Apparatus for irrigating and suctioning oral cavity

Abstract

To provide an apparatus for appropriately irrigating and suctioning the oral cavity of a patient with ease.SOLUTION: A medical apparatus according to the present invention includes: a suction element with an elongated arm for placement between a cheek 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.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] In this specification, various embodiments of a medical device for performing suction and irrigation of a patient's oral cavity will be described.

Background Art

[0002] The background art will be described below. However, it is not admitted that the discussion is part of the prior art or the knowledge of those skilled in the art.

[0003] Mechanically ventilated patients require a tube to be inserted into the trachea so that a ventilator can deliver oxygen to the lungs. The tube may be an endotracheal tube or a tube introduced through a tracheostomy. The proximal end of the tube, which is outside the patient's mouth, is connected to a pipe attached to the ventilator so that it can transfer air to the patient's lungs, and the distal end is placed at the glottis where the patient's trachea branches into the bronchi. The cuff on the tube generally expands to engage the patient's tracheal wall to form a seal that allows ventilation while preventing substances such as fluid from being inhaled into the lungs.

[0004] Mechanically ventilated patients require regular oral care to prevent the growth of bacteria in the oral cavity. Also, patients in a relaxation care, acute care, or other care environment are completely dependent on caregivers for the provision of oral care. This may be done by a liquid delivery process that distributes fluid into the patient's mouth and removes it by suction. Therefore, a device for appropriately and simply delivering liquid and suctioning the patient's oral cavity is needed.

Summary of the Invention

Problems to be Solved by the Invention

[0005] This disclosure generally discloses various configurations of a device that can be inserted into a patient's oral cavity to facilitate fluid delivery and suction, and one or more methods of using such a device. [Means for solving the problem]

[0006] In one embodiment, according to the teachings of this specification, at least one embodiment of a medical device for suction and irrigation of an oral cavity in a patient is provided, comprising: a suction element configured to be positioned on one side of the oral cavity, the suction element comprising an elongated arm positioned between the patient's cheek and upper and lower teeth, and the suction element further comprising at least one suction inlet configured to suction fluid from the oral cavity; a fluid delivery element configured to be positioned on a second side of the oral cavity, the fluid delivery element comprising a second plate positioned between the upper and lower teeth on the second side of the oral cavity, and one or more fluid delivery outlets configured to deliver fluid to the oral cavity; a suction port fluidically coupled to the suction element to supply negative pressure to the suction element during use to suction the oral cavity; and a fluid delivery port fluidically coupled to the fluid delivery element to supply fluid to the fluid delivery element during use to deliver fluid to the oral cavity.

[0007] In other embodiments, according to the teachings of this specification, at least one embodiment of a medical device for suctioning and delivering fluid to a patient's oral cavity is provided, comprising: a suction element configured to be positioned on one side of the oral cavity, the suction element comprising a first plate positioned between upper and lower teeth on one side of the oral cavity, and a paddle positioned between the patient's cheek and upper and lower teeth, the suction element further comprising at least one suction inlet configured to suction fluid from the oral cavity; a fluid delivery element configured to be positioned on a second side of the oral cavity, the fluid delivery element comprising a second plate positioned between upper and lower teeth on the second side of the oral cavity, and one or more fluid delivery outlets configured to deliver fluid to the oral cavity; a suction port fluidically coupled to the suction element to supply negative pressure to the suction element during use to suction the oral cavity; and a fluid delivery port fluidically coupled to the fluid delivery element to supply fluid to the fluid delivery element during use to deliver fluid to the oral cavity.

[0008] In at least one embodiment, the device includes a bridge adapted to connect the suction element to the fluid delivery element.

[0009] In at least one embodiment, the bridge comprises an upper edge and a lower edge, the upper edge tapering toward the lower edge.

[0010] In at least one embodiment, the lower edge of the bridge tapers towards the upper edge.

[0011] In at least one embodiment, the bridge is low profile.

[0012] In at least one embodiment, the bridge comprises a substantially flat upper surface and a lower surface that are spaced equally apart laterally from each other from the suction element to the fluid delivery element.

[0013] In at least one embodiment, the suction port and the fluid delivery port are located on the bridge or are laterally offset from the bridge and are configured to extend outside the oral cavity when in use.

[0014] In at least one embodiment, the paddle of the suction element comprises an elongated arm and an enlarged head.

[0015] In at least one embodiment, the paddle of the suction element is provided with an elongated arm.

[0016] In at least one embodiment, the suction element includes a paddle formed on the elongated arm and positioned near the distal end of the suction element.

[0017] In at least one embodiment, the paddle has a raised surface on the inner surface of the suction element.

[0018] In at least one embodiment, at least one suction inlet is located at the distal end of the raised surface of the suction element.

[0019] In at least one embodiment, the paddle comprises a disc located on the inner surface of the paddle, the disc including at least one suction port.

[0020] In at least one embodiment, the device further comprises a clip adapted to be releasably coupled to the suction port, the fluid delivery port, and the outside of the oral cavity when in use, the clip configured to control the distance between the suction element and the fluid delivery element when the device is positioned inside the oral cavity.

[0021] In at least one embodiment, the clip comprises a first slot configured to receive the suction port, a second slot configured to receive an endotracheal tube, a dental instrument, or other medical device, and a third slot configured to receive the fluid delivery port.

[0022] In at least one embodiment, the suction port and the liquid delivery port are each located at a distance from the front surface of the bridge, and include positioning slots for releasably receiving the clip. The first slot and the third slot of the clip are arranged such that when the clip is disposed in the positioning slot, both the suction port and the liquid delivery port are allowed to move, thereby increasing the distance between the suction element and the liquid delivery element.

[0023] In at least one embodiment, a suction line is fluidly coupled to the suction port.

[0024] In at least one embodiment, a liquid delivery line is fluidly coupled to the liquid delivery port.

[0025] In at least one embodiment, the liquid delivery line includes a tip connector that fluidly couples to an external liquid delivery device.

[0026] In at least one embodiment, the suction line includes a tip connector that fluidly couples to an external suction device.

[0027] In at least one embodiment, the second plate of the liquid delivery element includes an upper surface, a lower surface, and an edge that surrounds the outer edges of the upper and lower surfaces. The liquid delivery outlet is located near an edge of at least one of the upper surface and the lower surface of the liquid delivery element.

[0028] In at least one embodiment, the second plate of the liquid delivery element includes an upper surface, a lower surface, and an edge that surrounds the outer edges of the upper and lower surfaces. The liquid delivery outlet is located on at least one of the upper surface and the lower surface of the liquid delivery element.

[0029] In at least one embodiment, a liquid delivery flow path is provided, which is disposed inside the liquid delivery element and has a first end fluidly coupled to the liquid delivery port and a second end fluidly coupled to the one or more liquid delivery outlets.

[0030] In at least one embodiment, the suction channel within the suction element has a first end fluidly coupled to the suction port and a second end fluidly coupled to the at least one suction inlet.

[0031] In another embodiment, according to the teachings of this specification, at least one embodiment of a kit for oral fluid delivery to a patient is provided, comprising a medical device described in any one embodiment described herein and a medical instrument placed inside the patient's oral cavity.

[0032] In at least one embodiment, the medical device is an endotracheal tube, a dental instrument, or a disposable oral care product.

[0033] In another embodiment, the teachings of this specification provide at least one embodiment of a method for delivering fluid to a patient's oral cavity, comprising: placing a medical device described in any one embodiment described herein inside the patient's oral cavity; delivering a fluid delivered using the fluid delivery element of the medical device into the oral cavity; and aspirating the fluid or any other liquid from the oral cavity using the suction element of the medical device.

[0034] In at least one embodiment, the method further includes receiving an endotracheal tube in the bridge of the medical device.

[0035] In at least one embodiment, the method further includes releasably coupling the suction port and the fluid delivery port of the medical device so that a clip controls the distance between the suction element and the fluid delivery element when the medical device is placed inside the oral cavity.

[0036] In at least one embodiment, the method further includes fluidly coupling the suction port to a suction line.

[0037] In at least one embodiment, the method further includes fluidly coupling the suction line to an external suction device by a tip connector.

[0038] In at least one embodiment, the method further includes fluidically coupling the fluid delivery port to a fluid delivery line.

[0039] In at least one embodiment, the method further includes fluidically connecting the fluid delivery line to an external fluid delivery device or to a fluid-filled bag adapted to provide fluid by gravity or coupled to a pressurized system, via an end connector.

[0040] In at least one embodiment, the method further includes positioning the patient such that the patient's head is lower relative to the patient's feet before providing fluid delivery.

[0041] In at least one embodiment, the method further includes positioning the patient's torso on the side where the suction element is located in the buccal pocket at the lowest position of the oral cavity, before providing fluid delivery.

[0042] In at least one embodiment, the method further includes instilling a fluid into the patient's nostril.

[0043] In other embodiments, according to the teachings of this specification, a medical device for suctioning and delivering fluid to a patient's oral cavity, comprising: a suction element configured to be positioned on one side of the oral cavity, the suction element comprising an elongated arm positioned between the patient's cheek and upper and lower teeth, and the suction element further comprising at least one suction inlet configured to suction fluid from the oral cavity; a fluid delivery element configured to be positioned on a second side of the oral cavity, the fluid delivery element comprising a plate positioned between the upper and lower teeth on the second side of the oral cavity, and one or more fluid outlets configured to deliver fluid to the oral cavity; and a fluidically coupled to the suction element, which, when in use, creates a negative pressure on the suction element. The present invention provides at least one embodiment of a medical device comprising: a suction port for supplying fluid to aspirate the oral cavity; a fluid delivery port, which is fluidically coupled to the fluid delivery element and supplies fluid to the fluid delivery element for delivery to the oral cavity during use; and a locking mechanism adapted to be releasably coupled to the outside of the suction port, the fluid delivery port and the oral cavity during use, the locking mechanism comprising: a first arm having at least one clip; and a second arm having at least one protrusion, the at least one protrusion being releasably engaged by the at least one clip and configured to control the distance between the suction element and the fluid delivery element when the device is placed in the oral cavity.

[0044] In at least one embodiment, the locking mechanism comprises three protrusions on the second arm for releasably engaging with the at least one clip on the first arm, the first protrusions allowing the suction port and the fluid delivery port to move apart when the clip is positioned on the first protrusion, thereby narrowing the distance between the suction element and the fluid delivery element, and the third protrusions allowing the suction port and the fluid delivery port to move together when the clip is positioned on the third protrusion, thereby widening the distance between the suction element and the fluid delivery element.

[0045] In another embodiment, according to the teachings of this specification, a medical device for suctioning and delivering fluid to a patient's oral cavity, comprising: a suction element configured to be positioned on one side of the oral cavity, the suction element comprising an elongated arm positioned between the patient's cheek and upper and lower teeth, and the suction element further comprising at least one suction inlet configured to suction fluid from the oral cavity; and a fluid delivery element configured to be positioned on the second side of the oral cavity, the fluid delivery element comprising a plate positioned between the upper and lower teeth on the second side of the oral cavity, and delivering fluid to the oral cavity The present invention provides at least one embodiment of a medical device comprising: a fluid delivery element having one or more fluid delivery outlets configured to: a suction port fluidically coupled to the suction element and supplying negative pressure to the suction element during use to suction the oral cavity; a fluid delivery port fluidically coupled to the fluid delivery element and supplying fluid to the fluid delivery element during use to deliver fluid to the oral cavity; and a handle mechanism adapted to be releasably coupled to the suction port, the fluid delivery port and the outside of the oral cavity during use, the handle mechanism comprising a male connector and a female connector.

[0046] In at least one embodiment, the female connector includes a slot of a size and shape that accommodates the posts of the male connector, and when the male connector is slid into the female connector during use, the male connector and the female connector engage releasably to connect the suction element and the fluid delivery element.

[0047] In at least one embodiment, the male connector and the female connector are configured to connect the suction element and the fluid delivery element by a button snap, buckle, Velcro®, double-sided adhesive, screw, or pin, respectively.

[0048] In at least one embodiment of the medical device described herein, at least one suction element includes a rectangular slot, a conical slot, an elliptical slot, a semicircular slot, an almond-shaped slot, a curved slot, or a curved slit.

[0049] Other features and advantages of this application will become apparent from the following detailed description, along with the accompanying drawings. However, the detailed description and specific examples illustrating preferred embodiments of this application are for illustrative purposes only, and it goes without saying that those skilled in the art can make various modifications and changes within the scope of the technical idea presented in this specification. [Brief explanation of the drawing]

[0050] To provide a clearer understanding of the various embodiments described herein and to illustrate how these embodiments are carried out, an example of accompanying drawings illustrating at least one embodiment of the present invention will be described below. The drawings are not intended to limit the scope of the present invention.

[0051] [Figure 1] Figure 1 is a perspective view showing one embodiment of a medical device for oral suction and fluid delivery. [Figure 2] Figure 2 is a top view of the medical device shown in Figure 1. [Figure 3] Figure 3 is a bottom view of the medical device shown in Figure 1. [Figure 4A] Figure 4A is a right-side view of the medical device shown in Figure 1, and shows the fluid delivery element and the suction element. [Figure 4B] Figure 4B is a left side view of the medical device shown in Figure 1, indicating the outside of the suction element. [Figure 5] Figure 5 is a front perspective view showing another embodiment of a medical device having a clip that can be attached and detached. [Figure 6] Figure 6 is a partial top perspective view of the suction element of the medical devices shown in Figures 1 to 5. [Figure 7A] Figure 7A is a partial top view showing one embodiment of a fluid delivery element that can be used in the medical devices shown in Figures 1 to 6. [Figure 7B] Figure 7B is a partial right side view of the fluid delivery element in Figure 7A, showing the direction of fluid outflow from the fluid delivery outlet. [Figure 8A] Figure 8A shows a front perspective view of one embodiment of a clip used in the medical devices shown in Figures 1 to 7B. [Figure 8B] Figure 8B shows a front view of one embodiment of a clip used in the medical devices shown in Figures 1 to 7B. [Figure 8C] Figure 8C shows a top view of one embodiment of a clip used in the medical devices shown in Figures 1 to 7B. [Figure 9A] Figure 9A shows a front view of the clip embodiment shown in Figure 8A. [Figure 9B] Figure 9B shows a front view of the clip embodiment shown in Figure 8B. [Figure 9C] Figure 9C shows a front view of the clip embodiment shown in Figure 8C. [Figure 10] Figure 10 shows a front view of a patient using the medical device of the present invention without using clips. [Figure 11] Figure 11 shows a side view of a patient using the medical device of the present invention without using clips. [Figure 12] Figure 12 shows a front view of a patient using the medical device of the present invention with a clip. [Figure 13] Figure 13 shows a side view of a patient using the medical device of the present invention with a clip. [Figure 14] Figure 14 is a top perspective view of another embodiment of a medical device having a clip that includes a locking mechanism to control the movement of the medical device. [Figure 15] Figure 15 is a partial top view of another embodiment of a medical device having a clip that includes a locking mechanism for controlling the movement of the medical device. [Figure 16] Figure 16 is a partial top perspective view of another embodiment of a medical device having a different locking mechanism for controlling the movement of the medical device. [Figure 17A] Figure 17A is a partial top perspective view of the medical device shown in Figure 16, with the locking mechanism moved to a different position. [Figure 17B] Figure 17B is a partial top perspective view of the medical device shown in Figure 16 with the locking mechanism moved to a different position. [Figure 18] Figure 18 is a partial top perspective view of another embodiment having a different locking mechanism for controlling the movement of a medical device. [Figure 19A]Figure 19A is a partial top view of the medical device shown in Figure 18, with the locking mechanism moved to a different position. [Figure 19B] Figure 19B is a partial top view of the medical device shown in Figure 18, with the locking mechanism moved to a different position. [Figure 20] Figure 20 is a front perspective view showing another embodiment of a medical device for oral suction and fluid delivery. [Figure 21A] Figure 21A is a partial top view of the suction element of the medical device shown in Figure 20. [Figure 21B] Figure 21B is a right-side cross-sectional view of the suction element of the medical device shown in Figure 20. [Figure 22] Figure 22 is a perspective view showing another embodiment of a medical device for oral suction and fluid delivery. [Figure 23A] Figure 23A is a front and rear side view of the medical device shown in Figure 22, indicating the suction port and the fluid delivery port. [Figure 23B] Figure 23B is a front and rear side view of the medical device shown in Figure 22, illustrating the suction element and the fluid delivery element. [Figure 24A] Figure 24A is a right-side view of the medical device shown in Figure 22, and shows the fluid delivery element and the suction element. [Figure 24B] Figure 24B is a left side view of the medical device shown in Figure 22, indicating the outside of the suction element. [Figure 25] Figure 25 shows a top view of the medical device shown in Figure 22. [Figure 26] Figure 26 is a perspective view showing another embodiment of a medical device for oral suction and fluid delivery. [Figure 27A] Figure 27A is a front side view of the medical device shown in Figure 26, and shows the suction line and the fluid delivery line. [Figure 27B] Figure 27B is a rear side view of the medical device shown in Figure 26, and shows the suction element and the fluid delivery element. [Figure 28A] Figure 28A is a right-side view of the medical device shown in Figure 26, and shows the fluid delivery element and the suction element. [Figure 28B] Figure 28B is a left side view of the medical device shown in Figure 26, indicating the outside of the suction element. [Figure 29A] Figure 29A is a partial top view of the suction element of the medical device shown in Figure 26. [Figure 29B] Figure 29B is a right-side cross-sectional view of the suction element of the medical device shown in Figure 26. [Figure 30] Figure 30 is a perspective view showing another embodiment of a medical device for oral suction and fluid delivery. [Figure 31] Figure 31 is a perspective view showing another embodiment of a medical device for oral suction and fluid delivery, equipped with a locking mechanism to control the movement of the medical device. [Figure 32A] Figure 32A is a partial perspective view of a medical device equipped with the locking mechanism of Figure 31 in an open and locked configuration. [Figure 32B] Figure 32B is a partial perspective view of a medical device equipped with the locking mechanism of Figure 31 in an open and locked configuration.

[0052] Further aspects and features of the embodiments described herein will become apparent from the following description and accompanying drawings. [Modes for carrying out the invention]

[0053] The headings and abstracts of the inventions described herein are for illustrative purposes only and do not constitute a conjecture regarding the scope or meaning of the inventions.

[0054] The following describes various embodiments of this specification, providing examples of at least one embodiment of the invention described in the claims. The embodiments described herein are not intended to limit the invention described in the claims. Furthermore, the invention described in the claims is not limited to devices, systems, or methods having all of the features described below, or to devices, systems, or methods having features common to some or all of the devices, systems, or methods described herein. The devices, systems, and methods described herein do not necessarily have to be embodiments of the invention described in the claims. Matters described herein that are not claimed may be the subject of other means of protection, such as a continuing patent application, and the applicant, inventor, or rights holder does not intend to abandon, deny, or open up any invention disclosed herein.

[0055] For the sake of simplicity and clarity, the same reference numerals may be used for corresponding or similar components in the drawings as appropriate. Furthermore, many specific details are included to facilitate a detailed understanding of the embodiments described herein. However, it will be understood by those skilled in the art that the embodiments described herein may be implemented without these specific details. In addition, known methods, procedures, and components are not described in detail so as not to impair the embodiments described herein. Moreover, such descriptions do not limit the scope of the embodiments described herein.

[0056] In this specification, the terms "coupled" or "coupling" can have several different meanings depending on the context in which they are used. For example, "coupled" or "coupling" can have a mechanical, structural, or fluid meaning. For instance, in this specification, "coupled" or "coupling" can, depending on the context, mean that two members or devices are directly connected or connected through one or more intermediate elements or devices via mechanical elements, structural elements, airflow, or fluid flow.

[0057] In this specification and in the claims, unless otherwise specified, the word “comprise” and its variations such as “comprises” or “comprising” in the claims and variations thereof should be interpreted in an open and comprehensive manner, that is, “including but not limited to.”

[0058] In this specification, "and / or" is intended to be inclusive and separate. That is, "X and / or Y" means, for example, X, Y, or both. As a further example, "X, Y, and / or Z" means X, Y, Z, or any combination thereof.

[0059] In this specification, terms of degree such as "substantially," "about," and "approximately" mean a reasonable amount of deviation from the modifying term that does not significantly alter the result. These degree terms may be interpreted to include deviations from the modifying term such as 1%, 2%, 5%, 10%, 15%, and 20%, unless they negate the meaning of the modifying term.

[0060] Furthermore, in this specification, the description of a numerical range by an endpoint includes all numbers and fractions that fall within that range (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, and 5). Also, the term "approximately," which means a change up to a certain amount of the base number unless it is a significant change, such as 1%, 2%, 5%, 10%, 15%, 20%, etc., is presumed to modify all numbers and fractions.

[0061] In this specification, "one embodiment," "an embodiment," "at least one embodiment," or "some embodiments" means that in one or more embodiments, one or more specific features, structures, or properties may be combined in any suitable manner, unless otherwise explicitly stated as incompatible or alternative.

[0062] As used herein and in the appended claims, the singular forms "a," "an," and "the" refer to multiple subjects unless explicitly indicated otherwise. "Or" is used in a broad sense and, unless otherwise explicitly stated, is used substantially to mean "and / or."

[0063] As described above, mechanically ventilated patients require a tube to be inserted into the trachea so that the ventilator can deliver oxygen to the lungs. The tube may generally be an endotracheal tube or a tube introduced through a tracheostomy. The proximal end of the tube is connected to the piping attached to the ventilator so that air can be delivered to the lungs, and the distal end is positioned in the bronchi from below the glottis.

[0064] The teachings herein provide various embodiments of medical devices that can be used for routine cleaning of areas that may become reservoirs for pathogens, thereby preventing or significantly slowing the formation of biological membranes containing pathogenic microorganisms.

[0065] It is advantageous to provide various devices and related methods that offer superior oral care. The devices described herein may be used to shorten the duration of mechanical ventilation. The devices described herein may be used to remove bacteria and organic matter fragments from the oral cavity, which are two main reservoirs for various pathogens. These devices can deliver and aspirate fluids without the use of an external suction catheter, reducing the risk of mucosal damage and promoting mucosal health. Furthermore, because fluids can be delivered without dwell time, solutions can be introduced into the patient's oral cavity and aspirated simultaneously. Such devices and methods are cost-effective, efficient, and easy to use, enabling frequent interventions.

[0066] Referring to Figure 1, a top perspective view of one embodiment of the medical device 100 as taught herein is shown. The medical device 100 may be used in conjunction with an endotracheal tube (not shown) for intraoral fluid delivery and suction of the patient. The medical device 100 comprises two parts: a first part including a suction element 102 and a second part including an irrigation element 104. The suction element 102 and the irrigation element 104 are connected by a bridge 106. Each of the elements 102 and 104 is designed to be positioned within the side of the patient's oral cavity. For example, the suction element 102 may be positioned within the right side of the patient's oral cavity and the irrigation element 104 within the left side. In another embodiment, the suction element 102 may be positioned within the left side of the patient's oral cavity and the irrigation element 104 within the right side. In another embodiment, the medical device 100 may be configured to allow for easy reversal of the medical device 100, and the suction element 102 may be positioned on either the left or right side of the oral cavity.

[0067] In at least one embodiment, as shown in Figure 1, the suction element 102 may comprise a first plate 108 and a paddle (or side wall) 110. The first plate 108 may be flat or have some curvature or contour. The paddle 110 comprises an elongated arm 112 and an enlarged head 114. However, in at least one other embodiment, the suction element does not use the enlarged head 114 and has a more uniformly shaped elongated arm. The first plate 108 of the suction element 102 may also be used to be positioned between the upper and lower teeth on one side of the patient's mouth. The first plate 108 may be rectangular, square, rounded rectangle, oval, circular, or any shape that can be positioned in the patient's mouth to fit between the patient's upper and lower teeth. The paddle 110 may also be positioned outside the patient's upper and lower teeth such that the elongated arm 112 and the enlarged head 114 of the paddle 110 are located between the outer surfaces of the patient's upper and lower teeth and the inner surface of the patient's cheek. The paddle 110 may be rectangular, square, rounded rectangle, oval, circular, or any other shape that can be positioned in the patient's mouth to fit between the patient's teeth and cheek.

[0068] The suction element 102 has at least one suction inlet 116. The suction inlet 116 is for aspirating fluid from the oral cavity. As further illustrated in Figure 6, the expanding head 114 of the paddle 110 may have a disk 118 on its inner surface or a raised surface. The disk 118 extends inward away from the inner surface of the expanding head 114. The disk 118 may rise from the surface of the paddle 110 to create a space between the baffle (i.e., a point on the suction element 102) where the paddle 110 contacts the user's cheek tissue and the suction inlet 116. The suction inlet 116 of the suction element 102 may be defined by an opening formed on the upper part of the disk 118. In other embodiments, there may be multiple suction inlets 116 included in the suction element 102, or suction inlets may be formed on other parts of the disk 118. In various embodiments, the suction inlets may have any shape, size, position, and number along the suction element.

[0069] The suction element 102 further includes a suction port 120 protruding from its outer surface. In at least one embodiment, the suction port 120 is located substantially in front of the suction element 102, which may be located outside the patient's mouth when the medical device 100 is in use. In at least one embodiment, the suction port 120 may be located on the bridge 106 or laterally offset from the bridge 106. The suction port 120 may protrude from the suction element 102 by any appropriate distance.

[0070] The fluid delivery element 104 of the medical device 100 comprises a second plate 122. The second plate 122 is positioned on the opposite side of the oral cavity, opposite to the first plate 108 of the suction element 102, and may be located between the patient's teeth and / or in the cheek. The second plate 122 may be flat or have some curvature or contour. The second plate 122 may be rectangular, square, rounded rectangle, elliptical, circular, or any shape that is slidable between the patient's teeth or positioned inside the teeth. The second plate 122 of the fluid delivery element 104 comprises one or more irrigation outlets 124. The irrigation outlets 124 discharge or deliver fluid directly into the oral cavity. The irrigation outlets 124 will be further described with reference to Figures 7A and 7B. The fluid delivery element 104 further comprises an irrigation port 126 that protrudes from the outer surface of the fluid delivery element 104, which may be outside the patient's mouth during use. In at least one embodiment, the irrigation port 126 is located substantially in front of the fluid delivery element 104. In at least one embodiment, the irrigation port 126 may be located on the bridge 106 or laterally offset from the bridge 106. The irrigation port 126 may protrude from the fluid delivery element 104 by any appropriate distance.

[0071] The suction element 102 and the fluid delivery element 104 of the medical device 100 are connected by a bridge 106. As shown in Figure 1, the bridge 106 connecting the suction element 102 and the fluid delivery element 104 may taper in the middle. In at least one embodiment, the upper edge of the bridge 106 may taper relative to the upper edge of the medical device 100 to receive the endotracheal tube without obstruction by the medical device 100. In at least one embodiment, the lower edge of the bridge 106 may taper upward from the lower edge of the medical device 100 to facilitate placement on the inner surface of the patient's lower lip. In at least one embodiment, the medical device 100 may be configured to be easily inverted in the patient's oral cavity, enabling suction from both sides of the mouth. Thus, the bridge 106 may have tapered upper and lower edges to allow the endotracheal tube to be positioned appropriately regardless of the orientation of the medical device 100.

[0072] In at least one embodiment, one end of the suction port 120 of the medical device 100 is fluidically coupled to a suction line 128. The other end of the suction port 120 is fluidically coupled to an internal suction channel formed inside the suction element 102. The suction line 128 may further include a first tip connector 130 that is fluidically coupled to an external suction device, such as a wall-mounted suction device. Suction may be performed by operating the first tip connector 130 of the suction line 128 with a switch or thumb. In at least one embodiment, the first end of the fluid delivery port 126 is fluidically coupled to a fluid delivery line 132. The second end of the fluid delivery port 126 is fluidically coupled to an internal fluid delivery channel formed inside the fluid delivery element 104. The fluid delivery line 132 may further include a second end connector 134 that is fluidically coupled to an external fluid delivery device, such as a syringe or a bag of saline solution in a pressure bag, used for delivering fluid to the patient's oral cavity. In at least one embodiment, the fluid delivery line may be connected to a fluid-filled bag that provides fluid by gravity or is connected to a pressurized system.

[0073] In other embodiments, the suction port 120 and the fluid delivery port 126 may be a single port. This single port may be positioned along any surface of the medical device 100. In such embodiments, the fluid to be delivered to the oral cavity may be introduced into the oral cavity through the same port through which it is aspirated. In this embodiment, this single port may be fluidically coupled to fluid lines for delivery and suction. The fluid lines are distally connected to a device capable of sequentially supplying the delivery fluid, after which the fluid can be removed from the patient's oral cavity by suction.

[0074] In at least one embodiment, the medical device 100 may further include a clip 150 (see Figures 8A to 9C). The clip 150 may be releasably coupled to the suction port 120 and the fluid delivery port 126. The clip 150 may be configured to be positioned outside the patient's oral cavity. The clip 150 may bias the suction element 102 and the fluid delivery element 104 in a direction that separates them or brings them together when placed in the patient's mouth, in order to accommodate (fit) a larger size mouth where the two quadrants of the patient's lower (upper) teeth are further apart from each other.

[0075] The medical device 100 can be formed from any number of soft and elastic materials, such as silicone, polyurethane, or other known materials. For example, the medical device 100 may be formed from a flexible material, and the suction element 102 and fluid delivery element 104 of the medical device 100 may be movable relative to the bridge 106. The flexibility of the material allows the medical device 100 to narrow laterally, bringing the suction element 102 and fluid delivery element 104 closer to each other, thus facilitating insertion into the oral cavity, and thus making it easier to insert the medical device 100 into the patient's mouth. Once the medical device 100 is inserted into the patient's oral cavity, the medical device 100 may expand back to its initial pre-use configuration, where the suction element 102 and fluid delivery element 104 are separated from each other. In at least one embodiment, the suction element 102 and fluid delivery element 104 may be formed from a non-flexible (i.e., rigid) material, and the bridge 106 may be formed from a flexible material. The rigidity of the suction element 102 and the fluid delivery element 104 maintains the structure of the medical device 100, while the flexibility of the bridge 106 makes it easier to insert the medical device 100 into the patient's mouth. In at least one embodiment, the medical device 100 may be composed of any combination of non-flexible (rigid) material and / or flexible material.

[0076] In at least one embodiment, the medical device 100 has a depth of approximately 40 mm, which can be defined by the distance from the bridge 106 of the medical device 100 to the ends of the suction element 102 and the fluid delivery element 104 (i.e., the ends of the suction element 102 and the fluid delivery element 104 that extend furthest into the patient's oral cavity). Alternatively, in at least one embodiment, for patients with small oral cavities, the medical device 100 may have a depth of less than 40 mm. Alternatively, in at least one embodiment, for patients with large oral cavities, the medical device may have a depth greater than 40 mm.

[0077] In at least one embodiment, the medical device 100 has a width of approximately 85 mm, which can be defined by the distance from the outermost edge of the suction element 102 relative to the bridge 106 to the outermost edge of the fluid delivery element 104 relative to the bridge 106. In at least one embodiment, for patients with small oral cavities, the medical device 100 may have a width of less than 85 mm. In at least one embodiment, for patients with large oral cavities, the medical device 100 may have a width greater than 85 mm. In any embodiment of this disclosure, the medical device 100 is compressible laterally by a certain amount, for example, about 15 mm.

[0078] In at least one embodiment, the first and second plates are narrow in width, which can be defined by the distance from the outer edge of the plate to the inner edge of the plate. This narrow width is useful for a small embodiment intended for use by children or people with anatomically small jaws. In at least one embodiment, the first and second plates may be wide. This wide width is useful for a large embodiment intended for use by adults or people with anatomically large jaws. In at least one embodiment, the suction inlet is positioned at a distance of at least 3 mm from the baffle (i.e., a point on the suction element) that contacts the patient's cheek tissue.

[0079] In Figures 2 to 5, the suction port 120 is fluidically coupled to the suction line 128, and the fluid delivery port 126 is fluidly coupled to the fluid delivery line 132. Figures 2 and 3 show one embodiment of the suction element 102, in which the suction inlet 116 may be located on a disc 118 along the inner surface of the expanding head 114 of the paddle 110. In this embodiment, the suction element 102 has one suction inlet 116 located on the upper part of the disc 118 and the other suction inlet 116 located on the lower part of the disc 118. Figures 2 and 3 show an embodiment of the fluid delivery element 104 in which the fluid delivery outlet 124 is located along the outer edge, rear end, and inner edge or an inner region away from any of the edges of the second plate 122 of the fluid delivery element 104.

[0080] Figure 5 shows the clip 150 of this embodiment. The clip 150 includes a first slot 152 that releasably receives a portion of the suction port 120, a second slot 154 that releasably receives a portion of the endotracheal tube, and a third slot 156 that releasably receives a portion of the fluid delivery port 126. As shown in Figure 5, the second slot 154 of the clip 150 and the taper of the bridge 106 of the medical device 100 may be aligned in the frontal direction. When the device 100 is inserted into the mouth of a patient during intubation, the second slot 154 of the clip 150 and the upper edge taper of the bridge 106 may be aligned to create an unobstructed path for the endotracheal tube. The endotracheal tube may be used before insertion of the medical device 100, or it may be inserted into the patient after the medical device 100 has been inserted into the oral cavity.

[0081] Figure 6 is a partial top perspective view of the suction element 102 of the medical device 100 shown in Figures 1 to 5. Figure 6 shows a disc 118 along the inner surface of the enlarged head 114 of the paddle 110 of the suction element 102. At least one suction inlet 116 is provided on the disc 118. In at least one embodiment, multiple suction inlets 116 are arranged along the disc 118. In at least one embodiment, the suction inlets 116 are located on the upper side of the disc 118, as shown in Figure 6, and also on the lower side of the disc 118, as shown in Figure 4B. Alternatively, in at least one embodiment, the paddle 110 does not have a disc 118, and at least one suction inlet 116 is provided on the first plate 108 of the suction element 102. In such an embodiment, multiple suction inlets of any size may be provided on the outer circumference of the first plate 108. In at least one embodiment, this at least one suction element 116 may be located on the paddle 110 of the suction element 102. In this embodiment, the elongated arm portion 112 or the expanding head 114 of the paddle 110 may be provided with multiple suction inlets 116 of any size.

[0082] The suction inlet 116 of the suction element 102 is fluidically coupled to the suction port 120 by a suction channel. This suction channel allows, for example, fluid aspirated from the patient's oral cavity to be easily and readily removed and disposed of by a wall-mounted suction device via the suction port 120 and suction line 128.

[0083] In at least one embodiment, the patient may lie down to create a low point in the oral cavity, allowing the fluid to accumulate. The medical device 100 may be positioned in the oral cavity such that the suction element 102 fits within the buccal pocket between the patient's teeth and cheek. The low point in the oral cavity may also be located within the buccal pocket. This allows for easy suction of the fluid from the oral cavity. The disc 118 of the suction element 102 may be used to prevent the mucous membrane from becoming lodged in the suction opening 116. For example, the expanding head 114 of the paddle 110 of the suction element 102 may be in contact with the patient's mucous membrane of the oral cavity. The suction opening 116 is provided on the disc 118 on the inner surface of the expanding head 114, providing a protective member that separates the patient's mucous membrane from the suction opening 116. The disc 118 allows for suction in the oral cavity without the mucous membrane obstructing suction or causing injury to the patient.

[0084] Next, referring to Figures 7A and 7B, partial views of embodiments of the fluid delivery outlet 124 of the medical device 100 shown in Figures 1 to 5 are displayed. Figure 7A is a partial top view of the fluid delivery element 104 having a second plate 122. Figure 7B is a partial right side view of the fluid delivery element 104. The second plate 122 has an upper surface 136, a lower surface 138, and a tapered edge 140 formed around the outer edge of the upper surface 136. As shown in Figure 7A, in at least one embodiment, the fluid delivery outlet 124 may be located on the upper surface 136 around the tapered edge 140 of the second plate 122. Alternatively, as shown in Figure 7B, the fluid delivery outlet 124 may be located along the tapered edge 140 of the second plate 122 on both the upper surface 136 side and the lower surface 138 side. Alternatively, in at least one embodiment, the fluid delivery outlet 124 may be scattered across the entire upper surface 136. Alternatively, in at least one embodiment, the fluid outlets 124 may be scattered across the entire lower surface 138. Alternatively, in at least one embodiment, the fluid outlets 124 may be scattered across the entire upper surface 136 and the lower surface 138. In any of the embodiments described above, the fluid outlets 124 may be positioned so that the delivered fluid is distributed along the outer surface of the patient's teeth, or between the teeth and the inner surface of the cheek, or along the inner surface of the patient's teeth, or between the teeth and the tongue. Figure 7B further illustrates the direction of fluid flow from the fluid outlets 124 (indicated by arrows).

[0085] The fluid outlet 124 of the fluid delivery element 104 is fluidically coupled to the fluid delivery port 126 by a fluid flow path. The fluid flow path is for introducing fluid from a fluid dispersing device, such as a syringe, into the patient's oral cavity. In at least one embodiment, there may be a plurality of small fluid flow paths extending from the inner edge of the fluid delivery port 126 to each fluid outlet 124. In other embodiments, the flow path may include, for example, fluid flow paths running around the tapered edge 140 of the fluid delivery element 104 to each fluid outlet 124, and each fluid outlet 124 may have an opening for discharging fluid into the patient's oral cavity.

[0086] The suction inlet 116 and fluid outlet 124 may shorten the fluid's residence time in the patient's mouth by simultaneously introducing fluid into the patient's mouth and removing fluid from the patient's mouth. By introducing fluid at the same time as suction, an unlimited amount of fluid can be delivered and then suctioned from the patient's mouth. A large amount of fluid can be flushed out of the mouth without the fluid passing from the oral cavity to the throat.

[0087] Next, referring to Figures 8A to 8C, Figure 8A shows a perspective view of the clip 150, Figure 8B shows a front view of the clip 150, and Figure 8C shows a top view of the clip 150. As described above, the clip 150 may include a first slot 152 for receiving a suction port 120, a second slot 154 for receiving medical devices such as an endotracheal tube and / or dental instruments, and a third slot 156 for receiving a fluid delivery port 126.

[0088] In at least one embodiment, the clip 150 is releasably coupled to the suction port 120 and fluid delivery port 126 of the medical device 100 shown in Figures 1 to 5. The clip 150 may be positioned on the outer surface of the patient's mouth. When positioned in the patient's oral cavity, the clip 150 may be used to control the distance between the inner edges of the suction element 102 and the fluid delivery element 104 of the medical device 100. The diameter of the clip 150 may be changed to accommodate anatomical variations in the patient's jaw diameter. By adjusting the width of the clip 150 accordingly, it is ensured that the outer edges of the suction element 102 and the outer edges of the fluid delivery element 104 are in the appropriate position to contact the cheeks in the patient's oral cavity.

[0089] In at least one embodiment, the suction port 120 and the fluid delivery port 126 each include an indentation (e.g., a groove) for accommodating the clip 150. The clip 150 may be inserted into these indentations. These indentations can be positioned at any distance from the suction element 102 and the fluid delivery element 104 of the medical device 100 and can be sized appropriately for the patient. In one embodiment, the indentation for receiving the clip 150 may be positioned close to the suction element 102 and the fluid delivery element 104. In this embodiment, the distance between the suction element 102 and the fluid delivery element 104 may be slightly increased when the clip 150 is inserted into the indentation. Alternatively, in at least one embodiment, the indentation for receiving the clip 150 may be positioned further away from the suction element 102 and the fluid delivery element 104. In this embodiment, the distance between the suction element 102 and the fluid delivery element 104 may be significantly increased when the clip 150 is inserted into the indentation. Such embodiments can be used to install the medical device 100 of this disclosure for patients with large mouths.

[0090] In at least one embodiment, the suction port 120 and the fluid delivery port 126 do not need to have recesses. In this embodiment, the clip 150 may be slidable along the suction port 120 and the fluid delivery port 126 and may be positioned in close contact with these ports. In this way, as the clip 150 is slid from the patient's outside mouth (i.e., the outer surface of the lips), the suction element 102 and the fluid delivery element 104 of the medical device 100 can be further separated. In each embodiment disclosed herein, the clip 150 may remain on the suction port 120 and the fluid delivery port 126 to ensure that the medical device 100 is positioned in the patient's oral cavity after it has been inserted into the patient's oral cavity.

[0091] In other embodiments, the clip 150 may be in direct contact with the outer surface of the patient's mouth (i.e., the lips). By remaining in contact with the outside of the patient's mouth, the clip 150 can reduce exposure to bodily fluids expelled from the mouth, as well as avoid or eliminate the possibility of pathogens or aerosols escaping or entering the patient's mouth.

[0092] Next, referring to Figures 9A to 9C, several embodiments of clips 150a to 150c that are releasably coupled to the suction port 120 and fluid delivery port 126 of medical device 100 are shown, as shown in Figures 1 to 5. In one embodiment, as shown in Figure 9A, the first slot 152a and the third slot 156a are located at a greater distance from each other than in the embodiments shown in Figures 8A to 8C. When clip 150a is coupled to the suction port 120 and fluid delivery port 126 of medical device 100, it may reduce the distance between the suction element 102 and the fluid delivery element 104. By reducing the distance, device 100 can be used for patients with small oral cavities. Figure 9B shows a second embodiment of clip 150b in which the first slot 152b and the third slot 156b are located at a medium distance from each other. Figure 9C shows a third embodiment of the clip 150c in which the first slot 152c and the third slot 156c are positioned at a greater distance than in the embodiments shown in Figures 8A and 8B. When the clip 150c is coupled to the suction port 120 and the fluid delivery port 126 of the medical device 100, it may increase the distance between the suction element 102 and the fluid delivery element 104. By increasing the distance, the device can be used for patients with larger oral cavities.

[0093] In further embodiments (not shown), the first slot 152 and the third slot 156 may be positioned further or closer than those shown in Figures 9A-9C to accommodate patients with different oral cavity sizes.

[0094] Next, referring to Figures 10 and 11, these are a front view and a side view showing one embodiment of the medical device 100 in Figures 1 to 5 in a patient's position with the device inserted. As shown, the medical device 100 is positioned inside the patient's mouth, and the endotracheal tube 170 is also located inside the patient's mouth and may be positioned above the medical device 100. The medical device 100 and the endotracheal tube 170 may be releasably coupled to each other. In at least one embodiment, the medical device 100 and the endotracheal tube 170 may be located together in a kit.

[0095] Next, referring to Figures 12 and 13, we see a front view and a side view showing a patient wearing one embodiment of the medical device 100 shown in Figures 1 to 5, combined with the clip 150 shown in Figures 8A to 9C. As shown, the clip 150 is located outside the patient's mouth. The endotracheal tube 170 is located inside the patient's mouth, above the medical device 100 and above the second slot 154 of the clip 150. In at least one embodiment, the medical device 100, the clip 150, and the endotracheal tube 170 may be installed together in a kit.

[0096] In at least one embodiment, the medical device 100 and / or clip 150 may constitute a kit comprising a disposable oral care product. This disposable oral care product may include disposable oral care products such as an electric toothbrush and a non-foaming toothpaste.

[0097] Next, referring to Figures 14 and 15, a top perspective view and a partial top view illustrating another embodiment of the medical device 200 of the present invention are shown. The medical device 200 is similar to the medical device 100, except that it includes a locking mechanism 250 instead of a clip 150. The locking mechanism 250 may be used to change the distance between the suction element 202 and the fluid delivery element 204. The locking mechanism 250 includes a ratchet 252. The medical device 200 may include a first mouthpiece component 254 and a second mouthpiece component 256. The ratchet 252 (e.g., a first arm) is partly connected to the suction port 220 and the other part (e.g., a second arm) is connected to the fluid delivery port 226 of the medical device 200. The ratchet 252 has a clip or hook on one side and a protrusion or teeth on the other side that the clip can engage and disengage. The ratchet 252 may be adjusted from a first position 258 (see Figure 15) to a second position 260, a third position 262, etc., based on the number of protrusions or teeth included in the ratchet 252. The ratchet 252 may have any number of positions for engaging with teeth. The ratchet 252 may also have any number of protrusions or teeth. The protrusions or teeth may be of any shape and may be able to lock into any corresponding position on the ratchet 252. When the clip of one arm of the ratchet is in the first position 258, which engages with the furthest protrusion or tooth of the other arm of the ratchet with respect to the coupling of the other arm to one port 220 or 226 of the device 200, the ratchet 252 may increase the distance between the suction element 202 and the fluid delivery element 204 by a first amount. At the third position 262, where the clip engages with the nearest protrusion / tooth, the ratchet 252 may increase the distance between the suction element 202 and the fluid delivery element 204 by a second amount greater than the first amount.

[0098] The first nozzle portion 254 and the second nozzle portion 256 may be positioned outside the patient's mouth when the device 200 is in use. The first and second nozzle portions 254 and 256 allow the user to easily grasp and handle the device to properly position and remove it from the patient's mouth.

[0099] In at least one embodiment, the locking mechanism 250 may be releasably connected to the suction port 220 and the fluid delivery port 226. For example, each arm of the ratchet may be equipped with a clip or hook that releasably engages with the ports 220 and 226. Alternatively, in at least one embodiment, the locking mechanism 250 may be permanently connected to the suction port 220 and the fluid delivery port 226.

[0100] Next, referring to Figures 16, 17A, and 17B, Figure 16 shows a top perspective view illustrating another embodiment of the medical device 300 of the present invention. Figure 17A shows a top perspective view of the medical device 300 in a wide locking position. Figure 17B shows a top perspective view of the medical device 300 in a narrow locking position. The medical device 300 includes a fluid delivery outlet and a suction inlet, as described in other embodiments described herein.

[0101] The medical device 300 optionally includes a handle assembly 380 connected to a suction port 320 and a fluid delivery port 326. The handle assembly 380 has a first tab 382 connected to the suction port 320 and a second tab 384 connected to the fluid delivery port 326. The first tab 382 and the second tab 384 may be referred to as a male connector and a female connector, respectively. The first tab 382 and the second tab 384 are held together by the user's thumb and index finger. The first tab 382 and the second tab 384 may also be used as positions for the user to hold while pressing the mouthpiece when placing the device in the patient's oral cavity.

[0102] As shown in Figure 17A, the suction port 320 and the fluid delivery port 326 may be pressed together and brought into a pressed position by the user pressing the bottoms of the first tab 382 and the second tab 384. After the device 300 is inserted into the patient's mouth, the first tab 382 and the second tab 384 are pressed together and lock into place, and the positions of the suction port 320 and the fluid delivery port 326 are held in a pressed position that increases the distance between the suction element 302 and the fluid delivery element 304, thereby allowing the device 300 to be more securely fitted to patients with larger oral cavities.

[0103] As shown in Figure 17B, the suction port 320 and the fluid delivery port 326 may be pulled apart to the expanded position by the user. This may be done by the user pressing the first tab 382 and the second tab 384. The first tab 382 and the second tab 384 may be pressed downward and locked together, holding the positions of the suction port 320 and the fluid delivery port 326 in the expanded position. In this embodiment, when the device 300 is inserted into the patient's mouth, the distance between the suction element 302 and the fluid delivery element 304 is reduced to fit within the patient's oral cavity.

[0104] Next, referring to Figures 18, 19A, and 19B, Figure 18 shows a top perspective view illustrating another embodiment of the medical device 300 of the present invention. Figure 19A shows a top view of the medical device 300 in the wide locked position. Figure 19B shows a top view of the medical device 300 in the narrow locked position.

[0105] The medical device 300 includes a handle assembly 380 connected to a suction port 320 and a fluid delivery port 326. The handle assembly 380 has a first tab 382 connected to the suction port 320 and a second tab 384 connected to the fluid delivery port 326. The handle assembly may further include a fastener 386, such as a pin or rivet, on the first tab 382. The second tab 384 of the handle assembly 380 may further include one or more receiving parts, such as slots or holes, for receiving the fastener 386. The first tab 382 and the second tab 384 are held together by the user's thumb and index finger. The fastener 386 may be pressed down by the user and connected to one of the receiving parts of the second tab 384 to lock the handle assembly 380. The first tab 382 and the second tab 284 may further be used as positions for the user to hold the mouthpiece while pressing it when placing it in the patient's oral cavity.

[0106] As shown in Figure 19A, the suction port 320 and the fluid delivery port 326 may be pressed together and brought into a pressed position by the user pressing the bottoms of the first tab 382 and the second tab 384. After the device 300 is inserted into the patient's mouth, the fasteners 386 lock together when pressed against one of the receiving parts, and the positions of the suction port 320 and the fluid delivery port 326 are held in a pressed position that increases the distance between the suction element 302 and the fluid delivery element 304, thereby allowing the device 300 to be more securely fitted to patients with larger oral cavities.

[0107] As shown in Figure 19B, the suction port 320 and the fluid delivery port 326 may be pulled apart to the expanded position by the user. This may be done by the user pressing the first tab 382 and the second tab 384. The fastener 386 may engage with one of the receiving portions when pressed downward, holding the positions of the suction port 320 and the fluid delivery port 326 in the expanded position. In this embodiment, when the device 300 is inserted into the patient's mouth, the distance between the suction element 302 and the fluid delivery element 304 is reduced to fit within the patient's oral cavity.

[0108] Next, referring to Figure 20, a perspective view is shown illustrating another embodiment of the medical device 400 of the present invention. The medical device 400 comprises a suction element 402 and a fluid delivery element 404. The attributes, features, and functions described for the fluid delivery element 104 of the medical device 100 may also apply to the fluid delivery element 404. The suction element 402 has a paddle 410 and at least one suction inlet 420. The suction element 402 does not have a plate (also called a bite plate or bite wing). The paddle 410 may have a long arm of uniform structure (i.e., the height is the same along the entire length of the arm). In other embodiments, the paddle 410 may have an arm that is enlarged distally and decreases in height as it approaches the bridge 406, forming a teardrop-like shape (see Figure 21B). The paddle 410 may also be positioned outside the patient's upper and lower teeth so as to be located between the outer surfaces of the patient's upper and lower teeth and the inner surface of the patient's oral cavity cheek.

[0109] Next, referring to Figures 21A and 21B, partial views of an embodiment of the suction element 402 of the medical device 400 shown in Figure 20 are displayed. Figure 21A shows a top view of the medical device 400. Figure 21B shows a cross-sectional right side view of the suction element 402 of the medical device 400.

[0110] The suction element 402 has at least one suction inlet 416 for aspirating fluid from the oral cavity. The paddle 410 may have a raised surface 417 on its inner surface. The suction inlet 416 of the suction element 402 may be defined by an opening formed at the tip of the raised surface 417. In other embodiments, there may be multiple suction inlets 416 included in the suction element 402, or suction inlets may be formed on other parts of the raised surface 417. In other embodiments, the paddle 410 may not have a raised surface 417. One or more suction inlets 416 included in the suction element 402 may be formed on any part of the paddle 410. Alternatively, in at least one embodiment, as shown in Figure 21B, there may be multiple suction inlets 416 at the distal end of the paddle 410. Figure 21B further shows the direction of fluid flow to the suction inlets 416 (indicated by arrows). Line AA indicates the cheek tissue in the oral cavity, as shown in Figure 21B. As shown in the figure, the suction inlet 416 is slightly away from the edge of the paddle 410. In this way, the fluid drawn in from the suction inlet 416 is blocked by the edge of the paddle 410 that comes into contact with the mucosal tissue, minimizing the occurrence of blockage.

[0111] Other features of the medical device 400 may be the same as those of the medical device 100 in terms of attributes, characteristics, and functions. For example, the medical device 400 may include a handle assembly 380 as shown in Figures 16, 17A, and 17B, as in the illustrated embodiment. In other embodiments, the medical device 400 may include a locking mechanism as shown in Figures 14 and 15. In other embodiments, the medical device 400 may include a clip as shown in Figures 8A to 9C instead of the locking mechanism in Figures 14 to 17B.

[0112] Next, with reference to Figures 22 and 25, perspective views illustrating another embodiment of the medical device 500 of the present invention are shown. The medical device 500 comprises a suction element 502 and a fluid delivery element 504. The attributes, features, and functions described for the fluid delivery element 104 of the medical device 100 may also apply to the fluid delivery element 504. The attributes, features, and functions described for the suction element 402 of the medical device 400 may generally apply to the suction element 502. However, as described below, the suction element 502 and the fluid delivery element 504 are modified in certain ways compared to the suction element 402 and the fluid delivery element 104, respectively.

[0113] Next, referring to Figures 23A and 23B, the front and rear views of the medical device 500 are shown. Figure 23A is a front view of the medical device 500, and in particular shows an example of the arrangement of the suction port 520, the fluid delivery port 526, and the bridge 506. Figure 23B shows the rear views of the suction element 502 and the fluid delivery element 504 with the suction inlet 516 displayed on the paddle 510 of the suction element 502.

[0114] The bridge 506 of the medical device 500 connecting the suction element 502 and the fluid delivery element 504 may be composed of a relatively flat portion that is thinner or lower in profile than the bridge of the medical device described herein, with flat upper and lower surfaces. The upper edge of the bridge 506 may be lower and flatter than the upper edge of the suction element 502, and in at least one embodiment, the endotracheal tube can be received in a position that is not obstructed by the medical device 500, regardless of the lateral position of the endotracheal tube in the patient's mouth. Compared to the medical device according to the embodiments described herein, the endotracheal tube can be moved more laterally over the upper part of the bridge 506 in the patient's mouth, so that a healthcare professional can move the position of the endotracheal tube without being obstructed by the bridge 506 of the medical device 500. By narrowing the width of the bridge 506, in at least one embodiment, the medical device 500 may be able to be inverted in the patient's oral cavity, enabling suction on both sides of the mouth. In this way, by keeping the bridge 506 relatively low and flat compared to the suction element 502, the endotracheal tube can be appropriately positioned and moved regardless of the orientation of the medical device 500 (i.e., regardless of whether the medical device 500 is in the orientation shown in Figures 23A and 23B, or rotated 180 degrees relative to the orientation shown in Figures 23A and 23B).

[0115] Next, referring to Figures 24A and 24B, the right and left side views of the medical device 500 are shown. In particular, Figure 24A shows the fluid delivery element 502 and the suction element 504, and Figure 24B shows the outside of the suction element 502.

[0116] The suction element 502 is curved along all edges, eliminating any sharp parts. This prevents the medical device 500 from injuring or damaging the patient's oral mucosa when it comes into contact with it. For example, the smooth edges of the suction element 502 reduce the possibility of tissue damage during insertion into and removal from the patient's mouth.

[0117] The suction element 502 of the medical device 500 may have at least one suction inlet 516 for aspirating fluid from the oral cavity. The suction inlet 516 of the suction element 502 may be defined by an opening formed on the inside of the suction element 502 in an arrangement similar to that shown in Figure 24A. The suction inlet 516 may be elliptical, semicircular, or almond-shaped. In at least one embodiment, the suction inlet 516 may have a shape with smooth curvature. In at least one embodiment, there may be two suction inlets 516, as shown in Figure 24A. As shown, the suction inlet 516 is slightly away from the edge of the paddle 510. In this way, the fluid aspirated from the suction inlet 516 is blocked by the edge of the paddle 510 that comes into contact with the mucosal tissue, minimizing the occurrence of blockage. In at least one embodiment, the suction inlet 516 may be located on the paddle 510 of the suction element 502. In at least one embodiment, the suction inlet 516 may be formed to extend inward from the upper edge of the suction element 502 to the lower edge of the suction element 502. In other embodiments, there may be more than two suction inlets.

[0118] Other features of the medical device 500 may be the same as those of the medical device 100 in terms of attributes, characteristics, and functions. For example, the medical device 500 may include a handle assembly 380 as shown in Figures 16, 17A, and 17B, as in the illustrated embodiment. In other embodiments, the medical device 500 may include a locking mechanism as shown in Figures 14 and 15. In other embodiments, the medical device 500 may include a clip as shown in Figures 8A to 9C instead of the locking mechanism in Figures 14 to 17B.

[0119] Next, referring to Figure 26, a perspective view is shown illustrating another embodiment of the medical device 600 of the present invention. The medical device 600 comprises a suction element 602 and a fluid delivery element 604. The attributes, features, and functions described for the suction element 502 and fluid delivery element 504 of the medical device 500 may generally apply to the suction element 602 and fluid delivery element 604 of the medical device 600, respectively. However, as described below, the suction element 602 is modified in certain ways compared to the suction element 502.

[0120] Next, referring to Figures 27A and 27B, the front and rear views of the medical device 600 are shown. Figure 27A is a front view of the medical device 600, and in particular shows an example of the arrangement of the fluid delivery port 626, suction line 628, and fluid delivery line 632. Figure 27B shows the rear view of the suction element 602 and fluid delivery element 604 with the suction inlet 616 displayed on the paddle 610 of the suction element 602, and the shape of the bridge 606.

[0121] The bridge 606 of the medical device 600 connecting the suction element 602 and the fluid delivery element 604 may consist of a relatively flat portion with flat upper and lower surfaces, and which is thinner or lower in profile, similar to the bridge 506 of the medical device 500. For example, the thickness of the bridge 606 may be substantially the same as or equal to the thickness of the fluid delivery element 604. Next, referring to Figure 29A, the bridge 606 may have a greater thickness along axis BB than the bridge of the above embodiment of the medical device described herein. This allows for the creation of a product that is less prone to breakage during use and improves ease of manufacture by increasing the thickness along axis BB. For example, in at least one embodiment, increasing the thickness of the bridge 606 makes it easier to manufacture the bridge 606 because the body of the product becomes larger while maintaining the advantages of a lower profile similar to the bridge 506 of the medical device 500 (i.e., ease of inversion in the oral cavity and movement of the endotracheal tube).

[0122] Next, referring to Figures 28A and 28B, the right and left side views of the medical device 600 are shown. In particular, Figure 28A shows the fluid delivery element 602 (inner surface) and the suction element 604, and Figure 28B shows the outside of the suction element 602. The suction element 602 of the medical device 600 may have at least one suction inlet 616 for drawing fluid from the oral cavity. The suction inlet 616 of the suction element 602 may be defined by an opening formed on the inside of the suction element 602 in a similar arrangement to that shown in Figure 24A. However, the suction inlet 616 may have a curved oval opening formed in a slit shape when viewed from the right side, as shown in Figure 28A. In this embodiment, the raised outer shape of the suction element 602 creates a depth in the suction inlet 616, allowing the fluid to flow properly from the suction inlet 616. The opening shape of the suction inlet 616, as shown in the above embodiment, eliminates all corners or sharp edges, thereby reducing patient discomfort when the medical device 600 is placed in the mouth. In at least one embodiment, there may be, for example, two suction inlets 616, as shown in Figure 28A. In at least one embodiment, the suction inlet 616 may be located on the paddle 610 of the suction element 602. For example, in at least one embodiment, the suction inlet 616 may be formed to extend inward from near the upper edge of the suction element 602 to near the lower edge of the suction element 602 (for example, it may be a single slit-shaped inlet, or a combination of an upper inlet and a lower inlet 616). In other embodiments, as shown in Figure 28A, there may be two or more upper and lower suction inlets located adjacent to the right side of the suction inlet 616.

[0123] Next, referring to Figures 29A and 29B, partial views of an embodiment of the suction element 602 of the medical device 600 of Figure 26 are shown. Figure 29A shows a top view of the medical device 600. Figure 29B shows a cross-sectional right side view of the suction element 602 and suction inlet 616 of the medical device 600. The suction inlet 616 of the suction element 602 may be defined by an opening formed at the tip of the paddle 610. The suction inlet 616 may be rectangular or conical. The suction inlet 616 may have a curved, elongated oval shape, as described with respect to Figure 28A, but the angle in Figure 29B indicates the depth of the suction inlet 616 along the outer shape of the suction element 602. In other embodiments, there may be two or more suction inlets 616 included in the suction element 602 (as shown). One or more suction inlets 616 included in the suction element 602 may be formed in any part of the paddle 610. Figure 29B further shows the direction of fluid flow to the suction inlet 616 (indicated by arrows). Line CC indicates the cheek tissue in the oral cavity when the device 600 is in use and is shown in Figure 29B. As shown in the figure, the suction inlet 616 is slightly separated from the upper and lower edges of the paddle 610 and is set inward from the distal end of the suction element 602. For example, the distance of the suction inlet 616 from the distal end of the suction element 602 may be approximately the same as or equal to the width of the suction inlet 616. In this way, the fluid drawn in from the suction inlet 616 is blocked by the edge of the paddle 610 that is in contact with the mucosal tissue, minimizing the occurrence of blockage.

[0124] Other features of the medical device 600 may be the same as those of the medical device 100 in terms of attributes, characteristics, and functions. For example, the medical device 600 may include a handle assembly 380 as shown in Figures 16, 17A, and 17B, as in the illustrated embodiment. In other embodiments, the medical device 600 may include a locking mechanism as shown in Figures 14 and 15. In other embodiments, the medical device 600 may include a clip as shown in Figures 8A to 9C instead of the locking mechanism in Figures 14 to 17B.

[0125] Next, referring to Figure 30, a top view is shown illustrating another embodiment of the medical device 700 of the present invention. The medical device 700 comprises a suction element 702 and a fluid delivery element 704. The attributes, features, and functions described for the suction element 602 and fluid delivery element 604 of the medical device 600 may generally apply to the suction element 702 and fluid delivery element 704 of the medical device 700, respectively. However, as described below, the medical device 700 is modified in certain ways compared to the medical device 600.

[0126] The suction element 702 and the fluid delivery element 704 are separate from the medical device 700. Therefore, the medical device 700 may be designed so that each part is placed one at a time in the patient's mouth. For example, the fluid delivery element 704 may be placed in the patient's mouth, delivered to the oral cavity, and then removed. The suction element 702 may be placed in the oral cavity, aspirated, and then removed. In another example, both the fluid delivery element 704 and the suction element 702 may be placed in the oral cavity simultaneously. When both the fluid delivery element 704 and the suction element 702 are placed in the oral cavity, the user needs to hold these parts of the medical device 700 during use and maintain them in the appropriate position in the patient's oral cavity. This two-part configuration of the medical device 700 may be applied to other embodiments of the medical device described herein.

[0127] The suction port 720 and the fluid delivery port 726 may be of any length. For example, as shown in Figure 30, the lengths of the suction port 720 and the fluid delivery port 726 are shorter than those of the embodiments of the medical device described herein. However, in other embodiments, the lengths of the suction port 720 and the fluid delivery port 726 may be increased to improve user operability. In other embodiments, the suction port 720 and the fluid delivery port 726 may be connected to a rod, suction device, or other intraoral fluid delivery / suction device of any length. In at least one embodiment, the fluid delivery port 726 may be connected to a syringe 790 filled with fluid, and the plunger of the syringe 790 may be pressed to deliver fluid to the patient's mouth.

[0128] Next, referring to Figure 31, a perspective view is shown illustrating another embodiment of the medical device 800 of the present invention. The medical device 800, like the medical devices 600 and 700, may be maintained as two separate components, but the medical device 800 also includes a handle assembly 880 for releasably connecting the suction element 802 and the fluid delivery element 804.

[0129] The handle assembly 880 of the medical device 800 may include a male connector 882 connected to the suction port 820 and a female connector 884 connected to the fluid delivery port 826. The male connector 882 has a low-profile post or a small boss-like projection, and the female connector 884 has an opening and slot of a shape and size that releasably receive the post and tab or flat portion of the male connector 882. In other embodiments, the male connector 882 and the female connector 824 may be located at the fluid delivery port 826 and the suction port 820, respectively. The suction port 820 and the fluid delivery port 826 can be connected by inserting the post of the male connector 882 into the opening of the female connector 884, as shown in Figure 31. The male connector 882 and the female connector 884 may be used to connect the suction element 802 and the fluid delivery element 804 to maintain the position of the medical device 800 in the patient's oral cavity. The handle assembly 880 may also serve as a mouthpiece when placed in the patient's oral cavity, while also being used as a place for the user to grasp.

[0130] In another embodiment, the user may pinch the male connector 882 and the female connector 884 with their thumb and index finger to connect and lock the suction element 802 and the fluid delivery element 804. In yet another embodiment, the male connector 882 and the female connector 884 may be connected to each other using a ratchet such as a ratchet 252, as shown in Figures 14 and 15. In yet another embodiment, the male connector 882 and the female connector 884 may be connected and locked using a mechanism such as a button snap, buckle, Velcro®, double-sided adhesive, screw, or pin to connect and lock the two members.

[0131] Next, a method for delivering fluid into the patient's oral cavity will be described. This method comprises placing one of the medical devices 100-800 described herein inside the patient's oral cavity, delivering the fluid into the oral cavity using the fluid delivery elements 104-804 of the medical device, and aspirating the fluid from the oral cavity using the suction elements 102-802. The distal ends of the suction line 128 and fluid delivery line 132 of the medical devices 100-800 may be connected to a wall-mounted suction device and a syringe, respectively. In at least one embodiment, the patient may be positioned so that the patient's head and oral cavity are below the patient's feet (i.e., the Trendelenburg position). This position of the patient can mitigate the risk of fluid entering the gastrointestinal tract from the oral cavity. The patient may then be placed on their side, and the suction elements 102-802 may be placed in a buccal pocket located at the lowest position in the patient's oral cavity.

[0132] The medical devices described herein can be used to clean and disinfect a patient's mouth by delivering a fluid into the mouth and aspirating the delivered fluid. This fluid may be water, saline solution, or any other type of fluid, such as a preservative, antibiotic, or lubricant. Additional cleaning steps, such as brushing teeth or brushing the mouth, or any of the other cleaning steps described above, may be used in conjunction with this device, such as before using this device.

[0133] This method may further include nasal irrigation in conjunction with a medical device. In such treatment, the fluid may be dripped into the patient's nostrils simultaneously with or during oral irrigation.

[0134] Furthermore, the embodiments of medical devices described herein are used for patients on mechanical ventilation, but are not limited thereto. For example, the medical devices described herein may be used in the dental industry, for example, to assist with fluid delivery and suction during dental treatment. In such applications, a portion of the medical device housing the endotracheal tube may be used to arrange specific dental instruments for the performance of a particular dental treatment. In other embodiments, the medical devices described above can be used in any hospital setting where the patient relies on staff and / or oral caregivers.

[0135] Furthermore, each suction step may be performed using high-vacuum suction (e.g., high negative pressure, high vacuum) that can apply a vacuum up to 250 mmHg without causing damage to the patient's oral tissues by drawing them into the suction inlet.

[0136] Furthermore, each fluid delivery process may be carried out by low-pressure, medium-pressure, and high-pressure fluid delivery. For high-pressure fluid delivery, a fluid flow rate of 250 mL / min or more may be used as appropriate, based on the required washing volume and the suction volume during use.

[0137] Various embodiments of the devices and methods disclosed herein can provide additional protection against other pathogens, such as the COVID-19 virus, by preventing or suppressing the generation of aerosols that may contain pathogens such as viruses, in addition to maintaining oral hygiene. By using the clips and fluid delivery / washing and sanitizing procedures described herein, inhalation of open airways can be avoided, and the aerosolization of pathogens can be suppressed or prevented. This is because the clips reduce or prevent leakage from the patient's mouth, and the devices engage more securely with the patient's oral cavity. Furthermore, by improving oral fluid delivery / washing and sanitizing that is possible with the devices described herein, aerosols can be reduced, providing additional protection to critical frontline care staff.

[0138] The applicant's teachings described herein are accompanied by various embodiments for illustrative purposes; however, these embodiments are illustrative and do not limit the applicant's teachings to such embodiments. On the other hand, the applicant's teachings described and illustrated herein include various alternatives, modifications, and equivalents, which do not depart from the embodiments described herein, and their general scope is defined in the claims.

Claims

1. A medical device for suction and fluid transfer to the oral cavity of a patient, a suction element for placement at the oral cavity, the suction element including an elongated arm and at least one suction inlet for aspirating fluid from the oral cavity; a fluid delivery element disposed at a second location in the oral cavity, the fluid delivery element comprising a plate and one or more fluid delivery outlets for delivering fluid to the oral cavity; a suction port coupled to the suction element for removing fluid from at least a first portion of the oral cavity; a fluid delivery port coupled to the fluid delivery element for providing fluid to at least a second portion of the oral cavity; A medical device comprising:

2. The device of claim 1 , comprising a bridge connecting the aspiration element to the delivery element.

3. The device of claim 2 , wherein a central portion of the bridge has a lower profile relative to outer portions of the bridge.

4. A bridge is provided, The device of claim 1 , wherein the suction port and the fluid delivery port are located on the bridge, laterally offset from a center of the bridge and configured to extend outside the oral cavity in use.

5. The device of claim 1 , wherein the suction element comprises a paddle, the paddle comprising the elongated arm having an enlarged head.

6. The device of claim 1 , wherein the suction element comprises a paddle, the paddle comprising the elongated arm.

7. The device of claim 1 , wherein the suction element comprises a paddle formed on the long arm and positioned near a distal end of the suction element.

8. The device of claim 1 comprising a paddle having a raised surface on an inner surface.

9. The device described in claim 1, comprising at least one suction inlet spaced apart from the distal end of the raised surface of the suction element.

10. The device described in claim 1, comprising a clip releasably coupled to the suction port and the fluid delivery port and positioned outside the oral cavity in use, the clip configured to control the distance between the inner edges of the suction element and the fluid delivery element when the device is positioned inside the oral cavity.

11. 2. The device of claim 1, wherein the suction port and the fluid delivery port each have a positioning slot for releasably receiving a clip, the positioning slots being located a distance away from a front surface of the bridge, and at least one of the clip slots being positioned to allow the suction port and the fluid delivery port to move together when the clip is positioned in the positioning slot, thereby increasing the distance between the inner edges of the suction element and the fluid delivery element.

12. The device of claim 1, comprising a suction line fluidly coupled to the suction port.

13. The device described in claim 1, comprising a fluid delivery line fluidly coupled to the fluid delivery port.

14. An instrument as described in claim 1, comprising a locking mechanism that, in use, is releasably coupled to the suction port, the fluid delivery port and the outside of the oral cavity, the locking mechanism comprising 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 the distance between the suction element and the fluid delivery element when the instrument is positioned in the oral cavity.

15. The device of claim 1, comprising a handle mechanism including a male connector and a female connector, the male connector and the female connector each including a first tab and a second tab, the first tab and the second tab releasably engage together when pressed to control the distance between the suction element and the delivery element.

16. The device of claim 1, wherein the suction element includes at least one of a rectangular slot, a conical slot, an elliptical slot, a semicircular slot, an almond shaped slot, a curved slot, or a curved slit.

17. The device described in claim 1, wherein the long arm is positioned at the oral cavity, between the patient's cheek and upper and lower teeth.

18. The position of the oral cavity is a first position of the oral cavity, The appliance of claim 1 , wherein the plate is configured to be placed between the patient's upper and lower teeth at a second location in the oral cavity.

19. The device described in claim 1, wherein the suction element includes a paddle between the patient's cheek and upper and lower teeth at the oral cavity.

20. The device described in claim 1, including a suction port fluidly coupled to a suction element and providing negative pressure to suction at least a first portion of the oral cavity.

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