Two-stage sustained-release insulin patch pump

Abstract

Two-stage slow-release insulin patch pump, including shell, insulin pump, detection mechanism, a plurality of piezoelectric ceramic mechanisms, a plurality of flow control mechanisms, injection mechanism and control circuit module, the insulin pump is arranged at the top center of the shell, the detection mechanism is arranged at the bottom of the shell around, the inner cavity of the shell is uniformly divided into a plurality of injection cavities, each piezoelectric ceramic mechanism is uniformly distributed on the top of the shell, each flow control mechanism is correspondingly arranged in each injection cavity, the injection mechanism is uniformly arranged on the bottom of the shell and is communicated with each injection cavity, the insulin pump is connected with each injection cavity through the catheter assembly, the insulin pump, the detection mechanism and each piezoelectric ceramic mechanism are signal connected with the control circuit module.The present application can monitor the blood glucose concentration and body temperature of human body in real time, provide technical support for safe injection, can realize two-stage slow-release of insulin liquid, can realize partition control of injection of insulin liquid according to needs, and prevent the occurrence of sudden situation.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of insulin injection, in particular to a two-stage slow-release insulin patch pump. BACKGROUND

[0002] For diabetic patients, their blood is in a high glucose environment for a long time, which can cause many complications and serious damage to the body. Therefore, it is crucial to control the blood glucose concentration. Insulin injection is the most effective method to control the blood glucose concentration. Today, various insulin pumps have been applied to insulin injection to replace manual injection.

[0003] Among them, the existing piezoelectric pump system is to act on the piezoelectric vibrator by an electric drive signal to produce vibration, so that the piezoelectric vibrator vibrates up and down in the pump cavity to cause the volume change in the pump cavity, thereby causing the output dose of insulin to change. This technology involves the combination of electricity and structure, as well as the solid-liquid coupling process of the solid-initiated liquid as the load, which is a cross-disciplinary analysis. It is very difficult to use theoretical derivation to design the piezoelectric pump, and it is difficult to control the geometry and boundary, which is not accurate enough.

[0004] In the conventional injection method, when an insulin treatment is performed using a syringe with a needle, needle breakage often occurs. In addition, when insulin is injected, the injection area should be carefully selected. Before injection, the injection area should be marked on the abdomen, and the last injection point should be avoided as much as possible. 75% medical alcohol should be used to spiral disinfection from the center of the injection point to the surrounding area. The disinfection straight line should be greater than 5 cm in general. The injection site should be regularly rotated, and the same site should not be repeatedly injected, otherwise it is easy to form a hard lump, which affects the absorption of insulin.

[0005] To solve the above technical problems, we propose a two-stage slow-release insulin patch pump. SUMMARY

[0006] The purpose of the present application is to provide a two-stage slow-release insulin patch pump. The present application can monitor the blood glucose concentration and body temperature of the human body in real time, provide technical support for safe injection, and realize two-stage slow-release of insulin liquid through the insulin pump, piezoelectric ceramic mechanism, microporous elastic pad and multi-layer slow-release pad. The injection of insulin liquid can be controlled according to the needs to prevent the occurrence of sudden situations.

[0007] To achieve the above purpose, the present application adopts the following technical solutions:

[0008] The two-stage slow-release insulin patch pump comprises a shell, an insulin pump, a detection mechanism, a plurality of piezoelectric ceramic mechanisms, a plurality of flow control mechanisms, an injection mechanism and a control circuit module, the insulin pump is arranged at the top center of the outer area of the shell, and the two are connected through a catheter assembly, the detection mechanism is arranged at the bottom of the shell, the inner cavity of the shell is evenly divided into a plurality of injection cavities arranged in a circumferential array around the vertical center line of the shell by a plurality of vertical partitions, each piezoelectric ceramic mechanism is uniformly arranged at the top of the shell and corresponds to each injection cavity one by one, each flow control mechanism is arranged in each injection cavity correspondingly, each piezoelectric ceramic mechanism is correspondingly applied to each flow control mechanism, the injection mechanism is evenly arranged at the bottom of the shell and communicates with each injection cavity, the insulin pump pumps the insulin liquid into the upper part of each flow control mechanism in each injection cavity through the catheter assembly, the control circuit module is arranged in the main machine of the insulin pump, the shell of the insulin pump is provided with a button, a display screen and an alarm connected with the control circuit module, the insulin pump, the detection mechanism and each piezoelectric ceramic mechanism are connected with the control circuit module.

[0009] The shell comprises a long box body which is permeable up and down, the upper end of the long box body is sealingly installed with an upper cover plate, the lower end of the long box body is sealingly installed with a bottom cover plate, and each vertical partition is fixedly arranged in the long box body to evenly divide the inner cavity of the long box body into each injection cavity.

[0010] The insulin pump is fixedly installed at the top center of the upper cover plate, the upper cover plate is provided with a plurality of extrusion holes which are permeable up and down and correspond to the middle positions of each injection cavity, the size of the extrusion hole is 1 / 4-1 / 2 of the cross-sectional size of the corresponding injection cavity, and each piezoelectric ceramic mechanism is correspondingly fixedly installed in each extrusion hole.

[0011] The detection mechanism comprises four long microneedles, the four long microneedles are vertically arranged at the bottom corners of the bottom cover plate, the long microneedle is provided with a blood glucose concentration sensor and a body temperature sensor, the signal lines of the blood glucose concentration sensor and the body temperature sensor are led out of the bottom cover plate and connected with the control circuit module through a first sensor wire.

[0012] The structure of each piezoelectric ceramic mechanism is the same, each piezoelectric ceramic mechanism includes an open-bottomed outer cover, a sealed flexible diaphragm and a piezoelectric ceramic, the lower end of the outer cover corresponds to the upper and lower positions of the corresponding extrusion hole and is matched in size and shape, the outer cover is arranged directly above the corresponding extrusion hole, a ring-shaped flange end plate is arranged on the outer side of the lower end edge of the outer cover, the outer cover is fixedly connected to the upper cover plate through the ring-shaped flange end plate, the sealed flexible diaphragm is fixedly connected in the corresponding extrusion hole and seals the corresponding extrusion hole, the size and shape of the piezoelectric ceramic are matched with the size and shape of the corresponding extrusion hole, the piezoelectric ceramic is arranged in the cavity enclosed by the sealed flexible diaphragm and the outer cover and is correspondingly matched and embedded in the corresponding extrusion hole, the top of the piezoelectric ceramic is in top pressing contact with the inner top surface of the outer cover, the bottom of the piezoelectric ceramic is arranged on the upper surface of the sealed flexible diaphragm, the lower surface of the sealed flexible diaphragm is flush with the inner surface of the upper cover plate, and the electric control wire of the piezoelectric ceramic is led out of the outer cover and is signal-connected with the control circuit module.

[0013] The structure of each flow regulation mechanism is the same, each flow regulation mechanism includes a microporous elastic pad and a multilayer sustained-release pad, the microporous elastic pad and the multilayer sustained-release pad are arranged in the corresponding injection cavity in a superimposed and matched manner, the microporous elastic pad and the multilayer sustained-release pad are in clearance fit with the corresponding injection cavity, the top surface of the microporous elastic pad is in pressing contact with the inner surface of the upper cover plate, the bottom surface of the multilayer sustained-release pad is in pressing contact with the inner surface of the bottom cover plate, and the lower surface of the sealed flexible diaphragm is in pressing contact with the middle part of the top surface of the microporous elastic pad;

[0014] The multilayer sustained-release pad is composed of three layers of multi-cavity compressible extrusion materials.

[0015] The catheter assembly includes a plurality of branch catheters, each of which is arranged in one-to-one correspondence with each injection cavity, the liquid inlet end of each branch catheter is introduced into the inside of the insulin pump and connected with the insulin medicine bottle built in the insulin pump, the liquid outlet end of each branch catheter is correspondingly introduced into the inside of each injection cavity and guided to the upper part of each microporous elastic pad, and a sleeve tube is arranged outside a section of each branch catheter between the insulin pump and the upper cover plate, a liquid medicine flow sensor is arranged on each branch catheter, and each liquid medicine flow sensor is signal-connected with the control circuit module through the second sensor wire.

[0016] The injection mechanism includes a plurality of short microneedles arranged in an array on the lower surface of the bottom cover plate and corresponding to each injection cavity in an upper and lower manner, and the upper end of each short microneedle passes through the bottom cover plate upward and communicates with the corresponding injection cavity.

[0017] By adopting the above technical scheme, the two-stage sustained-release control method for insulin injection specifically includes the following steps:

[0018] (1) The injection end of the two-stage sustained-release insulin application patch pump is applied to the skin of a specified area of a human body;

[0019] (ii) The detection mechanism collects the blood glucose concentration and body temperature data of the human body in real time, and stores them in the control circuit module according to the set period;

[0020] (iii) The insulin pump is started, and the set injection amount and speed of the insulin liquid are pumped into the shell according to the artificial medical advice;

[0021] (iv) The extension amount of each piezoelectric ceramic mechanism is controlled by the control circuit module, and the corresponding flow control mechanism is squeezed to realize the flow control of the insulin liquid;

[0022] (v) The insulin liquid passes through the corresponding flow control mechanism from top to bottom and is injected into the human body subcutaneously through the injection mechanism;

[0023] (vi) After the insulin liquid is injected, the two-stage slow-release insulin patch pump is removed.

[0024] Step (ii) is specifically: the bottom cover plate is attached to the skin of the human body in the designated area, and the four long microneedles are inserted into the human body subcutaneously. On the one hand, the four long microneedles can position the two-stage slow-release insulin patch pump, and on the other hand, the four long microneedles can collect the blood glucose concentration and body temperature data of the human body in real time through the built-in blood glucose concentration sensor and body temperature sensor. The blood glucose concentration sensor and the body temperature sensor store the collected blood glucose concentration and body temperature data in the control circuit module through the corresponding signal line and sensor lead connected thereto according to the set period. The control circuit module determines whether there is an abnormality in the entire injection process. If there is an abnormality, the control circuit module sends the abnormal information to the display for display to remind the user, and at the same time, the alarm sends an alarm signal.

[0025] Step (iii) is specifically: the insulin pump is started, and the injection amount and speed of the insulin liquid are set by the key artificial medical advice. The control circuit module controls the insulin pump to pump the insulin liquid into each injection cavity in the shell according to the set injection amount and speed of the artificial medical advice, so that the insulin liquid is injected into the upper part of each microporous elastic pad.

[0026] Step (iv) is specifically: each liquid flow sensor detects the flow of insulin liquid in each branch conduit in real time and transmits the detected information to the control circuit module through the corresponding sensor lead. The control circuit module controls the extension amount of each piezoelectric ceramic according to the real-time detection of the insulin liquid flow by each liquid flow sensor in two modes, changes the micropore gap distribution of each microporous elastic pad, and then controls the injection flow of the insulin liquid in each injection cavity. The two modes are specifically:

[0027] (I) Abnormality detection and processing

[0028] When a certain drug liquid flow sensor detects that the insulin drug liquid flow in the corresponding branch conduit is greater than 30% of the expected injection speed, the control circuit module determines that there is an abnormality in the region where the injection chamber connected with the corresponding branch conduit is attached, that is, each short microneedle under the region is not correctly worn, and the insulin drug liquid leaks, so the control circuit module controls the piezoelectric ceramic electrostrictive stretching above the region through the corresponding electric control line, the lower part of the piezoelectric ceramic extrudes the sealing flexible diaphragm below it to protrude into the corresponding injection chamber through the corresponding extrusion hole, and then extrudes the microporous elastic pad, changes the microporous gap distribution of the microporous elastic pad, and at the same time, the microporous elastic pad extrudes the multilayer slow-release pad below it, so that the insulin drug liquid in the injection chamber of the region cannot flow out.

[0029] (II) The insulin drug liquid flow of each injection chamber corresponding region is dynamically balanced

[0030] When each drug liquid flow sensor detects that the insulin drug liquid flow in each branch conduit is inconsistent, the control circuit module dynamically adjusts the up-down stretching amount and control period of each piezoelectric ceramic according to the current injection speed and its current flow deviation by using a fuzzy control strategy, and then dynamically extrudes each microporous elastic pad to change the microporous gap distribution of each microporous elastic pad, and at the same time, each microporous elastic pad extrudes the multilayer slow-release pad below it, so as to dynamically control the insulin drug liquid flow in each injection chamber, and dynamically balance the insulin drug liquid flow in each branch conduit.

[0031] Step (five) is: the insulin drug liquid pumped into each injection chamber flows from the upper part of each microporous elastic pad under the action of the pumping pressure, and then flows out from the lower part of each microporous elastic pad, and then flows through the multilayer slow-release pad below each microporous elastic pad to the bottom cover plate, and the insulin drug liquid is injected into the human body subcutaneously through each short microneedle on the bottom cover plate, and the display screen displays the working state of the two-stage slow-release insulin patch pump in real time, if there is an abnormal condition, the control circuit module sends the abnormal information to the display for display to remind the user, and at the same time, the alarm sends an alarm signal.

[0032] The present application has the following beneficial effects compared with the prior art:

[0033] (1) The amount of insulin liquid injected by the user is dynamically changing, and needs to be handled according to different situations. In order to detect the injection of insulin liquid in real time, a long microneedle is arranged at each corner of the bottom of the bottom cover plate, and a blood glucose concentration sensor and a body temperature sensor are arranged in the long microneedle. When the insulin liquid is injected, the four long microneedles can monitor the blood glucose concentration and body temperature of the human body in real time through the built-in blood glucose concentration sensor and body temperature sensor, so that the harm to the user's body caused by excessive or insufficient amount of insulin liquid can be avoided, and whether there is an abnormality in the whole injection process can be judged. If there is an abnormality, the control circuit module sends the abnormal information to the display for display to remind the user, and at the same time, the alarm sends an alarm signal, thereby providing technical support for safe injection. Finally, whether the injection achieves the expected effect is evaluated by the collected blood glucose concentration.

[0034] (2) Since the depth of each short microneedle arranged in an array under the bottom cover plate may not be consistent, the injection flow of the area corresponding to each injection cavity may be unbalanced, and in severe cases, the local area may leak insulin liquid. The control circuit module collects the detection data of each liquid flow sensor, and dynamically adjusts the up-down stretching amount and control period of each piezoelectric ceramic independently, thereby dynamically extruding each microporous elastic pad, changing the microporous gap distribution of each microporous elastic pad, and simultaneously extruding the multi-layer sustained-release pad under each microporous elastic pad, so as to dynamically control the flow of insulin liquid in each injection cavity, and further control the injection speed of the insulin liquid in each branch conduit.

[0035] (3) When the two-stage sustained-release insulin patch pump of the application works, the specific principle of the two-stage sustained-release of the insulin liquid is as follows: the first stage of sustained-release is that the insulin pump pumps the insulin liquid into each injection cavity in the shell through each branch conduit according to the injection amount and speed set by the artificial doctor's advice, and the second stage of sustained-release is that each piezoelectric ceramic will be subjected to electrostriction under the control of the control circuit module, thereby each piezoelectric ceramic extrudes the microporous elastic pad below it, changes the microporous gap distribution of each microporous elastic pad, and simultaneously extrudes the multi-layer sustained-release pad below each microporous elastic pad, so as to dynamically control the flow of insulin liquid in each injection cavity; in this way, the injection of the insulin liquid can be controlled according to the needs, and the occurrence of sudden situations can be prevented.

[0036] (4) The two-stage sustained-release insulin patch pump of the application can still work normally in the case of breakage or blockage of one or several short microneedles during injection, since the multiple short microneedles arranged in an array and corresponding to each injection cavity are used for insulin liquid injection.

[0037] In summary, the present application can monitor the blood glucose concentration and body temperature of human in real time, provide technical support for safe injection, and realize two-stage release of insulin liquid through the insulin pump, piezoelectric ceramic mechanism, microporous elastic pad and multi-layer slow-release pad, so that the injection of insulin liquid can be controlled in different areas according to the needs, and sudden situations can be prevented. BRIEF DESCRIPTION OF DRAWINGS

[0038] Figure 1 It is a structural schematic diagram of the present application.

[0039] Figure 2 It is a control flow chart during use of the present application.

[0040] Figure 3 It is a partial sectional view of the present application.

[0041] Figure 4 It is a structural schematic diagram of the present application after omitting the insulin pump and the outer cover.

[0042] Figure 5 It is a structural schematic diagram of the present application after omitting the insulin pump, each piezoelectric ceramic mechanism and the upper cover plate.

[0043] Figure 6 It is a structural schematic diagram of the present application after omitting the insulin pump, each piezoelectric ceramic mechanism, the upper cover plate and the rectangular box. EMBODIMENT

[0044] The embodiments of the present application are further described below with reference to the accompanying drawings.

[0045] As shown in Figures 1-6 , the two-stage release insulin patch pump comprises a shell, an insulin pump, a detection mechanism, a plurality of piezoelectric ceramic mechanisms, a plurality of flow control mechanisms, an injection mechanism and a control circuit module. The insulin pump is arranged at the top center of the outer region of the shell and connected to the shell through a catheter assembly 1. The detection mechanism is arranged at the bottom of the shell. The inner cavity of the shell is evenly divided into a plurality of injection cavities arranged in a circumferential array around the vertical center line by a plurality of vertical partitions 2. Each piezoelectric ceramic mechanism is arranged around the insulin pump at the top of the shell and corresponds to each injection cavity one by one. Each flow control mechanism is arranged in each injection cavity. Each piezoelectric ceramic mechanism is correspondingly pressed on each flow control mechanism. The injection mechanism is evenly arranged at the bottom of the shell and communicates with each injection cavity. The insulin pump pumps the insulin liquid into the upper part of the corresponding flow control mechanism in each injection cavity through the catheter assembly 1. The control circuit module is arranged in the main machine of the insulin pump. The shell of the insulin pump is provided with a button, a display screen and an alarm connected with the control circuit module. The insulin pump, the detection mechanism and each piezoelectric ceramic mechanism are signal connected with the control circuit module.

[0046] The shell comprises a long box 3 which is permeable from top to bottom, an upper cover plate 4 is sealingly installed at the upper end of the long box 3, and a bottom cover plate 5 is sealingly installed at the lower end of the long box 3; each vertical partition plate 2 is fixedly arranged in the long box 3 to uniformly divide the inner cavity of the long box 3 into each injection cavity.

[0047] An insulin pump is fixedly installed at the top center of the upper cover plate 4; the upper cover plate 4 is provided with a plurality of vertically permeable pressing holes at the middle positions corresponding to each injection cavity; the size of each pressing hole is 1 / 4-1 / 2 of the cross-sectional size of the corresponding injection cavity; and each piezoelectric ceramic mechanism is fixedly installed in the corresponding pressing hole.

[0048] The detection mechanism comprises four long microneedles 6 which are vertically arranged at the bottom four corners of the bottom cover plate 5; the long microneedles 6 are internally provided with a blood glucose concentration sensor and a body temperature sensor; the signal lines of the blood glucose concentration sensor and the body temperature sensor are led out of the bottom cover plate 5 and are signal-connected with the control circuit module through the first sensor lead wire 7.

[0049] Each piezoelectric ceramic mechanism has the same structure and comprises an open-bottomed outer cover 8, a sealing flexible diaphragm and a piezoelectric ceramic 9; the lower port of the outer cover 8 corresponds to the vertically permeable pressing hole in size and shape and is sealingly connected with the vertically permeable pressing hole; the outer cover 8 is arranged above the vertically permeable pressing hole; a ring-shaped flange end plate 10 is arranged at the outer side of the lower end edge of the outer cover 8; the outer cover 8 is fixedly connected with the upper cover plate 4 through the ring-shaped flange end plate 10; the sealing flexible diaphragm is fixedly connected in the vertically permeable pressing hole and sealingly blocks the vertically permeable pressing hole; the piezoelectric ceramic 9 is arranged in the cavity surrounded by the sealing flexible diaphragm and the outer cover 8 and is correspondingly matched and embedded in the vertically permeable pressing hole; the top of the piezoelectric ceramic 9 is in top pressing contact with the inner top surface of the outer cover 8; the bottom of the piezoelectric ceramic 9 is arranged on the upper surface of the sealing flexible diaphragm; the lower surface of the sealing flexible diaphragm is flush with the inner surface of the upper cover plate 4; and the electric control wire 11 of the piezoelectric ceramic 9 is led out of the outer cover 8 and is signal-connected with the control circuit module.

[0050] Each flow regulating mechanism has the same structure and comprises a microporous elastic pad 12 and a multilayer sustained-release pad 13; the microporous elastic pad 12 and the multilayer sustained-release pad 13 are vertically stacked and matched in the corresponding injection cavity; the microporous elastic pad 12 and the multilayer sustained-release pad 13 are gap-fitted with the corresponding injection cavity; the top surface of the microporous elastic pad 12 is in pressing contact with the inner surface of the upper cover plate 4; the bottom surface of the multilayer sustained-release pad 13 is in pressing contact with the inner surface of the bottom cover plate 5; and the lower surface of the sealing flexible diaphragm is in pressing contact with the middle part of the top surface of the microporous elastic pad 12.

[0051] The multilayer sustained-release pad 13 is composed of three layers of hollow compressible extrusion materials.

[0052] The catheter assembly 1 comprises a plurality of branch catheters 14, each of which is arranged in one-to-one correspondence with each injection cavity, the liquid inlet end of each branch catheter 14 is introduced into the inside of the insulin pump and connected with the insulin medicine bottle built-in the insulin pump, the liquid outlet end of each branch catheter 14 is correspondingly introduced into the inside of each injection cavity through the upper cover plate 4 and guided to the upper part of each micro-hole elastic pad 12, the outer part of each branch catheter 14 between the insulin pump and the upper cover plate 4 is wrapped with a sheath tube 15, each branch catheter 14 is provided with a medicine liquid flow sensor, and each medicine liquid flow sensor is signal connected with the control circuit module through the second sensor lead wire.

[0053] The injection mechanism comprises a plurality of short micro-needles 16 which are arranged in an array on the lower surface of the bottom cover plate 5 and correspond to each injection cavity in the up-down direction, the upper end of each short micro-needle 16 penetrates through the bottom cover plate 5 and communicates with the corresponding each injection cavity.

[0054] By adopting the above technical scheme, the two-stage slow-release control method for insulin injection specifically comprises the following steps:

[0055] (1) the injection end of the two-stage slow-release insulin patch pump is attached to the skin of the designated area of the human body;

[0056] (2) the detection mechanism collects the blood glucose concentration and body temperature data of the human body in real time and stores them into the control circuit module according to the set period;

[0057] (3) the insulin pump is started, and the insulin medicine liquid is pumped into the shell according to the injection amount and speed set by the artificial medical order;

[0058] (4) the extension amount of each piezoelectric ceramic mechanism is adjusted by the control circuit module, and the piezoelectric ceramic mechanism extrudes the corresponding flow control mechanism to realize the flow control of the insulin medicine liquid;

[0059] (5) the insulin medicine liquid is injected into the subcutaneous tissue of the human body by the injection mechanism after passing through the corresponding flow control mechanism from top to bottom;

[0060] (6) after the injection of the insulin medicine liquid, the two-stage slow-release insulin patch pump is removed.

[0061] Step (two) is specifically: the bottom cover plate 5 is pasted on the skin of the designated area of the human body, and the four long microneedles 6 are inserted into the human body subcutaneously. On the one hand, the four long microneedles 6 can position the two-stage slow-release insulin patch pump, and on the other hand, the four long microneedles 6 can collect the blood glucose concentration and body temperature data of the human body in real time through the blood glucose concentration sensor and the body temperature sensor built therein. The blood glucose concentration sensor and the body temperature sensor store the collected blood glucose concentration and body temperature data into the control circuit module through the corresponding signal lines and sensor leads connected thereto at a set period. The control circuit module judges whether there is an abnormality in the entire injection process. If there is an abnormality, the control circuit module sends the abnormal information to the display for display to remind the user, and at the same time, the control alarm sends an alarm signal.

[0062] Step (three) is specifically: starting the insulin pump, setting the injection amount and speed of the insulin liquid by the key artificial medical order, and then the control circuit module controls the insulin pump to pump the insulin liquid into each injection cavity in the shell through each branch conduit 14 according to the injection amount and speed set by the artificial medical order, so that the insulin liquid is injected into the upper part of each microporous elastic pad 12.

[0063] Step (four) is specifically: each liquid flow sensor detects the insulin liquid flow in each branch conduit 14 in real time and transmits the detected information to the control circuit module through the corresponding sensor lead. The control circuit module controls the extension and contraction amount of each piezoelectric ceramic 9 according to the insulin liquid flow detected by each liquid flow sensor in real time, changes the micropore gap distribution of each microporous elastic pad 12, and then controls the injection flow of the insulin liquid in each injection cavity, which is divided into two modes:

[0064] (I) Abnormality detection and processing

[0065] When a certain liquid flow sensor detects that the insulin liquid flow in the corresponding branch conduit 14 is greater than 30% of the expected injection speed and above, the control circuit module determines that there is an abnormality in the area above the injection cavity connected with the corresponding branch conduit 14, i.e. each short microneedle 16 below the area is not correctly worn, and the insulin liquid leaks. The control circuit module controls the piezoelectric ceramic 9 above the area to stretch up and down quickly through the corresponding electric control line 11, and the lower part of the piezoelectric ceramic 9 presses the sealing flexible diaphragm below it to protrude downward into the corresponding injection cavity through the corresponding extrusion hole, thereby extruding the corresponding microporous elastic pad 12 and changing the micropore gap distribution of the microporous elastic pad 12. At the same time, the microporous elastic pad 12 extrudes the multi-layer slow-release pad 13 below it, so that the insulin liquid in the injection cavity of the area cannot flow out.

[0066] (II) Dynamic balance of insulin liquid flow in the area corresponding to each injection cavity

[0067] When each drug liquid flow sensor detects that the insulin drug liquid flow in each branch conduit 14 is inconsistent, the control circuit module dynamically adjusts the up-and-down stretching amount and control period of each piezoelectric ceramic 9 according to the current injection speed and its current flow deviation, and then dynamically extrudes each micro-porous elastic pad 12, changes the micro-porous gap distribution of each micro-porous elastic pad 12, and at the same time, each micro-porous elastic pad 12 extrudes the multi-layer slow-release pad 13 below it, so as to dynamically control the insulin drug liquid flow in each injection cavity, and dynamically keep the insulin drug liquid flow in each branch conduit 14 balanced.

[0068] Step (five) is specifically: the insulin drug liquid pumped into each injection cavity flows from the upper part of the corresponding each micro-porous elastic pad 12 under the action of the pumping pressure, and then flows out from the lower part of the corresponding each micro-porous elastic pad 12, and then the insulin drug liquid flows downward through the multi-layer slow-release pad 13 below the corresponding each micro-porous elastic pad 12 to the bottom cover plate 5, and then the insulin drug liquid is injected into the human body subcutaneously through each short microneedle 16 on the bottom cover plate 5, and the display screen displays the working state of the two-stage slow-release insulin patch pump in real time. If there is an abnormal condition, the control circuit module sends the abnormal information to the display for display to remind the user, and at the same time, the alarm sends an alarm signal.

[0069] In order to fully explain the "control circuit module controls the stretching amount of each piezoelectric ceramic 9 according to the insulin drug liquid flow detected by each drug liquid flow sensor in real time" in step (four), two modes (I) and (II) are exemplified:

[0070] (I), abnormal detection and processing

[0071] For example, the catheter assembly 1 includes two branch catheters 14: branch catheter A and branch catheter B. Assuming that the injection speed of insulin drug solution PS = 160 mU / sec is the target requirement, if the short microneedles 16 under the area where the injection cavity connected with the branch catheter A are not properly worn, the flow rate of insulin drug solution in the branch catheter A will be greater than the expected injection speed (80 mU / sec). Once the flow rate detected by the drug solution flow sensor on the branch catheter A is greater than 30% of the expected injection speed or more, the control circuit module determines that there is an abnormality in the area where the injection cavity connected with the branch catheter A is attached, i.e., there is a situation of insulin drug solution leakage in the area. At this time, the control circuit module controls the piezoelectric ceramic 9 above the area to stretch up and down quickly. The piezoelectric ceramic 9 presses the microporous elastic pad 12 below it downward, changes the microporous gap distribution of the microporous elastic pad 12, and at the same time, the microporous elastic pad 12 presses the multi-layer sustained-release pad 13 below it, so that the insulin drug solution in the injection cavity of the area cannot flow out.

[0072] (II) Dynamic balance of insulin drug solution flow rate in each corresponding area of the injection cavity

[0073] For example, the catheter assembly 1 includes two branch catheters 14: branch catheter A and branch catheter B. Assuming that the injection speed of insulin drug solution PS = 160 mU / sec is the target requirement, the injection speeds of the two injection cavities in the areas connected with the branch catheter A and the branch catheter B are respectively PS a = 80 mU / sec and PS b = 80 mU / sec under ideal conditions. When the injection speed of the injection cavity in the area connected with the branch catheter A or the branch catheter B is greater or less than the injection speed under the ideal conditions, the injection speed of the corresponding area needs to be controlled. The control circuit module dynamically adjusts the up-and-down stretching amount and control period of the piezoelectric ceramic 9 above the corresponding area according to the current injection speed and the current flow rate deviation using a fuzzy control strategy. The fuzzy control strategy is shown in Table 1 below:

[0074]

[0075]

[0076] ;

[0077] For other catheter assembly 1 includes a branch catheter 14 or three to six branch catheter 14, the injection rate of each branch catheter 14 is regulated in a manner similar to the fuzzy control strategy adopted by the above two branch catheters A and B.

[0078] Insulin pump, control circuit module, button, display screen, alarm, blood glucose concentration sensor, body temperature sensor, sealed flexible diaphragm and liquid flow sensor are not shown in the figure.

[0079] Insulin pump, control circuit module, button, display screen, alarm, long microneedle 6, blood glucose concentration sensor, body temperature sensor, piezoelectric ceramic 9, sealed flexible diaphragm, microporous elastic pad 12, multi-layer sustained-release pad 13, liquid flow sensor and short microneedle 16 are conventional technologies, and the specific structure and working principle will not be described.

[0080] It should be noted that the tight arrangement of stratum corneum cells makes it difficult for macromolecular drugs to pass through, which is the biggest obstacle to transdermal drug delivery technology. A large number of applications about microneedles began to appear in the 1990s when micro-electro-mechanical technology gradually matured. The height of general microneedles is 300-1000 μm Can penetrate the epidermis layer with a height of 200 μm Open a large number of microchannels on the surface of the skin, which are used for transdermal passage of macromolecular drugs, so microneedles begin to be widely used as a transdermal drug delivery technology.

[0081] The short microneedle 16 in the application can adopt a soluble microneedle, which refers to a microneedle prepared by using some water-soluble polymer materials. When the two-stage sustained-release insulin patch pump is removed, even if there are a small amount of short microneedles 16 remaining in the skin or muscle, these small amount of short microneedles 16 will be biologically dissolved over time and will not affect the human body.

[0082] The application has the following beneficial effects:

[0083] (1) The amount of insulin liquid injected by the user is dynamically changing, and needs to be handled according to different situations. In order to detect the injection of insulin liquid in real time, a long microneedle 6 is arranged at the bottom of the bottom cover plate 5. The long microneedle 6 is internally provided with a blood glucose concentration sensor and a body temperature sensor. When the insulin liquid is injected, the four long microneedles 6 can monitor the blood glucose concentration and body temperature of the human body in real time through the internally provided blood glucose concentration sensor and body temperature sensor, so that the harm to the user's body caused by excessive or insufficient amount of insulin liquid can be avoided, and whether the whole injection process is abnormal can be judged. If there is an abnormal situation, the control circuit module sends the abnormal information to the display for display to remind the user, and at the same time controls the alarm to send an alarm signal, thereby providing technical support for safe injection. Finally, whether the injection reaches the expected effect is evaluated by the collected blood glucose concentration.

[0084] (2) Since the depth of each short microneedle 16 arranged in an array under the bottom cover plate 5 may not be consistent, the injection flow of the area corresponding to each injection cavity may not be balanced, and in severe cases, the local area may leak insulin liquid. The control circuit module collects the detection data of each liquid flow sensor, and dynamically adjusts the up-down stretching amount and control period of each piezoelectric ceramic 9 independently, thereby dynamically extruding each microporous elastic pad 12, changing the micropore gap distribution of each microporous elastic pad 12, and simultaneously extruding the multi-layer sustained-release pad 13 under each microporous elastic pad 12, thereby dynamically controlling the insulin liquid flow in each injection cavity, and further controlling the injection speed of the insulin liquid in each branch conduit 14.

[0085] (3) When the two-stage sustained-release insulin patch pump of the application works, the specific principle of the two-stage sustained-release of the insulin liquid is: the first stage of sustained-release is controlled by the pressure of the insulin pump. The insulin pump pumps the insulin liquid into each injection cavity in the housing through each branch conduit 14 according to the injection amount and speed set by the artificial medical order. The second stage of sustained-release is that each piezoelectric ceramic 9 will undergo electrostriction under the control of the control circuit module, thereby extruding the microporous elastic pad 12 below each piezoelectric ceramic 9, changing the micropore gap distribution of each microporous elastic pad 12, and simultaneously extruding the multi-layer sustained-release pad 13 below each microporous elastic pad 12, thereby dynamically controlling the insulin liquid flow in each injection cavity. In this way, the injection of the insulin liquid can be controlled according to the needs, and the occurrence of sudden situations can be prevented.

[0086] (4) The present application adopts a plurality of short microneedles 16 arranged in an array and corresponding to each injection cavity to inject insulin liquid, which can ensure that the two-stage sustained-release insulin patch pump can still work normally in the case of breakage or blockage of one or several short microneedles 16 during injection.

[0087] The above examples are only used to illustrate but not to limit the technical solutions of the present application. Although the present application is described in detail with reference to the above examples, those skilled in the art should understand that the present application can be modified or equivalently replaced without departing from the spirit and scope of the present application, and any modification or partial replacement should be covered in the scope of claims of the present application.

Claims

1. A two-stage sustained-release insulin pump, characterized by: The invention comprises a shell, an insulin pump, a detection mechanism, a plurality of piezoelectric ceramic mechanisms, a plurality of flow control mechanisms, an injection mechanism and a control circuit module. The insulin pump is arranged in the external area at the top center of the shell, and the connection between the two is achieved through a catheter assembly. The detection mechanism is arranged around the bottom of the shell. The inner cavity of the shell is evenly divided into a plurality of injection cavities in a circumferential array around its vertical center line by a plurality of vertical partitions. The piezoelectric ceramic mechanisms are evenly distributed on the top of the shell and correspond to the injection cavities one by one. The flow control mechanisms are respectively arranged in the injection cavities. The piezoelectric ceramic mechanisms respectively exert an extrusion effect on the flow control mechanisms. The injection mechanisms are evenly arranged at the bottom of the shell and communicate with the injection cavities. The insulin pump pumps the insulin liquid into the upper part of the corresponding flow control mechanism in each injection cavity through the catheter assembly. The control circuit module is arranged in the host of the insulin pump. The outer shell of the insulin pump is provided with a button, a display screen and an alarm connected to the control circuit module signal. The insulin pump, the detection mechanism and the piezoelectric ceramic mechanisms are all connected to the control circuit module signal. The shell comprises a rectangular box body which is transparent from top to bottom. The upper end of the rectangular box body is sealed with an upper cover plate, and the lower end of the rectangular box body is sealed with a bottom cover plate. Each vertical partition is fixedly arranged in the rectangular box body to evenly divide the inner cavity of the rectangular box into various injection cavities. The insulin pump is fixedly installed at the top center of the upper cover. An extrusion hole that is transparent from top to bottom is opened in the middle of each injection cavity on the upper cover. The size of the extrusion hole is 1 / 4 to 1 / 2 of the cross-sectional size of the corresponding injection cavity. Each piezoelectric ceramic mechanism is fixedly installed in each extrusion hole. The detection mechanism includes four long microneedles, which are vertically arranged at the four corners of the bottom of the bottom cover. The long microneedles have built-in blood glucose concentration sensors and body temperature sensors. The signal lines of the blood glucose concentration sensor and body temperature sensor are led out of the bottom cover and connected to the control circuit module through the first sensor wire; The structures of each piezoelectric ceramic mechanism are the same. Each piezoelectric ceramic mechanism includes an outer cover with an open lower side, a sealed flexible diaphragm and a piezoelectric ceramic. The lower port of the outer cover corresponds to the corresponding extrusion hole up and down and is adapted to the size and shape. The outer cover is directly above the corresponding extrusion hole. An annular flange end plate is provided around the outer side of the lower edge of the outer cover. The outer cover is fixedly connected to the upper cover through the annular flange end plate. The sealed flexible diaphragm is fixedly connected to the corresponding extrusion hole and seals the corresponding extrusion hole. The size and shape of the piezoelectric ceramic are adapted to the size and shape of the corresponding extrusion hole. The piezoelectric ceramic is arranged in a cavity enclosed by the sealed flexible diaphragm and the outer cover and is correspondingly matched and embedded in the corresponding extrusion hole. The top of the piezoelectric ceramic is in pressure contact with the inner top surface of the outer cover, and the bottom of the piezoelectric ceramic is pressed on the upper surface of the sealed flexible diaphragm. The lower surface of the sealed flexible diaphragm is flush with the inner surface of the upper cover. The electric control line of the piezoelectric ceramic is led out of the outer cover and connected to the signal of the control circuit module.

2. The two-stage sustained-release insulin patch pump according to claim 1, characterized in that: The structures of the various flow control mechanisms are the same. Each flow control mechanism includes a microporous elastic pad and a multi-layer sustained-release pad. The microporous elastic pad and the multi-layer sustained-release pad are stacked and matched in the corresponding injection cavity. The microporous elastic pad and the multi-layer sustained-release pad are both matched with the corresponding injection cavity gap. The top surface of the microporous elastic pad is pressed against the inner surface of the upper cover plate, the bottom surface of the multi-layer sustained-release pad is pressed against the inner surface of the bottom cover plate, and the lower surface of the sealing flexible diaphragm is pressed against the middle of the top surface of the microporous elastic pad; the multi-layer sustained-release pad is composed of three layers of porous compressible extruded material.

3. The two-stage sustained-release insulin patch pump according to claim 2, characterized in that: The catheter assembly includes several branch catheters, each of which is arranged in a one-to-one correspondence with each injection cavity. The liquid inlet end of each branch catheter is introduced into the interior of the insulin pump and connected to the built-in insulin bottle of the insulin pump. The liquid outlet end of each branch catheter corresponds to the position of each injection cavity, passes downward through the upper cover plate, is introduced into the interior of each injection cavity, and is respectively guided to the upper part of each corresponding microporous elastic pad. Each branch catheter is wrapped with an outer sleeve on the outside of a section between the insulin pump and the upper cover plate. Each branch catheter is provided with a drug liquid flow sensor, and each drug liquid flow sensor is connected to the control circuit module signal through a second sensor wire.

4. The two-stage sustained-release insulin patch pump according to claim 1, characterized in that: The injection mechanism includes a plurality of short microneedles evenly distributed in an array on the lower surface of the bottom cover and corresponding to each injection cavity. The upper end of each short microneedle passes through the bottom cover upward and communicates with the corresponding injection cavity.

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