AU2012268881A1 - Oral Device - Google Patents

Abstract

A system for oral care of patients ventilated with a ventilation tube 120 comprising: a deformable fluid blocking element 200 reversibly mountable around a ventilation tube, the fluid blocking element having: a midsection channel 205 sized to fit snugly and reversibly around the ventilation tube 120 when the fluid blocking element is mounted thereto; and an outer surface configured, when the fluid blocking element is mounted, to fit snugly and reversibly into the back of the mouth of an adult human patient so as to span both lateral left-to-right tonsils and tongue-soft palate dimensions thereof, wherein the fluid blocking element 200 is reversibly inflatable to simultaneously press against the soft pallet and the tongue and/or the fluid blocking element 200 is collapsible and outwardly biased so that when placed in the back of the human mouth, the fluid blocking element expands so as to simultaneously press against the soft pallet and the tongue. w 4 vN 0 Q) 0 ) r_2 0 i 0 rW> tor Vm r-0oea 0C C2i > 4 -J

Description

1 ORAL DEVICE BACKGROUND AND RELATED ART [0001] FIG. 1A illustrates various elements of the human oral cavity including: tongue 710, left 115 and right 114 tonsils, soft palate 740, uvula 112, and back teeth 110. [0002] FIG. 1B refers to the situation where the human subject is intubation with a ventilation tube 120 - i.e. an endotracheal tube (ETT) or a tracheostomy tube. [0003] The following issued patents and patent publications provide potentially relevant background material, and are all incorporated by reference in their entirety: US 7866477 entitled "Oral care Q2 kits"; US 4984984 entitled "Dental tool and nozzle therefor"; and WO 2005/070324 entitled "Droplet Jet System For Cleaning" SUMMARY OF EMBODIMENTS [0004] Embodiments of the present invention relate to a system for oral care of patients ventilated with a ventilation tube comprising a deformable fluid blocking element that is reversibly mountable around the ventilation tube - e.g. slidable along the ventilation tube when mounted thereon. The 'reversibly mountable' feature of the fluid blocking element means it can be mounted to and detached from the ventilation tube, in contrast to any permanent attachment such as one based on gluing the fluid blocking element to the ventilation tube.

2 [0005] The fluid blocking element has (i) a midsection channel 205 sized to fit snugly and reversibly around the ventilation tube 120 when the fluid blocking element is mounted thereto; and (ii) an outer surface configured, when the fluid blocking element is mounted, to fit snugly and reversibly into the back of the mouth of an adult human patient so as to span both lateral left-to-right tonsils and tongue-soft palate dimensions thereof. [0006] For the present disclosure, when the fluid blocking element fits "snugly" into the back of the mouth outer pressure is applied, by the fluid blocking element, simultaneously on both the tongue (e.g. the back of the tongue) and the soft palate. There is no requirement that outward pressure is applied upon any surface other than the on the tongue and the soft palate, although such pressure may, in fact, be applied. [0007] In some embodiments, the fluid blocking element 200 is reversibly inflatable (e.g. including a balloon) to simultaneously press against the soft pallet and the tongue and/or the fluid blocking element 200 is collapsible and outwardly biased so that when placed in the back of the human mouth, the fluid blocking element expands so as to simultaneously press against the soft pallet and the tongue. [0008] In exemplary embodiments, the fluid blocking element may be provided as a balloon and/or foam and/or sponge and/or diaphragm.

3 [0009] In some embodiments, the fluid blocking element permanently has an annular shape and is top-mounted onto the ventilation tube (e.g. by sliding onto the ventilation tube at the top/proximal end). In preferably embodiments, the fluid blocking element has a 'clip on' or is otherwise side-mountable to the ventilation tube. This allows for mounting the fluid blocking element to the ventilation tube and removing the fluid blocking therefrom to clean the patient's teeth with no need to even briefly interrupt ventilation of the patient. [0010] Some embodiments relate to an oral cleaning kit comprising: (i) the aforementioned reversably mountable deformable fluid blocking element and (ii) a spray device for spraying a fluid into the oral cavity to clean the teeth. When fluid is sprayed into the intubated oral cavity, the presence of the fluid blocking element blocks fluids from penetrating into the airway below the blocking element. [0011] In patients intubated with an endo tracheal tube (ETT), the ETT inhibits the swallowing ability. Hence cleaning the oral cavity with streams of liquid containing fluids is problematic, since oral biofilm and/or plaque contaminated fluids may descend into the trachea and the lungs. By combining the use of a fluids blocking element 200, the oral care kit facilitates safe use of fluids spray device 500 for cleaning of the teeth and/or gums of patients intubated with an endo tracheal tube (ETT). [0012] Preferably, suctioning means are connected to the fluids blocking element 200, such that the contaminated cleaning fluids are not only blocked from descending into the trachea but are also suctioned out of the patient oral cavity.

4 [0013] In use of preferred embodiments, the fluids blocking element 200 is first fitted over the ETT at the back of the oral cavity of the intubated patient. Suctioning is operated to suction fluids proximally to the blocking element 200. The fluids spray device 500 is then operated to cleaning the patient oral cavity while suctioning. [0014] It is now disclosed a system for oral care of patients ventilated with a ventilation tube comprising: a deformable fluid blocking element reversibly mountable around a ventilation tube, the fluid blocking element having a midsection channel sized to fit snugly and reversibly around the ventilation tube when the fluid blocking element is mounted thereto; and an outer surface configured, when the fluid blocking element is mounted, to fit snugly and reversibly into the back of the mouth of an adult human patient so as to span both lateral left-to-right tonsils and tongue-soft palate dimensions thereof, wherein the fluid blocking element is reversibly inflatable to simultaneously press against the soft pallet and the tongue and/or the fluid blocking element is collapsible and outwardly biased so that when placed in the back of the human mouth, the fluid blocking element expands so as to simultaneously press against the soft pallet and the tongue. [0015] In some embodiments, the deformable fluid blocking element is side-mountable to the ventilation tube. [0016] In some embodiments, the system further comprises a suction tube attached to the fluid blocking element so that a distal end of the suction tube is oriented to suck fluids from a proximal surface of the fluid blocking element.

5 [0017] In some embodiments, the system further comprises a spray-head device having at least one inlet for receiving pressurized stream of fluid and at least one fluid-delivery orifice for liquid-gas mixture spray delivery of into the mouth at a time when the fluid blocking element is deployed therein. [0018] In some embodiments, the spray-head device further includes a suction lumen and a suction orifice, both the fluid delivery orifice and the suction orifice being disposed at or near a distal end of the spray-head device. [0019] In some embodiments, the spray is of sufficient strength to remove dental plaque. [0020] In some embodiments, the fluid blocking element comprises one or more of a compressible foam, or a sponge, or an inflatable balloon, or a diaphragm. [0021] It is now disclosed an oral cleaning method comprising: a. inserting, into a mouth of an adult human subject, a deformable fluid blocking element having a midsection channel sized to fit snugly and reversibly around a ventilation tube having an outer diameter of at least 6 mm and at most 13 mm, b. concurrent with or subsequent to the insertion, expanding the deformable fluid blocking element so that an outer surface thereof fits snugly and reversibly into the back of the mouth of the adult human subject so as to span both lateral and tongue soft palate dimensions thereof. [0022] It is now disclosed an oral cleaning method comprising: a. inserting a deformable fluid blocking element 200 into a 6 mouth of an adult human subject who is ventilated with a ventilation tube, the fluid blocking element having a midsection channel 205 sized to fit snugly and reversibly around the ventilation tube, the fluid blocking element being inserted so the ventilation tube passes through the midsection channel 205; b. concurrent with or subsequent to the insertion, expanding the deformable fluid blocking element so that an outer surface thereof fits snugly and reversibly into the back of the mouth of the adult human subject so as to span both lateral and tongue soft palate dimensions thereof. [0023] In some embodiments, the method further comprises spraying a cleaning fluid into the mouth of human subject so as to clean teeth thereof, wherein the fluid blocking element substantially blocks the cleaning fluid from penetrating into an airway of the human subject. [0024] In some embodiments, the fluid comprises a gas-liquid mixture. [0025] In some embodiments, the method further comprises suctioning away cleaning fluid which is retained in the mouth by the fluid blocking element. [0026] In some embodiments, at least some of the suctioned cleaning fluid is suctioned out of the mouth via enters via a suction port deployed substantially on an upper surface of the fluid blocking element. [0027] In some embodiments, the cleaning fluid is sprayed by a spray device, and at least some of the suctioned cleaning fluid 7 is suctioned out of the mouth via a suction port that is deployed on or within the spray device. [0028] In some embodiments, the expanding is performed by inflating the fluid blocking element. [0029] In some embodiments, the fluid blocking element is compressible and outwardly biased so that it is inserted into the mouth when compressed, and expands upon insertion into the mouth. [0030] In some embodiments, the blocking element is inserted when the tube is within the mouth of the human subject so that the midsection channel of the blocking element fits snugly and reversibly around an outer surface of the tube. [0031] In some embodiments, the tube is a ventilation tube. [0032] In some embodiments, the tube is a tracheostomy tube. [0033] In some embodiments, the fluid blocking element is reversibly inflatable to simultaneously press against the soft pallet and the tongue. [0034] In some embodiments, the fluid blocking element is collapsible and outwardly biased so that when placed in the back of the human mouth, the fluid blocking element expands so as to simultaneously press against the soft pallet and the tongue.

8 BRIEF DESCRIPTION OF THE DRAWINGS [0035] FIG. 1A illustrates various elements of the human oral cavity including. [0036] FIG. 1B refers to the situation where the human subject is intubation with a ventilation tube. [0037] FIGS. 2-4 illustrate systems, apparatus and portions thereof of a fluid blocking element part of kit for oral cleaning according to some embodiments of the invention. [0038] FIGS. 5-8 illustrate systems, apparatus and portions thereof of a spray cleaning element part of kit for oral cleaning according to some embodiments of the invention. DETAILED DECSRIPTION OF EMBODIMENTS [0039] Embodiments of the present invention relate to systems, methods and kits for cleaning the oral cavity of an intubated subject. [0040] 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 9 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. [0041] For brevity, some explicit combinations of various features are not explicitly illustrated in the figures and/or described. It is now disclosed that any combination of the method or device features disclosed herein can be combined in any manner - including any combination of features - any combination of features can be included in any embodiment and/or omitted from any embodiments. [0042] In relation to the figures the following numbers indicate: 110 - back teeth 112 - uvula 114 - right tonsil 115 - left tonsil 200 - fluid blocking element 205 - cavity at bottom mid-section of fluid blocking element 200. 210 - surface of cavity in blocking element 220 - main suction tube 221 - right suction branch 222 - right suction inlet 223 - left suction branch 224 - left suction inlet 10 225 - suction tube end connector 226 - suction branches (221 and/or 223) linkage into main suction tube 220 230 - optional inflation tube 335 - inflation tube end connector 500 - spray device 510 - elongated body of spray device 520 - spray outlet orifice 521 - liquid lumen 523 - gas lumen 525 - mixing chamber 526 - acceleration duct 527 - distal outlet of acceleration duct 531 - liquid delivery tube 532 - liquid tube distal connector 533 - gas delivery tube 534 - gas tube distal connector 541 - liquid reservoir 543 - pressurized gas source 560 - elevation bump 585 - protective shield 590 - spray 620,630,640,650 - various schematic surfaces of a fluid-blocking element 200 710 - tongue of human subject 740 - soft palate of human subject [0043] In the non-limiting example of FIG. 2, the system includes: a fluid blocking element 200 having a channel (see element 205 of FIGS. 3F and 4A-44E) through which ventilation 11 tube 120 passes. The fluid blocking element 200 fits snugly into the back of the subject's mouth so as to substantially span both 'width' dimensions of the mouth - i.e. the lateral dimension between the left 115 and right 114 tonsils and the 'soft palate tongue' dimension between the subject's soft palate 740 and the tongue 710. Fluid blocking element 200 is dimensioned so as to substantially fill an entirety of the annular region outside of ventilation tube 120 within the back of the subject's mouth. [0044] In order to clean the subject's gums and/or teeth, is possible to deliver a pressurized fluid (e.g. a spray or mist or jet of fluid) into the subject's mouth at a time when the fluid blocking element 200 is deployed within the back of the subject's mouth so as to substantially fill the entirety of the annular region outside of ventilation tube 120 within the back of the subject's mouth. The presence of fluid-blocking element substantially blocks fluids associated with the gums/teeth cleaning process (i.e. 'cleaning fluids') from penetrating deeper into the patient's oral cavity. Because the cleaning fluids may include oral-cavity microbes (e.g. derived from plaque or oral biofilm which may mix with the cleaning fluids after introduction into the oral cavity), blocking of these microbes-containing fluids by fluid blocking element 200 may reduce or eliminate collateral contamination of the trachea associated with the cleaning of the teeth or gums. [0045] Some embodiments relate to kits including both the fluid blocking element 200 and a spray-head device for delivering a pressurized stream of fluid into the subject's mouth. Other embodiments relate to systems including fluid-blocking element 200 which may or may not include the spray-head device. A more 12 detailed discussion about example spray-head devices with reference to FIGS. 5-7 is provided below. [0046] In order to further protect the trachea from microbes mixed into the cleaning fluid, and in order to further reduce the rate at which contaminating cleaning fluid leaks into locations below fluid-blocking element 200, it is possible to suction the contaminated or 'used' cleaning fluids from a location above the fluid-blocking element 200. In the non limiting example of FIG. 2, a tube assembly 220 of one or more tubes for suctioning away cleaning fluids is provided. In the particular example of FIG. 2, tube assembly 220 may include multiple branches 221, 223 each having its own respective port 222, 224. On the proximal end, a suction tube connector 225 may be connected to a source of negative pressure. [0047] Fig.2 illustrates a preferred embodiment of the blocking element 200 further comprising attached suction tube 220. To enable better suctioning action on both sides of an ETT, it is preferred to have both a right suction branch tube 221 to one side of the cavity 205, and a left suction branch tube 223 on the other side of the cavity 205, each of which connect at its proximal end to the main suction tube 220. The right suction branch 221 comprises a distal suction port 222, and the left suction branch 223 comprises a distal suction port 224. The proximal end of the suction tube 220 includes a connector 225 suitable to connect to a suction source. [0048] In some embodiments, one or more tubes of tube assembly 220 is attached to the fluid-blocking element 200 so that a distal end thereof (e.g. 222 or 224 as illustrated in 13 FIG. 2) is oriented to suck fluids from a proximal surface (see element 640 of FIG. 3D) of fluid-blocking element 200. For example, port 222 or 224 may be held on or slightly above proximal surface 640 of fluid-blocking element 200. [0049] As noted above, fluid-blocking element 200 may snugly fit within the subject's mouth so as to substantially fill the entire annular region outside of the ventilation tube 120 and within the back of the subject's mouth. Although fluid-blocking element 200 is not required to be shaped as a rectangular prism, roughly speaking, fluid-blocking element 200 may include six 'outer' surfaces: (i) a soft-palate facing surface 630 facing and in contact with (or nearly in contact with) soft palate 740; (ii) a tongue-facing surface 620 facing and in contact with (or nearly in contact with) tongue 710; (iv) left-tonsil and right tonsil facing surfaces (not numbered in the figures); (v) proximate surface 640 and (vi) distal surface 650. [0050] The term 'outer surface' of the fluid blocking element refers to the union of all of the six aforementioned surfaces. This is in contrast to the 'inner surface' discussed below which is the surface of the midsection channel 205 faces the ventilation tube. In order for the 'outer surface' to fit snugly into the back of the mouth, the following two activities must occur simultaneously (i) the soft-palate facing surface 630 must press onto the soft palate and (ii) the tongue-facing surface 620 must press onto the tongue. [0051] In some embodiments, the fluid blocking element permanently has an annular shape and is top-mounted onto the ventilation tube (e.g. by sliding onto the ventilation tube at 14 the top/proximal end). In preferably embodiments, the fluid blocking element has a 'clip on' or is otherwise side-mountable to the ventilation tube. This allows for mounting the fluid blocking element to the ventilation tube and removing the fluid blocking therefrom to clean the patient's teeth with no need to even briefly interrupt ventilation of the patient. [0052] Fluid-blocking element 200 may also include an inner surface - i.e. a surface of the midsection channel 205 through which ventilation tube 120 passes. This inner surface is referred to as ventilation tube-facing surface 210 and is typically shaped like a side of a cylinder or a portion thereof. When ventilation tube 120 passes through the midsection channel 205, there is a snug fit between an outer surface of ventilation tube 120 and ventilation tube-facing surface 210. [0053] FIG. 3A-3F illustrate these various surfaces 620, 630, 640, 650, 210 for the non-limiting case of a fluid-blocking element 200 shaped as a rectangular prism. [0054] In the example of FIGS. 3A-3F, fluid-blocking element 200 (and proximal 640 and distal 650 surfaces thereof) is annular in shape. This is also the case for the example of FIG. 4A and 4D. Although fluid-blocking element 200 is dimensioned to substantially (but not necessarily entirely fill) fill an entirety of the annular region outside of ventilation tube 120 within the back of the subject's mouth, there is no requirement that fluid-blocking element 120 itself have an annular shape.

15 [0055] Alternatively, as illustrated in FIGS. 4B and 4E, fluid blocking element 200 and mid-section channel 205 thereof need to surround an entirety of ventilation tube 120. For the present disclosure, when the mid-section channel 205 is configured to fit snugly 'around' the ventilation tube, it only needs to surround a majority of orientations of the ventilation tube 120 in a 'cross section plane' of ventilation tube perpendicular to an elongate axis thereof - for example, to define an arc of at least 180 degrees or at least 270 degrees. Thus, the term 'around' is not synonymous with 'surround' which would require an arc of 360 degrees. [0056] In some embodiments, employing a fluid blocking element 200 that is not annular in shape allows for one to 'clip on' blocking element onto ventilation tube 120 and 'clip off' blocking element from ventilation tube 120 without an need to slide into place the fluid blocking element from an end (e.g. proximal end) of ventilation tube 120. The "open arc" fluid channels 205 illustrated in FIGS. 4B and 4E may facilitate this process. [0057] One advantage of the 'open arc' configuration is that the fluid blocking element can be side-mountable to the ventilation tube. In another example, the fluid blocking element is sometimes annular in shape and sometimes has an open arc and is also side-mountable. [0058] Fluid-blocking element 200 may be compressible and/or expandable to snugly fit within the human oral cavity, particularly at the back of the mouth behind the back teeth 110 and near the soft palate 740 , spanning the width between the 16 left 115 and right 114 tonsils. For that purpose, blocking element 200 may, in different embodiments, be primarily constructed from foam, and/or sponge, and/or diaphragm, and/or inflatable balloon. [0059] In some embodiments, ventilation tube-facing surface 210 of midsection channel 205 may be made of a relatively stiff non compressible material. In such case, where the stiff surface 210 is an arc of more than 180 degrees, the stiff surface 210 can clip-on with stronger attachment on the ventilation tube 120. [0060] Because ventilation tube 120 passes through blocking element 200 (i.e. through mid-section channel 205 thereof), a diameter of channel 205 is sized to enable an outer surface ventilation tube 120 to go through blocking element 200. Typical outer diameters of ventilation tube (e.g. ETT tubes) are in the range of 6 mm - 13 mm. [0061] As noted above, fluid blocking element 200 is not required to be shaped as a rectangular prism. FIG. 4E is a 3D view of blocking element 200 where a soft palate-facing surface 630 has a shape that may better match that of the soft-palate to allow a snug contact with soft-palate 740. [0062] FIGS. 5-7 refer to non-limiting examples of spray-head devices. In FIGS. 5-7, the following elements are labeled: 500 - spray device; 510 - elongated body of spray device; 520 spray outlet orifice; 521 - liquid lumen; 523 - gas lumen; 525 mixing chamber ; 526 - acceleration duct; 527 - distal outlet of acceleration duct; 531 - liquid delivery tube; 532 - liquid tube distal connector; 533 - gas delivery tube; 534 - gas tube distal 17 connector; 541 - liquid reservoir; 543 - pressurized gas source; 560 - elevation bump and 590 - spray. [0063] Fig. 5a and Fig. 5b illustrate an embodiment of the spray device 500 for teeth cleaning, comprising: and elongated body 510 of dimensions (length/width) similar to a tooth brush, spray outlet 520 near the distal end of the elongated body 510, liquid delivery tube 531, and gas delivery tube 533. The liquid and gas tubes are preferably connected at a proximal portion of the elongated body 510. [0064] In embodiments, the liquid delivery tube 531 and gas delivery tube 533 are detachable/re-connectable from/to the elongated body 510. Thereby, the elongated body 510 may be disposable while the delivery tubes can be re-used with other main body 510 devices. [0065] In operation, the spray device is to be connected with a pressurized gas source 543, and to a liquid reservoir 541. The liquid reservoir may or may not be pressurized relative to atmospheric pressure. In embodiments, the gas source is pressure is between 2-8atm, in order to create spray 590 suitable for cleaning of dental biofilm and/or plaque. [0066] Fig. 6a illustrates embodiments of the spray device 500 of the type illustrated in Fig. 6b. In particular, lumen 521 is in fluid communication between the proximal inlet of the liquid delivery tube 531 and a distal mixing chamber 525, lumen 523 is in fluid communication between the proximal inlet of the gas delivery tube 533 and a distal mixing chamber 525. The mixing chamber 525 is in fluid communication with the spray outlet 18 orifice 520. [0067] Fig.6c illustrates embodiments of the spray device 500 of the type illustrated in Fig.4b, emphasizing the option of an acceleration duct 526 connecting and in fluid communication from the mixing chamber 525 to the spray outlet orifice 520. As illustrated in Fig. 6c, it should be understood that the mixing chamber 525 may consist simply of a tube junction of size comparable any of the lumens 521 or 523 diameters. [0068] Fig. 7a and 7b illustrate a similar embodiment of the spray device 500. The difference emphasized in the cross-section view 4c is that the lumen 523 is place behind lumen 521 (with respect to the facet of the spray outlet orifice 520). [0069] In embodiments, the lumens 521 and 523 are simultaneously extruded. [0070] In operation of the spray device 500, the gas streams (flows) intercept the liquid flow at an angle, preferably approximately perpendicularly. The velocity of the gas flows is sufficient to break up the liquid stream into a spray of droplets of desired size and velocity, optionally accelerating them through an acceleration duct and out of the orifice 520 at a desired high velocity effective for removal of biofilm and/or plaque from teeth and/or gums. [0071] Fig. 8 illustrates a preferred embodiment where a protective shield 585, e.g., in the form of a flat plate, is mounted on the spray device main body 510. The shield 585 functions to block spray deflected from the mouth to reach the 19 operator of the spray device (e.g., a nurse cleaning the mouth of ICU patient). [0072] Definitions [0073] 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. [0074] 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. [0075] 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 are within the scope of embodiments of the invention.

20 [0076] 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. [0077] 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. [0078] 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. [0079] 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". [0080] 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 21 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 (20)

1. A system for oral care of patients ventilated with a ventilation tube comprising: a deformable fluid blocking element reversibly mountable around a ventilation tube, the fluid blocking element having: a midsection channel sized to fit snugly and reversibly around the ventilation tube when the fluid blocking element is mounted thereto; and an outer surface configured, when the fluid blocking element is mounted, to fit snugly and reversibly into the back of the mouth of an adult human patient so as to span both lateral left-to-right tonsils and tongue-soft palate dimensions thereof, wherein the fluid blocking element is reversibly inflatable to simultaneously press against the soft pallet and the tongue and/or the fluid blocking element is collapsible and outwardly biased so that when placed in the back of the human mouth, the fluid blocking element expands so as to simultaneously press against the soft pallet and the tongue.

2. The system of any one of the preceding claims wherein the deformable fluid blocking element is side-mountable to the ventilation tube.

3. The system of any one of the preceding claims further comprising a suction tube attached to the fluid blocking element so that a distal end of the suction tube is oriented to suck fluids from a proximal surface of the fluid blocking element.

4. The system of any one of the preceding claims further comprising: a spray-head device having at least one inlet for receiving pressurized stream of fluid and at least one fluid- 23 delivery orifice for liquid-gas mixture spray delivery of into the mouth at a time when the fluid blocking element is deployed therein.

5. The system of claim 4 wherein the spray-head device further includes a suction lumen and a suction orifice, both the fluid delivery orifice and the suction orifice being disposed at or near a distal end of the spray-head device.

6. The system of any of claims 4-5 wherein the spray-head device is operative to deliver spray of a sufficient strength to remove dental plaque.

7. The system of any one of the preceding claims wherein the fluid blocking element comprises one or more of : a compressible foam, or a sponge, or an inflatable balloon, or a diaphragm.

8. An oral cleaning method comprising: a. inserting a deformable fluid blocking element into a mouth of an adult human subject who is ventilated with a ventilation tube, the fluid blocking element having a midsection channel sized to fit snugly and reversibly around the ventilation tube, the fluid blocking element being inserted so the ventilation tube passes through the midsection channel; b. concurrent with or subsequent to the insertion, expanding the deformable fluid blocking element so that an outer surface thereof fits snugly and reversibly into the back of the mouth of the adult human subject so as to span both lateral and tongue-soft palate dimensions thereof.

9. The method of claim 8 further comprising spraying a cleaning fluid into the mouth of human subject so as to clean teeth thereof, wherein the fluid blocking element substantially blocks the cleaning fluid from penetrating into an airway of the human subject. 24

10. The method of claim 9 wherein the fluid comprises a gas liquid mixture.

11. The method of any one of claims 9-10 further comprising suctioning away cleaning fluid which is retained in the mouth by the fluid blocking element.

12. The method of claim 11 wherein at least some of the suctioned cleaning fluid is suctioned out of the mouth via enters via a suction port deployed substantially on an upper surface of the fluid blocking element.

13. The method of any one of claims 8-12 wherein the cleaning fluid is sprayed by a spray device, and at least some of the suctioned cleaning fluid is suctioned out of the mouth via a suction port that is deployed on or within the spray device.

14. The method of any one of claims 8-13 wherein the expanding is performed by inflating the fluid blocking element.

15. The method of any one of claims 8-14 wherein the fluid blocking element is compressible and outwardly biased so that it is inserted into the mouth when compressed, and expands upon insertion into the mouth.

16. The method of any one of claims 8-15 wherein the blocking element is inserted when the tube is within the mouth of the human subject so that the midsection channel of the blocking element fits snugly and reversibly around an outer surface of the tube.

17. The method of any one of claims 8-16 wherein the ventilation tube is an endotracheal tube (ETT). 25

18. The method of any one of claims 8-16 wherein the ventilation tube is a tracheotomy tube.

19. The method of any one of claims 8-18 wherein the fluid blocking element is reversibly inflatable to simultaneously press against the soft pallet and the tongue.

20. The method of any one of claims 8-19 wherein the fluid blocking element is collapsible and outwardly biased so that when placed in the back of the human mouth, the fluid blocking element expands so as to simultaneously press against the soft pallet and the tongue.