One-way tracheostomy valve to provide variable positive end-expiratory pressure

Abstract

A one-way tracheostomy valve includes an open-bore assembly having a first end that defines a first diameter and a second end opposite the first end that defines a second diameter. A one-way occluder is fixedly arranged to the second end of the open-bore assembly. A rotatable cover is arranged on the second end and configured to rotate around the second end.

Description

ONE-WAY TRACHEOSTOMY VALVE TO PROVIDE VARIABLE POSITIVE END- EXPIRATORY PRESSURECROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to United States Provisional Patent Application No. 63 / 530,040, filed on July 31, 2023, the disclosure of which is incorporated herein by reference.BACKGROUND OF THE DISCLOSURE

[0002] Atelectasis, the collapse of a part or all of the lung is a common complication in post-operative patients. Lack of ambulation and the use of anesthesia during surgery and during post-operative pain increases a patient’s chance of atelectasis.

[0003] An incentive spirometer device is a handheld device used post-operatively that promotes deep breathing. The use of an incentive spirometer may aid in the prevention of atelectasis by encouraging maximal inspiration. The utility of incentive spirometers is controversial. Incentive spirometers devices are generally given to post-operative patients, especially to those in the general surgery department who have undergone abdominal or thoracic surgery.

[0004] Handheld devices that provide positive expiratory pressure as patient exhales are newer methods that also exist to address atelectasis. Patients with tracheostomies cannot use handheld devices, such as incentive spirometers or positive expiratory pressure devices, to prevent and treat atelectasis because they breathe (exhale) through their tracheostomies, not through their mouths. Therefore, patients with a tracheostomy do not have access to the same tools to prevent and treat atelectasis.

[0005] Thus, there is a need for a tracheostomy device that can be fitted to the tracheostomy tube of a patient to help prevent and treat atelectasis.SUMMARY OF THE DISCLOSURE

[0006] The present disclosure provides a one-way tracheostomy valve that provides variable positive end-expiratory pressure for the prevention and treatment of atelectasis.

[0007] The one-way tracheostomy valve may be positioned on a tracheotomy tube to allow for unobstructed inhalation while allowing for a variable pressure during exhalation with closure of the valve.

[0008] An embodiment of the present disclosure may increase resistance to exhalation with closure of the aperture.

[0009] The present disclosure provides a one-way tracheostomy valve including an openbore assembly having a first end defining a first diameter and a second end opposite the first end defining a second diameter, a one-way occluder fixedly arranged to a portion of the second end of the open-bore assembly, and a rotatable cover disposed on the second end of the open-bore assembly, the rotatable cover configured to rotate around the second end. In an embodiment, the second diameter may be larger than or equal to the first diameter.

[0010] In an embodiment of the present disclosure, the open-bore assembly may be made of a medical grade non-permeable material.

[0011] In an embodiment of the present disclosure, the open-bore assembly may be made of polycarbonate, polyethylene, polypropylene, and / or polystyrene. In an embodiment, the openbore assembly may be made of plastic or a plastic material.

[0012] In an embodiment of the present disclosure, the first diameter may be from 5 mm to 30 mm.

[0013] In an embodiment of the present disclosure, the second diameter may be from 5 mm to 70 mm.

[0014] In an embodiment of the present disclosure, the one-way occluder may be made of a flexible film material.

[0015] In an embodiment of the present disclosure, the one-way occluder may be made of silicone.

[0016] In an embodiment of the present disclosure, the second end may include a support structure that extends across the second diameter and separates the second end into a first portion and a second portion. In an embodiment, the first portion may define a first assembly aperture, and the second portion may define a second assembly aperture.

[0017] In an embodiment of the present disclosure, the one-way occluder may be fixedly arranged to a side of the support structure that is opposite of the rotatable cover.

[0018] In an embodiment of the present disclosure, the first portion and the second portion may include one or more spokes.

[0019] In an embodiment of the present disclosure, the one or more spokes of the first portion may be arranged from a center point of the support structure toward a circumference ofthe first portion of the second end. In other embodiments, the one or more spokes of the first portion may be arranged from any other point of the support structure toward a circumference of the first portion of the second end.

[0020] In an embodiment of the present disclosure, the rotatable cover may be made of a medical grade non-permeable material.

[0021] In an embodiment of the present disclosure, the rotatable cover may be made of polycarbonate, polyethylene, polypropylene, and / or polystyrene. In an embodiment, the rotatable cover may be made of plastic or a plastic material.

[0022] In an embodiment of the present disclosure, an axis of the rotatable cover may divide the rotatable cover into a first portion and a second portion. In an embodiment, the first portion may define a rotatable cover aperture.

[0023] In an embodiment of the present disclosure, the first portion of the rotatable cover may include one or more spokes.

[0024] In an embodiment of the present disclosure, the one or more spokes may be arranged from a center point of the axis toward a circumference of the first portion of the rotatable cover. In other embodiments, the one or more spokes of the first portion may be arranged from any other point of the axis toward a circumference of the first portion of the second end.

[0025] In an embodiment of the present disclosure, the one-way tracheostomy valve may be configured to be fitted into a tracheostomy tube.

[0026] In an embodiment of the present disclosure, the rotatable cover may be configured to rotate around the second end of the assembly to obstruct a variable amount of the first assembly aperture and / or the second assembly aperture.

[0027] The present disclosure provides a method providing a one-way tracheostomy valve including an open-bore assembly having a first end and a second end, a one-way occluder fixedly arranged to the second end of the assembly, and a rotatable cover arranged on the second end, directing a fluid in a first direction from the second end to the first end, whereby the oneway occluder may flex toward the first end as the fluid is directed in the first direction, and directing the fluid in a second direction from the first end to the second end, whereby movement of the one-way occluder may be blocked by one or more spokes fixedly arranged to the second end such that the occluder may form a seal against the one or more spokes.

[0028] In an embodiment of the present disclosure, the method may further provide rotating the rotatable cover around the second end of the assembly to obstruct a variable amount of one or more apertures of the second end.BRIEF DESCRIPTION OF THE FIGURES

[0029] For a fuller understanding of the nature and objects of the disclosure, reference should be made to the following detailed description taken in conjunction with the accompanying figures.

[0030] FIG. 1 displays a top plan view of an embodiment of the present disclosure.

[0031] FIG. 2A displays a top plan view of an embodiment of the present disclosure as disclosed herein.

[0032] FIG. 2B displays a top perspective view of an embodiment of the open-bore assembly as disclosed herein.

[0033] FIG. 2C displays a front view of an embodiment of the open-bore assembly as disclosed herein.

[0034] FIG. 3A displays a top perspective view of an embodiment of the rotatable cover as disclosed herein.

[0035] FIG. 3B displays a top plan view of an embodiment of the rotatable cover as disclosed herein.

[0036] FIG. 4A displays a top perspective view of an embodiment of the present disclosure when 0% of the aperture is open.

[0037] FIG. 4B displays a top perspective view of an embodiment of the present disclosure when 50% of the aperture is open.

[0038] FIG. 4C displays a top perspective view of an embodiment of the present disclosure when 100% of the aperture is open.

[0039] FIG. 4D displays a front view of an embodiment of the present disclosure.

[0040] FIG. 5A displays a top plan view of an embodiment of the present disclosure when 0% of the aperture is open.

[0041] FIG. 5B displays a top plan view of an embodiment of the present disclosure when 50% of the aperture is open.

[0042] FIG. 5C displays a top plan view of an embodiment of the present disclosure when 100% of the aperture is open.

[0043] FIG. 6A displays a partial transparent top plan view of an embodiment of FIG. 5 A when 0% of the aperture is open.

[0044] FIG. 6B displays a partial transparent top plan view of an embodiment of FIG. 5B when 50% of the aperture is open.

[0045] FIG. 6C displays a partial transparent top plan view of an embodiment of FIG. 5C when 100% of the aperture is open.

[0046] FIG. 7A displays a partial transparent top perspective view of an embodiment of FIG. 4A when 0% of the aperture is open.

[0047] FIG. 7B displays a partial transparent top perspective view of an embodiment of FIG. 4B when 50% of the aperture is open.

[0048] FIG. 7C displays a partial transparent top perspective view of an embodiment of FIG. 4C when 100% of the aperture is open.

[0049] FIG. 8A displays a partial transparent front view of an embodiment of FIG. 4D when 0% of the aperture is open.

[0050] FIG. 8B displays a partial transparent front view of an embodiment of FIG. 4D when 50% of the aperture is open.

[0051] FIG. 8C displays a partial transparent front view of an embodiment of FIG. 4D when 100% of the aperture is open.

[0052] FIG. 9A displays pressure and velocity as applied to an embodiment of the present disclosure when 0% of the aperture is open.

[0053] FIG. 9B displays pressure and velocity as applied to an embodiment of the present disclosure when 50% of the aperture is open.

[0054] FIG. 9C displays pressure and velocity as applied to an embodiment of the present disclosure when 100% of the aperture is open.

[0055] FIG. 10A displays the movement of an embodiment of the one-way occluder during inhalation.

[0056] FIG. 10B displays the movement of an embodiment of the one-way occluder during exhalation.DETAILED DESCRIPTION OF THE DISCLOSURE

[0057] Although claimed subject matter will be described in terms of certain embodiments, other embodiments, including embodiments that do not provide all of the benefitsand features set forth herein, are also within the scope of this disclosure. Various structural, logical, process step, and electronic changes may be made without departing from the scope of the disclosure. Accordingly, the scope of the disclosure is defined only by reference to the appended claims.

[0058] Ranges of values are disclosed herein. The ranges set out a lower limit value and an upper limit value. Unless otherwise stated, the ranges include all values to the magnitude of the smallest value (either lower limit value or upper limit value) and ranges between the values of the stated range.

[0059] The present disclosure provides a one-way tracheostomy valve that can be attached to a tracheostomy tube to help prevent or treat atelectasis in patients with tracheostomies.

[0060] As shown in FIGS. 1 and 4A-4D, in an embodiment of the present disclosure, the one-way tracheostomy valve 10 may include an open-bore assembly 16. The open-bore assembly 16 may extend through the entire length of the assembly open-bore assembly 16. The open-bore assembly 16 may include a first end 12 defining a first diameter 13 (shown with a dotted line in FIG. 1) and a second end 14, opposite the first end 12, defining a second diameter 15 (shown with a dotted line in FIG. 1). The second diameter 15 may be larger than or equal to the first diameter 13. The first end 12 and the second end 14 may be open to allow for fluid flow (e.g., air or oxygen) through the open-bore assembly 16. The one-way tracheostomy valve 10 may further include a one-way occluder 18 fixedly arranged to the second end 14 of the open-bore assembly 16. Further, the one-way tracheostomy valve 10 may include a rotatable cover 19 disposed on the second end 14 of the open-bore assembly 16. The rotatable cover 19 may be configured to rotate around the second end 14 of the open-bore assembly 16. In an embodiment, the first diameter 13 of the first end 12 may be fitted to a standard tracheostomy (trach) tube.

[0061] In an embodiment, the open-bore assembly 16 may be fabricated of a non- permeable flexible medical grade material. For example, the open-bore assembly 16 may be made of plastic. The open-bore assembly 16 may be fabricated of polycarbonate, polyethylene, polypropylene, polystyrene, etc. In another instance, the open-bore assembly 16 may be fabricated from a rigid material. In an embodiment, the open-bore assembly 16 may have a funnel shape, a cylindrical shape, and / or a cone shape.

[0062] In an embodiment of the present disclosure, the first diameter 13 may be from, for example, 5 mm to 30 mm. The second diameter 15 may be from, for example, 5 mm to 70 mm. In an instance, the second diameter 15 may be twice the size of the first diameter 13. For example, the first diameter 13 may be 15 mm, and the second diameter 15 may be 30 mm. The second diameter 15 may be twice the size of the first diameter 13 to allow for the occluding of half of the one-way tracheostomy valve 10 to provide variable resistance. In embodiments in which the first diameter 13 is equal to the second diameter 15, inhalation may be more restricted.

[0063] In embodiments of the present disclosure, the area of the second end 14 may be larger than or equal to the area of the first end 12. For example, the second diameter 15 may be equal to the square root of two times of the first diameter 13. Other ratios are possible if the second diameter 15 is larger than or equal to the first diameter 13.

[0064] As shown in FIGS. 1 and 2A-2C, the second end 14 of the open-bore assembly 16 may include a support structure 21. The support structure 21 may extend across the second diameter 15 of the second end 14. Further, the support structure 21 may separate the second end 14 into a first portion 23 and a second portion 24. The first portion 23 of the second end 14 may define a first assembly aperture 17A. The second portion 24 of the second end 14 may define a second assembly aperture 17B. The first assembly aperture 17A and the second assembly aperture 17B may allow for fluid flow through the open-bore assembly 16. In an embodiment, the first assembly aperture 17A and the second assembly aperture 17B may have a semi-circular shape.

[0065] As shown in FIGS. 2A and 2B, in an embodiment of the present disclosure, the first portion 23 of the second end 14 and the second portion 24 of the second end 14 may include one or more spokes 25. The one or more spokes 25 of the first portion 23 of the second end 14 may be arranged from a center point 22 of the support structure 21 toward a circumference of the first portion 23 of the second end 14. The one or more spokes 25 of the first portion 23 may define the first assembly aperture 17A therebetween. Further, one or more spokes 25 may be arranged across the second portion 24 of the second end 14. The one or more spokes 25 of the second portion 24 may define the second aperture 17B therebetween. As shown, the one or more spokes 25 may have the same or different sizes, such as length, width, and height. In an embodiment, the one or more spokes 25 of the first portion 23 of the second end 14 may be equal in length, width, and height. For example, the one or more spokes 25 of the first portion 23 mayhave three spokes with the same dimensions to form four separate open cavities with the same dimensions, and the one or more spokes 25 of the second portion 24 of the second end 14 may have three spokes with different dimensions to form four separate open cavities with different dimensions. In an embodiment, the one or more spokes 25 of the first portion 23 may have the same or different quantity and / or dimensions as the one or more spokes 25 of the second portion 24.

[0066] In an embodiment, the one-way occluder 18 may be made of a flexible film material, such as silicone. The one-way occluder 18 may be any shape, size, or thickness. In an embodiment, the one-way occluder 18 may have a semi-circular shape. In embodiments, the oneway occluder 18 may be sized to fit into the semi-circular first assembly aperture 17A. The oneway occluder 18 may be arranged below the one or more spokes 25 of the first portion 23 of the second end 14 and / or the second portion 24 of the second end 14.

[0067] As shown in FIGS. 2A-2C, the one-way occluder 18 may be fixedly arranged to a side of the support structure 21 that is opposite of the rotatable cover 19. For example, in an embodiment in which the one-way occluder 18 is a semi-circle, the flat portion of the semi-circle may be fixedly arranged to the support structure 21, and the unaffixed portion may be free to move in all directions. The unaffixed portion of the one-way occluder 18 may be able to flex, collapse, or become rigid in response to fluid flow.

[0068] In an instance, the one-way occluder 18 may be fixedly arranged to the support structure 21 by one or more rivets. Further, the one-way occluder 18 may be fixed to a straight edge of the support structure 21 with an adhesive material. Other ways to attach the one-way occluder 18 to the support structure 21 of the second end 14 are possible.

[0069] As shown in FIGS. 2A and 2B, in an embodiment, the one-way occluder 18 may be fixedly arranged to a portion of the second diameter 15 of the second end 14. For example, the one-way occluder 18 may cover a portion or the entirety of the first portion 23 of the second end 14. Further, the one-way occluder 18 may cover a portion or the entirety of the first assembly aperture 17 A.

[0070] In an embodiment, the rotatable cover 19 may be made of a non-permeable flexible medical grade material. For example, the rotatable cover 19 may be made of plastic. For example, the rotatable cover 19 may be made of polycarbonate, polyethylene, polypropylene, polystyrene, etc. In another instance, the rotatable cover 19 may be made of rigid material.

[0071] As shown in FIGS. 3 A and 3B, the rotatable cover 19 may include an axis 26. The axis 26 may be a center axis or an axis across the rotatable cover 19 that need not be in the center. The axis 26 may separate the rotatable cover 19 into a first portion 28 and a second portion 29. In an embodiment, the first portion 28 of the rotatable cover 19 may define a rotatable cover aperture 20. Further, as shown, the first portion 28 of the rotatable cover 19 may include one or more spokes 30. The one or more spokes 30 of first portion 28 of the rotatable cover 19 may be arranged from a center point 27 (or a point on the axis 26 that is not in the center) of the axis 26 towards a circumference of the first portion 28 of the rotatable cover 19. The one or more spokes 30 of the first portion 28 may define the rotatable cover aperture 20 therebetween. The one or more spokes 30 may have the same or different sizes, such as length, width, and height. In an embodiment, the second portion 29 of the rotatable cover 19 may be a closed / solid portion. In an embodiment, the rotatable cover 19 may be arranged to the second end 14 of the open -bore assembly 16.

[0072] As shown in FIGS. 4A-4C, the rotatable cover 19 may rotate around the second end 14. The open-bore assembly 16 may have ridges near the second end 14 to allow for attaching the rotatable cover 19 thereto by a twisting or a screwing motion (FIG. 2B). The ridges may allow the rotatable cover 19 to rotate freely around the second end 14 while also being affixed to the second end 14. In an embodiment, the position of the rotatable cover 19 may be changed by twisting or screwing the rotatable cover 19 in a clockwise or counterclockwise direction. For example, a physician may secure the rotatable cover 19 to the second end 14 of the open-bore assembly 16 and / or position the rotatable cover 19 to the desired position by twisting the rotatable cover 19 with their hand. The rotatable cover 19 can be secured to the open-bore assembly 16 through threads, a clip-on system, a lip, or other mechanisms. The rotatable cover 19 may be securely fit onto the second end 14 so that when the second portion 29 of the rotatable cover 19 is covering the first assembly aperture 17A and / or the second assembly aperture 17B, fluid cannot move through the second portion 29. For example, the rotatable cover 19 may be optionally sealed to the second end 14.

[0073] In an embodiment, the rotatable cover 19 may include a textured outer edge to allow for optimal grip of the rotatable cover 19. The rotatable cover 19 may be circular in shape, but the rotatable cover 19 may be any shape, size, dimension, to fit on the second end 14 of the open-bore assembly 16.

[0074] In an embodiment, the rotatable cover 19 may be positioned in various arrangements onto the second end 14 of the open-bore assembly 16, the one-way occluder 18, and / or the one or more spokes 25 of the open-bore assembly 16 to allow for controlled variable resistance during exhalation. For example, as shown in FIGS. 4A-4C and 5A-5C, the second portion 29 of the rotatable cover 19 may be arranged onto the second end 14 so that 0% to 100% of the first assembly aperture 17A and / or of the second assembly aperture 17B are covered / blocked.

[0075] As shown in FIGS. 4A, 5A, 6A, 7A, and 8A, the first portion 28 of the rotatable cover 19 may be arranged onto the second end 14 such that the first portion 28 of the rotatable cover 19 is covering 100% the first portion 23 of the second end 14 of the open-bore assembly 16 and the second portion 29 of the rotatable cover 19 is covering 100% the second portion 24 of the second end 14 of the open-bore assembly 16. In this configuration, the one or more spokes 25 of the first portion 23 of the second end 14 of the open -bore assembly 16 may line up with the one or more spokes 30 of the first portion 28 of the rotatable cover 19 so that the first assembly aperture 17A and the rotatable cover aperture 20 line up. As shown, the one-way occluder 18 is exposed through the first assembly aperture 17A and the rotatable cover aperture 20. The positioning of the one-way occluder 18 allows for the first assembly aperture 17A of the openbore assembly 16 to be 0% open for exhalation. Further the positioning of the second portion 29 of the rotatable cover 19 over the second assembly aperture 17B allows for the second assembly aperture 17B to be 0% open for exhalation, but 100% open for inhalation. In this embodiment, the one-way tracheostomy valve 10 is 100% closed during exhalation. In an embodiment of the one-way tracheostomy valve 10 in this position, a patient using the one-way tracheostomy valve 10 may be able to exhale with 100% of the maximum expiratory obstruction (i.e., exhalation is entirely prevented), and to inhale with 0% obstruction. During inhalation, fluid moves through the rotatable cover aperture 20 and the first assembly aperture 17A, past the occluder, and into the patient’s mouth. During exhalation, fluid may move from the first end 12, but will be blocked by the one-way occluder 18 pushing up against the one or more spokes 25. The one-way occluder 18 may form a tight fit against the one or more spokes 25 to prevent exhalation. FIG. 9A displays a diagram of pressure and velocity in relation to this configuration. As shown, when the first assembly aperture 17A is 0% open, there is 100% of the maximum expiratory obstruction, resulting in the generation of 100% of possible backpressure. In this configuration,there is a complete obstruction of exhalation, and a high backpressure is generated, but still allows for full inhalation.

[0076] As shown in FIGS. 4B, 5B, 6B, 7B, and 8B, the first portion 28 of the rotatable cover 19 may be arranged onto the second end 14 such that the first portion 28 of the rotatable cover 19 may cover of 50% of the first portion 23 of the second end 14 and 50% of the second portion 24 of the second end 14 of the open-bore assembly 16. The second portion 29 of the rotatable cover 19 may also cover 50% of the first portion 23 of the second end 14 and 50% of the second portion 24 of the second end 14 of the open-bore assembly 16. In this configuration, the one or more spokes 25 of the first portion 23 and the second portion 24 of the second end 14 of the open-bore assembly 16 may line up with the one or more spokes 30 of the first portion 28 of the rotatable cover 19 so that at least a portion the first assembly aperture 17A and the rotatable cover aperture 20 line up. As shown, a portion of the one-way occluder 18 is exposed through the first assembly aperture 17A and the rotatable cover aperture 20. This positioning allows for the first assembly aperture 17A of the open-bore assembly 16 to be 50% open and 50% closed for exhalation and for the second assembly aperture 17B of the open-bore assembly 16 to be 50% open and 50% closed for exhalation. In this embodiment, the one-way tracheostomy valve 10 is 50% open and 50% closed for exhalation, and 100% open for inhalation. In an embodiment of the one-way tracheostomy valve 10 in this position, a patient using the device may be able to exhale with 50% of the maximum expiratory obstruction. During inhalation, fluid moves through the rotatable cover aperture 20 and the first assembly aperture 17A, past the occluder, and into the patient’s mouth. Further, during inhalation, fluid also moves through the second assembly aperture 17B and into the patient’s mouth. During exhalation, fluid may move from the first end 12, but will be blocked from moving through the first assembly aperture 17A by the one-way occluder 18 pushing up against the one or more spokes 25. Further, fluid may be prevented from moving through the second assembly aperture 17B by the second portion 29 of the rotatable cover 19 covering a portion of the second assembly aperture 17B. FIG. 9B displays a diagram of pressure and velocity in relation to this configuration. As shown, when 50% of the one-way tracheostomy valve 10 is open, there is 50% of the maximum expiratory obstruction, resulting in the generation of 50% of possible backpressure. In this configuration, there is a partial obstruction of exhalation, and a partial backpressure is generated, but still allows for full inhalation.

[0077] As shown in FIGS. 4C, 5C, 6C, 7C, and 8C, the first portion 28 of the rotatable cover 19 may be arranged onto the second end 14 such that the first portion 28 of the rotatable cover 19 is covering 100% of the second portion 24 of the second end 14 of the open-bore assembly 16 and the second portion 29 of the rotatable cover 19 is covering 100% the first portion 23 of the second end 14 of the open-bore assembly 16. In this configuration, the one or more spokes 25 of the second portion 24 of the second end 14 of the open-bore assembly 16 may line up with the one or more spokes 30 of first portion 28 of the rotatable cover 19 so that the second assembly aperture 17B and the rotatable cover aperture 20 line up. As shown, the oneway occluder 18 is covered by the second portion 29 of the rotatable cover. The positioning of the rotatable cover aperture 20 of the first portion 28 of the rotatable cover 19 over the second assembly aperture 17B allows for the second assembly aperture 17B of the open-bore assembly 16 to be 100% open for both inhalation and exhalation. In this embodiment, the one-way tracheostomy valve 10 is 100% open. In an embodiment of the one-way tracheostomy valve 10 in this position, a patient using the one-way tracheostomy valve 10 may be able to exhale with 0% of the maximum expiratory obstruction, and inhale with 0% obstruction. During inhalation, fluid moves through the rotatable cover aperture 20 and the second assembly aperture 17B and into the patient’s mouth. During exhalation, fluid may move from the first end 12 and out through the second assembly aperture 17B and the rotatable cover aperture 20. In an embodiment of the one-way tracheostomy valve 10 in this position, a patient using the device may be able to inhale and exhale without any expiratory obstruction. FIG. 9C displays a diagram of pressure and velocity in relation to this configuration. As shown, when the second assembly aperture 17B is 100% open, there is no obstruction of exhalation resulting in the generation of low or no amounts of backpressure.

[0078] Other rotation positions are possible and are disclosed herein. For example, the second portion 29 of the rotatable cover 19 may be arranged to cover from 0% to 100% of the first assembly aperture 17A and / or the second assembly aperture 17B of the first portion 23 of the second end 14 of the open-bore assembly 16. The present disclosure covers multiple configurations of the arrangement and coverage of the one-way occluder 18 and the rotatable cover 19 to serve as a one-way valve.

[0079] In embodiments in which the one-way tracheostomy valve 10 is 100% open, the patient may be able to inhale and exhale without obstruction. This configuration may not providea therapeutic benefit but may be used to allow the patient to take breathing breaks in between therapeutic respiratory exercises. In embodiments in which the one-way tracheostomy valve 10 is 0% open, the patient may be able to inhale without obstruction, but may have 100% exhalation obstruction. Embodiments in which the one-way tracheostomy valve 10 is partially closed would be optimal for a therapeutic benefit through respiratory exercises. These embodiments allow for the gradual increase of expiratory resistance.

[0080] As shown in FIG. 10A, in an embodiment, the one-way occluder 18 may be configured to flex toward the first end 12 of the open-bore assembly 16 during inhalation (i.e., during fluid flow from the second end 14 to the first end 12 of the open-bore assembly 16). As shown, during inhalation, a portion of the one-way occluder 18 remains affixed to the underside of the support structure 21 and the unaffixed portion of the one-way occluder 18 flexes or collapses towards the first end 12. This movement and positioning of the one-way occluder 18 allows for fluid flow into the one-way tracheostomy valve 10.

[0081] As shown in FIG. 10B, in an embodiment, the one-way occluder 18 may be configured to not flex toward the second end 14 of the open-bore assembly 16 during exhalation (i.e., during fluid flow from the first end 12 to the second end 14 of the open-bore assembly 16). Thus, the one-way occluder 18 may remain rigid during exhalation and / or block the fluid flow through the first assembly aperture 17A. During fluid flow from the first end 12 to the second end 14, the one-way occluder 18 may push up against the one or more spokes 25 of the first portion 23 of the second end 14 (FIG. 2B). This movement and positioning of the one-way occluder 18 against the one or more spokes 25 prevents fluid flow out of the first assembly portion 17A and thus the one-way tracheostomy valve 10 by preventing the one-way occluder 18 from collapsing outward toward the second end 14. In an embodiment in which the rotatable cover 19 is not covering the entirety of the second assembly aperture 17B of the second portion 24 of the second end 14, fluid may be excreted through the portion of the second assembly aperture 17B that is open.

[0082] As described herein, the one-way occluder 18 and the rotatable cover 19 can serve as a one-way valve by allowing for obstructed exhalation and unobstructed inhalation.

[0083] The one-way tracheostomy valve 10 may allow for unobstructed inhalation while allowing for variable resistance during exhalation to increase pressure with the closure of the first assembly aperture 17A and the second assembly aperture 17B of the open-bore assembly 16via the second portion 29 of the rotatable cover 19. Dynamic fluid simulations show an increase in the resistance to exhalation when the first assembly aperture 17A and / or the second assembly aperture 17B of the open-bore assembly 16 is closed. To increase the positive expiratory end pressure, the rotatable cover 19 may be rotated to obstruct variable amounts of the first assembly aperture 17A and / or the second assembly aperture 17B of the open-bore assembly 16.

[0084] In embodiments of the present disclosure, the one-way tracheostomy valve 10 may be rounded. Further, the one-way tracheostomy valve 10 may be configured to be fitted onto a tracheostomy adaptor. In other embodiments, the one-way tracheostomy valve 10 may be configured to be fitted into a tracheostomy tube within a patient with a tracheostomy. Even further, embodiments of the present disclosure may be held up to a tracheostomy of a patient for use. An embodiment of the disclosure may treat lung conditions, such as atelectasis, by providing positive end expiratory pressure.

[0085] In patients without a tracheostomy, an embodiment of the one-way tracheostomy valve 10 may be configured to allow the patient to exhale in order to provide variable positive expiratory pressure to treat lung conditions, such as atelectasis.

[0086] Although the present disclosure has been described with respect to one or more particular embodiments and / or examples, it will be understood that other embodiments and / or examples of the present disclosure may be made without departing from the scope of the present disclosure.

Claims

CLAIMS:

1. A one-way tracheostomy valve comprising: an open-bore assembly comprising a first end defining a first diameter and a second end opposite the first end defining a second diameter, wherein the second diameter is larger than or equal to the first diameter; a one-way occluder fixedly arranged to a portion of the second end of the open-bore assembly; and a rotatable cover disposed on the second end of the open-bore assembly, the rotatable cover configured to rotate around the second end.

2. The one-way tracheostomy valve of claim 1, wherein the open-bore assembly is made of a medical grade non-permeable material.

3. The one-way tracheostomy valve of claim 2, wherein the open-bore assembly is made of polycarbonate, polyethylene, polypropylene, and / or polystyrene.

4. The one-way tracheostomy valve of claim 1, wherein the first diameter is from 5 mm to 30 mm.

5. The one-way tracheostomy valve of claim 1, wherein the second diameter is from 5 mm to 70 mm.

6. The one-way tracheostomy valve of claim 1, wherein the one-way occluder is made of a flexible film material.

7. The one-way tracheostomy valve of claim 1, wherein the one-way occluder is made of silicone.

8. The one-way tracheostomy valve of claim 1, wherein the second end comprises a support structure that extends across the second diameter and separates the second end into a first portionand a second portion, wherein the first portion defines a first assembly aperture, and the second portion defines a second assembly aperture.

9. The one-way tracheostomy valve of claim 8, wherein the one-way occluder is fixedly arranged to a side of the support structure that is opposite of the rotatable cover.

10. The one-way tracheostomy valve of claim 8, wherein the first portion and the second portion comprise one or more spokes.

11. The one-way tracheostomy valve of claim 10, wherein the one or more spokes of the first portion are arranged from a center point of the support structure toward a circumference of the first portion of the second end.

12. The one-way tracheostomy valve of claim 1, wherein the rotatable cover is made of a medical grade non-permeable material.

13. The one-way tracheostomy valve of claim 12, wherein the rotatable cover is made of polycarbonate, polyethylene, polypropylene, and / or polystyrene.

14. The one-way tracheostomy valve of claim 1, wherein an axis of the rotatable cover divides the rotatable cover into a first portion and a second portion, wherein the first portion defines a rotatable cover aperture.

15. The one-way tracheostomy valve of claim 14, wherein the first portion of the rotatable cover comprise one or more spokes.

16. The one-way tracheostomy valve of claim 15, wherein the one or more spokes are arranged from a center point of the axis toward a circumference of the first portion of the rotatable cover.

17. The one-way tracheostomy valve of claim 1, wherein the one-way tracheostomy valve is configured to be fitted into a tracheostomy tube.

18. The one-way tracheostomy valve of claim 1 , wherein the rotatable cover is configured to rotate around the second end of the assembly to obstruct a variable amount of the first assembly aperture and / or the second assembly aperture.

19. A method comprising: providing a one-way tracheostomy valve comprising an open-bore assembly having a first end and a second end, a one-way occluder fixedly arranged to the second end of the assembly, and a rotatable cover arranged on the second end; directing a fluid in a first direction from the second end to the first end, whereby the one- way occluder flexes toward the first end as the fluid is directed in the first direction; and directing the fluid in a second direction from the first end to the second end, whereby movement of the one-way occluder is blocked by one or more spokes fixedly arranged to the second end such that the occluder forms a seal against the one or more spokes.

20. The method of claim 19, further comprising rotating the rotatable cover around the second end of the assembly to obstruct a variable amount of one or more apertures of the second end.

Images