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WO2025029978A2 - Valve de trachéotomie unidirectionnelle pour assurer une pression expiratoire positive variable - Google Patents

Valve de trachéotomie unidirectionnelle pour assurer une pression expiratoire positive variable Download PDF

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Publication number
WO2025029978A2
WO2025029978A2 PCT/US2024/040471 US2024040471W WO2025029978A2 WO 2025029978 A2 WO2025029978 A2 WO 2025029978A2 US 2024040471 W US2024040471 W US 2024040471W WO 2025029978 A2 WO2025029978 A2 WO 2025029978A2
Authority
WO
WIPO (PCT)
Prior art keywords
way
rotatable cover
assembly
open
tracheostomy valve
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/040471
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English (en)
Other versions
WO2025029978A3 (fr
Inventor
Stephanie Soo-Joong KIM
Mariane Hae-Joong KIM
Justin Yuyang YE
Joseph A. Paydarfar
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Mary Hitchcock Memorial Hospital For Itself And On Behalf Of Dartmouth Hitchcock Clinic
Dartmouth College
Original Assignee
Mary Hitchcock Memorial Hospital For Itself And On Behalf Of Dartmouth Hitchcock Clinic
Dartmouth College
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mary Hitchcock Memorial Hospital For Itself And On Behalf Of Dartmouth Hitchcock Clinic, Dartmouth College filed Critical Mary Hitchcock Memorial Hospital For Itself And On Behalf Of Dartmouth Hitchcock Clinic
Publication of WO2025029978A2 publication Critical patent/WO2025029978A2/fr
Publication of WO2025029978A3 publication Critical patent/WO2025029978A3/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0465—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
    • A61M16/0468—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters with valves at the proximal end limiting exhalation, e.g. during speaking or coughing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/208—Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves

Definitions

  • 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.
  • 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.
  • 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.
  • the present disclosure provides a one-way tracheostomy valve that provides variable positive end-expiratory pressure for the prevention and treatment of atelectasis.
  • 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.
  • An embodiment of the present disclosure may increase resistance to exhalation with closure of the aperture.
  • 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.
  • the second diameter may be larger than or equal to the first diameter.
  • the open-bore assembly may be made of a medical grade non-permeable material.
  • 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.
  • the first diameter may be from 5 mm to 30 mm.
  • the second diameter may be from 5 mm to 70 mm.
  • the one-way occluder may be made of a flexible film material.
  • the one-way occluder may be made of silicone.
  • 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.
  • the first portion may define a first assembly aperture
  • the second portion may define a second assembly aperture.
  • the one-way occluder may be fixedly arranged to a side of the support structure that is opposite of the rotatable cover.
  • the first portion and the second portion may include one or more spokes.
  • the one or more spokes of the first portion may be arranged from a center point of the support structure toward a circumference of the 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.
  • the rotatable cover may be made of a medical grade non-permeable material.
  • 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.
  • an axis of the rotatable cover may divide the rotatable cover into a first portion and a second portion.
  • the first portion may define a rotatable cover aperture.
  • the first portion of the rotatable cover may include one or more spokes.
  • 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.
  • the one-way tracheostomy valve may be configured to be fitted into a tracheostomy tube.
  • 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.
  • 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.
  • 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.
  • FIG. 1 displays a top plan view of an embodiment of the present disclosure.
  • FIG. 2A displays a top plan view of an embodiment of the present disclosure as disclosed herein.
  • FIG. 2B displays a top perspective view of an embodiment of the open-bore assembly as disclosed herein.
  • FIG. 2C displays a front view of an embodiment of the open-bore assembly as disclosed herein.
  • FIG. 3A displays a top perspective view of an embodiment of the rotatable cover as disclosed herein.
  • FIG. 3B displays a top plan view of an embodiment of the rotatable cover as disclosed herein.
  • FIG. 4A displays a top perspective view of an embodiment of the present disclosure when 0% of the aperture is open.
  • FIG. 4B displays a top perspective view of an embodiment of the present disclosure when 50% of the aperture is open.
  • FIG. 4C displays a top perspective view of an embodiment of the present disclosure when 100% of the aperture is open.
  • FIG. 4D displays a front view of an embodiment of the present disclosure.
  • FIG. 5A displays a top plan view of an embodiment of the present disclosure when 0% of the aperture is open.
  • FIG. 5B displays a top plan view of an embodiment of the present disclosure when 50% of the aperture is open.
  • FIG. 5C displays a top plan view of an embodiment of the present disclosure when 100% of the aperture is open.
  • FIG. 6A displays a partial transparent top plan view of an embodiment of FIG. 5 A when 0% of the aperture is open.
  • FIG. 6B displays a partial transparent top plan view of an embodiment of FIG. 5B when 50% of the aperture is open.
  • FIG. 6C displays a partial transparent top plan view of an embodiment of FIG. 5C when 100% of the aperture is open.
  • FIG. 7A displays a partial transparent top perspective view of an embodiment of FIG. 4A when 0% of the aperture is open.
  • FIG. 7B displays a partial transparent top perspective view of an embodiment of FIG. 4B when 50% of the aperture is open.
  • FIG. 7C displays a partial transparent top perspective view of an embodiment of FIG. 4C when 100% of the aperture is open.
  • FIG. 8A displays a partial transparent front view of an embodiment of FIG. 4D when 0% of the aperture is open.
  • FIG. 8B displays a partial transparent front view of an embodiment of FIG. 4D when 50% of the aperture is open.
  • FIG. 8C displays a partial transparent front view of an embodiment of FIG. 4D when 100% of the aperture is open.
  • FIG. 9A displays pressure and velocity as applied to an embodiment of the present disclosure when 0% of the aperture is open.
  • FIG. 9B displays pressure and velocity as applied to an embodiment of the present disclosure when 50% of the aperture is open.
  • FIG. 9C displays pressure and velocity as applied to an embodiment of the present disclosure when 100% of the aperture is open.
  • FIG. 10A displays the movement of an embodiment of the one-way occluder during inhalation.
  • FIG. 10B displays the movement of an embodiment of the one-way occluder during exhalation.
  • 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.
  • 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.
  • 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.
  • the open-bore assembly 16 may be fabricated of a non- permeable flexible medical grade material.
  • the open-bore assembly 16 may be made of plastic.
  • the open-bore assembly 16 may be fabricated of polycarbonate, polyethylene, polypropylene, polystyrene, etc.
  • the open-bore assembly 16 may be fabricated from a rigid material.
  • the open-bore assembly 16 may have a funnel shape, a cylindrical shape, and/or a cone shape.
  • 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.
  • the second diameter 15 may be twice the size of the first diameter 13.
  • 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.
  • inhalation may be more restricted.
  • the area of the second end 14 may be larger than or equal to the area of the first end 12.
  • 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.
  • 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.
  • the first assembly aperture 17A and the second assembly aperture 17B may have a semi-circular shape.
  • 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.
  • 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.
  • the one or more spokes 25 may have the same or different sizes, such as length, width, and height.
  • the one or more spokes 25 of the first portion 23 of the second end 14 may be equal in length, width, and height.
  • the one or more spokes 25 of the first portion 23 may have three spokes with the same dimensions to form four separate open cavities with the same dimensions
  • 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.
  • 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.
  • 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.
  • the one-way occluder 18 may have a semi-circular shape.
  • 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.
  • 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.
  • 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.
  • 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.
  • the one-way occluder 18 may be fixedly arranged to a portion of the second diameter 15 of the second end 14.
  • the one-way occluder 18 may cover a portion or the entirety of the first portion 23 of the second end 14.
  • the one-way occluder 18 may cover a portion or the entirety of the first assembly aperture 17 A.
  • the rotatable cover 19 may be made of a non-permeable flexible medical grade material.
  • the rotatable cover 19 may be made of plastic.
  • the rotatable cover 19 may be made of polycarbonate, polyethylene, polypropylene, polystyrene, etc.
  • the rotatable cover 19 may be made of rigid material.
  • 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.
  • 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.
  • 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.
  • 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.
  • the position of the rotatable cover 19 may be changed by twisting or screwing the rotatable cover 19 in a clockwise or counterclockwise direction.
  • 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.
  • the rotatable cover 19 may be optionally sealed to the second end 14.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the one-way tracheostomy valve 10 is 100% closed during exhalation.
  • 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.
  • inhalation fluid moves through the rotatable cover aperture 20 and the first assembly aperture 17A, past the occluder, and into the patient’s mouth.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the one-way tracheostomy valve 10 is 50% open and 50% closed for exhalation, and 100% open for inhalation.
  • a patient using the device may be able to exhale with 50% of the maximum expiratory obstruction.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the one-way tracheostomy valve 10 is 100% open.
  • 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.
  • 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.
  • 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.
  • the patient may be able to inhale and exhale without obstruction. This configuration may not provide a therapeutic benefit but may be used to allow the patient to take breathing breaks in between therapeutic respiratory exercises.
  • 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.
  • 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.
  • 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).
  • the one-way occluder 18 may remain rigid during exhalation and/or block the fluid flow through the first assembly aperture 17A.
  • 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.
  • 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.
  • 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.
  • 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 16 via 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.
  • 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.
  • 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.
  • 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.

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  • Prostheses (AREA)

Abstract

Une valve de trachéotomie unidirectionnelle comprend un ensemble à alésage ouvert ayant une première extrémité qui définit un premier diamètre et une seconde extrémité opposée à la première extrémité qui définit un second diamètre. Un dispositif d'occlusion unidirectionnel est disposé de manière fixe sur la seconde extrémité de l'ensemble à alésage ouvert. Un élément de couverture rotatif est disposé sur la seconde extrémité et conçu pour tourner autour de la seconde extrémité.
PCT/US2024/040471 2023-07-31 2024-07-31 Valve de trachéotomie unidirectionnelle pour assurer une pression expiratoire positive variable Pending WO2025029978A2 (fr)

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US202363530040P 2023-07-31 2023-07-31
US63/530,040 2023-07-31

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WO2025029978A2 true WO2025029978A2 (fr) 2025-02-06
WO2025029978A3 WO2025029978A3 (fr) 2025-06-05

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Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8678005B2 (en) * 2010-10-26 2014-03-25 Dawson Medical Technologies Llc Adjustable tracheostomy valve
JP2016532460A (ja) * 2013-10-09 2016-10-20 アトス メディカル アクティエボラーグ ブリージングプロテクター
US10596337B2 (en) * 2017-01-25 2020-03-24 Brian Kamradt Adjustable tracheostoma valve
CO2018008335A1 (es) * 2018-08-08 2018-11-13 Quintero Osorio Oscar Ivan Válvula de oclusión giratoria para traqueostomía
US11173267B2 (en) * 2018-12-18 2021-11-16 Freudenberg Medical, Llc Adjustable tracheostoma valve and heat and moisture exchanger
CN218075952U (zh) * 2022-06-14 2022-12-20 宁波司麦儿医学科技有限公司 一种说话瓣膜

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