Tracheal catheter device

Abstract

The utility model discloses a tracheal catheter device which comprises a tubular body provided with a near end and a far end opposite to the near end, and the far end is provided with an opening used for ventilation and a far-end tip; the cuff is arranged around the tubular body and is configured to seal the tracheal wall of the patient after being inflated, and the cuff is in a truncated cone shape and is provided with a conical near end and a far end opposite to the near end; marks disposed on the outer surface of the tubular body are configured to allow placement of the tracheal catheter device in the trachea with the cuff below the tracheal annulus cartilage outlet, preventing the opportunity of pressure damage to the airway when the cuff is located in the tracheal annulus cartilage region. According to the mark, the tracheal catheter device can be placed in the trachea of a patient so that the cuff can be located at the ideal position of the trachea of the patient, and due to the fact that the cuff is in a truncated cone shape, the chance that the airway is damaged by pressure when the cuff is located in the annular cartilage of the patient can be effectively prevented.

Description

Technical Field

[0001] The utility model relates to the technical field of tracheal tubes, in particular to a tracheal tube device. Background Art

[0002] An endotracheal tube (ETT) is a flexible plastic tube that is inserted into the trachea of ​​a patient for mechanical ventilation during intubation. For pediatric intubation, current endotracheal tubes typically consist of a long hollow tube (usually made of polyvinyl chloride) with a balloon (i.e., cuff or distal cuff) and a tip at the distal end. Due to multiple advantages, pediatric intubation has shifted from uncuffed endotracheal tubes to cuffed endotracheal tubes, where the distal cuff is used to prevent tube migration, seal the airway to prevent fluid secretions from sloshing in the upper airway, and prevent gas leaks. However, the cuff has been associated with pressure-related injury to the airway in children, particularly when it is placed in a less than ideal position. It is well known that the ideal position of a cuffed endotracheal tube in a pediatric patient is to ensure a subglottic airway in order to prevent cuff-related pressure effects, and the cricoid position is advocated as the ideal position. To ensure that the cuff is placed below the cricoid cartilage in real time, ultrasound has been used in real time and has become an effective tool to determine cuff placement.

[0003] Current endotracheal tubes for pediatric use have different cuff shapes and different cuff positions on the endotracheal tube shaft. The distal cuff is ideally located in the cricoid region within the trachea, while the endotracheal tube tip is ideally located in the

[0004] Located proximal to the carina in the trachea. However, a common problem after intubation is improper placement of the cuff in the trachea, often above the cricoid cartilage, resulting in airway injury. Since the cricoid cartilage is the only fixed dimension in the pediatric airway, the presence of an inflated cuff in this location can result in pressure injury to surrounding tissue. In addition, the cuff in current endotracheal tubes is positioned too close to the vocal cords, resulting in a significant risk of the inflated cuff being located within the cricoid cartilage even if the tip of the endotracheal tube is ideally positioned in the trachea.

[0005] The industry has focused on placing markers on the tracheal tube axis. Current markers on tracheal tubes guide the depth of intubation, ensuring that the tip of the tracheal tube is placed above the carina rather than

[0006] Consider cuff placement. However, these markings play no role in the correct positioning of the endotracheal tube cuff. In addition, the location and number of markings on current endotracheal tubes vary and lack clarity or purpose.

[0007] Therefore, there is a need for an endotracheal tube device that can easily place the cuff in the cricoid area and prevent the chance of pressure injury to the airway when the cuff is in the cricoid area. Utility Model Content

[0008] The utility model aims to provide a tracheal tube device, which can conveniently place a cuff at the position of the cricoid cartilage of a human body and prevent the chance of pressure injury when the cuff is located at the position of the cricoid cartilage.

[0009] A tracheal tube device, comprising:

[0010] a tubular body having a proximal end and a distal end opposite the proximal end, the distal end having an opening for ventilation and a distal tip;

[0011] a cuff disposed around the tubular body and configured to seal against the patient's tracheal wall after being inflated, the cuff being in a frustoconical shape and having a cuff distal end and a tapered cuff proximal end opposite to the cuff distal end;

[0012] Markings, disposed on an outer surface of the tubular body, are configured to allow the endotracheal tube device to be placed in the trachea of ​​a patient so that the cuff is located below the cricoid outlet of the patient's trachea.

[0013] The inner diameter of the tubular body is 2.5 mm to 6.0 mm.

[0014] Wherein, the outer diameter of the tubular body is 3.2 mm to 9.2 mm.

[0015] Wherein the markings are vocal cord markings based on customized anatomical measurements of the airway of a pediatric patient.

[0016] Wherein, the marking is further used to position the distal tip over the carina of the patient.

[0017] Wherein, the mark has a width of 10.0 mm-15.0 mm.

[0018] Wherein, the distance between the mark and the distal tip ranges from 28.0 mm to 66.0 mm.

[0019] Wherein, the proximal end of the cuff is further configured to prevent the cuff from causing pressure damage to the trachea when the cuff is inside the cricoid cartilage of the patient's trachea.

[0020] The length of the cuff is 8.0 mm to 18.0 mm, and the distance between the distal end and the distal tip of the cuff is 8.0 mm to 20.0 mm.

[0021] The distance between the mark and the proximal end of the cuff is 12.0 mm to 28.0 mm, and the distance between the mark and the distal end of the cuff is 20.0 mm to 46.0 mm.

[0022] The utility model can place the tracheal tube device in the trachea of ​​the patient by arranging the mark on the outer surface of the tubular body so that the cuff is located at an ideal position in the trachea of ​​the patient. At the same time, since the cuff is in a truncated cone shape, after the cuff is placed in the airway, the chance of pressure damage to the airway when the cuff is located in the cricoid cartilage area of ​​the patient is effectively prevented, which is of particular significance for child patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 is a schematic diagram of the distal end portion of an endotracheal tube device according to an embodiment of the utility model;

[0024] Figure 2 is a schematic diagram of an endotracheal tube device according to an embodiment of the utility model;

[0025] Figure 3 yes Figure 2 A side view of a distal portion of an endotracheal tube device is shown;

[0026] Figure 4 yes Figure 2 A schematic diagram of the endotracheal tube device being inserted into the trachea is shown;

[0027] Figure 5 is based on Figure 1-Figure 4 Distribution of patients in the study by endotracheal tube device size is shown. DETAILED DESCRIPTION

[0028] In order to make the purpose, technical solutions and advantages of the embodiments of the utility model clearer, the technical solutions in the embodiments of the utility model will be clearly and completely described below in combination with the embodiments of the utility model. Obviously, the described embodiments are part of the embodiments of the utility model, not all of the embodiments.

[0029] See also Figures 1 to 4 As shown, the tracheal tube device 100 provided by the embodiment of the utility model has a tubular body 104 and a cuff 108 coupled to the tubular body 104. The tracheal tube device 100 is a sterile disposable device configured to be inserted into the patient's trachea for ventilation. The tracheal tube device 100 can easily position the cuff 108 at the position of the patient's cricoid cartilage, and prevent the chance of pressure damage to the patient's airway when the cuff 108 is positioned in the area where the cricoid cartilage is located. The patient is an infant, and can also be an adult or an elderly patient. In one embodiment, the tracheal tube device 100 may further include an inflation tube 110, an indicator balloon connected to the proximal end of the inflation tube 110, and a one-way valve or other one-way inflation device connected to the proximal end of the indicator balloon.

[0030] The tubular body 104 includes a proximal end 112 and a distal end 116 opposite the proximal end 112. The tubular body 104 is hollow to allow air to be ventilated through the tubular body. The tubular body 104 includes a length L, which varies between 14.0 cm and 30.0 cm. The tubular body 104 also includes an inner diameter ID and an outer diameter OD, and the inner diameter ID is configured to vary according to the size of the trachea, with an inner diameter size ranging from about 2.5 mm to about 6.0 mm, and an outer diameter size ranging from about 3.2 mm to about 9.2 mm.

[0031] The tubular body 104 is flexible and has a shape having a standard arc curve of 140 degrees. In the illustrated embodiment, the tubular body 104 is made of polyvinyl chloride (PVC) resin. In alternative embodiments, the tubular body 104 is made of various materials including rubber and polyurethane.

[0032] The proximal end 112 is configured to connect to a connector 118. The connector 118 is configured to connect to a Y-shaped component of a breathing circuit, a ventilation bag, such as an Ambu bag, or a ventilator tube. The size and shape of the connector 118 can provide various connections between a breathing circuit, a ventilation bag, or a ventilation tube. In the illustrated embodiment, the connector 118 has a standard diameter of 15.0 millimeters. In other embodiments, the size of the connector diameter can vary.

[0033] The distal end 116 is configured to be inserted into the trachea of ​​the patient. The distal end 116 includes an opening 120 for ventilation and a blunt distal tip 122 spaced apart from the opening 120. The opening 120 is configured to provide a backup ventilator port when the insertion of the distal tip 122 into the trachea is blocked. In the illustrated embodiment, the distal tip 122 is tapered. In an alternative embodiment, the distal tip 122 has a straight or enlarged shape.

[0034] In the illustrated embodiment, the tubular body 104 includes a marker 124 disposed on the outer surface of the tubular body 104 to guide the depth of insertion of the tubular body 104 into the patient. Currently available endotracheal tubes include a vocal cord marker that is located at the vocal cords when the endotracheal tube is placed in the patient. The markers currently designed are intended to ensure that the endotracheal tube stays above the carina, i.e., the branching point of the patient's main airway, to ensure bilateral lung ventilation. However, current markers are not intended to ensure the ideal position of the cuff in the trachea.

[0035] In the illustrated embodiment, the marker 124 is configured to ensure that the cuff 108 stays below the patient's cricoid outlet (lower edge of the cricoid cartilage) and the distal tip 122 stays above the patient's carina. The marker 124 is further configured to allow the cuff 108 to be positioned and located below the cricoid outlet and allow the distal tip 122 to be positioned above the patient's carina, thereby preventing the cuff 108 from being positioned in the annular region of the cricoid cartilage, which minimizes the chance of the endotracheal tube being misinserted into the bronchus. The marker 124 is a vocal cord marker based on airway anatomical measurements of pediatric patients, and the marker 124 can be customized to fit a specific endotracheal tube size. The marker 124 can have a width of 10.0-15.0 mm. Depending on the patient's characteristics, the distance from the proximal end of the marker to the distal tip 122 can be 28.0 mm to 66.0 mm. In addition, the tubular body 104 also includes additional markers 125 positioned along the length of the tubular body 104. The additional markers 125 are further configured to identify the exact or precise location of the tubular body 104 at the patient's mouth, lips, or teeth. In one embodiment, the tubular body 104 further includes radiopaque along the entire length of the tubular body 104 .

[0036] The cuff 108 is disposed around the tubular body 104, and the cuff 108 is configured to seal against the patient's tracheal wall after being inflated. Current cuffs are either olive-shaped or cylindrical; however, these current cuff shapes are disadvantageous. The olive-shaped cuff tapers at the top and bottom of the tube, preventing pressure from being evenly distributed across the airway mucosa. In addition, the olive-shaped cuff allows the greatest pressure to occur at the point of greatest diameter, making the contact area more susceptible to injury. The cylindrical cuff allows the cuff to hang above and below the tube, increasing the chance that the cuff will extend into the annulus when inflated.

[0037] In the illustrated embodiment, the cuff 108 is frustoconical in shape and includes a tapered cuff proximal end 132 and a cuff distal end 136 having an outer diameter greater than the cuff proximal end 132. This configuration prevents the chance of pressure trauma to the airway in the rare event of cranial bone because it allows for low volumes and pressures in the tapered portion of the cuff.

[0038] In the illustrated embodiment, the cuff 108 is made of a thin polyurethane. In this configuration, the cuff 108 is thin-walled. In one embodiment, the cuff 108 is 10.0-12.0 microns thick. The thin-walled structure allows the thin polypropylene cuff membrane to be compressed at lower pressures (e.g., 12.0-15.0 cm H). 2 O) to seal the patient’s airway. This thin material allows the High Volume Low Pressure (HVLP) cuff to 2The cuff pressure is reduced to 0. This cuff pressure is lower than the capillary perfusion pressure in the airway mucosal lining, minimizing the risk of perfusion damage to the tracheal mucosal wall. In addition, in the rare event that the cuff 108 is too high in the airway, the tapered portion of the cuff 108 is configured to be located in the cricoid area, further minimizing the risk of pressure damage to surrounding tissue when the cuff is expanded away from the cricoid area.

[0039] The length of the cuff 108 may be from 8.0 mm to 18.0 mm. The distance between the marker 124 and the tapered cuff proximal end 132 may be from 12.0 mm to 28.0 mm. The distance between the marker 124 and the cuff distal end 136 may range from 20.0 mm to 46.0 mm. The distance between the cuff distal end 136 and the distal tip 122 may be about 8.0 mm to about 20.0 mm.

[0040] Proper vocal cord marking on the endotracheal tube, with standardized airway age measurements, can ensure that the endotracheal tube cuff is placed below the cricoid outlet, making intubation safer and better tolerated. Therefore, the shape and size of the pediatric airway have been studied to develop measurements for marking 124.

[0041] Using data from previous studies as a guide, the applicants calculated the ideal position of the vocal cord landmark on the endotracheal tube. Various measurements were used, including the size of the vocal cords to the cricoid outlet, the distance of the vocal cords to the carina, and the size of the cricoid and trachea to obtain the ideal distance (length) from the proximal end of the vocal cord to the cuff. Focusing on cuff placement below the cricoid cartilage and the effectiveness of the vocal cord landmark, the study examined the effectiveness of the vocal cord landmark (ensuring that the proximal end of the cuff remains below the cricoid outlet) and achieved good results in 96% of patients with an endotracheal tube cuff below the cricoid outlet.

[0042] To confirm the accuracy of the marker 124 in measuring at different ages, the applicant conducted a study to check the position of the cuff 108 of a patient using an endotracheal tube device 100 with a marker 124. The study included 50 pediatric patients between the ages of 1 day and 10 years old. Each patient was intubated with an endotracheal tube device 100. The marker 124 was placed at the vocal cord position of each patient, and the cuff 108 placement was then verified by real-time ultrasound. Figure 5 The percentage distribution of patients with different inner diameter sizes of ETT devices is depicted. The correlation between the position of the cuff 108 of the endotracheal tube device 100 with different inner diameter sizes and the cricoid cartilage and tracheal rings is shown in the following table.

[0043]

[0044] In the table: ETT Size means the specification of the endotracheal tube device, which refers to the inner diameter; Cricoid means cricoid cartilage, racheal ring means tracheal ring, Cuff position (Ultrasound based) means the cuff position measured by ultrasound, Association of ETT size with USG Position in study patients means the relationship between ETT size and USG (sonogram diagnosis) position in study patients.

[0045] The analysis results showed that when the endotracheal tube device 100 was used for intubation, the cuff 108 of all 50 patients was located below the cricoid cartilage (i.e., the cuff was located below the cricoid outlet), in two patients, the cuff 108 was located deeper than expected, and the endotracheal tube device 100 had to be repositioned, and even after the endotracheal tube device 100 was repositioned to the distal tip 122 close to the patient's carina, the cuff 108 remained below the cricoid outlet in the two patients. The results further showed that in most patients, when the marker 124 of the endotracheal tube device 100 was used during intubation, the cuff proximal end 132 of the cuff 108 was located between the first tracheal ring and the second tracheal ring, and the distal tip 122 was in the trachea without being mistakenly inserted into the left or right bronchus.

[0046] The above is only a preferred embodiment of the present invention. It should be pointed out that, for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be regarded as the protection scope of the present invention.

Claims

1. A tracheal tube device, characterized in that: include: a tubular body having a proximal end and a distal end opposite the proximal end, the distal end having an opening for ventilation and a distal tip; a cuff disposed around the tubular body and configured to seal against the patient's tracheal wall after being inflated, the cuff being in a frustoconical shape and having a cuff distal end and a tapered cuff proximal end opposite to the cuff distal end; Markings, disposed on an outer surface of the tubular body, are configured to allow the endotracheal tube device to be placed in a patient's trachea so that the cuff is located below the cricoid cartilage of the patient's trachea.

2. The endotracheal tube device according to claim 1, characterized in that: The inner diameter of the tubular body is 2.5 mm to 6.0 mm.

3. The endotracheal tube device according to claim 1, characterized in that: The outer diameter of the tubular body is 3.2 mm to 9.2 mm.

4. The endotracheal tube device according to claim 1, characterized in that: The landmarks are vocal cord landmarks based on customized anatomical measurements of the pediatric patient's airway.

5. The endotracheal tube device according to claim 1, characterized in that: The markings are further used to position the distal tip over the patient's carina.

6. The endotracheal tube device according to claim 1, characterized in that: The mark has a width of 10.0 mm - 15.0 mm.

7. The endotracheal tube device according to claim 1, characterized in that: The distance between the marker and the distal tip ranges from 28.0 mm to 66.0 mm.

8. The endotracheal tube device according to claim 1, characterized in that: The proximal end of the cuff is further configured to prevent pressure damage to the trachea when the cuff is within the cricoid cartilage of the trachea of ​​the patient.

9. The endotracheal tube device according to claim 1, characterized in that: The length of the cuff is 8.0 mm to 18.0 mm, and the distance between the distal end of the cuff and the distal tip is 8.0 mm to 20.0 mm.

10. The endotracheal tube device according to claim 1, characterized in that: The distance between the mark and the proximal end of the cuff is 12.0 mm to 28.0 mm, and the distance between the mark and the distal end of the cuff is 20.0 mm to 46.0 mm.

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