CN117563096A

CN117563096A - Catheter fixing device and system

Info

Publication number: CN117563096A
Application number: CN202410055654.8A
Authority: CN
Inventors: 郭雪莲; 马春梅
Original assignee: Xuanwu Hospital
Current assignee: Xuanwu Hospital
Priority date: 2024-01-15
Filing date: 2024-01-15
Publication date: 2024-02-20
Anticipated expiration: 2044-01-15
Also published as: CN117563096B

Abstract

The invention provides a catheter fixing device, which comprises a first closing piece and a second closing piece which can be detachably connected with each other, wherein a first locking piece and a second locking piece are respectively arranged in the first closing piece and the second closing piece, the two locking pieces can be partially jointed after the first closing piece and the second closing piece are connected, a channel for the catheter to pass through is formed between joint parts, and the catheter is maintained between the fixing devices based on the clamping action of the channel. The invention solves the problems that the disassembly of the traditional catheter fixing device is inconvenient and the nasal feeding tube of a patient is easy to be influenced. The locking pieces which can be quickly detached are arranged on the two sides, so that the disassembly and the assembly are convenient and quick, and the oral cavity condition can be conveniently observed. And because the mode of combining the left half and the right half is used, small parts such as screws, nuts and the like are avoided, and the small parts are prevented from accidentally falling into the mouth of a patient.

Description

Catheter fixing device and system

Technical Field

The invention relates to the field of oral intubation, in particular to a catheter fixing device and system. The invention belongs to IPC classification A61M, and particularly relates to an apparatus for influencing the respiratory system of a patient by a gas treatment method.

Background

The tracheal intubation is a common operation, and is mainly suitable for patients with dyspnea, incapability of establishing spontaneous breathing, excessive respiratory tract secretion and other diseases, and a smooth respiratory passage is established for the patients. The main operation mode of the tracheal cannula is to insert a special catheter into the trachea of a patient through the glottis after entering the oral cavity of the patient. Meanwhile, a dental pad is required to be coated and arranged on the tooth part of the patient, and the middle of the dental pad passes through the catheter to prevent the patient from biting the catheter. The outer side of one end of the catheter, which is placed in the trachea of a patient, is also provided with an air bag in a surrounding mode, and after the catheter is placed in the trachea of the patient, the air bag is inflated by inputting air into the air bag, so that a gap between the catheter and the trachea of the patient is closed.

After the catheter is placed, the catheter may generate certain displacement, and the displacement has two general categories, namely horizontal shaking or deformation, such as horizontal deformation of the catheter caused by the biting of the catheter by a patient or horizontal movement of the catheter caused by the shaking of the head left and right of the patient; the other is a movement in a vertical direction, for example, the catheter is moved up and down along the axis of the trachea, and when moving down, the catheter is deeper into the trachea, which may cause damage to tissues and organs deep in the trachea, and when moving up, the catheter may be detached from the trachea. Since in most cases the patient needs to maintain this state for a long period of time after the catheter is placed, and most patients can move during the procedure, the stability of the catheter after placement is maintained. The prior art has devised some tracheal intubation fixtures.

One type of securement product provided by the prior art, for example, publication CN107847703a, is a catheter securement device currently used in some hospitals by securing a faceplate to the patient's mouth and securing a catheter threaded through the patient's mouth with a screw-nut locking mechanism. However, a problem with this prior art is that it has a well-defined mounting direction. When the device is installed, the side with the notch is required to correspond to the mouth of a patient, so that the device is inconvenient to install, and especially the problem that the device is easy to install in urgent time or delays installation aiming at some operations requiring urgent intubation is solved. In addition, the side of the device adjacent the patient's nose is of a unitary connection, in other words, if the securement device is to be removed, it is to be removed from the patient's mouth. And if the nasal feeding tube is detached from the nose, the nasal space of a patient is easily affected, and particularly if the patient is receiving nasal feeding, the nasal feeding tube can collide with the nasal feeding tube, so that the detachment work is affected. According to the nursing requirement, medical staff needs to observe the tracheal intubation condition of a patient regularly, so that the medical staff needs to detach the fixing device regularly to observe the condition, and the fixing device in the prior art is inconvenient to install and detach quickly. In addition, in the prior art, some tiny parts are used as components, and because a patient can keep a certain opening state after intubation, if the tiny parts fall off, the tiny parts possibly fall into the mouth of the patient, so that the patient can cough and asphyxia.

From the above procedure, it can be seen that the cannula needs to be fixed after the cannula is correctly inserted into the oral cavity, and the fixation is to prevent the cannula from being undesirably displaced, thereby being removed from the trachea, or prevent the trachea of the patient from being damaged due to the displacement of the cannula. While devices for securing endotracheal tubes are commonly referred to as catheter securement devices. The catheter securement devices of the prior art designs are capable of better securing a cannula inserted into a patient's mouth. For example, a tracheal cannula holder provided in the prior art with publication number CN107847703a, which is formed by binding a panel provided on the mouth of a patient, an opening provided on the panel to allow a cannula to pass therethrough, and a screw provided at a position on one side of the panel, constitutes a device capable of holding the cannula, and clamping or unclamping the cannula is achieved by rotating the screw so that the screw approaches or moves away from the surface of the cannula. However, the device still has several undesirable drawbacks, firstly the panel of the device is designed in an asymmetrical shape so that it can only be placed on the patient's face in a unique way. The panel has two edges up and down, in use, one end of the continuous edge must be placed close to the nose and one end with the open edge must be placed close to the mouth so that at least a portion of the patient's mouth can be exposed from the opening, which makes it more cumbersome for the operator to wear the device for the patient. Secondly, because the catheter fixing device is worn at a position close to the mouth of a patient, the design of tiny parts or easily-separated parts needs to be reduced or stopped as far as possible, so that the danger caused by blockage of esophagus or trachea of the patient due to accidental falling of the parts into the oral cavity of the patient is avoided. The design of the prior art screw may lead to screw falling or matched parts such as rubber rings, nuts and the like falling into the mouth of a patient, resulting in personal injury. In addition, this prior art screw handle design overlength, when the fixed intubate of installation, operating personnel need manual rotatory screw make it remove to the intubate, and stroke overlength at every turn leads to the labour great, and can't satisfy the demand of quick fixed trachea cannula and quick evacuation trachea cannula. Even if the prior art is designed with a quick release structure, at least one tightening operation is still required, wasting the effort of operators. Since the patient with the endotracheal tube needs to receive oral care or observation at least twice daily, the operator is required to loosen and tighten the endotracheal tube more frequently, especially for patients with increased airway secretions, the endotracheal tube is more required to be tightened and loosened often in order to perform operations such as secretion suction, and the like, the use of the device of the prior art results in an increased operation time. In addition, the prior art is used for fixing the cannula, the position of the cannula is limited and cannot move, and the prior art has a positive effect on stabilizing the position of the cannula. However, for patients with severe cough, the trachea can be regularly contracted and expanded in the cough process, and if the cannula is still fixed at the moment so that the cannula cannot move at all, the cannula can damage the trachea.

Furthermore, there are differences in one aspect due to understanding to those skilled in the art; on the other hand, since the applicant has studied a lot of documents and patents while making the present invention, the text is not limited to details and contents of all but it is by no means the present invention does not have these prior art features, but the present invention has all the prior art features, and the applicant remains in the background art to which the right of the related prior art is added.

Disclosure of Invention

In order to prevent the endotracheal tube from slipping off the patient's mouth, the prior art often provides for gripping of the endotracheal tube by providing additional tube securing means. For example, patent document with publication number CN217246055U discloses a fixing frame for a prone position tracheal cannula, comprising a supporting frame and a clamping assembly, wherein the supporting frame comprises a first supporting vertical plate and a second supporting vertical plate which are vertically arranged at intervals, the top ends of the first supporting vertical plate and the second supporting vertical plate are connected with a supporting top plate, and one side edge of the supporting top plate is provided with a through avoiding groove; the clamping assembly comprises a first clamping rod, a second clamping rod and a clamping piece, one ends of the first clamping rod and the second clamping rod are respectively fixedly arranged on two opposite side surfaces of a first supporting vertical plate and a second supporting vertical plate, the other end of the first clamping rod is connected to one side of the clamping piece, and the other end of the second clamping rod is connected to the other side of the clamping piece through an adjusting piece. This technical scheme supports patient's head through first supporting roof, makes patient's face down through dodging the groove, and it is fixed to carry out the centre gripping to endotracheal tube through first centre gripping semi-ring and second centre gripping semi-ring, avoids the endotracheal tube to the outer slippage in patient's oral cavity, provides the buffering through the cooperation of centre gripping arc board and spring moreover to the extrusion that endotracheal tube received, prevents to extrude the endotracheal tube deformation. However, this technical scheme can only be adapted to the patient of prone intubate on the one hand, prevents through the clamping force of mount that the trachea intubate from taking place the phenomenon that drops because of the gravity reason under the prone state, because needs to overcome extra gravity effect, the clamping force of prone posture is great relatively this moment, can't provide certain displacement space for the trachea intubate, and then makes the trachea intubate produce certain unexpected displacement and lead to the tissue organ damage of trachea depths because of the unexpected motion such as patient's cough produces in patient's trachea. On the other hand, the fixing frame device of the technical scheme can only be arranged on a sickbed structure of a patient, and cannot be directly connected with an endotracheal tube part of the patient, so that the fixing frame device cannot move along with the patient, the movable space of the patient is further limited, and good comfort cannot be achieved. In view of the shortcomings of the prior art, the present invention provides a catheter securement device comprising a first closure member and a second closure member removably connectable to each other, wherein the first closure member and the second closure member are each provided with a first locking member and a second locking member, respectively, the two locking members being capable of partially engaging after connection of the first closure member and the second closure member and forming a passageway between the engaging portions for passage of a catheter, the catheter being maintained between the catheter securement devices based on a clamping action of the passageway.

To the prior art that mentions in this application background art, it can realize the fixed to the trachea cannula, nevertheless this prior art only has unidirectional mounting means, and its upper and lower structure is asymmetric, and one side that is close to patient's nose is integrated with the connection structure for if upwards remove when the dismouting can influence other articles of patient's nose, for example influence the nasal feeding pipe. According to nursing requirements, the catheter fixing device needs to be frequently dismantled to care or observe the mouth of a patient, so that the structure in the prior art is inconvenient to install and disassemble, and the working efficiency of nursing staff is affected. And this application sets up main structural component into can control concatenation complex closure member to when installation and dismantlement, can follow the left and right sides of patient's oral area and go on, can not influence patient's nasal part or oral area's article, promote the simple operation nature. And the closing piece is spliced in a form-fit mode, so that tiny parts such as screws and nuts are avoided, the risk that the parts accidentally fall into the oral cavity of a patient is avoided, and meanwhile, the assembly and the disassembly are more convenient. Two retaining members form the pipeline passageway that can the centre gripping pipe when the closure member concatenation to avoid using such centre gripping regulation methods of screw nut, such regulation methods are unfavorable for quick installation and dismantlement, even if design quick split structure also need carry out at least once screw up work under the scheme of using the screw, are unfavorable for the demand of quick installation. Further, in contrast to the prior art described above, the two locking members of the present invention are capable of partially engaging after the first and second closure members are connected and allowing the catheter to be maintained between the catheter securement devices by forming a passageway for the passage of the catheter between the engagement sites. Based on the above distinguishing technical features, the problems to be solved by the present invention may include: how to realize the connection of the locking piece and the fixation of the catheter at the same time. Specifically, conventional tracheal catheter fixing devices generally adopt an independently arranged clamping structure, and the specific clamping structure is only in contact with the tracheal catheter, so that the fixation of the catheter can only be realized through the independent contact of the catheter and the tracheal catheter, and the connection of the clamping structure serving as a locking member cannot be realized at the same time, so that the actual connection stability of the device is poor. On the other hand, the two locking elements according to the invention make it possible on the one hand to achieve a fixed connection of the entire device under the connection of the first and second closure elements, thereby increasing the stability of the connection between the device and the patient. On the other hand, the tracheal catheter structure is formed by accommodating the joint part between the first closing part and the second closing part, and the first closing part and the second closing part act as the outer shell of the catheter fixing device at the moment, so that after the outer shell part is installed, the first locking part and the second locking part inside the outer shell part can be mutually clamped to fix the tracheal catheter.

Preferably, the patient monitoring device further comprises a detection module configured to collect data information about whether the patient is in a cough state, and a processor in data communication with the detection module, wherein the processor controls the first locking member and the second locking member to be converted from a state without the ability to move in a direction away from each other to a state with the ability to move in a direction away from each other in a case that the processor determines that the patient is in the cough state based on the data collected by the detection module.

In contrast to the prior art described above, the processor of the present invention is capable of adjusting the locking member in response to irregular patient movement. Based on the above distinguishing technical features, the problems to be solved by the present invention may include: how to prevent the damage to the intubation site of the patient caused by the unexpected movement of the patient. The prior art considers that the aim of fixing the cannula is to dead the cannula so that it cannot move, which is reasonable for the nursing requirements of the cannula, as the cannula movement can lead to risks of tube removal, damage to the patient's trachea, etc. However, this approach finds that for patients with coughing, there are serious adverse effects along with the idea of dead cannula. When a patient coughs, the trachea is displaced or deformed to some extent, such as by vibration or frequent dilatation and contraction. At this time, if the intubation is fixed, the absolute position of the intubation is unchanged, and the relative position of the intubation relative to the trachea is changed under the action of the displacement or deformation of the trachea, so that the intubation can generate relative motion to the trachea, and the trachea of a patient is damaged. The scheme selects to release or reduce the clamping and fixing effect on the cannula when the cough of the patient is detected, so that the cannula can move to a certain extent along with the cough of the patient. At the moment, the cannula can only shake, move or expand and contract to a certain extent along the direction of the elasticity of the leaf spring under the action of the leaf spring so as to adapt to the displacement or deformation of the trachea when a patient coughs, and thus the damage of the clamped cannula to the patient when the patient coughs can be remarkably reduced. On the other hand, under the condition of cough, the clamping limit to the intubation tube is not completely removed, but the elastic structure is continuously utilized to realize a certain degree of buffering or damping effect, so that the effect of continuously clamping the intubation tube is realized to a certain degree, and the occurrence of large displacement such as tube removal and the like is prevented.

Preferably, the first locking member and the second locking member are disposed within the first closure member and the second closure member, respectively, by leaf springs disposed in a manner that provides resistance to movement of the first locking member and the second locking member in a direction away from each other.

Preferably, in the case of the first closure element and the second closure element being combined, the first locking element and the second locking element, respectively, which are arranged inside, contact one another under the effect of the leaf spring to form the line channel.

Preferably, a self-unlocking assembly capable of locking the first locking member and the second locking member to move in a direction away from each other is provided, respectively, and in the case where the catheter needs to be fixed, the self-unlocking assembly is locked so that the first locking member and the second locking member do not have the capability of moving in the direction away from each other. The locking and the separation of the clamping structure are realized by arranging components such as an adjusting rod in the tracheal catheter fixing device, and the locking and the separation belong to a conventional arrangement mode. For example, patent document publication No. CN213941858U discloses a catheter holder for interventional radiology, which comprises a U-shaped bottom plate, a positioning component for positioning an interventional reflection catheter is fixed on the U-shaped bottom plate, two mounting seats are fixed on the U-shaped bottom plate, and an adjusting driving piece for adjusting the position of the positioning component is installed in the mounting seats. According to the technical scheme, the two L-shaped plates are driven to move by adjusting the operation of the driving piece, and the two clamping pieces can move in opposite directions stably through the moving support of the moving plate, and the guide pipe is clamped through the arc-shaped clamping plate, so that the fixing of the guide pipe is completed. However, the adjusting driving piece in the technical scheme can only realize the locking and the separation of the clamping piece respectively through an active adjustment mode, namely, the operation process of clamping and loosening the catheter is realized through the rotation of the turntable fixed at the outer end of the bidirectional threaded rod of the adjusting driving piece, and the driving piece cannot realize active adjustment when a patient takes a cough action, so that the clamping piece can adjust the clamping state of the catheter. Compared with the prior art, the self-unlocking assembly can respectively control the first locking piece and the second locking piece to move along the direction away from each other. Based on the above distinguishing technical features, the problems to be solved by the present invention may include: how to control the movement of the locking member according to the movement state information of the patient so as to realize flexible control of the locking state of the catheter. Specifically, the two locking members of the present invention can automatically perform an unlocking operation in a specific case in response to the self-unlocking assembly. Conventionally, the operator may not operate the first locking member and the second locking member separately, but fix the whole of the first closing member and the second closing member in a form-fitting or magnetic-fitting manner, and at this time, the endotracheal tube is clamped by the inner walls of the tube passage formed by the first locking member and the second locking member and having elasticity; at the same time, the self-unlocking assembly provides a force towards the endotracheal tube, thereby ensuring that the endotracheal tube does not undergo relative displacement in the tube passage, thereby enabling a secure locked state of the tube to be maintained. The control mode of the locking piece is obviously different from the conventional mode that the clamping piece is driven to move only through the screw rod.

Preferably, the processor is configured to control the self-unlocking assembly to unlock or lower the first locking member and the second locking member such that in such a case, the conduit channel formed by the first locking member and the second locking member is expandable under the influence of elasticity.

Preferably, the dental pad is further provided in the oral cavity of the patient, the portions constituting the dental pad are connected to the first locking member and the second locking member, respectively, and the dental pad can be detached with the first locking member and the second locking member being apart from each other in a state that the locking of the first locking member and the second locking member is released or lowered from the unlocking assembly.

The present invention provides a catheter securement system comprising the catheter securement device of any of the preceding claims, further comprising a first detection module configured to enable detection of a physiological indicator of a patient, thereby enabling a healthcare worker to grasp a position of an endotracheal tube and a life state of the patient, a second detection module mounted to the catheter securement device to detect an open-closed state of a tube passage, and a processor configured to generate instructions related to the open-closed condition of the catheter securement device and/or the life state of the patient based on detection results of the first detection module and the second detection module, to reduce invalid alarm cues.

Preferably, the catheter fixing system further comprises a feedback module for receiving and executing instructions of the processor, and the feedback module outputs early warning information related to the opening and closing condition of the catheter fixing device or the life state of the patient according to the type of the instructions sent by the processor.

Preferably, the second detection module is arranged in the first closure member and/or the second closure member so as to acquire the position relationship between the first closure member and the second closure member, and when the fluctuation condition of the abnormal physiological index detected by the first detection module coincides with the opening condition of the first closure member and the second closure member detected by the second detection module, the processor controls the feedback module not to send an alarm prompt.

Drawings

FIG. 1 is a schematic diagram of the structure of the present invention in combination;

FIG. 2 is a schematic illustration of the construction of the closure assembly of the present invention shown disassembled;

FIG. 3 is a bottom view of the closure portion of the present invention;

FIG. 4 is a schematic view of the structure of the locking and unlocking elements of the present invention;

FIG. 5 is a flow chart of the self-unlocking component of the present invention performing the locking and unlocking functions;

FIG. 6 is a schematic diagram of the electrical connections of the catheter securement device of the present invention;

FIG. 7 is a schematic diagram of the functional modules of the present invention;

FIG. 8 is a schematic top view of another embodiment of a downcomer fixing apparatus according to the present invention;

fig. 9 is a schematic bottom view of another embodiment of a downcomer fixing device according to the present invention.

In the figure: 100: a closure assembly; 110: a first closure; 120: a second closure; 200: a locking assembly; 210: a first locking member; 220: a second locking member; 230: a conduit channel; 300: a self-unlocking assembly; 310: a leaf spring; 320: a locking element; 330: an unlocking element; 400: a conduit; 500: binding a belt; 600: binding buckles; 700: a bite-block; 800: a first detection module; 810: a second detection module; 820: a processor; 830: a feedback module; 900: a catheter securement device; 1000: a sound monitoring device; 1100: an acceleration sensor.

Detailed Description

The following detailed description refers to the accompanying drawings.

The tracheal intubation is a method of placing a special catheter into the trachea or bronchus through the oral cavity or the nasal cavity and the glottis, provides optimal conditions for the respiratory tract to be unobstructed, ventilation and oxygen supply, respiratory tract suction and the like, and is an important measure for rescuing patients with respiratory dysfunction. The trachea cannula can adapt to the conditions of general anesthesia operation, spontaneous breathing stop or weak, incapacitation of spontaneous breathing, influence of excessive secretion of respiratory tract on breathing, existence of respiratory tract injury, acute respiratory failure and the like. The general process of trachea cannula is: the patient is adjusted to a supine position, and the shoulder bolster makes the head of the patient lean backwards, so that the oral cavity, the throat and the trachea are positioned in the same longitudinal axis direction; the hand-held laryngoscope is inserted along the tongue root to pick up epiglottis cartilage, and the glottis is exposed; when the glottis of inspiration is opened, the catheter 400 is quickly inserted into the trachea, the tube core is pulled out, and the bite block 700 is arranged; checking if the cannula is in place; after checking for errors, the cannula is secured with the bite block 700.

From the above procedure, it can be seen that the cannula needs to be fixed after the cannula is correctly inserted into the oral cavity, and the fixation is to prevent the cannula from being undesirably displaced, thereby being removed from the trachea, or prevent the trachea of the patient from being damaged due to the displacement of the cannula. While devices for securing endotracheal tubes are commonly referred to as catheter securement devices. The prior art is designed with catheter securement devices that are capable of better securing a cannula inserted into a patient's mouth. For example, a tracheal cannula holder provided in the prior art with publication number CN107847703a, which is formed by binding a panel provided on the mouth of a patient, an opening provided on the panel to allow a cannula to pass therethrough, and a screw provided at a position on one side of the panel, constitutes a device capable of holding the cannula, and clamping or unclamping the cannula is achieved by rotating the screw so that the screw approaches or moves away from the surface of the cannula. However, the device still has several undesirable drawbacks, firstly the panel of the device is designed in an asymmetrical shape so that it can only be placed on the patient's face in a unique way. The panel has two edges up and down, in use, one end of the continuous edge must be placed close to the nose and one end with the open edge must be placed close to the mouth so that at least a portion of the patient's mouth can be exposed from the opening, which makes it more cumbersome for the operator to wear the device for the patient. Secondly, because the catheter fixing device is worn at a position close to the mouth of a patient, the design of tiny parts or easily-separated parts needs to be reduced or stopped as far as possible, so that the danger caused by blockage of esophagus or trachea of the patient due to accidental falling of the parts into the oral cavity of the patient is avoided. The design of the prior art screw may lead to screw falling or matched parts such as a rubber ring nut falling into the mouth of a patient, resulting in personal injury. In addition, this prior art screw handle design overlength, when the fixed intubate of installation, operating personnel need manual rotatory screw make it remove to the intubate, and stroke overlength at every turn leads to the labour great, and can't satisfy the demand of quick fixed trachea cannula and quick evacuation trachea cannula. Since the patient with the endotracheal tube needs to receive oral care or observation at least twice daily, the operator is required to loosen and tighten the endotracheal tube more frequently, especially for patients with increased airway secretions, the endotracheal tube is more required to be tightened and loosened often in order to perform operations such as secretion suction, and the like, the use of the device of the prior art results in an increased operation time. In addition, the prior art is used for fixing the cannula, the position of the cannula is limited and cannot move, and the prior art has a positive effect on stabilizing the position of the cannula. However, for patients with severe cough, the trachea can be regularly contracted and expanded in the cough process, and if the cannula is still fixed at the moment so that the cannula cannot move at all, the cannula can damage the trachea.

The tracheal cannula fixer provided by the prior art (such as the catheter fixing device proposed by the prior art with the publication number of CN 107847703A) prescribes a specific direction when in use (one end is required to be placed on the nose, the other end is required to be placed on the mouth), and when in use, a medical staff also needs to take time to adjust the direction, namely one end of the device needs to be aligned with the nose, the other end is required to be aligned with the mouth, and when in tracheal cannula, the situation is usually urgent, the medical staff can reverse the fixer, so that the setting is unfavorable for emergency. On the other hand, the end of the holder near the nose blocks the opening of the nasal passage, in which case nasal feeding is not possible.

Because the catheter fixing device needs to be worn on the mouth of a patient for a long time, the parts of the catheter fixing device should meet the requirements of small quantity and firm fixation, and the situation that complicated parts fall off to enter the mouth of the patient when oral care operation is carried out is avoided, so that danger is caused. The fixator provided by the prior art contains more parts, and the probability that the parts fall into the oral cavity during operation is high. In addition, as shown in fig. 3, since the bite block 700 is required to be installed after the endotracheal tube is in place to prevent the patient's teeth from being unintentionally engaged to collapse the endotracheal tube 400, the bite block 700 of the present embodiment is provided only at one side in a plate-like structure, the length direction of which extends into the patient's mouth. Preferably, the bite block 700 is longer in length, at least capable of exceeding the patient's teeth, and preferably capable of extending to the middle of the patient's mouth. This solution provides only one side bite block 700 already sufficient to prevent the patient from biting the tube while also reducing the overall device weight.

Under the condition that the oral intubation is completed, as a part of patients accumulate and dry in the catheter 400 due to more secretion of respiratory tract, the inner diameter of the catheter 400 is narrowed, even the catheter 400 is blocked, the normal ventilation of the patients is affected, and complications are easily caused. In addition, since the subglottic suction operation is required every 4 to 6 hours, and such operation generally requires the removal of the catheter fixing device, the fixing and removal of the catheter fixing device on such a premise is required to satisfy the requirement of simplicity and cheapness to relieve the burden of medical staff. While the handles of the screws of the prior art catheter securement devices such as those mentioned above are too long, the caregiver needs to rotate the screws to move the screws toward the other end of the catheter, which prevents the caregiver from quickly securing the airway catheter 400 or quickly withdrawing the catheter 400.

For patients who frequently suffer from severe cough, the conventional catheter fixing device cannot be adaptively adjusted when the severe cough occurs, so that the catheter 400 is still in a locking state when the patient suffers from the severe cough, and the catheter 400 in the locking state is locked to scratch the throat or the airway of the patient.

In the tracheal intubation process or the subsequent nursing process, when a patient takes a cough action, for example, the physiological index of the patient can be abnormally fluctuated to cause the alarm to send out alarm information, and for the patient with frequent cough, if the patient takes a cough each time to send out an alarm prompt, the workload of medical staff can be obviously increased. As shown in fig. 3 and 7, a catheter fixing system is proposed based on the above scheme, which includes a catheter fixing device 900 placed on the mouth of a patient to fix a catheter 400, a first detection module 800, a second detection module 810, and a feedback module 830. The circuit relationship of the module of the invention is shown in fig. 6. As shown in fig. 1, 3 and 7, the first detection module 800 is mounted to the catheter-fixing device 900 proximate to the inner side of the patient's mouth to detect the physiological index of the patient, thereby enabling the medical staff to grasp the position of the catheter 400 and the life state of the patient. A second detection module 810 is installed into the catheter fixture 900 to detect the opened and closed state of the catheter holder. Also having a processor 820 and a feedback module 830, the processor 820 may be a device with data processing computing capabilities, such as a computer, a smart device terminal, etc., disposed within a patient room, capable of receiving detection data from the first detection module 800 and the second detection module 810, and capable of being configured to generate instructions related to the opening and closing condition of the catheter securement device 900 and/or the life condition of the patient based on the detection results of the first detection module 800 and the second detection module 810, the feedback module 830 disposed within the catheter securement device 900 may accept such instructions and feedback the related information to the healthcare staff to reduce ineffective alarm cues.

As shown in fig. 1 and 2, the catheter fixing device 900 of the present invention includes a closure assembly 100, the closure assembly 100 constituting a holding portion, the closure assembly 100 including a first closure member 110 and a second closure member 120 detachably connectable in a form-fitting or magnetic-fitting manner, the two closure members being fitted to be connected from left and right sides with respect to a corner of a patient's mouth in opposition, the shape being rectangular-like. Preferably, the two closure element combinations and the split parting line are arranged at an asymmetric axis position. In other words, the first closure element 110 and the second closure element 120 may be differently shaped and sized, which may be advantageous in that a healthcare worker may more conveniently grasp the closure elements for quick assembly and disassembly operations during assembly and disassembly. The closure assembly 100 serves as a housing protecting the internal structure, and is internally provided with a locking assembly 200 for constituting the structure of the locking catheter 400, as the internal components are shown by dotted lines in fig. 1. The closure assembly 100 acts as a housing that protects the internal components from the external environment, such as being somewhat waterproof and dust-proof, while the closure assembly 100 also prevents accidental dropping of internal components, particularly relatively small internal components, into the patient's mouth. The present solution recognizes that for catheter retention devices for use on the patient's mouth, the internal structure is not necessarily complex, too many parts are not available, nor are parts of relatively small volume. To promote ease of use and intellectualization of the catheter retention device while still meeting the requirements for compact construction and safety, the present solution chooses to provide the closure assembly 100 as a housing. Preferably, in the case of the closure assembly 100 being used to conform to the face of a patient, the edges of the closure assembly 100 form a lateral curvature in a manner that is curved downwardly in response to the human face, which has a curvature that is curved toward the center, and which is capable of adapting to the shape of the face of the patient without causing edge lifting after the fitting. As shown in fig. 1, the first locking member 210 and the second locking member 220 inside the closure assembly 100, and the self-unlocking assembly 300 provided corresponding to the two locking members are shown in dotted lines, and the specific structure of the self-unlocking assembly 300 may refer to the structure shown in fig. 4.

A locking assembly 200 is movably disposed within the closure assembly 100. Fig. 2 of the present application shows a schematic view of the structure of the locking member showing the interior of the closure assembly 100 after removal. The locking assembly 200 according to fig. 2 includes a first locking member 210 and a second locking member 220 disposed opposite each other, wherein the first locking member 210 is movably disposed in the first closing member 110, and the second locking member 220 is movably disposed in the second closing member 120. The locking members are capable of movement relative to or relative to each other to effect locking or unlocking of endotracheal tube 400. The locking assembly 200 and the closure assembly 100 each perform different functions, specifically, the locking assembly 200 is a specific device for fixing the endotracheal tube 400, and the closure assembly 100 is an integral part of the catheter fixing device 900, that is, the catheter fixing device 900 is integrally formed by relatively clamping the first closure member 110 and the second closure member 120, and the catheter fixing device 900 is partially implemented by the first locking member 210 and the second locking member 220 to lock and unlock the endotracheal tube 400. The first closure element 110 and the second closure element 120 are magnetically or positively engaged to form a unitary body that can be assembled by means of a mortise and tenon engagement. The first and second closure elements 110 and 120 serve as the outer shell of the catheter fixing device 900, and the purpose is to fix the endotracheal tube 400 in a self-abutting manner by the first and second locking elements 210 and 220 inside the outer shell after the outer shell is partially mounted. The retention portion of the closure assembly 100 can be sleeved onto the patient's head using the combination of the binding belt 500 and the binding 600. Specifically, one of the closure members is provided with a strap 500 on one side and the other closure member is provided with a binding button 600 on one side, and a binding loop is formed by the mating relationship of the binding strap 500 and the binding button 600 so that the holding portion can be sleeved to the patient's head.

Referring to fig. 1, further, endotracheal tube 400 can be defined within a tube passage 230 formed by opposing portions of first retaining member 210 and second retaining member 220, that is, endotracheal tube 400 is held by first retaining member 210 and second retaining member 220. The side of the first locking member 210 and the second locking member 220, which are relatively far from each other, is provided with a self-unlocking assembly 300, and both locking members can automatically perform an unlocking operation in a specific case in response to the self-unlocking assembly 300. Conventionally, first locking member 210 and second locking member 220 are capable of automatically securing endotracheal tube 400 following the closing of first closing member 110 and second closing member 120, i.e., an operator may not individually manipulate first locking member 210 and second locking member 220, but rather, endotracheal tube 400 is self-securing by securing the entirety of first closing member 110 and second closing member 120 in a form-fitting or magnetic-fitting manner. At this time, the endotracheal tube 400 is held by the inner wall of the tube passage 230 having elasticity formed by the first locking member 210 and the second locking member 220, and at the same time, the self unlocking assembly 300 provides a force toward the endotracheal tube 400, ensuring that the endotracheal tube 400 is not relatively displaced in the tube passage 230, and maintains a fixed state.

Referring to fig. 1, the first locking member 210 and the second locking member 220 form a pipe passage 230 for holding the guide pipe 400 at a position where they are in contact with each other. The present solution is directed to a catheter 400 that is cylindrical in shape and the opening that clamps the catheter 400 needs to be able to clamp the cylindrical catheter 400 therein. The two edges of the first locking member 210 and the second locking member 220 forming the opening are respectively provided in an arc shape, and the arc-shaped edges are provided to have a structure capable of increasing friction. For example, in one embodiment, the arcuate edges have a rubber layer that is roughened to promote friction against the conduit 400 when in contact with the conduit 400, thereby enabling the openings formed by the first retaining member 210 and the second retaining member 220 to stabilize the grip of the conduit 400.

When the self-unlocking assembly 300 reaches the self-unlocking condition, the direction of the force provided to the locking assembly 200 by the self-unlocking assembly 300 is switched, so that the attraction force of the first locking member 210 and the second locking member 220, which is applied to each other, is converted into the pulling force for moving the two locking members away from each other. Expanding the inner diameter of the tube passage 230 in this manner allows the tracheal tube 400 to follow the patient's vibration caused by coughing or the like in an unconventional state to perform a corresponding movement within the tube passage 230, thereby avoiding abrasion or squeezing of the patient's trachea.

The opposite portions of the first locking member 210 and the second locking member 220 are provided with a self-unlocking assembly 300 capable of performing state switching in response to an external condition. Self-unlocking assembly 300 is preferably an assembly structure capable of automatically unlocking first retaining member 210 and second retaining member 220 according to a program instruction. In other alternative embodiments, the self-unlocking assembly 300 may also be unlocked by manual operation, e.g., the system is provided with an assembly that gives a prompt to the person, who, after seeing the prompt, manually operates the self-unlocking assembly 300 to unlock it. In order to achieve the purposes of achieving higher automation degree and unlocking the locking piece without manual intervention, the scheme is preferably provided with a component structure capable of automatically unlocking in response to an instruction. Preferably, the self-unlocking assembly 300 is an electromagnet assembly structure, as shown in fig. 1, and the electromagnet assembly of the self-unlocking assembly 300 includes a locking member 320 for maintaining the locked state of the first locking member 210 and the second locking member 220 and an unlocking member 330 for separating the first locking member 210 and the second locking member 220, and the cooperation of the locking member 320 and the unlocking member 330 enables the first locking member 210 and the second locking member 220 to be automatically locked and unlocked. Specifically, as shown in fig. 4, the locking element 320 and the unlocking element 330 are both located at distal ends of the first locking member 210 and the second locking member 220 that are far away from each other, where the locking element 320 is provided with a plate spring 310 structure in which several sets of end portions are fixedly connected to the closing member and the raised middle portion abuts against the locking member, and the unlocking element 330 is provided with at least one electromagnet that is arranged in pairs and can generate or release a magnetically attractive locking force under the condition of power on and power off, that is, the electromagnet generates magnetism only when power is on, and the magnetism disappears after power off. Preferably, one of the electromagnets of the same set is located on the distal end face of the first retaining member 210 and the second retaining member 220, and the other is located on the first closure member 110 and the second closure member 120, with the two electromagnets being disposed opposite to each other to ensure that the two electromagnets attract each other when energized. To unlock or lock the locking member from the unlocking assembly 300, only the circuit controlling the electromagnet needs to be energized or de-energized. Specifically, when energized, a magnetic attraction force is generated between two oppositely disposed electromagnets of the same group in unlocking element 330, thereby moving first locking member 210 and second locking member 220 of locking assembly 200 away from each other and unlocking catheter 400 in a manner that enlarges tubing passage 230; in the case of power failure, the electromagnet in the unlocking element 330 does not generate a magnetic attraction force, and the first locking member 210 and the second locking member 220 in the locking assembly 200 are kept tightly fitted under the action of the plate spring 310 in the locking element 320, so as to maintain the locking state of the catheter 400, thereby realizing the locking and unlocking processes as shown in fig. 5. The locking member 320 is disposed adjacent to the unlocking member 330 and can be self-locking by the structure of the leaf spring 310. In this embodiment, the locking element 320 may be in the form of an arcuate single leaf spring 310, with the arcuate top projection of the single leaf spring 310 abutting the distal end face of the first locking member 210 or the second locking member 220, and the arcuate ends of the single leaf spring 310 being fixedly attached to the first closure member 110 or the second closure member 120. The magnitude of the elastic force of the plate spring 310 is represented by the degree of curvature of the arc-shaped tip thereof, specifically, when the degree of curvature thereof becomes high, the stored elastic potential energy thereof becomes small (i.e., the plate spring 310 is relaxed, the degree of bulge representing the tip arc becomes apparent), the elastic supporting force which it can apply to the locker is reduced, and when the degree of curvature thereof is reduced, the stored elastic potential energy thereof increases (i.e., the plate spring 310 is compressed, the tip arc becomes flat), and the elastic supporting force which it can apply to the locker is increased. By such arrangement, in the case that the unlocking member 330 is energized, the first locking member 210 or the second locking member 220 is separated from each other by the magnetic attraction force between the oppositely disposed electromagnets in the unlocking member 330, in the course of which the plate spring 310 is compressed, which continuously accumulates elastic potential energy, and stops the compression when the magnitude of the elastic supporting force provided for the first locking member 210 or the second locking member 220 is changed to be the same as the magnitude of the magnetic attraction force provided for the unlocking member 330, at which time the self-unlocking assembly 300 completes the unlocking; when the unlocking element 330 is powered off, the magnetic attraction force provided by the unlocking element 330 disappears, and the locking element 320 can reset the first locking member 210 or the second locking member 220 by means of the stored elastic potential energy of the plate spring 310, and the proximal end surfaces of the first locking member and the second locking member are always kept in a tightly attached state. The use of the leaf spring 310 construction can avoid the use of a conventional coil spring construction, thereby avoiding the accidental falling of the coil spring into the patient's mouth. It should be noted that, in this embodiment, there should be a relationship between the magnetic attraction force generated between the oppositely disposed electromagnets in the unlocking element 330 and the elastic force of the leaf spring 310 in the locking element 320, specifically, since the electromagnets are energized to generate the magnetic attraction force for unlocking the self-unlocking assembly 300 so as to leave free space for the catheter 400 therein, the magnetic attraction force of the locking element 320 must overcome the elastic supporting force generated by the leaf spring 310 in the locking element 320 to enable the first locking member 210 and the second locking member 220 to be separated from each other to some extent. Therefore, the values of the adsorption force or the supporting force of the locking element 320 and the unlocking element 330 can be limited to a certain extent by means of experiments, etc., so as to satisfy the normal realization of the locking and unlocking functions. In particular, one of the purposes of providing unlocking element 330 as an electromagnet assembly rather than as a permanent magnet is to circumvent the generation of a persistent magnetic field. The existence of the continuous magnetism can interfere with the normal operation of medical equipment such as a monitor, for example, the sensor, the circuit and the signal transmission of the monitor can be interfered, so that the monitoring result is inaccurate or misjudged, and the treatment of a patient and the judgment of medical staff are affected. Thus, the magnetic element used in the vicinity of the medical device should be non-permanent. Since the unlocking element 330 is only briefly activated in a special stage of patient cough, the interference to the medical device can be reduced as much as possible, and the normal use of the medical device is ensured.

As shown in fig. 3, the sound monitoring device 1000 can be disposed on an inner sidewall of the bite block 700. When a patient experiences a cough, the sound monitoring device 1000 can detect a sound caused by the cough, and in response to the sound reaching a certain decibel threshold, the sound monitoring device 1000 can transmit a sound signal to the processor 820 and send an unlock instruction by the processor 820 such that the lock assembly 200 that received the unlock instruction is conditionally unlocked.

The monitoring device may also be an acceleration sensor 1100, as shown in fig. 3, the acceleration sensor 1100 may also be disposed on the inside wall of the bite-block 700. In the event of a cough in the patient, the acceleration sensor 1100 can determine whether the device has been dithered to a preset limit based on a logic determination, and in response to the jitter meeting the preset limit, the acceleration sensor 1100 can transmit a dithering signal to the processor 820 and an unlock command can be sent by the processor 820 such that the lock assembly 200 that received the unlock command is conditionally unlocked. The jitter caused by the cough is often short and regular, and the daily motion of the patient can be distinguished from the cough based on the special jitter frequency and jitter amplitude of the cough, so that the special jitter limit of the cough can be preset.

Preferably, the sound monitoring device 1000 and the acceleration sensor 1100 can be alternatively provided, or can be provided simultaneously so that both can improve the accuracy of cough behavior monitoring in a mutually authenticated manner.

In the case of using the sound monitoring device 1000, as shown in fig. 3, the sound monitoring device 1000 is preferably provided on the bite block 700. More preferably, the sound monitoring device 1000 is positioned on the bite block 700 near the interior of the patient's mouth. The sound monitoring device 1000 adopted in the scheme does not need to be particularly high in precision, and only needs to be capable of collecting sound in the oral cavity of a patient. The volume of the current sound monitoring device 1000, such as a patch microphone, can be very small, and the device is only in the centimeter level, and also has a certain waterproof performance, and the microphone is mounted on the bite block 700, so that the sound in the oral cavity of the patient can be collected. The sound monitoring device 1000 is arranged on the dental pad 700, on one hand, in order to isolate or reduce interference noise outside the oral cavity of a patient, because the environment of the ward where the patient is located is noisy, too many useless signals are easily collected by the sound monitoring device 1000, the sound signal processing is affected, and the sound monitoring device 1000 is arranged on the dental pad 700, so that most of noise outside the oral cavity of the patient can be isolated; on the other hand, in order to be able to collect the cough sound of a specific patient with a slight cough, such as a serious patient or an unconscious patient, the cough may be very slight, and sometimes only a certain regular laryngeal peristaltic sound or vibration sound exists, without the cough sound in the conventional sense. In order to accurately measure the cough of the special patient, the system selectively arranges the sound monitoring device 1000 on the tooth pad 700, so that the system can be more suitable for patients who cannot cough normally. After the sound data is collected, noise is filtered through a filter in the sound monitoring device 1000, and low-frequency noise is filtered through a high-pass filter. The analysis of the cough sounds can be performed in an intelligent core, the oral sounds of a plurality of patients are collected in advance, the cough sounds are determined from the oral sounds (can be selected manually), short-time audio samples (for example, samples with the length of 0.7 s) with the cough sounds are input into a computer, time-frequency domain analysis is performed on the cough sounds, time-domain signal patterns and frequency domain signal patterns are obtained, cough sound features are extracted from the patterns, and feature and time-frequency domain analysis data are input into a machine learning model to obtain a cough sound recognition model. For patients who cannot cough normally, the characteristics of peristaltic sounds or vibration sounds of the throat are extracted by the same method, and a cough recognition model is trained and updated.

As shown in fig. 5, based on the above-described scheme, in another aspect, the preferred step of detecting a patient cough control self-unlocking assembly 300 based on a monitoring device is presented:

s1, collecting information related to cough of a patient based on a monitoring device;

s2, outputting acquired information to an external analysis device based on data transmission to determine a cough level;

s3 in the event that it is determined that the cough level exceeds the threshold, processor 820 initiates a disassociation procedure;

s4, after the separation procedure is started to unlock the locking piece, determining the current cough level based on the information currently collected by the monitoring device, and deciding to start the resetting locking procedure or alarm according to the lifting of the cough level.

The information related to the cough of the patient collected by the monitoring device can be the cough sound of the patient or regular jitter generated by the cough (collected in a way of acceleration change). The collected information is transmitted to an external analysis device for analysis in a wired or wireless communication mode, wherein the external analysis device can be a monitoring device arranged in a ward. At present, intelligent medical treatment is rising, one or more monitoring intelligent cores are arranged in a plurality of wards, and the intelligent medical treatment intelligent device is usually a device with certain data processing and calculating capacity such as a computer and an intelligent device terminal and is used for summarizing the uploaded information of all sub-devices in the wards. These sub-devices may be monitors, test bracelets, etc., and may also include catheter securement systems in accordance with the present invention. Because the system is not capable of large-scale processing due to its size and cost, the present approach delivers the processing information to an external analysis device (i.e., the monitoring intelligent core described above) for determining the patient's cough level. The external analysis means determines the cough level from the acquired information in a manner that processes the information according to preset rules and determines the cough level based on the comparison. For example, the cough characteristic sound data is extracted from the collected sound information, and the cough level is determined based on the parameters of volume, frequency, etc. Cough grades can be classified, for example, as mild, moderate and severe. The threshold may be set to a medium cough level and processor 820 initiates a disassociation procedure when the currently determined cough level is medium or above. The detachment procedure controls the self-unlocking assembly 300 to unlock the locking member, thereby enabling movement of the catheter 400. After the separation procedure is performed, the detection means continuously detects the current information related to cough and uploads it to the external analysis means, which continuously processes the information and determines the current cough level. Processor 820 performs a reset lock, i.e., controls the self-unlocking assembly 300 to lock, when it is determined that the current cough level is light or no cough. When it is determined that the current cough level is continuously in heavy cough, an alarm is sent to the healthcare worker, which can be performed by the external analysis device, and particularly in the case of using the guardian smart core as the external analysis device, the guardian smart core can rapidly alarm the nurse of the nurses 'station by means of its communication connection established with the nurses' station. The above-described solution avoids patient coughing due to the catheter 400 itself, in addition to automatically unlocking the catheter 400 for the patient when the patient is coughing, to prevent the cannula from damaging the patient's trachea. The lack of proper placement of the catheter 400 may also cause discomfort to the patient to cough, which may not be detected by the healthcare provider when the catheter 400 is placed, as discomfort may be delayed. The locking and unlocking of the catheter 400 can be automatically adjusted to adapt to the cough of the patient, so that the catheter 400 is adjusted to a position suitable for the patient. Preferably, the intelligent core may be a hospital HIS system or an ICU management system, and because the information security level of these information systems is high, in consideration of data security, the raw data collected by the system is filtered and then is communicated with the hospital HIS system or ICU management system by establishing an encrypted data transmission manner, and the processor 820 of the system may not be equipped with a working environment for complex information processing and computing, so that virus infection of the system can be avoided to the greatest extent. The original data transmitted has a fixed file format, in other words, the data structure transmitted to the intelligent core by the system is single, and the data structure can be rapidly checked by the firewall when transmitted to the intelligent core, so that malicious data can be effectively prevented from being uploaded. The processing calculation of the data and the work of generating the instruction can be completed in the intelligent core, so that the system can safely interact with the intelligent core information.

In another case, processor 820 determines the separation duration after manually initiating the separation procedure externally to determine the duration and time cadence of oral care, records the time point of oral care to the current patient, predicts the sputum aspiration time based on the length of time, and provides a physician with a trend analysis of the data related to the current patient's progress of the condition based on the trend of the sputum aspiration time.

The first detection module 800 includes a blood oxygen sensor provided on or in the holding portion to acquire blood oxygen information of the patient and a multifunctional sensor to acquire carbon dioxide exhalation information of the patient.

According to a preferred embodiment, the multi-function sensor is capable of both monitoring the patient's carbon dioxide exhalation information and acquiring humidity information of the input gas. This arrangement facilitates the health care personnel to maintain the input gas (oxygen) at a suitable humidity level while grasping patient vital signs. The multifunctional sensor can be provided at the oral cavity opening of the holding portion. The blood oxygen sensor may be a reflective photoelectric sensor, and may be provided at a portion of the holding portion near the lips.

According to a preferred embodiment, feedback module 830 includes an LED light on catheter fixture 900 and a paging device worn by the healthcare worker.

When the closing condition of the first and second closing members 110 and 120 acquired by the second detection module 810 coincides with the occurrence time of the abnormal physiological index of the patient, the processor 820 controls not to send an instruction of the alarm prompt. For example: the time period during which the first and second closure members 110 and 120 are opened, the patient's blood oxygen changes and carbon dioxide exhalations are abnormal; the period of time that the first and second closure members 110 and 120 are closed, the patient's blood oxygen changes and carbon dioxide exhalations return to normal.

When the opening time of the first and second closing members 110 and 120 acquired by the second detection module 810 exceeds a predetermined time, for example: the length of time that the healthcare worker takes to oral care of the patient is 5 minutes, the predetermined time can be set to 5 minutes, and the processor 820 sends an alarm indication when the second detection module 810 detects that the first closure element 110 and the second closure element 120 are open for more than 5 minutes. This arrangement provides for the timely discovery of an unexpected situation in which the medical personnel do not return the first and second closure members 110, 120 to the intended closed position after the care session has been performed.

For the intubated patient with frequent cough, the physiological index of the cough can exceed the normal range, generally, the cough can last for a period of time, and the cough can automatically return to the normal state after the cough. However, during coughing of the patient, a physiological indicator outside of normal range triggers an alarm prompt of the system, but in practice such an alarm is ineffective or otherwise of no particular concern, and if the healthcare worker is looking for such an alarm, meaningless workload is increased and the healthcare worker is expended. The present solution therefore adds a second detection module 810 to determine the deployment of the catheter-securement device 900. When a cough occurs, the first and second closure elements 110, 120 of the catheter securement device 900 may be subjected to forces in a direction opposite to the clamping direction, which may cause the first and second closure elements 110, 120 to have a tendency to separate from each other. When the separation condition of the first closing member 110 and the second closing member 120 detected by the second detection module 810 matches with the abnormal physiological index fluctuation condition detected by the first detection module 800, the processor 820 controls not to send out an alarm prompt.

On the other hand, when the healthcare worker nurses the patient, there may be a failure of the catheter-fixing device 900 to return to the optimal closed position, and the second detection module 810 can detect an abnormal closing condition of the catheter-fixing device 900.

The above scheme designs the special catheter clamping structure and the matched control mode thereof firstly aiming at the condition that a part of special patients have serious coughs, and can release or reduce the clamping effect on the catheter 400 under the condition that the patients generate coughs. This approach has found that for some more specific patients, such as those with more respiratory secretions, those with injuries in the respiratory tract, and those with poor respiratory habits, it frequently causes a cough after the catheter 400 is placed, and most of them will cause a longer and more severe cough, which will cause the trachea of the patient to vibrate greatly and generate a displacement or deformation of the trachea, while if the position of the catheter 400 is still unchanged, it will cause a larger relative displacement between the catheter 400 and the trachea, resulting in the trachea being rubbed and damaged. Thus, the present approach recognizes that when a patient experiences a cough, the clamping and securing action on the catheter 400 needs to be properly reduced or released to allow the catheter 400 to undergo a certain displacement or deformation in response to the patient's cough, so that the relative movement can be reduced and the frictional damage can be reduced. And while reducing the clamping action, it is still necessary to ensure that the catheter 400 does not fall out or penetrate too far into the patient's trachea, so that proper retention of the catheter 400 is still desirable. Therefore, the present solution is designed to allow the catheter 400 to perform a certain displacement and deformation along with the cough of the patient under the action of elasticity on the premise that the catheter 400 is kept not to fall out or go deep into the trachea by using the elastic action, so that the position balance of the catheter 400 in a certain range is realized.

The present solution provides, on the other hand, a preferred embodiment in which the present catheter securement device 900 is designed as an asymmetric structure that is integrally formed from two separable sections that differ from each other in structure and circuit design. In detail, as shown in fig. 8, the present device is still composed of a first closure member 110 and a second closure member 120, wherein the first closure member 110 has a first locking member 210 therein, the second closure member 120 has a second locking member 220 therein, and the first locking member 210 and the second locking member 220 can form a pipe passage 230 for holding a catheter 400 when they are closed in contact with each other, wherein the first locking member 210 can move in the first closure member 110 after unlocking, and the second locking member 220 remains fixed in the second closure member 120. Preferably, the self-unlocking assembly 300 of the plate spring 310 and the magnet shown in fig. 4 described in the present specification is adopted in this embodiment, and the detailed description of the structure is described above, which is not repeated here. In this embodiment, the self-unlocking component 300 is disposed only in the first closure member 110, and the self-unlocking component 300 is not disposed in the second closure member 120. The second locking member 220 of the present embodiment may be fixedly disposed within the second closure member 120 such that the second locking member 220 cannot move within the second closure member 120. As a preferred alternative, as shown in fig. 8, the second locking member 220 may be integrally provided with the second closing member 120 in order to reduce the number of parts, improve integration, and reduce weight. Preferably, the first and second closure elements 110, 120 of the present embodiment are configured asymmetrically in terms of volume size, the first closure element 110 being larger in volume than the second closure element 120, for situations where frequent disassembly of the present device is required for care or viewing. In other words, the connection of the first closure element 110 to the second closure element 120 is not in the middle of the mouth of the patient. This solution allows to further reduce the volume and the weight of the second closure element 120, so that the operator can more conveniently detach the second closure element 120 first when detaching the device. Further, as shown in fig. 9, in the present embodiment, the bite block 700 is disposed only on the first locking member 210, and the bite block 700 is generally configured in an elongated plate-like structure. In this embodiment, the bite block 700 is only disposed on the first locking member 210, so that on one hand, the overall weight of the structure can be reduced, and the portability can be improved, on the other hand, when the patient takes a cough, the bite block 700 can have a certain degree of freedom of movement in the oral cavity of the patient along with the unlocking of the first locking member 210. As shown in fig. 9, in addition, in the present embodiment, the sound monitoring device 1000 is disposed on the bite block 700, so that, on one hand, the sound monitoring device 1000 is contained in the oral cavity to isolate external noise, and on the other hand, targeted sound collection (such as peristaltic sounds in the throat, vibration sounds, etc.) can be performed for some patients (such as severe patients) who cannot cough normally, and the first locking member 210 of the device can be unlocked when such patients cough. As shown in fig. 9, in this embodiment, the internal circuits of the processor 820, the detection module, etc. are further disposed in the first closing member 110, and the second closing member 120 is not disposed with a circuit structure. The design makes the first closing member 110 and the second closing member 120 also form an asymmetric relation in circuit, a circuit is arranged in the first closing member 110, the circuit of the sound monitoring device 1000 arranged on the tooth pad 700 can directly run on the inner side of the first closing member 110 to be communicated with other circuits, and the circuit is not required to be transmitted in a crossing structure, so that the circuit integration level is higher, the waterproof, dustproof and anticreep performance is better, the circuit damage is avoided to a great extent, the weight and the structural complexity of the second closing member 120 are further reduced, and the second closing member 120 is more convenient to assemble and disassemble. Still further, the pipe passage 230 of the present embodiment may be configured in an asymmetric shape, and in particular, the pipe passage 230 may be split into an arc portion located on the first locking member 210 and an arc portion located on the second locking member 220, wherein the arc portion located on the first locking member 210 is configured to have a larger arc than the arc portion located on the second locking member 220. This scheme adopts this kind of asymmetric pipeline passageway 230 structure to set up for the arc part on the second retaining member 220 is stronger to the clamp force of pipeline, and because the second retaining member 220 is fixed under this embodiment, consequently can keep better effect to the fixed of providing of pipeline, and first retaining member 210 is owing to there is the self-unlocking subassembly 300, therefore probably has the circumstances of certain becoming flexible, and asymmetric pipeline passageway 230 structure of this embodiment can prevent this not hard up to a certain extent.

It should be noted that the above-described embodiments are exemplary, and that a person skilled in the art, in light of the present disclosure, may devise various solutions that fall within the scope of the present disclosure and fall within the scope of the present disclosure. It should be understood by those skilled in the art that the present description and drawings are illustrative and not limiting to the claims. The scope of the invention is defined by the claims and their equivalents. The description of the invention includes a plurality of inventive concepts, such as "preferably", "according to a preferred embodiment" or "optionally" each meaning that the corresponding paragraph discloses a separate concept, the applicant reserves the right to filed a divisional application according to each inventive concept. Throughout this document, the word "preferably" is used in a generic sense to mean only one alternative, and not to be construed as necessarily required, so that the applicant reserves the right to forego or delete the relevant preferred feature at any time.

Claims

1. A catheter securement device comprising a first closure member (110) and a second closure member (120) removably connectable to each other, wherein the first closure member (110) is provided with a first locking member (210) and a second locking member (220) respectively within the first closure member (110) and the second closure member (120), the two locking members being capable of partially engaging after the first closure member (110) and the second closure member (120) are connected and forming a passageway between the engaging portions for passage of a catheter (400), the catheter (400) being maintained between said catheter securement devices (900) by a clamping action of the passageway.

2. The apparatus of claim 1, further comprising a detection module configured to collect data information about whether the patient is in a coughing state, and further comprising a processor (820) in data communication with the detection module, the processor (820) controlling the first retaining member (210) and the second retaining member (220) to transition from a state that does not have the ability to move in a direction away from each other to a state that does have the ability to move in a direction away from each other if the processor (820) determines that the patient is in a coughing state based on the data collected by the detection module.

3. The device according to claim 2, wherein the first locking member (210) and the second locking member (220) are connected within the first closure member (110) and the second closure member (120), respectively, by means of a resilient structure arranged in such a way as to provide a movement in a direction away from each other against the first locking member (210) and the second locking member (220).

4. A device according to claim 3, characterized in that, in the case of a combination of the first closure element (110) and the second closure element (120), the first locking element (210) and the second locking element (220), respectively, which are arranged inside, contact each other under the influence of the elastic structure to form the channel (230).

5. A device according to claim 3, characterized in that a self-unlocking assembly (300) is provided, which is capable of locking the first locking member (210) and the second locking member (220) in a direction away from each other, respectively, said self-unlocking assembly (300) being locked such that the first locking member (210) and the second locking member (220) do not have the ability to move in a direction away from each other in case a catheter (400) needs to be secured.

6. The device of claim 5, wherein the processor (820) is configured to control the self-unlocking assembly (300) to unlock or lower the locking of the first locking member (210) and the second locking member (220) such that in such a case, the conduit channel (230) formed by the first locking member (210) and the second locking member (220) is expandable under the influence of elasticity.

7. The device of claim 1, further comprising a bite block (700) disposed within the patient's mouth, portions comprising the bite block (700) being coupled to the first locking member (210) and the second locking member (220), respectively, the bite block (700) being detachable with the first locking member (210) and the second locking member (220) away from one another upon unlocking or lowering the locking of the first locking member (210) and the second locking member (220) from the unlocking assembly (300).

8. A catheter securement system comprising the catheter securement device (900) of any of the preceding claims, further comprising a first detection module (800) configured to detect a physiological indicator of a patient, thereby enabling a healthcare worker to grasp a position of an endotracheal tube and a life state of the patient, a second detection module (810) mounted to the catheter securement device (900) to detect an open and closed state of the conduit channel (230), the processor (820) configured to generate instructions related to the open and closed condition of the catheter securement device (900) and/or the life state of the patient based on detection results of the first detection module (800) and the second detection module (810) to reduce invalid alarm cues.

9. The system of claim 8, wherein the catheter securement system further comprises a feedback module (830) that receives and executes instructions from the processor (820), the feedback module (830) outputting pre-alarm information related to the open/close condition of the catheter securement device (900) or the patient's vital state based on the type of instructions issued by the processor (820).

10. The system of claim 8, wherein the second detection module (810) is disposed inside the first closure member (110) and/or inside the second closure member (120) to obtain a positional relationship between the first closure member (110) and the second closure member (120), and the processor (820) controls the feedback module (830) not to send the alarm prompt when a fluctuation condition of the abnormal physiological index detected by the first detection module (800) coincides with an opening condition of the first closure member (110) and the second closure member (120) detected by the second detection module (810).