阅读说明：本技术 一种新型人体呼吸道模型 (Novel human respiratory tract model ) 是由 周旭东 佟振博 陈江 于 2019-09-18 设计创作，主要内容包括：本发明提出一种新型人体呼吸道模型,其包括：人工喉1、直通气管21、Y形三通3、第一支气管模型、第二支气管模型、第一密封圈16和人工肺泡模型5,其特征在于：第一支气管模型和第二支气管模型分别模拟解剖学的形态设定,并且将第一支气管模型和第二支气管模型的末端的支气管出口进行合并,合并后的支气管出口形成Y形三通3、直通管22和末端枝节4的接口,然后连接到人工肺泡模型5；在第一支气管模型和第二支气管模型中的各种不同的位置具体选择直通管22、Y形三通3或者末端枝节4,是根据该分段的结构决定的,直通管22使用在受力较大的位置,Y形三通和末端枝节4使用在空间比较小的位置。(The invention provides a novel human respiratory tract model, which comprises: artifical larynx 1, straight trachea 21, Y shape tee bend 3, first bronchus model, second bronchus model, first sealing washer 16 and artifical alveolar model 5, its characterized in that: the first bronchus model and the second bronchus model respectively simulate the shape setting of anatomy, and the bronchus outlets at the tail ends of the first bronchus model and the second bronchus model are combined, and the combined bronchus outlets form the interfaces of a Y-shaped tee joint 3, a straight-through pipe 22 and a tail end branch joint 4 and are then connected to the artificial alveolus model 5; the straight-through pipe 22, the Y-shaped tee 3 or the end branch 4 is specifically selected at various positions in the first and second bronchus models and is determined according to the structure of the segment, the straight-through pipe 22 is used at a position with larger stress, and the Y-shaped tee and the end branch 4 are used at a position with smaller space.)

1. A novel human respiratory model, comprising: the artificial larynx comprises an artificial larynx (1), a straight-through trachea (21), a Y-shaped tee joint (3), a first bronchus model, a second bronchus model, a first sealing ring (16) and an artificial alveolus model (5), wherein the artificial larynx (1) comprises an artificial pharynx port interface (11), a first artificial larynx component (12), a second artificial larynx component (13), an artificial larynx trachea interface (14) and an artificial larynx internal air passage (15), the artificial larynx internal air passage (15) is respectively arranged inside the first artificial larynx component (12) and the second artificial larynx component (13), the artificial larynx internal air passage (15) inside the first artificial larynx component (12) and the second artificial larynx component (13) can be matched with each other, a sealing groove is arranged on the periphery of the artificial larynx air passage (15), the first sealing ring (16) is arranged in the sealing groove, one end of the artificial larynx internal air passage (15) is communicated with the air passage interface (11), the other end of the artificial larynx internal air passage (15) is communicated with the artificial larynx trachea interface (14); the straight-through trachea (21) comprises a trachea main body structure, a first interface (211) and a second interface (212) which are positioned at two ends of the straight-through trachea (21), the first interface (211) is connected with the artificial laryngotracheal interface (14), the second interface (212) is connected with a fourth interface (311) of the Y-shaped tee joint (3), a fifth interface (312) of the first Y-shaped tee joint (3) is connected with the first bronchus model, a sixth interface (313) of the first Y-shaped tee joint (3) is connected with the second bronchus model, the first bronchus model and the second bronchus model are connected in a segmented mode by adopting one or more of the Y-shaped tee joint (3), the straight-through tube (22) and the tail end branch (4), the tail ends of the interfaces of the Y-shaped tee joint (3), the straight-through tube (22) and the tail end branch (4) are connected with the artificial alveolus model (5), and when one segment is connected with an adjacent segment, the kneck is the cooperation of a pin thread and a box respectively to be equipped with sealing washer or seal ring in pin thread and box mouth cooperation department, can make the connection between two adjacent subsections not have gaseous revealing its characterized in that like this: the first bronchus model and the second bronchus model respectively simulate the anatomical form setting, the bronchus outlets at the tail ends of the first bronchus model and the second bronchus model are combined, and the combined bronchus outlets form a Y-shaped tee joint (3), a straight-through pipe (22) and an interface of a tail-end branch joint (4) and are then connected to the artificial alveolar model (5); the straight pipe (22), the Y-shaped tee joint (3) or the end branch (4) is specifically selected at various positions in the first bronchus model and the second bronchus model and is determined according to the structure of the segment, the straight pipe (22) is used at a position with larger stress, and the Y-shaped tee joint and the end branch (4) are used at a position with smaller space.

2. The novel human airway model of claim 1 wherein: the number of the artificial alveolus models (5) is 5-50.

3. The novel human airway model of claim 1 wherein: the interfaces of all the artificial alveolus models (5) adopt one of a male buckle or a female buckle.

4. The novel human airway model of claim 1 wherein: when the interfaces on all the artificial alveolar models (5) adopt male buckles, the interfaces of the straight-through pipe (22), the Y-shaped tee (3) or the tail end branch (4) connected with the interfaces on the artificial alveolar models (5) are female buckles; when the interfaces on all the artificial alveolus models (5) adopt female buckles, the interfaces of the straight-through pipe (22), the Y-shaped tee (3) or the tail end branch (4) connected with the interfaces on the artificial alveolus models (5) are male buckles.

5. The novel human airway model of claim 1 wherein: the assembly mouth of first artificial larynx subassembly (12) adopts first U-shaped incision (121), the assembly mouth of second artificial larynx subassembly (13) adopts second U-shaped incision (131), first U-shaped incision (121) and second U-shaped incision (131) can match and coincide, artificial pharynx mouth portion interface (11) and artificial larynx trachea interface (14) are complete structure, the complete entry position in first artificial larynx subassembly (12) of combination of artificial pharynx mouth portion interface (11), the complete combination in the export position of first artificial larynx subassembly (12) of artificial larynx trachea interface (14).

6. The novel human airway model of claim 1 wherein: the first bronchus model comprises a second Y-shaped tee joint (32), a third Y-shaped tee joint (33), a fourth Y-shaped tee joint (34), a terminal branch joint (4) and an artificial alveolar model (5), wherein the second Y-shaped tee joint (32) comprises a seventh interface (321), an eighth interface (322) and a ninth interface (323), the third Y-shaped tee joint (33) comprises a tenth interface (331), an eleventh interface (332) and a twelfth interface (333), the fourth Y-shaped tee joint (34) comprises a thirteenth interface (341), a fourteenth interface (342) and a fifteenth interface (343), the terminal branch joint (4) comprises a twenty-second interface (41), a twenty-third interface (42), a twenty-fourth interface (43) and a twenty-fifth interface (44), wherein the seventh interface (321) is connected with the fifth interface (312), and the eighth interface (322) is connected with the thirteenth interface (341), the ninth interface (323) is connected with the tenth interface (331), the eleventh interface (332) and the twelfth interface (333) are connected with the artificial alveolar model (5), the fourteenth interface (342) is connected with the artificial alveolar model (5), the fifteenth interface (343) is connected with the twenty-second interface (41), and the twenty-third interface (42), the twenty-fourth interface (43) and the twenty-fifth interface (44) are connected with the artificial alveolar model (5).

7. The novel human airway model of claim 1 wherein: the second bronchus model comprises a straight-through pipe (22), a fifth Y-shaped tee joint (35), a sixth Y-shaped tee joint (36), a seventh Y-shaped tee joint (37) and an artificial alveolar model (5), wherein the straight-through pipe (22) comprises a third interface (221) and a fourth interface (222), the fifth Y-shaped tee joint (35) comprises a sixteenth interface (351), a seventeenth interface (352) and an eighteenth interface (353), the sixth Y-shaped tee joint (36) comprises a nineteenth interface (361), a twentieth interface (362) and a twenty-first interface (363), the seventh Y-shaped tee joint (37) comprises a twenty-sixth interface (371), a twenty-seventh interface (372) and a twenty-eighth interface, the third interface (221) is connected with the sixth interface (313), the fourth interface (222) is connected with the sixteenth interface (351), the seventeenth interface (352) is connected with the nineteenth interface (361), the twentieth interface (362) and the twenty-first interface (363) are respectively connected with the artificial alveolar model (5), the eighteenth interface (353) is connected to the twenty-sixth interface (371), and the twenty-seventh interface (372) and the twenty-eighth interface are respectively connected with the artificial alveolar model (5).

8. The novel human airway model of claim 6 or 7 wherein: the interface of the artificial alveolar model (5) adopts a male buckle, and the artificial laryngotracheal interface (14), the second interface (212), the third interface (221), the fourth interface (222), the seventh interface (321), the eighth interface (322), the sixteenth interface (351), the nineteenth interface (361), the twenty-sixth interface (371) and the twenty-second interface (41) adopt male buckles, and the first interface (211), the fourth interface (311), the fifth interface (312), the sixth interface (313), the ninth interface (323), the tenth interface (331), the eleventh interface (332), the twelfth interface (333), the thirteenth interface (341), the fourteenth interface (342), the fifteenth interface (343), the seventeenth interface (352), the eighteenth interface (353), the twentieth interface (362), the twenty-first interface (363), the twenty-seventh interface (372), the twenty-eighth interface, the twenty-second interface (41), The twenty-third interface (42), the twenty-fourth interface (43) and the twenty-fifth interface (44) adopt female buckles.

9. The novel human airway model of claim 1 wherein: interface connection department of pin thread and box include pin thread (6), box (7), sealing washer or seal ring (8), wherein one end of pin thread (6) is connected at one of them section end in the segmentation of novel human respiratory tract model, the one end of box (7) is connected at other one section end in the segmentation of novel human respiratory tract model, and can match each other between pin thread (6) and box (7), make one of them section end in the segmentation of novel human respiratory tract model can with other one section end-to-end connection in the segmentation of novel human respiratory tract model, its characterized in that: male buckle main body (65) of male buckle (6) is cylindrical, a gas passage is passed in the inside of male buckle main body (65), be equipped with first spacing guide way (61) on male buckle main body (65), first locking guide way (62), second spacing guide way (63), second locking guide way (64), first spacing guide way (61) and second spacing guide way (63) are located the outside of male buckle main body (65) and are close to the position of free end face, first locking guide way (62) are connected to the position that free end face was kept away from in first spacing guide way (61), second locking guide way (64) are connected to the position that free end face was kept away from in second spacing guide way (63), and the contained angle of first locking guide way (62) and free end face is theta₁The included angle between the second locking guide groove (64) and the free end surface is theta₂(ii) a The box main part (73) of box (7) is the cylinder that upper portion was drawn empty, and box main part (73) includes lateral wall and bottom plate, and the center of bottom plate is equipped with gas passage (4), and the inside of the lateral wall of box (73) is equipped with first spacing boss (71) and second spacing boss (72), and the width of first spacing boss (71) equals with the width of first spacing guide way (61), and the width and the first spacing boss (72) of second spacing boss (72) areThe two limit guide grooves (63) are equal in width, the first limit boss (71) can be inserted into the first limit guide groove (61) and rotate along the first locking guide groove (62), and the second limit boss (72) can be inserted into the second limit guide groove (63) and rotate along the second limit guide groove (64); the sealing ring or the sealing washer (8) is positioned below the free end face of the assembled male buckle (6) and on the upper surface of the base plate of the female buckle (7), the first limiting boss (71) rotates in the first locking guide groove (62), and the second limiting boss (72) can compress the sealing ring or the sealing washer (8) when rotating in the second locking guide groove (64).

10. The novel human airway model of claim 9 wherein: the sealing ring or the sealing washer (8) can be fixed on the upper surface of the bottom plate of the female buckle (7) or the free end surface of the male buckle (6).

11. The novel human airway model of claim 9 wherein: the sealing ring or the sealing washer (8) can be fixed on the upper surface of the bottom plate of the female buckle (7) or the free end surface of the male buckle (6) in an adhesive mode.

12. The novel human airway model of claim 9 wherein: when the sealing ring or the sealing washer (8) is fixed on the free end face of the male buckle (6), the free end face of the male buckle (65) is a plane or the free end face of the male buckle (65) is provided with a sealing ring limiting groove, when the free end face of the male buckle (6) is a plane, the sealing ring or the sealing washer (8) is directly placed on the plane of the free end face, and when the free end face of the male buckle (65) is provided with the sealing ring limiting groove, the sealing ring or the sealing washer (8) is placed in the sealing ring limiting groove of the male buckle (65); when the sealing ring or the sealing washer (8) is placed on the upper surface of the base plate of the female buckle (7), the upper surface of the base plate of the female buckle (7) is a plane or a concave surface, and when the upper surface of the base plate of the female buckle (7) is a plane, the sealing ring or the sealing washer (8) is directly placed on the plane of the upper surface of the base plate; when the upper surface of the bottom plate of the female buckle (7) is a concave surface, a sealing ring limiting groove is formed in the concave area, and a sealing ring or a sealing washer (8) is placed in the sealing ring limiting groove.

13. The novel human airway model of claim 9 wherein: the sealing ring or the sealing gasket (8) can be a standard round or square sealing ring or a sealing gasket, and can also be a customized sealing ring or a customized sealing gasket with an inner special-shaped opening, and the shape of the special-shaped opening is consistent with the shape of an inner gas channel of the male buckle body (65) and the shape of an inner gas channel contacted with the upper surface of the bottom plate of the female buckle (7).

14. The novel human airway model of claim 9 wherein: the included angle theta between the first locking guide groove (62) and the free end surface₁The included angle theta between the second locking guide groove (64) and the free end surface₂And theta₁And theta₂Is acute angle.

15. The novel human airway model of claim 9 wherein: one or more sealing ring fixing clamping grooves are formed in the position, close to the upper surface of the bottom plate, of the side wall of the female buckle main body (73).

16. The novel human airway model of claim 9 wherein: each segment of the novel human respiratory tract model is marked with a code.

17. The novel human airway model of claim 1 wherein: the artificial alveolus model comprises: the filter membrane comprises an upper end cover (51), a second sealing washer (52), a support net (53), a filter membrane (54) and a lower end cover (55), wherein the upper end cover (51) comprises an upper cover main body and a first sealing rib (512), the handle is positioned above the upper cover main body, the lower surface of the upper cover main body is a plane, and the first sealing rib (512) is positioned at the position, close to the outer edge, of the lower surface of the upper cover main body; the lower end cover (55) comprises a lower cover main body, a second sealing rib (552), a bottom air passage (553) and a connector (555), an accommodating cavity is arranged inside the lower cover main body, a bottom air passage (53) is arranged in the accommodating cavity, a through hole is formed in the center of the lower cover main body, the connector (555) penetrates through the through hole, the connector (555) is a through cylindrical through hole, the connector (555) extends towards the direction far away from the accommodating cavity of the lower cover main body, and the second sealing rib (552) is located at the position, close to the edge of the accommodating cavity, of the bottom of the accommodating cavity; the filter membrane (54), the support net (53) and the second sealing washer (52) are sequentially arranged in the accommodating chamber of the lower end cover (55) from bottom to top, and the filter membrane (54) can be fixed by the upper end cover (5) and the support net (53); the upper end cover (51) and the lower end cover (55) can be matched.

18. The novel human airway model of claim 1 wherein: diameter d of the filter membrane (54)₄Diameter d of the supporting net (53)₃Inner diameter d of the second sealing rib (552)_5aThe outer diameter d of the second sealing washer (52)_2bInner diameter d of lower end cap (55)_5bInside diameter d of sealing washer_2a< second sealing rib d_5aThe first sealing rib d₁< second bead inner diameter d_5a。

19. The novel human airway model of claim 17 wherein: the total height of the filter membrane (54) and the supporting net (53) is less than or equal to the height of the second sealing rib (552).

20. The novel human airway model of claim 17 wherein: the outer side edge of the lower cover main body is provided with an anti-slip line (554).

21. The novel human airway model of claim 17 wherein: the upper end cover (51) further comprises a limiting boss (511), the limiting boss (511) is located on the outer side edge of the upper cover main body, a limiting locking groove (551) is formed in the inner edge of the side wall of the lower cover main body, the limiting boss (511) of the upper end cover (51) and the limiting locking groove (551) of the lower end cover (55) are matched and arranged up and down, and the upper end cover (51) is rotated to enable the upper end cover (51) to lock and press the second sealing washer (52); the number of the limit bosses (511) and the limit locking grooves (551) is one or more.

22. The novel human airway model of claim 17 wherein: the material of the filter membrane (54) comprises one of glass fiber, mixed fiber resin or nylon.

23. The novel human airway model of claim 17 wherein: the supporting net (53) is provided with a plurality of air holes, the shape of the air holes is round, oval, triangular or rhombic, and the size of the air holes is 0.1 mm-10 mm.

24. The novel human airway model of claim 17 wherein: the upper end cover (51) and the lower end cover (55) can be locked by a thread locking structure.

Technical Field

The invention relates to the technical field of medical instruments, in particular to a novel human respiratory tract model.

Background

The inhalation preparation has wide application prospect as a drug delivery mode which can target the lung and can deliver drug systemically. At present, relevant inhalation therapeutic drugs are used for treating diseases such as asthma, COPD (chronic obstructive pulmonary disease) and diabetes at home and abroad, but the inhalation therapeutic drugs are still in the imitation stage at home. The evaluation of the inhalation preparation is needed in the imitation of the inhalation preparation and the development of new drugs, and the currently in vitro evaluation and test device guided by the U.S. FDA and Chinese pharmacopoeia is the NGI (cascade impactor). The structure for in vitro evaluation test by adopting the cascade impactor comprises: the air flow outlet is connected with a vacuum pump. The agent enters the inlet through the dispersion device and is deposited at various locations of the device, and the aerodynamic diameter distribution of the agent is calculated by testing the amount of deposition at each location. The L-shaped connecting pipe is the American FDA right-angle larynx, the oral cavity and the throat of a human body are idealized into two circular pipes which are connected in a right-angle mode, the structural difference between the L-shaped connecting pipe and the real human body is large, so some ideal oral cavity and throat models are developed at present, even the ideal oral cavity and throat models only comprise the oral cavity and throat structures of a respiratory system, the difference between other respiratory structures such as a main trachea, a bronchus and the like and the real human body throat structure is not considered, and the ideal oral cavity and throat models cannot represent different groups due to the fact that the respiratory structures of different ages, sexes, race, disease histories and the like are large in difference; in addition, the same person in different respiratory states has different oral cavity volumes, tongue positions, glottis sizes and the like, so that the ideal oral-laryngeal model cannot cover respiratory tracts in all different respiratory states. Moreover, the test result of the structure which adopts the traditional in-vitro evaluation test by adopting the cascade impactor is only the aerodynamic characteristics of the fine particles, and then the lung entering amount of the preparation is calculated according to the generally accepted lung entering diameter of the aerodynamic diameter less than 5 μm in the industry. However, in the real drug particle deposition, particles smaller than 5 μm are also likely to be deposited at the croup position without entering the deep lung, and the structure adopting the cascade impactor for in vitro evaluation test cannot test the deposition amount of the particles at a specific position of the respiratory tract, and has no guiding significance for the evaluation of inhalation preparations requiring the definite drug preparation deposition position.

The invention patent with the patent publication number of CN204797996U discloses an experimental device for measuring the aerosol deposition in a real human upper respiratory tract model flow field, which does not disclose a method for segmenting the model and a method for ensuring the connection among segments, and the air tightness and the segment connection mode of the human respiratory tract model for evaluating the relativity between the inside and the outside of an inhaled preparation are important factors for ensuring the accuracy of a test result. In addition, the method uses a weighing method to measure the deposition amount in the model, and the test precision of the method cannot meet the test requirement of the low dose of the inhalation preparation. In addition, the model uses transparent resin to construct a human respiratory tract model, and the dissolution of the transparent resin determines that the model cannot use an accurate test method such as HPLC, and the like, because unknown reaction may exist between the resin material and the components of the inhalation preparation, such as decomposition of the inhalation preparation, and the test result is influenced.

The invention patent with patent publication number CN206930556U discloses a human body alveolar aerosol deposition measurement experiment system, which only has one connection structure, namely a Y-shaped tee joint and a large number of alveolar clusters, and the defect in the processing technology of the alveolar clusters can cause poor sealing performance of the alveolar clusters and can directly cause inaccurate test results; moreover, because the alveolar cluster is a closed structure in principle, and a breathing machine is adopted to provide negative pressure or positive pressure for the transparent container, the control precision of the respiratory flow is poor, and the control precision can cause the inaccurate test result; in the testing process, the medicine is deposited in the alveolus cluster, and the number of the alveolus is large, so that the difficulty in collecting and testing the medicine powder is large due to the increase of the testing workload.

Disclosure of Invention

In view of the above, in order to solve the above problems, it is urgently needed to develop a model capable of simulating the real human respiratory tract structure and improving the in vitro and in vivo correlation, so as to improve the correlation of the in vitro test result and reduce the development cost of the inhalation preparation imitation drug and the new drug. This company's technical staff plans to develop a novel human respiratory tract model according to real human respiratory tract structure, novel human respiratory tract model include all characteristics of human respiratory tract structure, include: the structure of the oral cavity, oropharynx, epiglottis, larynx, main bronchus and bronchus, etc. can be used as an inhalation preparation evaluation device to replace the ideal oropharynx; the human respiratory tract model is reconstructed based on human respiratory tract CT data, so that the respiratory tracts of different people such as age, sex, race, medical history and the like can be tested; meanwhile, the parameters of the human respiratory tract model can be adjusted according to different crowds and different respiratory states, so that the evaluation of inhalation preparations on different respiratory tract structures can be realized; the last point is that technicians of the company design a human respiratory tract model into a detachable and quick-connectable form, so that the accurate measurement of the deposition amount of preparations at different fine parts of the respiratory tract can be realized, and certainly, if only one part of the artificial lung is assembled, the rapid measurement of a part of the whole assembled parts can be realized, so that different test requirements can be met; because the artificial lung provided by technicians of the company can truly and directly reflect the deposition amount of the inhaled preparation at each position of the respiratory tract, the relevance of in-vitro and in-vivo tests is improved. The human respiratory tract model developed by technicians of the company is adopted to carry out drug imitation evaluation before clinical test and in the development stage, so that the development time and cost can be greatly saved, the passing rate of clinical experiments is improved, and great convenience is provided for enterprises or scientific research.

A novel human respiratory model, comprising: an artificial larynx 1, a straight-through trachea 21, a Y-shaped tee joint 3, a first bronchus model, a second bronchus model, a first sealing ring 16 and an artificial alveolus model 5, wherein, the artificial larynx 1 comprises an artificial pharynx mouth part interface 11, a first artificial larynx component 12, a second artificial larynx component 13, an artificial larynx trachea interface 14 and an artificial larynx internal air channel 15, the artificial larynx internal air channel 15 is respectively arranged inside the first artificial larynx component 12 and the second artificial larynx component 13, and the artificial larynx air channel 15 in the first artificial larynx component 12 and the second artificial larynx component 13 can be matched with each other, and a sealing groove is arranged on the periphery of the artificial larynx air channel 15, a first sealing ring 16 is arranged in the sealing groove, one end of an internal air passage 15 of the artificial larynx is communicated with an air passage in the interface 11 of the artificial pharynx mouth, and the other end of the internal air passage 15 of the artificial larynx is communicated with the interface 14 of the artificial larynx trachea; the straight-through trachea 21 comprises a trachea main body structure, a first interface 211 and a second interface 212 which are positioned at two ends of the straight-through trachea 21, the first interface 211 is connected with the artificial laryngotracheal interface 14, the second interface 212 is connected with a fourth interface 311 of the Y-shaped tee joint 3, a fifth interface 312 of the first Y-shaped tee joint 3 is connected with a first bronchus model, a sixth interface 313 of the first Y-shaped tee joint 3 is connected with a second bronchus model, the first bronchus model and the second bronchus model are connected in sections by adopting one or more of the Y-shaped tee joint 3, the straight-through pipe 22 and the tail end branch joint 4, the artificial alveolus model 5 is connected at the tail ends of the interfaces of the Y-shaped tee joint 3, the straight-through pipe 22 and the tail end branch joint 4, when one section is connected with an adjacent section, the interface is respectively matched with a male buckle and a female buckle, and a sealing ring or a sealing gasket is arranged at the, this makes it possible to make the connection between two adjacent segments free from leaks of gas, characterized in that: the first bronchus model and the second bronchus model respectively simulate the shape setting of anatomy, and the bronchus outlets at the tail ends of the first bronchus model and the second bronchus model are combined, and the combined bronchus outlets form the interfaces of a Y-shaped tee joint 3, a straight-through pipe 22 and a tail end branch joint 4 and are then connected to the artificial alveolus model 5; the straight-through pipe 22, the Y-shaped tee 3 or the end branch 4 is specifically selected at various positions in the first and second bronchus models and is determined according to the structure of the segment, the straight-through pipe 22 is used at a position with larger stress, and the Y-shaped tee and the end branch 4 are used at a position with smaller space.

Furthermore, the number of the artificial alveolus models 5 is 5-50, preferably, the number of the artificial alveolus models 5 is 10-20, and the lower the number of the artificial alveolus models 5 is, the more the outlets of the bronchus are merged, so that the simple structure is favorable for reducing the detection number and improving the detection efficiency; the higher the number of the artificial alveolar models 5 is, the less the combination of the bronchial outlets is, and the more vivid structure is adopted, which is beneficial to improving the test accuracy. By adopting a segmented structure, the content of particles or powder entering each position of a specific lung can be known, and the segmented structure has a larger data reference value with site-specific drug delivery such as targeted drug delivery.

Further, in order to improve the efficiency of assembling the whole novel human respiratory tract model, the interfaces on all the artificial alveolus models 5 are all one of male buckles or female buckles.

Further, when the interfaces on all the artificial alveolar models 5 adopt male buckles, the interfaces of the straight-through pipe 22, the Y-shaped tee 3 or the tail end branch 4 connected with the interfaces on the artificial alveolar models 5 are female buckles; when the interfaces on all the artificial alveolar models 5 adopt female buckles, the interfaces of the straight-through pipe 22, the Y-shaped tee 3 or the tail end branch 4 connected with the interfaces on the artificial alveolar models 5 are male buckles.

Further, the assembly opening of first artificial larynx subassembly 12 adopts first U-shaped incision 121, the assembly opening of second artificial larynx subassembly 13 adopts second U-shaped incision 131, first U-shaped incision 121 and second U-shaped incision 131 can match and coincide, artificial pharynx mouth portion interface 11 and artificial larynx trachea interface 14 are complete structure, the complete combination of artificial pharynx mouth portion interface 11 is at the entry position of first artificial larynx subassembly 12, the complete combination of artificial larynx trachea interface 14 is at the exit position of first artificial larynx subassembly 12. Adopt first U-shaped incision 121 and second U-shaped incision 131 of U-shaped, can make first artificial larynx subassembly 12 and the artifical larynx subassembly 13 of second split easier, can also keep the integrality of artifical pharynx mouth portion interface 11 and artifical larynx trachea interface 12 simultaneously, it is good to have guaranteed the leakproofness of split structure, the bad situation of kneck seal when having avoided artifical larynx 1 to be connected with other devices, and adopt first artifical larynx subassembly 12 and the artifical larynx subassembly 13 of second to carry out the structure of assembling, can conveniently coat and wash the coating on the inside gas circuit 15 of artifical larynx of the inside of first artifical larynx subassembly 12 and the artifical larynx subassembly 13 of second, the use degree of difficulty has been reduceed, very big improvement inhale the efficiency of preparation evaluation test.

Further, the first bronchial model includes a second Y-shaped tee 32, a third Y-shaped tee 33, a fourth Y-shaped tee 34, a terminal branch 4 and an artificial alveolar model 5, wherein the second Y-shaped tee 32 includes a seventh interface 321, an eighth interface 322 and a ninth interface 323, the third Y-shaped tee 33 includes a tenth interface 331, an eleventh interface 332 and a twelfth interface 333, the fourth Y-shaped tee 34 includes a thirteenth interface 341, a fourteenth interface 342 and a fifteenth interface 343, the terminal branch 4 includes a twenty-second interface 41, a twenty-third interface 42, a twenty-fourth interface 43 and a twenty-fifth interface 44, wherein the seventh interface 321 is connected with the fifth interface 312, the eighth interface 322 is connected with the thirteenth interface 341, the ninth interface 323 is connected with the tenth interface 331, the eleventh interface 332 and the twelfth interface 333 are connected with the artificial alveolar model 5, the fourteenth interface 342 is connected with the artificial alveolar model 5, the fifteenth interface 343 is connected to the twenty-second interface 41, and the twenty-third interface 42, the twenty-fourth interface 43, and the twenty-fifth interface 44 are connected to the artificial alveolar model 5.

Further, the second bronchus model comprises a straight-through pipe 22, a fifth Y-shaped tee 35, a sixth Y-shaped tee 36, a seventh Y-shaped tee 37 and an artificial alveolus model 5, the straight-through pipe 22 comprises a third interface 221 and a fourth interface 222, the fifth Y-shaped tee 35 comprises a sixteenth interface 351, a seventeenth interface 352 and an eighteenth interface 353, the sixth Y-shaped tee 36 comprises a nineteenth interface 361, a twentieth interface 362 and a twenty-first interface 363, the seventh Y-shaped tee 37 comprises a twenty-sixth interface 371, a twenty-seventh interface 372 and a twenty-eighth interface, the third interface 221 is connected with the sixth interface 313, the fourth interface 222 is connected with the sixteenth interface 351, the seventeenth interface 352 is connected with the nineteenth interface 361, the twentieth interface 362 and the twenty-first interface 363 are respectively connected with the artificial alveolar model 5, the eighteenth interface 353 is connected with the twenty-sixth interface 371, and the twenty-seventh interface 372 and the twenty-eighth interface are respectively connected with the artificial alveolar model 5.

Further, the interfaces of the artificial alveolar model 5 are male connectors, the artificial laryngotracheal interface 14, the second interface 212, the third interface 221, the fourth interface 222, the seventh interface 321, the eighth interface 322, the sixteenth interface 351, the nineteenth interface 361, the twenty-sixth interface 371, and the twenty-second interface 41 are male connectors, and the first interface 211, the fourth interface 311, the fifth interface 312, the sixth interface 313, the ninth interface 323, the tenth interface 331, the eleventh interface 332, the twelfth interface 333, the thirteenth interface 341, the fourteenth interface 342, the fifteenth interface 343, the seventeenth interface 352, the eighteenth interface 353, the twentieth interface 362, the twenty-first interface 363, the twenty-seventh interface 372, the twenty-eighth interface, the twenty-third interface 42, the twenty-fourth interface 43, and the twenty-fifth interface 44 are female connectors.

Furthermore, the interface connection part of the male buckle and the female buckle comprises a male buckle 6, a female buckle 7 and a sealing ring or a sealing washer 8, wherein one of the male buckle 6The end connection is at one of them section end in novel human respiratory tract model's the segmentation, and other one section end in novel human respiratory tract model's the segmentation is connected to the one end of box 7, and can match mutually between pin thread 6 and the box 7 for one of them section end in novel human respiratory tract model's the segmentation can with other one section end-to-end connection in novel human respiratory tract model's the segmentation, its characterized in that: male buckle main body 65 of male buckle 6 is cylindrical, a gas passage is passed in the inside of male buckle main body 65, be equipped with first spacing guide way 61 on the male buckle main body 65, first locking guide way 62, the spacing guide way 63 of second, the spacing guide way 64 of second, first spacing guide way 61 and the spacing guide way 63 of second are located the outside of male buckle main body 65 and are close to the position of free end face, first locking guide way 62 is connected to the position that free end face was kept away from to first spacing guide way 61, second locking guide way 64 is connected to the position that free end face was kept away from to the spacing guide way 63 of second, and the contained angle of first locking guide way 62 and free end face is theta₁The angle between the second locking guide groove 64 and the free end surface is theta₂(ii) a The female buckle body 73 of the female buckle 7 is a cylinder with a hollow upper part, the female buckle body 73 comprises a side wall and a bottom plate, the center of the bottom plate is provided with the gas channel 4, a first limiting boss 71 and a second limiting boss 72 are arranged inside the side wall of the female buckle 73, the width of the first limiting boss 71 is equal to that of the first limiting guide groove 61, the width of the second limiting boss 72 is equal to that of the second limiting guide groove 63, the first limiting boss 71 can be inserted into the first limiting guide groove 61 and rotate along the first locking guide groove 62, and the second limiting boss 72 can be inserted into the second limiting guide groove 63 and rotate along the second limiting guide groove 64; the sealing ring or sealing washer 8 is positioned on the upper surface of the base plate of the female buckle 7 below the free end surface of the assembled male buckle 6, the first limiting boss 71 rotates in the first locking guide groove 62, and the second limiting boss 72 compresses the sealing ring or sealing washer 8 when rotating in the second locking guide groove 64.

Further, a sealing ring or a sealing washer 8 can be fixed on the upper surface of the bottom plate of the female buckle 7 and also can be fixed on the free end surface of the male buckle 6.

Further, the sealing ring or the sealing washer 8 may be fixed on the upper surface of the bottom plate of the female buckle 7 or the free end surface of the male buckle 6 by gluing.

Further, the free end surface of the male snap 65 is a plane, and the sealing ring or the sealing washer 8 is placed on the upper surface of the base plate of the female snap 7.

Further, the upper surface of the base plate of the female buckle 7 is a plane or a concave surface, and when the upper surface of the base plate of the female buckle 7 is a plane, the sealing ring or the sealing washer 8 is directly placed on the plane of the upper surface of the base plate; when the upper surface of the bottom plate of the female buckle 7 is a concave surface, a sealing ring limiting groove is formed in the concave area, and a sealing ring or a sealing washer 8 is placed in the sealing ring limiting groove.

Further, a sealing ring limiting groove is formed in the free end face of the male buckle 65, and a sealing ring or a sealing washer 8 is placed in the sealing ring limiting groove of the male buckle 65.

Further, the sealing ring or the sealing washer 8 can use a standard circular or square sealing ring or a standard sealing washer, and can also be a customized sealing ring or a customized sealing washer with an inner special-shaped opening, the shape of the special-shaped opening is consistent with the shape of an inner gas channel of the male buckle main body 65 and an inner gas channel contacted with the upper surface of the base plate of the female buckle 7, and a better sealing effect can be realized by using the customized sealing ring or the customized sealing washer with the inner special-shaped opening.

Further, the angle θ between the first lock guide groove 62 and the free end surface₁Angle θ between the second locking guide groove 64 and the free end face₂And theta₁And theta₂And the angle is acute, so that better sealing effect can be realized.

Further, one or more sealing ring fixing clamping grooves are formed in the side wall of the female buckle main body 73, which is close to the upper surface of the bottom plate. When the sealing washer 8 is used, one or more sealing washer limiting bosses 81 are arranged on the outer side of the sealing washer 8, and the sealing washer limiting bosses 81 just can be matched with the sealing washer fixing clamping grooves, so that the sealing washer 8 can be better fixed on the upper surface of the base plate of the female buckle 7.

Furthermore, each section of the novel human body respiratory tract model is marked with a code, so that assembly errors of the artificial lung can be prevented, and the assembly efficiency is improved.

Further, the artificial alveolar model includes: the upper end cover 51 comprises an upper cover main body and a first sealing rib 512, the handle is positioned above the upper cover main body, the lower surface of the upper cover main body is a plane, and the first sealing rib 512 is positioned on the lower surface of the upper cover main body and close to the outer edge of the upper surface; the lower end cover 55 comprises a lower cover main body, a second sealing rib 552, a bottom air passage 553 and a connector 555, wherein an accommodating cavity is arranged in the lower cover main body, a bottom air passage 53 is arranged in the accommodating cavity, a through hole is formed in the center of the lower cover main body, the connector 555 penetrates through the through hole, the connector 555 is a through cylindrical through hole, the connector 555 extends towards the direction far away from the accommodating cavity of the lower cover main body, and the second sealing rib 552 is positioned at the bottom of the accommodating cavity and close to the edge of the accommodating cavity; the filter membrane 54, the support net 53 and the second sealing washer 52 are sequentially arranged in the accommodating chamber of the lower end cover 55 from bottom to top, and the filter membrane 54 can be fixed by the upper end cover 5 and the support net 53; the upper end cap 51 and the lower end cap 55 can be mated. Because filter membrane 54 is between upper end cover 5 and supporting mesh 53, and can be fixed by upper end cover 5 and supporting mesh 53 to make the structure of filter membrane 54 keep intact difficult impaired, make filter membrane 54, supporting mesh 53 and second seal ring 52 constitute sealed and filtration structure, upper end cover 51 matches the back with lower end cover 55 simultaneously, seals through second seal ring 52 and acts on, make novel artificial alveolus model can be used for artificial lung respirator's analogue test.

Further, in order to make the sealing of the artificial alveolar model more new and better, the sizes of the elements in the artificial alveolar model are defined as follows: diameter d of the filter membrane 54₄Diameter d of the support net 53₃Inner diameter d of the second sealing rib 552_5aSecond seal washer 52 outer diameter d_2bInner diameter d of lower end cap 55_5bInside diameter d of sealing washer_2a< second sealing rib d_5aThe first sealing rib d₁< second bead inner diameter d_5a。

Further, the total height of the filter membrane 54 and the support net 53 is less than or equal to the height of the second sealing rib 552, and the sealing performance is better.

Furthermore, the outer side edge of the lower cover main body is provided with an anti-slip line 554, which can facilitate the disassembly of the artificial alveolus model.

Further, the interface 555 can be directly connected with devices such as a breathing simulator, and the like, so as to directly perform simulation tests of different breathing modes.

Further, the upper end cover 51 further comprises a limiting boss 511, the limiting boss 511 is located on the outer side edge of the upper cover main body, a limiting locking groove 551 is arranged on the inner edge of the side wall of the lower cover main body, the limiting boss 511 of the upper end cover 51 and the limiting locking groove 551 of the lower end cover 55 are assembled in an up-and-down matching mode, the upper end cover 51 is rotated, the upper end cover 51 can be locked to press down the second sealing washer 52, and the sealing performance of the second sealing washer 52 is guaranteed to be good.

Further, the number of the limit bosses 511 and the limit locking grooves 551 is one or more.

Further, the material of the filter membrane 54 includes glass fiber, mixed fiber resin, nylon, and the like.

Furthermore, a plurality of air holes are arranged in the supporting net 53, the shape of the air holes is circular, oval, triangular, rhombic or other polygons, and the size of the air holes is 0.1 mm-10 mm.

Furthermore, the upper end cover 51 and the lower end cover 55 can be locked by a thread locking structure, and pressure can be generated to ensure that the sealing performance of the sealing ring is good.

The novel human respiratory tract model is adopted to compare with the test result of the pharmacopoeia method NGI under the same test condition: drug delivery dose error ± 5%, lung deposition error ± 5% from FPF (< 5 um). Compared with the in vivo clinical results in the literature, the error of the drug delivery amount is less than +/-10%, and the pulmonary deposition is less than +/-10% and is consistent.

Drawings

Fig. 1 is a schematic structural view of a human respiratory tract model of the present invention.

Fig. 2 is a schematic structural diagram of the human respiratory tract model of the present invention.

Fig. 3 is an exploded view of the model human airway of the present invention.

Fig. 4 is an exploded view of the model human airway of the present invention.

FIG. 5 is a schematic view of a U-shaped cross-section of the first assembly.

Fig. 6 is a schematic structural view of the first bronchus model.

Fig. 7 is a schematic structural view of the first bronchus model.

Fig. 8 is a schematic structural view of the first bronchus model.

Fig. 9 is a schematic structural view of the second bronchial model.

Fig. 10 is a schematic structural view of the male buckle and the female buckle.

Fig. 11 is a schematic structural view of the male buckle.

FIG. 12 is an exploded view of an artificial alveolar model.

FIG. 13 is a schematic view of the structure of the sealing ring, the supporting net and the filter membrane.

Fig. 14 is a structural schematic diagram of the upper end cap.

Fig. 15 is a schematic structural view of the upper end cap.

Fig. 16 is a schematic view of the structure of the sealing rib on the upper end cap.

Fig. 17 is a schematic structural view of the lower end cap.

Fig. 18 is a schematic structural view of the lower end cap.

FIG. 19 is a cross-sectional view of the lower endcap.

The drawings are described in detail below with reference to specific embodiments.

Detailed Description