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Title:
ARTICULATED AND HIGH-VOLUME GAS DELIVERY CAPABLE NASAL CANNULA FOR HIGH CURRENT OXYGEN THERAPY
Document Type and Number:
WIPO Patent Application WO/2021/221590
Kind Code:
A1
Abstract:
This is an ergonomically and functionally improved nasal cannula which can be adjusted to different nose types to deliver gas to the patients with respiratory problems without leaking the gas to the environment. The mask is ergonomic, minimally small, and does not interfere with the patient's eating, drinking and speaking functions. It increases gas delivery volume by actively lifting the patient's nasal wings and widening the nasal airway. It clings to the alar fatty tissue of the nose and can be adjusted to any type of nose.

Inventors:
OZKUL TARIK (TR)
OZKUL MURAT HALUK (TR)
Application Number:
PCT/TR2021/050395
Publication Date:
November 04, 2021
Filing Date:
April 27, 2021
Export Citation:
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Assignee:
STRATEJIK YENILIKCI GIRISIMLER ARGE MUH VE SAG SAN TIC LTD STI (TR)
International Classes:
A61M16/06; A61M16/08
Domestic Patent References:
WO2014035261A12014-03-06
Foreign References:
CN101653632A2010-02-24
NZ562410A2009-02-28
Download PDF:
Claims:
Claims:

1. An apparatus designed to give gas to patients with respiratory problems through the nose comprising; at least one nose cone (30) entering the patient's nostril (3), at least one lower mask body (5) to which the nose cone will be connected, at least one upper swingarm (15) mounted on the lower mask body.

2. An apparatus of claim 1, where the nose cone (30) comprises a nose cone hinge protrusion (55) that connects to nose cone hinge point (25) located on the lower mask body (5) so as to provide movement in the direction of the horizontal movement axis (47).

3. An apparatus of claim 1, where the upper swingarm (15) comprises an upper fork arm connection point (45) connected to at least one connection point (50) located on the lower mask body (5) so as to provide movement in the direction of the vertical movement axis (46).

4. An apparatus of claim 3, where the position of the upper swingarm (15) adjusted by attaching to more than one connection point (50) on the lower mask body (5) through the upper fork arm connection point (45) so that upper swing arm alar adipose tissue pressure end (40) and the distance between the nose cone (30) changes.

5. An apparatus of claim 3, where the upper swing arm alar adipose tissue pressure end (40) connected to upper swingarm (15) which is attached to connection point (50) on the lower mask body (5) through the upper fork arm connection point (45) presses toward the nose cone (30) by way of force applied by tension instrument (80).

6. An apparatus of claim 1, where at least one head tie connection ring (20) on the lower mask body (5) and a head strap (85) wrapped around the head of the patient, provide the ability to attach to the patient's head.

7. An apparatus of claim 1, where a silicone cone sleeve (92) that covers the nose cone (30) and a silicone tube (93) that covers the upper swingarm (15) provide protection to the patient's skin.

8. A method for delivering high volume gas to nose of patients with respiratory problems in a leak-proof way to by actions comprising: widening and shaping the nostril (3) by the nose cone (30) entering the patient's nostril (3), pressing upper swingarm alar adipose tissue pressure end (40) of upper swingarm (15) to alar adipose tissue (2) by way of tension instrument (80) so that the nose cone (30) makes gas tight contact with nostril (3).

AMENDED CLAIMS received by the International Bureau on 25 September 2021

[Claim 1] [Amended] An apparatus designed to give gas to patients with res piratory problems through the nose comprising; at least one nose cone (30) entering the patient's nostril (3), at least one lower mask body (5) to which the nose cone will be connected, at least one upper swingarm (15) mounted on the lower mask body, at least one tension instrument (80) pressing upper swingarm (15) toward nose cone (30) squeezing alar adipose tissue (2) in between to ensure attachment to nose.

[Claim 2] An apparatus of claim 1, where the nose cone (30) comprises a nose cone hinge protrusion (55) that connects to nose cone hinge point (25) located on the lower mask body (5) so as to provide movement in the direction of the horizontal movement axis (47).

[Claim 3] An apparatus of claim 1, where the upper swingarm (15) comprises an upper fork arm connection point (45) connected to at least one connection point (50) located on the lower mask body (5) so as to provide movement in the direction of the vertical movement axis (46).

[Claim 4] An apparatus of claim 3, where the position of the upper swingarm (15) adjusted by attaching to more than one connection point (50) on the lower mask body (5) through the upper fork arm connection point (45) so that upper swing arm alar adipose tissue pressure end (40) and the distance between the nose cone (30) changes.

[Claim 5] An apparatus of claim 3, where the upper swing arm alar adipose tissue pressure end (40) connected to upper swingarm (15) which is attached to connection point (50) on the lower mask body (5) through the upper fork arm connection point (45) presses toward the nose cone (30) by way of force applied by tension instrument (80).

[Claim 6] An apparatus of claim 1, where at least one head tie connection ring (20) on the lower mask body (5) and a head strap (85) wrapped around the head of the patient, provide the ability to attach to the patient's head.

[Claim 7] An apparatus of claim 1, where a silicone cone sleeve (92) that covers the nose cone (30) and a silicone tube (93) that covers the upper swingarm (15) provide protection to the patient's skin.

[Claim 8] A method for delivering high volume gas to nose of patients with res piratory problems in a leak-proof way to by actions comprising: widening and shaping the nostril (3) by the nose cone (30) entering the patient's nostril (3), pressing upper swingarm alar adipose tissue pressure end (40) of upper swingarm (15) to alar adipose tissue (2) by way of tension instrument (80) so that the nose cone (30) makes gas tight contact with nostril (3).

Description:
ARTICULATED AND HIGH-VOLUME GAS DELIVERY CAPABLE NASAL CANNULA FOR HIGH CURRENT OXYGEN THERAPY

FIELD

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.

BACKGROUND

Delivering oxygen or similar therapeutic gases to patients through the nose is a technique known for a long time and the first patent on this technique dates back to the 1980s. Supplemental oxygen delivery is an integral part of treatment for the underlying etiology of respiratory failure. The most efficient method for supportive oxygen therapy is the high flow nasal cannula (HFNC). The HFNC was patented in 1988 to prevent exercise- induced lung problems in racehorses. Overtime, different versions of this technology have been developed. The application numbered 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.

After the spread of sleep apnea problem, CPAP (Continuous Positive Airway Pressure) devices have been developed to prevent such patients from stopping their breathing during sleep. These CPAP devices need to be used with special nasal masks which can be considered as advanced version of the earlier HFNC type nasal cannulas. 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. In current medical practice oxygen delivery to patients is done either with a HFNC type nasal cannula or by the oronasal masks which deliver gas through mouth and nose of the type used by CPAP machines. This type of respiratory support is called "NIV" (non-invasive ventilation) in the medical literature. In the past two decades, the use of non-invasive ventilation (NIV) has been widely discussed in the medical world (Girou E, Brun-Buisson C, Taille S, Lemaire F, Brochard L., Secular trends in nosocomial infections and mortality associated with noninvasive ventilation in patients with exacerbation of COPD and pulmonary edema. JAMA 2003; 290 (22): 2985-2991)

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.

Unfortunately, this type of mask is not comfortable and many patients find it difficult to tolerate the mask. In addition, high air leakage frequently occurs during use in such masks. (Conti G, Antonelli M, Navalesi P, Rocco M, Bufi M, Spadetta G, Meduri GU. Noninvasive vs. conventional mechanical ventilation in patients with chronic obstructive pulmonary disease after failure of medical treatment in the ward: a randomized trial. Med 2002; 28 (12): 1701-1707.)

In addition, skin lesions that occur in the nose due to the use of such masks cause frequent interruptions during long-term use of this device. (Schwabbauer N, Berg B, Blumenstock G, Haap M, Hetzel J, Riessen R. Nasal high-flow oxygen therapy in patients with hypoxic respiratory failure: effect on functional and subjective respiratory parameters compared to conventional oxygen therapy and non-invasive ventilation (NIV). BMC Anesthesiol 2014; 14: 66)

In addition, skin lesions that occur in the nose due to the use of such masks cause frequent interruptions during long-term use of this device. (Schwabbauer N, Berg B, Blumenstock G, Haap M, Hetzel J, Riessen R. Nasal high-flow oxygen therapy in patients with hypoxic respiratory failure: effect on functional and subjective respiratory parameters compared to conventional oxygen therapy and non-invasive ventilation ( NIV). BMC Anesthesiol 2014; 14: 66)

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.

In adult patients, HFNC-type oxygen delivery has been reported to show relatively less skin damage than administering with a CPAP-type nasal / oronasal mask. (Stephan F, Barrucand B, Petit P, Rezaiguia-Delclaux S, Medard A, Delannoy B, et ah, High-flow nasal oxygen vs noninvasive positive airway pressure in hypoxemic patients after cardiothoracic surgery: A randomized clinical trial. JAMA 2015; 313 (23): 2331—2339)

In the study conducted by Schwabbauer et ak, HFNC and other types of CPAP masks were applied alternately to the patients for 30 minutes, and as a result of the study, it was found that HFNC offered a better alternative for oxygenation. (Schwabbauer N, Berg B, Blumenstock G, Haap M, Hetzel J, Riessen R. Nasal high-flow oxygen therapy in patients with hypoxic respiratory failure: effect on functional and subjective respiratory parameters compared to conventional oxygen therapy and non-invasive ventilation ( NIV). BMC Anesthesiol 2014; 14: 66)

In their study, Peters et al. Applied oxygen delivery with HFNC for 2-144 hours and found that it was more efficient and preferred by patients than CPAP-type masks in patients who could not be intubated. (Peters SG, Holets SR, Gay PC. High-flow nasal cannula therapy in do-not-intubate patients with hypoxemic respiratory distress. Respir Care 2013; 58 (4): 597-600

These results revealed that although the respiratory masks used in CPAP treatment are more advanced than HFNC type masks, the medical world and patients prefer HFNC type masks.

These studies have revealed the need for a new type of mask between the CPAP type mask and the HFNC type open mask. In particular, the insufficiency of two types of masks in providing oxygen to COVID-19 patients has shown the need in this regard.

SUMMARY

Oxygen therapy is critical in infectious diseases such as the disease caused by the COVID-19 virus. In such patients, 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. However, as with COVID-19 patients, adhering to intubation for days and weeks due to ventilation alone creates many problems in terms of both patients, healthcare professionals and drugs to be used. As stated by the experts of the subject, the need for intubation arises due to the inadequate oxygenation with the current HFNC and CPAP type mask methods.

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. For this purpose, 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.

According to researches, 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.

Ozkul, M. H. "A study towards fuzzy logic -based assessment of nasal harmony of rhinoplasty patients" Journal of the Franklin Institute, Vol. 343, Issues 4-5, July 2006, pp 329-339)

(https://www.zwivel.com/blog/sniffmg-nose-shapes-12-commo n-nose-types/)

Naturally, there are differences in the size of the nose, differences in rotation and projections of the nose tip, the nasal valve area competence of the nose, all of which plays a role in respiratory physiology. An important feature of the invention is that it can be adjusted to adapt to different types of nose. In this way, this new nasal cannula / mask can be adapted to all kinds of noses, and the patient can change these adjustment parameters to find the most suitable and comfortable format for him/her.

BRIEF DESCRIPTION OF DRAWINGS

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. DESCRIPTION

The details of the working principle of the present invention will now be described with the aid of the figures. 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. In order to understand the working principle, 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. There is only the skin at the base of the nostril. 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. There are at least one, preferably more than one connection point (50) on the lower mask body (5). 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). 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). In this way, 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). By using 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).

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.

Due to the adjustable height and rotatable nature of the upper swingarm (15) and rotatable nose cones (30), 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.

Since the surfaces in contact with the patient's skin must be silicone for medical reasons, the silicone cone sleeve (92) placed on the nose cone (30) and the silicone tubing (93) placed on the upper swingarm alar adipose tissue pressure end (40), all surfaces in contact with the patient's skin are covered with silicone material. This is shown in Fig.7

The use of the invention can be described as follows. Before usage, 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). However, the nostril (3) will take a circular shape at this stage and the opening area will increase. After this procedure, 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. After this process, 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.