IL302467A

IL302467A - Oral care device

Info

Publication number: IL302467A
Application number: IL302467A
Authority: IL
Inventors: GARGI Yonatan
Original assignee: Tel Hashomer Medical Res Infrastructure & Services Ltd; GARGI Yonatan
Priority date: 2023-04-27
Filing date: 2023-04-27
Publication date: 2024-11-01
Also published as: WO2024224388A1

Description

ORAL CARE DEVICE FIELD The present invention relates to an oral care device configured to rinse an oral cavity of a ventilated patient.

BACKGROUND Ventilator-associated pneumonia (VAP) remains an important threat to critically ill patients as it is associated with considerable morbidity, prolonged ventilation, and possibly mortality. Preventive strategies mainly target optimization of basic infection control measures, avoidance of delayed extubation, bioflm formation on the endotracheal tube and of micro-aspiration of subglottic secretions, prevention of bacterial translocation from stomach to oropharynx, and modulation of oropharyngeal colonization. Chlorhexidine oral care has been extensively studied regarding the last of these.

Chlorhexidine oral care is widely used to reduce the occurrence of VAP, and thus has become common procedure. Rinsing a patient's mouth with chlorhexidine oral is an essential part of a VAP prevention bundle, as it can prevent the growth and aspiration of oral bacteria that can lead to VAP. However, continuous rinsing can lead to accumulation of excessive amounts of chlorhexidine, which can in turn pose undesirable safety risks.

Combined oral health care, including antiseptics and manual removal of oral biofilm, rather than relying on antiseptics alone, may be more successful in reducing VAP and shortening the length of stay in the ICU, though this will require more frequent manual intervention from caregivers.

SUMMARY id="p-1"

[0001]At present, manual oral care of anesthetized intubated patients by a healthcare worker is both time-consuming and uncomfortable. Therefore, there is a great need for simplification and automation of the procedure. id="p-2"

[0002]According to some aspects of the disclosure, there is provided an oral care device comprising a main body and a distal extension distally extending from a body distal end of the main body. The main body comprises an inlet opening, an outlet opening, a plurality of outflow openings in fluid communication with the inlet opening and a sealed channel defining a sealed channel lumen. The sealed channel lumen is in fluid communication with the outlet opening and is fluidly sealed from the plurality of outflow openings. The distal extension comprises an extension lumen which is in fluid communication with the sealed channel lumen, and a plurality of inflow openings in fluid communication with the extension lumen and fluidly sealed from the plurality of outflow openings. id="p-3"

[0003]The aspects of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF THE FIGURES id="p-4"

[0004]Some examples of the invention are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some examples may be practiced. The figures are for the purpose of illustrative description and no attempt is made to show structural details of an example in more detail than is necessary for a fundamental understanding of the invention. For the sake of clarity, some objects depicted in the figures are not to scale.

In the Figures: id="p-5"

[0005]Fig. 1A is a view in perspective from an upper-posterior view angle of an exemplary oral care device. id="p-6"

[0006]Fig. 1B is a view in perspective from a lower-anterior view angle of the oral care device of Fig. 1A. id="p-7"

[0007]Fig. 2A is a view in perspective from an upper view angle of an exemplary oral care device. id="p-8"

[0008]Fig. 2B is a side view in perspective of the oral care device of Fig. 2A. id="p-9"

[0009]Fig. 2C shows an enlarged view in perspective of a portion of the oral care device of Fig. 2B. id="p-10"

[0010]Fig. 2D is a view in perspective from an upper-anterior view angle of the oral care device of Fig. 2A. id="p-11"

[0011]Fig. 2E is a cross-sectional view in perspective taken along line 2E-2E of Fig. 2A. id="p-12"

[0012]Fig. 2F shows an enlarged view in perspective of a distal portion of the oral care device, taken from a posterior view angle. id="p-13"

[0013]Fig. 2G shows an enlarged view in perspective of a distal portion of the oral care device, taken from an anterior view angle. id="p-14"

[0014]Fig. 3A is a view in perspective of a portion of an exemplary oral care device including a main body thereof. id="p-15"

[0015]Fig. 3B is a view in perspective of a portion of the exemplary oral care device of Fig. 3A, including a distal extension thereof. id="p-16"

[0016]Fig. 4 is a cross-sectional view along line 4-4 of Fig. 2E. id="p-17"

[0017]Fig. 5 is a view in perspective of an exemplary oral care device. id="p-18"

[0018]Figs. 6A - 6D show sequential steps in an exemplary method for insertion of an oral care device into a patient.

DETAILED DESCRIPTION id="p-19"

[0019]For purposes of this description, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present, or problems be solved. The technologies from any example can be combined with the technologies described in any one or more of the other examples. In view of the many possible examples to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope of the disclosed technology. id="p-20"

[0020]Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art. id="p-21"

[0021]All features described herein are independent of one another and, except where structurally impossible, can be used in combination with any other feature described herein. id="p-22"

[0022]As used in this application and in the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the terms "have" or "includes" means "comprises". Further, the terms "coupled", "connected", and "attached", as used herein, are interchangeable and generally mean physically, mechanically, chemically, magnetically, and/or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language. As used herein, "and/or" means "and" or "or", as well as "and" and "or". id="p-23"

[0023]Directions and other relative references may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms may be used such as "inner", "outer", "upper", "lower", "inside", "outside", "top", "bottom", "interior", "exterior", "left", right", and the like. Such terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated examples. Such terms are not, however, intended to imply absolute relationships, positions, and/or orientations. For example, with respect to an object, an "upper" part can become a "lower" part simply by turning the object over, such as prior to insertion of the device into a patient. Nevertheless, it is still the same part and the object remains the same. id="p-24"

[0024]The term "plurality" or "plural" when used together with an element means two or more of the element. Directions and other relative references (e.g., inner and outer, upper and lower, above and below, left and right, and proximal and distal) may be used to facilitate discussion of the drawings and principles herein but are not intended to be limiting. id="p-25"

[0025]The terms "proximal", "distal", "bottom" and "upper" are defined relative to the position of an oral care device in the body of the patient after insertion. In general, the end of the oral care device closest to the mouth or to a caregiver placing the device inside a patient's mouth is the proximal end, and the end of the oral care device farthest from the mouth and closer to the lungs is the distal end. The term "proximal", when used with two spatially separated positions or parts of an object, can be understood to mean closer to or oriented towards the proximal end of the airway assembly. The term "distal", when used with two spatially separated positions or parts of an object, can be understood to mean closer to or oriented towards the distal end of the airway assembly. The term "upper" refers to a side that faces the patient's soft palate, whereas the term "bottom" refers to a side that faces the tongue. The terms "longitudinal" and "axial" are interchangeable, and refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined. The term "lateral direction", as used herein, refers to a direction that is perpendicular to the longitudinal direction. The term "lateral", when referred to a side or a surface of a device or a component thereof, as disclosed herein, refers to a surface or a side that is offset in the lateral direction from a central longitudinal axis of the device. id="p-26"

[0026]The term "anterior" refers to a side that faces the front of a patient, whereas the term "posterior" refers to a side that faces the back of the patient. An "upper" side or surface of a portion of a device or any component thereof can be continuous with a "posterior" side or surface of another portion of the device or a component thereof, depending on the position of the device within the patient. Similarly, a "lower" side or surface of a portion of a device or any component thereof can be continuous with an "anterior" side or surface of another portion of the device or a component thereof, depending on the position of the device within the patient. id="p-27"

[0027]The terms "longitudinal direction", "lateral direction", and "circumferential direction", have been used herein to describe the arrangement and assembly of components relative to the geometry of the device. Such terms have been used for convenient description, but the disclosed examples are not strictly limited to the description. In particular, where a component or action is described relative to a particular direction, directions parallel to the specified direction as well as minor deviations therefrom are included. id="p-28"

[0028]As used herein, the term "substantially" means the listed value and/or property and any value and/or property that is at least 75% of the listed value and/or property. Equivalently, the term "substantially" means the listed value and/or property and any value and/or property that differs from the listed value and/or property by at most 25%. For example, "at least substantially parallel" refers to directions that are fully parallel, and to directions that diverge by up to 22.5 degrees. id="p-29"

[0029]In the present disclosure, a reference numeral that includes an alphabetic label (for example, "a," "b," "c," etc.) is to be understood as labeling a particular example of the structure or component corresponding to the reference numeral. Accordingly, it is to be understood that components sharing like names and/or like reference numerals (for example, with different alphabetic labels or without alphabetic labels) may share any properties and/or characteristics as disclosed herein even when certain such components are not specifically described and/or addressed herein. id="p-30"

[0030]Throughout the figures of the drawings, different superscripts for the same reference numerals are used to denote different examples of the same elements. Examples of the disclosed devices and assemblies may include any combination of different examples of the same elements. Specifically, any reference to an element without a superscript may refer to any alternative example of the same element denoted with a superscript. In order to avoid undue clutter from having too many reference numbers and lead lines on a particular drawing, some components will be introduced via one or more drawings and not explicitly identified in every subsequent drawing that contains that component. id="p-31"

[0031]Figs. 1A-3B show an exemplary oral care device 100. Figs. 1A and 1B are views in perspective from an upper-posterior and a lower-anterior view angle, respectively, of an oral care device 100, illustrated without some components such as a tube retainer and strap retainers for clarity. Fig. 2A is a view in perspective from an upper view angle of an exemplary oral care device 100 shown to include a tube retainer 132 and strap retainers 136. Fig. 2B is a side view in perspective of the oral care device 100 of Fig. 2A. Fig. 2C shows an enlarged view in perspective of a portion of the oral care device 100 of Fig. 2B. Fig. 2D is a view in perspective from an upper-anterior view angle of the oral care device 100 of Fig. 2A. Fig. 2E is a cross-sectional view in perspective taken along line 2E-2E of Fig. 2A. Fig. 2F shows an enlarged view in perspective of a distal portion of the oral care device 100 from a posterior view angle. Fig. 2G shows an enlarged view in perspective of a distal portion of the oral care device 1from an anterior view angle. Fig. 3A is a view in perspective of a portion of an exemplary oral care device 100 including a main body 102 thereof. Fig. 3B is a view in perspective of a portion of the exemplary oral care device 100 of Fig. 3A, including a distal extension thereof. The terms "device 100" and "oral care device 100", as used herein, are interchangeable. Figs. 1A-3B are described herein together. id="p-32"

[0032]The oral care device 100 comprises a main body 102 extending from a body proximal end 104 to a body distal end 106, and a distal extension 150 extending from the body distal end 106 to extension distal end 156. The distal extension 150 can be integrally formed with main body 102, or can be formed as a separate component affixed to main body 102 such that it continuously extends distally therefrom. Main body 102 comprises a body wall 116 and has a body upper side 110 configured to face the soft palate 30, and a body lower side 114 configured to face the patient's tongue 20, when placed in a patient's oral cavity 40 (oral cavity 40, soft palate 30 and tongue 20 indicated, for example, in Figs. 6A-6D). The body upper 110 and lower 114 sides extend between body lateral sides 108 of main body 102. Main body 102 further comprises a body internal space 120, which can be bound by internal surfaces (not indicated separately) of body wall 116. For example, each of the body upper side 110, body lower side 114, and body lateral sides 108, can include inner and outer surfaces (not indicated separately in the drawings) defines by the body wall 116, wherein the internal surfaces of body wall 1can defined the body internal space 120. Main body 102 further comprises a plurality of outflow openings 130 which are in fluid communication with the body internal space 120, such that the plurality of outflow openings 130 extend through the thickness of body wall 116. id="p-33"

[0033]The distal extension 150 comprises a distal extension wall 174 and has a posterior-facing side 162 configured to face a posterior wall of a patient's hypopharynx 50, and an anterior-facing side 164 configured to face the anterior wall of a patient's hypopharynx 50, when device 100 is inserted into a patient such that the distal extension is positioned inside the hypopharynx 50 (indicated, for example, in Figs. 6A-6D). As illustrated, the distal extension 150 curves downwards from the body distal end 106 towards the extension distal end 156 to follow the anatomical path leading from the oral cavity 40 into the hypopharynx 50. Thus, it is to be understood that any reference to a posterior-facing side 162 refers to at least a lower portion of a side 162 of distal extension 150 facing the posterior or back-side of the patient, when positioned in the hypopharynx 50, while an upper portion of the side 162 (i.e., closer to the body distal end 106) may be facing upwards (such as be being oriented towards a rear portion of the soft palate 30). Thus, a posterior-facing side 162 can be also referred to as an upper/posterior-facing side 162. Similarly, any reference to an anterior-facing side 164 refers to at least a lower portion of a side 164 of distal extension 150 facing the anterior or front-side of the patient, when positioned in the hypopharynx 50, while an upper portion of the side 1(i.e., closer to the body distal end 106) may be facing downwards (such as be being oriented towards a rear portion of the tongue 20). Thus, an anterior-facing side 164 can be also referred to as a lower/anterior-facing side 164. id="p-34"

[0034]Device 100 further comprises a suction lumen 170, and distal extension 150 comprises a plurality of inflow openings 160 which are in fluid communication with the suction lumen 170, such that the plurality of inflow openings 160 extend through the thickness of distal extension wall 174. Main body 102 comprises an inlet opening 126 and an outlet opening 1at its body proximal end 104, wherein the inlet opening 126 is in fluid communication with body internal space 120 and outflow openings 130, and outlet opening 128 is in fluid communication with suction lumen 170 and inflow openings 160. The outflow openings 1and body internal space 120 are fluidly sealed from the inflow openings 160 and suction lumen 170, such that two separate flow paths are defined in device 100: an inflow flow path directed from the inlet opening 126, via body internal space 120, towards and through the outflow openings 130, through which a fluid can be supplied and injected into a patient's oral cavity to rinse it, and an outflow flow path, which can be also referred to as a suction flow path, from the inflow openings 160, via suction lumen 170, toward and through the outlet opening 128, such that fluids can be aspirated from a patient's hypopharynx 50, or other suitable patient cavity at or distal to the oral cavity 40. Since the outflow openings 130 and any lumen or cavity in communication therewith, are fluidly sealed from the inflow openings 160 and any lumen or cavity in communication therewith, the fluids flowing through body internal space 120 and outflow openings 130 to rinse a patient's oral cavity 40 are not mixed in the device 100 with fluids suctioned through the inflow openings 160 and suction lumen 170. id="p-35"

[0035]The main body 102 comprises a sealed channel 122 defining a sealed channel lumen 124, and the distal extension 150 comprises an extension lumen 172 which is in fluid communication with, and continuous with, the sealed channel lumen 124, such that the suction lumen 170 is comprised by the sealed channel lumen 124 at a portion thereof extending through the main body 102, and by the extension lumen 172 at a portion thereof extending through the distal extension 150 and leading to the inflow openings 160. The device 100 comprises an extension opening 158 at the body distal end 106, fluidly open to the sealed channel lumen 1and the extension lumen 172, such that the sealed channel lumen 124 extends from the outlet opening 128 to the extension opening 158, and the extension lumen 172 extends distally from the extension opening 158, being in direct fluid communication with the inflow openings 160. The sealed channel 122 can separate between the sealed channel lumen 124 and the body internal space 120 and/or any lumen or cavity in communication therewith, such that the sealed channel lumen 124 is fluidly sealed from the body internal space 120 and the outflow openings 130. id="p-36"

[0036]In some examples, the outflow openings 130 can be formed at the body lateral sides 108. The body lateral sides 108 can define, in some examples, a curved outer surface such as in the form of U-shaped or V-shaped surfaces, though any other shape is contemplated. In the illustrated example, each lateral sides 108a and 108b is shown to include two series of outflow openings 130 arranged in parallel to each other, each comprising a plurality of axially spaced outflow openings 130 arranged between the body proximal end 104 and body distal end 106, such that a first series of outflow openings 130 can be upwardly oriented, and a second series of outflow openings can be downwardly oriented. It is to be understood that this arrangement is shown by way of illustration and not limitation, and that other arrangements of the outflow openings 130 over main body 102 are contemplated. For example, while shown at or in the vicinity of body lateral sides 108, some or all of the outflow openings 130 can be arranged over other portion of main body 102, such as over body upper sides 110 and/or body lower side 114, including at regions that can be closer to the center of main boy 102 between lateral sides 108. Similarly, any number of series of outflow openings 130 can be included, such as a single series of outflow openings 130, or any plurality of series of outflow openings 130. id="p-37"

[0037]In some examples, the plurality of inflow openings 160 can be defined at a distal end portion of the distal extension 150, closer to the extension distal end 156 than to the body distal end 106. In some examples, the inflow openings 160 can include, as illustrated, a series of posteriorly-oriented inflow openings 160a defined at the posterior-facing side 162, and a series of anteriorly-oriented inflow openings 160b defined at the anterior-facing side 164, as illustrated. It is to be understood that this arrangement is shown by way of illustration and not limitation, and that other arrangements of the inflow openings 160 over distal extension 150are contemplated. For example, inflow openings 160 can extend over any desired region of the distal extension 150, including closer to the body distal end 106. In some examples, the inflow openings 160 can be defined only over one side of the distal extension 150. For example, the posterior-facing side 162 can include posteriorly-oriented inflow openings 160a, while the anterior-facing side 164 can be devoid of inflow openings. In some examples, when device 1includes posteriorly-oriented inflow openings 160a and anteriorly-oriented inflow openings 160b, they can be differently sized and/or shaped from each other, and/or can span along different lengths or areas of the posterior-facing side 162 and anterior-facing side 164. id="p-38"

[0038]The inlet opening 126 is configured to be attached to an inflow tube 180 defining an inflow tube lumen 182, such that when connected, the inflow tube lumen 182 is in fluid communication with the inlet opening 126, body internal space 120, and outflow openings 130. In some examples, device 100 comprises an inlet port 127 (and example of which is indicated in Fig. 5) extending from the body proximal end 104 and comprising the inlet opening 126, the inlet port 127 configured to facilitate attached to the inflow tube 180 thereto. id="p-39"

[0039]The outlet opening 128 is configured to be attached to an outflow tube 184 defining an outflow tube lumen 186, such that when connected, the outflow tube lumen 186 is in fluid communication with the outlet opening 128 suction lumen 170, and inflow openings 160. In some examples, device 100 comprises an outlet port 129 (and example of which is indicated in Fig. 5) extending from the body proximal end 104 and comprising the outlet opening 128, the outlet port 129 configured to facilitate attached to the outflow tube 184 thereto. id="p-40"

[0040]Oral care device 100 is configured to be placed inside a patient over an endotracheal tube 10, such as shown and described in further detail below with respect to Figs. 6A-6D. In some examples, the device 100 can include a tube retainer 132 that can define a tube retainer opening 134 through which a the endotracheal tube 10 (or any other suitable tube) can extend. In some examples, the tube retainer 132 is in the form of a ring or loop defining a circular (or any other suitable shape) tube retainer opening 134, sized to accommodate an endotracheal tube 10. While not shown for simplicity in the figures of the present disclosure, it is to be understood that exemplary tube retainers 132 described herein can comprises a latch, a catch, a retention device, a quick and easy release, or similar securement means and/or mechanism for opening and closing the tube retainer 132, such that in the closed state of the tube retainer, it defines the tube retainer opening 134. In some examples, the tube retainer 132 can be proximal to the main body 102. id="p-41"

[0041]In some examples, the main body 102 can define a recessed alignment surface 1defined over body upper side 110. The recessed alignment surface 112 can be aligned with the tube retainer 132 and tube retainer opening 134, for example at the center of body upper side 110 between the body lateral sides 108, and can be shaped in the form of a curved (for example, semi-circular) surface, such as an upwardly concave surface, configured to accommodate the endotracheal tube 10 therein, allowing the device 100 and the endotracheal tube 10 to be slid relative to each other, aligning the endotracheal tube 10 in position through the tube retainer 132 and along the recessed alignment surface 112. The curvature, shape and size of the recessed alignment surface 112 can be designed to fit the size and shape of endotracheal tube 10. id="p-42"

[0042]In some examples, device 100 further comprises strap retainers 136, such as the two strap retainer 136a and 136b shown to extend laterally, proximal to main body 102, the strap retainer 136 configured to be attached or integrally formed with a strap (not shown) to secure the device 100 to the patient's head. Each strap retainer 136a, 136b can include a slot (shown but not separately annotated) through which an end of a strap can be inserted and connected to. In some examples, the device 100 comprises a strap (not shown) that can be optionally coupled to strap retainers 136, and can be in the form of a circumferential adjustable strap proximal to the main body 102. When included, a circumferential adjustable strap can facilitate fixation of the device 100 to a patient's head. id="p-43"

[0043]In some examples, the distal extension 150 can include a curved or U-shaped section 154 terminating at extension distal end 156. In some examples, distal extension 150 can be in the form of a loop that includes two side arms 152 extending distally from the body distal end 106, the side arms 152 leading to the U-shaped section 154, such that the side arms 152 and U-shaped section 154 can be integrally formed proximal and distal regions of a unitary distal extension 150, as illustrated. While shown to define a space between the side arms 152 in the illustrated examples, it is to be understood that this is shown by way of illustrated and not limitation, and that in some examples, distal extension 150 can be formed as a curved plate that includes a wall (e.g., portions of distal extension wall 174) extending between the side arms 152, in which case any reference to side arms 152 will reflect lateral sides of the distal extensions 150 which are not necessarily spaced from each other by absent material of the device 100. id="p-44"

[0044]In some examples, the oral care device 100 further comprises at least one curved support member. In some examples, the distal extension 150 comprises at least one curved support member. Any of the at least one curved support member can be in the form of a bridge extending between the lateral sides or side arms 152 of the distal extension 150, curved away from a surface defined between the side arms 152 and/or U-shaped section 154, such that the center of the curved support member, between both lateral sides or side arms 152, is offset from such a surface. In some examples, the device 100 comprises a first curved support member 166, and a second curved support member 168, as illustrated. The first curved support member 166 and the second curved support member 168 can be axially spaced from each other, wherein each can curve in an opposite direction relative to a surface defined between the side arms 1and/or U-shaped section 154. In the illustrated examples, the first curved support member 1can curve in a posterior and/or upper direction, while the second curved support member 168, shown to be positioned distal to the first curved support member 166, can curve in an anterior and/or lower direction. id="p-45"

[0045]The at least one curved support member is configured to align the distal extension 1over the endotracheal tube 10, facilitating easier sliding and positioning of the device 1relative to and along the endotracheal tube 10. For example, the first curved support member 166 in the illustrated example can be positioned over a posterior and/or upper side of the endotracheal tube 10, while the second curved support member 168 can be positioned over an anterior and/or lower side of the endotracheal tube 10. The curvature, size, and position of the at least one curved support member can be designed according to the size and shape of the endotracheal tube 10. Thus, the tube retainer 132, recessed alignment surface 112, and the at least one curved support member, such as any of the curved support members 166 and/or 168, can be aligned with each other and utilized to facilitate proper alignment of the device 100 over endotracheal tube 10, including easier and more accurate sliding of device 100 over endotracheal tube 10 and/or of endotracheal tube 10 through device 100. id="p-46"

[0046]When both the first curved support member 166 and the second curved support member 168 are included, they can provide improved support and alignment of the endotracheal tube 10, embracing the tube 10 from both posterior and anterior sides thereof for improved alignment and stability thereof. Nevertheless, it is to be understood that in some examples, the device 100 can include a single curved support member, which can be shaped in a similar manner to that of either the first curved support member 166 or the second curved support member 168, or more than two curved support members. When at least two curved support members are included, such as support members 166 and 168, they can be arranged such that a proximal curved support member is posteriorly-curved, and a distal curved support member is anteriorly-curved, as in the illustrated examples, or such that the proximal curved support member is anteriorly-curved, while the distal support member is posteriorly-curved. id="p-47"

[0047]In some examples, the main body 102 further comprises a inflow channel 140 defining an inflow channel lumen 142, wherein the inflow channel lumen 142 extends from the inlet opening 126 and is in fluid communication with body internal space 120 and outflow openings 130. The inflow channel 140 can include one or more inflow channel openings 148 which are exposed to inflow channel lumen 142 and are in fluid communication with body internal space 120 and outflow openings 130. The inflow channel lumen 142 is fluidly sealed from the sealed channel lumen 124. In some examples, the main body 102 does not necessarily include an inflow channel 140, such that inlet opening 126 may be directly exposed to body internal space 120 (example not illustrated). id="p-48"

[0048]In some examples, the device 100 is attachable of separately provided inflow tube 1and/or outflow tube 184. In some examples, the device 100 includes inflow tube 180 and/or outflow tube 184, which can be optionally integrally formed with main body 102 or portion(s) thereof. id="p-49"

[0049]When a separately provided inflow tube 180 is connected to device 100, the inflow tube lumen 182 is continuous with the inflow channel lumen 142 when main body 102 includes an inflow channel 140, or can be continuous with body internal space 120 when the main body 102 is devoid of an inflow channel 140. When a device 100 includes an integrally formed inflow tube 180, the inflow tube 180 can include a portion that extends into the main body 102, defining the inflow channel 140, such that the inflow channel lumen 142 is defined as a portion of the inflow tube lumen 182 that resides inside main body 102. id="p-50"

[0050]When a separately provided outflow tube 184 is connected to device 100, the outflow tube lumen 186 is continuous with the sealed channel lumen 124. When a device 100 includes an integrally formed outflow tube 184, the outflow tube 184 can include a portion that extends into the main body 102, defining the sealed channel 122, such that the sealed channel lumen 124 is defined as a portion of the outflow tube lumen 186 that resides inside main body 102. id="p-51"

[0051]In some examples, some parts or components of the oral care device 100, such as body wall 116 and/or distal extension wall 174, can be made of flexible biocompatible materials. Non-limiting examples of such materials may include silicon or other suitable flexible polymers. Flexibility of the oral care device 100, such as flexibility of main body 102 and/or distal extension 150, can facilitate easier insertion of device 100 into a patient, while avoiding the risk of harming tissue material due to otherwise increased rigidity of such components. id="p-52"

[0052]When main body 102 is formed of a relatively flexible material, injection of fluid at high pressure into body internal space 120 can cause undesirable inflation and deformation of the main body 102. Thus, in some examples, main body 102 can further include one or more body internal support 118 that can extend through body internal space 120 between body upper side 110 and body lower side 114, to provide structural support to main body 102. Though illustrated in Fig. 2E as a plurality of columnar body internal support 118, it is to be understood that other forms of body internal support 118 are contemplated, configured to prevent deformation and/or inflation of the main body 102 upon injecting pressurized fluid into body internal space 120. id="p-53"

[0053]When distal extension 150 is formed of a relatively flexible material, suction of fluid at negative pressure into extension lumen 172 can cause undesirable collapse and deformation of the distal extension 150. Thus, in some examples, distal extension 150 can further include one or more internal supports (not shown) that can extend through extension lumen 172 between posterior-facing side 162 and anterior-facing side 164, to provide structural support to distal extension 150. Though not illustrated, internal supports of distal extension 150 can be similarly formed to any examples of body internal support 118 described above, configured to prevent deformation and/or collapse of the distal extension 150 upon subjecting the extension lumen 172 to negative pressure. id="p-54"

[0054]While body internal space 120 is shown in the illustrated examples to extend across the majority of the volume defined by main body 102, generally tracking the contour of outer surfaces of main body 102, it is to be understood that this is shown by way of illustration and not limitation, and that other shapes of body internal space 120 are contemplated, including being formed as one or more tubular or otherwise formed chambers that can span across a portion of main body 102, and including various axially-extending channels or chambers that can be optionally fluidly connected by crossing lateral channels (examples not illustrated). id="p-55"

[0055]When vacuum or negative pressure is applied to suction fluids through inflow openings 160 into extension lumen 172, the negative pressure may press the inflow openings 160 against an anatomical wall, such as a wall of the hypopharynx 50, which may pose a risk of blocking at least some of the inflow openings 160. Thus, in some examples, distal extension 150 further comprises circumferential protrusions or bumpers (not shown) around the circumference of inflow openings 160, that can protrude outwards towards the anatomical wall of the hypopharynx 50, such that when negative pressure is applied, these protrusions contact the anatomical wall. The protrusions or bumpers can form uneven outer edges, for example by having a wavy shape around the circumference of the corresponding inflow openings 160, such that even when pressed against the wall of the hypopharynx 50, continued fluid flow may be maintained through the spaces formed along the throughs of such bumpers, into the inflow openings 160, thereby mitigating the risk of clogging the inflow openings 160. id="p-56"

[0056]The term "opening", with reference to any of the outflow openings 130, inflow opening 160, inlet opening 126, outlet opening 128, extension opening 158, and the like, refer to an orifice, a hole, an aperture, a gap, a perforation and the like, that can have a circular or any other shape through which fluid can flow. The term "effective diameter", with respect to some openings disclosed herein, such as outflow openings 130 and/or inflow openings 160, refers to the diameter required for a circle to circumscribe the corresponding opening. id="p-57"

[0057]An outflow opening 130 can define an effective diameter DO (indicated, for example, in Fig. 2C), and an inflow opening 160 can define an effective diameter D I (indicated, for example, in Fig. 2F). In some examples, outflow openings 130 can be provided in non-identical shapes and/or sizes, in which case, any reference herein to an effective diameter DO of outflow openings 130 can refer to an averaged value of the effective diameters of outflow openings 130.. In some examples, inflow openings 160 can be provided in non-identical shapes and/or sizes (for example, inflow openings 160b are shown to be differently shaped from inflow openings 160a in the illustrated examples), in which case, any reference herein to an effective diameter DI of inflow openings 160 can refer to an averaged value of the effective diameters of inflow openings 160. id="p-58"

[0058]The size of each opening can be designed to fill its role. For example, it may be desired to enable high-velocity jets to stream out of outflow opening 130 to rinse a patient's oral cavity, in which case the effective diameter DO of outflow openings 130 can be relatively small to facilitate higher outflow velocity, and as illustrated in Fig. 2E for example, each outflow opening 130 can be formed as an exit opening of a tubular nozzle. In contrast, it may be desirable to allow a large volume of fluid to be suctioned through inflow openings 160, in which case the effective diameter DI of inflow openings 160 can be relatively large to allow entrance of fluid flow therethrough. In some examples, the effective diameter DI of inflow openings 160 is greater than effective diameter DO of outflow openings 130. In some examples, the effective diameter DI of inflow openings 160 is at least two times greater than the effective diameter DO of outflow openings 130. In some examples, the effective diameter DI of inflow openings 160 is at least three times greater than the effective diameter DO of outflow openings 130. id="p-59"

[0059]Various exemplary implementations for oral care device 100, and/or components thereof, can be referred to, throughout the specification, with superscripts, for ease of explanation of features that refer to such exemplary implementations. It is to be understood, however, that any reference to structural or functional features of any device or component, without a superscript, refers to these features being commonly shared by all specific exemplary implementations that can be also indicated by superscripts. In contrast, features emphasized with respect to an exemplary implementation of any device or component, referred to with a superscript, may be optionally shared by some but not necessarily all other exemplary implementations. For example, oral care device 100a illustrated in Figs. 2A-4 is an exemplary implementation of oral care device 100, and thus includes all of the features described for oral care device 100 throughout the current disclosure, except that while an oral care device 1can have any arrangement of inflow tube 180 and outflow tube 184 included in or attachable to device 100, the oral care device 100a is adapted for use with a tube-in-tube arrangement. id="p-60"

[0060]In some examples, the inlet opening 126 and outlet opening 128 can be arranged around each other, optionally, but not necessarily, in a concentric manner. Figs. 2A-4 show an exemplary oral care device 100a that includes an outlet opening 128 arranged around an inlet opening 126, connectable or connected to an inflow tube 180 extending through an outflow tube 184 in a tube-in-tube arrangement. For an oral care device 100a implemented to include an inflow channel 140, the inflow channel 140 extends through the sealed channel 122. Fig. is a cross-sectional view across line 4-4 of Fig. 2E, showing an optional implementation of channel-in-channel arrangement of exemplary oral care device 100a. id="p-61"

[0061]As mentioned above, the inflow channel lumen 142 should be in fluid communication with body internal space 120, while the seal channel lumen 124 should be fluidly sealed from body internal space 120. In the illustrated example, inflow channel 140 can include a plurality of inflow channel openings 148 exposed to the inflow channel lumen 142, and the sealed channel 122 can include a plurality of sealed channel openings 146 exposed to the body internal space 120, wherein a plurality of radial channels 144 extend between the inflow channel openings 148 and the sealed channel openings 146 so as to enable fluid communication between the inflow channel lumen 142 and the body internal space 120 through the sealed channel 122, while the radial channels 144 are sealed from the sealed channel lumen 124 to prevent the sealed channel lumen 124 from being exposed to the sealed channel openings 1and body internal space 120. id="p-62"

[0062]When an oral care device 100 is provided with an inflow channel 140, the inflow channel 140 can terminate at an inflow channel distal end 138, which can be proximal to the body distal end 106 as shown in Figs. 3A-3B for example, or can terminate at or even distal to the body distal end 106 (examples not shown). If the channel distal end 138 is distal to the body distal end 106, the portion of the inflow channel 140 extending into the distal extension 1can be devoid of inflow channel openings 148. id="p-63"

[0063]The extension lumen 172, defined as the portion of the suction lumen 170 continuously extending from the extension opening 158 into and through distal extension 150, is exposed to the plurality of inflow openings 160, and can terminate at suction lumen distal end 176. In some examples, suction lumen distal end 176 resides inside distal extension 150, past the series of inflow openings 160, optionally at an opposite side to the side extending from extension opening 158. In some examples, the extension lumen 172 can extend along the entire circumference of the distal extension 150, such that suction lumen 170 further extends back into main body 102, resulting in the suction lumen distal end 176 positioned proximal to the body distal end 106 (example not shown). In such examples, the portion of suction lumen 1extending back into main body 102 will be similarly fluidly sealed from body internal space 120. id="p-64"

[0064]While a tube-in-tube and channel-in-channel arrangements of oral care device 100a are illustrated to include an inlet opening 126 defined inside an outflow openings 130, such that the effective diameter of inlet opening 126, of inflow tube lumen 182, and of inflow channel lumen 142, is smaller than the effective diameter of outflow opening 130, of outflow tube lumen 186, and of sealed channel lumen 124, respectively, it is to be understood that these arrangements can be reversed. For example, an outflow opening 130 can be defined inside of an inlet opening 126, with the outflow tube 184 extending through the inflow tube 180 and the sealed channel 122 extending through the inflow channels 140, such that the effective diameter of inlet opening 126, of inflow tube lumen 182, and of inflow channel lumen 142, is greater than the effective diameter of outflow opening 130, of outflow tube lumen 186, and of sealed channel lumen 124, respectively. In such examples, there is no need for inclusion of radial channels 144 and the sealed channels 122 can be devoid of sealed channel opening 146, while inflow channel openings 148 can expose the inflow channel lumen 142 directly to the body internal space 120. id="p-65"

[0065]Fig. 5 is a view in perspective of an exemplary oral care device 100b, which is an exemplary implementation of oral care device 100, and thus includes all of the features described for oral care device 100 throughout the current disclosure, except that oral care device 100b is adapted for use with inflow tube 180 and outflow tube 184 which are separated from each other, without extending through each other. In the illustrated example, an inflow tube 180 is shown to be connected to an inlet opening 126 in proximity to a first body lateral side 108a, while the outflow tube 184 is shown to be connected to an outlet opening 128 in proximity to a second body lateral side 108b, opposite to the first body lateral side 108a. When the oral care device 100b comprises an inflow channel 140, the inflow channel 140 can be closer to the first body lateral side 108a, while the sealed channel 122 can be closer to the second body lateral side 108b. The inflow channel 140 can include a plurality of inflow channel openings 148, and can terminate at an inflow channel distal end 138 that can be proximal to the body distal end 106 as illustrated in Fig. 5, or the inflow channel distal end 138 can be at or distal to the body distal end 106 as described above. The suction lumen 170 can terminate at a suction lumen distal end 176 that can be generally positioned at or proximate to a side arm 152a as illustrated in Fig. 5, or can further extend back into main body 102 as described above. id="p-66"

[0066]While two separated tubes 180, 184 are illustrated in Fig. 5 to connect, each, with corresponding inlet 126 and outlet 128 openings defined at opposite lateral sides of the main body 102, it is to be understood that other arrangement are contemplated, such as the inlet opening 126 and outlet opening 128 arranged, side by side and/or atop each other at the same lateral side of the device 100, adapted for used with inflow 180 and outflow 184 tubes that can be provided in tandem arrangements (examples not shown). id="p-67"

[0067]Figs. 6A-6D show steps in an exemplary method for insertion of an oral care device 100 into a patient. The oral care device 100 can be inserted so as to position the main body 1inside the patient's oral cavity 40, and the distal extension 150 in the pharynx of an intubated human subject. An endotracheal tube 10 can be inserted according to any conventional method known to those skilled in the art, after which insertion of the oral care device 100 can be accomplished utilizing the endotracheal tube 10 as a guide tube. For example, a proximal portion of the endotracheal tube 10 can be initially positioned between the first curved support member 166 and the second curved support member 168, as shown in Fig. 6A, allowing the device 100 to be distally slid such that the proximal portion of the tube 10 is placed over recessed alignment surface 112 of the main body 102, as shown in Fig. 6B. id="p-68"

[0068]The device 100 is further distally slid in this manner, as shown in Fig, 6C, pushing the distal extension into the pharynx, until the main body 102 is properly positioned in the patient oral cavity 40 as shown in Fig. 6D, and the distal extension 150 extending into the hypopharynx 50, with the proximal portion of the endotracheal tube 10 extending through the tube retainer. In the final position shown in Fig. 6D, the body lower side 114 is placed over the tongue with the body upper side 110 facing the soft palate 30, and the U-shaped section 154 of the distal extension 150 is placed in the hypopharynx 50, posterior to the laryngeal inlet and the adjacent endotracheal tube segment entering the glottis. The inflow tube 180 can be connected to a pump or injector (not shown) that supplies pressurized fluid into body internal space 120. The outflow tube 184 can be connected to a vacuum source or suction pump (not shown) that negative pressure to aspirate fluid from the patient into suction lumen 170. id="p-69"

[0069]In use, a fluid, such as water or a disinfectant that can include chlorhexidine or a mixture thereof, is injected from an external reservoir by a pump or injector, via inflow tube lumen 182, into body internal space 120, and is subsequently jetted via the plurality of outflow openings 130 into the oral cavity 40. In order to prevent such injected excess fluid from being accumulated in, or traveling further down the patient's respiratory tract, at least a portion of the fluid, which can be mixed with the patient's bodily fluids (such as saliva and the like), is evacuated from the patient by being sucked through the plurality of inflow openings 160 into the suction lumen 170, and subsequently via outflow tube lumen 186 towards the external pump. The aspirated fluid may be then drained or collected and optionally analyzed. The fluid can be any liquid or gas, can include therapeutic agents, and can be in the form of a liquid paste in some examples. id="p-70"

[0070]In some examples, the oral care device further comprises at least one sensor 190, which can be a camera or any other suitable type of sensor. In some examples, the sensor 190 can be attached to the at least one curved support member, such as to the first curved support member 166 in the illustrated example. In some examples, the sensor 190, which can be n the form of an optical sensor such as a camera, is capable of sensing and/or filming the process and can be operationally coupled to a circuitry (not shown) for analyzing the acquired data, such as data related to the composition of fluids surrounding portions of the device 100. While a single sensor 190 is illustrated, n some examples, the device 100 comprises two or more sensors, at least one of which can be in the form of a camera. For example, one sensor 190 can be coupled to the first curved support member 166 and another sensor 190 can be coupled to the second curved support member 168. In some examples, two or more sensors can be coupled to the same curved support member. In some examples, at least two sensors 190 can be of different types, configured to measure different parameters, such as one of the sensor 190 being implemented as a camera, another sensor 190 being implemented as a Ph sensor, and the like. id="p-71"

[0071]In some examples, a sensor 190, such as a camera, can be used to acquire data regarding the patient's oral secretion and pharyngeal mucosa. For example, imagery of mucosal color and texture may be acquired and analyzed, optionally utilizing artificial intelligence and machine learning algorithms, to associate between mucosal appearance and composition and various pathologies such as inflammation. In some examples, a sensor 190 can be used to detect and identify the presence of bacteria in the pharyngeal space in real time, wherein therapeutic agent can be supplied via outflow openings, in response to the type and concentration of detected bacteria.

Some Examples of the Disclosed Implementations id="p-72"

[0072]Some examples of above-described implementations are enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more examples below are examples also falling within the disclosure of this application. id="p-73"

[0073]Example 1. An oral care device comprising: a main body comprising: an inlet opening; an outlet opening; a plurality of outflow openings in fluid communication with the inlet opening; and a sealed channel defining a sealed channel lumen, wherein the sealed channel lumen is in fluid communication with the outlet opening and is fluidly sealed from the plurality of outflow openings; a distal extension distally extending from a body distal end of the main body, the distal extension comprising: an extension lumen which is in fluid communication with the sealed channel lumen; and a plurality of inflow openings in fluid communication with the extension lumen and fluidly sealed from the plurality of outflow openings. id="p-74"

[0074]Example 2. The oral care device of claim 1, wherein the main body further comprises a body internal space in fluid communication with the inlet opening and with the plurality of outflow openings, and fluidly sealed from the sealed channel lumen. id="p-75"

[0075]Example 3. The oral care device of claim 2, wherein the main body further comprises an inflow channel defining an inflow channel lumen extending from the inlet opening, wherein the inflow channel comprises one or more inflow channel openings exposed to the inflow channel lumen and in fluid communication with the body internal space. id="p-76"

[0076]Example 4. The oral care device of claim 3, wherein the sealed channel is disposed around the inflow channel, and wherein the sealed channel comprises one or more sealed channel openings which are exposed to the body internal space and are in fluid communication with the one or more inflow channel openings, and wherein the sealed channel lumen is fluidly sealed from the one or more sealed channel openings. id="p-77"

[0077]Example 5. The oral care device of claim 4, further comprising one or more radial channels extending between the one or more sealed channel openings and the one or more inflow channel openings, and wherein the sealed channel lumen is fluidly sealed from the one or more radial channels. id="p-78"

[0078]Example 6. The oral care device of any one of claims 1 - 5, wherein the inlet opening is disposed inside the outlet opening. id="p-79"

[0079]Example 7. The oral care device of any one of claims 1 - 6, wherein the inflow openings define an effective diameter which is greater than an effective diameter defined by the outflow openings. id="p-80"

[0080]Example 8. The oral care device of claim 7, wherein the effective diameter of the inflow openings is at least two times greater than the effective diameter of the outflow openings. id="p-81"

[0081]Example 9. The oral care device of claim 7, wherein the effective diameter of the inflow openings is at least three times greater than the effective diameter of the outflow openings. id="p-82"

[0082]Example 10. The oral care device of any one of claims 1 - 9, wherein the plurality of outflow openings are disposed over body lateral sides of the main body. id="p-83"

[0083]Example 11. The oral care device of claim 2, wherein the main body further comprises one or more body internal supports extending therethrough, between a body upper side and a body lower side of the main body. id="p-84"

[0084]Example 12. The oral care device of any one of claims 1 - 10, wherein the distal extension further comprises one or more internal supports extending through the extension lumen. id="p-85"

[0085]Example 13. The oral care device of any one of claims 1 - 10, wherein a body upper side of the main body defines a recessed alignment surface. id="p-86"

[0086]Example 14. The oral care device of any one of claims 1 - 13, further comprising a tube retainer defining a tube retainer opening. id="p-87"

[0087]Example 15. The oral care device of any one of claims 1 - 14, further comprising strap retainers. id="p-88"

[0088]Example 16. The oral care device of any one of claims 1 - 15, wherein the distal extension comprises a U-shaped section. id="p-89"

[0089]Example 17. The oral care device of any one of claims 1 - 16, wherein the distal extension further comprises at least one curved support member extending between side arms of the distal extension. id="p-90"

[0090]Example 18. The oral care device of claim 17, wherein the at least one curved support member comprises a first curved support member and a second curved support member. id="p-91"

[0091]Example 19. The oral care device of claim 18, wherein the first curved support member and the second curved support member are curved in opposite directions, relative to a plane defined between the side arms. id="p-92"

[0092]Example 20. The oral care device of any one of claims 17 - 19, further comprising at least one sensor attached to the at least one curved support member. id="p-93"

[0093]Example 21. The oral care device of claim 20, wherein the at least one sensor comprises a camera. id="p-94"

[0094]Example 22. The oral care device of any one of claims 1 - 21, wherein the distal extension is curved relative to the main body. id="p-95"

[0095]Example 23. The oral care device of any one of claims 1 - 22, further comprising an inflow tube defining an inflow tube lumen which is in fluid communication with the inlet opening. id="p-96"

[0096]Example 24. The oral care device of any one of claims 1 - 23, further comprising an outflow tube defining an outflow tube lumen which is in fluid communication with the outlet opening. id="p-97"

[0097]Example 25. The oral care device of any one of claims 1 - 24, further comprising circumferential protrusions formed around the circumference of the inflow openings. id="p-98"

[0098]Example 26. The oral care device of claim 25, wherein the circumferential protrusions form uneven outer edges. id="p-99"

[0099]It is appreciated that certain features of the disclosure, which are, for clarity, described in the context of separate examples, may also be provided in combination in a single example. Conversely, various features of the disclosure, which are, for brevity, described in the context of a single example, may also be provided separately or in any suitable sub-combination or as suitable in any other described example of the disclosure. No feature described in the context of an example is to be considered an essential feature of that example, unless explicitly specified as such. id="p-100"

[0100]In view of the many possible examples to which the principles of the disclosure may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope. Rather, the scope is defined by the following claims. We therefore claim all that comes within the scope and spirit of these claims.

Claims

1. An oral care device comprising: a main body comprising: an inlet opening; an outlet opening; a plurality of outflow openings in fluid communication with the inlet opening; and a sealed channel defining a sealed channel lumen, wherein the sealed channel lumen is in fluid communication with the outlet opening and is fluidly sealed from the plurality of outflow openings; a distal extension distally extending from a body distal end of the main body, the distal extension comprising: an extension lumen which is in fluid communication with the sealed channel lumen; and a plurality of inflow openings in fluid communication with the extension lumen and fluidly sealed from the plurality of outflow openings.

2. The oral care device of claim 1, wherein the main body further comprises a body internal space in fluid communication with the inlet opening and with the plurality of outflow openings, and fluidly sealed from the sealed channel lumen.

3. The oral care device of claim 2, wherein the main body further comprises an inflow channel defining an inflow channel lumen extending from the inlet opening, wherein the inflow channel comprises one or more inflow channel openings exposed to the inflow channel lumen and in fluid communication with the body internal space.

4. The oral care device of claim 3, wherein the sealed channel is disposed around the inflow channel, and wherein the sealed channel comprises one or more sealed channel openings which are exposed to the body internal space and are in fluid communication with the one or more inflow channel openings, and wherein the sealed channel lumen is fluidly sealed from the one or more sealed channel openings.

5. The oral care device of claim 4, further comprising one or more radial channels extending between the one or more sealed channel openings and the one or more inflow channel openings, and wherein the sealed channel lumen is fluidly sealed from the one or more radial channels.

6. The oral care device of any one of claims 1 - 5, wherein the inlet opening is disposed inside the outlet opening.

7. The oral care device of any one of claims 1 - 6, wherein the inflow openings define an effective diameter which is greater than an effective diameter defined by the outflow openings.

8. The oral care device of claim 7, wherein the effective diameter of the inflow openings is at least two times greater than the effective diameter of the outflow openings.

9. The oral care device of claim 7, wherein the effective diameter of the inflow openings is at least three times greater than the effective diameter of the outflow openings.

10. The oral care device of any one of claims 1 - 9, wherein the plurality of outflow openings are disposed over body lateral sides of the main body.

11. The oral care device of claim 2, wherein the main body further comprises one or more body internal supports extending therethrough, between a body upper side and a body lower side of the main body.

12. The oral care device of any one of claims 1 - 10, wherein the distal extension further comprises one or more internal supports extending through the extension lumen.

13. The oral care device of any one of claims 1 - 10, wherein a body upper side of the main body defines a recessed alignment surface.

14. The oral care device of any one of claims 1 - 13, further comprising a tube retainer defining a tube retainer opening.

15. The oral care device of any one of claims 1 - 14, further comprising strap retainers.

16. The oral care device of any one of claims 1 - 15, wherein the distal extension comprises a U-shaped section.

17. The oral care device of any one of claims 1 - 16, wherein the distal extension further comprises at least one curved support member extending between side arms of the distal extension.

18. The oral care device of claim 17, wherein the at least one curved support member comprises a first curved support member and a second curved support member.

19. The oral care device of claim 18, wherein the first curved support member and the second curved support member are curved in opposite directions, relative to a plane defined between the side arms.

20. The oral care device of any one of claims 17 - 19, further comprising at least one sensor attached to the at least one curved support member.

21. The oral care device of claim 20, wherein the at least one sensor comprises a camera.

22. The oral care device of any one of claims 1 - 21, wherein the distal extension is curved relative to the main body.

23. The oral care device of any one of claims 1 - 22, further comprising an inflow tube defining an inflow tube lumen which is in fluid communication with the inlet opening.

24. The oral care device of any one of claims 1 - 23, further comprising an outflow tube defining an outflow tube lumen which is in fluid communication with the outlet opening.

25. The oral care device of any one of claims 1 - 24, further comprising circumferential protrusions formed around the circumference of the inflow openings.

26. The oral care device of claim 25, wherein the circumferential protrusions form uneven outer edges. For the Applicant, Webb+Co. Patent Attorneys