Closed-loop blood glucose regulation pump and method of use

Abstract

The invention relates to the technical field of blood glucose regulating pumps, in particular to a closed-loop blood glucose regulating pump and a using method.The closed-loop blood glucose regulating pump comprises a dynamic glucose monitoring system, a first cavity containing blood glucose regulating medicine, a first pump connected with the first cavity through a pipeline, a microprocessor and a second cavity containing normal saline; the second pump is connected with the second chamber through a pipeline; the first pump and the second pump are connected with a mixing chamber through a first pipe and a second pipe, and the mixing chamber is connected with a needle inserted into a human body through a pipeline; glucagon is diluted through normal saline and then injected into the subcutaneous part of the human body, the concentration of the glucagon is reduced, and therefore finer control over the glucagon is achieved, and too large fluctuation of blood sugar is avoided; glucagon always keeps flowing no matter in an infusion state or an infusion stopping state, and the phenomenon that glucagon remaining in a pipeline is caked due to the fact that the glucagon stops flowing is avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of blood sugar regulating pumps, and in particular to a closed-loop blood sugar regulating pump and a method of use. Background Art

[0002] Congenital hyperinsulinemic hypoglycemia is the main cause of refractory hypoglycemia in children; repeated hypoglycemic episodes can lead to brain damage, followed by delayed motor and speech development, secondary epilepsy, and in severe cases, coma or even death; current acute phase treatment requires intravenous glucose infusion or glucagon injection; chronic phase medication diazoxide should pay attention to the risk of water and sodium retention, secondary heart failure and pulmonary hypertension; children who are insensitive to diazoxide need to try octreotide, which has the risk of necrotizing enterocolitis, etc.; given that congenital hyperinsulinemic hypoglycemia exists in a temporary type; therefore, there is an urgent clinical need to invent a non-invasive, effective blood sugar-elevating treatment method to enable patients to safely pass through the dangerous period of hypoglycemia. Regulating blood sugar is crucial to reducing serious complications and improving long-term prognosis.

[0003] A closed-loop blood glucose regulating pump is a pump system with built-in electronic equipment that adjusts the delivery of glucagon in real time according to the patient's blood glucose level and drug metabolism status. Its working principle is to use a small hardware device called a "blood glucose sensor" to continuously monitor blood glucose values, and then send this data to the closed-loop blood glucose regulating pump. The pump will automatically adjust the injection dose to control the blood glucose concentration in the patient's body. The closed-loop blood glucose regulating pump can adjust the injection volume of glucagon according to the real-time blood glucose value, achieving precise blood glucose management and maintaining blood glucose at normal levels.

[0004] The shortcomings of existing closed-loop blood glucose regulation pumps are: 1. The pump directly controls the injection of pure glucagon into the human body. The high concentration of glucagon makes it difficult to achieve precise dosage control, which can easily cause large blood sugar fluctuations; 2. When the patient injects glucagon when needed, the pump stops after the injection. The glucagon remaining in the needle and syringe can easily cause blockage and damage the needle and syringe. Summary of the Invention

[0005] The main purpose of the present invention is to provide a closed-loop blood glucose regulating pump and a method of use, so as to solve the problems in the above-mentioned prior art that the pump directly controls the injection of pure glucagon into the human body, the concentration of glucagon is high, and it is difficult for the closed-loop blood glucose regulating pump to achieve precise dosage control, which easily causes large blood glucose fluctuations; and the injected glucagon remaining in the needle and syringe easily causes blockage and damages the needle and syringe.

[0006] In order to achieve the above-mentioned objectives, the present invention provides a closed-loop blood glucose regulating pump, comprising a dynamic glucose monitoring system, a first chamber filled with blood glucose regulating drugs, a first pump connected to the first chamber through a pipeline, and a microprocessor. It also includes a second chamber filled with physiological saline and a second pump connected to the second chamber through a pipeline; the first pump and the second pump are connected to a mixing chamber through a first tube and a second tube, and the mixing chamber is connected to a needle for insertion into the human body through a pipeline.

[0007] Furthermore, a three-way valve is connected to the first tube, and the three-way valve is connected to the first chamber through a reflux pipe.

[0008] Furthermore, both the first pipe and the second pipe are provided with a one-way valve.

[0009] Furthermore, an agitator is provided in the mixing chamber.

[0010] Furthermore, the microprocessor is in communication with the dynamic glucose monitoring system, the first pump and the second pump; the microprocessor includes a touch screen for parameter setting and status display and a built-in alarm module for abnormal situation prompts.

[0011] The present invention also provides a method for using the closed-loop blood glucose regulating pump, comprising the following steps: S1, the continuous glucose monitoring system detects the blood glucose value X and transmits it to the microprocessor; S2. The microprocessor receives the blood glucose value X and controls the first pump, the second pump, and the three-way valve. When the blood glucose value is lower than normal, the microprocessor starts infusion and infuses glucagon diluted with saline into the human body. S3. When the blood sugar level returns to normal, stop the infusion.

[0012] Furthermore, in step S2, when 3.9≤X<5.0mmol / L, glucagon is mixed with normal saline in a ratio of 1:3 and infused into the human body at an infusion rate of 1-2.5ug / kg.h; when 3.0≤X<3.9mmol / L, glucagon is mixed with normal saline in a ratio of 1:2 and infused into the human body at an infusion rate of 1-5ug / kg.h; when X<3.0mmol / L, glucagon is mixed with normal saline in a ratio of 1:1 and infused into the human body at an infusion rate of 5-20ug / kg.h; when blood sugar returns to a normal value of 5≤X<10, the infusion is stopped; if the blood sugar still does not return to normal value after 15 minutes of infusion, an alarm is issued.

[0013] Furthermore, in step S3, when the infusion is stopped, the channel flowing from the first tube to the mixing chamber is first closed, and the channel flowing from the first tube to the reflux tube is opened, and the infusion of glucagon is stopped; then, the normal saline is maintained at the original infusion rate for 1-3 minutes before the infusion is stopped.

[0014] Furthermore, in steps S1-S3, the first pump is always kept on to provide power for the flow of glucagon; when glucagon is infused into the human body, the glucagon is transported to the mixing chamber through the first tube; when the infusion is stopped, the glucagon flows back to the first chamber through the first tube and the reflux tube.

[0015] Furthermore, in step S2, before infusing the glucagon diluted with physiological saline into the human body, physiological saline is infused into the human body at a rate of 0.1-0.5 ml / h to flush the tube to ensure smooth subsequent infusion.

[0016] The beneficial effects of the present invention are: 1. Dilute glucagon with saline before injecting it subcutaneously to reduce the concentration of glucagon, thereby achieving more precise control of glucagon and avoiding excessive fluctuations in blood sugar. 2. The concentration of glucagon decreases after dilution, which is less likely to cause blockage of the pipes and needles. After the glucagon infusion stops, the normal saline is infused at the original speed for a period of time, thereby flushing out the glucagon in the mixing chamber, pipes, and needles and infusing them into the human body, avoiding the residual glucagon from agglomerating and causing blockage of the pipes and needles. Regardless of whether the infusion is in progress or stopped, glucagon always keeps flowing, avoiding the glucagon remaining in the pipe from agglomerating due to the cessation of glucagon flow.

[0017] 3. In case of mild hypoglycemia, low-concentration glucagon is infused at a low rate. In case of severe hypoglycemia, high-concentration glucagon is infused at a high rate, achieving refined control in stages. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The drawings in the specification, which constitute a part of this application, are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute improper limitations on the present invention.

[0019] Figure 1 It is a structural schematic diagram of an embodiment of a closed-loop blood glucose regulating pump; In the figure: 1. dynamic glucose monitoring system; 2. first chamber; 3. first pump; 4. second chamber; 5. second pump; 6. mixing chamber; 7. needle; 8. first tube; 9. three-way valve; 10. reflux tube; 11. second tube; 12. one-way valve; 13. stirrer; 14. microprocessor. DETAILED DESCRIPTION

[0020] It should be noted that, in the absence of conflict, the embodiments and features of the embodiments in this application can be combined with each other. The present invention will be described in detail below with reference to the accompanying drawings and in combination with the embodiments.

[0021] Closed-loop blood glucose regulating pump embodiment like Figure 1 As shown, a closed-loop blood glucose regulating pump includes a dynamic glucose monitoring system 1, a first chamber 2 filled with glucagon, a first pump 3 connected to the first chamber 2 through a pipeline, and a microprocessor 14; the dynamic glucose monitoring system 1 is also called a dynamic blood glucose meter, which can be worn on the body to automatically detect blood glucose values ​​in real time; it also includes a second chamber 4 filled with physiological saline, and a second pump 5 connected to the second chamber 4 through a pipeline; the first pump 3 and the second pump 5 are both micro peristaltic pumps; the first pump 3 and the second pump 5 are connected to a mixing chamber 6 through a first tube 8 and a second tube 11, and the mixing chamber 6 is connected to a needle 7 for insertion under the skin of the human body through a pipeline, and an adhesive patch is connected to the needle 7 to assist in fixation.

[0022] A three-way valve 9 is connected to the first tube 8, and the three-way valve 9 is connected to the first chamber 2 through a reflux pipe 10; after the glucagon in the first chamber 2 enters the first tube 8, it is split at the three-way valve 9, one path can enter the mixing chamber 6, and the other path can enter the first chamber 2 through the reflux pipe 10; the flow direction is controlled by the three-way valve 9.

[0023] Both the first tube 8 and the second tube 11 are provided with a one-way valve 12 to prevent the liquid from flowing back into the first chamber 2 and the second chamber 4 .

[0024] The microprocessor 14 is in communication with the dynamic glucose monitoring system 1, the three-way valve 9, the first pump 3 and the second pump 5; the microprocessor 14 includes a touch screen for parameter setting and status display and a built-in alarm module for abnormal situation prompts.

[0025] When in use, the closed-loop blood glucose regulating pump can be worn on the user using a strap or adhesive patch without affecting the user's normal work and life.

[0026] In some embodiments, a stirrer 13 is provided in the mixing chamber 6 to mix the glucagon and the saline solution uniformly.

[0027] Example of using method of closed-loop blood glucose regulating pump A method for using the closed-loop blood glucose regulating pump comprises the following steps: S1, the continuous glucose monitoring system 1 detects a blood glucose value X and transmits it to the microprocessor 14; S2. The microprocessor 14 receives the blood glucose value X and controls the first pump 3, the second pump 5, and the three-way valve 9. When the blood glucose value is lower than normal, the microprocessor 14 starts the infusion and subcutaneously infuses glucagon diluted with saline into the human body. When 3.9≤X<5.0mmol / L, glucagon is mixed with normal saline in a ratio of 1:3 and infused into the human body at an infusion rate of 1-2.5ug / kg.h; when 3.0≤X<3.9mmol / L, glucagon is mixed with normal saline in a ratio of 1:2 and infused into the human body at an infusion rate of 1-5ug / kg.h; when X<3.0mmol / L, glucagon is mixed with normal saline in a ratio of 1:1 and infused into the human body at an infusion rate of 5-20ug / kg.h; when blood sugar returns to the normal value of 5≤X<10, the infusion is stopped; if the blood sugar still does not return to normal value after 15 minutes of infusion, an alarm is issued; Before infusing glucagon diluted with normal saline into the human body, normal saline is infused into the human body at a rate of 0.1-0.5 ml / h to flush the tube and ensure smooth subsequent infusion; S3. When the blood sugar level returns to normal, stop the infusion; When stopping the infusion, first close the passage from the first tube 8 to the mixing chamber 6, open the passage from the first tube 8 to the return tube 10, and stop the infusion of glucagon; then, maintain the original infusion rate of saline for 1-3 minutes before stopping the infusion; In steps S1-S3, the first pump 3 is always kept in the open state to provide power for the flow of glucagon. When glucagon is infused into the human body, the glucagon is transported to the mixing chamber 6 through the first tube 8. When the infusion is stopped, the glucagon flows back to the first chamber 2 through the first tube 8 and the reflux tube 10.

[0028] Patient A originally wore a single-chamber closed-loop blood glucose regulating pump. This closed-loop blood glucose regulating pump only had one chamber containing glucagon and no return tube. The minimum infusion rate of pure glucagon in this closed-loop blood glucose regulating pump was 0.0005ug / h. The blood glucose value fluctuated widely, and it was easy to experience a sudden increase in blood drug concentration, a sharp increase in blood glucose, and even exceed the target range. The needle and pipeline often became clogged, and the needle and pipeline had to be replaced frequently.

[0029] Patient A later changed to wearing the closed-loop blood glucose regulating pump in this embodiment. The closed-loop blood glucose regulating pump of the present application infuses diluted glucagon, which is converted into pure glucagon for calculation. The pure glucagon infusion rate can be infinitely small, and the fluctuation range of blood glucose values ​​is small; the rise in blood glucose is more gradual and controllable, reducing the risk of rebound hyperglycemia, and the blood glucose curve is smoother; and there is no problem of needle and pipeline being blocked.

[0030] The closed-loop blood glucose regulation pump in this embodiment dilutes glucagon with saline before injecting it subcutaneously into the human body, reducing the concentration of glucagon, thereby achieving more refined control of glucagon and avoiding excessive blood glucose fluctuations. It can achieve precise dosage adjustment, suitable for small dosage requirements (such as children), and is safer, has a high fault tolerance rate, and reduces the risk of over-injection.

[0031] In this embodiment, the concentration of glucagon is reduced after dilution, which is less likely to cause blockage of the tube and needle. After the glucagon infusion is stopped, the normal saline is infused at the original rate for a period of time, thereby flushing out the glucagon in the mixing chamber, tube, and needle and infusing it into the human body, thereby preventing residual glucagon from agglomerating and causing blockage of the tube and needle. Regardless of whether the infusion is in progress or stopped, the glucagon always keeps flowing, thereby preventing the glucagon remaining in the tube from agglomerating due to the cessation of glucagon flow.

[0032] In this embodiment, a low-concentration glucagon is infused at a low rate in the case of mild hypoglycemia, and a high-concentration glucagon is infused at a high rate in the case of severe hypoglycemia, thereby achieving refined control in stages.

[0033] The foregoing description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Those skilled in the art will readily appreciate that various modifications and variations of the present invention are possible. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention are intended to be within the scope of protection of the present invention.

Claims

1. A closed-loop blood glucose regulating pump, comprising a dynamic glucose monitoring system (1), a first chamber (2) containing a blood glucose regulating drug, a first pump (3) connected to the first chamber (2) via a pipeline, and a microprocessor (14), characterized in that: The invention also includes a second chamber (4) filled with physiological saline, and a second pump (5) connected to the second chamber (4) via a pipeline; the first pump (3) and the second pump (5) are connected to a mixing chamber (6) via a first tube (8) and a second tube (11); the mixing chamber (6) is connected to a needle (7) for insertion into a human body via a pipeline.

2. The closed-loop blood glucose regulating pump according to claim 1, wherein: The first tube (8) is connected to a three-way valve (9), and the three-way valve (9) is connected to the first chamber (2) via a return pipe (10).

3. The closed-loop blood glucose regulating pump according to claim 1, wherein: Both the first tube (8) and the second tube (11) are provided with a one-way valve (12).

4. The closed-loop blood glucose regulating pump according to claim 1, wherein: A stirrer (13) is provided in the mixing chamber (6).

5. The closed-loop blood glucose regulating pump according to claim 1, wherein: The microprocessor (14) is in communication with the dynamic glucose monitoring system (1), the first pump (3) and the second pump (5); the microprocessor (14) includes a touch screen for parameter setting and status display and a built-in alarm module for abnormal situation prompts.

6. A method for using the closed-loop blood glucose regulating pump according to claim 2, characterized in that: The following steps are involved: S1, the dynamic glucose monitoring system (1) detects a blood glucose value X and transmits it to the microprocessor (14); S2, the microprocessor (14) receives the blood glucose value X and controls the first pump (3), the second pump (5) and the three-way valve (9); when the blood glucose value is lower than the normal value, the microprocessor (14) starts the infusion and infuses the glucagon diluted with physiological saline into the human body; S3. When the blood sugar level returns to normal, stop the infusion.

7. The method of use according to claim 6, wherein: In step S2, when 3.9≤X<5.0mmol / L, glucagon is mixed with normal saline in a ratio of 1:3 and infused into the human body at an infusion rate of 1-2.5ug / kg.h; when 3.0≤X<3.9mmol / L, glucagon is mixed with normal saline in a ratio of 1:2 and infused into the human body at an infusion rate of 1-5ug / kg.h; when X<3.0mmol / L, glucagon is mixed with normal saline in a ratio of 1:1 and infused into the human body at an infusion rate of 5-20ug / kg.h; when blood sugar returns to a normal value of 5≤X<10, the infusion is stopped; if the blood sugar still does not return to normal value after 15 minutes of infusion, an alarm is issued.

8. The method of use according to claim 7, wherein: In step S3, when the infusion is stopped, the channel flowing from the first tube (8) to the mixing chamber (6) is first closed, and the channel flowing from the first tube (8) to the return tube (10) is opened, and the infusion of glucagon is stopped; then, the normal saline is maintained at the original infusion rate for 1-3 minutes, and then the infusion is stopped.

9. The method of use according to claim 7, wherein: In steps S1-S3, the first pump (3) is always kept in an open state to provide power for the flow of glucagon; when glucagon is infused into the human body, the glucagon is transported to the mixing chamber (6) through the first tube (8); when the infusion is stopped, the glucagon flows back to the first chamber (2) through the first tube (8) and the reflux tube (10).

10. The method of use according to claim 6, wherein: In step S2, before infusing the glucagon diluted with physiological saline into the human body, physiological saline is infused into the human body at a rate of 0.1-0.5 ml / h to flush the tube to ensure smooth subsequent infusion.

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