Mask supporting device and mask manufacturing method

Abstract

The invention belongs to the technical field of medical apparatus and instruments, and discloses a mask supporting device and a mask manufacturing method.The mask supporting device comprises a shell, a mask supporting part, a mask supporting part and a mask supporting part, the shell is internally provided with a breathing channel, and the breathing channel is used for being connected with a trachea sleeve installed after laryngeal or hypopharyngeal tumor resection; the housing can support a radiotherapy positioning mask so as to provide forming support for the mask while protecting the trachea sleeve. According to the mask supporting device, the trachea sleeve is effectively protected through the breathing channel in the shell, mask materials are prevented from making direct contact with or extruding the trachea sleeve, and therefore breathing safety of a patient is guaranteed. Meanwhile, the external structure of the shell provides a stable supporting point for the mask, so that the mask can keep a proper shape and space at the position of the trachea sleeve of the patient, and the situation that the mask extrudes the trachea sleeve to stimulate the airway of the patient to cause bucking and finally cause radiotherapy positioning errors due to slight movement of the patient is avoided.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and more specifically, relates to a mask support device and a method for manufacturing a mask for positioning radiotherapy after laryngeal or hypopharyngeal cancer tumor resection. Background Art

[0002] Head and neck cancer is usually treated with a combination of surgery, radiotherapy and chemotherapy. Figure 7 As shown, a radiotherapy positioning mask is usually needed to fix the position of the patient's head and neck to ensure the accuracy of radiotherapy. The existing mask manufacturing method usually places the softened mask on the patient's head and neck and fits it. After the mask cools down, the patient's personalized mask can be obtained.

[0003] However, for patients with postoperative laryngeal or hypopharyngeal cancer, since such patients have their throats cut and tracheostomies performed, first, they cannot speak. Second, they breathe mainly from the added tracheal cuff through the human trachea to the artificial tracheal cuff and finally exhale and inhale to the front of the neck (not conventionally breathing through the mouth and nose). Third, the postoperative tracheal segment and the artificial stoma segment are congested, edematous, and inflammatory exudates are easily stimulated to cause sputum choking and coughing. Therefore, there are some problems when using the traditional mask production method: First, during the production process, the mask may block the patient's tracheal cuff's breathing channel because it needs to fit the patient's head and neck, thereby affecting the patient's breathing and causing the patient to breathe poorly. Secondly, after the mask is fixed, it may compress the tracheal cuff, thereby stimulating the patient's postoperative tracheal inflammatory response and causing choking and coughing. The sputum coughed up by the patient may block the tracheal cuff or the mesh of the mask, further causing the patient to breathe poorly. For patients who have undergone laryngeal or hypopharyngeal cancer surgery, they can only breathe by breathing through the artificial tracheal cuff, which is much more laborious than normal oral and nasal breathing.

[0004] In addition, during the mask manufacturing process, it is difficult for patients to speak because they are fixed by the mask; therefore, it is difficult for patients to give timely feedback after experiencing breathing difficulties or discomfort. Summary of the invention

[0005] To achieve the above object, the present invention provides a mask support device in a first aspect, comprising:

[0006] A housing having a breathing passage therein, wherein the breathing passage is used for access to a tracheal cannula installed after laryngeal or hypopharyngeal tumor resection;

[0007] The shell can support a radiotherapy positioning mask to provide shaping support for the mask while protecting the tracheal cuff.

[0008] A further technical solution may be that a first opening and a second opening are respectively provided at both ends of the breathing channel; the opening size of the second opening is larger than the first opening; and the cross-sectional area of ​​the breathing channel gradually increases from the first opening toward the direction where the second opening is located.

[0009] A further technical solution may be that the angle between the line connecting the center points of the first opening and the second opening and the direction of the tracheal cuff is an acute angle.

[0010] A further technical solution may be that the breathing passage comprises:

[0011] an accommodating section, located on a side close to the first opening and capable of accommodating the tracheal cuff, wherein an extending direction of the accommodating section is consistent with a direction of the tracheal cuff;

[0012] The guide section is connected to the accommodating section and is located on a side close to the second opening. The included angle between the extending direction of the guide section and the direction of the tracheal cuff is an acute angle.

[0013] A further technical solution may be that the size of the accommodating section matches that of the tracheal cuff, and the cross-sectional area of ​​the guiding section gradually increases from the first opening toward the direction where the second opening is located.

[0014] A further technical solution may also include:

[0015] A respiratory monitoring component, used to monitor the patient's respiratory dynamics and form a respiratory signal;

[0016] a guiding component for guiding the movement of fluid in the breathing passage;

[0017] The controller is communicatively connected with the respiratory monitoring component and the guiding component respectively, and the controller controls the guiding component to work in response to the respiratory signal.

[0018] A further technical solution may also be that the guiding component is:

[0019] a fan, disposed in the breathing passage and facing the second opening;

[0020] Alternatively, a drainage component is connected to the second opening.

[0021] A further technical solution may also be that the respiratory monitoring component is:

[0022] Piezoelectric ceramic sheets are used to convert air vibrations caused by the patient's breathing into electrical signals to monitor the patient's breathing dynamics.

[0023] The second aspect of the present application also proposes a method for manufacturing a mask for positioning laryngeal or hypopharyngeal cancer radiotherapy, comprising the following steps:

[0024] Mask softening steps: Soften the mask;

[0025] Support device setting step: setting the mask support device on the patient's tracheal cuff so that the tracheal cuff is connected to the breathing passage of the mask support device;

[0026] Placing step: placing the softened mask on the patient's head and neck, so that the shell of the mask support device supports the portion of the mask located at the tracheal cuff;

[0027] Molding step: Cooling and molding the mask.

[0028] A further technical solution may also be that, after the support device setting step, it also includes: acquiring the patient's breathing dynamics and forming a breathing signal; and controlling the guide component to operate in response to the breathing signal to guide the fluid movement in the breathing channel.

[0029] The mask support device effectively protects the tracheal cuff through the breathing channel inside the shell, preventing the mask material from directly contacting or squeezing the tracheal cuff, thereby ensuring the patient's breathing safety. At the same time, the external structure of the shell provides a stable support point for the mask, so that the mask can maintain an appropriate shape and space at the location of the patient's tracheal cuff, avoiding the mask squeezing the tracheal cuff to stimulate the patient's airway and cause choking and coughing, and ultimately causing the patient to move slightly and cause radiotherapy positioning errors.

[0030] This mask manufacturing method, through the use of a mask support device, cleverly solves the special needs of patients with laryngeal or hypopharyngeal cancer in the process of making radiotherapy positioning masks. It not only protects the patient's tracheal cuff, but also provides support for the mask's molding, ensuring the proper shape of the mask at the tracheal cuff position. The innovation of this method is that it combines the mask manufacturing process with tracheal cuff protection, improving the accuracy of radiotherapy positioning and the comfort of the patient. At the same time, this method also simplifies the mask manufacturing process, improves efficiency, and provides a practical solution for medical staff. In addition, the mask made by this method can provide accurate radiotherapy positioning while protecting the tracheal cuff. Compared with traditional methods, this method significantly reduces the risk of compression of the tracheal cuff and improves the comfort of the patient. At the same time, the appropriate space formed by the mask at the tracheal cuff position not only protects the tracheal cuff, but also provides better breathing conditions for the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to more clearly illustrate the embodiments of the present invention or the existing technical solutions, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0032] Figure 1 This is a structural schematic diagram of a mask support device in an embodiment of the present invention;

[0033] Figure 2 It is a structural schematic diagram of a mask supporting device in another embodiment of the present invention;

[0034] Figure 3 It is a structural schematic diagram of a mask supporting device in another embodiment of the present invention;

[0035] Figure 4 It is a structural schematic diagram of a mask supporting device in another embodiment of the present invention;

[0036] Figure 5 is a flow chart of a mask manufacturing method according to an embodiment of the present invention;

[0037] Figure 6 It is a structural schematic diagram of a mask supporting device in another embodiment of the present invention;

[0038] Figure 7 This is a schematic diagram of the usage status of a positioning mask used to fix a patient in a radiotherapy environment, where the arrow in the figure points to the tracheal cuff.

[0039] Description of reference numerals:

[0040] 1. Shell;

[0041] 2. breathing passage; 21. first opening; 22. second opening; 23. accommodation section; 24. guide section;

[0042] 3. Respiratory monitoring component; 4. Fan. DETAILED DESCRIPTION

[0043] In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0044] Implementation Method 1

[0045] In a first aspect, the present embodiment discloses a mask support device, such as Figure 1 As shown, including:

[0046] A housing 1, wherein the housing 1 has a breathing passage 2 therein, and the breathing passage 2 is used for access to a tracheal cannula installed after laryngeal or hypopharyngeal tumor resection;

[0047] The shell 1 can support a radiotherapy positioning mask to provide molding support for the mask while protecting the tracheal cuff.

[0048] The mask support device effectively protects the tracheal cuff through the breathing channel 2 inside the shell 1, preventing the mask material from directly contacting or squeezing the tracheal cuff, thereby ensuring the patient's breathing safety. At the same time, the external structure of the shell 1 provides a stable support point for the mask, so that the mask can maintain an appropriate shape and space at the location of the patient's tracheal cuff, avoiding the mask from squeezing the tracheal cuff to stimulate the patient's airway and cause choking, and ultimately causing the patient to move slightly and cause radiotherapy positioning errors.

[0049] It is worth mentioning that the mask support device significantly improves the comfort and safety of patients during mask making and radiotherapy. In traditional methods, in order to ensure the fit of the mask, a certain degree of compression is sometimes caused to the tracheal cuff, causing breathing discomfort or anxiety in patients. The mask support device in this embodiment completely protects the tracheal cuff through the breathing channel 2, avoiding any compression of the tracheal cuff by the mask, greatly improving the comfort and sense of security of patients, and helping patients to better cooperate with radiotherapy treatment.

[0050] The second aspect of the embodiment also discloses a method for manufacturing a mask for positioning laryngeal or hypopharyngeal cancer radiotherapy, such as Figure 5 As shown, the following steps are included:

[0051] Mask softening steps: Soften the mask;

[0052] Support device setting step: setting the mask support device on the patient's tracheal cuff so that the tracheal cuff is connected to the breathing passage 2 of the mask support device;

[0053] Placing step: placing the softened mask on the patient's head and neck, so that the shell 1 of the mask support device props up the part of the mask located at the tracheal cuff;

[0054] Molding step: Cooling and molding the mask.

[0055] Among them, the mask softening step softens the mask so that it can fit the shape of the patient's head and neck, preparing for subsequent molding.

[0056] The support device setting step sets the mask support device on the patient's tracheal cuff to ensure that the tracheal cuff is connected to the breathing passage 2. This step not only protects the tracheal cuff, but also provides support for the mask.

[0057] The placement step places the softened mask on the patient's head and neck, and uses the shell 1 of the support device to prop up the mask, which ensures that there is enough space for the mask at the tracheal cuff position and does not compress the tracheal cuff.

[0058] The molding step shapes the mask through cooling, fixes the position of the patient's head and neck, and provides an accurate reference for radiotherapy positioning.

[0059] The mask manufacturing method disclosed in this embodiment, through the use of a mask support device, cleverly solves the special needs of patients with laryngeal or hypopharyngeal cancer in the process of making radiotherapy positioning masks. It not only protects the patient's tracheal cuff, but also provides support for the molding of the mask, ensuring the appropriate shape of the mask at the tracheal cuff position. The innovation of this method lies in combining the mask manufacturing process with tracheal cuff protection, improving the accuracy of radiotherapy positioning and the comfort of the patient. At the same time, this method also simplifies the mask manufacturing process, improves efficiency, and provides a practical solution for medical staff. In addition, the mask made by this method can provide accurate radiotherapy positioning while protecting the tracheal cuff. Compared with traditional methods, this method significantly reduces the risk of compression of the tracheal cuff and improves the comfort of the patient. At the same time, the appropriate space formed by the mask at the tracheal cuff position not only protects the tracheal cuff, but also provides better breathing conditions for the patient.

[0060] Implementation Method 2

[0061] This embodiment is a further improvement based on the first embodiment, and its improvement is: Figure 2 As shown, the two ends of the breathing passage 2 are respectively provided with a first opening 21 and a second opening 22;

[0062] The opening size of the second opening 22 is larger than the first opening 21;

[0063] The cross-sectional area of ​​the breathing passage 2 gradually increases from the first opening 21 toward the second opening 22 .

[0064] Openings of different sizes are set at both ends of the breathing channel 2, and the second opening 22 is larger than the first opening 21. This design can reduce airflow resistance and facilitate patient breathing. The cross-sectional area of ​​the breathing channel 2 gradually increases from the first opening 21 to the second opening 22, forming an expanded channel structure. This structural design helps to reduce the airflow velocity, reduce turbulence and eddy currents, and make the airflow more stable, thereby improving breathing comfort. Through this special design of the breathing channel 2, the mask support device can better adapt to the patient's breathing needs. The expanded channel structure can not only reduce the resistance of the patient's breathing, but also improve the gas exchange efficiency. This design takes into account the physical properties of gas flow. By gradually increasing the cross-sectional area, the airflow velocity can be effectively reduced and the turbulence phenomenon can be reduced, so that the patient can breathe more smoothly and comfortably. At the same time, this structure is also conducive to reducing the noise generated during the breathing process, further enhancing the patient's user experience. It is worth mentioning that in this embodiment, the first opening 21 corresponds to the tracheal cuff, and the first opening 21 and the second opening 22 are respectively located on the bottom and top surfaces of the shell 1. The size of the second opening 22 is set to be larger than the size of the first opening 21, which can effectively improve the stability of the mask support device and avoid the mask from collapsing when it is pressed down.

[0065] In some preferred embodiments, the angle between the line connecting the center points of the first opening 21 and the second opening 22 and the direction of the tracheal cuff is an acute angle.

[0066] During the mask manufacturing process, the patient lies flat. At this time, the direction of the tracheal cuff on the patient is roughly vertical; the angle between the line connecting the center points of the first opening 21 and the second opening 22 and the direction of the tracheal cuff is defined as an acute angle, in other words, the extension direction of the breathing passage 2 is a direction inclined to the horizontal plane.

[0067] By such arrangement, the inclined breathing passage 2 can guide the airflow exhaled or inhaled in the airway. In addition, in practical applications, the mask support device is placed in a form in which the first opening 21 is close to the head and the second opening 22 is close to the patient's feet. In this way, by using the inclined breathing passage 2, the flow direction of the airflow is staggered with the patient's chin, so that the airflow is not affected by the patient's chin, and the situation that the backflow of carbon dioxide affects the breathing due to the formation of reflux in the breathing passage 2 is avoided, so as to protect the patient's only remaining life passage.

[0068] In addition, since the temperature of the airflow exhaled by the patient is higher and the temperature of the airflow inhaled is lower, in the inclined respiratory passage 2, the airflow with a higher temperature exhaled by the patient flows along the upper part of the respiratory passage 2, while the fresh air from the outside flows along the lower part of the respiratory passage 2 due to its higher temperature. In other words, the exhaled airflow and the inhaled airflow can flow along their respective paths in the respiratory passage 2, with less influence on each other, which can reduce the resistance of the patient's breathing, improve the gas exchange efficiency, and provide better breathing conditions for the patient.

[0069] It is worth mentioning that in some embodiments, in order to avoid interference between the inclined breathing channel 2 and the tracheal cuff, Figure 6 As shown, the side of the breathing channel 2 close to the airway can be set in a vertical form. In this way, on the one hand, the inner diameter of the breathing channel 2 can be increased to ensure smooth breathing of the patient; on the other hand, an avoidance space can be provided for the access of the airway to avoid interference between the breathing channel 2 and the tracheal cuff, thereby improving the comfort of the patient.

[0070] Implementation Method 3

[0071] This embodiment is a further improvement based on the first embodiment or the second embodiment, and the improvement lies in that the structure of the breathing passage 2 is further limited. Specifically, Figure 3 As shown, the breathing channel 2 includes:

[0072] An accommodating section 23, located on a side close to the first opening 21 and capable of accommodating the tracheal cuff, wherein an extending direction of the accommodating section 23 is consistent with a direction of the tracheal cuff;

[0073] The guide section 24 is connected to the accommodating section 23 and is located on a side close to the second opening 22 . The included angle between the extending direction of the guide section 24 and the direction of the tracheal cuff is an acute angle.

[0074] In this embodiment, the function of the accommodating section 23 is to accommodate the tracheal cuff, and its extending direction is consistent with the direction of the tracheal cuff, so that the tracheal cuff can be stably placed in the breathing passage 2. The guiding section 24 is connected to the accommodating section 23 and extends toward the second opening 22. The extending direction of the guiding section 24 forms an acute angle with the first direction (i.e., the extending direction of the accommodating section 23), and this design can guide the direction of the airflow, making it easier to circulate.

[0075] Through this structural design, the breathing channel 2 can well adapt to the placement of the tracheal cuff, and can also effectively guide the airflow. The accommodating section 23 ensures the stability of the tracheal cuff, while the guiding section 24 optimizes the flow path of the airflow. This design can not only protect the tracheal cuff, but also improve the efficiency of breathing, thereby better meeting the needs of patients.

[0076] The design of setting the angle between the extending direction of the guide section 24 and the direction of the tracheal cuff to an acute angle can guide the airflow exhaled or inhaled in the trachea. In addition, in actual application, the mask support device is placed in a form in which the first opening 21 is close to the head and the second opening 22 is close to the patient's feet. In this way, the flow direction of the airflow and the patient's chin are staggered by the inclined guide section 24, so that the airflow will not be affected by the patient's chin, avoiding the formation of vortices in the respiratory duct 2 due to the airflow hitting the chin, thereby causing carbon dioxide backflow to affect breathing.

[0077] In addition, since the temperature of the airflow exhaled by the patient is higher and the temperature of the airflow inhaled is lower, in the inclined guide section 24, the airflow with a higher temperature exhaled by the patient flows along the upper part of the guide section 24, while the fresh air from the outside flows along the lower part of the guide section 24 due to its higher temperature. In other words, the exhaled airflow and the inhaled airflow can flow along their own paths in the guide section 24 respectively, with less influence on each other, which can reduce the resistance of the patient's breathing, improve the gas exchange efficiency, and provide better breathing conditions for the patient.

[0078] In some preferred embodiments, the size of the accommodating section 23 matches that of the tracheal cuff, and the cross-sectional area of ​​the guiding section 24 gradually increases from the first opening 21 toward the direction where the second opening 22 is located.

[0079] The accommodating section 23 is arranged to match the size of the tracheal cuff, which can play a role in fixing and positioning the mask support device. During the placement of the mask, the mask support device is kept stable through the cooperation between the accommodating section 23 and the tracheal cuff, avoiding the situation where the mask molding is affected by displacement, thereby improving the accuracy and adaptability of the mask molding.

[0080] Setting the guide section 24 to an expanded channel structure can not only reduce the resistance of the patient's breathing, but also improve the gas exchange efficiency. This design takes into account the physical characteristics of gas flow. By gradually increasing the cross-sectional area, it can effectively reduce the airflow speed and reduce turbulence, so that the patient can breathe more smoothly and comfortably. At the same time, this structure is also conducive to reducing the noise generated during breathing, further improving the patient's experience.

[0081] Specifically, in this embodiment, Figure 3 As shown, the mask support device is placed along the length of the patient's neck when in use, and the first opening 21 of the breathing passage 2 is close to the head, while the second opening 22 is close to the patient's feet. Therefore, the size setting of the mask support device can refer to the following settings:

[0082] 1. The mask support device needs to be placed flat on the patient's neck and not fall easily. According to clinical experience, the flat area for placing the mask support device is roughly the area between the patient's chin and the bilateral clavicles. According to clinical knowledge, the male-to-female ratio of laryngeal cancer is 10.5:1 and it is more common in northern provinces. Therefore, the inventor measured data on 30 patients from northern provinces. The measured distance data was the distance between the patient's chin and the bilateral clavicles, and the average value of the measured data was 7.22cm. In this embodiment, in order to ensure that the mask support device can be placed stably on the patient's neck with room to spare and not fall, the distance is reduced by 1cm, and the distance is used as the distance from the bottom of the mask support device (i.e., the surface where the first opening 21 is located) along the length of the patient's neck in the extension direction, that is, the length distance of the bottom of the mask support device is set to 6.22cm;

[0083] 2. The top of the mask support device needs to ensure that the second opening 22 is fully accommodated, and in order to avoid the mask support device being top-heavy, the length of the top of the mask support device can be set to be less than or equal to the length of the bottom. In this embodiment, in order to achieve the maximum ventilation space for the patient, the length of the top of the mask support device is set to 6.22 cm;

[0084] 3. The accommodating section 23 is used to accommodate the tracheal cuff. Therefore, in principle, the height setting of the accommodating section 23 should ensure that the tracheal cuff can be fully accommodated. According to clinical surgical guidelines, the tracheal cuff for laryngeal cancer surgery is generally less than 2 cm. Based on clinical experience, most laryngeal cancer patients have difficulty breathing, and the rise and fall of the chest will pull the neck up and down. In order to prevent the tracheal cuff from hitting the inclined guide section 24, the height of the accommodating section 23 can be set outward and 0.5 cm can be reserved, that is, the height of the accommodating section 23 can be set to 2.5 cm;

[0085] 4. The first opening 21 is used to connect the tracheal cuff. Therefore, the diameter of the first opening should ensure that the tracheal cuff is fully accommodated in principle. According to clinical surgical guidelines, the diameter of the tracheal cuff is 1.5 cm. Based on clinical experience, most laryngeal cancer patients have difficulty breathing, and the rise and fall of the chest will pull the neck to move together. In order to prevent interference between the tracheal cuff and the first opening 21, the diameter can be increased by 2 times, that is, the diameter of the first opening is set to 3 cm;

[0086] 5. The diameter of the second opening 22 should, in principle, be smaller than the length of the top of the mask support device; however, in order to ensure smooth ventilation, the diameter of the second opening 22 should be larger than the lower opening diameter, and to ensure overall stability and achieve maximum ventilation, the diameter of the second opening 22 can be set to 5 cm;

[0087] 6. The overall height of the mask support device should in principle ensure that the tracheal sleeve and the guide section 24 are fully accommodated; however, the overall height cannot be too high to prevent collapse. Therefore, the height of the accommodating section 23 is 2.5 cm, and the overall height of the mask support device can be set to 5 cm.

[0088] Implementation Method 4

[0089] This embodiment is a further improvement based on any one of the first, second or third embodiments, and the improvement is that: Figure 4 As shown, the mask support device also includes:

[0090] A respiratory monitoring component 3, used to monitor the patient's respiratory dynamics and form a respiratory signal;

[0091] A guiding component, used for guiding the movement of fluid in the breathing passage 2;

[0092] The controller is respectively connected to the respiratory monitoring component 3 and the guiding component for communication, and the controller controls the guiding component to work in response to the respiratory signal.

[0093] The respiratory monitoring component 3 provides the controller with real-time data of the patient's respiratory status by monitoring the patient's respiratory dynamics and generating respiratory signals. The guiding component is used to guide the fluid movement in the respiratory channel 2. As a core component, the controller receives the signals from the respiratory monitoring component 3 and controls the operation of the guiding component according to these signals, thereby realizing intelligent regulation of the fluid in the respiratory channel 2.

[0094] In some embodiments, Figure 4 As shown, the guide component is:

[0095] The fan 4 is disposed in the breathing passage 2 and faces the second opening 22 .

[0096] The fan 4 is arranged in the respiratory passage 2 and faces the second opening 22. It can generate airflow by rotating, thereby guiding the fluid in the respiratory passage 2 to flow in the direction of the second opening 22. This method can actively control the direction and speed of the airflow, which is conducive to timely removal of respiratory secretions. Specifically, in practical applications, when the patient wears the mask support device, the respiratory monitoring component 3 will start working immediately and continuously monitor the patient's respiratory state. The controller can analyze these data in real time to determine whether the patient has difficulty breathing or abnormalities. If a problem is detected, the controller will immediately activate the fan 4 and adjust the airflow state in the respiratory passage 2. For example, if the patient's breathing rate is detected to be accelerated, it may indicate that the patient needs more oxygen, and the controller may instruct the fan 4 to increase the air intake; if the exhalation is detected to be poor, the controller may instruct the fan 4 to adjust the airflow direction to help the patient exhale more easily.

[0097] This real-time monitoring and automatic adjustment method can quickly respond to changes in the patient's breathing needs and effectively prevent possible breathing difficulties. At the same time, because the system can automatically adapt to the patient's breathing pattern, it also greatly reduces the workload of medical staff.

[0098] The mask support device effectively solves the breathing difficulties that may occur during use of the patient through the respiratory monitoring and adjustment system, improves the safety and comfort of the mask support device, and provides patients with a better treatment experience.

[0099] In some other embodiments, the guide assembly can also be a drainage assembly, which is connected to the second opening 22. The drainage assembly can be essentially an aspirator, which uses the negative pressure principle to guide the fluid in the respiratory passage 2 to flow out. In practical applications, when the patient wears the mask support device, the respiratory monitoring assembly 3 will start working immediately and continuously monitor the patient's respiratory state. The controller will analyze these data in real time to determine whether the patient has difficulty breathing or abnormalities. If a problem is detected, the controller will immediately activate the drainage assembly and use the drainage assembly to suck the respiratory secretions accumulated in the tracheal sleeve to avoid blocking the through hole of the tracheal sleeve and affecting the patient's breathing. For example, the drainage assembly includes an external aspirator, and the suction tube of the aspirator is connected to the respiratory passage 2 from the second opening 22, and extends to the first opening 21, which is used to suck the secretions of the respiratory tract from the air duct.

[0100] The above two guide components can effectively guide the fluid movement in the respiratory passage 2, thereby maintaining the patency of the respiratory passage 2, reducing the accumulation of secretions, and reducing the risk of infection. At the same time, they can also cooperate with the respiratory monitoring component 3 and the controller to automatically adjust the working state according to the patient's respiratory dynamics, thereby improving the intelligence level and comfort of the device. Specifically, the respiratory monitoring component 3 can monitor the patient's respiratory state in real time, and the controller adjusts the working parameters of the guide component according to the monitoring results. For example, when the patient exhales, the speed of the fan 4 is increased or the negative pressure value is increased to accelerate the discharge of secretions; when inhaling, the guidance intensity is appropriately reduced to reduce the impact on normal breathing. This intelligent control not only improves the guidance effect, but also enhances the patient's comfort.

[0101] In some embodiments, the respiratory monitoring component 3 is:

[0102] Piezoelectric ceramic sheets are used to convert air vibrations caused by the patient's breathing into electrical signals to monitor the patient's breathing dynamics.

[0103] The use of piezoelectric ceramics as the respiratory monitoring component 3 can convert the air vibrations generated during the patient's breathing process into electrical signals. This method has the advantages of high sensitivity and fast response speed, and can accurately monitor the patient's respiratory state in real time. By using piezoelectric ceramics to monitor respiratory dynamics, the patient's respiratory information can be obtained in time. This information can be transmitted to the controller, and the controller adjusts the working state of the guide component according to the respiratory signal. For example, when it is detected that the patient has difficulty breathing, the speed of the fan 4 can be increased or the working intensity of the drainage component can be adjusted to ensure that the patient can breathe normally. This technical solution can provide a more comfortable and safe breathing environment for patients wearing mask support devices by accurately monitoring respiratory dynamics and combining intelligent control of the guide component. At the same time, this non-invasive monitoring method will not cause additional discomfort to the patient and is suitable for long-term use.

[0104] Implementation Method 5

[0105] This embodiment is a further improvement based on the fourth embodiment, and its improvement lies in:

[0106] After the support device setting step, the method further includes:

[0107] Acquiring the patient's respiratory dynamics and forming a respiratory signal;

[0108] The guiding component is controlled to work in response to the breathing signal to guide the movement of the fluid in the breathing passage 2 .

[0109] The purpose of the above arrangement is to solve the respiratory management problem in the mask manufacturing process, by monitoring the patient's respiratory condition in real time, responding to respiratory changes in a timely manner, and adjusting the working mode of the guide component, so as to effectively manage the fluid flow in the respiratory channel 2.

[0110] In some embodiments, the breathing signal can be a breathing interval signal. The air vibration caused by the patient's breathing is converted into an electrical signal through a piezoelectric ceramic sheet. The controller can obtain the patient's breathing pattern according to the fluctuation pattern of the electrical signal of the piezoelectric ceramic sheet, and generate a breathing interval signal. The controller can control the guide component to work according to the breathing interval signal to adapt to the patient's breathing interval. For example, if the guide component is a fan 4, the controller controls the fan 4 to rotate forward or reverse according to the breathing interval signal to adapt to the patient's breathing pattern.

[0111] In some embodiments, after the support setting step, the method further includes:

[0112] Respiratory calibration steps: obtain the patient's respiratory dynamics and record the patient's basic respiratory parameters;

[0113] Respiratory detection steps: obtain the patient's real-time respiratory dynamics and obtain the patient's real-time respiratory parameters;

[0114] Comparison step: comparing the real-time breathing parameters with the basic breathing parameters;

[0115] If the difference between the real-time breathing parameter and the basic breathing parameter is greater than the set threshold, a breathing adjustment signal is generated, and the control guidance component works according to the breathing adjustment signal.

[0116] In some embodiments, the respiratory parameters may include a respiratory frequency parameter for indicating the patient's respiratory frequency; and a respiratory depth parameter for indicating the patient's respiratory depth. For example, a piezoelectric ceramic piece is used as the respiratory monitoring component 3, and the electrical signal of the piezoelectric ceramic piece is used as the y-axis and the time is used as the x-axis to draw a respiratory curve. The respiratory curve is roughly a fluctuation curve, in which the time interval between adjacent peaks and valleys is the patient's respiratory frequency; the peaks and valleys of the fluctuation curve represent the patient's exhalation and inhalation, respectively.

[0117] When the patient breathes normally, the time interval between adjacent peaks and valleys is relatively stable, that is, the basic respiratory rate parameter. If the difference between the real-time respiratory rate parameter and the basic respiratory rate parameter is greater than the set threshold, it means that the patient's breathing is not smooth, and the guidance component needs to intervene to guide the patient's respiratory airflow. For example, if the respiratory rate increases from the normal 16 times / minute to 22 times / minute, the system will increase the speed of fan 4 from 50% to 75% to increase gas exchange efficiency.

[0118] When the patient breathes normally, the size of the electrical signal corresponding to the peak of the fluctuation curve is also relatively fixed; similarly, the size of the electrical signal corresponding to the valley of the fluctuation curve is also relatively fixed. In some embodiments, the size of the electrical signal corresponding to the peak of the fluctuation curve can be used as a breathing depth parameter, the size of the electrical signal corresponding to the valley of the fluctuation curve can be used as a breathing depth parameter, and the difference in electrical signals between adjacent peaks and valleys of the fluctuation curve can also be used as a breathing depth parameter. When the patient breathes normally, the measured breathing depth parameter is the basic breathing depth parameter. If the difference between the real-time respiratory frequency parameter and the basic respiratory frequency parameter is greater than the set threshold, it means that the patient's breathing is not smooth or the tracheal cuff is blocked by respiratory secretions, and the guide component needs to intervene to guide the patient's respiratory airflow or suction respiratory secretions.

[0119] In the embodiment, when solving the respiratory management problem in the mask manufacturing process, the patient's respiratory dynamics are first monitored in real time through the respiratory monitoring component 3, and a respiratory signal is generated. After receiving these respiratory signals, the controller will analyze and process them according to a preset algorithm. For example, it may calculate the respiratory frequency and depth, and identify whether there are abnormal conditions such as apnea. Based on these analysis results, the controller will generate corresponding control instructions.

[0120] The guide component adjusts its working state according to these control instructions. If the fan 4 is used, the controller may adjust the speed and direction of the fan 4; if the drainage component is used, its opening or suction intensity may be adjusted. These adjustments are all to ensure that the gas flow in the breathing channel 2 is synchronized with the patient's breathing rhythm, so as not to cause excessive breathing resistance or gas stagnation.

[0121] Through this real-time monitoring and dynamic adjustment mechanism, the technical solution of the present application can effectively manage breathing problems during the mask manufacturing process. It can not only ensure that the patient breathes smoothly during the mask manufacturing process, but also make personalized adjustments based on the patient's breathing characteristics, thereby improving the comfort and safety of mask manufacturing. Compared with traditional static breathing management methods, the solution of the present application is more flexible and accurate, can adapt to the needs of different patients, and significantly improves the production quality and use effect of radiotherapy positioning masks for patients with laryngeal or hypopharyngeal cancer.

[0122] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the embodiments of the present invention rather than to limit them. Although the embodiments of the present invention have been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solutions of the embodiments of the present invention can still be modified or replaced by equivalents, and these modifications or equivalent replacements cannot cause the modified technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A mask support device, characterized in that: include: A housing having a breathing passage therein, wherein the breathing passage is used for access to a tracheal cannula installed after laryngeal or hypopharyngeal tumor resection; The shell can support a radiotherapy positioning mask to provide shaping support for the mask while protecting the tracheal cuff.

2. The mask support device according to claim 1, characterized in that: The two ends of the breathing passage are respectively provided with a first opening and a second opening; The second opening has an opening size larger than the first opening; The cross-sectional area of ​​the breathing passage gradually increases from the first opening toward the direction where the second opening is located.

3. The mask support device according to claim 1, characterized in that: The angle between the line connecting the center points of the first opening and the second opening and the direction of the tracheal cuff is an acute angle.

4. The mask support device according to claim 1, characterized in that: The breathing passage comprises: an accommodating section, located on a side close to the first opening and capable of accommodating the tracheal cuff, wherein an extending direction of the accommodating section is consistent with a direction of the tracheal cuff; The guide section is connected to the accommodating section and is located on a side close to the second opening. The included angle between the extending direction of the guide section and the direction of the tracheal cuff is an acute angle.

5. The mask support device according to any one of claim 4, characterized in that: The size of the accommodating section matches that of the tracheal cuff, and the cross-sectional area of ​​the guiding section gradually increases from the first opening toward the direction where the second opening is located.

6. The mask support device according to any one of claims 2 to 5, characterized in that: Also includes: A respiratory monitoring component, used to monitor the patient's respiratory dynamics and form a respiratory signal; a guiding component for guiding the movement of fluid in the breathing passage; The controller is communicatively connected with the respiratory monitoring component and the guiding component respectively, and the controller controls the guiding component to work in response to the respiratory signal.

7. The mask support device according to claim 5, characterized in that: The guide component is: a fan, disposed in the breathing passage and facing the second opening; or, The drainage component is connected to the second opening.

8. The mask support device according to claim 7, characterized in that: The respiratory monitoring component is: Piezoelectric ceramic sheets are used to convert air vibrations caused by the patient's breathing into electrical signals to monitor the patient's breathing dynamics.

9. A method for manufacturing a mask for positioning radiotherapy for laryngeal or hypopharyngeal cancer, characterized in that: The following steps are involved: Mask softening steps: Soften the mask; Support device setting step: setting the mask support device on the patient's tracheal cuff so that the tracheal cuff is connected to the breathing passage of the mask support device; Placing step: placing the softened mask on the patient's head and neck, so that the shell of the mask support device supports the portion of the mask located at the tracheal cuff; Molding step: Cooling and molding the mask.

10. The mask manufacturing method according to claim 9, characterized in that: After the support device setting step, the method further includes: Acquiring the patient's respiratory dynamics and forming a respiratory signal; The guiding component is controlled to operate in response to the breathing signal to guide the movement of fluid in the breathing passage.

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