Endotracheal tube cleaning device

Abstract

The present invention relates generally to the technological field of medical devices. More specifically, the present invention relates to cleaning devices adapted for cleaning flexible tubular medical instruments, such as endotracheal tubes. The present invention represents a cleaning device for an endotracheal tube, which provides an improvement of the technological field of medical devices, by reducing and / or preventing endotracheal tube occlusion during cleaning, thereby enabling continuous airflow through the endotracheal tube to the respiratory system.

Description

ENDOTRACHEAL TUBE CLEANING DEVICECROSS REFERENCE TO RELATED APPLICATIONS

[0001] This Application claims the benefit of priority of Israeli Patent Application No. 310666, titled “ENDOTRACHEAL TUBE CLEANING DEVICE” filed 5 February 2024, the contents of which are incorporated herein by reference in their entirety.BACKGROUND OF THE INVENTION

[0002] The present invention relates generally to the technological field of medical devices. More specifically, the present invention relates to cleaning devices adapted for cleaning flexible tubular medical instruments, such as endotracheal tubes.

[0003] Endotracheal tube is used to provide a clear airway through the mouth, pharynx and trachea or nose, nasopharynx and trachea into the tracheobronchial tree of a patient. This instrument helps supporting life during and after major surgery, trauma, or the development of certain severe tracheal conditions, such as pneumonia and sepsis, as well as most cases of respiratory failure.

[0004] Ventilator-associated pneumonia (VAP) is a common complication that develops in patients receiving mechanical ventilation. VAP significantly hampers the recovery process, increases hospitalization duration, escalates treatment expenses, and, in severe cases, may lead to mortality. After several days of intubation and mechanical ventilation, the lumen of an endotracheal tube becomes heavily colonized by bacteria, which usually organize into a thick, mature biofilm. The formation of endotracheal tube biofilms and subsequent, recurrent transfer of bacteria to the lower respiratory tract may lead to the development of lower respiratory tract infection, thereby resulting in ventilator-associated pneumonia.

[0005] The state of the art teaches about various devices and methods of cleaning endotracheal tube without interrupting intubation, that is, while the tube remains inserted into a patient’s body. Known solutions usually comprise a flexible rod with the cleaning head attached to the distal end, which is threaded through the endotracheal tube, normally prior to the intubation, so as to have the cleaning head positioned distally beyond the distal rim of the endotracheal tube. The cleaning is further performed by retracting the rod with the cleaning head in the proximal direction, out of the endotracheal tube. When being retracted through the endotracheal tube, the cleaning head applies friction to the inner surface of the endotracheal tube, thereby rubbing it and moving the debris up to the proximal end of the endotracheal tube, where they are collected and removed. After cleaning, the rod with the cleaning head may be reinserted into the endotracheal tube for subsequent cleanings.

[0006] The major drawback of the known solutions lies in that, when the cleaning head passes through the endotracheal tube (e.g., when being retracted in the proximal direction for collecting debris, or when being pushed distally, for reinsertion before the next retraction), the cleaning head significantly or even completely occludes the inner space of the tube, unavoidably laboring the breath, and thereby subjecting the patient to undesired conditions.SUMMARY OF THE INVENTION

[0007] Accordingly, there is a need for a solution which would provide an improvement of the technological field of medical devices, by reducing and / or preventing endotracheal tube occlusion during cleaning, thereby enabling continuous airflow through the endotracheal tube to the respiratory system.

[0008] In the general aspect, the invention may be directed to a cleaning device for an endotracheal tube. The cleaning device may include: a hollow longitudinal tube; a hollow cleaning head attached to a distal end of the hollow longitudinal tube; a ventilation adapter being in gas connection with a proximal end of the hollow longitudinal tube, and connectable to an endotracheal ventilation unit; an endotracheal tube connector fluidically connectable to the endotracheal tube at a first end and detachably connectable to the ventilation adapter at a second end; and at least one expandable bag, fluidically connecting the endotracheal tube connector with an outer wall of the ventilation adapter; wherein upon detaching and pulling of the ventilation adapter, the hollow cleaning head is configured to remove tracheal secretions from the inner walls of the endotracheal tube and deliver the removed tracheal secretions into the at least one expandable bag.

[0009] In some embodiments, the cleaning device may further include an outer housing connected to the endotracheal tube connector and detachably connected to the ventilation adapter; wherein the at least one expandable bag is positioned in a volume defined by an inner wall of the outer housing and the outer wall of the ventilation adapter.

[0010] In some embodiments, the at least one expandable bag is configured to expand upon detaching and pulling of the ventilation adapter.

[0011] In some embodiments, the cleaning device further includes a suction adapter connectable to a suction unit, wherein the suction adapter is connected to the hollow longitudinal tube at the proximal end, and wherein the ventilation adapter is connected to the suction adapter, such that one or more gaps are formed between an inner wall of the ventilation adapter and an outer wall of the suction adapter.

[0012] In some embodiments, the suction adapter includes one or more side ventilation opening configured to allow airflow from the endotracheal ventilation unit to the hollowlongitudinal tube through the suction adapter when the suction unit is disabled and / or detached.

[0013] In some embodiments, the cleaning head includes: a tubular body; at least one bendable circular fin, extending from the outer walls of the tubular body having an outer diameter equal or larger than an inner diameter of the endotracheal tube; and a restriction circular element, extending from the outer walls of the tubular body, located as to restrict the bending of the at least one bendable circular fin when the cleaning head is being pulled through the endotracheal tube in a proximal direction thereof.

[0014] In some embodiments, the restriction circular element is located closer to a distal end of the endotracheal tube.

[0015] In some embodiments, the cleaning head further comprises an extended funnel extending from a distal end of the tubular body.

[0016] In some embodiments, the restriction circular element is a ring extending from the outer walls of the tubular body.

[0017] In some embodiments, the at least one bendable circular fin is connected to the tubular body via the restriction circular element.

[0018] In some embodiments, the restriction circular element is a thickened portion of the tubular body.

[0019] In some embodiments, the cleaning head is a single part made from an elastomer.BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The subject matter regarded as the invention is particularly pointed out and distinctly claimed in the concluding portion of the specification. The invention, however, both as to organization and method of operation, together with objects, features, and advantagesthereof, may best be understood by reference to the following detailed description when read with the accompanying drawings in which:

[0021] Fig. 1 is an isometric view of a cleaning device in the assembled state, connected to an endotracheal tube and to a suction tube, according to some embodiments;

[0022] Fig. 2 A is an exploded view of the cleaning device, showing relationship between the elements of thereof, according to some embodiments;

[0023] Fig. 2B is an exploded view of the cleaning device, showing relationship between the elements of thereof, according to alternative embodiments of endotracheal ventilation unit and suction unit connection;

[0024] Fig. 3A is an isometric longitudinal sectional view of the cleaning device in the assembled state, the suction tube detached, according to some embodiments;

[0025] Fig. 3B is another isometric longitudinal sectional view of the cleaning device in the assembled state, the suction tube attached, according to some embodiments;

[0026] Fig. 3C is an isometric cross-sectional view of the cleaning device in the assembled state, showing the connection of the suction adapter to the ventilation adapter;

[0027] Fig. 4A is an isometric view of the cleaning device having the outer housing with the endotracheal tube connector detached from the ventilation adapter (bag in the expanded state), according to some embodiments;

[0028] Fig. 4B is an isometric view of the cleaning device having the endotracheal tube connector detached from the ventilation adapter (bag in the expanded state, shown transparent), the outer housing not shown, according to some embodiments;

[0029] Fig. 5A is a partial side view of the endotracheal tube (shown transparent) during cleaning with the cleaning head (shown transparent) moving in the proximal direction, according to some embodiments;

[0030] Fig. 5B is a partial side view of the endotracheal tube (shown transparent) with the cleaning head (shown transparent) positioned distally beyond the distal rim of the endotracheal tube, according to some embodiments;

[0031] Fig. 5C is a partial side view of the endotracheal tube (shown transparent) during insertion of the cleaning head (shown transparent) in the distal direction, according to some embodiments;

[0032] Fig. 5D is a set of cleaning head configuration examples, shown in a side longitudinal sectional view, according to some embodiments.

[0033] It will be appreciated that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements.DETAILED DESCRIPTION OF THE PRESENT INVENTION

[0034] One skilled in the art will realize the invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The foregoing embodiments are therefore to be considered in all respects illustrative rather than limiting of the invention described herein. Scope of the invention is thus indicated by the appended claims, rather than by the foregoing description, and all changes that come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

[0035] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be understood by those skilled in the art that the present invention may be practiced without these specificdetails. In other instances, well-known methods, procedures, and components have not been described in detail so as not to obscure the present invention. Some features or elements described with respect to one embodiment may be combined with features or elements described with respect to other embodiments. For the sake of clarity, discussion of same or similar features or elements may not be repeated.

[0036] Although embodiments of the invention are not limited in this regard, the terms “plurality” and “a plurality” as used herein may include, for example, “multiple” or “two or more”. The terms “plurality” or “a plurality” may be used throughout the specification to describe two or more components, devices, elements, units, parameters, or the like. The term “set” when used herein may include one or more items.

[0037] In the present disclosure, the orientation of elements is often indicated with respect to a “proximal” and “distal” direction. In the context of the present disclosure, the terms “proximal” and “distal” shall be understood as referring to the position and direction corresponding to the trachea orientation. E.g., “proximal” shall be understood as “further in the direction from lower trachea to the upper trachea”, while “distal” shall be understood as “further in the direction from upper trachea to the lower trachea”.

[0038] In the present invention, the connection between elements is often indicated by terms “in fluid connection” (or “fluidically connected”) and “in gas connection”. It shall be understood that such “fluid” or “gas” connection may not necessarily mean that the respective elements are directly attached to each other. In some embodiments, the respective elements may be attached via other element or elements, forming respective “fluid” or “gas” connection therethrough. Hence, respective embodiments shall be considered as falling under the scope of the present invention, as defined in the appended claims.

[0039] Unless explicitly stated, the method embodiments described herein are not constrained to a particular order in time or chronological sequence. Additionally, some of the described method elements may be skipped, or they may occur or be performed simultaneously, at the same point in time, or concurrently.Clarification of the concept

[0040] As can be seen, the indicated problem of the prior art is addressed herein by providing cleaning device having hollow cleaning head attached to the distal end of the hollow longitudinal tube, which, in turn, from the proximal end, is in gas connection with the ventilation adapter, connectable to an endotracheal ventilation unit. Therefore, in contrast to the solutions known in the art, the cleaning head passing through the endotracheal tube (in any direction) creates no occlusion thereof, as the airflow can freely pass through the lumen formed by hollow bodies of the longitudinal tube and the cleaning head. Thereby, continuous gas connection between the endotracheal ventilation unit and patient’s respiratory system may be maintained.

[0041] The use of the expandable bag fluidically connected to the endotracheal tube connector completes the solution by providing means for collecting the debris removed from the endotracheal tube. Once the debris is collected, the entire cleaning device can be detached from the endotracheal tube, or, alternatively, the expandable bag can be detached from the endotracheal tube connector, to be sterilized or replaced with a new one. Depending on embodiments, either the entire cleaning device or parts thereof may be reusable or disposable. E.g., the bag may be disposable, and the rest of the elements may be reusable.Fig. 1 - General isometric view

[0042] Reference is now made to Fig. 1, which is an isometric view of cleaning device 100 in the assembled state, according to some embodiments of the present invention.

[0043] As can be seen in Fig. 1, in some embodiments, the cleaning device 100, at a distal end, may be connected to endotracheal tube 200, so as to have hollow longitudinal tube 30 fully extended through the lumen of endotracheal tube 200, up to having the distal end of tube 30 positioned distally beyond the distal rim of endotracheal tube 200. At a proximal end, device 100 may be connected, via T-shaped adapter 400, to a suction unit (not shown) (e.g., using suction tube 401), and to an endotracheal ventilation unit (not shown), e.g., via flexible ventilation connector 300.

[0044] In combination with the suction unit, cleaning device 100 may be used to remove an excessive fluid accumulating in the lower respiratory tract during intubation, without necessitating its interruption, which also provides for an improvement of the relevant technological field as it helps to avoid unnecessary patient disturbance (e.g., caused by removing and then replacing endotracheal tube 200 and / or cleaning device 100). Same as the improvement indicated above, this function is made possible by having a lumen formed by hollow bodies of longitudinal tube 30 and cleaning head 70, which, in the respective mode of device 100 operation (e.g., suction mode, as described further below), may be utilized to transfer the fluid from the lower respiratory tract to the suction unit, by inducing a low pressure inside the lumen of longitudinal tube 30.Figs. 2A and 2B - Exploded view. Description of elements

[0045] Reference is now made to Fig. 2A which is an exploded view of cleaning device 100, showing relationship between the elements thereof, according to some embodiments. It shall be appreciated that the content of elements is provided only as an illustrative exampleproving enablement of the invention, and other content of elements, their configuration and / or their relationship may fall under the scope of the present invention, as defined by the appended set of claims.

[0046] As shown in Fig. 2A, in some embodiments, device 100 may include ventilation adapter 40, suction adapter 50, expandable bag 60, hollow longitudinal tube 30, hollow cleaning head 70, endotracheal tube connector 20, and outer housing 10.

[0047] In some embodiments, ventilation adapter 40 may have two tubular portions 42 and 43, wherein portion 43 may have narrower diameter than portion 42. Portion 42 may be configured to be connected to suction adapter 50.

[0048] From the outer side, ventilation adapter 40 may have radial pin 41 for engaging with L-shaped slot 11 of outer housing 10, thereby establishing bayonet mount between outer housing 10 and ventilation adapter 40.

[0049] In some embodiments, suction adapter 50 may have a tubular body and may be connected to a suction unit at the proximal end (e.g., via suction tube 401), and to longitudinal tube 30 at the distal end, thereby forming a suction channel for removing an excessive fluid from the lower respiratory tract by the suction unit.

[0050] Suction adapter 50 may also have side ventilation openings 51 in the side surface thereof, by which a gas connection between ventilation adapter 40 and a proximal end of the longitudinal tube 30 may be established (as further discussed in detail with reference to Fig. 3A). Thereby, openings 51 may be configured to allow airflow from the endotracheal ventilation unit to hollow longitudinal tube 30 through suction adapter 50, when the suction unit is disabled and / or detached (e.g., when suction tube 401 is detached).

[0051] At the distal end, from the outer side, suction adapter 50 may be equipped with distance members 52, protruding radially, and having, e.g., a crosswise arrangement.Suction adapter 50 may be arranged axially with respect to ventilation adapter 40 and be fixed within the inner cavity thereof, e.g., by being detachably engaged with the inner surface of ventilation adapter 40 via distance members 52.

[0052] In some embodiments, bag 60 may include expandable portion 61 having tubular shape and tightening rings 62 and 63, respectively attached to the proximal and distal ends of expandable portion 61.

[0053] Tightening rings 62 and 63 may be made of rigid or semi-rigid material and be configured to fluidically connect, via expandable portion 61, endotracheal tube connector 20 with the outer wall of ventilation adapter 40, e.g., by tightly encompassing respective elements. In particular, tightening ring 62 may be configured to connect the proximal end of expandable portion 61 to outer wall of ventilation adapter 40, and tightening ring 63 may be configured to connect the distal end of expandable portion 61 to the outer wall of endotracheal tube connector 20. The proximal end of endotracheal tube connector 20 and outer wall of ventilation adapter 40 may have respective circumferential recesses for accommodating rings 63 and 62 respectively.

[0054] In some embodiments, longitudinal tube 30 may be made of flexible material to be able to bend together with endotracheal tube 200. Tube 30 may be attached to suction adapter 50 at the proximal end, pass through ventilation adapter 40, bag 60, endotracheal tube connector 20, and, if device 100 is attached to endotracheal tube 200, through tube 200, so as to have the distal end positioned beyond the distal rim of tube 200. Accordingly, it shall be understood that, in such embodiments, longitudinal tube 30 may have length such as to have the distal end positioned beyond the distal rim of endotracheal tube 200, when device 100, in assembled state, is attached to tube 200. As indicated above, at the distal end,longitudinal tube 30 may be attached to cleaning head 70, e.g., cleaning head 70 may be configured to tightly encompass the outer wall of tube 30.

[0055] In some embodiments, endotracheal tube connector 20 may be fluidically connectable to endotracheal tube 200 at the distal end and detachably connectable to ventilation adapter 40 at the proximal end. E.g., endotracheal tube connector 20 may have, at the proximal end, a tubular portion which may be configured to tightly fit with the distal end of portion 43 of ventilation adapter 40 (e.g., by having a respective inner diameter). At the distal end, endotracheal tube connector 20 may further have a tubular portion with an outer diameter such as to tightly fit inside the lumen of endotracheal tube 200, at its proximal end.

[0056] In some embodiments, outer housing 10 may be connected to the endotracheal tube connector 20. E.g., endotracheal tube connector 20 may include circular lip 21 extending radially and configured to be locked inside outer housing 10, e.g., using snap elements (not shown in Fig. 2A) positioned inside the inner cavity of housing 10 and configured to establish snap-fit connection with circular lip 21. Endotracheal tube connector 20 may further include circular lip 22 extending radially and having an outer diameter such as to tightly fit into the inner cavity of housing 10.

[0057] Outer housing 10 may also be configured to be detachably connected to ventilation adapter 40, e.g., using the bayonet mount, as described above.

[0058] Outer housing 10 may be further configured to accommodate endotracheal tube connector 20, bag 60 and tubular portion 43 (ventilation adapter 40).

[0059] In some embodiments, fluidical connection between endotracheal tube connector 20 and endotracheal tube 200 may be established via a portion of outer housing 10. In such embodiments, outer housing 10 may be detachably connectable to endotracheal tube 200from the distal end (e.g., by being configured to tightly fit with the proximal end of endotracheal tube 200).

[0060] In some embodiments, endotracheal tube 200 may have a standard configuration, commonly used in the art. Tube 200 may include flexible longitudinal tube 200” with connector 200’ at the proximal end.

[0061] In some embodiments, T-shaped adapter 400 may have two tubular portions 402 and 403. Portion 402, at the proximal end, may have an opening for insertion of suction tube 401 (which then may be connected to suction adapter 50, as described in detail with reference to Fig. 3B). Portion 402, at the distal end, may have a diameter such as to tightly fit the inner diameter of ventilation adapter 40. Portion 403, at the distal end, may have an opening for the endotracheal ventilation unit connection (e.g., via flexible ventilation connector 300).

[0062] In the subsequent description, when referring to other figures, the discussion of the same or similar elements may not be repeated for the purpose of clarity.

[0063] Reference is now made to Fig. 2B which is an exploded view of cleaning device 100, showing relationship between the elements thereof, according to alternative embodiments of endotracheal ventilation unit and suction unit connection.

[0064] In the embodiment, shown in Fig. 2B, it is shown that device 100 may be connected to endotracheal ventilation unit (not shown) via flexible ventilation connector 300 only, without using T-shaped adapter 400. For this reason, ventilation adapter 40, at the proximal end, may have an inner diameter such as to tightly encompass outer wall of the respective end of flexible ventilation connector 300.

[0065] In such embodiments, the connection to the suction unit (e.g., via suction tube 401, not shown in Fig. 2B) may be established, e.g., when device 100 is disconnected fromconnector 300, by connecting suction tube 401 directly to the proximal end of suction adapter 50. For this reason, in such embodiments, suction adapter 50 may be made shorter, than in the embodiment, shown in Fig. 2A, and may not have side ventilation openings 51.

[0066] In some embodiments (e.g., in the embodiments represented in Figs. 2A and 2B), device 100 may be configured to have the following operational modes: a ventilation mode, an endotracheal tube cleaning mode, and a suction mode, which are further described in detail with reference to the appended figures.Fig. 3A - Isometric view. Longitudinal section. Ventilation mode

[0067] Reference is now made to Fig. 3 A which is an isometric longitudinal sectional view of cleaning device 100 in the assembled state, according to some embodiments.

[0068] Fig. 3A shows the configuration of cleaning device 100 for a ventilation mode, according to some embodiments. In this configuration, hollow longitudinal tube 30 may be inserted into endotracheal tube 200 (flexible longitudinal tube 200” with connector 200’ at the proximal end) and positioned so as to have the distal end with cleaning head 70 (not shown in Fig. 3A) extending beyond the distal rim of endotracheal tube 200 (e.g., as shown in Fig. 1).

[0069] As can be seen, ventilation adapter 40 may be in gas connection with a proximal end of the hollow longitudinal tube 30, e.g., via side ventilation openings 51 made in the side wall of suction adapter 50. Ventilation adapter 40 may further be connectable to the endotracheal ventilation unit (not shown), e.g., via T-shaped adapter 400 and flexible ventilation connector 300.

[0070] In this mode, suction tube 401 (not shown in Fig. 3 A) may be detached from device 100. As can be seen, when suction tube 401 is detached, side ventilation openings 51 in the side wall of suction adapter 50 may be open, enabling a gas connection between ventilationadapter 40 (e.g., between the inner cavity formed together with the attached T-shaped adapter 400) and the proximal end of longitudinal tube 30.

[0071] In some additional or alternative embodiments (not shown in figures), suction tube 401 may remain attached to device 100, while not hampering the gas connection between ventilation adapter 40 (e.g., between the inner cavity formed together with the attached T- shaped adapter 400) and the proximal end of longitudinal tube 30. E.g., suction tube 401 may have additional openings in the side wall thereof and be positioned (rotated and / or slightly shifted in the proximal direction) so as to have these openings aligned with openings 51, thereby establishing gas connection between a proximal end of hollow longitudinal tube 30 and ventilation adapter 40.

[0072] In the configuration for the ventilation mode, two gas flow channels may be established: (i) a first ventilation channel, established by the successive arrangement of inner cavities of the following elements (shown in order starting from the distal end): flexible longitudinal tube 200” - connector 200’ - endotracheal tube connector 20 - ventilation adapter 40 - T-shaped adapter 400 (when applied) - flexible ventilation connector 300; (ii) a second ventilation channel, established by the successive arrangement of inner cavities of the following elements (shown in order starting from the distal end): hollow longitudinal tube 30 - suction adapter 50 - T-shaped adapter 400 (when applied) - flexible ventilation connector 300.

[0073] It shall be understood that, in some embodiments, establishment of the second ventilation channel, in the ventilation mode, may be considered optional, as ventilation through the first channel may be considered sufficient.

[0074] As can be also seen in Fig. 3A, expandable bag 60 may be positioned in a volume defined by an inner wall of outer housing 10 and the outer wall of the ventilation adapter 40 (portion 43).

[0075] As can be further seen in Fig. 3A, by having an outer diameter such as to tightly fit into the inner cavity of outer housing 10, circular lip 22 of endotracheal tube connector 20 is configured to serve as an air-tight barrier sealing the inner cavity of outer housing 10 when device 100 is assembled.Fig. 3B - Isometric view. Longitudinal section. Suction mode

[0076] Reference is now made to Fig. 3B, which is another isometric longitudinal sectional view of the cleaning device in the assembled state, according to some embodiments.

[0077] Fig. 3B shows the configuration of cleaning device 100 for the suction mode, according to some embodiments. Same as in ventilation mode, in this configuration, hollow longitudinal tube 30 may be inserted into endotracheal tube 200 (flexible longitudinal tube 200” with connector 200’ at the proximal end) and positioned so as to have the distal end with attached cleaning head 70 (not shown in Fig. 3 A) extending beyond the distal rim of endotracheal tube 200 (e.g., as shown in Fig. 1).

[0078] In some embodiments, in the suction mode, suction tube 401 may be attached to device 100. As can be seen, when suction tube 401 is inserted in the respective opening of T-shaped adapter 400 (portion 402), side ventilation openings 51 (shown in Fig. 3A) in the side wall of suction adapter 50 may be sealed, disabling a gas connection between ventilation adapter 40 (e.g., between the inner cavity formed together with the attached T- shaped adapter 400) and the proximal end of longitudinal tube 30. As can be seen, suction tube 401 may be inserted in suction adapter 50 from distal end thereof, thereby forming a suction channel together with longitudinal tube 30.

[0079] Therefore, in the suction mode, a low pressure inside the suction channel may be induced by suction unit (not shown), attached to the distal end of suction tube 401. Thereby, fluid transferring from the lower respiratory tract to the suction unit may be induced.

[0080] As can be seen, in the suction mode, ventilation through the first ventilation channel may still be maintained, if required.Fig. 3C - Isometric view. Cross-section. Suction adapter configuration

[0081] Reference is now made to Fig. 3C, which is an isometric cross-sectional view of cleaning device 100 in the assembled state, showing the connection of suction adapter 50 to ventilation adapter 40.

[0082] As can be seen, at the distal end, from the outer side, suction adapter 50 may be equipped with distance members 52, protruding radially, and having, e.g., a crosswise arrangement. Suction adapter 50 may be arranged axially with respect to ventilation adapter 40 and be fixed within the inner cavity thereof, e.g., by being detachably engaged with the inner surface of portion 42 of ventilation adapter 40 via distance members 52. In some nonexclusive embodiments, distance members 52 may be configured to detachably engage with the inner surface of ventilation adapter 40 using a snap-fit connection.

[0083] Thereby, in such configuration, when ventilation adapter 40 is connected to the suction adapter 50, gaps 53 are formed between the inner wall of ventilation adapter 40 (portion 42) and the outer wall of the suction adapter 50. Therefore, air or gas flow may be enabled through ventilation adapter 40 and endotracheal tube connector 20 (not shown) to endotracheal tube 200 (not shown), and the abovementioned first ventilation channel may be established.Figs. 4A and 4B - Isometric view. Cleaning mode

[0084] Reference is now made to Figs. 4A and 4B, which are isometric views of cleaning device 100 having outer housing 10 with endotracheal tube connector 20 detached from ventilation adapter 40, according to some embodiments. Bag 60 is shown in the expanded state (shown transparent in Fig. 4B). In Fig. 4B, outer housing 10 is not shown for the purpose of clarity.

[0085] Figs. 4A and 4B show the configuration of cleaning device 100 during the cleaning mode, according to some embodiments. In the cleaning mode, in some embodiments, housing 10 may be detached from ventilation adapter 40, e.g., by rotating ventilation adapter 40 so as to disconnect radial pin 41 from L-shaped slot 11 of outer housing 10, thereby disengaging the bayonet mount.

[0086] In the cleaning mode, upon detaching and pulling ventilation adapter 40 in proximal direction, suction adapter 50 (not shown) attached to the proximal end of longitudinal tube 30, may be pulled together with ventilation adapter 40. Thereby, hollow cleaning head 70 may be retracted through the lumen of endotracheal tube 200 and may remove tracheal secretions from the inner walls of endotracheal tube 200. During retraction of hollow cleaning head 70 through endotracheal tube 200, the abovementioned second ventilation channel may remain enabled, hence, preventing endotracheal tube 200 occlusion during cleaning and enabling continuous airflow to the respiratory system.

[0087] In some embodiments, expandable bag 60 may be configured to expand upon detaching and pulling of ventilation adapter 40. In particular, in some embodiments, expandable portion 61 may be configured to expand in a bellows-like manner. In embodiments, wherein bag 60 is reusable, expandable portion 61 may be configured to collapse and expand multiple times.

[0088] Hence, by remaining attached to outer wall of ventilation adapter 40 (portion 43) from the proximal end, and to endotracheal tube connector 20, from the distal end, expandable portion 61 may expand by being subjected to pulling force.

[0089] As indicated above, in some embodiments, bag 60 may be in fluid connection with endotracheal tube connector 20, hence, by retracting hollow cleaning head 70, the removed tracheal secretions may be delivered into bag 60. Upon retraction, cleaning head 70 may be configured to pass endotracheal tube connector 20 and be disengaged therefrom (as shown in Fig. 4B).

[0090] In some embodiments, bag 60 may be further configured to be detached from endotracheal tube connector 20 (e.g., by detaching tightening ring 63 from endotracheal tube connector), thereby the entire proximal part of device 100, including: bag 60, ventilation adapter 40, suction adapter 50 and longitudinal tube 30 with cleaning head 70; may be detached from the proximal part of device 100, including outer housing 10, and endotracheal tube connector 20, which may remain attached to endotracheal tube 200.

[0091] Additionally or alternatively, after retraction of cleaning head 70, entire device 100 may be disconnected from endotracheal tube 200.

[0092] After disconnection, the respective elements may be sterilized or replaced with new ones, depending on the respective embodiments. It shall be understood that, for a subsequent connection of device 100 to endotracheal tube 200, the intubation may not be interrupted. Furthermore, when reinserting longitudinal tube 30 with head 70, the abovementioned second ventilation channel remains enabled, allowing continuous airflow to the respiratory system and not laboring the breath.Figs. 5A-5D - Description of the cleaning head

[0093] Reference is now made to Figs. 5A-5D, wherein Fig. 5A shows a partial side view of endotracheal tube 200 (shown transparent) during cleaning, with cleaning head 70 being retracted (being moved in proximal direction 204), according to some embodiments; Fig. 5B shows a partial side view of endotracheal tube 200 (shown transparent) with the cleaning head 70 (shown transparent) positioned distally beyond the distal end of endotracheal tube 200, according to some embodiments; Fig. 5C is a partial side view of endotracheal tube 200 (shown transparent) during insertion of cleaning head 70 (shown transparent) in distal direction 206, according to some embodiments; and Fig. 5D shows a set of cleaning head 70 configuration examples, shown in a side longitudinal sectional view, according to some embodiments.

[0094] As shown in Fig. 5A, endotracheal tube 200 (tube 200”) at distal end may include distal inlet 202 and “Murphy eye” opening 203.

[0095] As indicated above, cleaning head 70 may be configured to remove debris 205 (e.g., tracheal secretions) from the inner walls of endotracheal tube 200 and deliver the removed tracheal secretions into expandable bag 60 (not shown) via tube 200.

[0096] In some embodiments, cleaning head 70 may include tubular body 71 and at least one bendable circular fin 72 extending from the outer walls of tubular body 71 and having an outer diameter equal or larger than an inner diameter of endotracheal tube 200. Therefore, when being retracted through endotracheal tube 200 in proximal direction 204, circular fin 72 may bend in the distal direction, closer to its end in order to fit the inner diameter of tube 200, thereby applying friction to the inner surface of thereof, rubbing it, collecting debris 205 and moving debris 205 up to the proximal end of tube 200.

[0097] As can be seen in Fig. 5B, when cleaning head 70 is positioned distally beyond the distal end of endotracheal tube 200 (distal inlet 202), circular fin 72 takes its natural position.

[0098] As can be seen in Fig. 5C, when cleaning head 70 is being inserted (or reinserted) through tube 200 in distal direction 206 thereof, circular fin 72 may bend (collapse) in the proximal direction, facilitating cleaning head 70 insertion.

[0099] Cleaning head 70 may further include restriction circular element 73 extending from the outer walls of tubular body 71, and located so as to restrict the bending of at least one bendable circular fin 72, when cleaning head 70 is being pulled through endotracheal tube 200 in proximal direction 204 thereof.

[0100] To achieve restriction of circular fin 72 bending, in some embodiments, restriction circular element 73 may be located closer to the distal end of endotracheal tube 200, e.g., may be located distal to at least one bendable circular fin 72. In some embodiments, restriction circular element 73 may have wider diameter 75 (e.g., measured further than fin 72 in distal direction, as shown in Fig. 5D) than portion 74 of tubular body 71 that located proximal to at least one bendable circular fin 72 (having diameter 76, as shown in Fig. 5D). Thereby, at least one bendable circular fin 72 may be configured to bend in the proximal direction with less tension than in the distal direction. Hence, at least one bendable circular fin 72 may easily bend to fit the inner space of tube 200, when moved in distal direction thereof, thereby not hampering the insertion of longitudinal tube 30 into endotracheal tube 200, however, when being retracted in proximal direction, at least one bendable circular fin 72 may be harder to bend, thereby the desired level of friction with the inner wall of endotracheal tube 200 may be achieved.

[0101] As can be seen in Fig. 5A, due to said restriction, only narrow portion 77 of fin 72 may bend in distal direction (the opposite direction of retraction), when head 70 is being moved through endotracheal tube 200 in proximal direction.

[0102] In some embodiments, restriction circular element 73 may be a ring extending from the outer walls of tubular body 71.

[0103] In some embodiments , restriction circular element 73 may be a thickened portion of tubular body 71.

[0104] In some embodiments, at least one bendable circular fin 72 may be connected to tubular body 71 via restriction circular element 73.

[0105] In some embodiments, at least one bendable circular fin 72 may be inclined in the proximal direction. E.g., at least one bendable circular fin 72 may form, together with restriction circular element 73, a solid cone-shaped (or similar shape) element, as may be seen in some embodiments shown in Fig. 5D. In some embodiments, at least one bendable circular fin 72 may be configured so as to form additional space 78 further in proximal direction thereof, thereby further facilitating the collection of debris 205, as well as further facilitating circular fin 72 collapse (when cleaning head 70 is being reinserted).

[0106] In some embodiments, the cleaning head 70 may be a single part. E.g., cleaning head 70 may be made from a flexible material, e.g., elastomer.

[0107] In some embodiments, cleaning head 70 may further include extended funnel 79 (shown in Fig. 5D), extending from the distal end of tubular body 71. By using extended funnel 79, the suction efficiency and, consequently, the efficiency of removing fluids from the lower respiratory tract (the abovementioned suction mode) may be further improved.

[0108] As shown in Fig. 5D, depending on the embodiments, cleaning head 70 may significantly vary in shape, size and position of elements. Embodiments of cleaning head 70 shown in Fig. 5D, shall be considered a non-exclusive example of said variety.Closing statement

[0109] As can be seen from the provided description, the present invention represents a cleaning device for an endotracheal tube, that provides an improvement of the technological field of medical devices, by reducing and / or preventing endotracheal tube occlusion during cleaning, thereby enabling continuous airflow through the endotracheal tube to the respiratory system.Disclaimer

[0110] While certain features of the invention have been illustrated and described herein, many modifications, substitutions, changes, and equivalents will now occur to those of ordinary skill in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.

[0111] Various embodiments have been presented. Each of these embodiments may of course include features from other embodiments presented, and embodiments not specifically described may include various features described herein.

Claims

CLAIMSWhat is claimed is:

1. A cleaning device for an endotracheal tube, comprising: a hollow longitudinal tube; a hollow cleaning head attached to a distal end of the hollow longitudinal tube; a ventilation adapter being in gas connection with a proximal end of the hollow longitudinal tube, and connectable to an endotracheal ventilation unit; an endotracheal tube connector fluidically connectable to the endotracheal tube at a first end and detachably connectable to the ventilation adapter at a second end; and at least one expandable bag, fluidically connecting the endotracheal tube connector with an outer wall of the ventilation adapter; wherein upon detaching and pulling of the ventilation adapter, the hollow cleaning head is configured to remove tracheal secretions from the inner walls of the endotracheal tube and deliver the removed tracheal secretions into the at least one expandable bag.

2. The cleaning device of claim 1, further comprising an outer housing connected to the endotracheal tube connector and detachably connected to the ventilation adapter; wherein the at least one expandable bag is positioned in a volume defined by an inner wall of the outer housing and the outer wall of the ventilation adapter.

3. The cleaning device according to any one of claims 1 and 2, wherein the at least one expandable bag is configured to expand upon detaching and pulling of the ventilation adapter.

4. The cleaning device according to any one of claims 1-3, further comprising a suction adapter connectable to a suction unit, wherein the suction adapter is connected to the hollow longitudinal tube at the proximal end, and wherein the ventilation adapter isconnected to the suction adapter, such that one or more gaps are formed between an inner wall of the ventilation adapter and an outer wall of the suction adapter.

5. The cleaning device of claim 4, wherein the suction adapter comprises one or more side ventilation opening configured to allow airflow from the endotracheal ventilation unit to the hollow longitudinal tube through the suction adapter when the suction unit is disabled and / or detached.

6. The cleaning device according to any one of claims 1 -5, wherein the cleaning head comprises: a tubular body; at least one bendable circular fin, extending from the outer walls of the tubular body having an outer diameter equal or larger than an inner diameter of the endotracheal tube; and a restriction circular element, extending from the outer walls of the tubular body, located as to restrict the bending of the at least one bendable circular fin when the cleaning head is being pulled through the endotracheal tube in a proximal direction thereof.

7. The cleaning device of claim 6, wherein the restriction circular element is located closer to a distal end of the endotracheal tube.

8. The cleaning device according to any one of claims 6 and 7, wherein the cleaning head further comprises an extended funnel extending from a distal end of the tubular body.

9. The cleaning device according to any one of claims 6-8, wherein the restriction circular element is a ring extending from the outer walls of the tubular body.

10. The cleaning device according to any one of claims 6-9, wherein the at least one bendable circular fin is connected to the tubular body via the restriction circular element.

11. The cleaning device of claim 10, wherein the restriction circular element is a thickened portion of the tubular body.

12. The cleaning device according to any one of claims 1 to 11, wherein the cleaning head is a single part made from an elastomer.

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