Insulin syringe replacement system for insulin pump

Abstract

The present invention relates to an insulin pump, which is a medical device for diabetic patients, and to a system for providing a safety device for preventing an accident that may occur when an insulin syringe for supplying insulin to the insulin pump is replaced. An insulin syringe replacement system for an insulin pump provided by the present invention comprises: a control unit for controlling the operation of the insulin pump; an operation unit for performing an initialization setting operation when an insulin syringe is replaced under the control of the control unit; and a battery unit for supplying power to the control unit and the operation unit; a housing unit for mounting the insulin syringe; and a sensor unit for confirming whether a stopper of the insulin syringe mounted on the housing unit is coupled and notifying the control unit of the confirmation, wherein the control unit controls the operation unit to perform the initialization setting operation only after receiving the confirmation from the sensor unit that the stopper of the insulin syringe mounted on the housing unit is coupled.

Description

Insulin syringe replacement system applicable to insulin pumps

[0001] The present invention relates to an insulin pump, which is a medical device for diabetic patients, and to a system that provides a safety device to prevent accidents that may occur when replacing an insulin syringe that supplies insulin to an insulin pump.

[0002] Diabetes mellitus is a condition in which the body fails to properly maintain the hormone secretion system necessary to maintain blood sugar levels, resulting in prolonged, excessively high blood sugar levels, which eventually lead to glucose excretion in the patient's urine. High urine glucose levels lead to increased urination, dehydration, and intense thirst. Furthermore, nutrients are lost without being utilized by the body, causing chronic, significant fatigue. Furthermore, severe diabetes causes abnormalities in the blood vessels through which high-glucose blood flows, impairing blood supply. This can lead to problems with the retina, kidneys, and nerves, leading to vision loss, chronic renal failure, and numbness and pain in the upper and lower extremities.

[0003] Treatment options for diabetes include diet, exercise, and medication. Pharmacological treatment, based on the understanding that diabetes is caused by a deficiency of the hormone insulin, which maintains appropriate blood sugar levels, involves administering insulin externally through various methods. Insulin, supplied externally instead of through the pancreas, lowers and maintains the patient's blood sugar levels to normal levels and alleviates the aforementioned symptoms of diabetes.

[0004] Insulin pumps are widely used as a method for appropriately delivering insulin to patients' bodies. Insulin pumps are typically portable and connected to the patient's body via tubes and needles. They are always connected and carried by the patient, and are designed to automatically control the dosage using electronic and mechanical devices.

[0005] Meanwhile, insulin administration to diabetic patients is performed with precision. Even a very small amount of insulin can significantly alter a patient's blood sugar level. For this reason, insulin pumps are designed to administer insulin by minutely advancing a plunger rod, which presses against the plunger gasket of an insulin syringe, through the rotation of multiple gears. The control unit of the insulin pump determines the amount of insulin to be administered by determining the rotational speed of the gears. Figure 1 illustrates an insulin pump equipped with the above system.

[0006] Meanwhile, for the above-mentioned tasks, the insulin pump needs to determine the exact amount of insulin stored in the insulin syringe in advance. The task performed by the insulin pump for this task is hereinafter referred to as the "initialization setting operation." The initialization setting operation is an operation in which the gear mechanism rotates until the plunger moving rod advances and contacts the plunger gasket, and the control unit measures the number of rotations of the gear mechanism during the initialization setting operation to determine the exact amount of insulin stored in the insulin syringe. During the initialization setting operation, the plunger moving rod stops moving forward when a pressure sensor or other means detects a repulsive force above a certain strength. This repulsive force is generated by the increase in internal pressure of the cylinder, which prevents the insulin from being discharged externally by blocking the discharge port of the insulin syringe with a stopper. Therefore, for the normal initialization setting operation to be performed, the user must manually block the discharge port with a stopper in advance.

[0007] While this process is typically performed by the patient themselves, considering the age and health of diabetic patients, the initialization process of the insulin pump often begins without this essential preparatory work. Furthermore, since the insulin pump's operating device is typically attached to the patient's body, it can be triggered into the initialization process unintentionally by the patient's movements, falls, or leaning against a wall.

[0008] Although the frequency of this situation may not be considered significantly high, the risk associated with it is significantly high. As previously mentioned, due to the human body's high sensitivity to insulin, diabetic patients must administer very small amounts of insulin through careful control. In this situation, if the initialization operation is performed while the stopper is not blocking the discharge port—for example, while the patient is connected to the insulin syringe via a tube and receiving insulin—the plunger rod, unaware of the repulsive force, will continue to advance, ultimately injecting a large amount of insulin into the patient's body. This event can lead to acute hypoglycemia and, in severe cases, death.

[0009] The present invention is for the operation of a safe insulin syringe replacement and setting initialization operation of an insulin pump, and provides an insulin syringe replacement system that can be applied to the operation method of an insulin pump.

[0010] The present invention provides a safety device for preventing an unexpected accident that may occur when replacing an insulin syringe, comprising: a control unit for controlling the operation of an insulin pump; an operating unit for performing an initial setting operation when replacing an insulin syringe under the control of the control unit; a battery unit for providing power to the control unit and the operating unit; a housing unit for mounting an insulin syringe; And a sensor unit for checking whether the stopper of the insulin syringe mounted on the housing is engaged and notifying the control unit; wherein the insulin syringe mounted on the housing unit includes a cylinder for storing insulin, a discharge port provided at one end of the cylinder for discharging insulin, a stopper coupled to the discharge port to prevent the insulin stored in the cylinder from being discharged, a plunger gasket located at the other end of the cylinder so as to change the pressure inside the cylinder, and a plunger moving rod for advancing by pushing the plunger gasket, and an initial setting operation performed by the operating unit is an operation in which the operating unit advances the plunger moving rod to reach the plunger gasket while the stopper is engaged to the discharge port of the insulin syringe, and the control unit controls the operating unit to perform the initial setting operation only after receiving a stopper engagement notification of the insulin syringe mounted on the housing unit from the sensor unit, and recognizes the amount of insulin contained in the cylinder based on the moving distance or position of the plunger moving rod after the initial setting operation performed by the operating unit is completed.

[0011] One embodiment of the present invention is an insulin syringe replacement system applicable to an insulin pump, wherein the housing portion includes a holder on which a discharge port of a mounted insulin syringe is mounted so that the discharge port is exposed to the outside of the insulin pump to allow a plug to be connected, the sensor portion is a magnetic sensor, and is positioned on the holder so as to detect the connection of the discharge port and the plug, and the plug connected to the discharge port is provided to be magnetic, so that when the plug is connected to the discharge port, the magnetic sensor detects the magnetic force line of the plug and notifies the control unit.

[0012] Another embodiment of the present invention is a system for replacing an insulin syringe applicable to an insulin pump, wherein a plug coupled to a discharge port has a coupling groove extending from a hole into which the discharge port is inserted when coupled, and a magnetic substance is attached to an area of ​​a surface facing a magnetic sensor when coupling with the discharge port is normally completed, and the discharge port coupled to the plug is a discharge port having a coupling protrusion provided on the side thereof so as to be coupled by engaging with a coupling groove of the plug coupled to the discharge port, so that when the discharge port and the plug are normally coupled, an area of ​​a surface of the plug facing the magnetic sensor is specified.

[0013] The present invention has the following effects.

[0014] First, when the insulin pump is connected to the body through a tube, the accident of insulin overdose due to an initial setting operation being performed due to an error caused by the wearer's actions can be fundamentally prevented.

[0015] Second, if the user of the insulin pump is unaware that the cap has not been engaged and operates the initialization setting operation, the plunger rod, which does not sense sufficient resistance, may advance until all the insulin inside the cylinder is discharged, thereby preventing the waste of replacement insulin syringes.

[0016] Third, the initial setting operation method of existing insulin pumps can be maintained while applying this system for safety, saving additional research and development costs.

[0017] Figure 1 illustrates an existing insulin pump and insulin syringe, and an insulin pump and insulin syringe to which the system of the present invention is applicable.

[0018] Figure 2 illustrates an insulin syringe replacement system, which is one embodiment of the present invention.

[0019] Figure 3 illustrates a view of a plug being coupled according to one embodiment of the present invention.

[0020] Figure 4 illustrates an insulin pump initialization setting process according to the present invention.

[0021]

[0022] <Explanation of symbols>

[0023] 10: Insulin pump

[0024] 20: Insulin syringe

[0025] 21: Cylinder

[0026] 22: Plunger gasket

[0027] 23: outlet

[0028] 23a: Connective tissue

[0029] 24: Stopper

[0030] 24a: Combination home

[0031] 25: Plunger moving rod, plunger moving screw

[0032] 26: Plunger movement fixing nut

[0033] 27: Magnetic body

[0034] 100: Insulin Syringe Replacement System

[0035] 110: Movement section

[0036] 111: Electric motor

[0037] 112: Gear device

[0038] 120: Control unit

[0039] 130: Housing Department

[0040] 131: Stand

[0041] 140: Sensor unit, magnetic sensor

[0042] 150: Battery compartment

[0043] A more detailed description of a preferred embodiment of the present invention will be given, but already well-known technical details will be omitted or compressed for the sake of brevity.

[0044] Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the attached drawings.

[0045] Before explaining the present invention, it should be noted that the insulin pump (10) to which the system of the present invention is applied is provided so that a replacement insulin syringe (20) (hereinafter referred to as “insulin syringe (20)”) can be removed to replenish the insulin administered to the patient. When the insulin in the insulin pump (10) is completely used up, the patient replaces the used insulin syringe (20) with a new insulin syringe (20) and causes the insulin pump (10) to perform an initialization setting operation to measure the amount of insulin stored in the replaced insulin syringe (20). Fig. 1 illustrates an insulin pump to which the insulin replacement system of the present invention is applied, and Fig. 2 illustrates the operation of the insulin replacement system of the present invention. The following description will be made with reference to Figs. 1 and 2.

[0046] The insulin syringe replacement system (100) provided in the insulin pump (10) of the present invention is implemented in the form of an insulin pump (10) including a control unit (120), an operating unit (110), a battery unit (150), a housing unit (130), and a sensor unit (140). That is, the present invention should be understood as a type of system implemented with the above-described components constituting the insulin pump (10).

[0047] It is preferable that the control unit (120) be implemented in the form of a microchip or microcontroller capable of performing calculations for electronically controlling the operation of the insulin pump (10), but if it can perform the role of the control unit (120) described above and described later, it should be considered to be included in the scope of the present invention.

[0048] The operating unit (110) performs an initialization setting operation when the insulin syringe (20) is replaced under the control of the control unit (120). The initialization setting operation performed by the operating unit (110) is an operation in which the operating unit (110) advances the plunger moving rod (25) to reach the plunger gasket (22) while the stopper (24) is coupled to the discharge port (23) of the insulin syringe (20). Therefore, the operating unit (110) is provided so as to be coupled to or in contact with the plunger moving rod (25) so as to advance it. The operating unit (110) may also be provided so as to advance the plunger moving rod (25) for a general insulin injection operation other than the initialization setting operation.

[0049] The operating unit (110) may include an electric motor that provides a power source for the operation being performed and a gear device (112) connected to the electric motor (111).

[0050] The electric motor may be connected to and supplied with power from a battery, as described later.

[0051] The gear device (112) rotates and simultaneously advances the plunger moving rod (25). The plunger moving rod (25) is typically included as a component of a replacement insulin syringe (20) to be described later, but in some cases, it may be included in the operating unit (110) as a component of the insulin syringe replacement system (100) of the present invention.

[0052] The gear unit (112) does not necessarily have to be plural, but it is preferable to be composed of multiple gears with various gear ratios. A gear unit (112) composed of such multiple gears is convenient for performing the operation of administering only extremely small amounts of insulin.

[0053] In one embodiment, the plunger moving rod (25) that is advanced by the gear device (112) may be provided as a plunger moving screw (25). In this embodiment, the plunger moving screw (25) is provided to be fastened with a plunger moving fixing nut (26). The plunger moving fixing nut (26) is provided to be fixed to an insulin pump (10) or an insulin syringe (20). Since the plunger moving fixing nut (26) is fixed, when the gear device (112) rotates the plunger moving screw (25) fastened to the plunger moving fixing nut (26), the plunger moving screw (25) moves forward. In this embodiment as well, the plunger moving screw (25) and the plunger moving fixing nut (26) may be components of a replacement insulin syringe (20), or may be provided as components of an operating unit (110) as a component of an insulin syringe replacement system (100) of the present invention.

[0054] The operating unit (110) preferably includes a sensor or device capable of measuring the rotational speed of the electric motor (111), the gear device (112), or the plunger moving screw (25). Such a sensor or device provides information about the rotational speed to the control unit (120). The control unit (120) determines the amount of insulin administered based on the provided information. Conversely, the control unit (120) can administer a predetermined amount of insulin by adjusting the rotational angle of the electric motor (111). If a gear device (112) composed of a plurality of gears with various gear ratios is provided, the rotational angle of the electric motor (111) can be determined to be sufficiently large to administer only a very small amount of insulin, and thus, operation of the electric motor (111) for administering a very small amount of insulin can be made easier.

[0055] The battery unit (150) provides power to the control unit (120) and the operation unit (110).

[0056] The housing (130) is provided to mount an insulin syringe (20). The insulin pump (10) replenishes the used insulin by replacing the insulin syringe (20).

[0057] An insulin syringe (20) includes a cylinder (21) for storing insulin, a discharge port (23) provided at one end of the cylinder (21) for discharging insulin, a stopper (24) coupled to the discharge port (23) to prevent the insulin stored in the cylinder (21) from being discharged, a plunger gasket (22) located at the other end of the cylinder (21) so as to change the internal pressure of the cylinder (21), and a plunger moving rod (25) for advancing the plunger gasket (22) by pushing it. However, the plunger moving rod (25) may also be provided to be included in the operating unit (110) as described above.

[0058] If the plunger moving rod (25) is implemented in the form of a plunger moving screw (25) as in the above-described embodiment, the insulin syringe (20) further includes a plunger moving fixing nut (26). However, even in this case, the plunger moving screw (25) and the plunger moving fixing nut (26) may be provided to be included in the operating portion (110). It is also possible for only the plunger moving screw (25) to be included in the insulin syringe (20), and for the plunger moving fixing nut (26) to be provided to be included in the operating portion (110), or vice versa. That is, it should be understood that anything is possible as long as the plunger moving screw (25) and the plunger moving fixing nut (26) interact to press the cylinder (21) when the insulin syringe (20) is mounted on the housing portion (130) to increase pressure or to discharge insulin through the discharge port (23).

[0059] In the initial setting mode, the plug (24) is coupled to the outlet (23), so that even if the plunger moving rod (25) pushes the plunger gasket (22), the plunger gasket (22) does not advance. The plunger moving rod (25) detects pressure based on the principle of action and reaction while in contact with the plunger gasket (22), and when the detection of the pressure is notified to the control unit (120), the control unit (120) stops the operation of the operating unit (110) for advancing the plunger moving rod (25).

[0060] The control unit (120) recognizes the amount of insulin contained in the cylinder (21) based on the movement distance or position of the plunger moving rod (25) after the initial setting operation performed by the operating unit (110) is completed. The movement distance or position of the plunger moving rod (25) can be known by measuring the rotation angle of the gear or electric motor included in the operating unit (110).

[0061] The sensor unit (140) checks whether the stopper (24) of the insulin syringe (20) mounted on the housing unit (130) is engaged and notifies the control unit (120). The control unit (120) controls the operation unit (110) to perform an initialization setting operation only after receiving a notification of the stopper (24) of the insulin syringe (20) mounted on the housing unit (130) being engaged by the sensor unit (140).

[0062] If the plug (24) is not connected to the discharge port (23), the plunger moving rod (25) continues to advance by pushing the plunger gasket (22) even after it comes into contact with the plunger gasket (22), and thus, all of the insulin stored in the cylinder (21) is discharged through the discharge port (23). If the discharge port (23) is connected to the user through a tube, the patient may receive an overdose of insulin, which may lead to death or an emergency situation.

[0063] Accordingly, by confirming whether the plug (24) is connected by the sensor unit (140) and allowing the initialization setting operation to be performed only after the connection of the plug (24) is confirmed, it is possible to fundamentally prevent accidents such as the above from occurring due to an unintentional or mistaken initialization setting operation.

[0064] In another embodiment of the present invention, the housing part (130) may include a stand (131), and the sensor part (140) may be positioned on the stand (131). The stand (131) is provided so that the discharge port (23) of the insulin syringe (20) mounted on the housing part (130) is mounted and exposed to the outside of the housing part (130) so that the stopper (24) can be coupled thereto. In addition, the sensor part (140) is positioned on the stand (131) so as to easily detect the coupling of the discharge port (23) mounted on the stand (131) and the stopper (24).

[0065] In this embodiment, the sensor unit (140) may be provided as a magnetic sensor (140). At this time, the plug (24) coupled to the discharge port (23) is provided to be magnetic, so that when the plug (24) is coupled to the discharge port (23), the magnetic sensor (140) can detect the magnetic force lines of the plug (24) and notify the control unit (120).

[0066] At this time, it is preferable that the position of the magnetic sensor (140) be positioned in the direction in which the discharge port (23) is exposed to the outside of the insulin pump (10) or housing (130) so that it is easy to detect the magnetic field line when the plug (24) is connected.

[0067] Fig. 3 illustrates a coupling appearance of a plug (24) of another embodiment of the present invention. In this embodiment, only a portion of the plug (24), that is, a portion that comes into contact with or is close to the magnetic sensor (140) on the holder (131) when coupled with the outlet (23), may be made of a magnetic material. In this embodiment, the plug (24) has a coupling groove (24a) extending from a hole into which the outlet (23) is inserted, and the outlet (23) has a coupling protrusion (23a) provided on the side so as to be engaged with the coupling groove (24a). In this case, the plug (24) can be coupled to the outlet (23) only in a specific direction, so that when normal coupling is achieved, a specific surface of the plug (24) faces the magnetic sensor (140). In this embodiment, it may be configured to detect the coupling of the plug (24) by attaching a magnetic body (27) to the specific surface and positioning it in contact with or close to the magnetic sensor (140).

[0068] In summary, the plug (24) coupled to the discharge port (23) according to the present embodiment has a coupling groove (24a) extending from the hole into which the discharge port (23) is inserted when coupled, and when the coupling with the discharge port (23) is normally completed, the plug (24) has a magnetic substance (27) attached to the area of ​​the surface facing the magnetic sensor (140), and the discharge port (23) coupled with the plug (24) is a discharge port (23) having a coupling protrusion (23a) provided on the side so as to be engaged with the coupling groove (24a) of the plug (24) coupled with the discharge port (23), and then, when the normal coupling of the discharge port (23) and the plug (24) is completed, an insulin syringe replacement system is provided in which the area of ​​the surface of the plug (24) facing the magnetic sensor (140) is specified. The present embodiment minimizes the use of a magnetic material to lower the production cost of the plug (24). Can be.

[0069] Meanwhile, the magnetic sensor (140) must be provided to notify the control unit (120) of the plug (24) engagement when a sufficiently strong magnetic field is detected. The insulin pump (10) is used by being attached to the user's body or clothing, and there may be cases where the user's clothing, watch, or mobile phone, etc. are magnetic. In this case, if the magnetic sensor (140) is not provided to notify the plug (24) engagement only when a sufficiently strong magnetic field is detected, the magnetic sensor (140) may detect the magnetic field generated from the user's object and notify the control unit (120) of the plug (24) engagement even when the plug (24) is not engaged. Therefore, the above-mentioned false alarm can be prevented by setting the sensing threshold of the magnetic sensor (140) sufficiently high.

[0070] Referring to FIG. 4, the initialization setting process after replacing the insulin syringe (20) of the insulin pump (10) to which the present invention is applied is described as follows.

[0071] First, the user correctly installs the syringe into the housing (130). Then, the user operates or inputs an initialization setting operation for the insulin pump (10). The control unit (120) that receives the input checks whether a stopper (24) connection notification has been received from the sensor unit (140).

[0072] When a notification is received, the control unit (120) causes the operation unit (110) to perform an initialization setting operation.

[0073] If no notification is received, the user is asked to connect the plug (24). This can be done in various ways, including through a display or voice notification. If the user then performs another operation or input to perform the initialization setting operation, the control unit (120) again confirms the connection of the plug (24).

[0074] Depending on whether the stopper (24) is connected or not, one of the two paths above is re-entered.

[0075] While the detailed description and accompanying drawings of the present invention have described specific embodiments, the present invention is not limited to the disclosed embodiments, and various substitutions, modifications, and changes are possible for those skilled in the art without departing from the technical spirit of the present invention. Therefore, the scope of the present invention should not be limited to the described embodiments, but should be interpreted to include not only the claims described below but also equivalents thereof.

Claims

1. A control unit for controlling the operation of the insulin pump; An operating unit that performs an initialization setting operation when replacing an insulin syringe under the control of the above control unit; A battery unit for providing power to the above control unit and operating unit; A housing portion for mounting an insulin syringe; and A sensor unit that checks whether the stopper of the insulin syringe mounted on the housing unit is connected and notifies the control unit; The insulin syringe mounted on the housing part includes a cylinder for storing insulin, a discharge port provided at one end of the cylinder for discharging insulin, a stopper coupled to the discharge port to prevent the insulin stored in the cylinder from being discharged, a plunger gasket located at the other end of the cylinder so as to change the pressure inside the cylinder, and a plunger moving rod for advancing the plunger gasket by pushing it. The initialization setting operation performed by the above-mentioned operating unit is an operation in which the operating unit advances the plunger moving rod to reach the plunger gasket while the stopper is connected to the discharge port of the insulin syringe. The control unit controls the operating unit to perform an initial setting operation only after receiving a stopper connection notification of the insulin syringe mounted on the housing unit by the sensor unit, and recognizes the amount of insulin contained in the cylinder based on the movement distance or position of the plunger moving rod after the initial setting operation performed by the operating unit is completed. An insulin syringe replacement system applicable to insulin pumps.

2. In paragraph 1 The housing part includes a holder on which the discharge port of the equipped insulin syringe is mounted so that the discharge port is exposed to the outside of the insulin pump and a stopper can be connected. The above sensor part is a magnetic sensor and is positioned on the stand so as to detect the combination of the outlet and the plug. The plug that is connected to the outlet is provided with a magnetic field so that when the plug is connected to the outlet, the magnetic sensor detects the magnetic field lines of the plug and notifies the control unit. An insulin syringe replacement system applicable to insulin pumps.

3. In paragraph 2 The plug coupled to the outlet has a coupling groove extending from the hole into which the outlet is inserted when coupled, and is a plug in which a magnetic substance is attached to the area of ​​the surface facing the magnetic sensor when the coupling with the outlet is normally completed. The outlet that is combined with the plug is a discharge outlet that has a coupling projection that is provided on the side so that it can be combined by interlocking with the coupling groove of the plug that is combined with the discharge outlet. When the discharge port and the plug are normally connected, the area of ​​the surface of the plug facing the magnetic sensor is specified. An insulin syringe replacement system applicable to insulin pumps.

Images