APPARATUS FOR IRRIGATION, SUCTIONING AND OBTAINING SAMPLES OF THE ORAL CAVITY

Various embodiments are provided herein for a medical device that has: a suction element with an elongated arm for placement between a check and the upper and lower teeth of a patient, and at least one suction inlet configured to suction fluid out of the oral cavity; an irrigation element with a second plate for placement between the upper and lower teeth of the second side of the oral cavity and one or more irrigation outlets configured to irrigate the oral cavity with fluid; a suction port that is fluidically coupled to the suction element for providing suctioning of the oral cavity during use; and an irrigation port that is fluidically coupled to the irrigation element for providing irrigation to the oral cavity during use.

FIELD

Various embodiments are described herein of a medical device for suction and irrigation of an oral cavity in a patient.

BACKGROUND

The following paragraphs are provided by way of background. They are not, however, an admission that anything discussed therein is prior art or part of the knowledge of persons skilled in the art.

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.

Mechanically ventilated patients require 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.

SUMMARY

Disclosed here are various configurations of a device for insertion into the mouth of a patient to allow for irrigation and/or suction to occur with ease as well as for one or more methods for use of the device.

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

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

In at least one embodiment, the device comprises a bridge that is adapted to couple the suction element to the irrigation element.

In at least one embodiment, the bridge comprises a top edge and a bottom edge, the top edge being tapered towards the bottom edge.

In at least one embodiment, the bottom edge of the bridge is tapered towards the top edge.

In at least one embodiment, a center portion of the bridge has a low profile relative to outer portions of the bridge.

In at least one embodiment, the bridge comprises a top surface and a bottom surface that are substantially flat and spaced apart from one another by the same distance in their lateral extent from the suction element to the irrigation element.

In at least one embodiment, the suction port and the irrigation port are located at the bridge and may be laterally offset from a center of the bridge and are configured to extend outside of the oral cavity during use.

In at least one embodiment, the paddle of the suction element comprises an elongated arm with an enlarged head.

In at least one embodiment, the paddle of the suction element comprises an elongated arm.

In at least one embodiment, the suction element comprises a paddle formed on the elongated arm and disposed adjacent a distal end of the suction element.

In at least one embodiment, the paddle has a raised surface on an inner surface thereof.

In at least one embodiment, at least one suction inlet near and spaced apart from the distal end of the raised surface of the suction element.

In at least one embodiment, the paddle comprises a disk located at an interior surface of the paddle, the disk containing the at least one suction inlet.

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

In at least one embodiment, the clip comprises a first slot that is configured to slidably receive the suction port, a second slot that is configured to slidably receive an endotracheal tube, dental instrument or other medical instrument, and a third slot that is configured to slidably receive the irrigation port.

In at least one embodiment, the suction port and the irrigation port each comprise a positioning slot for releasably receiving the clip where the positioning slot is located at a distance away from a front surface of the bridge and the first and third slots of the clip are located to allow the suction port and the irrigation port to be moved together when the clip is placed at the positioning slots thereby widening a distance between inner edges of the suction element and the irrigation element.

In at least one embodiment, a suction line is fluidly coupled to the suction port.

In at least one embodiment, an irrigation line is fluidly coupled to the irrigation port.

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

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

In at least one embodiment, the second plate of the irrigation element comprises a top surface, a bottom surface, and an edge around an outer border of the top surface and the bottom surface, and the irrigation outlets are located proximally to the edge on at least one of the top surface and the bottom surface of the second plate of the irrigation element.

In at least one embodiment, the second plate of the irrigation element comprises a top surface, a bottom surface, and an edge around an outer border of the top surface and the bottom surface, and the irrigation outlets are located on at least one of the top surface and the bottom surface of the irrigation element.

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

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

In at least one embodiment, the medical device further comprises a locking mechanism that is adapted to be releasably coupled to the suction port and the irrigation port and exterior to the oral cavity during use, wherein the locking mechanism comprises a first arm having at least one clip and a second arm having at least one ridge, the at least one ridge being releasably engaged by the at least one clip and configured to control a distance between the suction element and the irrigation element when the device is placed within the oral cavity.

In at least one embodiment, the locking mechanism comprises first, second and third ridges on the second arm for releasable engagement by the at least one clip on the first arm, the first ridge being located to allow the suction port and the irrigation port to be moved apart when the at least one clip is placed at the first ridge thereby narrowing a distance between the suction element and the irrigation element and the third ridge being located to allow the suction port and the irrigation port to be moved together when the at least one clip is placed at the third ridge thereby widening the distance between the suction element and the irrigation element.

In at least one embodiment, the medical device further comprises a handle mechanism that is adapted to be releasably coupled to the suction port and the irrigation port and located exterior to the oral cavity during use, wherein the handle mechanism comprises a male connector and a female connector.

In at least one embodiment, the male and female connectors include first and second tabs, respectively, and the first tab and the second tab are releasably engaged when pressed together to control a distance between the suction element and the irrigation element when the device is placed within the oral cavity.

In at least one embodiment, the female connector includes a slot sized and shaped to accommodate a post of the male connector and during use the male and female connectors are releasably engaged when the male connector is slid into the female connector to connect the suction element and the irrigation element.

In at least one embodiment, the male and female connectors are first and second tabs, respectively, that are configured to connect the suction element and the irrigation element by a button snap, buckle, Velcro, double sided adhesive, screws or a pin.

In at least one embodiment of a medical device described herein, the at least one suction element comprises a rectangular shaped slot, a conical shaped slot, an elliptical shaped slot, a semi-circular shaped slot, an almond-shaped slot, a curved slot or a curved slit.

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.

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

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 a medical device within the oral cavity of the patient, the medical device being defined in accordance with any one of embodiments described herein; irrigating the oral cavity with fluid delivered using the irrigation element of the medical device; and suctioning the fluid or any other liquids out of the oral cavity using the suction element of the medical device.

In at least one embodiment, the method further comprises receiving, at the bridge of the medical device, an endotracheal tube.

In at least one embodiment, the method further comprises releasably coupling the suction port and the irrigation port of the medical device to a clip configured to control a distance between the suction element and the irrigation element when placing the medical device within the oral cavity.

In at least one embodiment, the method further comprises fluidly coupling the suction port to a suction line.

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

In at least one embodiment, the method further comprises fluidly coupling the irrigation port to an irrigation line.

In at least one embodiment, the method further comprises fluidly coupling, by a distal connector, the 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.

In at least one embodiment, prior to providing irrigation, the method further comprises positioning the patient such that a head of the patient is in a lower position relative to feet of the patient.

In at least one embodiment, the method further comprises positioning a torso of the patient on a side so that the suction element is disposed in a buccal pocket located in a lowest position of the oral cavity.

In at least one embodiment, the method further comprises instilling fluid into a nostril of the patient.

In at least one embodiment, the method further comprises obtaining at least one oral sample using the medical device when providing suctioning to the at least second portion of the oral cavity.

In at least one embodiment, the method comprises obtaining the at least one oral sample without providing irrigation, after providing irrigation or during providing irrigation.

In at least one embodiment, the method comprises using a syringe to provide the suctioning so that the at least one oral sample is contained in a portion of the syringe.

In at least one embodiment, the method comprises using a sample container that is coupled to the suction line of the device for receiving the at least one oral sample when suctioning is provided to the at least second portion of the oral cavity of the patient.

In another aspect, in accordance with the teachings herein there is provided a use of a medical device for irrigating, suctioning and/or obtaining at least one sample from an oral cavity in a patient wherein the medical device is defined according to any one of the embodiments described herein, wherein the medical device is adapted to perform any one of the methods described herein during the use.

In another aspect, in accordance with the teachings herein there is provided at least one embodiment of a medical device for suction and irrigation of an oral cavity in a patient, the device comprising: a suction element configured to be placed at one side of the oral cavity, the suction element comprising an elongated arm for placement between a cheek and the upper and lower teeth of the patient, the suction element further comprising at least one suction inlet configured to suction fluid out of the oral cavity; an irrigation element that is configured to be disposed at a second side of the oral cavity, the irrigation element comprising a plate for placement between the upper and lower teeth of the second side of the oral cavity and one or more irrigation outlets configured to irrigate the oral cavity with fluid; a suction port that is fluidically coupled to the suction element for providing a negative pressure thereto for suctioning the oral cavity during use; an irrigation port that is fluidically coupled to the irrigation element for providing the fluid thereto for irrigating the oral cavity during use, and a locking mechanism that is adapted to be releasably coupled to the suction port and the irrigation port and exterior to the oral cavity during use, wherein the locking mechanism comprises a first arm having at least one clip and a second arm having at least one ridge, the at least one ridge being releasably engaged by the at least one clip and configured to control a distance between the suction element and the irrigation element when the device is placed within the oral cavity.

In another aspect, in accordance with the teachings herein there is provided at least one embodiment of a medical device for suction and irrigation of an oral cavity in a patient, the device comprising: a suction element configured to be placed at one side of the oral cavity, the suction element comprising an elongated arm for placement between a cheek and the upper and lower teeth of the patient, the suction element further comprising at least one suction inlet configured to suction fluid out of the oral cavity; an irrigation element that is configured to be disposed at a second side of the oral cavity, the irrigation element comprising a plate for placement between the upper and lower teeth of the second side of the oral cavity and one or more irrigation outlets configured to irrigate the oral cavity with fluid; a suction port that is fluidically coupled to the suction element for providing a negative pressure thereto for suctioning the oral cavity during use; an irrigation port that is fluidically coupled to the irrigation element for providing the fluid thereto for irrigating the oral cavity during use, and a handle mechanism that is adapted to be releasably coupled to the suction port and the irrigation port and exterior to the oral cavity during use, wherein the handle mechanism comprises a male connector and a female connector.

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.

Further aspects and features of the example embodiments described herein will appear from the following description taken together with the accompanying drawings.

DETAILED DESCRIPTION OF THE EMBODIMENTS

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.

It should also be noted that the terms “coupled” or “coupling” as used herein can have several different meanings depending in 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.

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.

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.

As mentioned mechanically ventilated patients require a tube to be inserted into the trachea so that a ventilator can deliver oxygen to the lungs. The tube is generally an endotracheal tube, or a tube introduced via a tracheostomy. The proximal end of the tube is coupled to tubing attached to a ventilator so that air can be delivered to and from the lungs and the distal end of the tube is disposed below the glottis into the trachea.

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

Accordingly, the various devices and associated methods described herein may be used for providing improved oral care compared to conventional devices and techniques. The various devices described herein may be used to reduce the length for which mechanical ventilation is needed since the various devices described herein may be used to remove bacteria and organic debris from the oral cavity, the two main reservoir for various pathogens that can damage/impair a patient's respiratory system. 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. The devices may also 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.

Referring now toFIG.1, a top perspective view of an example embodiment of a medical device100in accordance with the teachings herein is shown. The medical device100may be used in conjunction with an endotracheal tube (not shown) for irrigation and suctioning of an oral cavity of a patient. However, the medical device100, which may also be referred to as an oral appliance, may be used without an endotracheal tube. The medical device100includes two portions, where a first portion includes a suction element102and a second side portion includes an irrigation element104. The suction element102and the irrigation element104are coupled to one another by a bridge106. Each of elements102and104is designed to be placed within certain locations of an oral cavity of a patient. For example, the suction element102may be configured to be placed at a first location (e.g., at the right side) of the oral cavity of a patient while the irrigation element104is placed at a second location (e.g., at the left side) of the oral cavity of the patient. In an alternative embodiment, the suction element102may be configured to be placed at the left side of the oral cavity of a patient while the irrigation element104is placed at the right side of the oral cavity of the patient. In an alternative embodiment, the medical device100may be configured so as to allow for the medical device100to be flipped easily and the suction element102to be placed on either the left or right side of the oral cavity.

In at least one embodiment, as shown inFIG.1, the suction element102may comprise a first plate108and a paddle (or side wall)110. The first plate108may be flat or may have a slight contour or curvature. The paddle110may comprise an elongated arm112and an enlarged head114. However, in at least one alternative embodiment, the enlarged head114is not used but rather the suction element is an elongated arm with a more uniform shape. The first plate108of the suction element102may be used for placement between the upper and lower teeth at one side of the patient's mouth. The first plate108preferably has smooth edges and 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 paddle110may be placed on the outer side of the upper and lower teeth of the patient such that the elongated arm112and the enlarged head114of the paddle110are 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 paddle110preferably has smooth edges and 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 teeth and the cheek of the patient.

The suction element102comprises at least one suction inlet116. The suction inlet116is for suctioning fluid out from at least a first portion of the oral cavity. As further described inFIG.6, the enlarged head114of the paddle110may have a disk118or raised surface on its inner surface. The disk118extends inwardly and away from the inner surface of the enlarged head114. The disk118may be raised from the surface of the paddle110so as to ensure a space between the suction inlet116and a baffle (i.e., a point on the suction element102) where the paddle110comes in contact with the cheek tissue of the user. The suction inlet116of the suction element102may be defined by an opening formed on a top portion of the disk118. In alternative embodiments, there may be more than one suction inlet116that is included in the suction element102or the suction inlet may be formed on another portion of the disk118. In various embodiments, suction apertures may have any shape, size, location, or number along the suction element.

The suction element102further contains a suction port120protruding from an outer surface of the suction element102that faces away from the patient's oral cavity in use. In at least one embodiment, the suction port120is located approximately on a front portion of the suction element102that may be located on the outside of the patient's mouth when the medical device100is in use. In at least one embodiment, the suction port120may be located on the bridge106or laterally offset from the bridge106. The suction port120may protrude from the suction element102by any suitable distance such that it may be connected to a physical element that provides suction such as a suction line or syringe.

The irrigation element104of the medical device100comprises a second plate122. The second plate122is for placement on the opposite side of the oral cavity and may be positioned between the teeth and/or against the cheek of patient, on the side opposite to that of the first flat plate108of the suction element102. The second plate122may be flat or may have a slight contour or curvature. The second plate122may preferably has smooth edges and 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 second plate122of the irrigation element104comprises one or more irrigation outlets124. The irrigation outlets124allow a fluid to be discharged or irrigated directly into at least a second portion of the oral cavity. The irrigation outlets124are further discussed in relation toFIGS.7A-7B. The irrigation element104further contains an irrigation port126protruding from an outer surface of the irrigation element104that faces away from the patient's oral cavity in use and may be exterior to the patient's mouth during use. In at least one embodiment, the irrigation port126is located approximately on the front of the irrigation element104. In at least one embodiment, the irrigation port126may be located on the bridge106or laterally offset from the bridge106. The irrigation port126may protrude from the irrigation element104by any suitable distance such that it may be connected to a physical element that provides suction such as a suction line or syringe.

As mentioned, the suction element102and the irrigation element104of the medical device100may be coupled to one another by a bridge106. As can be seen inFIG.1, the bridge106connecting the suction element102and the irrigation element104may be tapered in the middle. The top edge of the bridge106may be tapered downwards relative to the upper edges of the medical device100to allow for, in at least one embodiment, to receive an endotracheal tube to be located at an upper surface there unimpeded by the medical device100. In at least one embodiment, the bottom edge of the bridge106may be tapered upwards away from bottom edges of the medical device100to be easily placed at the inner surface of the bottom lip of the patient. The medical device100may be, in at least one embodiment, configured 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, in at least one embodiment, the bridge106may 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 device100.

In at least one embodiment, an end of the suction port120of the medical device100is fluidly coupled to a suction line128. A second end of the suction portion120is fluidically coupled to an interior suction channel that is formed within the suction element102(an example of this for another embodiment is shown inFIG.21C). The suction line128may further comprise a first distal connector130that 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 connector130of the suction line128. In at least one embodiment, a first end of the irrigation port126is fluidly coupled to an irrigation line132. A second end of the irrigation port126is fluidically coupled to an interior irrigation channel that is formed within the irrigation element104(an example of this for another embodiment is shown inFIG.21C). The irrigation line132may further comprise a second distal connector134that 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. In at least one embodiment, the irrigation line may be coupled to a fluid-filled bag that is adapted to provide fluid through gravity or is coupled to a pressurized system.

In another embodiment, the suction port120and the irrigation port126may be a single port. The single port may be located along any surface of the medical device100. In such embodiment, the fluid used to irrigate the oral cavity may be introduced to the oral cavity through the same port as it is suctioned out. In such embodiments, the single port may be fluidly coupled to a fluid line used for both irrigation and suction. The fluid line may be distally connected to a device that is able to alternate between providing fluid for irrigation and then removing the fluid from the patient's oral cavity by applying suction.

In at least one embodiment, the medical device100may further include a clip150(seeFIGS.8A-9C). The clip150may be releasably coupled to the suction port120and the irrigation port126. The clip150may be configured to sit at the exterior of the oral cavity of the patient. The clip150may be used to urge the suction element102and irrigation element104closer together when they are placed in a patient's mouth and then optionally farther apart 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.

The medical device100may 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 device100may be formed of a flexible material to allow for the suction element102and the irrigation element104of the medical device100to be movable with respect to the bridge106. The flexibility of the material may allow the medical device100to be easier to insert into the mouth of the patient, as the suction element102and the irrigation element104may be moved such that they are closer together to allow for easier insertion into the oral cavity as the medical device100may be laterally narrower. Once the medical device100is inserted into the oral cavity of the patient, the medical device100may “expand” back to the original configuration before use where the suction element102and the irrigation element104move away from one another. In at least one embodiment, the suction element102and the irrigation element104may be formed of a non-flexible (i.e., rigid) material and the bridge106may be formed of a flexible material. The flexibility of the bridge106may still allow the medical device100to be inserted into the mouth of the patient easily while the rigidity of the suction element102and irrigation element104may help retain the structure of the medical device100. Alternatively, in at least one embodiment, the medical device100may be formed of any combination of a non-flexible (i.e., rigid) material and/or a flexible material.

In at least one embodiment, the medical device100may have a depth of approximately 40 mm, where the depth is characterized by the distance from the bridge106of the medical device100to the ends of the suction element102and the irrigation element104(i.e., the ends of the suction element102and the irrigation element104that reach the furthest into the patient's oral cavity). Alternatively, in at least one embodiment, the medical device100may have a depth smaller than about 40 mm for use with patients that have smaller oral cavities. Alternatively, in at least one embodiment, the medical device100may have a depth larger than about 40 mm for use with patients that have larger oral cavities.

In at least one embodiment, the medical device100may have a width of approximately 85 mm, where the width is characterized by the distance from the furthest outer edge of the suction element102relative to the bridge106to the furthest outer edge of the irrigation element104relative to the bridge106. In at least one embodiment, the medical device100may have a width of less than about 85 mm for use with patients that have smaller oral cavities. In at least one embodiment, the medical device100may have a width greater than about 85 mm for use with patients that have larger oral cavities. In any of the disclosed embodiments, the medical device100may be compressed laterally by a certain amount, such as approximately 15 mm, for example.

In at least one embodiment, the first and second plates108and122may have a narrower width, where the width is characterized by the distance from an outer edge of a given plate to an inner edge of the given plate. The narrow width may be useful for a smaller embodiment directed towards the use of children or those with a smaller anatomy in the jaw. In at least one embodiment, the first and second plates108and122may have a wider width. The wider width may be of a larger embodiment that is directed towards adult use or use for those with a larger anatomy in the jaw. In at least one embodiment, the suction inlet is disposed at least a distance of about 3 mm from the baffle (i.e., a point on the suction element) where there is contact with the cheek tissue of the patient.

FIGS.2to5show the suction port120being fluidly connected to the suction line128and the irrigation port126being fluidly connected to the irrigation line132.FIGS.2and3further show an example embodiment of the suction element102, where the suction inlet116may be located on a disk118along the inner surface of the enlarged head114of the paddle110. In this example embodiment, the suction element102may have two suction inlets116, where a first suction inlet is located along the top of the disk118and a second located suction inlet is located along the bottom of the disk118.FIGS.2and3also show an example embodiment of the irrigation element104in which irrigation outlets124may be located near an outer edge, a rear edge and an inner edge or an inner region away from any edges of the second plate122of the irrigation element104.

FIG.5shows a perspective view of the clip150in one example embodiment. The clip150may comprise a first slot152for releasably receiving a portion of the suction port120, a second slot154for releasably receiving a portion of an endotracheal tube (not shown), and a third slot156for releasably receiving a portion of the irrigation port126. As shown inFIG.5, the second slot154of the clip150and the taper of the bridge106of the medical device100may align in a frontal upwards direction. The second slot154of the clip150and the top edge taper of the bridge106may align so as to create an unimpeded path for the endotracheal tube when the device100is interested into the mouth of a patient that is currently intubated. The endotracheal tube may be in use before insertion of the medical device100or may be inserted into the patient's oral cavity after the medical device100has been inserted into the patient's oral cavity.

FIG.6shows a partial top perspective view of the suction element102of the medical device100ofFIGS.1to5. Shown inFIG.6is the disk118along the inner surface of the enlarged head114of the paddle110of the suction element102. At least one suction inlet116is located on the disk118. In at least one embodiment, multiple suction inlets116are disposed along the disk118. In at least one embodiment, the suction inlet116is located on the top of the disk118(as shown inFIG.6) as well as on the bottom of the disk118(as shown inFIG.4B). Alternatively, in at least one embodiment, the paddle110does not include a disk118, and the at least one suction inlet116is located on and/or under the first plate108of the suction element102. In such embodiments, there may be multiple suction inlets of any size located around the perimeter and/or central region of the first plate108. In at least one embodiment, the at least one suction element116may be located on the paddle110of the suction element102. In said embodiments, there may be multiple suction inlets116of any size located on the elongated arm112or the enlarged head114of the paddle110.

The suction inlet116of the suction element102is fluidly connected to the suction port120by a suction channel. This suction channel may allow for the fluid suctioned from the oral cavity of the patient to be removed more easily and disposed of through the suction port120and the suction line128to a wall mounted suction device, for example.

In at least one embodiment, the patient may be positioned on their side to create a low point in the patient's oral cavity where the irrigation fluid can accumulate. The medical device100may be placed within the oral cavity such that the suction element102is within the buccal pocket between the teeth and cheek of the patient. The low point of the medical device100in 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 disk118of the suction element102may be used to prevent mucous membranes from invaginating into the suction inlet116. For example, the enlarged head114of the paddle110of the suction element102may contact the mucous membrane of the oral cavity of the patient. As the suction inlet116is located on the disk118on the inner surface of the enlarged head114, there is a protective component separating the mucous membrane of the patient from the suction inlet116. The disk118allows suction to occur in the oral cavity without the mucous membrane impeding suction or damaging the patient.

Referring now toFIGS.7A and7B, shown therein are partial views of example embodiments of the irrigation outlets124of the medical device100ofFIGS.1to5.FIG.7Ashows a partial top view of an irrigation element104with a second plate122.FIG.7Bshows a partial right-side view of the irrigation element104. The second plate122comprises a top surface136, a bottom surface138, and a tapered edge140around the outer border of the top surface136. In at least one embodiment, the irrigation outlets124may be placed on the top surface136around the tapered edge140of the second plate122, as shown inFIG.7A. Alternatively, in at least one embodiment, as shown inFIG.7B, the irrigation outlets124may be located along the tapered edge140of the second plate122on both the top surface136and the bottom surface138. In another alternative, in at least one embodiment, the irrigation outlets124may be interspersed throughout the top surface136. In yet another alternative, in at least one embodiment, the irrigation outlets124may be interspersed throughout the bottom surface138. In yet another alternative, in at least one embodiment, the irrigation outlets124may be interspersed throughout both the top surface136and the bottom surface138. In any of the previously disclosed embodiments, the irrigation outlets124may be placed so as to allow for irrigation fluid to be ejected/sprayed along: (1) an outer surface of the teeth, (2) between the teeth and the inner surface of the cheek of the patient, (3) between lower and/or upper surfaces of the upper teeth and lower teeth side, and/or (4) between the inner surface of the teeth and the tongue of the patient. Further shown inFIG.7Bis the direction of fluid flow from the irrigation outlets124(as shown by the arrows).

The irrigation outlets124of the irrigation element104are fluidly connected to the irrigation port126by a fluid channel (an example of this is shown for another embodiment inFIG.21C). The fluid channel allows for fluid from a syringe, for example, or any other fluid dispersing device/fluid source, to be introduced into the oral cavity of the patient. In at least one embodiment, there may be multiple smaller fluid channels travelling from the inner edge of the irrigation port126to each of the irrigation outlets124individually. In another embodiment, the channel may include a single fluid channel travelling, for example, around the tapered edge140of the irrigation element104to each or the irrigation outlets124, wherein the fluid channel may have a fenestration at each of the irrigation outlets124to allow for fluid to be discharged into the patient's oral cavity and this channel then follows a return path back to the irrigation port126.

The suction inlet116and irrigation outlets124may 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. The simultaneous introduction of fluid while suctioning out fluid may allow for a high amount of fluid to be irrigated and subsequently suctioned through the mouth of the patient when the irrigation flow and suction flow are about equal. Accordingly, a majority or about all of the 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.

Referring now toFIGS.8A to8C,FIG.8Ashows a perspective view of a clip150,FIG.8Bshows a front view of the clip150andFIG.8Cshows a top view of the clip150. As disclosed above, the clip150may include a first slot152for receiving a suction port120of a medical device described herein, a second slot154for receiving an endotracheal tube, dental instrument, and/or other medical instrument, and a third slot156for receiving an irrigation port126of a medical device described herein.

In at least one embodiment, the clip150is releasably coupled to the suction port120and the irrigation port126of the medical device100ofFIGS.1to5. The clip150may be positioned on the outer surface of the mouth of the patient. The clip150may be used to control the distance between the inner edges of the suction element102and the irrigation element104of the medical device100once it has been placed within the oral cavity of the patient. Accordingly, the clip150may be used to alter the diameter of the mouthpiece to accommodate for variations in anatomy of jaw size of the patient. Further, the width adjustment accommodated for by the clip150may ensure that the outer edge of the suction element102and the outer edge of the irrigation element104are in the appropriate position to be in contact with the inner surface of one or both of the cheeks within the oral cavity of the patient.

In at least one embodiment, the suction port120and the irrigation port126may each comprise an indentation (e.g., a groove) for placement of the clip150. The edges of the slots152and156of the clip150may be inserted into these indentations. These indentations may be located at any distance from the suction element102and irrigation element104of the medical device100to allow for appropriate sizing for the patient. In one embodiment, the indentations for receiving the clip150may be located closer to the suction element102and irrigation element104. The insertion of the clip150into the indentations, in this embodiment, may only increase the distance between the suction element102and the irrigation element104by a small amount. Alternatively, in at least one embodiment, the indentations for receiving the clip150may be located further away from the suction element102and the irrigation element104. The insertion of the clip150into the indentation, in such embodiments, may increase the distance between the suction element102and the irrigation element104by a larger amount. Such embodiments may be used for patients with larger mouths to allow the medical device100to be placed as disclosed herein.

In at least one embodiment, the suction port120and the irrigation port126may not comprise an indentation. In such embodiments, the clip150may be positioned snugly on the suction port120and the irrigation port126while having the ability to slide along the ports. As such, the further from the outer surface of the mouth (i.e., the outer surface of the lips) of the patient the clip150is slid, the further apart the suction element102and the irrigation element104of the medical device100are moved relative to one another. In each embodiment disclosed herein, the clip150may remain in place on the suction port120and irrigation port126to ensure the medical device100remains in position within the oral cavity of the patient after the medical device100has been inserted into the patient's mouth.

In another embodiment, the clip150may be placed directly in contact with the outer surface of the mouth (i.e., the lips) of the patient. The clip150may remain in position abutting against the outside of the patient's mouth to help seal the mouth as much as possible thereby avoiding or eliminating the possibility of pathogens or aerosols from escaping or entering the patient's mouth in addition to reducing exposure to bodily fluid splashed from the mouth.

Referring now toFIGS.9A to9C, shown therein are several embodiments of clips150a-150cthat may be releasably coupled to the suction port120and irrigation port126of the medical device100as shown inFIGS.1to5, or another embodiment of the medical device. In one embodiment, as shown inFIG.9A, the first slot152aand third slot156aare located at an increased distance from one another in relation to the embodiment shown inFIGS.8A-8C. The clip150amay, when coupled to the suction port120and irrigation port126of the medical device100, decrease the distance between the inner edges of the suction element102and the irrigation element104. The decrease in distance may allow the device100to be used for patients with a smaller oral cavity.FIG.9Bshows a second embodiment of the clip150bwhere the first slot152band third slot156bare located at an intermediate distance from one another.FIG.9Cshows a third embodiment of the clip150cwherein the first slot152cand third slot156care located at a decreased distance from one another in relation to the embodiments shown inFIGS.8A-8B. The clip150cmay, when coupled to the suction port120and irrigation port126of the medical device100, increase the distance between the inner edges of the suction element102and the irrigation element104. The increase in distance may allow the device to be used for patients with a larger oral cavity.

Further embodiments (not shown) may be used wherein the first slot152and third slot156are located at a further distance apart or a smaller distance apart, relative to what is shown inFIGS.9A-9C, to accommodate patients with differently sized oral cavities.

It should be noted that in the various embodiments of the clips150-150cdescribed herein that the clips150-150cmay be made of a similar material as the medical devices described herein. Furthermore, the material used to make the clips150-150cis preferably flexible to allow the outer portions of the clips150-150cto be contoured such that they wrap around and touch the outer surfaces of the patient's mouth and cheeks to improve the amount of sealing that is provided by the clips150-150cand the medical devices described herein during use.

Referring now toFIGS.10to11, shown therein are front and side views of a patient wearing in which one embodiment of the medical device100fromFIGS.1-5has been inserted. As shown, the medical device100is placed within the mouth of the patient and an endotracheal tube170may be positioned within the mouth of the patient above the medical device100. The medical device100and the endotracheal tube170may be releasably coupled to one another. For example, the bridge of the medical device100may be shaped to make a releasable friction fit with a portion of the outer perimeter of the endotracheal tube170. In at least one embodiment, the medical device100and the endotracheal tube170may be provided together in a kit.

Referring now toFIGS.12to13, shown therein are front and side views of a patient wearing one embodiment the medical device100fromFIGS.1-5combined with the clip150ofFIGS.8A-9C. As shown, the clip150is positioned outside the mouth of the patient. The endotracheal tube170is positioned within the mouth of the patient and positioned above the medical device100and also above the second slot154of the clip150. In at least one embodiment, the medical device100, the clip150and the endotracheal tube170may be provided together in a kit.

In at least one embodiment, the medical device100and/or the clip150may be provided with disposable oral care products to form a kit. The disposable oral care products may include an electric toothbrush, non-foaming toothpaste, or any other disposable oral care product.

Referring now toFIGS.14and15, shown therein are a top perspective view and a partial top view of another embodiment of a medical device200in accordance with the teachings herein. The medical device200is similar to medical device100but the medical device200also includes a locking mechanism250instead of the clip150. Accordingly, the medical device200generally operates in a similar manner as was discussed for medical device100but with some differences described below. The locking mechanism250may be used to alter the distance between the inner edges of the suction element202and the irrigation element204. The locking mechanism250includes a ratchet252. The medical device200may also include a first mouthpiece component254and a second mouthpiece component256. One portion (e.g., a first arm) of the ratchet252is connected to the suction port220and another portion (e.g., a second arm) of the ratchet252is connected to the irrigation port226of the medical device200. One portion of the ratchet252includes a clip or hook and the other portion of the ratchet252includes ridges or teeth that can be releasably engaged by the clip/hook. The ratchet252may be adjusted from a first position258(as shown inFIG.15) to a second position260, a third position262, or any other position based on the number of ridges or teeth that are included in the ratchet252. The ratchet252may comprise any number of positions for the teeth/ridges to be engaged. Further, the ratchet252may include any number of ridges or teeth. The ridges or teeth may be any shape and/or able to lock with any corresponding position of the clip/hook on the ratchet252. The ratchet252, when in the first position258, such that the clip of one arm of the ratchet engages the ridge or tooth that is furthest located on the second arm of the ratchet relative to the connection of the second arm on one of the ports220or226of the device200may increase the distance between the inner edges of the suction element202and the irrigation element204by a first amount. In contrast, the ratchet252, when in the third position262where the clip engages the closest located ridge/tooth relative to the connection of the second arm to one of the ports220or226of the device200, may increase the distance between the inner edges of the suction element202and the irrigation element204by a second amount that is larger than the first amount.

The first mouthpiece component254and the second mouthpiece component256may be releasably placed on the outside of the mouth of the patient when the device200is in use. The first and second mouthpiece components254,256may provide the user with a way to easily grasp and handle the medical device200for appropriate placement into and removal from the mouth of the patient.

In at least one embodiment, the locking mechanism250may be releasably connected to the suction port220and the irrigation port226. For example, the arms of the ratchet may include clips or hooks that releasably engage the ports220and226. Alternatively, in at least one embodiment, the locking mechanism250may be permanently connected to the suction port220and the irrigation port226.

Reference is now made toFIGS.16,17A and17B.FIG.16shows a top perspective view of another example embodiment of a medical device300in accordance with the teachings herein.FIG.17Ashows a top perspective view of the medical device300in a wide locked position.FIG.17Bshows a top perspective view of the medical device300in a narrow locked position. The medical device300includes the irrigation holes and suction inlet as was discussed for other embodiments described herein although they are not shown in these figures for simplicity of illustration. The medical device300generally operates in a similar manner as was discussed for medical device100but with some differences described below.

The medical device300includes an optional handle assembly380that is connected to the suction port320and the irrigation port326. The handle assembly380includes a first tab382connected to the suction port320and a second tab384connected to the irrigation port326. The first and second tabs382and384may be referred to as male and female connectors, respectively. The first tab382and the second tab384may be pinched together by the thumb and forefinger of the user. The first tab382and the second tab284may further be used as a portion of the medical device300for the user to hold onto while compressing the mouthpiece during placement within or removal from the oral cavity of the patient.

As shown inFIG.17A, the inner edges of the suction port320and the irrigation port326may be moved away from one another by the user such that they are in a compressed position, by pressing on the outer horizontal surfaces of the first tab382and the second tab384. In at least one embodiment, the first tab382and the second tab384may include elements (not shown) that lock together when the tabs382and284are compressed together and hold the position of the suction port320and the irrigation port326in the compressed position where the distance between the inner edges of the suction element302and the irrigation element304is increased which may be done after the device300is inserted into the patient's mouth so that the device300can be more firmly fitted into a patient with a larger oral cavity.

As shown inFIG.17B, the suction port320and the irrigation port326may be moved apart by a user such that they are in an expanded position. This may be done by a user pressing inserting their finger or another object between the inner horizontal surfaces on the first and second tabs382and384. The first tab382and the second tab384may then be locked together in embodiments where locking elements are included to hold the position of the suction port320and the irrigation port326in an expanded position. In such a position, the distance between the suction element302and the irrigation element304is decreased so as to fit within the oral cavity of a patient when the device300is being inserted into the patient's mouth.

Reference is now made toFIGS.18,19A and19B.FIG.18shows a top perspective view of another example embodiment of a medical device300in accordance with the teachings herein.FIG.19Ashows a top view of the medical device300in a wide locked position.FIG.19Bshows a top view of the medical device300in a narrow locked position.

The medical device300includes a handle assembly380that is connected to the suction port320and the irrigation port326. The handle assembly380includes a first tab382connected to the suction port320and a second tab384connected to the irrigation port326. The handle assembly may further comprise a fastener386, such as a button, pin or a rivet, for example, on the first tab382. The second tab384of the handle assembly380may further comprise one or more slots, holes, or any other receiving component to receive the fastener386. The first tab382and the second tab384may be pinched together by the thumb and forefinger of the user. The fastener386may be pushed down by the user to connect with one of the receiving components of second tab384to lock the handle assembly380in position. The first tab382and the second tab284may further be used as a place for the user to hold while compressing the mouthpiece during placement within the oral cavity of the patient. In other embodiments, the positions of the tabs382and384may be reversed so that they are connected to the suction and irrigation ports, respectively, or other portions of the medical device300.

As shown inFIG.19A, the suction port320and the irrigation port326may be moved together by the user such that they are in a compressed position, by pressing on the bottoms of the first tab382and the second tab384. The fastener386may lock into one of the receiving components when compressed together and hold the position of the suction port320and the irrigation port326in the compressed position where the distance between the inner edges of the suction element302and the irrigation element304is increased which may be done after the device300is inserted into the patient's mouth so that the device300can be more firmly fitted into a patient with a larger oral cavity.

As shown inFIG.19B, the suction port320and the irrigation port326may be pulled apart by a user such that they are in an expanded position. This may be done by a user pressing down on the first and second tabs382and384when they are not locked with one another. The fastener386may lock into one of the receiving components when pushed downwards to hold the position of the suction port320and the irrigation port326in an expanded position. This may occur when there are multiple receiving components or multiple tabs that are each laterally spaced from one another thereby allowing the distance of the ports320and326to be locked at different distances with respect to one another. In the expanded position, the distance between the inner edges of the suction element302and the irrigation element304is decreased so as to fit within the oral cavity of a patient when the device300is being inserted into or removed from the patient's mouth.

Referring now toFIG.20, shown is a perspective view of another example embodiment of a medical device400in accordance with the teachings herein. The medical device400comprises a suction element402and an irrigation element404. The properties, characteristics and functions that were described for the suction and irrigation elements102,104of medical device100may generally apply to the suction and irrigation elements102,404. Accordingly, the medical device400generally operates in a similar manner as was discussed for medical device100but with some differences described below. The suction element402may comprise a paddle410and at least one suction inlet420. The suction element402does not include a plate (which also may be called a bite plate or a bite wing). The paddle410may comprise an elongated arm that is of a uniform construction (i.e., approximately the same height the entire length of the arm). In alternative embodiments, the paddle410may comprise an arm wherein the distal end of the paddle410is enlarged and the arm decreases in height as it gets closer to the bridge406, forming a shape similar to that of a teardrop (as shown inFIG.21B). The paddle410may be placed on the outer side of the upper and lower teeth of the patient such that the paddle410is 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.

Referring now toFIGS.21A and21B, shown therein are partial views of example embodiments of the suction element402of the medical device400ofFIG.20.FIG.21Ashows a top view of medical device400.FIG.21Bshows a cross-sectional right side view of the suction element402of medical device400.

The suction element402comprises at least one suction inlet416for suctioning fluid out of the oral cavity. The paddle410may have a raised surface417on the inner surface. The suction inlet416of the suction element402may be defined by an opening formed on a distal portion of the raised surface417. In alternative embodiments, there may be more than one suction inlet416that is included in the suction element402or the suction inlet may be formed on another portion of the raised surface417. In alternative embodiments, the paddle410may not have a raised surface417and/or the one or more suction inlets416included on the suction element402may be formed on any portion of the paddle410. Alternatively, in at least one embodiment, as shown inFIG.21B, there may be multiple suction inlets416near the distal end of the paddle410. Further shown inFIG.21Bis the direction of fluid flow into the suction inlets416(as shown by the arrows). A line A-A represents the tissue of the inner cheek of the oral cavity and is shown inFIG.21B. As can be seen, the suction inlets416are a slight distance from the edge of the paddle410. As such, intake of the fluid through the suction inlets416is set back from the edge of the paddle410that contacts the mucosal tissue, thereby minimizing chances of occlusion.

Referring now toFIG.21C, shown therein is a top view of a horizontal cross section of the medical device400ofFIG.20without showing the irrigation or suction lines that are external to the irrigation and suction ports, respectively. The medical device400, as well as the other embodiments of the medical devices described herein as well as alternatives thereof, includes an interior irrigation channel (here comprised of irrigation subchannels404aand404b) that is located within the irrigation element404and has a first end that is fluidly coupled to an irrigation inlet port404iand a second end that is fluidically coupled to one or more irrigation outlets424(only one of which is labelled for simplicity). The medical device400, as well as the other embodiments of the medical devices described herein as well as alternatives thereof, also includes an interior suction channel (here comprised of irrigation subchannels402aand402b) within the suction element402has a first end that is fluidly to a suction outlet port4020and a second end that is fluidically coupled to at least one suction inlet416. The interior irrigation and suction channels are not connected to one another.

The interior irrigation and suction channels may have varying shapes and are not connected to one another. For example, the suction channel may have a first cross-section closer to the suction inlet416and a second cross-section closer to the suction outlet port4020where the first cross-section may be larger than the second cross-section in at least one embodiment. Alternatively, the first cross-section may be smaller than the first cross-section in some cases. For the interior irrigation channel, the portion404bmay irregularly shaped such that there are curved portions near the irrigation outlets to aid in directing the irrigation fluids to the irrigation outlets as shown. Alternatively, the interior irrigation channel may have smooth walls without these curved portions in some cases. In other embodiments, the interior irrigation and suction channels may have different shapes and sizes.

The remaining features of the medical device400, may be of the same properties, characteristics and functions of the previous medical devices that were described. For example, the medical device400may, as in the illustrated embodiment, comprise a handle feature380as described in relation toFIGS.16and17A-17B. In an alternative embodiment, medical device400may comprise a locking mechanism as disclosed in relation toFIGS.14and15. In an alternative embodiment, medical device400may, instead of the locking mechanisms ofFIGS.14to17B, comprise a clip as disclosed in relation toFIGS.8A-9C.

Referring now toFIGS.22and25, shown therein is a perspective view of another example embodiment of a medical device500in accordance with the teachings herein. The medical device500comprises a suction element502and an irrigation element504. The properties, characteristics and functions that were described for the suction and irrigation elements102,104of medical device100may apply to the suction and irrigation elements502,504. Accordingly, the medical device500generally operates in a similar manner as was discussed for medical device100but with some differences described below. However, suction element502and irrigation element504has also both been modified in certain aspects in comparison to suction element402and irrigation element104, respectively, as will now be described.

Referring now toFIGS.23A and23B, shown therein are front and back views of the medical device500.FIG.23Ashows a front view of the medical device500, and in particular, an example of the location of the suction port520, the irrigation port526, and the shape of the bridge506.FIG.23Bshows a back view of the suction element502and the irrigation element504with the suction ports516being shown on the paddle510of the suction element502.

The bridge506of the medical device500connecting the suction element502and the irrigation element504may be comprised of a relatively flat section that is has flat upper and lower surfaces and is thinner (e.g., lower or smaller) in profile relative to the bridge of the previous medical device embodiments described herein. The top edge of the bridge506may be low and flat relative to the upper edge of the suction element502to allow for, in at least one embodiment, receiving an endotracheal tube to be located there unimpeded by the medical device500regardless of the lateral position of the endotracheal tube within the patient's mouth. The endotracheal tube may be moved laterally within the mouth of the patient across the top of the bridge506, to a greater degree than with the previous medical device embodiments herein, thereby allowing medical professionals to move the location of the endotracheal tube without the bridge506of the medical device500being in the way. The bridge506having a thin height may allow, in at least one embodiment, for the medical device500to be flipped over within the oral cavity of the patient to allow for suctioning on either side of the mouth. As such, the profile of the bridge506may remain low and flat relative to the suction element502so that the endotracheal tube may be placed and moved appropriately no matter the orientation of the medical device500within the patient's mouth (i.e., regardless of whether the medical device500has the orientation shown inFIGS.23A and23Bor is rotated 180 degrees relative to the orientation shown inFIGS.23A and23B).

Referring now toFIGS.24A and24B, shown therein are right and left side views of the medical device500. In particular,FIG.24Ashows the irrigation and suction elements502and504, whileFIG.24Bshows an outer side of the suction element502.

Suction element502is curved and smooth along all edges to eliminate any sharp components. This allows for the medical device500to prevent injury or damage when in contact with the mucous membranes of a patient's mouth. For example, the smooth edges of the suction element502reduce the likelihood of tissue damage during insertion into and removal from the mouth of the patient.

Suction element502of medical device500may comprise at least one suction inlet516for suctioning fluid out of the oral cavity. The suction inlet516of the suction element502may be defined by an opening formed on the inner side of the suction element502, in a similar location as shown inFIG.24A. Suction inlet516may have an elliptical, semi-circular or almond-shaped opening. In at least one embodiment, the suction inlet516may be any shape with a smooth curvature. In at least one embodiment, as shown inFIG.24Afor example, there may be two suction inlets516. As can be seen, the suction inlets516are a slight distance from the edge of the paddle510that extends rearmost into the patient's mouth during use. As such, intake of the fluid through the suction inlets516is set back from the edge of the paddle510that contacts the mucosal tissue, thereby minimizing chances of occlusion. In at least one embodiment, the suction inlet516may be located at other locations on the paddle510of the suction element502. In at least one embodiment, the suction inlet516may be sized so as to reach from the upper edge of the suction element502to the bottom edge of the suction element502along the inner side. In another alternative embodiment, there may be more than two suction inlets that may be located at additional locations on the paddle510of the suction element502such as closer to the middle and/or front of the patient's mouth while including the rearmost position shown inFIG.24A.

The remaining features of the medical device500, may be of the same properties, characteristics and functions of other medical devices described herein. For example, the medical device500may, as in the illustrated embodiment, comprise a handle feature380as described in relation toFIGS.16and17A-17B. In an alternative embodiment, medical device500may comprise a locking mechanism as disclosed in relation toFIGS.14and15. In an alternative embodiment, medical device500may, instead of the locking mechanisms ofFIGS.14to17B, comprise a clip as disclosed in relation toFIGS.8A-9C.

Referring now toFIG.26, shown therein is a perspective view of another example embodiment of a medical device600in accordance with the teachings herein. The medical device600comprises a suction element602and an irrigation element604. The properties, characteristics and functions that were described for the suction element502and the irrigation element504of medical device500may generally apply to the suction element602and the irrigation element604of medical device600, respectively. However, suction element602has been modified in certain aspects in comparison to suction element502. Accordingly, the medical device500generally operates in a similar manner as was discussed for medical device100but with some differences. which will now be described.

Referring now toFIGS.27A and27B, shown therein are front and back perspective views of the medical device600.FIG.27Ashows a front perspective view of the medical device600, and in particular, an example of the location of the suction port620, irrigation port626, suction line628and irrigation line632.FIG.27Bshows a back view of the suction element602and the irrigation element604with the suction inlets616being shown on the paddle610of the suction element602, as well as the shape of the bridge606.

The bridge606of the medical device600connecting the suction element602and the irrigation element604may be comprised of a relatively flat section that has flat upper and lower surfaces and a height such that it has a lower profile similar to that described for the bridge506of medical device500. For example, the height of the bridge606may be substantially similar or about the same as the height of the irrigation element604. Referring now toFIG.29A, the bridge606may have an increased thickness along axis B-B relative to the bridge of the previous medical device embodiments described herein. This increased thickness along axis B-B may create a product that is less prone to breakage during use, as well as to increase ease of manufacture. For example, increasing the front to back thickness of the bridge606may allow, in at least one embodiment, the bridge606to be manufactured more easily as the product has more body, while maintaining the benefits from the lower profile similar to bridge506of medical device500(i.e., flipped over within the oral cavity, ability to move the endotracheal tube easily, etc.).

Referring now toFIGS.28A and28B, shown therein are right and left side views of the medical device600. In particular,FIG.28Ashows the irrigation and suction elements602(inner surface) and604, whileFIG.28Bshows an outer side of the suction element602. Suction element602of medical device600may comprise at least one suction inlet616for suctioning fluid out of the oral cavity. The suction inlet616of the suction element602may be defined by an opening formed on the inner side of the suction element602, in a somewhat similar location as shown inFIG.24A. However, suction inlet616may have a curved thin oval shaped opening with upper and lower arcs that are both curved upwardly and sized such that the openings appear more like a slit when viewed from the right side, such as inFIG.28A. In such embodiments, the raised profile of suction element602creates a depth to the suction inlet616to allow for adequate fluid flow through suction inlet616. The shape of the opening of suction inlet616may remove any corners or sharp edges that may be shown in previous embodiments to reduce patient discomfort when the medical device600is placed in the mouth. In at least one embodiment, as shown inFIG.28A, there may be two suction inlets616, for example. In at least one embodiment, the suction inlet616may be located at other locations on the paddle610of the suction element602or have different sizes. For example, in at least one embodiment, the suction inlet616may be sized so as to reach from near the upper edge of the suction element602to near the bottom edge of the suction element602along the inner surface (e.g., there may be one inlet that is shaped as a slit and may be a combination of upper and lower inlets616). In another alternative embodiment, there may be two or more upper and lower suction inlets that are located adjacent and to the right of suction inlets616inFIG.28A.

Referring now toFIGS.29A and29B, shown therein are partial views of another example embodiment of the suction element602of the medical device600ofFIG.26.FIG.29Ashows a top view of medical device600.FIG.29Bshows a cross-sectional right side view of the suction element602and suction inlet616of medical device600. The suction inlet616of the suction element602may be defined by an opening formed on a distal portion of paddle610. The suction inlet616may have a rounded rectangular shape with upper and lower portions that are curved upwards and downwards, respectively and the vertical extent of the slits may be closer to the vertical edges of the paddle610. The angle ofFIG.29Bshows the depth of the suction inlet616along the profile of the suction element602. In alternative embodiments, there may be two suction inlets616(as shown) or more than two suction inlets616that are included in the suction element602. The one or more suction inlets616included on the suction element602may be formed on other portions of the paddle610as was described previously in other embodiments. Further shown inFIG.29Bis the direction of fluid flow into the suction inlets616(as shown by the arrows). A line C-C represents the tissue of the inner cheek of the oral cavity and is shown inFIG.29Bwhen the device600is in use. As can be seen, the suction inlets616are a slight distance from the upper and lower edges of the paddle610and set inwards from the distal end of the suction element602. For example, the distance of the suction inlet616from the distal end of the suction element602may be substantially similar or the same as the width of the suction inlet616. As such, intake of the fluid through the suction inlets616is set back from the edge of the paddle610that contacts the mucosal tissue, thereby minimizing chances of occlusion.

The remaining features of the medical device600, may be of the same properties, characteristics and functions as other medical device embodiments described herein. For example, the medical device600may, as in the illustrated embodiment, comprise a handle feature380as described in relation toFIGS.16and17A-17B. In an alternative embodiment, medical device600may comprise a locking mechanism as disclosed in relation toFIGS.14and15. In an alternative embodiment, medical device600may, instead of the locking mechanisms ofFIGS.14to17B, comprise a clip as disclosed in relation toFIGS.8A-9C.

Referring now toFIG.30, shown therein is a top view of another example embodiment of a medical device700in accordance with the teachings therein. The medical device700comprises a suction element702and an irrigation element704. The properties, characteristics and functions that were described for the suction element602and the irrigation element604of medical device600may generally apply to suction element702and the irrigation element704, respectively, of the medical device600. Accordingly, the medical device700generally operates in a similar manner as was discussed for medical device600. However, medical device700has been modified in certain aspects in comparison to medical device600, as will now be described.

The suction element702and the irrigation element704are separate pieces of the medical device700. Therefore, medical device700may be used so that a single piece at a time to be placed within the mouth of the patient. For example, irrigation element704may be placed within the mouth of the patient to irrigate the oral cavity, and then removed. Suction element702may then be placed within the oral cavity to suction any fluid, and then removed. In another example, both the irrigation element704and the suction element702may be placed within the oral cavity simultaneously. Where both the irrigation element704and the suction element702are placed within the oral cavity together, the user may be required to hold onto these pieces of the medical device700to keep them in the appropriate place within the mouth of the patient during use. The two part design of the medical device700may be applied to other embodiments of the medical device described herein.

Suction port720and irrigation port726may be of any length. For example, as shown inFIG.30, suction port720and irrigation port726are of a shorter length compared to previous embodiments of the medical devices described herein. However, in an alternative embodiment, suction port720and irrigation port726may be of an increased length to allow for improved maneuverability by the user. In another alternative embodiment, the suction port720and irrigation port726may be connected to a wand of any length, to any device for irrigation and/or suctioning of an oral cavity. In at least one embodiment, the irrigation port726may be connected to a syringe790that is filled with fluid and the plunger of the syringe790may be pushed during use to irrigate the patient's mouth. The same syringe790, when empty, or another empty syringe may be used connected to the suction port to suction the fluid from the patient's mouth.

Referring now toFIG.31, shown therein is a perspective view of another embodiment of a medical device800in accordance with the teachings herein. The medical device800is somewhat similar to medical devices600and700in that the medical device800may be maintained as two separate elements. The medical device700generally operates in a similar manner as was discussed for medical device600but with some differences. For example, the medical device800also includes a handle assembly880that may be used to releasably connect the suction element802and the irrigation element804together.

The handle assembly880of medical device800may include a male connector882connected to the suction port820and a female connector884connected to the irrigation port826. The male connector882includes a slight protrusion in the form of a low profile post, pin or boss, while the female connector884includes an aperture and a slot that are shaped and sized to releasably receive the post and a tab or flat portion of the male connector882. In an alternative embodiment, the location of the male and female connectors882and824may be on the irrigation and suction ports826and820, respectively. The two halves of the medical device800may be connected by inserting the post of the male connector882into the aperture of the female connector884, as shown inFIG.31. The male and female connectors882and884may be used to connect the suction element802and the irrigation element804together to keep the position of the medical device800at somewhat or fully fixed within the oral cavity of the patient. The handle assembly880may further be used as a physical element for the user to hold onto while configuring the mouthpiece during placement within the oral cavity of the patient.

In an alternative embodiment, the male and female connectors882and884may be implemented such that they are vertically pinched together by the thumb and forefinger of the user to connect and lock the suction element802and the irrigation element804. In another alternative embodiment, the male and female connectors882and884may connect to one another through use of a ratchet, such as ratchet252as shown in relation toFIGS.14and15. In another alternative embodiment, the male and female connectors882and884may be connected and locked through use of a button snap, a buckle, Velcro, double sided adhesive, screws, pins, or any other mechanism to releasably connect and lock two components together.

A method for irrigation of an oral cavity of a patient is now described. The method includes placing one of the medical devices described herein, such as any of medical devices100-800or alternatives thereof, within the oral cavity of the patient, irrigating the oral cavity with fluid delivered using the irrigation element104-804and suctioning the fluid out of the oral cavity by suctioning provided through the suction element102-802. The distal ends of the suction line128and irrigation line132of the medical device100-800may be connected to a wall mounted suction device, an empty syringe or another suction device, and a syringe filled with fluid or an irrigation device, respectively. The irrigation fluid is then provided through the irrigation outlets and fluid in the oral cavity may be suctioned at the same time. The provision of irrigation fluid and suctioning may be done continuously for a certain time duration, or there may be a lag time between the beginning of applying irrigation and the beginning of applying suctioning. Either technique may also be repeated and/or applied periodically over a certain period of time.

In at least one embodiment, the patient may be positioned so that the head and oral cavity of the patient is at a lower position in relation to the feet of the patient (i.e., Trendelenburg position). This patient position may mitigate the risk of fluid being translocated from the oral cavity further down the aerodigestive tract. The patient may then be positioned on their side so that the suction element102-802is disposed within the buccal pocket located in the vertically lowest position of the oral cavity of the patient.

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 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 one of the medical devices described herein or alternative thereof, such as prior to using such devices.

In an alternative embodiment, a method may be applied that further involves 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 suctioning is being performed.

Furthermore, while embodiments of the medical devices described and depicted herein are for use with ventilated patients, alternatives are possible. For example, the medical devices described herein or any alternatives thereof may be used within the dentistry industry for assistance with irrigation and suctioning during certain 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 herein or any alternative thereof may be used within any hospital setting wherein the patient is dependent on a staff member and/or other person for oral care.

In addition, any of the suctioning steps may be performed using high pressure suctioning (e.g., a high negative pressure) which may involve using up to about 250 mm Hg or higher such as up to about 400 mm Hg, for example, of suction applied without causing any tissue within the patient's mouth to be drawn into suction inlets and causing obstruction.

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.

In addition to helping maintain oral hygiene, the various embodiments of 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.

In accordance with another aspect of the teachings herein, any of the medical devices described herein or alternatives thereof may be used to obtain oral samples from the patient during use. These oral samples may then be analyzed using known analytical techniques to detect a variety of pathogens, microbes and/or bacteria such as, but not limited to, various fungi or viruses, for example, that may be responsible for various illnesses or negative physiological conditions. These oral samples may be obtained by using the suction element of the various medical devices described herein. In some cases, the sampling may be done without irrigation. In other cases, the sampling may be done after irrigation or at the same time as irrigation. In such cases, the irrigation may help to dislodge certain bacteria and/or pathogens such that they are easier to obtain in the oral sample(s). In either case, since the suction inlets of the various medical devices described herein reach further back into the oral cavity, these devices enable the provision of oral sample(s) further rearward areas of the oral cavity where it might be particularly hard to otherwise obtain such samples. Another benefit is that sampling these difficult to reach areas may allow for the detection and/or quantification of certain bacteria or pathogens that reside there which would otherwise be difficult to sample using known techniques. This may also allow for identifying and quantifying bacteria, fungi, and viruses, for example, that are known to cause illness not limited to pneumonia and systemic illness, for example.

For example, the suction line/port of one of the medical devices described herein or an alternative thereof, might be connected to a suction device for withdrawing fluid and small particulate matter as one or more samples from a patient's oral cavity. The suction device is then activated or engaged with or without irrigating the oral cavity (as described earlier) to provide suction to withdraw the oral sample(s) from the patient's mouth. For example, the suction device might be a syringe where the sample is obtained and may reside in the reservoir of the syringe or a conduit of the syringe that would connect the reservoir to an opening at an end of the syringe that is connected to the suction line/suction port and is opposite the end of the syringe where the plunger is located. The plunger of the syringe may be pulled back away from the body of the syringe when obtaining the sample and then pushed into the body of the syringe when dispending the sample into a sample container or on a petri dish, for example.

Alternatively, a sample container may be used that includes two tubes, which may be referred to as a sample tube and a suction tube for example, and the suction device may be coupled to the suction tube and the sample tube can be coupled to the suction line/suction port of one of the medical devices described herein. The suction device may then be activated/engaged such that one or more oral samples are suctioned out of the patient's oral cavity due to the suction force that is provided by the suction device then through the fluidic coupling to the suction tube, the interior of the sample container, the sample tube, the suction line to the suction element and suction inlets of the medical device. Once the oral sample(s) is visibly seen to be exiting the sample tube and entering into the sample container, the suction device may be deactivated/disengaged to retain the oral sample(s) within the sample container. In alternative embodiments, one of the medical devices described herein or an alternative thereof may be used in a similar manner with other types of sample containers to obtain at least one oral sample.

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.