WO2025160339A1

WO2025160339A1 - Oral care device

Info

Publication number: WO2025160339A1
Application number: PCT/US2025/012866
Authority: WO
Inventors: Jacob Marshall Rolnick HORSEY; Kathryn ATWELL; Deanne McCARTHY; Christopher Gillespie; Matthew Page; Aaron CANTRELL
Original assignee: Swiftsure Innovations Inc
Current assignee: Swiftsure Innovations Inc
Priority date: 2024-01-26
Filing date: 2025-01-24
Publication date: 2025-07-31
Anticipated expiration: 2026-07-26

Abstract

A device includes a first element having a tube, a distal end, and a first aperture positioned proximate the distal end. The distal end can suction fluid from an oral cavity or a patient via the first aperture. A second element includes a body to provide fluid into the oral cavity via a second aperture. A first port is fluidly coupled with the first element to provide negative pressure to the first element to suction fluid from the oral cavity via the first aperture. A second port is fluidly coupled with the second element to provide fluid into oral cavity via the second aperture. A guide is coupled with the second element and defines an opening that can receive the tube to movably couple the tube with the second element to selectively reposition the distal end within the oral cavity.

Description

ORAL CARE DEVICE

CROSS-REFERENCE TO RELATED PATENT APPLICATION

[0001] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63/625,895, filed January 26, 2024, which is incorporated herein by reference in its entirety.

BACKGROUND

[0002] Medical patients, such as patients who are mechanically ventilated, can require a tube (e.g., an endotracheal tube) inserted into their trachea. The tube can obstruct access to a patient’s mouth and prevent adequate administration of oral care to the patient.

SUMMARY

[0003] Disclosed herein are various configurations of a device for insertion into an oral cavity of a patient to allow for irrigation and suction to occur with ease as well as for one or more methods for use of the device. The device can include a first element (e.g., a suction element) that can suction a fluid from the oral cavity and a second element (e.g., an irrigation element) that can provide the fluid to the oral cavity. The first element can be movably coupled to the second element via a guide such that the first element can be selectively repositioned within the oral cavity of the patient. For example, the first element can include tube that can be movably coupled with a guide such that the first element can slide (e.g., translate axially) or rotate relative to the guide to reposition a distal end of the first element within the oral cavity. The tube of the first element or portion thereof can be or include a flexible material such that the first element is bendable or posable. For example, the distal end of the first element can be selectively repositioned within the oral cavity of the patient by bending or otherwise articulating the tube. The guide can be integrally coupled with the second element such that coupling the first element with the guide can couple the first element with the second element. The tube (or the first element more broadly) can be or include a Yankauer suction device that can, when coupled to the second element, form an oral care device that can both provide irrigation fluid to the oral cavity of the patient and remove the same fluid (along with any undesirable debris or particulate matter residing within the oral cavity of the patent) to cleanse or treat the oral cavity of the patient.

[0004] At least one aspect is directed to a device. The device can be a medical device or an oral care device. The device can include a first element having a tube, a distal end, and a first aperture positioned proximate the distal end. The distal end can be positioned within an oral cavity of a patient to suction fluid from the oral cavity via the first aperture. The device can include a second element. The second element can include a body and a second aperture. The body can be placed within the oral cavity to provide fluid into the oral cavity via the second aperture. The device can include a first port fluidly coupled with the first element to provide a negative pressure to the distal end of the first element to suction fluid from the oral cavity via the first aperture. The device can include a second port fluidly coupled with the second element to provide fluid into oral cavity via the second aperture. The device can include a guide coupled with the second element and defining an opening. The opening can receive at least a first portion of the tube to movably couple the tube with the second element. The tube can move relative to the guide to selectively reposition the distal end of the first element within the oral cavity.

|0005| At least one aspect relates to a device. The device can be an oral care device or a medical device. The device can include a first element having a tube, a distal end, and a first aperture positioned proximate the distal end. The distal end can be positioned within an oral cavity of a patient. The first element can be couplable with a suction source to cause the first element to suction fluid from the oral cavity via the first aperture. The device can include a second element having a body and a second aperture. The body can be positioned within the oral cavity. The second element can be couplable with an irrigation source to cause the second element to provide fluid into the oral cavity via the second aperture. The device can include a flexible bridge coupled with the first element and the second element. The bridge can include a guide having an opening. The opening of the guide can receive at least a first portion of the tube to movably couple the tube with the second element. The tube can move relative to the guide to selectively reposition the distal end of the first element within the oral cavity. [0006] At least one aspect relates to an apparatus. The apparatus can be an oral care device or a medical device. The apparatus can include a body having including a top surface, a bottom surface, an aperture, and a tapered edge, the tapered edge extending at least partially around an outer boundary of the body. The body can be positioned within an oral cavity of a patient at least partially between upper and lower teeth of the patient, the aperture positioned proximate to the tapered edge on at least one of the top surface and the bottom surface of the body, the aperture to provide an irrigation fluid within the oral cavity. The apparatus can include a port coupled with the body. The port can receive the irrigation fluid from an irrigation fluid source and provide the irrigation fluid to the body. The apparatus can include a bridge integrally coupled with the port. The bridge can include a guide defining an opening. The bridge extending from the port to position the opening of the guide a distance from the port. The opening of the guide can slidably receive a tube of a suction element and permit selective movement of a suction element within the oral cavity.

[0007] At least one aspect relates to a method. The method can be a method of irrigating an oral cavity. For example, the method can include placing an oral care device within the oral cavity of the patient. The method can include irrigating the oral cavity with fluid delivered using a first element or a second element of the oral care device. The method can include suctioning the fluid out of the oral cavity by suctioning provided through the first element or the second element of the oral care device.

[0008] At least one aspect relates to a method. The method can be a method of providing a device. The device can be an oral care device or a medical device. For example, the device can include a first element having a tube, a distal end, and a first aperture positioned proximate the distal end. The distal end can be positioned within an oral cavity of a patient to suction fluid from the oral cavity via the first aperture. The device can include a second element. The second element can include a body and a second aperture. The body can be placed within the oral cavity to provide fluid into the oral cavity via the second aperture. The device can include a first port fluidly coupled with the first element to provide a negative pressure to the distal end of the first element to suction fluid from the oral cavity via the first aperture. The device can include a second port fluidly coupled with the second element to provide fluid into oral cavity via the second aperture. The device can include a guide coupled with the second element and defining an opening. The opening can receive at least a first portion of the tube to movably couple the tube with the second element, the tube to move relative to the guide to selectively reposition the distal end of the first element within the oral cavity.

[0009] There is provided herein a medical device for suction and irrigation of an oral cavity in a patient, the device comprising: a first element comprising a tube to be placed at a first location of the oral cavity, the tube having a distal end and being posable within the first location, the first element further comprising at least one aperture configured to transfer fluid into and out of the oral cavity; a second element comprising a body for placement in a second location of the oral cavity and comprising one or more apertures to transfer fluid into and out of the oral cavity; a first port that is fluidically coupled to the first element for providing at least one of a negative pressure thereto for suctioning at least a first portion of the oral cavity during use and a fluid thereto for irrigating at least the first portion of the oral cavity during use; a second port that is fluidically coupled to the second element for providing at least one of the fluid thereto for irrigating at least a second portion of the oral cavity during use and the negative pressure thereto for suctioning at least the second portion of the oral cavity during use; and a guide for positioning the first element within the first location of the oral cavity, the guide integrally connected to the second port.

[001.0] In at least one embodiment, the tube of the first element comprises one or more apertures.

[0011] In at least one embodiment, at least one aperture is located at the distal end of the tube of the first element.

[0012] In at least one embodiment, the guide is configured to control the location of the distal end of the first element within the oral cavity when the device is placed within the oral cavity. [0013] In at least one embodiment, the first element is moldable such that the distal end of the first element is located anywhere within the first location of the oral cavity when the device is placed within the oral cavity.

[0014] In at least one embodiment, an external suction line is fluidly coupled to the first port to provide the negative pressure thereto to the first element for suctioning the oral cavity.

[0015] In at least one embodiment, an external irrigation line is fluidly coupled to the first port to provide the fluid thereto to the first element for irrigating the oral cavity.

[0016] In at least one embodiment, an external suction line and an internal irrigation line are fluidly coupled to the first port.

[0017] In at least one embodiment, an external suction line is fluidly coupled to the second port to provide the negative pressure thereto to the second element for suctioning the oral cavity.

[0018] In at least one embodiment, an external irrigation line is fluidly coupled to the second port to provide the fluid thereto to the second element for irrigating the oral cavity.

[0019] In at least one embodiment, an external suction line and an internal irrigation line are fluidly coupled to the second port.

[0020] In at least one embodiment, the external irrigation line comprises a distal connector to fluidly couple to an external irrigation device.

[0021] In at least one embodiment, the external suction line comprises a distal connector to fluidly couple to an external suction device.

[0022] In at least one embodiment, the body of the second element comprises a top surface, a bottom surface, and an edge around an outer border of the top surface and the bottom surface and is for placement between the upper and lower teeth of the patient, and the outlets are located proximally to the edge on at least one of the top surface and the bottom surface of the plate of the second element. [0023| In at least one embodiment, the body of the second element comprises a top surface, a bottom surface, and an edge around an outer border of the top surface and the bottom surface and is for placement between the upper and lower teeth of the patient, and the outlets are located on at least one of the top surface and the bottom surface of the second element.

[0024] In at least one embodiment, the body of the second element comprises first and second elongated arms, the first elongated arm for placement on the exterior of the dentition and the second elongated arm for placement on the interior of the dentition of the patient, and the outlets are located along the first and second elongated arms of the second element.

[0025] In at least one embodiment, the body of the second element further comprises a connecting arm for joining a distal end of each of the first and second elongated arms, the connecting arm for placement between a rear of the oral cavity and the dentition of the patient such that the first elongated arm, the second elongated arm, and the connecting arm surround the perimeter of the dentition, and the outlets are located along the connecting arm.

[0026] In at least one embodiment, the device comprises an interior channel that is located within the second element and has a first end that is fluidly coupled to the second port and a second end that is fluidically coupled to the one or more outlets.

[0027] In at least one embodiment, the first element further comprises an end cap at the distal end of the tube.

[0028] In at least one embodiment, the device comprises a bridge that is adapted to couple the first element to the second element, the bridge being integrally connected to the second element.

[0029] In at least one embodiment, the guide is integrally connected to the bridge.

[0030] In another aspect, in accordance with the teachings herein, there is provided a medical device for suction and irrigation of an oral cavity in a patient, the device comprising: a first element configured to be placed at a first location of the oral cavity, the first element comprising a first plate for placement between upper and lower teeth at the first location of the oral cavity and a first paddle for placement between a cheek and a dentition of the patient at the first location, the first element further comprising at least one suction inlet configured to suction fluid out of the oral cavity and one or more irrigation outlets configured to irrigate the oral cavity with fluid; a second element configured to be placed at a second location of the oral cavity, the second element comprising a second plate for placement between upper and lower teeth at the second location of the oral cavity and a second paddle for placement between a cheek and the dentition of the patient at the second location, the second element further comprising at least one suction inlet configured to suction fluid out of the oral cavity and one or more irrigation outlets configured to irrigate the oral cavity with fluid; a first port that is fluidically coupled to the first element for providing a negative pressure thereto for suctioning at least a first portion of the oral cavity during use and providing a fluid thereto for irrigating at least the first portion of the oral cavity during use; and a second port that is fluidically coupled to the second element for providing negative pressure thereto for suctioning at least a second portion of the oral cavity during use and providing the fluid thereto for irrigating at least the second portion of the oral cavity during use.

[0031] In at least one embodiment, the first port is fluidly coupled to a first line, the first line having a first interior lumen for providing a negative pressure for suctioning and a second interior lumen for providing the fluid for irrigation.

[0032] In at least one embodiment, the second port is fluidly coupled to a second line, the second line having a first interior lumen for providing a negative pressure for suctioning and a second interior lumen for providing the fluid for irrigation.

[0033] In at least one embodiment, the first line and the second line are fluidly connected to an external suction line and an external irrigation line.

[0034] In at least one embodiment, the external irrigation line comprises a distal connector to fluidly couple to an external irrigation device. [0035| In at least one embodiment, the external suction line comprises a distal connector to fluidly couple to an external suction device.

[0036] In at least one embodiment, the first interior lumen of the first line and the first interior lumen of the second line are fluidly connected to the external suction line by a fluid controller.

[0037] In at least one embodiment, the second interior lumen of the first line and the second interior lumen of the second line are fluidly connected to the external irrigation line by a fluid controller.

[0038] In at least one embodiment, the device comprises a bridge that is adapted to couple the first element to the second element.

[0039] In at least one embodiment, the device further comprises a clip that is adapted to be releasably coupled to the first port and the second port and located exterior to the oral cavity during use, wherein the clip is configured to control a distance between inner edges of the first element and the second element when the device is placed within the oral cavity.

[0040] In at least one embodiment, the device comprises an interior suction channel within the first element having a first end that is fluidly coupled to the first port and a second end that is fluidically coupled to the at least one suction inlet of the first element.

[00411 In at least one embodiment, the device comprises an interior suction channel within the second element having a first end that is fluidly coupled to the second port and a second end that is fluidically coupled to the at least one suction inlet of the second element.

[0042] In at least one embodiment, the device comprises an interior irrigation channel within the first element having a first end that is fluidly coupled to the first port and a second end that is fluidically coupled to the one or more irrigation elements of the first element. ]0043| In at least one embodiment, the device comprises an interior irrigation channel within the second element having a first end that is fluidly coupled to the second port and a second end that is fluidically coupled to the one or more irrigation elements of the second element.

[0044] In at least one embodiment, the first paddle of the first element and the second paddle of the second element are each for placement between the cheek and the lower teeth of the patient.

[0045] In at least one embodiment, the first paddle of the first element and the second paddle of the second element are each for placement between the cheek and the upper teeth of the patient.

[0046] In another aspect, in accordance with the teachings herein, there is provided at least one embodiment of a kit for irrigation of an oral cavity of a patient, the kit comprising: a medical device defined in accordance with any one of the embodiments described herein; and a medical instrument for placement within the oral cavity of the patient.

[0047] In at least one embodiment, the medical instrument is an endotracheal tube, a dental instrument or a disposable oral care product.

[0048] In another aspect, in accordance with the teachings herein, there is provided at least one embodiment of a method for irrigating and suctioning an oral cavity in a patient, the method comprising: placing at least one element of a medical device within the oral cavity of the patient, the medical device being defined according to any one of the embodiments described herein; irrigating the oral cavity with fluid delivered; and suctioning the fluid or any other liquids out of the oral cavity.

[0049] In at least one embodiment, the first element of the medical device is placed within the oral cavity of the patient.

[0050 In at least one embodiment, the second element of the medical device is placed within the oral cavity of the patient.

[0051 ] In at least one embodiment, the method further comprises receiving an endotracheal tube. [0052| In at least one embodiment, the method further comprises fluidly coupling the medical device to an external suction line.

[0053] In at least one embodiment, the method further comprises fluidly coupling, by a distal connector, the external suction line to an external suction device.

[0054] In at least one embodiment, the method further comprises fluidly coupling the medical device to an external irrigation line.

[0055] In at least one embodiment, the method further comprises fluidly coupling, by a distal connector, the external irrigation line to an external irrigation device or a fluid-filled bag that is adapted to provide fluid through gravity or is coupled to a pressurized system to provide the fluid for irrigation during use.

[0056] Other features and advantages of the present application will become apparent from the following detailed description taken together with the accompanying drawings. It should be understood, however, that the detailed description and the specific examples, while indicating preferred embodiments of the application, are given by way of illustration only, since various changes and modifications within the spirit and scope of the application will become apparent to those skilled in the art from this detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

[0057] For a better understanding of the various embodiments described herein, and to show more clearly how these various embodiments may be carried into effect, reference will be made, by way of example, to the accompanying drawings which show at least one example embodiment, and which are now described. The drawings are not intended to limit the scope of the teachings described herein.

[0058] FIG. l is a perspective view of an example embodiment of a medical device for suction and irrigation of an oral cavity, in accordance with some aspects; [0059] FIG. 2 is a top view of the medical device of FIG. 1, showing a second element of the device, in accordance with some aspects;

[0060] FIG. 3 is a top view of the medical device of FIG. 1, showing the device with the first element in an alternative positioning, in accordance with some aspects;

[0061] FIGS. 4A and 4B are top and side views, respectively, of the medical device of FIG. 1, showing the device with the first element in an alternative positioning, in accordance with some aspects;

|0062] FIG. 5 is a top view of the medical device of FIG. 1, showing an example of the first element of the device, in accordance with some aspects;

[0063] FIG. 6A is a partial top view of an example of a second element that may be used with the medical devices of FIGS. 1 to 5, in accordance with some aspects;

[0064] FIG. 6B is a partial right-side view of the second element of FIG. 6A, showing the direction of fluid flow into and out of the outlets, in accordance with some aspects;

[0065] FIGS. 7A-7B show a top perspective view and a top view, respectively, of an example of another medical device, in accordance with some aspects;

[0066] FIGS. 8A-8B show a top perspective view and a rear view, respectively, of an example of another medical device, in accordance with some aspects;

10067] FIG. 9 shows a perspective view of another example of a medical device, in accordance with some aspects; and

[0068] FIG. 10 shows a top view of the example medical device of FIG. 9, in accordance with some aspects;

[0069] FIG. 11 is a flow chart of an example method of irrigating an oral cavity of a patient, in accordance with some aspects; and [0070| FIG. 12 is a flow chart of an example method of providing a oral care device, in accordance with some aspects.

[0071 ] Further aspects and features of the examples described herein will appear from the following description taken together with the accompanying drawings.

DETAILED DESCRIPTION

[0072] Various embodiments in accordance with the teachings herein will be described below to provide an example of at least one embodiment of the claimed subject matter. No embodiment described herein limits any claimed subject matter. The claimed subject matter is not limited to devices, systems, or methods having all of the features of any one of the devices, systems, or methods described below or to features common to multiple or all of the devices, systems, or methods described herein. It is possible that there may be a device, system, or method described herein that is not an embodiment of any claimed subject matter. Any subject matter that is described herein that is not claimed in this document may be the subject matter of another protective instrument, for example, a continuing patent application, and the applicants, inventors, or owners do not intend to abandon, disclaim, or dedicate to the public any such subject matter by its disclosure in this document.

[0073] It will be appreciated that for simplicity and clarity of illustration, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements. In addition, numerous specific details are set forth in order to provide a thorough understanding of the embodiments described herein. However, it will be understood by those of ordinary skill in the art that the embodiments described herein may be practiced without these specific details. In other instances, well-known methods, procedures, and components have not been described in detail so as not to obscure the embodiments described herein. Also, the description is not to be considered as limiting the scope of the embodiments described herein.

[0074] It should also be noted that the terms “coupled” or “coupling” as used herein can have several different meanings depending on the context in which these terms are used. For example, the terms coupled or coupling can have a mechanical, structural or fluidic connotation. For example, as used herein, the terms coupled or coupling can indicate that two elements or devices can be directly connected to one another or connected to one another through one or more intermediate elements or devices via a mechanical element, a structural element, a gas flow or a fluid flow depending on the particular context.

|0075| Unless the context requires otherwise, throughout the specification and claims which follow, the word “comprise” and variations thereof, such as, “comprises” and “comprising” are to be construed in an open, inclusive sense, that is, as “including, but not limited to”.

[0076] It should also be noted that, as used herein, the wording “and/or” is intended to represent an inclusive-or. That is, “X and/or Y” is intended to mean X or Y or both, for example. As a further example, “X, Y, and/or Z” is intended to mean X or Y or Z or any combination thereof.

[0077] It should be noted that terms of degree such as “substantially”, “about” and “approximately” as used herein mean a reasonable amount of deviation of the modified term such that the end result is not significantly changed. These terms of degree may also be construed as including a deviation of the modified term, such as by 1%, 2%, 5%, 10%, 15% or 20%, for example, if this deviation does not negate the meaning of the term it modifies.

[0078] Furthermore, the recitation of numerical ranges by endpoints herein includes all numbers and fractions subsumed within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, and 5). It is also to be understood that all numbers and fractions thereof are presumed to be modified by the term “about” which means a variation of up to a certain amount of the number to which reference is being made if the end result is not significantly changed, such as 1%, 2%, 5%, 10%, 15% or 20%, for example.

|0079] Reference throughout this specification to “one embodiment”, “an embodiment”, “at least one embodiment” or “some embodiments” means that one or more particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments, unless otherwise specified to be not combinable or to be alternative options. [0080] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the content clearly dictates otherwise. It should also be noted that the term “or” is generally employed in its broadest sense, that is, as meaning “and/or” unless the content clearly dictates otherwise.

[0081] Various examples are described herein of a medical device for suction and irrigation of an oral cavity in a patient. A mechanically ventilated patient requires a tube to be inserted into their trachea so that a ventilator can deliver oxygen to their lungs. The tube may be an endotracheal tube, or a tube introduced via a tracheostomy. The proximal end of the tube that is outside of the patient’s mouth is coupled to tubing that is attached to a ventilator so that air can be delivered to and received from the patient’s lungs and the distal end of the tube is disposed below the patient’s glottis where the trachea branches into the bronchial tubes. A cuff on the tube generally expands to engage with the patient’s tracheal wall to thereby form a seal which permits ventilation while also preventing fluids and other material from being aspirated into the patient’s lungs.

[0082] Mechanically ventilated patient requires oral care periodically to prevent bacteria from proliferating in the oral cavity. Patients in palliative care, acute care, and other care environments are also completely dependent on their caregivers to provide oral care. This may be done by performing an irrigation process where fluid is distributed into the patient’s mouth and removed by a suctioning process. Therefore, a device for appropriately irrigating and suctioning the patient’s oral cavity with ease is needed.

[0083] In accordance with the teachings herein, there are provided various examples of medical devices that may be used to routinely cleanse the oral areas that may otherwise serve as a reservoir for pathogens which may prevent or dramatically slow the formation of biofilms that contain pathogenic microorganisms.

[0084] It may be advantageous to provide the various devices and associated methods of use for providing excellent oral care. In first aspect, at least one of the various devices described herein may be used to reduce the length of mechanical ventilation. In a second aspect, at least one of the various devices described herein may be used to remove bacteria and organic debris from the oral cavity, the two main reservoirs for various pathogens. In a third aspect, at least one of these various devices may allow for irrigation and suctioning of irrigation fluid without the required use of external suction catheters, which decreases risk of mucous membrane injury and may promote healthy mucous membranes. In a fourth aspect, at least one of the devices described herein may allow for irrigation without dwell time, meaning that solution can be introduced into the patient’s oral cavity and simultaneously suctioned out. Such devices and methods may be cost effective, efficient, and easy to use, allowing for frequent intervention. At least one of the devices described in accordance with the teachings herein may provide one, two or all of the first, second, third and fourth aspects described above.

[0085| Referring now to FIG. 1, a front perspective view of an example medical device 100 in accordance with the teachings herein is shown. The medical device 100 may be used in conjunction with an endotracheal tube (not shown) for irrigation and suctioning of an oral cavity of a patient, or the medical device 100 may be used without an endotracheal tube for irrigation and suctioning of an oral cavity of a patient. The medical device 100 includes two elements. A first element 102 is a tube, which may be used for suctioning or irrigation. A second element 104 (e.g., an irrigation element) can be or include a rigid body, which may be used for irrigation or suctioning. The first element 102 and the second element 104 are designed to be placed within a side of an oral cavity of a patient. For example, the first element 102 may be configured to be placed within the right side of the oral cavity of a patient while the second element 104 is placed within the left side. The first element 102 can be placed within the left side of the oral cavity of a patient while the second element 104 is placed within the right side. The medical device 100 can allow for the medical device 100 to be flipped easily and the first element 102 to be placed on either the left or right side of the oral cavity.

|0086| As shown in FIG. 1, the first element 102 can include a tube 106. The tube 106 may be any shape and/or length. The tube 106 may be used for placement within the patient’s mouth. The tube 106 may be posable (e.g., flexible, pliable, bendable, or otherwise posable), such that the tube 106 can be moved between different locations within the patient’s mouth, can be bent, or can be positioned as desired by the patient and the health care practitioner. For example, the tube 106 can be or include a bendable material that, once bent into a bent position can retain the bent position. At least a portion of the tube 106 (e.g., a portion of the tube 106 coupled with a guide 114, as discussed below) can define a tube axis. For example, the tube 106 can be a generally elongate and tubular member that defines a tube axis extending through a center of the tube 106. The tube 106 can include a distal end 108. The distal end 108 of the tube 106 can be positioned within the oral cavity of the patient at a position further away (e.g., closer to the back of the mouth) from the entry (e.g., lips) of the mouth.

[0087] The first element 102 comprises at least one aperture 116 (e.g., at least one inlet 116). The aperture 116 can be for suctioning fluid out of the oral cavity or for discharging or irrigating the oral cavity with fluid. The aperture acts as an inlet when used for suctioning or an outlet when used for irrigation. The tube 106 can have a single aperture 116 at the distal end 108 of the tube 106. The distal end 108 of the tube 106 can include an end cap 118. The tube 106 may or may not have an end cap 118 over the aperture 116. As further shown in FIG. 5, among others, the tube 106 can have multiple apertures 1 16 along the length of the tube 106. There can be more than one aperture 116 included on the tube 106, or the aperture 116 can be located on another portion of the tube 106. Apertures 116 may have any shape, size, location, or number along the first element 102.

[0088] The first element 102 further contains a first port 120 (e.g., a suction port 120) protruding from the first element 102. The first port 120 can be located approximately on a front portion of the first element 102 that may be located on the outside of the patient’s mouth when the medical device 100 is in use. The first port 120 can be located on the bridge 112 or laterally offset from the bridge 112. The first port 120 may protrude from the first element 102 by any suitable distance.

[0089] The second element 104 of the medical device 100 comprises a body 122 (e.g., a rigid body). The body 122 is for placement in a second location of the oral cavity of the patient. The second location can be on the opposite side of the oral cavity of the first element 102. The body 122 can be structured for placement on the opposite side of the oral cavity from the first element 102 and may be positioned between the teeth and/or against the cheek of patient, on the side opposite to that of the tube 106. The body 122 may be flat or may have a slight contour or curvature. The body 122 may be rectangular, square, rectangular with rounded edges, oval, circular, or any other shape that may be slid between or placed within the teeth of a patient. The body 122 of the second element 104 comprises one or more apertures 124 (e.g., outlets 124). The outlets 124 may act as outlets and allow a fluid to be discharged or irrigated directly into the oral cavity or the apertures 124 may act as inlets and allow a fluid to be suctioned from the oral cavity into the body 122. The apertures 124 are further discussed in relation to FIGS. 6A-6B.

[0090] The second element 104 further contains a second port 126 protruding from an outer surface of the second element 104 which may be exterior to the patient’s mouth during use. The second port 126 can be located approximately on the front of the second element 104. The second port 126 can also be located on the bridge 112 or laterally offset from the bridge 112. The second port 126 may protrude from the second element 104 by any suitable distance.

[0091] The first element 102 and the second element 104 of the medical device 100 may be connected by a bridge 112. As can be seen in FIG. 1, the bridge 112 connecting the first element 102 and the second element 104 may be tapered in the middle. The top edge of the bridge 112 may be tapered down towards or relative to the upper edges of the medical device 100 to allow for receipt of an endotracheal tube to be located there unimpeded by the medical device 100. The bottom edge of the bridge 112 can be tapered upwards away from bottom edges of the medical device 100 to be easily placed at the inner surface of the bottom lip of the patient. The medical device 100 may be configured so as to be easily flipped over within the oral cavity of the patient to allow for suctioning on either side of the mouth. As such, the bridge 112 may be tapered on the top edge and the bottom edge so the endotracheal tube may be placed appropriately no matter the orientation of the medical device 100. The bridge 112 can be used to permanently connect the first element 102 and the second element 104. The bridge 112 can also be removeable/attachable to each of the first element 102 and the second element 104. The bridge 112 may be or include a flexible material to allow the first element 102 to selectively move relative to the second element 104. For example, the bridge 112 can be flexed to facilitate insertion of the device 100 into an oral cavity of a patient.

[0092] The first element 102 is positioned within the oral cavity of the patient by use of a guide 114. The guide 114 can be integrally connected to the second port 126. The guide 114 can be connected to the second port 126 through bridge 112. The guide 114 can be operable to hold the first element 102 in place within the oral cavity of the patient. For example, the guide 114 can include an opening 115 to receive a portion of the tube 106 of the first element 102. As illustrated in FIGS. 1-5, among others, the guide 114 can be of a circular shape or can define a circular opening 115 to hold at least a portion of the tube 106. The guide 114 can be a semi-circle shape such that an opening 115 of the guide 114 does not completely surround a circumference of the tube 106 to allow tube 106 to be inserted into the oral cavity of the patient and retained with the second element 104. The guide 114 can be of any size or shape or include an opening 115 of any size or shape to accommodate first element 102. The guide 114 can hold the first element 102 in a single position without allowing for any movement into and/or out of the oral cavity of the patient. The tube 106 of the first element 102 can be movably coupled with the guide 114. For example, the first element 102 can be movably coupled with the second element 104 via the guide 114 such that the first element 102 (e.g., the tube 106 of the first element 102 or the distal end 108 of the first element 102) can rotate, slide, pivot or otherwise move relative to the guide 114. For example, the first element 102 can slide within the opening 115 of the guide along the axis of the tube 106 to selectively reposition the distal end 108 of the first element 102 within the oral cavity of the patient (e.g., to move the distal end 108 further into the oral cavity). The first element 102 can rotate relative to the guide 114 to alter a position of the distal end 108 of the first element 102 within the oral cavity of the patient or to otherwise assist with positioning within the oral cavity.

[0093] An end of the first port 120 of the medical device 100 can be fluidly coupled to a first line 128 (e.g., a suction line 128). A second end of the first port 120 is fluidically coupled to an interior suction channel that is formed within the first element 102. The first line 128 may further comprise a first distal connector 130 that may be fluidly coupled to an external suction device, such as a wall mounted suction device, or any other suction device. The suctioning may be activated by a switch or active thumb actuation on the first distal connector 130 of the first line 128. The tube 106 itself can function as a suction line. The tube 106 may be fluidly coupled to an external suction device.

[0094] An end of the first port 120 of the medical device 100 can be fluidly coupled to an irrigation line 132. A second end of the first port 120 is fluidically coupled to an interior irrigation channel that is formed within the first element 102. The irrigation line 132 may further comprise a second distal connector 134 that may be fluidly coupled to an external irrigation device, such as a syringe, a bag of saline within a pressure bag, or any other device used to irrigate the oral cavity of a patient. The irrigation line can be coupled to a fluid-filled bag that is adapted to provide fluid through gravity or is coupled to a pressurized system or to a pump.

[0095] The end of the second port 126 of the medical device 100 can be fluidly coupled to the first line 128. A second end of the second port 126 is fluidically coupled to an interior suction channel that is formed within the second element 104. The first line 128 may further comprise a first distal connector 130 that may be fluidly coupled to an external suction device, such as a wall mounted suction device, or any other suction device. The suctioning may be activated by a switch or active thumb actuation on the first distal connector 130 of the first line 128.

[0096] The first end of the second port 126 can be fluidly coupled to an irrigation line 132. A second end of the second port 126 is fluidically coupled to an interior irrigation channel that is formed within the second element 104. The irrigation line 132 may further comprise a second distal connector 134 that may be fluidly coupled to an external irrigation device, such as a syringe, a bag of saline within a pressure bag, or any other device used to irrigate the oral cavity of a patient. The irrigation line can be coupled to a fluid-filled bag that is adapted to provide fluid through gravity or is coupled to a pressurized system.

[0097] The first port 120 and the second port 126 can be a single port. The single port may be located along any surface of the medical device 100 and is fluidically coupled to the first and second elements such as by a fluid channel that runs along the bridge 112. The fluid used to irrigate the oral cavity can be introduced to the oral cavity using the same port as it is suctioned out. For example, the single port can be fluidly coupled to a fluid line used for irrigation and suction. The fluid line may be distally connected to a device that is able to sequentially provide fluid for irrigation and then remove the fluid from the patient’s oral cavity by applying suction.

[0098] Each of the first port 120 and the second port 126 can also introduce the fluid used to irrigate the oral cavity as well as suction out the fluid from the oral cavity. For example, a single port may be fluidly coupled to both the first and second ports 120 and 126 and the single port may then be coupled to a fluid line used for irrigation and suction. The fluid line may be distally connected to a device that is able to sequentially provide fluid for irrigation and then remove the fluid from the patient’s oral cavity by applying suction. The first line 128 and the irrigation line 132 may each be multi-purpose lines, to allow for suction of the oral cavity as well as irrigation of the oral cavity. These lines may include an inner lumen and an outer lumen, with the inner lumen supplying the negative pressure for suctioning of the oral cavity, with the outer lumen supplying the irrigation for irrigating the oral cavity. The inner lumen can supply the irrigation and the outer lumen may supply the suctioning. The lines can also provide suction and irrigation in any additional way, such as a portion of the line for use for suctioning and another portion for irrigation.

[0099] The medical device 100 can further include a clip (not pictured). The clip may be releasably coupled to the first port 120 and the second port 126. The clip may be configured to sit at the exterior of the oral cavity of the patient. The clip may be used to urge the first element 102 and the second element 104 away from each other or closer together when they are placed in a patient’s mouth in order to accommodate (i.e., fit) a larger sized mouth in which the two quadrants of a patient’s lower (upper) teeth are spaced further apart from one another.

[0100] The medical device 100 may be formed of any number of materials such as soft resilient materials like silicone, polyurethane, or other materials known in the art. For example, the medical device 100 may be formed of a flexible material to allow for the first element 102 and the second element 104 of the medical device 100 to be movable with respect to the bridge 112. The flexibility of the material may allow the medical device 100 to be easier to insert into the mouth of the patient, as the first element 102 and the second element 104 may be moved such that they are closer together to allow for easier insertion into the oral cavity as the medical device 100 may be laterally narrower. Once the medical device 100 is inserted into the oral cavity of the patient, the medical device 100 may expand (e.g., using shape memory materials) back to the original configuration before use where the first element 102 and the second element 104 move away from one another. The second element 104 can be formed of a non-flexible (i.e., rigid) material and the bridge 112 may be formed of a flexible material. The flexibility of the bridge 112 may still allow the medical device 100 to be inserted into the mouth of the patient easily while the rigidity of the second element 104 may retain the structure of the medical device 100. The medical device 100 can be formed of any combination of a non-flexible (i.e., rigid) material and/or a flexible material.

[0101] The medical device 100 can have a depth of approximately 40 mm, where the depth is characterized by the distance from the first port 120 and/or the second port 126 of the medical device 100 to the ends of the first element 102 and the second element 104 (i.e., the ends of the first element 102 and the second element 104 that reach the furthest into the patient’s oral cavity). The medical device 100 can have a depth smaller than 40 mm for use with patients that have smaller oral cavities. The medical device may have a depth larger than 40 mm for use with patients that have larger oral cavities. When, for example, the first element 102 is or includes a tube 106, the depth of the medical device 100 can be variable.

[0102] The medical device 100 can have a width of approximately 85 mm, where the width is characterized by the distance from the furthest outer edge of the first element 102 relative to the first port 120 to the furthest outer edge of the second element 104 relative to the second port 126. The medical device 100 can have a width of less than 85 mm for use with patients that have smaller oral cavities. The medical device 100 can have a width greater than 85 mm for use with patients that have larger oral cavities. The medical device 100 can be compressed laterally by a certain amount, such as approximately 15 mm., for example. [0103| The first plate may have a narrower width, where the width is characterized by or based on the distance from an outer edge of the plate to an inner edge of the plate. The narrow width may be useful for a smaller device, system, or apparatus directed towards the use of children or those with a smaller anatomy in the jaw. The first plate can have a wider width. The wider width may be of a larger device, system, or apparatus that is directed towards adult use or use for those with a larger anatomy in the jaw.

[0104] The medical device 100 may have different sizes for different parts so that they are useable with different sized mouths for similarly aged people, or different sized mouths for infants, versus adolescents, adults and seniors.

[0105] FIGS. 2 to 5 show examples of medical device 100. FIG. 2 shows a front view of the medical device 100 wherein the first element 102 is not present with the medical device 100. In this example, the second element 104 may be responsible for the suctioning and irrigating of the oral cavity through the second port 126.

[0106] FIG. 3 shows the first element 102 in an extended position from the medical device 100 as shown in FIG. 1. In this example, the first element 102 may be moveable through the opening 115 of the guide 114 relative to bridge 112 or to second element 104 to allow for the first element 102 to be placed within the oral cavity of the patient at the desired depth (i.e., distance from the first port 120 to the distal end 108 of the first element 102). The first element 102 can be in a reduced position from the medical device 100 as shown in FIG. 1.

[0107] FIGS. 4A and 4B show front and side views, respectively, of an example medical device 100 where the first element 102 is in a bended position from the medical device 100 as shown in FIG. 1, among others. FIG. 4A shows tube 106 bent in a lateral direction relative to body 122 of second element 104. The tube 106 can be bendable to be laterally closer to or laterally further away from second element 104. This can allow for appropriate placement of first element 102 within the oral cavity of a patient. FIG. 4B shows tube 106 bent in a vertical direction relative to the body 122 of second element 104. The tube 106 can be bendable to be of a higher elevation or a lower elevation than second element 104 within the oral cavity of a patient. [0108| The bendable and moveable aspect of first element 102 can allow the patient themselves, or a health care professional, to maneuver the first element 102 within the oral cavity of the patient. This can allow for targeted suctioning and/or irrigation out of a specific area within the oral cavity of the patient.

[0.109] FIG. 5 shows a front view of the medical device 100 of FIG. 1, among others. The first element 102 can include multiple apertures 116 along the length of tube 106. One of the apertures 116 can be located at the distal end 108 of first element 102. There may be multiple apertures 116 of any size located around or along the first element 102.

[011 ] The at least one aperture 116 of the first element 102 may be fluidly connected to the first port 120 by a first channel. This first channel may allow for the fluid suctioned from the oral cavity of the patient to be removed easily and disposed of through the first port 120 to a wall mounted suction device, for example. This first channel may also allow for the fluid irrigating the oral cavity of the patient to be pushed through a syringe, for example, into and through first port 120 into the first channel and into the oral cavity of the patient. The first channel can comprise an interior lumen and an exterior lumen, with the interior lumen providing the suctioning from the oral cavity and the exterior lumen providing the irrigation to the oral cavity. There may be multiple smaller fluid channels travelling from the inner edge of the first port 120 to each of the inlets 116 individually.

[0111 ] Referring now to FIGS. 6A and 6B, among others, shown are partial views of the apertures 124 that may act as irrigation outlets or suction inlets for the medical device 100 of FIGS. 1 to 5. FIG. 6A shows a partial top view of the second element 104 with the body 122. FIG. 6B shows a partial right-side view of the second element 104. The body 122 can comprise a top surface 136, a bottom surface 138, and a tapered edge 140 around the outer border of the top surface 136. The outlets 124 can be placed on the top surface 136 around the tapered edge 140 of the body 122, as shown in FIG. 6A. As shown in FIG. 6B, among others, the outlets 124 may be located along the tapered edge 140 of the body 122 on both the top surface 136 and the bottom surface 138. The apertures 124 may be interspersed throughout the top surface 136. The outlets 124 can also be interspersed throughout the bottom surface 138. The apertures 124 can also be interspersed throughout both the top surface 136 and the bottom surface 138. Further shown in FIG. 6B is the direction of fluid flow from the apertures 124 (as shown by the arrows).

[0112] The apertures 124 of the irrigation element 104 are fluidly connected to the second port 126 by a fluid channel. The fluid channel allows for fluid from a syringe, for example, or any other fluid dispersing device, to be introduced to the oral cavity of the patient. The fluid channel also allows for fluid to be suctioned from the oral cavity of the patient to be removed easily and disposed of through the second port 126 to a wall mounted suction device, for example. There may be multiple smaller fluid channels travelling from the inner edge of the second port 126 to each of the aperture 124 individually. The channel can include a single fluid channel travelling, for example, around the tapered edge 140 of the irrigation element 104 to each of the apertures 124, wherein the fluid channel may have a fenestration at each of the apertures 124 to allow for fluid to be discharged into the patient’s oral cavity or suctioned from the oral cavity.

[0113] The apertures 116 and 124 may allow for simultaneous introduction of a fluid into the patient’s mouth and removal of the fluid from the patient’s mouth, thereby reducing dwell time of the fluid within the mouth of the patient by using one of the apertures 116 and 124 as irrigation outlets and the other of the apertures 116 and 124 as suction inlet apertures. The simultaneous introduction of fluid while suctioning may allow for an unlimited amount of fluid to be irrigated and subsequently suctioned through the mouth of the patient. A large amount of fluid may be able to be rinsed through the mouth without having the fluid be translocated from the oral cavity down the throat of the patient.

[0114] The patient can be positioned on their side to create a low point in the patient’s oral cavity where the irrigation fluid can accumulate. The medical device 100 may be placed within the oral cavity such that the first element 102 or the second element 104 are within the buccal pocket between the teeth and cheek of the patient. The low point in the oral cavity may also be in the buccal pocket. This may allow for easier suctioning of the irrigation fluid out of the oral cavity. In some cases, the end cap 118 of the first element 102 may then be used to prevent mucous membranes from invaginating into the aperture 116.

[0115] Referring now to FIGS. 7A and 7B, shown therein is a perspective view and a top view of the medical device 200 in accordance with the teachings herein. The medical device 200 is similar to medical device 100 in functionality. The medical device 200 comprises a first element 202 and a second element 204.

|0116| The first element 202 may comprise a paddle 210 and at least one aperture 216 (e.g., inlet 216). The paddle 210 may comprise an elongated arm that is of a uniform construction (i.e., the same height the entire length of the arm). The paddle 210 can comprise an arm wherein the distal end of the paddle 210 is enlarged and the arm decreases in height as it gets closer to the bridge 212, forming a shape similar to that of a teardrop. The paddle 210 may be placed on the outer side of the upper and lower teeth of the patient such that the paddle 210 is located between the outer surface of the patient’s upper and lower teeth and the inner surface of the cheek of the patient’s oral cavity.

[0117] The first element 202 comprises at least one aperture 216 for suctioning fluid out of the oral cavity or irrigating fluid into the oral cavity. The paddle 210 may have a raised surface 217 on the inner surface. The aperture 216 of the first element 202 may be defined by an opening formed on a distal portion of the raised surface 217. There may be more than one aperture 216 that is included in the first element or the aperture 216 may be formed on another portion of the raised surface 217. The paddle 210 may not have a raised surface 217. The one or more apertures 216 included on the first element 202 may be formed on any portion of the paddle 210. As shown in FIG. 7A, there may be multiple apertures 216 on the distal end of the paddle 210.

[0118] The second element 204 may comprise a rigid body 222 and at least one aperture 224 (e g., outlet 224). As illustrated, the rigid body 222 may comprise two elongated arms 222a, 222b that are of the same length as first element 202. The rigid body 222 can comprise a first elongated arm 222a, a second elongated arm 222b, and a connecting arm for connecting the distal end of the first elongated arm 222a and the distal end of the second elongated arm 222b. The first elongated arm 222a may be placed on the outer side of the upper and lower teeth of the patient such that the first elongated arm 222a is located between the outer surface of the patient’s upper and lower teeth and the inner surface of the cheek of the patient’s oral cavity. The second elongated arm 222b may be placed on the interior side of the upper and lower teeth of the patient. The connecting arm may be placed along the rear of the dentition of the patient. For example, the first and second elongated arms 222a, 222b, and the connecting arm may surround the dentition of the patient.

[0119] The second element 204 may comprise multiple apertures 224 along the length of the first elongated arm 222a and the second elongated arm 222b for suctioning the fluid out of the oral cavity or irrigating fluid into the oral cavity. The apertures 224 may be along any surface of the first and second elongated arms 222a, 222b.

[0120] The remaining features of the medical device 200, may be of the same properties, characteristics and functions of the medical device 100.

[0121 ] Referring now to FIGS. 8A and 8B, shown therein is a perspective view and a top view of the medical device 300 in accordance with the teachings herein. The medical device 300 is similar to medical device 100 in functionality. The medical device 300 comprises a first element 302 and a second element 304. The properties, characteristics and functions that were described for the second element 104 of medical device 100 may apply to the second element 304 of medical device 300.

[0122] First element 302 may comprise a paddle 310 and at least one aperture 316 (e.g., inlet 316). The paddle 310 may comprise an elongated arm with a flat plane 344 (as illustrated in FIG. 8B). The flat plane 344 may extend from the raised surface 317 of the paddle 310 to an exterior surface 319 of the paddle 310, forming a flat surface along the top of paddle 310. The paddle 310 may be placed on the outer side of the lower teeth of the patient such that the paddle 310 is located between the outer surface of the patient’s lower teeth and the inner surface of the cheek of the patient’s oral cavity. The medical device 300 may be turned such that the paddle 310 may be placed on the outer side of the upper teeth of the patient such that the paddle 310 is located between the outer surface of the patient’s upper teeth and the inner surface of the cheek of the patient’s oral cavity. The flat plane 344 can extend along the bottom of paddle 310 from raised surface 317 to exterior surface 319 of paddle 310.

[0123] The first element 302 comprises at least one aperture 316 for suctioning fluid out of the oral cavity or irrigating fluid into the oral cavity. The aperture 316 of the first element 302 may be defined by an opening formed on a distal portion of the raised surface 317, as illustrated.

|O124| The remaining features of the medical device 300, may be of the same properties, characteristics and functions of the medical device 100.

[0125| Referring now to FIGS. 9 and 10, shown therein is a front perspective view and a front view of the medical device 400 in accordance with the teachings herein. The medical device 400 is similar to medical device 100 in functionality. The medical device 400 comprises a first element 402 and a second element 404.

[0126] The first element 402 has a first plate 422a and a first paddle (or side wall) 410a. The first plate 422a may be flat or may have a slight contour or curvature. The first plate 422a of the first element 402 may be used for placement between the upper and lower teeth at one side of the patient’s mouth. The first plate 422a may be rectangular, square, rectangular with rounded edges, oval, circular, or any other shape that may be placed within the patient’s mouth to fit between the upper and lower teeth of the patient. The first paddle 410a may be placed on the outer side of the upper and lower teeth of the patient such that the first paddle 410a is located between the outer surface of the patient’s upper and lower teeth and the inner surface of the cheek of the patient’s oral cavity.

[0127] The first element 402 includes apertures such as at least one first aperture 416a (e.g., suction inlet 416a) and at least one second aperture 424a (e.g., irrigation outlet 424a). First aperture 416a may be used to suction fluid out of the oral cavity. Second aperture 424a may be used for irrigating the oral cavity. First aperture 416a may be located along first paddle 410a and second aperture 424a may be located along the first plate 422a. [0128] The second element 404 has a second plate 422b and a second paddle (or side wall) 410b. The second plate 422b may be flat or may have a slight contour or curvature. The second plate 422b of the second element 404 may be used for placement between the upper and lower teeth at one side of the patient’s mouth. The second plate 422b may be rectangular, square, rectangular with rounded edges, oval, circular, or any other shape that may be placed within the patient’s mouth to fit between the upper and lower teeth of the patient. The second paddle 410b may be placed on the outer side of the upper and lower teeth of the patient such that the second paddle 410b is located between the outer surface of the patient’s upper and lower teeth and the inner surface of the cheek of the patient’s oral cavity.

[01.29] The second element 404 includes apertures such as at least one third aperture 416b (e.g., suction inlet 416b) and at least one fourth aperture 424b (e.g., irrigation outlet 424b). Third aperture 416b may be used to suction fluid out of the oral cavity. Fourth aperture 424b may be used for irrigating the oral cavity. Third aperture 416b may be located along second paddle 410b and fourth aperture 424b may be located along the second plate 422b.

[0130] The first element 402 is fluidically coupled to a first port 420 and the second element 404 is fluidically coupled to a second port 426, as discussed in relation to medical device 100. Each of the first port 420 and the second port 426 can introduce the fluid used to irrigate the oral cavity as well as suction out the fluid from the oral cavity. For example, the first port 420 may be fluidly coupled to a first fluid line 428 and the second port 426 may be fluidly coupled to a second fluid line 432, where each of the first fluid line 428 and the second fluid line 432 allow for irrigation and suctioning. Each fluid line 428, 432 may be distally connected to a device that is able to sequentially provide fluid for irrigation and then remove the fluid from the patient’s oral cavity by applying suction. The first fluid line 428 and the second fluid line 432 can each be multi-purpose lines, to allow for suction of the oral cavity as well as irrigation of the oral cavity. The lines may include an inner lumen and an outer lumen, with the inner lumen supplying the negative pressure for suctioning of the oral cavity, with the outer lumen supplying the irrigation for irrigating of the oral cavity. The inner lumen may supply the irrigation and the outer lumen may supply the suctioning. The lines may provide suction and irrigation in any additional way, such as a portion of the line for use for suctioning and another portion for irrigation.

[0131 ] The first fluid line 428 and the second fluid line 432 can each be connected to an external irrigation line 454 and an external suction line 452. The inner lumen of each of the first fluid line 428 and the second fluid line 432 can be fluidly connected to the external suction line 452 by a fluid controller 450. The outer lumen of each of the first fluid line 428 and the second fluid line 432 can be fluidly connected to the external irrigation line 454 by a fluid controller 450. The inner lumen of each of the first fluid line 428 and the second fluid line 432 can be fluidly connected to the external irrigation line 454 by a fluid controller 450. The outer lumen of each of the first fluid line 428 and the second fluid line 432 can be fluidly connected to the external suction line 452 by a fluid controller 450. The fluid controller 450 can include a three-way stop cock. The fluid controller 450 may be any other mechanical device with the ability to selectively control and divert fluid or air.

[0132] The first element 402 and the second element 404 may not be connected by bridge 412. For example, the first element 402 and the second element 404 may each be separate components. The first element 402 and the second element 404 can be connected by a releasable connection mechanism, such as a snap, a clasp, or any other releasable mechanism.

[0133] The remaining features of the medical device 400, may be of the same properties, characteristics and functions of the medical device 100.

[0134] The device may be implemented within a system to allow suctioning and irrigating of the oral cavity of the patient. The system may include one of the medical devices described herein, such as medical device 100-400 or alternatives thereof.

[0135] Medical device 100 may be placed within the patient while connected to external devices to assist with irrigation and suctioning of the oral cavity. The first fluid line 428 can be connected to external suction line 452 and the second fluid line 432 may be connected to external irrigation line 454. The second fluid line 432 may be connected to external suction line 452 and the first fluid line 428 may be connected to external irrigation line 454.

[0136] External irrigation line 454 may comprise a distal connector for fluidly coupling the medical device 400 to an external irrigation device, such as a syringe, a bag of saline within a pressure bag, or any other device used to irrigate the oral cavity of a patient. External suction line 452 may comprise a distal connector for fluidly coupling the medical device 400 to an external suctioning device, such as a wall mounted suction device, or any other suction device.

[0137] FIG. 11 depicts an example flowchart for a method 1100. The method 1100 can be a method of irrigating an oral cavity of a patient. The method 1100 can include placing one of the medical devices described herein, such as medical devices 100, 200, 300, or 400, within the oral cavity of the patient at step 1105. The method 1100 can include irrigating the oral cavity with fluid delivered using the first element 102, 202, 302, 402 or the second element 104, 204, 304, or 404 at step 1110. The method 1100 can include suctioning the fluid out of the oral cavity by suctioning provided through the first element 102, 202, 302, or 402 or the second element 104, 204, 304, or 404 at step 1115. The distal ends of the suction line and/or irrigation line of the medical device 100, 200, 300, or 400 may be connected to a wall mounted suction device and a syringe, respectively. The patient may be positioned on their side so that the first element 102, 202, 302, or 402 or the second element 104, 204, 304, or 404 is disposed within the buccal pocket located in the lowest position of the oral cavity of the patient.

(0138] The entire medical device 100, 200, 300, or 400 may be placed within the oral cavity of the patient. The first element 102, 202, 302, or 402 may be placed within the oral cavity of the patient prior to the second element 104, 204, 304, or 404. For example, such as with medical device 100, the second element 104 may be placed within the oral cavity, and then the first element 102 may be placed within the oral cavity and connected to the second element 104 through the opening 115 of the guide 114.

|0139] For example, such as with medical device 400, the first element 402 and the second element 404 may be placed within the oral cavity of the patient separately and then the first element 402 may be connected to the second element 404. The first element 402 and the second element 404 may be connected together in any way, such as through a handle, the bridge 412, a snap, or any other connection. This can allow the medical device 400 to be stabilized within the oral cavity of the patient so the medical practitioner may maneuver the medical device 400 with one hand, leaving their second hand free to operate a syringe or any other medical devices.

|0l40| For example, such as with medical device 400, only one of the first element 402 or the second element 404 may be placed within the oral cavity of the patient to provide irrigation and suctioning.

[0141 ] FIG. 12 depicts an example flowchart for a method 1200. The method 1200 can be a method of providing a device, such as an oral care device or a medical device. For example, the method 1200 can include providing one or more of the medical devices 100, 200, 300, or 400. The method 1200 can include providing a device having a first element 102 having a tube 106, a distal end 108, and a first aperture 116 positioned proximate the distal end 108. The device 100 can include the distal end 108 to be positioned within an oral cavity of a patient to suction fluid from the oral cavity via the first aperture 116. The device 100 can include a second element 104 having a body 122 and a second aperture 124, the body 122 to be placed within the oral cavity to provide fluid into the oral cavity via the second aperture 124. The device 100 can include a first port 120 fluidly coupled with the first element 102 to provide a negative pressure to the distal end 108 of the first element 102 to suction fluid from the oral cavity via the first aperture 116. The device 100 can include a second port 126 fluidly coupled with the second element 104 to provide fluid into oral cavity via the second aperture 124. The device 100 can include a guide 114 coupled with the second element 104 and defining an opening 115. For example, the opening 115 can receive at least a first portion of the tube 106 to movably couple the tube 106 with the second element 104. The device can include the tube 106 to move relative to the guide 114 to selectively reposition the distal end 108 of the first element 102 within the oral cavity.

101421 The medical devices described herein may be used to irrigate the oral cavity and suction out the irrigation fluids, thereby cleaning and disinfecting a patient’s oral cavity. The fluid may be water, saline, or any other fluid such as antiseptics, antibiotics or lubricants, or fluid of any kind. Additional cleaning steps such as brushing the teeth or oral cavity with a brush or any of the other cleaning steps previously described above may also be used in conjunction with this device, such as prior to using the device.

[0.143] The method may further involve nasal irrigation in conjunction with use of the medical device. In such a procedure, fluid may be instilled into the nostril of a patient either at the same time as oral irrigation or separately while suction is engaged.

[0I44| Furthermore, while the medical device described and depicted herein can be for use with ventilated patients, alternatives are possible. For example, the medical devices described herein may be used within the dentistry industry for assistance with irrigation and suctioning during dentistry procedures. In such applications, the portion of the medical device that is used to accommodate an endotracheal tube may instead be used for placement of certain dental tools for performance of certain dental procedures. In another alternative, the medical devices described and depicted may be used within any hospital setting wherein the patient is dependent on a staff member and/or other person for oral care.

[0145] In addition, any of the suctioning steps may be performed using high pressure suctioning (e g., high negative pressure, or high vacuum) which may involve using up to 250 mm Hg of vacuum applied without causing any tissue within the patient’s mouth to be drawn into suction inlets and causing obstruction.

[0146] In addition, any of the irrigation steps may be performed using low pressure irrigation, intermediate pressure irrigation or high pressure irrigation. High pressure irrigation may use about 250 mL of fluid per minute or greater as is appropriate based on the amount of cleaning that needs to be done and the amount of suction that is being used.

[0147] In addition to helping maintain oral hygiene, the devices and methods descried in accordance with the teachings herein may provide additional protection against other pathogens such as the COVID 19 virus by preventing or minimizing generation of aerosols which may contain the virus or other pathogens. Use of the clip and irrigation/lavage and sanitization procedures described herein help avoid open airway suctioning as well as minimize or prevent aerosolization of pathogens. This is because any leakage from the patient’s mouth is reduced or eliminated by use of the clip so that the device more firmly engages the patient’s oral cavity. Also, the increased irrigation/lavage and sanitization of the oral cavity that is possible with the devices described herein can be used to reduce aerosols and provide additional protection to front line critical care staff.

[0148] While the applicant’s teachings described herein are in conjunction with various embodiments for illustrative purposes, it is not intended that the applicant’s teachings be limited to such embodiments as the embodiments described herein are intended to be examples. On the contrary, the applicant’s teachings described and illustrated herein encompass various alternatives, modifications, and equivalents, without departing from the embodiments described herein, the general scope of which is defined in the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A device, comprising: a first element having a tube, a distal end, and a first aperture positioned proximate the distal end, the distal end to be positioned within an oral cavity of a patient to suction fluid from the oral cavity via the first aperture; a second element having a body and a second aperture, the body to be placed within the oral cavity to provide fluid into the oral cavity via the second aperture; a first port fluidly coupled with the first element to provide a negative pressure to the distal end of the first element to suction fluid from the oral cavity via the first aperture; a second port fluidly coupled with the second element to provide fluid into oral cavity via the second aperture; and a guide coupled with the second element and defining an opening, the opening to receive at least a first portion of the tube to movably couple the tube with the second element, the tube to move relative to the guide to selectively reposition the distal end of the first element within the oral cavity.

2. The device of claim 1, comprising: the tube including a second portion, the second portion posable to adjust a position of the distal end within the oral cavity.

3. The device of claim 1, comprising: the tube including a bendable material to allow the tube to bend, the bendable material to retain a bent shape to maintain a posed position of the distal end of the tube within the oral cavity.

4. The device of claim 1, comprising: the first aperture positioned on the tube between the distal end and the first portion of the tube.

5. The device of claim 1, comprising: the tube rotatably coupled with guide to rotate within the opening of the guide to selectively reposition the distal end of the tube within the oral cavity.

6. The device of claim 1, comprising: the tube slidably coupled with the guide to slide along an axis of the tube within the opening of the guide to selectively reposition the distal end of the tube within the oral cavity.

7. The device of any one of claims 1, comprising: the first port fluidly coupled with an external suction line, the external suction line to provide the negative pressure to the first port to suction fluid from the oral cavity.

8. The device of claim 1, comprising: the first element including a third aperture, the first element to provide an irrigation fluid into the oral cavity via the second aperture; and the first port fluidly coupled with an external irrigation line, the external irrigation line to port to provide the irrigation fluid to the first element.

9. The device of claim 1, comprising: the second port fluidly coupled with an external irrigation line is fluidly coupled to the second port to provide the fluid thereto to the second element for irrigating the oral cavity.

10. The device of claim 1, comprising: the guide integrally coupled with the second port via a bridge, the bridge to extend from the second port to position the first port a distance from the second port with the first portion of the tube positioned within the opening of the guide.

11. The device of claim 1, comprising: the tube slidably coupled with the guide to slide along an axis of the tube within the opening of the guide to selectively reposition the distal end of the tube within the oral cavity; and the guide integrally coupled with the second port via a bridge, the bridge to extend from the second port to position the first port a distance from the second port with the first portion of the tube positioned within the opening of the guide.

12. The device of claim 1, comprising: the body of the second element including a top surface, a bottom surface, and a tapered edge around an outer boundary of the body, the body to be positioned at least partially between upper and lower teeth of the patient, the second aperture positioned proximate to the tapered edge on at least one of the top surface and the bottom surface of the body of the second element.

13. The device of claim 1, comprising: the tube slidably coupled with the guide to slide along an axis of the tube within the opening of the guide to selectively reposition the distal end of the tube within the oral cavity; the guide integrally coupled with the second element via a bridge, the bridge to extend from the second port to position the first port a distance from the second port with the first portion of the tube positioned within the opening of the guide; and the body of the second element including a top surface, a bottom surface, and a tapered edge around an outer boundary of the body, the body to be positioned at least partially between upper and lower teeth of the patient, the second aperture positioned proximate to the tapered edge on at least one of the top surface and the bottom surface of the body of the second element.

14. The device of claim 1, comprising: the tube slidably coupled with the guide to slide along an axis of the tube within the opening of the guide to selectively reposition the distal end of the tube within the oral cavity; the tube including a bendable material to allow the tube to bend, the bendable material to retain a bent shape to maintain a posed position of the distal end of the tube within the oral cavity; the guide integrally coupled with the second element via a bridge, the bridge to extend from the second port to position the first port a distance from the second port with the first portion of the tube positioned within the opening of the guide; and the body of the second element including a top surface, a bottom surface, and a tapered edge around an outer boundary of the body, the body to be positioned at least partially between upper and lower teeth of the patient, the second aperture positioned proximate to the tapered edge on at least one of the top surface and the bottom surface of the body of the second element.

15. A device, comprising: a first element having a tube, a distal end, and a first aperture positioned proximate the distal end, the distal end to be positioned within an oral cavity of a patient, the first element couplable with a suction source to cause the first element to suction fluid from the oral cavity via the first aperture; a second element having a body and a second aperture, the body to be positioned within the oral cavity, the second element couplable with an irrigation source to cause the second element to provide fluid into the oral cavity via the second aperture; and a flexible bridge coupled with the first element and the second element, the bridge including a guide having an opening, the opening of the guide to receive at least a first portion of the tube to movably couple the tube with the second element, the tube to move relative to the guide to selectively reposition the distal end of the first element within the oral cavity.

16. The device of claim 15, comprising: the tube including a bendable material to allow the tube to bend, the bendable material to retain a bent shape to maintain a posed position of the distal end of the tube within the oral cavity.

17. The device of claim 15, comprising: the distal end of the first element including an end cap, the end cap defining a plurality of first apertures including the first aperture.

18. The device of claim 15, comprising: the bridge integrally coupled with the second element and extending; and the tube slidably coupled with the guide to slide along an axis of the tube within the opening of the guide to selectively reposition the distal end of the tube within the oral cavity

19. An apparatus, comprising: a body having including a top surface, a bottom surface, an aperture, and a tapered edge, the tapered edge extending at least partially around an outer boundary of the body, the body to be positioned within an oral cavity of a patient at least partially between upper and lower teeth of the patient, the aperture positioned proximate to the tapered edge on at least one of the top surface and the bottom surface of the body, the aperture to provide an irrigation fluid within the oral cavity; a port coupled with the body, the port to receive the irrigation fluid from an irrigation fluid source and provide the irrigation fluid to the body; and a bridge integrally coupled with the port, the bridge including a guide defining an opening, the bridge extending from the port to position the opening of the guide a distance from the port, the opening of the guide to slidably receive a tube of a suction element and permit selective movement of a suction element within the oral cavity.

20. The apparatus of claim 19, comprising: the guide to retain a tube of a suction element and permit a tube of a suction element to rotate within the opening to facilitate selective repositioning of a distal end of a suction element relative to the body within the oral cavity.