A super-small wirelessly controlled patch-type insulin pump and its preparation method

Abstract

The present invention provides a super-small wirelessly controlled patch-type insulin pump and a preparation method thereof, belonging to the technical field of biomedical engineering devices. The present invention uses the near-field communication (NFC) technology of a smart phone to supply power to the circuit, and drives insulin to be injected into a patient's body through the volume change of a thermal expansion material and the gas generated by an electrolytic electrode, so as to realize the insulin infusion of a large dose before a meal and a basal rate. The insulin pump of the present invention has a simple structure, a small volume, and no need for an internal power supply, reduces the use burden of patients, improves the wearing comfort and convenience, and at the same time is controlled through a smart phone application program, simplifies the operation process, and provides an accurate and convenient insulin injection method for users.

Description

Technical Field

[0001] The present invention belongs to the technical field of biomedical engineering devices, and particularly relates to a super-small wirelessly controlled patch insulin pump and a preparation method thereof. Background Art

[0002] Diabetes is a global public health problem with a consistently high incidence and a rising trend. Type 1 diabetes and type 2 diabetes are two different types of diabetes. Type 1 diabetes is usually caused by an autoimmune reaction that destroys pancreatic beta cells, resulting in insufficient insulin production. Type 2 diabetes is mainly caused by reduced sensitivity to insulin (insulin resistance) and / or insufficient insulin secretion in the body.

[0003] Insulin therapy is a key part of the treatment plan for diabetes patients. Its goal is to mimic the normal insulin secretion pattern to maintain blood glucose levels as close to normal as possible. Type 1 diabetes patients need to rely on exogenous insulin injections to control blood glucose levels. Type 2 diabetes also requires the assistance of insulin therapy while taking oral hypoglycemic drugs. Patients need to inject insulin multiple times a day, and the dosage of insulin injection also needs to be strictly allocated. Therefore, diabetes patients urgently need a safe, accurate, and convenient insulin injection method to reduce the inconvenience brought by the treatment process to their lives while receiving insulin therapy.

[0004] Traditional daily insulin injection methods use syringes or insulin pens for multiple subcutaneous injections to mimic the physiological insulin secretion pattern of the human body. Daily insulin therapy requires patients to inject themselves multiple times a day. Common injection sites include the abdomen, thighs, buttocks, and upper arms. The insulin absorption rate may vary at different sites. To avoid subcutaneous fat hyperplasia or atrophy, different injection sites are rotated during injection. Depending on the patient's body type and injection site, the insertion depth and angle of the needle may need to be adjusted. There are also differences in the types of insulin injected. Intermediate-acting or long-acting insulin analogs are used as basal insulin, with a longer action time, which can provide all-day basal insulin coverage to help control fasting and pre-meal blood glucose levels; short-acting or rapid-acting insulin analogs are used as bolus insulin, injected before meals to help control post-meal blood glucose levels. At the same time, the injection dosage also needs to be adjusted according to actual living conditions such as blood glucose levels, diet, and exercise plans. Traditional insulin injection methods require patients to have good self-management ability and discipline to ensure timely insulin injection and blood glucose monitoring. In addition, patients also need to communicate regularly with medical professionals to optimize the treatment plan. As an advanced diabetes management tool, an insulin pump can achieve more accurate dosage control compared to traditional insulin injection methods.

[0005] An insulin pump is controlled by an electronic device to infuse insulin, with a basal rate and a bolus injection function before meals. The basal rate is a continuous, low-dose insulin infusion set by the patient to simulate the secretion function of the human pancreas and maintain blood glucose levels between meals and at night. The bolus injection before meals is a larger insulin dose infusion manually set by the patient before eating to cope with the increase in blood glucose after meals. The insulin pump provides a treatment plan closer to the physiological insulin secretion pattern, enabling more precise blood glucose control and better quality of life, but it requires certain learning and maintenance costs. The traditional insulin injection method, although simple to operate and low in cost, is not as flexible and precise in blood glucose control as the insulin pump. Summary of the Invention

[0006] The traditional daily insulin injection method is still the current mainstream insulin treatment method, and it has some deficiencies that may affect the patient's blood glucose control and quality of life. First, it is difficult for the traditional insulin injection method to precisely simulate the physiological secretion pattern of human insulin, resulting in less precise blood glucose control and prone to blood glucose fluctuations. Due to the inaccuracy of insulin dosage and the inability to adjust it in a timely manner, patients may face a higher risk of hypoglycemia, especially before meals or after exercise. Second, patients may need to inject insulin multiple times a day, which may affect their daily activities and may cause pain or discomfort at the injection site. Long-term insulin injection may also lead to disorders of fat metabolism at the injection site, such as lipohypertrophy or lipoatrophy, affecting insulin absorption and blood glucose control. Third, it is difficult for the traditional insulin injection method to adapt to sudden changes in the patient's daily life, such as changes in meal times, increases or decreases in exercise volume, etc. Frequent injections and strict dietary planning limit the patient's social activities and daily life, affecting the quality of life, and frequent injections will bring psychological pressure to the patient. Fourth, traditional syringes or insulin pens cannot provide the fine adjustment of basal rate and bolus before meals like an insulin pump, nor can they automatically adjust the insulin infusion amount according to blood glucose levels. Self-injection by patients is also inevitable to occur situations such as reusing needles or unclean injection techniques, increasing the risk of infection.

[0007] Insulin pumps can address some of the deficiencies of traditional insulin injection methods. Insulin pumps can set a basal rate to simulate the body's insulin secretion pattern during non-meal times, providing continuous and stable insulin infusion to reduce blood glucose fluctuations. It allows users to set very precise insulin doses, which helps to more finely adjust blood glucose control and reduce the probability of hypoglycemia. At the same time, compared with traditional multiple daily injections, insulin pumps reduce the number of injections, improve patient compliance and convenience, and help reduce problems such as lipohypertrophy or atrophy at the injection site, and also help reduce the risk of infection. Moreover, insulin pumps offer greater flexibility, allowing users to arrange their diet and activities more freely without being restricted by strict injection times, which can greatly improve the patient's quality of life and relieve the patient's psychological burden. However, there are also many limitations in the current insulin pumps on the market. First of all, the initial purchase cost of insulin pumps is relatively high, and consumables such as reservoirs, infusion sets, and needles need to be replaced regularly. These consumables that match the system will bring continuous and substantial costs. Secondly, the setting and operation procedures of current insulin pumps on the market are relatively cumbersome and require certain learning and practice to master proficiently. Finally, as a precision electronic device, insulin pumps may encounter technical failures or mechanical problems, such as pump damage, battery depletion, or infusion set blockage. These limitations all restrict the existing insulin pumps from occupying a larger market share.

[0008] To solve the above technical problems, the present invention uses smartphone near-field communication (NFC) technology to power the circuit and injects insulin into the patient's body by using the volume change of a thermally expandable material and a gas generated, providing a super-small wirelessly controlled patch-type insulin pump. The specific technical solutions are as follows:

[0009] A super-small wirelessly controlled patch-type insulin pump includes a circular medicine chamber cover, two complementary semi-cylindrical groove medicine chambers, and a semi-implantable base;

[0010] The middle line of the circular medicine chamber cover has a groove, enabling the medicine chamber cover to be folded along the middle line; the upper surface of the medicine chamber cover integrates a control circuit 1-1 and an NFC coil 1-3; the medicine chamber cover is divided into a first semi-circular cover and a second semi-circular cover along the middle line. The lower surface of the first semi-circular cover integrates a heating electrode 1-11, and the lower surface of the second semi-circular cover integrates an electrolytic electrode 1-12. Magnetic snap fasteners are respectively provided at the edges of the lower surfaces of the first semi-circular cover and the second semi-circular cover; the control circuit, NFC coil, heating electrode, and electrolytic electrode are electrically connected; the control circuit controls the heating electrode or the electrolytic electrode to work;

[0011] The upper edge of the semi-cylindrical groove medicine bin has a magnetic attraction card slot, which corresponds to the magnetic attraction buckle position of the medicine bin cover; the fitting part of the two medicine bins corresponds to the middle line groove position of the medicine bin cover; there are through holes at the bottom of the medicine bin; the two medicine bins are specifically divided into a large-dose execution medicine bin and a basal rate execution medicine bin; inside the large-dose execution medicine bin are a heat-driven fluid pump and insulin, and the heat-driven fluid pump is located above the insulin; the heat-driven fluid pump includes an aluminum heat-conducting film encapsulation layer 1-4, a thermal expansion material 1-5, and a large-dose insulin propulsion piston 1-6a; the aluminum heat-conducting film encapsulation layer is in contact with the heating electrode, and heat is conducted to the thermal expansion material through the heating electrode, and then the large-dose insulin propulsion piston is pushed. The insulin is extruded by the piston and flows out from the through hole at the bottom of the medicine bin; inside the basal rate execution medicine bin are a pneumatic fluid pump and insulin, and the pneumatic fluid pump is located above the insulin; the pneumatic fluid pump includes a polyethylene laminated paper electrolyte encapsulation layer 1-14, an electrolyte 1-15, and a basal rate insulin propulsion piston 1-6b; the electrolysis electrode is inserted through the polyethylene laminated paper electrolyte encapsulation layer to the bottom of the electrolyte to electrolyze the electrolyte to generate gas, push the basal rate insulin propulsion piston, and the insulin is extruded by the piston and flows out from the through hole at the bottom of the medicine bin; the through hole at the bottom of the medicine bin is sealed with aluminum foil;

[0012] The semi-implanted base includes a base body 1-10, a contact base 1-17, and an infusion tube 1-18; two through holes are provided in the base body and the contact base, and the positions of the through holes correspond to the through holes at the bottom of the two medicine bins. The two through holes of the base respectively correspond to an infusion tube, and the medicine bin through hole, the base body through hole, the contact base through hole, and the infusion tube form an infusion passage;

[0013] The through hole of the base body protrudes upward, and there is a layer of aluminum foil at the medicine outlet in the medicine bin. When the medicine bin is installed on the base, the through hole pierces the aluminum foil to form a passage.

[0014] Furthermore, the shape of the medicine bin cover can also be rectangular, oval, trapezoidal or other shapes. Correspondingly, the planar shapes of the two medicine bins correspond to the shape of the medicine bin cover, specifically, a three-dimensional groove with a set height and a bottom shape of rectangular, oval, trapezoidal or other shapes.

[0015] The specific process of the control circuit controlling the heating electrode and the electrolysis electrode to work is as follows:

[0016] The NFC coil receives the NFC energy signal transmitted by the smart terminal, transmits it to the NFC chip, and the NFC chip hands the signal to the MCU for processing, and generates an analog voltage output through the integrated energy harvesting function to supply power to the entire control circuit.

[0017] The present invention also provides a preparation method for a super-small wirelessly controlled patch-type insulin pump, and the specific steps are as follows:

[0018] Step 1: Obtain a base body, two complementary semi-cylindrical medicine cartridges, and a circular medicine cartridge cover that match in size through 3D printing, and use epoxy resin glue to embed two magnets into the positions of the medicine cartridge cover corresponding to the magnetic attraction slots; specifically, there is a groove in the middle line of the circular medicine cartridge cover, and the complementary positions of the two medicine cartridges correspond to the groove of the medicine cartridge cover; there is a through hole at the bottom of each medicine cartridge, and there are two through holes in the base body, and the positions of each through hole correspond to the through holes at the bottom of the medicine cartridge; the through holes in the base cylinder protrude upward so that they can be embedded into the through holes at the bottom of the medicine cartridge; through holes are reserved on both sides of the groove of the medicine cartridge cover; the medicine cartridge cover is a cylindrical sheet with a radius of 12 ± 0.2 mm and a thickness of 2 ± 0.1 mm; the outer radius of the medicine cartridge is 12 ± 0.2 mm, the inner radius is 11.3 ± 0.2 mm, and the height is 5.5 ± 0.1 mm.

[0019] Step 2: Use epoxy resin glue to pass one end of a tubular polyimide film through the through hole position of the base body as an infusion pipeline; nest a sterile-packaged 316L stainless steel needle tip outside the polyimide film as the infusion pipeline needle tip; use PDMS to encapsulate the bottom surface of the base body as a contact base;

[0020] Step 3: Insert two semi-circular insulin propulsion pistons into the two medicine cartridges, and add a certain amount of insulin from the through holes at the bottom of the medicine cartridges; adjust the positions of the insulin propulsion pistons so that the insulin liquid level is flush with the medicine outlet, and use aluminum foil to encapsulate the medicine outlet to obtain two semi-circular insulin medicine cartridges with complementary shapes;

[0021] Step 4: Add swelling particles to the mixture of polydimethylsiloxane and curing agent, stir evenly, and add the mixture with swelling particles to the top of the insulin propulsion piston in one medicine cartridge to form a thermal-driven fluid pump; encapsulate the top of the medicine cartridge with aluminum foil to form a large-dose execution medicine cartridge;

[0022] Step 5: Add electrolyte to the top of the insulin propulsion piston in the other medicine cartridge to form a pneumatic fluid pump; encapsulate the top of the medicine cartridge with polyethylene laminated paper to form a basal rate execution medicine cartridge;

[0023] Step 6: Coat the upper surface of the medicine cartridge cover with an NFC coil by electron beam evaporation, and coat one side of the reserved through hole on the lower surface of the medicine cartridge cover with a heating electrode by electron beam evaporation; fix the electrolytic electrode at the through hole reserved on the other side of the medicine cartridge cover with epoxy resin glue;

[0024] Step 7: Embed the circuit board integrated with the control circuit into the top of the medicine cartridge cover, connect it to the heating electrode and the electrolytic electrode through the reserved through holes, connect it to the NFC coil, and encapsulate the upper surface of the medicine cartridge cover with PDMS;

[0025] Step 8: Fix the two medicine cartridges to the base, cover the medicine cartridge lid over the medicine cartridge, and insert the magnetic snap into the magnetic slot to complete the preparation of the ultra-small detachable patch-type insulin pump for wireless control of insulin injection.

[0026] Compared with the prior art, the present invention has the following advantages:

[0027] Through the embodiments of the present invention, an ultra-small detachable patch-type insulin pump for wireless control of insulin injection is realized.

[0028] (1) The present invention adopts a disposable insulin medicine cartridge. The structure design of this medicine cartridge is simple, and the manufacturing cost is low, which can effectively reduce the usage burden of patients. Moreover, compared with traditional insulin pumps, the consumables of the present invention are easier to replace, reducing the operation complexity and improving the user experience of patients. The drug loading capacity of the medicine cartridge can be customized to meet the personalized needs of different patients.

[0029] (2) The present invention has no built-in power supply and realizes power supply and control through NFC technology, greatly reducing the weight and volume of the patch-type insulin pump and improving the wearing comfort of patients. Controlled through a smartphone application, users can easily select bolus or basal rate infusion through the mobile phone interface.

[0030] (3) The present invention adopts a simplified mechanical structure design, reducing the number of internal parts. The circuit design is simple and efficient. Insulin is injected using a thermal expansion material thermal drive fluid pump and a pneumatic fluid pump that electrolyzes to produce gas. The fluid pumps are assembled in the medicine cartridge for single use, with good reliability and durability, providing a stable treatment effect for users. Description of the Drawings

[0031] Figure 1 is a schematic cross-sectional dual-view structure diagram of the present invention; specifically, the following are the reference numerals: NFC coil 1-2 for receiving NFC signals, medicine cartridge lid 1-3, aluminum thermal conductive film layer encapsulation 1-4, thermal expansion material 1-5, insulin push piston 1-6, insulin 1-7, magnetic slot 1-8, bolus medicine cartridge 1-9, base body 1-10, heating electrode 1-11, electrolysis electrode 1-12, magnetic snap 1-13, polyethylene laminated paper electrolyte encapsulation layer 1-14, electrolyte 1-15, basal rate medicine cartridge 1-16, contact base 1-17, infusion tube 1-18.

[0032] Figure 2 is a schematic diagram of the working mode of the present invention;

[0033] Figure 3 is a flowchart of the working process of the present invention;

[0034] Figure 4 is a schematic diagram of the principle of the control circuit module of the present invention;

[0035] Figure 5 Test results of the operation of a fluid pump, where Figure 5-1 shows the changes in temperature and the volume of the thermally driven fluid pump over time, Figure 5-2 and shows the change in the volume of the pneumatic fluid pump over time. Detailed implementation mode

[0036] To better understand the purpose, structure and function of the present invention, the following further describes in detail a super-small wirelessly controlled patch-type insulin pump of the present invention with reference to the accompanying drawings.

[0037] The present invention provides a super-small patch-type insulin pump for wirelessly controlling insulin injection. Based on near-field communication technology, it uses the NFC of a smart phone to supply power to the circuit and realizes wireless control of the insulin pump.

[0038] The present invention stores the energy transmitted by the NFC technology in the circuit to supply power to the electrolytic electrodes. The electrolytic electrodes slowly electrolyze water to generate gas, which pushes the medicine chamber to slowly infuse insulin to achieve basal rate injection. The heating electrodes rapidly increase the volume of the thermally expandable material, which pushes the medicine chamber to rapidly infuse insulin to achieve bolus injection before meals.

[0039] In this embodiment, two working modes are adopted to perform insulin infusion on an agarose gel block in vitro to simulate the situation of wearing by the human body. Wireless power supply is carried out through the NFC of a smart phone. The patch does not require a power supply or battery, and short-time large-dose insulin infusion and long-lasting basal rate insulin infusion are completed.

[0040] As Figure 2 shown, a super-small wirelessly controlled patch-type insulin pump provided in this embodiment is generally cylindrical. The main body of the device is attached to the skin surface, and the infusion tube is inserted into the subcutaneous tissue. The infusion position is usually located on the abdomen, buttocks, upper arm or the outer side of the thigh. The whole can be divided into a medicine chamber cover, two complementary semi-cylindrical groove medicine chambers and a semi-implanted base; the patch-type insulin pump is generally divided into a large-dose insulin pump in the left half and a basal rate insulin pump in the right half, and the two do not interfere with each other.

[0041] The specific internal structure sectional view of the patch-type insulin pump is as Figure 1As shown, there is a groove in the middle line of the circular medicine cartridge cover 1-3, enabling the medicine cartridge cover 1-3 to be folded along the middle line; the upper surface of the medicine cartridge cover integrates a control circuit 1-1 and an NFC coil 1-3; the medicine cartridge cover is divided into a first semi-circular cover and a second semi-circular cover along the middle line. The lower surface of the first semi-circular cover integrates a heating electrode 1-11, and the lower surface of the second semi-circular cover integrates an electrolysis electrode 1-12. Magnetic snap fasteners 1-13 are respectively provided at the edges of the lower surfaces of the first semi-circular cover and the second semi-circular cover; the control circuit 1-1, the NFC coil, the heating electrode, and the electrolysis electrode are electrically connected; among them, the control circuit includes a large dose circuit module and a basal rate circuit module, which respectively control the operation of the heating electrode or the electrolysis electrode.

[0042] Specifically, the NFC coil 1-2 receives the NFC signal sent by the smart phone, transmits it to the control circuit 1-1, controls the large dose circuit module and the basal rate circuit module. The large dose circuit module is connected to the heating electrode, and the basal rate circuit module is connected to the electrolysis electrode; the heating electrode and the electrolysis electrode do not affect each other.

[0043] The upper edge of the semi-cylindrical groove medicine cartridge has a magnetic snap slot, which corresponds to the position of the magnetic snap fastener of the medicine cartridge cover and is used to fix the medicine cartridge; the fitting part of the two medicine cartridges corresponds to the middle line groove position of the medicine cartridge cover; there are through holes at the bottom of the medicine cartridge; the two medicine cartridges are specifically divided into a large dose execution medicine cartridge and a basal rate execution medicine cartridge; inside the large dose execution medicine cartridge are a thermal drive fluid pump and insulin, and the thermal drive fluid pump is located above the insulin; the thermal drive fluid pump includes an aluminum thermal conductive film encapsulation layer 1-4, a thermal expansion material 1-5, and a large dose insulin propulsion piston 1-6a; the aluminum thermal conductive film encapsulation layer is in contact with the heating electrode, and heat is conducted to the thermal expansion material 1-5 through the heating electrode, and then the large dose insulin propulsion piston 1-6a is pushed. Insulin is extruded by the piston and flows out from the through hole at the bottom of the medicine cartridge; inside the basal rate execution medicine cartridge are a pneumatic fluid pump and insulin, and the pneumatic fluid pump is located above the insulin; the pneumatic fluid pump includes a polyethylene laminated paper electrolyte encapsulation layer 1-14, an electrolyte 1-15, and a basal rate insulin propulsion piston 1-6b; the electrolysis electrode penetrates through the polyethylene laminated paper electrolyte encapsulation layer 1-14 and inserts into the bottom of the electrolyte 1-15 to electrolyze the electrolyte to generate gas, pushing the basal rate insulin propulsion piston 1-6b. Insulin is extruded by the piston and flows out from the through hole at the bottom of the medicine cartridge; the through hole at the bottom of the medicine cartridge is sealed with aluminum foil;

[0044] The two medicine cartridges are two complementary semi-cylindrical grooves, with an outer radius of 12 mm, an inner radius of 11.3 mm, and a height of 5.5 mm.

[0045] The semi-implantable base includes a base body 1-10, a contact base 1-17, and an infusion tube 1-18. The base body and the contact base are provided with two through holes, and the positions of the through holes correspond to the through holes at the bottoms of the two medicine cartridges. Each of the two through holes in the base corresponds to an infusion tube, and the through holes of the medicine cartridge, the through holes of the base body, the through holes of the contact base, and the infusion tube form an infusion passage. The maximum radius of the base is 14 mm and the thickness is 2 mm. The contact base is soft in texture and can be well attached to the skin.

[0046] Furthermore, the through hole of the base body protrudes upward. There is a layer of aluminum foil at the medicine outlet in the medicine cartridge. When the medicine cartridge is installed on the base, the through hole pierces the aluminum foil to form a passage.

[0047] As Figure 2 shown, it is a working schematic diagram of the ultra-small patch-type insulin pump provided by this embodiment. The main body of the device is attached to the skin surface, and the infusion tube is inserted into the subcutaneous tissue. The infusion position is usually located on the abdomen, buttocks, upper arm or the outer side of the thigh. The NFC coil, control circuit, heating electrode, and electrolysis electrode are integrated on the three-dimensional printed polylactic acid (PLA) medicine cartridge cover. The two-piece medicine cartridge cover can be folded and opened, and is fixed to the disposable detachable medicine cartridge by a magnetic snap. The basal rate medicine cartridge and the bolus dose medicine cartridge can be independently disassembled and replaced. Each single medicine cartridge is a semi-cylindrical groove with a radius of 11.3 mm and a depth of 2.5 mm, and the volume is 0.5 mL. The medicine cartridge is fixed to the base body and communicated with the infusion tube. The base in contact with the skin is encapsulated by polydimethylsiloxane (PDMS). The tip of the infusion tube is made of 316L stainless steel with a sterile package and a length of 4 mm to ensure that it can reach the subcutaneous tissue to release insulin and simulate the release mode of normal human insulin.

[0048] The NFC coil at the top and the control circuit receive and process the NFC signals transmitted by the smartphone application. The NFC signals carry information and energy. First, they are used for the control circuit to judge the bolus dose infusion or basal rate infusion work, and then the control circuit supplies the energy signals collected by the NFC coil to the corresponding circuit modules.

[0049] When the bolus dose circuit module works, it will immediately supply all the collected energy to the heating electrode. The heating electrode generates Joule heat, and the temperature rapidly rises within 15 - 20 seconds, exciting the rapid increase in the volume of the thermal expansion material. The thermal-driven fluid pump completes the injection of insulin in the bolus dose infusion execution medicine cartridge into the body within 30 seconds.

[0050] When the basal rate circuit module is working, the collected energy will be temporarily stored in the capacitor integrated in the NFC chip and slowly used for electrolyzing the electrolyte. The electrolysis electrodes are inserted into the bottom of the electrolyte to generate gas evenly and slowly, enabling the pneumatic insulin propulsion piston of the basal rate infusion execution medicine cartridge to consume for 6 - 12 hours and slowly and uniformly inject insulin into the body. The specific single basal rate infusion cycle can be adjusted by the user on the smartphone terminal according to the user's situation.

[0051] After a single NFC signal powers the basal rate circuit module, the basal rate circuit starts and continues to work for a long time. Only 2 energy supplies per day are required to meet the basal insulin infusion at all times of the day. After a single NFC signal powers the bolus dose circuit module, the patch insulin pump will complete the pre-meal bolus insulin injection in a short time. This process shares a single NFC receiver with the basal rate working module and is otherwise independent of each other and does not affect each other.

[0052] Figure 3 It is the usage flowchart of the patch insulin pump. When in use, attach the patch insulin pump to the disinfected skin surface, insert the infusion tube needle into the subcutaneous tissue, and fix the device. After wearing it, use the NFC application of the smartphone to approach the device NFC label on the top of the medicine cartridge cover and establish a connection. Select the basal rate option in the mobile phone NFC application, turn on the NFC signal transmission to power the basal rate circuit module, and the basal rate circuit module continues to work. The electrolysis electrodes electrolyze the electrolyte evenly and slowly to generate gas to push the pneumatic injection pump, and the pneumatic injection pump pushes the insulin into the body. This process can last up to 12 hours after a single 1-minute NFC power supply, realizing the basal rate infusion of the insulin pump. The basal rate medicine cartridge is designed to exactly deplete the medicine when the power runs out. Replace the medicine cartridge and recharge again to maintain the basal rate supply. The electrolysis process will not affect the operation of the bolus dose circuit module.

[0053] When there is a need for pre-meal bolus injection, use the NFC application of the smartphone to approach the device NFC label on the top of the medicine cartridge cover and establish a connection. Select the bolus dose option in the mobile phone NFC application, turn on the NFC signal transmission to power the bolus dose circuit module, and the heating electrode of the bolus dose circuit is energized to generate Joule heat. The heat is transferred to the thermally expandable material through the heat-conducting thin film layer packaging. The volume of the thermally expandable material increases rapidly, pushing the insulin into the body. This infusion process is quickly completed after each NFC power supply and does not interfere with the basal rate infusion. After the infusion is completed, the medicine cartridge can be directly disassembled and replaced, or a medicine cartridge with a different drug load can be replaced as appropriate when the next bolus dose is needed. The two working modules do not affect each other and are combined to complete the regulation of blood sugar.

[0054] The maximum drug loading capacity of the drug chamber is 0.5mL, which can be loaded with 50 units of U-100 insulin. The specific drug loading can be customized according to the user's personalized needs to meet a variety of actual situations. Regardless of the drug loading of the drug chamber, the large dose injection will infuse all the insulin in the drug chamber at one time in a short period of time, while the basal rate infusion will adjust the speed of the electrolyte according to the drug loading entered in the smartphone application so that the pneumatic fluid pump can complete the insulin infusion at a uniform speed in 12 hours.

[0055] Figure 4 This is a control circuit schematic based on the cover of the patch-type insulin pump. The NFC antenna is responsible for receiving the NFC signal carrying energy and information from the smartphone. The NFC chip passes the NFC signal carrying the circuit selection signal to the MCU for processing, and generates an analog voltage output through the integrated energy harvesting function to power itself, the MCU, the basal rate circuit module, and the high-dose circuit module.

[0056] The thermal expansion material is a mixture of PDMS and expandable microparticles, where PDMS acts as a binder and the microspheres act as the expansion body. The microspheres have a core-shell structure, with the shell being a thermoplastic acrylic polymer and the core being a spherical plastic particle composed of hydrocarbon gas. When heated to a specific temperature, the thermoplastic shell softens and the gas in the core expands, resulting in an expansion effect. The thermal expansion material expands under the action of the heating electrode, thereby squeezing the drug from the storage layer to the injection line for release.

[0057] The metal heating electrode consists of a 100nm chromium layer and a 500nm gold layer, and is made using an electron beam evaporation coating process.

[0058] The electrolyte is a 50mM NaOH solution. This weak alkaline solution produces oxygen and hydrogen at the anode and cathode of the energized electrolytic electrode, pushing the drug into the injection line for release. The anode of the electrolytic electrode is made of gold and the cathode is made of copper. Gold has good electrochemical stability and is not easily oxidized. Copper as the cathode can effectively reduce hydrogen ions in water.

[0059] This embodiment also provides a method for preparing an ultra-small patch-type insulin pump for wirelessly controlling insulin injection, and the specific steps are as follows:

[0060] Step 1: Obtain a base body, two complementary semi-cylindrical medicine bins and a circular medicine bin cover of matching sizes through 3D printing, and use epoxy resin glue to embed two magnets into the positions of the medicine bin cover corresponding to the magnetic card slots; specifically, the circular medicine bin cover has a groove in the center line, and the complementary positions of the two medicine bins correspond to the grooves of the medicine bin cover; each medicine bin has a through hole at the bottom, and the base body has two through holes, each of which corresponds to the position of the through hole at the bottom of the medicine bin; the through hole of the base column protrudes upward so that it can be embedded in the through hole at the bottom of the medicine bin; through holes are reserved on both sides of the groove of the medicine bin cover;

[0061] Step 2: Pass one end of the tubular polyimide film through the through-hole position of the base body using epoxy resin glue to serve as the infusion tube; nest the sterile-packed 316L stainless steel needle tip outside the polyimide film to serve as the infusion tube needle tip; use PDMS to encapsulate the bottom surface of the base body to serve as the contact base;

[0062] Step 3: Insert two semi-circular insulin propulsion pistons into the two medicine cartridges, add a certain amount of insulin through the through-hole at the bottom of the medicine cartridge, up to 0.5 mL; adjust the position of the insulin propulsion piston so that the insulin liquid level is flush with the medicine outlet, and use aluminum foil to encapsulate the medicine outlet to obtain two semi-circular insulin medicine cartridges with complementary shapes;

[0063] Step 4: Add the swelling particles to the mixture of polydimethylsiloxane and curing agent and stir evenly, and add the mixture with the swelling particles to the top of the insulin propulsion piston of one medicine cartridge to form a thermal-driven fluid pump; encapsulate the top of the medicine cartridge with aluminum foil to form a large-dose execution medicine cartridge;

[0064] Step 5: Add the electrolyte to the top of the insulin propulsion piston of the other medicine cartridge to form a pneumatic fluid pump; encapsulate the top of the medicine cartridge with polyethylene laminated paper to form a basal rate execution medicine cartridge;

[0065] Step 6: Coat the upper surface of the medicine cartridge cover with an NFC coil by electron beam evaporation, and coat one side of the reserved through-hole on the lower surface of the medicine cartridge cover with a heating electrode by electron beam evaporation; fix the electrolytic electrode at the through-hole reserved on the other side of the medicine cartridge cover with epoxy resin glue;

[0066] Step 7: Embed the circuit board integrated with the control circuit into the top of the medicine cartridge cover, connect it to the heating electrode and the electrolytic electrode through the reserved through-hole, connect it to the NFC coil, and encapsulate the upper surface of the medicine cartridge cover with PDMS;

[0067] Step 8: Fix the two medicine cartridges on the base, cover the medicine cartridge cover above the medicine cartridge, and insert the magnetic snap into the magnetic snap groove to complete the preparation of the ultra-small detachable patch-type insulin pump for wireless control of insulin injection.

[0068] In this embodiment, an infrared thermal imager was used to test the temperature change of the heating electrode, and the volume change of the fluid pumps in the two medicine cartridges was recorded by recording the position of the insulin propulsion piston in the semi-transparent medicine cartridge, so as to reflect the insulin infusion situation. The results are as Figure 5 shown. For the large-dose medicine cartridge, Figure 5-1It shows the changes in the temperature of its heating electrode and the volume of the thermally driven fluid pump over time. The results show that within 30 seconds after the heating module starts working, the temperature of the heating electrode rapidly rises from about 60 °C to nearly 90 °C, triggering a rapid increase in the volume of the thermally expandable material. At 17 seconds, the thermally expandable material pushes the piston forward until the volume increases to twice the original, and at this time, the insulin infusion in the large-dose medicine chamber is completed. Figure 5-2 It shows the changes in the volume of the pneumatic fluid pump over time. The results show that within 12 hours after the electrolysis module starts working, electrolyzed water generates gas, and the insulin propulsion piston in the basal rate medicine chamber can linearly propel insulin slowly at a constant speed. After 12 hours, the volume of the pneumatic fluid pump increases to twice the original, the basal rate medicine chamber is exhausted, and a basal rate infusion cycle is completed.

[0069] It can be understood that the present invention is described through some embodiments. Those skilled in the art know that without departing from the spirit and scope of the present invention, various changes or equivalent replacements can be made to these features and embodiments. Additionally, under the teaching of the present invention, these features and embodiments can be modified to adapt to specific situations and materials without departing from the spirit and scope of the present invention. Therefore, the present invention is not limited by the specific embodiments disclosed herein, and all embodiments falling within the scope of the claims of this application belong to the scope protected by the present invention.

Claims

1. An ultra-small wirelessly controlled patch-type insulin pump, characterized in that: The patch-type insulin pump comprises a circular medicine chamber cover, two complementary semi-cylindrical groove medicine chambers and a semi-implant base; The circular medicine compartment cover has a groove at the center line, so that the medicine compartment cover can be folded along the center line; the medicine compartment cover has an integrated control circuit (1-1) and an NFC coil (1-3) on its upper surface; the medicine compartment cover is divided into a first semicircular cover and a second semicircular cover along its center line, the first semicircular cover has an integrated heating electrode (1-11) on its lower surface, and the second semicircular cover has an integrated electrolysis electrode (1-12) on its lower surface, and the first semicircular cover and the second semicircular cover have magnetic buckles on their lower surface edges respectively; the control circuit, the NFC coil, the heating electrode and the electrolysis electrode are electrically connected; and the control circuit controls the heating electrode or the electrolysis electrode to work; The upper edge of the semi-cylindrical groove medicine bin is provided with a magnetic card slot, which corresponds to the magnetic card buckle position of the medicine bin cover; the fitting parts of the two medicine bins correspond to the midline groove position of the medicine bin cover; there is a through hole at the bottom of the medicine bin; the two medicine bins are specifically divided into a large-dose execution medicine bin and a basal rate execution medicine bin; the large-dose execution medicine bin contains a heat-driven fluid pump and insulin, and the heat-driven fluid pump is located above the insulin; the heat-driven fluid pump includes an aluminum heat-conducting film packaging layer (1-4), a heat-expanding material (1-5), and an insulin propulsion piston (1-6a); the aluminum heat-conducting film packaging layer is in contact with the heating electrode, and heat is conducted to the heat-expanding material through the heating electrode, and then The large dose insulin advancing piston is pushed, and the insulin is squeezed by the piston and flows out from the through hole at the bottom of the medicine chamber; the basal rate execution medicine chamber contains a pneumatic fluid pump and insulin, and the pneumatic fluid pump is located above the insulin; the pneumatic fluid pump comprises a polyethylene coated paper electrolyte packaging layer (1-14), an electrolyte (1-15), and a basal rate insulin advancing piston (1-6b); the electrolytic electrode is inserted into the bottom of the electrolyte through the polyethylene coated paper electrolyte packaging layer, and the electrolyte is electrolyzed to generate gas, and the basal rate insulin advancing piston is pushed, and the insulin is squeezed by the piston and flows out from the through hole at the bottom of the medicine chamber; the through hole at the bottom of the medicine chamber is packaged with aluminum foil; The semi-implanted base comprises a base body (1-10), a contact base (1-17), and an infusion pipeline (1-18); the base body and the contact base are provided with two through holes, the positions of the through holes correspond to the through holes at the bottoms of the two medicine chambers, the two through holes of the base respectively correspond to an infusion pipeline, and the medicine chamber through hole, the base body through hole, the contact base through hole, and the infusion pipeline form an infusion passage; The through hole of the base body protrudes upward, and a layer of aluminum foil is provided at the medicine outlet in the medicine bin. When the medicine bin is installed on the base, the through hole breaks through the aluminum foil to form a passage.

2. The ultra-small wireless controlled patch-type insulin pump according to claim 1, characterized in that: The control circuit includes an MCU and an NFC chip, wherein the NFC chip collects information and energy received by the NFC coil, outputs analog voltage to the MCU, and the MCU controls the independent operation of the heating electrode or the electrolysis electrode; specifically, the specific process of the control circuit controlling the operation of the heating electrode and the electrolysis electrode is as follows: The NFC coil receives the NFC energy signal emitted by the smart terminal and transmits it to the NFC chip. The NFC chip passes the signal to the MCU for processing and generates an analog voltage output through the integrated energy harvesting function, which serves as a power source to power the entire control circuit.

3. The ultra-small wireless controlled patch-type insulin pump according to claim 1, characterized in that: The semi-cylindrical groove medicine chamber is a detachable medicine chamber.

4. The ultra-small wireless controlled patch-type insulin pump according to claim 1, characterized in that: The maximum drug loading capacity of the drug chamber is 0.5mL, which can hold 50 units of U-100 insulin.

5. The ultra-small wireless controlled patch-type insulin pump according to claim 1, characterized in that: The shape of the medicine bin cover is replaced with a rectangle, an ellipse, a trapezoid or other shapes, and correspondingly, the plane shapes of the two medicine bins correspond to the shape of the medicine bin cover, specifically, a three-dimensional groove with a set height and a bottom shape of a rectangle, an ellipse, a trapezoid or other shapes.

6. A method for preparing an ultra-small wirelessly controlled patch-type insulin pump, characterized in that: The specific steps are as follows: Step 1: Obtain a base body, two complementary semi-cylindrical medicine bins and a circular medicine bin cover of matching sizes through 3D printing, and use epoxy resin glue to embed two magnets into the positions of the medicine bin cover corresponding to the magnetic card slots; specifically, the circular medicine bin cover has a groove in the center line, and the complementary positions of the two medicine bins correspond to the grooves of the medicine bin cover; each medicine bin has a through hole at the bottom, and the base body has two through holes, each of which corresponds to the position of the through hole at the bottom of the medicine bin; the through hole of the base cylinder protrudes upward so that it can be embedded in the through hole at the bottom of the medicine bin; through holes are reserved on both sides of the groove of the medicine bin cover; Step 2: Use epoxy resin glue to penetrate one end of the tubular polyimide film into the through hole of the base body as an infusion line; embed the needle tip outside the polyimide film as the infusion line needle tip; use PDMS to encapsulate the bottom surface of the base body as a contact base; Step 3: Insert two semicircular insulin push pistons into the two medicine chambers, and add a certain amount of insulin from the through hole at the bottom of the medicine chamber; adjust the position of the insulin push piston so that the insulin liquid level is flush with the medicine outlet, and use aluminum foil to seal the medicine outlet to obtain two semicircular insulin medicine chambers with complementary shapes; Step 4: adding the expanded microparticles to the mixture of polydimethylsiloxane and the curing agent, stirring evenly, and adding the mixture with the expanded microparticles to the top of the insulin push piston of a drug chamber to form a heat-driven fluid pump; wrapping the top of the drug chamber with aluminum foil to form a large-dose execution drug chamber; Step 5: Add electrolyte to the top of the insulin push piston of another medicine chamber to form a pneumatic fluid pump; seal the top of the medicine chamber with polyethylene coated paper to form a basal rate execution medicine chamber; Step 6: The NFC coil is coated on the upper surface of the medicine chamber cover by electron beam evaporation, and the heating electrode is coated on one side of a reserved through hole on the lower surface of the medicine chamber cover by electron beam evaporation; the electrolytic electrode is fixed to the through hole reserved on the other side of the medicine chamber cover with epoxy resin glue; Step 7: Embed the circuit board with integrated control circuit into the top of the medicine compartment cover, connect it with the heating electrode, electrolysis electrode and NFC coil through the reserved through holes, and encapsulate the upper surface of the medicine compartment cover with PDMS; Step 8: Fix the two medicine chambers to the base, cover the medicine chamber covers on top of the medicine chambers, and embed the magnetic buckles into the magnetic card slots to complete the preparation of the ultra-small detachable patch-type insulin pump for wireless control of insulin injection.

7. The method for preparing an ultra-small wireless controlled patch-type insulin pump according to claim 6, characterized in that: The medicine chamber cover is a cylindrical sheet with a radius of 12±0.2 mm and a thickness of 2±0.1 mm; the medicine chamber has an outer radius of 12±0.2 mm, an inner radius of 11.3±0.2 mm, and a height of 5.5±0.1 mm.

8. The method for preparing an ultra-small wireless controlled patch-type insulin pump according to claim 6, characterized in that: The infusion line needle tip is made of sterile packaged 316L stainless steel and has a length of 4 mm.

9. The method for preparing an ultra-small wireless controlled patch-type insulin pump according to claim 6, characterized in that: The heating electrode is composed of a 100nm chromium layer and a 500nm gold layer.

10. The method for preparing an ultra-small wireless controlled patch-type insulin pump according to claim 6, characterized in that: The electrolyte is a 50 mM NaOH solution, the anode of the electrolytic electrode is made of gold, and the cathode is made of copper.

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