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WO2021221590A1 - Canule nasale articulée et capable d'administration d'un volume élevé d'un gaz permettant l'oxygénothérapie à courant élevé - Google Patents

Canule nasale articulée et capable d'administration d'un volume élevé d'un gaz permettant l'oxygénothérapie à courant élevé Download PDF

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Publication number
WO2021221590A1
WO2021221590A1 PCT/TR2021/050395 TR2021050395W WO2021221590A1 WO 2021221590 A1 WO2021221590 A1 WO 2021221590A1 TR 2021050395 W TR2021050395 W TR 2021050395W WO 2021221590 A1 WO2021221590 A1 WO 2021221590A1
Authority
WO
WIPO (PCT)
Prior art keywords
nose
patient
nose cone
mask body
lower mask
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/TR2021/050395
Other languages
English (en)
Inventor
Tarik Ozkul
Murat Haluk Ozkul
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.)
Stratejik Yenilikci Girisimler Arge Muh Ve Sag San Tic Ltd Sti
Original Assignee
Stratejik Yenilikci Girisimler Arge Muh Ve Sag San Tic Ltd Sti
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 Stratejik Yenilikci Girisimler Arge Muh Ve Sag San Tic Ltd Sti filed Critical Stratejik Yenilikci Girisimler Arge Muh Ve Sag San Tic Ltd Sti
Publication of WO2021221590A1 publication Critical patent/WO2021221590A1/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
    • 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
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/1005—Preparation of respiratory gases or vapours with O2 features or with parameter measurement
    • 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
    • A61M2210/0618—Nose

Definitions

  • the present invention relates to the category of medical devices for introducing media into or onto the body. More specifically, the present invention relates to the sub-category of “Inhaling devices inserted into the nose” and “devices for influencing the respiratory system of patients by gas treatment”.
  • the apparatus is designed to efficiently deliver high flow and high-volume oxygen-enriched air to patients with conscious and spontaneous breathing through the patient's nostrils.
  • HFNC high flow nasal cannula
  • US20080223375A1 teaches the single channel type of the HFNC type nasal cannula, while the application numbered US20100224196A1 developed a more ergonomic version of the nasal cannula with the help of a steel wire.
  • CPAP Continuous Positive Airway Pressure
  • Patent US 7,913,692 B2 teaches the making of such nasal mask. These types of masks have been studied extensively and different versions have been developed. Patent US7845352B2 teaches a more ergonomic version of such masks, while patent US 9 205 214B2 teaches a different version with improvements in the wearing style of the patient's head.
  • NIV has become the most preferred primary treatment and support modality for patients with Chronic Obstructive Pulmonary Disease (COPD), as it increases patients' inspiratory level. Even in the absence of high-value evidence, the use of NIV in other respiratory diseases is also on the rise. Although no studies reported a 100% success rate, disease severity and initial responses to NIV are the main determinants of this treatment success. According to researches, it has been declared that selection of an appropriate mask to be used is more important than the mode to be used in the ventilation device to achieve good results. (Navalesi P, Fanfulla F, Frigerio P, Gregoretti C, Nava S., Physiologic evaluation of noninvasive mechanical ventilation delivered with three types of masks in patients with chronic hypercapnic respiratory failure. Crit Care Med 2000; 28 (6): 1785-1790)
  • Masks that cover both the nose (nasal) and the mouth and nose (oronasal) are the most commonly used mask types for NIV in CPAP treatment. Oronasal masks are usually tried first because they provide the effectiveness of NIV better than other interfaces.
  • Nasal trauma is considered to be an important problem when applying CPAP to preterm babies and newborns' noses with nasal cannula. Since the nasal CPAP mask interface requires secure fixation to prevent air leakage, the incidence of pressure ulcers varies between 15% and 100% due to the pressure applied to the skin. (Collins CL, Barfield C, Home RS, Davis PG., A comparison of nasal trauma in preterm infants extubated to either heated humidified high-flow nasal cannulae or nasal continuous positive airway pressure. Eur J Pediatr 2014; 173 (2): 181— 186.) In this study, less nasal trauma was reported with HFNC, which is an open system, despite the leak.
  • Oxygen therapy is critical in infectious diseases such as the disease caused by the COVID-19 virus.
  • the patient's need for oxygen is known to be given with classical HFNC (High Flow Nasal Canula) and CPAP type mouth-nose or only nasal masks, but since sufficient oxygen could not be given to the patients through these masks, intubation was started to be applied to the patients.
  • the intubation method which is well known by the medical community, is a method used during surgery performed under general anesthesia, and it is a method that prevents gas from escaping by inserting into the patient's windpipe and inflating the balloon around it. Intubation is a method with acceptable complications for few hours of surgery.
  • the aim of the present invention is to eliminate the insufficient aspects of the existing HFNC and CPAP masks in providing oxygen to patients with high contagiousness such as Covid 19.
  • the aim is to deliver high volume oxygen to patients without gas leakage, while doing this, to be in minimum contact with the patient's skin and provide maximum comfort for the patient.
  • a design that is suitable for the nasal anatomy of people which enlarges the nostrils in a non-invasive way in order to provide a high level of flow is developed. While doing this the new design grasps the patient's nose with minimum pressure.
  • the invention is physically small and does not prevent the patient from eating and talking while effectively increasing nasal aperture by 20-40% by shaping the patient's nostrils. Possible allergic reactions are minimized by using silicon in the parts that contact the skin.
  • the places around nose where the invention makes contact have cartilage and adipose tissue and this causes minimum distress for the patient.
  • the nose which is the most striking element of the human face, appears in about 12 different types, although it varies from person to person. (Ozkul, T.
  • FIGURE 1 Shows the anatomy of the nose where the invention is attached to.
  • FIGURE 2 Showing the front and side view of the nasal mask.
  • FIGURE 3 Shows parts of the nasal mask
  • FIGURE 4 Shows the nasal mask as attached to the patient's nose.
  • FIGURE 5 Shows the nose grip principle of the nasal mask.
  • FIGURE 6 Shows the view of the nasal mask on the patient's head, the method of attachment to the head and the position of the gas pipes.
  • FIGURE 7 Shows the silicone pieces covering the surfaces contacting the patient's skin in line with medical needs.
  • the aim of the invention is to deliver high volume gas to the patients through the nostrils without leaking out the gas.
  • the most important difference of the invention from other nasal masks with a similar purpose is the way it contacts the patient's nostrils and the way it grips the nose.
  • the part of the nose anatomy related to the invention is described in Figure 1.
  • the nostrils (nares) located at the sides of our nose are surrounded by skin containing cartilage and adipose tissue, and on the side of the nose, there is a roughly "v" shaped cartilage called Alar cartilage (1).
  • Alar cartilage (1) covers both sides of the roughly triangular shaped nostrils.
  • the alar adipose tissue (2) under the cartilage of this region called the nasal wing (70), which is lateral to the nostril (3), surrounds the nostrils.
  • the invention attaches to the alar adipose tissue (2) part of the nose.
  • Figure 2 shows the main parts of the invention in perspective.
  • Figure 3 shows individual parts of the invention.
  • the other figures are intended to explain the functioning of the individual parts of the invention with each other shown in Figure 2.
  • the invention consists of the lower mask body (5), the upper swingarm (15) connected to it, and the nose cone (30) parts.
  • the upper swingarm (15) is connected to the lower mask body (5) via the connection point (50) and the upper fork connection point (45).
  • the upper swingarm (15) is hinged to the lower mask body (5) from the point of the upper swingarm connection point (45) and can freely rotate on the vertical movement axis (46).
  • connection points (50) on the lower mask body (5) Since there is at least one, preferably several connection points (50) on the lower mask body (5), the position of the upper swingarm (15) can be changed and its height can be adjusted according to the nasal size of the patient's nose.
  • the upper swingarm (15) exerts a force towards the lower mask body (5) by means of the tension instrument (80) to be attached around the upper mask protrusion (10) and the lower mask protrusion (11) on the upper swingarm (15).
  • the upper swingarm alar adipose tissue pressure end (40) clings to the patient’s nose by applying pressure on the alar adipose tissue (2) of the patient's nose.
  • the nose cone (30) is hinged via nose cone hinge point (25) to the lower mask body (5) through the nose cone hinge protrusion (55) and can freely rotate in the direction of the horizontal movement axis (47).
  • the head strap attachment loop (20) located on the lower mask body (5) the mask is connected to the patient's head via the head strap (85).
  • nose cones (30) There are two nose cones (30) on the invention, and they are connected to the gas pipe (90) where the oxygen or therapeutic gas is delivered via the gas pipe connection point (35) located under the cone.
  • the ability of the nose cone (30) to move in the direction of the horizontal movement axis (47) enables the distance between nose cones (30) to be adjusted according to the distance between the nostrils of the patient.
  • the nose cone lower diameter (33) is larger than the nose cone upper diameter (32) and when it enters the nostril (3), it shapes and expands the nostril circularly. As a result, the nostril (3) widens and the nasal wing (70) moves up.
  • the upper swingarm alar adipose tissue pressure end (40) exerts a gentle pressure on the enlarged nasal wing (70) of the patient's nose. This pressure allows the mask to hold onto the nose.
  • the position in the direction of the horizontal movement axis (47) and the vertical movement axis (46) can be adjusted and a perfect contact is provided between the nose cones (30) and the patient's nostrils (3) in a gas-tight manner.
  • the weight of the mask and the weight of the gas pipes (90) connected to the mask are carried by the head strap (85) attached to the patient's head.
  • the nose cones (30) are turned in the direction of the horizontal movement axis (47) and the distance between the cones (30) is adjusted fit the distance between the nostrils (3) of the patient.
  • Another adjustment before the usage is the adjustment of the height of the upper swingarm (15) via a suitable connection point (50) located on the lower mask body (5) for adaptation into the patient's nose.
  • Silicone cone sleeve (92) suitable for the size of the patient's nostrils is placed on the nose cone (30) and pushed into the patient's nostril (3). Since nose cone lower diameter (33) is larger than the diameter of the nostril (3) of normal people, the nose cone (30) cannot completely enter the nostril (3).
  • the nostril (3) will take a circular shape at this stage and the opening area will increase.
  • the upper swingarm (15) will be placed on the nose of the patient and the upper swingarm alar adipose tissue pressure end (40) presses over the nostril (3) which is expanded and swollen due to the nose cone (30) entered inside.
  • gentle pressure applied by the tension instrument (80) will exert pressure on the nasal wing (70). This completes attachment of the mask to the nose.
  • the mask will be connected to the head of the patient via the head strap (85) and the gas pipe (90) will be positioned in a suitable position behind the head of the patient.

Landscapes

  • 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)
  • Respiratory Apparatuses And Protective Means (AREA)

Abstract

La présente invention concerne une canule nasale ergonomiquement et fonctionnellement améliorée qui peut être ajustée à différents types de nez pour administrer du gaz aux patients présentant des problèmes respiratoires sans fuite du gaz vers l'environnement. Le masque est ergonomique, minimalement petit, et n'interfère pas avec les fonctions d'alimentation, de boisson et de parole du patient. Il accroît le volume d'administration de gaz en levant activement les ailes nasales du patient et en élargissant les voies respiratoires nasales. Il se lie au tissu gras alaire du nez et peut être ajusté à n'importe quel type de nez.
PCT/TR2021/050395 2020-04-27 2021-04-27 Canule nasale articulée et capable d'administration d'un volume élevé d'un gaz permettant l'oxygénothérapie à courant élevé Ceased WO2021221590A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2020/06558 2020-04-27
TR2020/06558A TR202006558A1 (tr) 2020-04-27 2020-04-27 Yüksek akimli oksi̇jen terapi̇si̇ i̇çi̇n ayarlanabi̇li̇r burun maşali nazal maske

Publications (1)

Publication Number Publication Date
WO2021221590A1 true WO2021221590A1 (fr) 2021-11-04

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ID=78374186

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/TR2021/050395 Ceased WO2021221590A1 (fr) 2020-04-27 2021-04-27 Canule nasale articulée et capable d'administration d'un volume élevé d'un gaz permettant l'oxygénothérapie à courant élevé

Country Status (2)

Country Link
TR (1) TR202006558A1 (fr)
WO (1) WO2021221590A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NZ562410A (en) * 2003-02-21 2009-02-28 Resmed Ltd Nasal pillow mask assembly
CN101653632A (zh) * 2008-06-04 2010-02-24 雷斯梅德有限公司 患者接口系统
WO2014035261A1 (fr) * 2012-08-29 2014-03-06 Fisher & Paykel Healthcare Limited Interfaces nasales pour thérapie respiratoire

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NZ562410A (en) * 2003-02-21 2009-02-28 Resmed Ltd Nasal pillow mask assembly
CN101653632A (zh) * 2008-06-04 2010-02-24 雷斯梅德有限公司 患者接口系统
WO2014035261A1 (fr) * 2012-08-29 2014-03-06 Fisher & Paykel Healthcare Limited Interfaces nasales pour thérapie respiratoire

Also Published As

Publication number Publication date
TR202006558A1 (tr) 2021-11-22

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