GB2482618A

GB2482618A - Balloon cleaning device

Info

Publication number: GB2482618A
Application number: GB1116735.0A
Authority: GB
Inventors: Elad Einav; Oron Zachar
Original assignee: Airway Medix Sp zoo
Current assignee: Airway Medix Sp zoo
Priority date: 2011-09-26
Filing date: 2011-09-28
Publication date: 2012-02-08
Anticipated expiration: 2031-09-28
Also published as: PL396436A1; GB201116735D0; GB2482618B

Abstract

A ballooned cleaning device for use with an ETT or tracheostomy ventilation tube 60, a ventilator machine 900, a source(s) 602 of pressurized liquid and a source(s) of suctioning 601 is disclose. In some embodiments, the cleaning device comprises a. a tube-connector assembly 158 for connecting the ventilation tube 60 to the ventilator machine 900, in a substantially air-tight manner b. an elongate, flexible, main body 210 that is insertable through the tube-connector assembly 158 into the ventilation tube 60 to form an interstitial region outside of the main body 210 within ventilation tube 60; c. a balloon 588 mounted to the main body 210 at a location in the distal half of the main body and inflatable into contact with an inner surface 201 of the ventilation tube 60; d. one or more liquid-delivery lumen(s) 520 arranged within or along the elongated main body, and operative to transport pressurized liquid received from pressurized liquid source(s) outside of the ventilation tube 60, into a proximal portion 774 of the interstitial region that is proximal of the balloon 588 so that the transported liquid enters the proximal portion 774 via liquid delivery orifice(s) 525 located on or mechanically coupled to the main body 210; e. suction lumen(s) 530 arranged within or along the main body, and operative to convey negative pressure from suction source(s) 603 predominantly into the proximal portion 774 of interstitial region via suction orifice(s) 440 when balloon 588 is inflated into contact, suction orifice(s) 440 being open to the proximal portion 774 and mechanically coupled to the main body 210. f. a suction port 820 connectable to the suction source(s) 603 for mediating a connection between the suction source and the suction lumen(s); and g. a pliable sleeve 610 around at least a portion of the main body 210 in locations proximal to the tube-connector assembly 158

Description

BALLOONED VENTILATION TUBE CLEANING DEVICE

INVENTORS: ElacI Einav, Oron Zachar

FIELD OF THE INVENTION

The present invention relates to apparatus and methods of medical suction catheter device with application to aspiration of trachea-bronchial fluids.

BACKGROUND AND RELATED ART

References Cited

US patent publication no. 2007/0038226; US patent publication no. 2010/0137899; US patent publication no. 2010/0186748 titled "Endotracheal Tube Cleaning Apparatus"; US patent publication no. 20 10/023885; US patent 6,082,361; US patent 6,318,368; US patent 5,709,691; US 2011/180072; Us 2006/099434; US 2007/089748; Us 2007/024288; Us 5,067,497; PCT patent publication WO 2007/146613; US patent 5125893 titled "Suction catheter with wall lumen for irrigation"; US patent 6923184 titled "Suction system with high efficiency suction control valve" US patent 7051737 titled "Mucus Shaving Apparatus for Endotracheal Tubes"; US patent 7669600 titled "Endotracheal Tube Cleaning Apparatus"; US patent 4762125 titles "Balloon-tipped suction catheter"; US patent 4351328; US patent 5738091 US patent 6602219; US patent 6612304; US patent 6805125; US patent 6935339; US patent 7273473; US patent application 20090178681 Suction catheters are commonly used to aspirate trachea-bronchial fluids in patients ventilated with endo-tracheal tube (ETT) devices. A problematic aspect of the use of suction catheters is the presence of bacterial bioflim 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 biofllm thickness reduces the effective free lumen of the ETT for air passage. Therefore, there is a need for maintaining cleaner ETT lumen between suction operations, and preventing buildup of significant biofilm thickness.

Another application is the use of cleaning catheters to clean the lumen of other catheters. An example of such cleaning catheter device is illustrated in Fig. ic adapted from PCT patent publication WO 89/07466. These devices are mostly intended for the removal of substantial local clogging of the tube lumen. Yet such devices would be inefficient for cleaning of thin biofilm buildup on the lumen surface of medical device catheters such as endo tracheal tubes.

Prior art of ETT lumen cleaning devices include US patent 7051737 titled "Mucus Shaving Apparatus for Endotracheal Tubes", and US patent 7669600 titled "Endotracheal Tube Cleaning Apparatus", US patent publication no. 2010/0186748 titled "Endotracheal Tube Cleaning Apparatus", and references therein. The characteristics of prior art are represented in Figs. 2a-2d.

The art of suction catheters is exemplified in US patent 5125893 titled "Suction catheter with wall lumen for irrigation", US patent 6923184 titled "Suction system with high efficiency suction control valve", and US patent 4762125 titles "Balloon-tipped suction catheter".

The type of "closed suction systems" are where the suction catheter can be used repeatedly without being detached from the tube system including the ventilation air supply. Such types of systems are known in the art of suction catheters, as exemplified in the discussion of US patent 6923184 and PCT patent publication WO 2007/146613, as well as US patents 5738091, 6602219, 6612304, 6805125, 6935339, 7273473, US patent application 20090178681, and references therein (together "closed system art").

Representative prior art devices are illustrated in Fig. la and Fig. lb. Such systems employ a tubing connector with at least two ports -one for air delivery and one for catheter delivery. Patent 6923184 further discloses the option for cleaning the external surface of the catheter flexible shaft in a chamber located in front of the isolator seal of the multi-port tubing connector. The discussion of the closed system art patents is in the context of suction catheters.

Several problems plague present art devices: (a) The suction flexible shaft is coming up from the ETT with significant amount of bacterial rich slime drawn up bronchi; (b) the closed suction system needs to be replaced every about 48h due to risk of bacterial proliferation on the flexible shaft exterior surface wall; (c) the ETT lumen cleaning operation is performed by a distinct catheter which requires disconnection of ventilation process and/or tube connection; (d) the ETT lumen cleaning sweeps up biofilm which itself require removal from the cleaning catheter, and this removal is done in a manual open way and not within a closed system.

SUMMARY OF EMBODIMENTS

Some embodiments of the present invention relate to a ballooned device for cleaning an inner surface of a ventilation tube in a closed system where air is mechanically forced into the ventilation tube by an external ventilator. The ballooned device includes an elongate flexible main body, an inflatable balloon, one or more suction orifice(s) and one or more liquid delivery orifice(s).

In order to clean an inside surface of a ventilation tube, it is possible to (i) carry out a wiping operation where the balloon (after being inflated into contact with an interior surface of the ventilation tube), moves longitudinally within the ventilation tube; (ii) carry out a fluid delivery operation where a stream of liquid is sent, via the liquid delivery orifice(s), into the ventilation tube (e.g. incident upon an inner surface of the ventilation tube) and (iii) carry out a suction where material within the ventilation tube outside of the main body is suctioned out of the ventilation tube.

Examples of ventilation tubes which may be cleaned include an endo-tracheal tubes (ETF) and tracheostomy ventilation tubes.

Tn some embodiments, a distal end of the flexible main body (i.e. of the closed system device') may be inserted into the ventilation tube via the ventilation tube proximal end at a time that a patient is being ventilated. In some embodiments, the flexible main body distal snuggly and slidably traverses an interior region of a ventilation tube assembly, which is mechanically coupled to a proximal end of the ventilation tube to form a substantially air-tight connection.

After insertion of a distal end of the elongate flexible main body into the ventilation tube (i.e. at a time that the main body traverses the interior of the ventilation tube assembly), an inflatable balloon mounted to the elongate flexible main body (e.g. at or near a distal end) is then inflated with a liquid or gas so as that a wall of the inflatable balloon contacts the ventilation tube inner surface.

Inflation of the balloon may also be useful for creating a slidable boundary' which at least partially obstructs fluid communication between (i) a more proximal portion of the interstitial region' outside of the main body within the ventilation tube from (ii) more distal locations within the ventilation tube -i.e. a more distal portion of the interstitial region and/or locations in the ventilation tube that are distal of the balloon position. As will be discussed below, by at least partially obstructing fluid communication between the proximal and distal portions of the interstitial region (e.g. by balloon inflation) so as to significantly hinder' (but not necessarily completely prevent) this fluid communication, it is possible to introduce negative pressure (i.e. via suction orifice(s)) predominantly into the proximal portion of the interstitial region.

In this sense, even if the balloon does not completely prevent fluid communication between the more proximal and more distal portions of the tube interior, the balloon at hinders and/or at least partially obstructs such communications. Thus, it may be said that the balloon is a boundary-forming balloon' which forms a boundary between the two regions (i.e. more proximal and more distal to the balloon) and which may or may not form a complete seal between the two regions..

Mechanical motion in a longitudinal direction (e.g. in a proximal direction) of the inflated ventilation-tube-inner-surface-contacting balloon may wipe biofilm from the ventilation tube inner surface. The liquid delivery and the suction orifice(s), which operate within the ventilation tube (e.g. mechanically coupled to a distal half of the flexible, elongate main body and/or operating in a distal half of ventilation tube) but proximal to the inflatable balloon, respectively stream liquid into and suction material out of the more proximal portion of the interstitial region.

Outside of the ventilation tube and proximal to the ventilation tube connector assembly, a pliable and/or impermeable sleeve around at least a portion of the main body in location proximal to the tube connector assembly inhibits contamination (e.g. inhibits the transport of microbes from within the ventilation tube to an ambient environment or in the opposite direction). In some embodiments, the sleeve may be deployed around at least 5 cm or least 10 cm of the elongate flexible main body in locations proximal to the tube connector assembly. In some embodiments, the sleeve may be around at least a majority or at least a substantial majority that is at least 75%, or substantially an entirety of that is at least 90%, or an entirety of) the portion of the flexible main body that is proximal to the tube connector assembly and distal to a suction port in fluid communication with a suction orifice(s) (e.g. via a suction lumen(s)).

In some embodiments, liquid delivery operation includes streaming liquid (e.g. some sort of cleaning fluid) into the more proximal portion' of the interstitial region (e.g. so that liquid is incident upon the inner surface of the ventilation tube) via the liquid delivery ports located near the distal end of the main body and proximal to the inflatable balloon inflated in contact with the inner surface of the ventilation tube. A strength' or intensity or velocity of delivered liquid may depend on the degree to which the liquid is pressurized before delivery and/or on the size of the aperture of the field and/or on other factors. In some embodiments, a jet of liquid is incident upon an inner surface of the ventilation tube.

The delivered or streamed liquid may have sufficient linear momentum to be incident upon an inner surface of the ventilation tube. Material proximal to the balloon within the ventilation tube (e.g. including materials that was formerly bioflim and/or dirt andior the delivered fluid) may, after being suctioned through the suction orifice, be proximally transported out of the ventilation tube within suction lumen(s) using negative pressure from the suction source.

A number of additional features are described herein.

According to a first example, the ballooned catheter device includes at least two balloons mounted and/or attached to the flexible main body (e.g. at or near the distal end of flexible main body): (i) the aforementioned inflatable wiping' and/or boundary forming' balloon which is inflated into contact with an inner surface of the ventilation tube (i.e. inflated by a liquid or gas) and/or is inflated to concentrate' suction into the proximal portion of the interstitial region; and (ii) a second balloon (referred to as the more proximal balloon') which may or may not be inflatable, is located proximal to the inflatable boundary-forming' or wiping' balloon, and which includes one or more of the liquid delivery ports.

Tn some embodiments, the inflatable boundary-forming' balloon is completely fluid-tight and substantially does not leak.

Alternatively, in a second example, the inflatable boundary-forming' balloon is not completely fluid-tight. According to this second' example, the balloon is inflated into contact with an inner surface 201 of ventilation tube 60 by liquid so to maintain balloon shape to contact the ventilation tube (i.e. for wiping) and/or so as to at least partially obstruct fluid communication within the tube. However, for the example where the boundary-forming balloon' is not fluid tight, some of the liquid within the balloon leaks into the more proximal portion' of the interstitial liquid via one or more relatively small holes in the surface of the inflatable boundary-forming' balloon. Although these hole(s) are small enough so as to allow the boundary-forming' balloon to maintain its shape and slidable contact with the ventilation tube inner surface (i.e. when receiving a relatively steady supply of pressurized liquid via the lumen(s)), the holes are large enough to allow liquid within the boundary-forming' inflatable balloon to stream into the more proximal section of the interstitial region -for example, so that a stream of fluid is incident upon the ventilation tube inner surface.

Tn this second example, the hole(s) function as the aforementioned liquid delivery ports' discussed herein. As will be discussed below, this embodiment may provide a number of safety features discussed below.

Optionally, and in some embodiments preferably, the one or more liquid delivery ports' include a plurality of liquid delivery ports, and a multiple direction' feature is provided whereby fluid is simultaneously streamed into the more proximal' portion of the interstitial region in multiple directions. Towards this end, the catheter device includes (i) a first liquid delivery port disposed at a first location on a first side of the flexible main body; and (ii) a second delivery port disposed at a second location substantially (e.g. within a tolerance of 75 degrees or more) on a second side of the flexible main body. Not wishing to be bound by any theory, it is noted that the streaming of fluid in substantially opposite directions may facilitate the cleaning of the ventilation tube inner surface.

A number of implementations of this multi-direction' feature are described herein.

In a first implementation, the more proximal balloon' may include liquid delivery ports that face in different directions relative to an elongate or central' axis of the flexible main body. In a second implementation, the liquid-filled boundary-forming balloon that includes multiple small' holes. For example, it is possible to provide first and second holes that both face in a proximal direction but which face in substantially the opposite direction relative to the flexible main body central axis.

In a third implementation, the device includes a plurality of liquid delivery ports located substantially on a surface of the flexible main body. In some embodiments, a first of the liquid delivery ports faces in a first direction while a second of liquid delivery ports faces substantially in the opposite directions.

Some embodiments of the present invention relate to a multi-mode technique for operating the aforementioned ballooned catheter device in a closed system. In both modes of operation, the flexible main body is inserted into the ventilation tube via the proximal end of the ventilation tube and via an inner channel of a ventilation tube connector assembly that is sealingly connected to a proximal end of the ventilator tube.

Tn the first operating mode, a balloon-inner wall contact within the interstitial region is maintained by the inflatable balloon (e.g. so as to obstruct -i.e. significantly hinder -longitudinal flow between locations proximal and distal to the balloon), and the suction and liquid delivery orifice(s) are operated as described above. The suction and liquid delivery orifice(s) are operated as described in one or more of the previous paragraphs so as to deliver liquid (e.g. a stream of liquid) into the more proximal portion' of the interstitial region while the slidable boundary' is maintained. A wiping operation caused by sliding the inflated balloon (i.e. inflated into contact with the ventilation tube inner surface) may be carried out simultaneous with or not simultaneous with the suction and fluid delivery operations.

In the second operating mode, the boundary-forming' balloon is deflated and/or not sufficiently inflated to contact the ventilation tube inner surface and/or not sufficiently inflated to at least partially obstruct (i.e. and significantly inhibit') fluid communication interstitial region into more proximal' and more distal' regions.

In the second mode of operation, suction provided by the suctioning port(s) may be used primarily to remove material from locations distal of the balloon (e.g. in the more distal' portion of the interstitial region or even from locations that are distal to the distal end of the ETT) and to transport this distally-located' material in a proximal direction out of the ETT. One example of such distally-located' material is tracheo-bronchial fluid or mucus located in the subject's trachea.

Some embodiments relate to a method of cleaning a main lumen of an ETT or tracheostomy ventilation tube 60 comprising: at a time when: (i) a ventilation tube connector assembly 158 mediates a substantially air-tight connection between a ventilator machine and an interior of a main lumen of the ventilation tube 60 (e.g. such that air is forced from the ventilator machine through the ventilation tube connector assembly 158 into the main lumen of the ventilation tube 60); and/or (ii) an elongate, narrow, flexible, main body 210 (e.g. of a length that is at least 15 cm) slidably and internally traverses the ventilation tube connector assembly 158 without substantially breaking the substantially air-tight breathing circuit such that: A. a proximal end 204 of the main body 210 is located outside of the ventilation tube 60 proximal to the ventilation tube connector assembly 158; and B. a boundary-forming balloon 588 mounted to the elongate, flexible main body 210 is located within the ventilation tube 60, and/or (iii) at least a portion of the main body is a connection-assembly-proximal-portion 598 that is located proximal to the ventilation tube connector assembly 158; and/or (iv) at least 5 cm of the connection-assembly-proximal-portion 598 is covered and/or enveloped by a substantially impermeable pliable sleeve; carrying out the following steps: A. effecting a balloon-inflation operation by forcing a fluid from outside of the ventilation tube 60 into the boundary-forming balloon 588 so that inflation of the boundary-forming balloon 588 obstructs (i.e. significantly hinders) fluid flow to forms a slidable boundary 770 between: L a more proximal portion 774 of an interstitial region outside of the flexible main body and within the ventilation tube; and II. locations 778 within the ventilation tube 60 that are distal to slidable boundary 770, the slidable boundary 770 being located in a distal half of the ventilation tube 60; A. concurrent with a maintaining of the slidable boundary 770, effecting a fluid delivery operation by forcing a pressurized liquid from outside of the ventilation tube 60 into the more proximal portion 774 of the interstitial region through one or more liquid delivery orifice(s) 525 that is: I. mechanically coupled to the flexible main body 210; H. located proximal of the slidable boundary 770 and longitudinally closer to the slidable boundary 770 location than to a proximal opening of the ventilation tube; C. concurrent with the maintaining of the slidable boundary 770, proximally suctioning, out of the ventilation tube 60, material located: I. within the more proximal portion 774 of the ventilation tube 60; II. in the distal half of the ventilation tube, via one or more suction orifice(s) 440 that is: I. mechanically coupled to the flexible main body 21 0;and II. located proximal of the slidable boundary and longitudinally closer to the slidable boundary 770 location than to a proximal opening of the ventilation tube.

In some embodiments, the one or more suction orifice(s) is(are) longitudinally displaced from the slidable boundary 770 and/or to a midpoint of the boundary-forming balloon 588 by at most a suction-orifice-displacement-value that is at most 3 cm.

In some embodiments, i. the pressurized liquid is simultaneously forced through first 525A and second 525B liquid delivery orifices to respectively produce first 556A and second 556B fluid streams that are respectively and simultaneously incident upon an inner surface 201 of the ventilation tube 60 at first 552A and second 552B locations; and ii. the first 552A and second 552B locations are substantially on opposite sides of the ventilation tube 60 inner surface 201 within a tolerance that is at most 75 degrees.

In some embodiments, each liquid-delivery-orifice is proximally displaced from the slidable boundary 770 and/or from a midpoint of the boundary-forming balloon 588 by at most a fluid-orifice-displacement-value that is at most 3 cm, or at most 2 cm.

In some embodiments, the fluid-orifice-displacement-value that is at most 2 cm.

In some embodiments, the tolerance is at most 45 degrees or at most 25 degrees.

In some embodiments, the first 525A and second 525B liquid delivery orifices are respectively supplied via first 520A and second 520B fluid-delivery lumens.

In some embodiments, the first 520A and second 520B liquid second liquid delivery lumens are simultaneously supplied by a common pressurized liquid chamber.

In some embodiments, immediately before exiting each liquid delivery port 525, the delivered liquid is pressurized to at least 1.5 atmospheres or at least 2 atmospheres or at least 3 atmospheres.

In some embodiments, each liquid delivery orifice 525 has a width of at most 3 mm or at most 2 mm or at most 1 mm, or at most 0.5mm, at most 0.3mm, at most 0.2mm.

In some embodiments, each liquid delivery orifice 525 has width that is at most 50°A of an average width of the 440 suction orifice(s).

In some embodiments, each liquid delivery orifice 525 has width that is at most 25°A of an average width of the 440 suction orifice(s).

In some embodiments, each liquid delivery orifice 525 has width that is at most 10°/'o, or at most 5%, of an average width of the 440 suction orifice(s).

In some embodiments, at a time that the slidable boundary is maintained, substantially no suction or suction at a significantly lower proximal air flow rate than the suction of step C is applied to locations distal of the slidable boundary.

In some embodiments, the suction-orifice-displacement-value is at most 2 cm or at most 1 cm or at most 0.5 cm.

In some embodiments, the ventilation tube 60 is an ETT. In some embodiments, the ventilation tube 60 is a tracheostomy tube.

In some embodiments, the fluid delivery operation and the suctioning are carried out simultaneously.

In some embodiments, the fluid delivery operation and the suctioning are carried out sequentially.

In some embodiments, the method further comprises: concurrent to the maintaining of the slidable boundary, longitudinally moving the boundary-forming balloon 588 so as to mechanically dislodge and/or loosen biofilm material located on the inner surface 201 of the ventilation tube 60.

In some embodiments, the longitudinal moving is carried out simultaneously with the fluid delivery operation and/or the suctioning.

In some embodiments, at least one of the fluid delivery orifice(s) 525 are deployed to and/or voids within a second balloon 586 deployed distal to the boundary-forming balloon 588.

In some embodiments, the second balloon 586 is inflatable.

In some embodiments, the second balloon 586 is not inflatable.

In some embodiments, at least one of the at least one of the fluid delivery orifice(s) 525 is an inner-surface-facing void in the main body 210 facing towards the inner surface 201 of the ventilation tube 60 or a inner-surface-facing-void in a fluid-delivery lumen 520 that at least spans a longitudinal range between the fluid delivery orifice(s) 525 and a location on or within the main body 210 that is proximal to the ventilation tube connector assembly 158.

In some embodiments, i. at least one of the at least one of the fluid delivery orifice(s) 525 is a void in the boundary-forming balloon 588 so that the boundary-forming balloon 588 is leaky; ii. forcing of pressurized liquid into the boundary-forming balloon 588 is operative to carry out at least some of both of the balloon-inflation operation and the fluid-delivery of the fluid-delivery operation.

In some embodiments, a surface of the boundary-forming balloon 588 is at least 90°/'o or at least 95% and/or at most 99% by surface area, substantially impermeable.

In some embodiments, the boundary-forming 588 balloon is substantially sealed and is not leaky.

In some embodiments, the method further comprises carrying out the additional step of: D. concurrent with the maintaining of the ventilation circuit, and at a time that the boundary-forming balloon 588 mounted to the elongate, flexible main body 210 is located within the ventilation tube 60 and in a non-obstructing or so that the slidable boundary (i.e. for significantly hindering fluid flow within the ventilation tube 60) with the inner surface 201 of the ventilation tube 60 is not maintained andlor non-contact mode so that balloon 588 is not inflated into contact with the inner surface 201 of ventilation tube 60, proximally suctioning into the suction orifice(s) 440 material that is located: I. within the ventilation tube 60 and distal to the boundary-forming balloon 588; andior II. distal to the ventilation tube distal end 60 so that the material located distal to the ventilation tube distal end 60 enters an interior region of ventilation tube 60 en route to the suction orifice(s), wherein the suctioning step when the boundary-forming balloon 588 is in non-obstructing and/or non-contact mode is carried out to proximally transport material suctioned in step D proximally out of ventilation tube 60 via a proximal opening of the ventilation tube 60.

Some embodiments relate to a -system ballooned cleaning system comprising: a.

an ETT or tracheostomy ventilation tube 60; b. a ventilator machine; c. ventilation tube connector assembly 158 directly or indirectly connected to both the ventilation tube 60 and the a ventilator machine so as to mediate a substantially air-tight connection between the ventilator machine and an interior of the ventilation tube; d. an elongate, narrow, flexible, main body 210 of a length that is at least 15 cm (or at least 20 cm or at least 25 cm or at least 30 cm); e. a boundary-forming balloon 588 mounted to the elongate, flexible main body 210, the main body configured to slidably and internally traverse the ventilation tube connector assembly 158 without substantially breaking the air-tight connection between the ventilator machine and an interior of the ventilation tube such that: I. a proximal end 204 of the main body 210 is located outside of the ventilation tube proximal to the ventilation tube connector assembly 158; and II. the mounted boundary-forming balloon 588 is located in the ventilation tube 60; the boundary-forming balloon 588 being configured so that, when the mounted boundary-forming balloon 588 is located in the ventilation tube 60, inflation of the boundary-forming balloon 588 forms a slidable boundary between: I. a more proximal portion 774 of an interstitial region outside of the flexible main body and within the ventilation tube; and II, locations 778 within the ventilation tube 60 that are distal to slidable boundary, f. a plurality of fluid-communication lumens located within and/or along the elongate, flexible main body 210 including one or more suction lumen(s) 530 and one or more liquid delivery lumen(s) 520; g. one or more liquid delivery orifice(s) 525 that: I. is(are) mechanically coupled to flexible main body 210 so that longitudinal motion of the flexible main body 210 induces longitudinal motion of the liquid delivery orifice(s) (e.g. so the orifice(s) move closer towards a; II. is located proximal to the slidable boundary when the boundary-forming balloon 558 is inflated into contact with an inner surface of tube 60 to form a slidable boundary'; h. one or more suction orifice(s) 440 that: I. is(are) mechanically coupled to flexible main body 210 50 that longitudinal motion of the flexible main body 210 induces longitudinal motion of the liquid delivery orifice(s); H. is located proximal to the slidable boundary when the boundary forming balloon 558 is inflated to form the slidable boundary; i. a source 602 of pressurized liquid located outside of the ventilation tube 60 and operative, at least some of the time and concurrent with the maintaining of the slidable boundary, to deliver pressurized liquid into more proximal portion 774 of the interstitial region such that the pressurized liquid travels to the liquid delivery orifice(s) 525 via the liquid delivery lumen(s) 520 and enters into the more proximal portion 774 of the interstitial region via the liquid delivery orifice(s) 525; and j. a suction source 603 located outside of the ventilation tube 60, and operative, at least some of the time and concurrent with the maintaining of the slidable boundary, to proximally transport material located within the more proximal portion 774 of the interstitial region out of the ventilation tube 60 such that the transported material exits the more proximal portion 774 of the interstitial region via the suction orifice(s) 440, enters into suction lumen(s) 530 and proximally exits the ventilation tube within suction lumen(s) 530.

In some embodiments, boundary-forming balloon 588 is mounted to the main body 210 at a location in a distal half (or third or quarter or fifth or tenth) of the main body 210.

In some embodiments, the pressurized liquid source 602 and the suction source 603 are respectively operative, in combination with the lumens and the orifices, to effect the fluid delivery and the suctioning when the boundary-forming balloon 588 is located in a distal half of the ventilation tube 60.

Some embodiments closed-system ballooned cleaning system for use with an ETT or tracheostomy ventilation tube 60, a ventilator machine, a source 602 of pressurized liquid and a source of suctioning 603, the cleaning system comprising: a. a ventilation tube connector assembly 158 operative, when directly or indirectly connected to both the ventilation tube 60 and the ventilator machine, to mediate a substantially air-tight mediating connection between the ventilator machine and an interior of the ventilation tube via an interior of the ventilation tube connector assembly 158; b. an elongate, narrow, flexible, main body 210 of a length that is at least 15 cm (or at least 20 cm or at least 25 cm or at least 30 cm);; c. a boundary-forming balloon 588 mounted to the elongate, flexible main body 210, the flexible main body operative to slidably and internally traverse the ventilation tube connector assembly 158 without substantially breaking the air-tight connection between the ventilator machine and an interior of the ventilation tube such that: I. a proximal end 204 of the main body 210 is located outside of the ventilation tube 60 proximal to the ventilation tube connector assembly 158; and II. the mounted boundary-forming balloon 588 is located in the ventilation tube 60; the boundary-forming balloon 588 being configured so that, when the mounted boundary- forming balloon 588 is located in the ventilation tube 60, inflation of the boundary-forming balloon 588 forms a slidable boundary between: I. a more proximal portion 774 of an interstitial region outside of the flexible main body and within the ventilation tube; and II. locations 778 within the ventilation tube 60 that are distal to slidable boundary,f. a plurality of fluid-communication lumens located within and/or along the elongate, flexible main body 210 including one or more suction lumen(s) 530 and one or more liquid delivery lumen(s) 520; g. one or more distal liquid delivery orifice(s) 525 that: 1.

is(are) mechanically coupled to flexible main body 210 so that longitudinal motion of the flexible main body 210 induces longitudinal motion of the liquid delivery orifice(s); II. is located proximal to the slidable boundary when the boundary-forming balloon 558 is inflated to form the slidable boundary; h. one or more distal suction orifice(s) 440 that: I. is(are) mechanically coupled to flexible main body 210 so that longitudinal motion of the flexible main body 210 induces longitudinal motion of the liquid delivery orifice(s); II. is located proximal to the slidable boundary when the boundary forming balloon 558 is inflated to form the slidable bonudary; i. a rigid or resilient proximal liquid delivery port 827 in liquid communication with proximal interior location 829 within liquid delivery lumen(s) 520 that is proximal to the connector assembly 158, the proximal liquid delivery port 827 being configured, when directly or indirectly connected to the pressurized liquid source 602, to mediate a substantially liquid-tight coupling between the pressurized liquid source 602 and the liquid delivery lumen proximal interior location 829 via an interior of the proximal liquid delivery port 827, the proximal liquid delivery port 827, the liquid delivery lumen(s) 520 and the fluid delivery orifice(s) 525 being operative so that pressurized fluid distally delivered from the pressurized liquid source 602 into the liquid delivery lumen(s) 520 via the proximal liquid delivery port 827 distally flows through the liquid delivery lumen(s) 520 to liquid delivery orifice(s) 525 and enters into the more proximal portion 774 of the interstitial region via the liquid delivery orifice(s) 525; and j. a proximal rigid or resilient suction port 830 in liquid communication with proximal interior location S3lwithin suction lumen(s) 530 that is proximal to the connector assembly 158, the proximal suction port 830 being configured, when directly or indirectly connected to the suction source 603, to mediate a substantially air-tight coupling between the suction source 603 and the suction lumen proximal interior location 531 via an interior of the proximal suction port 830, the proximal suction port 830, the suction lumen(s) 530 and the suction orifice(s) 440 being operative so that negative pressure applied via the proximal suction port 830 causes material to exit the more proximal portion 774 of the interstitial region via the suction orifice(s) 440 and travel proximally to the suction lumen proximal interior location 531.

Some embodiments relate to a ballooned cleaning apparatus comprising: a. an elongate, narrow, flexible, main body 210 having length of at least 15 cm (or at least 20 cm or at least 25 cm or at least 30 cm); and a width of between 1 mm and 1 cm (for example, at least 3 mm and/or at most 6 mm -for example, between 3 and 6 mm); b. a boundary-forming balloon 588 mounted to the main body 210 in a distal half of the main body 210, the boundary-forming balloon 588 being inflatable so that when the balloon 588 is inserted into an enclosing tube having a diameter between 4 and 11 mm so that the balloon 588, inflation of the balloon 588 causes the balloon outer surface to contact an inner surface of the enclosing tube forms a slidable boundary between: I. a more proximal portion 774 of an interstitial region outside of the flexible main body and within the enclosing tube; and locations 778 within the ventilation tube 60 that are distal to the enclosing tube, c. a plurality of lumens located within and/or along the main body 210 including one or more suction lumen(s) 530 and one or more fluid delivery lumen(s) 520, each lumen of the plurality of lumens substantially spanning a length of the main body 210 between the proximal end 204 of main body 210 and boundary-forming balloon 588, each fluid delivery lumen(s) having an inner width of at most 3 mm (for example, at most 2 mm or at most 1 mm and/or at least 0.1 mm or at least 0.2 mm or at least 0.5 mm) each suction lumen(s) having an inner width of between 1 and 5 mm (for example, at least 2mm and/or at least 5 mm) (for example, a ratio between an inner width of the suction lumen and an inner width of the fluid delivery lumen).at least one of the plurality of lumens in fluid communication with the inner surface of the balloon; d. one or more distal suction orifice(s) 440 that: i. have an inner width of between 1 and 5 mm; ii.

is(are) mechanically coupled to flexible main body 210 50 thatlongitudinal motion of the flexible main body 210 induces longitudinal motion of the liquid delivery orifice(s); iii.

is located proximal to the slidable boundary when the boundary-forming balloon 558 is inflated to form the slidable boundary longitudinally displaced from the slidable boundary by at most 2 cm; e. one or more distal liquid delivery orifice(s) 525 that: i.

have an inner width of at most 3 mm and at most 30% of the inner width of the distal suction orifice(s) 440; ii. is(are) mechanically coupled to flexible main body 210 so that longitudinal motion of the flexible main body 210 induces longitudinal motion of the liquid delivery orifice(s) 525; iii. is located proximal to the slidable boundary when the boundary-forming balloon 558 is inflated to form the slidable boundary and is longitudinally displaced from the slidable boundary by at most 2 cm.

In some embodiments, the flexible main body 210 includes a connection-assembly-proximal portion 598, at least 5 cm of which is covered and/or enveloped by a substantially impermeable pliable sleeve 610.

In some embodiments, a distal end of sleeve 610 is directly or indirectly attached to ventilation tube connector assembly 158 -for example, so that the main body 210 may slide through the sleeve. In contrast, in some embodiments, a proximal end of sleeve 610 is configured to have a substantially fixed longitudinal position relative to a proximal end of elongate flexible main body 210.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-3 describe prior-art devices.

FIGS. 4-18 illustrate systems, apparatus and portions thereof for cleaning an inner surface of a ventilation tube according to some embodiments.

FIGS. 19-21 are flowcharts of methods for cleaning an inner surface of a ventilation tube according to some embodiments.

BRIEF DESCRIPTION OF EMBODIMENTS

The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the exemplary system only and are presented in the cause of providing what is believed to be a useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how several forms of the invention may be embodied in practice and how to make and use the embodiments.

For brevity, some explicit combinations of various features are not explicitly illustrated in the figures and/or described. Tt 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.

Definitions For convenience, in the context of the description herein, various terms are presented here. To the extent that definitions are provided, explicitly or implicitly, here or elsewhere in this application, such definitions are understood to be consistent with the usage of the defined terms by those of skill in the pertinent art(s). Furthermore, such definitions are to be construed in the broadest possible sense consistent with such usage.

Some embodiments relate to a width' of an objection -for example, a width' of an elongate flexible main body 210 or a width of an orifice(s) or a width of a lumen. A width' is defined as the square root of the cross section.

Fig. 4A illustrates a closed system ballooned cleaning system comprising: (i) an ETT or tracheostomy ventilation tube 60; (ii) a ventilator machine 900; (iii) a ventilation tube connector assembly 158 including a ventilator port 664, a ventilation tube port 660, and a main body inlet 640; and (iv) a flexible, elongate main body 210 having proximal 204 and distal 208 ends.

In some embodiments, the cleaning system is operative to clean an interior 201 of the ventilation tube 60 at a time when ventilation tube connector assembly 158 is directly or indirectly connected to both the ventilation tube 60 and the ventilator machine 900 so as to mediate a substantially air-tight connection (e.g. via an interior chamber(s) and/or conduit(s) of ventilation tube connector assembly 158) the between the ventilator machine and an interior of the ventilation tube. In one non-limiting example, an interior region and/or outer shape of ventilation tube port 660 matches a proximal end 62 of the ventilation tube 60 to create a substantial air-tight seal. In one non-limiting example, a tube or other conduit of a tube assembly (NOT SHOWN) may be connected to ventilator port 664 so that an interior of ventilator port 664 receives air from the ventilator machine and is in fluid communication with the ventilator machine 900 in a substantially air-tight manner.

In some embodiments, flexible, elongate main body 210 slidably and snugly passes through an interior of ventilation tube connector assembly 158 so that a proximal-distal direction of the main body 210 is aligned with a proximal-distal direction of the ventilation tube connector assembly 158 -i.e. distal end 208 of flexible main body 208 is on a distal side 908 of ventilation tube connector assembly 158 and proximal end 208 of flexible main body 208 is on a proximal side 908 of ventilation tube connector assembly 158.

It is appreciated that when elongate main body 210 "snugly" passes through an interior of ventilation tube connector assembly 158 that there is no requirement for the fit between an outer surface of main body 210 and an interior of connector assembly 158 to be snug' in every location within connector assembly 158. In some embodiments, a snug fit' in one or more locations is sufficient to provide the snugly passing through' feature.

In some embodiments, flexible, elongate main body 210 slidably and snugly passes through the interior of ventilation tube connector assembly 158 in a manner that does not substantially break the substantially air-tight connection between the ventilator machine 900 and the interior of the ventilation tube 60.

The systems 600A-C of FIGS. 4-16 all include an inflatable boundary-forming balloon' 588, mounted to the flexible main body 200. When inflated, the boundary forming balloon, in some embodiments, may provide two types of functionality: (i) an flow obstruction functionality' to significantly hinder fluid flow between locations on opposite longitudinal sides of the boundary-forming balloon (as discussed below, this may be useful for concentrating' suction so that the suction is predominantly in a proximal portion 774); and (ii) a wiping functionality useful for cleaning the inner surface 201 of ventilator tube 60, One salient feature of the ballooned cleaning apparatus provided by some embodiments is that the cleaning apparatus operates in a closed system' environment.

During operation, it is possible to clean the inner surface 201 of ventilator tube 60 when the ventilation tube connector assembly 158-mediated substantially air-tight seal between (i) ventilator machine 900 and/or an interior of ventilator port 664 and (ii) an interior of ventilation tube 60 and/or an interior of ventilation tube port 660 is maintained -this substantially air-tight seal is referred to as the ventilation machine-ventilator tube' seal.

As will be discussed below, concurrent with a maintaining of this ventilation machine-ventilator tube' seal, it is possible to position the mounted balloon 588 within the ventilation tube 60 (e.g. in a distal half of ventilation tube 60) for example, by moving a distal end 208 of the main body 210 in a distal direction towards a distal end 64 of ventilation tube 60. For example, it is possible to distally move the mounted balloon 588 at a time when the mounted balloon 588 is in a non-contact state' (i.e. not in contact with an inner surface 201 of ventilation tube 60) . After the boundary-forming balloon 588 is thus positioned, inflation of the balloon induces contact between an outer surface of the balloon 588 and an inner surface 201 of ventilation tube 60 and/or obstructs' (i.e. significant hinders) longitudinal flow between proximal 774 and distal 778 portions of the interior of ventilation tube 60. As will be disused below, this slidable boundary; between proximal 774 and distal 778 portions is useful for facilitating the cleaning of the inner surface 201 -for example, for substantially confining locations of negative pressure andior liquid (e.g. pressurized liquid) introduced into an interstitial region outside of main body 210 and within ventilation tube 60 so that the suction or pressurized liquid is introduced predominantly' in a proximal portion 774.

In some embodiments, as illustrated in various figures (e.g. FIGS. 4A, 8, 14), inflatable "boundary forming" or inflated-into-contact-with-an-inner-surface-of-ventilation-tube' balloon 588 is mounted to flexible main body 210 at a location that is or near a distal end 208 or flexible main body 210.

In different embodiments, a location near a distal end' 208 of main body 210 may refer to: (i) in a distal half of flexible main body 210; or (ii) in a distal third of flexible main body 210, or (iii) in a distal fifth of flexible main body 210, or in (iv) a distal tenth of flexible main body 210.

Also shown in FIG. 4A is a second balloon 550 (which may or may not be inflatable) which is mounted to flexible main body 210 at a second balloon mounting location' that is proximal to a boundary-forming balloon mounting location' of the main body 210 to which "boundary forming" and/or inner surface-contacting' balloon 588 is mounted. In some embodiments, the second balloon mounting location' is near a distal end' 208 of main body 210 -for example, in a distal half or third or fifth or tenth of flexible main body.

In the non-limiting example of FIG. 4A, second balloon 550 includes one or more liquid delivery orifice(s) 525 located on the surface of the second balloon 550. In other embodiments, the liquid delivery orifice(s) 525 may be located in other locations.(e.g. see FIGS. 8 or 14). In various embodiments, liquid delivered from pressurized liquid source 602 into an interior of the ventilation tube 60 via liquid delivery orifice(s) 525 may be used to clean an inner surface 201 of ventilation tube 60. In the non-limiting example of FIG. 4A, liquid delivery orifice(s) 525 located on the surface of the second balloon 550 -for example, as voids or holes in the surface of the second balloon 550. This is not a limitation, and in the examples of FIGS. 8 and 16 alternative configurations are illustrated.

Also illustrated in FIG. 4A are suction orifice(s) 440, which, in some embodiments, are supplied with negative pressure by suction source 601 and facilitate cleaning of the inner surface 201 of ventilation tube 60. In some embodiments, material within the interior of ventilation tube 60 may be suctioned into suction orifice(s) 440 and proximally transported out of ventilation tube 60 -e.g. to a location that is proximal of ventilation tube connector assembly 158.

As will be discussed below, fluid communication between the suction source 601 and/or pressurized liquid source 602 and the suction 440 or fluid delivery 525 orifice(s) may be provided by one or more connecting lumen(s) within or along the main body 210/ As illustrate in FIGS. 4A-4B, at least a portion 598 of elongate main body 210 is located proximal to ventilation tube connector assembly 158. The magnitude of this portion' may depend on an extent to which distal end 208 and/or balloon 588 is deployed within ventilation tube 60 and/or an extent to which distal end 208 and/or balloon 588 is longitudinally displaced from ventilation tube connector assembly 158 -for example, an extent to which the main body 210 slides through ventilation tube connector assembly 158 in a distal direction.

Because The system or method of FIGS. 4A-4B if a closed system,' in some embodiments, the system may include a substantially impermeable and/or pliable sleeve 610 for protecting an outer surface of main body 210. In some embodiments, sleeve 610 envelops and/or protects at least some (e.g. at least a majority or at least a substantial majority of at least 75% or substantially all of (i.e. at least 90%)) of an outer surface of the ventilation-tube-connector-assembly-proximal portion 598 of elongate main body 210. In some embodiments, sleeve 610 may provide this enveloping and/or protection functionality when a length of the ventilation-tube-connector-assembly-proximal portion 598 of main body 210 is at least 3 cm or at least 5 cm or at least 7 cm or at least 10 cm.

As noted above, in some embodiments, a length of this proximal portion 598 may be modified by sliding, in a proximal or distal end, main body 210 through ventilation tube connector assembly 158.

In some embodiments, a distal end 908 of sleeve 610 is (i) directly or indirectly attached to and/or (ii) has a location that is fixed and/or longitudinally fixed relative to ventilation tube connector assembly 158. In some embodiments, a longitudinal position of a location of a distal end 908 of sleeve 610 corresponds to a location on ventilation tube connector assembly 158 (e.g. at or near main body inlet 640) and/or is longitudinally displaced from a proximal end (e.g. corresponding to main body inlet 640) of ventilation tube connector assembly 158 by at most 5 cm or at most 3 cm or at most 2 cm or at most 1 cm and/or at most 50% or at most 30% or at most 20% or at most 10% of a length of ventilation-tube-connector-assembly-proximal portion 598 of main body 210.

In some embodiments, a location of distal end 908 of sleeve 610 is not fixed relative to main body 210. For example, main body 210 may be longitudinally slidable within the sleeve 610 at or near a location of the distal end 908.

In some embodiments, a location of proximal end 904 of sleeve 610 is fixed and/or longitudinally fixed relative to a proximal end 204 of main body 210.

In some embodiments, sleeve 610 forms a substantially air-tight seal between the external environment and an outer surface of ventilation-tube-connector-assembly-proximal portion 598 of main body 210 and/or between the external environment and region of space outside of an outer surface of ventilation-tube-connector-assembly-proximal portion 598 of main body 210 and within sleeve 610.

In the non-limiting example of FIGS. 4A, an input module assembly 156 includes respective ports for interfacing: (i) with suction source 601 (i.e. suction port 820 -for example, shaped as in element 34 of FIG. 1A or any other shape appropriate to function as a suction port), (ii) a source 602 of pressurized liquid (i.e. a port for receiving pressurized liquid from 602), and (iii) inflation source 603 (i.e. a port for receiving a gas flow or liquid flow from 603 -for balloon inflation). Suction source 601 provides negative pressure for suctioning material out of an interior of ventilation tube 60 (e.g. material formerly attached to an interior surface 201 of ventilation tube 60 -e.g. as biofilm) -e.g. via suction orifice(s) 440.

In some embodiments, pressurized liquid from source 602 forced, via a fluid delivery lumen 520 (not shown in FIGS. 4A-4B) may enter, via fluid delivery orifice(s) 525, into an interstitial region inside of the ventilation tube 60 and outside of the main body 210. In some embodiments, a stream of the delivered liquid passes through an interstitial region en route to the inner surface 201 of ventilation tube 60, and is incident upon the ventilation tube inner surface 201. Delivery of the liquid into the interstitial region and/or to the inner surface 201 may be useful for cleaning the ventilation tube inner surface 201.

In some embodiments, pressurized liquid or gas delivered from inflation source 603 is delivered to boundary-forming inflatable balloon 588 inflate boundary-forming balloon 588 (e.g. to form a slidable boundary as will be discussed below).

In the non-limiting example of FIGS. 4A-4B, the fluids source 602 (i.e. for pressurized liquid) and the inflation source 603 are illustrated as two separate elements.

This is not a limitation. In other embodiments (see, for example, FIG. 14) the source of pressurized liquid 602 may be used to both inflate boundary-forming balloon 588 and to delivery fluid via fluid delivery orifice(s) 525.

FIG. 5 is a close-up view of locations near distal end 208 of main body 210 in some embodiments and in some configurations. Inflatable balloon 588, suction orifice(s) 440 and liquid delivery orifice(s) are all visible close to the distal end 208 of main body 210.

FIG. 6 illustrates the distal end of main body 210 after insertion into ventilation tube 60 having an inner surface 201. In the example of FIG. 6A, inflatable balloon 588 divides the region of space within the ventilation tube 60 but outside of main body 210 into two regions: (i) A first sub-region 774 that is proximal to slidable boundaiy' whose longitudinal location is identified in FIG. 6 by a dividing line 780 (it is appreciated that the dividing line 780 is only a mathematical construct).

This first sub-region 774 is referred to as the more proximal portion of the interstitial region outside of the main body 210 and inside of ventilation tube 60; (ii) A second sub-region 778 that is distal to dividing line 780.

In the example of FIGS. 6A, 6E (also see FIG. bA, 1 1A; 16A-16C) the balloon in contact with the inner surface 201 of ventilation tube 60 actually provides a seal between the first (i.e. proximal 774) and second (i.e. distal 778) regions. However, this is not a limitation, and in other embodiments (see, for example, FIGS. 6F-61; 1OC, 1 1C; 16D) it is possible for the inflated balloon to obstruct (i.e. significantly hinder) longitudinal flow between the first (i.e. proximal 774) and second (i.e. distal 778) regions without forming such a seal.

The first sub-region 774 may be referred to as the more proximal portion of the region within the ventilation tube and outside of main body' while the second sub-region 778 may be referred to as the the more distal portion of the region within the ventilation tube and outside of main body.' This second sub-region 778 may include: (i) locations in the interstitial region that are distal to the slidable boundary 770; and (ii) locations in the interior of the ventilation tube that are distal to the slidable boundary 770.

In the examples of FIGS. 6A, 6B, 1OA, 14A, 14B,14C, contact balloon 588 (i.e. inflatable into contact) is deployed near the distal end 208 of main body 210 (but not at the distal end 208), and sub-region 778A is visible. In the examples of FIGS. 6E and 1 1A, inflatable balloon 588 is deployed at distal end 208 of main body 210 and sub-region 778A is absence. In both sets of examples, sub-region 778B is visible.

In the example of FIGS. 6, a plurality of balloons located within ventilation tube 60 (i.e.. each mounted to the main body 210 -e.g. at or near a distal 208 end) include: (i) inflatable first' balloon 588 and (ii) second balloon 586 deployed to main body 210 (e.g. mounted to main body) which may or may not be inflatable and which functions as a liquid supply balloon.' The second balloon 586 includes one or more holes or voids which are liquid delivery orifice(s) 525 (in the example of FIG. 6A, four holes 525A- 525D are illustrated). A pressurized liquid 525 may enter, via the liquid delivery orifice(s) 525 into "the more proximal portion of the region within the ventilation tube and outside of main body' 774 of the interstitial region proximal to inflatable balloon 588 (for example, when balloon 588 is inflated into contact and/or so as to obstruct).

In some embodiments, the delivered liquid takes the form of a stream 556 -for example, strong enough so that upon exit from the liquid delivery port 525 the flowing liquid has enough momentum to reach an interior surface 201 of ventilation tube 60. In some embodiments, the delivered liquid is pressurized immediately before exiting liquid delivery port 525 by at least 1.5 atmospheres or at least 2 atmospheres or at least 3 atmospheres.

In some embodiments, the delivered liquid is pressurized enough so that upon exiting liquid delivery port 525 a jet of fluid' or a strong jet' of fluid is obtained. In some embodiments, pressurized under a pressurize of at least 1.5 atmospheres or at least 2 atmospheres or at least 3 atmospheres exits a liquid delivery orifice having an internal width that is at most 1.5 mm or at most 1 mm or at most 0.75 mm or at most 0.5 mm.

In some embodiments, the includes only a single liquid delivery orifice.

Alternatively, in other embodiments, it is advantageous to employ a plurality of delivery ports. FIG. 7A illustrates four streams of liquid 556A-556D respectively exit from four different liquid delivery orifices 525A-525B.

In some embodiments, pressurized liquid (e.g. from a source outside of the ventilation tube and/or proximal to connector 158 -e.g. from pressurized liquid source 602) is forced (e.g. simultaneously forced) through first 525A and second 525B liquid delivery orifices to respectively produce first 556A and second 556B fluid streams that are respectively incident (e.g. simultaneously incident) upon an inner surface 201 of the ventilation tube 60 at first 552A and second 552B locations. In some embodiments, the first 552A and second 552B locations are substantially on opposite sides of the ventilation tube 60 inner surface 201 within a tolerance that is at most 75 degrees (i.e. angle theta is between 105 and 180 degrees) or within a tolerance of at most 45 degrees (i.e. angle theta is between 135 and 180 degrees) or within a tolerance of at most 25 degrees (i.e. angle theta is between 155 and 180 degrees). Note that there is no requirement for first 552A and second 552B locations to have the same longitudinal position -i.e. it is possible to calculate theta by projecting the first and second positions into a plane that is perpendicular to a central axis of ventilation tube (e.g. having a longitudinal position that is the average of the longitudinal positions of the for first 552A and second 552B locations).

Although not a limitation, in some embodiments, one or more of the streams 556 may have enough momentum to reach an enclosing tube (e.g. ventilation tube 60). For example, any combination of the extent to which the delivered liquid pressurized and/or the size of the orifice (i.e. smaller sizes facilitated greater fluid momentum in stream 556) may be such that, for any position of main body 210 within tube 60, when the local central axis 202 (i.e. in the region of locations 552A and 552B) of main body 210 is perpendicular to the gravity vector, and when the local central axis (i.e. in the region of locations 552A and 552B) of an enclosing tube (e.g. ventilation tube 60) is parallel to gravity (e.g. both local axes are substantially straight), momentum of the delivered liquid upon exit via orifices 525A and 525B is sufficient such that respective streams 556A and 556B are incident upon locations in the inner wall For example, this may be true any position of main body 210 relative to an enclosing tube -e.g. a "reference" cylindrical tube having an inner diameter that is at least 4 mm or at least 6 mm and/or at most 12 mm or at most 10mm or at most 8 mm. In some embodiments, under these conditions (e.g. both central axes parallel to the gravity vector so that the enclosing tube and main body 210 are at least locally upright', size features of the enclosing tube -e.g. ventilation tube 60) streams 556A and 556B may have enough momentum so as to be incident upon inner surface 201 of the enclosing tube at locations 552A, 552B that are substantially on opposite sides of the inner surface 201 of the enclosing tube 60.

Any features described with relation to FIGS. 7A-7B are not limited to embodiments of FIG. 6, and may relate to the any other embodiment.

Not wishing to be bound by any particular theory, in some embodiments, delivering a stream of fluid with sufficient momentum to be incident upon inner surface 201 of ventilation tube 60 may be useful for mechanically dislodging biofllm temporarily attached to the ventilation tube inner surface 201 and/or chemically interacting with the biofilm in order to reduce any forces causing the biofilm to adhere to inner surface 201.

Not wishing to be bound by any particular theory, in some embodiments, ensuring that a plurality of streams are incident upon different sides' of ventilation tube inner surface 201 may be useful for achieving this effect throughout ventilation tube inner surface 201 (e.g. for longitudinal locations being cleaned -for example, located in a distal half of ventilation tube 60).

Reference is made once again to FIG. 6A. In FIG. 6A, suction orifice(s) 440 is also illustrated.

As illustrated in FIG. 6A, fluid delivery orifice(s) 525 is supplied with pressurized liquid (e.g. from liquid source 602) via liquid delivery lumen(s) 520. In some non-limiting embodiments, pressurized liquid received via liquid delivery lumen(s) 520 also functions to inflate second balloon 586. Tn some embodiments, second balloon 586 is inflatable. Alternatively, second balloon 586 is not required to be inflatable.

Suction orifice(s) 440 is supplied with negative pressure from suction source 601 via suction lumen(s) 530.

Inflatable balloon 588 is inflated with liquid or gas received from inflation source 603 via balloon inflation lumen 585.

Tn some embodiments, when inflatable balloon 588 is inserted into ventilation tube 60, balloon 588 is not sufficiently inflated to contact an inner surface 201 of tube 60 and thus free longitudinal motion of inflatable sealing balloon 588 is possible. After inflation, a slidable obstructing boundary' is created so that inflatable balloon 588 may longitindally move in ventilation tube 60 while in contact with the tube and/or inflated so as to obstruct' (i.e. significantly hinder) longitudinal flow, In some embodiments, inflation of balloon 588 is sufficient (e.g. for at least one location of main body 588 within main tube 210) to cause contact with an enclosing ventilation tube 60 and/or to obstruct flow' with the aforementioned reference' enclosing tube having an inner diameter of at least 4 mm or at least 6 mm and/or at most 12 mm or at most 11 mm or at most 10 mm or at most 8 mm.

FIG. 6C illustrates a cross section of main body 210 according to some embodiments. In some non-limiting example, lumen(s) may be embedded within main body 210 and provided as elongate voids within main body 210. In FIG. 6C, cross sections of three lumens are illustrated: (i) of suction lumen 530; and (ii) fluid delivery lumen 520 and (iii) of balloon lumen 580 via which pressurized gas or liquid is delivered from inflation source 603 into boundary-forming inflatable balloon 588. As noted earlier, there is no requirement for separate sources 602, 603 for fluid delivery into proximal region 744 and for balloon inflation. Similarly, there is no requirement separate lumen 520, 580.

FIGS. 8-1 1 illustrates an embodiment that lacks the second balloon 586. In the example of FIGS. 8-11, suction 440 orifice(s) and fluid delivery 525 orifice(s) are located on the surface of elongate main body 588. As was the case in the embodiments of FIGS. 4-6, (i) boundary-forming balloon 588 is inflated to form the slidable boundary between proximal 774 and distal 778 regions of the interior of tube 60, (ii) pressurized liquid enters proximal region 774 via fluid delivery 525 orifice(s), and (iii) material is suctioned into suction 440 orifice(s) for proximal transport out of ventilation tube 60. As noted elsewhere, fluid delivery and suctioning operations may be carried out sequentially or simultaneously. As noted elsewhere, in some embodiments, longitudinal motion of inflated boundary-forming balloon 588 (e.g. in a proximal direction) may be useful for wiping biofllm or other material attached to ventilation tube inner surface 201.

In the example of FIGS. 1OA-1OB, balloon 588 is not mounted at the distal end of main body 210. In the example of FIGS. 11A-11B, balloon 588 is mounted at the distal end of main body 210. In different embodiments, balloon 588 may be mounted to main body 210 at different locations, including locations not illustrated in the figures.

In the example of FIG. 12, boundary-forming balloon is not inflated and/or not sufficiently inflated to form a boundary that obstructs (i.e. significantly hinders) longitudinal flow between locations proximal and distal to balloon 588. This NON-CONTACT configuration may be useful for: (i) insertion of balloon 588 into tube 60 and'or distal motion of balloon 588 within tube 60 to a desired or target cleaning location; (ii) operation so that material located distal to balloon 588 (e.g. within the interior of tube 60 or distal to tube 60) may be suctioned into suction orifice(s) 440 and subsequently proximally transported out of tube 60 (e.g. within suction lumen(s) 530).

Thus, in some examples, it is possible to operate the cleaning device in multiple modes. In the first mode (see, e.g. FIGS.6A-6B, 6E, bA, 1 1A, 16A, 16B), (i) boundary-forming balloon 588 is in CONTACT mode so that obstructing' boundary (i.e. to significantly hinder longitudinal flow) is maintained; and (ii) material suctioned via proximally-located suction orifice(s) 440 (i.e. located proximal to boundary and/or balloon 588) is restricted, by the presence of boundary, to material within the proximal portion 774 of the interstitial region. This mode may used, in some embodiments, primarily to clean biofilm adhering to and/or temporarily attached to inner surface 201 of ventilation tube 60.

In the second mode (see FIG. 12), boundary forming balloon 588 is not sufficiently inflated to main boundary -however, proximally-located suction orifice(s) 440 are used to suction material distal of balloon 588 (for example, tracheo-bronchal fluids in the patient's trachea).

FIG. 13 illustrated proximal ends of various lumens. For example, it is possible to deliver pressurized liquid from pressurized liquid source 602 through a proximal liquids port 827 into pressurized liquid reservoir 820. Pressurized liquid enters liquid delivery lumens 520 via respective openings in fluid delivery lumen located near the proximal end of the liquid delivery lumen 520.

As noted above, there is no requirement for multiple liquid delivery orifices 525, and some embodiments relate to the case where only a single liquid delivery orifice 525 is present. For embodiments where pressurized liquid is distally sent to multiple liquid delivery orifices 525, it is possible to supply a multiple orifices by a single liquid delivery lumen 520 and/or to include multiple delivery lumen(s) 520. In FIG. 13, where the device includes five liquid delivery orifice 525, both features are illustrated. Multiple (e.g. two) liquid delivery lumen(s) are employed, and two of these lumens supply pressurized liquid to multiple liquid delivery orifices 525.

FIGS. 14-16 illustrate an embodiment of the invention where the fluid delivery orifices are actually located on surface 589 of boundary-forming balloon. In the non-limiting example of FIG. 4A, liquid delivery orifice(s) 525 located on the surface of the second balloon 550 -for example, as voids or holes in the surface 589 of the balloon 588.

In some embodiments, fluid delivered via these orifice(s) 525 is restricted to proximal' locations 774 within the interstitial region but proximal to boundary. As such, it may be useful to locate orifice(s) 525 on a proximal part of balloon and/or to orient orifice(s) 525 to deliver fluid in a proximal direction. In some embodiments (see FIG. 7) streams of fluid are incident upon substantially different sides of the inner surface 201 of tube 60 -this feature is also provided in FIGS. 1 6A-1 6C.

In the example of FIG. 1 6A, a single balloon is provided 588. Because this balloon includes one or more voids/holes on its surface 589 (i.e. these function as fluid-delivery orifices), pressurized fluid needs to be supplied (e.g. from a source outside of tube 60 such as fluids source 602) at a sufficient rate (e.g. via lumen(s) 620) to maintain sufficient inflation of balloon 588 to maintain boundary. In some embodiments, the rate of pressurized liquid delivery to balloon 588 should, in the steady state, exceed that rate at which fluid is delivered from orifice(s) 525 in balloon surface 589 to maintain the contact between balloon 588 and inner surface 201 of tube 60.

In some embodiments, a ratio between an area of all orifice(s) 525 or voids in a surface 589 of boundary-forming balloon 588 to the total area of the surface 589 of boundary-forming balloon is at most 0.2 or at most 0.1 or at most 0.05 or at most 0.03 or at most 0.01 and/or at least 0.005 or at least 0.01 or at least 0.03 or at least 0.05.

Not wishing to be bound by theory, it is noted that in some clinical situations, a practitioner (e.g. nurse or doctor) needs to deflate and/or remove the balloon rather quickly' -e.g. within 60 seconds or 30 seconds or 15 seconds from a time that boundary is formed. This may be useful for reducing a risk of suffocation to the patient. Not wishing to be bound by theory, the provisioning of a single mechanism for both pressurized liquid delivery as well as maintenance of boundary can be useful for reducing the risk that, at the end of the procedure whereby an inner surface 201 of tube 60 is cleaned, the practitioner remembers to shut off' the liquid delivery but neglects to deflate boundary-forming balloon 588.

In some embodiments (see FIG. 14), it is no longer necessary to include separate pressurized liquid 602 and inflation 603 sources -it is sufficient to provide a single source for liquid delivery and for inflation.

In one variation (see FIG. 1 6B), it is possible to include a balloon within a balloon.

For example, the inner balloon may be supplied with liquid or with a gas, and may have a separate fluids supply (and/or lumen(s)) than that of the outer balloon. In another variation (see FIG. 16C), a single balloon may include multiple compartments which are supplied by a common fluid supply and/or lumen or by separate supplies and/or lumens.

For the example of FIG. 16C, the proximal compartment includes liquid delivery orifice(s) 525, while the distal compartment lacks such orifices. The device may be operated in multiple modes. In one mode, distal compartment is sufficiently inflated (e.g. with gas or fluid) to form boundary. In this mode, delivery of fluid via fluid orifice(s) 525 in the proximal compartment is not needed to maintain the contact.

Tn a second mode, the distal compartment is not inflated or not sufficiently inflated to form boundary. Tn this mode, the device may provide features similar to those observed in the embodiment of FIG. 16A.

In some embodiments it is possible to manually regulate the suctioning and liquid delivery operations that are carried out within ventilation tube 60 using suction 440 and liquid delivery 525 orifices. In the example of FIG. 17, a switching assembly is provided -for example, to regulate behavior of a valve Fluids switch 6022 regulates liquid delivery and suction switch 6011 regulates suction. In some embodiments, it is possible to easily and simultaneously control both switches. For example, a single switch may regulate both liquid delivery or suctioning. In some embodiments, any one of these switches, or both of these switches are biased to an off' position where there, substantially, is no suction and/or no liquid delivery.

In some embodiments, pressurized liquid source 602 may include a syringe assembly -when the syringe is depressed, this distally forces liquid into ventilation tube via the liquid delivery lumen.

Alternatively or additionally, a continuous (i.e. constant or non-constant) source of suction 601 or pressurized liquid 602 may be provided.

Tn various examples described above, suctioning was restricted by slidable boundary to locations, within the interior of the tube. In some embodiments, concurrent with the maintaining of the slidable boundary, there is no suctioning carried out distal to the slidable boundary and/or only a "small" amount of suction relative to the suctioning of material from proximal locations 774 via suctioning orifice(s) 440. For example, a ratio between the suctioning flow' rate of material from the distal locations 778 to the suctioning flow' rate of material from the proximal 774 locations may be at most 0.25 or at most 0.2 or at most 0.1 or at most 0.05.

One feature provided by some embodiments is that when boundary-forming balloon 588 is inflated so that boundary is maintained, there is little or no suctionlnegative pressure applied to locations 778 distal of the boundary. Not wishing to be bound by any theory, the inventors presently believe that application so such distal' suction while boundary is maintained may reduce an amount of air available to the patient and/or located in the patient's trachea precisely during the short period of time when the balloon 588/boundary block air from the ventilator from reaching the patient's lungs.

FIGS. 18A-18C describes a manufacturing technique which, in some non-limiting embodiments, is useful to facilitating this feature. During an earlier stage of manufacturing (FIG. 1 8A), suction lumen 520 and/or suction orifice(s) 440 is in fluid communication with a distal opening 519 which is located distal of the balloon mounting location 587 to which balloon 588 is mounted (for example, mounted at a later time).

During a later stage of manufacturing, it is possible to completely (see FIG. 18B) or at least partially (see FIG. 1SC) block this opening 519. There is no limitation on how this may be accomplished -appropriate techniques include melting the lumen (e.g. near opening 519) so as to close opening 519 or introduction of glue or any other foreign materials into 520 (e.g. near 519). Blocking of 519 creates some sort of blocking element' or blocking structure' which partially or completely blocks opening 519.

In some embodiments, after balloon 588 is inflated to create boundary, an interior of suction lumen 520 (e.g. at a half-way' location halfway between proximal 204 and distal 208 ends of main body 210 and/or at a location that is 3 cm or 5 cm or 10 cm proximal to balloon mounting location 587 or balloon 588) andlor one or more or all of suction lumen(s) 440 (e.g. located proximal to balloon mounting location 587) is not in substantially fluid communication with any location 778 outside of main body 210 and distal to boundary and/or is only in fluid communications with one or more opening(s) 519 whose total aggregate size is relatively small' relative to an aggregate size of suction port(s) 440 open to proximal locations 774 and/or located proximal to mounting location 587 or balloon 588.

This, in exemplary embodiments, the device is configured, when sleeve 770 is maintained, to substantially restrict suctionlnegative pressure to proximal locations 774 -for example, at most 3O°/ or at most 20% or at most 10% of a total negative pressure applied within an interior of tube 60 and/or applied via suction lumen 520 and/or via all suction lumen(s) 520 within or along main body 210 is applied to distal locations 778 -i.e. a significant majority or an entirety of the negative pressure is restricted (i.e. by the presence of inflatable balloon 588 which maintains the obstructing boundary') to proximal location(s) 774.

In some embodiments, one or more of the suction orifice(s) 440 (e.g. proximal to mounting location 587 or balloon 588 or boundary and/or open to proximal locations 774) (e.g. which is supplied or primarily supplied with negative pressure via suction lumen(s) 520) is in fluid communication, through suction lumen 520, with a blocking element' or blocking structure' which partially or completely blocks opening 519.

Some additional features (e.g. related to numerical parameters) are discussed in the present section. As with all features, they are intended as exemplary and not as limiting.

There is no limitations on the material from which any element (e.g. main body, lumen(s), orifice(s), balloon, etc) may be constructed. Tn non limiting embodiments, material used may include, but are not limited to biocompatible materials, polymer-based materials, plastics, silicone, polyurethane and latex. As the skilled artisan will appreciated after reading the present disclosure, other materials may be used.

In various embodiments (not limited to the embodiments of FIG. 4A or in any other figure), there is no particular limitation on the size of the liquid delivery orifice(s) 525 and/or suction 440 orifice(s).

Tn some embodiments, an average suction lumen(s) 520 width (e.g. averaged over a longitudinal direction) is between 2 and 5 mm. In some embodiments, an average fluide delivery lumen(s) 530 width (e.g. averaged over a longitudinal direction) is at most 0.75 or at most 0.5 or at most 0.25 or at most 0.2 or at most 0.15 or at most 0.1 times an average suction lumen(s) 520 width.

In some embodiments, an inner width of one or more of the liquid delivery orifice(s) 525, or an average orifice inner width for any number (i.e. 2 or 3 or 4 or any other number) of fluid delivery orifice(s) 525 is at most 3 mm or at most 2 mm or at most 1 mm or at most 0.75 mm or at most 0.5 mm and/or at least 0.25 mm or at least 0.5 mm or at least 1 mm.

In some embodiments, an inner width of one or more of the suction orifice(s) 440, or an average orifice inner width for any number (i.e. 2 or 3 or 4 or any other number) of suction orifice(s) 440 is at most 7 mm or at most 3 mm or at most 2 mm and/or at least 0.5 mm or at least 1 mm or at least 2 mm or at least 3 mm or at least 4 mm.

In some embodiments, an inner width of one or two or three or any number of fluid delivery orifice(s) 525 is at most 50% or at most 30% or at most 20% or at most 1 5°A of an inner width of one or two or three or any number of suction orifice(s) 440.

In some embodiments, one or more of the suction 440 and/or fluid delivery 525 orifice(s) is deployed at most 5 cm or at most 3 cm or at most 2 cm or at most 1 cm proximal to a balloon mounting location 770 and/or an average or proximal location of boundary-forming balloon 588 and/or a location of boundary.

In some embodiments, an cross section of the suction lumen 530 exceeds a cross section of fluid delivery lumen 530 by a factor of at least 1.5 or a factor of at least 2 or a factor of at least 4 or a factor of at least 5 or a factor of between 6 and 15 or a factor of between 8 and 12.

Although various embodiments were describe with respect to assembled systems, it is appreciate that kits including one or more parts which, when assembled, form any presently disclosed apparatus or device or portion thereof are also in the scope of the invention. In different non-limiting examples, connector assembly 158 and/or input module assembly 156 and/or any port disclosed herein may be provided as parts which may be assembled on-site (e.g. in the intensive care ward). In some examples, sleeve 610 may be part of a kit and deployed on site. Other configurations ai within the scope of embodiments of the invention.

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.

All references cited herein are incorporated by reference in their entirety. Citation of a reference does not constitute an admission that the reference is prior art.

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".

The present invention has been described using detailed descriptions of embodiments thereof that are provided by way of example and are not intended to limit the scope of the invention. The described embodiments comprise different features, not all of which are required in all embodiments of the invention. Some embodiments of the present invention utilize only some of the features or possible combinations of the features. Variations of embodiments of the present invention that are described and embodiments of the present invention comprising different combinations of features noted in the described embodiments will occur to persons of the art.

Claims

WHAT IS CLAIMED IS: 1. A ballooned cleaning device for use with an ETT or tracheostomy ventilation tube 60, a ventilator machine 900, a source(s) 602 of pressurized liquid and a source(s) of suctioning 603, the cleaning device comprising: a. a tube-connector assembly 158 for connecting the ventilation tube 60 to the ventilator machine 900, in a substantially air-tight manner b. an elongate, flexible, main body 210 that is insertable through the tube-connector assembly 158 into the ventilation tube 60 to form an interstitial region outside of the main body 210 within ventilation tube 60; c. a balloon 588 mounted to the main body 210 at a location in the distal half of the main body and inflatable into contact with an inner surface 201 of the ventilation tube 60; d. one or more liquid-delivery lumen(s) 520 arranged within or along the elongated main body, and operative to transport pressurized liquid received from pressurized liquid source(s) outside of the ventilation tube 60, into a proximal portion 774 of the interstitial region that is proximal of the balloon 588 so that the transported liquid enters the proximal portion 774 via liquid delivery orifice(s) 525 located on or mechanically coupled to the main body 210; e. suction lumen(s) 520 arranged within or along the main body, and operative to convey negative pressure from suction source(s) 603 predominantly into the proximal portion 774 of interstitial region via suction orifice(s) 440 when balloon 588 is inflated into contact, suction orifice(s) 440 being open to the proximal portion 774 and mechanically coupled to the main body 210.f. a suction port 820 connectable to the suction source(s) 603 for mediating a connection between the suction source and the suction lumen(s); and g. a pliable sleeve 610 around at least a portion of the main body 210 in locations proximal to the tube-connector assembly 158 and distal to the suction port 820 to inhibit contamination.
2. The system of any preceding claim wherein the system is configured so that: i. the pressurized liquid is simultaneously forced through first 525A and second 525B liquid delivery orifices to respectively produce first 556A and second 556B fluid streams that are respectively and simultaneously incident upon an inner surface 201 of the ventilation tube 60 at first 552A and second 552B locations; and ii. the first 552A and second 552B locations are substantially on opposite sides of the ventilation tube 60 inner surface 201 within a tolerance that is at most 75 degrees or at most 45 degrees or at most 25 degrees.
3. The system of any preceding claim wherein each liquid delivery orifice 525 has width that is at most 50%, or at most 25% or at most 10%, or at most 5%, of an average width of the 440 suction orifice(s).
4. The system of any of preceding claim wherein: i. inflatable balloon 588 is a leaky balloon having one or more surface-located leak holes; and ii. one or more of the fluid delivery orifice(s) 525 are leak holes that facing in a direction having a proximal component; iii. inflatable balloon is operative to be inflated by pressurized liquid source 603 via fluid delivery lumen(s),
5. The system of claim 4 wherein an average width of all holes in the leaky balloon surface is less than 1 mm.
6. The system of any of claims 4-5 wherein an aggregate surface area of all holes in the leaky balloon surface is at most 10%, or at most 5%, or at most 2.5%, or at most 1% of a total surface area of inflatable balloon 588.
7. The system of preceding claim wherein the system lacks suction orifice(s) more distal than the balloon 588..
8. The system of preceding claim wherein the system lacks suction orifice(s) more distal than the balloon 558 and/or distal to boundary and in fluid communication with suction source 603.
9. The system of any preceding claim wherein the combined total aperture area of any and all suction orifices more distal than the balloon 588 and/or open to distal locations 778 is at most 50%, or at most 40%, or at most 30%, or at most 20%, or at most 10% of the combined total aperture area of any and all suction orifices 440 proximal to the balloon 558 and/or open to proximal location(s) 774.
10. The system of any preceding claim wherein the combined total aperture area of any and all suction orifices in fluid communication with suction source 603 and more distal than the balloon 588 and/or open to distal locations 778 is at most 50%, or at most 40%, or at most 30%, or at most 20%, or at most 10% of the combined total aperture area of any and all suction orifices 440 in fluid communication with suction source 603 and proximal to the balloon 558 and/or open to proximal location(s) 774.
11. The system of any preceding claim wherein at least one liquid-delivery-orifice 525 is proximally displaced from the slidable boundary by at most a fluid-orifice-displacement-value that is at most 3 cm, or at most 2 cm or at most 1 cm.
12. The system of any of preceding claim wherein the first 525A and second 525B liquid delivery orifices are respectively supplied via first 520A and second 520B fluid-delivery lumens.
13. The system of claim 12 wherein the first 520A and second 520B liquid second liquid delivery lumens are simultaneously supplied by a common pressurized liquid chamber.
14. The system of any preceding claim wherein each liquid delivery orifice 525 has a width of at most 3 mm, or at most 2 mm, or at most 0.5mm, at most 0.3mm, at most 0.2mm.
15. The system of any preceding claim wherein a length of the pliable sleeve 610 is at least 5 cm.
16. The system of any preceding claim wherein the pliable sleeve 610 is arrangable around at least a portion of the main body 210 in locations 598 proximal to the tube-connector assembly 158.
17. The system of any preceding claim the pliable sleeve 610 is arranged around at least a portion of the main body 210 in locations 598 proximal to the tube-connector assembly and distal to a suction port 820 which mediates a connection between suction source(s) 603 and suction lumen(s) 520.
18. The system of any preceding claim wherein the one or more suction orifice(s) is(are) longitudinally displaced from the balloon 588 by at most a suction-orifice-displacement-value that is at most 3 cm or at most 2 cm or at most 1 cm.
19. The system of any preceding claim wherein the suction-orifice-displacement-value is at most 2 cm, or at most 1 cm or at most 0.5 cm.
20. The system of any preceding claim, operative so that the fluid delivery operation and the suctioning are carried out simultaneously.
21. The system of any preceding claim operative so that the fluid delivery operation and the suctioning are carried out sequentially.
22. The system or any preceding claim wherein at least one of the fluid delivery orifice(s) 525 are deployed to and/or voids within a second balloon 586 deployed distal to the boundary-forming balloon 588.
23. The system of claim 22 wherein the second balloon 586 is inflatable.
24. The system of claim 22 wherein the second balloon 586 is not inflatable.35. The system of preceding claim wherein at least one of the at least one of the fluid delivery orifice(s) 525 is an inner-surface-facing void in the main body 210 facing towards the inner surface 201 of the ventilation tube 60 or a inner-surface-facing-void in a fluid-delivery lumen 520 that at least spans a longitudinal range between the fluid delivery orifice(s) 525 and a location on or within the main body 210 that is proximal to the ventilation tube connector assembly 158.30. The system of any claims 1-29: i. at least one of the at least one of the fluid delivery orifice(s) 525 is a void in the boundary-forming balloon 588 50 that the boundary-forming balloon 588 is leaky; ii. forcing of pressurized liquid into the boundary-forming balloon 588 is operative to carry out at least some of both of the balloon-inflation operation and the fluid-delivery of the fluid-delivery operation.31. The system of claim 30 wherein a surface of the boundary-forming balloon 588 is at least 90%, by surface area, substantially impermeable.32. The system of claim 30 wherein a surface of the boundary-forming balloon 588 is at least 95%, by surface area, substantially impermeable.33. The system of any of claims 30-32 wherein a surface of the boundary-forming balloon 588 is at most 99%, by surface area, substantially impermeable.34. The system of any claims 1-33 wherein the boundary-forming 588 balloon is substantially sealed and is not leaky.35. The system or method of any of claims 1-34 further comprising canying out the additional step of: D. concurrent with the maintaining of the ventilation circuit, and at a time that the boundary-forming balloon 588 mounted to the elongate, flexible main body 210 is located within the ventilation tube 60 and in a non-obstructing mode so that the slidable boundary with the inner surface 201 of the ventilation tube 60 is not maintained and/or in non-contact mode so that balloon 588 is not inflated into contact with the inner surface 201 of ventilation tube 60, proximally suctioning into the suction orifice(s) 440 material that is located: I. within the ventilation tube 60 and distal to the boundary-forming balloon 588; and/or II. distal to the ventilation tube distal end 60 so that the material located distal to the ventilation tube distal end 60 enters an interior region of ventilation tube 60 en route to the suction orifice(s), wherein the suctioning step when the boundary-forming balloon 588 is in non-obstructing and/or non-contact mode is carried out to proximally transport material suctioned in step D proximally out of ventilation tube 60 via a proximal opening of the ventilation tube 60.36. The system or method of any preceding claim wherein the balloon is mounted to the main body 210 at a location in a distal half, or distal third, or distal quarter, or distal fifth or distal tenth of the main body 210.37. The system or method of any preceding claim wherein an inner diameter of ventilation tube 60 is at least 4 mm and/or at most 11 mm.38. The system or method of any preceding claim wherein the pressurized liquid source 602 and the suction source 603 are respectively operative, in combination with the lumens and the orifices, to effect the fluid delivery and the suctioning when the boundary-forming balloon 588 is located in a distal half of the ventilation tube 60.39. The system or method of any preceding claim wherein the balloon 588 is inflated by liquid or gas supplied by balloon fluid source that is located in the tube-assembly-proximal location.40. The system or method of any preceding claim wherein balloon 588 is supplied via a balloon lumen(s) 580 that is different from liquid delivery lumen(s) 520.41. The system or method of any preceding claim wherein balloon 588 is inflated by gas.42. The system or method of any preceding claim wherein balloon 588 is inflated by liquid.43. A method of cleaning a main lumen of an ETT or tracheostomy ventilation tube 60 compnsing: at a time when: i. a ventilation machine 900 is connected to the ventilation tube 60 via a tube connector assembly 158 in a substantially air-tight manner; ii. an elongate, flexible, main body 210 traverses an interior of the tube connector assembly 158 so that a distal end of the main body 210 is located within the ventilation tube 60 to form an interstitial region outside of the main body 210 and within the ventilator tube; iii. a balloon 588 mounted to the main body 210 is located within the ventilation tube 60; iv. sources of pressurized liquid 602 and suction 603 are: A. both located in a tube-connector-assembly-proximal location outside of the ventilation tube 60 and proximal to tube connector assembly 158; and B. are respectively in fluid communication with liquid delivery orifice(s) 525 and suction orifice(s) 440 via liquid delivery lumen(s) 520 and suction lumen(s) 530, each of the suction 440 and liquid delivery 525 orifice(s) being: A. located proximal to balloon 588 within ventilation tube 60, and B. on main body 210 or mechanically coupled to main body 210, carrying out the following steps: a. inflating the balloon 588 mounted to the main body 210 into contact with an inner surface 201 of the ventilation tube 60 so that both suction 440 and liquid delivery 525 orifice(s) are open to a proximal portion 774 of the interstitial region that is proximal to balloon 588; b. concurrent with a maintaining of the contact by the balloon 588, forcing pressurized liquid from the pressurized liquid source(s) 602 through the liquid delivery lumen(s) 520 and orifice(s) 525, into the interstitial region proximal portion 774; c. concurrent with a maintaining of the contact by the balloon 588, conveying negative pressure from the suction source(s) 603, via the suction lumen(s) 530 and orifice(s) 440, predominantly into the proximal portion 774 of the interstitial region.44. The method of clami 43 wherein the method is carried out when the suction orifice(s) andior the liquid delivery are located closer to balloon 588 than to a proximal end 62 of ventilation tube 60.45. The method of any of claims 43-44 further comprising: concurrent to the maintaining of the slidable boundary, longitudinally moving the boundary-forming balloon 588 so as to mechanically dislodge and/or loosen bioflim material located on the inner surface 201 of the ventilation tube 60.46. The method of claim 45 wherein the longitudinal moving is carried out simultaneously with the fluid delivery operation and/or the suctioning.47. The method of any of claims 43-46 wherein: i. the pressurized liquid is simultaneously forced through first 525A and second 525B liquid delivery orifices to respectively produce first 556A and second 556B fluid streams that are respectively and simultaneously incident upon an inner surface 201 of the ventilation tube 60 at first 552A and second 552B locations; and ii. the first 552A and second 552B locations are substantially on opposite sides of the ventilation tube 60 inner surface 201 within a tolerance that is at most 75 degrees or at most 45 degrees or at most 25 degrees.48. The method of any claims 43-47 wherein: i. at least one of the at least one of the fluid delivery orifice(s) 525 is a void in the boundary-forming balloon 588 SO that the boundary-forming balloon 588 is leaky; ii. forcing of pressurized liquid into the boundary-forming balloon 588 is operative to carry out at least some of both of the balloon-inflation operation and the fluid-delivery of the fluid-delivery operation.49. The method of claim 48 wherein a surface of the boundary-forming balloon 588 is at least 90%, by surface area, substantially impermeable.50. The method of claim 48 wherein a surface of the boundary-forming balloon 588 is at least 95%, by surface area, substantially impermeable.51. The method of any of claims 48-50 wherein a surface of the boundary-forming balloon 588 is at most 99%, by surface area, substantially impermeable.Amendments to the claims have been filed as follows.Claims 1. A ballooned cleaning device for use with an ETT or tracheostomy ventilation tube 60, a ventilator machine 900, a source(s) 602 of pressurized liquid and a source(s) of suctioning 601, the cleaning device comprising: a. a tube-connector assembly 158 for connecting the ventilation tube 60 to the ventilator machine 900, in a substantially air-tight manner b. an elongate, flexible, main body 210 that is insertable through the tube-connector assembly 158 into the ventilation tube 60 to form an interstitial region outside of the main body 210 within ventilation tube 60; c. a balloon 588 mounted to the main body 210 at a location in the distal half of the main body and inflatable into contact with an inner surface 201 of the ventilation tube 60; d. one or more liquid-delivery lumen(s) 520 arranged within or along the elongated main body, and operative to transport pressurized liquid received from pressurized liquid source(s) outside of the ventilation tube 60, into a proximal portion 774 of the interstitial region that is proximal of the balloon 588 so that the transported liquid enters the proximal portion 774 via liquid delivery orifice(s) 525 located on or mechanically coupled to the main body 210; e. suction lumen(s) 530 arranged within or along the main body, and operative to convey negative pressure from suction source(s) 601 predominantly into the proximal portion 774 of interstitial region via suction orifice(s) 440 when balloon 588 is inflated into contact, suction orifice(s) 440 being open to the proximal portion 774 and mechanically coupled to the main body 210.f. a suction port 820 connectable to the suction source(s) 601 for mediating a connection between the suction source and the suction lumen(s); and g. a pliable sleeve 610 around at least a portion of the main body 210 in locations proximal to the tube-connector assembly 158 and distal to the suction port 820 to inhibit contamination.2. The system of any preceding claim wherein the system is configured so that: i. the pressurized liquid is simultaneously forced through first 525A and second 525B liquid delivery orifices to respectively produce first 556A and second 556B fluid streams that are respectively and simultaneously incident upon an inner surface 201 of the ventilation tube 60 at first 552A and second 552B locations; and ii. the first 552A and second 552B locations are substantially on opposite sides of the ventilation tube 60 inner surface 201 within a tolerance that is at most 75 degrees or at most 45 degrees or at most 25 degrees.3. The system of any preceding claim wherein each liquid delivery orifice 525 has width that is at most 50%, or at most 25% or at most 10%, or at most 5%, of an average width of the 440 suction orifice(s).4. The system of any of preceding claim wherein: i. inflatable balloon 588 is a leaky balloon having one or more surface-located leak holes; and ii. one or more of the fluid delivery orifice(s) 525 are leak holes that facing in a direction having a proximal component; iii. inflatable balloon is operative to be inflated by pressurized liquid source 603 via fluid delivery lumen(s), 5. The system of claim 4 wherein an average width of all holes in the leaky balloon surface is less than 1 mm.6. The system of claim 4 or 5 wherein an aggregate surface area of all holes in the leaky balloon surface is at most 10%, or at most 5%, or at most 2.5%, or at most 1% of a total surface area of inflatable balloon 588.7. The system of any preceding claim wherein the system lacks suction orifice(s) more distal than the balloon 588..8. The system of any preceding claim wherein the system lacks suction orifice(s) more distal than the balloon 558 and/or distal to boundary and in fluid communication with suction source 603.9. The system of any preceding claim wherein the combined total aperture area of any and all suction orifices more distal than the balloon 588 and/or open to distal locations 778 is at most 50%, or at most 40%, or at most 30%, or at most 20%, or at most 10% of the combined total aperture area of any and all suction orifices 440 proximal to the balloon 558 and/or open to proximal location(s) 774.10. The system of any preceding claim wherein the combined total aperture area of any and all suction orifices in fluid communication with suction source 601 and more distal than the balloon 588 and/or open to distal locations 778 is at most 50%, or at most 40%, or at most 30%, or at most 20%, or at most 10% of the combined total aperture area of any and all suction orifices 440 in fluid communication with suction source 601 and proximal to the balloon 558 and/or open to proximal location(s) 774.11. The system of any preceding claim wherein at least one liquid-delivery-orifice 525 is proximally displaced from the slidable boundary by at most a fluid-orifice-displacement-value that is at most 3 cm, or at most 2 cm or at most 1 cm.12. The system of any preceding claim wherein the first 525A and second 525B liquid delivery orifices are respectively supplied via first 520A and second 520B fluid-delivery lumens.13. The system of claim 12, wherein the first 520A and second 520B liquid second liquid delivery lumens are simultaneously supplied by a common pressurized liquid chamber.14. The system of any preceding claim wherein each liquid delivery orifice 525 has a width of at most 3 mm, or at most 2 mm, or at most 0.5mm, at most 0.3mm, at most 0.2mm.15. The system of any preceding claim wherein a length of the pliable sleeve 610 is at least 5 cm.16. The system of any preceding claim wherein the pliable sleeve 610 is arrangable around at least a portion of the main body 210 in locations 598 proximal to the tube-connector assembly 158.17. The system of any preceding claim the pliable sleeve 610 is arranged around at least a portion of the main body 210 in locations 598 proximal to the tube-connector assembly and distal to a suction port 820 which mediates a connection between suction source(s) 603 and suction lumen(s) 530.18. The system of any preceding claim wherein the one or more suction orifice(s) is(are) longitudinally displaced from the balloon 588 by at most a suction-orifice-displacement-value that is at most 3 cm or at most 2 cm or at most 1 cm.19. The system of any preceding claim wherein the suction-orifice-displacement-value is at most 2 cm, or at most 1 cm or at most 0.5 cm.20. The system of any preceding claim, operative so that the fluid delivery operation and the suctioning are carried out simultaneously.21. The system of any preceding claim operative so that the fluid delivery operation and the suctioning are carried out sequentially.22. The system or any preceding claim wherein at least one of the fluid delivery orifice(s) 525 are deployed to and/or voids within a second balloon 586 deployed distal to the boundary-forming balloon 588.23. The system of claim 22 wherein the second balloon 586 is inflatable.24. The system of claim 22 wherein the second balloon 586 is not inflatable.
25. The system of preceding claim wherein at least one of the at least one of the fluid delivery orifice(s) 525 is an inner-surface-facing void in the main body 210 facing towards the inner surface 201 of the ventilation tube 60 or a inner-surface-facing-void in a fluid-delivery lumen 520 that at least spans a longitudinal range between the fluid delivery orifice(s) 525 and a location on or within the main body 210 that is proximal to the ventilation tube connector assembly 158.
26. The system of any preceding claim, wherein i. at least one of the at least one of the fluid delivery orifice(s) 525 is a void in the boundary-forming balloon 588 so that the boundary-forming balloon 588 is leaky; ii. forcing of pressurized liquid into the boundary-forming balloon 588 is operative to carry out at least some of both of the balloon-inflation operation and the fluid-delivery of the fluid-delivery operation.
27. The system of claim 26, wherein a surface of the boundary-forming balloon 588 is at least 90%, by surface area, substantially impermeable.
28. The system of claim 26, wherein a surface of the boundary-forming balloon 588 is at least 95%, by surface area, substantially impermeable.
29. The system of any of claims 26 to 28, wherein a surface of the boundary-forming balloon 588 is at most 99%, by surface area, substantially impermeable.
30. The system of any preceding claim, wherein the boundary-forming 588 balloon is substantially sealed and is not leaky.
31. The system of any preceding claim, further comprising carrying out the additional step of: D. concurrent with the maintaining of the ventilation circuit, and at a time that the boundary-forming balloon 588 mounted to the elongate, flexible main body 210 is located within the ventilation tube 60 and in a non-obstructing mode so that the slidable boundary with the inner surface 201 of the ventilation tube 60 is not maintained and/or in non-contact mode so that balloon 588 is not inflated into contact with the inner surface 201 of ventilation tube 60, proximally suctioning into the suction orifice(s) 440 material that is located: I. within the ventilation tube 60 and distal to the boundary-forming balloon 588; and/or TT. distal to the ventilation tube distal end 60 so that the material located distal to the ventilation tube distal end 60 enters an interior region of ventilation tube 60 en route to the suction orifice(s), wherein the suctioning step when the boundary-forming balloon 588 is in non-obstructing and/or non-contact mode is carried out to proximally transport material suctioned in step D proximally out of ventilation tube 60 via a proximal opening of the ventilation tube 60.
32. The system of any preceding claim wherein the balloon is mounted to the main body 210 at a location in a distal half, or distal third, or distal quarter, or distal fifth or distal tenth of the main body 210.
33. The system of any preceding claim wherein an inner diameter of ventilation tube 60 is at least 4 mm and/or at most 11 mm.
34. The system of any preceding claim wherein the pressurized liquid source 602 and the suction source 601 are respectively operative, in combination with the lumens and the orifices, to effect the fluid delivery and the suctioning when the boundary-forming balloon 588 is located in a distal half of the ventilation tube 60.
35. The system of any preceding claim wherein the balloon 588 is inflated by liquid or gas supplied by balloon fluid source that is located in the tube-assembly-proximal location.
36. The system of any preceding claim wherein balloon 588 is supplied via a balloon lumen(s) 580 that is different from liquid delivery lumen(s) 520.
37. The system of any preceding claim wherein balloon 588 is inflated by gas.
38. The system of any preceding claim wherein balloon 588 is inflated by liquid.
39. A method of cleaning a main lumen of an ETT or tracheostomy ventilation tube 60 comprising: at a time when: i. a ventilation machine 900 is connected to the ventilation tube 60 via a tube connector assembly 158 in a substantially air-tight manner; ii. an elongate, flexible, main body 210 traverses an interior of the tube connector assembly 158 so that a distal end of the main body 210 is located within the ventilation tube 60 to form an interstitial region outside of the main body 210 and within the ventilator tube; iii. a balloon 588 mounted to the main body 210 is located within the ventilation tube 60; iv. sources of pressurized liquid 602 and suction 601 are: A. both located in a tube-connector-assembly-proximal location outside of the ventilation tube 60 and proximal to tube connector assembly 158; and B. are respectively in fluid communication with liquid delivery orifice(s) 525 and suction orifice(s) 440 via liquid delivery lumen(s) 520 and suction lumen(s) 530, each of the suction 440 and liquid delivery 525 orifice(s) being: A. located proximal to balloon 588 within ventilation tube 60, and B. on main body 210 or mechanically coupled to main body 210, carrying out the following steps: a. inflating the balloon 588 mounted to the main body 210 into contact with an inner surface 201 of the ventilation tube 60 so that both suction 440 and liquid delivery 525 orifice(s) are open to a proximal portion 774 of the interstitial region that is proximal to balloon 588; b. concurrent with a maintaining of the contact by the balloon 588, forcing pressurized liquid from the pressurized liquid source(s) 602 through the liquid delivery lumen(s) 520 and orifice(s) 525, into the interstitial region proximal portion 774; c. concurrent with a maintaining of the contact by the balloon 588, conveying negative pressure from the suction source(s) 601, via the suction lumen(s) 530 and orifice(s) 440, predominantly into the proximal portion 774 of the interstitial region.
40. The method of claim 39, wherein the method is carried out when the suction orifice(s) andior the liquid delivery are located closer to balloon 588 than to a proximal end 62 of ventilation tube 60.
41. The method of claim 39 or 40, further comprising: concurrent to the maintaining of the slidable boundary, longitudinally moving the boundary-forming balloon 588 so as to mechanically dislodge and/or loosen biofilm material located on the inner surface 201 of the ventilation tube 60.
42. The method of claim 41, wherein the longitudinal moving is carried out simultaneously with the fluid delivery operation andlor the suctioning.
43. The method of any of claims 39 to 42 wherein: i. the pressurized liquid is simultaneously forced through first 525A and second 525B liquid delivery orifices to respectively produce first 556A and second 556B fluid streams that are respectively and simultaneously incident upon an inner surface 201 of the ventilation tube 60 at first 552A and second 552B locations; and ii. the first 552A and second 552B locations are substantially on opposite sides of the ventilation tube 60 inner surface 201 within a tolerance that is at most 75 degrees or at most 45 degrees or at most 25 degrees.
44. The method of any claims 39 to 43 wherein: i. at least one of the at least one of the fluid delivery orifice(s) 525 is a void in the boundary-forming balloon 588 SO that the boundary-forming balloon 588 is leaky; ii. forcing of pressurized liquid into the boundary-forming balloon 588 is operative to carry out at least some of both of the balloon-inflation operation and the fluid-delivery of the fluid-delivery operation.
45. The method of claim 44, wherein a surface of the boundary-forming balloon 588 is at least 90%, by surface area, substantially impermeable.
46. The method of claim 44, wherein a surface of the boundary-forming balloon 588 is at least 95%, by surface area, substantially impermeable.
47. The method of any of claims 44 to 46, wherein a surface of the boundary-forming balloon 588 is at most 99%, by surface area, substantially impermeable.