Interlocking drug infusion device

Abstract

This invention discloses an interlocking drug infusion device, comprising a drug reservoir for containing drugs, a piston and a screw disposed within the reservoir; a drive wheel connected to the screw, which drives the piston forward by rotating the drive screw; a drive unit that moves in the drive direction to drive the drive wheel to rotate; a driver electrically connected to the drive unit, which, when energized, provides power to the drive unit in the drive direction; a program module electrically connected to the driver, which provides a first drive instruction to control the driver to perform periodic power output; and a position detection module for determining the periodic drug infusion volume. When the drug infusion volume reaches a set threshold, the position detection module and / or the program module provide a second drive instruction to the driver. The program module and the position detection module physically form a synchronous interlocking mechanism to prevent over-infusion in the event of electronic component or preset program failure, thus preventing the risk of hypoglycemia or even coma.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims the benefit of and priority to PCT Patent Application No. PCT / CN2021 / 070207 filed January 5, 2021 and PCT Patent Application No. PCT / CN2021 / 117647 filed September 10, 2021. TECHNICAL FIELD

[0003] The present application relates generally to the field of medical devices, and more particularly to an interlocked drug infusion device. BACKGROUND

[0004] The pancreas in a normal human body can automatically monitor the glucose content in the human blood and automatically secrete the required insulin / glucagon. The pancreas of a diabetic patient is abnormal and cannot normally secrete the required insulin for the human body. Therefore, diabetes is a metabolic disease caused by abnormal function of the human pancreas, and diabetes is a lifelong disease. Current medical technology cannot cure diabetes, and can only control the occurrence and development of diabetes and its complications by stabilizing blood sugar.

[0005] A diabetic patient needs to detect blood sugar before injecting insulin into the body. Most current detection methods can continuously detect blood sugar and send blood sugar data to a remote device in real time for the user to view. This detection method is called continuous glucose monitoring (CGM). The method requires a detection device to be attached to the skin surface, and a probe carried by the detection device to be inserted into subcutaneous tissue fluid to complete the detection. According to the blood glucose value detected by the CGM, an infusion device inputs the required insulin into the subcutaneous tissue, thereby forming a closed loop or semi-closed loop artificial pancreas.

[0006] However, the traditional drug infusion device adopts a driving mode of a direct current motor combined with a reduction box and an encoder. Once the encoder fails, the entire drug infusion is completely out of control, thereby causing a potential risk of hypoglycemic coma caused by excessive infusion. The current drug infusion device adopts a driving mode of a control program controlling a linear driver. Once the control program or electronic components fail, the drug infusion is also completely out of control, thereby causing a potential risk of hypoglycemic coma.

[0007] Therefore, there is an urgent need in the prior art for a drug infusion device that can ensure infusion safety in the event of a control program or electronic component failure. SUMMARY

[0008] The embodiment of the present application discloses an interlocking drug infusion device, a program module provides a first driving instruction for controlling a driver to output power periodically, a position detection module is further arranged in the infusion device to determine a periodic drug infusion amount, and the position detection module and / or the program module provide a second driving instruction for the driver when the drug infusion amount reaches a set threshold. The program module and the position detection module physically form a synchronous interlocking mechanism to prevent over-infusion in the case of failure of electronic components or a preset program, and to cause the risk of hypoglycemia or even coma.

[0009] The present application discloses an interlocking drug infusion device, comprising a drug storage cartridge for containing a drug, a piston and a screw rod arranged in the drug storage cartridge; a driving wheel connected with the screw rod to drive the screw rod to push the piston to move forward by rotating; a driving unit moving in a driving direction to drive the driving wheel to rotate; a driver electrically connected with the driving unit, the linear driver after being electrified is used for providing power for the driving unit in the driving direction; a program module electrically connected with the driver, the program module provides a first driving instruction for controlling the driver to output power periodically; and a position detection module for determining a periodic drug infusion amount, and the position detection module and / or the program module provide a second driving instruction for the driver when the drug infusion amount reaches a set threshold.

[0010] According to an aspect of the present application, the infusion device further comprises an elastic component, the elastic component applies a restoring elastic force to the driving unit to reset the driving unit.

[0011] According to an aspect of the present application, the infusion device comprises two drivers, the two drivers alternately output power periodically.

[0012] According to an aspect of the present application, the driver is a linear driver.

[0013] According to an aspect of the present application, the linear driver is a shape memory alloy or a shape memory polymer.

[0014] According to an aspect of the present application, the first driving instruction comprises an electrification time T1 and a de-energization time T2, the de-energization time T2 is not less than the shortest time t required for the linear driver to recover deformation.

[0015] According to an aspect of the present application, the second driving instruction comprises a de-energization time T3, the de-energization time T3 is not less than the shortest time t required for the linear driver to recover deformation.

[0016] According to an aspect of the present application, after the de-energization time T3 ends, the first driving instruction replaces the second driving instruction.

[0017] According to an aspect of the present application, after the de-energization time T3 ends, the first driving instruction does not replace the second driving instruction.

[0018] According to one aspect of the present invention, the position detection module includes a position detection element, wherein the detection element detects the position of the piston in a non-contact detection manner.

[0019] According to one aspect of the invention, the position detection element is a magnetic element.

[0020] According to one aspect of the invention, a position detection element is disposed at the piston or screw or the connection between the screw and the piston.

[0021] According to one aspect of the invention, a position detection element is disposed in a piston, and at least one recess is provided in the piston for accommodating the position detection element.

[0022] According to one aspect of the invention, a plurality of protrusions are provided in the recess for fixing the position detection element.

[0023] According to one aspect of the invention, a positioning part is further provided in the recess for further fixing the position detection element.

[0024] According to one aspect of the present invention, the infusion device includes a control structure and an infusion structure, a drug reservoir, a drive wheel, a drive unit and a driver are disposed on the infusion structure, and a program module and a position detection module are disposed on the control structure.

[0025] According to one aspect of the invention, the control structure and the infusion structure are separate structures, and the control structure is reusable.

[0026] According to one aspect of the invention, the control structure and the infusion structure are an integral structure, and are discarded as a whole after use.

[0027] The present invention also discloses an artificial pancreas, including an interlocked drug infusion device and a detection structure for continuously detecting blood glucose level parameters, which is connected to or integrated with the control structure and infusion structure of the infusion device.

[0028] According to one aspect of the invention, two of the detection structure, control structure, and infusion structure are interconnected or integrated to form a single integral structure, and are respectively attached to a third structure at different locations on the skin.

[0029] According to one aspect of the invention, the detection structure, control structure, and infusion structure are connected or integrated into a single integral structure and are adhered to the same location on the skin.

[0030] Compared with the prior art, the technical solution of the present invention has the following advantages:

[0031] In the drug infusion device disclosed in this invention, the program module provides a first drive instruction to control the driver to perform periodic power output. The infusion device also includes a position detection module for determining the drug infusion volume. When the drug infusion volume reaches a set threshold, the position detection module and / or the program module provide a second drive instruction to the driver. The program module and the position detection module physically form a synchronous interlocking mechanism to prevent over-infusion in the event of electronic component or preset program failure, which could lead to hypoglycemia or even coma.

[0032] Furthermore, the program module and the position detection module can form an interlock mechanism in various ways to ensure that over-infusion will not occur in the event of failure of electronic components or control program, thus preventing the risk of hypoglycemia or even coma. For example, when the predetermined threshold is the normal drug infusion amount within time T1, the position detection module and / or program module control the linear driver to power off for time T3, after which the second drive indicator is replaced by the first drive indicator, and the linear driver can perform periodic power output normally according to the preset program; when the predetermined threshold exceeds the normal drug infusion amount within time T1, the position detection module and / or program module control the linear driver to power off for time T3, after which the second drive indicator is no longer replaced by the first drive, that is, the linear driver terminates periodic power output and stops drug infusion.

[0033] Furthermore, in the first drive instruction of the program module, the power-off time of the linear driver in each cycle is greater than the minimum time required for the linear driver to recover its deformation. In the second drive instruction, the power-off time of the linear driver is also greater than the minimum time required for the linear driver to recover its deformation. Both of these measures ensure that the linear driver can enter the next deformation state only after it has fully recovered to its initial state.

[0034] Furthermore, the elastic component applies a restoring force to the drive unit, and the elastic component cooperates with the linear actuator to cause the drive unit to reciprocate. The elastic component enables the drive unit to automatically reset without consuming electrical energy, thus reducing the power consumption of the infusion device.

[0035] Furthermore, the position detection element can be flexibly set at one or more locations on the piston, screw, or piston-screw connection according to the actual structure, thereby optimizing the internal design of the infusion structure.

[0036] Furthermore, the piston is provided with a recess, and the recess is provided with a protrusion and a positioning part to accommodate and fix the position detection element, which can prevent the detection element from shaking and causing deviation in the sensing information, thus affecting the detection result. Attached Figure Description

[0037] Figures 1a-1b These are top views of drug infusion systems according to two different embodiments of the present invention;

[0038] Figures 2a-2bThis is a three-dimensional structural diagram of a control structure according to an embodiment of the present invention;

[0039] Figure 3a This is a three-dimensional structural diagram of an infusion structure according to an embodiment of the present invention;

[0040] Figure 3b This is a side view of the control structure and the infusion structure being assembled together according to an embodiment of the present invention;

[0041] Figure 3c This is a top view of the lower housing of the infusion structure according to an embodiment of the present invention;

[0042] Figure 3d This is a top view of the lower housing of the infusion structure according to another embodiment of the present invention;

[0043] Figure 4a This is a three-dimensional structural diagram of an infusion structure according to an embodiment of the present invention;

[0044] Figure 4b This is a three-dimensional structural diagram of the internal structure of the infusion structure according to another embodiment of the present invention;

[0045] Figure 4c This is a three-dimensional structural schematic diagram of the internal structure of the infusion structure according to another embodiment of the present invention;

[0046] Figure 5 This is a schematic diagram of the relationship between artificial pancreas modules according to an embodiment of the present invention. Detailed Implementation

[0047] As mentioned above, existing drug infusion devices use a control program to control the linear actuator. If the control program or electronic components fail, the drug infusion may become completely out of control, potentially leading to hypoglycemic coma.

[0048] To address this problem, the present invention provides a drug infusion device. A program module provides a first drive instruction to control the actuator to perform periodic power output. The infusion device also includes a position detection module for determining the drug infusion volume. When the drug infusion volume reaches a set threshold, the position detection module and / or the program module provide a second drive instruction to the actuator. The program module and the position detection module physically form a synchronous interlocking mechanism to prevent over-infusion in the event of electronic component or preset program failure, thus preventing the risk of hypoglycemia or even coma.

[0049] Various exemplary embodiments of the present invention will now be described in detail with reference to the accompanying drawings. It should be understood that, unless otherwise specifically stated, the relative arrangement, numerical expressions, and values ​​of the components and steps set forth in these embodiments should not be construed as limiting the scope of the invention.

[0050] Furthermore, it should be understood that, for ease of description, the dimensions of the various components shown in the accompanying drawings are not necessarily drawn to actual scale; for example, the thickness, width, length, or distance of some units may be enlarged relative to other structures.

[0051] The following description of exemplary embodiments is merely illustrative and is not intended to limit the invention or its application or use in any way. Techniques, methods, and apparatus known to those skilled in the art may not be discussed in detail herein, but where applicable, such techniques, methods, and apparatus should be considered part of this specification.

[0052] It should be noted that similar reference numerals and letters in the following figures indicate similar items; therefore, once an item is defined or described in a figure, it will not need to be discussed further in the subsequent description of the figures.

[0053] Figures 1a-1b This is a top view of a drug infusion apparatus according to two different embodiments of the present invention.

[0054] The interlocking drug infusion device of this invention comprises two parts: a control structure 100, an infusion structure 110, and an adhesive patch 120. These structures will be described separately below. In other embodiments of this invention, the interlocking drug infusion device may include more parts, and no specific limitations are set herein.

[0055] In this embodiment of the invention, the control structure 100 and the infusion structure 110 are separate designs, connected by a waterproof plug or directly snapped together and electrically connected to form a whole. Directly snapping together and electrically connecting the control structure 100 and the infusion structure 110 to form a whole improves the reliability of the electrical connection, as will be detailed below. The control structure 100 is reusable, while the infusion structure 110 is disposable after single use. Figure 1a As shown. In another embodiment of the invention, the infusion structure 110 and the control structure 100 are an integrated design, connected by wires, and housed inside the same housing 10. They are attached to a specific location on the user's skin using an adhesive patch 120, and are disposable after single use. Figure 1b As shown.

[0056] The interlocked drug infusion device of this invention includes a control structure 100. The control structure 100 receives signals or information from a remote device or a body fluid parameter detection device (such as a continuous glucose monitoring device), and then controls the infusion device to complete drug infusion. The housing 101 of the control structure 100 houses a program module, circuit board, and related electronic components for receiving signals or issuing control commands, as well as other physical components or structures necessary to realize the infusion function, which are not specifically limited here. In some embodiments of this invention, a power supply is also provided in the control structure. In this embodiment, the power supply 133 is located in the infusion structure 110, as described below.

[0057] Figures 2a-2b This is a three-dimensional structural diagram of the control structure 100 according to an embodiment of the present invention.

[0058] The control structure 100 also includes a plurality of first electrical contacts 103 exposed on the surface of the control structure 100. The first electrical contacts 103 serve as circuit connection terminals, used to electrically connect the internal circuits disposed in the control structure 100 and the infusion structure 110 respectively. This embodiment of the invention does not impose specific limitations on the location of the first electrical contacts 103. Compared to connection terminals configured as plug-in connectors, electrical contacts have a smaller contact area, allowing for flexible design and effectively reducing the volume of the control structure. Simultaneously, electrical contacts can be directly electrically connected to internal circuits or electrical components, or can be directly soldered onto a circuit board, optimizing the design of the internal circuits and effectively reducing circuit complexity, thus saving costs and reducing the volume of the infusion device. Furthermore, the electrical contacts being exposed on the surface of the control structure 100 facilitates mutual electrical connection with connection terminals on other structures. The above-mentioned technical advantages of the electrical contacts apply to the first electrical contacts 103 on the control structure 100 and the second electrical contacts 113 on the infusion structure 110, which will not be described in detail below.

[0059] The first electrical contact 103 may be a rigid metal contact or an elastic conductive element. Preferably, in this embodiment of the invention, the first electrical contact 103 is a rigid metal contact. One end of the first electrical contact 103 is electrically connected to a connection terminal disposed inside the control structure 100, and the other end is exposed on the surface of the housing 101. The remaining portion of the first electrical contact 103 is tightly embedded in the housing 101 to isolate the interior of the control structure 100 from the outside.

[0060] Here, the elastic conductive element includes a conductive spring, conductive silicone, conductive rubber, or conductive sheet, etc. Clearly, one end of the elastic conductive element is used for electrical connection with a connection terminal inside the control structure 100, and the other end is used for electrical connection with other connection terminals. For example, in one embodiment of the invention, the first electrical contact 103 is a conductive spring. When the electrical contacts come into contact with each other, the elasticity of the conductive spring enhances the reliability of the electrical connection. Similar to rigid metal contacts, except for one end exposed on the surface of the housing 101, the other part of the conductive spring is tightly embedded in the housing 101 and electrically connected to the internal circuitry or electrical components. Clearly, the connection terminal located inside the control structure 100 can be a conductive lead or a specific part of a circuitry or electrical component.

[0061] It should be noted that, in this embodiment of the invention, "tightly embedded" means that there is no gap between the electrical contacts and the housing 101, thereby achieving a seal on the interior of the control structure 100. The term "tightly embedded" will be used in the following text for the same purpose.

[0062] In another embodiment of the present invention, the first electrical contact 103 is a conductive spring, but it is not tightly embedded in the housing 101. Instead, a sealing element is provided around the area where the first electrical contact 103 is located. The sealing element is located in a groove to achieve sealing of the electrical connection position and the interior of the control structure 100.

[0063] In an embodiment of the present invention, the control structure 100 is further provided with a first engaging portion 102. The first engaging portion 102 is used to engage with the second engaging portion 112 of the infusion structure 110, so as to realize the mutual assembly of the control structure 100 and the infusion structure 110, thereby making the first electrical contact 103 and the second electrical contact 113 electrically connected, which will be described in detail below.

[0064] The first engaging part 102 and the second engaging part 112 include one or more of the following: hooks, blocks, holes, and slots that can engage with each other. Their positions can be flexibly designed according to the shape and structure of the control structure 100 and the infusion structure 110, such as being located inside or on the surface of the corresponding structure. No specific restrictions are imposed here.

[0065] In this embodiment of the invention, the control structure 100 is further provided with a recess 104 for mutual assembly with the protrusion 114 at the bottom of the infusion structure 110 housing, as will be described in detail below. Specifically, the first electrical contact 103 is disposed within the recess 104, such as... Figure 2b As shown.

[0066] In this embodiment of the invention, a buzzer (not shown) is also provided within the control structure 100. The buzzer is used to emit sound, vibration, or other alarm signals in situations such as the start or end of infusion, malfunction of the infusion device, depletion of medication, issuance of erroneous commands by the control structure 100, or receipt of erroneous information, so that the user can be aware of the situation and make timely adjustments.

[0067] In this embodiment of the invention, the outer casing 101 of the control structure 100 is provided with a sound-permeable hole 105 to facilitate the transmission of the buzzer's audible alarm signal. To achieve a good sealing effect and ensure the normal operation of the buzzer, a waterproof and sound-permeable membrane (not shown) is provided between the sound-permeable hole 105 and the buzzer. Therefore, the waterproof and sound-permeable membrane needs to have a certain porosity to prevent water molecules from entering the buzzer while ensuring that the sound is transmitted.

[0068] Compared with the traditional technical solution of enclosing the buzzer inside the control structure 100, the sound-transmitting hole 105 allows the buzzer to be heard by the user with a smaller sound, reducing the energy consumption of the buzzer, optimizing the power consumption configuration of the infusion device, and saving production costs.

[0069] Figure 3a This is a three-dimensional structural diagram of the infusion structure 110 according to an embodiment of the present invention. Figure 3b This is a side view of the control structure 100 and the infusion structure 110 being assembled together according to an embodiment of the present invention. Figure 3c This is a top view of the lower housing of the infusion structure according to an embodiment of the present invention. Figure 3d This is a top view of the lower housing of the infusion structure according to another embodiment of the present invention.

[0070] The interlocked drug infusion device also includes an infusion structure 110. Its housing contains an infusion module, a circuit module, and other auxiliary modules for completing drug infusion, which will be described in detail below. The housing of the infusion structure 110 may include multiple parts. For example, in this embodiment of the invention, the housing of the infusion device includes an upper housing 111a and a lower housing 111b.

[0071] As described above, in this embodiment of the invention, the infusion structure 110 is provided with a second engaging portion 112. The second engaging portion 112 is used to engage with the first engaging portion 102. Therefore, the positions of the first engaging portion 102 and the second engaging portion 112 correspond to each other.

[0072] In this embodiment of the invention, the infusion structure 110 is provided with a second electrical contact 113. The second electrical contact 113 is used to press against the corresponding first electrical contact 103 to achieve electrical connection between the control structure 100 and the infusion structure 110. The pressing between two electrical contacts of different structures can improve the reliability of the electrical connection. Similar to the first electrical contact 103, the type of the second electrical contact 113 also includes a rigid metal contact or an elastic conductive element. Specifically, in this embodiment of the invention, the second electrical contact 113 is a conductive spring. Similarly, the conductive spring can improve the electrical connection performance. A groove is also provided around the area where the second electrical contact 113 is provided, and a sealing element 115 is provided in the groove.

[0073] Preferably, in this embodiment of the invention, the two ends of the conductive spring have different diameters, with a shorter diameter exposed outside the infusion structure 110 and a longer diameter inside the infusion structure 110. The longer diameter can keep the conductive spring inside the housing. Therefore, when the control structure 100 is not installed on the infusion structure 110, the longer diameter can prevent the conductive spring from falling off the infusion structure 110.

[0074] The embodiments of the present invention do not limit the position of the second electrical contact 113, as long as it can be electrically connected to the corresponding first electrical contact 103. Specifically, in the embodiments of the present invention, the bottom of the upper housing 111a of the infusion structure 110 includes a protrusion 114. The second electrical contact 113 is disposed on the protrusion 114, such as... Figure 3a As shown, the protrusion 114 corresponds to the recess 104 on the control structure 100, and the two can be assembled together so that the first electrical contact 103 and the corresponding second electrical contact 113 are pressed against each other, thereby realizing electrical connection.

[0075] In other embodiments of the present invention, the protrusion 114 may be disposed on the lower housing 111b, or when the housing of the infusion structure 110 is an integral unit, the protrusion 114 may be part of the integral housing, and no specific limitation is made here.

[0076] The control structure 100 and the infusion structure 110 are assembled in several ways, including pressing the control structure 100 onto the infusion structure 110 along its thickness direction, so that the first engaging portion 102 and the second engaging portion 112 engage with each other; or pressing the control structure 100 onto the infusion structure 110 along its length direction; or pressing the control structure 100 at any angle between the thickness direction and the length direction of the infusion structure 110, so that the first engaging portion 102 and the second engaging portion 112 engage with each other. Preferably, in this embodiment of the invention, the control structure 100 and the infusion structure 110 are assembled in such a way that the control structure 100 is pressed onto the infusion structure 110 along its thickness direction, so that the first engaging portion 102 and the second engaging portion 112 engage with each other, such as... Figure 3b The installation direction is shown.

[0077] In this embodiment of the invention, the lower housing 111b of the infusion structure 110 includes an outwardly extending portion 116, and a blocking block 117 is provided on the outer side of the extending portion 116, such as... Figure 3a As shown. As described above, when the control structure 100 is pressed to the engaged position along the thickness direction of the infusion structure 110, the blocking block 117 prevents the control structure 100 from falling off along the length direction of the infusion structure 110, ensuring the normal operation of the infusion device. Obviously, in other embodiments of the present invention, if the control structure 100 is pressed to the engaged position in other directions, adjusting the position of the blocking block 117 can also prevent the control structure 100 from falling off the infusion structure 110.

[0078] It should be noted here that "outward" and "outer side" are relative to the main body of the infusion structure 110, and are relative positional concepts. The positional relationship is as follows: Figure 3a or Figure 3b As shown. The meaning of "outer side" in the following text is the same as here.

[0079] In this embodiment of the invention, a pressing part 118 is also provided at the outer end of the extension 116 to release the blocking effect of the blocking block 117. When the user replaces the infusion structure 110, pressing the pressing part 118 with a finger will release the blocking block 117 from the control structure 100. The user can then use two fingers to remove the control structure 100 from the infusion structure 110.

[0080] This embodiment of the invention may also include an unlocking hole 119. The unlocking hole 119 is located inside the blocking block 117. While pressing the pressing part 118, the index finger can smoothly enter the unlocking hole 119, thereby pushing out the control structure 100 and separating the control structure 100 from the infusion structure 110. In this embodiment, the unlocking hole 119 is square. The square unlocking hole 119 facilitates easy finger entry. In other embodiments of the invention, the unlocking hole 119 may also be of other shapes, and no specific limitation is made here.

[0081] The lower housing 111b of the infusion structure 110 is also provided with a crease groove 140. The crease groove 140 is located on both sides of the unlocking hole 119, such as... Figure 3c and Figure 3d As shown. After setting the crease groove 140, the thickness or width of the lower housing 111b at the position of the crease groove 140 (e.g.) Figure 3c and Figure 3d As indicated by the middle arrow, the lower housing 111b is thinned so that when the user presses the pressing part 118, it can be easily broken at the crease groove 140, thus more smoothly releasing the obstruction of the blocking block 117 on the control structure 100.

[0082] Preferably, in this embodiment of the invention, the crease grooves 140 are disposed at both ends of the blocking block 117, such as... Figure 3c As shown. In another embodiment of the invention, the crease groove 140 is provided on one side of the two corresponding sides of the unlocking hole 119, as shown. Figure 3d As shown.

[0083] The infusion structure 110 of this embodiment of the invention is further provided with an infusion needle unit 121 for infusing drugs subcutaneously.

[0084] The bottom of the lower housing 111b of the infusion structure 110 is also provided with an adhesive patch 120 for attaching the infusion device to the user's skin surface.

[0085] Figure 4a These are three-dimensional structural schematic diagrams of the infusion structure 110 according to an embodiment of the present invention. Figure 4b This is a three-dimensional structural diagram of the internal structure 130 of the infusion structure 110 according to another embodiment of the present invention.

[0086] In this embodiment of the invention, the internal structure 130 includes mechanical units and electrical control units for performing the infusion function, such as a drug reservoir 131, a drug outlet 132, a power supply 133, drive wheels 134a and 134b, a screw 135, a piston 136, a drive unit 1310, and a main frame 137 supporting these components. The drug reservoir 131 is used to contain drugs, including but not limited to insulin, glucagon, antibiotics, nutrient solutions, analgesics, anticoagulants, gene therapy drugs, cardiovascular drugs, or chemotherapy drugs. A piston 136 and a screw 135 are disposed within the drug reservoir 131. The piston is used to infuse the drug into the body. The screw 135 is connected to the piston, thereby pushing the piston forward to achieve the purpose of drug infusion. The screw 135 can be a rigid screw or a flexible screw.

[0087] In one embodiment of the present invention, the driving unit 1310 includes two driving arms 1310a and 1310b, such as... Figure 4a As shown, drive wheels 134a and 134b are provided with teeth, and both drive arms can move forward by the teeth. The main frame 137 is also provided with a rotating shaft 138. The power unit 139 is electrically connected to the drive unit 1310 and includes power components 139a and 139b. When the program module in the control structure 100 controls the power component 139b to rotate clockwise around the rotating shaft 138, the drive arm 1310a of the drive unit 1310 pushes the teeth of the drive wheel 134a forward. The drive wheels 134a and 134b rotate synchronously, the drive screw 135 moves forward, the infusion device performs drug infusion, and the drive arm 1310b slides on the surface of the drive wheel 134b to complete the reset. When the program module in the control structure 100 controls the power component 139a to rotate counterclockwise around the rotating shaft 138, the drive arm 1310b of the drive unit 1310 pushes the teeth of the drive wheel 134b forward. The drive wheels 134a and 134b rotate synchronously, and the infusion device infuses the drug. Meanwhile, the drive arm 1310a slides on the surface of the drive arm 134a to complete the reset.

[0088] In this embodiment of the invention, power components 139a and 139b are actuators, specifically, electrically driven linear actuators or electrically heated linear actuators; more specifically, power components 139a and 139b are shape memory alloys or shape memory polymers. Upon energization, the physical state of the linear actuator material changes, causing the linear actuator to contract and deform, outputting power to rotate the drive unit 1310. The greater the current, the greater the contraction deformation of the linear actuator within a limited time, and the greater the power. Clearly, when the current is constant, the contraction deformation of the linear actuator remains unchanged within a limited time, and the driving force output by the linear actuator is constant. After power component 139a or 139b completes one drive cycle within time T1, the program module controls power component 139a or 139b to be de-energized for time T2, so that power component 139a or 139b returns to its initial state from the deformed state. Therefore, in this embodiment of the invention, the program module is preset with a first drive instruction to control the power component 139a or 139b to perform periodic power output. The power component 139a or 139b is energized for a predetermined time T1 and de-energized for a predetermined time T2. The energizing and de-energizing are performed alternately, and the de-energizing time T2 is greater than the shortest time t required for the linear actuator to recover its deformation. This ensures that the linear actuator can fully recover to its initial state within the time of the de-energizing time T2, and avoids inaccurate infusion caused by the linear actuator not fully recovering to its initial state before entering the next cycle in one cycle.

[0089] Obviously, when power component 139a deforms during the energizing time T1, power component 139b is within the de-energizing time T2. Conversely, when power component 139b deforms during the energizing time T1, power component 139a is within the de-energizing time T2. That is, in the first drive instruction of the program module, power components 139a and 139b are alternately energized and de-energized. The energizing time of power component 139a is the de-energizing time of power component 139b, and the de-energizing time of power component 139a is the energizing time of power component 139b. In order to ensure that the linear actuator can fully recover to the initial state during the de-energizing time T2, the energizing time T1 and the de-energizing time T2 of power components 139a and 139b are both greater than the shortest time t required for the linear actuator to recover its deformation. In this embodiment of the invention, the relationship between the energizing time T1 and the de-energizing time T2 is not limited. For example, in one embodiment of the invention, in order to achieve stable infusion of the infusion device, the energizing time of the power components 139a and 139b is equal when the voltage or current applied to the power components 139a and 139b is constant and equal. In another embodiment of the invention, also in order to achieve stable infusion of the infusion device, a constant but unequal voltage or current can be applied to the power components 139a and 139b. In this case, stable infusion is achieved by adjusting the energizing time of the power components 139a and 139b.

[0090] The power components 139a and 139b can be made of a single continuous shape memory alloy or shape memory polymer, or two segments of shape memory alloy or shape memory polymer. No specific restrictions are imposed here, as long as the conditions for driving the unit 1310 to rotate when a force is applied are met.

[0091] In another embodiment of the present invention, the driving unit 1310 includes only one driving arm 1310a, such as... Figure 4b As shown, when the first drive instruction of the program module controls the power component 139a to rotate counterclockwise around the shaft 138, the drive arm 1310a pushes the teeth of the drive wheel 134a forward. The drive wheels 134a and 134b rotate synchronously, driving the screw 135 to move forward, and the infusion device performs drug infusion. At this time, the power component 139a is a linear actuator, specifically, a shape memory alloy or shape memory polymer, and the power component 139b is an elastic component. The elastic component generates gradually increasing elastic force. When the program module controls the power component 139a to be energized for time T1 and then de-energized for time T2, the power component 139a stops providing power, and the drive arm 1310a of the drive unit 1310 rotates clockwise around the shaft 160 under the elastic force of the power component 139b. The drive arm 1310a stops pushing the teeth of the drive wheel 134a, the drive wheels 134a and 134b stop rotating, the screw 135 stops moving forward, and the infusion device does not perform drug infusion. The drive end 1310a slides and resets on the tooth surface of the drive wheel 134a until the drive unit 1310 stops rotating. In this embodiment of the invention, the types of elastic components include, but are not limited to, compression springs, tension springs, torsion springs, spring sheets, elastic plates, elastic rods, and elastic rubber. The elastic components can automatically spring the drive unit 1310 back to its original position without the aid of external force, eliminating the need for electrical energy consumption and reducing the power consumption of the infusion device. Specifically, in this embodiment of the invention, the elastic component 139b is a torsion spring. Torsion springs are more conducive to the reset of the drive unit 1310.

[0092] Similarly, in this embodiment of the invention, the program module provides a first drive instruction for controlling the power component 139a to perform periodic power output. Specifically, the power component 139a is energized for a predetermined time T1 and de-energized for a predetermined time T2. The energizing and de-energizing are performed alternately, and the de-energizing time T2 is greater than the shortest time t required for the linear actuator to recover its deformation. This ensures that the linear actuator can fully recover to its initial state within the time of the de-energizing time T2, and avoids inaccurate infusion caused by the linear actuator failing to fully recover to its initial state before entering the next cycle in one cycle.

[0093] To prevent the linear actuator from remaining energized for extended periods due to electronic component or control program failures, i.e., prolonged deformation, which could lead to drug over-infusion, hypoglycemia, or even coma due to deformation exceeding a predetermined length, or permanent deformation exceeding its tolerance limit and causing complete failure of the infusion device, this embodiment of the invention includes a position detection module operably connected to the control structure for periodically determining the drug infusion volume. The position detection module includes a detection circuit (not shown) and at least one position detection element 1361. The detection circuit is located within the control structure, and the position detection element 1361 is located within the infusion structure 110. The detection circuit and the at least one position detection element 1361 cooperate to provide the necessary signals, data, or information for analysis and processing to determine the drug infusion volume. When the drug infusion volume within a cycle reaches a set threshold, the position detection module and / or the program module provide a second drive indication to the actuator. This second drive indication controls the linear actuator to be de-energized for a time T3. It should be noted that when the drug infusion volume in a cycle reaches the set threshold, the position detection module and / or the program module provides a second drive indication to the driver. This means that when the drug infusion volume in a cycle reaches the set threshold, the position detection module or the program module can provide a second drive indication to the driver independently, or the position detection module and the program module can jointly provide a second drive indication to the driver.

[0094] For example, in one embodiment of the present invention, the predetermined threshold is equal to the normal drug infusion volume of the drug infusion device within time T1. When the drug infusion volume within a cycle detected by the position detection module reaches the set threshold, the position detection module provides a second drive indication, that is, controls the linear actuator to be powered off for time T3. After that, the second drive indication is replaced by the first drive indication, and the linear actuator can perform periodic power output normally according to the preset program, thus preventing drug over-infusion and hypoglycemic coma in advance. In another embodiment of the present invention, when the drug infusion volume within a cycle detected by the position detection module reaches the set threshold, the program module provides a second drive indication to control the linear actuator to be powered off for time T3. In yet another embodiment of the present invention, when the drug infusion volume within a cycle detected by the position detection module reaches the set threshold, the position detection module and the program module provide a second drive indication simultaneously to control the linear actuator to be powered off for time T3.

[0095] In another embodiment of the present invention, if a predetermined threshold is greater than the normal drug infusion rate of the drug infusion device within time T1, when the drug infusion rate within a cycle detected by the position detection module reaches the set threshold, the position detection module and / or the program module provide a second drive indication to control the linear actuator to cut off power for time T3. Afterward, the second drive indication will not be replaced by the first drive indication; that is, the linear actuator will terminate its periodic power output and will no longer perform drug infusion, thus avoiding the risk of hypoglycemic coma due to over-infusion. The significance of the second drive indication provided by the position detection module and / or the program module is as described above and will not be repeated here.

[0096] It should be noted that the power outage time T3 is not less than the shortest time t required for the linear actuator to recover its deformation, ensuring that the linear actuator can fully recover to its initial state before entering the next deformation state.

[0097] In this embodiment of the invention, the position detection element 1361 is disposed in the piston 136. In other embodiments of the invention, the position detection element 1361 may also be disposed in other components of the infusion structure 110, such as one or more positions of the screw 135, the joint between the screw 135 and the piston 136, etc., without limitation, and can be flexibly set according to the actual layout to optimize the internal design of the infusion structure. During drug infusion, the position detection element 1361 detects the axial (along the direction of movement of the screw 135) position change of the piston 136 or the end of the screw 135 in the drug reservoir 131. The detection circuit converts the axial position information of the piston 136 or the end of the screw 135 within the energization time T1 into drug infusion volume information. The position detection module receives the drug infusion volume information. When the drug infusion volume information is equal to a predetermined threshold, the program module and / or the position detection module controls the linear driver to be de-energized for time T3.

[0098] Preferably, in this embodiment of the invention, the position detection element detects the position of the piston 136 or screw 135 end in a non-contact detection method. The position detection element is a magnetic element used to provide a magnetic field. The detection circuit is provided with a magnetic sensing element. The magnetic field strength sensed by the magnetic sensing element changes with the position of the magnetic element, i.e., the piston 136 or screw 135 end. Therefore, by sensing the change in the magnetic field, the detection circuit can calculate the position change of the piston 136 or screw 135 end and further convert it into drug infusion information within the cycle.

[0099] Preferably, in this embodiment of the invention, the detection element 1361 is disposed in the piston 136, and the piston 136 is provided with at least one recess 1362 for accommodating the detection element 1361. The inner side of the recess 1362 is also provided with a plurality of protrusions 1363 for fixing the position detection element 1361. The recess 1362 is also provided with a positioning part 1364 in the middle to further fix the position detection element 1361 and prevent the position detection element 1361 from shaking and causing deviation in the sensing information, thus affecting the detection result.

[0100] In this embodiment of the invention, the power supply 133 is a conventional button cell battery. In other embodiments of the invention, the power supply 133 can also be other types of batteries, as long as they can meet the requirements of supplying power to the infusion device. Preferably, in this embodiment of the invention, the power supply 133 is a dual-row battery, that is, two rows of batteries are respectively arranged on both sides of the drive wheel 134, such as... Figure 4c As shown. Conventionally, button cells have low discharge capacity. Using a dual-row design reduces the discharge level of each cell, extending battery life. Furthermore, the dual-row design of the power supply 133 fully utilizes the internal space of the infusion device, improving the integration of the internal structure.

[0101] In this embodiment of the invention, the infusion structure 110 also includes a circuit board or a three-dimensional circuit coated on part of the structural surface for supplying power to specific structural units. Depending on the internal structural characteristics of the infusion device, the shape and position of the three-dimensional circuit can be flexibly designed to fully utilize the internal space of the infusion structure, resulting in a more compact structure. The circuit board can be a rigid circuit board or a flexible circuit board. Preferably, in this embodiment of the invention, the circuit board is a flexible circuit board. The flexible circuit board is malleable and its shape can be flexibly designed according to the internal space of the infusion structure 110. Simultaneously, multiple connection terminals can be provided on the flexible circuit board to electrically connect with different second electrical contacts 113, thereby connecting the control structure 100 and the infusion structure 110, enabling the infusion device to perform its normal infusion function.

[0102] The infusion structure 130 also contains an elastic conductor 1311. The elastic conductor 1311 is electrically connected to the power supply 133 and specific connection terminals on the circuit board (or three-dimensional circuit), thereby enabling power supply to specific structural units. The elastic conductor 1311 has protrusions, which can enhance the stability of the electrical connection between the elastic conductor and the power supply and the specific connection terminals on the circuit board or three-dimensional circuit, and improve the reliability of the electrical connection.

[0103] Figure 5 This is a schematic diagram of the relationship between artificial pancreas modules according to an embodiment of the present invention.

[0104] One embodiment of the present invention provides an artificial pancreas comprising the power-integrated infusion device described in the preceding embodiments, and further comprising a detection structure 340 connected to or integrated with the control structure 300 and the infusion structure 310 in the infusion device, for continuously detecting the patient's real-time blood glucose level parameters. In this embodiment of the present invention, the detection structure 340 is a continuous glucose meter, capable of detecting blood glucose values ​​in real time, monitoring blood glucose changes, and sending real-time blood glucose data to the control structure 300.

[0105] The control mechanism 300 controls the infusion mechanism 310 and the detection mechanism 340. Specifically, the control mechanism 300 receives blood glucose parameter signals from the detection mechanism 340 and controls the detection process of the detection mechanism 340 and records the infusion information and operating status of the infusion mechanism 310. For example, if the blood glucose information detected by the detection mechanism 340 is inaccurate after its lifespan ends, the control mechanism 300 can issue a stop detection command to the detection mechanism 340. Furthermore, if insulin blockage occurs in the infusion mechanism 310, the control mechanism 300 can promptly record the blockage status and provide feedback to the patient, eliminating potential safety hazards. Therefore, the control mechanism 300 is connected to both the detection mechanism 340 and the infusion mechanism 310 (here, connection includes conventional electrical connection or wireless connection).

[0106] The infusion structure 310 includes the necessary mechanical structures for insulin infusion and is controlled by the control structure 300. Based on the current insulin infusion volume data issued by the control structure 300, the infusion structure 310 infuses the patient with the required amount of insulin. Simultaneously, the infusion structure 310 provides real-time feedback on the infusion status to the control structure 300.

[0107] The embodiments of the present invention do not limit the specific positions and connection or integration relationships of the detection structure 340, control structure 300 and infusion structure 310, as long as the aforementioned functional conditions can be met.

[0108] In one embodiment of the invention, the control structure 300 and the infusion structure 310 are interconnected or integrated to form a single structure, while the detection structure 340 is separately disposed in another structure. In this case, the detection structure 340 and the control structure 300 transmit wireless signals to each other to achieve interconnection. Therefore, the control structure 300 and the infusion structure 310 are attached to one location on the patient's skin, while the detection structure 340 is attached to other locations on the patient's skin.

[0109] In another embodiment of the invention, the control structure 300 and the detection structure 340 are interconnected or integrated to form a single device, while the infusion structure 310 is disposed separately in another structure. The infusion structure 310 and the control structure 300 transmit wireless signals to each other to achieve interconnection. Therefore, the control structure 300 and the detection structure 340 can be attached to one location on the patient's skin, while the infusion structure 310 can be attached to other locations on the patient's skin.

[0110] In another embodiment of the invention, the infusion structure 310 and the detection structure 340 are interconnected or integrated to form a single device, while the control structure 300 is separately disposed in another structure. The infusion structure 310, the detection structure 340, and the control structure 300 transmit wireless signals to each other to achieve interconnection. Therefore, the infusion structure 310 and the detection structure 340 can be attached to a location on the patient's skin, while the control structure 300 can be attached to other locations on the patient's skin or independently of the user, i.e., not attached to any location on the user's skin.

[0111] In one embodiment of the invention, the three components are connected or integrated to form a single structure. Therefore, all three are adhered to the same location on the patient's skin. By adhering the three modules to the same location, the number of devices that need to be applied to the patient's skin is reduced, thereby lessening the interference with the patient's movement caused by having too many devices. Simultaneously, it effectively solves the problem of poor wireless communication between separate devices, further enhancing the patient experience.

[0112] In another embodiment of the invention, the three components are disposed in different structures. Therefore, they are respectively attached to different locations on the patient's skin. In this case, the control structure 300 transmits wireless signals to the detection structure 340 and the infusion structure 310 to achieve interconnection.

[0113] It should be noted that the control structure 300 in this embodiment of the invention also has functions such as storage, recording, and database access; therefore, the control structure 300 can be reused. This not only allows for the storage of patient health data but also saves on production costs and patient costs. As mentioned above, when the detection structure 340 or the infusion structure 310 reaches the end of its lifespan, the control structure 300 can be separated from the detection structure 340, the infusion structure 310, or simultaneously from both.

[0114] Generally, the detection structure 340, control structure 300, and infusion structure 310 have different lifespans. Therefore, when the three are electrically connected to form a single device, they can also be separated into pairs. If one module reaches the end of its lifespan first, the patient can replace only that module while retaining the other two modules for continued use.

[0115] It should be noted that the control structure 300 in this embodiment of the invention may also include multiple sub-modules. Depending on the function of each sub-module, different sub-modules can be set in different structures; no specific limitations are imposed here, as long as their corresponding functional conditions are met.

[0116] It should be noted that the control structure 300 in this embodiment of the invention may also include multiple sub-modules. Depending on the function of each sub-module, different sub-modules can be set in different structures; no specific limitations are imposed here, as long as their corresponding functional conditions are met.

[0117] In summary, this invention discloses an interlocked drug infusion device and its artificial pancreas. The program module provides a first drive instruction to control the actuator for periodic power output. The infusion device also includes a position detection module to determine the periodic drug infusion volume. When the drug infusion volume reaches a set threshold, the position detection module and / or the program module provide a second drive instruction to the actuator. The program module and the position detection module physically form a synchronous interlocking mechanism to prevent over-infusion in the event of electronic component or preset program failure, thus avoiding the risk of hypoglycemia or even coma.

[0118] While specific embodiments of the invention have been described in detail by way of examples, those skilled in the art should understand that the above examples are for illustrative purposes only and are not intended to limit the scope of the invention. Those skilled in the art should understand that modifications can be made to the above embodiments without departing from the scope and spirit of the invention. The scope of the invention is defined by the appended claims.

Claims

1. An interlocked medication infusion device, characterized by, The injection device comprises: a cartridge for containing medicine, the cartridge being provided with a piston and a screw rod; a driving wheel connected with the screw rod, the driving wheel driving the screw rod to push the piston forward by rotating; a driving unit, the driving unit moving in a driving direction to drive the driving wheel to rotate; a driver electrically connected with the driving unit, the driver being used to provide power for the driving unit in the driving direction after being electrified; a program module electrically connected with the driver, the program module providing a first driving instruction for controlling the driver to output power periodically, the driver being a linear driver, the first driving instruction comprising an electrified time T1 and a de-energized time T2, the de-energized time T2 being not less than a time t required for the linear driver to recover deformation; and a position detection module for determining a periodic medicine injection amount, when the medicine injection amount in a period reaches a set threshold, the position detection module or the program module separately provides a second driving instruction for the driver, or the position detection module and the program module jointly provide the second driving instruction for the driver; the second driving instruction comprises a de-energized time T3, the de-energized time T3 being not less than the shortest time t required for the linear driver to recover deformation, after the de-energized time T3 ends, the second driving instruction is replaced by the first driving instruction to control the driver to normally output power periodically according to a preset program, or the second driving instruction is not replaced by the first driving instruction.

2. The interlocked medication infusion device of claim 1, wherein, The injection device further comprises an elastic component, the elastic component applying a restoring elastic force to the driving unit to reset the driving unit.

3. The interlocked medication infusion device of claim 1, wherein, The injection device comprises two drivers, the two drivers alternately output power periodically.

4. The interlocked medication infusion device of claim 1, wherein, The linear driver is a shape memory alloy or a shape memory polymer.

5. The interlocked medication infusion device of claim 1, wherein, The position detection module comprises a position detection element, the position detection element detecting the position of the piston by a non-contact detection method.

6. The interlocked medication infusion device of claim 5, wherein, The position detection element is a magnetic element.

7. The interlocked medication infusion device of claim 6, wherein, The position detection element is arranged on the piston or the screw rod or the connection between the screw rod and the piston.

8. The interlocked medication infusion device of claim 7, wherein, The position detection element is arranged in the piston, the piston being provided with at least one recess for accommodating the position detection element.

9. The interlocked medication infusion device of claim 8, wherein, The recess is provided with a plurality of protrusions for fixing the position detection element.

10. The interlocked medication infusion device of claim 9, wherein, The recess is further provided with a positioning portion for further fixing the position detection element.

11. The interlocked medication infusion device of claim 1, wherein, The injection device comprises a control structure and an injection structure, the cartridge, the driving wheel, the driving unit and the driver being arranged on the injection structure, the program module and the position detection module being arranged on the control structure.

12. The interlocked medication infusion device of claim 11, wherein, The control structure and the injection structure are a split structure, the control structure being reusable.

13. The interlocked medication infusion device of claim 11, wherein, The control structure and the injection structure are an integrated structure, the whole being discarded after use.

14. An artificial pancreas, comprising: The injection device comprises the interlocking injection device according to any one of claims 11-13, further comprising a detection structure for continuously detecting a blood glucose level parameter, the detection structure being connected with or integrated with the control structure and the injection structure of the injection device.

15. The artificial pancreas of claim 14, wherein, Two of the detection structure, the control structure and the infusion structure are connected or integrated into one whole structure, and the third structure is respectively pasted on different positions of the skin.

16. The artificial pancreas of claim 14, wherein, The detection structure, the control structure and the infusion structure are connected or integrated into one whole structure, and are pasted on the same position of the skin.

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