Subminiature wireless control patch type insulin pump and preparation method thereof

Abstract

The invention provides a subminiature wireless control patch type insulin pump and a preparation method thereof, and belongs to the technical field of biomedical engineering devices. A smart phone near field communication (NFC) technology is used for supplying energy to a circuit, insulin is pushed to be injected into the body of a patient through the volume change of a thermal expansion material and gas generated by an electrolysis electrode, and pre-meal large-dose and basic-rate insulin infusion is achieved. The insulin pump is simple in structure and small in size, a built-in power source is not needed, the use burden of a patient is reduced, the wearing comfort and convenience are improved, meanwhile, control is conducted through an intelligent mobile phone application program, the operation process is simplified, and an accurate and convenient insulin injection mode is provided for a user.

Description

Technical Field

[0001] The invention belongs to the technical field of biomedical engineering devices, and in particular relates to an ultra-small wirelessly controlled patch-type insulin pump and a preparation method thereof. Background Art

[0002] Diabetes is a global public health problem, with a high incidence rate all year round and a trend of gradual increase. Type 1 diabetes and type 2 diabetes are two different types of diabetes. Type 1 diabetes is usually caused by autoimmune reactions that lead to the destruction of pancreatic beta cells, which are unable to produce enough insulin. Type 2 diabetes is mainly caused by the body's reduced sensitivity to insulin (insulin resistance) and / or insufficient insulin secretion.

[0003] Insulin therapy is a key part of the treatment plan for patients with diabetes. Its goal is to simulate the normal insulin secretion pattern to maintain blood sugar levels as close to normal as possible. Patients with type 1 diabetes need to rely on exogenous insulin injections to control blood sugar levels. Type 2 diabetes also requires the assistance of insulin therapy in addition to oral antihypertensive drugs. Patients need to inject insulin multiple times a day, and the dose of injected insulin also needs to be strictly allocated. Therefore, diabetic patients urgently need a safe, accurate and convenient way to inject insulin to reduce the inconvenience brought to their lives by the treatment process while taking insulin.

[0004] The traditional daily insulin injection method uses a syringe or insulin pen for multiple subcutaneous injections to simulate the physiological secretion pattern of human insulin. Daily insulin treatment requires patients to inject themselves multiple times a day. Common injection sites include the abdomen, thighs, buttocks and upper arms. The absorption rate of insulin in different parts may be different. In order to avoid hyperplasia or atrophy of subcutaneous fat, different injection sites are used in rotation during injection. Depending on the patient's body shape and injection site, the insertion depth and angle of the needle may need to be adjusted. The type of insulin injected is also different. Intermediate-acting or long-acting insulin analogs are used as basal insulins. They have a longer duration of action and can provide all-day basal insulin coverage to help control fasting and pre-meal blood sugar levels; short-acting or rapid-acting insulin analogs are used as mealtime insulins and are injected before meals to help control post-meal blood sugar levels. At the same time, the injection dose also needs to be adjusted according to actual life situations such as blood sugar levels, meal conditions, and exercise plans. The traditional insulin injection method requires patients to have good self-management skills and discipline to ensure that insulin is injected on time and blood sugar is monitored. In addition, patients also need to communicate with medical professionals regularly to optimize treatment plans. As an advanced diabetes management tool, insulin pump can achieve more precise dosage control compared with traditional insulin injection methods.

[0005] Insulin pumps use electronic devices to control the infusion of insulin, and have a basal rate and a large-dose injection function before meals. The basal rate is a continuous, low-dose insulin infusion set by the patient to simulate the secretory function of the human pancreas and maintain blood sugar levels between meals and at night. The large-dose injection before meals is a larger insulin dose infusion manually set by the patient before eating to cope with the increase in blood sugar after meals. Insulin pumps provide a treatment option that is closer to the physiological insulin secretion pattern, which can provide more precise blood sugar control and better quality of life, but requires certain learning and maintenance costs. Although the traditional insulin injection method is easy to operate and low in cost, it is not as flexible and accurate as insulin pumps in blood sugar control. Summary of the invention

[0006] The traditional daily insulin injection method is still the mainstream insulin treatment method at present. It has some shortcomings that may affect the patient's blood sugar control and quality of life. First, the traditional insulin injection method is difficult to accurately simulate the physiological secretion pattern of human insulin, resulting in insufficient blood sugar control and prone to blood sugar fluctuations. Due to the inaccuracy of insulin dosage and the inability to adjust it in time, 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 cause fat metabolism disorders at the injection site, such as fat hyperplasia or atrophy, affecting insulin absorption and blood sugar control. Third, the traditional insulin injection method is difficult to adapt to sudden changes in patients' daily lives, such as changes in eating time, increase or decrease in exercise, etc. Frequent injections and strict planning of diet restrict patients' social activities and daily life, affecting their quality of life, and frequent injections will bring psychological pressure to patients. Fourth, traditional syringes or insulin pens cannot provide fine adjustment of basal rate and pre-meal large doses like insulin pumps, nor can they automatically adjust the insulin infusion amount according to blood sugar levels. Self-injection by patients may also inevitably lead to the reuse of needles or unclean injection techniques, increasing the risk of infection.

[0007] Insulin pumps can solve some of the shortcomings of traditional insulin injection methods. Insulin pumps can set the basal rate, simulate the insulin secretion pattern of the human body during non-meal time, provide continuous and stable insulin infusion, and reduce blood sugar fluctuations. It allows users to set very precise insulin doses, which helps to adjust blood sugar control more finely 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 the problem of fat hyperplasia or atrophy at the injection site, and also help reduce the risk of infection. In addition, insulin pumps provide greater flexibility, and users can arrange their diet and activities more freely without being restricted by strict injection time, which can greatly improve the quality of life of patients and relieve their psychological burden. However, there are also many limitations to the insulin pumps currently on the market. First, the initial purchase cost of insulin pumps is high, and consumables such as drug reservoirs, infusion lines and needles need to be replaced regularly. These consumables that match the system will bring continuous and expensive costs. Secondly, the setup and operation steps of the insulin pumps currently on the market are relatively cumbersome, and require a certain amount of learning and practice to master them. Finally, as a sophisticated electronic device, insulin pumps may encounter technical failures or mechanical problems, such as pump damage, battery exhaustion, or blockage of the infusion line. These limitations restrict existing insulin pumps from occupying a larger market share.

[0008] In order to solve the above technical problems, the present invention uses the near field communication (NFC) technology of a smart phone to power the circuit, utilizes the volume change of thermal expansion materials and generated gas to inject insulin into the patient's body, and provides an ultra-small wirelessly controlled patch-type insulin pump. The specific technical solution is as follows:

[0009] An ultra-small wirelessly controlled patch-type insulin pump comprises a circular medicine chamber cover, two complementary semi-cylindrical groove medicine chambers and a semi-implant base;

[0010] 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 control circuit 1-1 and the NFC coil 1-3 are integrated on the upper surface of the medicine compartment cover; the medicine compartment cover is divided into a first semicircular cover and a second semicircular cover along the center line, the lower surface of the first semicircular cover is integrated with a heating electrode 1-11, and the lower surface of the second semicircular cover is integrated with an electrolysis electrode 1-12, and the lower surface edges of the first semicircular cover and the second semicircular cover are respectively provided with magnetic buckles; the control circuit, the NFC coil, the heating electrode and the electrolysis electrode are electrically connected; the control circuit controls the heating electrode or the electrolysis electrode to work;

[0011] The upper edge of the semi-cylindrical groove medicine bin has 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 thermal conductive film packaging layer 1-4, a thermal expansion material 1-5, and an insulin propulsion piston 1-6a; the aluminum thermal conductive film packaging layer is in contact with the heating electrode, and heat is conducted to the thermal expansion material through the heating electrode, and then Push the piston to push the large dose of insulin, and the insulin is squeezed by the piston and flows out from the through hole at the bottom of the medicine chamber; the inside of the basal rate execution medicine chamber is a pneumatic fluid pump and insulin, and the pneumatic fluid pump is located above the insulin; the pneumatic fluid pump includes a polyethylene coated paper electrolyte packaging layer 1-14, an electrolyte 1-15, and a basal rate insulin push 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 push 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;

[0012] The semi-implanted base includes 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 bottom of the two medicine chambers, the two through holes of the base correspond to an infusion pipeline respectively, and the medicine chamber through hole, the base body through hole, the contact base through hole, and the infusion pipeline form an infusion passage;

[0013] 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.

[0014] Furthermore, the shape of the medicine bin cover can also be rectangular, elliptical, 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 a rectangle, elliptical, trapezoidal or other shapes.

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

[0016] 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.

[0017] The present invention also provides a method for preparing an ultra-small wirelessly controlled patch-type insulin pump, the specific steps of which are as follows:

[0018] Step 1: Obtain a base body, two complementary semi-cylindrical medicine bins and a circular medicine bin cover of matching size through 3D printing, and use epoxy resin glue to embed two magnets into the position of the medicine bin cover corresponding to the magnetic card slot; specifically, the circular medicine bin cover has a groove in the midline, and the complementary positions of the two medicine bins correspond to the groove of the medicine bin cover; each medicine bin has a through hole at the bottom, and the base body has two through holes, each through hole 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; the medicine bin cover is a cylindrical sheet with a radius of 12±0.2mm and a thickness of 2±0.1mm; the outer radius of the medicine bin is 12±0.2mm, the inner radius is 11.3±0.2mm, and the height is 5.5±0.1mm.

[0019] 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 sterile packaged 316L stainless steel needle tip on the outside of the polyimide film as the infusion line needle tip; use PDMS to encapsulate the bottom surface of the base body as a contact base;

[0020] 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;

[0021] 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;

[0022] 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;

[0023] 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;

[0024] 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;

[0025] 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.

[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 wirelessly controlling insulin injection is realized.

[0028] (1) The present invention adopts a disposable insulin medicine chamber. The structure design of the medicine chamber is simple, the manufacturing cost is low, and the use burden of the patient can be effectively reduced. Compared with the traditional insulin pump, the consumables of the present invention are easier to replace, the operation complexity is reduced, and the patient's use experience is improved. The drug loading capacity of the medicine chamber can be customized to meet the personalized needs of different patients.

[0029] (2) The present invention has no built-in power supply, and uses NFC technology to achieve energy supply and control, which greatly reduces the weight and volume of the patch-type insulin pump and improves the wearing comfort of patients. It is controlled by a smartphone application, and users can easily select a large dose or a basal rate infusion through the mobile phone interface.

[0030] (3) The present invention adopts a simplified mechanical structure design, reduces the number of internal parts, and has a simple and efficient circuit design. It uses a thermal expansion material heat-driven fluid pump and an electrolytic gas-generating pneumatic fluid pump to inject insulin. The fluid pumps are assembled in the medicine chamber and are disposable. They have good reliability and durability, and provide users with stable treatment effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 It is a cross-sectional dual-viewing structure schematic diagram of the present invention; the specific figure numbers are as follows: NFC coil 1-2 for receiving NFC signals, medicine chamber cover 1-3, aluminum thermal conductive film layer package 1-4, thermal expansion material 1-5, insulin propulsion piston 1-6, insulin 1-7, magnetic card slot 1-8, large-dose medicine chamber 1-9, base body 1-10, heating electrode 1-11, electrolysis electrode 1-12, magnetic buckle 1-13, polyethylene coated paper electrolyte packaging layer 1-14, electrolyte 1-15, basal rate medicine chamber 1-16, contact base 1-17, infusion pipeline 1-18.

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

[0033] Figure 3 It is a work flow chart of the present invention;

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

[0035] Figure 5 Test results for fluid pump operation, where Figure 5-1 is the time variation of temperature and heat-driven fluid pump volume, Figure 5-2 is the volume change of the pneumatic fluid pump over time. DETAILED DESCRIPTION

[0036] In order to better understand the purpose, structure and function of the present invention, the following is a further detailed description of an ultra-small wirelessly controlled patch-type insulin pump of the present invention in conjunction with the accompanying drawings.

[0037] The present invention provides an ultra-small patch-type insulin pump for wirelessly controlling insulin injection. Based on near field communication technology, the NFC of a smart phone is used to power a circuit to realize wireless control of the insulin pump.

[0038] The present invention stores the energy transmitted by NFC technology in the circuit to power the electrolysis electrode. The electrolysis electrode slowly electrolyzes water to generate gas, which drives the medicine chamber to slowly infuse insulin and achieve basal rate injection. The heating electrode rapidly increases the volume of the thermal expansion material, which drives the medicine chamber to quickly infuse insulin and achieves large-dose injection before meals.

[0039] In this embodiment, two working modes are used to perform insulin infusion on agarose gel blocks in vitro, simulating the wearing and use of the patch by the human body. Wireless power is supplied by NFC of a smartphone, the patch does not require power or battery, and completes short-term high-dose insulin infusion and long-term basal rate insulin infusion.

[0040] like Figure 2 As shown, the present embodiment provides an ultra-small wireless controlled patch-type insulin pump that is cylindrical in shape. The device body is attached to the skin surface, and the infusion line is inserted into the subcutaneous tissue. The infusion position is usually located on the abdomen, buttocks, upper arm or outer thigh. The whole can be divided into a medicine compartment cover, two complementary semi-cylindrical groove medicine compartments and a semi-implanted base; the patch-type insulin pump is divided into a large-dose insulin pump on the left half and a basal rate insulin pump on the right half, and the two do not interfere with each other.

[0041] The specific internal structure of the patch insulin pump is shown in the cross-sectional diagram. Figure 1As shown, the circular medicine compartment cover 1-3 has a groove in the midline, so that the medicine compartment cover 1-3 can be folded along the midline; the upper surface of the medicine compartment cover is integrated with a control circuit 1-1 and an NFC coil 1-3; the medicine compartment cover is divided into a first semicircular cover and a second semicircular cover along the midline, the lower surface of the first semicircular cover is integrated with a heating electrode 1-11, the lower surface of the second semicircular cover is integrated with an electrolysis electrode 1-12, and the lower surface edges of the first semicircular cover and the second semicircular cover are respectively provided with magnetic buckles 1-13; the control circuit 1-1, the NFC coil, the heating electrode and the electrolysis electrode are electrically connected; wherein the control circuit includes a high-dose circuit module and a basal rate circuit module, which respectively control the heating electrode or the electrolysis electrode to work. ;

[0042] Specifically, the NFC coil 1-2 receives the NFC signal sent by the smart phone and transmits it to the control circuit 1-1 to control the high-dose circuit module and the basal rate circuit module. The high-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 bin is provided with a magnetic card slot, which corresponds to the magnetic card buckle position of the medicine bin cover and is used to fix the medicine bin; 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 the heat is conducted to the heat-expanding material 1-5 through the heating electrode, and then the large-dose execution medicine bin is pushed. The dose insulin pushes the piston 1-6a, 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 includes a polyethylene coated paper electrolyte packaging layer 1-14, an electrolyte 1-15, and a basal rate insulin push piston 1-6b; the electrolytic electrode penetrates the polyethylene coated paper electrolyte packaging layer 1-14 and is inserted into the electrolyte bottom 1-15, and the electrolyte is electrolyzed to generate gas, pushing the basal rate insulin push piston 1-6b, 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;

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

[0045] The semi-implanted base includes a base body 1-10, a contact base 1-17, and an infusion line 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 bottom of the two medicine chambers, and the two through holes of the base correspond to an infusion line respectively, and the through holes of the medicine chamber, the through holes of the base body, the through holes of the contact base, and the infusion line form an infusion passage. The maximum radius of the base is 14mm, the thickness is 2mm, and the contact base is soft and can be well attached to the skin.

[0046] Furthermore, the through hole of the base body is upwardly protruding, 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 breaks through the aluminum foil to form a passage.

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

[0048] The NFC coil and control circuit at the top receive and process the NFC signal transmitted by the smartphone application. The NFC signal carries information and energy, which is first used to determine whether the control circuit is working with a large dose or a basal rate infusion, and then the control circuit supplies the energy signal collected by the NFC coil to the corresponding circuit module.

[0049] When the high-dose circuit module is working, all the collected energy will be immediately supplied to the heating electrode. The heating electrode generates Joule heat, and the temperature rises rapidly within 15-20 seconds, stimulating the rapid increase in the volume of the thermal expansion material. The heat-driven fluid pump completes the high-dose infusion execution within 30 seconds to inject the insulin in the medicine chamber into the body.

[0050] When the basal rate circuit module is working, it will temporarily store the collected energy in the capacitor integrated in the NFC chip and slowly use it to electrolyze the electrolyte. The electrolysis electrode is inserted into the bottom of the electrolyte, and gas is generated evenly and slowly, so that the pneumatic insulin propulsion piston of the basal rate infusion execution chamber consumes 6-12 hours, and insulin is slowly and evenly injected into the body. The specific single basal rate infusion cycle can be adjusted in the smartphone terminal according to the user's situation.

[0051] After a single NFC signal supplies energy to the basal rate circuit module, the basal rate circuit starts and continues to work for a long time. Only two times a day are needed to meet the basic insulin infusion requirements at all times of the day. After a single NFC signal supplies energy to the high-dose circuit module, the patch-type insulin pump will complete the high-dose insulin injection before meals in a short time. This process shares an NFC receiving terminal with the basal rate working module, and other than that, they are independent of each other and do not affect each other.

[0052] Figure 3 This is a flowchart for the use of a patch insulin pump. When in use, apply the patch insulin pump to the disinfected skin surface, insert the infusion line needle into the subcutaneous tissue, and fix the device. After wearing it, use the NFC application of the smartphone to approach the device NFC tag on the top of the medicine compartment 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, the basal rate circuit module continues to work, the electrolysis electrode electrolyzes the electrolyte at a uniform and slow speed, and the gas generated drives the pneumatic injection pump, which pushes the insulin into the body. This process can last up to 12 hours after a single NFC energy supply lasting 1 minute, realizing the basal rate infusion of the insulin pump. The basal rate medicine compartment is designed to run out of medicine just when the power is exhausted. The basal rate supply can be maintained by replacing the medicine compartment and charging it again. The electrolysis process will not affect the operation of the high-dose circuit module.

[0053] When a large dose injection is required before a meal, use the NFC application of a smartphone to bring the device NFC tag close to the top of the medicine compartment cover and establish a connection. Select the large dose option in the mobile phone NFC application, turn on the NFC signal transmission to power the large dose circuit module, and the large dose circuit heating electrode is energized to generate Joule heat, which is transferred to the thermal expansion material through the thermal conductive film layer package. The volume of the thermal expansion material increases rapidly, pushing the insulin into the body. The infusion process is completed quickly after each NFC power supply, and does not interfere with the basal rate infusion. After the infusion is completed, the medicine compartment can be directly disassembled and replaced, or it can be replaced with a different drug loading when the next large dose is required. The two working modules do not affect each other and are used in combination 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: 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 sterile packaged 316L stainless steel needle tip on the outside of the polyimide film as the infusion line needle tip; use PDMS to encapsulate the bottom surface of the base body as a contact base;

[0062] Step 3: Insert two semicircular insulin push pistons into the two medicine chambers, add a certain amount of insulin from the through hole at the bottom of the medicine chamber, up to 0.5 mL; 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;

[0063] 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;

[0064] 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;

[0065] 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;

[0066] 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;

[0067] 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.

[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 pump of the two medicine chambers was recorded by recording the position of the insulin push piston in the translucent medicine chamber, thereby reflecting the infusion of insulin. Figure 5 For large doses of medicine, Figure 5-1The experiment demonstrated how the temperature of the heating electrode and the volume of the heat-driven fluid pump changed over time. The results showed that within 30 seconds after the heating module started working, the temperature of the heating electrode quickly increased from about 60°C to nearly 90°C, stimulating the rapid increase in the volume of the thermal expansion material. At 17 seconds, the thermal expansion material pushed the piston forward until its volume increased to twice its original size. At this time, the infusion of insulin in the large-dose medicine chamber was completed. Figure 5-2 The volume of the pneumatic fluid pump changes over time. The results show that within 12 hours after the electrolysis module starts working, the electrolysis of water produces gas, and the insulin push piston of the basal rate drug chamber can push the insulin slowly linearly at a uniform speed. After 12 hours, the volume of the pneumatic fluid pump increases to 2 times of the original, the basal rate drug chamber is exhausted, and a basal rate infusion cycle is completed.

[0069] It is to be understood that the present invention is described by some embodiments, and it is known to those skilled in the art that various changes or equivalent substitutions may be made to these features and embodiments without departing from the spirit and scope of the present invention. In addition, under the teachings of the present invention, these features and embodiments may be modified to adapt to specific circumstances 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 are within the scope of protection of 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 (1-1) 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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