Insulin pump injection two-stage release control method

Abstract

The two-stage slow-release control method of insulin pump injection specifically comprises the following steps: (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; (2) the detection mechanism collects the blood glucose concentration and body temperature data of the human body in real time; (3) the insulin pump is started, and the insulin liquid is pumped into the shell according to the injection amount and speed set by the artificial medical order; (4) the flow control of the insulin liquid is realized through the control circuit module, the piezoelectric ceramic mechanism and the flow control mechanism; (5) the insulin liquid is injected into the human body subcutaneously from top to bottom through the injection mechanism; (6) after the insulin liquid is injected, the two-stage slow-release insulin patch pump is removed. 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, realize two-stage slow-release of the insulin liquid, and realize partition control of the injection of the insulin liquid according to the needs, thereby preventing the occurrence of sudden situations.

Description

Technical Field

[0001] This invention relates to the field of insulin pump technology, and more specifically, to a two-stage sustained-release control method for insulin pump injection. Background Technology

[0002] For diabetic patients, a chronically high blood sugar level can lead to numerous complications and cause serious damage to the body. Therefore, controlling blood sugar levels is crucial. Insulin injection is the most effective method for controlling blood sugar levels. Currently, various insulin pumps are used to replace manual injections.

[0003] The existing piezoelectric pump system uses an electric drive signal to generate vibration on a piezoelectric oscillator, causing the oscillator to vibrate up and down in the pump chamber, resulting in changes in the volume of the pump chamber and thus changes in the output dose of insulin. This technology involves the combination of electrical and structural science, as well as the solid-liquid coupling process initiated by a solid and loaded by a liquid, which are interdisciplinary analyses. The theoretical derivation process is very difficult for the design of piezoelectric pumps, and the geometric design and boundary control are difficult and not accurate enough.

[0004] In conventional insulin injection methods, needle breakage is a common occurrence when using a syringe with a single needle. Furthermore, the injection site must be carefully chosen. Before injection, the injection area should be marked on the abdomen, avoiding previous injection sites as much as possible. Disinfect the area with 75% medical alcohol in a spiral motion from the center outwards, ensuring the disinfection diameter is greater than 5cm. Regularly rotate injection sites to avoid repeatedly injecting into the same area, as this can easily lead to lumps and impair insulin absorption.

[0005] To address the above technical issues, we propose a two-stage sustained-release control method for insulin pump injection. Summary of the Invention

[0006] The purpose of this invention is to provide a two-stage sustained-release control method for insulin pump injection. This invention can monitor the blood glucose concentration and body temperature of the human body in real time, providing technical assurance for safe injection. Through the insulin pump, piezoelectric ceramic mechanism, microporous elastic pad and multi-layer sustained-release pad, two-stage sustained release of insulin solution can be achieved. The injection of insulin solution can be controlled in zones as needed to prevent the occurrence of emergencies.

[0007] To achieve the above objectives, the present invention adopts the following technical solution:

[0008] The two-stage sustained-release insulin pump injection method includes the following steps:

[0009] (i) The injection end of the two-stage sustained-release insulin patch pump is applied to the skin of the human body in the designated area. The two-stage sustained-release insulin patch pump includes a housing, an insulin pump, a detection mechanism, several piezoelectric ceramic mechanisms, several flow control mechanisms, an injection mechanism, and a control circuit module.

[0010] (ii) The detection mechanism collects 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 cycle;

[0011] (iii) Start the insulin pump and pump the insulin solution into the housing according to the injection dosage and rate set by the doctor.

[0012] (iv) The extension and retraction of each piezoelectric ceramic mechanism is adjusted by the control circuit module, and the squeezing action of each piezoelectric ceramic mechanism corresponds to the flow control mechanism to realize the flow control of insulin solution.

[0013] (v) The insulin solution is injected subcutaneously into the human body through the injection mechanism after passing through the corresponding flow control mechanisms from top to bottom.

[0014] (vi) After the insulin solution is injected, remove the two-stage sustained-release insulin patch pump.

[0015] The insulin pump is located in the outer area of ​​the top center of the housing and is connected to it via a catheter assembly. The detection mechanism is located around the bottom of the housing. The inner cavity of the housing is evenly divided into several injection chambers arranged circumferentially around its vertical center line by several vertical partitions. Each piezoelectric ceramic mechanism is evenly distributed on the top of the housing and corresponds vertically to each injection chamber. Each flow control mechanism is located in each injection chamber, and each piezoelectric ceramic mechanism applies pressure to each flow control mechanism. The injection mechanism is evenly distributed at the bottom of the housing and communicates with each injection chamber. The insulin pump pumps insulin solution into the upper part of the corresponding flow control mechanism in each injection chamber through the catheter assembly. The control circuit module is located in the main unit of the insulin pump. The outer shell of the insulin pump has buttons, a display screen, and an alarm that are connected to the control circuit module. The insulin pump, the detection mechanism, and each piezoelectric ceramic mechanism are all connected to the control circuit module.

[0016] The shell includes a rectangular box that is open at the top and bottom. A top cover plate is sealed at the top of the rectangular box, and a bottom cover plate is sealed at the bottom of the rectangular box. Each vertical partition is fixedly installed inside the rectangular box to evenly divide the inner cavity of the rectangular box into various injection chambers.

[0017] The insulin pump is fixedly installed at the top center of the top cover plate. Each injection chamber on the top cover plate has a vertically perforated extrusion hole at the middle position. The size of the extrusion hole is 1 / 4 to 1 / 2 of the cross-sectional size of the corresponding injection chamber. Each piezoelectric ceramic mechanism is fixedly installed in the corresponding extrusion hole.

[0018] The detection mechanism includes four long microneedles, which are vertically set at the four corners of the bottom of the bottom cover plate. The long microneedles have built-in blood glucose concentration sensors and body temperature sensors. The signal lines of the blood glucose concentration sensors and body temperature sensors are led out of the bottom cover plate and connected to the control circuit module through the first sensor wire.

[0019] Each piezoelectric ceramic mechanism has the same structure. Each piezoelectric ceramic mechanism includes an outer cover with a lower opening, a sealing flexible diaphragm, and a piezoelectric ceramic. The lower port of the outer cover corresponds vertically to the corresponding extrusion hole and is adapted in size and shape. The outer cover covers the corresponding extrusion hole directly above it. An annular flange end plate is provided around the outer edge of the lower end of the outer cover. The outer cover is fixedly connected to the upper cover plate through the annular flange end plate. The sealing 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 set in the cavity enclosed by the sealing 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 contact with the inner top surface of the outer cover, and the bottom of the piezoelectric ceramic is pressed against 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. The electrical control line of the piezoelectric ceramic is led out of the outer cover and connected to the control circuit module signal.

[0020] Each flow control mechanism has the same structure. 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 chamber. The microporous elastic pad and the multi-layer sustained-release pad are fitted with the corresponding injection chamber with a 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.

[0021] The multi-layer slow-release pad is composed of three layers of porous compressible material.

[0022] The catheter assembly includes several branch catheters, each corresponding to a specific injection chamber. The inlet end of each branch catheter is introduced into the insulin pump and connected to the insulin vial inside the pump. The outlet end of each branch catheter is located at the position of each injection chamber, passes downward through the top cover plate, and is introduced into each injection chamber and guided to the upper part of the corresponding microporous elastic pad. Each branch catheter has an outer sheath covering the section between the insulin pump and the top cover plate. Each branch catheter is equipped with a drug flow sensor, and each drug flow sensor is connected to the control circuit module via a second sensor wire.

[0023] The injection mechanism includes several short microneedles that are evenly distributed in an array on the lower surface of the bottom cover plate and correspond to each injection cavity. The upper end of each short microneedle passes through the bottom cover plate and communicates with the corresponding injection cavity.

[0024] Step (II) is as follows: The bottom cover is applied to the skin of the designated area, and four long microneedles are inserted under the skin. On the one hand, the four long microneedles can locate the two-stage slow-release insulin patch pump. On the other hand, the four long microneedles collect blood glucose concentration and body temperature data in real time through their built-in blood glucose concentration sensor and body temperature sensor. The blood glucose concentration sensor and body temperature sensor then store the collected blood glucose concentration and body temperature data into the control circuit module through the corresponding signal lines and sensor wires connected to them at a set period. The control circuit module determines whether there is any abnormality in the entire injection process. If there is an abnormality, the control circuit module sends the abnormality information to the display to remind the user, and at the same time controls the alarm to issue an alarm signal.

[0025] Step (3) is as follows: Start the insulin pump, manually set the injection dosage and speed of the insulin solution by pressing the button, and the control circuit module controls the insulin pump to pump the insulin solution into each injection chamber in the housing through each branch catheter according to the injection dosage and speed set by the manual doctor, so that the insulin solution is injected into the upper part of each corresponding microporous elastic pad.

[0026] Step (iv) specifically involves: Each insulin flow sensor continuously monitors the insulin flow rate in each branch catheter and transmits the detected information to the control circuit module via the corresponding sensor wires. The control circuit module, based on the real-time insulin flow rate detected by each flow sensor, controls the expansion and contraction of the corresponding piezoelectric ceramics in two modes, thereby altering the micropore distribution of the corresponding microporous elastic pads and ultimately controlling the injection flow rate of the insulin in each injection cavity. The two modes are as follows:

[0027] (I) Anomaly Detection and Handling

[0028] When a flow sensor detects that the insulin flow rate in a corresponding branch catheter is 30% or more greater than the expected injection rate, the control circuit module determines that there is an abnormality in the area where the injection cavity connected to the corresponding branch catheter is located. That is, the short microneedles below this area are not properly attached, resulting in insulin leakage. The control circuit module then controls the piezoelectric ceramic above this area to electrostrict and rapidly extend up and down via the corresponding electrical control line. The lower part of the piezoelectric ceramic then presses down on the sealing flexible diaphragm below it and protrudes downward into the corresponding injection cavity through the corresponding extrusion hole, thereby pressing the corresponding microporous elastic pad and changing the micropore distribution of the microporous elastic pad. At the same time, the microporous elastic pad presses the multi-layer sustained-release pad below it, so that the insulin in the injection cavity in this area cannot flow out.

[0029] (II) The insulin flow rate in the corresponding area of ​​each injection chamber is dynamically balanced.

[0030] When the insulin flow sensors detect inconsistencies in the insulin flow rates of the corresponding branch catheters, the control circuit module employs a fuzzy control strategy to dynamically adjust the vertical expansion and contraction of each piezoelectric ceramic and the adjustment cycle based on the current injection speed and the current flow deviation. This dynamically compresses each microporous elastic pad, altering the micropore distribution of each pad. Simultaneously, each microporous elastic pad compresses the multi-layered sustained-release pad beneath it, achieving dynamic control of the insulin flow rate in each injection chamber and ensuring a dynamic balance in the insulin flow rate within each branch catheter.

[0031] Step (5) is as follows: The insulin solution pumped into each injection chamber flows from top to bottom from the upper part of the corresponding microporous elastic pad under the pumping pressure. The insulin solution then flows out from the lower part of the corresponding microporous elastic pad. After that, the insulin solution flows down through the multi-layered sustained-release pad below the corresponding microporous elastic pad to the bottom cover plate. The insulin solution is injected into the subcutaneous tissue of the human body through the short microneedles on the bottom cover plate. The display screen shows the working status of the two-stage sustained-release insulin patch pump in real time. If there is any abnormality, the control circuit module sends the abnormal information to the display to remind the user, and at the same time controls the alarm to issue an alarm signal.

[0032] This invention has outstanding substantive features and significant progress compared to the prior art. Specifically, this invention has the following beneficial effects:

[0033] (1) The dosage of insulin injected by the user is dynamic and needs to be handled according to different situations. In order to monitor the injection status of insulin in real time, a long microneedle is set at each of the four corners of the bottom cover plate. The long microneedle has a built-in blood glucose concentration sensor and body temperature sensor. When injecting insulin, the four long microneedles can monitor the blood glucose concentration and body temperature of the human body in real time through their built-in blood glucose concentration sensor and body temperature sensor. This can avoid the use of too much or too little insulin, which may cause certain harm to the user's body. It can also determine whether there is any abnormality in the entire injection process. If there is an abnormality, the control circuit module will send the abnormal information to the display to remind the user, and at the same time control the alarm to issue an alarm signal, providing technical guarantee for safe injection. Finally, the blood glucose concentration collected is used to evaluate whether the injection has achieved the expected effect.

[0034] (2) Since the depth of each short microneedle arranged in an array under the bottom cover plate may be inconsistent, there may be an uneven injection flow rate in the corresponding area of ​​each injection chamber. In severe cases, this may lead to leakage of insulin solution in local areas. The control circuit module collects the detection data of each drug flow sensor and independently adjusts the vertical extension and control cycle of each piezoelectric ceramic, thereby dynamically squeezing each microporous elastic pad and changing the micropore distribution of each microporous elastic pad. At the same time, each microporous elastic pad squeezes the multi-layer sustained-release pad below it, thereby realizing the dynamic control of the insulin solution flow rate in each injection chamber and thus controlling the insulin solution injection speed in each branch catheter.

[0035] (3) When the two-stage sustained-release insulin patch pump of the present invention is working, the specific principle of the two-stage sustained release of insulin solution is as follows: The first stage of sustained release is achieved by controlling the pressure of the insulin pump. The insulin pump pumps the insulin solution into each injection chamber in the housing through each branch catheter according to the injection dosage and speed set by the doctor. The second stage of sustained release is achieved by the electrostriction of each piezoelectric ceramic under the control of the control circuit module. In turn, each piezoelectric ceramic squeezes the microporous elastic pad below it, changing the micropore distribution of each microporous elastic pad. At the same time, each microporous elastic pad squeezes the multi-layer sustained-release pad below it, realizing dynamic control of the insulin solution flow rate in each injection chamber. In this way, the injection of insulin solution can be controlled by zone as needed, and the occurrence of emergencies can also be prevented.

[0036] (4) The present invention uses multiple short microneedles arranged in an array and corresponding to each injection chamber for insulin injection. This ensures that the two-stage sustained-release insulin patch pump can still work normally even if one or more short microneedles break or become blocked during injection.

[0037] In summary, this invention can monitor blood glucose concentration and body temperature in real time, providing technical assurance for safe injection. Through the insulin pump, piezoelectric ceramic mechanism, microporous elastic pad, and multi-layer sustained-release pad, it can achieve two-stage sustained release of insulin solution. It can also achieve zoned control of insulin injection as needed to prevent the occurrence of emergencies. Attached Figure Description

[0038] Figure 1 This is a schematic diagram of the structure of the two-stage sustained-release insulin patch pump of the present invention.

[0039] Figure 2 This is a control flow diagram of the present invention.

[0040] Figure 3 This is a partial cross-sectional view of the two-stage sustained-release insulin patch pump of the present invention.

[0041] Figure 4 This is a schematic diagram of the two-stage sustained-release insulin patch pump of the present invention, omitting the insulin pump and outer casing.

[0042] Figure 5 This is a schematic diagram of the two-stage sustained-release insulin patch pump of the present invention, omitting the insulin pump, various piezoelectric ceramic mechanisms, and the top cover plate.

[0043] Figure 6 This is a schematic diagram of the two-stage sustained-release insulin patch pump of the present invention, omitting the insulin pump, various piezoelectric ceramic mechanisms, the top cover plate, and the rectangular box. Implementation

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

[0045] like Figure 1-6 As shown, the two-stage sustained-release control method for insulin pump infusion specifically includes the following steps:

[0046] (i) The injection end of the two-stage sustained-release insulin patch pump is applied to the skin of the human body in the designated area. The two-stage sustained-release insulin patch pump includes a housing, an insulin pump, a detection mechanism, several piezoelectric ceramic mechanisms, several flow control mechanisms, an injection mechanism, and a control circuit module.

[0047] (ii) The detection mechanism collects 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 cycle;

[0048] (iii) Start the insulin pump and pump the insulin solution into the housing according to the injection dosage and rate set by the doctor.

[0049] (iv) The extension and retraction of each piezoelectric ceramic mechanism is adjusted by the control circuit module, and the squeezing action of each piezoelectric ceramic mechanism corresponds to the flow control mechanism to realize the flow control of insulin solution.

[0050] (v) The insulin solution is injected subcutaneously into the human body through the injection mechanism after passing through the corresponding flow control mechanisms from top to bottom.

[0051] (vi) After the insulin solution is injected, remove the two-stage sustained-release insulin patch pump.

[0052] The insulin pump is located in the outer area of ​​the top center of the housing and is connected to the pump via a conduit assembly 1. The detection mechanism is located around the bottom of the housing. The inner cavity of the housing is evenly divided into several injection chambers arranged circumferentially around its vertical center line by several vertical partitions 2. Each piezoelectric ceramic mechanism is evenly distributed on the top of the housing and corresponds vertically to each injection chamber. Each flow control mechanism is located in each injection chamber. Each piezoelectric ceramic mechanism applies pressure to each flow control mechanism. The injection mechanism is evenly distributed at the bottom of the housing and communicates with each injection chamber. The insulin pump pumps insulin solution into the upper part of the corresponding flow control mechanism in each injection chamber through the conduit assembly 1. The control circuit module is located in the main unit of the insulin pump. The outer shell of the insulin pump is equipped with buttons, a display screen, and an alarm that are connected to the control circuit module. The insulin pump, the detection mechanism, and each piezoelectric ceramic mechanism are all connected to the control circuit module.

[0053] The shell includes a rectangular box 3 that is open at the top and bottom. The upper end of the rectangular box 3 is sealed with an upper cover plate 4, and the lower end of the rectangular box 3 is sealed with a bottom cover plate 5. Each vertical partition 2 is fixedly installed inside the rectangular box 3 to evenly divide the inner cavity of the rectangular box 3 into various injection chambers.

[0054] The insulin pump is fixedly installed at the top center of the upper cover plate 4. Each injection chamber on the upper cover plate 4 has a vertically penetrating extrusion hole. The size of the extrusion hole is 1 / 4 to 1 / 2 of the cross-sectional size of the corresponding injection chamber. Each piezoelectric ceramic mechanism is fixedly installed in each extrusion hole.

[0055] The detection mechanism includes four long microneedles 6, which are vertically set at the four corners of the bottom of the bottom cover plate 5. The long microneedles 6 have built-in blood glucose concentration sensors and body temperature sensors. The signal lines of the blood glucose concentration sensors and body temperature sensors are led out of the bottom cover plate 5 and connected to the control circuit module through the first sensor wire 7.

[0056] Each piezoelectric ceramic mechanism has the same structure. Each piezoelectric ceramic mechanism includes an outer cover 8 with an open lower side, a sealing flexible diaphragm, and a piezoelectric ceramic 9. The lower port of the outer cover 8 corresponds vertically to the corresponding extrusion hole and is adapted in size and shape. The outer cover 8 covers the corresponding extrusion hole directly above it. An annular flange end plate 10 is provided around the outer edge of the lower end of the outer cover 8. The outer cover 8 is fixedly connected to the upper cover plate 4 through the annular flange end plate 10. The sealing flexible diaphragm is fixedly connected to the corresponding extrusion hole and seals the corresponding extrusion hole. The size and shape of the piezoelectric ceramic 9 are adapted to the size and shape of the corresponding extrusion hole. The piezoelectric ceramic 9 is set in the cavity enclosed by the sealing flexible diaphragm and the outer cover 8 and is correspondingly matched and embedded in the corresponding extrusion hole. The top of the piezoelectric ceramic 9 is in contact with the inner top surface of the outer cover 8. The bottom of the piezoelectric ceramic 9 is pressed against 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. The electrical control line 11 of the piezoelectric ceramic 9 is led out of the outer cover 8 and connected to the control circuit module signal.

[0057] Each flow control mechanism has the same structure. Each flow control mechanism includes 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 stacked and matched in the corresponding injection chamber. The microporous elastic pad 12 and the multilayer sustained-release pad 13 are fitted with the corresponding injection chamber with a gap. The top surface of the microporous elastic pad 12 is pressed against the inner surface of the upper cover plate 4, the bottom surface of the multilayer sustained-release pad 13 is pressed against the inner surface of the bottom cover plate 5, and the lower surface of the sealing flexible diaphragm is pressed against the middle of the top surface of the microporous elastic pad 12.

[0058] The multi-layer slow-release pad 13 is composed of three layers of porous compressible extrusion material.

[0059] The catheter assembly 1 includes several branch catheters 14, each branch catheter 14 being configured to correspond one-to-one with each injection chamber. The inlet end of each branch catheter 14 is introduced into the insulin pump and connected to the insulin vial inside the insulin pump. The outlet end of each branch catheter 14 is respectively positioned corresponding to the position of each injection chamber, passing downward through the upper cover plate 4 and being introduced into the injection chamber and guided to the upper part of the corresponding microporous elastic pad 12. Each branch catheter 14 is covered with an outer tube 15 for a section between the insulin pump and the upper cover plate 4. Each branch catheter 14 is equipped with a drug flow sensor, and each drug flow sensor is connected to the control circuit module via a second sensor wire.

[0060] The injection mechanism includes several short microneedles 16 that are evenly distributed in an array on the lower surface of the bottom cover plate 5 and correspond to each injection cavity. The upper end of each short microneedle 16 passes through the bottom cover plate 5 and communicates with the corresponding injection cavity.

[0061] Step (II) is as follows: The bottom cover plate 5 is applied to the skin of the designated area, and four long microneedles 6 are inserted under the skin. On the one hand, the four long microneedles 6 can locate the two-stage slow-release insulin patch pump. On the other hand, the four long microneedles 6 collect the blood glucose concentration and body temperature data of the human body in real time through their built-in blood glucose concentration sensor and body temperature sensor. The blood glucose concentration sensor and body temperature sensor then store the collected blood glucose concentration and body temperature data into the control circuit module through the corresponding signal lines and sensor wires connected to them at a set cycle. The control circuit module determines whether there is any abnormality in the entire injection process. If there is an abnormality, the control circuit module sends the abnormality information to the display to remind the user, and at the same time controls the alarm to issue an alarm signal.

[0062] Step (3) is as follows: Start the insulin pump, set the injection dosage and speed of insulin solution by pressing the button, and the control circuit module controls the insulin pump to pump the insulin solution into each injection chamber in the housing through each branch catheter 14 according to the injection dosage and speed set by the doctor, so that the insulin solution is injected into the upper part of each corresponding microporous elastic pad 12.

[0063] Step (four) specifically involves: Each insulin flow sensor continuously monitors the insulin flow rate in each branch catheter 14 and transmits the detected information to the control circuit module via the corresponding sensor wires. The control circuit module, based on the real-time insulin flow rate detected by each flow sensor, controls the expansion and contraction of each piezoelectric ceramic 9 in two modes, thereby changing the micropore distribution of each microporous elastic pad 12 and ultimately controlling the injection flow rate of the insulin in each injection cavity. The two modes are as follows:

[0064] (I) Anomaly Detection and Handling

[0065] When a certain drug flow sensor detects that the insulin flow rate in the corresponding branch catheter 14 is 30% or more greater than the expected injection rate, the control circuit module determines that there is an abnormality in the area where the injection cavity connected to the corresponding branch catheter 14 is located. That is, the short microneedles 16 below the area are not properly attached, resulting in insulin leakage. The control circuit module then controls the piezoelectric ceramic 9 above the area to electrostrict and rapidly extend up and down through the corresponding electrical control line 11. The lower part of the piezoelectric ceramic 9 then presses down on the sealing flexible diaphragm below it and protrudes downward into the corresponding injection cavity through the corresponding extrusion hole, thereby pressing the corresponding microporous elastic pad 12 and changing the micropore distribution of the microporous elastic pad 12. At the same time, the microporous elastic pad 12 presses the multilayer sustained-release pad 13 below it, so that the insulin in the injection cavity of the area cannot flow out.

[0066] (II) The insulin flow rate in the corresponding area of ​​each injection chamber is dynamically balanced.

[0067] When the insulin flow sensors detect inconsistencies in the insulin flow rates of the corresponding branch catheters 14, the control circuit module employs a fuzzy control strategy to dynamically adjust the vertical expansion and contraction of each piezoelectric ceramic 9 and the adjustment cycle based on the current injection speed and the current flow deviation. This dynamically compresses each microporous elastic pad 12, changing the micropore distribution of each microporous elastic pad 12. Simultaneously, each microporous elastic pad 12 compresses the multi-layer sustained-release pad 13 below it, achieving dynamic control of the insulin flow rate in each injection chamber and keeping the insulin flow rate in each branch catheter 14 dynamically balanced.

[0068] Step (5) is as follows: The insulin solution pumped into each injection chamber flows from top to bottom from the upper part of the corresponding microporous elastic pad 12 under the action of the pumping pressure. The insulin solution then flows out from the lower part of the corresponding microporous elastic pad 12. After that, the insulin solution flows down through the multi-layer sustained-release pad 13 below the corresponding microporous elastic pad 12 to the bottom cover plate 5. The insulin solution is injected into the subcutaneous tissue of the human body through the short microneedles 16 on the bottom cover plate 5. The display screen shows the working status of the two-stage sustained-release insulin patch pump in real time. If there is any abnormality, the control circuit module sends the abnormal information to the display to remind the user, and at the same time controls the alarm to issue an alarm signal.

[0069] To fully explain step (iv) where "the control circuit module controls the extension and retraction of each piezoelectric ceramic 9 in two modes based on the real-time insulin flow rate detected by each drug flow sensor," examples of modes (I) and (II) are provided:

[0070] (I) Anomaly Detection and Handling

[0071] Taking catheter assembly 1, which includes two branch catheters 14 (branch catheter A and branch catheter B), as an example, assuming an insulin injection rate of PS = 160 mU / sec as the target requirement, if the short microneedles 16 below the injection chamber connected to branch catheter A are not properly attached, the insulin flow rate in branch catheter A will be greater than the expected injection rate (80 mU / sec). Once the flow rate detected by the flow sensor on branch catheter A is 30% or more greater than the expected injection rate, the control circuit module determines that there is an abnormality in the application of the injection chamber connected to branch catheter A, i.e., there is insulin leakage in this area. At this time, the control circuit module controls the piezoelectric ceramic 9 above this area to electrostrict and rapidly extend up and down. The piezoelectric ceramic 9 presses down on the microporous elastic pad 12 below it, changing the micropore distribution of the microporous elastic pad 12. At the same time, the microporous elastic pad 12... The multi-layer sustained-release pad 13 below is squeezed, preventing insulin from flowing out of the injection cavity in that area. Similarly, if the short microneedles 16 below the injection cavity connected to branch catheter B are not properly attached, the insulin flow rate in branch catheter B will be greater than the expected injection speed. Once the flow rate detected by the flow sensor on branch catheter B is 30% or more greater than the expected injection speed, the control circuit module determines that there is an abnormality in the application of the injection cavity connected to branch catheter B, that is, there is insulin leakage in that area. At this time, the control circuit module controls the piezoelectric ceramic 9 above the area to electrostrict and rapidly extend up and down. The piezoelectric ceramic 9 squeezes the microporous elastic pad 12 below it, changing the micropore distribution of the microporous elastic pad 12. At the same time, the microporous elastic pad 12 squeezes the multi-layer sustained-release pad 13 below it, preventing insulin from flowing out of the injection cavity in that area.

[0072] (II) The insulin flow rate in the corresponding area of ​​each injection chamber is dynamically balanced.

[0073] Taking catheter assembly 1, which includes two branch catheters 14, as an example: branch catheter A and branch catheter B, assuming an insulin injection rate of PS = 160 mU / sec as the target requirement, the ideal injection rates of the two injection chambers connected by branch catheters A and B are PS, respectively. a =80mU / sec and PS b =80mU / sec. When the injection speed in the region where the injection chamber connected to branch catheter A or branch catheter B is located is greater than or less than the ideal injection speed, it is necessary to adjust the injection speed in the corresponding region. The control circuit module adopts a fuzzy control strategy to dynamically adjust the vertical extension and adjustment period of the piezoelectric ceramic 9 above the corresponding region based on the current injection speed and its current flow deviation. The fuzzy control strategy is detailed in Table 1 below:

[0074]

[0075]

[0076] ;

[0077] For other catheter assemblies 1, including one branch catheter 14 or three to six branch catheters 14, the injection rate control method of each branch catheter 14 is similar to the fuzzy control strategy used by the two branch catheters A and B above.

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

[0079] The insulin pump, control circuit module, buttons, display screen, alarm, long microneedle 6, blood glucose concentration sensor, body temperature sensor, piezoelectric ceramic 9, sealing flexible diaphragm, microporous elastic pad 12, multilayer sustained-release pad 13, drug flow sensor and short microneedle 16 are all conventional technologies, and their specific structures and working principles will not be described in detail.

[0080] It should be noted that the tightly packed arrangement of stratum corneum cells makes it difficult for large molecule drugs to pass through, which is the biggest obstacle to transdermal drug delivery technology. In the 1990s, as microelectromechanical systems (MEMS) technology matured, numerous applications of microneedles emerged. Generally, the height of a microneedle is 300-1000 μm. μm It can be seen through a height of 200 μm The epidermis opens numerous microchannels on the skin surface to facilitate the transdermal delivery of large molecule drugs. Therefore, microneedles have become widely used as a transdermal drug delivery technique.

[0081] The short microneedles 16 in this invention can be soluble microneedles, which are microneedles prepared using water-soluble polymer materials. When the two-stage sustained-release insulin patch pump is removed, even if a small amount of short microneedles 16 remain in the skin or muscle, these small amounts will biodissolve over time and will not have any impact on the human body.

[0082] The present invention has the following beneficial effects:

[0083] (1) The dosage of insulin injected by the user is dynamic and needs to be handled according to different situations. In order to monitor the injection status of insulin in real time, a long microneedle 6 is set at each of the four corners of the bottom of the bottom cover plate 5. The long microneedle 6 has a built-in blood glucose concentration sensor and body temperature sensor. When injecting insulin, the four long microneedles 6 can monitor the blood glucose concentration and body temperature of the human body in real time through their built-in blood glucose concentration sensor and body temperature sensor. This can avoid the use of too much or too little insulin, which may cause certain harm to the user's body. It can also determine whether there is any abnormality in the entire injection process. If there is an abnormality, the control circuit module will send the abnormal information to the display to remind the user, and at the same time control the alarm to issue an alarm signal, providing technical guarantee for safe injection. Finally, the blood glucose concentration collected is used to evaluate whether the injection has achieved the expected effect.

[0084] (2) Since the depth of each short microneedle 16 arranged in an array below the bottom cover plate 5 may be inconsistent, there may be an uneven injection flow rate in the corresponding area of ​​each injection chamber. In severe cases, this may lead to leakage of insulin solution in local areas. The control circuit module collects the detection data of each drug flow sensor and independently adjusts the vertical extension and adjustment cycle of each piezoelectric ceramic 9, thereby dynamically squeezing each microporous elastic pad 12 and changing the micropore distribution of each microporous elastic pad 12. At the same time, each microporous elastic pad 12 squeezes the multilayer sustained-release pad 13 below it, thereby realizing the dynamic control of the insulin solution flow rate in each injection chamber and thus controlling the insulin solution injection speed in each branch catheter 14.

[0085] (3) When the two-stage sustained-release insulin patch pump of the present invention is working, the specific principle of the two-stage sustained release of insulin solution is as follows: The first stage of sustained release is achieved by controlling the pressure of the insulin pump. The insulin pump pumps the insulin solution into each injection chamber in the housing through each branch catheter 14 according to the injection dosage and speed set by the doctor. The second stage of sustained release is achieved by the electrostriction of each piezoelectric ceramic 9 under the control of the control circuit module. In turn, each piezoelectric ceramic 9 compresses the microporous elastic pad 12 below it, changing the microporous pore distribution of each microporous elastic pad 12. At the same time, each microporous elastic pad 12 compresses the multilayer sustained-release pad 13 below it, realizing the dynamic control of the insulin solution flow rate in each injection chamber. In this way, the injection of insulin solution can be controlled by zone as needed, and the occurrence of emergencies can be prevented.

[0086] (4) The present invention uses multiple short microneedles 16 arranged in an array and corresponding to each injection chamber for insulin injection. This ensures that the two-stage sustained-release insulin patch pump can still work normally even if one or more short microneedles 16 break or become blocked during injection.

[0087] The above embodiments are only used to illustrate and not limit the technical solutions of the present invention. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that modifications or equivalent substitutions can still be made to the present invention without departing from the spirit and scope of the present invention. Any modifications or partial substitutions should be covered within the scope of the claims of the present invention.

Claims

1. A two-stage sustained-release control device for insulin pump injection, characterized in that: It includes a housing, an insulin pump, a detection mechanism, several piezoelectric ceramic mechanisms, several flow control mechanisms, an injection mechanism, and a control circuit module; The insulin pump is located in the outer area of ​​the top center of the housing and is connected to the housing via a catheter assembly. The detection mechanism is located around the bottom of the housing. The inner cavity of the housing is evenly divided into several injection chambers arranged circumferentially around its vertical center line by several vertical partitions. Each piezoelectric ceramic mechanism is evenly distributed on the top of the housing and corresponds one-to-one with each injection chamber. Each flow control mechanism is correspondingly located in each injection chamber. Each piezoelectric ceramic mechanism applies pressure to each flow control mechanism. The injection mechanism is evenly located at the bottom of the housing and communicates with each injection chamber. The insulin pump pumps insulin solution into the upper part of the corresponding flow control mechanism in each injection chamber through the catheter assembly. The control circuit module is located in the main body of the insulin pump. The outer shell of the insulin pump is equipped with buttons, a display screen and an alarm connected to the control circuit module. The insulin pump, the detection mechanism and each piezoelectric ceramic mechanism are all connected to the control circuit module. The shell includes a rectangular box that is open at the top and bottom. A top cover plate is sealed at the top of the rectangular box, and a bottom cover plate is sealed at the bottom of the rectangular box. Each vertical partition is fixedly installed inside the rectangular box to evenly divide the inner cavity of the rectangular box into various injection chambers. The insulin pump is fixedly installed at the top center of the top cover plate. Each injection chamber on the top cover plate has a vertically penetrating extrusion hole at the middle position. The size of the extrusion hole is 1 / 4 to 1 / 2 of the cross-sectional size of the corresponding injection chamber. Each piezoelectric ceramic mechanism is fixedly installed in each extrusion hole. The detection mechanism includes four long microneedles, which are vertically set at the four corners of the bottom of the bottom cover plate. The long microneedles have built-in blood glucose concentration sensors and body temperature sensors. The signal lines of the blood glucose concentration sensors and body temperature sensors are led out of the bottom cover plate and connected to the control circuit module through the first sensor wire. Each piezoelectric ceramic mechanism has the same structure. Each piezoelectric ceramic mechanism includes an outer cover with an open lower side, a sealing flexible diaphragm, and a piezoelectric ceramic. The lower port of the outer cover corresponds to the corresponding extrusion hole and is adapted in size and shape. The outer cover covers the corresponding extrusion hole directly above it. An annular flange end plate is provided around the outer edge of the lower end of the outer cover. The outer cover is fixedly connected to the upper cover plate through the annular flange end plate. The sealing 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 set in the cavity enclosed by the sealing 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 contact with the inner top surface of the outer cover. The bottom of the piezoelectric ceramic is pressed against 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. The electrical control line of the piezoelectric ceramic is led out of the outer cover and connected to the control circuit module signal. The catheter assembly includes several branch catheters, each corresponding to a specific injection chamber. The inlet end of each branch catheter is introduced into the insulin pump and connected to the insulin vial inside the pump. The outlet end of each branch catheter is located at the position of each injection chamber, passes downward through the top cover plate, and is introduced into each injection chamber and guided to the upper part of the corresponding microporous elastic pad. Each branch catheter has an outer sheath covering the section between the insulin pump and the top cover plate. Each branch catheter is equipped with a drug flow sensor, and each drug flow sensor is connected to the control circuit module via a second sensor wire. The injection mechanism includes several short microneedles that are evenly distributed in an array on the lower surface of the bottom cover plate and correspond to each injection cavity. The upper end of each short microneedle passes through the bottom cover plate and communicates with the corresponding injection cavity.

2. The two-stage sustained-release control device for insulin pump injection according to claim 1, characterized in that: Each flow control mechanism has the same structure. 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 chamber. The microporous elastic pad and the multi-layer sustained-release pad are fitted with the corresponding injection chamber with a gap. The top surface of the microporous elastic pad is pressed against the inner surface of the upper cover plate, and the bottom surface of the multi-layer sustained-release pad is pressed against the inner surface of the bottom cover plate. 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 extrusion material.

3. The two-stage sustained-release control device for insulin pump injection according to claim 2, characterized in that: Each insulin flow sensor detects the insulin flow rate in each branch catheter in real time and transmits the detected information to the control circuit module via the corresponding sensor wires. The control circuit module controls the expansion and contraction of the corresponding piezoelectric ceramics in two modes based on the real-time insulin flow rate detected by each sensor, thereby changing the micropore distribution of the corresponding microporous elastic pads and ultimately controlling the injection flow rate of the insulin in each injection cavity. The two modes are as follows: (I) Anomaly Detection and Handling When a flow sensor detects that the insulin flow rate in a corresponding branch catheter is 30% or more greater than the expected injection rate, the control circuit module determines that there is an abnormality in the area where the injection cavity connected to the corresponding branch catheter is located. That is, the short microneedles below this area are not properly attached, resulting in insulin leakage. The control circuit module then controls the piezoelectric ceramic above this area to electrostrict and rapidly extend up and down via the corresponding electrical control line. The lower part of the piezoelectric ceramic then presses down on the sealing flexible diaphragm below it and protrudes downward into the corresponding injection cavity through the corresponding extrusion hole, thereby pressing the corresponding microporous elastic pad and changing the micropore distribution of the microporous elastic pad. At the same time, the microporous elastic pad presses the multi-layer sustained-release pad below it, so that the insulin in the injection cavity in this area cannot flow out. (II) The insulin flow rate in the corresponding area of ​​each injection chamber is dynamically balanced. When the insulin flow sensors detect inconsistencies in the insulin flow rates of the corresponding branch catheters, the control circuit module employs a fuzzy control strategy to dynamically adjust the vertical expansion and contraction of each piezoelectric ceramic and the adjustment cycle based on the current injection speed and the current flow deviation. This dynamically compresses each microporous elastic pad, altering the micropore distribution of each pad. Simultaneously, each microporous elastic pad compresses the multi-layered sustained-release pad beneath it, achieving dynamic control of the insulin flow rate in each injection chamber and ensuring a dynamic balance in the insulin flow rate within each branch catheter.

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