US20150133864A1

Movatterモバイル変換

Info

Publication number: US20150133864A1
Application number: US14/596,905
Authority: US
Inventors: Oron Zachar; Elad Einav; Gil Yigal
Original assignee: Airway Medix Sp zoo
Current assignee: Teleflex Life Sciences Pte Ltd
Priority date: 2011-03-29
Filing date: 2015-01-14
Publication date: 2015-05-14
Also published as: US20190381266A1; WO2013030821A1; US8999074B2; EP2809382A1; EP2809382B1; US20160121066A1; US20170106160A1; AU2017204274A1; US10143814B2; US10328224B2; JP6122435B2; BR112014004602A2; AU2012303609A1; EP2809382A4; JP2014525285A; US20160193439A1; GB201119794D0; US20140142496A1

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.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

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:

- International Application PCT/IB2012/051532, filed Mar. 29, 2012, which published as PCT Publication WO 2012/131626, which claims priority from:
  - U.S. Provisional Application 61/539,998, filed Sep. 28, 2011;
  - 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.;
  - UK Application GB 1119794.4, filed Nov. 16, 2011;
  - U.S. Provisional Application 61/468,990, filed Mar. 29, 2011;
  - U.S. Provisional Application 61/473,790, filed Apr. 10, 2011;
  - U.S. Provisional Application 61/483,699, filed May 8, 2011;
  - U.S. Provisional Application 61/496,019, filed Jun. 12, 2011;
  - U.S. Provisional Application 61/527,658, filed Aug. 26, 2011;
  - U.S. Provisional Application 61/560,385, filed Nov. 16, 2011;
  - U.S. Provisional Application 61/603,340, filed Feb. 26, 2012;
  - U.S. Provisional Application 61/603,344, filed Feb. 26, 2012;
  - U.S. Provisional Application 61/609,763, filed Mar. 12, 2012; and
  - U.S. Provisional Application 61/613,408, filed Mar. 20, 2012;
- UK Application GB 1116735.0, filed Sep. 28, 2011; and
- UK Application GB 1119794.4, filed Nov. 16, 2011; and
- the present patent application claims priority from:
- U.S. Provisional Application 61/527,658, filed Aug. 26, 2011;
- U.S. Provisional Application 61/539,998, filed Sep. 28, 2011;
- U.S. Provisional Application 61/560,385, filed Nov. 16, 2011;
- U.S. Provisional Application 61/603,340, filed Feb. 26, 2012;
- U.S. Provisional Application 61/603,344, filed Feb. 26, 2012;
- U.S. Provisional Application 61/609,763, filed Mar. 12, 2012;
- U.S. Provisional Application 61/613,408, filed Mar. 20, 2012;
- U.S. Provisional Application 61/635,360, filed Apr. 19, 2012;
- U.S. Provisional Application 61/655,801, filed Jun. 5, 2012;
- U.S. Provisional Application 61/660,832, filed Jun. 18, 2012; and
- U.S. Provisional Application 61/673,744, filed Jul. 20, 2012.

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

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

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.

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

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).

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.

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.

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.

For some applications, the flow regulator controls both fluid delivery and inflation of an inflatable element of the multi-lumen catheter.

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.

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.

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.

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.

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.

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.

For some applications, the cleaning system may be used for two different purposes:

- 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
- 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.

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.

The cleaning system may implement one or more of the features described above, or any combination thereof.

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.

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:

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

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 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
- 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,

wherein the input module is configured such that:

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,

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

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.

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.

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.

For some applications, the suction port includes a male conical interface.

For some applications, the fluid port includes a Luer-Lok interface.

For some applications, the one or more fluid-delivery lumens are arranged along the main body at least partially within the main body.

For some applications, 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.

For some applications, the one or more suction lumens are arranged along the main body at least partially outside the main body.

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.

For some applications, the apparatus further includes a pliable sleeve around at least a portion of the main body to inhibit contamination.

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,

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

the one or more suction lumens may be arranged to convey suction from the suction source to the one or more distal suction orifices.

For some applications, a wall of the main body is shaped so as to define the one or more fluid-delivery orifices.

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.

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.

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.

For some applications, a wall of the inflatable element is shaped so as to define the one or more fluid-delivery orifices.

For some applications, the expandable element includes an inflatable element.

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.

For some applications, the inflatable element includes a balloon.

For some applications, the inflatable element has a greatest diameter of between 6 and 12 mm when fully inflated and unconstrained.

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.

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.

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.

For some applications:

the flow regulator further includes a valve, which is in fluid communication with the suction port, and

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.

For some applications, at least one of the fluid-delivery orifices is located within 10 cm of the expandable element.

For some applications:

the one or more suction lumens include (a) at least a first suction lumen and (b) at least a second suction lumen,

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,

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

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.

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.

For some applications, the one or more fluid-delivery orifices are located within 3 cm of the expandable element.

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.

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.

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:

a protective selector first state, in which the state protective selector locks mechanical user control element in the first configuration,

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

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.

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:

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:

- an elongate, flexible, tubular main body; and
- 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; and

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:

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

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.

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 toFIG. 11B, and/or of the first activation state of the configuration of the cleaning system described hereinbelow with reference toFIG. 13A.

For some applications, the suction port is coupled in fluid communication with the suction source.

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.

For some applications, the flow regulator, when in the first activation state, effects fluid communication between the suction source and the distal orifices.

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.

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.

For some applications, the expandable element includes a balloon.

For some applications, the inflatable element is mounted to the main body is within 5 cm of a distal end of the main body.

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.

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.

For any of the applications described above,

the apparatus may be for use with a pressurized fluid source,

the cleaning catheter may further include one or more fluid-delivery lumens arranged along the main body,

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,

the flow regulator may be shaped so as to further define a fluid port coupleable in fluid communication with the pressurized fluid source,

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

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.

For some applications, the fluid port is coupled in fluid communication with the pressurized fluid source.

For some applications, at least one of the fluid-delivery orifices is located within 10 cm of the inflatable element.

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.

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:

when the user control element is in the first configuration, the flow regulator is in the first activation state, and

when the user control element is in the second configuration, the flow regulator is in the second activation state.

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.

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.

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 and second axial positions with respect to the input module, corresponding to the first and the second configurations of the mechanical user control element.

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:

an elongate, flexible, tubular main body; and

an inflatable element, which is mounted to the main body,

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.

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.

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.

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.

For some applications, all of the fluid-delivery orifices are located within 10 cm of the inflatable element.

For some applications, the expandable element includes a balloon.

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.

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.

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:

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, 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

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.

For some applications, a distal tip of the main body is shaped so as to define the distal-most suction orifice.

For some applications, a lateral wall of the main body is shaped so as to define the distal-most suction orifice.

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.

For some applications, the suction lumen includes exactly one suction lumen.

For some applications, the suction lumen includes a plurality of suction lumens.

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.

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.

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.

There is yet 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 (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

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.

For some applications, the flow regulator is configured to modulate the relative levels of suction between at least two levels that include:

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

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.

For some applications, the flow regulator is configured to modulate the relative levels of suction between the at least two levels that include:

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

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.

For some applications:

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

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.

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.

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.

For any of the applications described above:

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,

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,

the inflatable element may be mounted to the main body at least partially along the opening,

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,

the collapsible membrane may be positioned to at least partially occlude the suction lumen upon at least partial inflation of the inflatable chamber, and

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.

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.

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:

an input module, which is coupled to the cleaning catheter, and includes:

wherein the input module is configured such that:

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

For some applications, the suction port includes a male conical interface.

For some applications, the fluid port includes a Luer-Lok interface.

For some applications:

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,

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

the one or more suction lumens are arranged to convey suction from the suction source to the one or more distal suction orifices.

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.

For some applications, the expandable element includes an inflatable element.

For some applications, the inflatable element includes a balloon.

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.

For some applications:

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:

coupling, in fluid communication with the suction source, a suction port of a flow regulator of an input module;

coupling, in fluid communication with the pressurized fluid source, a fluid port of the flow regulator;

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

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:

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,

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

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.

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:

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;

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

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.

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:

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

inserting the cleaning catheter into the ventilation tube inserted in a trachea of a patient.

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:

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

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.

For some applications, modulating includes modulating the relative levels of suction between at least two levels that include:

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

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.

For some applications, modulating includes modulating the relative levels of suction between the at least two levels that include:

For some applications:

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.

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.

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.

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.

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:

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

FIGS. 1A-D are schematic illustrations of a closed suction cleaning system, in accordance with respective applications of the present invention;

FIG. 2 is a schematic illustration of a main body of the cleaning system ofFIGS. 1A-C, in accordance with an application of the present invention;

FIG. 3 is a schematic illustration of a portion of a proximal portion of the main body ofFIG. 2, in accordance with an application of the present invention;

FIGS. 4A-C are schematic illustrations of several states of a flow regulator of an input module of the cleaning system ofFIG. 1A-C, in accordance with an application of the present invention;

FIGS. 5A-C are schematic illustrations of an input module and a portion of a main body of the cleaning system ofFIGS. 1A-C, in accordance with an application of the present invention;

FIGS. 6A-B are schematic illustrations of an input module and a portion of a main body of the cleaning system ofFIGS. 1A-C, in accordance with an application of the present invention;

FIGS. 7A and 7B are schematic illustrations of a distal portion of a main body of the cleaning system ofFIGS. 1A-C inserted into a ventilation tube, in accordance with an application of the present invention;

FIG. 8 is a schematic illustration of a portion of a proximal portion of a main body of the cleaning system ofFIGS. 1A-C, in accordance with an application of the present invention;

FIGS. 9A-C are schematic illustrations of several states of a flow regulator of a input module of the cleaning system ofFIGS. 1A-C, in accordance with an application of the present invention;

FIG. 10 is a schematic illustration of a portion of a proximal portion of a main body of the cleaning system ofFIGS. 1A-C, in accordance with an application of the present invention;

FIGS. 11A-C are schematic illustrations of several states of a flow regulator of a input module of the cleaning system ofFIGS. 1A-C, in accordance with an application of the present invention;

FIG. 12 is a schematic illustration of a portion of a proximal portion of a main body of the cleaning system ofFIGS. 1A-C, in accordance with an application of the present invention;

FIGS. 13A-B are schematic illustrations of several states of a flow regulator of a input module of the cleaning system ofFIGS. 1A-C, in accordance with an application of the present invention;

FIG. 14 is a schematic illustration of a portion of a proximal portion of a main body of the cleaning system ofFIGS. 1A-C, in accordance with an application of the present invention;

FIGS. 15A-B are schematic illustrations of several states of a flow regulator of a input module of the cleaning system ofFIGS. 1A-C, in accordance with an application of the present invention;

FIGS. 16A-C are schematic illustrations of a configuration of an input module of the cleaning system ofFIGS. 1A-C comprising a state protective selector, in accordance with an application of the present invention;

FIGS. 17A-C are schematic illustrations of another configuration of an input module of the cleaning system ofFIGS. 1A-C, in accordance with an application of the present invention;

FIGS. 18A-C are schematic illustrations of yet another configuration of an input module of the cleaning system ofFIGS. 1A-C, in accordance with an application of the present invention;

FIGS. 19A-C are schematic illustrations of an input module of the cleaning system ofFIGS. 1A-C, in accordance with an application of the present invention;

FIGS. 19D-F are schematic illustrations of buttons of the input module ofFIGS. 19A-C, in accordance with an application of the present invention;

FIG. 20 is a schematic illustration of an input module of the cleaning system ofFIGS. 1A-C, in accordance with an application of the present invention;

FIGS. 21A-B and22A-C are schematic illustrations of a distal portion of a main body of the cleaning system ofFIGS. 1A-C inserted into a ventilation tube, in accordance with an application of the present invention;

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

FIGS. 24A-C are schematic illustrations of several states of a flow regulator of a input module of the cleaning system ofFIG. 23, in accordance with an application of the present invention.

DETAILED DESCRIPTION OF APPLICATIONS

FIGS. 1A-D are schematic illustrations of a closed suctionsystem cleaning system100, in accordance with respective applications of the present invention.Cleaning system100 is configured for use with atracheal ventilation tube160, aventilator170, a pressurizedfluid source602, asuction source601, and, optionally, aninflation source603, which may comprise, for example, a conventional syringe. Some of the configurations described herein, such as with reference toFIGS. 1A,3, and4A-C, and5A-C, provideinflation source603, while other configurations, such as described with reference toFIGS. 1B-D,7A-B,8 and9A-C,10 and11A-C,12 and13A-B,14 and15A-B,16A-C,17A-C,19A-C,18A-C,21A-B and22A-C, and23 and24A-C, do not provideinflation source603. Some applications of the present invention provide a closed suction cleaning system that is configured to be coupled to (e.g., is coupled to) pressuredfluid source602 andsuction source601, and not to an independent inflation source, such as a syringe. For some applications,cleaning system100 comprises one or more oftracheal ventilation tube160,ventilator170, pressurizedfluid source602,suction source601, and/or aninflation source603, in any combination.

As used in the present application, including in the claims, a “tracheal ventilation tube” comprises an endotracheal tube (ETT) or a tracheostomy tube.Suction source601 provides a pressure less than one atm, and pressurizedfluid source602 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.

Cleaning system

100 comprises a distal ventilationtube connector assembly158, a flexible, acleaning catheter200, and aninput module156.Cleaning catheter200 comprises amain body210.Cleaning catheter200 includes adistal portion212 located distal toventilation tube connector158, and aproximal portion214 located proximal toventilation tube158.Distal portion212 is configured to be inserted intoventilation tube160.Proximal portion214 includes aproximal-most input portion216 ofmain body210, which is configured to be inserted intoinput module156. For some applications,proximal-most input portion216 is axially slidable with respect toinput module156, 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 and214 may depend on an extent to which a distal end is deployed withinventilation tube160 and/or an extent to which the distal end is longitudinally displaced from ventilationtube connector assembly158, for example, an extent to whichmain body210 slides through ventilationtube connector assembly158 in a distal direction.

Ventilationtube connector assembly158 comprises: (a) aventilator port664, configured to be coupled in fluid communication withventilator170, (b) aventilation tube port660, configured to be coupled in fluid communication with a proximal end ofventilation tube160, and (c) amain body inlet640, which is configured to allow passage therethrough of elongatemain body210.

In some applications of the present invention,cleaning system100 is operative to clean an interior ofventilation tube160 when ventilationtube connector assembly158 is directly or indirectly connected to bothventilation tube160 and ventilator900 so as to mediate a substantially air-tight connection (e.g., via an interior chamber(s) and/or conduit(s) of ventilation tube connector assembly158) between the ventilator and an interior of the ventilation tube. In one non-limiting example, an interior region and/or outer shape ofventilation tube port660 matches a proximal end ofventilation tube160 to create a substantial air-tight seal. In another non-limiting example, atube910 or other conduit of a tube assembly may be connected toventilator port664 so that an interior ofventilator port664 receives air from the ventilator and is in fluid communication with ventilator900 in a substantially air-tight manner.

For some applications, cleaningcatheter200 further comprises anexpandable element588, mounted to flexiblemain body210 near a distal end of flexiblemain body210, e.g., within 5 cm, e.g., within 3 cm, of the distal end, and/or in a distal half ofdistal portion212 of cleaningcatheter200, such as a distal third, a distal fifth, or a distal tenth ofdistal portion212. Alternatively or additionally,expandable element588 is mounted to flexiblemain body210 within 3 cm of at least one of the one or moredistal suction orifices440.Expandable element588 is expandable into contact with aninner surface201 ofventilation tube160. For some applications,expandable element588 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 ofventilation tube160, in order to provide sealing contact withinner surface201 of the ventilation tube. For some applications,main body210 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 ofexpandable element588 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 ofmain body210.

When expanded,expandable element588 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 toFIG. 21B, this may be useful for concentrating suction so that the suction is predominantly in aproximal portion774 of the lumen of theventilation tube160 proximal to the expandable element588), and/or (ii) a wiping functionality useful for cleaninginner surface201 ofventilation tube160. Typically,cleaning system100 operates in a closed system environment.

For some applications,expandable element588 comprises an inflatable element, such as a balloon, which is configured to expand upon being inflated. For other applications,expandable element588 expands other than by inflation; for example,expandable element588 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.

During one state of operation,cleaning system100 cleansinner surface201 ofventilation tube160 when ventilationtube connector assembly158 mediates a substantially air-tight seal between (i) ventilator900 and/or an interior ofventilator port664 and (ii) an interior ofventilation tube160 and/or an interior of ventilation tube port660 (this substantially air-tight seal is referred to hereinbelow as the “ventilation machine-ventilator tube seal”).

As is described below, concurrent with maintaining of this ventilation machine-ventilator tube seal,expandable element588 may be positioned within ventilation tube160 (e.g., in a distal portion of ventilation tube160), for example by moving a distal end ofmain body210 in a distal direction towards a distal end ofventilation tube160. For example,expandable element588 may be distally advanced whenexpandable element588 is in a non-contact state (i.e., not in contact withinner surface201 of ventilation tube160). Afterexpandable element588 is thus positioned, expansion of the expandable element induces contact between an outer surface ofexpandable element588 and the inner surface ofventilation tube160 and/or obstructs (i.e., significant hinders) longitudinal flow between proximal and distal portions of the interior ofventilation tube160. As is described below, this slidable boundary between the proximal and distal portions may be useful for facilitating the cleaning of the inner surface ofventilation tube160, for example for substantially confining locations of negative pressure and/or fluid (e.g., pressurized fluid) introduced into an interstitial region outside ofmain body210 and withinventilation tube160 so that the suction or pressurized fluid is introduced predominantly in the proximal portion ofventilation tube160.

For some applications,distal portion212 of cleaningcatheter200 is shaped so as to define one or more fluid-delivery orifices525. Alternatively or additionally, for some applications, one or more fluid-delivery orifices525 are defined by a wall ofexpandable element588, such as described hereinbelow with reference toFIGS. 7B and/or21A-B. Fluid-delivery orifices525 are in fluid communication with an outer surface of cleaning catheter200 (including with an outer surface of main body210) and an outer surface of expandable element588 (typically a proximal side of the outer surface), including whendistal portion212 of cleaningcatheter200 is inserted intoventilation tube160. For some applications, one or more fluid-delivery orifices525 are defined by a wall ofmain body210, such as described herein with reference toFIGS. 1A,1B,1D, and7A. Alternatively or additionally, for some applications,distal portion212 of cleaningcatheter200 comprises one or moredistal suction orifices440, typically through a lateral wall ofdistal portion212. Typically, one or moredistal suction orifices440 are located alongdistal portion212 at one or more respective locations proximal toinflatable element588. Typically, at least one of fluid-delivery orifices525 (such as all of one or more fluid-delivery orifices525) is located within 10 cm of theexpandable element588, such as within 5 cm, e.g., within 3 cm of the expandable element. For some applications, fluid-delivery orifices525 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.

For some applications,distal suction orifices440 are supplied with negative pressure bysuction source601 and facilitate cleaning of the inner surface ofventilation tube160. For some applications, material within the interior ofventilation tube160 may be suctioned intodistal suction orifices440 and proximally transported out ofventilation tube160, e.g., to a location that is proximal to ventilationtube connector assembly158. As described below in detail, fluid communication betweensuction source601 and/or pressurizedfluid source602 and suction and/or fluid-delivery orifices440 and/or525 may be provided by one or more connecting lumens within or along themain body210. 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.

For some applications,cleaning system100 comprises a substantially impermeable and/orpliable sleeve610 for protecting an outer surface ofmain body210. In some embodiments,sleeve610 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 portion214 of elongatemain body210, typically in locations proximal to tube-connector assembly158 and distal tosuction port830, and typically to inhibit contamination. For some applications,sleeve610 provides this enveloping and/or protection functionality when a length of the ventilation-tube-connector-assembly-proximal portion214 ofmain body210 is at least 3 cm, e.g., at least 5 cm, at least 7 cm, or at least 10 cm.

For some applications, a length ofproximal portion214 may be modified by sliding, in a proximal or distal direction,main body210 through ventilationtube connector assembly158.

For some applications, a distal end ofsleeve610 is (i) directly or indirectly attached to and/or (ii) has a location that is fixed and/or longitudinally fixed relative to ventilationtube connector assembly158. For some applications, a longitudinal position of a location of the distal end ofsleeve610 corresponds to a location on ventilation tube connector assembly158 (e.g., at or near main body inlet640) and/or is longitudinally displaced from a proximal end (e.g., corresponding to main body inlet640) of ventilationtube connector assembly158 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 portion214 ofmain body210.

For some applications, a location of the distal end ofsleeve610 is not fixed relative tomain body210. For example,main body210 may be longitudinally slidable within thesleeve610 at or near a location of the distal end. Alternatively or additionally, for some applications, a location of a proximal end ofsleeve610 is fixed and/or longitudinally fixed relative to a proximal end ofmain body210. For some applications,sleeve610 forms a substantially air-tight seal between the external environment and an outer surface of ventilation-tube-connector-assembly-proximal portion214 ofmain body210 and/or between the external environment and region of space outside of an outer surface of ventilation-tube-connector-assembly-proximal portion214 ofmain body210 and withinsleeve610.

Reference is made toFIG. 1D. In this configuration ofcleaning system100, fluid-delivery orifices525 are not provided, and one or more fluid-delivery lumens520, described hereinbelow with reference toFIG. 2, may not be provided. Instead, a separatesecondary tube211, distinct frommain body210, is provided for delivering irrigation fluid to trickle down from the proximal (top) end ofventilation tube160 when the distal end ofdistal portion212 of cleaningcatheter200 is already inserted into the distal portion of the ventilation tube and suctioning is activated.Secondary tube211 provides fluid communication betweeninput module156 and distal ventilationtube connector assembly158, and allows delivery of irrigation fluid to be controlled by a flow regulator ofinput module156. For some applications,inflation lumen580, described hereinbelow with reference toFIG. 2, is provided for inflatingexpandable element588.

Reference is made toFIGS. 1A,1B, and1C. For some applications,depth markings620 are provided on cathetermain body210. For some applications, astopper element625 is attached to cathetermain body210. For some applications, aninterface630 is provided between a distal end ofpliable sleeve610 andconnector assembly158. For some applications, aninterface678 is provided between a proximal end ofpliable sleeve610 andinput module156.

Reference is now made toFIG. 2, which is a schematic illustration ofmain body210, in accordance with an application of the present invention. Main body includes one or more of the following lumens arranged alongmain body210. For some applications, one or more of the lumens are arranged alongmain body210 at least partially within the main body, e.g., integrally formed in themain body210, formed in the wall ofmain body210, or provided as a separate tube withmain body210. Alternatively or additionally, one or more of the lumens are arranged alongmain body210 at least partially outside the main body, e.g., provided as a separate tube outside main body210). The lumens include:

- one or more fluid-delivery lumens520, which provide fluid communication between at least one proximal fluid-delivery inlet521 and one or more respective fluid-delivery orifices525 (and, optionally, for some applications,expandable element588, as described hereinbelow); typically,input portion216 is shaped so as to define proximal fluid-delivery inlet521, anddistal portion212 of cleaningcatheter200 is shaped so as to define fluid-delivery orifices525;
- one ormore suction lumens530, which provide fluid communication between at least oneproximal suction inlet531 and one or moredistal suction orifices440; typically,input portion216 ofmain body210 is shaped so as to defineproximal suction inlet531, anddistal portion212 of cleaningcatheter200 is shaped so as to definedistal suction orifices440. The one or more suction lumens are arranged in intermittent fluid communication withfluid source601, 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 withfluid source601 together rather than separately); and/or
- at least oneinflation lumen580, which provides fluid communication between at least oneinflation inlet581 and at least oneinflation outlet585 which is in fluid communication with an interior ofexpandable element588; typically,input portion216 is shaped so as to defineinflation inlet581, anddistal portion212 is shaped so as to defineinflation outlet585.

Reference is now made toFIG. 3, which is a schematic illustration of a portion ofproximal portion214 ofmain body210, in accordance with an application of the present invention.FIG. 3 shows one or more fluid-delivery lumens520, one ormore suction lumens530, andinflation lumen580, which have been omitted fromFIGS. 4A-C for clarity of illustration. For some applications,proximal suction inlet531 is located proximal to proximal fluid-delivery inlet521, and/or proximal fluid-delivery inlet521 is located proximal toinflation inlet581. For some applications, proximal fluid-delivery inlet521 is located longitudinally betweenproximal suction inlet531

inflation inlet

581. For some applications, as shown,proximal suction inlet531 is defined by a lateral wall ofmain body210, while for other applications,proximal suction inlet531 is defined by a proximal end ofmain body210, such as shown inFIGS. 5B-C,17A-C, and18A-C.

Reference is made toFIGS. 4A-C, which are schematic illustrations of several states of aflow regulator700 ofinput module156, in accordance with an application of the present invention. As mentioned above, in someconfigurations input portion216 of proximal portion ofmain body210 is configured to be inserted into and axially slidable with respect toinput module156.Input module156 has a plurality of ports for connection with various fluid sources, including atleast suction source601 and pressurizedfluid source602.Input module156 comprisesflow regulator700, a mechanicaluser control element320, and ahousing310

encasing input portion

216 ofmain body210. Mechanicaluser control element320 is shown schematically inFIGS. 4A-C and in some of the other figures; actual implementations ofcleaning system100 typically include a more ergonomic design for comfortable interface with a human hand, such as the configuration shown inFIGS. 18A-C. Typically,input module156 comprises exactly one mechanicaluser control element320 having the properties described herein, and/orsystem100 comprises exactly one mechanicaluser control element320 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 mechanicaluser control element320.

Input module

156 is configured to assume a plurality of activation states.Mechanical control unit320 is typically configured to mechanically and non-electrically set the states offlow regulator700.Input module156 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 ofinput module156, which chambers are or are not in fluid communication with respective ports. The shifts in alignment are typically effected via axial motion ofinput portion216 of cathetermain body210 withininput module housing310, along the longitudinal axes ofinput portion216 andinput module156.

For some applications, one or more of

lumen inlets

521,531, and581 are isolated from one another by one or more

fluid separators

341,342,343, and344, 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 ofinput portion216 ofmain body210, and are slidable with respect tohousing310. For some applications, such as shown inFIGS. 4A-C, the sealing elements are directly fixed to the outer surface ofinput portion216, while for other applications, such as shown inFIGS. 5B-C, described hereinbelow, the sealing elements are indirectly fixed to the outer surface ofinput portion216. Alternatively, the separators are fixed tohousing310, and are slidable with respect to cathetermain body210, such as described hereinbelow with reference toFIGS. 17A-C and18A-C.

For some applications,input module156 includes one or more of the following ports:

- afluid port827, which is coupleable in fluid communication with pressurizedfluid source602, and coupled in fluid communication with pressurizedfluid source602 during use ofcleaning system100;
- asuction port830, which is coupleable in fluid communication withsuction source601, and coupled in fluid communication withsuction source601 during use ofcleaning system100; and/or
- aninflation port832, which is coupleable in fluid communication withinflation source603, and coupled in fluid communication withinflation source603 during use ofcleaning system100.

Typically,fluid port827 comprises a screw-on fitting, such as a Luer-Lock interface. Typically,suction port830 is shaped as a conventional suction port in accordance with hospital standards for coupling to standard hospital suctions sources. For example,suction port830 may have a male conical interface, such as described hereinbelow with reference toFIGS. 18A-C. Typically,suction port830 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.

For some applications, pressurized fluid fromfluid source602 is delivered, via one or more fluid-delivery lumens520 (shown inFIG. 3) and fluid-delivery orifices525 (shown inFIGS. 1A-D), into an interstitial region inside ofventilation tube160 and outside of themain body210. For some applications, a stream of the delivered fluid passes through the interstitial region en route toinner surface201 ofventilation tube160, 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.

For some applications in whichexpandable element588 is inflatable, pressurized fluid or gas delivered frominflation source603 is delivered toexpandable element588 to inflate expandable element588 (e.g., to form a slidable boundary, as described hereinbelow).

In the exemplary configuration ofcleaning system100 shown inFIGS. 4A-C, fluid source602 (which provides pressurized fluid) andinflation source603 are provided as two separate elements. Alternatively, in other configurations of cleaning system (such as that described hereinbelow with reference to FIGS.12 and13A-B), pressurizedfluid source602 is used to both inflateexpandable element588 and to deliver fluid via fluid-delivery orifices525. In the configuration shown in FIGS.3 and4A-C,expandable element588 comprises aninflatable element588, such as a balloon.

In the configuration illustrated in FIGS.3 and4A-C,main body210 is shaped so as to define at least three lumens: one or more fluid-delivery lumens520 (e.g., exactly one fluid-delivery lumen520), one or more suction lumens530 (e.g., exactly one suction lumen530), and at least one inflation lumen580 (e.g., exactly one inflation lumen580), and respective at least one proximal fluid-delivery inlet521 (e.g., exactly one proximal fluid-delivery inlet521), at least one proximal suction inlet531 (e.g., exactly one proximal suction inlet531), and at least one inflation inlet581 (e.g., exactly one inflation inlet581). For some applications, as shown in FIGS.3 and4A-C and some of the other figures,

inlets

521,531, and/or581 are defined by a lateral wall ofmain body210. Alternatively or additionally, for some applications, such as described hereinbelow with reference toFIGS. 17A-C, one or more of

inlets

521,531, and/or581 are defined by a proximal end of the main body.

In this configuration,flow regulator700 is configured to have three principal activation states, typically associated with three configurations of mechanicaluser control element320. For some applications, the three configurations are three spatial positions, respectively. In the configuration illustrated inFIGS. 4A-C, the three states are actuated by axial motion ofproximal portion214 of elongatedmain body210 relative to input module housing310:

- as shown inFIG. 4A, a first activation state, in which flowregulator700 blocks fluid communication (a) betweensuction port830 andproximal suction inlet531, and thus one ormore suction lumens530 and (b) betweenfluid port827 and proximal fluid-delivery inlet521, and thus one or more fluid-delivery lumens520 (but not necessarily blocked from inflatable element588); however, fluid communication can be established betweeninflation port832 andinflation inlet581, and thus toinflatable element588 viainflation lumen580. 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 toFIGS. 5B-C. In this particular configuration, such inflation is typically manually enabled by the user. Inflation ofinflatable element588 before applying suction via thedistal suction orifices440 may serve to isolate the lungs from the suction;
- as shown inFIG. 4B, a second activation state, in which flowregulator700 effects suction fluid communication betweensuction port830 and one ormore suction lumens530 viaproximal suction inlet531, and blocks flow of cleaning fluid betweenfluid port827 and one or more fluid-delivery lumens520; and
- as shown inFIG. 4C, a third activation state, in which flowregulator700 effects both (a) suction fluid communication betweensuction port830 and one ormore suction lumens530 viaproximal suction inlet531, and (b) cleaning fluid communication betweenfluid port827 and one or more fluid-delivery lumens520 via proximal fluid-delivery inlet521.

As mentioned above, mechanicaluser control element320 is configured to mechanically and non-electrically set the states offlow regulator700. Typically, mechanicaluser control element320 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 mechanicaluser control element320 is configured to transition between the first and the third spatial positions via the second spatial position. For example, mechanicaluser control element320 is shown inFIG. 4A in its first configuration (e.g., spatial position) (right-most position), inFIG. 4B in its second configuration (e.g., spatial position) (center position), and inFIG. 4C in its third configuration (e.g., spatial position) (left-most position).Input module156 is configured such that:

- whenuser control element320 is in the first configuration (e.g., spatial position),flow regulator700 is in the first activation state, as described above;
- whenuser control element320 is in the second configuration (e.g., spatial position),flow regulator700 is in the second activation state, as described above; and
- whenuser control element320 is in the third configuration (e.g., spatial position),flow regulator700 is in the third activation state, as described above.

Typically, in this configuration, as well as in the other configurations described herein (except with reference to FIGS.23 and24A-B),cleaning system100 may be used for two different purposes:

- for cleaning the lumen oftracheal ventilation tube160—the user typically rapidly transitionsuser control element320 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 cleaningventilation tube160, 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
- for suctioning the trachea outside of and distal toventilation tube160—the user transitionsuser control element320 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.

The user may use cleaningsystem100 for both of these purposes at different times during patient care. For example, the system may be used to cleanventilation tube160 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 puttinguser control element320 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 ofventilation tube160.

Typically, mechanicaluser control element320 comprises an axial-motion element318, which is configured to assume at least first, second, and third axial positions along a single axis, when mechanicaluser control element320 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 element318 are shown inFIGS. 4A,4B, and4C, respectively. The single axis is parallel with a longitudinal axis ofproximal portion214 ofmain body210. The second axial position, shown inFIG. 4B, is spatially between the first and the second axial positions along the axis. For configurations in which mechanicaluser control element320 is configured such that the motion of all parts thereof is along the single axis (such as shown inFIGS. 4A-C.5A-C,9A-C,11A-C,13A-B,15A-B,16A-C,17A-C), mechanicaluser control element320 it its entirety functions as axial-motion element318. For other configurations in which portions of mechanicaluser control element320 move in directions other than along the single axis (such as described hereinbelow with reference toFIGS. 6A-B and18A-C), only a portion of mechanicaluser control element320 functions as axial-motion element318.

It is noted that when mechanicaluser control element320 assumes the at least first, second and third configurations (e.g., spatial positions) mentioned above, either (a) the entire mechanicaluser control element320 assumes these configuration (e.g., spatial positions), such as shown inFIGS. 4A-C.5A-C,9A-C,11A-C,13A-B,15A-B,16A-C,17A-C, or (b) only a portion of entire mechanicaluser control element320 assumes these configuration (e.g., spatial positions), such as shown inFIGS. 6A-B and18A-C (for example, in these configurations,axis720 remains stationary as the remainder of mechanicaluser control element320, includinguser control handle718 and axial-motion element318, assume these configuration (e.g., spatial positions)).

For some applications,input module156 is configured such that changes in configuration (e.g., spatial position) of mechanical user control element320 (typically axial-motion element318 thereof) cause corresponding changes in axial position ofinput portion216 ofmain body210 with respect toinput module156. Typically,input module156 is configured such thatinput portion216 assumes first, second, and third axial positions with respect to input module156 (e.g., with respect tosuction port830 and/or fluid port827), corresponding to the first, the second, and the third configuration (e.g., spatial positions) of mechanicaluser control element320. The first, second, and third axial positions ofinput portion216 are typically along a single axis.

As mentioned above,FIG. 4A showsflow regulator700 in the first (blocked) state.Input portion216 ofmain body210 is encased, yet axially movable (slidable), withinhousing310 ofinput module156. Cathetermain body210 is slidable through adistal wall314 ofhousing310.Inflation inlet581 is fixedly attached to aconnector880, which, for example, may comprise a screw-on fitting, such as a Luer-Lock interface, and inoperation connector880 is connected to an inflation source (e.g., a syringe).Housing310 is shaped so as to definesuction port830 and cleaning fluid port827 (main body210 does not define these ports).

Asinput portion216 ofmain body210 axially moves within the inner compartment ofhousing310, transverse sealing

separators

341,342,343, and344 delineate distinct chambers within the housing. Whenflow regulator700 is in the first activation state, as shown inFIG. 4A,

separators

342 and343 and the outer surface of elongatedmain body210 delineate afirst chamber350 around proximal fluid-delivery inlet521, and thereby block direct fluid communication withinhousing310 between proximal fluid-delivery inlet521 andproximal suction inlet531, andinflation inlet581. The separators are attached to the main body and snugly pressed against the inner surface ofhousing310, so that the insulated chamber around proximal fluid-delivery inlet521 is maintained even as the main body slides a certain distance along the longitudinal axis thereof with respect the housing.

Also as shown inFIG. 4A, in the first activation state, elongatedmain body210 is positioned in its closest position to aproximal end360 ofhousing310,proximal-most separator344 creates a seal which prevents direct fluid communication betweensuction port830 ofhousing310 andproximal suction inlet531 of elongatedmain body210. In this base position, cleaning fluid flow is blocked within a second sealedchamber352 delineated by

separators

341 and342 and the outer surface of elongatedmain body210.

Whenflow regulator700 is in the second activation state, as shown inFIG. 4B, fluid communication is established betweensuction port830 ofhousing310 andproximal suction inlet531 and into one ormore suction lumens530 in elongatedmain body210, yet cleaning fluid flow remains blocked within second sealedchamber352 delineated by

separators

341 and342 and the outer surface of elongatedmain body210. This activation is achieved by sliding elongatedmain body210 distally along the axial direction by a limited distance such thatseparator342 does not yet cross into the space of cleaningfluid port827. Typically, this sliding motion is induced by distally pushing on mechanicaluser control element320, which is coupled to elongatedmain body210 and passes through aslit312 inhousing310 which allows axial motion of mechanicaluser control element320.

Whenflow regulator700 is in the third activation state, as shown inFIG. 4C, fluid communication is established infirst chamber350 betweenfluid port827 ofhousing310 and proximal fluid-delivery inlet521 and one or more fluid-delivery lumens520 of elongatedmain body210.Suction port830 ofhousing310 remains in fluid communication withproximal suction inlet531 and into one ormore suction lumens530 in elongatedmain body210. Therefore, in this third activation state,flow regulator700 effects both (a) cleaning fluid flow into one or more fluid-delivery lumens520 and (b) suction in one ormore suction lumens530 of elongatedmain body210. This activation is achieved by sliding elongatedmain body210 more distally along the axial direction by a limited distance such thatseparator342 crosses into or passes across the space of cleaningfluid port827. Typically, the sliding motion is induced by distally pushing on mechanicaluser control element320, which is coupled to elongatedmain body210 and passes throughslit312 inhousing310.

Thus, three activation states can be actuated, typically associated with three configurations (e.g., spatial positions) of mechanicaluser control element320. In the configuration illustrated inFIGS. 4A-C, the three states are actuated by axial motion ofinput portion216 of elongatedmain body210 relative to input module housing310:

- the first activation state, in whichinflatable element588 can be inflated, but suction flow and cleaning fluid flow is blocked;
- the second activation state, in which suction flow is enabled between one ormore suction lumens530 andsuction port830 viaproximal suction inlet531 into one ormore suction lumens530, but cleaning fluid flow into one or more fluid-delivery lumens520 remains blocked; and
- the third activation state, in which suction flow is enabled both between one ormore suction lumens530 andsuction port830 viaproximal suction inlet531 into one ormore suction lumens530, and cleaning fluid flow into one or more fluid-delivery lumens520 fromfluid port827 ofhousing310 via proximal fluid-delivery inlet521.

Operational safely is inherent because there is no activation state in which cleaning fluid flow is enabled without suction also being activated.

Reference is now made toFIGS. 5A-C, which are schematic illustrations ofinput module156 and a portion ofmain body210, in accordance with an application of the present invention.FIG. 5A is an isometric view ofinput module156 withmain body210 extends distally out of a distal end of the input module.FIGS. 5B and 5C are cross-sectional views ofinput module156 and the portion ofmain body210.FIGS. 5B and 5C showflow regulator700 in the first and third activation states, respectively, which are described hereinabove with reference to FIGS.3 and4A-C.

In the configuration shown inFIGS. 5B and 5C,input portion216 of elongatedmain body210 is attached to a mediatingproximal encasing element590, to which

separators

341,342,343, and344 are fixed. Thus, the sealing elements are indirectly fixed to the outer surface ofinput portion216.FIGS. 5B and 5C also show an elastic return force element349 (e.g., a spring), which sets the resting, default state offlow regulator700 to be the first activation state.

Reference is now made toFIGS. 6A-B, which are schematic illustrations ofinput module156 and a portion ofmain body210, in accordance with an application of the present invention.FIGS. 6A-B illustrate an alternative mechanism for causing axial motion of cathetermain body210 relative to inputmodule housing310. In the configuration shown inFIGS. 4A-C, mechanicaluser control element320 is pushed parallel to the axial motion of cathetermain body210. In contrast, in the configuration shown inFIGS. 6A-B, mechanicaluser control element320 comprises auser control handle718, which is configured to undergo rotational motion around anaxis720. Alever711, which is rigidly connected to mechanicaluser control element320, imparts a force having a component in cathetermain body210 axial direction onto axial-motion element318, which may comprise, for example, apin730 rigidly connected to cathetermain body210. As a result, although the motion of mechanicaluser control element320 includes a substantial component perpendicular to the catheter axial direction (in user control handle718), mechanicaluser control element320 nevertheless imparts an axial force onto axial-motion element318 (e.g., pin730), which causes axial motion of cathetermain body210 relative to inputmodule housing310. In other words, mechanicaluser control element320 translates the movement of user control handle718 into axial motion ofaxial motion element318. In this configuration, the larger arc motion of user control handle718 relative to the smaller motion ofpin730 and cathetermain body210 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.

This configuration of mechanicaluser control element320 may be used with any of the configurations ofinput module156 described herein. In particular, in order to integrate this control arrangement into the configurations described herein, pin730 of this configuration is substituted for mechanicaluser control element320 in the other configurations, and the other elements of this configuration are added to the other configurations. Alternative configurations of mechanicaluser control element320 for effecting axial motion ofaxial motion element318 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, mechanicaluser control element320 may comprise a knob that assumes three different rotational configuration (e.g., spatial positions) that causeaxial motion element318 to assume three different corresponding axial positions.

In the configurations ofinput module156 described herein, the states of the flow regulator are generally effected by linear axial motion of cathetermain body210 with respect tohousing310. This linear motion may be triggered by the user's linearly moving mechanicaluser control element320, or by the user's rotationally moving mechanicaluser control element320, as described with reference toFIGS. 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 ofhousing310 and the lumen inlets of the catheter main body.

Reference is now made toFIGS. 7A and 7B, which are schematic illustrations ofdistal portion212 of cleaningcatheter200 inserted intoventilation tube160, in accordance with an application of the present invention. The configurations illustrated inFIGS. 7A and 7B may be used with any of the configurations ofcleaning system100 described herein, including with reference toFIGS. 1A-D,3,4A-C,5A-C,6A-B,8 and9A-C,10 and11A-C,12 and13A-B,14 and15A-B,16A-C,17A-C,18A-C,19A-C,20,21A-B and22A-C, and23 and24A-C. In the configurations illustrated inFIGS. 7A and 7B,expandable element588 comprises an inflatable element, and at least one of one or more fluid-delivery lumens520 is in fluid communication with an interior ofexpandable element588.Inflatable element588 is inflated by fluid pressure provided from the same source as the fluid delivered to one or more fluid-delivery lumens520, namelyfluid source602.

In the configurations shown in bothFIGS. 7A and 7B, one or more fluid-delivery orifices525 are in fluid communication with the interior ofinflatable element588.Inflatable element588 is inflated by fluid communication with the at least one of one or more fluid-delivery lumens520 via one ormore inflation outlets585 defined bydistal portion212 of cleaningcatheter200. Fluid is ejected from one or more fluid-delivery orifices525 that are also in fluid communication with one or more fluid-delivery lumens520.

In the configuration shown inFIG. 7A, a wall ofmain body210 atdistal portion212 of cleaningcatheter200 is shaped so as to define fluid-delivery orifices525. In the configuration shown inFIG. 7B, the wall ofinflatable element588 defines one or more fluid-delivery orifices525, typically on a surface ofinflatable element588 that faces proximally. Fluid sprayed from these orifices is symbolically illustrated as fluid streams556. Alternatively, a portion of fluid-delivery orifices525 are defined by the wall ofmain body210, and another portion of fluid-delivery orifices525 are defined by the wall of inflatable element588 (configuration not shown).

Generally, one ormore suction lumens530 facilitate fluid communication between itsproximal suction inlet531 anddistal suction orifices440, and one or more fluid-delivery lumens520 facilitate fluid communication between itsproximal suction inlet531 and distal fluid delivery to fluid-delivery orifices525. Inflation of inflatable element588 (i.e., fluid communication to its inner surface) is facilitated either via adedicated inflation lumen580 or via one or more of fluid-delivery lumens520.

Upon inflation ofinflatable element588 when the inflatable element is positioned withinventilation tube160, the inflated inflatable element forms a sliding boundary which obstructs (i.e., significantly hinders) fluid flow to between: (a) a moreproximal portion774 of an interstitial region outside ofmain body210 and withinventilation tube160 and (b)locations778 within theventilation tube160 that are distal to the slidable boundary formed and delineated by theinflatable element588.

In some applications of the present invention, cathetermain body210 comprises at least two separate suction lumens: (a) at least afirst suction lumen530 which is in fluid communication with one or moredistal suction orifices440 proximal toexpandable element588, 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.

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 thelargest orifice440 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 thelargest orifice440 proximal to the expandable element.

Reference is now made toFIG. 8, which is a schematic illustration of a portion ofproximal portion214 ofmain body210, in accordance with an application of the present invention.FIG. 8 (andFIGS. 9A-C) illustrate configurations ofproximal portion214 ofmain body210 appropriate for use with either of the configurations ofdistal portion212 of cleaningcatheter200 described hereinabove with reference toFIGS. 7A and 7B. In these configuration,expandable element588 is inflated via fluid communication to pressurized fluid in at least one of one or more fluid-delivery lumens520, e.g., exactly one fluid-delivery lumen520, which are in fluid communication with an interior ofexpandable element588. There is thus no need to provideseparate inflation lumen580 to the expandable element (such as described hereinabove with reference to FIGS.3 and4A-C), because the expandable element is inflated via one ormore inflation outlets585 from the at least one of the one or more fluid-delivery lumens520 itself. Alternatively,expandable element588 is inflated viadedicated inflation lumen580 which is in fluid communication directly with one or more fluid-delivery lumens520, or with thesame source602 of pressurized fluid with which one or more fluid-delivery lumens520 are in fluid communication (configuration not shown).

In the particular configuration shown inFIG. 8 (andFIGS. 9A-C),main body210 is shaped so as to define at least two lumens: one or more fluid-delivery lumens520 (e.g., exactly one fluid-delivery lumen520), and one or more suction lumens530 (e.g., exactly one suction lumen530), and respective at least one proximal fluid-delivery inlet521 (e.g., exactly one proximal fluid-delivery inlet521), and at least one proximal suction inlet531 (e.g., exactly one proximal suction inlet531). In this particular configuration,main body210 is not shaped so as to defineinflation lumen580 orinflation inlet581, described hereinabove with reference to FIGS.3 and4A-C. In this particular configuration,expandable element588 comprises aninflatable element588, such as a balloon.

FIG. 8 shows one or more fluid-delivery lumens520 and one ormore suction lumens530, which have been omitted fromFIGS. 9A-B for clarity of illustration. For some applications,proximal suction inlet531 is located proximal to proximal fluid-delivery inlet521. For some applications, as shown,proximal suction inlet531 is defined by a lateral wall ofmain body210, while for other applications,proximal suction inlet531 is defined by a proximal end ofmain body210, such as shown inFIGS. 5B-C,17A-C, and18A-C.

Reference is made toFIGS. 9A-C, which are schematic illustrations of several states of aflow regulator710 ofinput module156, in accordance with an application of the present invention. Except as described as follows,input module156 is configured as described hereinabove with reference toFIGS. 4A-C. Except as described as follows,flow regulator710 is generally similar to flowregulator700, described hereinabove with reference toFIGS. 4A-C. As mentioned above, in someapplications input portion216 of proximal portion ofmain body210 is configured to be inserted into and axially slidable with respect toinput module156.Input module156 has a plurality of ports for connection with various fluid sources, including atleast suction source601 and pressurizedfluid source602. In this configuration,input module156 includesfluid port827, which is coupleable in fluid communication with pressurizedfluid source602, andsuction port830, which is coupleable in fluid communication withsuction source601, but does not includeinflation port832, described hereinabove with reference toFIGS. 4A-C. In addition,inflation source603 is not provided.

As mentioned above,input module156 is configured to assume a plurality of activation states.Mechanical control unit320 is typically configured to mechanically and non-electrically set the states offlow regulator710.Input module156 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 ofinput module156, which chambers are or are not in fluid communication with respective ports. The shifts in alignment are typically effected via axial motion ofinput portion216 of cathetermain body210 withininput module housing310, along the longitudinal axes ofinput portion216 andinput module156.

In this configuration,flow regulator710 is configured to have three principal activation states, typically associated with three configurations (e.g., spatial positions) of mechanicaluser control element320. In the configuration illustrated inFIGS. 9A-C, the three states are actuated by axial motion ofproximal portion214 of elongatedmain body210 relative to input module housing310:

- as shown inFIG. 9A, a first activation state, in which flowregulator710 blocks fluid communication (a) betweensuction port830 andproximal suction inlet531, and thus one ormore suction lumens530 and (b) betweenfluid port827 and proximal fluid-delivery inlet521, and thus one or more fluid-delivery lumens520; as a result, fluid communication is blocked to both fluid-delivery orifices525 and the interior of inflatable element588 (this configuration can be used with either the configuration described with reference toFIG. 7A or that described with reference toFIG. 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 toFIGS. 5B-C;
- as shown inFIG. 9B, a second activation state, in which flowregulator710 effects suction fluid communication betweensuction port830 and one ormore suction lumens530 viaproximal suction inlet531, and blocks flow of fluid betweenfluid port827 and one or more fluid-delivery lumens520; and
- as shown inFIG. 9C, a third activation state, in which flowregulator710 effects both (a) suction fluid communication betweensuction port830 and one ormore suction lumens530 viaproximal suction inlet531, and (b) fluid communication betweenfluid port827 and one or more fluid-delivery lumens520 via proximal fluid-delivery inlet521; as a result, fluid communication is provided to both fluid-delivery orifices525 and the interior ofinflatable element588.

As mentioned above, mechanicaluser control element320 is configured to mechanically and non-electrically set the states offlow regulator710. Typically, mechanicaluser control element320 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, mechanicaluser control element320 is shown inFIG. 9A in its first configuration (e.g., spatial position) (right-most position), inFIG. 9B in its second configuration (e.g., spatial position) (center position), and inFIG. 9C in its third configuration (e.g., spatial position) (left-most position).Input module156 is configured such that:

- whenuser control element320 is in the first configuration (e.g., spatial position),flow regulator710 is in the first activation state, as described above;
- whenuser control element320 is in the second configuration (e.g., spatial position),flow regulator710 is in the second activation state, as described above; and
- whenuser control element320 is in the third configuration (e.g., spatial position),flow regulator710 is in the third activation state, as described above.

As mentioned,FIG. 9A showsflow regulator710 in the first (blocked) state.Input portion216 ofmain body210 is encased, yet movable, withinhousing310 ofinput module156. Cathetermain body210 is slidable through adistal wall314 ofhousing310.Housing310 is shaped so as to definesuction port830 and cleaning fluid port827 (main body210 does not define these ports).

Asmain body210 moves within the inner compartment ofhousing310, transverse sealing

separators

341,342,343, and344 delineate distinct chambers within the housing. Whenflow regulator710 is in the first activation state, as shown inFIG. 9A,

separators

342 and343 and the outer surface of elongatedmain body210 delineatefirst chamber350 around proximal fluid-delivery inlet521, and thereby block direct fluid communication withinhousing310 between proximal fluid-delivery inlet521 andproximal suction inlet531. The separators are attached to the main body and snugly pressed against the inner surface ofhousing310, so that the insulated chamber around proximal fluid-delivery inlet521 is maintained even as the main body slides a certain distance along the longitudinal axis thereof with respect the housing.

Also as shown inFIG. 9A, in the first activation state, elongatedmain body210 is positioned in its closest position to aproximal end360 ofhousing310,proximal-most separator344 creates a seal which prevents direct fluid communication betweensuction port830 ofhousing310 andproximal suction inlet531 of elongatedmain body210. In this base position, cleaning fluid flow is blocked within a second sealedchamber352 delineated by

separators

341 and342 and the outer surface of elongatedmain body210.

Whenflow regulator710 is in the second activation state, as shown inFIG. 9B, fluid communication is established betweensuction port830 ofhousing310 andproximal suction inlet531 and into one ormore suction lumens530 in elongatedmain body210, yet cleaning fluid flow remains blocked within second sealedchamber352 delineated by

separators

Whenflow regulator710 is in the third activation state, as shown inFIG. 9C, fluid communication is established infirst chamber350 between cleaningfluid port827 ofhousing310 and proximal fluid-delivery inlet521 and one or more fluid-delivery lumens520 in elongatedmain body210.Suction port830 ofhousing310 remains in fluid communication withproximal suction inlet531 and into one ormore suction lumens530 in elongatedmain body210. Therefore, in this third activation state,flow regulator710 effects both (a) cleaning fluid flow into one or more fluid-delivery lumens520 and (b) suction in one ormore suction lumens530 of elongatedmain body210. This activation is achieved by sliding elongatedmain body210 more distally along the axial direction by a limited distance such thatseparator342 crosses into or passes across the space of cleaningfluid port827. Typically, the sliding motion is induced by distally pushing on mechanicaluser control element320, which is coupled to elongatedmain body210 and passes throughslit312 inhousing310.

Thus, three activation states can be actuated, typically associated with three configurations (e.g., spatial positions) of mechanicaluser control element320. In the configuration illustrated inFIGS. 9A-C, the three states are actuated by axial motion ofinput portion216 of elongatedmain body210 relative to input module housing310:

- the first activation state, in which suction flow and cleaning fluid flow is blocked;
- the second activation state, in which suction flow is enabled between one ormore suction lumens530 andsuction port830 viaproximal suction inlet531 into one ormore suction lumens530, but cleaning fluid flow into one or more fluid-delivery lumens520 remains blocked; and
- the third activation state, in which suction flow is enabled both between one ormore suction lumens530 andsuction port830 viaproximal suction inlet531 into one ormore suction lumens530, and cleaning fluid flow into one or more fluid-delivery lumens520 fromfluid port827 ofhousing310 via proximal fluid-delivery inlet521, thereby both providing fluid to fluid-delivery orifices525 and the interior ofinflatable element588, so as to inflate the inflatable element.

For some applications,expandable element588 is emptied by suction via thesame suction source601 which is connected to suctionport830. 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 lumens520 or inflation lumen580). For some applications,expandable element588 can be both inflated via pressurized delivery fluid in communication with one or more fluid-delivery lumens520 and be deflated by suction provided by thesame source601 connected to one ormore suction lumens530. Examples of such configurations are described hereinbelow with reference to FIGS.10 and11A-C,FIGS. 12A-B and13A-B, FIGS.14 and15A-B, andFIGS. 16A-C.

Reference is now made toFIG. 10, which is a schematic illustration of a portion ofproximal portion214 ofmain body210, in accordance with an application of the present invention.FIG. 10 shows one or more fluid-delivery lumens520 and one ormore suction lumens530, which have been omitted fromFIGS. 11A-C for clarity of illustration.FIG. 10 (andFIGS. 11A-C) illustrate configurations ofproximal portion214 ofmain body210 appropriate for use with either of the configurations ofdistal portion212 of cleaningcatheter200 described hereinabove with reference toFIGS. 7A and 7B. In these configuration,expandable element588 is inflated via fluid communication to pressurized fluid in at least one of one or more fluid-delivery lumens520, e.g., exactly one fluid-delivery lumen520, which are in fluid communication with an interior ofexpandable element588. There is thus no need to provideseparate inflation lumen580 to the expandable element, because the expandable element is inflated via one ormore inflation outlets585 from the at least one of the one or more fluid-delivery lumens520 itself. Alternatively,expandable element588 is inflated viadedicated inflation lumen580 which is in fluid communication directly with one or more fluid-delivery lumens520, or with thesame source602 of pressurized fluid with which one or more fluid-delivery lumens520 are in fluid communication (configuration not shown). The configuration shown inFIG. 10 is the same as that shown inFIG. 8, described hereinabove.

Reference is made toFIGS. 11A-C, which are schematic illustrations of several states of aflow regulator712 ofinput module156, in accordance with an application of the present invention. Except as described as follows,input module156 is configured as described hereinabove with reference toFIGS. 4A-C and9A-C. Except as described as follows,flow regulator712 is generally similar to flowregulator710, described hereinabove with reference toFIGS. 9A-C. As mentioned above, in someapplications input portion216 of proximal portion ofmain body210 is configured to be inserted into and axially slidable with respect toinput module156.Input module156 has a plurality of ports for connection with various fluid sources, including atleast suction source601 and pressurizedfluid source602. In this configuration,input module156 includesfluid port827, which is coupleable in fluid communication with pressurizedfluid source602, andsuction port830, which is coupleable in fluid communication withsuction source601, but does not includeinflation port832, described hereinabove with reference toFIGS. 4A-C. In addition,inflation source603 is not provided.

As mentioned above,input module156 is configured to assume a plurality of activation states.Mechanical control unit320 is typically configured to mechanically and non-electrically set the states offlow regulator712.Input module156 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 ofinput module156, which chambers are or are not in fluid communication with respective ports. The shifts in alignment are typically effected via axial motion ofinput portion216 of cathetermain body210 withininput module housing310, along the longitudinal axes ofinput portion216 andinput module156.

In this configuration,flow regulator712 is configured to have three principal activation states, typically associated with three configurations (e.g., spatial positions) of mechanicaluser control element320. In the configuration illustrated inFIGS. 11A-C, the three states are actuated by axial motion ofproximal portion214 of elongatedmain body210 relative to input module housing310:

- as shown inFIG. 11A, a first activation state, in which flowregulator712 blocks fluid communication (a) betweensuction port830 andproximal suction inlet531, and thus one ormore suction lumens530 and (b) betweenfluid port827 and proximal fluid-delivery inlet521, and thus one or more fluid-delivery lumens520; as a result, fluid communication is blocked to both fluid-delivery orifices525 and the interior of inflatable element588 (this configuration can be used with either the configuration described with reference toFIG. 7A or that described with reference toFIG. 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 toFIGS. 5B-C;
- as shown inFIG. 11B, a second activation state, in which flow regulator712 (a) effects suction fluid communication betweensuction port830 and one ormore suction lumens530 viaproximal suction inlet531, (b) effects suction fluid communication betweensuction port830 and one or more fluid-delivery lumens520 via proximal fluid-delivery inlet521 (thereby deflating inflatable element588), and (c) blocks flow of fluid betweenfluid port827 and one or more fluid-delivery lumens520. In this second activation state, flow regulator typically does not effect the fluid communication betweensuction source601 anddistal orifices440; and
- as shown inFIG. 11C, a third activation state, in which flowregulator712 effects both (a) suction fluid communication betweensuction port830 and one ormore suction lumens530 viaproximal suction inlet531, and (b) fluid communication betweenfluid port827 and one or more fluid-delivery lumens520 via proximal fluid-delivery inlet521; as a result, fluid communication is provided to both fluid-delivery orifices525 and the interior ofinflatable element588, thereby inflating the inflatable element. (In this third activation state,flow regulator712 does not effect the fluid communication betweensuction source601 and the interior ofinflatable element588.)

As mentioned above, mechanicaluser control element320 is configured to mechanically and non-electrically set the states offlow regulator712. Typically, mechanicaluser control element320 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, mechanicaluser control element320 is shown inFIG. 11A in its first configuration (e.g., spatial position) (right-most position), inFIG. 11B in its second configuration (e.g., spatial position) (center position), and inFIG. 11C in its third configuration (e.g., spatial position) (left-most position).Input module156 is configured such that:

- whenuser control element320 is in the first configuration (e.g., spatial position),flow regulator712 is in the first activation state, as described above;
- whenuser control element320 is in the second configuration (e.g., spatial position),flow regulator712 is in the second activation state, as described above; and
- whenuser control element320 is in the third configuration (e.g., spatial position),flow regulator712 is in the third activation state, as described above.

As mentioned,FIG. 11A showsflow regulator712 in the first (blocked) state.Input portion216 ofmain body210 is encased, yet movable, withinhousing310 ofinput module156. Cathetermain body210 is slidable through adistal wall314 ofhousing310.Housing310 is shaped so as to definesuction port830 and cleaning fluid port827 (main body210 does not define these ports).

separators

341,342,343, and344 delineate distinct chambers within the housing. Whenflow regulator712 is in the first activation state, as shown inFIG. 11A,

separators

However, the insulating capability ofseparator343 between proximal fluid-delivery inlet521 andproximal suction inlet531 also depends on the full engagement of the separator with the inner wall ofhousing310. A widening348 of the encasing inner wall ofhousing310, shown inFIGS. 11A-C, creates a path of fluid communication between proximal fluid-delivery inlet521 andproximal suction inlet531 around theseparator343 edge, i.e., betweenfirst chamber350 and athird chamber354 defined by

separators

343 and344 and the outer surface of elongatedmain body210.

Also as shown inFIG. 11A, in the first activation state, elongatedmain body210 is positioned in its closest position to aproximal end360 ofhousing310,proximal-most separator344 creates a seal which prevents direct fluid communication betweensuction port830 ofhousing310 andproximal suction inlet531 of elongatedmain body210. In this base position, cleaning fluid flow is blocked within a second sealedchamber352 delineated by

separators

341 and342 and the outer surface of elongatedmain body210.

Whenflow regulator712 is in the second activation state, as shown inFIG. 11B, fluid communication is established betweensuction port830 ofhousing310 andproximal suction inlet531 and into one ormore suction lumens530 in elongatedmain body210, yet cleaning fluid flow remains blocked within second sealedchamber352 delineated by

separators

In addition, in this second activation state, fluid communication is established between proximal fluid-delivery inlet521 and proximal suction inlet531 (e.g., around the outermost edge ofseparator343 via widening348 in the wall of housing310). Thus, in the second activation state, the suction force acts both on one ormore suction lumens530 and on expandable element588 (e.g., communicated via one or more fluid-delivery lumens520).

Whenflow regulator712 is in the third activation state, as shown inFIG. 11C, fluid communication is established infirst chamber350 between cleaningfluid port827 ofhousing310 and proximal fluid-delivery inlet521 and one or more fluid-delivery lumens520 in elongatedmain body210.Suction port830 ofhousing310 remains in fluid communication withproximal suction inlet531 and into one ormore suction lumens530 in elongatedmain body210. Therefore, in this third activation state,flow regulator712 effects both (a) cleaning fluid flow into one or more fluid-delivery lumens520 and (b) suction in one ormore suction lumens530 of elongatedmain body210. This activation is achieved by sliding elongatedmain body210 more distally along the axial direction by a limited distance such thatseparator342 crosses into or passes across the space of cleaningfluid port827. Typically, the sliding motion is induced by distally pushing on mechanicaluser control element320, which is coupled to elongatedmain body210 and passes throughslit312 inhousing310.

In addition, in this third activation state, the path of fluid communication between proximal fluid-delivery inlet521 andproximal suction inlet531 is blocked (e.g., because full engagement ofseparator343 with the bounding wall of encasinghousing310 is established, becauseseparator343 is no longer axially aligned with widening348). Thus, in the third activation state, suction force is blocked fromexpandable element588 and acts only on one ormore suction lumens530. Additional arrangements for achieving fluid communication between first and

third chambers

350 and354 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.

Thus, three activation states can be actuated, typically associated with three configurations (e.g., spatial positions) of mechanicaluser control element320. In the configuration illustrated inFIGS. 11A-C, the three states are actuated by axial motion ofinput portion216 of elongatedmain body210 relative to input module housing310:

- the first activation state, in which suction flow and cleaning fluid flow is blocked;
- the second activation state, in which suction flow is enabled between one ormore suction lumens530 andsuction port830 viaproximal suction inlet531 into one ormore suction lumens530, and suction flow is also enabled betweensuction port830 and the interior ofinflatable element588 via one or more fluid-delivery lumens520 (thereby deflating the inflatable element), but cleaning fluid flow into one or more fluid-delivery lumens520 remains blocked; and
- the third activation state, in which suction flow is enabled both between one ormore suction lumens530 andsuction port830 viaproximal suction inlet531 into one ormore suction lumens530, and cleaning fluid flow into one or more fluid-delivery lumens520 fromfluid port827 ofhousing310 via proximal fluid-delivery inlet521, thereby both providing fluid to fluid-delivery orifices525 and the interior ofinflatable element588, so as to inflate the inflatable element.

For some applications:

- flow regulator712, when in the second activation state, effects fluid communication betweensuction source601 and an interior of theinflatable element588 via at least one of one or more fluid-delivery lumens520, thereby deflatinginflatable element588, and
- flow regulator712, when in the third activation state, effects fluid communication betweensuction source601 anddistal suction orifices440 via one ormore suction lumens530, and does not effect the fluid communication betweensuction source601 and the interior ofinflatable element588.

Reference is now made toFIG. 12, which is a schematic illustration of a portion ofproximal portion214 ofmain body210, in accordance with an application of the present invention.FIG. 12 shows one or more fluid-delivery lumens520 and one ormore suction lumens530, which have been omitted fromFIGS. 13A-B for clarity of illustration.FIG. 12 (andFIGS. 13A-B) illustrate configurations ofproximal portion214 ofmain body210 appropriate for use with either of the configurations ofdistal portion212 of cleaningcatheter200 described hereinabove with reference toFIGS. 7A and 7B. In these configurations,expandable element588 is inflated via fluid communication to pressurized fluid in at least one of one or more fluid-delivery lumens520, e.g., exactly one fluid-delivery lumen520, which are in fluid communication with an interior ofexpandable element588. There is thus no need to provideseparate inflation lumen580 to the expandable element (such as described hereinabove with reference to FIGS.3 and4A-C), because the expandable element is inflated via one ormore inflation outlets585 from the at least one of the one or more fluid-delivery lumens520 itself. Alternatively,expandable element588 is inflated viadedicated inflation lumen580 which is in fluid communication directly with one or more fluid-delivery lumens520, or with thesame source602 of pressurized fluid with which one or more fluid-delivery lumens520 are in fluid communication (configuration not shown). The configuration shown inFIG. 12 is the same as that shown inFIGS. 8 and 10, described hereinabove.

Reference is made toFIGS. 13A-B, which are schematic illustrations of several states of aflow regulator714 ofinput module156, in accordance with an application of the present invention. Except as described as follows,input module156 is configured as described hereinabove with reference toFIGS. 9A-C and11A-C. Except as described as follows,flow regulator714 is generally similar to flowregulator712, described hereinabove with reference toFIGS. 11A-C. As mentioned above, in someapplications input portion216 of proximal portion ofmain body210 is configured to be inserted into and axially slidable with respect toinput module156.Input module156 has a plurality of ports for connection with various fluid sources, including atleast suction source601 and pressurizedfluid source602. In this configuration,input module156 includesfluid port827, which is coupleable in fluid communication with pressurizedfluid source602, andsuction port830, which is coupleable in fluid communication withsuction source601, but does not includeinflation port832, described hereinabove with reference toFIGS. 4A-C. In addition,inflation source603 is not provided.

As mentioned above,input module156 is configured to assume a plurality of activation states.Mechanical control unit320, together with avalve946 if provided, are typically configured to mechanically and non-electrically set the states offlow regulator714.Input module156 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 ofinput module156, which chambers are or are not in fluid communication with respective ports. The shifts in alignment are typically effected via axial motion ofinput portion216 of cathetermain body210 withininput module housing310, along the longitudinal axes ofinput portion216 andinput module156.

In addition,flow regulator714 optionally comprises a fluidcommunication suction channel551, having distal and

proximal inlets

941 and942. For some applications, fluidcommunication suction channel551 is disposed external tohousing310; for example,channel551 may be provided by a separate tube, such as shown inFIGS. 13A-B. Suction channelproximal inlet942 is in fluid communication withsuction source601; for example,proximal inlet942 may be in fluid communication withsuction port830, such as shown inFIG. 13A. Suction channeldistal inlet941 is coupled in fluid communication withhousing310 such that, whenflow regulator714 is in the first activation state shown inFIG. 13A,distal inlet941 is in fluid communication with an interior ofexpandable element588, e.g., via fluid-delivery inlet521 and at least one of one or more fluid-delivery lumens520, as shown inFIG. 13A, or via aninflation inlet581 andinflation lumen580 in the alternative configuration described hereinbelow with reference toFIG. 15A. As a result, suction can be delivered toexpandable element588 via the at least one of the one or more fluid-delivery lumens520 orinflation lumen580, even at a time when no suction is delivered to one ormore suction lumens530, in the first position shownFIG. 13A.

For some applications,flow regulator714 further comprises avalve946, which is in fluid communication withsuction port830, and which is arranged to regulate fluid flow throughsuction channel551.Valve946 is switchable between closed and open fluid communication states betweendistal inlet941 andproximal inlet942 ofsuction channel551.

In this configuration,flow regulator714 enables independent control over the suction communication toexpandable element588 for deflation thereof.Flow regulator714 is configured to have up to four principal activation states, typically associated with three configurations (e.g., spatial positions) of mechanicaluser control element320. In the configuration illustrated inFIGS. 13A-B, the states are actuated by axial motion ofproximal portion214 of elongatedmain body210 relative to inputmodule housing310 and, optionally by setting the state of valve946:

- as shown inFIG. 13A, a primary first activation state, in whichvalve946 is in the open state. In thisstate flow regulator714 blocks fluid communication (a) betweensuction port830 andproximal suction inlet531, and thus one ormore suction lumens530; as a result, fluid communication is blocked to fluid-delivery orifices525 (this configuration can be used with either the configuration described with reference toFIG. 7A or that described with reference toFIG. 7B). In addition, in thisstate flow regulator714 effects suction fluid communication betweensuction port830 and the interior ofinflatable element588 via (a)suction channel551, (b) proximal fluid-delivery inlet521, and (c) one or more fluid-delivery lumens520, thereby deflatinginflatable element588. 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 toFIGS. 5B-C;
- also as shown inFIG. 13A, a secondary activation state, in whichvalve946 is in the open state, andproximal portion214 of elongatedmain body210 is in the same relative axial position with respect toinput module housing310 as in the primary first activation state. In this secondary activation state,flow regulator714 blocks fluid communication (a) betweensuction port830 andproximal suction inlet531, and thus one ormore suction lumens530 and (b) betweenfluid port827 and proximal fluid-delivery inlet521 (becausevalve946 blocks suction channel551), and thus one or more fluid-delivery lumens520; as a result, fluid communication is blocked to both fluid-delivery orifices525 and the interior ofinflatable element588. For some applications, this secondary first activation state may be considered to be a secondary base, default activation state;
- a second activation state, in which flowregulator714 effects suction fluid communication betweensuction port830 and one ormore suction lumens530 viaproximal suction inlet531, and blocks flow of fluid betweenfluid port827 and one or more fluid-delivery lumens520. This second activation state is not shown inFIGS. 13A-B, but is typically identical to the state show inFIG. 9B, except for the difference inflow regulator714 described above. In this state,suction channel551 typically has no effect on the state of fluid flow; and
- as shown inFIG. 13C, a third activation state, in which flowregulator714 effects both (a) suction fluid communication betweensuction port830 and one ormore suction lumens530 viaproximal suction inlet531, and (b) fluid communication betweenfluid port827 and one or more fluid-delivery lumens520 via proximal fluid-delivery inlet521; as a result, fluid communication is provided to both fluid-delivery orifices525 and the interior ofinflatable element588, thereby inflating the inflatable element. (In this third activation state,flow regulator714 does not effect the fluid communication betweensuction source601 and the interior ofinflatable element588.)

As mentioned above, mechanicaluser control element320 andvalve946 if provided are configured to mechanically and non-electrically set the states offlow regulator714. Typically, mechanicaluser control element320 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, mechanicaluser control element320 is shown inFIG. 13A in its first configuration (e.g., spatial position) (right-most position) and inFIG. 13C in its third configuration (e.g., spatial position) (left-most position).Input module156 is configured such that:

- whenuser control element320 is in the first configuration (e.g., spatial position),flow regulator714 is in the primary or second first activation state (depending on the state of valve946), as described above;
- whenuser control element320 is in the second configuration (e.g., spatial position),flow regulator714 is in the second activation state, as described above; and
- whenuser control element320 is in the third configuration (e.g., spatial position),flow regulator714 is in the third activation state, as described above.

Thus, four activation states can be actuated (three mandatory and one optional), typically associated with three configurations (e.g., spatial positions) of mechanicaluser control element320 and, optionally, two states ofvalve946. In the configuration illustrated inFIGS. 13A-B, the four states are actuated by axial motion ofinput portion216 of elongatedmain body210 relative to inputmodule housing310, as well as by the state of valve946:

- the primary first activation state, in which suction flow to one ormore suction lumens530 and cleaning fluid flow is blocked, andinflatable element588 is deflated by active suction (viaopen suction channel551 flow);
- the secondary first activation state, in which suction flow to one ormore suction lumens530 is blocked and cleaning fluid flow is blocked, and also suction flow toinflatable element588 is blocked (becausevalve946 blocks flow through suction channel551);
- the second activation state, in which suction flow is enabled between one ormore suction lumens530 andsuction port830 viaproximal suction inlet531 into one ormore suction lumens530, but cleaning fluid flow into one or more fluid-delivery lumens520 remains blocked; and
- the third activation state, in which suction flow is enabled both between one ormore suction lumens530 andsuction port830 viaproximal suction inlet531 into one ormore suction lumens530, and cleaning fluid flow into one or more fluid-delivery lumens520 fromfluid port827 ofhousing310 via proximal fluid-delivery inlet521, thereby both providing fluid to fluid-delivery orifices525 and the interior ofinflatable element588, so as to inflate the inflatable element.

Reference is now made toFIG. 14, which is a schematic illustration of a portion ofproximal portion214 ofmain body210, in accordance with an application of the present invention, andFIGS. 15A-B, which are schematic illustrations of several states of aflow regulator714 ofinput module156, in accordance with an application of the present invention. Except as described hereinbelow, the configuration shown in FIGS.14 and15A-B is identical to the configuration described hereinabove with reference to FIGS.12 and13A-B, and achieves the same activation states.

In this configuration, cathetermain body210, in addition to one or more fluid-delivery lumens520 and one ormore suction lumens530, comprisesindependent inflation lumen580 in fluid communication with an interior ofexpandable element588. In order to achieve the same dual activation as in the configuration of FIGS.12 and13A-B,input portion216 of elongatedmain body210 is shaped so as defineinflation inlet581 toinflation lumen580 at about the same axial position alongmain body210 as proximal fluid-delivery inlet521 to one or more fluid-delivery lumens520. As a result,inflation lumen580 and one or more fluid-delivery lumens520 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 toexpandable element588 can be provided either viadedicated lumen580, as shown in FIGS.14 and15A-B, or via one or more shared fluid-delivery lumens520, as shown in FIGS.12 and13A-B. One difference between the configuration of FIGS.12 and13A-B and the configuration of FIGS.14 and15A-B is that, in the configuration of FIGS.12 and13A-B, unlike in the configuration of FIGS.14 and15A-B, the interior ofexpandable element588 is in fluid communication with fluid-delivery orifices525.

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.

Reference is now made toFIGS. 16A-C, which are schematic illustrations of a configuration ofinput module156 comprising a stateprotective selector390, in accordance with an application of the present invention. Although the configuration ofinput module156 shown generally corresponds to the configurations described hereinabove with reference to FIGS.12 and13A-B and FIGS.14 and15A-B, stateprotective selector390 may also be provided for the other configurations described herein.

Stateprotective selector390 provides a plurality of protective states, each of which prevents certain movements of mechanicaluser control element320, while allowing other movements ofelement320. In a protective selectorfirst state391, shown inFIG. 16A, movement of mechanicaluser control element320 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 selectorsecond state392, shown inFIG. 16B, movement of mechanicaluser control element320 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 selectorthird state393, movement of mechanicaluser control element320 is enabled to reach all three of the first, second, and third configuration (e.g., spatial positions), corresponding to all three activation states, respectively.

Therefore, as illustrated inFIGS. 16A-C, at least activation states can be actuated (three mandatory, and one optional), typically associated with three configuration (e.g., spatial positions) of mechanicaluser control element320, and an optional independent control valve state of suction flow to the expandable element. In the configuration illustrated inFIGS. 16A-C, the activation states are actuated by axial motion of elongatedmain body210 relative to inputmodule housing310, as well as by the state of valve946:

- a first activation state, in which both suction flow to one ormore suction lumens530 and cleaning fluid flow are blocked, andinflatable element588 is deflated by active suction (viaopen suction channel551 flow);
- a second activation state, in which suction flow is enabled between one ormore suction lumens530 andsuction port830 viaproximal suction inlet531 into one ormore suction lumens530,inflatable element588 is deflated by active suction (viaopen suction channel551 flow), but cleaning fluid flow into one or more fluid-delivery lumens520 remains blocked; and
- a third activation state, in which suction flow is enabled both between one ormore suction lumens530 andsuction port830 viaproximal suction inlet531 into one ormore suction lumens530, and cleaning fluid flow into one or more fluid-delivery lumens520 fromfluid port827 ofhousing310 via proximal fluid-delivery inlet521, andinflatable element588 is inflated.

Alternatively, similar to the configuration described hereinabove with reference to FIGS.12 and13A-B,valve946 is implemented onsuction channel551. In such a configuration, the first activation state includes primary and secondary activation states, as described hereinabove with reference to FIGS.12 and13A-B.

Reference is now made toFIGS. 17A-C, which are schematic illustrations of another configuration ofinput module156, in accordance with an application of the present invention. In this configuration, the sealing separators are fixed with respect to housing310 (and slidable with respect to the catheter main body). Optionally,main body210 is shaped so as to defineproximal suction inlet531 at a proximal end of the main body. In the configuration shown inFIGS. 17A-C, one or more fluid-delivery lumens520 are in fluid communication withinflatable element588, such as described hereinabove with reference toFIG. 7A or with reference toFIG. 7B.

In this configuration,input module156 comprises a sealingseparator373, such as an o-ring, which is fixed with respect tohousing310.Sealing separator373 sealingly separates betweenfluid port827 andsuction port830. Cathetermain body210 is slidable with respect to sealingseparator373. Thus, fluid communication to one or more fluid-delivery lumens520 (and optionally also to inflation lumen580) is switchable from suction communication to fluid delivery communication by axial motion of cathetermain body210. As a result, activation of fluid delivery to fluid-delivery orifices525 and inflation ofinflatable element588 is activated by switching and enabling fluid communication to the same fluid-delivery-pressure source602. The activation of the switching is done by axial motion of cathetermain body210 with respect tohousing310, to which the suction connectors and fluid delivery connectors are coupled. On the other hand,inflatable element588 is deflated by cessation of fluid delivery to one or more fluid-delivery lumens520 and then switching and enabling fluid communication of theinflatable element588 to thesame suction source601 connected to suction connector830 (e.g., viachannel551 as illustrated inFIG. 17A).

Proximal suction inlet

531 is configured to sealingly engage asuction sealer375. Thesuction sealer375 is fixed with respect tohousing310. Whenproximal suction inlet531 is sealingly engaged with suction sealer375 (as shown inFIG. 17A), fluid communication is blocked betweenproximal suction inlet531 andsuction port830, thereby blocking fluid communication betweensuction source601 andlumen530 in the first activation state. Whenproximal suction inlet531 is disengaged from suction sealer375 (as shown inFIG. 17B), fluid communication is enabled betweenproximal suction inlet531 andsuction port830. This engaging/disengaging is preferably actuated by axial motion of cathetermain body210 with respect tosuction sealer375.

As shown inFIG. 17A, at least onesuction channel551 facilitates fluid communication tosuction port830 around thesuction sealer375. Therefore, when proximal fluid-delivery inlet521 is in fluid communication withsuction channel551, suction is communicated to one or more fluid-delivery lumens520, while suction remains blocked bysuction sealer375 from communication to one ormore suction lumens530.

For example, in applications in whichinflatable element588 is in fluid communication with at least one of one or more fluid-delivery lumens520, suction deflation of the inflatable element is effected while no suction is communicated todistal suction orifices440 of the catheter main body.

Reference is now made toFIGS. 18A-C, which are schematic illustrations of yet another configuration ofinput module156, in accordance with an application of the present invention. This configuration is similar to that described hereinabove with reference toFIGS. 17A-C, except that mechanicaluser control element320 comprisesuser control handle718, the movement of which includes a component perpendicular to the associated axial motion of cathetermain body210, similar to the configuration of mechanicaluser control element320 described hereinabove with reference toFIGS. 6A-B. Mechanicaluser control element320 translates the movement of user control handle718 into axial motion ofaxial motion element318.

Reference is now made toFIGS. 19A-C, which are schematic illustrations of aninput module356, in accordance with an application of the present invention.Input module356 is generally similar toinput module156, described hereinabove, except thatinput module356 comprises a mechanicaluser control element420 that comprises at least first and

second buttons

321 and322.First button321 controls the activation of suction into one ormore suction lumens530, andsecond button322 controls the activation of fluid delivery into one or more fluid-delivery lumens520, such as using the techniques described hereinbelow with reference toFIGS. 19D-F.

For some applications, mechanicaluser control element420 further comprises abutton joining element324, which is fixed tofirst button321, and arranged to allow depression offirst button321 only to a certain extent independently of depression ofsecond button322.Button joining element324 allows the depression offirst button321 and/orbutton joining element324 from the state of depression offirst button321 shown inFIG. 19A to the greater state of depression offirst button321 shown inFIG. 19B, without also depressingsecond button322. However, further depression offirst button321 and/orbutton joining element324 causes the simultaneous depression ofsecond button322, as shown inFIG. 19C.

Typically, the activation states of the configuration described with reference toFIGS. 19A-C correspond with those described hereinabove with reference toFIGS. 18A-C.

FIGS. 19D-F are schematic illustrations of the operation of

buttons

321 and322, 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 body210 (e.g., no motion relative to suction inlet830). The states shown inFIGS. 19D,19E, and19F correspond to the states shown inFIGS. 19A,19B, and19C, respectively.

As illustrated inFIG. 19D,suction lumen530 is intermitted by agate area327 traversed bysuction control button321, and fluid-delivery lumen520 is intermitted by agate area328 traversed bysuction control button322. Thus, in this configuration, the fluid communication is blocked inlumen530 acrossgate327 and blocked in fluid-delivery lumen520 acrossgate328.

FIG. 19D, when understood to show a sub-detail ofFIG. 19A, illustrates the main principle of the button press mechanism in which fluid communication betweensuction port830 and the distal end of themain body210 is interrupted bybutton gate321. By way of non-limiting example,FIG. 19D illustrates such interruption as taking place on a portion oflumen530 inmain body210 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 betweensuction port830 andinlet531 tolumen530. Similarly, the same principles of this mechanism of button action is applicable tobutton322 interrupting the fluid communication betweenfluid port827 and proximal fluid-delivery inlet521 to the fluid-delivery lumen520.

As illustrated inFIG. 19E, thecontrol button321 has ahole passage325. When thebutton321 is partially depressed to the level thathole passage325 overlaps with thelumen530 cross-section, fluid communication is enabled insuction lumen530 across thegate327. Yet, at thisbutton321 depression level, there is no change inbutton322 depression level, and therefore fluid communication remains blocked in fluid-delivery lumen520 across thegate328 in this second activation state.

As illustrated inFIG. 19F, thecontrol button322 has ahole passage326. Whenbutton321 is further depressed such that also thebutton322 is depressed to the level thathole passage326 overlaps with the fluid-delivery lumen520 cross-section, fluid communication is enabled in fluid-delivery lumen520 acrossgate328. Therefore, fluid communication is enabled across both fluid-delivery lumen520 andsuction lumen530 in this button control configuration for the third activation state.

Reference is now made toFIG. 20, which is a schematic illustration ofinput module156, in accordance with an application of the present invention. This configuration may be implemented in conjunction with any of the configurations ofinput module156 described herein in whichexpandable element588 is inflatable. In this configuration,input module156 comprises anexternal inflation indicator583, which indicates inflation/deflation state ofexpandable element588. For some applications,inflation indicator583 comprises pilot balloon.Pilot balloon583 is in fluid communication with the lumen in fluid communication withinflatable element588, 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 element588).

Reference is now made toFIGS. 21A-B and22A-C, which are schematic illustrations ofdistal portion212 of cleaningcatheter200 inserted intoventilation tube160, in accordance with an application of the present invention.FIGS. 21A and 21B are side view ofexpandable element588 in uninflated and inflated states, respectively. FIGS.22A,22B, and22C are cross-sectional views ofdistal portion212 of cleaningcatheter200 taken along lines at an axial location proximal to theproximal-most suction orifices440 inFIG. 21A, atinflatable element588 inFIG. 21A, and atinflatable element588 in21B, respectively. In this configuration,expandable element588 comprises an inflatable element, such as a balloon. The configuration described with reference toFIGS. 21A-B and22A-C may be used in combination with any of the other configurations ofcleaning system100 described hereinabove, mutatis mutandis. For some applications, one ormore suction lumens530 comprise exactly onesuction lumen530, while for other applications, one ormore suction lumens530 comprise a plurality ofsuction lumens530.

In this configuration, one or moredistal suction orifices440 comprise one or morelateral suction orifices440 located alongdistal portion212 at one or more respective locations proximal toinflatable element588. In addition tolateral suction orifices440, cathetermain body210 is shaped so as to define adistal-most suction orifice444 at a distal end ofdistal portion212 of cleaningcatheter200, distal toinflatable element588.Distal-most suction orifice444 is in fluid communication with a distal portion ofsuction lumen530. For some applications,distal-most suction orifice444 is defined by a distal tip of the cleaning catheter (as shown), while for other applicationsdistal-most suction orifice444 is defined by a lateral wall of the cleaning catheter distal to inflatable element588 (configuration not shown).Distal-most suction orifice444 enables cleaningsystem100 to selectively apply suction to the trachea. The techniques ofFIGS. 21A-B and22A-C allowcleaning system100 to modulate suction provided fromdistal-most suction orifice444 distal toinflatable element588, relative to the suction provided to thedistal suction orifices440. The techniques include modulating occlusion ofsuction lumen530, at an axial location446 at which location446

inflatable element

588 is positioned. Axial location446 is proximal todistal-most suction orifice444, and longitudinally between distal-most suction port orifice and one or more distal suction orifices440 (in typically configurations in whichdistal suction orifices440 are provided).

For some applications, this occlusion ofsuction lumen530 at axial location446 is achieved using acollapsible membrane599 at least partially positioned along anopening448 extending through the outer wall ofmain body210 intosuction lumen530, at axial location446. Inflatable element558 is mounted tomain body210 at least partially alongopening448. The collapsible membrane is positioned within an interior ofinflatable element588, such that aninflatable chamber587 is defined between the wall ofinflatable element588 andcollapsible membrane599. The collapsible membrane typically forms a fluid-tight seal with the wall ofsuction lumen530 aroundopening448.

Wheninflatable element588 is inflated via inflation port825, as shown inFIGS. 21B and 22C, the inflation also causes inflation and expansion ofinflatable chamber587 and ofcollapsible membrane599 intosuction lumen530, so as to at least partially occlude the passage between distal-most suction orifice444 (distal to inflatable element588) and distal suction orifices440 (proximal to the inflatable element), thereby modulating a level of suction delivered todistal-most suction orifice444 viasuction lumen530. For good occlusion,collapsible membrane599 typically penetrates deep enough intosuction lumen530 across a centrallongitudinal axis533 ofsuction lumen530. The occlusion is reversible, as illustrated inFIGS. 21A and 22B. Upon deflation ofinflatable element588, the deflation collapsesmembrane599 towards the wall ofinflatable element588, out of the suction lumen, preferably so thatcollapsed membrane599 is in a collapsed configuration which does not crossaxis533 ofsuction lumen530. Typically,membrane599 comprises a material that is thinner than a material of the wall ofinflatable element588, such as less than 70%, e.g., less than 50%, such as less than 30%, of a thickness of the material of the wall ofinflatable element588. 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.

For some applications, cleaningcatheter100, configured as described with reference toFIGS. 21A-B and22A-C is used to modulate relative levels of suction delivered bysuction lumen530 to (a) thedistal-most suction orifice444 and (b) the one or morelateral suction orifices440 between at least two levels that include:

- a relatively low distal-most level, in which a level of suction delivered to thedistal-most suction orifice444 is less than 25% of a level of suction delivered to one of the one or morelateral suction orifices440 having a greatest cross-sectional area, and
- a relatively high distal-most level, in which the level of suction delivered to thedistal-most suction orifice444 is greater than 25% of the level of suction delivered to the one of the one or morelateral suction orifices440 having the greatest cross-sectional area.

For some applications, in the relatively low distal-most level, the level of suction delivered to thedistal-most suction orifice444 is less than 10% of the level of suction delivered to the one of the one or morelateral suction orifices440 having the greatest cross-sectional area, and, in the relatively high distal-most level, the level of suction delivered to thedistal-most suction orifice444 is greater than 10% of the level of suction delivered to the one of the one or morelateral suction orifices440 having the greatest cross-sectional area. For some applications, in the relatively low distal-most level, substantially no suction is delivered to thedistal-most suction orifice444.

For some applications,inflatable element588 andinflatable chamber587 are inflated via one or more fluid-delivery lumens520, as shown inFIGS. 21A-B. For other applications,inflatable element588 andinflatable chamber587 are inflated viainflation lumen580, described hereinbelow with reference toFIG. 2 (configuration not shown).

For some applications, an alternative configuration is provided in whichmembrane599 andinflatable element588 are positioned at different axial locations alongmain body210. In this configuration,membrane599 definesinflatable chamber587 with an inner surface of one of the one or more fluid-delivery lumens520, rather than withinflatable element588. Typically,inflatable chamber587 andinflatable element588 are inflated via the same lumen. Alternatively, they are inflated via different lumens, which may or may not be in fluid communication either alongmain body210 and/or in aflow regulator700.

For some applications, a method, which optionally uses the configuration of cleaningcatheter200 described hereinabove with reference toFIGS. 21A-B and22A-C comprises:

providingcleaning catheter200, which includes (a)main body210, which is shaped so as to definedistal-most suction orifice444 and one or morelateral suction orifices440, and (b)inflatable element588, which is mounted tomain body210 axially between (i)distal-most suction orifice444 and (ii) one or morelateral suction orifices440; and

modulating relative levels of suction delivered bysuction source601 to (a)distal-most suction orifice444 and (b) one or morelateral suction orifices440.

For some applications, modulating comprises modulating the relative levels of suction between at least two levels that include:

For some applications, modulating comprises modulating the relative levels of suction between the at least two levels that include:

- the relatively low distal-most level, in which the level of suction delivered to thedistal-most suction orifice444 is less than 10% of the level of suction delivered to the one of the one or morelateral suction orifices440 having a greatest cross-sectional area, and
- the relatively high distal-most level, in which the level of suction delivered to thedistal-most suction orifice444 is greater than 10% of the level of suction delivered to the one of the one or morelateral suction orifices440 having the greatest cross-sectional area.

For some applications, modulating the relative levels of suction comprises reversibly modulating a level of occlusion of at least one of the one ormore suction lumens530 at a portion thereof axially between (x) thedistal-most suction orifice444 and (y) the one or morelateral suction orifices440.

For some applications, cleaningcatheter200 further includessuction lumen530 arranged alongmain body210, in fluid communication withdistal-most suction orifice444 andlateral suction orifices440, and modulating the relative levels of suction comprises reversibly modulating a level of occlusion ofsuction lumen530 at a portion thereof axially between (a)distal-most suction orifice444 and (b) one or morelateral suction orifices440.

For some applications, providingcleaning catheter200 comprises providingcleaning catheter200 further including exactly onesuction lumen530 arranged alongmain body210, in fluid communication withdistal-most suction orifice444 andlateral suction orifices440.

For some applications, providingcleaning catheter200 comprises providingcleaning catheter200 further including a plurality ofsuction lumens530 arranged alongmain body210, in fluid communication with one another and withdistal-most suction orifice444 andlateral suction orifices440.

For some applications, further comprising, before modulating the relative levels of suction, insertingdistal portion212 of cleaningcatheter200 intoventilation tube160 inserted in a trachea of a patient.

Reference is now made toFIG. 23, which is a schematic illustration of a portion ofproximal portion214 ofmain body210, in accordance with an application of the present invention.FIG. 8 shows one or more fluid-delivery lumens520 and one ormore suction lumens530, which have been omitted fromFIGS. 24A-C for clarity of illustration.FIG. 23 (andFIGS. 24A-C) illustrate configurations ofproximal portion214 ofmain body210 appropriate for use with either of the configurations ofdistal portion212 of cleaningcatheter200 described hereinabove with reference toFIGS. 7A and 7B. In these configuration,expandable element588 is inflated via fluid communication to pressurized fluid in at least one of one or more fluid-delivery lumens520, e.g., exactly one fluid-delivery lumen520, which are in fluid communication with an interior ofexpandable element588. There is thus no need to provideseparate inflation lumen580 to the expandable element (such as described hereinabove with reference to FIGS.3 and4A-C), because the expandable element is inflated via one ormore inflation outlets585 from the at least one of the one or more fluid-delivery lumens520 itself. Alternatively,expandable element588 is inflated viadedicated inflation lumen580 which is in fluid communication directly with one or more fluid-delivery lumens520, or with thesame source602 of pressurized fluid with which one or more fluid-delivery lumens520 are in fluid communication (configuration not shown).

In the particular configuration shown inFIG. 23 (andFIGS. 24A-C),main body210 is shaped so as to define at least two lumens: one or more fluid-delivery lumens520 (e.g., exactly one fluid-delivery lumen520), and one or more suction lumens530 (e.g., exactly one suction lumen530), and respective at least one proximal fluid-delivery inlet521 (e.g., exactly one proximal fluid-delivery inlet521), and at least one proximal suction inlet531 (e.g., exactly one proximal suction inlet531). In this particular configuration,main body210 is not shaped so as to defineinflation lumen580 orinflation inlet581, described hereinabove with reference to FIGS.3 and4A-C. In this particular configuration,expandable element588 comprises aninflatable element588, such as a balloon.

FIG. 23 shows one or more fluid-delivery lumens520 and one ormore suction lumens530, which have been omitted fromFIGS. 24A-B for clarity of illustration. For some applications,proximal suction inlet531 is located distal to proximal fluid-delivery inlet521. This axial arrangement of

inlets

521 and531 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 deflatinginflatable element588, mutatis mutandis. For some applications, as shown, proximal fluid-delivery inlet521 is defined by a lateral wall ofmain body210, while for other applications, proximal fluid-delivery inlet521 is defined by a proximal end ofmain body210, such as shown inFIGS. 5B-C,17A-C, and18A-C forproximal suction inlet531.

Reference is made toFIGS. 24A-C, which are schematic illustrations of several states of aflow regulator1000 ofinput module156, in accordance with an application of the present invention. Except as described as follows,input module156 is configured as described hereinabove with reference toFIGS. 9A-C. Except as described as follows,flow regulator1000 is generally similar to flowregulator710, described hereinabove with reference toFIGS. 9A-C. As mentioned above, in someapplications input portion216 of proximal portion ofmain body210 is configured to be inserted into and axially slidable with respect toinput module156.Input module156 has a plurality of ports for connection with various fluid sources, including atleast suction source601 and pressurizedfluid source602. In this configuration,input module156 includesfluid port827, which is coupleable in fluid communication with pressurizedfluid source602, andsuction port830, which is coupleable in fluid communication withsuction source601, but does not includeinflation port832, described hereinabove with reference toFIGS. 4A-C. In this configuration, the locationsfluid port827 andsuction port830 alonghousing310 are reversed with respect to the locations in the other configurations described herein. In addition,inflation source603 is not provided.

As mentioned above,input module156 is configured to assume a plurality of activation states.Mechanical control unit320 is typically configured to mechanically and non-electrically set the states offlow regulator1000.Input module156 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 ofinput module156, which chambers are or are not in fluid communication with respective ports. The shifts in alignment are typically effected via axial motion ofinput portion216 of cathetermain body210 withininput module housing310, along the longitudinal axes ofinput portion216 andinput module156.

In this configuration,flow regulator1000 is configured to have three principal activation states, typically associated with three configurations (e.g., spatial positions) of mechanicaluser control element320. In the configuration illustrated inFIGS. 24A-C, the three states are actuated by axial motion ofproximal portion214 of elongatedmain body210 relative to input module housing310:

- as shown inFIG. 24A, a first activation state, in which flowregulator1000 blocks fluid communication (a) betweensuction port830 andproximal suction inlet531, and thus one ormore suction lumens530 and (b) betweenfluid port827 and proximal fluid-delivery inlet521, and thus one or more fluid-delivery lumens520; as a result, fluid communication is blocked to both fluid-delivery orifices525 and the interior of inflatable element588 (this configuration can be used with either the configuration described with reference toFIG. 7A or that described with reference toFIG. 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 toFIGS. 5B-C;
- as shown inFIG. 24B, a second activation state, in which flowregulator1000 effects fluid communication betweenfluid port827 and one or more fluid-delivery lumens520 via proximal fluid-delivery inlet521, and blocks the fluid communication betweensuction port830 and one ormore suction lumens530; and
- as shown inFIG. 24C, a third activation state, in which flowregulator1000 effects both (a) suction fluid communication betweensuction port830 and one ormore suction lumens530 viaproximal suction inlet531, and (b) fluid communication betweenfluid port827 and one or more fluid-delivery lumens520 via proximal fluid-delivery inlet521; as a result, fluid communication is provided to both fluid-delivery orifices525 and the interior ofinflatable element588.

As mentioned above, mechanicaluser control element320 is configured to mechanically and non-electrically set the states offlow regulator1000. Typically, mechanicaluser control element320 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, mechanicaluser control element320 is shown inFIG. 24A in its first configuration (e.g., spatial position) (right-most position), inFIG. 24B in its second configuration (e.g., spatial position) (center position), and inFIG. 24C in its third configuration (e.g., spatial position) (left-most position).Input module156 is configured such that:

- whenuser control element320 is in the first configuration (e.g., spatial position),flow regulator1000 is in the first activation state, as described above;
- whenuser control element320 is in the second configuration (e.g., spatial position),flow regulator1000 is in the second activation state, as described above; and
- whenuser control element320 is in the third configuration (e.g., spatial position),flow regulator1000 is in the third activation state, as described above.

As mentioned,FIG. 24A showsflow regulator1000 in the first (blocked) state.Input portion216 ofmain body210 is encased, yet movable, withinhousing310 ofinput module156. Cathetermain body210 is slidable through adistal wall314 ofhousing310.Housing310 is shaped so as to definesuction port830 and cleaning fluid port827 (main body210 does not define these ports).

separators

341,342,343, and344 delineate distinct chambers within the housing. Whenflow regulator1000 is in the first activation state, as shown inFIG. 24A,

separators

342 and343 and the outer surface of elongatedmain body210 delineatefirst chamber350 aroundproximal suction inlet531, and thereby block direct fluid communication withinhousing310 between proximal fluid-delivery inlet521 andproximal suction inlet531. The separators are attached to the main body and snugly pressed against the inner surface ofhousing310, so that the insulated chamber aroundproximal suction inlet531 is maintained even as the main body slides a certain distance along the longitudinal axis thereof with respect the housing.

Also as shown inFIG. 24A, in the first activation state, elongatedmain body210 is positioned in its closest position to aproximal end360 ofhousing310,proximal-most separator344 creates a seal which prevents direct fluid communication betweenfluid port827 ofhousing310 and proximal fluid-delivery inlet521 of elongatedmain body210. In this base position, suction fluid flow is blocked within a second sealedchamber352 delineated by

separators

341 and342 and the outer surface of elongatedmain body210.

Whenflow regulator1000 is in the second activation state, as shown inFIG. 24B, fluid communication is established betweenfluid port827 ofhousing310 and proximal fluid-delivery inlet521 and into one or more fluid-delivery lumens520 in elongatedmain body210, yet suction remains blocked within second sealedchamber352 delineated by

separators

341 and342 and the outer surface of elongatedmain body210. This activation is achieved by sliding elongatedmain body210 distally along the axial direction by a limited distance such thatseparator342 does not yet cross into the space of cleaningsuction port830. Typically, this sliding motion is induced by distally pushing on mechanicaluser control element320, which is coupled to elongatedmain body210 and passes through aslit312 inhousing310 which allows axial motion of mechanicaluser control element320.

Whenflow regulator1000 is in the third activation state, as shown inFIG. 24C, fluid communication is established infirst chamber350 betweensuction port830 ofhousing310 andproximal suction inlet531 and one ormore suction lumens530 in elongatedmain body210. Cleaningfluid port827 ofhousing310 remains in fluid communication with proximal fluid-delivery inlet521 and into one or more fluid-delivery lumens520 in elongatedmain body210. Therefore, in this third activation state,flow regulator1000 effects both (a) cleaning fluid flow into one or more fluid-delivery lumens520 and (b) suction in one ormore suction lumens530 of elongatedmain body210. This activation is achieved by sliding elongatedmain body210 more distally along the axial direction by a limited distance such thatseparator342 crosses into or passes across the space ofsuction port830. Typically, the sliding motion is induced by distally pushing on mechanicaluser control element320, which is coupled to elongatedmain body210 and passes throughslit312 inhousing310.

Thus, three activation states can be actuated, typically associated with three configurations (e.g., spatial positions) of mechanicaluser control element320. In the configuration illustrated inFIGS. 24A-C, the three states are actuated by axial motion ofinput portion216 of elongatedmain body210 relative to input module housing310:

- the first activation state, in which suction flow and cleaning fluid flow is blocked;
- the second activation state, in fluid communication is enabled betweenfluid port827 and one or more fluid-delivery lumens520 via proximal fluid-delivery inlet521, but suction flow to one ormore suction lumens530 is remains blocked; and
- the third activation state, in which suction flow is enabled both between one ormore suction lumens530 andsuction port830 viaproximal suction inlet531 into one ormore suction lumens530, and cleaning fluid flow into one or more fluid-delivery lumens520 fromfluid port827 ofhousing310 via proximal fluid-delivery inlet521, thereby both providing fluid to fluid-delivery orifices525 and the interior ofinflatable element588, so as to inflate the inflatable element.

For some applications,expandable element588 is emptied by suction via thesame suction source601 which is connected to suctionport830. 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 lumens520 or inflation lumen580). For some applications,expandable element588 can be both inflated via pressurized delivery fluid in communication with one or more fluid-delivery lumens520 and be deflated by suction provided by thesame source601 connected to one ormore suction lumens530. Examples of such configurations are described hereinabove with reference to FIGS.10 and11A-C,FIGS. 12A-B and13A-B, FIGS.14 and15A-B, andFIGS. 16A-C.

Although the activation states ofinput module156 are sometimes characterized hereinabove as “first,” “second,” or “third,” these ordinal numbers do not necessarily imply a particular order of activation during use ofcleaning system100 unless explicitly stated. In addition,input module156 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.

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.

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.”

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.

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.

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):

- International Application PCT/IB2012/051532, filed Mar. 29, 2012, which published as PCT Publication WO 2012/131626;
- UK Application GB 1116735.0, filed Sep. 28, 2011, which published as GB 2482618 A to Einav et al.;
- UK Application GB 1119794.4, filed Nov. 16, 2011;
- U.S. Provisional Application 61/468,990, filed Mar. 29, 2011;
- U.S. Provisional Application 61/473,790, filed Apr. 10, 2011;
- U.S. Provisional Application 61/483,699, filed May 8, 2011;
- U.S. Provisional Application 61/496,019, filed Jun. 12, 2011;
- U.S. Provisional Application 61/527,658, filed Aug. 26, 2011;
- U.S. Provisional Application 61/539,998, filed Sep. 28, 2011;
- U.S. Provisional Application 61/560,385, filed Nov. 16, 2011;
- U.S. Provisional Application 61/603,340, filed Feb. 26, 2012;
- U.S. Provisional Application 61/603,344, filed Feb. 26, 2012;
- U.S. Provisional Application 61/609,763, filed Mar. 12, 2012;
- U.S. Provisional Application 61/613,408, filed Mar. 20, 2012;
- U.S. Provisional Application 61/635,360, filed Apr. 19, 2012;
- U.S. Provisional Application 61/655,801, filed Jun. 5, 2012;
- U.S. Provisional Application 61/660,832, filed Jun. 18, 2012; and
- U.S. Provisional Application 61/673,744, filed Jul. 20, 2012.

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.

Claims

1.-82. (canceled)

83. Apparatus for use with a suction source, the apparatus comprising a cleaning catheter, which comprises:

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;

84. The apparatus according toclaim 83, wherein a distal tip of the main body is shaped so as to define the distal-most suction orifice.

85. The apparatus according toclaim 83, wherein a lateral wall of the main body is shaped so as to define the distal-most suction orifice.

86. The apparatus according toclaim 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 toclaim 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 toclaim 83, wherein the inflatable element has a greatest diameter of between 6 and 12 mm when fully inflated and unconstrained.

89. The apparatus according toclaim 83, wherein the suction lumen comprises exactly one suction lumen.

90. The apparatus according toclaim 83, wherein the suction lumen comprises a plurality of suction lumens.

91. The apparatus accordingclaim 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 toclaim 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 accordingclaim 83, further comprising a pliable sleeve around at least a portion of the main body to inhibit contamination.

94.-152. (canceled)