Endotracheal catheter assembly
By using a banana-shaped suction channel and an upper glottic barrier in the endotracheal catheter assembly, the problems of vocal cords and swallowing damage during suction of secretions in the prior art are solved, and a more efficient and safe secretion suction effect is achieved.
Patent Information
- Application Number
- CN202280100936.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2022-10-18
- Publication Date
- 2025-06-10
AI Technical Summary
The prior art methods of aspirating secretions at the end of anesthesia are insufficient, and the risks of bronchial aspiration, laryngeal spasm and pneumonia cannot be effectively avoided. At the same time, the vocal cords and swallowing damage are easily caused during the aspiration.
An endotracheal catheter assembly is adopted, including an adjacent suction channel, a banana-shaped suction channel, a low-hard endotracheal catheter and a suction barrier, which is located above the vocal cords, larynx and epiglottic to ensure that the secretions are pumped before reaching the breathing tree.
It effectively reduces the risks of spasms, painful swallowing, oropharyngeal injury and cough after anesthesia recovery, reduces the damage to the vocalization and swallowing nerves by aspiration, and improves the aspiration ability and efficiency.
Smart Images
Figure CN120129552A_ABST
Abstract
Description
Technical Field
[0001] The present invention may be included within the field of instruments and devices for mechanical ventilation of patients. Specifically, the object of the present invention relates to an endotracheal tube assembly. Background Art
[0002] Currently, at the end of anesthesia, those secretions from the oral or pharyngeal cavity are aspirated before extubating the patient to avoid bronchial aspiration, laryngospasm, and bronchospasm. In patients with a long intubation time, these secretions should normally be aspirated continuously or intermittently within 24 hours in an amount of 500 ml to 1500 ml (in pathological situations such as intestinal obstruction, the amount can even be greater). Another source of secretions is the fluid from gastric or esophageal reflux.
[0003] The purpose of the mentioned aspiration is to avoid bronchial aspiration, that is, to prevent any type of secretions from entering the airway (which will cause bronchospasm, laryngospasm, coughing or, in more complex situations, pneumonia within a few days after a surgical operation requiring anesthesia).
[0004] Currently, the following two methods are used to remove secretions during anesthesia.
[0005] According to the first method, aspiration is performed blindly, that is, a probe is inserted and aspiration is carried out until no more secretions are obtained. This method cannot guarantee that all the contents are aspirated, and thus when residues remain, once the anesthesia is reversed and the patient regains all reflexes, laryngospasm, bronchial aspiration, bronchospasm, and coughing occasionally occur. Another negative effect of current blind aspiration is the formation of small tears on the mucosal wall due to the adhesion of the probe, which is called the wall effect, causing damage to the structure where the probe adheres, resulting in painful swallowing, and additionally reducing the aspiration efficiency. Currently, in anesthesia, most of these procedures are blind.
[0006] According to the second method, aspiration-assisted laryngoscopy is performed under direct vision. Since aspiration-assisted laryngoscopy is one of the means that trigger the most known sympathetic nerve activations, a high level of anesthesia is required. From the perspective of anesthesia, since the patient has to be in the lightest state at the end of anesthesia due to the need to "wake up" the patient. By deepening the anesthesia for this means, the time the patient is under the effect of anesthesia will be prolonged.
[0007] In some cases, reflux and vomiting occur during anesthesia, and aspiration must be carried out immediately in the appropriate position. If the flow rate is very low, bronchial aspiration will be inadvertently caused, and if the flow rate is too high, the aspiration is insufficient.
[0008] In patients in whom the intubation time exceeds the duration of anesthesia (e.g., in intensive care patients), an endotracheal tube having a suction channel below the vocal cords is used to reduce the passage of the above-mentioned secretions, and thus significantly reduce the incidence of ventilator-associated pneumonia (but does not eliminate the possibility of ventilator-associated pneumonia). Such a channel is present in the thickness of the endotracheal tube, thus greatly reducing the capacity of the channel and restricting the channel to non-reinforced tubes only.
[0009] The suction channel is a great advance. Current devices have a suction point in the subglottic space, which is a reasonable location, below the vocal cords and within the so-called conus elasticus, and just above the balloon placed in the trachea, which is a common point through which any secretions must pass to enter the respiratory tree. This significantly promotes any suction at this location. Another site implies that some secretions will be allowed to pass through.
[0010] However, the area where secretions accumulate the most is the oropharynx, rather than the area described above (below the level of the conus elasticus), because the area described above is a small space that is sometimes no more than 1.5 cm. It is at this point that all the nerves that govern the complex vocal organs, especially eleven of the twelve muscles involved in vocalization, swallowing, and defense against bronchial aspiration, enter. Negative pressure on these nerves (even slight) can cause permanent or temporary damage.
[0011] For this reason, the applicant points out that in the current technology, from an anatomical and physiological perspective, secretions are aspirated at the worst possible site, even though the site is obvious, at a high cost of damage to the vocal cords and swallowing. Aspiration usually requires very high negative pressures (in the range of 40 to 100 millimeters of mercury), and thus an increase in vocal cord damage has been observed. Although it can effectively reduce the incidence of ventilator-associated hospital-acquired pneumonia, it cannot completely eliminate the incidence. To date, the device has led to such a frequent mechanism of damage, especially in recent years (during the recent coronavirus pneumonia pandemic, its incidence has increased significantly). Additionally, it is in this area that the main arteries, veins, and lymphatics enter and leave, supplying blood to and draining the larynx. Therefore, a completely different and novel approach is needed to avoid such damage and ensure that aspiration is always performed in the best possible area and with much greater absorption capacity.
[0012] According to the current solution described above, although this is the most obvious area for aspiration, in the current technology, a high price is still paid in terms of voice and swallowing damage.
[0013] In the prior art, a suction channel having a circular cross-section is accommodated inside the wall of the same endotracheal tube (intrawall suction channel), which limits its suction capacity due to the small diameter of the suction channel (the suction channel is more prone to blockage), and at the same time weakens the strength of the same tube due to the partially hollow wall. This forces the current endotracheal tube to have a greater hardness, which increases the damage to the body structures adjacent to the tube during use. Additionally, since excessive thickness is not allowed in non-reinforced tubes, the suction channel is restricted to non-reinforced tubes only.
[0014] Figure 1 shows the anatomical position of the current location where suction is performed in a patient (1) through an intrawall suction channel (2), and the suction channel (2) is disadvantageously very close to the vocal cords (3), larynx (4), and epiglottis (5).
[0015] As part of it, Figure 3A also shows a cross-section of an endotracheal tube assembly with an intrawall channel (2) in the prior art with reference to the prior art. Summary of the Invention
[0016] The present invention solves the above problems through an endotracheal tube assembly that combines five novel aspects: 1) adjacent suction channels; 2) the novel banana shape of the suction channels according to the independent claims, which ensures suction capacity in any situation that may occur in these patients; 3) a hardness lower than that of the endotracheal tube; 4) the correct position for aspirating secretions, which is firmly in the supraglottic region due to the supraglottic region being fixed. Different from the current channels located below the vocal cords and thus below the glottis, the suction channels are located above the vocal cords, larynx, and epiglottis, because this is the convergence point where all secretions reach before reaching the respiratory tree. 5) Using the suction channels in combination with a supraglottic barrier (described in WO 2021 / 234183 (BRAVO)) prevents the risk of wall effects during suction and allows aspiration of secretions in a higher area; this isolates the epiglottic space, thereby protecting the vocal cords.
[0017] The present invention particularly limits the above risks and incidence of laryngospasm (laryngeal spasm, bronchospasm), painful swallowing, oropharyngeal injury, and coughing after anesthesia recovery caused by residual secretions that are not aspirated.
[0018] The present invention also limits the tearing caused by the above-mentioned wall effects.
[0019] In addition, the present invention also limits the damage to the nerves involved in phonation and swallowing caused by suction.
[0020] So far, experts have never recommended suction above the epiglottis because it cannot be guaranteed that secretions will continue to enter the respiratory tree or respiratory tract according to this concept; additionally, the aforementioned wall effects will occur. Completely changing the position will go against the prior art.
[0021] In the present invention, the suction channel is adjacent to and independent of the endotracheal tube, rather than passing through the interior of the wall of the endotracheal tube. Thus, the suction channel can have a larger diameter due to not being restricted by the wall of the endotracheal tube, which allows for suctioning of a larger volume of secretions and higher viscosities.
[0022] Using the endotracheal tube assembly of the present invention in combination with a supraglottic balloon as disclosed, for example, in WO 2021 / 234183 (BRAVO) improves the performance of both, since the supraglottic balloon isolates the subglottic space from the arrival of secretions; further reduces the risk of wall effects; allows for suctioning of secretions in the upper region; and isolates the epiglottic space, thus protecting the vocal cords.
[0023] The solution proposed by the present invention is based on the combination of: a new morphology of the banana-shaped suction channel; located in different positions; fixed; adhered to the endotracheal tube with a lower hardness and associated with WO 2021 / 234183 (BRAVO), which was not achievable before. BRIEF DESCRIPTION OF THE DRAWINGS
[0024] As a complement to the description and to help make the features of the present invention more understandable, according to a preferred practical exemplary embodiment of the present invention, the description is accompanied by assembly schematics that form an integral part thereof, which schematics represent, by way of illustration and not limitation, as follows:
[0025] Figure 1 shows an image of a patient being intubated with an endotracheal tube equipped with an intramural suction channel according to the prior art.
[0026] Figure 2 An image of the patient shown in Figure 1 being intubated with the endotracheal tube assembly according to the present invention is shown.
[0027] Figure 3A and Figure 3B respectively show cross-sections of an endotracheal tube assembly of the prior art (Figure 3A) and of the present invention ( Figure 3B ).
[0028] Figure 4 A detailed view showing the distal end of the suction channel and its relationship with the supraglottic barrier is shown.
[0029] Figure 5 A detailed view of the proximal end is shown, where the distal connector has a 45° suction window and a universal connection to any suction source. DETAILED DESCRIPTION
[0030] With the aid of the above-mentioned Figures 1 to Figure 5 , a detailed description of a preferred embodiment of the endotracheal tube assembly according to the present invention is provided below.
[0031] According to Figure 2 what is shown in Figure 2 , the assembly of the present invention includes an endotracheal tube (10), which is known in the prior art and includes an outer wall (11). The assembly further includes a suction channel (12), the suction channel (12) having a first part (13) (more distal) linked to the endotracheal tube (10), wherein the first part (13) includes a more distal suction end (14) through which secretions enter the suction channel (12). Advantageously, the most distal first part (13) of the suction channel (12) is fixed (e.g., adhered) externally along the outer wall (11) of the endotracheal tube (10). The suction channel (12) is preferably positioned such that the suction channel (12) occupies an upper position along the cephalocaudal axis within the patient (1) during use.
[0032] In addition, the first part (13) of the suction channel (12) is arranged such that the suction end (14) is preferably arranged in a position of the endotracheal tube (10) which, during use, corresponds to the supraglottic region within the patient (1), i.e., above the vocal cords (3), larynx (4) and epiglottis (5), which region has a large space. Figure 1 is contrasted with the part of the prior art (2) that caused the injury, as this part is the anatomical region where the nerves and main blood vessels of the larynx (4) enter, and is also the location where the main veins and lymphatics of the larynx (4) originate, which is a region with very little space. Additionally, since the suction channel is within the wall, it is a channel with low capacitance and is prone to blockage.
[0033] Figure 3B Preferably, the suction channel (12) is shown to have a so-called "banana" - shaped cross - section, which is formed by two opposing curved segments (15, 16) with different curvatures: an inner segment (15) having a circular curvature equivalent to that of the endotracheal tube (10); and an outer segment (16) having a curvature less than that of the inner segment (15) and preferably (but not necessarily) also circular. The inner segment (15) and the outer segment (16) converge at the end of the inner segment (15). Thus, by having the banana shape, compared with the inner - wall suction channel (2) of the prior art shown in Figure 3A, the suction channel (12) has a greatly improved suction capacity and prevents more viscous secretions from blocking the cross - section of the suction channel (12).
[0034] The endotracheal tube (10) may optionally be provided with a supraglottic balloon (17) (see Figure 2 and Figure 4) associated, the supraglottic balloon (17) preferably corresponds to the supraglottic barrier described in WO 2021 / 234183 A1 (BRAVO), in which case it is ensured that aspiration carried out at any time in a patient (1) who must be intubated for a long time during anesthesia or in the intensive care unit is carried out at an appropriate site, thus having sufficient aspiration capacity and preventing damage to the mucosa and structures of the patient (1). In contrast to Figure 1, Figure 2 Shows the arrangement of the assembly of the present invention in a intubated patient (1).
[0035] At the proximal end of the aspiration channel (12) opposite the aspiration end (14), the aspiration channel (12) is fixed to a connector (18) (see Figure 5 ), said connector (18) can be a universal connector (18) for connecting to any aspiration connection (see Figure 2 and Figure 5 ), which on the one hand allows the aspiration channel (12) to be connected to an aspiration source (not shown), and on the other hand allows the start or stop of aspiration to be adjusted by finger as required, where in this case, the angle at which the finger is placed is 45°, thus reducing the possibility of user contamination when using the aspiration channel (12). The connector (18), specifically the universal connector (18), is generally configured to be connected to any operating room or intensive care unit system, for which the connector (18) preferably has a conical shape, said conical shape having an outer grading (19), and having a minimum inner diameter of 4 mm and at least 7 mm at the point of the minimum outer diameter, and thus gradually advancing from this point until an outer diameter of 9.5 mm or 10 mm is reached. Such a connection and specifically the cited dimensions can be independent of the type of endotracheal tube (10) used. Such a connection allows aspiration to be carried out continuously and intermittently.
[0036] The length of the aspiration channel (12) then depends on the size of the endotracheal tube (10). For example, for an endotracheal tube (10) with an inner diameter of 7 mm, the aspiration channel (12) can have a total length of approximately 38 cm to 40 cm starting from the aspiration end (14) located at a more distal position. Approximately the first third (about the first 12 cm to 13 cm) from the aspiration end (14) extends to be fixed (such as adhered, welded, etc.) to the endotracheal tube (10), and in the case where the epiglottic (upper) balloon (17) is arranged, the position is approximately 1 cm to 3 cm, such as 1.5 cm, from the nearest part of the supraglottic balloon (17).
[0037] See Figure 2, the aspiration channel (12) includes a more proximal second part (20), the second part (20) being located after the first part (13) and separated from the outer wall (11) of the endotracheal tube (10). As a guide, for an endotracheal tube (10) with an inner diameter of 7 mm, the first part (13) is approximately 25 cm long. The first part (13) terminates at an attachment point for attachment (such as welding, adhesion, etc.) to the endotracheal tube (10), allowing the second part (20) to start at an angle of no more than 25° relative to the first part (13), so as to avoid tearing of the first part (13) during fixation (whether by adhesive or welding, etc.) on the one hand, and to prevent kinking of the aspiration channel (12) during the operation of the assembly of the present invention on the other hand.
[0038] The dimensions of the cross-section of the aspiration channel (12) then depend on the cross-section of the endotracheal tube (10). For the case where both the inner section (15) and the outer section (16) are circular and the inner diameter of the endotracheal tube (10) is 7 mm, it is recommended that the inner diameter of the inner section (15) be approximately 1 mm or 2 mm, and the inner diameter of the outer section (16) be 4 mm.
[0039] Similarly, as an example, for a 7 mm diameter catheter, the inner dimensions of the aspiration channel (12) are 6 mm long and 4 mm wide, in the shape of a banana. The absolute dimensions vary according to the size of the endotracheal tube (10) (including the sizes of adult and pediatric endotracheal tubes). These dimensions of the aspiration channel (12) are in its first part (13), which is adhered to the endotracheal tube (10).
[0040] According to Figure 4 , near the aspiration end (14) (for example, about 10 mm), the aspiration channel (12) has at least one orifice (21), preferably two lateral orifices (21) opposite each other, the size of the lateral orifices depending on the diameter of the endotracheal tube (10). The orifices (21) are countersunk and spaced apart by a distance of 3 mm to 10 mm (for example, 5 mm) between their closest points. The presence of the orifice (21) or orifices (21) increases the aspiration capacity on the one hand due to Poiseuille's law, and also avoids loss of function in the case of blockage of the aspiration end (14).
[0041] At the aspiration end (14), the aspiration channel (12) terminates in a bevel (22) of, for example, 60° to prevent collapse. Similarly, Figure 4 shows the relationship with the supraglottic barrier (17) described in WO 2021 / 234183 (BRAVO). In this sense, FIGS. 3A and Figure 3BShows a corresponding vacuum channel (24), which is preferably in the wall, for generating and releasing pressure according to the operation of the supraglottic barrier (17).
[0042] The banana-shaped cross-section of the orifice (21) and the suction channel (12), as well as the inclined plane (22), improve the ability to suck liquid according to the liquid viscosity. In the case of saline, water, saliva or gastric secretion reflux, more than 1 liter can be absorbed in only 15 seconds in an endotracheal tube (10) with an inner diameter of 7 mm to 8 mm, which is impossible in the prior art.
[0043] Due to its supraglottic (or supra-epiglottic) arrangement, although the suction channel (12) is arranged outside the endotracheal tube (10), its size still allows the assembly not to interfere with the narrowest area, i.e., the vocal cords (3), through which the endotracheal tube (10) will pass. In addition to greatly simplifying the manufacture of the suction channel (12), the suction channel (12) also has better characteristics by increasing the size of the cross-section as needed. Compared with the currently used catheters or channels, this increases the absorption capacity by more than 70%. Compared with the prior art, due to the "banana" shape of the cross-section of the suction channel (12), the suction resistance is also surprisingly reduced by up to 90%.
[0044] The described "banana" shape is used to reduce the "decubitus" effect (damage to the structure caused by continuous support); in addition, due to its much lower hardness than the endotracheal tube (10), it is also used to minimize the mentioned decubitus effect. Contrary to the circular cross-section used in current suction catheters, the banana shape allows for a more efficient distribution of the support pressure. The shape allows the suction channel to adhere to the endotracheal tube (10), rather than being a part of the endotracheal tube (10). The suction channel requires this shape in order to be able to suck the required amount with a much higher suction capacity than the existing channels inside the endotracheal tube (10). Once the endotracheal tube (10) is inserted, this shape also allows for better tolerance in the pharynx of the patient (1), due to the much lower tangential pressure on the pharyngeal wall. Since the suction channel is fixed, there is no frictional force or shear force. The shape requirement is also due to the fact that the present invention can be used with any type of endotracheal tube (10) (whether circular; reinforced or unreinforced). Figure 3B Shows a joint for use with an endotracheal tube (10) having a reinforcing ring (23).
[0045] Figure 3BA cross-section is shown that illustrates the relationship of the aspiration channel (12) to the morphology of the endotracheal tube (10). This arrangement allows the aspiration channel (12) to be attached to any type of endotracheal tube (10) having one lumen or having different lumens, whether reinforced or non-reinforced. Referring to Figure 3A, the prior art uses the aforementioned in-wall aspiration channel (2), which greatly reduces the aspiration capacity and weakens the catheter wall. In the opposite direction, the aspiration channel (12) of the present invention is attached to the endotracheal tube (10) with a larger cross-section and thus has a higher aspiration capacity.
[0046] Since the endotracheal tube (10) according to the present invention can be inserted into the reference position of the vocal cords (3), it is ensured that the aspiration channel (12) is at an appropriate distance, which is a function of the patient's age. For example, for an endotracheal tube (10) with an inner diameter of 7 mm, the aspiration channel (12) is advantageously located at a non-hazardous distance from the vocal cords (about 7 cm) on the one hand and at the site where the most secretions accumulate on the other hand.
[0047] When the assembly of the present invention is used with the epiglottic (upper) balloon (17), the balloon (17) keeps the aspiration channel (12) isolated from the oropharyngeal wall, thus allowing better aspiration and preventing the aspiration channel (12) from being blocked due to the aforementioned wall effect.
[0048] Similarly, the aspiration channel (12) can also be present in an endotracheal tube (10) without the balloon (17), which at least ensures the optimal position for aspiration, but does not guarantee that the wall effect will not occur, nor that the airway will be completely isolated.
[0049] By solving bronchial aspiration, the present invention greatly reduces ventilator-associated pneumonia, which is much more effective than the prior art of subglottic aspiration channels; and, contrary to the prior art, it is carried out without damaging the nerves or blood vessels that innervate the larynx (4) and supply blood to the larynx (4).
[0050] Compared with the in-wall aspiration channel (2) of the existing device, the assembly of the present invention allows more contents to be aspirated. Considering the savings in terms of ventilator-associated pneumonia and the resulting injuries (which are permanent in many cases), it has a reasonable guarantee of success.
[0051] The present invention can be used industrially, and since the change is made at the end once the endotracheal tube (10) is extruded, this does not pose a problem for its industrial production and does not cause major changes to any production line of the endotracheal tube (10).
[0052] The sizes and arrangements of both the endotracheal tube (10) and the aspiration channel (12) and their components can vary according to the patient's morphology, specifically differentiated for adult patients and pediatric patients with appropriate modifications.
[0053] Symbol Explanation
[0054] 1: Patient
[0055] 2: Intramural aspiration channel
[0056] 3: Vocal cords
[0057] 4: Larynx
[0058] 5: Epiglottis
[0059] 10: Endotracheal tube
[0060] 11: Outer wall
[0061] 12: External aspiration channel
[0062] 13: First part
[0063] 14: Aspiration end
[0064] 15: Inner segment
[0065] 16: Outer segment
[0066] 17: Supraglottic barrier (described in WO 2021 / 234183 (BRAVO))
[0067] 18: Connector
[0068] 19: External grading
[0069] 20: Second part
[0070] 21: Orifice
[0071] 22: Bevel
[0072] 23: Reinforcing ring
[0073] 24: Vacuum channel
Claims
1. An endotracheal tube assembly, comprising: an endotracheal tube (10) having an outer wall (11); and a suction channel (12) having a first, more distal portion (13) and equipped with a suction end (14) for suctioning secretions; characterized in that the first portion (13) of the suction channel (12) is externally attached along the outer wall (11) of the endotracheal tube (10).
2. The endotracheal tube assembly according to claim 1, characterized in that the suction channel (12) is positioned such that in use it occupies an upper position within the patient (1) along the cranio-caudal axis of the patient (1).
3. The endotracheal tube assembly according to any one of claims 1-2, characterized in that the first portion (13) of the suction channel (12) is arranged such that the suction end (14) is located in a position of the endotracheal tube (10) which, in use, corresponds to the supraglottic region within the patient (1), i.e. above the vocal cords (3), larynx (4) and epiglottis (5).
4. The endotracheal tube assembly according to any one of claims 1-3, characterized in that the suction channel (12) has a banana-shaped cross-section formed by two opposing curved segments (15, 16) of different curvatures: an inner segment (15) having a circular curvature equal to that of the endotracheal tube (10); and an outer segment (16) having a curvature less than that of the inner segment (15) and preferably also circular, the inner segment (15) converging with the outer segment (16) at the end of the inner segment (15).
5. The endotracheal tube assembly according to any one of claims 1-4, characterized in that the suction channel (12) includes a second, more distal portion (20) which is located after the first portion (13) and is separated from the outer wall (11) of the endotracheal tube (10).
6. The endotracheal tube assembly according to claim 5, characterized in that the first portion (13) terminates at an attachment point for attachment to the endotracheal tube (10), thereby allowing the second portion (20) to start at an angle of not more than 25° relative to the first portion (13).
7. The endotracheal tube assembly according to any one of claims 1-6, characterized in that the suction channel (12) has at least one orifice (21) near the suction end (14), preferably two opposing lateral orifices (21).
8. The endotracheal tube assembly according to any one of claims 1-7, characterized in that the suction channel (12) terminates at the suction end (14) in an inclined plane (22).
9. The endotracheal tube assembly according to any one of claims 1-8, characterized in that the endotracheal tube assembly further includes a supraglottic barrier (17) received within the endotracheal tube (10).
Citation Information
Patent Citations
Chaises
WO006516
Endotracheal device for mechanical ventilation of a patient
WO2021234183A1