Novel human respiratory tract model
Technical Field
The utility model relates to the technical field of medical equipment, it is comparatively concrete, relate to a novel human respiratory track 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 utility model with the patent publication number of CN204797996U discloses a real human upper respiratory tract model flow field aerosol deposition measurement experimental apparatus, and it does not disclose the mode that the model carries out the segmentation and guarantees to connect between each segmentation, and to the gas tightness and the segmentation connected mode of the human respiratory tract model that are used for the internal and external relevance evaluation of inhalation preparation make the accurate important factor of 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 utility model 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 and a large number of alveolar clusters, and the defect in the processing technology of the alveolar clusters can lead to poor sealing performance of the alveolar clusters and can directly lead to 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.
SUMMERY OF THE UTILITY MODEL
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 inner air path 15 inside 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 at the periphery of the artificial larynx inner air path 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 an artificial laryngotracheal interface 14, the second interface 212 is connected with a first Y-shaped three-way interface 311 of a Y-shaped three-way 3, a fifth interface 312 of the first Y-shaped three-way 3 is connected with a first bronchus model, a sixth interface 313 of the first Y-shaped three-way 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 three-way 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 three-way 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, 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 first Y-shaped three-way 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, a female buckle, a sealing ring or a sealing washer, wherein one end of the male buckle is connected with the tail end of one section in the section of the novel human body respiratory tract model, one end of the female buckle is connected with the tail ends of the other sections in the section of the novel human body respiratory tract model, and the male buckle and the female buckle can be matched with each other, so that the tail end of one section in the section of the novel human body respiratory tract model can be connected with the tail ends of the other sections in the section of the novel human body respiratory tract model, the male buckle main body of the male buckle is cylindrical, a gas channel passes through the interior of the male buckle main body, the male buckle main body is provided with a first limit guide groove, a first locking guide groove, a second limit guide groove 63 and a second locking guide groove 64, the first limit guide groove and the second limit guide groove 63 are positioned at the outer side of the male buckle main body, the position of the first limit guide groove far away from the free end surface is connected with a first locking guide groove, the position of the second limit guide groove 63 far away from the free end surface is connected with a second locking guide groove 64, and the included angle between the first locking guide groove and the free end surface is theta1The angle between the second locking guide groove 64 and the free end surface is theta2(ii) a The female buckle body of the female buckle is a cylinder with a hollowed upper part, the female buckle body comprises a side wall and a bottom plate, a gas channel is arranged in the center of the bottom plate, a first limiting boss and a second limiting boss are arranged inside the side wall of the female buckle, the width of the first limiting boss is equal to that of a first limiting guide groove, the width of the second limiting boss is equal to that of a second limiting guide groove 63, the first limiting boss can be inserted into the first limiting guide groove and rotate along the first locking guide groove, and the second limiting boss can be inserted into the second limiting guide groove 63 and rotate along the second limiting guide groove 63; the sealing ring or the sealing washer is positioned below the free end surface of the assembled male buckle and on the upper surface of the base plate of the female buckle, the first limiting boss rotates in the first locking guide groove,and the second limit boss compresses the sealing ring or gasket when rotated in the second locking guide groove 64.
Further, the sealing ring or the sealing washer can be fixed on the upper surface of the base plate of the female buckle and also can be fixed on the free end surface of the male buckle.
Further, the sealing ring or the sealing washer can be fixed on the upper surface of the base plate of the female buckle or the free end surface of the male buckle in an adhesive mode.
Furthermore, the free end face of the male buckle main body is a plane, and the sealing ring or the sealing washer is placed on the upper surface of the base plate of the female buckle.
Furthermore, the upper surface of the base plate of the female buckle is a plane or a concave surface, and when the upper surface of the base plate of the female buckle is a plane, the sealing ring or the sealing washer 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 is a concave surface, the concave surface forms a sealing ring limiting groove, and the sealing ring or the sealing washer is placed in the sealing ring limiting groove.
Furthermore, the free end face of the male buckle main body is provided with a sealing ring limiting groove, and a sealing ring or a sealing washer is placed in the sealing ring limiting groove of the male buckle main body.
Furthermore, the sealing ring or the sealing washer 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 that of an inner gas channel of the male buckle body and that of an inner gas channel contacted with the upper surface of the base plate of the female buckle, 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.
Furthermore, the included angle theta between the first locking guide groove 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.
Furthermore, the position that the lateral wall of box main part is close to the bottom plate upper surface is equipped with one or more sealing washer fixed slot. When the sealing washer is used, one or more sealing washer limiting bosses are arranged on the outer side of the sealing washer and can be just matched with the sealing washer fixing clamping grooves, so that the sealing washer can be better fixed on the upper surface of the base plate of the female buckle.
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 gas passage 553 and a connector 555, wherein an accommodating cavity is arranged in the lower cover main body, the bottom gas passage 553 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 51 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 51 and supporting mesh 53, and can be fixed by upper end cover 51 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 533 Second sealing rib 552 inner diameter d5a Second seal washer 52 outer diameter d2bInner diameter d of lower end cap 555bInside diameter d of sealing washer2a< second sealing rib d5aThe first sealing rib d1< second bead inner diameter d5a。
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.
Adopt the utility model discloses a novel human respiratory track model, under the same test condition, with pharmacopoeia method NGI test result contrast: 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 the 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 of human respiratory tract of the present invention.
Fig. 4 is an exploded view of the model of human respiratory tract 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
Specific embodiment example 1:
as shown in fig. 1 and fig. 2, the structure of the human respiratory tract model of the present invention is schematically illustrated; as shown in fig. 3 and 4, the human body respiratory tract model of the present invention is an exploded view; FIG. 5 is a schematic view of a U-shaped cross-section of the first assembly; as shown in fig. 6 to 8, which are schematic structural views of the first bronchus model; fig. 9 is a schematic structural diagram of the second bronchial model. 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 inner air path 15 inside 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 at the periphery of the artificial larynx inner air path 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 an artificial laryngotracheal interface 14, the second interface 212 is connected with a first Y-shaped three-way interface 311 of a Y-shaped three-way 3, a fifth interface 312 of the first Y-shaped three-way 3 is connected with a first bronchus model, a sixth interface 313 of the first Y-shaped three-way 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 three-way 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 three-way 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, 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.
The assembly mouth of first artificial larynx subassembly 12 adopts first U-shaped incision 121, and the assembly mouth of second artificial larynx subassembly 13 adopts second U-shaped incision 131, and first U-shaped incision 121 and second U-shaped incision 131 can match and coincide, and artificial pharynx mouth portion interface 11 and artificial larynx trachea interface 14 are complete structure, and the complete combination of artificial pharynx mouth portion interface 11 is at the entry position of first artificial larynx subassembly 12, and 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.
The first bronchus model comprises a second Y-shaped tee 32, a third Y-shaped tee 33, a fourth Y-shaped tee 34, a terminal branch knot 4 and an artificial alveolar model 5, wherein the second Y-shaped tee 32 comprises a seventh interface 321, an eighth interface 322 and a ninth interface 323, the third Y-shaped tee 33 comprises a tenth interface 331, an eleventh interface 332 and a twelfth interface 333, the fourth Y-shaped tee 34 comprises a thirteenth interface 341, a fourteenth interface 342 and a fifteenth interface 343, the terminal branch knot 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, 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.
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.
The interfaces of the artificial alveolar model 5 adopt male buckles, 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 first Y-shaped three-way 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 adopt female buckles.
Adopt the utility model discloses a novel human respiratory track model, under the same test condition, with pharmacopoeia method NGI test result contrast: the error of drug delivery is + -5%, and the error of lung deposition and FPF (< 5um) is + -5%. 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.
Fig. 10 is a schematic view of a male buckle and a female buckle; fig. 11 is a schematic structural view of the male buckle. The interface connection part of the male buckle and the female buckle comprises a male buckle, a female buckle, a sealing ring or a sealing washer, wherein one end of the male buckle is connected with the tail end of one section in the section of the novel human body respiratory tract model, one end of the female buckle is connected with the tail end of the other section in the section of the novel human body respiratory tract model, the male buckle and the female buckle can be matched with each other, so that the tail end of one section in the section of the novel human body respiratory tract model can be connected with the tail end of the other section in the section of the novel human body respiratory tract model, the male buckle main body of the male buckle is cylindrical, a gas channel passes through the interior of the male buckle main body, a first limiting guide groove, a first locking guide groove, a second limiting guide groove 63 and a second locking guide groove 64 are arranged on the male buckle main body, and the first limiting guide groove and the second limiting guide groove 63 are positioned at the outer side of the male buckle, the position of the first limit guide groove far away from the free end surface is connected with a first locking guide groove, the position of the second limit guide groove 63 far away from the free end surface is connected with a second locking guide groove 64, and the included angle between the first locking guide groove and the free end surface is theta1The angle between the second locking guide groove 64 and the free end surface is theta2(ii) a The female button main body of the female button is a cylinder with the upper part hollowed outThe female buckle comprises a female buckle body and a female buckle body, wherein the female buckle body comprises a side wall and a bottom plate, a gas channel is arranged in the center of the bottom plate, a first limiting boss and a second limiting boss are arranged inside the side wall of the female buckle, the width of the first limiting boss is equal to that of a first limiting guide groove, the width of the second limiting boss is equal to that of a second limiting guide groove 63, the first limiting boss can be inserted into the first limiting guide groove and rotate along the first locking guide groove, and the second limiting boss can be inserted into the second limiting guide groove 63 and rotate along the second limiting guide groove 63; the sealing ring or the sealing washer is positioned below the free end face of the assembled male buckle and on the upper surface of the base plate of the female buckle, the first limiting boss rotates in the first locking guide groove, and the second limiting boss compresses the sealing ring or the sealing washer when rotating in the second locking guide groove 64. The free end face of the male buckle main body is a plane, and the sealing ring or the sealing washer is placed on the upper surface of the bottom plate of the female buckle; the upper surface of the base plate of the female buckle is a plane, the sealing ring or the sealing washer is directly placed on the plane of the upper surface of the base plate, the free end face of the male buckle body is provided with a sealing ring limiting groove, and the sealing ring or the sealing washer is placed in the sealing ring limiting groove of the male buckle body. The sealing ring or the sealing washer 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 that of an inner gas channel of the male buckle body and that of an inner gas channel contacted with the upper surface of the base plate of the female buckle, and a better sealing effect can be realized by adopting the customized sealing ring or the customized sealing washer with the inner special-shaped opening.
The included angle theta between the first locking guide groove and the free end surface1Angle θ between the second locking guide groove 64 and the free end face2And theta1And theta2Is acute angle. 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. When the sealing washer is used, one or more sealing washer limiting bosses are arranged on the outer side of the sealing washer and can be just matched with the sealing washer fixing clamping grooves, so that the sealing washer can be better fixed on the upper surface of the base plate of the female 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 to 15 show schematic structural views of the upper end cap. Fig. 16 is a schematic structural view of a sealing rib on the upper end cap; FIG. 17 is a schematic view of the structure of the lower end cap; FIG. 18 is a schematic view of the structure of the lower end cap; as shown in fig. 19, a cross-sectional view of the lower end cap is shown. The artificial alveolus model comprises: 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 gas passage 553 and a connector 555, wherein an accommodating cavity is arranged in the lower cover main body, the bottom gas passage 553 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 51 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 51 and supporting mesh 53, and can be fixed by upper end cover 51 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.
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 5525a Second seal washer 52 outer diameter d2bInner diameter d of lower end cap 555bInside diameter d of sealing washer2a< second sealing rib d5aThe first sealing rib d1< second bead inner diameter d5a. 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 ribs 552, and the sealing performance is better.
The outer edge of the lower cover main body is provided with anti-skid lines 554, so that the artificial alveolus model can be conveniently detached. Interface 555 can be directly connected with equipment such as breathing analog machine, directly carries out the simulation test of different breathing modes. 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 lock and press the second sealing washer 52, and the sealing performance of the second sealing washer 52 is good.
The number of the limit projections 511 and the limit locking grooves 551 is one or more. The filter membrane 54 is made of glass fiber, mixed fiber resin, nylon, or the like. The supporting net 53 is provided with a plurality of air holes, the shape of the air holes is round, oval, triangular, rhombic or other polygons, and the size of the air holes is 0.1 mm-10 mm. 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 above-mentioned embodiments only represent some embodiments of the present invention, and the description thereof is specific and detailed, but not to be construed as limiting the scope of the present invention. It should be noted that, for those skilled in the art, without departing from the spirit of the present invention, several variations and modifications can be made, which are within the scope of the present invention. Therefore, the protection scope of the present invention should be subject to the appended claims.