JP2015516180A - Oral care system, method and kit - Google Patents

Abstract

A system for oral patient care, ventilated using an ETT tube 120, which can be repositionably mounted around the ETT (e.g. it can be mounted on the side) A fluid blocking member 200, the fluid blocking member comprising an intermediate channel 205 and an outer surface, the intermediate channel 205 being snug and positioned about the vent tube 120 when the fluid blocking member is attached to the intermediate channel The outer surface is fitted with the fluid blocking member so that the outer surface fits snugly and adjustably in the back of the mouth of a human adult patient. Configured to span dimensions, the fluid blocking member 200 is configured to be positionably inflatable to simultaneously compress the palatal and tongue and / or the fluid blocking The member is foldable and is configured to apply an outward bias that, when placed behind a human mouth, expands the fluid blocking member to simultaneously press the palate sail and tongue. Methods and kits are also disclosed herein. [Selection] Figure 9

Description

CROSS REFERENCE FOR RELATED APPLICATIONS This application claims priority of US61609331 filed on March 11, 2012, and is incorporated herein by reference in its entirety.

Background and Related Art Endotracheal tube (ETT) is known as prior art. One non-limiting example (a copy of US Patent Publication 20120097168 incorporated herein) is illustrated in FIG. 1A. The ETT of FIG. 1A includes an expandable cuff that prevents fluid from entering the trachea. The expandable cuff is non-adjustable attached halfway from the distal side of the ETT. The expandable cuff of FIG. 1A is inflatable, but is not limited thereto. For example, WO / 2010/151713 and WO / 2012/176112 show cuffs that do not necessarily depend on expansion. The endotracheal tube is equipped with a “Murphey eye” at the distal end of the ETT.

  FIG. 1B illustrates various sites in the human oral cavity, including tongue 710, left tonsil 115 and right tonsil 114, palatal sail 740, uvula 112, and back teeth 110.

  FIG. 1C shows a state in which a human subject is intubated using an endotracheal tube (ETT) or tracheostomy tube.

  The following patents and patent publications provide potentially relevant background content, all of which are incorporated by reference: US 7866477 “Title of Invention: Oral care Q2 kits” US 4984984 “Title of the invention: Dental tool and nozzle therefor”; and WO 2005/070324 “Title of the invention: Droplet Jet System For Cleaning”, WO 1995/006492 “Title of the invention: Cuffed Oro-Pharyngeal Airway” and US 2,099,127 “Title of Invention: Pharyngeal Bulb Gasway”.

Summary of Embodiments The following system is disclosed herein: In a positionable / side-mounted system for patient oral care ventilated using an endotracheal tube (ETT) There,
The system includes a deformable fluid blocking member that can be mounted to adjust the position around the ETT and can be mounted on a side surface.
The fluid blocking member comprises (i) an intermediate channel and (ii) an outer surface,
The intermediate channel is dimensioned to fit snugly and positionably around the ETT when the fluid blocking member is attached to the intermediate channel;
When the fluid blocking member is mounted, the outer surface is configured to fit in the back of the mouth of a human adult patient in a snug and position-adjustable manner and extend to the left and right tonsils and tongue-palate sail dimensions,
When the fluid blocking member is attached to the ETT,
(A) The fluid blocking member is configured to be inflatable in a position-adjustable manner so as to simultaneously press the palate sail and the tongue, and / or
(B) The fluid blocking member is foldable and is configured to apply an outward bias that expands so that the fluid blocking member compresses the palate sail and tongue simultaneously when placed in the back of a human mouth. The

  The term “positionably mountable” is a term opposite to “mounting non-positionally adjustable”. The term “side mountable” refers to “at least” mountable from the side. If the fluid blocking member is “possibly adjustable” and “side-mountable” on the patient's ETT that has been intubated and ventilated, the patient can be ventilated for a short time when ventilating through the ETT. Without being interrupted, it is possible to (i) mount the fluid blocking member on the ETT and (ii) then remove the fluid blocking from there. While wearing the fluid blocking member, the patient can continuously vent (e.g., while cleaning the patient's teeth), so that the fluid blocking member is free of cleaning fluid and / or dust in the oral cavity. Substantially prevent entry into the airway area under the epiglottis of the patient, a human subject.

  In certain embodiments, the deformable fluid blocking member is configured such that the fluid blocking member does not completely surround the ETT when attached to the ETT.

  In certain embodiments, the deformable fluid blocking member does not comprise a permanent ring.

  In certain embodiments, the deformable fluid blocking member is configured such that when attached to the ETT, the fluid blocking member does not completely surround the ETT using a permanent ring.

  In certain embodiments, the deformable fluid blocking member is configured to completely enclose the ETT with a ring that can be repositionably opened when the fluid blocking member is attached to the ETT.

The following kit is disclosed herein: a kit for oral care of a patient ventilated using an endotracheal tube (ETT), the kit comprising:
a. at least one spraying device configured to transport the droplets;
b. a deformable fluid blocking member that can be mounted to adjust the position around the ETT, and
The fluid blocking member comprises: i. An intermediate channel; and ii. An outer surface;
The intermediate channel is dimensioned to fit snugly and positionably around the ETT when the fluid blocking member is attached to the intermediate channel;
When the fluid blocking member is mounted, the outer surface is configured to fit in the back of the mouth of a human adult patient in a snug and position-adjustable manner and extend to the left and right tonsils and tongue-palate sail dimensions,
When the fluid blocking member is attached to the ETT,
(A) The fluid blocking member is configured to be inflatable in a position-adjustable manner so as to simultaneously press the palate sail and the tongue, and / or
(B) The fluid blocking member is foldable and is configured to apply an outward bias that expands so that the fluid blocking member compresses the palate sail and tongue simultaneously when placed in the back of a human mouth. The

  In certain embodiments, the spray device is a spray-suction hybrid device that is configured to both transport droplets and aspirate a substance (ie, liquid and / or solid matter).

  In some embodiments, the spray device is a spray-suction hybrid device configured to simultaneously transport droplets and suction a material.

  In certain embodiments, the deformable fluid blocking member is adjustably mountable and laterally mountable about the ETT.

  In certain embodiments, the spray device comprises first and second inlets configured to receive a liquid stream and a gas stream, respectively, and the spray device forms a droplet from the received liquid and gas stream. Is configured to do.

In the present specification, the following ventilation system is disclosed:
a endotracheal tube (ETT);
b. a deformable fluid blocking member that can be mounted to adjust the position around the ETT, and
The fluid blocking member includes an intermediate channel and an outer surface,
The intermediate channel is dimensioned to fit snugly and positionably around the ETT when the fluid blocking member is attached to the intermediate channel;
When the fluid blocking member is mounted, the outer surface is configured to fit in the back of the mouth of a human adult patient in a snug and position-adjustable manner and extend to the left and right tonsils and tongue-palate sail dimensions,
(i) the fluid blocking member is configured to be inflatable in a position-adjustable manner to simultaneously press the palate sail and tongue, and / or
(ii) The fluid blocking member is foldable and configured to apply an outward bias that, when placed behind a human mouth, expands the fluid blocking member to simultaneously press the palate sail and tongue. The

  In certain embodiments, the fluid blocking member is adjustably mounted about the proximal half of the ETT.

  In certain embodiments, c. Further comprises a fluid-blocking cuff and / or an inflatable balloon that is non-positionably mounted to the ETT at a location distal to the fluid blocking member.

  In certain embodiments, the fluid-blocking cuff substantially seals from the lower side to the upper side of the gap region when the ETT is placed in the trachea and a gap region is defined between the outside of the ETT and the inside of the trachea. Therefore, it is configured to be expandable.

In the present specification, the following oral cleaning method is disclosed:
inserting a deformable fluid blocking member into the mouth of an adult human subject ventilated using an endotracheal tube (ETT);
b. At the same time or after the insertion step, the deformable fluid blocking member is expanded so that its outer surface fits snugly and repositionably in the back of the adult human subject's mouth. Extending to the dimensions of the tonsils and tongue-palate sails;
c. cleaning the teeth by introducing a cleaning solution into the mouth of a human subject (e.g., by spraying or otherwise forcing),
The fluid blocking member comprises an intermediate channel dimensioned to fit snugly and repositionably around the ETT;
The fluid blocking member is inserted so that the ETT passes through the intermediate channel,
The fluid blocking member substantially prevents the cleaning liquid from entering the human subject's airway.

  The introduced fluid may be a liquid or a liquid-gas mixture (eg, droplets or mist).

  In certain embodiments, the fluid is introduced as droplets and / or the fluid includes a gas-liquid mixture.

  In certain embodiments, pressurized fluid is introduced.

  In some embodiments, the method further comprises aspirating the fluid blocking member at a position proximal to the fluid blocking member to remove cleaning liquid remaining in the mouth.

  In certain embodiments, at least a portion of the aspirated cleaning liquid is aspirated out of the mouth via introduction through a suction port that is substantially disposed on the top surface of the fluid blocking member.

  In certain embodiments, the cleaning liquid is sprayed by the spray device, and at least a portion of the suctioned cleaning liquid is sucked from the mouth via a suction port located in or within the spray device.

  In certain embodiments, the expansion step is performed by inflating the fluid blocking member.

  In certain embodiments, the fluid blocking member can be compressed and outwardly biased so that it is inserted into the mouth during compression and expands upon insertion into the mouth.

  In certain embodiments, the blocking member is inserted such that the intermediate channel of the blocking member fits snugly and repositionably around the outer surface of the tube when the tube is in the mouth of a human subject.

  In one embodiment, the fluid blocking member is inflatable in an adjustable manner to simultaneously press the palate sail and tongue.

Disclosed herein is the following system: a system for oral care of a patient ventilated using an endotracheal tube (ETT), the system comprising:
a deformable fluid blocking member that can be mounted to adjust its position around the ETT;
b. a suction tube,
The suction tube is attached to the fluid blocking member, and is arranged and oriented so that a distal end of the suction tube sucks fluid from a proximal side of the fluid blocking member;
The fluid blocking member comprises: i. An intermediate channel; and ii. An outer surface;
The intermediate channel is dimensioned to fit snugly and positionably around the ETT when the fluid blocking member is attached to the intermediate channel;
When the fluid blocking member is mounted, the outer surface is configured to fit in the back of the mouth of a human adult patient in a snug and position-adjustable manner and extend to the left and right tonsils and tongue-palate sail dimensions,
(A) The fluid blocking member is configured to be inflatable in a position-adjustable manner so as to simultaneously press the palate sail and the tongue, and / or
(B) The fluid blocking member is foldable and is configured to apply an outward bias that expands so that the fluid blocking member compresses the palate sail and tongue simultaneously when placed in the back of a human mouth. The

In the present specification, the following oral cleaning method is disclosed:
inserting a deformable fluid blocking member into the mouth of an adult human subject ventilated using an endotracheal tube (ETT);
b. At the same time or after the insertion step, the deformable fluid blocking member is expanded so that its outer surface fits snugly and repositionably in the back of the adult human subject's mouth. Spanning the dimensions of the tonsils and tongue-palate sail, and
The fluid blocking member comprises an intermediate channel dimensioned to fit snugly and repositionably around the ETT;
The fluid blocking member is inserted so that the ETT passes through the intermediate channel.

Disclosed herein is the following system: a system for oral care of a patient ventilated using an endotracheal tube (ETT), the system comprising:
A deformable fluid blocking member that can be mounted to adjust the position around the ETT,
The fluid blocking member comprises (i) an intermediate channel and (ii) an outer surface,
The intermediate channel is dimensioned to fit snugly and positionably around the ETT when the fluid blocking member is attached to the intermediate channel;
When the fluid blocking member is mounted, the outer surface is configured to fit in the back of the mouth of a human adult patient in a snug and position-adjustable manner and extend to the left and right tonsils and tongue-palate sail dimensions,
When the fluid blocking member is attached to the ETT,
(A) The fluid blocking part is configured to be inflatable in a position-adjustable manner so as to simultaneously press the palate sail and the tongue, and / or
(B) The fluid blocking member is foldable and is configured to apply an outward bias that expands so that the fluid blocking member compresses the palate sail and tongue simultaneously when placed in the back of a human mouth. The

  In some embodiments, the deformable flow fluid blocking member can be side mounted to the ETT.

  In one embodiment, the apparatus further comprises a suction tube, the suction tube being attached to the fluid blocking member, the distal end of the suction tube being oriented to suck fluid from the proximal side of the fluid blocking member. ing.

  In certain embodiments, at least one inlet for receiving a pressurized flow of fluid, and at least one fluid transport orifice for transporting liquid-gas mixture droplets to the mouth when a fluid blocking member is disposed in the mouth; The spray head apparatus which comprises these.

  In certain embodiments, the spray head device further comprises a suction lumen and a suction orifice, both the fluid transport orifice and the suction orifice being located at or near the distal end of the spray head device.

  In certain embodiments, the spray head device operates to deliver droplets of sufficient force to remove plaque.

  In certain embodiments, the fluid blocking member comprises one or more compressible foams, sponges, inflatable balloons or diaphragms.

  In certain embodiments, the channel may be dimensioned to fit an ETT having a diameter of at least 7 mm, at least 8 mm, or at least 10 mm, or the opening may be extendable relative to the ETT.

  In certain embodiments, the dimensions of the fluid blocking member range from a width of at least 3 cm and a tongue-to-palate height of at least 1.5 cm.

  In certain embodiments, the ETT comprises a Murphy eye at its distal end.

FIG. 1A shows an example of an endotracheal tube (ETT) (prior art). FIG. 1B illustrates various parts of the human oral cavity (prior art). FIG. 1C illustrates the oral cavity of FIG. 1B when intubated using ETT (prior art). FIGS. 2-4 illustrate a system, apparatus, and portions thereof illustrating a fluid blocking member portion of a kit for oral cleaning, according to an embodiment of the present invention. FIGS. 5-8 illustrate a system, apparatus, and portions thereof showing a spray cleaning member portion of a kit for oral cleaning, in accordance with an embodiment of the present invention. FIG. 9 illustrates a subject intubated with an ETT, with an expandable fluid blocking member mounted on the ETT (e.g., positionably mounted) near a non-positionable cuff. Yes.

DETAILED DESCRIPTION OF EMBODIMENTS Embodiments of the present invention relate to systems, methods and kits for cleaning an intubated subject's oral cavity.

  The present invention is described herein by way of example only with reference to the accompanying drawings. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Reference will now be made in detail to the drawings, and the description will be provided by way of example only, to illustrate and describe preferred embodiments of exemplary systems, and to the principles and concepts according to the invention. It is emphasized that the above aspects are presented to provide what is believed to be a useful and easily understandable description. In this regard, no attempt has been made to show the structural details of the invention in detail other than those necessary for a basic understanding of the invention, and the description with the drawings will not Several forms can actually be implemented, and it will be clear to those skilled in the art how to make and use this embodiment.

  For the sake of brevity, some obvious combinations of the various features are not explicitly illustrated and / or described in the figures. Any combination of features of a method or apparatus disclosed herein can be combined by any method (and includes any combination of features), and any combination of features can be Can be included in any embodiment and / or not included in any embodiment.

In the figure, the following symbols are indicated:
110-back teeth
112-uvula
114-right tonsil
115-left tonsil
200-Fluid blocking member
205-Intermediate channel of fluid blocking member 200
210-ETT facing surface of channel in blocking member
220-Main suction tube
221-Right suction branch
222-Right suction inlet
223-Left suction branch
224-Left suction inlet
225-Suction tube end connector
226-suction branch (221 and / or 223) to ETT 220
230-any expansion tube
335-Expansion tube end connector
500-spraying equipment
510-Body of elongated sprayer
520-Splash outlet orifice
521-Liquid lumen
523-Gas lumen
525-mixing chamber
526-Acceleration duct
527-Acceleration duct distal outlet
531-Liquid transport tube
532-Liquid tube tip connector
533-Gas transport tube
534-Gas tube tip connector
541-Liquid reservoir
543-Pressurized gas source
560-Solid projection
585-Protective shield
590-Splash
620,630,640,650-various schematic surfaces of the fluid blocking member 200
710-Tongue of a human subject
740-Human subject's palate sail

  In the non-limiting example of FIG. 2, the system includes a fluid blocking member 200 comprising a channel (see member 205 of FIGS. 3F and 4A-4E) through which the ETT 120 passes. The fluid blocking member 200 includes a "width" dimension of the mouth (i.e., a lateral dimension between the left tonsil 115 and the right tonsil 114) and a "palate sail-tongue" between the subject's palate sail 740 and the tongue 710. The fluid blocking member 200 is dimensioned to substantially block the entire annular area outside the ETT 120 in the back of the subject's mouth so that it substantially covers the dimensions of the subject. It is.

  In order to clean the subject's gums and / or teeth, the fluid blocking member 200 is placed in the back of the subject's mouth so as to substantially block the entire annular area outside the ETT 120 in the back of the subject's mouth. , Pressurized fluid (e.g., fluid splash or mist or jet) can be delivered to the subject's mouth. The presence of the fluid blocking member prevents fluids associated with the gum / tooth cleaning process (ie, “cleansing fluid”) from penetrating deeply into the patient's oral cavity. Since the cleaning liquid may contain oral bacteria (for example, bacteria derived from plaque or oral biofilm mixed with the cleaning liquid after being introduced into the oral cavity), the fluid blocking member 200 blocks these bacteria-containing fluids. This can reduce or eliminate tracheal cross-contamination associated with tooth or gum cleaning.

  One embodiment relates to a kit that includes a fluid blocking member 200 and a spray head device for delivering a pressurized flow of fluid to a subject's mouth. Other embodiments relate to a system comprising a fluid blocking member 200 that may or may not include a spray head device. A more detailed description of the spray head device example with respect to FIGS. 5-7 is provided below.

  In order to further protect the trachea from bacteria mixed with cleaning fluid and to further reduce the rate at which contaminated cleaning fluid leaks to a location downstream from the fluid blocking member 200, contamination or “use” from a location upstream from the fluid blocking member 200 The “done” cleaning solution can be aspirated. In the non-limiting example of FIG. 2, a tube assembly 220 of one or more tubes for aspirating away from the cleaning solution is provided. In the particular example of FIG. 2, tube assembly 220 may include a plurality of branches 221, 223, each with its own port 222, 224, respectively. At the proximal end, the suction tube connector 225 may be connected to a negative pressure source.

  FIG. 2 illustrates a preferred embodiment of a blocking member 200 further comprising an attached suction tube 220. It is preferable to have both the right suction branch tube 221 on one side of the channel 205 and the left suction branch tube 223 on the other side of the channel 205 so that a good suction action can be exerted on both sides of the ETT. , Each connected at its proximal end to the main suction tube 220. The right suction branch 221 includes a distal suction port 222, and the left suction branch 223 includes a distal suction port 224. The proximal end of the suction tube 220 is provided with a connector 225 suitable for connection to a suction source.

  In certain embodiments, the one or more tube assembly 220 has a distal end (e.g., 222 or 224 illustrated in FIG. 2) proximal to the fluid blocking member 200 (see member 640 of FIG.3D). Is attached to the fluid blocking member 200 so as to be in the direction of sucking fluid from the fluid. For example, the port 222 or 224 may be retained on or slightly above the proximal surface 640 of the fluid blocking member 200.

  As described above, the fluid blocking member 200 can fit snugly in the subject's mouth and in the back of the subject's mouth to substantially occlude the entire annular region outside the ETT 120. Although the fluid blocking member 200 does not have to be shaped as a cuboid, roughly speaking, the fluid blocking member 200 has six “outer” surfaces: (i) facing and (or nearly contacting) the palatal sail 740. Palate sail facing surface 630, (ii) tongue facing surface 620 facing (or almost touching) tongue 710, (iv) tonsil facing surface and right tonsil facing surface (not numbered) ), (V) a proximal surface 640 and (vi) a distal surface 650.

  The term “outer surface” of the fluid blocking member refers to the collection of all six surfaces described above. This is in contrast to the “inner surface”, described below, which is the surface of the intermediate channel 205 facing the ETT. In order for the “outer surface” to fit snugly in the back of the mouth, the following two actions must occur simultaneously: (i) The palate sail facing surface 630 must squeeze the palate sail; ) The tongue facing surface 620 must squeeze the tongue.

  In certain embodiments, the fluid blocking member is permanently provided with an annular shape and is mounted on the ETT (eg, by sliding over the ETT at the top / proximal end). In a preferred embodiment, the fluid blocking member comprises a “clip” to the ETT, otherwise it can be side mounted to the ETT. This makes it possible to attach the fluid blocking member to the ETT and remove the fluid blocking member therefrom in order to clean the patient's teeth without having to interrupt ventilation to the patient even for a short time.

  The fluid blocking member 200 may have an inner surface (ie, the surface of the intermediate channel 205 through which the ETT 120 passes). This inner surface is referred to as the ETT facing surface 210 and is generally formed like the side surface of a cylinder or a portion thereof. As the ETT 120 passes through the intermediate channel 205, it slides between the outer surface of the ETT 120 and the ETT facing surface 210.

  FIGS. 3A-3F illustrate various surfaces 620, 630, 640, 650, 210 of the fluid blocking member 200 shaped as, but not limited to, a cuboid.

  In the embodiment of FIGS. 3A-3F, the fluid blocking member 200 (and its proximal surface 640 and distal surface 650) comprises an annular shape. This is also the case for the embodiment of FIGS. 4A and 4D. The fluid blocking member 200 is sized to substantially block the entire annular area outside the ETT 120 in the back of the subject's mouth (but not necessarily completely closed), but the fluid blocking member 120 itself has an annular shape. There is no need to be.

  Also shown in FIG. 3F is the proximal side 660 of the intermediate channel 205 and the distal side 670 of the intermediate channel 205.

  Alternatively, as illustrated in FIGS. 4B and 4E, the fluid blocking member 200 and its intermediate channel 205 need to surround the entire ETT 120. For the present disclosure, when the intermediate channel 205 is configured to fit snugly "around" the ETT, the majority orientation of the ETT 120 (e.g., at least 180 degrees or There is only a need to enclose (which defines an arc of at least 270 degrees). Thus, the term “around” is not synonymous with “enclose” which requires a 360 degree arc.

  In some embodiments, by using a fluid blocking member 200 that does not have an annulus shape, the blocking member can be moved onto the ETT 120 without having to slide the fluid blocking member into place from the end (e.g., proximal end) of the ETT 120. It becomes possible to “clip” the blocking member from the ETT 120 by “clipping”. The “open arc” fluid channel 205 illustrated in FIGS. 4B and 4E can facilitate this process.

  One advantage of the “open arc” configuration is that the fluid blocking member can be side mounted to the ETT. In other embodiments, the fluid blocking member is optionally provided with an annular shape, and optionally with an open arc, which can also be side mounted.

  The fluid blocking member 200 is compressible to fit snugly over the width of the left tonsil 115 to the right tonsil 114 in the human oral cavity, particularly in the back of the mouth behind the back teeth 110 and near the palatal sail 740, and / or Or it may be expandable. For this reason, the blocking member 200 may, in various embodiments, be composed primarily of foam and / or sponges and / or diaphragms and / or inflatable balloons.

  In some embodiments, the ETT facing surface 210 of the intermediate channel 205 may be made of a relatively hard incompressible material. In such cases, the hard surface 210 is an arc greater than 180 degrees, and the hard surface 210 can be clipped to the ETT 120 by a stronger bond.

  Since the ETT 120 passes through the blocking member 200 (ie, through its intermediate channel 205), the diameter of the channel 205 is sized so that the outer surface of the ETT 120 can pass through the blocking member 200. The typical outer diameter of ETT (eg ETT tube) is 6 to 13 mm.

  As described above, the fluid blocking member 200 need not be formed as a rectangular parallelepiped. FIG. 4E is a three-dimensional view of the blocking member 200 having a shape that allows the palate sail facing surface 630 to better match the surface of the palate sail and closely contact the palate sail 740.

  FIGS. 5-7 illustrate embodiments of the spray head device, but are not limiting. In FIG. 5-7, the following components are: 500-spray device; 510-body of elongated spray device; 520-splash outlet orifice; 521-liquid lumen; 523-gas lumen; 525-mixing chamber; Duct; 527-Distal outlet of acceleration duct; 531-Liquid transport tube; 532-Liquid tube tip connector; 533-Gas transport tube; 534-Gas tube tip connector; 541-Liquid reservoir; 543-Pressurization Gas source; 560-three-dimensional projection and 590-splashes, are labeled.

  FIGS. 5a and 5b show tooth cleaning comprising an elongated body 510 of similar dimensions (length / width) as a toothbrush, a splash outlet 520 near the distal end of the elongated body 510, a liquid transport tube 531 and a gas transport tube 533. 1 illustrates one embodiment of an apparatus 500 for The liquid and gas tubes are preferably connected at the proximal portion of the elongated body 510.

  In an embodiment, the liquid transport tube 531 and the gas transport tube 533 are detachable / reconnectable from / to the elongated body 510. This allows the transport tube to be reused in other body 510 devices, while the elongated body 510 may be disposable.

  In operation, the spray device is connected to the pressurized gas source 543 and the liquid reservoir 541. The liquid reservoir may or may not be pressurized compared to atmospheric pressure. In an embodiment, the pressure of the gas source is 2-8 atmospheres to create a droplet 590 suitable for cleaning dental biofilm and / or plaque.

  FIG. 6a illustrates an embodiment of a spray device 500 of the type illustrated in FIG. 6b. In particular, lumen 521 provides fluid communication between the proximal inlet of liquid transport tube 531 and distal mixing chamber 525, and lumen 523 connects the proximal inlet of gas transport tube 533 and distal mixing chamber 525. Fluid communication. Mixing chamber 525 is in fluid communication with splash outlet orifice 520.

  FIG. 6c illustrates an embodiment of a spray device 500 of the type illustrated in FIG. 4b, featuring the option of an acceleration duct 526 connected from the mixing chamber 525 to the droplet outlet orifice 520 and in fluid communication. It is. It should be understood that the mixing chamber 525 may simply comprise a tube joint of any size corresponding to the diameter of the lumen 521 or 523, as illustrated in FIG. 6c.

  FIGS. 7 a and 7 b illustrate an embodiment similar to the spray device 500. A characteristic difference from the cross-sectional view 4c is that the lumen 523 is located behind the lumen 521 (after the plane with the splash outlet orifice 520).

  In an embodiment, lumens 521 and 523 are extruded simultaneously.

  In operation of the spray device 500, the gas flow (flow) is at an angle, preferably approximately vertical, and the liquid flow is interrupted. The flow rate of the gas is sufficient if it breaks the liquid flow into droplets of the desired size and velocity, optionally removing them from the biofilm and / or plaque from the teeth and / or gums. Accelerate out of the orifice 520 through the acceleration duct at the desired high speed.

  FIG. 8 illustrates a preferred embodiment in which a protective shield 585 (eg, a flat plate) is attached to the spray device body 510. The shield 585 has the function of preventing splashes that have escaped from the mouth from reaching the operator of the spray device (eg, a nurse cleaning the mouth of the ICU patient).

  FIG. 9 illustrates the fluid blocking member attached to the ETT in a. Position above the epiglottis and / or b. Not in contact with the posterior pharyngeal wall.

Definitions For convenience, various terms are presented herein in the context described herein. Here, unless otherwise explicitly or implicitly defined elsewhere in this application, it is understood that such definitions are consistent with the usage of terms defined by those skilled in the art. Furthermore, such definitions should be construed as the broadest possible meaning consistent with such usage.

  Some embodiments relate to the “width” of a subject (eg, the “width” of an elongated flexible body 210 or the width of an orifice or the width of a lumen). “Width” is defined as the square root of the cross-sectional area.

Further Discussion Embodiments of the present invention relate to a patient oral care system ventilated using an ETT, which can be repositionably mounted around the ETT (e.g., mounted thereon). A fluid barrier (sometimes slidable along the ETT). The “positionably attachable” feature of the fluid blocking member means that it can be attached to and detached from the ETT, and any permanent bond (e.g., based on adhesion of the fluid blocking member to the ETT) In contrast.

The fluid blocking member comprises (i) an intermediate channel 205 and (ii) an outer surface,
The intermediate channel 205 is dimensioned to fit snugly and positionably around the ETT 120 when the fluid blocking member is attached to the intermediate channel.
The outer surface is configured to fit snugly and positionably in the back of the human adult patient's mouth and to cover the left and right tonsils and tongue-palate sail dimensions when fitted with the fluid blocking member.

  With respect to the present disclosure, when the fluid blocking member fits “just” in the back of the mouth, outward pressure is simultaneously applied by the fluid blocking member to both the tongue (eg, the back of the tongue) and the palatal sail. Although outward pressure need not be applied to any surface other than the tongue and palate sail, such pressure may actually be applied.

  In certain embodiments, the fluid blocking member 200 is configured to be repositionably inflatable (e.g., including a balloon) and / or fluid to compress the soft pallet and tongue simultaneously. The blocking member 200 is foldable and is configured to apply an outward bias that, when placed behind a human mouth, expands so that the fluid blocking member presses the palate sail and tongue simultaneously.

  In exemplary embodiments, the fluid blocking member can be provided as a balloon and / or foam and / or sponge and / or diaphragm.

  In certain embodiments, the fluid blocking member is permanently provided with an annular shape and is mounted on the ETT (eg, by sliding over the ETT at the top / proximal end). Alternatively, the fluid blocking member comprises a “clip” to the ETT, otherwise it can be side mounted to the ETT. This makes it possible to attach the fluid blocking member to the ETT and remove the fluid blocking member therefrom in order to clean the patient's teeth without having to interrupt ventilation to the patient even for a short time.

  An embodiment relates to an oral cleaning kit comprising (i) a deformable fluid blocking member that can be mounted in an adjustable manner as described above, and (ii) a spraying device for spraying fluid onto the oral cavity to clean teeth. When the fluid is sprayed on the intubated oral cavity, the presence of the fluid blocking member prevents the fluid from entering the airway below the blocking member.

  In patients who have been intubated with an endotracheal tube (ETT), ETT interferes with swallowing ability. Therefore, cleaning the oral cavity with a liquid-containing fluid stream is problematic. The reason is that fluids contaminated with oral biofilm and / or plaque can descend into the trachea and lungs. By combining the use of the fluid blocking member 200, the oral care kit facilitates the safe use of the fluid spray device 500 to clean the patient's teeth and / or gums that have been intubated with an endotracheal tube (ETT). .

  Preferably, the suction means is connected to the fluid blocking member 200 to prevent the contaminated cleaning liquid from descending into the trachea and is sucked out of the patient's mouth.

  In preferred embodiment applications, the fluid blocking member 200 is initially fitted to cover the ETT behind the intubated patient's oral cavity. A suction operation is performed to suck the fluid near the blocking member 200. The fluid spray device 500 is then operated to clean the patient's mouth while aspirating.

Disclosed herein is the following system: a patient oral care system ventilated using an ETT, the system being deformable fluid that can be adjustably mounted about the ETT. With a blocking member,
The fluid blocking member includes an intermediate channel and an outer surface,
The intermediate channel is dimensioned to fit snugly and positionably around the ETT when the fluid blocking member is attached to the intermediate channel;
When the fluid blocking member is mounted, the outer surface is configured to fit in the back of the mouth of a human adult patient in a snug and position-adjustable manner and extend to the left and right tonsils and tongue-palate sail dimensions,
The fluid blocking member is configured to be positionably expandable to compress the palatal sail and tongue simultaneously and / or
The fluid blocking member is foldable and is configured to apply an outward bias that, when placed behind a human mouth, expands the fluid blocking member to simultaneously press the palate sail and tongue.

  In certain embodiments, the deformable fluid blocking member can be side mounted to the ETT.

  In certain embodiments, the system comprises a suction tube, wherein the suction tube is attached to the fluid blocking member and oriented such that the distal end of the suction tube draws fluid from the proximal side of the fluid blocking member It is attached.

  In certain embodiments, the system includes at least one inlet for receiving a pressurized flow of fluid and at least one for transporting liquid-gas mixture droplets to the mouth when a fluid blocking member is disposed at the mouth. And a spray head device comprising a fluid transport orifice.

  In certain embodiments, the spray head device further comprises a suction lumen and a suction orifice, both the fluid transport orifice and the suction orifice being located at or near the distal end of the spray head device.

  In certain embodiments, the splash has sufficient power to remove plaque.

  In certain embodiments, the fluid blocking member comprises one or more compressible foams or sponges or inflatable balloons or diaphragms.

In the present specification, the following oral cleaning method is disclosed:
inserting a deformable fluid blocking member into the mouth of an adult human subject with an intermediate channel dimensioned to fit snugly and repositionably around an ETT having an outer diameter of at least 6 mm and a maximum of 13 mm;
b. At the same time or after the insertion step, the deformable fluid blocking member is expanded so that its outer surface fits snugly and repositionably in the back of the adult human subject's mouth. Extending to the tonsil and tongue-palate dimensions.

In the present specification, the following oral cleaning method is disclosed:
a. inserting the deformable fluid blocking member 200 into the mouth of an adult human subject ventilated using ETT;
b. At the same time or after the insertion step, the deformable fluid blocking member is expanded so that its outer surface fits snugly and repositionably in the back of the adult human subject's mouth. Spanning the dimensions of the tonsils and tongue-palate sail, and
The fluid blocking member comprises an intermediate channel 205 sized to fit snugly and repositionably around the ETT;
The fluid blocking member is inserted so that the ETT passes through the intermediate channel 205.

  In certain embodiments, the method further comprises the step of spraying a cleaning liquid on the mouth of the human subject to clean the teeth, and the fluid blocking member substantially prevents the cleaning liquid from entering the airway of the human subject. Prevent it.

  In certain embodiments, the fluid includes a gas-liquid mixture.

  In certain embodiments, the method further comprises aspirating the fluid blocking member to remove cleaning liquid remaining in the mouth.

  In certain embodiments, at least a portion of the aspirated cleaning liquid is aspirated out of the mouth via introduction through a suction port that is substantially disposed on the top surface of the fluid blocking member.

  In an embodiment, the cleaning liquid is sprayed by a spraying device, and at least a portion of the suctioned cleaning liquid is sucked from the mouth via a suction port located in or within the spraying device.

  In certain embodiments, the expansion step is performed by inflating the fluid blocking member.

  In certain embodiments, the fluid blocking member can be compressed and outwardly biased so that it is inserted into the mouth during compression and expands upon insertion into the mouth.

  In certain embodiments, the blocking member is inserted such that the intermediate channel of the blocking member fits snugly and repositionably around the outer surface of the tube when the tube is in the mouth of a human subject.

  In certain embodiments, the tube is ETT.

  In certain embodiments, the tube is a tracheostomy tube. In one embodiment, the fluid blocking member is inflatable in an adjustable manner to simultaneously press the palate sail and tongue.

  In one embodiment, the fluid blocking member is foldable so that when placed behind a human mouth, the fluid blocking member applies an outward bias that expands to simultaneously press the palate sail and tongue. Composed.

  While various embodiments have been described in the context of a pre-assembled system, a kit comprising one or more parts that, when assembled, forms any currently disclosed device or apparatus or part thereof. It is understood that it is also within the scope of the present invention. In various non-limiting examples, the connector assembly 158 or input module assembly 156 or any port disclosed herein can be provided as a part that can be assembled in the field (eg, an intensive care unit). In some embodiments, the sleeve 610 may be a kit part or may be placed in the field. Other configurations are within the scope of embodiments of the present invention.

  In the description and claims of this application, each of the verbs “comprising”, “comprising”, “including” and “having” and combinations thereof are those in which the object (s) of the verb is the verb (s) ) Used to indicate that the object, part, part, element or part need not be a complete list.

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

  The articles “a” and “an” are used herein as the grammatical purpose of the article relates to one or more (ie, at least one). As an example, “member” means one member or a plurality of members.

  The term “comprising” is used herein to mean the phrase “including but not limited to” and is used interchangeably with this phrase. The term “or” is used herein to mean the term “and / or” and is used interchangeably unless the context clearly indicates otherwise. The term “for example” is used herein to mean the phrase “for example, but is not limited to,” and is used interchangeably with this phrase.

  Although the present invention has been described using detailed descriptions of embodiments thereof, this is provided by way of example and is not intended to limit the scope of the invention. The described embodiments comprise various features, not all of which are required in all embodiments of the invention. Certain embodiments of the invention utilize only certain features or possible combinations of features. Variations of embodiments of the present invention, including various combinations of features described in the described embodiments of the invention and described, will occur to those skilled in the art.

Claims (38)

A positionable / side-mounted system for patient oral care, ventilated using an endotracheal tube (ETT),
The system includes a deformable fluid blocking member that can be mounted to adjust the position around the ETT and can be mounted on a side surface.
The fluid blocking member comprises (i) an intermediate channel and (ii) an outer surface,
The intermediate channel is dimensioned to fit snugly and repositionably around the ETT when the fluid blocking member is attached to the intermediate channel;
The outer surface is configured to fit snugly and positionably in the back of the human adult patient's mouth when the fluid blocking member is mounted, and extends to the left and right tonsils and tongue-palat sail dimensions;
When the fluid blocking member is attached to the ETT,
(A) The fluid blocking member is configured to be inflatable in a position-adjustable manner so as to simultaneously press the palate sail and the tongue, and / or
(B) The fluid blocking member is foldable and is configured to apply an outward bias that expands so that the fluid blocking member compresses the palatal sail and tongue simultaneously when placed behind a human mouth. System.   The system of claim 1, wherein the deformable fluid blocking member is configured such that the fluid blocking member does not completely surround the ETT when attached to the ETT.   The system according to claim 1 or 2, wherein the deformable fluid blocking member does not comprise a permanent ring.   4. The deformable fluid blocking member according to any one of claims 1 to 3, wherein the deformable fluid blocking member is configured such that the fluid blocking member does not completely surround the ETT using a permanent ring when attached to the ETT. system.   5. The system of claim 4, wherein the deformable fluid blocking member is configured to completely enclose the ETT using a ring that can be repositionably opened when the fluid blocking member is attached to the ETT. . A kit for oral care of a patient, ventilated using an endotracheal tube (ETT), the kit comprising:
a. at least one spraying device configured to transport the droplets;
b. a deformable fluid blocking member that can be mounted to adjust its position around the ETT, and
The fluid blocking member comprises: i. An intermediate channel; and ii. An outer surface;
The intermediate channel is dimensioned to fit snugly and repositionably around the ETT when the fluid blocking member is attached to the intermediate channel;
The outer surface is configured to fit snugly and positionably in the back of the human adult patient's mouth when the fluid blocking member is mounted, and extends to the left and right tonsils and tongue-palat sail dimensions;
When the fluid blocking member is attached to the ETT,
(A) The fluid blocking member is configured to be inflatable in a position-adjustable manner so as to simultaneously press the palate sail and the tongue, and / or
(B) The fluid blocking member is foldable and is configured to apply an outward bias that expands so that the fluid blocking member compresses the palatal sail and tongue simultaneously when placed behind a human mouth. The kit.   7. The kit according to claim 6, wherein the spraying device is a spray-suction hybrid device configured to perform both transport of the droplets and suctioning excluding a substance.   7. The kit according to claim 6, wherein the spray device is a spray-suction hybrid device configured to simultaneously transport the droplets and perform suction of the substance.   9. The kit according to any one of claims 6 to 8, wherein the deformable fluid blocking member can be mounted so as to be position-adjustable around the ETT and can be mounted on a side surface.   The spray device includes first and second inlets configured to receive a liquid flow and a gas flow, respectively, and the spray device forms the droplets from the received liquid and gas flow. The kit according to any one of claims 6 to 9, wherein the kit is constituted. A ventilation system, the ventilation system comprising:
a endotracheal tube (ETT);
b. a deformable fluid blocking member that can be mounted to adjust its position around the ETT, and
The fluid blocking member comprises an intermediate channel and an outer surface;
The intermediate channel is dimensioned to fit snugly and repositionably around the ETT when the fluid blocking member is attached to the intermediate channel;
The outer surface is configured to fit snugly and positionably in the back of the human adult patient's mouth when the fluid blocking member is mounted, and extends to the left and right tonsils and tongue-palat sail dimensions;
(i) the fluid blocking member is configured to be positionably expandable to simultaneously press the palate sail and tongue, and / or
(ii) The fluid blocking member is foldable and is configured to apply an outward bias that, when placed behind a human mouth, expands the fluid blocking member to simultaneously press the palate sail and tongue. System.   12. The system of claim 11, wherein the fluid blocking member is adjustably mounted about a proximal half of the ETT.   13. The system of claim 11 or 12, further comprising a fluid-blocking cuff and / or an inflatable balloon that is non-positionably mounted to the ETT at a location distal to the fluid blocking member.   The fluid-blocking cuff is arranged to place the ETT in the trachea and define a gap region between the outside of the ETT and the inside of the trachea, so as to substantially seal the gap region from below to above 14. The system of claim 13, configured to be enabled. An oral cleaning method, wherein the oral cleaning method includes:
inserting a deformable fluid blocking member into the mouth of an adult human subject ventilated using an endotracheal tube (ETT);
b. At the same time or after the insertion step, the deformable fluid blocking member is expanded so that its outer surface fits snugly and repositionably behind the mouth of an adult human subject, Extending to the dimensions of the tonsils and tongue-palate sails;
c. introducing a cleaning solution into the mouth of a human subject to clean the teeth;
The fluid blocking member comprises an intermediate channel dimensioned to fit snugly and repositionably about the ETT;
The fluid blocking member is inserted so that the ETT passes through the intermediate channel;
The fluid blocking member substantially prevents the cleaning liquid from entering the airway region below the epiglottis of a human subject.   16. A method according to claim 15, wherein the fluid is introduced as droplets and / or the fluid comprises a gas-liquid mixture.   17. A method according to claim 15 or 16, wherein a pressurized fluid is introduced.   18. A method according to any of claims 15 to 17, further comprising the step of aspirating to remove the cleaning liquid remaining in the mouth by the fluid blocking member at a position proximal to the fluid blocking member.   19. The method of claim 18, wherein at least a portion of the cleaning liquid to be aspirated is aspirated out of the mouth via introduction through a suction port substantially disposed on the top surface of the fluid blocking member.   20. The cleaning liquid is sprayed by a spray device, and at least a part of the suctioned cleaning liquid is sucked from a mouth via a suction port arranged in or in the spray device. the method of.   21. A method according to any of claims 15 to 20, wherein the expanding step is performed by inflating the fluid blocking member.   22. A method according to any of claims 15 to 21, wherein the fluid blocking member is capable of being compressed and outwardly biased so that it is inserted into the mouth upon compression and expands upon insertion into the mouth.   The blocking member is inserted such that the intermediate channel of the blocking member fits snugly and repositionably around the outer surface of the tube when the tube is in the mouth of a human subject. 23. The method according to any one of 22.   24. A method according to any of claims 15 to 23, wherein the fluid blocking member is positionably expandable to simultaneously press the palate sail and tongue. A system for oral care of a patient, ventilated using an endotracheal tube (ETT), the system comprising:
a deformable fluid blocking member that can be mounted to adjust its position around the ETT;
b. a suction tube,
The suction tube is attached to the fluid blocking member and is arranged and oriented so that a distal end of the suction tube sucks fluid from a proximal surface side of the fluid blocking member;
The fluid blocking member comprises: i. An intermediate channel; and ii. An outer surface;
The intermediate channel is dimensioned to fit snugly and repositionably around the ETT when the fluid blocking member is attached to the intermediate channel;
The outer surface is configured to fit snugly and positionably in the back of the human adult patient's mouth when the fluid blocking member is mounted, and extends to the left and right tonsils and tongue-palat sail dimensions;
(A) The fluid blocking member is configured to be inflatable in a position-adjustable manner so as to simultaneously press the palate sail and the tongue, and / or
(B) The fluid blocking member is foldable and is configured to apply an outward bias that expands so that the fluid blocking member compresses the palatal sail and tongue simultaneously when placed behind a human mouth. System. An oral cleaning method, wherein the oral cleaning method includes:
inserting a deformable fluid blocking member into the mouth of an adult human subject ventilated using an endotracheal tube (ETT);
b. At the same time or after the insertion step, the deformable fluid blocking member is expanded so that its outer surface fits snugly and repositionably behind the mouth of an adult human subject, Spanning the dimensions of the tonsils and tongue-palate sail, and
The fluid blocking member comprises an intermediate channel dimensioned to fit snugly and repositionably about the ETT;
The fluid blocking member is inserted such that the ETT passes through the intermediate channel. A system for oral care of a patient, ventilated using an endotracheal tube (ETT), the system comprising:
A deformable fluid blocking member that can be mounted to adjust the position around the ETT,
The fluid blocking member comprises (i) an intermediate channel and (ii) an outer surface,
The intermediate channel is dimensioned to fit snugly and repositionably around the ETT when the fluid blocking member is attached to the intermediate channel;
The outer surface is configured to fit snugly and positionably in the back of the human adult patient's mouth when the fluid blocking member is mounted, and extends to the left and right tonsils and tongue-palat sail dimensions;
When the fluid blocking member is attached to the ETT,
(A) The fluid blocking member is configured to be inflatable in a position-adjustable manner so as to simultaneously press the palate sail and the tongue, and / or
(B) The fluid blocking member is foldable and is configured to apply an outward bias that expands so that the fluid blocking member compresses the palatal sail and tongue simultaneously when placed behind a human mouth. System.   28. The system, kit or method according to any one of claims 1 to 27, wherein the deformable fluid blocking member is side mountable to the ETT. A suction tube;
29. The suction tube of claim 1 to 28, wherein the suction tube is attached to the fluid blocking member, and a distal end of the suction tube is oriented to suck fluid from a proximal surface side of the fluid blocking member. The system, kit or method according to any one of the above.   A spray comprising at least one inlet for receiving a pressurized flow of fluid and at least one fluid transport orifice for transporting liquid-gas mixture droplets to the mouth when the fluid blocking member is disposed in the mouth 30. A system, kit or method according to any of claims 1 to 29, comprising a head device.   32. The spray head device of claim 30, further comprising a suction lumen and a suction orifice, wherein both the fluid transport orifice and the suction orifice are located at or near a distal end of the spray head device. System, kit or method.   32. A system, kit or method according to claim 30 or 31, wherein the spray head device is operative to transport droplets of sufficient force to remove plaque.   33. A system, kit or method according to any of claims 1 to 32, wherein the fluid blocking member comprises one or more compressible foams, sponges, inflatable balloons or diaphragms.   34. The channel of any of claims 1-33, wherein the channel is dimensioned to fit snugly into an ETT having a diameter of at least 7mm, at least 8mm, or at least 10mm, or capable of extending an opening relative to the ETT. A system, kit or method according to 1.   35. A system, kit or method according to any of the preceding claims, wherein the dimensions of the fluid blocking member span both a width of at least 3 cm and a tongue-palate height of at least 1.5 cm.   36. The suction tube is attached to the fluid blocking member, and the distal end of the suction tube is arranged and oriented to suck fluid from a proximal surface side of the fluid blocking member. A system, kit or method according to any one of.   During ventilation, the fluid blocking member is attached or attachable to the ETT at a. A position above the epiglottis and / or b. A position not in contact with the posterior pharyngeal wall. 36. The system, kit or method according to any of 36.   During ventilation, the fluid blocking member is in contact with the posterior pharyngeal wall, a. A position above the epiglottis and / or b. To prevent the cleaning fluid from entering the airway area under the epiglottis of the human subject. 38. A system, kit or method according to any of claims 1 to 37, wherein the system, kit or method is attached to or attachable to the ETT in a non-existing position.