CN115779184A

CN115779184A - Interlocking type medicine infusion device

Info

Publication number: CN115779184A
Application number: CN202210079894.2A
Authority: CN
Inventors: 杨翠军
Original assignee: Medtrum Technologies Inc
Current assignee: Medtrum Technologies Inc
Priority date: 2021-09-10
Filing date: 2022-01-24
Publication date: 2023-03-14
Also published as: EP4398956A1

Abstract

The invention discloses an interlocking type drug infusion device, which comprises a drug storage cylinder, a piston and a screw rod, wherein the drug storage cylinder is used for containing drugs; the driving wheel is connected with the screw rod and pushes the piston to advance by rotating the driving screw rod; the driving unit moves in the driving direction to drive the driving wheel to rotate; the linear driver is electrically connected with the driving unit and used for providing power for the driving unit in the driving direction after being electrified; the program module is electrically connected with the driver and provides a first driving instruction for controlling the driver to carry out periodic power output; and a position detection module for determining a periodic volume of drug infusion, the position detection module and/or the program module providing a second actuation indication to the actuator when the volume of drug infusion reaches a set threshold. The program module and the position detection module physically form a synchronous interlocking mechanism, so that the risk of hypoglycemia and even coma caused by excessive infusion under the condition that the electronic components or the preset program fails is prevented.

Description

Interlocking type medicine infusion device

Cross Reference to Related Applications

This application claims the benefit and priority of the following patent applications: PCT patent applications filed on 5/1/2021 and having application numbers PCT/CN2021/070207 and on 10/9/2021 and having application numbers PCT/CN2021/117647.

Technical Field

The invention mainly relates to the field of medical instruments, in particular to an interlocking type drug infusion device.

Background

The pancreas in a normal human body can automatically monitor the glucose content in the blood of the human body and secrete the required insulin/glucagon automatically. The function of pancreas of diabetics is abnormal, and insulin required by human bodies cannot be normally secreted. Therefore, diabetes is a metabolic disease caused by abnormal pancreatic functions of a human body, and is a lifelong disease. At present, the medical technology can not cure the diabetes radically, and only can control the occurrence and the development of the diabetes and the complications thereof by stabilizing the blood sugar.

Diabetics need to test their blood glucose before injecting insulin into their body. At present, most detection means can continuously detect blood sugar and transmit blood sugar data to remote equipment in real time, so that a user can conveniently check the blood sugar data. The method needs the detection device to be attached to the surface of the skin, and the probe carried by the detection device is penetrated into subcutaneous tissue fluid to finish detection. According to the blood sugar value detected by the CGM, the infusion equipment subcutaneously inputs the currently required insulin so as to form a closed-loop or semi-closed-loop artificial pancreas.

However, the traditional drug infusion device adopts a driving mode of combining a direct current motor with a reduction box and an encoder, once the encoder fails, the whole drug infusion is completely out of control, so that the potential risk of hypoglycemia coma caused by excessive infusion is caused, the current drug infusion device adopts a driving mode of controlling a linear driver by a control program, and once the control program or electronic components fail, the drug infusion is also completely out of control, so that the potential risk of hypoglycemia coma is caused.

Accordingly, there is a need in the art for a drug infusion device that ensures infusion safety in the event of a failure of the control program or electronics.

Disclosure of Invention

The embodiment of the invention discloses an interlocking type drug infusion device, wherein a program module provides a first driving instruction for controlling a driver to carry out periodic power output, a position detection module is further arranged in the infusion device and used for determining the periodic drug infusion amount, and when the drug infusion amount reaches a set threshold value, the position detection module and/or the program module provides a second driving instruction for the driver. The program module and the position detection module physically form a synchronous interlocking mechanism, so that the risk of hypoglycemia and even coma caused by excessive infusion under the condition that the electronic components or the preset program fails is prevented.

The invention discloses an interlocking type drug infusion device, which comprises a drug storage cylinder, a piston and a screw rod, wherein the drug storage cylinder is used for containing drugs; the driving wheel is connected with the screw rod and pushes the piston to advance by rotating the driving screw rod; the driving unit moves in the driving direction to drive the driving wheel to rotate; the driver is electrically connected with the driving unit, and the electrified linear driver is used for providing power for the driving unit in the driving direction; the program module is electrically connected with the driver and provides a first driving instruction for controlling the driver to carry out periodic power output; and a position detection module for determining a periodic volume of drug infusion, the position detection module and/or the program module providing a second actuation indication to the actuator when the volume of drug infusion reaches a set threshold.

According to an aspect of the invention, the infusion set further comprises an elastic member that applies a return elastic force to the drive unit to reset the drive unit.

According to one aspect of the invention, the infusion device comprises two drivers that alternately perform a periodic power take-off.

According to one aspect of the invention, the driver is a linear driver.

According to one aspect of the invention, the linear actuator is a shape memory alloy or a shape memory polymer.

According to one aspect of the invention, the first driving indication comprises a power-on time T1 and a power-off time T2, the power-off time T2 being not less than a minimum time T required for the linear actuator to recover the deformation.

According to an aspect of the invention, the second actuation indication comprises a power-down time T3, the power-down time T3 being not less than a minimum time T required for the linear actuator to resume deformation.

According to an aspect of the present invention, the first driving instruction replaces the second driving instruction after the power-off time T3 ends.

According to one aspect of the invention, the first actuation indication is no longer substituted for the second actuation indication after the power-down time T3 has elapsed.

According to one aspect of the invention, the position detection module comprises a position detection element for detecting the position of the piston by non-contact detection.

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

According to one aspect of the invention, the position sensing element is provided at the piston or the screw or the connection of the screw and the piston.

According to one aspect of the invention, the position sensing element is disposed in a piston having at least one recess disposed therein for receiving the position sensing element.

According to an aspect of the present invention, a plurality of projections are provided in the recess for fixing the position detecting element.

According to an aspect of the invention, a positioning portion is further provided in the recess for further fixing the position detecting element.

According to one aspect of the invention, an infusion device comprises a control structure and an infusion structure, a cartridge, a drive wheel, a drive unit and a driver being arranged on the infusion structure, and a program module and a position detection module being arranged on the control structure.

According to one aspect of the invention, the control structure and the infusion structure are of a split type, and the control structure is reusable.

According to one aspect of the invention, the control structure and the infusion structure are a unitary structure that is discarded in its entirety after use.

The invention also discloses an artificial pancreas, which comprises an interlocking type drug infusion device and a detection structure, wherein the detection structure is used for continuously detecting the blood sugar level parameters and is connected with or integrated with the control structure and the infusion structure of the infusion device.

According to one aspect of the invention, two of the sensing, control and infusion structures are connected or integrated to form a unitary structure and are affixed to the skin at different locations relative to the third structure.

According to one aspect of the invention, the sensing, control and infusion structures are connected or integrated into a unitary structure and affixed to the skin at the same location.

Compared with the prior art, the technical scheme of the invention has the following advantages:

in the drug infusion device disclosed by the invention, the program module provides a first driving instruction for controlling the driver to carry out periodic power output, the infusion device is also provided with a position detection module for determining the drug infusion amount, and when the drug infusion amount reaches a set threshold value, the position detection module and/or the program module provides a second driving instruction for the driver. The program module and the position detection module physically form a synchronous interlocking mechanism, so that the risk of hypoglycemia and even coma caused by excessive infusion under the condition that the electronic components or the preset program fails is prevented.

Furthermore, the program module and the position detection module can form an interlocking mechanism in various ways to ensure that excessive infusion cannot occur under the condition that the electronic components or the control program fails, so that the risk of hypoglycemia or even coma is caused, for example, when the preset threshold is normal drug infusion amount within T1 time, the position detection module and/or the program module controls the linear driver to be powered off for T3 time, the second driving instruction is replaced by the first driving instruction, and the linear driver can normally perform periodic power output according to the preset program; when the predetermined threshold is that the normal drug infusion amount is exceeded within the time T1, after the position detection module and/or the program module controls the linear driver to be powered off for the time T3, the second driving instruction is not replaced by the first driving instruction, namely, the linear driver terminates the periodic power output, and the drug infusion is not performed any more.

Furthermore, the power-off time of each period of the linear driver in the first driving instruction of the program module is longer than the shortest time required by the linear driver to restore the deformation, and the power-off time of the linear driver in the second driving instruction is also longer than the shortest time required by the linear driver to restore the deformation, so that the linear driver can be ensured to enter the next deformation state after being completely restored to the initial state.

Further, the elastic component applies a return resilience force to the driving unit, and the elastic component and the linear driver are matched with each other to enable the driving unit to reciprocate. The elastic component can enable the driving unit to reset automatically, electric energy does not need to be consumed, and power consumption of the infusion device is reduced.

Furthermore, the position detection element can be flexibly arranged at one or more positions of the piston, the screw rod or the joint of the piston and the screw rod according to actual construction, so that the internal design of the infusion structure is optimized.

Further, a concave portion is arranged in the piston, a protruding portion and a positioning portion are arranged in the concave portion and used for accommodating and fixing the position detection element, and the detection result is prevented from being influenced by the fact that the detection element shakes to cause deviation of sensing information.

Drawings

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

FIGS. 2 a-2 b are schematic perspective views of a control structure according to an embodiment of the present invention;

FIG. 3a is a schematic perspective view of an infusion set according to one embodiment of the present invention;

FIG. 3b is a side view of the control structure and infusion structure assembled with each other in accordance with one embodiment of the present invention;

FIG. 3c is a schematic top view of a lower housing of a portion of an infusion set, in accordance with one embodiment of the invention;

FIG. 3d is a schematic top view of a lower housing of a portion of an infusion set in accordance with another embodiment of the invention;

FIG. 4a is a schematic perspective view of an infusion set according to one embodiment of the present invention;

FIG. 4b is a schematic perspective view of the internal structure of an infusion set in accordance with another embodiment of the invention;

FIG. 4c is a schematic perspective view of another perspective of the internal structure of an infusion set in accordance with another embodiment of the invention;

FIG. 5 is a schematic diagram of artificial pancreas module relationships according to one embodiment of the present invention.

Detailed Description

As mentioned above, the prior art infusion devices use a control program to control the actuation of the linear drive, which can lead to a complete loss of control of the drug delivery in case of a control program or electronic component failure, thereby causing a potential risk of hypoglycemic coma.

In order to solve the problem, the invention provides a drug infusion device, wherein a program module provides a first driving instruction for controlling a driver to perform periodic power output, a position detection module is further arranged in the infusion device and used for determining the drug infusion amount, and when the drug infusion amount reaches a set threshold value, the position detection module and/or the program module provides a second driving instruction for the driver. The program module and the position detection module physically form a synchronous interlocking mechanism, so that the risk of hypoglycemia and even coma caused by excessive infusion under the condition that the electronic components or the preset program fails is prevented.

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

Further, it should be understood that the dimensions of the various elements shown in the figures are not necessarily drawn to scale, for example, the thickness, width, length or distance of some elements may be exaggerated relative to other structures for ease of illustration.

The following description of the exemplary embodiment(s) is merely illustrative and is not intended to limit the invention, its application, or uses in any way. Techniques, methods, and apparatus known to those of ordinary skill in the relevant art may not be discussed in detail herein, but are intended to be part of the present description where applicable.

It should be noted that like reference numerals and letters refer to like items in the following figures, and thus, once an item is defined or illustrated in one figure, further discussion thereof will not be required in the subsequent figure description.

Fig. 1 a-1 b are top views of a drug infusion device in accordance with two different embodiments of the present invention.

The interlocking type drug infusion device provided by the embodiment of the 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 the present invention, the interlocking medication infusion device may also include further parts, which are not specifically limited herein.

In an embodiment of the present invention, the control structure 100 and the infusion structure 110 are of a split design, and are connected by a waterproof plug or directly snap-fit and electrically connected as a unit. The control structure 100 and the infusion structure 110 directly engage and electrically connect as a unit to improve the reliability of the electrical connection, as will be described in more detail below. The control structure 100 may be reusable and the infusion structure 110 disposable after a single use, as shown in fig. 1 a. In another embodiment of the present invention, the infusion structure 110 and the control structure 100 are designed as an integral unit, connected by wires, disposed inside the same housing 10, and adhered to a certain position of the skin of the user by the adhesive patch 120, and the whole is discarded after one-time use, as shown in fig. 1b.

An interlocking drug infusion device according to an embodiment of the present invention includes a control structure 100. The control structure 100 is used to receive signals or information from a remote device or a body fluid parameter testing device (e.g., a continuous blood glucose testing device) and control the infusion apparatus to perform drug infusion. The housing 101 of the control structure 100 is provided with a program module, a circuit board and related electronic components for receiving signals or sending control instructions, and other physical components or structures necessary for implementing the infusion function, which are not limited in particular here. In some embodiments of the invention, a power supply is also provided in the control structure. In an embodiment of the present invention, a power source 133 is disposed in the infusion structure 110, as described below.

Fig. 2 a-2 b are schematic perspective views of a control structure 100 according to an embodiment of the invention.

The control structure 100 further comprises a plurality of first electrical contacts 103 exposed at a surface of the control structure 100. The first electrical contact 103 serves as a circuit connection terminal for electrically connecting the internal circuitry provided in the control structure 100 and the infusion structure 110, respectively. The position where the first electrical contact 103 is disposed is not particularly limited by the embodiment of the present invention. Compared with the connecting end which is arranged into the plug connector, the contact area of the electric contact is smaller, the flexible design can be realized, and the volume of the control structure is effectively reduced. Meanwhile, the electric contact can be directly and electrically connected with an internal circuit or an electric element or can be directly welded on a circuit board, the design of the internal circuit is optimized, the complexity of the circuit is effectively reduced, the cost is saved, and the volume of the infusion device is reduced. Furthermore, electrical contacts exposed on the surface of the control structure 100 may facilitate electrical interconnection with connections on other structures. The above technical advantages of the electrical contacts apply to the first electrical contact 103 on the control structure 100 and the second electrical contact 113 on the infusion structure 110, which will not be described in detail below.

The type of first electrical contact 103 includes a rigid metal contact or a resilient conductive member. Preferably, in the present embodiment, the first electrical contact 103 is a rigid metal contact. One end of the first electrical contact 103 is electrically connected to the connection terminal disposed inside the control structure 100, the other end is exposed to the surface of the housing 101, and the rest of the first electrical contact 103 is tightly embedded in the housing 101, so as to isolate the inside of the control structure 100 from the outside.

Here, the elastic conductive member includes a conductive spring, a conductive silicone, a conductive rubber, a conductive elastic sheet, or the like. It is apparent that one end of the elastic conductive member is used to electrically connect with the connection terminal inside the control structure 100, and the other end is used to electrically connect with the other connection terminal. As in one embodiment of the invention, the first electrical contact 103 is a conductive spring. The elasticity of the conductive spring can enhance the reliability of the electrical connection when the electrical contacts are in contact with each other. Similar to the rigid metal contacts, other portions of the conductive spring are tightly embedded in the housing 101 and electrically connected to internal circuitry or electrical components, except that one end is exposed to the surface of the housing 101. Obviously, the connection terminals located inside the control structure 100 may be conductive leads, and may also be specific parts of a circuit or an electrical element.

It should be noted that "tightly embedded" in the embodiment of the present invention means that no gap is formed between the electrical contact and the casing 101, so as to seal the inside of the control structure 100. Hereinafter, "closely embedded" is the same as that of the present embodiment.

In another embodiment of the invention, the first electrical contact 103 is a conductive spring, but is not tightly embedded in the housing 101, but a seal is provided around the area where the first electrical contact 103 is located, the seal being located in a recess to seal the electrical connection location and the interior of the control structure 100.

In the embodiment of the present invention, the control structure 100 is further provided with a first engaging portion 102. The first engaging portion 102 is adapted to engage with the second engaging portion 112 of the infusion structure 110, so as to achieve the mutual assembly of the control structure 100 and the infusion structure 110, and further to electrically connect the first electrical contact 103 with the second electrical contact 113, which will be described in detail later.

The first engaging portion 102 and the second engaging portion 112 include one or more of hooks, blocks, holes, and grooves, which can be engaged with each other, and the positions thereof can be flexibly designed according to the shape and structure of the control structure 100 and the infusion structure 110, such as being disposed inside or on the surface of the corresponding structure, and are not limited in particular.

In an embodiment of the present invention, the control structure 100 is further provided with a recess 104 for interfitting with a protrusion 114 on the bottom of the housing of the infusion structure 110, as will be described in more detail below. In particular, the first electrical contact 103 is arranged in the recess 104, as shown in fig. 2 b.

In the embodiment of the present invention, a buzzer (not shown) is further disposed in the control structure 100. The buzzer is used for giving out alarm signals such as sound, vibration and the like under the conditions of starting or ending infusion, failure of an infusion device, exhaustion of medicines, sending of error instructions by the control structure 100 or receiving of error information and the like, so that the buzzer can be conveniently perceived by a user and timely adjusted.

In the embodiment of the present invention, the casing 101 of the control structure 100 is provided with a sound-transparent hole 105 for transmitting the sound alarm signal of the buzzer. In order to have a good sealing effect to ensure the normal operation of the buzzer, a waterproof sound-transmitting membrane (not shown) is disposed between the sound-transmitting hole 105 and the buzzer. Therefore, the waterproof sound-transmitting membrane needs to have a certain porosity, so that water molecules can be prevented from entering the buzzer, and sound can be ensured to be transmitted out.

Compared with the traditional technical scheme that the buzzer is sealed in the control structure 100, after the sound transmission hole 105 is formed, the buzzer emits small sound to be perceived by a user, the energy consumption of the buzzer is reduced, the power consumption configuration of the infusion device is optimized, and the production cost is saved.

Fig. 3a is a schematic perspective view of an infusion structure 110 according to an embodiment of the present invention. Fig. 3b is a side view of the control structure 100 and infusion structure 110 assembled with each other in accordance with an embodiment of the present invention. Fig. 3c is a schematic top view of a lower housing of a portion of an infusion set, in accordance with an embodiment of the present invention. Fig. 3d is a schematic top view of a lower housing of a portion of an infusion set, in accordance with another embodiment of the present invention.

The interlocking medication infusion device further comprises an infusion structure 110. The housing is provided with an infusion module, a circuit module and other auxiliary modules for completing the infusion of the drug, as will be described in detail below. The housing of the infusion structure 110 may comprise multiple portions. As in the present embodiment, the housing of the infusion device comprises an upper housing 111a and a lower housing 111b.

As previously described, in the present embodiment, the infusion structure 110 is provided with the second engaging portion 112. The second engaging portion 112 is adapted to engage with the first engaging portion 102. Therefore, the first engaging portion 102 corresponds to the position where the second engaging portion 112 is provided.

In an embodiment of the invention, the infusion structure 110 is provided with a second electrical contact 113. The second electrical contacts 113 are adapted to be pressed into contact with the corresponding first electrical contacts 103 to electrically interconnect the control structure 100 and the infusion structure 110. The mutual pressing between the two electric contacts with different structures can improve the reliability of the electric connection. Similar to the first electrical contact 103, the second electrical contact 113 is also of the type comprising a rigid metal contact or a resilient conductive member. Specifically, in the embodiment of the present invention, the second electrical contact 113 is a conductive spring. Also, 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, in which groove a sealing element 115 is provided.

Preferably, in the embodiment of the present invention, the conductive spring has different diameters at both ends, a shorter diameter exposed outside the infusion structure 110 and a longer diameter at the inner portion of the infusion structure 110. The longer diameter can block the conductive spring within the housing. Thus, the longer diameter prevents the conductive spring from falling off the infusion structure 110 when the control structure 100 is not mounted to the infusion structure 110.

The embodiment of the present invention does not limit the position where the second electrical contact 113 is disposed, as long as it can be electrically connected to the corresponding first electrical contact 103. Specifically, in the present embodiment, the bottom of the housing 111a of the infusion structure 110 includes a protrusion 114. The second electrical contact 113 is arranged on the protrusion 114, as shown in fig. 3 a. The protrusion 114 corresponds to the recess 104 of the control structure 100, and the two can be assembled with each other, so that the first electrical contact 103 and the corresponding second electrical contact 113 are pressed against each other, and thus electrically connected.

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 a unitary body, the protrusion 114 is a portion of the unitary body, and is not particularly limited herein.

The manner in which the control structure 100 and the infusion structure 110 are assembled to each other includes pressing the control structure 100 against the infusion structure 110 along the thickness direction of the infusion structure 110 to cause the first and

second catch portions

102, 112 to catch each other. Or along the length of the infusion structure 110, the control structure 100 is pressed against the infusion structure 110. Alternatively, the control structure 100 may be pressed at any angle between the thickness direction and the length direction of the infusion structure 110 to engage the first engaging portion 102 and the second engaging portion 112 with each other. Preferably, in the practice of the present invention, the control structure 100 and the infusion structure 110 are assembled with each other by pressing the control structure 100 against the infusion structure 110 along the thickness direction of the infusion structure 110 to engage the first engaging portion 102 and the second engaging portion 112 with each other, as shown in the installation orientation of fig. 3 b.

In an embodiment of the present invention, the lower housing 111b of the infusion structure 110 comprises an outward extension 116, and the outside of the extension 116 is provided with a blocking block 117, as shown in fig. 3 a. As mentioned above, the control structure 100 is pressed to the engagement position along the thickness direction of the infusion structure 110, and the blocking block 117 can prevent the control structure 100 from falling off along the length direction of the infusion structure 110, so as to ensure the normal operation of the infusion device. Obviously, in other embodiments of the present invention, if the control structure 100 is pressed to the engagement position along other directions, the control structure 100 can be prevented from falling off the infusion structure 110 by adjusting the position of the stopper 117.

It should be noted that "outward" and "outside" are relative to the main body of the infusion structure 110, and belong to the concept of relative positions, and the positional relationship is shown in fig. 3a or fig. 3 b. Hereinafter, "outside" is the same as that here.

In the embodiment of the present invention, the outer end of the extending portion 116 is further provided with a pressing portion 118 for releasing the blocking function of the blocking block 117. When the user is replacing the infusion structure 110, the control structure 100 can be unblocked by the blocking block 117 by pressing the pressing portion 118 with a finger. The user removes the control structure 100 from the infusion structure 110 with two fingers.

The embodiment of the present invention may further include an unlocking hole 119. The unlocking hole 119 is provided inside the stopper 117. While pressing the pressing portion 118, the index finger can enter the unlocking hole 119, so as to eject the control structure 100, thereby separating the control structure 100 from the infusion structure 110. In the embodiment of the present invention, the unlocking hole 119 is square. The square unlocking hole 119 can facilitate smooth entry of a finger. In other embodiments of the present invention, the unlocking hole 119 may have other shapes, and is not limited herein.

The lower housing 111b of the infusion structure 110 is also provided with a creased groove 140. The indenting grooves 140 are disposed on both sides of the unlocking hole 119, as shown in fig. 3c and 3 d. After the folding groove 140 is provided, the thickness or width (as indicated by arrows in fig. 3c and 3 d) of the lower shell 111b at the position of the folding groove 140 is reduced, and when the user presses the pressing portion 118, the lower shell 111b is easily broken at the folding groove 140, so as to more smoothly release the blocking of the control structure 100 by the blocking block 117.

Preferably, in the embodiment of the present invention, the crease groove 140 is provided at both end positions of the blocking piece 117, as shown in fig. 3 c. In another embodiment of the present invention, the crease groove 140 is disposed on one side of two corresponding edges of the unlocking hole 119, as shown in fig. 3 d.

The infusion structure 110 of the present embodiment is further provided with an infusion needle unit 121 for infusing a drug subcutaneously.

The bottom of the lower housing 111b of the infusion set 110 is also provided with an adhesive patch 120 for adhering the infusion set to the skin surface of the user.

Fig. 4a is a schematic perspective view of an infusion structure 110 according to an embodiment of the present invention. Fig. 4b is a schematic perspective view of an internal structure 130 of an infusion structure 110 in accordance with another embodiment of the invention.

In an embodiment of the present invention, the internal structure 130 comprises a mechanical unit, an electrical control unit, etc. for performing the infusion function, such as the drug reservoir 131, the drug outlet 132, the power source 133, the driving

wheels

134a and 134b, the screw 135, the piston 136, the driving unit 1310, and the main frame 137 carrying these components, etc. The cartridge 131 is used to contain medication, including but not limited to insulin, glucagon, antibiotics, nutritional fluids, analgesics, anticoagulants, gene therapy medications, cardiovascular medications, chemotherapy medications, or the like. Disposed within the cartridge 131 is a piston 136 for infusing a medication into the body and a screw 135. The screw 135 is connected to the piston to push the piston forward for drug infusion. The screw 135 is a rigid screw or a flexible screw.

In one embodiment of the present invention, the driving unit 1310 includes two driving

arms

1310a and 1310b, as shown in fig. 4a, the driving

wheels

134a and 134b are provided with gear teeth, and both driving arms can advance the gear teeth, the main frame 137 is further provided with a rotating shaft 138, the power unit 139 is electrically connected to the driving 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 driving arm 1310a of the driving unit 1310 pushes the gear teeth of the driving wheel 134a to advance, the driving

wheels

134a and 134b rotate synchronously, the driving screw 135 moves forward, the infusion device performs drug infusion, and the driving arm 1310b slides on the surface of the driving wheel 134b to complete the reset. When the power unit 139a is controlled by the program module in the control structure 100 to rotate counterclockwise around the rotating shaft 138, the driving arm 1310b of the driving unit 1310 pushes the teeth of the driving wheel 134b to advance, the driving

wheels

134a and 134b rotate synchronously, the infusion device performs drug infusion, and the driving arm 1310a slides on the surface of the driving arm 134a to complete the reset.

In the present embodiment, the

power components

139a and 139b are actuators, specifically, electrically driven type linear actuators or electrically heated type linear actuators, and more specifically, the

power components

139a and 139b are shape memory alloys or shape memory polymers. After the power is turned on, the physical form of the material of the linear actuator changes, and the linear actuator contracts and deforms, thereby outputting power for rotating the driving unit 1310. The greater the current, the greater the amount of contraction deformation of the linear actuator over a defined time, and the greater the power. Obviously, when the current is constant, the contraction deformation amount of the linear driver is kept constant in a limited time, and the driving force output by the linear driver is constant. After the

power component

139a or 139b completes one driving within the time T1, the program module controls the

power component

139a or 139b to be powered off for the time T2, so that the

power component

139a or 139b is restored to the initial state from the deformed state. Therefore, in the embodiment of the present invention, a first driving instruction for controlling the

power unit

139a or 139b to perform periodic power output is preset in the program module, the

power unit

139a or 139b is powered on for a time T1, powered off for a time T2, and powered on and powered off alternately at a predetermined current or voltage, and the power off time T2 is greater than the minimum time T required for the linear actuator to recover from deformation, so that the linear actuator can be completely recovered to the initial state within the time T2 of power off, and inaccurate infusion due to the fact that the linear actuator fails to completely recover to the initial state and enters the next cycle within one cycle is avoided.

Obviously, when the power component 139a deforms during the energization time T1, the power component 139b is in the deenergizing time T2, and conversely, when the power component 139b deforms during the energization time T1, the power component 139a is in the deenergizing time T2, that is, in the first driving instruction of the program module in the embodiment of the present invention, the

power components

139a and 139b are alternately energized and de-energized, the energization time of the power component 139a is the deenergizing time of the power component 139b, and the deenergizing time of the power component 139a is the energization time of the power component 139b, in order to ensure that the linear driver can be completely restored to the initial state during the deenergizing time T2, the energization time T1 and the deenergizing time T2 of the

power components

139a and 139b are both greater than the shortest time T required for the linear driver to restore the deformation. In the embodiment of the present invention, the relationship between the energization time T1 and the deenergization time T2 is not limited, as in one embodiment of the present invention, in order to achieve smooth infusion of the infusion device, the energization times of the

power members

139a and 139b are equal in the case where the voltages or currents applied to the

power members

139a and 139b are constant and equal; in another embodiment of the present invention, also to achieve a smooth infusion of the infusion set, a constant but unequal voltage or current may be applied to the

powered members

139a and 139b, with the smooth infusion being achieved by adjusting the energization time of the

powered members

139a and 139 b.

The

power members

139a and 139b may be formed of one continuous shape memory alloy or shape memory polymer, or may be formed of two segments of shape memory alloy or shape memory polymer, and are not particularly limited as long as the condition that the driving unit 1310 is rotated by the application of force is satisfied.

In another embodiment of the present invention, the driving unit 1310 includes only one driving arm 1310a, as shown in fig. 4b, when the first driving instruction of the program module controls the power component 139a to rotate counterclockwise around the rotating shaft 138, the driving arm 1310a pushes the teeth of the driving wheel 134a to advance, the driving

wheels

134a and 134b rotate synchronously, the driving screw 135 moves forward, and the infusion device performs the drug infusion. At this time, the power component 139a is a linear driver, specifically, a shape memory alloy or a shape memory polymer, 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 powered on for T1 time and then powered off for T2 time, the power component 139a stops providing power, the driving arm 1310a of the driving unit 1310 rotates clockwise around the rotating shaft 160 under the elastic force of the power component 139b, the driving arm 1310a stops pushing the gear teeth of the driving wheel 134a, the driving

wheels

134a and 134b stop rotating, the screw 135 stops advancing, and the infusion device does not perform drug infusion. The driving end 1310a is slidingly reset on the surface of the gear teeth of the driving wheel 134a until the driving unit 1310 stops rotating. In the embodiment of the present invention, the types of the elastic member include, but are not limited to, a compression spring, an extension spring, a torsion spring, a spring plate, an elastic rod, an elastic rubber, and the like. The elastic member can automatically rebound the driving unit 1310 to reset without external force, and power consumption is not required, thereby reducing power consumption of the infusion device. Specifically, in the embodiment of the present invention, the elastic member 139b is a torsion spring. The torsion spring is more advantageous for the reset of the driving unit 1310.

Similarly, in the embodiment of the present invention, a first driving instruction for controlling the power unit 139a to perform periodic power output is provided in the program module, specifically, the power unit 139a is powered on for a time T1, powered off for a time T2, and powered on and powered off alternately at a predetermined current or voltage, and the powered off time T2 is greater than the minimum time T required for the linear actuator to recover from deformation, so as to ensure that the linear actuator can completely recover to the initial state during the powered off time T2, and avoid inaccurate infusion due to entering the next cycle after the linear actuator fails to completely recover to the initial state during one cycle.

In order to prevent the linear actuator from being in a power-on state for a long time due to failure of electronic components or control programs, i.e., the linear actuator is in a deformation state for a long time, on one hand, the deformation of the linear actuator exceeds a predetermined length to cause excessive drug infusion, thereby causing hypoglycemia or even coma, and on the other hand, the deformation of the linear actuator exceeds a limit deformation which the linear actuator can bear, thereby causing the infusion apparatus to be completely failed. The position detection module includes a detection circuit (not shown in the drawings) and at least one position detection element 1361. The detection circuitry is disposed in the control structure and the position detection element 1361 is disposed in the infusion structure 110. The detection circuitry cooperates with the at least one position detection element 1361 to provide corresponding signals, data or information, etc., that need to be analyzed and processed for the purpose of determining the amount of drug infusion. The position detection module and/or the program module provides a second actuation indication to the actuator when the volume of drug infused during a cycle reaches a set threshold. The second drive indication is to control the linear drive to power down for a time T3. It should be noted that, when the drug infusion amount in one period reaches the set threshold, the position detection module and/or the program module provides the second driving instruction for the driver, which means that when the drug infusion amount in one period reaches the set threshold, the position detection module or the program module may provide the second driving instruction for the driver alone, or the position detection module and the program module may provide the second driving instruction for the driver together.

For example, in one embodiment of the present invention, the predetermined threshold is equal to the normal drug infusion amount of the drug infusion device during the time T1, when the drug infusion amount detected by the position detection module during one period reaches the set threshold, the position detection module provides the second driving indication, i.e. the linear driver is controlled to be powered off for the time T3, and then the second driving indication is replaced by the first driving indication, so that the linear driver can normally perform the periodic power output according to the preset program, thereby preventing the drug from being excessively infused and causing the hypoglycemic coma. In another embodiment of the present invention, the program module provides a second actuation indication when the amount of drug infused during a cycle detected by the position detection module reaches a set threshold, controlling the linear drive to power down for a time T3. In yet another embodiment of the present invention, the position detection module and the program module provide a simultaneous second actuation indication when the volume of drug infused during a cycle detected by the position detection module reaches a set threshold, controlling the linear drive to power down for a time T3.

In another embodiment of the present invention, the predetermined threshold is greater than the normal drug infusion amount of the drug infusion device during the time T1, when the drug infusion amount detected by the position detection module during one period reaches the set threshold, the position detection module and/or the program module provides a second driving instruction to control the linear driver to be powered off for the time T3, and then the second driving instruction is not replaced by the first driving instruction, i.e., the linear driver terminates the periodic power output and does not perform the drug infusion, thereby avoiding the risk of hypoglycemia due to drug overdusion. The meaning of the position detection module and/or the program module providing the second actuation indication is as described above and will not be repeated here.

It should be noted that the power-off time T3 is not less than the shortest time T required by the linear actuator to recover the deformation, so as to ensure that the linear actuator can completely recover to the initial state and then enter the next deformation state.

In the embodiment of the present invention, the position detecting element 1361 is provided in the piston 136. In other embodiments of the present invention, the position detecting element 1361 may be disposed in other parts of the infusion structure 110, such as one or more positions of the screw 135, the joint of the screw 135 and the piston 136, etc., and may be flexibly disposed according to the actual layout to optimize the internal design of the infusion structure. During drug infusion, the axial position change of the piston 136 or the end of the screw 135 in the drug storage cylinder 131 (along the moving direction of the screw 135) is detected by the position detection element 1361, the detection circuit converts the axial position information of the piston 136 or the end of the screw 135 in the power-on time T1 into drug infusion amount information, the position detection module receives the drug infusion amount information, and the program module and/or the position detection module controls the power-off time T3 of the linear driver when the drug infusion amount information is equal to a preset threshold value.

Preferably, in the embodiment of the present invention, the position detecting element detects the position of the end of the piston 136 or the screw 135 by a non-contact detection manner, the position detecting element is a magnetic element and is used for providing a magnetic field, and the detecting circuit is provided with a magnetic induction element, and the magnetic field intensity induced by the magnetic induction element changes along with the change of the position of the magnetic element, i.e., the end of the piston 136 or the screw 135, so that the detecting circuit can calculate the position change of the end of the piston 136 or the screw 135 by the induced magnetic field change and further convert the position change into the drug infusion information in the cycle.

Preferably, in the embodiment of the present invention, the detecting element 1361 is disposed in the piston 136, at least one recess 1362 is disposed in the piston 136 for accommodating the detecting element 1361, a plurality of protrusions 1363 are further disposed inside the recess 1362 for fixing the position of the detecting element 1361, a positioning portion 1364 is further disposed in the middle of the recess 1362 for further fixing the position of the detecting element 1361, so as to prevent the position of the detecting element 1361 from shaking to cause deviation of the sensed information and affect the detection result.

In the present embodiment, the power source 133 is a conventional button cell battery. In other embodiments of the present invention, the power source 133 may also be other types of batteries as long as the conditions for supplying power to the infusion device are met. Preferably, in the embodiment of the present invention, the power source 133 is a dual-row battery, that is, two rows of batteries are respectively disposed on both sides of the driving wheel 134, as shown in fig. 4 c. Conventionally, the discharge capacity of the button cell is low, and the discharge level of each cell can be reduced by arranging the double rows of button cells, so that the service life of the cells is prolonged. Furthermore, the double-row design of the power source 133 can make full use of the internal space of the infusion device, and the integration level of the internal structure of the infusion device is improved.

The infusion structure 110 of the present embodiment is further provided with a circuit board or a three-dimensional circuit coated on a portion of the structure surface for supplying power to a specific structure unit. According to the characteristics of the internal structure of the infusion device, the shape and the position of the three-dimensional circuit can be flexibly designed, and the internal space of the infusion structure can be fully utilized, so that the structure is more compact. The circuit board is a rigid circuit board or a flexible circuit board. Preferably, in the embodiment of the present invention, the circuit board is a flexible circuit board. The flexible circuit board is flexible in shape and can be flexibly designed according to the internal space of the infusion structure 110. Meanwhile, a plurality of connecting ends can be arranged on the flexible circuit board to be electrically connected with different second electric contacts 113, so that the circuit between the control structure 100 and the infusion structure 110 is conducted, and the normal infusion function of the infusion device is realized.

An elastic electrical conductor 1311 is also disposed within infusion structure 130. The elastic conductor 1311 is electrically connected to the power source 133 and a specific connection terminal on the circuit board (or the three-dimensional circuit), respectively, so as to supply power to a specific structural unit. The elastic conductor 1311 is provided with a protrusion, which can enhance the stability of electrical connection between the elastic conductor and a power supply and a circuit board or a specific connection terminal on a solid, and improve the reliability of electrical connection.

FIG. 5 is a schematic diagram of the relationship of modules of an artificial pancreas according to an embodiment of the present invention.

An embodiment of the present invention provides an artificial pancreas comprising the power integrated infusion device of the previous embodiments, and further comprising a sensing structure 340 coupled to or integrated with the control structure 300 and the infusion structure 310 of the infusion device for continuously sensing a real-time blood glucose level parameter of a patient. In the embodiment of the present invention, the detecting structure 340 is a continuous glucose detector, which can detect the blood glucose value in real time, monitor the blood glucose variation, and send the real-time blood glucose data to the control structure 300.

The control mechanism 300 is used for controlling the infusion mechanism 310 and the detection mechanism 340, and specifically, the control mechanism 300 can receive the blood glucose parameter signal sent by the detection mechanism 340, and is used for controlling the detection process of the detection mechanism 340 and recording the infusion information and the operating status of the infusion mechanism 310. For example, when the blood glucose information detected by the detection structure 340 after the end of life is inaccurate, the control structure 300 may issue a stop detection instruction to the detection structure 340. As another example, when an insulin occlusion occurs in the infusion structure 310, the control structure 300 can timely record the occlusion and provide feedback to the patient, eliminating a safety hazard. Thus, the control structure 300 is connected to the detection structure 340 and the infusion structure 310, respectively (where the connection includes a conventional electrical connection or a wireless connection).

The infusion structure 310 contains the necessary mechanical structure for infusing insulin and is controlled by the control structure 300. The infusion structure 310 infuses the currently desired insulin into the patient in accordance with the current insulin infusion amount data from the control structure 300. Simultaneously, the infusion structure 310 feeds back the infusion status to the control structure 300 in real time.

Embodiments of the present invention are not limited to the specific locations and connection or integration relationships of the detection structure 340, the control structure 300 and the infusion structure 310, as long as the aforementioned functional conditions are satisfied.

As in one embodiment of the present invention, the control structure 300 and the infusion structure 310 are interconnected or integrated to form a unitary structure, while the detection structure 340 is provided separately in another structure. At this time, the detection structure 340 and the control structure 300 transmit wireless signals to each other to achieve connection with each other. Thus, the control structure 300 and the infusion structure 310 are affixed to a location on the patient's skin, while the detection structure 340 is affixed to another location on the patient's skin.

As in yet another embodiment of the present invention, the control structure 300 and the sensing structure 340 are interconnected or integrated to form the same device, while the infusion structure 310 is separately disposed in another structure. The infusion construct 310 and the control construct 300 transmit wireless signals to each other to enable connection to each other. Thus, the control structure 300 and the detection structure 340 may be affixed to a certain location of the patient's skin, while the infusion structure 310 may be affixed to another location of the patient's skin.

As in yet another embodiment of the present invention, the infusion construct 310 and the detection construct 340 are interconnected or integrated to form the same device, while the control construct 300 is separately disposed in another construct. The infusion structure 310, the detection structure 340 and the control structure 300 transmit wireless signals to each other to enable connection to each other. Thus, the infusion structure 310 and the detection structure 340 may be affixed to the skin of the patient at one location, while the control structure 300 may be affixed to the skin of the patient at another location or independently of the user, i.e., not affixed to the skin of the user at any location.

As in one embodiment of the present invention, the three are connected or integrated to form a unitary structure. Therefore, the three are stuck on the same position of the skin of the patient. The three modules are pasted at the same position, so that the number of the patient skin pasting devices is reduced, and the interference of pasting more devices on the movement and extension of the patient is further weakened; meanwhile, the problem of unsmooth wireless communication between the separation devices is effectively solved, and the experience of the patient is further enhanced.

In another embodiment of the present invention, the three components are disposed in different structures. Therefore, the three parts are respectively stuck on different positions of the skin of the patient. At this time, the control structure 300 and the detection structure 340 and the infusion structure 310 respectively transmit wireless signals to each other to achieve connection with each other.

It should be noted that the control structure 300 of the embodiment of the present invention further has functions of storing, recording, and accessing a database, and therefore, the control structure 300 can be reused. Therefore, the physical condition data of the patient can be stored, and the production cost and the consumption cost of the patient are saved. As described above, when the detection structure 340 or the infusion structure 310 is end of life, the control structure 300 may be separate from the detection structure 340, the infusion structure 310, or both the detection structure 340 and the infusion structure 310.

Generally, the sensing structure 340, the control structure 300, and the infusion structure 310 have different lifetimes. Therefore, when the three are electrically connected with each other to form the same device, the three can be separated from each other two by two. If one module is first to end its life, the patient can only replace the module and keep the other two modules for continuous use.

Here, it should be noted that the control structure 300 of the embodiment of the present invention may further include a plurality of sub-modules. Different sub-modules may be respectively arranged in different structures according to the functions of the sub-modules, and there is no specific limitation as long as the corresponding functional conditions can be satisfied.

In summary, the present invention discloses an interlocking type drug infusion device and an artificial pancreas thereof, wherein a program module provides a first driving instruction for controlling a driver to perform periodic power output, a position detection module is further disposed in the infusion device for determining the periodic drug infusion amount, and when the drug infusion amount reaches a set threshold, the position detection module and/or the program module provides a second driving instruction for the driver. The program module and the position detection module physically form a synchronous interlocking mechanism, so that the risk of hypoglycemia and even coma caused by excessive infusion under the condition that the electronic components or the preset program fails is prevented.

Although some specific embodiments of the present invention have been described in detail by way of illustration, it should be understood by those skilled in the art that the above illustration is only for the purpose of illustration and is not intended to limit the scope of the invention. It will be appreciated by those skilled in the art that modifications may 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 interlocking drug infusion device comprising:

the medicine storage cylinder is used for containing medicines and is internally provided with a piston and a screw rod;

the driving wheel is connected with the screw rod and drives the screw rod to push the piston to advance through rotation;

a driving unit moving in a driving direction to drive the driving wheel to rotate;

the driver is electrically connected with the driving unit, and the electrified driver is used for providing power for the driving unit in the driving direction;

the program module is electrically connected with the driver and provides a first driving instruction for controlling the driver to carry out periodic power output; and

the position detection module is used for determining the periodic drug infusion amount, and when the drug infusion amount reaches a set threshold value, the position detection module and/or the program module provides a second driving instruction for the driver.

2. The interlocking drug infusion device of claim 1, further comprising a resilient member that applies a return spring force to the drive unit to reset the drive unit.

3. The interlocking drug infusion device of claim 1, wherein the infusion device comprises two drivers that alternate in their periodic power output.

4. The interlocking drug infusion device of claim 2 or 3, wherein the driver is a linear driver.

5. The interlocking drug infusion device of claim 4, wherein the linear actuator is a shape memory alloy or a shape memory polymer.

6. The interlocked drug infusion device of claim 5, wherein the first actuation indication includes a power-on time T1 and a power-off time T2, the power-off time T2 being no less than a time T required for the linear actuator to resume deformation.

7. The interlocking drug infusion device according to claim 5, wherein the second actuation indication comprises a power-off time T3, the power-off time T3 being not less than a minimum time T required for the linear actuator to resume deformation.

8. The interlocking drug infusion device of claim 7, wherein the first actuation indication replaces the second actuation indication after the power-off time T3 is over.

9. The interlocking drug infusion device of claim 7, wherein the first actuation indication no longer replaces the second actuation indication after the power-off time T3.

10. The interlocking drug infusion device of claim 1, wherein the position detection module comprises a position detection element that detects the position of the piston by non-contact detection.

11. The interlocking drug infusion device of claim 10, wherein the position sensing element is a magnetic element.

12. The interlocking drug infusion device according to claim 11, wherein the position detection element is provided at the piston or the screw or a connection of the screw and the piston.

13. The interlocking drug infusion device according to claim 12, wherein the position sensing element is disposed in the piston, the piston having at least one recess disposed therein for receiving the position sensing element.

14. The interlocking drug infusion device as claimed in claim 13, wherein a plurality of projections are provided in the recess for securing the position sensing element.

15. The interlocked drug infusion device of claim 14, wherein a locating portion is further provided in the recess for further securing the position detection element.

16. An interlocking medication infusion device according to claim 1, wherein said infusion device comprises a control structure and an infusion structure, said reservoir cartridge, said drive wheel, said drive unit and said driver being arranged on said infusion structure, said program module and said position detection module being arranged on said control structure.

17. The interlocking drug infusion device of claim 16, wherein the control structure and the infusion structure are a split structure, the control structure being reusable.

18. The interlocking drug infusion device of claim 16, wherein the control structure and the infusion structure are a unitary structure that is discarded in its entirety after use.

19. An artificial pancreas comprising the interlocked drug infusion device of any one of claims 16 to 18, further comprising a detection structure for continuously detecting a blood glucose level parameter, connected to or integrated with the control structure of the infusion device, the infusion structure.

20. The artificial pancreas as claimed in claim 19, wherein two of said sensing structure, said control structure and said infusion structure are connected to or integrated with each other to form a unitary structure and are affixed to the skin at different locations with the third structure.

21. The artificial pancreas as claimed in claim 19, wherein said sensing structure, said control structure and said infusion structure are connected or integrated into a unitary structure and affixed to the skin at the same location.