A kind of analog device of alimentary system
Technical field
The present invention relates to a kind of analog device of alimentary system, relate in particular to a kind of device that the alimentary canal states of physiologic function is simulated, can carry out the continuous adjusting of the inner pH value of alimentary canal, pressure, enzyme etc., and can carry out the peristalsis of the digest tract simulation.
Background technology
Current social people's life stress constantly increases, disease of digestive tract also is on the increase, the instrument means that are used for disease of digestive tract diagnosis, treatment, monitoring accordingly are increasing, but because this quasi-instrument generally belongs to two, three class Medical Instruments, so need carry out corresponding human clinical's experiment.Find product deficiency and hidden danger early in order to reduce clinical trial danger, one of ordinary skill in the art's expectation is by a kind of analogue means, strengthen on the one hand gastral understanding, improve the skilled operation degree of instruments such as alimentary tract endoscope, make the alimentary canal doctor shorten the training cycle and make the best of one's way and go up qualified work position; Carry out experimental examination reliability of products, bio-compatibility etc. by analogue means on the other hand; Simultaneously, wish that this analogue means to the exploitation of pharmaceutical dosage form (the check medicine is in the absorption characteristic of the alimentary canal diverse location) means of can offering help, shortens the Products Development cycle, and can be used for studying gastral metabolism status and relevant biochemical characteristic etc.But the technology of at present relevant alimentary canal analogue means is not appeared in the newspapers as yet.
U.S. Pat 5807115 has proposed a kind of device that utilizes decomposition instrument simulation alimentary canal physiological situation, and this device comprises a pH registering instrument, and one is decomposed detector, a spectrophotometer, decomposition data registering instrument with processor, a personal computer, a printer.This invention can be regulated the pH value, based on the decomposition media content and the transmission time adjusting of human body alimentary canal acquire knowledge.Can obtain pH value and content with the drug release rate relating to parameters.But there is following problem in this device: at first, this device is primarily aimed at the drug release rate situation and designs, and has only carried out pH value and the simulation of drug delivery time; Secondly, just simulate a part of situation of alimentary canal separately by the decomposing pool of several separation; In addition, for pressure, the digestive ferment parameter does not relate to, and can not carry out the simulation of peristalsis of the digest tract function.
Summary of the invention
The objective of the invention is for reducing clinical trial dangerously and find product deficiency and hidden danger early, and provide a kind of close, the simulation degree height with the alimentary canal profile, function is more complete, and can carry out parameter at any time and reconcile, simulate more situations, alimentary canal analogue means simple in structure.
The object of the present invention is achieved like this: a kind of analog device of alimentary system is characterized in that comprising and is located in the shell, successively the simulation oral cavity of Lian Tonging, simulation oesophagus, simulation stomach, simulation small intestine, simulation large intestine and simulation anus; Be provided with simulation throat switch in the simulation oral cavity, the simulation oesophagus is provided with simulation orifice of the stomach switch with the junction of simulation stomach, and the simulation stomach is provided with simulation pylorus switch with simulation small intestine junction, and the end of simulation large intestine is provided with the simulation anus switch; Described 4 switches are one-way valve structures, open shutoff operation under the control of central control unit, to avoid alimentary canal different parts content generation adverse current.
Be respectively equipped with automatically controlled driver in simulation oesophagus, simulation stomach, simulation small intestine and the simulation large intestine; Automatically controlled driver forms electromagnet and central control unit control linkage by the permanent magnet that is located on simulation alimentary canal outer wall by sleeve pipe or fixing glue with the supporting electromagnet combination of permanent magnet; Described automatically controlled driver is connected the action of control simulation peristalsis of the digest tract with central control unit.
Being provided with acid solution apotheca, damping fluid apotheca and digestive ferment apotheca in the device is communicated with the simulation stomach by corresponding flow controller respectively, alkali lye apotheca, damping fluid apotheca and enteron aisle digestive ferment apotheca are communicated with the simulation small intestine by corresponding flow controller respectively, and the damping fluid apotheca is communicated with the simulation oral cavity by flow controller; The simulation large intestine is communicated with the waste liquid recovery pond by semi-permeable diaphragm; Be provided with pressure transducer in the simulation large intestine, be respectively equipped with the sensor that detects pH value, pressure and enzyme in simulation stomach and the simulation small intestine; Pressure transducer and the sensor that can detect pH value, pressure and enzyme are electrically connected with central control unit respectively, and testing result is fed back to central control unit, and by data storage cell and data output interface output data; Consuming parts such as described central control unit, analog switch, automatically controlled driver, data storage cell, data output interface and sensor all are connected with power supply.
Above-mentioned acid solution, alkali lye, damping fluid, digestive ferment apotheca and corresponding flow controller are worked under the regulation and control of central control unit, are used to control flow into what of simulation gastral acid ﹠ alkali liquid, damping fluid and digestive ferment liquid measure.PH sensor, pressure transducer and enzyme sensor are used to detect pH value, pressure size and the digestive ferment content of simulation alimentary canal different parts, and testing result is fed back to central control unit.Waste liquid recovery pond at simulation large intestine place is used to reclaim the useless liquid through in the simulation alimentary canal of semi-permeable diaphragm.Central control unit is used to be provided with the gastral whole parameters of simulation, the testing result of receiving sensor feedback, regulating flow controller, analog switch, automatically controlled driver movement range and duration etc., and parameters is kept at data storage cell, export by data output interface.Power supply provides energy resource supply for total system.Each parts subregion of whole simulation alimentary canal is fixed on enclosure.
Described central control unit can adopt multiple mode to work, and wherein a kind of is to detect pH value, pressure, enzyme content parameter in real time, moves regulation and control in real time.
Described simulation alimentary canal structure can adopt multiple version, except that above-mentioned structure, also can in position increase or reduce sensor, flow controller, automatically controlled driver, analog switch number, a change interelement spacing or mutual order.
The course of work of the present invention is as follows: after the simulation alimentary canal device energising start, by central control unit system is carried out initialization, and according to the parameters that detects total system is controlled in real time; After system's parameters initialization was finished, central controller can be started working by pilot lamp prompting user; After the user put into article to be measured or instrument in the simulation oral cavity, damping fluid (playing the saliva lubrication) flow speed controller was opened in the simulation oral cavity, and the throat switch opens is simulated in damping fluid inflow oral cavity thereafter; Under action of gravity, article to be measured enter the simulation oesophagus, and the automatically controlled driver that at this moment is in simulation oesophagus position is started working, and realizes the esophageal peristalsis action, and article to be measured are transmitted to the orifice of the stomach direction; Simulate the orifice of the stomach switch opens thereafter, article to be measured enter the simulation stomach, acid solution, the stomach digestive ferment, stomach damping fluid flow controller is opened, acid solution, stomach digestive ferment and damping fluid flow into the simulation stomach, the automatically controlled driver of at this moment simulating stomach start working (the automatically controlled driver in oesophagus place quits work after 5 minutes), realize the stomach peristaltic action, article to be measured are transmitted to the pylorus direction, the pH value of stomach, pressure and enzyme sensor are started working, (5 seconds) are detected primary parameter and are sent central controller with the result at regular intervals, by central controller according to circumstances, regulating flow controller opens size, automatically controlled driver movement range and follow-up pylorus switch opens time; (10 minutes) simulation pylorus switch opens behind the certain hour, article to be measured enter the simulation small intestine with acid solution, alkali lye, enteron aisle digestive ferment and damping fluid flow controller are opened, alkali lye, enteron aisle digestive ferment and damping fluid flow into the simulation small intestine, the automatically controlled driver at simulation small intestine and large intestine position start working in succession (the automatically controlled driver of stomach quits work after 30 minutes), realize the peristaltic action of small intestine and large intestine, article to be measured are transmitted to the anus direction by large intestine, the pH value at enteron aisle position, pressure and enzyme sensor are started working, (5 seconds) are detected primary parameter and are sent central controller with the result at regular intervals, by central controller according to circumstances, regulating flow controller opens size, automatically controlled driver movement range; At simulation large intestine position, waste liquid infiltrates waste liquid recovery pond (play the kidney effect, reach a constant volume then concentrate discharging) by semi-permeable diaphragm; After simulation anus position pressure transducer detected parameters reaches certain thresholding, send signal by central control unit by pilot lamp, the prompting user carries out waste discharge and article reclaim, and manually controls the simulation anus switch by the user at last and opens.Working time wherein all can artificially be provided with by central control unit as required.
The present invention has following technique effect:
1, can simulate the peristalsis of the digest tract action, and can reach the control simulation alimentary canal purpose of working time by control to movement range, actuation time.
2, can mediate to pH value, pressure, digestive ferment content in the simulation alimentary canal, realize the simulation digestive tract function, be used to study gastral metabolism status and relevant biochemical characteristic etc.
3, control system can adopt the Multistage Control mode to work, and is easy to realize alimentary canal different parts function.
4, can strengthen gastral understanding by this device, improve the skilled operation degree of instruments such as alimentary tract endoscope, make the alimentary canal doctor shorten the training cycle and make the best of one's way and go up qualified work position.
5, carry out simulation test by this device, not only can check reliability, bio-compatibility of drug products etc.; Also can be used for the check (the check medicine is in the absorption characteristic of alimentary canal diverse location) of pharmaceutical dosage form exploitation, shorten the Products Development cycle.
6, can according to circumstances carry out systematic parameter and set, satisfy the different examination requirementses of different experiments object (apparatus, medicine etc.).
This device has advantages such as system architecture is simple, the working time long, analog parameter is many, and function is more comprehensive.
Description of drawings
Fig. 1 is a simulation alimentary canal one-piece construction synoptic diagram;
Fig. 2 is a kind of structural representation of the automatically controlled driver of oesophagus;
Fig. 3 is the automatically controlled driver of stomach and a kind of structural representation of simulation pylorus switch.
Wherein: 1. simulate the oral cavity, 2. simulation throat switch, 3. simulation oesophagus, 4. the automatically controlled driver of oesophagus is 5. simulated orifice of the stomach switch, 6. acid solution apotheca, 7. acid solution flow controller, the 8. automatically controlled driver of stomach, 9.pH duty pressure enzyme sensor, 10 simulation stomaches, 11. the alkali lye apotheca, 12 flux of alkaline liquor controllers, 13. simulation small intestines, 14.pH duty pressure enzyme sensor, 15. the automatically controlled driver of small intestine, 16. simulation large intestines, 17. simulation anuses, 18. pressure transducer, 19. semi-permeable diaphragm, 20. waste liquid recovery ponds, the automatically controlled driver of 21. large intestines, 22. oral cavity damping fluid flow controller, 23. stomach damping fluid flow controller, 24. small intestine damping fluid flow controllers, 25. damping fluid apothecas, 26. stomach digestive ferment apotheca, 27. stomach digestive ferment flow controller, 28. simulation pylorus switches, 29. enteron aisle digestive ferment flow controllers, 30. enteron aisle digestive ferment apotheca, 31. central controller, 32. data storage cells, 33. output interfaces, 34. power supply, 35. shell, 36. fixed sleevings, 37. flexure strips, 38. permanent magnet, 39. electromagnet, 40. elastic sliding vanes, 41. fixing glue rings, 42. permanent magnet, 43. electromagnet.
Embodiment
The invention will be further described below in conjunction with specific embodiment.
As shown in Figure 1, alimentary canal analogue means of the present invention comprises and is located at simulation oral cavity 1, simulation oesophagus 3, simulation stomach 10, simulation small intestine 13, simulation large intestine 16 and the simulation anus switch door 17 that is communicated with successively in the shell 35.The high size of shell 35 bulk shape length and width is about 45 * 25 * 65 centimetres, the simulation oesophagus is about 2.0 * 20 centimetres of φ, the simulation gastric capacity is about 1500 milliliters, the simulation small intestine is about 2.0 * 500 centimetres of φ, the simulation large intestine is about 3.0 * 100 centimetres of φ, several liquid storage room volume is about 1000 milliliters, and waste liquid recovery pond volume is about 3000 milliliters.
Be provided with simulation throat switch 2 in the simulation oral cavity 1, simulation oesophagus 3 is provided with simulation orifice of the stomach switch 5 with the junction of simulation stomach 10, and simulation stomach 10 is provided with simulation pylorus switch 28 with simulation small intestine 13 junctions, and the end of simulation large intestine 16 is provided with simulation anus switch 17; 4 above-mentioned analog switches are one-way valve structures, open shutoff operation under the control of central control unit, to avoid alimentary canal different parts content generation adverse current.Be respectively equipped with corresponding automatically controlled driver 4,8,15 and 21 in simulation oesophagus 3, simulation stomach 10, simulation small intestine 13 and the simulation large intestine 16, described automatically controlled driver 4,8,15 is identical with 21 26S Proteasome Structure and Function, the installation site is different with mode, all is connected with central control unit 31 to be used for the action of control simulation peristalsis of the digest tract.
Also being provided with acid solution apotheca 6, damping fluid apotheca 25 and digestive ferment apotheca 26 in the device is connected with simulation stomach 10 with 27 by corresponding flow controller 7,23 respectively, alkali lye apotheca 11, damping fluid apotheca 25 and enteron aisle digestive ferment apotheca 30 are connected with simulation small intestine 13 with 29 by flow controller 12,24 respectively, and damping fluid apotheca 25 is communicated with simulation oral cavity 1 by flow controller 22; One side of simulation large intestine 16 is communicated with waste liquid recovery pond 20 by semi-permeable diaphragm 19.
Be provided with pressure transducer 18 in the simulation large intestine 16, simulation stomach 10 is provided with the sensor 9 that can detect pH value, pressure and enzyme, is provided with pH value, pressure and enzyme sensor 14 in the simulation small intestine 13; Pressure transducer 18 and the sensor 9,14 that can detect pH value, pressure and enzyme are electrically connected with central control unit 31 respectively testing result are fed back to central control unit 31, and by data storage cell 32 and data output interface 33 output datas.
Described switch 2,5,28 and 17, automatically controlled driver 4,8,15 and 21, sensor 9,18 and 14, data storage cell 32 and data output interface 33, and central control unit 31 all are connected with power supply 34, and power supply 34 provides energy resource supply for total system.
Central control unit is used to be provided with the gastral whole parameters of simulation, the testing result of receiving sensor feedback, regulating flow controller, analog switch, automatically controlled driver movement range and duration etc., and parameters is kept at data storage cell, export by data output interface.
This device is by power supply 34 power supply start work, and 31 pairs of systems carry out initialization by central control unit, and after system's parameters initialization was finished, each analog switch 2,5,17,28 was in closed condition, and the simulation gi system is started working; After the user put into simulation oral cavity 1 with article, damping fluid flow speed controller 22 was opened in the simulation oral cavity, and the damping fluid in the damping fluid apotheca 25 flows into the oral cavity, simulates throat switch 2 thereafter and opens; Under action of gravity, article enter simulation oesophagus 3, and the automatically controlled driver 4 that at this moment is in simulation oesophagus position is started working, and the oesophagus of extruding simulation successively tube wall is realized the esophageal peristalsis action, and article are transmitted to simulation orifice of the stomach switch 5 directions; Thereafter simulating orifice of the stomach switch 5 opens, article enter simulation stomach 10, acidic liquid in the acid solution apotheca 6 is by acid solution flow controller 7, stomach digestive ferment apotheca 26 is by stomach digestive ferment flow controller 27, damping fluid flows into simulation stomach 10 by stomach damping fluid flow controller 23, at this moment simulate the automatically controlled driver 8 of stomach start working (the automatically controlled driver 4 in oesophagus place quits work behind the certain hour), the coat of the stomach of extruding simulation successively, realize the stomach peristaltic action, article are transmitted to simulation pylorus switch 28 directions, the detection pH value of stomach, the sensor 9 of pressure and enzyme is started working, detect primary parameter at regular intervals and send central control unit 31 result, by central control unit 31 according to circumstances, regulating flow controller 23,27 open size, automatically controlled driver 8 movement ranges and follow-up simulation pylorus switch 28 are opened the time; Simulation pylorus switch 28 is opened behind the certain hour, article enter simulation small intestine 13 with acid solution, akaline liquid in the alkali lye apotheca 11 is by flux of alkaline liquor controller 12, enteron aisle digestive ferment apotheca 30 is by enteron aisle digestive ferment flow controller 29, damping fluid flows into simulation small intestine 13 by small intestine damping fluid flow controller 24, the automatically controlled driver 15 of small intestine and the large intestine electric controller 21 at simulation small intestine 13 and simulation large intestine 16 positions start working in succession (the automatically controlled driver 8 of stomach quits work behind the certain hour), the intestines of extruding simulation successively wall, realize the peristaltic action of small intestine and large intestine, article are transmitted to simulation anus switch 17 directions by simulation small intestine 13 and simulation large intestine 16, the detection pH value at enteron aisle position, the sensor 14 of pressure and enzyme is started working, each certain hour detects primary parameter and send central control unit 31 with the result, by central control unit 31 according to circumstances, regulating flow controller 24,29,12 open size, automatically controlled driver 15,21 movement ranges and actuation time; At simulation large intestine 16 positions, waste liquid infiltrates waste liquid recovery pond 20 by semi-permeable diaphragm 19; After simulation anus switch 17 site pressure sensors 18 detected parameters reach certain thresholding, go out signal by central control unit 31, the prompting user carries out waste discharge and article reclaim; Central control unit 31 is stored in parameter after a while in the data storage cell 32, and can data be exported by data output interface 33; Simulate gastral each parts and be installed in shell 35 inside.
As shown in Figure 2, the concrete course of work of the automatically controlled driver 4 of oesophagus is as follows: electromagnet 39 is worked under the control of central control unit 31, break-make by the electric current that flows through electromagnet 39 solenoids, direction and size that size and flow direction control generate an electromagnetic field, fixed sleeving 36 and simulation oesophagus outer wall tight bond, but the flexure strip 37 that comprises a free shrink in the sleeve pipe 36, the contraction of flexure strip 37 forces simulation oesophagus 3 chamber walls to shrink, flexure strip 37 closely is connected with permanent magnet 38, under the effect of electromagnet 39 electromagnetic fields, permanent magnet 38 is produced attraction and repulsion, and then drive flexure strip 37 and tighten up or unclamp, realize the peristaltic action of oesophagus.
As shown in Figure 3, the course of work of the automatically controlled driver 8 of stomach is as follows: electromagnet 43 is worked under the control of central control unit 31, break-make by the electric current that flows through electromagnet 43 solenoids, direction and size that size and flow direction control generate an electromagnetic field, electromagnet 43 closely contacts with fixing glue ring 41 on being fixed on simulation stomach 10 outer walls, there is a permanent magnet 42 with simulation stomach 10 wall tight bond fixing glue ring 41 centers, the motion of permanent magnet 42 drives the chamber wall motion of simulation stomach 10, under the effect of electromagnet 43 electromagnetic fields, permanent magnet 42 is produced attraction and repulsion, and then drive the coat of the stomach motion, realize the peristaltic action of stomach.Comprise electromagnet and one and the close-connected elastic sliding vane 40 of permanent magnet in the simulation pylorus switch 28, under the effect of electromagnetic field, permanent magnet drives elastic sliding vane 40 and moves up and down, and then realizes the action that opens or closes of pylorus switch.
Optional usefulness has certain flexible rubber tube or rubber bag tank is made for material of main part of the present invention (simulation enteron aisle and simulation stomach etc.); Described central control unit, various sensor, flow controller and automatically controlled driver adopt existing matured product to get final product, as: adopt existing ripe single chip computer AT 89C51 can realize the function of central control unit, adopt DPA/DPAS/InPro3200pH sensor, YX-PS1500 pressure transducer and U.S. BIO-RAD microplate reader to measure pH value, pressure and enzyme content, use German EGE flow controller to carry out flow control, adopt common electromagnetism winding and permanent magnet to act on mutually and realize automatically controlled driver functions.Certainly also can adopt some homemade related sensors and components and parts to realize above-mentioned identical work purpose.
Certainly because the restriction of present technology and material, the present invention can not simulate gastral all physiological situations fully, can only have the several main parameters (pH value, pressure, digestive ferment content etc.) of material impact to simulate to alimentary canal physiological situation, food decomposition and absorption of nutrient ingredients.