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WO2018031278A1 - Dispositif d'administration de gaz. - Google Patents

Dispositif d'administration de gaz. Download PDF

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Publication number
WO2018031278A1
WO2018031278A1 PCT/US2017/044631 US2017044631W WO2018031278A1 WO 2018031278 A1 WO2018031278 A1 WO 2018031278A1 US 2017044631 W US2017044631 W US 2017044631W WO 2018031278 A1 WO2018031278 A1 WO 2018031278A1
Authority
WO
WIPO (PCT)
Prior art keywords
gas
patient
nasal cavity
tubular
cavity component
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.)
Ceased
Application number
PCT/US2017/044631
Other languages
English (en)
Inventor
Hugh W. PAYTON
Campbell C. CAUTHEN
John Stephens
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.)
UPODS LLC
Original Assignee
UPODS LLC
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
Priority claimed from US15/235,665 external-priority patent/US9925348B2/en
Application filed by UPODS LLC filed Critical UPODS LLC
Publication of WO2018031278A1 publication Critical patent/WO2018031278A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0666—Nasal cannulas or tubing
    • A61M16/0672—Nasal cannula assemblies for oxygen therapy
    • 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
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0683—Holding devices therefor
    • A61M16/0688—Holding devices therefor by means of an adhesive
    • 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
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • 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
    • A61M16/0402—Special features for tracheal tubes not otherwise provided for
    • A61M16/0418—Special features for tracheal tubes not otherwise provided for with integrated means for changing the degree of curvature, e.g. for easy intubation
    • 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
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/1005—Preparation of respiratory gases or vapours with O2 features or with parameter measurement
    • A61M2016/102—Measuring a parameter of the content of the delivered gas
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3561—Range local, e.g. within room or hospital
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3584—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using modem, internet or bluetooth
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
    • 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
    • A61M2206/00—Characteristics of a physical parameter; associated device therefor
    • A61M2206/10—Flow characteristics
    • A61M2206/16—Rotating swirling helical flow, e.g. by tangential inflows
    • 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
    • A61M2209/00—Ancillary equipment
    • A61M2209/08—Supports for equipment
    • A61M2209/088—Supports for equipment on the body
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0662—Ears
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/40—Respiratory characteristics
    • A61M2230/43—Composition of exhalation

Definitions

  • This application relates to an apparatus for supplying supplemental oxygen or other gas to a patient via a nasal cannula.
  • a conventional dual prong cannula can become quite uncomfortable for a patient and can lead to pressure ulcers at contact points.
  • the comfort of the patient becomes even more critical, both to the patient and to the professionals attending the patient, when the patient is also fitted with a naso-gastric or Levine tube.
  • the nose becomes a fairly cluttered access route, and adhesive tape is often used, by application to the face, to position all the tubes and secure them in place.
  • a patient may also suffer from "free floating anxiety" as a result of reduced blood oxygen. Such a patient may believe something is wrong but cannot quite identify the problem, and may not be thinking clearly. Often such patients have feelings of claustrophobia and may attempt to remove the nasal cannula despite the resulting adverse impact on the patient's condition. It is not uncommon to find the tubing disconnected or the cannula prongs displaced from the nose due to pulling on the cannula that results from the movement of the patient's head, especially during sleep. Further, patient non-compliance or lack of cooperation, resulting from irritation and discomfort caused by a nasal cannula, may necessitate the use of some more expensive or aggressive means of oxygen administration, including face masks or catheters.
  • supplemental oxygen is used on an outpatient basis, such as in a patient's home.
  • the cosmetic appearance of the oxygen delivery apparatus can be important, and the commonly-used dual prong cannula can make a person feel conspicuous and, as previously mentioned, cause irritation from interface pressure.
  • An exemplary embodiment of the present invention provides a gas delivery device comprising a single prong nasal cannula that can be securely affixed to a patient while providing an adequate supply of oxygen or other gas to the patient with the least possible amount of skin irritation and/or discomfort to the patient.
  • An exemplary embodiment of the present invention provides a gas delivery device comprising a single prong nasal cannula for insertion into a patient's right or left nostril to deliver oxygen or other gas to the patient.
  • a the gas delivery device includes a single tubular cannula prong or single tubular nasal cavity component that has a gas passageway, with a tubular wall surrounding the gas passageway, a first end of the single tubular nasal cavity component is adapted to be inserted a single nostril of a patient.
  • a longitudinal body portion of the single tubular nasal cavity component extends between the first end and a second end, which second end is positioned outside the patient's nostril.
  • a tubular guidance-stabilization system includes a longitudinal tubular conduit having a longitudinal gas passageway, with a tubular wall surrounding the gas passageway, and includes a first end that is connected to and in fluid communication with the second end of the nasal cavity component, and further includes a second end that is connected to and in fluid communication with an attachable gas supply or gas extension tube.
  • a first stabilization patch secures the tubular guidance-stabilization system to the patient's face proximate the patient's cheek; and a second stabilization patch secures the tubular guidance-stabilization system behind the patient's ear at the tip of the mastoid.
  • a bendable or flexible, thin wire is located within the tubular wall of the tubular guidance-stabilization system, and the thin flexible wire extends substantially axially along and within the tubular wall, beginning at the first end of the tubular guidance-stabilization system and terminating at a position approximately one inch below where the tubular guidance-stabilization system is secured behind the patient's ear.
  • the tubular guidance-stabilization system may have a flexible strap, made of metal, composite or other suitable material, located within the tubular wall of the longitudinal tubular conduit that extends substantially axially along and within the tubular wall.
  • the purpose of the flexible wire or flexible strap is to support the plastic tubular conduit of the tubular guidance-stabilization system that has become flaccid as a result of being heated up by the patient's body temperature.
  • the tubular guidance-stabilization system supports the integrity of the gas delivery device in order to maintain the tubular nasal cavity component in the patient's nostril.
  • An exemplary embodiment of the tubular guidance-stabilization system is designed to allow the gas delivery device to be adjusted to skirt the patient's face and to be contoured to the patient's face and head, minimizing contact of device to the patient's skin.
  • an exemplary embodiment of the tubular guidance- stabilization system provides guidance, stabilization, strain-relief and retention of the gas delivery device and supports the nasal cavity component within a single nostril of the patient.
  • the flexible wire or flexible strap that is embedded (or otherwise inserted) within the wall of the longitudinal tubular conduit of the tubular guidance-stabilization system is isolated from the patient's skin, nose secretions, moisture and oxygen to avoid harm to the patient or damage or corrosion to the wire or strap.
  • the single tubular nasal cavity component and the tubular guidance-stabilization system may be made of medical grade plastic materials, silicon or polyvinylchloride (PVC), a vinyl polymer, a silicone polymer, Urethanes, or other medical grade elastomeric plastic(s) that are Latex or DEHP free.
  • PVC polyvinylchloride
  • vinyl polymer a vinyl polymer
  • silicone polymer a silicone polymer
  • Urethanes or other medical grade elastomeric plastic(s) that are Latex or DEHP free.
  • the tubular nasal cavity component may be flexible and may be constructed of soft, pliable, bendable or shape memory materials to allow the nasal cavity component to retain its shape when manually configured during either the initial placement or the subsequent adjustment of the gas delivery device on the patient, to thereby allow the tubular nasal cavity component to be retained within the patient's nostril during clinical use.
  • the tubular nasal cavity component may be formed to fit within one of the patient's nostril passageway and, based on the size of the patient's nostril, will be of a size and shape to provide soft and rounded surfaces to prevent membrane irritation when the nasal cavity component is inserted within the nasal cavity.
  • the tubular nasal cavity component may have a first end that is inserted into the patient's nostril, where the first end has a funnel or trumpet shape or contour to securely fit in within the patient's nostril and promote the flow of gas into the patient.
  • the width and diameter (or cross-sectional area) of the opening of the first end of the nasal cavity component, which is inserted into the patient's nostril may be larger than the width and diameter (or cross-sectional area) of the center portion of the longitudinal body and also larger than the width and diameter (or cross-sectional area) of the second end of the nasal cavity component.
  • the funnel shape (frustoconical shape) or trumpet shape (flared shape) of the opening of the first end of the tubular nasal cavity component creates a diverging flow path to promote a diverging gas flow through such first end such that the oxygen or other gas, to be dispersed into the nasal cavity, flows in all directions instead of in a single, narrow flow path.
  • a diverging flow path of gas into the nostril results in less irritation and less dryness and cracking of the inside of the nostril.
  • the funnel shape or trumpet shape of the opening of the tubular nasal cavity component prevents or at least inhibits or reduces the risk of backflow or escape of the gas outside the nostril and into the ambient air, which in turn establishes a potentially greater nasal cavity reservoir of gas that is available for the patient's next breath.
  • the gas delivery device includes a substantially U-shaped portion that is adapted to extend downward from the patient's nostril, around an outer surface of the patient's nostril, and then extend upward toward the patient's eye.
  • a tubular guidance-stabilization system is adapted to extend from the substantially U-shaped portion, across the patient's cheek and over the patient's ear.
  • the substantially U-shaped portion may be integrally formed or molded within and made part of to be in fluid communication with the tubular nasal cavity component as described above.
  • the substantially U-shaped portion may be integrally formed within and part of the tubular guidance-stabilization system.
  • U-shaped describes the relative shape of a nasal cavity component, a tubular guidance-stabilization system, or any portion of the nasal cavity component or a tubular guidance-stabilization system that is bent, formed or molded to resemble the shape of either a "U” or a "J” or a "V.”
  • the gas delivery device includes a tubular nasal cavity component having a gas passageway, a tubular wall surrounding the gas passageway, a first end that is adapted to be inserted in either nostril of a patient, a longitudinal body portion between the first end and a second end.
  • the second end is positioned outside the patient's nostril, and a flexible or bendable wire may be embedded within at least a portion of the tubular wall, with the wire extending substantially axially along at least a portion of the tubular wall.
  • the tubular nasal cavity component may be bent into shape and may retain the bent shape. Alternatively, the tubular nasal cavity component may return to its original shape after bending.
  • the tubular nasal cavity component may have a substantially seventy plus or minus ten degrees (70 + 10°) bend, wherein the tubular nasal cavity component is adapted to extend downward from the patient's nostril, around an outer surface of the patient's nostril, and then in an upward direction toward the patient's eye.
  • the gas delivery device may have a relatively straight tubular nasal cavity component that is connected to and in fluid communication with a tubular guidance-stabilization system that is adapted extend downward from the tubular nasal cavity component when in use by a patient, bend in an upward direction toward the patient's eye, and extend across the patient's cheek and over the patient's ear.
  • a U- shaped bend portion having a substantially seventy degrees plus or minus ten degrees (70 + 10°) bend is formed within the tubular guidance-stabilization system. This bend prevents the formation of kinks and folding in the tubular guidance-stabilization system of the gas delivery device that could reduce or restrict the flow of gas and also enhances the support and placement of tubular nasal cavity component and tubular guidance- stabilization system on the patient's face.
  • a secondary coiled section of flexible tubing when fitted to a patient, may then extend from the tubular guidance-stabilization system downward to the patient's shoulder.
  • the coiled section of tubing allows the patient to move his or her head without affecting the placement of (e.g., dislodging) the tubular nasal cavity component in the nostril.
  • a flexible piece of tubing when fitted to a patient, extends from the tubular guidance-stabilization system, below the location where the tubular guidance-stabilization system is secured to the mastoid tip of the patient, on one side of the patient.
  • the flexible tubing then extends around the back of the patient's neck and over to the opposite shoulder of the patient, where a clip located on the tubing may be used to attach the tubing to the patient's clothing, providing additional strain relief for the device.
  • the flexible piece of tubing extends to the supply source for supplying oxygen or another gas.
  • the clip may be positioned and moved along the tubing for optimal placement and attachment of the clip to the patient's clothing. The clip is used to prevent either the weight of the gas supply tubing or movement of the patient from moving or pulling on the gas delivery device and dislodging the nasal cavity component from the patient's nostril and causing irritation and/or discomfort to the patient.
  • a gas delivery device in yet another embodiment, includes a substantially planar, semi-rigid stabilization patch having a clip or flap that further secures the tubular guidance-stabilization system to the cheek of the patient, when the gas delivery device is fitted to a patient.
  • the clip or flap may be a semi-rigid substantially C-shaped clip located on an upper surface of the planar stabilization patch.
  • the C-shaped clip is sized and configured to open to receive therein flexible tubing of the tubular guidance-stabilization system and to then close to hold the flexible tubing without pinching off gas delivery via the flexible tubing.
  • the substantially planar stabilization patch has a patient safe adhesive located on a rear surface for attaching the patch to the patient's cheek.
  • the tubular guidance- stabilization system may be pressed into the C-shaped clip and held in place.
  • the substantially planar, semi-rigid stabilization patch may also have other sizes, shapes and means of holding the tubular guidance-stabilization system to the cheek, such as an adhesive, a hook and loop fastener, and so forth.
  • the gas delivery device includes a flexible stabilization patch made of flexible, breathable and non-irritating material.
  • the flexible stabilization patch may have a barbell shape with two patch sections that are separated and connected by a tubing securement area.
  • the flexible stabilization patch may be placed on and secured to the patient's cheek and/or to the skin behind the patient's ear by an adhesive located on one side of a patch section.
  • the flexible stabilization patch When fitted to a patient, the flexible stabilization patch having a barbell shape secures the tubular guidance-stabilization system to the face of the patient and over and behind the patient's ear by placing the tubular guidance-stabilization system along and perpendicularly across the tube securement area of the stabilization patch, folding the stabilization patch over the tubular guidance-stabilization system to mate the first patch section to the second patch section with an adhesive, and then affixing the stabilization patch on the skin using the adhesive located on the exposed side of a patch section.
  • the flexible stabilization patch is preferably breathable, having tiny perforations for the health of the skin and for escape of fluids and heat. Alternatively, the patch may use water based adhesives.
  • the patch is approximately may be about one inch in diameter and may have release liner at the adhesive side that covers the medical grade adhesive to protect and promote the shelf-life of the patch.
  • the adhesive side can be placed on the patient's skin and should hold the tubing for clinical periods of time (e.g., up to seven days) without significant irritation to the skin.
  • the medical grade patches can be changed from time to time.
  • the medical grade adhesive that is used does not damage the skin when the stabilization patch is removed from the patient's face.
  • the medical grade adhesive is a self-stick adhesive that is suitable for the duration of its application and will adhere to the patient's skin.
  • the composition of the medical grade adhesive may include polymers, medical grade solvents, and/ or water based coating systems.
  • the gas delivery device includes a one-piece flexible stabilization patch made of flexible, breathable and non-irritating material, with a patient-friendly adhesive located on one-side of the patch.
  • the flexible stabilization patch is preferably breathable, having tiny perforations for the health of the skin and for escape of fluids and heat.
  • the one-piece flexible stabilization patch may be about one inch in diameter and may have a peel off protective covering on the adhesive side, on which a medical adhesive or glue is applied.
  • the flexible stabilization patch is used to secure the tubular guidance-stabilization system onto the tip of the patient's cheek bone and behind the lower portion of the patient's ear proximate the mastoid tip, where there is no hair and little oil.
  • a medical provider will first position the tubular guidance- stabilization system at the tip of the cheek bone as described herein and then cover the portion of the guidance-stabilization system on the tip of the cheek bone with the adhesive side of the patch and firmly press the remainder of the exposed patch onto the patient's skin.
  • the gas delivery device is secured and stabilized at three locations, namely by securing the tubular guidance-stabilization system at the tip of the cheekbone with a stabilization patch, by securing the tubular guidance- stabilization system at the tip of the mastoid (located behind the lower part of the patient's ear where no hair is located) with a stabilization patch, and by clipping the tubular guidance-stabilization system to the patient's clothing on the shoulder that is opposite of where the tubular guidance-stabilization system is secured at the tip of the mastoid.
  • the gas delivery system includes an adapter for connecting the gas delivery system to an oxygen or gas supply source.
  • the gas delivery system may include the male side of the adapter at its terminal end, which mates with a female adapter that is located on gas supply tubing or in a wall mounted adapter that runs to the gas source.
  • the design of the gas delivery system allows for interchangeability to either nostril to reduce skin irritation from the contact of the medical grade plastic materials to the human skin and within the nasal cavity.
  • the guidance-stabilization system may have internal or external keys to properly align, during assembly or adjustment of the gas delivery device, the guidance- stabilization system with the nasal cavity component, which has a corresponding external or internal groove or slot.
  • the connection between the guidance-stabilization system and the nasal cavity component insures ease of use and correct placement of device throughout the clinical time period.
  • the end of the tubular guidance-stabilization system in forming the connection between the guidance-stabilization system and the nasal cavity component, acts as the female portion of the connection and corresponding end of the nasal cavity component acts as the male portion of the connection.
  • the end of the tubular guidance-stabilization system in forming the connection between the guidance-stabilization system and the nasal cavity component, acts as the male portion of the connection and the corresponding end of the nasal cavity component acts as the female portion of the connection.
  • a system for delivery of a gas to a patient that has a single tubular nasal cavity component having only two terminal ends, including one end for gas inlet and one end for gas outlet.
  • a single gas flow path extends from the gas inlet to the gas outlet ends.
  • the tubular nasal component is conflgured for insertion into a nostril of a patient and adapted to maintain an inserted position without adhesive.
  • the single tubular nasal cavity component incudes:
  • a first portion having a first longitudinal axis along the single gas flow path, a proximal end of the first portion flared outward and configured for insertion into a nostril of a patient, and
  • a second portion having a second longitudinal axis, the second portion having a gas inlet end to receive gas from a gas supply, a distal end of the second portion intersecting a distal end of the first portion in a bend portion, such that the second longitudinal axis and the first longitudinal axis intersect at an angle of between about 60 and about 80°.
  • the system may include at least one sensor in proximity to or in the nasal cavity component, and the at least one flexible electricity-conducting conduit is in communication with the at least one sensor.
  • the at least one flexible electricity conducting conduit may be comprised of metal or an electricity-conducting polymer.
  • the exemplary system further may include at least one sensor in proximity to or in the nasal cavity component. The at least one sensor may transmit sensed data wirelessly.
  • the exemplary system for delivery of a gas to a patient of has the tip and the length of the first portion each sized such that air flows around the nasal cannula when the nasal cannula is inserted in a nostril of a user.
  • the tip and the length of the first portion are each sized such that gas exits from the nasal cannula in a vortex flow pattern when the nasal cannula is in use.
  • the vortex flow of the oxygen-containing gas increases oxygen intake by the user, as compared to using a nasal cannula without a vortex flow.
  • the gas delivery device can be used to supply oxygen and other gas, such as nitrous oxide or other anesthesia, to a patient.
  • gas delivery device When using the gas delivery device to supply oxygen, it may be desirable to avoid fully blocking the nostril with the nasal cavity component, providing partial occlusion of the nostril.
  • gas delivery device When using the gas delivery device to supply anesthesia, however, it may be desirable to completely block the nostril with the nasal cavity component, providing full occlusion of the nostril.
  • FIG. 4 is a side view of a U-shaped tubular nasal cavity component of the present invention constructed of a flexible, formable, or memory material;
  • FIG. 5 is a front view of a semi-rigid stabilization patch of the present invention.
  • FIG. 7 is an open view of a flexible stabilization patch of the present invention.
  • FIG. 10B is a perspective of a tubular nasal cavity component of the present invention
  • FIG. 11 is a perspective of a first section of a tubular guidance-stabilization system of the present invention, showing a tubing wall in which a bendable wire may be embedded;
  • FIG. 17 is a cross-sectional view of a U-shaped tubular nasal cavity component of the present invention.
  • FIG. 24 is a side view of an embodiment of a trumpet-shaped tubular nasal cavity component of the present invention, showing the outward flaring opening at the end that fits into the user's nasal cavity.
  • FIG 25 F is a side cross sectional view of the component of FIG. 25 A depicting an example of a sensor and an example of a connected signal transmitting cable.
  • the gas delivery device 1 comprises a single substantially U-shaped nasal cavity component 3 that may be non-flexible or flexible and may be inserted into either nostril of the patient 2 to deliver oxygen or other gas to the patient.
  • the substantially U-shaped nasal cavity component 3 is preferably constructed from formable or memory material.
  • the nasal cavity component 3 is tubular.
  • the substantially U-shaped nasal cavity component 3 may have a bendable or flexible wire 19 embedded within at least a portion of the tubular wall 20, with the wire 19 extending substantially axially along the tubular wall 20.
  • a wire 19 in a nasal cavity component and with the -tubular guidance-stabilization system, as described below, softer and more flexible materials, which in turn are more comfortable and less irritating to the patient, may be used.
  • Such materials may include a vinyl polymer or a silicone polymer.
  • the substantially U-shaped nasal cavity component 3 has a first end 4 that fits inside the patient's nostril and a second end 6 that is exterior to the nostril and extends downward from the patient's nostril, around an outer surface of the patient's nostril, and upward toward the patient's eye.
  • the substantially U-shaped nasal cavity component 3 attaches to flexible and preferably formable or bendable tubing 8, also referred to herein as the tubular guidance-stabilization system.
  • the tubular guidance-stabilization system 8 then extends upward from the second end 6 of the nasal cavity component 3 and toward the patient's eye or ear.
  • the substantially U-shaped nasal cavity component 3 has a first end 4 that fits inside the nostril from which oxygen or other gasses are delivered to the patient.
  • the second end 6 of the U-shaped nasal cavity component 3 may further comprise a substantially ninety degree bend 5 preferably constructed from the same material as the rest of the substantially U-shaped nasal cavity component 3 to prevent formation of kinks which could reduce or restrict the flow of oxygen or other gas and to enhance placement of the nasal cavity component within the patient's nostril and the tubular guidance- stabilization system on the patient's face.
  • the substantially U-shaped nasal cavity component second end 6 is joined at the juncture 7 of nasal cavity component 3 to the first section of tubular guidance-stabilization system 8.
  • the first section of the tubular guidance-stabilization system 8 which is preferably flexible, formable or bendable tubing, and which may have a bendable wire 32 (not shown) embedded in the wall 33 of the longitudinal tubular conduit of the tubular guidance-stabilization system, extends from a second end 6 of the U-shaped nasal cavity component across the patient's cheek (where the tubular guidance- stabilization system is secured by a stabilization patch, as described below), around the side of the face and toward the top of the patient's ear.
  • the first section of tubular guidance-stabilization system 8 may be contoured over the patient's ear and bent slightly inward against the patient's scalp behind the ear to the mastoid tip (where the tubular guidance-stabilization system is further secured by a stabilization patch, as described below). This configuration allows the tubular guidance-stabilization system 8 to be positioned and worn slightly above the ear, thereby preventing interface pressure and friction behind the ear and allowing a patient to wear eye glasses without interference from the tubular guidance-stabilization system.
  • first section of the tubular guidance-stabilization system 8 may be joined at juncture 9 to a second section of the tubular guidance-stabilization system 10.
  • the second section of the tubular guidance-stabilization system 10 extends over and behind the ear and may be flexible, formable or bendable so that it may be contoured over the ear and bent slightly inward against the patient's scalp behind the ear to secure the tubing placement. This configuration of the second section of the tubular guidance- stabilization system 10 allows the tubing to be worn slightly above the ear, thereby preventing interface pressure and friction behind the ear and allowing a patient to wear eye glasses without interference from the tubing.
  • a second section of the tubular guidance-stabilization system 10 is affixed to a third section of the tubular guidance- stabilization system 12 at a juncture 11.
  • the third section of the tubular guidance- stabilization system 12 preferably consists of coiled flexible tubing which allows the patient to move his or her head without affecting the placement of the U-shaped nasal cavity component 3 in the nostril.
  • a third section of the tubular guidance-stabilization system 12 is joined at juncture 13 to a fourth section of the tubular guidance-stabilization system 14.
  • a fourth section of the tubular guidance-stabilization system 14 extends directly to the gas supply source and is preferably draped across the back of the patient's neck and crossing to the shoulder of the patient that is opposite to the side of the patient's nostril into which the nasal cavity component 3 is inserted, and thence to the gas supply source.
  • a clip 15 may be used to attach the fourth section of tubing 14 to the patient's clothing, further securing and stabilizing the tubular guidance-stabilization system to patient and, in turn, securing the placement of the nasal cavity component 3 within the nostril.
  • a fourth section of the tubular guidance-stabilization system 14 is attached to the gas supply at connector 16. Also illustrated in FIG.
  • a semi-rigid stabilization patch 17 on the patient's face that further secures the tubular guidance-stabilization system 8 to the cheek of the patient and is discussed in greater detail below.
  • a flexible stabilization patch 18 may be used to secure the tubular guidance-stabilization system 8 to the patient's cheek.
  • the first section of the tubular guidance-stabilization system 8 extends from a second end 6 of the U-shaped nasal cavity component across the patient's cheek (where the tubular guidance-stabilization system is secured by a stabilization patch, as described below), around the side of the face and toward the top of the patient's ear.
  • the first section of tubular guidance-stabilization system 8 may be contoured over the patient's ear and bent slightly inward against the patient's scalp behind the ear to the mastoid tip (where the tubular guidance-stabilization system is further secured by a stabilization patch, as described below), and joined to a gas supply tubing.
  • a substantially U-shaped nasal cavity component 3 is tubular and includes a bendable wire 19 that is embedded within at least a portion of the nasal cavity component wall 20 and extends substantially axially along the nasal cavity component wall 20, a first end 4 that fits inside the patient's nostril and a second end 6 that is exterior to the nostril.
  • the second end 6 of the nasal cavity component 3 extends downward from the patient's nostril, around an outer surface of the patient's nostril, upward toward the patient's eye to a substantially 90 degree bend 5 across the patient's cheek, around the side of the face, toward the top of and over the patient's ear.
  • FIG. 2 a rear view of an gas delivery device of the present invention being worn by a patient, a flexible stabilization patch 18 affixed behind the patient's ear is illustrated.
  • This flexible stabilization patch 18 functions to additionally secure the tubing placed over the ear and reduce the movement of the tubing in the vicinity of the ear, reducing the interface pressure and friction of the tubing against the skin.
  • FIG. 3 a side view of a U-shaped nasal cavity component 3 of the present invention constructed out of non-flexible tubing is illustrated, which is self- explanatory when viewed in conjunction with the description above.
  • the nasal cavity component 3 is tubing that is flexible and constructed out of formable or shape-memory material.
  • the nasal cavity component 3 has a first end 34, which is adapted to fit inside the patient's nostril, and a second end 35 having a substantially U-shaped portion 36, which that is adapted to extend downward from the patient's nostril, around an outer surface of the patient's nostril, and then upward toward the patient's eye.
  • a nasal cavity component wall 20 surrounds the gas passageway 37.
  • a substantially ninety degree bend 5 in the second end 35 is also shown in FIG. 3.
  • the location of the juncture 7 of the U-shaped nasal cavity component 3 to first section of tubing (not shown). The length of the nasal cavity component extends from the first end 34 to the location of the juncture 7.
  • the length of the nasal cavity component extends from the first end 34 to the location of the juncture 7.
  • the wire 19 extends substantially axially along the tubular wall 20 of the nasal cavity component 3.
  • the length of the wire 19 is typically less than the length of the nasal cavity component 3 so that the wire does not protrude into the patient's nostril and potentially harm the patient.
  • the substantially U-shaped nasal cavity component 3 retains its shape when bent and in another embodiment the substantially U-shaped nasal cavity component 3 returns to its original shape after bending.
  • the material used to form the flexible, formable or memory tubing of the nasal cavity component 3 may also be a semirigid plastic, polyurethane, elastomer or other material that retains its shape when bent without the assistance of the embedded flexible wire 19. Such tubing may also be applied to the section of tubing 10 that fits over the ear of the patient.
  • a flexible stabilization patch 18 in an open configuration 25 is illustrated.
  • the flexible stabilization patch 18 may be affixed to the face as shown in FIG. 1 in replacement of the semi-rigid stabilization patch 17 and/or behind the patient's ear 18 as shown in FIG. 2.
  • the flexible stabilization patch 18 preferably should be made of flexible, breathable and non-irritating material.
  • the flexible stabilization patch 18 has two patch sections, a first patch section 38 and a second patch section 39, that are separated and connected by a tubing securement area 27.
  • the flexible stabilization patch may have a barbell shape with two patch sections that are separated and connected by a tubing securement area 27.
  • the tip 31 is preferably made of pliable or formable materials which may be affixed to the end of the nasal cavity component 4.
  • the tip 31 secures the nasal cavity component 4 within the nostril and enhances the inspired oxygen by reducing the backflow of oxygen out of the nostril.
  • the first end 42 of the nasal cavity component 41 has a width 44 and is adapted to be placed in a patient's nostril.
  • the second end 43 of the tubular nasal cavity component 41 has a width 45 and is attached to and is in fluid communication with the tubular guidance-stabilization system (not shown).
  • the first end 41 typically has a width 44, which is larger than the width 45 of the second end 43 of the nasal cavity component tip 41.
  • the specific size and shape of the nasal cavity component 41 to be used for a specific patient may be selected according to the size of the patient's nostril (not shown) to comfortably secure the nasal cavity component in the nostril while mitigating any irritation and /or discomfort to the patient.
  • a nasal cavity component tip 41 will be selected so that the width 44 of the first end 42 of the nasal cavity component tip 41 is greater than the width 45 of the second end 43.
  • tubular wall 33 of the guidance-stabilization system 8 is illustrated as having a circular opening and cross-sectional area for flow, the tubular may have an opening and cross-sectional area of other shapes, such as oblong, elliptical, or even rectangular.
  • the substantially U-shaped nasal cavity component 103 When the gas delivery device 101 is in use, the substantially U-shaped nasal cavity component 103 has a first end 134 that fits inside the patient's nostril and a second end 135 exterior to the nostril.
  • the substantially U-shaped nasal cavity component 103 attaches to and is in fluid communication with a flexible and preferably formable or bendable tubular guidance-stabilization system 108.
  • the tubular guidance-stabilization system 108 then extends upward from the second end 135 of the nasal cavity component 103, to the tip of the patient's cheekbone (where the tubular guidance-stabilization system 108 is secured using a stabilization patch 118), and up and over the patient's ear.
  • FIG. 14 Another exemplary embodiment of a nasal cavity component 103 having unique features is depicted in FIG. 14.
  • one or more internal ribs 155 may be formed during the manufacturing process on the internal side of the tubular wall 120 and extend approximately the entire length of the nasal cavity component 103.
  • the internal ribs 155 provide both axial and radial support to the tubular wall 120, preventing the collapse of the nasal cavity component 103 and the formation of any restrictions that could reduce or restrict the passage of gas through the gas passageway 137.
  • the internal ribs 155 also promote turbulent flow of gas through the nasal cavity component 103 by reducing sharp angled flow conditions therein.
  • FIG. 19 Another exemplary embodiment of a nasal cavity component 103 having unique features is depicted in FIG. 19, which shows a nasal cavity component 103 having an internal slot 190 that promotes alignment of the nasal cavity component 103 with a corresponding tubular guidance-stabilization system 108 (not shown in FIG. 19), during either the initial assembly or subsequent alignment of the gas delivery device.
  • the nasal cavity component 103 when connecting the nasal cavity component 103 to a tubular guidance- stabilization system 108 (not shown in FIG. 19), the nasal cavity component 103 is considered the female portion of the connection into which fits the male portion of the connection found in the tubular guidance-stabilization system 108.
  • FIG. 23 shows a cross-sectional view of a tubular guidance-stabilization system 108 having an external grove or slot 180 on the interior of the wall 130 for mating with the internal groove 190 on the nasal cavity component 103 as shown in FIG. 23.
  • tubular guidance-stabilization system 108 extending from the second end 134 of the tubular nasal cavity component 103 would be bent approximately seventy plus or minus ten degrees (70 + 10°) to allow the tubular guidance-stabilization system 108 to then extends upward to the tip of the patient's cheekbone (where the tubular guidance-stabilization system 108 is secured using a stabilization patch 118), and up and over the patient's ear.
  • the tubular guidance-stabilization system 108 includes a tubular wall 133 and an internal key 170 that extends inwardly in a radial direction from the wall and extends along at least a portion of the tubular wall 133 in a longitudinal direction starting from the end of the tubular guidance-stabilization system 108 that is connected to, in fluid connection with, and mates with the tubular nasal cavity component 103 (not shown in FIG.21).
  • the tubular guidance-stabilization system 108 includes a tubular wall 133 and an external key 185 that extends inwardly in a radial direction from the wall and extends along at least a portion of the tubular wall 133 in a longitudinal direction starting from the end of the tubular guidance-stabilization system 108 that is connected to, in fluid connection with, and mates with the tubular nasal cavity component 103 (not shown in FIG.23).

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  • Health & Medical Sciences (AREA)
  • Emergency Medicine (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Otolaryngology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Un dispositif d'administration d'un gaz à un utilisateur comprend un seul composant de cavité nasale tubulaire ayant uniquement deux extrémités terminales : une entrée et une sortie de gaz avec un trajet d'écoulement de gaz unique entre les deux. Le composant est conçu pour être inséré dans la narine d'un utilisateur et être maintenu en position sans adhésif. Le composant de cavité nasale comprend une première partie ayant un premier axe longitudinal le long du trajet d'écoulement de gaz. L'extrémité proximale de la première partie est évasée vers l'extérieur pour être introduite dans la narine d'un patient. La seconde partie a un second axe longitudinal et une entrée de gaz pour recevoir du gaz provenant d'une source d'alimentation en gaz. L'extrémité distale de la seconde partie passe à travers l'extrémité distale de la première partie dans une partie de courbure, de sorte que les premier et second axes longitudinaux se coupent à un angle compris entre environ 60° et environ 80°.
PCT/US2017/044631 2016-08-12 2017-07-31 Dispositif d'administration de gaz. Ceased WO2018031278A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US15/235,665 2016-08-12
US15/235,665 US9925348B2 (en) 2013-07-17 2016-08-12 Gas delivery device

Publications (1)

Publication Number Publication Date
WO2018031278A1 true WO2018031278A1 (fr) 2018-02-15

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Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1873160A (en) * 1929-02-08 1932-08-23 Harold V Sturtevant Breathing apparatus
US4660555A (en) * 1984-09-21 1987-04-28 Payton Hugh W Oxygen delivery and administration system
US4742824A (en) * 1986-11-19 1988-05-10 Hugh W. Payton Oxygen tube support patch
US20020165482A1 (en) * 1997-05-27 2002-11-07 Erik Keldmann Method for introducing a powdered substance into a nostril
US20100242959A1 (en) * 2006-07-25 2010-09-30 Per Gisle Djupesland Delivery of gases to the nasal airway
US20110126830A1 (en) * 2006-11-28 2011-06-02 Optinose As Delivery devices
US20110203591A1 (en) * 2010-02-19 2011-08-25 Resmed Limited Supplemental gas delivery device for mask assembly
US20140158127A1 (en) * 2012-12-07 2014-06-12 Parion Sciences, Inc. Nasal cannula for delivery of aerosolized medicaments
US20140360499A1 (en) * 2013-06-09 2014-12-11 Ronal Peets Intranasal Airway Device

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1873160A (en) * 1929-02-08 1932-08-23 Harold V Sturtevant Breathing apparatus
US4660555A (en) * 1984-09-21 1987-04-28 Payton Hugh W Oxygen delivery and administration system
US4742824A (en) * 1986-11-19 1988-05-10 Hugh W. Payton Oxygen tube support patch
US20020165482A1 (en) * 1997-05-27 2002-11-07 Erik Keldmann Method for introducing a powdered substance into a nostril
US20100242959A1 (en) * 2006-07-25 2010-09-30 Per Gisle Djupesland Delivery of gases to the nasal airway
US20110126830A1 (en) * 2006-11-28 2011-06-02 Optinose As Delivery devices
US20110203591A1 (en) * 2010-02-19 2011-08-25 Resmed Limited Supplemental gas delivery device for mask assembly
US20140158127A1 (en) * 2012-12-07 2014-06-12 Parion Sciences, Inc. Nasal cannula for delivery of aerosolized medicaments
US20140360499A1 (en) * 2013-06-09 2014-12-11 Ronal Peets Intranasal Airway Device

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