U.S. patent application number 14/596905 was filed with the patent office on 2015-05-14 for suction catheter with distal suction modulation.
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 Elad EINAV, Gil YIGAL, Oron ZACHAR.
Application Number | 20150133864 14/596905 |
Document ID | / |
Family ID | 45444235 |
Filed Date | 2015-05-14 |
United States Patent
Application |
20150133864 |
Kind Code |
A1 |
ZACHAR; Oron ; et
al. |
May 14, 2015 |
SUCTION CATHETER WITH DISTAL SUCTION MODULATION
Abstract
A cleaning catheter includes tubular main body, shaped so as to
define a distal-most suction orifice; and a suction lumen arranged
along the main body in intermittent fluid communication with a
suction source. A distal portion of the suction lumen is in fluid
communication with the distal-most suction orifice. An outer wall
of the main body is shaped so as to define an opening extending
through the outer wall into the suction lumen at an axial location
proximal to the distal-most suction orifice. An inflatable element
is mounted to the main body along the opening. A collapsible
membrane is positioned along the opening within an interior of the
inflatable element, so as to define an inflatable chamber between a
wall of inflatable element and the collapsible membrane. The
collapsible membrane is positioned to at least partially occlude
the suction lumen upon at least partial inflation of the inflatable
chamber.
Inventors: |
ZACHAR; Oron; (Tel Aviv,
IL) ; EINAV; Elad; (Moshav Salit, IL) ; YIGAL;
Gil; (Gan Yavne, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
AIRWAY MEDIX S.A. |
Warszawa |
|
PL |
|
|
Assignee: |
AIRWAY MEDIX S.A.
Warszawa
PL
|
Family ID: |
45444235 |
Appl. No.: |
14/596905 |
Filed: |
January 14, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13806958 |
Feb 4, 2013 |
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PCT/IL2012/000320 |
Aug 26, 2012 |
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14596905 |
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PCT/IB2012/051532 |
Mar 29, 2012 |
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13806958 |
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61527658 |
Aug 26, 2011 |
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61539998 |
Sep 28, 2011 |
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61560385 |
Nov 16, 2011 |
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61603340 |
Feb 26, 2012 |
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61603344 |
Feb 26, 2012 |
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61609763 |
Mar 12, 2012 |
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61613408 |
Mar 20, 2012 |
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61635360 |
Apr 19, 2012 |
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61655801 |
Jun 5, 2012 |
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61660832 |
Jun 18, 2012 |
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61673744 |
Jul 20, 2012 |
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61468990 |
Mar 29, 2011 |
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61473790 |
Apr 10, 2011 |
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61483699 |
May 8, 2011 |
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61496019 |
Jun 12, 2011 |
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Current U.S.
Class: |
604/119 |
Current CPC
Class: |
A61M 1/0039 20130101;
A61M 16/0486 20140204; A61M 1/0084 20130101; A61M 2209/10 20130101;
A61M 1/0064 20130101; A61M 39/22 20130101; A61M 1/0023 20130101;
A61M 16/0463 20130101 |
Class at
Publication: |
604/119 |
International
Class: |
A61M 1/00 20060101
A61M001/00; A61M 16/04 20060101 A61M016/04 |
Foreign Application Data
Date |
Code |
Application Number |
Sep 28, 2011 |
GB |
1116735.0 |
Nov 16, 2011 |
GB |
1119794.4 |
Claims
1.-82. (canceled)
83. Apparatus for use with a suction source, the apparatus
comprising a cleaning catheter, which comprises: an elongate,
flexible, tubular main body, which is shaped so as to define a
distal-most suction orifice; a suction lumen arranged along the
main body at least partially within the main body in intermittent
fluid communication with the suction source, wherein a distal
portion of the suction lumen is in fluid communication with the
distal-most suction orifice, and wherein an outer wall of the main
body is shaped so as to define an opening extending through the
outer wall of the main body into the suction lumen at an axial
location proximal to the distal-most suction orifice; an inflatable
element, which is mounted to the main body at least partially along
the opening; and a collapsible membrane, which is at least
partially positioned along the opening within an interior of the
inflatable element, so as to define an inflatable chamber between a
wall of inflatable element and the collapsible membrane, wherein
the collapsible membrane is positioned to at least partially
occlude the suction lumen upon at least partial inflation of the
inflatable chamber, thereby modulating a level of suction delivered
to the distal-most suction orifice via the suction lumen.
84. The apparatus according to claim 83, wherein a distal tip of
the main body is shaped so as to define the distal-most suction
orifice.
85. The apparatus according to claim 83, wherein a lateral wall of
the main body is shaped so as to define the distal-most suction
orifice.
86. The apparatus according to claim 83, wherein the expandable
element is mounted to the main body at a location within 5 cm of a
distal end of the main body.
87. The apparatus according to claim 83, wherein the collapsible
membrane is configured such that upon sufficient inflation of the
inflatable chamber, the collapsible membrane penetrates into the
suction lumen sufficiently to cross a central longitudinal axis of
the suction lumen.
88. The apparatus according to claim 83, wherein the inflatable
element has a greatest diameter of between 6 and 12 mm when fully
inflated and unconstrained.
89. The apparatus according to claim 83, wherein the suction lumen
comprises exactly one suction lumen.
90. The apparatus according to claim 83, wherein the suction lumen
comprises a plurality of suction lumens.
91. The apparatus according claim 83, wherein the main body is
shaped so as to further define one or more lateral suction orifices
at one or more respective locations along the main body proximal to
the inflatable element.
92. The apparatus according to claim 83, wherein the cleaning
catheter further comprises one or more fluid-delivery lumens
arranged along the main body, and which are in fluid communication
with the inflatable chamber.
93. The apparatus according claim 83, further comprising a pliable
sleeve around at least a portion of the main body to inhibit
contamination.
94.-152. (canceled)
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S.
application Ser. No. 13/806,958, filed Feb. 4, 2013, which is the
US National Stage of International Application PCT/IL2012/000320,
filed Aug. 26, 2012, which claims priority from and is a
continuation-in-part of: [0002] International Application
PCT/IB2012/051532, filed Mar. 29, 2012, which published as PCT
Publication WO 2012/131626, which claims priority from: [0003] U.S.
Provisional Application 61/539,998, filed Sep. 28, 2011; [0004] UK
Application GB 1116735.0, filed Sep. 28, 2011, which published as
GB 2482618 A to Einav et al. and GB 2482618 B to Einav et al.;
[0005] UK Application GB 1119794.4, filed Nov. 16, 2011; [0006]
U.S. Provisional Application 61/468,990, filed Mar. 29, 2011;
[0007] U.S. Provisional Application 61/473,790, filed Apr. 10,
2011; [0008] U.S. Provisional Application 61/483,699, filed May 8,
2011; [0009] U.S. Provisional Application 61/496,019, filed Jun.
12, 2011; [0010] U.S. Provisional Application 61/527,658, filed
Aug. 26, 2011; [0011] U.S. Provisional Application 61/560,385,
filed Nov. 16, 2011; [0012] U.S. Provisional Application
61/603,340, filed Feb. 26, 2012; [0013] U.S. Provisional
Application 61/603,344, filed Feb. 26, 2012; [0014] U.S.
Provisional Application 61/609,763, filed Mar. 12, 2012; and [0015]
U.S. Provisional Application 61/613,408, filed Mar. 20, 2012;
[0016] UK Application GB 1116735.0, filed Sep. 28, 2011; and [0017]
UK Application GB 1119794.4, filed Nov. 16, 2011; and [0018] the
present patent application claims priority from: [0019] U.S.
Provisional Application 61/527,658, filed Aug. 26, 2011; [0020]
U.S. Provisional Application 61/539,998, filed Sep. 28, 2011;
[0021] U.S. Provisional Application 61/560,385, filed Nov. 16,
2011; [0022] U.S. Provisional Application 61/603,340, filed Feb.
26, 2012; [0023] U.S. Provisional Application 61/603,344, filed
Feb. 26, 2012; [0024] U.S. Provisional Application 61/609,763,
filed Mar. 12, 2012; [0025] U.S. Provisional Application
61/613,408, filed Mar. 20, 2012; [0026] U.S. Provisional
Application 61/635,360, filed Apr. 19, 2012; [0027] U.S.
Provisional Application 61/655,801, filed Jun. 5, 2012; [0028] U.S.
Provisional Application 61/660,832, filed Jun. 18, 2012; and [0029]
U.S. Provisional Application 61/673,744, filed Jul. 20, 2012.
[0030] All of the above-listed regular and provisional applications
are assigned to the assignee of the present application, and are
incorporated herein by reference.
FIELD OF THE APPLICATION
[0031] 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
[0032] 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.
[0033] 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.
SUMMARY OF THE APPLICATION
[0034] 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 suctioning and irrigation
(fluid delivery) in closed suction systems for use with tracheal
ventilation tubes. Closed suction systems allow 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
multiple fluids under positive and negative pressure (suction).
[0035] In some applications of the present invention, a closed
suction cleaning system comprises an input module, which comprises
a flow regulator for activating delivery of both suction and
positive-pressure fluid. For some applications, the input module
comprises a mechanical user control element having first, second,
and third configurations corresponding to first, second, and third
activation states of the flow regulator. For some applications, the
first, second, and third configurations are first, second, and
third spatial positions, respectively. Typically, the input module
is configured to provide a predetermined serial order of the
activation of suction and fluid delivery operations inherently
built into and limited by the device mechanical structure.
Typically, the input module is configured necessarily to begin
fluid delivery after beginning suction delivery, and to cease fluid
delivery before ceasing suction delivery.
[0036] Some applications of the present invention provide increased
safety of operation, by automatically initiating delivery of
suction before initiating delivery of cleaning fluid, and
terminating the delivery of suction after terminating the delivery
of cleaning fluid. In some configurations of the cleaning system,
this desired order of operating states is inherently built into the
mechanical user control element. Activation of the mechanical user
control element by a user automatically activates the different
states of fluid and suction delivery in a predetermined desired
order. This prevents possible error by the user, and simplifies
activation by the user. As a result, in these configurations of the
cleaning system, operational safely is inherent because there is no
activation state in which cleaning fluid flow is enabled without
suction also being activated. In contrast, in conventional cleaning
system, activation of suction and activation of fluid delivery are
typically performed independently by the user and are not
correlated by the system in a particular manner.
[0037] Typically, the mechanical user control element comprises a
single user-interface element (e.g., a handle or a button) for
activating both suction and fluid delivery.
[0038] For some applications, the flow regulator controls both
fluid delivery and inflation of an inflatable element of the
multi-lumen catheter.
[0039] For some applications, the input module is configured such
that a predetermined serial order of the activation of suction and
balloon inflation operations is inherently built into and limited
by the mechanical structure of the device.
[0040] For some applications, the cleaning system further comprises
an expandable, e.g., inflatable, element near the distal end of the
catheter. For some applications, inflation of the inflatable
element is effected by fluid pressure communication with a fluid
port of the input module, which fluid port is in fluid
communication with a pressurized fluid source.
[0041] For some applications, deflation of the inflatable element
is effected via suction fluid communication with a suction port of
the input module, which suction port is in fluid communication with
a suction source.
[0042] For some applications, the cleaning system is configured to
enable selective activation of suction through orifices located
both proximal and distal to the expandable element, or primarily
(e.g., exclusively) proximal to the expandable element. For some
applications, the cleaning system is configured to enable selective
combined activation of suction through orifices located proximal to
the expandable element with or without suction through orifices
located distal to the inflatable element.
[0043] For some applications, the closed suction cleaning system
comprises an elongated catheter main body and an input module
having multiple connectors for connection with various fluid
sources. The fluids sources typically include at least a suction
source and a pressurized fluid source, and, optionally, an
inflation source. The catheter main body typically comprises at
least one suction lumen and one fluid-delivery lumen.
[0044] For some applications, the input module comprises a
mechanical user control element, which is configured to control
activation of the delivery of a plurality of fluids to the catheter
in a predefined order of activation. The mechanical user control
element typically mechanically and non-electrically sets the
activation states of the flow regulator. For some applications, the
mechanical user control element is configured to assume at least
first, second, and third configurations, and, typically, to
transition between the first and the third spatial positions via
the second configuration. For some applications, the first, second,
and third configurations are first, second, and third spatial
positions, respectively. The configurations (e.g., spatial
positions) activate the flow regulator to assume respective
corresponding distinct modes of fluids flow in the lumens of the
catheter main body.
[0045] For some applications, the cleaning system may be used for
two different purposes: [0046] for cleaning the lumen of a tracheal
ventilation tube--the user typically rapidly transitions the user
control element from the first to the third configurations (e.g.,
spatial positions) via the second configuration (e.g., spatial
position), for example, in less than one second, typically is less
than 0.5 seconds. For cleaning the ventilation tube, there is
generally no benefit to putting the flow regulator in the second
activation state (suction without cleaning fluid flow), rather than
transitioning directly from the first activation state (suction and
cleaning fluid flow both blocked) directly to the third activation
state (suction and cleaning fluid flow both enabled); and [0047]
for suctioning the trachea outside of and distal to the ventilation
tube--the user transitions the user control element from the first
to the second configurations (e.g., spatial positions), and leaves
the flow regulator in the second activation state (suction without
cleaning fluid flow) throughout most the trachea suctioning
procedure.
[0048] The user may use the cleaning system for both of these
purposes at different times during patient care. For example, the
system may be used to clean the ventilation tube once every six
hours, and for suctioning the lungs once every three hours. The
user may choose to perform these two functions serially during a
single session; the user first suctions the trachea by putting the
user control element in the second configuration, and then
immediately upon conclusion of this suctioning, transitions the
user control element to the third configuration to activate
cleaning of the lumen of the ventilation tube.
[0049] The cleaning system may implement one or more of the
features described above, or any combination thereof.
[0050] In some applications of the present invention, the cleaning
catheter comprises an elongate flexible main body, an inflatable,
one or more suction orifices, and one or more fluid delivery
orifices. The cleaning catheter is typically integrated into a
closed suction system. The cleaning system described herein may
implemented in combination with techniques described in 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.
[0051] There is therefore provided, in accordance with an
application of the present invention, apparatus for use with a
tracheal ventilation tube, a pressurized fluid source, and a
suction source, the apparatus including:
[0052] a cleaning catheter, which is insertable into the
ventilation tube, and which includes: (a) an elongate, flexible,
tubular main body; (b) one or more fluid-delivery lumens arranged
along the main body; and (c) one or more suction lumens arranged
along the main body; and
[0053] an input module, which is coupled to the cleaning catheter,
and includes: [0054] a flow regulator, which (a) is shaped so as to
define a suction port coupleable in fluid communication with the
suction source, and a fluid port coupleable in fluid communication
with the pressurized fluid source, and (b) which is configured to
assume at least first, second, and third activation states; and
[0055] a mechanical user control element, which is configured (a)
to mechanically and non-electrically set the activation states of
the flow regulator, (b) to assume at least first, second, and third
configurations, and (c) to transition between the first and the
third configurations via the second configuration,
[0056] wherein the input module is configured such that:
[0057] when the user control element is in the first configuration,
the flow regulator is in the first activation state, in which the
flow regulator blocks fluid communication (a) between the suction
port and the one or more suction lumens and (b) between the fluid
port and the one or more fluid-delivery lumens,
[0058] when the user control element is in the second
configuration, the flow regulator is in the second activation
state, in which the flow regulator effects the fluid communication
between the suction port and the one or more suction lumens, and
blocks the fluid communication between the fluid port and the one
or more fluid-delivery lumens, and
[0059] when the user control element is in the third configuration,
the flow regulator is in the third activation state, in which the
flow regulator effects the fluid communication (a) between the
suction port and the one or more suction lumens and (b) between the
fluid port and the one or more fluid-delivery lumens.
[0060] For some applications, the first, the second, and the third
configurations are first, second, and third spatial positions,
respectively, and the mechanical user control element is configured
to assume at least the first, the second, and the third spatial
positions.
[0061] For some applications, the suction port is coupled in fluid
communication with the suction source, and the fluid port is
coupled in fluid communication with the pressurized fluid
source.
[0062] For some applications, the suction port includes a male
conical interface.
[0063] For some applications, the fluid port includes a Luer-Lok
interface.
[0064] For some applications, the one or more fluid-delivery lumens
are arranged along the main body at least partially within the main
body.
[0065] For some applications, the one or more fluid-delivery lumens
are arranged along the main body at least partially outside the
main body.
[0066] For some applications, the one or more suction lumens are
arranged along the main body at least partially within the main
body.
[0067] For some applications, the one or more suction lumens are
arranged along the main body at least partially outside the main
body.
[0068] 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.
[0069] For some applications, the apparatus further includes a
pliable sleeve around at least a portion of the main body to
inhibit contamination.
[0070] For any of the applications described above, the main body
may be shaped so as to define one or more fluid-delivery orifices
in fluid communication with an outer surface of the cleaning
catheter, and one or more distal suction orifices,
[0071] the one or more fluid-delivery lumens may be arranged to
transport fluid received at respective one or more proximal
portions of the one or more lumens from the pressurized fluid
source, to the fluid-delivery orifices, and
[0072] the one or more suction lumens may be arranged to convey
suction from the suction source to the one or more distal suction
orifices.
[0073] For some applications, a wall of the main body is shaped so
as to define the one or more fluid-delivery orifices.
[0074] For some applications, the one or more fluid-delivery
orifices have a total cross-sectional area in aggregate of between
0.04 and 1 mm2.
[0075] For some applications, the cleaning catheter further
includes an expandable element, which is mounted to the main body
at a location within 3 cm of at least one of the one or more distal
suction orifices, and is expandable into contact with an inner
surface of the ventilation tube.
[0076] For some applications, the location at which the expandable
element is mounted to the main body is within 5 cm of a distal end
of the main body.
[0077] For some applications, a wall of the inflatable element is
shaped so as to define the one or more fluid-delivery orifices.
[0078] For some applications, the expandable element includes an
inflatable element.
[0079] For some applications, the input module is configured such
that the flow regulator, when in the first operating state, effects
fluid communication between the inflatable element and the suction
port, such that the inflatable element is deflated by the suction
delivered via the suction port.
[0080] For some applications, the inflatable element includes a
balloon.
[0081] For some applications, the inflatable element has a greatest
diameter of between 6 and 12 mm when fully inflated and
unconstrained.
[0082] For some applications, the cleaning catheter is configured
such that an interior of the inflatable element is in fluid
communication with at least one of the one or more fluid-delivery
lumens, such that when the flow regulator is in the third
activation state, the flow regulator effects fluid communication
between the fluid port and the interior of the inflatable element,
thereby inflating the inflatable element.
[0083] For some applications, the input module is configured such
that the flow regulator, when in the second activation state, in
addition to effecting the fluid communication between the suction
port and the one or more suction lumens and blocking the fluid
communication between the fluid port and the one or more
fluid-delivery lumens, effects suction fluid communication between
suction port and the one or more fluid-delivery lumens, thereby
deflating the inflatable element.
[0084] For some applications, the input module is configured such
that the flow regulator, when in the first activation state, in
addition to blocking the fluid communication (a) between the
suction port and the one or more suction lumens and (b) between the
fluid port and the one or more fluid-delivery lumens, effects fluid
communication between the suction port and the one or more
fluid-delivery lumens, thereby deflating the inflatable
element.
[0085] For some applications:
[0086] the flow regulator further includes a valve, which is in
fluid communication with the suction port, and
[0087] the input module is configured such that the flow regulator,
when in the first activation state, in addition to blocking the
fluid communication (a) between the suction port and the one or
more suction lumens and (b) between the fluid port and the one or
more fluid-delivery lumens: (a) when the valve is in an open
position, effects fluid communication between the suction port and
the one or more fluid-delivery lumens, thereby deflating the
inflatable element, and (b) when the valve is in a closed position,
blocks fluid communication between the suction port and the one or
more fluid-delivery lumens.
[0088] For some applications, at least one of the fluid-delivery
orifices is located within 10 cm of the expandable element.
[0089] For some applications:
[0090] the one or more suction lumens include (a) at least a first
suction lumen and (b) at least a second suction lumen,
[0091] the one or more distal suction orifices include (a) one or
more first distal suction orifices, all of which first distal
suction orifices are located proximal to the expandable element,
and (b) one or more second suction orifices, all of which second
distal suction orifices are located distal to the expandable
element,
[0092] the at least a first suction lumen is arranged to convey the
suction from the suction source to the one or more first distal
suction orifices, and
[0093] the at least a second suction lumen is arranged to convey
the suction from the suction source to the one or more second
distal suction orifices.
[0094] For some applications, the input module is configured such
that the flow regulator, when in at least one of the first, the
second, and the third activation states, delivers the suction
through the one or more second distal suction orifices at a
strength that is weaker than 20% of the suction force applied
through a largest one of the one or more first distal suction
orifices, and, in at least another of the activation states,
delivers the suction through the one or more second distal suction
orifices at a strength that at a strength that is stronger than 20%
of the suction force through the applied through the largest of the
first distal suction orifices.
[0095] For some applications, the one or more fluid-delivery
orifices are located within 3 cm of the expandable element.
[0096] For any of the applications described above, the mechanical
user control element may include an axial-motion element, which is
configured to assume at least first, second, and third axial
positions along a single axis, when the mechanical user control
element is in the first, the second, and the third configurations,
respectively, and the second axial position is spatially between
the first and the second axial positions along the axis.
[0097] For any of the applications described above, the main body
may include a proximal-most input portion, which is inserted into
and axially slidable with respect to the input module. For some
applications, the input module is configured such that changes in
configuration of the mechanical user control element cause
corresponding changes in axial position of the input portion of the
main body with respect to the input module. For some applications,
the input module is configured such that the input portion assumes
first, second, and third axial positions with respect to the input
module, corresponding to the first, the second, and the third
configurations of the mechanical user control element.
[0098] For any of the applications described above, the input
module may further include a state protective selector, which is
configured to provide a plurality of protective states,
including:
[0099] a protective selector first state, in which the state
protective selector locks mechanical user control element in the
first configuration,
[0100] a protective selector second state, in which the state
protective selector allows the mechanical user control element to
move only between the first configuration and the second
configuration, and
[0101] a protective selector third state, in which the state
protective selector allows the mechanical user control element to
reach the first, the second, and the third configurations.
[0102] 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:
[0103] 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: [0104] an elongate,
flexible, tubular main body; and [0105] an inflatable element,
which is mounted to the main body at a location
[0106] within 3 cm of at least one of the one or more distal
suction orifices; and
[0107] an input module, which is coupled to the cleaning catheter,
and includes 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
activation states, such that:
[0108] the flow regulator, when in the first activation state,
effects fluid communication between the suction source and an
interior of the inflatable element, thereby deflating the
inflatable element, and
[0109] the flow regulator, when in the second activation state,
effects fluid communication between the suction source and the
distal suction orifices, and does not effect the fluid
communication between the suction source and the interior of the
inflatable element.
[0110] The ordinal numbers of the states recited in claims do not
necessarily correspond to the ordinal numbers of the states
described in the specification. For example, the first activation
state described in the previous paragraph may include certain
features of the second activation state of the configuration of the
cleaning system described hereinbelow with reference to FIG. 11B,
and/or of the first activation state of the configuration of the
cleaning system described hereinbelow with reference to FIG.
13A.
[0111] For some applications, the suction port is coupled in fluid
communication with the suction source.
[0112] For some applications, the flow regulator, when in the first
activation state, does not effect the fluid communication between
the suction source and the distal orifices.
[0113] For some applications, the flow regulator, when in the first
activation state, effects fluid communication between the suction
source and the distal orifices.
[0114] For some applications, the cleaning catheter further
includes one or more fluid-delivery lumens arranged along the main
body, and the flow regulator, when in the first activation state,
effects the fluid communication between the suction source and the
interior of the inflatable element via at least one of the one or
more fluid-delivery lumens, thereby deflating the inflatable
element.
[0115] For some applications, the cleaning catheter further
includes one or more suction lumens arranged along the main body,
and the flow regulator, when in the second activation state,
effects the fluid communication between the suction source and the
distal suction orifices via the one or more suction lumens.
[0116] For some applications, the expandable element includes a
balloon.
[0117] For some applications, the inflatable element is mounted to
the main body is within 5 cm of a distal end of the main body.
[0118] For some applications, the inflatable element has a greatest
diameter of between 6 and 12 mm when fully inflated and
unconstrained.
[0119] 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.
[0120] For some applications, the flow regulator, when in the first
activation state, in addition to effecting fluid communication
between the suction source and the interior of the inflatable
element, effects fluid communication between the suction source and
the distal suction orifices.
[0121] For some applications, the one or more fluid-delivery lumens
are arranged along the main body at least partially within the main
body. Alternatively or additionally, the one or more fluid-delivery
lumens are arranged along the main body at least partially outside
the main body. For some applications, the one or more suction
lumens are arranged along the main body at least partially within
the main body. Alternatively or additionally, the one or more
suction lumens are arranged along the main body at least partially
outside the main body.
[0122] For any of the applications described above,
[0123] the apparatus may be for use with a pressurized fluid
source,
[0124] the cleaning catheter may further include one or more
fluid-delivery lumens arranged along the main body,
[0125] the main body may be shaped so as to further define one or
more fluid-delivery orifices in fluid communication with the outer
surface of the cleaning catheter,
[0126] the flow regulator may be shaped so as to further define a
fluid port coupleable in fluid communication with the pressurized
fluid source,
[0127] the flow regulator, when in the first activation state, in
addition to effecting fluid communication between the suction
source and the interior of the inflatable element, blocks fluid
communication between the fluid port and the one or more
fluid-delivery lumens, and
[0128] the flow regulator, when in the second activation state, in
addition to effecting the fluid communication between the suction
source and the distal suction orifices, effects fluid communication
between the fluid source and (a) the fluid-delivery orifices via at
least one of the one or more fluid-delivery lumens, and (b) the
interior of the inflatable element via at least one of the
fluid-delivery lumens that are in fluid communication with the
interior of the inflatable element, thereby inflating the
inflatable element.
[0129] For some applications, the fluid port is coupled in fluid
communication with the pressurized fluid source.
[0130] For some applications, at least one of the fluid-delivery
orifices is located within 10 cm of the inflatable element.
[0131] For some applications, a wall of the main body is shaped so
as to define the one or more fluid-delivery orifices.
[0132] For some applications, a wall of the inflatable element is
shaped so as to define the one or more fluid-delivery orifices.
[0133] For some applications, the one or more fluid-delivery
orifices have a total cross-sectional area in aggregate of between
0.04 and 1 mm2.
[0134] For some applications, the flow regulator, when in the
second activation state, additionally effects fluid communication
between the fluid source and the interior of the inflatable element
via at least one of the one or more fluid-delivery lumens.
[0135] For any of the applications described above, the apparatus
may further include a mechanical user control element, which is
configured (a) to mechanically and non-electrically set the
activation states of the flow regulator, (b) to assume at least
first and second configurations, and the input module may be
configured such that:
[0136] when the user control element is in the first configuration,
the flow regulator is in the first activation state, and
[0137] when the user control element is in the second
configuration, the flow regulator is in the second activation
state.
[0138] 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.
[0139] For some applications, the main body includes a
proximal-most input portion, which is inserted into and axially
slidable with respect to the input module.
[0140] For some applications, the input module is configured such
that changes in configuration of the mechanical user control
element cause corresponding changes in axial position of the input
portion of the main body with respect to the input module.
[0141] For some applications, the input module is configured 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.
[0142] There is still further provided, in accordance with an
application of the present invention, apparatus for use with a
tracheal ventilation tube, the apparatus including a cleaning
catheter having an outer surface, which (a) is insertable into the
ventilation tube, (b) is shaped so as to define one or more
fluid-delivery orifices in fluid communication with the outer
surface of the cleaning catheter, and (c) includes:
[0143] an elongate, flexible, tubular main body; and
[0144] an inflatable element, which is mounted to the main
body,
[0145] wherein the one or more fluid-delivery orifices are in fluid
communication with an interior of the inflatable element.
For some applications, the expandable element is mounted to the
main body at a location within 5 cm of a distal end of the main
body.
[0146] For some applications, the cleaning catheter further
includes one or more fluid-delivery lumens arranged along the main
body, which are in fluid communication with the one or more
fluid-delivery orifices and the interior of the inflatable
element.
[0147] For some applications, a wall of the main body is shaped so
as to define the one or more fluid-delivery orifices.
[0148] For some applications, a wall of the inflatable element is
shaped so as to define the one or more fluid-delivery orifices.
[0149] For some applications, the one or more fluid-delivery lumens
include exactly one fluid-delivery lumen, which is in fluid
communication with the one or more fluid-delivery orifices and the
interior of the inflatable element.
[0150] For some applications, the cleaning catheter includes
exactly one fluid-delivery lumen at at least one axial location
along the cleaning catheter proximal to a proximal-most one of the
one or more fluid-delivery orifices.
[0151] For some applications, at least one of the fluid-delivery
orifices is located within 10 cm of the inflatable element.
[0152] For some applications, all of the fluid-delivery orifices
are located within 10 cm of the inflatable element.
[0153] For some applications, the expandable element includes a
balloon.
[0154] For some applications, the inflatable element has a greatest
diameter of between 6 and 12 mm when fully inflated and
unconstrained.
[0155] 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.
[0156] For some applications, the one or more fluid-delivery lumens
are arranged along the main body at least partially within the main
body.
[0157] For some applications, the one or more fluid-delivery lumens
are arranged along the main body at least partially outside the
main body.
[0158] For some applications, the apparatus further includes a
pliable sleeve around at least a portion of the main body to
inhibit contamination.
[0159] For some applications, the one or more fluid-delivery
orifices have a total cross-sectional area in aggregate of between
0.04 and 1 mm2.
[0160] For any of the applications described above, the apparatus
may be for use with a pressurized fluid source, and the one or more
fluid-delivery orifices and the interior of the inflatable element
may be arranged in intermittent fluid communication with the fluid
source. For some applications, the cleaning catheter further
includes one or more fluid-delivery lumens arranged along the main
body, which are in fluid communication with the one or more
fluid-delivery orifices and the interior of the inflatable element,
and in intermittent fluid communication with the fluid source. For
some applications, the apparatus further includes an input module,
which is coupled to the cleaning catheter, and includes a flow
regulator, which (a) is shaped so as to define a fluid port
coupleable in fluid communication with the pressurized fluid
source, and (b) is configured to assume at least one activation
state, in which the flow regulator, effects fluid communication via
the one or more fluid-delivery lumens between the pressurized fluid
source and (i) the one or more fluid-delivery orifices and (ii) the
interior of the inflatable element, thereby inflating the
inflatable element. For some applications, the fluid port is
coupled in fluid communication with the pressurized fluid
source.
[0161] For any of the applications described above, the cleaning
catheter may further include one or more suction lumens arranged
along the main body, and the cleaning catheter may be shaped so as
to further define one or more distal suction orifices that are in
fluid communication with the one or more suction lumens.
[0162] There is additionally provided, in accordance with an
application of the present invention, apparatus for use with a
suction source, the apparatus including a cleaning catheter, which
includes:
[0163] an elongate, flexible, tubular main body, which is shaped so
as to define a distal-most suction orifice;
[0164] a suction lumen arranged along the main body at least
partially within the main body in intermittent fluid communication
with the suction source, a distal portion of the suction lumen is
in fluid communication with the distal-most suction orifice, and an
outer wall of the main body is shaped so as to define an opening
extending through the outer wall of the main body into the suction
lumen at an axial location proximal to the distal-most suction
orifice; and
[0165] an inflatable element, which is mounted to the main body at
least partially along the opening; and
[0166] a collapsible membrane, which is at least partially
positioned along the opening within an interior of the inflatable
element, so as to define an inflatable chamber between a wall of
inflatable element and the collapsible membrane,
[0167] wherein the collapsible membrane is positioned to at least
partially occlude the suction lumen upon at least partial inflation
of the inflatable chamber, thereby modulating a level of suction
delivered to the distal-most suction orifice via the suction
lumen.
[0168] For some applications, a distal tip of the main body is
shaped so as to define the distal-most suction orifice.
[0169] For some applications, a lateral wall of the main body is
shaped so as to define the distal-most suction orifice.
[0170] For some applications, the expandable element is mounted to
the main body at a location within 5 cm of a distal end of the main
body.
[0171] For some applications, the collapsible membrane is
configured such that upon sufficient inflation of the inflatable
chamber, the collapsible membrane penetrates into the at least one
of the one or more suction lumens sufficiently to cross a central
longitudinal axis of the at least one of the one or more suction
lumens.
[0172] For some applications, the inflatable element has a greatest
diameter of between 6 and 12 mm when fully inflated and
unconstrained.
[0173] For some applications, the suction lumen includes exactly
one suction lumen.
[0174] For some applications, the suction lumen includes a
plurality of suction lumens.
[0175] For any of the applications described above, the main body
may be shaped so as to further define one or more lateral suction
orifices at one or more respective locations along the main body
proximal to the inflatable element.
[0176] For any of the applications described above, the cleaning
catheter may further include one or more fluid-delivery lumens
arranged along the main body, and which are in fluid communication
with the inflatable chamber.
[0177] For any of the applications described above, the apparatus
may further include a pliable sleeve around at least a portion of
the main body to inhibit contamination.
[0178] There is yet additionally provided, in accordance with an
application of the present invention, apparatus for use with a
suction source, the apparatus including:
[0179] a cleaning catheter, which includes (a) an elongate,
flexible, tubular main body, which is shaped so as to define a
distal-most suction orifice and one or more lateral suction
orifices, and (b) an inflatable element, which is mounted to the
main body axially between (i) the distal-most suction orifice and
(ii) the one or more lateral suction orifices; and
[0180] an input module, which is coupled to the cleaning catheter,
and includes a flow regulator, which is configured to modulate
relative levels of suction delivered by the suction source to (a)
the distal-most suction orifice and (b) the one or more lateral
suction orifices.
[0181] For some applications, the flow regulator is configured to
modulate the relative levels of suction between at least two levels
that include:
[0182] a relatively low distal-most level, in which a level of
suction delivered to the distal-most suction orifice is less than
25% of a level of suction delivered to one of the one or more
lateral suction orifices having a greatest cross-sectional area,
and
[0183] a relatively high distal-most level, in which the level of
suction delivered to the distal-most suction orifice is greater
than 25% of the level of suction delivered to the one of the one or
more lateral suction orifices having the greatest cross-sectional
area.
[0184] For some applications, the flow regulator is configured to
modulate the relative levels of suction between the at least two
levels that include:
[0185] the relatively low distal-most level, in which the level of
suction delivered to the distal-most suction orifice is less than
10% of the level of suction delivered to the one of the one or more
lateral suction orifices having the greatest cross-sectional area,
and
[0186] the relatively high distal-most level, in which the level of
suction delivered to the distal-most suction orifice is greater
than 10% of the level of suction delivered to the one of the one or
more lateral suction orifices having the greatest cross-sectional
area.
[0187] For some applications:
[0188] the cleaning catheter further includes a suction lumen
arranged along the main body, in fluid communication with the
distal-most suction orifice and the lateral suction orifices,
and
[0189] the flow regulator is configured to modulate the relative
levels of suction by reversibly modulating a level of occlusion of
the suction lumen at a portion thereof axially between (a) the
distal-most suction orifice and (b) the one or more lateral suction
orifices.
[0190] For some applications, the cleaning catheter further
includes exactly one suction lumen arranged along the main body, in
fluid communication with the distal-most suction orifice and the
lateral suction orifices.
[0191] For some applications, the cleaning catheter further
includes a plurality of suction lumens arranged along the main
body, in fluid communication with one another and with the
distal-most suction orifice and the lateral suction orifices.
[0192] For any of the applications described above:
[0193] the cleaning catheter may further include a suction lumen
arranged along the main body at least partially within the main
body in intermittent fluid communication with the suction
source,
[0194] a distal portion of the suction lumen may be in fluid
communication with the distal-most suction orifice, and an outer
wall of the main body is shaped so as to define an opening
extending through the outer wall of the main body into the suction
lumen at an axial location proximal to the distal-most suction
orifice,
[0195] the inflatable element may be mounted to the main body at
least partially along the opening,
[0196] the cleaning catheter may further include a collapsible
membrane, which is at least partially positioned along the opening
within an interior of the inflatable element, so as to define an
inflatable chamber between a wall of inflatable element and the
collapsible membrane,
[0197] the collapsible membrane may be positioned to at least
partially occlude the suction lumen upon at least partial inflation
of the inflatable chamber, and
[0198] the flow regulator may be configured to control a level of
inflation of the inflatable chamber in order to modulate a level of
suction delivered to the distal-most suction orifice via the
suction lumen.
[0199] For some applications, a distal tip of the main body is
shaped so as to define the distal-most suction orifice.
[0200] For some applications, a lateral wall of the main body is
shaped so as to define the distal-most suction orifice.
[0201] For some applications, the expandable element is mounted to
the main body at a location within 5 cm of a distal end of the main
body.
[0202] For some applications, the collapsible membrane is
configured such that upon sufficient inflation of the inflatable
chamber, the collapsible membrane penetrates into the at least one
of the one or more suction lumens sufficiently to cross a central
longitudinal axis of the at least one of the one or more suction
lumens.
[0203] For some applications, the cleaning catheter further
includes one or more fluid-delivery lumens arranged along the main
body, and which are in fluid communication with the inflatable
chamber.
[0204] For some applications, the inflatable element has a greatest
diameter of between 6 and 12 mm when fully inflated and
unconstrained.
[0205] For some applications, the apparatus further includes a
pliable sleeve around at least a portion of the main body to
inhibit contamination.
[0206] There is also provided, in accordance with an application of
the present invention, apparatus for use with a tracheal
ventilation tube, a pressurized fluid source, and a suction source,
the apparatus including:
[0207] a cleaning catheter, which is insertable into the
ventilation tube, and which includes: (a) an elongate, flexible,
tubular main body; (b) one or more fluid-delivery lumens arranged
along the main body; and (c) one or more suction lumens arranged
along the main body; and
[0208] an input module, which is coupled to the cleaning catheter,
and includes: [0209] a flow regulator, which (a) is shaped so as to
define a suction port coupleable in fluid communication with the
suction source, and a fluid port coupleable in fluid communication
with the pressurized fluid source, and (b) which is configured to
assume at least first, second, and third activation states; and
[0210] a mechanical user control element, which is configured (a)
to mechanically and non-electrically set the activation states of
the flow regulator, (b) to assume at least first, second, and third
configurations, and (c) to transition between the first and the
third configurations via the second configuration,
[0211] wherein the input module is configured such that:
[0212] when the user control element is in the first configuration,
the flow regulator is in the first activation state, in which the
flow regulator blocks fluid communication (a) between the suction
port and the one or more suction lumens and (b) between the fluid
port and the one or more fluid-delivery lumens,
[0213] when the user control element is in the second
configuration, the flow regulator is in the second activation
state, in which the flow regulator effects the fluid communication
between the fluid port and the one or more fluid-delivery lumens,
and blocks the fluid communication between the suction port and the
one or more suction lumens, and
[0214] when the user control element is in the third configuration,
the flow regulator is in the third activation state, in which the
flow regulator effects the fluid communication (a) between the
suction port and the one or more suction lumens and (b) between the
fluid port and the one or more fluid-delivery lumens.
[0215] For some applications, the first, the second, and the third
configurations are first, second, and third spatial positions,
respectively, and the mechanical user control element is configured
to assume at least the first, the second, and the third spatial
positions.
[0216] For some applications, the suction port is coupled in fluid
communication with the suction source, and the fluid port is
coupled in fluid communication with the pressurized fluid
source.
[0217] For some applications, the suction port includes a male
conical interface.
[0218] For some applications, the fluid port includes a Luer-Lok
interface.
[0219] For some applications:
[0220] the main body is shaped so as to define one or more
fluid-delivery orifices in fluid communication with an outer
surface of the cleaning catheter, and one or more distal suction
orifices,
[0221] the one or more fluid-delivery lumens are arranged to
transport fluid received at respective one or more proximal
portions of the one or more lumens from the pressurized fluid
source, to the fluid-delivery orifices, and
[0222] the one or more suction lumens are arranged to convey
suction from the suction source to the one or more distal suction
orifices.
[0223] For some applications, a wall of the main body is shaped so
as to define the one or more fluid-delivery orifices.
[0224] For some applications, the one or more fluid-delivery
orifices have a total cross-sectional area in aggregate of between
0.04 and 1 mm2.
[0225] For some applications, the one or more fluid-delivery lumens
are arranged along the main body at least partially within the main
body.
[0226] For some applications, the one or more fluid-delivery lumens
are arranged along the main body at least partially outside the
main body.
[0227] For some applications, the one or more suction lumens are
arranged along the main body at least partially within the main
body.
[0228] For some applications, the one or more suction lumens are
arranged along the main body at least partially outside the main
body.
[0229] 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.
[0230] For some applications, the apparatus further includes a
pliable sleeve around at least a portion of the main body to
inhibit contamination.
[0231] For any of the applications described above, the cleaning
catheter may further include an expandable element, which is
mounted to the main body at a location within 3 cm of at least one
of the one or more distal suction orifices, and is expandable into
contact with an inner surface of the ventilation tube.
[0232] For some applications, the location at which the expandable
element is mounted to the main body is within 5 cm of a distal end
of the main body.
[0233] For some applications, a wall of the inflatable element is
shaped so as to define the one or more fluid-delivery orifices.
[0234] For some applications, the expandable element includes an
inflatable element.
[0235] For some applications, the input module is configured such
that the flow regulator, when in the first operating state, effects
fluid communication between the inflatable element and the suction
port, such that the inflatable element is deflated by the suction
delivered via the suction port.
[0236] For some applications, the inflatable element includes a
balloon.
[0237] For some applications, the inflatable element has a greatest
diameter of between 6 and 12 mm when fully inflated and
unconstrained.
[0238] For some applications, the cleaning catheter is configured
such that an interior of the inflatable element is in fluid
communication with at least one of the one or more fluid-delivery
lumens, such that when the flow regulator is in the third
activation state, the flow regulator effects fluid communication
between the fluid port and the interior of the inflatable element,
thereby inflating the inflatable element.
[0239] For some applications, the input module is configured such
that the flow regulator, when in the second activation state, in
addition to effecting the fluid communication between the fluid
port and the one or more fluid-delivery lumens, and blocking the
fluid communication between the suction port and the one or more
suction lumens, effects suction fluid communication between suction
port and the one or more fluid-delivery lumens, thereby deflating
the inflatable element.
[0240] For some applications, the input module is configured such
that the flow regulator, when in the first activation state, in
addition to blocking the fluid communication (a) between the
suction port and the one or more suction lumens and (b) between the
fluid port and the one or more fluid-delivery lumens, effects fluid
communication between the suction port and the one or more
fluid-delivery lumens, thereby deflating the inflatable
element.
[0241] For some applications:
[0242] the flow regulator further includes a valve, which is in
fluid communication with the suction port, and
[0243] the input module is configured such that the flow regulator,
when in the first activation state, in addition to blocking the
fluid communication (a) between the suction port and the one or
more suction lumens and (b) between the fluid port and the one or
more fluid-delivery lumens: (a) when the valve is in an open
position, effects fluid communication between the suction port and
the one or more fluid-delivery lumens, thereby deflating the
inflatable element, and (b) when the valve is in a closed position,
blocks fluid communication between the suction port and the one or
more fluid-delivery lumens.
[0244] For some applications, at least one of the fluid-delivery
orifices is located within 10 cm of the expandable element.
[0245] For some applications:
[0246] the one or more suction lumens include (a) at least a first
suction lumen and (b) at least a second suction lumen,
[0247] the one or more distal suction orifices include (a) one or
more first distal suction orifices, all of which first distal
suction orifices are located proximal to the expandable element,
and (b) one or more second suction orifices, all of which second
distal suction orifices are located distal to the expandable
element,
[0248] the at least a first suction lumen is arranged to convey the
suction from the suction source to the one or more first distal
suction orifices, and
[0249] the at least a second suction lumen is arranged to convey
the suction from the suction source to the one or more second
distal suction orifices.
[0250] For some applications, the input module is configured such
that the flow regulator, when in at least one of the first, the
second, and the third activation states, delivers the suction
through the one or more second distal suction orifices at a
strength that is weaker than 20% of the suction force applied
through a largest one of the one or more first distal suction
orifices, and, in at least another of the activation states,
delivers the suction through the one or more second distal suction
orifices at a strength that at a strength that is stronger than 20%
of the suction force through the applied through the largest of the
first distal suction orifices.
[0251] For some applications, the one or more fluid-delivery
orifices are located within 3 cm of the expandable element.
[0252] For any of the applications described above, the mechanical
user control element may include an axial-motion element, which is
configured to assume at least first, second, and third axial
positions along a single axis, when the mechanical user control
element is in the first, the second, and the third configurations,
respectively, and the second axial position is spatially between
the first and the second axial positions along the axis.
[0253] For any of the applications described above, the main body
may include a proximal-most input portion, which is inserted into
and axially slidable with respect to the input module. For some
applications, the input module is configured such that changes in
configuration of the mechanical user control element cause
corresponding changes in axial position of the input portion of the
main body with respect to the input module. For some applications,
the input module is configured such that the input portion assumes
first, second, and third axial positions with respect to the input
module, corresponding to the first, the second, and the third
configurations of the mechanical user control element.
[0254] For any of the applications described above, the input
module may further include a state protective selector, which is
configured to provide a plurality of protective states,
including:
[0255] a protective selector first state, in which the state
protective selector locks mechanical user control element in the
first configuration,
[0256] a protective selector second state, in which the state
protective selector allows the mechanical user control element to
move only between the first configuration and the second
configuration, and
[0257] a protective selector third state, in which the state
protective selector allows the mechanical user control element to
reach the first, the second, and the third configurations.
[0258] There is further provided, in accordance with an application
of the present invention, a method for use with a tracheal
ventilation tube, a pressurized fluid source, and a suction source,
the method including:
[0259] coupling, in fluid communication with the suction source, a
suction port of a flow regulator of an input module;
[0260] coupling, in fluid communication with the pressurized fluid
source, a fluid port of the flow regulator;
[0261] inserting a cleaning catheter into the ventilation tube
inserted in a trachea of a patient, which cleaning catheter is
coupled to the input module and includes (a) an elongate, flexible,
tubular main body, (b) one or more fluid-delivery lumens arranged
along the main body, and (c) one or more suction lumens arranged
along the main body; and
[0262] activating a mechanical user control element to assume at
least first, second, and third configurations, including
transitioning between the first and the third configurations via
the second configuration, so as to mechanically and
non-electrically set the activation states of the flow regulator,
such that:
[0263] when the user control element is in the first configuration,
the flow regulator is in a first activation state, in which the
flow regulator blocks fluid communication (a) between the suction
port and the one or more suction lumens and (b) between the fluid
port and the one or more fluid-delivery lumens,
[0264] when the user control element is in the second
configuration, the flow regulator is in a second activation state,
in which the flow regulator effects the fluid communication between
the suction port and the one or more suction lumens, and blocks the
fluid communication between the fluid port and the one or more
fluid-delivery lumens, and
[0265] when the user control element is in the third configuration,
the flow regulator is in a third activation state, in which the
flow regulator effects the fluid communication (a) between the
suction port and the one or more suction lumens and (b) between the
fluid port and the one or more fluid-delivery lumens.
[0266] There is still 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:
[0267] coupling, in fluid communication with the suction source, a
suction port of a flow regulator of an input module;
[0268] inserting a cleaning catheter into the ventilation tube
inserted in a trachea of a patient, which cleaning catheter (a) is
coupled to the input module, (b) is shaped so as to define one or
more distal suction orifices, and (c) includes (i) an elongate,
flexible, tubular main body, (ii) one or more fluid-delivery lumens
arranged along the main body, (iii) one or more suction lumens
arranged along the main body, and (iv) an inflatable element, which
is mounted to the main body at a location within 3 cm of at least
one of the one or more distal suction orifices;
[0269] activating the flow regulator to assume a first activation
state, in which the flow regulator effects fluid communication
between the suction source and an interior of the inflatable
element via at least one of the one or more fluid-delivery lumens,
thereby deflating the inflatable element; and
[0270] activating the flow regulator to assume a second activation
state, in which the flow regulator effects fluid communication
between the suction source and the distal suction orifices via the
one or more suction lumens, and does not effect the fluid
communication between the suction source and the interior of the
inflatable element.
[0271] There is additionally provided, in accordance with an
application of the present invention, a method for use with a
tracheal ventilation tube, the method including:
[0272] providing a cleaning catheter that is shaped so as to define
one or more fluid-delivery orifices in fluid communication with an
outer surface of the cleaning catheter, and includes an elongate,
flexible, tubular main body, and an inflatable element, which is
mounted to the main body, and the one or more fluid-delivery
orifices are in fluid communication with an interior of the
inflatable element; and
[0273] inserting the cleaning catheter into the ventilation tube
inserted in a trachea of a patient.
[0274] There is yet additionally provided, in accordance with an
application of the present invention, a method for use with a
suction source, the method including:
[0275] providing a cleaning catheter, which includes (a) an
elongate, flexible, tubular main body, which is shaped so as to
define a distal-most suction orifice and one or more lateral
suction orifices, and (b) an inflatable element, which is mounted
to the main body axially between (i) the distal-most suction
orifice and (ii) the one or more lateral suction orifices; and
[0276] modulating relative levels of suction delivered by the
suction source to (a) the distal-most suction orifice and (b) the
one or more lateral suction orifices.
[0277] For some applications, modulating includes modulating the
relative levels of suction between at least two levels that
include:
[0278] a relatively low distal-most level, in which a level of
suction delivered to the distal-most suction orifice is less than
25% of a level of suction delivered to one of the one or more
lateral suction orifices having a greatest cross-sectional area
proximal to the inflatable element, and
[0279] a relatively high distal-most level, in which the level of
suction delivered to the distal-most suction orifice is greater
than 25% of the level of suction delivered to the one of the one or
more lateral suction orifices having the greatest cross-sectional
area proximal to the inflatable element.
[0280] For some applications, modulating includes modulating the
relative levels of suction between the at least two levels that
include:
[0281] the relatively low distal-most level, in which the level of
suction delivered to the distal-most suction orifice is less than
10% of the level of suction delivered to the one of the one or more
lateral suction orifices having the greatest cross-sectional area,
and
[0282] the relatively high distal-most level, in which the level of
suction delivered to the distal-most suction orifice is greater
than 10% of the level of suction delivered to the one of the one or
more lateral suction orifices having the greatest cross-sectional
area.
[0283] For some applications:
[0284] the cleaning catheter further includes a suction lumen
arranged along the main body, in fluid communication with the
distal-most suction orifice and the lateral suction orifices,
and
[0285] modulating the relative levels of suction includes
reversibly modulating a level of occlusion of the suction lumen at
a portion thereof axially between (a) the distal-most suction
orifice and (b) the one or more lateral suction orifices.
[0286] For some applications, providing the cleaning catheter
includes providing the cleaning catheter further including exactly
one suction lumen arranged along the main body, in fluid
communication with the distal-most suction orifice and the lateral
suction orifices.
[0287] For some applications, providing the cleaning catheter
includes providing the cleaning catheter further including a
plurality of suction lumens arranged along the main body, in fluid
communication with one another and with the distal-most suction
orifice and the lateral suction orifices.
[0288] For some applications, the method further includes, before
modulating the relative levels of suction, inserting the cleaning
catheter into a ventilation tube inserted in a trachea of a
patient.
[0289] There is also provided, in accordance with an application of
the present invention, a method for use with a tracheal ventilation
tube, a pressurized fluid source, and a suction source, the method
including:
[0290] coupling, in fluid communication with the suction source, a
suction port of a flow regulator of an input module;
[0291] coupling, in fluid communication with the pressurized fluid
source, a fluid port of the flow regulator;
[0292] inserting a cleaning catheter into the ventilation tube
inserted in a trachea of a patient, which cleaning catheter is
coupled to the input module and includes (a) an elongate, flexible,
tubular main body, (b) one or more fluid-delivery lumens arranged
along the main body, and (c) one or more suction lumens arranged
along the main body; and
[0293] activating a mechanical user control element to assume at
least first, second, and third configurations, including
transitioning between the first and the third configurations via
the second configuration, so as to mechanically and
non-electrically set the activation states of the flow regulator,
such that:
[0294] when the user control element is in the first configuration,
the flow regulator is in the first activation state, in which the
flow regulator blocks fluid communication (a) between the suction
port and the one or more suction lumens and (b) between the fluid
port and the one or more fluid-delivery lumens,
[0295] when the user control element is in the second
configuration, the flow regulator is in the second activation
state, in which the flow regulator effects the fluid communication
between the fluid port and the one or more fluid-delivery lumens,
and blocks the fluid communication between the suction port and the
one or more suction lumens, and
[0296] when the user control element is in the third configuration,
the flow regulator is in the third activation state, in which the
flow regulator effects the fluid communication (a) between the
suction port and the one or more suction lumens and (b) between the
fluid port and the one or more fluid-delivery lumens.
[0297] 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
[0298] FIGS. 1A-D are schematic illustrations of a closed suction
cleaning system, in accordance with respective applications of the
present invention;
[0299] FIG. 2 is a schematic illustration of a main body of the
cleaning system of FIGS. 1A-C, in accordance with an application of
the present invention;
[0300] FIG. 3 is a schematic illustration of a portion of a
proximal portion of the main body of FIG. 2, in accordance with an
application of the present invention;
[0301] FIGS. 4A-C are schematic illustrations of several states of
a flow regulator of an input module of the cleaning system of FIG.
1A-C, in accordance with an application of the present
invention;
[0302] FIGS. 5A-C are schematic illustrations of an input module
and a portion of a main body of the cleaning system of FIGS. 1A-C,
in accordance with an application of the present invention;
[0303] FIGS. 6A-B are schematic illustrations of an input module
and a portion of a main body of the cleaning system of FIGS. 1A-C,
in accordance with an application of the present invention;
[0304] FIGS. 7A and 7B are schematic illustrations of a distal
portion of a main body of the cleaning system of FIGS. 1A-C
inserted into a ventilation tube, in accordance with an application
of the present invention;
[0305] FIG. 8 is a schematic illustration of a portion of a
proximal portion of a main body of the cleaning system of FIGS.
1A-C, in accordance with an application of the present
invention;
[0306] FIGS. 9A-C are schematic illustrations of several states of
a flow regulator of a input module of the cleaning system of FIGS.
1A-C, in accordance with an application of the present
invention;
[0307] FIG. 10 is a schematic illustration of a portion of a
proximal portion of a main body of the cleaning system of FIGS.
1A-C, in accordance with an application of the present
invention;
[0308] FIGS. 11A-C are schematic illustrations of several states of
a flow regulator of a input module of the cleaning system of FIGS.
1A-C, in accordance with an application of the present
invention;
[0309] FIG. 12 is a schematic illustration of a portion of a
proximal portion of a main body of the cleaning system of FIGS.
1A-C, in accordance with an application of the present
invention;
[0310] FIGS. 13A-B are schematic illustrations of several states of
a flow regulator of a input module of the cleaning system of FIGS.
1A-C, in accordance with an application of the present
invention;
[0311] FIG. 14 is a schematic illustration of a portion of a
proximal portion of a main body of the cleaning system of FIGS.
1A-C, in accordance with an application of the present
invention;
[0312] FIGS. 15A-B are schematic illustrations of several states of
a flow regulator of a input module of the cleaning system of FIGS.
1A-C, in accordance with an application of the present
invention;
[0313] FIGS. 16A-C are schematic illustrations of a configuration
of an input module of the cleaning system of FIGS. 1A-C comprising
a state protective selector, in accordance with an application of
the present invention;
[0314] FIGS. 17A-C are schematic illustrations of another
configuration of an input module of the cleaning system of FIGS.
1A-C, in accordance with an application of the present
invention;
[0315] FIGS. 18A-C are schematic illustrations of yet another
configuration of an input module of the cleaning system of FIGS.
1A-C, in accordance with an application of the present
invention;
[0316] FIGS. 19A-C are schematic illustrations of an input module
of the cleaning system of FIGS. 1A-C, in accordance with an
application of the present invention;
[0317] FIGS. 19D-F are schematic illustrations of buttons of the
input module of FIGS. 19A-C, in accordance with an application of
the present invention;
[0318] FIG. 20 is a schematic illustration of an input module of
the cleaning system of FIGS. 1A-C, in accordance with an
application of the present invention;
[0319] FIGS. 21A-B and 22A-C are schematic illustrations of a
distal portion of a main body of the cleaning system of FIGS. 1A-C
inserted into a ventilation tube, in accordance with an application
of the present invention;
[0320] FIG. 23 is a schematic illustration of a portion of a
proximal portion of a main body of a closed suction cleaning
system, in accordance with an application of the present invention;
and
[0321] FIGS. 24A-C are schematic illustrations of several states of
a flow regulator of a input module of the cleaning system of FIG.
23, in accordance with an application of the present invention.
DETAILED DESCRIPTION OF APPLICATIONS
[0322] FIGS. 1A-D are schematic illustrations of a closed suction
system cleaning system 100, in accordance with respective
applications of the present invention. Cleaning system 100 is
configured for use with a tracheal ventilation tube 160, a
ventilator 170, a pressurized fluid source 602, a suction source
601, and, optionally, an inflation source 603, which may comprise,
for example, a conventional syringe. Some of the configurations
described herein, such as with reference to FIGS. 1A, 3, and 4A-C,
and 5A-C, provide inflation source 603, while other configurations,
such as described with reference to FIGS. 1B-D, 7A-B, 8 and 9A-C,
10 and 11A-C, 12 and 13A-B, 14 and 15A-B, 16A-C, 17A-C, 19A-C,
18A-C, 21A-B and 22A-C, and 23 and 24A-C, do not provide inflation
source 603. Some applications of the present invention provide a
closed suction cleaning system that is configured to be coupled to
(e.g., is coupled to) pressured fluid source 602 and suction source
601, and not to an independent inflation source, such as a syringe.
For some applications, cleaning system 100 comprises one or more of
tracheal ventilation tube 160, ventilator 170, pressurized fluid
source 602, suction source 601, and/or an inflation source 603, in
any combination.
[0323] 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, and pressurized fluid source 602 provides a pressure
greater 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.
[0324] Cleaning system 100 comprises a distal ventilation tube
connector assembly 158, a flexible, a cleaning catheter 200, and an
input module 156. Cleaning catheter 200 comprises a main body 210.
Cleaning catheter 200 includes a distal portion 212 located distal
to ventilation tube connector 158, and a proximal portion 214
located proximal to ventilation tube 158. Distal portion 212 is
configured to be inserted into ventilation tube 160. Proximal
portion 214 includes a proximal-most input portion 216 of main body
210, which is configured to be inserted into 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 axially 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 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 main body 210 slides through ventilation tube connector
assembly 158 in a distal direction.
[0325] Ventilation tube connector assembly 158 comprises: (a) a
ventilator port 664, configured to be coupled in fluid
communication with ventilator 170, (b) a ventilation tube port 660,
configured to be coupled in fluid communication with a proximal end
of ventilation tube 160, and (c) a main body inlet 640, which is
configured to allow passage therethrough of elongate main body
210.
[0326] 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
900 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. In one non-limiting example, an interior
region and/or outer shape of ventilation tube port 660 matches a
proximal end of ventilation tube 160 to create a substantial
air-tight seal. In another non-limiting example, a tube 910 or
other conduit of a tube assembly may be connected to ventilator
port 664 so that an interior of ventilator port 664 receives air
from the ventilator and is in fluid communication with ventilator
900 in a substantially air-tight manner.
[0327] For some applications, cleaning catheter 200 further
comprises an expandable element 588, mounted to flexible main body
210 near a distal end of flexible main body 210, e.g., within 5 cm,
e.g., within 3 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, expandable element 588 is mounted to
flexible main body 210 within 3 cm of at least one of the one or
more distal suction orifices 440. Expandable element 588 is
expandable into contact with an inner surface 201 of ventilation
tube 160. For some applications, expandable 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 fully expanded (e.g., inflated) 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 inner surface 201 of the ventilation tube. For some
applications, 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 expandable element 588
when fully expanded (e.g., 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 main body 210.
[0328] When expanded, expandable 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 expandable element (as discussed below
with reference to FIG. 21B, this may be useful for concentrating
suction so that the suction is predominantly in a proximal portion
774 of the lumen of the ventilation tube 160 proximal to the
expandable element 588), and/or (ii) a wiping functionality useful
for cleaning inner surface 201 of ventilation tube 160. Typically,
cleaning system 100 operates in a closed system environment.
[0329] For some applications, expandable element 588 comprises an
inflatable element, such as a balloon, which is configured to
expand upon being inflated. For other applications, expandable
element 588 expands other than by inflation; for example,
expandable element 588 may comprise a deformable element such as a
gel, a foam, a fluid compartment, or a wire mesh or braid, which
can be deformed to expand its width in the direction perpendicular
to the main body longitudinal axis, either with or without an
overall change in volume.
[0330] During one state of operation, cleaning system 100 cleans
inner surface 201 of ventilation tube 160 when ventilation tube
connector assembly 158 mediates a substantially air-tight seal
between (i) ventilator 900 and/or an interior of ventilator port
664 and (ii) an interior of ventilation tube 160 and/or an interior
of ventilation tube port 660 (this substantially air-tight seal is
referred to hereinbelow as the "ventilation machine-ventilator tube
seal").
[0331] As is described below, concurrent with maintaining of this
ventilation machine-ventilator tube seal, expandable 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 main body 210 in a distal direction towards a distal end of
ventilation tube 160. For example, expandable element 588 may be
distally advanced when expandable element 588 is in a non-contact
state (i.e., not in contact with inner surface 201 of ventilation
tube 160). After expandable element 588 is thus positioned,
expansion of the expandable element induces contact between an
outer surface of expandable 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. As is described below, this
slidable boundary between the proximal and distal portions may be
useful for facilitating the cleaning of the inner surface of
ventilation tube 160, for example for substantially confining
locations of negative pressure and/or fluid (e.g., pressurized
fluid) introduced into an interstitial region outside of main body
210 and within ventilation tube 160 so that the suction or
pressurized fluid is introduced predominantly in the proximal
portion of ventilation tube 160.
[0332] For some applications, distal portion 212 of cleaning
catheter 200 is shaped so as to define one or more fluid-delivery
orifices 525. Alternatively or additionally, for some applications,
one or more fluid-delivery orifices 525 are defined by a wall of
expandable element 588, such as described hereinbelow with
reference to FIGS. 7B and/or 21A-B. Fluid-delivery orifices 525 are
in fluid communication with an outer surface of cleaning catheter
200 (including with an outer surface of main body 210) and an outer
surface of expandable element 588 (typically a proximal side of the
outer surface), including when distal portion 212 of cleaning
catheter 200 is inserted into ventilation tube 160. For some
applications, one or more fluid-delivery orifices 525 are defined
by a wall of main body 210, such as described herein with reference
to FIGS. 1A, 1B, 1D, and 7A. Alternatively or additionally, for
some applications, distal portion 212 of cleaning catheter 200
comprises one or more distal suction orifices 440, typically
through a lateral wall of distal portion 212. Typically, 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 fluid-delivery orifices 525
(such as all of one or more fluid-delivery orifices 525) is located
within 10 cm of the expandable element 588, such as within 5 cm,
e.g., within 3 cm of the expandable element. For some applications,
fluid-delivery orifices 525 have a total cross-sectional area in
aggregate of at least 0.04 mm2, no more than 1 mm2, and/or between
0.04 mm2 and 1 mm2.
[0333] For some applications, 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/or pressurized fluid source 602 and suction
and/or fluid-delivery orifices 440 and/or 525 may be provided by
one or more connecting lumens within or along the 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.
[0334] For some applications, cleaning system 100 comprises a
substantially impermeable and/or pliable sleeve 610 for protecting
an outer surface of 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
elongate main body 210, typically in locations proximal to
tube-connector assembly 158 and distal to suction port 830, 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 of main body 210 is at least 3 cm, e.g., at least 5 cm, at
least 7 cm, or at least 10 cm.
[0335] For some applications, a length of proximal portion 214 may
be modified by sliding, in a proximal or distal direction, main
body 210 through ventilation tube connector assembly 158.
[0336] 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 main body inlet 640) and/or is longitudinally displaced
from a proximal end (e.g., corresponding to main body inlet 640) 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 main
body 210.
[0337] For some applications, a location of the distal end of
sleeve 610 is not fixed relative to main body 210. For example,
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 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 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 main
body 210 and within sleeve 610.
[0338] Reference is made to FIG. 1D. In this configuration of
cleaning system 100, fluid-delivery orifices 525 are not provided,
and one or more fluid-delivery lumens 520, described hereinbelow
with reference to FIG. 2, may not be provided. Instead, a separate
secondary tube 211, distinct from main body 210, is provided for
delivering irrigation fluid to trickle down from the proximal (top)
end of ventilation tube 160 when the distal end of distal portion
212 of cleaning catheter 200 is already inserted into the distal
portion of the ventilation tube and suctioning is activated.
Secondary tube 211 provides fluid communication between input
module 156 and distal ventilation tube connector assembly 158, and
allows delivery of irrigation fluid to be controlled by a flow
regulator of input module 156. For some applications, inflation
lumen 580, described hereinbelow with reference to FIG. 2, is
provided for inflating expandable element 588.
[0339] Reference is made to FIGS. 1A, 1B, and 1C. For some
applications, depth markings 620 are provided on catheter main body
210. For some applications, a stopper element 625 is attached to
catheter main body 210. For some applications, an interface 630 is
provided between a distal end of pliable sleeve 610 and connector
assembly 158. For some applications, an interface 678 is provided
between a proximal end of pliable sleeve 610 and input module
156.
[0340] Reference is now made to FIG. 2, which is a schematic
illustration of main body 210, in accordance with an application of
the present invention. Main body includes one or more of the
following lumens arranged along main body 210. For some
applications, one or more of the lumens are arranged along main
body 210 at least partially within the main body, e.g., integrally
formed in the main body 210, formed in the wall of main body 210,
or provided as a separate tube with main body 210. Alternatively or
additionally, one or more of the lumens are arranged along main
body 210 at least partially outside the main body, e.g., provided
as a separate tube outside main body 210). The lumens include:
[0341] one or more fluid-delivery lumens 520, which provide fluid
communication between at least one proximal fluid-delivery inlet
521 and one or more respective fluid-delivery orifices 525 (and,
optionally, for some applications, expandable element 588, as
described hereinbelow); typically, input portion 216 is shaped so
as to define proximal fluid-delivery inlet 521, and distal portion
212 of cleaning catheter 200 is shaped so as to define
fluid-delivery orifices 525; [0342] one or more suction lumens 530,
which provide fluid communication between at least one proximal
suction inlet 531 and one or more distal suction orifices 440;
typically, input portion 216 of 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 are arranged in
intermittent fluid communication with fluid source 601, as
described in detail hereinbelow; for applications in which the one
or more suction lumens comprise a plurality of suction lumens, the
one or more suction lumens typically are arranged in fluid
communication with one another (and are thus typically brought into
fluid communication with fluid source 601 together rather than
separately); and/or [0343] at least one inflation lumen 580, which
provides fluid communication between at least one inflation inlet
581 and at least one inflation outlet 585 which is in fluid
communication with an interior of expandable element 588;
typically, input portion 216 is shaped so as to define inflation
inlet 581, and distal portion 212 is shaped so as to define
inflation outlet 585.
[0344] Reference is now made to FIG. 3, which is a schematic
illustration of a portion of proximal portion 214 of main body 210,
in accordance with an application of the present invention. FIG. 3
shows one or more fluid-delivery lumens 520, one or more suction
lumens 530, and inflation lumen 580, which have been omitted from
FIGS. 4A-C for clarity of illustration. For some applications,
proximal suction inlet 531 is located proximal to proximal
fluid-delivery inlet 521, and/or proximal fluid-delivery inlet 521
is located proximal to inflation inlet 581. For some applications,
proximal fluid-delivery inlet 521 is located longitudinally between
proximal suction inlet 531 inflation inlet 581. For some
applications, as shown, proximal suction inlet 531 is defined by a
lateral wall of main body 210, while for other applications,
proximal suction inlet 531 is defined by a proximal end of main
body 210, such as shown in FIGS. 5B-C, 17A-C, and 18A-C.
[0345] Reference is made to FIGS. 4A-C, which are schematic
illustrations of several states of a flow regulator 700 of input
module 156, in accordance with an application of the present
invention. As mentioned above, in some configurations input portion
216 of proximal portion of main body 210 is configured to be
inserted into and axially slidable with respect to input module
156. Input module 156 has a plurality of ports for connection with
various fluid sources, including at least suction source 601 and
pressurized fluid source 602. Input module 156 comprises flow
regulator 700, a mechanical user control element 320, and a housing
310 encasing input portion 216 of main body 210. Mechanical user
control element 320 is shown schematically in FIGS. 4A-C and in
some of the other figures; actual implementations of cleaning
system 100 typically include a more ergonomic design for
comfortable interface with a human hand, such as the configuration
shown in FIGS. 18A-C. Typically, 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. The input module and/or system may comprise further user
control elements that perform control functions in addition to
those performed by mechanical user control element 320.
[0346] Input module 156 is configured to assume a plurality of
activation states. Mechanical control unit 320 is typically
configured to mechanically and non-electrically set the states of
flow regulator 700. Input module 156 is configured to set the
activation states enabling or blocking fluid communication between
the various lumen inlets and the external fluid sources via
respective ports. For some applications, transitions between states
are effected 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 effected 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.
[0347] For some applications, one or more of lumen inlets 521, 531,
and 581 are isolated from one another by one or more fluid
separators 341, 342, 343, and 344, which function as separation
sealing elements. For example, the separators may comprise
respective o-rings. For some applications, the separators are fixed
to an outer surface of input portion 216 of main body 210, and are
slidable with respect to housing 310. For some applications, such
as shown in FIGS. 4A-C, the sealing elements are directly fixed to
the outer surface of input portion 216, while for other
applications, such as shown in FIGS. 5B-C, described hereinbelow,
the sealing elements are indirectly fixed to the outer surface of
input portion 216. Alternatively, the separators are fixed to
housing 310, and are slidable with respect to catheter main body
210, such as described hereinbelow with reference to FIGS. 17A-C
and 18A-C.
[0348] For some applications, input module 156 includes one or more
of the following ports: [0349] a fluid port 827, which is
coupleable in fluid communication with pressurized fluid source
602, and coupled in fluid communication with pressurized fluid
source 602 during use of cleaning system 100; [0350] a suction port
830, which is coupleable in fluid communication with suction source
601, and coupled in fluid communication with suction source 601
during use of cleaning system 100; and/or [0351] an inflation port
832, which is coupleable in fluid communication with inflation
source 603, and coupled in fluid communication with inflation
source 603 during use of cleaning system 100.
[0352] Typically, fluid port 827 comprises a screw-on fitting, such
as a Luer-Lock interface. 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
described hereinbelow with reference to FIGS. 18A-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.
[0353] For some applications, pressurized fluid from fluid source
602 is delivered, via one or more fluid-delivery lumens 520 (shown
in FIG. 3) and fluid-delivery orifices 525 (shown in FIGS. 1A-D),
into an interstitial region inside of ventilation tube 160 and
outside of the main body 210. For some applications, a stream of
the delivered fluid passes through the interstitial region en route
to inner surface 201 of ventilation tube 160, and is incident upon
the inner surface of the ventilation tube. The stream of the
delivered fluid may comprise, for example, a liquid stream, a gas
stream, and/or a stream of a gas/liquid mixture, e.g., a mist
stream or a stream of liquid including bubbles. Delivery of the
fluid into the interstitial region and/or to the inner surface of
the ventilation tube may be useful for cleaning the inner surface
of the ventilation tube.
[0354] For some applications in which expandable element 588 is
inflatable, pressurized fluid or gas delivered from inflation
source 603 is delivered to expandable element 588 to inflate
expandable element 588 (e.g., to form a slidable boundary, as
described hereinbelow).
[0355] In the exemplary configuration of cleaning system 100 shown
in FIGS. 4A-C, fluid source 602 (which provides pressurized fluid)
and inflation source 603 are provided as two separate elements.
Alternatively, in other configurations of cleaning system (such as
that described hereinbelow with reference to FIGS. 12 and 13A-B),
pressurized fluid source 602 is used to both inflate expandable
element 588 and to deliver fluid via fluid-delivery orifices 525.
In the configuration shown in FIGS. 3 and 4A-C, expandable element
588 comprises an inflatable element 588, such as a balloon.
[0356] In the configuration illustrated in FIGS. 3 and 4A-C, main
body 210 is shaped so as to define at least three lumens: one or
more fluid-delivery lumens 520 (e.g., exactly one fluid-delivery
lumen 520), one or more suction lumens 530 (e.g., exactly one
suction lumen 530), and at least one inflation lumen 580 (e.g.,
exactly one inflation lumen 580), and respective at least one
proximal fluid-delivery inlet 521 (e.g., exactly one proximal
fluid-delivery inlet 521), at least one proximal suction inlet 531
(e.g., exactly one proximal suction inlet 531), and at least one
inflation inlet 581 (e.g., exactly one inflation inlet 581). For
some applications, as shown in FIGS. 3 and 4A-C and some of the
other figures, inlets 521, 531, and/or 581 are defined by a lateral
wall of main body 210. Alternatively or additionally, for some
applications, such as described hereinbelow with reference to FIGS.
17A-C, one or more of inlets 521, 531, and/or 581 are defined by a
proximal end of the main body.
[0357] In this configuration, flow regulator 700 is configured to
have three principal activation states, typically associated with
three configurations of mechanical user control element 320. For
some applications, the three configurations are three spatial
positions, respectively. In the configuration illustrated in FIGS.
4A-C, the three states are actuated by axial motion of proximal
portion 214 of elongated main body 210 relative to input module
housing 310: [0358] as shown in FIG. 4A, a first activation state,
in which flow regulator 700 blocks fluid communication (a) between
suction port 830 and proximal suction inlet 531, and thus one or
more suction lumens 530 and (b) between fluid port 827 and proximal
fluid-delivery inlet 521, and thus one or more fluid-delivery
lumens 520 (but not necessarily blocked from inflatable element
588); however, fluid communication can be established between
inflation port 832 and inflation inlet 581, and thus to inflatable
element 588 via inflation lumen 580. For some applications, this
first activation state may be considered to be a base, default
activation state, which optionally is set by an elastic return
force element, such as described hereinbelow with reference to
FIGS. 5B-C. In this particular configuration, such inflation is
typically manually enabled by the user. Inflation of inflatable
element 588 before applying suction via the distal suction orifices
440 may serve to isolate the lungs from the suction; [0359] as
shown in FIG. 4B, a second activation state, in which flow
regulator 700 effects suction fluid communication between suction
port 830 and one or more suction lumens 530 via proximal suction
inlet 531, and blocks flow of cleaning fluid between fluid port 827
and one or more fluid-delivery lumens 520; and [0360] as shown in
FIG. 4C, a third activation state, in which flow regulator 700
effects both (a) suction fluid communication between suction port
830 and one or more suction lumens 530 via proximal suction inlet
531, and (b) cleaning fluid communication between fluid port 827
and one or more fluid-delivery lumens 520 via proximal
fluid-delivery inlet 521.
[0361] As mentioned above, mechanical user control element 320 is
configured to mechanically and non-electrically set the states of
flow regulator 700. Typically, mechanical user control element 320
is configured to assume at least first, second, and third
configurations, and, typically, is configured to transition between
the first and the third configurations via the second
configuration. For some applications, the first, second, and third
configurations are first, second, and third spatial positions,
respectively, and mechanical user control element 320 is configured
to transition between the first and the third spatial positions via
the second spatial position. For example, mechanical user control
element 320 is shown in FIG. 4A in its first configuration (e.g.,
spatial position) (right-most position), in FIG. 4B in its second
configuration (e.g., spatial position) (center position), and in
FIG. 4C in its third configuration (e.g., spatial position)
(left-most position). Input module 156 is configured such that:
[0362] when user control element 320 is in the first configuration
(e.g., spatial position), flow regulator 700 is in the first
activation state, as described above; [0363] when user control
element 320 is in the second configuration (e.g., spatial
position), flow regulator 700 is in the second activation state, as
described above; and [0364] when user control element 320 is in the
third configuration (e.g., spatial position), flow regulator 700 is
in the third activation state, as described above.
[0365] Typically, in this configuration, as well as in the other
configurations described herein (except with reference to FIGS. 23
and 24A-B), cleaning system 100 may be used for two different
purposes: [0366] for cleaning the lumen of tracheal ventilation
tube 160--the user typically rapidly transitions user control
element 320 from the first to the third configurations (e.g.,
spatial positions) via the second configuration (e.g., spatial
position), for example, in less than one second, typically is less
than 0.5 seconds. For cleaning ventilation tube 160, there is
generally no benefit to putting the flow regulator in the second
activation state (suction without cleaning fluid flow), rather than
transitioning directly from the first activation state (suction and
cleaning fluid flow both blocked) directly to the third activation
state (suction and cleaning fluid flow both enabled); and [0367]
for suctioning the trachea outside of and distal to ventilation
tube 160--the user transitions user control element 320 from the
first to the second configurations (e.g., spatial positions), and
leaves the flow regulator in the second activation state (suction
without cleaning fluid flow) throughout most the trachea suctioning
procedure.
[0368] The user may use cleaning system 100 for both of these
purposes at different times during patient care. For example, the
system may be used to clean ventilation tube 160 once every six
hours, and for suctioning the lungs once every three hours. The
user may choose to perform these two functions serially during a
single session; the user first suctions the trachea by putting user
control element 320 in the second configuration, and then
immediately upon conclusion of this suctioning, transitions the
user control element to the third configuration to activate
cleaning of the lumen of ventilation tube 160.
[0369] Typically, mechanical user control element 320 comprises an
axial-motion element 318, which is configured to assume at least
first, second, and third axial positions along a single axis, when
mechanical user control element 320 is in the first, the second,
and the third configurations (e.g., spatial positions),
respectively. The first, the second, and the third axial positions
of axial-motion element 318 are shown in FIGS. 4A, 4B, and 4C,
respectively. The single axis is parallel with a longitudinal axis
of proximal portion 214 of main body 210. The second axial
position, shown in FIG. 4B, is spatially between the first and the
second axial positions along the axis. For configurations in which
mechanical user control element 320 is configured such that the
motion of all parts thereof is along the single axis (such as shown
in FIGS. 4A-C. 5A-C, 9A-C, 11A-C, 13A-B, 15A-B, 16A-C, 17A-C),
mechanical user control element 320 it its entirety functions as
axial-motion element 318. For other configurations in which
portions of mechanical user control element 320 move in directions
other than along the single axis (such as described hereinbelow
with reference to FIGS. 6A-B and 18A-C), only a portion of
mechanical user control element 320 functions as axial-motion
element 318.
[0370] It is noted that when mechanical user control element 320
assumes the at least first, second and third configurations (e.g.,
spatial positions) mentioned above, either (a) the entire
mechanical user control element 320 assumes these configuration
(e.g., spatial positions), such as shown in FIGS. 4A-C. 5A-C, 9A-C,
11A-C, 13A-B, 15A-B, 16A-C, 17A-C, or (b) only a portion of entire
mechanical user control element 320 assumes these configuration
(e.g., spatial positions), such as shown in FIGS. 6A-B and 18A-C
(for example, in these configurations, axis 720 remains stationary
as the remainder of mechanical user control element 320, including
user control handle 718 and axial-motion element 318, assume these
configuration (e.g., spatial positions)).
[0371] For some applications, input module 156 is configured such
that changes in configuration (e.g., spatial position) of
mechanical user control element 320 (typically axial-motion element
318 thereof) cause corresponding changes in axial position of input
portion 216 of main body 210 with respect to input module 156.
Typically, input module 156 is configured such that input portion
216 assumes first, second, and third axial positions with respect
to input module 156 (e.g., with respect to suction port 830 and/or
fluid port 827), corresponding to the first, the second, and the
third configuration (e.g., spatial positions) of mechanical user
control element 320. The first, second, and third axial positions
of input portion 216 are typically along a single axis.
[0372] As mentioned above, FIG. 4A shows flow regulator 700 in the
first (blocked) state. Input portion 216 of main body 210 is
encased, yet axially movable (slidable), within housing 310 of
input module 156. Catheter main body 210 is slidable through a
distal wall 314 of housing 310. Inflation inlet 581 is fixedly
attached to a connector 880, which, for example, may comprise a
screw-on fitting, such as a Luer-Lock interface, and in operation
connector 880 is connected to an inflation source (e.g., a
syringe). Housing 310 is shaped so as to define suction port 830
and cleaning fluid port 827 (main body 210 does not define these
ports).
[0373] As input portion 216 of main body 210 axially moves within
the inner compartment of housing 310, transverse sealing separators
341, 342, 343, and 344 delineate distinct chambers within the
housing. When flow regulator 700 is in the first activation state,
as shown in FIG. 4A, separators 342 and 343 and the outer surface
of elongated main body 210 delineate a first chamber 350 around
proximal fluid-delivery inlet 521, and thereby block direct fluid
communication within housing 310 between proximal fluid-delivery
inlet 521 and proximal suction inlet 531, and inflation inlet 581.
The separators are attached to the main body and snugly pressed
against the inner surface of housing 310, so that the insulated
chamber around proximal fluid-delivery inlet 521 is maintained even
as the main body slides a certain distance along the longitudinal
axis thereof with respect the housing.
[0374] Also as shown in FIG. 4A, in the first activation state,
elongated main body 210 is positioned in its closest position to a
proximal end 360 of housing 310, proximal-most separator 344
creates a seal which prevents direct fluid communication between
suction port 830 of housing 310 and proximal suction inlet 531 of
elongated main body 210. In this base position, cleaning fluid flow
is blocked within a second sealed chamber 352 delineated by
separators 341 and 342 and the outer surface of elongated main body
210.
[0375] When flow regulator 700 is in the second activation state,
as shown in FIG. 4B, fluid communication is established between
suction port 830 of housing 310 and proximal suction inlet 531 and
into one or more suction lumens 530 in elongated main body 210, yet
cleaning fluid flow remains blocked within second sealed chamber
352 delineated by separators 341 and 342 and the outer surface of
elongated main body 210. This activation is achieved by sliding
elongated main body 210 distally along the axial direction by a
limited distance such that separator 342 does not yet cross into
the space of cleaning fluid port 827. Typically, this sliding
motion is induced by distally pushing on mechanical user control
element 320, which is coupled to elongated main body 210 and passes
through a slit 312 in housing 310 which allows axial motion of
mechanical user control element 320.
[0376] When flow regulator 700 is in the third activation state, as
shown in FIG. 4C, fluid communication is established in first
chamber 350 between fluid port 827 of housing 310 and proximal
fluid-delivery inlet 521 and one or more fluid-delivery lumens 520
of elongated main body 210. Suction port 830 of housing 310 remains
in fluid communication with proximal suction inlet 531 and into one
or more suction lumens 530 in elongated main body 210. Therefore,
in this third activation state, flow regulator 700 effects both (a)
cleaning fluid flow into one or more fluid-delivery lumens 520 and
(b) suction in one or more suction lumens 530 of elongated main
body 210. This activation is achieved by sliding elongated main
body 210 more distally along the axial direction by a limited
distance such that separator 342 crosses into or passes across the
space of cleaning fluid port 827. Typically, the sliding motion is
induced by distally pushing on mechanical user control element 320,
which is coupled to elongated main body 210 and passes through slit
312 in housing 310.
[0377] Thus, three activation states can be actuated, typically
associated with three configurations (e.g., spatial positions) of
mechanical user control element 320. In the configuration
illustrated in FIGS. 4A-C, the three states are actuated by axial
motion of input portion 216 of elongated main body 210 relative to
input module housing 310: [0378] the first activation state, in
which inflatable element 588 can be inflated, but suction flow and
cleaning fluid flow is blocked; [0379] the second activation state,
in which suction flow is enabled between one or more suction lumens
530 and suction port 830 via proximal suction inlet 531 into one or
more suction lumens 530, but cleaning fluid flow into one or more
fluid-delivery lumens 520 remains blocked; and [0380] the third
activation state, in which suction flow is enabled both between one
or more suction lumens 530 and suction port 830 via proximal
suction inlet 531 into one or more suction lumens 530, and cleaning
fluid flow into one or more fluid-delivery lumens 520 from fluid
port 827 of housing 310 via proximal fluid-delivery inlet 521.
[0381] Operational safely is inherent because there is no
activation state in which cleaning fluid flow is enabled without
suction also being activated.
[0382] Reference is now made to FIGS. 5A-C, which are schematic
illustrations of input module 156 and a portion of main body 210,
in accordance with an application of the present invention. FIG. 5A
is an isometric view of input module 156 with main body 210 extends
distally out of a distal end of the input module. FIGS. 5B and 5C
are cross-sectional views of input module 156 and the portion of
main body 210. FIGS. 5B and 5C show flow regulator 700 in the first
and third activation states, respectively, which are described
hereinabove with reference to FIGS. 3 and 4A-C.
[0383] In the configuration shown in FIGS. 5B and 5C, input portion
216 of elongated main body 210 is attached to a mediating proximal
encasing element 590, to which separators 341, 342, 343, and 344
are fixed. Thus, the sealing elements are indirectly fixed to the
outer surface of input portion 216. FIGS. 5B and 5C also show an
elastic return force element 349 (e.g., a spring), which sets the
resting, default state of flow regulator 700 to be the first
activation state.
[0384] Reference is now made to FIGS. 6A-B, which are schematic
illustrations of input module 156 and a portion of main body 210,
in accordance with an application of the present invention. FIGS.
6A-B illustrate an alternative mechanism for causing axial motion
of catheter main body 210 relative to input module housing 310. In
the configuration shown in FIGS. 4A-C, mechanical user control
element 320 is pushed parallel to the axial motion of catheter main
body 210. In contrast, in the configuration shown in FIGS. 6A-B,
mechanical user control element 320 comprises a user control handle
718, which is configured to undergo rotational motion around an
axis 720. A lever 711, which is rigidly connected to mechanical
user control element 320, imparts a force having a component in
catheter main body 210 axial direction onto axial-motion element
318, which may comprise, for example, a pin 730 rigidly connected
to catheter main body 210. As a result, although the motion of
mechanical user control element 320 includes a substantial
component perpendicular to the catheter axial direction (in user
control handle 718), mechanical user control element 320
nevertheless imparts an axial force onto axial-motion element 318
(e.g., pin 730), which causes axial motion of catheter main body
210 relative to input module housing 310. In other words,
mechanical user control element 320 translates the movement of user
control handle 718 into axial motion of axial motion element 318.
In this configuration, the larger arc motion of user control handle
718 relative to the smaller motion of pin 730 and catheter main
body 210 may facilitate easier human handling. This configuration
may also provide a more natural human interface similar to the hand
lever of bicycle brakes, which facilitates holding and activation
by the human hand.
[0385] This configuration of mechanical user control element 320
may be used with any of the configurations of input module 156
described herein. In particular, in order to integrate this control
arrangement into the configurations described herein, pin 730 of
this configuration is substituted for mechanical user control
element 320 in the other configurations, and the other elements of
this configuration are added to the other configurations.
Alternative configurations of mechanical user control element 320
for effecting axial motion of axial motion element 318 will be
evident to those skilled in the art who have read the present
patent application, and are within the scope of the present
invention. For example, mechanical user control element 320 may
comprise a knob that assumes three different rotational
configuration (e.g., spatial positions) that cause axial motion
element 318 to assume three different corresponding axial
positions.
[0386] In the configurations of input module 156 described herein,
the states of the flow regulator are generally effected by linear
axial motion of catheter main body 210 with respect to housing 310.
This linear motion may be triggered by the user's linearly moving
mechanical user control element 320, or by the user's rotationally
moving mechanical user control element 320, as described with
reference to FIGS. 6A-B), in order to cause linear motion of the
catheter main body. However, applications of the present invention
are not limited to such linear motion. The same principles may be
employed to activate a rotational motion of mechanical switching of
fluid communication between the ports of housing 310 and the lumen
inlets of the catheter main body.
[0387] Reference is now made to FIGS. 7A and 7B, which are
schematic illustrations of distal portion 212 of cleaning catheter
200 inserted into ventilation tube 160, in accordance with an
application of the present invention. The configurations
illustrated in FIGS. 7A and 7B may be used with any of the
configurations of cleaning system 100 described herein, including
with reference to FIGS. 1A-D, 3, 4A-C, 5A-C, 6A-B, 8 and 9A-C, 10
and 11A-C, 12 and 13A-B, 14 and 15A-B, 16A-C, 17A-C, 18A-C, 19A-C,
20, 21A-B and 22A-C, and 23 and 24A-C. In the configurations
illustrated in FIGS. 7A and 7B, expandable element 588 comprises an
inflatable element, and at least one of one or more fluid-delivery
lumens 520 is in fluid communication with an interior of expandable
element 588. Inflatable element 588 is inflated by fluid pressure
provided from the same source as the fluid delivered to one or more
fluid-delivery lumens 520, namely fluid source 602.
[0388] In the configurations shown in both FIGS. 7A and 7B, one or
more fluid-delivery orifices 525 are in fluid communication with
the interior of inflatable element 588. Inflatable element 588 is
inflated by fluid communication with the at least one of one or
more fluid-delivery lumens 520 via one or more inflation outlets
585 defined by distal portion 212 of cleaning catheter 200. Fluid
is ejected from one or more fluid-delivery orifices 525 that are
also in fluid communication with one or more fluid-delivery lumens
520.
[0389] In the configuration shown in FIG. 7A, a wall of main body
210 at distal portion 212 of cleaning catheter 200 is shaped so as
to define fluid-delivery orifices 525. In the configuration shown
in FIG. 7B, the wall of inflatable element 588 defines one or more
fluid-delivery orifices 525, typically on a surface of inflatable
element 588 that faces proximally. Fluid sprayed from these
orifices is symbolically illustrated as fluid streams 556.
Alternatively, a portion of fluid-delivery orifices 525 are defined
by the wall of main body 210, and another portion of fluid-delivery
orifices 525 are defined by the wall of inflatable element 588
(configuration not shown).
[0390] Generally, one or more suction lumens 530 facilitate fluid
communication between its proximal suction inlet 531 and distal
suction orifices 440, and one or more fluid-delivery lumens 520
facilitate fluid communication between its proximal suction inlet
531 and distal fluid delivery to fluid-delivery orifices 525.
Inflation of inflatable element 588 (i.e., fluid communication to
its inner surface) is facilitated either via a dedicated inflation
lumen 580 or via one or more of fluid-delivery lumens 520.
[0391] 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 774 of an interstitial region outside of main body 210 and
within ventilation tube 160 and (b) locations 778 within the
ventilation tube 160 that are distal to the slidable boundary
formed and delineated by the inflatable element 588.
[0392] In some applications of the present invention, catheter main
body 210 comprises at least two separate suction lumens: (a) at
least a first suction lumen 530 which is in fluid communication
with one or more distal suction orifices 440 proximal to expandable
element 588, but no suction orifices located distal to the
expandable element, and (b) at least a second suction lumen which
is in fluid communication with one or more suction orifices located
distal to the expandable element. Preferably, the second suction
lumen is not in fluid communication with any distal suction
orifices proximal to the expandable element.
[0393] Such dual suction lumen configuration has the advantage of
enabling selective performance of suction either exclusively
proximal to the expandable element, or exclusively distal to the
expandable element, or both. Also, this configuration enables more
gradual control of the suction forces applied distal and proximal
to the expandable element. For example, in at least one operating
state suction force delivered to the one or more suction orifices
distal to the expandable element is weaker than 20% of the suction
force applied through the largest orifice 440 proximal to the
expandable element, and in at least one other operating state
suction force delivered to the one or more suction orifices distal
to the expandable element is stronger than 20% of the suction force
applied through the largest orifice 440 proximal to the expandable
element.
[0394] Reference is now made to FIG. 8, which is a schematic
illustration of a portion of proximal portion 214 of main body 210,
in accordance with an application of the present invention. FIG. 8
(and FIGS. 9A-C) illustrate configurations of proximal portion 214
of main body 210 appropriate for use with either of the
configurations of distal portion 212 of cleaning catheter 200
described hereinabove with reference to FIGS. 7A and 7B. In these
configuration, expandable element 588 is inflated via fluid
communication to pressurized fluid in at least one of one or more
fluid-delivery lumens 520, e.g., exactly one fluid-delivery lumen
520, which are in fluid communication with an interior of
expandable element 588. There is thus no need to provide separate
inflation lumen 580 to the expandable element (such as described
hereinabove with reference to FIGS. 3 and 4A-C), because the
expandable element is inflated via one or more inflation outlets
585 from the at least one of the one or more fluid-delivery lumens
520 itself. Alternatively, expandable element 588 is inflated via
dedicated inflation lumen 580 which is in fluid communication
directly with one or more fluid-delivery lumens 520, or with the
same source 602 of pressurized fluid with which one or more
fluid-delivery lumens 520 are in fluid communication (configuration
not shown).
[0395] In the particular configuration shown in FIG. 8 (and FIGS.
9A-C), main body 210 is shaped so as to define at least two lumens:
one or more fluid-delivery lumens 520 (e.g., exactly one
fluid-delivery lumen 520), and one or more suction lumens 530
(e.g., exactly one suction lumen 530), and respective at least one
proximal fluid-delivery inlet 521 (e.g., exactly one proximal
fluid-delivery inlet 521), and at least one proximal suction inlet
531 (e.g., exactly one proximal suction inlet 531). In this
particular configuration, main body 210 is not shaped so as to
define inflation lumen 580 or inflation inlet 581, described
hereinabove with reference to FIGS. 3 and 4A-C. In this particular
configuration, expandable element 588 comprises an inflatable
element 588, such as a balloon.
[0396] FIG. 8 shows one or more fluid-delivery lumens 520 and one
or more suction lumens 530, which have been omitted from FIGS. 9A-B
for clarity of illustration. For some applications, proximal
suction inlet 531 is located proximal to proximal fluid-delivery
inlet 521. For some applications, as shown, proximal suction inlet
531 is defined by a lateral wall of main body 210, while for other
applications, proximal suction inlet 531 is defined by a proximal
end of main body 210, such as shown in FIGS. 5B-C, 17A-C, and
18A-C.
[0397] Reference is made to FIGS. 9A-C, which are schematic
illustrations of several states of a flow regulator 710 of input
module 156, in accordance with an application of the present
invention. Except as described as follows, input module 156 is
configured as described hereinabove with reference to FIGS. 4A-C.
Except as described as follows, flow regulator 710 is generally
similar to flow regulator 700, described hereinabove with reference
to FIGS. 4A-C. As mentioned above, in some applications input
portion 216 of proximal portion of main body 210 is configured to
be inserted into and axially slidable with respect to input module
156. Input module 156 has a plurality of ports for connection with
various fluid sources, including at least suction source 601 and
pressurized fluid source 602. In this configuration, input module
156 includes fluid port 827, which is coupleable in fluid
communication with pressurized fluid source 602, and suction port
830, which is coupleable in fluid communication with suction source
601, but does not include inflation port 832, described hereinabove
with reference to FIGS. 4A-C. In addition, inflation source 603 is
not provided.
[0398] As mentioned above, input module 156 is configured to assume
a plurality of activation states. Mechanical control unit 320 is
typically configured to mechanically and non-electrically set the
states of flow regulator 710. Input module 156 is configured to set
the activation states enabling or blocking fluid communication
between the various lumen inlets and the external fluid sources via
respective ports. For some applications, transitions between states
are effected 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 effected 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.
[0399] In this configuration, flow regulator 710 is configured to
have three principal activation states, typically associated with
three configurations (e.g., spatial positions) of mechanical user
control element 320. In the configuration illustrated in FIGS.
9A-C, the three states are actuated by axial motion of proximal
portion 214 of elongated main body 210 relative to input module
housing 310: [0400] as shown in FIG. 9A, a first activation state,
in which flow regulator 710 blocks fluid communication (a) between
suction port 830 and proximal suction inlet 531, and thus one or
more suction lumens 530 and (b) between fluid port 827 and proximal
fluid-delivery inlet 521, and thus one or more fluid-delivery
lumens 520; as a result, fluid communication is blocked to both
fluid-delivery orifices 525 and the interior of inflatable element
588 (this configuration can be used with either the configuration
described with reference to FIG. 7A or that described with
reference to FIG. 7B). For some applications, this first activation
state may be considered to be a base, default activation state,
which optionally is set by an elastic return force element, such as
described hereinbelow with reference to FIGS. 5B-C; [0401] as shown
in FIG. 9B, a second activation state, in which flow regulator 710
effects suction fluid communication between suction port 830 and
one or more suction lumens 530 via proximal suction inlet 531, and
blocks flow of fluid between fluid port 827 and one or more
fluid-delivery lumens 520; and [0402] as shown in FIG. 9C, a third
activation state, in which flow regulator 710 effects both (a)
suction fluid communication between suction port 830 and one or
more suction lumens 530 via proximal suction inlet 531, and (b)
fluid communication between fluid port 827 and one or more
fluid-delivery lumens 520 via proximal fluid-delivery inlet 521; as
a result, fluid communication is provided to both fluid-delivery
orifices 525 and the interior of inflatable element 588.
[0403] As mentioned above, mechanical user control element 320 is
configured to mechanically and non-electrically set the states of
flow regulator 710. Typically, mechanical user control element 320
has at least first, second and third configurations (e.g., spatial
positions), and, typically, is configured to transition between the
first and the third configuration (e.g., spatial positions) via the
second configuration (e.g., spatial position). For example,
mechanical user control element 320 is shown in FIG. 9A in its
first configuration (e.g., spatial position) (right-most position),
in FIG. 9B in its second configuration (e.g., spatial position)
(center position), and in FIG. 9C in its third configuration (e.g.,
spatial position) (left-most position). Input module 156 is
configured such that: [0404] when user control element 320 is in
the first configuration (e.g., spatial position), flow regulator
710 is in the first activation state, as described above; [0405]
when user control element 320 is in the second configuration (e.g.,
spatial position), flow regulator 710 is in the second activation
state, as described above; and [0406] when user control element 320
is in the third configuration (e.g., spatial position), flow
regulator 710 is in the third activation state, as described
above.
[0407] As mentioned, FIG. 9A shows flow regulator 710 in the first
(blocked) state. Input portion 216 of main body 210 is encased, yet
movable, within housing 310 of input module 156. Catheter main body
210 is slidable through a distal wall 314 of housing 310. Housing
310 is shaped so as to define suction port 830 and cleaning fluid
port 827 (main body 210 does not define these ports).
[0408] As main body 210 moves within the inner compartment of
housing 310, transverse sealing separators 341, 342, 343, and 344
delineate distinct chambers within the housing. When flow regulator
710 is in the first activation state, as shown in FIG. 9A,
separators 342 and 343 and the outer surface of elongated main body
210 delineate first chamber 350 around proximal fluid-delivery
inlet 521, and thereby block direct fluid communication within
housing 310 between proximal fluid-delivery inlet 521 and proximal
suction inlet 531. The separators are attached to the main body and
snugly pressed against the inner surface of housing 310, so that
the insulated chamber around proximal fluid-delivery inlet 521 is
maintained even as the main body slides a certain distance along
the longitudinal axis thereof with respect the housing.
[0409] Also as shown in FIG. 9A, in the first activation state,
elongated main body 210 is positioned in its closest position to a
proximal end 360 of housing 310, proximal-most separator 344
creates a seal which prevents direct fluid communication between
suction port 830 of housing 310 and proximal suction inlet 531 of
elongated main body 210. In this base position, cleaning fluid flow
is blocked within a second sealed chamber 352 delineated by
separators 341 and 342 and the outer surface of elongated main body
210.
[0410] When flow regulator 710 is in the second activation state,
as shown in FIG. 9B, fluid communication is established between
suction port 830 of housing 310 and proximal suction inlet 531 and
into one or more suction lumens 530 in elongated main body 210, yet
cleaning fluid flow remains blocked within second sealed chamber
352 delineated by separators 341 and 342 and the outer surface of
elongated main body 210. This activation is achieved by sliding
elongated main body 210 distally along the axial direction by a
limited distance such that separator 342 does not yet cross into
the space of cleaning fluid port 827. Typically, this sliding
motion is induced by distally pushing on mechanical user control
element 320, which is coupled to elongated main body 210 and passes
through a slit 312 in housing 310 which allows axial motion of
mechanical user control element 320.
[0411] When flow regulator 710 is in the third activation state, as
shown in FIG. 9C, fluid communication is established in first
chamber 350 between cleaning fluid port 827 of housing 310 and
proximal fluid-delivery inlet 521 and one or more fluid-delivery
lumens 520 in elongated main body 210. Suction port 830 of housing
310 remains in fluid communication with proximal suction inlet 531
and into one or more suction lumens 530 in elongated main body 210.
Therefore, in this third activation state, flow regulator 710
effects both (a) cleaning fluid flow into one or more
fluid-delivery lumens 520 and (b) suction in one or more suction
lumens 530 of elongated main body 210. This activation is achieved
by sliding elongated main body 210 more distally along the axial
direction by a limited distance such that separator 342 crosses
into or passes across the space of cleaning fluid port 827.
Typically, the sliding motion is induced by distally pushing on
mechanical user control element 320, which is coupled to elongated
main body 210 and passes through slit 312 in housing 310.
[0412] Thus, three activation states can be actuated, typically
associated with three configurations (e.g., spatial positions) of
mechanical user control element 320. In the configuration
illustrated in FIGS. 9A-C, the three states are actuated by axial
motion of input portion 216 of elongated main body 210 relative to
input module housing 310: [0413] the first activation state, in
which suction flow and cleaning fluid flow is blocked; [0414] the
second activation state, in which suction flow is enabled between
one or more suction lumens 530 and suction port 830 via proximal
suction inlet 531 into one or more suction lumens 530, but cleaning
fluid flow into one or more fluid-delivery lumens 520 remains
blocked; and [0415] the third activation state, in which suction
flow is enabled both between one or more suction lumens 530 and
suction port 830 via proximal suction inlet 531 into one or more
suction lumens 530, and cleaning fluid flow into one or more
fluid-delivery lumens 520 from fluid port 827 of housing 310 via
proximal fluid-delivery inlet 521, thereby both providing fluid to
fluid-delivery orifices 525 and the interior of inflatable element
588, so as to inflate the inflatable element.
[0416] Operational safely is inherent because there is no
activation state in which cleaning fluid flow is enabled without
suction also being activated.
[0417] For some applications, expandable element 588 is emptied by
suction via the same suction source 601 which is connected to
suction port 830. This can be enabled, for example, by establishing
fluid communication between the lumen which is in fluid
communication with expandable element (at least one of one or more
fluid-delivery lumens 520 or inflation lumen 580). For some
applications, expandable element 588 can be both inflated via
pressurized delivery fluid in communication with one or more
fluid-delivery lumens 520 and be deflated by suction provided by
the same source 601 connected to one or more suction lumens 530.
Examples of such configurations are described hereinbelow with
reference to FIGS. 10 and 11A-C, FIGS. 12A-B and 13A-B, FIGS. 14
and 15A-B, and FIGS. 16A-C.
[0418] Reference is now made to FIG. 10, which is a schematic
illustration of a portion of proximal portion 214 of main body 210,
in accordance with an application of the present invention. FIG. 10
shows one or more fluid-delivery lumens 520 and one or more suction
lumens 530, which have been omitted from FIGS. 11A-C for clarity of
illustration. FIG. 10 (and FIGS. 11A-C) illustrate configurations
of proximal portion 214 of main body 210 appropriate for use with
either of the configurations of distal portion 212 of cleaning
catheter 200 described hereinabove with reference to FIGS. 7A and
7B. In these configuration, expandable element 588 is inflated via
fluid communication to pressurized fluid in at least one of one or
more fluid-delivery lumens 520, e.g., exactly one fluid-delivery
lumen 520, which are in fluid communication with an interior of
expandable element 588. There is thus no need to provide separate
inflation lumen 580 to the expandable element, because the
expandable element is inflated via one or more inflation outlets
585 from the at least one of the one or more fluid-delivery lumens
520 itself. Alternatively, expandable element 588 is inflated via
dedicated inflation lumen 580 which is in fluid communication
directly with one or more fluid-delivery lumens 520, or with the
same source 602 of pressurized fluid with which one or more
fluid-delivery lumens 520 are in fluid communication (configuration
not shown). The configuration shown in FIG. 10 is the same as that
shown in FIG. 8, described hereinabove.
[0419] Reference is made to FIGS. 11A-C, which are schematic
illustrations of several states of a flow regulator 712 of input
module 156, in accordance with an application of the present
invention. Except as described as follows, input module 156 is
configured as described hereinabove with reference to FIGS. 4A-C
and 9A-C. Except as described as follows, flow regulator 712 is
generally similar to flow regulator 710, described hereinabove with
reference to FIGS. 9A-C. As mentioned above, in some applications
input portion 216 of proximal portion of main body 210 is
configured to be inserted into and axially slidable with respect to
input module 156. Input module 156 has a plurality of ports for
connection with various fluid sources, including at least suction
source 601 and pressurized fluid source 602. In this configuration,
input module 156 includes fluid port 827, which is coupleable in
fluid communication with pressurized fluid source 602, and suction
port 830, which is coupleable in fluid communication with suction
source 601, but does not include inflation port 832, described
hereinabove with reference to FIGS. 4A-C. In addition, inflation
source 603 is not provided.
[0420] As mentioned above, input module 156 is configured to assume
a plurality of activation states. Mechanical control unit 320 is
typically configured to mechanically and non-electrically set the
states of flow regulator 712. Input module 156 is configured to set
the activation states enabling or blocking fluid communication
between the various lumen inlets and the external fluid sources via
respective ports. For some applications, transitions between states
are effected 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 effected 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.
[0421] In this configuration, flow regulator 712 is configured to
have three principal activation states, typically associated with
three configurations (e.g., spatial positions) of mechanical user
control element 320. In the configuration illustrated in FIGS.
11A-C, the three states are actuated by axial motion of proximal
portion 214 of elongated main body 210 relative to input module
housing 310: [0422] as shown in FIG. 11A, a first activation state,
in which flow regulator 712 blocks fluid communication (a) between
suction port 830 and proximal suction inlet 531, and thus one or
more suction lumens 530 and (b) between fluid port 827 and proximal
fluid-delivery inlet 521, and thus one or more fluid-delivery
lumens 520; as a result, fluid communication is blocked to both
fluid-delivery orifices 525 and the interior of inflatable element
588 (this configuration can be used with either the configuration
described with reference to FIG. 7A or that described with
reference to FIG. 7B). For some applications, this first activation
state may be considered to be a base, default activation state,
which optionally is set by an elastic return force element, such as
described hereinbelow with reference to FIGS. 5B-C; [0423] as shown
in FIG. 11B, a second activation state, in which flow regulator 712
(a) effects suction fluid communication between suction port 830
and one or more suction lumens 530 via proximal suction inlet 531,
(b) effects suction fluid communication between suction port 830
and one or more fluid-delivery lumens 520 via proximal
fluid-delivery inlet 521 (thereby deflating inflatable element
588), and (c) blocks flow of fluid between fluid port 827 and one
or more fluid-delivery lumens 520. In this second activation state,
flow regulator typically does not effect the fluid communication
between suction source 601 and distal orifices 440; and [0424] as
shown in FIG. 11C, a third activation state, in which flow
regulator 712 effects both (a) suction fluid communication between
suction port 830 and one or more suction lumens 530 via proximal
suction inlet 531, and (b) fluid communication between fluid port
827 and one or more fluid-delivery lumens 520 via proximal
fluid-delivery inlet 521; as a result, fluid communication is
provided to both fluid-delivery orifices 525 and the interior of
inflatable element 588, thereby inflating the inflatable element.
(In this third activation state, flow regulator 712 does not effect
the fluid communication between suction source 601 and the interior
of inflatable element 588.)
[0425] As mentioned above, mechanical user control element 320 is
configured to mechanically and non-electrically set the states of
flow regulator 712. Typically, mechanical user control element 320
has at least first, second and third configurations (e.g., spatial
positions), and, typically, is configured to transition between the
first and the third configuration (e.g., spatial positions) via the
second configuration (e.g., spatial position). For example,
mechanical user control element 320 is shown in FIG. 11A in its
first configuration (e.g., spatial position) (right-most position),
in FIG. 11B in its second configuration (e.g., spatial position)
(center position), and in FIG. 11C in its third configuration
(e.g., spatial position) (left-most position). Input module 156 is
configured such that: [0426] when user control element 320 is in
the first configuration (e.g., spatial position), flow regulator
712 is in the first activation state, as described above; [0427]
when user control element 320 is in the second configuration (e.g.,
spatial position), flow regulator 712 is in the second activation
state, as described above; and [0428] when user control element 320
is in the third configuration (e.g., spatial position), flow
regulator 712 is in the third activation state, as described
above.
[0429] As mentioned, FIG. 11A shows flow regulator 712 in the first
(blocked) state. Input portion 216 of main body 210 is encased, yet
movable, within housing 310 of input module 156. Catheter main body
210 is slidable through a distal wall 314 of housing 310. Housing
310 is shaped so as to define suction port 830 and cleaning fluid
port 827 (main body 210 does not define these ports).
[0430] As main body 210 moves within the inner compartment of
housing 310, transverse sealing separators 341, 342, 343, and 344
delineate distinct chambers within the housing. When flow regulator
712 is in the first activation state, as shown in FIG. 11A,
separators 342 and 343 and the outer surface of elongated main body
210 delineate first chamber 350 around proximal fluid-delivery
inlet 521, and thereby block direct fluid communication within
housing 310 between proximal fluid-delivery inlet 521 and proximal
suction inlet 531. The separators are attached to the main body and
snugly pressed against the inner surface of housing 310, so that
the insulated chamber around proximal fluid-delivery inlet 521 is
maintained even as the main body slides a certain distance along
the longitudinal axis thereof with respect the housing.
[0431] However, the insulating capability of separator 343 between
proximal fluid-delivery inlet 521 and proximal suction inlet 531
also depends on the full engagement of the separator with the inner
wall of housing 310. A widening 348 of the encasing inner wall of
housing 310, shown in FIGS. 11A-C, creates a path of fluid
communication between proximal fluid-delivery inlet 521 and
proximal suction inlet 531 around the separator 343 edge, i.e.,
between first chamber 350 and a third chamber 354 defined by
separators 343 and 344 and the outer surface of elongated main body
210.
[0432] Also as shown in FIG. 11A, in the first activation state,
elongated main body 210 is positioned in its closest position to a
proximal end 360 of housing 310, proximal-most separator 344
creates a seal which prevents direct fluid communication between
suction port 830 of housing 310 and proximal suction inlet 531 of
elongated main body 210. In this base position, cleaning fluid flow
is blocked within a second sealed chamber 352 delineated by
separators 341 and 342 and the outer surface of elongated main body
210.
[0433] When flow regulator 712 is in the second activation state,
as shown in FIG. 11B, fluid communication is established between
suction port 830 of housing 310 and proximal suction inlet 531 and
into one or more suction lumens 530 in elongated main body 210, yet
cleaning fluid flow remains blocked within second sealed chamber
352 delineated by separators 341 and 342 and the outer surface of
elongated main body 210. This activation is achieved by sliding
elongated main body 210 distally along the axial direction by a
limited distance such that separator 342 does not yet cross into
the space of cleaning fluid port 827. Typically, this sliding
motion is induced by distally pushing on mechanical user control
element 320, which is coupled to elongated main body 210 and passes
through a slit 312 in housing 310 which allows axial motion of
mechanical user control element 320.
[0434] In addition, in this second activation state, fluid
communication is established between proximal fluid-delivery inlet
521 and proximal suction inlet 531 (e.g., around the outermost edge
of separator 343 via widening 348 in the wall of housing 310).
Thus, in the second activation state, the suction force acts both
on one or more suction lumens 530 and on expandable element 588
(e.g., communicated via one or more fluid-delivery lumens 520).
[0435] When flow regulator 712 is in the third activation state, as
shown in FIG. 11C, fluid communication is established in first
chamber 350 between cleaning fluid port 827 of housing 310 and
proximal fluid-delivery inlet 521 and one or more fluid-delivery
lumens 520 in elongated main body 210. Suction port 830 of housing
310 remains in fluid communication with proximal suction inlet 531
and into one or more suction lumens 530 in elongated main body 210.
Therefore, in this third activation state, flow regulator 712
effects both (a) cleaning fluid flow into one or more
fluid-delivery lumens 520 and (b) suction in one or more suction
lumens 530 of elongated main body 210. This activation is achieved
by sliding elongated main body 210 more distally along the axial
direction by a limited distance such that separator 342 crosses
into or passes across the space of cleaning fluid port 827.
Typically, the sliding motion is induced by distally pushing on
mechanical user control element 320, which is coupled to elongated
main body 210 and passes through slit 312 in housing 310.
[0436] In addition, in this third activation state, the path of
fluid communication between proximal fluid-delivery inlet 521 and
proximal suction inlet 531 is blocked (e.g., because full
engagement of separator 343 with the bounding wall of encasing
housing 310 is established, because separator 343 is no longer
axially aligned with widening 348). Thus, in the third activation
state, suction force is blocked from expandable element 588 and
acts only on one or more suction lumens 530. Additional
arrangements for achieving fluid communication between first and
third chambers 350 and 354 in the second activation state but not
the third activation state will be evident to those skilled in the
art who have read the present patent application, and are within
the scope of the present invention.
[0437] Thus, three activation states can be actuated, typically
associated with three configurations (e.g., spatial positions) of
mechanical user control element 320. In the configuration
illustrated in FIGS. 11A-C, the three states are actuated by axial
motion of input portion 216 of elongated main body 210 relative to
input module housing 310: [0438] the first activation state, in
which suction flow and cleaning fluid flow is blocked; [0439] the
second activation state, in which suction flow is enabled between
one or more suction lumens 530 and suction port 830 via proximal
suction inlet 531 into one or more suction lumens 530, and suction
flow is also enabled between suction port 830 and the interior of
inflatable element 588 via one or more fluid-delivery lumens 520
(thereby deflating the inflatable element), but cleaning fluid flow
into one or more fluid-delivery lumens 520 remains blocked; and
[0440] the third activation state, in which suction flow is enabled
both between one or more suction lumens 530 and suction port 830
via proximal suction inlet 531 into one or more suction lumens 530,
and cleaning fluid flow into one or more fluid-delivery lumens 520
from fluid port 827 of housing 310 via proximal fluid-delivery
inlet 521, thereby both providing fluid to fluid-delivery orifices
525 and the interior of inflatable element 588, so as to inflate
the inflatable element.
[0441] For some applications: [0442] flow regulator 712, when in
the second activation state, effects fluid communication between
suction source 601 and an interior of the inflatable element 588
via at least one of one or more fluid-delivery lumens 520, thereby
deflating inflatable element 588, and [0443] flow regulator 712,
when in the third activation state, effects fluid communication
between suction source 601 and distal suction orifices 440 via one
or more suction lumens 530, and does not effect the fluid
communication between suction source 601 and the interior of
inflatable element 588.
[0444] Operational safely is inherent because there is no
activation state in which cleaning fluid flow is enabled without
suction also being activated.
[0445] Reference is now made to FIG. 12, which is a schematic
illustration of a portion of proximal portion 214 of main body 210,
in accordance with an application of the present invention. FIG. 12
shows one or more fluid-delivery lumens 520 and one or more suction
lumens 530, which have been omitted from FIGS. 13A-B for clarity of
illustration. FIG. 12 (and FIGS. 13A-B) illustrate configurations
of proximal portion 214 of main body 210 appropriate for use with
either of the configurations of distal portion 212 of cleaning
catheter 200 described hereinabove with reference to FIGS. 7A and
7B. In these configurations, expandable element 588 is inflated via
fluid communication to pressurized fluid in at least one of one or
more fluid-delivery lumens 520, e.g., exactly one fluid-delivery
lumen 520, which are in fluid communication with an interior of
expandable element 588. There is thus no need to provide separate
inflation lumen 580 to the expandable element (such as described
hereinabove with reference to FIGS. 3 and 4A-C), because the
expandable element is inflated via one or more inflation outlets
585 from the at least one of the one or more fluid-delivery lumens
520 itself. Alternatively, expandable element 588 is inflated via
dedicated inflation lumen 580 which is in fluid communication
directly with one or more fluid-delivery lumens 520, or with the
same source 602 of pressurized fluid with which one or more
fluid-delivery lumens 520 are in fluid communication (configuration
not shown). The configuration shown in FIG. 12 is the same as that
shown in FIGS. 8 and 10, described hereinabove.
[0446] Reference is made to FIGS. 13A-B, which are schematic
illustrations of several states of a flow regulator 714 of input
module 156, in accordance with an application of the present
invention. Except as described as follows, input module 156 is
configured as described hereinabove with reference to FIGS. 9A-C
and 11A-C. Except as described as follows, flow regulator 714 is
generally similar to flow regulator 712, described hereinabove with
reference to FIGS. 11A-C. As mentioned above, in some applications
input portion 216 of proximal portion of main body 210 is
configured to be inserted into and axially slidable with respect to
input module 156. Input module 156 has a plurality of ports for
connection with various fluid sources, including at least suction
source 601 and pressurized fluid source 602. In this configuration,
input module 156 includes fluid port 827, which is coupleable in
fluid communication with pressurized fluid source 602, and suction
port 830, which is coupleable in fluid communication with suction
source 601, but does not include inflation port 832, described
hereinabove with reference to FIGS. 4A-C. In addition, inflation
source 603 is not provided.
[0447] As mentioned above, input module 156 is configured to assume
a plurality of activation states. Mechanical control unit 320,
together with a valve 946 if provided, are typically configured to
mechanically and non-electrically set the states of flow regulator
714. Input module 156 is configured to set the activation states
enabling or blocking fluid communication between the various lumen
inlets and the external fluid sources via respective ports. For
some applications, transitions between states are effected in part
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 effected 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.
[0448] In addition, flow regulator 714 optionally comprises a fluid
communication suction channel 551, having distal and proximal
inlets 941 and 942. For some applications, fluid communication
suction channel 551 is disposed external to housing 310; for
example, channel 551 may be provided by a separate tube, such as
shown in FIGS. 13A-B. Suction channel proximal inlet 942 is in
fluid communication with suction source 601; for example, proximal
inlet 942 may be in fluid communication with suction port 830, such
as shown in FIG. 13A. Suction channel distal inlet 941 is coupled
in fluid communication with housing 310 such that, when flow
regulator 714 is in the first activation state shown in FIG. 13A,
distal inlet 941 is in fluid communication with an interior of
expandable element 588, e.g., via fluid-delivery inlet 521 and at
least one of one or more fluid-delivery lumens 520, as shown in
FIG. 13A, or via an inflation inlet 581 and inflation lumen 580 in
the alternative configuration described hereinbelow with reference
to FIG. 15A. As a result, suction can be delivered to expandable
element 588 via the at least one of the one or more fluid-delivery
lumens 520 or inflation lumen 580, even at a time when no suction
is delivered to one or more suction lumens 530, in the first
position shown FIG. 13A.
[0449] For some applications, flow regulator 714 further comprises
a valve 946, which is in fluid communication with suction port 830,
and which is arranged to regulate fluid flow through suction
channel 551. Valve 946 is switchable between closed and open fluid
communication states between distal inlet 941 and proximal inlet
942 of suction channel 551.
[0450] In this configuration, flow regulator 714 enables
independent control over the suction communication to expandable
element 588 for deflation thereof. Flow regulator 714 is configured
to have up to four principal activation states, typically
associated with three configurations (e.g., spatial positions) of
mechanical user control element 320. In the configuration
illustrated in FIGS. 13A-B, the states are actuated by axial motion
of proximal portion 214 of elongated main body 210 relative to
input module housing 310 and, optionally by setting the state of
valve 946: [0451] as shown in FIG. 13A, a primary first activation
state, in which valve 946 is in the open state. In this state flow
regulator 714 blocks fluid communication (a) between suction port
830 and proximal suction inlet 531, and thus one or more suction
lumens 530; as a result, fluid communication is blocked to
fluid-delivery orifices 525 (this configuration can be used with
either the configuration described with reference to FIG. 7A or
that described with reference to FIG. 7B). In addition, in this
state flow regulator 714 effects suction fluid communication
between suction port 830 and the interior of inflatable element 588
via (a) suction channel 551, (b) proximal fluid-delivery inlet 521,
and (c) one or more fluid-delivery lumens 520, thereby deflating
inflatable element 588. For some applications, this primary first
activation state may be considered to be a primary base, default
activation state, which optionally is set in part by an elastic
return force element, such as described hereinbelow with reference
to FIGS. 5B-C; [0452] also as shown in FIG. 13A, a secondary
activation state, in which valve 946 is in the open state, and
proximal portion 214 of elongated main body 210 is in the same
relative axial position with respect to input module housing 310 as
in the primary first activation state. In this secondary activation
state, flow regulator 714 blocks fluid communication (a) between
suction port 830 and proximal suction inlet 531, and thus one or
more suction lumens 530 and (b) between fluid port 827 and proximal
fluid-delivery inlet 521 (because valve 946 blocks suction channel
551), and thus one or more fluid-delivery lumens 520; as a result,
fluid communication is blocked to both fluid-delivery orifices 525
and the interior of inflatable element 588. For some applications,
this secondary first activation state may be considered to be a
secondary base, default activation state; [0453] a second
activation state, in which flow regulator 714 effects suction fluid
communication between suction port 830 and one or more suction
lumens 530 via proximal suction inlet 531, and blocks flow of fluid
between fluid port 827 and one or more fluid-delivery lumens 520.
This second activation state is not shown in FIGS. 13A-B, but is
typically identical to the state show in FIG. 9B, except for the
difference in flow regulator 714 described above. In this state,
suction channel 551 typically has no effect on the state of fluid
flow; and [0454] as shown in FIG. 13C, a third activation state, in
which flow regulator 714 effects both (a) suction fluid
communication between suction port 830 and one or more suction
lumens 530 via proximal suction inlet 531, and (b) fluid
communication between fluid port 827 and one or more fluid-delivery
lumens 520 via proximal fluid-delivery inlet 521; as a result,
fluid communication is provided to both fluid-delivery orifices 525
and the interior of inflatable element 588, thereby inflating the
inflatable element. (In this third activation state, flow regulator
714 does not effect the fluid communication between suction source
601 and the interior of inflatable element 588.)
[0455] As mentioned above, mechanical user control element 320 and
valve 946 if provided are configured to mechanically and
non-electrically set the states of flow regulator 714. Typically,
mechanical user control element 320 has at least first, second and
third configurations (e.g., spatial positions), and, typically, is
configured to transition between the first and the third
configuration (e.g., spatial positions) via the second
configuration (e.g., spatial position). For example, mechanical
user control element 320 is shown in FIG. 13A in its first
configuration (e.g., spatial position) (right-most position) and in
FIG. 13C in its third configuration (e.g., spatial position)
(left-most position). Input module 156 is configured such that:
[0456] when user control element 320 is in the first configuration
(e.g., spatial position), flow regulator 714 is in the primary or
second first activation state (depending on the state of valve
946), as described above; [0457] when user control element 320 is
in the second configuration (e.g., spatial position), flow
regulator 714 is in the second activation state, as described
above; and [0458] when user control element 320 is in the third
configuration (e.g., spatial position), flow regulator 714 is in
the third activation state, as described above.
[0459] Thus, four activation states can be actuated (three
mandatory and one optional), typically associated with three
configurations (e.g., spatial positions) of mechanical user control
element 320 and, optionally, two states of valve 946. In the
configuration illustrated in FIGS. 13A-B, the four states are
actuated by axial motion of input portion 216 of elongated main
body 210 relative to input module housing 310, as well as by the
state of valve 946: [0460] the primary first activation state, in
which suction flow to one or more suction lumens 530 and cleaning
fluid flow is blocked, and inflatable element 588 is deflated by
active suction (via open suction channel 551 flow); [0461] the
secondary first activation state, in which suction flow to one or
more suction lumens 530 is blocked and cleaning fluid flow is
blocked, and also suction flow to inflatable element 588 is blocked
(because valve 946 blocks flow through suction channel 551); [0462]
the second activation state, in which suction flow is enabled
between one or more suction lumens 530 and suction port 830 via
proximal suction inlet 531 into one or more suction lumens 530, but
cleaning fluid flow into one or more fluid-delivery lumens 520
remains blocked; and [0463] the third activation state, in which
suction flow is enabled both between one or more suction lumens 530
and suction port 830 via proximal suction inlet 531 into one or
more suction lumens 530, and cleaning fluid flow into one or more
fluid-delivery lumens 520 from fluid port 827 of housing 310 via
proximal fluid-delivery inlet 521, thereby both providing fluid to
fluid-delivery orifices 525 and the interior of inflatable element
588, so as to inflate the inflatable element.
[0464] Operational safely is inherent because there is no
activation state in which cleaning fluid flow is enabled without
suction also being activated.
[0465] Reference is now made to FIG. 14, which is a schematic
illustration of a portion of proximal portion 214 of main body 210,
in accordance with an application of the present invention, and
FIGS. 15A-B, which are schematic illustrations of several states of
a flow regulator 714 of input module 156, in accordance with an
application of the present invention. Except as described
hereinbelow, the configuration shown in FIGS. 14 and 15A-B is
identical to the configuration described hereinabove with reference
to FIGS. 12 and 13A-B, and achieves the same activation states.
[0466] In this configuration, catheter main body 210, in addition
to one or more fluid-delivery lumens 520 and one or more suction
lumens 530, comprises independent inflation lumen 580 in fluid
communication with an interior of expandable element 588. In order
to achieve the same dual activation as in the configuration of
FIGS. 12 and 13A-B, input portion 216 of elongated main body 210 is
shaped so as define inflation inlet 581 to inflation lumen 580 at
about the same axial position along main body 210 as proximal
fluid-delivery inlet 521 to one or more fluid-delivery lumens 520.
As a result, inflation lumen 580 and one or more fluid-delivery
lumens 520 are commonly in fluid communication with one another
(e.g., in the flow regulator), and therefore receive fluid delivery
or suction actions essentially simultaneously. In other words, the
fluid communication to expandable element 588 can be provided
either via dedicated lumen 580, as shown in FIGS. 14 and 15A-B, or
via one or more shared fluid-delivery lumens 520, as shown in FIGS.
12 and 13A-B. One difference between the configuration of FIGS. 12
and 13A-B and the configuration of FIGS. 14 and 15A-B is that, in
the configuration of FIGS. 12 and 13A-B, unlike in the
configuration of FIGS. 14 and 15A-B, the interior of expandable
element 588 is in fluid communication with fluid-delivery orifices
525.
[0467] For some applications (although this feature is typically
not implemented), if the suction flow out of the expandable element
is relatively weak compared with the fluid flow into the expandable
element, it may be possible to maintain the expandable element
inflated even if both pressurized fluid and weak suction is
simultaneously communicated to it.
[0468] Reference is now made to FIGS. 16A-C, which are schematic
illustrations of a configuration of input module 156 comprising a
state protective selector 390, in accordance with an application of
the present invention. Although the configuration of input module
156 shown generally corresponds to the configurations described
hereinabove with reference to FIGS. 12 and 13A-B and FIGS. 14 and
15A-B, state protective selector 390 may also be provided for the
other configurations described herein.
[0469] State protective selector 390 provides a plurality of
protective states, each of which prevents certain movements of
mechanical user control element 320, while allowing other movements
of element 320. In a protective selector first state 391, shown in
FIG. 16A, movement of mechanical user control element 320 is
limited such that it is locked in the first configuration (e.g.,
spatial position), corresponding to the first activation state of
the flow regulator. In a protective selector second state 392,
shown in FIG. 16B, movement of mechanical user control element 320
is limited such that it can move only between the first
configuration (e.g., spatial position) and the second configuration
(e.g., spatial position), corresponding to the second activation
state. In a protective selector third state 393, movement of
mechanical user control element 320 is enabled to reach all three
of the first, second, and third configuration (e.g., spatial
positions), corresponding to all three activation states,
respectively.
[0470] Therefore, as illustrated in FIGS. 16A-C, at least
activation states can be actuated (three mandatory, and one
optional), typically associated with three configuration (e.g.,
spatial positions) of mechanical user control element 320, and an
optional independent control valve state of suction flow to the
expandable element. In the configuration illustrated in FIGS.
16A-C, the activation states are actuated by axial motion of
elongated main body 210 relative to input module housing 310, as
well as by the state of valve 946: [0471] a first activation state,
in which both suction flow to one or more suction lumens 530 and
cleaning fluid flow are blocked, and inflatable element 588 is
deflated by active suction (via open suction channel 551 flow);
[0472] a second activation state, in which suction flow is enabled
between one or more suction lumens 530 and suction port 830 via
proximal suction inlet 531 into one or more suction lumens 530,
inflatable element 588 is deflated by active suction (via open
suction channel 551 flow), but cleaning fluid flow into one or more
fluid-delivery lumens 520 remains blocked; and [0473] a third
activation state, in which suction flow is enabled both between one
or more suction lumens 530 and suction port 830 via proximal
suction inlet 531 into one or more suction lumens 530, and cleaning
fluid flow into one or more fluid-delivery lumens 520 from fluid
port 827 of housing 310 via proximal fluid-delivery inlet 521, and
inflatable element 588 is inflated.
[0474] Alternatively, similar to the configuration described
hereinabove with reference to FIGS. 12 and 13A-B, valve 946 is
implemented on suction channel 551. In such a configuration, the
first activation state includes primary and secondary activation
states, as described hereinabove with reference to FIGS. 12 and
13A-B.
[0475] Reference is now made to FIGS. 17A-C, which are schematic
illustrations of another configuration of input module 156, in
accordance with an application of the present invention. In this
configuration, the sealing separators are fixed with respect to
housing 310 (and slidable with respect to the catheter main body).
Optionally, main body 210 is shaped so as to define proximal
suction inlet 531 at a proximal end of the main body. In the
configuration shown in FIGS. 17A-C, one or more fluid-delivery
lumens 520 are in fluid communication with inflatable element 588,
such as described hereinabove with reference to FIG. 7A or with
reference to FIG. 7B.
[0476] In this configuration, input module 156 comprises a sealing
separator 373, such as an o-ring, which is fixed with respect to
housing 310. Sealing separator 373 sealingly separates between
fluid port 827 and suction port 830. Catheter main body 210 is
slidable with respect to sealing separator 373. Thus, fluid
communication to one or more fluid-delivery lumens 520 (and
optionally also to inflation lumen 580) is switchable from suction
communication to fluid delivery communication by axial motion of
catheter main body 210. As a result, activation of fluid delivery
to fluid-delivery orifices 525 and inflation of inflatable element
588 is activated by switching and enabling fluid communication to
the same fluid-delivery-pressure source 602. The activation of the
switching is done by axial motion of catheter main body 210 with
respect to housing 310, to which the suction connectors and fluid
delivery connectors are coupled. On the other hand, inflatable
element 588 is deflated by cessation of fluid delivery to one or
more fluid-delivery lumens 520 and then switching and enabling
fluid communication of the inflatable element 588 to the same
suction source 601 connected to suction connector 830 (e.g., via
channel 551 as illustrated in FIG. 17A).
[0477] Proximal suction inlet 531 is configured to sealingly engage
a suction sealer 375. The suction sealer 375 is fixed with respect
to housing 310. When proximal suction inlet 531 is sealingly
engaged with suction sealer 375 (as shown in FIG. 17A), fluid
communication is blocked between proximal suction inlet 531 and
suction port 830, thereby blocking fluid communication between
suction source 601 and lumen 530 in the first activation state.
When proximal suction inlet 531 is disengaged from suction sealer
375 (as shown in FIG. 17B), fluid communication is enabled between
proximal suction inlet 531 and suction port 830. This
engaging/disengaging is preferably actuated by axial motion of
catheter main body 210 with respect to suction sealer 375.
[0478] As shown in FIG. 17A, at least one suction channel 551
facilitates fluid communication to suction port 830 around the
suction sealer 375. Therefore, when proximal fluid-delivery inlet
521 is in fluid communication with suction channel 551, suction is
communicated to one or more fluid-delivery lumens 520, while
suction remains blocked by suction sealer 375 from communication to
one or more suction lumens 530.
[0479] For example, in applications in which inflatable element 588
is in fluid communication with at least one of one or more
fluid-delivery lumens 520, suction deflation of the inflatable
element is effected while no suction is communicated to distal
suction orifices 440 of the catheter main body.
[0480] Reference is now made to FIGS. 18A-C, which are schematic
illustrations of yet another configuration of input module 156, in
accordance with an application of the present invention. This
configuration is similar to that described hereinabove with
reference to FIGS. 17A-C, except that 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, similar to the configuration of
mechanical user control element 320 described hereinabove with
reference to FIGS. 6A-B. Mechanical user control element 320
translates the movement of user control handle 718 into axial
motion of axial motion element 318.
[0481] Reference is now made to FIGS. 19A-C, which are schematic
illustrations of an input module 356, in accordance with an
application of the present invention. Input module 356 is generally
similar to input module 156, described hereinabove, except that
input module 356 comprises a mechanical user control element 420
that comprises at least first and second buttons 321 and 322. First
button 321 controls the activation of suction into one or more
suction lumens 530, and second button 322 controls the activation
of fluid delivery into one or more fluid-delivery lumens 520, such
as using the techniques described hereinbelow with reference to
FIGS. 19D-F.
[0482] For some applications, mechanical user control element 420
further comprises a button joining element 324, which is fixed to
first button 321, and arranged to allow depression of first button
321 only to a certain extent independently of depression of second
button 322. Button joining element 324 allows the depression of
first button 321 and/or button joining element 324 from the state
of depression of first button 321 shown in FIG. 19A to the greater
state of depression of first button 321 shown in FIG. 19B, without
also depressing second button 322. However, further depression of
first button 321 and/or button joining element 324 causes the
simultaneous depression of second button 322, as shown in FIG.
19C.
[0483] Typically, the activation states of the configuration
described with reference to FIGS. 19A-C correspond with those
described hereinabove with reference to FIGS. 18A-C.
[0484] FIGS. 19D-F are schematic illustrations of the operation of
buttons 321 and 322, in accordance with an application of the
present invention. In particular, it is noted that the operation of
switching between activation states in this configuration does not
involve motion of catheter main body 210 (e.g., no motion relative
to suction inlet 830). The states shown in FIGS. 19D, 19E, and 19F
correspond to the states shown in FIGS. 19A, 19B, and 19C,
respectively.
[0485] As illustrated in FIG. 19D, suction lumen 530 is intermitted
by a gate area 327 traversed by suction control button 321, and
fluid-delivery lumen 520 is intermitted by a gate area 328
traversed by suction control button 322. Thus, in this
configuration, the fluid communication is blocked in lumen 530
across gate 327 and blocked in fluid-delivery lumen 520 across gate
328.
[0486] FIG. 19D, when understood to show a sub-detail of FIG. 19A,
illustrates the main principle of the button press mechanism in
which fluid communication between suction port 830 and the distal
end of the main body 210 is interrupted by button gate 321. By way
of non-limiting example, FIG. 19D illustrates such interruption as
taking place on a portion of lumen 530 in main body 210 itself. The
scope of the present invention includes other configuration. For
example, the same principles of this mechanism can be realized by
the button interrupting the fluid communication between suction
port 830 and inlet 531 to lumen 530. Similarly, the same principles
of this mechanism of button action is applicable to button 322
interrupting the fluid communication between fluid port 827 and
proximal fluid-delivery inlet 521 to the fluid-delivery lumen
520.
[0487] As illustrated in FIG. 19E, the control button 321 has a
hole passage 325. When the button 321 is partially depressed to the
level that hole passage 325 overlaps with the lumen 530
cross-section, fluid communication is enabled in suction lumen 530
across the gate 327. Yet, at this button 321 depression level,
there is no change in button 322 depression level, and therefore
fluid communication remains blocked in fluid-delivery lumen 520
across the gate 328 in this second activation state.
[0488] As illustrated in FIG. 19F, the control button 322 has a
hole passage 326. When button 321 is further depressed such that
also the button 322 is depressed to the level that hole passage 326
overlaps with the fluid-delivery lumen 520 cross-section, fluid
communication is enabled in fluid-delivery lumen 520 across gate
328. Therefore, fluid communication is enabled across both
fluid-delivery lumen 520 and suction lumen 530 in this button
control configuration for the third activation state.
[0489] Reference is now made to FIG. 20, which is a schematic
illustration of input module 156, in accordance with an application
of the present invention. This configuration may be implemented in
conjunction with any of the configurations of input module 156
described herein in which expandable element 588 is inflatable. In
this configuration, input module 156 comprises an external
inflation indicator 583, which indicates inflation/deflation state
of expandable element 588. For some applications, inflation
indicator 583 comprises pilot balloon. Pilot balloon 583 is in
fluid communication with the lumen in fluid communication with
inflatable element 588, such that the inflation pressures of the
pilot balloon and the inflatable element are correlated (though
likely not identical due to a pressure drop in the lumen in fluid
communication with inflatable element 588).
[0490] Reference is now made to FIGS. 21A-B and 22A-C, which are
schematic illustrations of distal portion 212 of cleaning catheter
200 inserted into ventilation tube 160, in accordance with an
application of the present invention. FIGS. 21A and 21B are side
view of expandable element 588 in uninflated and inflated states,
respectively. FIGS. 22A, 22B, and 22C are cross-sectional views of
distal portion 212 of cleaning catheter 200 taken along lines at an
axial location proximal to the proximal-most suction orifices 440
in FIG. 21A, at inflatable element 588 in FIG. 21A, and at
inflatable element 588 in 21B, respectively. In this configuration,
expandable element 588 comprises an inflatable element, such as a
balloon. The configuration described with reference to FIGS. 21A-B
and 22A-C may be used in combination with any of the other
configurations of cleaning system 100 described hereinabove,
mutatis mutandis. For some applications, one or more suction lumens
530 comprise exactly one suction lumen 530, while for other
applications, one or more suction lumens 530 comprise a plurality
of suction lumens 530.
[0491] In this configuration, one or more distal suction orifices
440 comprise one or more lateral suction orifices 440 located along
distal portion 212 at one or more respective locations proximal to
inflatable element 588. In addition to lateral suction orifices
440, catheter main body 210 is shaped so as to define a distal-most
suction orifice 444 at a distal end of distal portion 212 of
cleaning catheter 200, distal to inflatable element 588.
Distal-most suction orifice 444 is in fluid communication with a
distal portion of suction lumen 530. For some applications,
distal-most suction orifice 444 is defined by a distal tip of the
cleaning catheter (as shown), while for other applications
distal-most suction orifice 444 is defined by a lateral wall of the
cleaning catheter distal to inflatable element 588 (configuration
not shown). Distal-most suction orifice 444 enables cleaning system
100 to selectively apply suction to the trachea. The techniques of
FIGS. 21A-B and 22A-C allow cleaning system 100 to modulate suction
provided from distal-most suction orifice 444 distal to inflatable
element 588, relative to the suction provided to the distal suction
orifices 440. The techniques include modulating occlusion of
suction lumen 530, at an axial location 446 at which location 446
inflatable element 588 is positioned. Axial location 446 is
proximal to distal-most suction orifice 444, and longitudinally
between distal-most suction port orifice and one or more distal
suction orifices 440 (in typically configurations in which distal
suction orifices 440 are provided).
[0492] For some applications, this occlusion of suction lumen 530
at axial location 446 is achieved using a collapsible membrane 599
at least partially positioned along an opening 448 extending
through the outer wall of main body 210 into suction lumen 530, at
axial location 446. Inflatable element 558 is mounted to main body
210 at least partially along opening 448. The collapsible membrane
is positioned within an interior of inflatable element 588, such
that an inflatable chamber 587 is defined between the wall of
inflatable element 588 and collapsible membrane 599. The
collapsible membrane typically forms a fluid-tight seal with the
wall of suction lumen 530 around opening 448.
[0493] When inflatable element 588 is inflated via inflation port
825, as shown in FIGS. 21B and 22C, the inflation also causes
inflation and expansion of inflatable chamber 587 and of
collapsible membrane 599 into suction lumen 530, so as to at least
partially occlude the passage between distal-most suction orifice
444 (distal to inflatable element 588) and distal suction orifices
440 (proximal to the inflatable element), thereby modulating a
level of suction delivered to distal-most suction orifice 444 via
suction lumen 530. For good occlusion, collapsible membrane 599
typically penetrates deep enough into suction lumen 530 across a
central longitudinal axis 533 of suction lumen 530. The occlusion
is reversible, as illustrated in FIGS. 21A and 22B. Upon deflation
of inflatable element 588, the deflation collapses membrane 599
towards the wall of inflatable element 588, out of the suction
lumen, preferably so that collapsed membrane 599 is in a collapsed
configuration which does not cross axis 533 of suction lumen 530.
Typically, membrane 599 comprises a material that is thinner than a
material of the wall of inflatable element 588, such as less than
70%, e.g., less than 50%, such as less than 30%, of a thickness of
the material of the wall of inflatable element 588. For some
applications, the membrane and the inflatable element comprise an
elastic material such as polyurethane, silicone, or PCV. The
membrane and the inflatable element may comprise the same material
or different materials.
[0494] For some applications, cleaning catheter 100, configured as
described with reference to FIGS. 21A-B and 22A-C is used to
modulate relative levels of suction delivered by suction lumen 530
to (a) the distal-most suction orifice 444 and (b) the one or more
lateral suction orifices 440 between at least two levels that
include: [0495] a relatively low distal-most level, in which a
level of suction delivered to the distal-most suction orifice 444
is less than 25% of a level of suction delivered to one of the one
or more lateral suction orifices 440 having a greatest
cross-sectional area, and [0496] a relatively high distal-most
level, in which the level of suction delivered to the distal-most
suction orifice 444 is greater than 25% of the level of suction
delivered to the one of the one or more lateral suction orifices
440 having the greatest cross-sectional area.
[0497] For some applications, in the relatively low distal-most
level, the level of suction delivered to the distal-most suction
orifice 444 is less than 10% of the level of suction delivered to
the one of the one or more lateral suction orifices 440 having the
greatest cross-sectional area, and, in the relatively high
distal-most level, the level of suction delivered to the
distal-most suction orifice 444 is greater than 10% of the level of
suction delivered to the one of the one or more lateral suction
orifices 440 having the greatest cross-sectional area. For some
applications, in the relatively low distal-most level,
substantially no suction is delivered to the distal-most suction
orifice 444.
[0498] For some applications, inflatable element 588 and inflatable
chamber 587 are inflated via one or more fluid-delivery lumens 520,
as shown in FIGS. 21A-B. For other applications, inflatable element
588 and inflatable chamber 587 are inflated via inflation lumen
580, described hereinbelow with reference to FIG. 2 (configuration
not shown).
[0499] For some applications, an alternative configuration is
provided in which membrane 599 and inflatable element 588 are
positioned at different axial locations along main body 210. In
this configuration, membrane 599 defines inflatable chamber 587
with an inner surface of one of the one or more fluid-delivery
lumens 520, rather than with inflatable element 588. Typically,
inflatable chamber 587 and inflatable element 588 are inflated via
the same lumen. Alternatively, they are inflated via different
lumens, which may or may not be in fluid communication either along
main body 210 and/or in a flow regulator 700.
[0500] For some applications, a method, which optionally uses the
configuration of cleaning catheter 200 described hereinabove with
reference to FIGS. 21A-B and 22A-C comprises:
[0501] providing cleaning catheter 200, which includes (a) main
body 210, which is shaped so as to define distal-most suction
orifice 444 and one or more lateral suction orifices 440, and (b)
inflatable element 588, which is mounted to main body 210 axially
between (i) distal-most suction orifice 444 and (ii) one or more
lateral suction orifices 440; and
[0502] modulating relative levels of suction delivered by suction
source 601 to (a) distal-most suction orifice 444 and (b) one or
more lateral suction orifices 440.
[0503] For some applications, modulating comprises modulating the
relative levels of suction between at least two levels that
include: [0504] a relatively low distal-most level, in which a
level of suction delivered to the distal-most suction orifice 444
is less than 25% of a level of suction delivered to one of the one
or more lateral suction orifices 440 having a greatest
cross-sectional area, and [0505] a relatively high distal-most
level, in which the level of suction delivered to the distal-most
suction orifice 444 is greater than 25% of the level of suction
delivered to the one of the one or more lateral suction orifices
440 having the greatest cross-sectional area.
[0506] For some applications, modulating comprises modulating the
relative levels of suction between the at least two levels that
include: [0507] the relatively low distal-most level, in which the
level of suction delivered to the distal-most suction orifice 444
is less than 10% of the level of suction delivered to the one of
the one or more lateral suction orifices 440 having a greatest
cross-sectional area, and [0508] the relatively high distal-most
level, in which the level of suction delivered to the distal-most
suction orifice 444 is greater than 10% of the level of suction
delivered to the one of the one or more lateral suction orifices
440 having the greatest cross-sectional area.
[0509] For some applications, modulating the relative levels of
suction comprises reversibly modulating a level of occlusion of at
least one of the one or more suction lumens 530 at a portion
thereof axially between (x) the distal-most suction orifice 444 and
(y) the one or more lateral suction orifices 440.
[0510] For some applications, cleaning catheter 200 further
includes suction lumen 530 arranged along main body 210, in fluid
communication with distal-most suction orifice 444 and lateral
suction orifices 440, and modulating the relative levels of suction
comprises reversibly modulating a level of occlusion of suction
lumen 530 at a portion thereof axially between (a) distal-most
suction orifice 444 and (b) one or more lateral suction orifices
440.
[0511] For some applications, providing cleaning catheter 200
comprises providing cleaning catheter 200 further including exactly
one suction lumen 530 arranged along main body 210, in fluid
communication with distal-most suction orifice 444 and lateral
suction orifices 440.
[0512] For some applications, providing cleaning catheter 200
comprises providing cleaning catheter 200 further including a
plurality of suction lumens 530 arranged along main body 210, in
fluid communication with one another and with distal-most suction
orifice 444 and lateral suction orifices 440.
[0513] For some applications, further comprising, before modulating
the relative levels of suction, inserting distal portion 212 of
cleaning catheter 200 into ventilation tube 160 inserted in a
trachea of a patient.
[0514] Reference is now made to FIG. 23, which is a schematic
illustration of a portion of proximal portion 214 of main body 210,
in accordance with an application of the present invention. FIG. 8
shows one or more fluid-delivery lumens 520 and one or more suction
lumens 530, which have been omitted from FIGS. 24A-C for clarity of
illustration. FIG. 23 (and FIGS. 24A-C) illustrate configurations
of proximal portion 214 of main body 210 appropriate for use with
either of the configurations of distal portion 212 of cleaning
catheter 200 described hereinabove with reference to FIGS. 7A and
7B. In these configuration, expandable element 588 is inflated via
fluid communication to pressurized fluid in at least one of one or
more fluid-delivery lumens 520, e.g., exactly one fluid-delivery
lumen 520, which are in fluid communication with an interior of
expandable element 588. There is thus no need to provide separate
inflation lumen 580 to the expandable element (such as described
hereinabove with reference to FIGS. 3 and 4A-C), because the
expandable element is inflated via one or more inflation outlets
585 from the at least one of the one or more fluid-delivery lumens
520 itself. Alternatively, expandable element 588 is inflated via
dedicated inflation lumen 580 which is in fluid communication
directly with one or more fluid-delivery lumens 520, or with the
same source 602 of pressurized fluid with which one or more
fluid-delivery lumens 520 are in fluid communication (configuration
not shown).
[0515] In the particular configuration shown in FIG. 23 (and FIGS.
24A-C), main body 210 is shaped so as to define at least two
lumens: one or more fluid-delivery lumens 520 (e.g., exactly one
fluid-delivery lumen 520), and one or more suction lumens 530
(e.g., exactly one suction lumen 530), and respective at least one
proximal fluid-delivery inlet 521 (e.g., exactly one proximal
fluid-delivery inlet 521), and at least one proximal suction inlet
531 (e.g., exactly one proximal suction inlet 531). In this
particular configuration, main body 210 is not shaped so as to
define inflation lumen 580 or inflation inlet 581, described
hereinabove with reference to FIGS. 3 and 4A-C. In this particular
configuration, expandable element 588 comprises an inflatable
element 588, such as a balloon.
[0516] FIG. 23 shows one or more fluid-delivery lumens 520 and one
or more suction lumens 530, which have been omitted from FIGS.
24A-B for clarity of illustration. For some applications, proximal
suction inlet 531 is located distal to proximal fluid-delivery
inlet 521. This axial arrangement of inlets 521 and 531 is the
reverse of the configurations described hereinabove in the other
configurations, which affects the order of fluid delivery states,
as described below. The techniques of this configuration may be
implemented using any of the configurations described hereinabove
for inflating and deflating inflatable element 588, mutatis
mutandis. For some applications, as shown, proximal fluid-delivery
inlet 521 is defined by a lateral wall of main body 210, while for
other applications, proximal fluid-delivery inlet 521 is defined by
a proximal end of main body 210, such as shown in FIGS. 5B-C,
17A-C, and 18A-C for proximal suction inlet 531.
[0517] Reference is made to FIGS. 24A-C, which are schematic
illustrations of several states of a flow regulator 1000 of input
module 156, in accordance with an application of the present
invention. Except as described as follows, input module 156 is
configured as described hereinabove with reference to FIGS. 9A-C.
Except as described as follows, flow regulator 1000 is generally
similar to flow regulator 710, described hereinabove with reference
to FIGS. 9A-C. As mentioned above, in some applications input
portion 216 of proximal portion of main body 210 is configured to
be inserted into and axially slidable with respect to input module
156. Input module 156 has a plurality of ports for connection with
various fluid sources, including at least suction source 601 and
pressurized fluid source 602. In this configuration, input module
156 includes fluid port 827, which is coupleable in fluid
communication with pressurized fluid source 602, and suction port
830, which is coupleable in fluid communication with suction source
601, but does not include inflation port 832, described hereinabove
with reference to FIGS. 4A-C. In this configuration, the locations
fluid port 827 and suction port 830 along housing 310 are reversed
with respect to the locations in the other configurations described
herein. In addition, inflation source 603 is not provided.
[0518] As mentioned above, input module 156 is configured to assume
a plurality of activation states. Mechanical control unit 320 is
typically configured to mechanically and non-electrically set the
states of flow regulator 1000. Input module 156 is configured to
set the activation states enabling or blocking fluid communication
between the various lumen inlets and the external fluid sources via
respective ports. For some applications, transitions between states
are effected 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 effected 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.
[0519] In this configuration, flow regulator 1000 is configured to
have three principal activation states, typically associated with
three configurations (e.g., spatial positions) of mechanical user
control element 320. In the configuration illustrated in FIGS.
24A-C, the three states are actuated by axial motion of proximal
portion 214 of elongated main body 210 relative to input module
housing 310: [0520] as shown in FIG. 24A, a first activation state,
in which flow regulator 1000 blocks fluid communication (a) between
suction port 830 and proximal suction inlet 531, and thus one or
more suction lumens 530 and (b) between fluid port 827 and proximal
fluid-delivery inlet 521, and thus one or more fluid-delivery
lumens 520; as a result, fluid communication is blocked to both
fluid-delivery orifices 525 and the interior of inflatable element
588 (this configuration can be used with either the configuration
described with reference to FIG. 7A or that described with
reference to FIG. 7B). For some applications, this first activation
state may be considered to be a base, default activation state,
which optionally is set by an elastic return force element, such as
described hereinbelow with reference to FIGS. 5B-C; [0521] as shown
in FIG. 24B, a second activation state, in which flow regulator
1000 effects fluid communication between fluid port 827 and one or
more fluid-delivery lumens 520 via proximal fluid-delivery inlet
521, and blocks the fluid communication between suction port 830
and one or more suction lumens 530; and [0522] as shown in FIG.
24C, a third activation state, in which flow regulator 1000 effects
both (a) suction fluid communication between suction port 830 and
one or more suction lumens 530 via proximal suction inlet 531, and
(b) fluid communication between fluid port 827 and one or more
fluid-delivery lumens 520 via proximal fluid-delivery inlet 521; as
a result, fluid communication is provided to both fluid-delivery
orifices 525 and the interior of inflatable element 588.
[0523] As mentioned above, mechanical user control element 320 is
configured to mechanically and non-electrically set the states of
flow regulator 1000. Typically, mechanical user control element 320
has at least first, second and third configurations (e.g., spatial
positions), and, typically, is configured to transition between the
first and the third configuration (e.g., spatial positions) via the
second configuration (e.g., spatial position). For example,
mechanical user control element 320 is shown in FIG. 24A in its
first configuration (e.g., spatial position) (right-most position),
in FIG. 24B in its second configuration (e.g., spatial position)
(center position), and in FIG. 24C in its third configuration
(e.g., spatial position) (left-most position). Input module 156 is
configured such that: [0524] when user control element 320 is in
the first configuration (e.g., spatial position), flow regulator
1000 is in the first activation state, as described above; [0525]
when user control element 320 is in the second configuration (e.g.,
spatial position), flow regulator 1000 is in the second activation
state, as described above; and [0526] when user control element 320
is in the third configuration (e.g., spatial position), flow
regulator 1000 is in the third activation state, as described
above.
[0527] As mentioned, FIG. 24A shows flow regulator 1000 in the
first (blocked) state. Input portion 216 of main body 210 is
encased, yet movable, within housing 310 of input module 156.
Catheter main body 210 is slidable through a distal wall 314 of
housing 310. Housing 310 is shaped so as to define suction port 830
and cleaning fluid port 827 (main body 210 does not define these
ports).
[0528] As main body 210 moves within the inner compartment of
housing 310, transverse sealing separators 341, 342, 343, and 344
delineate distinct chambers within the housing. When flow regulator
1000 is in the first activation state, as shown in FIG. 24A,
separators 342 and 343 and the outer surface of elongated main body
210 delineate first chamber 350 around proximal suction inlet 531,
and thereby block direct fluid communication within housing 310
between proximal fluid-delivery inlet 521 and proximal suction
inlet 531. The separators are attached to the main body and snugly
pressed against the inner surface of housing 310, so that the
insulated chamber around proximal suction inlet 531 is maintained
even as the main body slides a certain distance along the
longitudinal axis thereof with respect the housing.
[0529] Also as shown in FIG. 24A, in the first activation state,
elongated main body 210 is positioned in its closest position to a
proximal end 360 of housing 310, proximal-most separator 344
creates a seal which prevents direct fluid communication between
fluid port 827 of housing 310 and proximal fluid-delivery inlet 521
of elongated main body 210. In this base position, suction fluid
flow is blocked within a second sealed chamber 352 delineated by
separators 341 and 342 and the outer surface of elongated main body
210.
[0530] When flow regulator 1000 is in the second activation state,
as shown in FIG. 24B, fluid communication is established between
fluid port 827 of housing 310 and proximal fluid-delivery inlet 521
and into one or more fluid-delivery lumens 520 in elongated main
body 210, yet suction remains blocked within second sealed chamber
352 delineated by separators 341 and 342 and the outer surface of
elongated main body 210. This activation is achieved by sliding
elongated main body 210 distally along the axial direction by a
limited distance such that separator 342 does not yet cross into
the space of cleaning suction port 830. Typically, this sliding
motion is induced by distally pushing on mechanical user control
element 320, which is coupled to elongated main body 210 and passes
through a slit 312 in housing 310 which allows axial motion of
mechanical user control element 320.
[0531] When flow regulator 1000 is in the third activation state,
as shown in FIG. 24C, fluid communication is established in first
chamber 350 between suction port 830 of housing 310 and proximal
suction inlet 531 and one or more suction lumens 530 in elongated
main body 210. Cleaning fluid port 827 of housing 310 remains in
fluid communication with proximal fluid-delivery inlet 521 and into
one or more fluid-delivery lumens 520 in elongated main body 210.
Therefore, in this third activation state, flow regulator 1000
effects both (a) cleaning fluid flow into one or more
fluid-delivery lumens 520 and (b) suction in one or more suction
lumens 530 of elongated main body 210. This activation is achieved
by sliding elongated main body 210 more distally along the axial
direction by a limited distance such that separator 342 crosses
into or passes across the space of suction port 830. Typically, the
sliding motion is induced by distally pushing on mechanical user
control element 320, which is coupled to elongated main body 210
and passes through slit 312 in housing 310.
[0532] Thus, three activation states can be actuated, typically
associated with three configurations (e.g., spatial positions) of
mechanical user control element 320. In the configuration
illustrated in FIGS. 24A-C, the three states are actuated by axial
motion of input portion 216 of elongated main body 210 relative to
input module housing 310: [0533] the first activation state, in
which suction flow and cleaning fluid flow is blocked; [0534] the
second activation state, in fluid communication is enabled between
fluid port 827 and one or more fluid-delivery lumens 520 via
proximal fluid-delivery inlet 521, but suction flow to one or more
suction lumens 530 is remains blocked; and [0535] the third
activation state, in which suction flow is enabled both between one
or more suction lumens 530 and suction port 830 via proximal
suction inlet 531 into one or more suction lumens 530, and cleaning
fluid flow into one or more fluid-delivery lumens 520 from fluid
port 827 of housing 310 via proximal fluid-delivery inlet 521,
thereby both providing fluid to fluid-delivery orifices 525 and the
interior of inflatable element 588, so as to inflate the inflatable
element.
[0536] For some applications, expandable element 588 is emptied by
suction via the same suction source 601 which is connected to
suction port 830. This can be enabled, for example, by establishing
fluid communication between the lumen which is in fluid
communication with expandable element (at least one of one or more
fluid-delivery lumens 520 or inflation lumen 580). For some
applications, expandable element 588 can be both inflated via
pressurized delivery fluid in communication with one or more
fluid-delivery lumens 520 and be deflated by suction provided by
the same source 601 connected to one or more suction lumens 530.
Examples of such configurations are described hereinabove with
reference to FIGS. 10 and 11A-C, FIGS. 12A-B and 13A-B, FIGS. 14
and 15A-B, and FIGS. 16A-C.
[0537] Although the activation states of input module 156 are
sometimes characterized hereinabove as "first," "second," or
"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, including before any states characterized as
"base" states 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.
[0538] The specifications of cleaning fluids/inflatable element
inflation/suction fluids and lumens should not be taken as
limiting. It is self-evident that other fluids can be delivered in
catheter lumens for various purposes.
[0539] 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."
[0540] 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.
[0541] 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.
[0542] 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 "activation 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): [0543] International Application PCT/IB2012/051532,
filed Mar. 29, 2012, which published as PCT Publication WO
2012/131626; [0544] UK Application GB 1116735.0, filed Sep. 28,
2011, which published as GB 2482618 A to Einav et al.; [0545] UK
Application GB 1119794.4, filed Nov. 16, 2011; [0546] U.S.
Provisional Application 61/468,990, filed Mar. 29, 2011; [0547]
U.S. Provisional Application 61/473,790, filed Apr. 10, 2011;
[0548] U.S. Provisional Application 61/483,699, filed May 8, 2011;
[0549] U.S. Provisional Application 61/496,019, filed Jun. 12,
2011; [0550] U.S. Provisional Application 61/527,658, filed Aug.
26, 2011; [0551] U.S. Provisional Application 61/539,998, filed
Sep. 28, 2011; [0552] U.S. Provisional Application 61/560,385,
filed Nov. 16, 2011; [0553] U.S. Provisional Application
61/603,340, filed Feb. 26, 2012; [0554] U.S. Provisional
Application 61/603,344, filed Feb. 26, 2012; [0555] U.S.
Provisional Application 61/609,763, filed Mar. 12, 2012; [0556]
U.S. Provisional Application 61/613,408, filed Mar. 20, 2012;
[0557] U.S. Provisional Application 61/635,360, filed Apr. 19,
2012; [0558] U.S. Provisional Application 61/655,801, filed Jun. 5,
2012; [0559] U.S. Provisional Application 61/660,832, filed Jun.
18, 2012; and [0560] U.S. Provisional Application 61/673,744, filed
Jul. 20, 2012.
[0561] 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.
* * * * *