flow into the
inflation chamber during at least a portion of a transition of the
mechanical user control element from the second configuration to
the first configuration.
2. The apparatus according to claim 1, wherein the mechanical user
control element is configured to mechanically and non-electrically
increase the pressure in the interior of the inflation chamber
during an entirely of the transition of the mechanical user control
element from the first configuration to the second
configuration.
3. The apparatus according to claim 1, wherein the input module is
configured such that during the at least a portion of the
transition of the mechanical user control element from the first
configuration to the second configuration, before the flow
regulator assumes the second fluid-control state, a volume of the
interior of the inflation chamber decreases by between 10% and
90%.
4. The apparatus according to claim 1, wherein the mechanical user
control element is configured to mechanically and non-electrically
increase the pressure in the interior of the inflation chamber
during motion of the mechanical user control element while the flow
regulator is in the second fluid-control state.
5. The apparatus according to claim 1, wherein the suction port is
coupled in fluid communication with the suction source.
6. The apparatus according to claim 1, wherein the input module
further comprises a user signal generator, which is configured to
generate a user signal during or upon deflation of the inflatable
element.
7. (canceled)
8. The apparatus according to claim 1, wherein when the mechanical
user control element is in the second configuration, the inflation
chamber has a volume of at least 1 cc less than when the mechanical
user control element is in the first configuration.
9. The apparatus according to claim 1, wherein the mechanical user
control element is biased toward the first configuration.
10. The apparatus according to claim 1, wherein the cleaning
catheter further comprises one or more suction lumens arranged
along the catheter main body, and wherein the flow regulator, when
in the second fluid-control state, connects in fluid communication
the suction source and the distal suction orifices via the one or
more suction lumens.
11. The apparatus according to claim 1, wherein the inflatable
element comprises a balloon.
12-13. (canceled)
14. The apparatus according to claim 1, wherein the apparatus is
for use with a ventilator, and wherein the apparatus further
comprises a tube-connector assembly, which is configured to couple
the ventilation tube in fluid communication with the ventilator, in
a substantially air-tight manner.
15. The apparatus according to claim 1, wherein the first and the
second configurations are first and second spatial positions,
respectively, and wherein the mechanical user control element is
configured to assume at least the first and the second spatial
positions.
16. The apparatus according to claim 15, wherein the mechanical
user control element is arranged to move between first and second
spatial end-points, and wherein the first and the second spatial
positions correspond with the first and the second spatial
end-points, respectively.
17. The apparatus according to claim 1, wherein the flow regulator
is configured to assume a third, intermediate fluid-control state,
between the first and the second fluid-control states, in which (a)
the suction source and the distal suction orifices are in fluid
communication with one another, and (b) the interior of the
inflation chamber and the interior of the inflatable element are
not in fluid communication with one another, and wherein the flow
regulator is configured to assume the third, intermediate
fluid-control state when the mechanical user control element is in
a third, intermediate configuration between the first configuration
and the second configuration.
18. The apparatus according to claim 1, wherein the one-way air
inlet valve is configured to generate a sound signal during at
least a portion of a period of fluid flow into the inflation
chamber.
19. The apparatus according to claim 1, wherein the mechanical user
control element is configured to increase the pressure in the
interior of the inflation chamber by mechanically and
non-electrically compressing the inflation chamber during the at
least a portion of the transition of the mechanical user control
element from the first configuration to the second
configuration.
20. The apparatus according to claim 19, wherein the inflation
chamber transitions from a lower level of compression to a higher
level of compression during the at least a portion of the
transition of the mechanical user control element from the first
configuration to the second configuration, and wherein the input
module is configured to elastically bias the inflation chamber
toward the lower level of compression.
21. The apparatus according to claim 20, wherein the inflation
module is elastically biased toward the lower level of
compression.
22-23. (canceled)
24. The apparatus according to claim 21, wherein the inflation
module comprises an elastic element that is arranged to bias the
inflation chamber toward the lower level of compression.
25. The apparatus according to claim 20, wherein the mechanical
user control element is elastically biased toward the lower level
of compression.
26. The apparatus according to claim 1, wherein the catheter main
body comprises a proximal-most input portion, which is disposed
within and axially slidable with respect to the input module.
27. The apparatus according to claim 26, wherein the input module
is arranged such that changes in configuration of the mechanical
user control element cause corresponding changes in axial position
of the input portion of the catheter main body with respect to the
input module.
28. (canceled)
29. The apparatus according to claim 1, wherein the catheter main
body comprises a proximal-most input portion, which is disposed
within and fixed with respect to the input module.
30. The apparatus according to claim 29, wherein the mechanical
user control element comprises a user control handle, wherein the
input module is arranged such that the user control handle is
moveable with respect to the catheter main body in two opposite
directions along a movement axis that forms a fixed angle of
between 45 and 135 degrees with a central longitudinal axis of the
proximal-most input portion of the catheter main body, and wherein
the input module is arranged such that movement of the user control
handle along the movement axis mechanically causes corresponding
movement, along or alongside the movement axis, of a distal opening
of the suction port, which selectively brings the distal end of the
suction port into and out of fluid communication with the interior
of the inflatable element and the distal suction orifices.
31. The apparatus according to claim 30, wherein the inflation
chamber is shaped so as to define an outlet, and wherein the input
module is arranged such that movement of the user control handle
along the movement axis mechanically causes corresponding movement
of the outlet of the inflation chamber along or alongside the
movement axis, which selectively brings the interior of the
inflation chamber into and out of fluid communication with the
interior of the inflatable element.
32. The apparatus according to claim 1, wherein the inflation
chamber is disposed within the mechanical user control element.
33. (canceled)
34. The apparatus according to claim 1, wherein the input module
comprises exactly one mechanical user control element configured
(a) to mechanically and non-electrically set the fluid-control
states of the flow regulator, (b) to assume the at least first and
second configurations, and (c) to mechanically and non-electrically
increase the pressure in the interior of the inflation chamber
during the at least a portion of the transition of the mechanical
user control element from the first configuration to the second
configuration.
35-88. (canceled)
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application (a) claims the benefit of (i) U.S.
Provisional Application 62/287,223, filed Jan. 26, 2016, and (ii)
U.S. Provisional Application 62/319,640, filed Apr. 7, 2016, and
(b) claims priority from UK Application 1600233.9, filed Jan. 6,
2016, all of which are assigned to the assignee of the present
application and are incorporated herein by reference.
FIELD OF THE APPLICATION
[0002] The present invention relates generally to medical suction
catheter devices, and specifically to catheter devices for
aspiration of tracheobronchial secretions and/or cleaning of
tracheal ventilation tubes.
BACKGROUND OF THE APPLICATION
[0003] Suction catheters are commonly used to aspirate
tracheobronchial fluids in patients ventilated with endotracheal
tube (ETT) and tracheostomy tube devices. A problematic aspect of
the use of suction catheters is the presence of bacterial biofilm
within the ETT lumen through which the suction catheter passes.
Consequently, as the suction catheter is inserted, there is high
risk of it carrying bacterial biofilm from the ETT lumen deeper
into the bronchial tree where the suction catheter reaches, and
thereby increasing the risk of lung infection. Moreover, buildup of
substantial biofilm thickness reduces the effective free lumen of
the ETT for air passage. Therefore, there is a need for maintaining
cleaner ETT lumens between suction operations, and preventing
buildup of significant biofilm thickness.
[0004] UK Publication GB 2482618 A to Einav et al., which is
assigned to the assignee of the present application and is
incorporated herein by reference, describes a multi-lumen catheter
for multiple fluids conduction, including balloon inflation with
air via an inflation lumen, suction via a suction lumen, and
cleaning fluids delivery via a cleaning fluid-delivery lumen.
[0005] U.S. Pat. No. 8,999,074 to Zachar et al., which is assigned
to the assignee of the present application and is incorporated
herein by reference, describes a cleaning catheter that includes
fluid-delivery and suction lumens. A flow regulator defines suction
and fluid ports. A mechanical user control element is configured to
mechanically and non-electrically set activation states of the flow
regulator, and transition between first and third configurations
via a second configuration. When the control element is in the
first configuration, the flow regulator blocks fluid communication
(a) between the suction port and the suction lumen and (b) between
the fluid port and the fluid-delivery lumen. When the control
element is in the second configuration, the flow regulator effects
fluid communication between the suction port and the suction lumen,
and blocks fluid communication between the fluid port and the
fluid-delivery lumen. When the control element is in the third
configuration, the flow regulator effects fluid communication (a)
between the suction port and the suction lumen and (b) between the
fluid port and the fluid-delivery lumen.
SUMMARY OF THE APPLICATION
[0006] Some applications of the present invention provide a
multi-lumen catheter for cleaning an inner surface of a tracheal
ventilation tube. Some techniques of the present invention enable
single-handed simultaneous activation of inflation of an inflatable
element and suctioning in a closed suction system for use with the
tracheal ventilation tube. A closed suction system allows catheters
to be used repeatedly without being detached from the tube system
including the ventilation air supply. Applications of the present
invention generally provide simple user control of conduction of
fluids under positive and negative pressure (suction).
[0007] The cleaning catheter is insertable into the tracheal
ventilation tube, and is shaped so as to define one or more distal
suction orifices. The cleaning catheter comprises an elongate,
flexible, tubular catheter main body, and an inflatable element,
which is mounted to the catheter main body, typically at a location
within 3 cm of at least one of the one or more distal suction
orifices. An input module is coupled to the cleaning catheter, and
comprises an inflation module, which comprises an inflation chamber
separate from the suction source. The input module also comprises a
flow regulator, which (a) is shaped so as to define a suction port
coupleable in fluid communication with the suction source, and (b)
is configured to assume at least first and second fluid-control
states.
[0008] The input module further comprises a mechanical user control
element, which is configured (a) to mechanically and
non-electrically set the fluid-control states of the flow
regulator, (b) to assume at least first and second configurations,
and (c) to mechanically and non-electrically increase pressure in
an interior of the inflation chamber during at least a portion of a
transition of the mechanical user control element from the first
configuration to the second configuration. The input module is
arranged such that: [0009] when the mechanical user control element
is in the first configuration, the flow regulator is in the first
fluid-control state, in which the flow regulator blocks fluid
communication between the suction source and the distal suction
orifices, and [0010] when the mechanical user control element is in
the second configuration, the flow regulator is in the second
fluid-control state, in which the flow regulator (A) connects the
suction source and the distal suction orifices in fluid
communication, and (B) connects the interior of the inflation
chamber and an interior of the inflatable element in fluid
communication to inflate the inflatable element.
[0011] As a result of this arrangement, a single mechanical user
control element both (a) mechanically creates pressure to inflate
the inflation element and (b) mechanically connects the suction
source and the distal suction orifices in fluid communication.
[0012] In some applications of the present invention, the input
module is arranged such that: [0013] when the mechanical user
control element is in the first configuration and the flow
regulator is in the first fluid-control state, the flow regulator
connects the suction source and the interior of the inflatable
element in fluid communication to deflate the inflatable element,
and [0014] when the mechanical user control element is in the
second configuration and the flow regulator is in the second
fluid-control state, the flow regulator does not connect the
suction source and the interior of the inflatable element in fluid
communication.
[0015] In some applications of the present invention, the
fluid-control states are actuated by axial motion of a proximal
portion of the catheter main body relative to an input module
housing. For some of these applications, transitions between the
states are caused by shifts in alignment of lumen inlets with
respect to various chambers of the input module. The shifts in
alignment are typically caused via axial motion of a proximal-most
input portion of the catheter main body within the input module
housing, along the longitudinal axes of the input portion and the
input module. For some applications, the mechanical user control
element comprises a user control handle, the movement of which
includes a component perpendicular to the associated axial motion
of the catheter main body. The mechanical user control element
translates the movement of the user control handle into axial
motion of the catheter main body with respect to the input module
housing.
[0016] In other applications of the present invention, the
fluid-control states are not actuated by axial motion of the
proximal portion of the catheter main body relative to the input
module housing, and the mechanical user control element does not
translate the movement of the user control handle into axial motion
of the catheter main body relative to the input module housing.
Instead, the proximal-most input portion of the catheter main body
is fixed with respect to the input module. The movement of the user
control handle actuates the fluid-control states without
translating the movement into axial motion of the proximal portion
of the catheter main body. The input module is arranged such that
the user control handle is moveable with respect to the catheter
main body in two opposite directions along a movement axis that
forms a fixed angle of between 45 and 135 degrees with a central
longitudinal axis of the proximal-most input portion of the
catheter main body, typically 90 degrees. The input module is
arranged such that movement of the user control handle along the
movement axis mechanically causes corresponding movement, along or
alongside the movement axis, of a distal opening of the suction
port, which selectively brings the distal end of the suction port
into and out of fluid communication with the interior of the
inflatable element and the distal suction orifices.
[0017] For some applications, the inflation chamber is disposed
within the mechanical user control element; for example, the
inflation chamber may be defined by one or more interior surfaces
of the user control handle.
[0018] In other applications of the present invention, the input
module is arranged such that when the mechanical user control
element is in the first configuration and the flow regulator is in
the first fluid-control state, the flow regulator connects the
interior of the inflation chamber and the interior of the
inflatable element in fluid communication to deflate the inflatable
element.
[0019] For cleaning a ventilation tube, the cleaning action
typically comprises the following steps, which are typically
performed in the following order: [0020] inserting the cleaning
catheter into the ventilation tube in a proximal to distal
direction while the inflatable element (e.g., balloon) is
essentially deflated; [0021] inflating the inflatable element at a
location near the distal end of the ventilation tube (typically
within 2 cm of the distal end); [0022] withdrawing the catheter
along the ventilation tube in a distal to proximal direction while
the inflatable element is inflated and suction is applied to the
one or more suction orifices; and [0023] deflating the inflatable
element when the inflatable element is near the proximal end of the
ventilation tube or fully outside the proximal end of the
ventilation tube.
[0024] There is therefore provided, in accordance with an
application of the present invention, apparatus for use with a
tracheal ventilation tube and a suction source, the apparatus
including:
[0025] (A) a cleaning catheter, which (a) is insertable into the
ventilation tube, (b) is shaped so as to define one or more distal
suction orifices, and (c) which includes: [0026] (i) an elongate,
flexible, tubular catheter main body; and [0027] (ii) an inflatable
element, which is mounted to the catheter main body at a location
within 3 cm of at least one of the one or more distal suction
orifices; and
[0028] (B) an input module, which is coupled to the cleaning
catheter, and includes: [0029] (i) an inflation module, which
includes (a) an inflation chamber separate from the suction source,
and (b) a one-way air inlet valve; [0030] (ii) a flow regulator,
which (a) is shaped so as to define a suction port coupleable in
fluid communication with the suction source, and (b) is configured
to assume at least first and second fluid-control states; and
[0031] (iii) a mechanical user control element, which is configured
(a) to mechanically and non-electrically set the fluid-control
states of the flow regulator, (b) to assume at least first and
second configurations, and (c) to mechanically and non-electrically
increase pressure in an interior of the inflation chamber during at
least a portion of a transition of the mechanical user control
element from the first configuration to the second
configuration,
[0032] wherein the input module is arranged such that: [0033] at
least when the mechanical user control element is in the first
configuration, the flow regulator is in the first fluid-control
state, in which the flow regulator (a) blocks fluid communication
between the suction source and the distal suction orifices and (b)
connects the suction source and an interior of the inflatable
element in fluid communication to deflate the inflatable element,
[0034] at least when the mechanical user control element is in the
second configuration, the flow regulator is in the second
fluid-control state, in which the flow regulator (a) connects the
suction source and the distal suction orifices in fluid
communication, (b) connects the interior of the inflation chamber
and an interior of the inflatable element in fluid communication to
inflate the inflatable element, and (c) does not connect the
suction source and the interior of the inflatable element in fluid
communication, and [0035] the flow regulator is (a) not in the
first fluid-control state when the mechanical user control element
is in the second configuration, and (b) not in the second
fluid-control state when the mechanical user control element is in
the first configuration,
[0036] wherein the one-way air inlet valve is arranged to allow air
to flow into the inflation chamber during at least a portion of a
transition of the mechanical user control element from the second
configuration to the first configuration.
[0037] For some applications, the mechanical user control element
is configured to mechanically and non-electrically increase the
pressure in the interior of the inflation chamber during an
entirely of the transition of the mechanical user control element
from the first configuration to the second configuration.
[0038] For some applications, the input module is configured such
that during the at least a portion of the transition of the
mechanical user control element from the first configuration to the
second configuration, before the flow regulator assumes the second
fluid-control state, a volume of the interior of the inflation
chamber decreases by between 10% and 90%.
[0039] For some applications, the mechanical user control element
is configured to mechanically and non-electrically increase the
pressure in the interior of the inflation chamber during motion of
the mechanical user control element while the flow regulator is in
the second fluid-control state.
[0040] For some applications, the suction port is coupled in fluid
communication with the suction source.
[0041] For some applications, the input module further includes a
user signal generator, which is configured to generate a user
signal during or upon deflation of the inflatable element.
[0042] For some applications, the inflation chamber has a volume of
between 1 and 10 cc when the mechanical user control element is in
the first configuration.
[0043] For some applications, when the mechanical user control
element is in the second configuration, the inflation chamber has a
volume of at least 1 cc less than when the mechanical user control
element is in the first configuration.
[0044] For some applications, the mechanical user control element
is biased toward the first configuration.
[0045] For some applications, the cleaning catheter further
includes one or more suction lumens arranged along the catheter
main body, and the flow regulator, when in the second fluid-control
state, connects in fluid communication the suction source and the
distal suction orifices via the one or more suction lumens.
[0046] For some applications, the inflatable element includes a
balloon.
[0047] For some applications, the inflatable element is mounted to
the catheter main body is within 5 cm of a distal end of the
catheter main body.
[0048] For some applications, the inflatable element has a greatest
outer diameter of between 6 and 12 mm when inflated at 1 bar above
atmospheric pressure and unconstrained.
[0049] For some applications, the apparatus is for use with a
ventilator, and the apparatus further includes a tube-connector
assembly, which is configured to couple the ventilation tube in
fluid communication with the ventilator, in a substantially
air-tight manner.
[0050] For some applications, the first and the second
configurations are first and second spatial positions,
respectively, and the mechanical user control element is configured
to assume at least the first and the second spatial positions.
[0051] For some applications, the mechanical user control element
is arranged to move between first and second spatial end-points,
and the first and the second spatial positions correspond with the
first and the second spatial end-points, respectively.
[0052] For some applications:
[0053] the flow regulator is configured to assume a third,
intermediate fluid-control state, between the first and the second
fluid-control states, in which (a) the suction source and the
distal suction orifices are in fluid communication with one
another, and (b) the interior of the inflation chamber and the
interior of the inflatable element are not in fluid communication
with one another, and
[0054] the flow regulator is configured to assume the third,
intermediate fluid-control state when the mechanical user control
element is in a third, intermediate configuration between the first
configuration and the second configuration.
[0055] For some applications, the one-way air inlet valve is
configured to generate a sound signal during at least a portion of
a period of fluid flow into the inflation chamber.
[0056] For any of the applications described hereinabove, the
mechanical user control element may be configured to increase the
pressure in the interior of the inflation chamber by mechanically
and non-electrically compressing the inflation chamber during the
at least a portion of the transition of the mechanical user control
element from the first configuration to the second
configuration.
[0057] For some applications, the inflation chamber transitions
from a lower level of compression to a higher level of compression
during the at least a portion of the transition of the mechanical
user control element from the first configuration to the second
configuration, and the input module is configured to elastically
bias the inflation chamber toward the lower level of
compression.
[0058] For some applications, the inflation module is elastically
biased toward the lower level of compression.
[0059] For some applications, at least one wall of the inflation
chamber is elastically biased toward the lower level of
compression.
[0060] For some applications, the at least one wall of the
inflation chamber is accordion-shaped.
[0061] For some applications, the inflation module includes an
elastic element that is arranged to bias the inflation chamber
toward the lower level of compression.
[0062] For some applications, the mechanical user control element
is elastically biased toward the lower level of compression.
[0063] For any of the applications described hereinabove, the
catheter main body may include a proximal-most input portion, which
is disposed within and axially slidable with respect to the input
module.
[0064] For some applications, the input module is arranged such
that changes in configuration of the mechanical user control
element cause corresponding changes in axial position of the input
portion of the catheter main body with respect to the input
module.
[0065] For some applications, the input module is arranged such
that the input portion assumes first and second axial positions
with respect to the input module, corresponding to the first and
the second configurations of the mechanical user control
element.
[0066] For any of the applications described hereinabove, the
catheter main body may include a proximal-most input portion, which
is disposed within and fixed with respect to the input module.
[0067] For some applications:
[0068] the mechanical user control element includes a user control
handle,
[0069] the input module is arranged such that the user control
handle is moveable with respect to the catheter main body in two
opposite directions along a movement axis that forms a fixed angle
of between 45 and 135 degrees with a central longitudinal axis of
the proximal-most input portion of the catheter main body, and
[0070] the input module is arranged such that movement of the user
control handle along the movement axis mechanically causes
corresponding movement, along or alongside the movement axis, of a
distal opening of the suction port, which selectively brings the
distal end of the suction port into and out of fluid communication
with the interior of the inflatable element and the distal suction
orifices.
[0071] For some applications:
[0072] the inflation chamber is shaped so as to define an outlet,
and
[0073] the input module is arranged such that movement of the user
control handle along the movement axis mechanically causes
corresponding movement of the outlet of the inflation chamber along
or alongside the movement axis, which selectively brings the
interior of the inflation chamber into and out of fluid
communication with the interior of the inflatable element.
[0074] For any of the applications described hereinabove, the
inflation chamber may be disposed within the mechanical user
control element.
[0075] For some applications, the mechanical user control element
includes a user control handle, and the inflation chamber is
defined by one or more interior surfaces of the user control
handle.
[0076] For some applications, the input module includes exactly one
mechanical user control element configured (a) to mechanically and
non-electrically set the fluid-control states of the flow
regulator, (b) to assume the at least first and second
configurations, and (c) to mechanically and non-electrically
increase the pressure in the interior of the inflation chamber
during the at least a portion of the transition of the mechanical
user control element from the first configuration to the second
configuration.
[0077] There is further provided, in accordance with an application
of the present invention, apparatus for use with a tracheal
ventilation tube and a suction source, the apparatus including:
[0078] (A) a cleaning catheter, which (a) is insertable into the
ventilation tube, (b) is shaped so as to define one or more distal
suction orifices, and (c) which includes: [0079] (i) an elongate,
flexible, tubular catheter main body, which includes a
proximal-most input portion; and [0080] (ii) an inflatable element,
which is mounted to the catheter main body at a location within 3
cm of at least one of the one or more distal suction orifices;
and
[0081] (B) an input module, which is fixed to the proximal-most
input portion of the catheter main body of the cleaning catheter,
and includes: [0082] (i) a flow regulator, which (a) is shaped so
as to define a suction port coupleable in fluid communication with
the suction source, and (b) is configured to assume at least first
and second fluid-control states; and [0083] (ii) a mechanical user
control element, which includes a user control handle, and which is
configured (a) to mechanically and non-electrically set the
fluid-control states of the flow regulator, and (b) to assume at
least first and second spatial positions,
[0084] wherein the input module is arranged such that: [0085] the
user control handle is moveable with respect to the catheter main
body in two opposite directions along a movement axis that forms a
fixed angle of between 45 and 135 degrees with a central
longitudinal axis of the proximal-most input portion of the
catheter main body, and [0086] movement of the user control handle
along the movement axis mechanically causes corresponding movement,
along or alongside the movement axis, of a distal end of the
suction port, which selectively brings the distal end of the
suction port into and out of fluid communication with an interior
of the inflatable element and the distal suction orifices.
[0087] For some applications, the suction port is coupled in fluid
communication with the suction source.
[0088] For some applications, the mechanical user control element
is biased toward the first spatial positions.
[0089] For some applications, the inflatable element includes a
balloon.
[0090] For any of the applications described hereinabove:
[0091] the input module may further include an inflation module,
which includes an inflation chamber separate from the suction
source, and
[0092] the mechanical user control element may be configured to
mechanically and non-electrically increase pressure in an interior
of the inflation chamber during at least a portion of a transition
of the mechanical user control element from the first spatial
position to the second spatial position.
[0093] For some applications, the inflation chamber is disposed
within the mechanical user control element.
[0094] For some applications, the inflation chamber is defined by
one or more interior surfaces of the user control handle.
[0095] For some applications:
[0096] the inflation chamber is shaped so as to define an outlet,
and
[0097] the input module is arranged such that movement of the user
control handle along the movement axis mechanically causes
corresponding movement of the outlet of the inflation chamber along
or alongside the movement axis, which selectively brings the
interior of the inflation chamber into and out of fluid
communication with the interior of the inflatable element.
[0098] For some applications, the input module is arranged such
that:
[0099] when the mechanical user control element is in the first
spatial position, the flow regulator is in the first fluid-control
state, in which the flow regulator blocks fluid communication
between the suction source and the distal suction orifices, and
[0100] when the mechanical user control element is in the second
spatial position, the flow regulator is in the second fluid-control
state, in which the flow regulator (A) connects the suction source
and the distal suction orifices in fluid communication, and (B)
connects the interior of the inflation chamber and an interior of
the inflatable element in fluid communication to inflate the
inflatable element.
[0101] For some applications:
[0102] the flow regulator is configured to assume a third,
intermediate fluid-control state, between the first and the second
fluid-control states, in which (a) the suction source and the
distal suction orifices are in fluid communication with one
another, and (b) the interior of the inflation chamber and the
interior of the inflatable element are not in fluid communication
with one another, and
[0103] the flow regulator is configured to assume the third,
intermediate fluid-control state when the mechanical user control
element is in a third, intermediate spatial position between the
first configuration and the second configuration.
[0104] For some applications, the input module is arranged such
that:
[0105] when the mechanical user control element is in the first
spatial position and the flow regulator is in the first
fluid-control state, the flow regulator connects the suction source
and the interior of the inflatable element in fluid communication
to deflate the inflatable element, and
[0106] when the mechanical user control element is in the second
spatial position and the flow regulator is in the second
fluid-control state, the flow regulator does not connect the
suction source and the interior of the inflatable element in fluid
communication.
[0107] For some applications, the inflation module includes a
one-way air inlet valve, which is arranged to allow air to flow
into the inflation chamber during at least a portion of a
transition of the mechanical user control element from the second
spatial position to the first spatial position.
[0108] For some applications, the one-way air inlet valve is
configured to generate a sound signal during at least a portion of
a period of fluid flow into the inflation chamber.
[0109] For some applications, the input module is arranged such
that when the mechanical user control element is in the first
spatial position and the flow regulator is in the first
fluid-control state, the flow regulator connects the interior of
the inflation chamber and the interior of the inflatable element in
fluid communication to deflate the inflatable element.
[0110] For some applications, the mechanical user control element
is configured to increase the pressure in the interior of the
inflation chamber by mechanically and non-electrically compressing
the inflation chamber during the at least a portion of the
transition of the mechanical user control element from the first
spatial position to the second spatial position.
[0111] For some applications, the inflation chamber transitions
from a lower level of compression to a higher level of compression
during the at least a portion of the transition of the mechanical
user control element from the first spatial position to the second
spatial position, and the input module is configured to elastically
bias the inflation chamber toward the lower level of
compression.
[0112] For some applications, the inflation module is elastically
biased toward the lower level of compression.
[0113] For some applications, at least one wall of the inflation
chamber is elastically biased toward the lower level of
compression.
[0114] For some applications, the at least one wall of the
inflation chamber is accordion-shaped.
[0115] For some applications, the inflation module includes an
elastic element that is arranged to bias the inflation chamber
toward the lower level of compression.
[0116] For some applications, the mechanical user control element
is elastically biased toward the lower level of compression.
[0117] There is still further provided, in accordance with an
application of the present invention, apparatus for use with a
tracheal ventilation tube and a suction source, the apparatus
including:
[0118] (A) a cleaning catheter, which (a) is insertable into the
ventilation tube, (b) is shaped so as to define one or more distal
suction orifices, and (c) which includes: [0119] (i) an elongate,
flexible, tubular catheter main body; and [0120] (ii) an inflatable
element, which is mounted to the catheter main body at a location
within 3 cm of at least one of the one or more distal suction
orifices; and
[0121] (B) an input module, which is coupled to the cleaning
catheter, and includes: [0122] (i) a flow regulator, which (a) is
shaped so as to define a suction port coupleable in fluid
communication with the suction source, and (b) is configured to
assume at least first and second fluid-control states; [0123] (ii)
an inflation module, which includes an inflation chamber separate
from the suction source; and [0124] (iii) a mechanical user control
element, within which the inflation chamber is disposed, and which
is configured (a) to mechanically and non-electrically set the
fluid-control states of the flow regulator, (b) to assume at least
first and second configurations, and (c) to mechanically and
non-electrically increase pressure in an interior of the inflation
chamber during at least a portion of a transition of the mechanical
user control element from the first configuration to the second
configuration.
[0125] For some applications, the mechanical user control element
includes a user control handle, and the inflation chamber is
defined by one or more interior surfaces of the user control
handle.
[0126] For some applications, the input module is arranged such
that:
[0127] when the mechanical user control element is in the first
configuration, the flow regulator is in the first fluid-control
state, in which the flow regulator blocks fluid communication
between the suction source and the distal suction orifices, and
[0128] when the mechanical user control element is in the second
configuration, the flow regulator is in the second fluid-control
state, in which the flow regulator (A) connects the suction source
and the distal suction orifices in fluid communication, and (B)
connects the interior of the inflation chamber and an interior of
the inflatable element in fluid communication to inflate the
inflatable element.
[0129] For some applications, the suction port is coupled in fluid
communication with the suction source.
[0130] For any of the applications described hereinabove, the
catheter main body may include a proximal-most input portion, which
is disposed within and fixed with respect to the input module.
[0131] For some applications:
[0132] the mechanical user control element includes a user control
handle,
[0133] the input module is arranged such that the user control
handle is moveable with respect to the catheter main body in two
opposite directions along a movement axis that forms a fixed angle
of between 45 and 135 degrees with a central longitudinal axis of
the proximal-most input portion of the catheter main body, and
[0134] the input module is arranged such that movement of the user
control handle along the movement axis mechanically causes
corresponding movement, along or alongside the movement axis, of a
distal end of the suction port, which selectively brings the distal
end of the suction port into and out of fluid communication with
the interior of the inflatable element and the distal suction
orifices.
[0135] For some applications:
[0136] the inflation chamber is shaped so as to define an outlet,
and
[0137] the input module is arranged such that movement of the user
control handle along the movement axis mechanically causes
corresponding movement of the outlet of the inflation chamber along
or alongside the movement axis, which selectively brings the
interior of the inflation chamber into and out of fluid
communication with the interior of the inflatable element.
[0138] There is additionally provided, in accordance with an
application of the present invention, apparatus for use with a
tracheal ventilation tube and a suction source, the apparatus
including:
[0139] (A) a cleaning catheter, which (a) is insertable into the
ventilation tube, (b) is shaped so as to define one or more distal
suction orifices, and (c) which includes: [0140] (i) an elongate,
flexible, tubular catheter main body; and [0141] (ii) an inflatable
element, which is mounted to the catheter main body at a location
within 3 cm of at least one of the one or more distal suction
orifices; and
[0142] (B) an input module, which is coupled to the cleaning
catheter, and includes: [0143] (i) an inflation module, which
includes an inflation chamber separate from the suction source;
[0144] (ii) a flow regulator, which (a) is shaped so as to define a
suction port coupleable in fluid communication with the suction
source, and (b) is configured to assume at least first and second
fluid-control states; [0145] (iii) a first mechanical user control
button, which is configured to (a) assume at least first and second
configurations, and (b) mechanically and non-electrically set the
fluid-control states of the flow regulator; [0146] (iv) a second
mechanical user control button, which is configured to (a) to
assume at least first and second configurations, and (b)
mechanically and non-electrically increase pressure in an interior
of the inflation chamber during a transition of the second
mechanical user control button from its first configuration to its
second configuration,
[0147] wherein the input module is arranged such that: [0148] at
least when the first mechanical user control button is in its first
configuration, the flow regulator is in the first fluid-control
state, in which the flow regulator (a) blocks fluid communication
between the suction source and the distal suction orifices and (b)
connects the suction source and an interior of the inflatable
element in fluid communication to deflate the inflatable element,
[0149] at least when the first mechanical user control button is in
its second configuration, the flow regulator is in the second
fluid-control state, in which the flow regulator (a) connects the
suction source and the distal suction orifices in fluid
communication, and (b) connects the interior of the inflation
chamber and an interior of the inflatable element in fluid
communication to inflate the inflatable element, and [0150] the
flow regulator is (a) not in the first fluid-control state when the
first mechanical user control button is in its second
configuration, and (b) not in the second fluid-control state when
the first mechanical user control button is in its first
configuration.
[0151] For some applications, the first and the second mechanical
user control buttons are arranged such that a portion of one of the
first and the second mechanical user control buttons at least
partially surrounds the other of the first and the second
mechanical user control buttons.
[0152] For some applications, the first and the second mechanical
user control buttons are arranged such that a closest distance
between the first and the second mechanical user control buttons is
between 0.1 mm and 2 mm.
[0153] For some applications, the input module is configured such
that during the at least a portion of the transition of the first
mechanical user control button from its first configuration to its
second configuration, before the flow regulator assumes the second
fluid-control state, a volume of the interior of the inflation
chamber decreases by between 10% and 90%.
[0154] For some applications, the second mechanical user control
button is configured to mechanically and non-electrically increase
the pressure in the interior of the inflation chamber during motion
of the second mechanical user control button while the flow
regulator is in the second fluid-control state.
[0155] For some applications, the suction port is coupled in fluid
communication with the suction source.
[0156] For some applications, the input module further includes a
user signal generator, which is configured to generate a user
signal during or upon deflation of the inflatable element.
[0157] For some applications, the inflation chamber has a volume of
between 1 and 10 cc when the mechanical user control element is in
the first configuration.
[0158] For some applications, when the second mechanical user
control button is in the second configuration, the inflation
chamber has a volume of at least 1 cc less than when the second
mechanical user control button is in the first configuration.
[0159] For some applications, the first mechanical user control
button is biased toward its first configuration.
[0160] For some applications, the second mechanical user control
button is biased toward its first configuration.
[0161] For some applications, the first and the second
configurations of the first mechanical user control button are
first and second spatial positions, respectively, and the first
mechanical user control button is configured to assume at least the
first and the second spatial positions.
[0162] For some applications, the first and the second
configurations of the second mechanical user control button are
first and second spatial positions, respectively, and the second
mechanical user control button is configured to assume at least the
first and the second spatial positions.
[0163] For some applications:
[0164] the flow regulator is configured to assume a third,
intermediate fluid-control state, between the first and the second
fluid-control states, in which (a) the suction source and the
distal suction orifices are in fluid communication with one
another, and (b) the interior of the inflation chamber and the
interior of the inflatable element are not in fluid communication
with one another, and
[0165] the flow regulator is configured to assume the third,
intermediate fluid-control state when the first mechanical user
control button is in a third, intermediate configuration between
its first configuration and its second configuration.
[0166] For any of the applications described hereinabove, the
inflation module may include a one-way air inlet valve, which is
arranged to allow air to flow into the inflation chamber during at
least a portion of a transition of the second mechanical user
control button from its second configuration to its first
configuration.
[0167] For some applications, the one-way air inlet valve is
configured to generate a sound signal during at least a portion of
a period of fluid flow into the inflation chamber.
[0168] For any of the applications described hereinabove, the
second mechanical user control button may be configured to increase
the pressure in the interior of the inflation chamber by
mechanically and non-electrically compressing the inflation chamber
during the at least a portion of the transition of the second
mechanical user control button from its first configuration to its
second configuration.
[0169] For some applications, the inflation chamber transitions
from a lower level of compression to a higher level of compression
during the at least a portion of the transition of the second
mechanical user control button from its first configuration to its
second configuration, and the input module is configured to
elastically bias the inflation chamber toward the lower level of
compression.
[0170] For some applications, the inflation module is elastically
biased toward the lower level of compression.
[0171] For some applications, at least one wall of the inflation
chamber is elastically biased toward the lower level of
compression.
[0172] For some applications, the at least one wall of the
inflation chamber is accordion-shaped.
[0173] For some applications, the inflation module includes an
elastic element that is arranged to bias the inflation chamber
toward the lower level of compression.
[0174] For some applications, the second mechanical user control
button is elastically biased toward the lower level of
compression.
[0175] There is further provided, in accordance with an application
of the present invention, a method for use with a tracheal
ventilation tube and a suction source, the method including:
[0176] coupling, in fluid communication with the suction source, a
suction port of a flow regulator of an input module that (a) is
configured to assume at least first and second fluid-control
states, and (b) includes (i) an inflation module, which includes an
inflation chamber separate from the suction source, and (ii) a
mechanical user control element, which is configured to
mechanically and non-electrically set the fluid-control states of
the flow regulator;
[0177] setting the mechanical user control element in a first
configuration, in which the flow regulator is in a first
fluid-control state, in which the flow regulator blocks fluid
communication between the suction source and one or more distal
suction orifices defined by a cleaning catheter that (a) is coupled
to the input module and (b) includes (i) an elongate, flexible,
tubular catheter main body, and (ii) an inflatable element, which
is mounted to the catheter main body at a location within 3 cm of
at least one of the one or more distal suction orifices, wherein at
least when the mechanical user control element is in the first
configuration, the flow regulator is in the first fluid-control
state, in which the flow regulator connects the suction source and
an interior of the inflatable element in fluid communication to
deflate the inflatable element;
[0178] while the mechanical user control element is in the first
configuration, inserting the cleaning catheter, in a proximal to
distal direction, into the ventilation tube inserted in a trachea
of a patient, and advancing the cleaning catheter until a distal
end of the catheter main body is axially disposed in the
ventilation tube at a location more distal than an axial mid-point
of the ventilation tube; and
[0179] while the cleaning catheter is thus disposed, transitioning
the mechanical user control element from the first configuration to
a second configuration, in which the flow regulator is in a second
fluid-control state, in which the flow regulator (a) connects the
suction source and the distal suction orifices in fluid
communication, and (b) connects an interior of the inflation
chamber and an interior of the inflatable element in fluid
communication to inflate the inflatable element,
[0180] wherein the mechanical user control element is configured to
mechanically and non-electrically increase pressure in an interior
of the inflation chamber during at least a portion of the
transitioning of the mechanical user control element from the first
configuration to the second configuration.
[0181] For some applications, the input module is configured such
that during the at least a portion of the transition of the
mechanical user control element from the first configuration to the
second configuration, before the flow regulator assumes the second
fluid-control state, a volume of the interior of the inflation
chamber decreases by between 10% and 90%.
[0182] For some applications, the inflation chamber includes a
one-way air inlet valve, which is arranged to allow air to flow
into the inflation chamber during at least a portion of a
transition of the mechanical user control element from the second
configuration to the first configuration.
[0183] The present invention will be more fully understood from the
following detailed description of embodiments thereof, taken
together with the drawings, in which:
BRIEF DESCRIPTION OF THE DRAWINGS
[0184] FIG. 1 is a schematic illustration of a closed suction
cleaning system, in accordance with an application of the present
invention;
[0185] FIG. 2 is another schematic illustration of the closed
suction cleaning system of FIG. 1, in accordance with an
application of the present invention;
[0186] FIG. 3 is a schematic illustration of a catheter main body
of the closed suction cleaning system of FIGS. 1 and 2, in
accordance with an application of the present invention:
[0187] FIG. 4 is a schematic cross-sectional illustration of a
closed suction cleaning system in a first fluid-control state, in
accordance with an application of the present invention;
[0188] FIGS. 5A-C are schematic cross-sectional illustrations of a
portion of the closed suction cleaning system of FIG. 4 in the
first fluid-control state, a second fluid-control state, and a
third fluid-control state, respectively, in accordance with an
application of the present invention;
[0189] FIGS. 6A-C are schematic cross-sectional illustrations of
another closed suction cleaning system in a first fluid-control
state, a third intermediate fluid-control state, and a second
fluid-control state, respectively, in accordance with an
application of the present invention;
[0190] FIG. 7 is another schematic cross-sectional illustration of
the closed suction cleaning system of FIGS. 6A-C in the first
fluid-control state, in accordance with an application of the
present invention;
[0191] FIGS. 8 and 9 are schematic cross-sectional illustrations of
yet another closed suction cleaning system in first and second
fluid-control states, respectively, in accordance with an
application of the present invention:
[0192] FIG. 10 is a schematic cross-sectional illustration of
another closed suction cleaning system in a first fluid-control
state, in accordance with an application of the present invention;
and
[0193] FIGS. 11A-C are schematic cross-sectional illustrations of a
portion of the closed suction cleaning system of FIG. 10 in the
first fluid-control state, a second fluid-control state, and a
third fluid-control state, respectively, in accordance with an
application of the present invention.
DETAILED DESCRIPTION OF APPLICATIONS
[0194] FIGS. 1 and 2 are schematic illustrations of a closed
suction cleaning system 100, in accordance with an application of
the present invention. Cleaning system 100 is configured for use
with a tracheal ventilation tube 160, a ventilator 170, and a
suction source 601. For some applications, cleaning system 100
comprises one or more of tracheal ventilation tube 160, ventilator
170, and/or suction source 601, in any combination.
[0195] As used in the present application, including in the claims,
a "tracheal ventilation tube" comprises an endotracheal tube (ETT)
or a tracheostomy tube. Suction source 601 provides a pressure less
than one atm. As used in the present application, including in the
claims, a "fluid" comprises liquid and/or gas, for example, a
liquid-gas mixture that is predominantly liquid, such as a liquid
with gas bubbles. The liquid may comprise water, such as saline
solution or a disinfectant solution.
[0196] Cleaning system 100 comprises a distal ventilation
tube-connector assembly 158, a cleaning catheter 200, and an input
module 156. Cleaning catheter 200 comprises an elongate, flexible,
tubular catheter main body 210. As shown in FIG. 3, described
hereinbelow, cleaning catheter 200 includes a distal portion 212
located distal to ventilation tube-connector assembly 158, and a
proximal portion 214 located proximal to ventilation tube-connector
assembly 158. Distal portion 212 is configured to be inserted into
ventilation tube 160. Proximal portion 214 includes a proximal-most
input portion 216 of catheter main body 210, which is configured to
be inserted into or is disposed within input module 156. For some
applications, proximal-most input portion 216 is axially slidable
with respect to input module 156, while for other applications, the
proximal-most input portion is fixed with respect to the input
module. Respective lengths of distal and proximal portions 212 and
214 may depend on an extent to which a distal end of catheter main
body 210 is deployed within ventilation tube 160 and/or an extent
to which the distal end is longitudinally displaced from
ventilation tube-connector assembly 158, for example, an extent to
which catheter main body 210 slides through ventilation
tube-connector assembly 158 in a distal direction.
[0197] As used in the present application, including in the claims,
"axial" and "axially" mean along an axis, and do not mean around or
about an axis. For example: (a) "axial motion" means motion along
an axis, and (b) "axially aligned" means aligned along an axis.
[0198] Ventilation tube-connector assembly 158 comprises: (a) a
ventilator port 664, configured to be coupled in fluid
communication with ventilator 170 via a ventilator connection tube
910, (b) a ventilation tube port, configured to be coupled in fluid
communication with a proximal end of ventilation tube 160, and (c)
a main body inlet, which is configured to allow passage
therethrough of catheter main body 210.
[0199] In some applications of the present invention, cleaning
system 100 is operative to clean an interior of ventilation tube
160 when ventilation tube-connector assembly 158 is directly or
indirectly connected to both ventilation tube 160 and ventilator
170 so as to mediate a substantially air-tight connection (e.g.,
via an interior chamber(s) and/or conduit(s) of ventilation
tube-connector assembly 158) between the ventilator and an interior
of the ventilation tube.
[0200] Cleaning catheter 200 further comprises an inflatable
element 588, such as a balloon, which is mounted to catheter main
body 210 near a distal end of catheter main body 210. e.g., within
3 cm, such as within 1 cm, of the distal end, and/or in a distal
half of distal portion 212 of cleaning catheter 200, such as a
distal third, a distal fifth, or a distal tenth of distal portion
212. Alternatively or additionally, inflatable element 588 is
mounted to catheter main body 210 within 3 cm, e.g., within 1 cm,
of at least one of the one or more distal suction orifices 440,
described hereinbelow. Inflatable element 588 is inflatable into
contact with an inner surface of ventilation tube 160. For some
applications, inflatable element 588 has a greatest outer diameter
of at least 6 mm, no more than 12 mm, and/or between 6 and 12 mm
when inflated at 1 bar above atmospheric pressure and unconstrained
(i.e., not constrained by the ventilation tube or anything else),
which is typically slightly greater than an inner diameter of
ventilation tube 160, in order to provide sealing contact with the
inner surface of the ventilation tube. For some applications,
inflatable element 588 has a volume of at least 0.5 cc, no more
than 2 cc, and/or between 0.5 and 2 cc when inflated at 1 bar above
atmospheric pressure and unconstrained. For some applications,
inflatable element 588 is elastic, while for other applications
inflatable element 588 is not elastic. For some applications,
inflatable element 588 comprises a thin pliable material, such that
the inflatable element crumples when deflated.
[0201] For some applications, catheter main body 210 has an outer
diameter of at least 6 mm, no more than 12 mm, and/or between 6 and
12 mm. For some applications, the greatest outer diameter of
inflatable element 588 when fully inflated and unconstrained (i.e.,
not constrained by the ventilation tube or anything else) equals at
least 60%, no more than 120%, and/or between 60% and 120% of the
outer diameter of catheter main body 210.
[0202] Reference is now made to FIG. 3, which is a schematic
illustration of catheter main body 210, in accordance with an
application of the present invention. Catheter main body 210
includes at least the following lumens arranged along catheter main
body 210. For some applications, one or more of the lumens are
arranged along catheter main body 210 at least partially within the
main body, e.g., integrally formed in the catheter main body 210,
formed in the wall of catheter main body 210, or provided as a
separate tube with catheter main body 210. Alternatively or
additionally, one or more of the lumens are arranged along catheter
main body 210 at least partially outside the main body, e.g.,
provided as a separate tube outside catheter main body 210. The
lumens include: [0203] at least one inflation lumen 520, which
provides fluid communication between at least one inflation inlet
521 and at least one inflation port 585 which is in fluid
communication with an interior of inflatable element 588;
typically, input portion 216 is shaped so as to define inflation
inlet 521, and distal portion 212 is shaped so as to define
inflation port 585; and [0204] one or more suction lumens 530,
which provide fluid communication between at least one proximal
suction inlet 531 and the one or more distal suction orifices 440:
typically, input portion 216 of catheter main body 210 is shaped so
as to define proximal suction inlet 531, and distal portion 212 of
cleaning catheter 200 is shaped so as to define distal suction
orifices 440. The one or more suction lumens 530 are arranged in
intermittent fluid communication with suction source 601, as
described in detail hereinbelow; for applications in which the one
or more suction lumens 530 comprise a plurality of suction lumens
530, the one or more suction lumens 530 typically are arranged in
fluid communication with one another (and are thus typically
brought into fluid communication with suction source 601 together
rather than separately).
[0205] Inflation lumen 520 typically has a cross-sectional area
smaller than that of suction lumen 530, e.g., less than 50%, less
than 30%, or less than 20% of the cross-sectional area of suction
lumen 530.
[0206] Reference is still made to FIG. 3, and is again made to
FIGS. 1 and 2. When inflated, inflatable element 588 typically
provides two types of functionality: (i) flow obstruction
functionality to significantly hinder fluid flow between locations
on opposite longitudinal sides of the inflatable element, and/or
(ii) wiping functionality useful for cleaning the inner surface of
ventilation tube 160. Typically, cleaning system 100 operates in a
closed system environment.
[0207] During one state of operation, cleaning system 100 cleans
the inner surface of ventilation tube 160 when ventilation
tube-connector assembly 158 mediates a substantially air-tight seal
between (i) ventilator 170 and/or an interior of ventilator port
664 and (ii) an interior of ventilation tube 160 and/or an interior
of the ventilation tube port.
[0208] Concurrently with maintaining of this ventilation
machine-ventilator tube seal, inflatable element 588 may be
positioned within ventilation tube 160 (e.g., in a distal portion
of ventilation tube 160), for example by moving a distal end of
catheter main body 210 in a distal direction towards a distal end
of ventilation tube 160. For example, inflatable element 588 may be
distally advanced when inflatable element 588 is in a non-contact
state (i.e., not in contact with the inner surface of ventilation
tube 160). After inflatable element 588 is thus positioned,
inflation of the inflatable element induces contact between an
outer surface of inflatable element 588 and the inner surface of
ventilation tube 160 and/or obstructs (i.e., significant hinders)
longitudinal flow between proximal and distal portions of the
interior of ventilation tube 160.
[0209] Upon inflation of inflatable element 588 when the inflatable
element is positioned within ventilation tube 160, the inflated
inflatable element forms a sliding boundary which obstructs (i.e.,
significantly hinders) fluid flow to between: (a) a more proximal
portion of an interstitial region outside of catheter main body 210
and within ventilation tube 160 and (b) locations within the
ventilation tube 160 that are distal to the slidable boundary
formed and delineated by inflatable element 588. This slidable
boundary between the proximal and distal portions may be useful for
facilitating the cleaning of the inner surface of ventilation tube
160 (by wiping), for example for substantially confining locations
of negative pressure and/or fluid (e.g., pressurized fluid)
introduced into an interstitial region outside of catheter main
body 210 and within ventilation tube 160 so that the suction is
introduced predominantly in the proximal portion of ventilation
tube 160.
[0210] Distal portion 212 of cleaning catheter 200 (labeled in FIG.
3) is shaped so as to define one or more distal suction orifices
440, typically through a lateral wall of distal portion 212.
Typically, the one or more distal suction orifices 440 are located
along distal portion 212 at one or more respective locations
proximal to inflatable element 588. Typically, at least one of
distal suction orifices 440 (such as all of the one or more distal
suction orifices 440) is located within 1 cm of inflatable element
588, such as within 0.8 cm. e.g., within 0.5 cm of the inflatable
element. For some applications, distal suction orifices 440 have a
total cross-sectional area in aggregate of at least 2 mm2, no more
than 25 mm2, and/or between 2 and 25 mm2, such as at least 4 mm2,
no more than 16 mm2, and/or between 4 and 16 mm2.
[0211] Distal suction orifices 440 are supplied with negative
pressure by suction source 601 and facilitate cleaning of the inner
surface of ventilation tube 160. For some applications, material
within the interior of ventilation tube 160 may be suctioned into
distal suction orifices 440 and proximally transported out of
ventilation tube 160, e.g., to a location that is proximal to
ventilation tube-connector assembly 158. As described below in
detail, fluid communication between suction source 601 and distal
suction orifices 440 may be provided by one or more connecting
lumens within or along catheter main body 210. As used in the
present application, including in the claims, "fluid communication"
includes both positive and negative pressure fluid communication,
and thus includes, for example, communication of a positive
pressure or of a suction force.
[0212] For some applications, cleaning system 100 comprises a
substantially impermeable and/or pliable sleeve 610 for protecting
an outer surface of catheter main body 210. In some embodiments,
sleeve 610 envelops, surrounds, and/or protects at least some
(e.g., at least a majority or at least a substantial majority,
e.g., at least 75% or substantially all of (e.g., at least 90%)) of
an outer surface of a ventilation-tube-connector-assembly-proximal
portion 214 of catheter main body 210, typically in locations
proximal to tube-connector assembly 158 and distal to suction port
830 (described hereinbelow), and typically to inhibit
contamination. For some applications, sleeve 610 provides this
enveloping and/or protection functionality when a length of the
ventilation-tube-connector-assembly-proximal portion 214 (labeled
in FIG. 3) of catheter main body 210 is at least 5 cm, e.g., at
least 10 cm, at least 15 cm, or at least 20 cm.
[0213] For some applications, a length of proximal portion 214 may
be modified by sliding, in a proximal or distal direction, catheter
main body 210 through ventilation tube-connector assembly 158.
[0214] For some applications, a distal end of sleeve 610 is (i)
directly or indirectly attached to and/or (ii) has a location that
is fixed and/or longitudinally fixed relative to ventilation
tube-connector assembly 158. For some applications, a longitudinal
position of a location of the distal end of sleeve 610 corresponds
to a location on ventilation tube-connector assembly 158 (e.g., at
or near the main body inlet) and/or is longitudinally displaced
from a proximal end (e.g., corresponding to the main body inlet) of
ventilation tube-connector assembly 158 by at most 5 cm, e.g., at
most 3 cm, at most 2 cm, or at most 1 cm, and/or at most 50%, e.g.,
at most 30%, at most 20%, at most 10% of a length of
ventilation-tube-connector-assembly-proximal portion 214 of
catheter main body 210.
[0215] For some applications, a location of the distal end of
sleeve 610 is not fixed relative to catheter main body 210. For
example, catheter main body 210 may be longitudinally slidable
within the sleeve 610 at or near a location of the distal end.
Alternatively or additionally, for some applications, a location of
a proximal end of sleeve 610 is fixed and/or longitudinally fixed
relative to a proximal end of catheter main body 210. For some
applications, sleeve 610 forms a substantially air-tight seal
between the external environment and an outer surface of
ventilation-tube-connector-assembly-proximal portion 214 of
catheter main body 210 and/or between the external environment and
region of space outside of an outer surface of
ventilation-tube-connector-assembly-proximal portion 214 of
catheter main body 210 and within sleeve 610.
[0216] Reference is now made to FIG. 4, which is a schematic
cross-sectional illustration of a closed suction cleaning system
400 in a first fluid-control state, in accordance with an
application of the present invention. Reference is also made to
FIGS. 5A-B, which are schematic cross-sectional illustrations of a
portion of closed suction cleaning system 400 in the first
fluid-control state and a second fluid-control state, respectively,
in accordance with an application of the present invention. Closed
suction cleaning system 400 is one implementation of closed suction
cleaning system 100, described hereinabove with reference to FIGS.
1-3. For illustrative purposes, inflatable element 588 is shown
inflated in FIG. 4, even though the inflatable element is in
practice not inflated in the first fluid-control state shown in
FIG. 4, as described hereinbelow.
[0217] As mentioned above, in some configurations input portion 216
of proximal portion of catheter main body 210 is configured to be
inserted into or is disposed within, and axially slidable with
respect to, input module 156. Input module 156 has at least one
port for connection with a fluid source, including at least suction
source 601. Input module 156 is coupled to cleaning catheter 200,
and comprises: [0218] an inflation module 330, which comprises an
inflation chamber 335 separate from suction source 601; [0219] a
flow regulator 700, which is (a) shaped so as to define suction
port 830, which is coupleable in fluid communication with suction
source 601 via a suction connection tube 920, and coupled in fluid
communication with suction source 601 during use of cleaning system
100, and (b) configured to assume at least first and second
fluid-control states; [0220] a mechanical user control element 320,
which is configured (a) to mechanically and non-electrically set
the fluid-control states of flow regulator 700, (b) to assume at
least first and second configurations, and (c) to mechanically and
non-electrically increase pressure in an interior of inflation
chamber 335 during at least a portion of a transition of mechanical
user control element 320 from the first configuration to the second
configuration; and [0221] typically, a housing 310 encasing input
portion 216 of catheter main body 210.
[0222] For some applications, the first and second configurations
of mechanical user control element 320 are first and second spatial
positions, respectively. Mechanical user control element 320 is
configured to assume at least the first and the second spatial
positions.
[0223] For some applications, input module 156 comprises exactly
one mechanical user control element 320 having the properties
described herein, and/or system 100 comprises exactly one
mechanical user control element 320 having the properties described
herein.
[0224] Input module 156 and/or system 100 may comprise further user
control elements that perform control functions in addition to
those performed by mechanical user control element 320.
[0225] Input module 156 is arranged such that: [0226] at least when
mechanical user control element 320 is in the first configuration
(e.g., spatial position), as shown in FIGS. 2, 4, and 5A, flow
regulator 70X) is in the first fluid-control state, in which flow
regulator 700 blocks fluid communication between suction source 601
and distal suction orifices 440, [0227] at least when mechanical
user control element 320 is in the second configuration (e.g.,
spatial position), as shown in FIG. 5B, flow regulator 700 is in
the second fluid-control state, in which flow regulator 70X) (A)
connects suction source 601 and distal suction orifices 440 in
fluid communication, and (B) connects the interior of inflation
chamber 335 and an interior of inflatable element 588 in fluid
communication to inflate inflatable element 588, and [0228] flow
regulator 700 is (a) not in the first fluid-control state when
mechanical user control element 320 is in the second configuration,
and (b) not in the second fluid-control state when mechanical user
control element 320 is in the first configuration.
[0229] Typically, mechanical user control element 320 is able to
assume an infinite number of intermediate configurations (e.g.,
spatial positions) between the first configuration and the second
configuration, as mechanical user control element 320 transitions
between the first configuration and the second configuration and
vice versa. For some applications, mechanical user control element
320 is arranged to move between first and second spatial
end-points, and the first and the second spatial positions
correspond with the first and the second spatial end-points,
respectively, as shown. Alternatively, the first and the second
spatial positions do not correspond with the first and the second
spatial end-points, respectively (configuration not shown), but
instead the first spatial position and/or the second spatial
position are between the first and the second spatial end-points.
For some applications, the above-mentioned intermediate
configurations include the third intermediate configuration (e.g.,
spatial position) described hereinbelow with reference to FIG.
5C.
[0230] Input module 156 is typically arranged such that flow
regulator 700 is in the first fluid-control state not only when
mechanical user control element 320 is in the first configuration
(e.g., spatial position), as shown in FIGS. 2, 4, and 5A, but also
during a portion of the intermediate configurations (e.g., spatial
positions), which are typically contiguous with the first
configuration (e.g., spatial position). Similarly, input module 156
is typically arranged such that flow regulator 700 is in the second
fluid-control state not only when mechanical user control element
320 is in the second configuration (e.g., spatial position), as
shown in FIG. 5B, but also during a portion of the intermediate
configurations (e.g., spatial positions), which are typically
contiguous with the second configuration (e.g., spatial position).
For applications in which the intermediate configurations include
the third, intermediate configuration (e.g., spatial position)
described hereinbelow with reference to FIG. 5C, input module 156
is typically arranged such that flow regulator 700 is in the third
fluid-control state not only when mechanical user control element
320 is in the third configuration (e.g., spatial position), as
shown in FIG. 5C, but also during a portion of the intermediate
configurations (e.g., spatial positions), which are typically
contiguous with the third configuration (e.g., spatial
position).
[0231] As mentioned above, mechanical user control element 320 is
configured to mechanically and non-electrically increase pressure
in an interior of inflation chamber 335 during at least a portion
of the transition of mechanical user control element 320 from the
first configuration to the second configuration. For some
applications, mechanical user control element 320 is configured to
mechanically and non-electrically increase the pressure in the
interior of inflation chamber 335 during an entirety of the
transition of mechanical user control element 320 from the first
configuration to the second configuration.
[0232] For some applications, input module 156 is configured such
that during the at least a portion of the transition of mechanical
user control element 320 from the first configuration to the second
configuration, before flow regulator 700 assumes the second
fluid-control state, a volume of the interior of inflation chamber
335 decreases by at least 10%, such as at least 20%, 30%, 40%, or
50%, and/or no more than 90%, such as no more than 80% or 70%,
e.g., by between 10% and 90%. In other words, the pressure in
inflation chamber 335 increases substantially before fluid
communication is established between the interior of inflation
chamber 335 and the interior of inflatable element 588.
[0233] For some applications, the mechanical user control element
320 is configured to mechanically and non-electrically increase the
pressure in the interior of inflation chamber 335 during motion of
mechanical user control element 320 while flow regulator 700 is in
the second fluid-control state. For example, the pressure may (a)
continue to increase while flow regulator 700 is in the second
fluid-control state, (b) increase only while flow regulator 700 is
in the second fluid-control state, or (c) increase only while flow
regulator 700 is in the second and the third fluid-control
states.
[0234] As mentioned above, mechanical user control element 320 is
configured to mechanically and non-electrically increase pressure
in the interior of inflation chamber 335 during at least a portion
of the transition of mechanical user control element 320 from the
first configuration to the second configuration. For some
applications, as labeled in FIG. 5B, a healthcare worker applies a
first force F1 to mechanical user control element 320 (such as to a
user control handle 718 thereof), and a second force F2, directed
toward the first force F1, to the opposite side of input module 156
from mechanical user control element 320. Typically, mechanical
user control element 320 is transitioned between the first and the
second configurations when the distal end of catheter main body 210
is axially disposed in ventilation tube 160 at a location more
distal than an axial mid-point of ventilation tube 160, typically
near the distal end of ventilation tube 160 (typically within 2 cm
of the distal end).
[0235] Typically, flow regulator 700: [0236] when in the first
fluid-control state, connects suction source 601 and the interior
of inflatable element 588 in fluid communication via an outlet 337
of inflation chamber 335 and inflation lumen 520, and [0237] when
in the second fluid-control state, connects in fluid communication
(a) suction source 601 and distal suction orifices 440 via the one
or more suction lumens 530, and (b) the interior of inflation
chamber 335 and the interior of inflatable element 588 via
inflation lumen 520.
[0238] Optionally, seals 342 and 343 are provided to seal around
outlet 337.
[0239] For some applications, such as shown in FIGS. 2, 3, 4, and
5A-B, input module 156 is arranged such that: [0240] when
mechanical user control element 320 is in the first configuration
(e.g., spatial position) and flow regulator 700 is in the first
fluid-control state, as shown in FIGS. 2, 4 and 5A, flow regulator
700 connects suction source 601 and the interior of inflatable
element 588 in fluid communication to deflate inflatable element
588, and [0241] when mechanical user control element 320 is in the
second configuration (e.g., spatial position) and flow regulator
700 is in the second fluid-control state, as shown in FIG. 5B, flow
regulator 700 does not connect suction source 601 and the interior
of inflatable element 588 in fluid communication.
[0242] In these applications, typically flow regulator 700, when in
the second fluid-control state, connects in fluid communication
suction source 601 and distal suction orifices 440 via the one or
more suction lumens 530.
[0243] Typically, each of the first and the second configurations
of mechanical user control element 320 includes a range of spatial
positions, such that each of the first and the second fluid-control
states of flow regulator 700 is stably activated over the
respective range of spatial positions, rather than only at single
respective spatial positions of mechanical user control element
320. Providing these ranges of spatial positions obviates the need
for the user to precisely position mechanical user control element
320 in order to achieve the different fluid-control states.
[0244] For some of these applications, inflation module 330
comprises a one-way air inlet valve 331, which is arranged to allow
air to flow into inflation chamber 335 during at least a portion of
a transition of mechanical user control element 320 from the second
configuration to the first configuration. One-way air inlet valve
331 allows ambient air 199 to enter (be sucked into) inflation
chamber 335 as inflation chamber 335 expands during at least a
portion of a transition between the second fluid-control state to
the first fluid-control state. For some applications, one-way air
inlet valve 331 is configured to generate a sound signal during at
least a portion of a period of fluid flow into inflation chamber
335 and/or during deflation of inflatable element 588; for example,
one-way air inlet valve 331 may be shaped so as to define a
whistle.
[0245] In the configuration illustrated in FIGS. 1-2, 4, 5A-C, 8-9,
10, and 11A-C the two fluid-control states are actuated by axial
motion of proximal portion 214 of catheter main body 210 relative
to input module housing 310. For some applications, transitions
between the two states are caused by shifts in alignment of the
lumen inlets with respect to various chambers of input module 156,
which chambers are or are not in fluid communication with
respective ports. The shifts in alignment are typically caused via
axial motion of input portion 216 of catheter main body 210 within
input module housing 310, along the longitudinal axes of input
portion 216 and input module 156. For some applications, input
module 156 is arranged such that changes in configuration of
mechanical user control element 320 cause corresponding changes in
axial position of input portion 216 with respect to input module
156. Typically, for these applications, input module 156 is
arranged such that input portion 216 assumes first and second axial
positions with respect to input module 156, corresponding to the
first and the second configurations of mechanical user control
element 320.
[0246] Typically, suction port 830 is shaped as a conventional
suction port in accordance with hospital standards for coupling to
standard hospital suctions sources. For example, suction port 830
may have a male conical interface, such as shown in FIGS. 2, 4,
5A-C, 8-9, 10, and 11A-C. Typically, suction port 830 has a lumen
size that corresponds with the lumen size of conventional tracheal
suction lumens, which generally having a gauge of between 5 Fr to
18 Fr.
[0247] Reference is now made to FIG. 5C, which is a schematic
cross-sectional illustration of a portion of closed suction
cleaning system 400 in a third fluid-control state, in accordance
with an application of the present invention. For some
applications, cleaning system 400 may also be used for suctioning
the trachea outside of and distal to ventilation tube 160,
typically when flow regulator 700 is in one of the following
states: [0248] as shown in FIG. 5B, the second fluid-control state,
in which suction source 601 and distal suction orifices 440 are in
fluid communication (and inflatable element 588 is inflated), or
[0249] as shown in FIG. 5C, a third, intermediate fluid-control
state, between the first and the second fluid-control states, in
which (a) suction source 601 and distal suction orifices 440 are in
fluid communication with one another, and (b) the interior of
inflation chamber 335 and the interior of inflatable element 588
are not in fluid communication with one another, and inflatable
element 588 is thus not inflated.
[0250] For some applications, flow regulator 700 is configured to
assume the third, intermediate fluid-control state when mechanical
user control element 320 is in a third, intermediate configuration
(e.g., spatial position), as shown in FIG. 5C, between the first
configuration (e.g., spatial position), as shown in FIG. 5A, and
the second configuration (e.g., spatial configuration), as shown in
FIG. 5B.
[0251] For some applications, when mechanical user control element
320 is in the third, intermediate configuration and flow regulator
700 is in the third, intermediate fluid-control state: [0252]
inflation inlet 521 is not in fluid communication with outlet 337
of inflation chamber 335; typically, inflation inlet 521 is in
fluid communication with suction port 830, such as via at least one
suction channel 831, to maintain inflatable element 588 deflated,
as shown in FIG. 5C (alternatively, inflation inlet 521 is axially
aligned with a wall of input module housing 310, e.g., slightly
proximal to (i.e., to the right of, in FIG. 5B) the position of
inflation inlet 521 shown in FIG. 5B (and thus slightly proximal to
outlet 337), because catheter main body 210 is positioned slightly
proximal to (i.e., to the right of, in FIG. 5B) the position shown
in FIG. 5B), and [0253] as shown in FIG. 5C, proximal suction inlet
531 is in fluid communication with suction port 830, such as via at
least one suction channel 831, e.g., with proximal suction inlet
531 disposed slightly proximal to (i.e., to the right of, in FIG.
5B) the position of proximal suction inlet 531 shown in FIG. 5B,
but not so proximal (e.g., far to the right in FIG. 5B) as to form
a seal with suction sealer 375.
[0254] Typically, as described above regarding the first and the
second configurations of mechanical user control element 320, the
third configuration of mechanical user control element 320 includes
a range of spatial positions, such that the third fluid-control
state of flow regulator 700 is stably activated over the range of
spatial positions, rather than only at a single spatial position of
mechanical user control element 320. Providing this range of
spatial positions obviates the need for the user to precisely
position mechanical user control element 320 in order to achieve
the third fluid-control states.
[0255] As mentioned above, for some of these applications, when
mechanical user control element 320 is in the third, intermediate
configuration and flow regulator 700 is in the third, intermediate
fluid-control state, inflation inlet 521 is in fluid communication
with suction port 830, as shown in FIG. 5C. For others of these
applications, when mechanical user control element 320 is in the
third, intermediate configuration and flow regulator 700 is in the
third, intermediate fluid-control state, inflation inlet 521 is not
in fluid communication with suction port 830 (configuration not
shown).
[0256] For some applications, during a transition of mechanical
user control element 320 between the first configuration and the
second configuration, mechanical user control element 320 assumes a
transient position in which inflation inlet 521 is neither in fluid
communication with suction port 830 nor in fluid communication with
outlet 337 of inflation chamber 335. Typically, the transient
position has a shorter range of spatial positions than do the
first, the second, and the third configurations of mechanical user
control element 320, as described above.
[0257] For some applications, the distal end of catheter main body
210 is closed (such as shown). In these applications, tracheal
suction is typically performed by advancing catheter main body 210
far enough beyond the distal end of ventilation tube 160 such that
at least one of the one or more distal suction orifices 440 is in
fluid communication with the interior of the trachea distally
beyond the end of ventilation tube 160. For other applications,
catheter main body 210 is shaped so as to define, in addition to
the one or more distal suction orifices 440, a distal-most suction
orifice at a distal end of distal portion 212 of cleaning catheter
200, distal to inflatable element 588, for example such as
described in above-mentioned U.S. Pat. No. 8,999,074, with
reference to FIGS. 21A-B and 22A-C thereof.
[0258] For some applications, input module 156 is configured such
that changes in configuration (e.g., spatial position) of
mechanical user control element 320 cause corresponding changes in
axial position of input portion 216 of catheter main body 210 with
respect to input module 156. Typically, input module 156 is
configured such that input portion 216 assumes first and second
axial positions with respect to input module 156 (e.g., with
respect to suction port 830), corresponding to the first and the
second configurations (e.g., spatial positions) of mechanical user
control element 320. The first and the second axial positions of
input portion 216 are typically along a single axis.
[0259] For some applications, such as shown in FIGS. 2, 4, 5A-C,
6A-C, and 7, mechanical user control element 320 is configured to
increase the pressure in the interior of inflation chamber 335 by
mechanically and non-electrically compressing inflation chamber 335
during the at least a portion of the transition of mechanical user
control element 320 from the first configuration to the second
configuration. In these applications, inflation chamber 335
functions as a compression pump. For some applications, mechanical
user control element 320 is directly or indirectly coupled to one
or more external surfaces of inflation chamber 335. Alternatively,
as shown in FIGS. 1-2, 4, 5A-C, and 8-9, mechanical user control
element 320 and inflation chamber 335 are not directly coupled
together, but are arranged such that activation (e.g., movement) of
mechanical user control element 320 applies a force to inflation
chamber 335. For example, mechanical user control element 320 and
inflation module 330 (and inflation chamber 335) may be arranged
such that user control handle 718 or a button of mechanical user
control element 320 applies a force to a top surface of inflation
module 330 (e.g., inflation chamber 335) when the handle or button
is pressed toward an axis of input module 156. Alternatively, for
example, inflation chamber 30 may be disposed at least partially
within mechanical user control element 320 (such as described
hereinbelow with reference to FIGS. 6A-C and 7). Other
configurations will be readily apparent to one of ordinary skill in
the art who has read the present application, and are within the
scope of the present application.
[0260] For some applications, as shown in FIGS. 1-2, 4, 5A-C, 6A-C,
7, and 8-9, inflation chamber 335 transitions from a lower level of
compression to a higher level of compression during the at least a
portion of the transition of mechanical user control element 320
from the first configuration to the second configuration. For some
of these applications, input module 156 is configured to
elastically bias inflation chamber 335 toward the lower level of
compression. For some applications, inflation chamber 335 (e.g., at
least one wall 332 of inflation chamber 335) is elastically biased
toward the lower level of compression. For example, the at least
one wall of inflation chamber 335 may be accordion-shaped and/or
the chamber walls comprise an elastic material, such as silicon,
rubber, or polyurethane. In some embodiments, substantially no
friction needs to be overcome during expansion of inflation chamber
335. Alternatively or additionally, inflation module 330 (such as
inflation chamber 335) comprises a distinct elastic element 333
(e.g., a spring) that is arranged to bias inflation chamber 335
toward the lower level of compression. Alternatively or
additionally, mechanical user control element 320 is elastically
biased toward the lower level of compression (and to the first
configuration), for example by a spring 349. In any event,
typically, when user control element 320 is released, inflation
chamber 335 expands. In other words, input module 156 is biased to
assume the first configuration and first fluid-control state when
in a resting state, such that inflation chamber 335 is in an
expanded state when input module 156 is in the resting state.
[0261] For some applications, input module 156 further comprises a
user signal generator, which is configured to generate a user
signal (e.g., a sound) during at least a portion of a period of
fluid flow into inflation chamber 335 and/or during or upon
deflation of inflatable element 588. The user signal generator may
be electrical and/or mechanical.
[0262] For some applications, inflation chamber 335 has a volume of
at least 1 cc, no more than 10 cc, and/or between 1 and 10 cc
(e.g., at least 1.5 cc, no more than 3 cc, and/or between 1.5 and 3
cc), when mechanical user control element 320 is in the first
configuration (i.e., not compressed). The volume typically equals
more than 1 times and less than 3 times the volume of inflatable
element 588. Typically, when mechanical user control element 320 is
in the second configuration (i.e., compressed), inflation chamber
335 has a volume of at least 1 cc less than when mechanical user
control element 320 is in the first configuration (i.e., not
compressed).
[0263] Reference is made to FIGS. 4 and 5A-C. For some
applications, as shown in these figures, catheter main body 210 is
shaped so as to define proximal suction inlet 531 at a proximal end
of the main body. For some of these applications, proximal suction
inlet 531 is configured to sealingly engage a suction sealer 375
that is fixed with respect to housing 310. When flow regulator 700
is in the first fluid-control state, proximal suction inlet 531 is
sealingly engaged with suction sealer 375 (as shown in FIGS. 4 and
5A), thereby blocking (a) fluid communication between proximal
suction inlet 531 and suction port 830, and (b) fluid communication
between suction source 601 and lumen 530. When flow regulator 700
is in the second fluid-control state, proximal suction inlet 531 is
disengaged from suction sealer 375 (as shown in FIG. 5B), thereby
enabling fluid communication between proximal suction inlet 531 and
suction port 830. This engaging/disengaging is typically actuated
by axial motion of catheter main body 210 with respect to suction
sealer 375.
[0264] Typically, as shown in FIG. 5B, at least one suction channel
831 facilitates fluid communication to suction port 830 around the
suction sealer 375. Therefore, when inflation inlet 521 is in fluid
communication with suction channel 831, suction is communicated to
inflation lumen 520, while suction remains blocked by suction
sealer 375 from communication to one or more suction lumens 530. As
a result, suction deflation of inflatable element 588 is caused
while no suction is communicated to distal suction orifices 440 of
the catheter main body.
[0265] For some applications, as shown in FIGS. 1-2, 4, 5A-C, and
8-9, mechanical user control element 320 comprises user control
handle 718, the movement of which includes a component
perpendicular to the associated axial motion of catheter main body
210.
[0266] Mechanical user control element 320 translates the movement
of user control handle 718 into axial motion of catheter main body
210. For example, mechanical user control element 320 may comprise
a side projection element 730 attached to catheter main body 210,
and an engaging element 711 that has a diagonal face which engages
side projection element 730, such that when engaging element 711
moves down, it pushes side projection element 730 sideways and thus
imparts axial motion to catheter main body 210.
[0267] Reference is now made to FIGS. 6A-C, which are schematic
cross-sectional illustrations of a closed suction cleaning system
500 in a first fluid-control state, a third intermediate
fluid-control state, and a second fluid-control state,
respectively, in accordance with an application of the present
invention. Reference is also made to FIG. 7, which is another
schematic cross-sectional illustration of closed suction cleaning
system 500 in the first fluid-control state, in accordance with an
application of the present invention. Closed suction cleaning
system 500 is one implementation of closed suction cleaning system
100, described hereinabove with reference to FIGS. 1-3, and, except
as described hereinbelow, may implement any of the features
described hereinabove with reference to FIG. 1-3.
[0268] Unlike in the other configurations described herein, in
closed suction cleaning system 500, the fluid-control states are
not actuated by axial motion of proximal portion 214 of catheter
main body 210 relative to input module housing 310, and mechanical
user control element 320 does not translate the movement of user
control handle 718 into axial motion of catheter main body 210.
Instead, in closed suction cleaning system 500, proximal-most input
portion 216 of catheter main body 210 is fixed with respect to
input module 156. The movement of user control handle 718 actuates
the fluid-control states without translating the movement into
axial motion of proximal portion 214 of catheter main body 210.
Input module 156 is arranged such that user control handle 718 is
moveable with respect to catheter main body 210 in two opposite
directions along a movement axis 618 that forms a fixed angle 3
(beta) of between 45 and 135 degrees with a central longitudinal
axis 620 of proximal-most input portion 216 of catheter main body
210, typically 90 degrees (as shown). Input module 156 is arranged
such that movement of user control handle 718 along movement axis
618 mechanically causes corresponding movement of a distal opening
832 of suction port 830 along or alongside movement axis 618. This
corresponding movement selectively brings distal opening 832 of
suction port 830 into and out of fluid communication with (a) the
interior of inflatable element 588 (via inflation lumen 520 of
catheter main body 210), and (b) distal suction orifices 440 (via
suction lumen 530 of catheter main body 210), as described
hereinbelow in detail. (Typically, input module 156 is arranged
such that user control handle 718 is constrained to movement with
respect to catheter main body 210 only along movement axis 618, and
not in other directions.)
[0269] For some applications, module 156 is arranged such that
movement of user control handle 718 along movement axis 618
mechanically causes corresponding movement of suction port 830
along or alongside movement axis 618, in addition to causing
corresponding movement of distal opening 832 of suction port 830.
For some of these applications, a longitudinal axis of suction port
830 is perpendicular to movement axis 618, and thus the
longitudinal axis of suction port 830 moves along or alongside
movement axis 618.
[0270] For some applications, mechanical user control element 320
is shaped so as to define first and second fluid-connection
chambers 631 and 632, which are arranged at respective different
locations along or alongside movement axis 618, with first
fluid-connection chamber 631 farther from catheter main body 210
than second fluid-connection chamber 632 is from catheter main body
210. For some applications, first and second fluid-connection
chambers 631 and 632 are annular (as shown). For example, in order
to define the chambers, mechanical user control element 320 may be
shaped so as to define, or comprise, first, second, and third
sealing rings 641, 642, and 643 (e.g., O-rings), arranged such that
first and second sealing rings 641 and 642 define first
fluid-connection chamber 631, and second and third sealing rings
642 and 643 define second fluid-connection chamber 632.
[0271] For some applications, mechanical user control element 320
is shaped so as to define: [0272] an inflation lumen 637, which
connects, in fluid communication, inflation inlet 521 of catheter
main body 210 and first fluid-connection chamber 631, via an
inflation lumen port 650 defined by inflation lumen 637, and [0273]
a suction lumen 638, which connects, in fluid communication,
proximal suction inlet 531 of catheter main body 210 and second
fluid-connection chamber 632, via a suction lumen port 652 defined
by suction lumen 638.
[0274] Inflation lumen port 650 may be disposed at or near an end
of inflation lumen 637 opposite the end connected to inflation
inlet 521 of catheter main body 210, as shown. Suction lumen port
652 may be disposed at or near an end of suction lumen 638 opposite
the end connected to proximal suction inlet 531 of catheter main
body 210, as shown.
[0275] Input module 156 is arranged such that when mechanical user
control element 320 (e.g., user control handle 718 thereof) is in a
first configuration (e.g., spatial position) along movement axis
618, as shown in FIGS. 6A and 7, flow regulator 700 is in the first
fluid-control state, in which flow regulator 700: [0276] connects
suction source 601 and the interior of inflatable element 588 in
fluid communication via inflation lumen 520 to deflate inflatable
element 588; for example, distal opening 832 of suction port 830
may be in fluid communication with first fluid-connection chamber
631, which in turn is in fluid communication with inflation inlet
521 via inflation lumen 637 and, and [0277] blocks fluid
communication between suction source 601 and distal suction
orifices 440 via suction lumen 530; for example, distal opening 832
of suction port 830 may not be in fluid communication with second
fluid-connection chamber 632.
[0278] Input module 156 is arranged such that when mechanical user
control element 320 is in the second configuration (e.g., spatial
position) along movement axis 618, as shown in FIG. 6C, flow
regulator 700 is in the second fluid-control state, in which flow
regulator 700: [0279] connects suction source 601 and distal
suction orifices 440 in fluid communication via suction lumen 530;
for example, distal opening 832 of suction port 830 may be in fluid
communication with second fluid-connection chamber 632, which in
turn is in fluid communication with proximal suction inlet 531 via
suction lumen 638, and [0280] connects the interior of inflation
chamber 335 and the interior of inflatable element 588 in fluid
communication to inflate inflatable element 588; for example,
outlet 337 of inflation chamber 335 may be in fluid communication
with first fluid-connection chamber 631, which in turn is in fluid
communication with inflation inlet 521 via inflation lumen 637.
[0281] For some applications, input module 156 is arranged such
that movement of user control handle 718 of mechanical user control
element 320 along movement axis 618 mechanically causes
corresponding movement along or alongside movement axis 618 of
both: [0282] distal opening 832 of suction port 830, which
selectively brings distal opening 832 of suction port 830 into and
out of fluid communication with (a) the interior of inflatable
element 588 (via inflation lumen 520 of catheter main body 210),
and (b) distal suction orifices 440 (via suction lumen 530 of
catheter main body 210), and [0283] outlet 337 of inflation chamber
335, which selectively brings the interior of inflation chamber 335
into and out of fluid communication with the interior of inflatable
element 588 (via inflation lumen 520 of catheter main body
210).
[0284] For some applications, during movement of user control
handle 718 of mechanical user control element 320 along movement
axis 618, first and second fluid-connection chambers 631 and 632
remain stationary with respect to catheter main body 210 (as
shown), while for other applications, first and second
fluid-connection chambers 631 and 632 move with respect to catheter
main body 210 (configuration not shown).
[0285] Reference is still made to FIGS. 6A-C and 7. For some
applications, such as described hereinabove with reference to FIGS.
5A-C, cleaning system 100 may also be used for suctioning the
trachea outside of and distal to ventilation tube 160, typically
when flow regulator 700 is in one of the following states: [0286]
the second fluid-control state, in which suction source 601 and
distal suction orifices 440 are in fluid communication (and
inflatable element 588 is inflated), or [0287] the third,
intermediate fluid-control state, between the first and the second
fluid-control states, such as shown in FIG. 6B, in which (a)
suction source 601 and distal suction orifices 440 are in fluid
communication with one another, and (b) the interior of inflation
chamber 335 and the interior of inflatable element 588 are not in
fluid communication with one another, and inflatable element 588 is
thus not inflated.
[0288] For some applications, flow regulator 700 is configured to
assume the third, intermediate fluid-control state when mechanical
user control element 320 is in a third, intermediate configuration
(e.g., spatial position) along movement axis 618 between the first
configuration (e.g., spatial position) and the second configuration
(e.g., spatial configuration), such as shown in FIG. 6B.
[0289] For some applications, such as shown in FIG. 6B, when
mechanical user control element 320 is in the third, intermediate
configuration and flow regulator 700 is in the third, intermediate
fluid-control state: [0290] inflation inlet 521 is not in fluid
communication with outlet 337 of inflation chamber 335 (because
outlet 337 is not in fluid communication with first
fluid-connection chamber 631), [0291] proximal suction inlet 531 is
in fluid communication with suction port 830, via suction lumen
638, second fluid-connection chamber 632, and distal opening 832 of
suction port 830, and [0292] inflation inlet 521 is in fluid
communication with suction port 830, via inflation lumen 637, first
fluid-connection chamber 631, and distal opening 832 of suction
port 830.
[0293] When flow regulator 700 is in the third, intermediate
fluid-control state (shown in FIG. 6B), air pressure within
inflation chamber 335 is greater than when flow regulator 700 is in
the first fluid-control state (shown in FIG. 6A), because inflation
chamber 335 has been compressed but the interior of the inflation
chamber is not yet in fluid communication with any lumens, as the
inflation chamber subsequently is in the second fluid-control state
(shown in FIG. 6C).
[0294] When flow regulator 700 is in the third, intermediate
fluid-control state, distal opening 832 of suction port 830 spans
both first and second fluid-connection chambers 631 and 632 along
or alongside movement axis 618 (because distal opening 832 of
suction port 830 is wider than sealing ring 642, measured along or
alongside movement axis 618). As a result, distal opening 832 of
suction port 830 is simultaneously in fluid communication with both
first and second fluid-connection chambers 631 and 632.
[0295] For some applications, as shown in FIGS. 6A-C and 7,
inflation chamber 335 is disposed within mechanical user control
element 320; for example, inflation chamber 335 may be defined by
one or more interior surfaces of user control handle 718.
[0296] For some applications, inflation module 330 comprises a
one-way air inlet valve 331, such as described hereinabove with
reference to FIGS. 4 and 5A-C.
[0297] Reference is now made to FIGS. 8-9, which are schematic
cross-sectional illustrations of a closed suction cleaning system
800 in first and second fluid-control states, respectively, in
accordance with an application of the present invention. Closed
suction cleaning system 800 is one implementation of closed suction
cleaning system 100, described hereinabove with reference to FIGS.
1-3, and, except as described hereinbelow, may implement any of the
features described hereinabove with reference to FIG. 1-3. Although
closed suction cleaning system 800 is shown in FIGS. 8-9 as
implementing features of closed suction cleaning system 400,
described hereinabove with reference to FIGS. 4 and 5A-C, closed
suction cleaning system 800 may alternatively implement features of
closed suction cleaning system 500, described hereinabove with
reference to FIGS. 6A-C and 7, mutatis mutandis.
[0298] In closed suction cleaning system 800, inflation module 330
(including inflation chamber 335) is arranged on the opposite side
of input module 156 from mechanical user control element 320.
Outlet 337 of inflation module 330 may be connected to chamber 335
by a tube 802. Input module 156 is arranged such that flow
regulator 700 assumes the first fluid-control state when in a
resting state; to this end, mechanical user control element 320 is
elastically biased toward the first configuration, for example by
spring 349, and inflation chamber 335 is elastically biased toward
the lower level of compression, for example as described
hereinabove with reference to FIGS. 2, 4, 5A-C, 6A-C, and 7.
[0299] Simultaneous application of respective forces (labeled as
first force F1 and second force F2), directed toward each other, to
mechanical user control element 320 and inflation module 330 (and
inflation chamber 335), simultaneously: [0300] transitions
mechanical user control element 320 from the first configuration to
the second configuration, thereby transitioning flow regulator 700
from the first fluid-control state to the second fluid-control
state, and [0301] mechanically and non-electrically increases
pressure in the interior of inflation chamber 335, by compression
of inflation chamber 335.
[0302] The respective forces are typically applied by a healthcare
worker squeezing mechanical user control element 320 and inflation
module 330 (and inflation chamber 335) toward each other, such as
using the thumb and fingers, respectively.
[0303] Reference is now made to FIG. 10, which is a schematic
cross-sectional illustration of a closed suction cleaning system
900 in a first fluid-control state, in accordance with an
application of the present invention. Reference is also made to
FIGS. 11A-B, which are schematic cross-sectional illustrations of a
portion of closed suction cleaning system 900 in the first
fluid-control state and a second fluid-control state, respectively,
in accordance with an application of the present invention. Closed
suction cleaning system 900 is one implementation of closed suction
cleaning system 100, described hereinabove with reference to FIGS.
1-3, and, except as described hereinbelow, may implement any of the
features of closed suction cleaning system 400 described
hereinabove with reference to FIGS. 4 and 5A-C. For illustrative
purposes, inflatable element 588 is shown inflated in FIG. 10, even
though the inflatable element is in practice not inflated in the
first fluid-control state shown in FIG. 10, as described
herein.
[0304] In this configuration, input module 156 comprises a first
mechanical user control element 320A, which is configured to
mechanically and non-electrically set the fluid-control states of
flow regulator 700. First mechanical user control element 320A is
configured to assume at least first and second configurations, such
as first and second spatial positions, respectively. For some
applications, as shown, first mechanical user control element 320A
comprises a first user control button 930A.
[0305] In this configuration, input module 156 further comprises a
second mechanical user control element 320B, which is configured
(a) to assume at least first and second configurations, such as
first and second spatial positions, and (b) to mechanically and
non-electrically increase pressure in the interior of inflation
chamber 335 during a transition of second mechanical user control
element 320B from its first configuration to its second
configuration. In these applications, inflation chamber 335
functions as a compression pump. For some applications, as shown,
second mechanical user control element 320B comprises a second user
control button 930B.
[0306] For some applications, input module 156 is arranged such
that: [0307] when first mechanical user control element 320A is in
its first configuration (e.g., spatial position), as shown in FIGS.
10 and 11A, flow regulator 700 is in the first fluid-control state,
in which flow regulator 700 blocks fluid communication between
suction source 601 and distal suction orifices 440, and [0308] when
first mechanical user control element 320A is in its second
configuration (e.g., spatial position), as shown in FIG. 11B, flow
regulator 700 is in the second fluid-control state, in which flow
regulator 700 (a) connects suction source 601 and distal suction
orifices 440 in fluid communication, and (b) connects the interior
of inflation chamber 335 and an interior of inflatable element 588
in fluid communication to inflate inflatable element 588.
[0309] For some applications, as labeled in FIG. 11B, a healthcare
worker applies: [0310] a first force F1 to first mechanical user
control element 320A (such as to first user control button 930A
thereof), [0311] a third force F3 to second mechanical user control
element 320B (such as to second user control button 930B thereof),
and [0312] a second force F2, directed toward the first and the
third forces F1 and F3, to the opposite side of input module 156
from first and second user control elements 320A and 320B.
[0313] For some applications, first and second mechanical user
control elements 320A and 320B (e.g., first and second user control
buttons 930A and 930B) are arranged side-by-side. For some
applications, first and second mechanical user control elements
320A and 320B (e.g., first and second user control buttons 930A and
930B) are arranged such that a portion of one of the mechanical
user control elements (e.g., control buttons) at least partially
(i.e., partially or entirely) surrounds the other user control
element (e.g., control button). For example, second mechanical user
control element 320B (e.g., second user control button 930B) may at
least partially surround at least two sides of first mechanical
user control element 320A (e.g., first user control button 930A),
such as at least three sides (e.g., three entire sides) of first
mechanical user control element 320A (e.g., first user control
button 930A), as shown in FIG. 10. Alternatively, for example,
first mechanical user control element 320A (e.g., first user
control button 930A) may at least partially surround at least two
sides of second mechanical user control element 320B (e.g., second
user control button 930B), such as at least three sides (e.g.,
three entire sides) of second mechanical user control element 320B
(e.g., second user control button 930B) (configurations not shown).
In these side-by-side arrangements, a closest distance between
first and second mechanical user control elements 320A and 320B
(e.g., first and second user control buttons 930A and 930B) is
typically at least 0.1 mm, no more than 2 mm (e.g., no more than 1
mm), and/or between 0.1 mm and 2 mm (e.g., 1 mm).
[0314] Providing the control elements side-by-side may enable both
(a) ergonomically-convenient simultaneous pressing of both control
elements, such as to transition flow regulator 700 from the first
fluid-control state to the second fluid-control state, and (b)
pressing of only first mechanical user control element 320A (e.g.,
first user control button 930A) to transition flow regulator 700
from the first fluid-control state to a third fluid-control state,
such as described hereinbelow.
[0315] Reference is now made to FIG. 11C, which is a schematic
cross-sectional illustration of a portion of closed suction
cleaning system 900 in a third fluid-control state, in accordance
with an application of the present invention. For some
applications, cleaning system 900 may also be used for suctioning
the trachea outside of and distal to ventilation tube 160,
typically when flow regulator 700 is in one of the following
states: [0316] as shown in FIG. 11B, the second fluid-control
state, in which suction source 601 and distal suction orifices 440
are in fluid communication (and inflatable element 588 is
inflated), or [0317] as shown in FIG. 11C, the third, intermediate
fluid-control state, between the first and the second fluid-control
states, in which (a) suction source 601 and distal suction orifices
440 are in fluid communication with one another, and (b) the
interior of inflation chamber 335 and the interior of inflatable
element 588 are not in fluid communication with one another, and
inflatable element 588 is thus not inflated.
[0318] For some applications, flow regulator 700 is configured to
assume the third, intermediate fluid-control state when: [0319]
first mechanical user control element 320A (e.g., first user
control button 930A) is in a third, intermediate configuration
(e.g., spatial position), as shown in FIG. 11C, between its first
configuration (e.g., spatial position), as shown in FIG. 11A, and
its second configuration (e.g., spatial configuration), as shown in
FIG. 11B, and [0320] second mechanical user control element 320B
(e.g., second user control button 930B) is in its first
configuration (e.g., spatial position), as shown in FIG. 11C.
[0321] For some applications, when first mechanical user control
element 320A (e.g., first user control button 930A) is in the
third, intermediate configuration and flow regulator 700 is in the
third, intermediate fluid-control state: [0322] inflation inlet 521
is not in fluid communication with outlet 337 of inflation chamber
335; typically, inflation inlet 521 is in fluid communication with
suction port 830, such as via at least one suction channel 831, to
maintain inflatable element 588 deflated, as shown in FIG. 11C
(alternatively, inflation inlet 521 is axially aligned with a wall
of input module housing 310, e.g., slightly proximal to (i.e., to
the right of, in FIG. 11B) the position of inflation inlet 521
shown in FIG. 11B (and thus slightly proximal to outlet 337),
because catheter main body 210 is positioned slightly proximal to
(i.e., to the right of, in FIG. 11B) the position shown in FIG.
11B), and [0323] as shown in FIG. 11C, proximal suction inlet 531
is in fluid communication with suction port 830, such as via at
least one suction channel 831, e.g., with proximal suction inlet
531 disposed slightly proximal to (i.e., to the right of, in FIG.
11B) the position of proximal suction inlet 531 shown in FIG. 11B,
but not so proximal (e.g., far to the right in FIG. 11B) as to form
a seal with suction sealer 375.
[0324] Flow regulator 700 may have any of the features thereof
described hereinabove with reference to FIG. 5C, mutatis
mutandis.
[0325] For other applications (configuration not shown), flow
regulator 700 is configured to assume the third, intermediate
fluid-control state when: [0326] first mechanical user control
element 320A (e.g., first user control button 930A) is in the
third, intermediate configuration (e.g., spatial position), as
shown in FIG. 11C, and [0327] second mechanical user control
element 320B (e.g., second user control button 930B) is in a third,
intermediate configuration (e.g., spatial position), between its
first configuration (e.g., spatial position), as shown in FIG. 11A,
and its second configuration (e.g., spatial configuration), as
shown in FIG. 11B (configuration not shown).
[0328] For still other applications (configuration not shown), flow
regulator 700 is configured to assume the third, intermediate
fluid-control state when: [0329] first mechanical user control
element 320A (e.g., first user control button 930A) is in its
second configuration (e.g., spatial position), as shown in FIG.
11B, and [0330] second mechanical user control element 320B (e.g.,
second user control button 930B) is in its first configuration
(e.g., spatial position), as shown in FIG. 11A.
[0331] For some applications, inflation chamber 335 transitions
from a lower level of compression to a higher level of compression
during the transition of second mechanical user control element
320B from its first configuration to its second configuration. For
some of these applications, input module 156 is configured to
elastically bias inflation chamber 335 toward the lower level of
compression. For some applications, inflation chamber 335 (e.g., at
least one wall 332 of inflation chamber 335) is elastically biased
toward the lower level of compression. For example, the at least
one wall of inflation chamber 335 may be accordion-shaped and/or
the chamber walls comprise an elastic material, such as silicon,
rubber, or polyurethane. In some embodiments, substantially no
friction needs to be overcome during expansion of inflation chamber
335. Alternatively or additionally, inflation module 330 (such as
inflation chamber 335) comprises a distinct elastic element 333
(e.g., a spring) that is arranged to bias inflation chamber 335
toward the lower level of compression. Alternatively or
additionally, second mechanical user control element 320B is
elastically biased toward the lower level of compression (and to
the first configuration), for example by a spring 349. In any
event, typically, when second mechanical user control element 320B
is released, inflation chamber 335 expands. In other words, input
module 156 is biased to assume the first configuration and first
fluid-control state when in a resting state, such that inflation
chamber 335 is in an expanded state when input module 156 is in the
resting state.
[0332] For some applications, first mechanical user control element
320A comprises user control handle 718, the movement of which
includes a component perpendicular to the associated axial motion
of catheter main body 210. First mechanical user control element
320A translates the movement of user control handle 718 into axial
motion of catheter main body 210. For example, first mechanical
user control element 320A may comprise side projection element 730
attached to catheter main body 210, and engaging element 711 that
has a diagonal face which engages side projection element 730, such
that when engaging element 711 moves down, it pushes side
projection element 730 sideways and thus imparts axial motion to
catheter main body 210.
[0333] Although the fluid-control states of flow regulator 700 of
input module 156 are sometimes characterized hereinabove as
"first," "second," and "third," these ordinal numbers do not
necessarily imply a particular order of activation during use of
cleaning system 100 unless explicitly stated. In addition, input
module 156 may have activation states in addition to those
described herein, which may be activated before, after, or
temporarily between the states described herein. The ordinal
numbers of the states recited in claims do not necessarily
correspond to the ordinal numbers of the states described
hereinabove in the specification.
[0334] In the description and claims of the present application,
each of the verbs, "comprise," "include" and "have," and conjugates
thereof, are used to indicate that the object or objects of the
verb are not necessarily a complete listing of members, components,
elements or parts of the subject or subjects of the verb. The
articles "a" and "an" are used herein to refer to one or to more
than one (i.e., to at least one) of the grammatical object of the
article. By way of example, "an element" means one element or more
than one element. The term "including" is used herein to mean, and
is used interchangeably with, the phrase "including but not limited
to." The term "or" is used herein to mean, and is used
interchangeably with, the term "and/or," unless context clearly
indicates otherwise. The term "such as" is used herein to mean, and
is used interchangeably, with the phrase "such as but not limited
to."
[0335] All publications, patent applications, patents, and other
references mentioned herein are incorporated by reference in their
entirety. In case of conflict, the present patent specification,
including definitions, will prevail. In addition, the materials,
methods, and examples are illustrative only and not intended to be
limiting.
[0336] For brevity, some explicit combinations of various features
are not explicitly illustrated in the figures and/or described. It
is now disclosed that any combination of the method or device
features disclosed herein can be combined in any manner--including
any combination of features--any combination of features can be
included in any embodiment and/or omitted from any embodiments.
[0337] The scope of the present invention includes embodiments
described in the following applications, which are assigned to the
assignee of the present application and are incorporated herein by
reference. In an embodiment, techniques and apparatus described in
one or more of the following applications are combined with
techniques and apparatus described herein. It is noted that the
phrase "fluid-control state" used herein may, for some
applications, correspond in some respects to the phrases "mode,"
"activation mode," and/or "operating mode" referred to in the
following applications (although many of the configurations of
these states described herein differ in at least some respects from
the configurations of the modes described in the following
applications). It is also noted that the phrase "mechanical user
control element" used herein may, for some applications, correspond
in some respects to the word "switch," referred to in the following
applications (although many of the configurations of these states
described herein differ in at least some respects from the
configurations of the modes described in the following
applications): [0338] PCT Publication WO/2012/131626 to Einav et
al. [0339] GB 2482618 A to Einav et al.; [0340] UK Application GB
1119794.4, filed Nov. 16, 2011; [0341] U.S. Provisional Application
61/468,990, filed Mar. 29, 2011; [0342] U.S. Provisional
Application 61/473,790, filed Apr. 10, 2011; [0343] U.S.
Provisional Application 61/483,699, filed May 8, 2011; [0344] U.S.
Provisional Application 61/496,019, filed Jun. 12, 2011; [0345]
U.S. Provisional Application 61/527,658, filed Aug. 26, 2011;
[0346] U.S. Provisional Application 61/539,998, filed Sep. 28,
2011; [0347] U.S. Provisional Application 61/560,385, filed Nov.
16, 2011; [0348] U.S. Provisional Application 61/603,340, filed
Feb. 26, 2012; [0349] U.S. Provisional Application 61/603,344,
filed Feb. 26, 2012; [0350] U.S. Provisional Application
61/609,763, filed Mar. 12, 2012; [0351] U.S. Provisional
Application 61/613,408, filed Mar. 20, 2012; [0352] U.S.
Provisional Application 61/635,360, filed Apr. 19, 2012; [0353]
U.S. Provisional Application 61/655,801, filed Jun. 5, 2012; [0354]
U.S. Provisional Application 61/660,832, filed Jun. 18, 2012;
[0355] U.S. Provisional Application 61/673,744, filed Jul. 20,
2012; [0356] PCT Publication WO 2013/030821 to Zachar et al.;
[0357] U.S. Pat. No. 8,999,074 to Zachar et al; [0358] UK
Application 1600233.9, filed Jan. 6, 2016; [0359] U.S. Provisional
Application 62/287,223, filed Jan. 26, 2016; and [0360] U.S.
Provisional Application 62/319,640, filed Apr. 7, 2016.
[0361] It will be appreciated by persons skilled in the art that
the present invention is not limited to what has been particularly
shown and described hereinabove. Rather, the scope of the present
invention includes both combinations and subcombinations of the
various features described hereinabove, as well as variations and
modifications thereof that are not in the prior art, which would
occur to persons skilled in the art upon reading the foregoing
description.
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