CN112237658B - Integrated drug infusion device - Google Patents
Integrated drug infusion device Download PDFInfo
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- CN112237658B CN112237658B CN201910655142.4A CN201910655142A CN112237658B CN 112237658 B CN112237658 B CN 112237658B CN 201910655142 A CN201910655142 A CN 201910655142A CN 112237658 B CN112237658 B CN 112237658B
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- infusion
- electrode
- tube
- wall
- conductive
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/16804—Flow controllers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
- A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
- A61M2005/1726—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure the body parameters being measured at, or proximate to, the infusion site
Abstract
The invention discloses an integrated drug infusion device, which comprises: an infusion unit for delivering a drug; the program unit comprises an input end and an output end, the input end comprises a plurality of electric connection areas for receiving the body fluid analyte parameter signals, and the program unit controls the infusion unit to output the drugs according to the received body fluid analyte parameter signals after the output end is electrically connected with the infusion unit; an infusion tube having a conductive region, the infusion tube being a drug infusion channel; and a plurality of electrodes for sensing an analyte parameter of the body fluid, the conductive area of the infusion tube functioning as at least one conductive area electrode, the infusion tube communicating with the infusion unit when the infusion tube is mounted in the operative position to allow the drug to flow through the infusion tube into the body, and different ones of the electrodes being electrically connected to different ones of the electrical connection areas. The detection and the infusion can be finished by puncturing the same position once.
Description
Technical Field
The invention mainly relates to the field of medical instruments, in particular to an integrated drug infusion device.
Background
Diabetes is mainly metabolic diseases caused by abnormal pancreas function of a human body, diabetes is a lifelong disease, and the occurrence and development of the diabetes and complications thereof can be controlled only by stabilizing blood sugar, but diabetes cannot be radically treated by the existing medical technology. The normal human pancreas can automatically monitor the change of the blood glucose content of the human body and automatically secrete the required insulin. Currently, the working mode of a medical device for stabilizing blood glucose is: the blood sugar change of a human body is dynamically monitored in real time through a glucose sensor implanted into subcutaneous tissues of the human body; and insulin can be accurately infused into the subcutaneous tissue of the human body for 24 hours continuously through the hose implanted into the subcutaneous tissue of the human body.
This method requires puncturing multiple locations on the skin surface of the human body to place the sensor probe and the infusion tube, respectively. Even though some devices currently integrate a sensor probe and an infusion tube in one device, separate punctures at different locations are required, increasing the risk of infection to the user.
Therefore, there is a need in the art for an integrated drug infusion device that can be punctured at one location to accomplish both the detection and infusion purposes.
Disclosure of Invention
The embodiment of the invention discloses an integrated drug infusion device, wherein a plurality of electrodes are arranged on an infusion tube with a conductive area, and the infusion tube is used as an electrode and an infusion channel. Analyte detection and drug infusion can be completed by puncturing one position at a time, and the risk of infection of a user is reduced.
The invention discloses an integrated drug infusion device, which comprises: an infusion unit for delivering a drug; the program unit comprises an input end and an output end, the input end comprises a plurality of electric connection areas for receiving the body fluid analyte parameter signals, and the program unit controls the infusion unit to output the medicine or not according to the received body fluid analyte parameter signals after the output end is electrically connected with the infusion unit; an infusion tube having a conductive region, the infusion tube being a drug infusion channel; and a plurality of electrodes for detecting parameters of the body fluid analyte, wherein the electrodes comprise a conductive area electrode and a tube wall electrode, the conductive area of the infusion tube is at least used as one conductive area electrode, one or more tube wall electrodes are arranged on the tube wall of the infusion tube, when the infusion tube is installed at a working position, the infusion tube is communicated with the infusion unit, so that the medicament can flow into the body through the infusion tube, and different electrodes are respectively electrically connected with different electric connection areas so as to input signals of the parameters of the body fluid analyte into the program unit.
According to one aspect of the invention, the wall electrode is disposed on an outer surface of the wall of the infusion tube or in the wall of the infusion tube.
According to one aspect of the invention, the wall electrode is disposed on an outer surface of a wall of the infusion tube, and the conductive area electrode and the wall electrode are each directly electrically connected to different electrical connection areas when the infusion tube is mounted in the operating position.
According to one aspect of the invention, the tube wall electrode is arranged on the outer surface of the tube wall of the subcutaneous part of the infusion tube, the outer surface of the tube wall of the infusion tube is also provided with an electrode lead electrically connected with the tube wall electrode, and when the infusion tube is installed to the working position, the electrode lead and the conductive area electrode are respectively and electrically connected with different electric connection areas.
According to one aspect of the invention, the infusion tube comprises an infusion steel needle and a flexible tube sleeved on the outer wall surface of the infusion steel needle, and the needle cavity of the infusion steel needle is used for infusing the medicine.
According to one aspect of the invention, the hose enters the subcutaneous space to a depth d when the infusion tube is mounted in the operative position 1 The depth of the injection steel needle entering into the subcutaneous space is d 2 ，d 1 ≤d 2 。
According to one aspect of the invention, the infusion steel needle is a conductive area electrode, and the tube wall electrode is arranged on the outer surface or the inner surface of the tube wall of the hose or on the outer wall surface of the infusion steel needle.
According to one aspect of the invention, the tubular wall electrode on the outer wall surface of the infusion steel needle is exposed in subcutaneous tissue fluid or is covered by the flexible tube in whole or in part when the infusion tube is mounted to the working position.
According to one aspect of the invention, when the tube wall electrode positioned on the outer wall surface of the infusion steel needle is completely or partially covered by the hose or the tube wall electrode is arranged on the inner wall surface of the hose, the material of the tube wall of the hose is a permeable membrane or a semi-permeable membrane.
According to one aspect of the invention, the infusion tube includes a plurality of electrically conductive regions electrically isolated from one another, the infusion tube includes a plurality of electrically conductive region electrodes, and the different electrically conductive region electrodes are different electrically conductive regions of the infusion tube.
According to one aspect of the present invention, the electrodes include a working electrode and an auxiliary electrode, and the number of the working electrode and the auxiliary electrode is one or more, respectively.
According to an aspect of the present invention, the conductive area electrode is a working electrode or an auxiliary electrode.
According to an aspect of the invention, the auxiliary electrode is a counter electrode, or the auxiliary electrode comprises a counter electrode and a reference electrode.
According to one aspect of the invention, the plurality of electrodes comprise one or more electrode combinations, each electrode combination comprising a working electrode and an auxiliary electrode, and the program element selects one or more electrode combinations for detecting the bodily fluid analyte parameter.
According to one aspect of the invention, the system further comprises a remote device, the remote device and the program unit mutually transmit wireless signals, the program unit transmits the body fluid analyte parameters or the drug infusion information to the remote device, and the remote device can transmit the artificially selected electrode combination or the drug infusion information to the program unit.
According to one aspect of the invention, the input end is an elastic member, and the elastic member comprises one or more combinations of a conductive adhesive tape, a directional conductive silica gel, a conductive ring and a conductive ball.
According to one aspect of the invention, the infusion unit comprises a plurality of infusion subunits, the plurality of infusion subunits are respectively electrically connected with the output ends, and the program unit selectively controls whether the infusion subunits output the medicines or not.
According to one aspect of the present invention, the integrated medication infusion device is composed of a plurality of parts, the infusion unit and the program unit are disposed in different parts, and the different parts are connected by a waterproof plug.
Compared with the prior art, the technical scheme of the invention has the following advantages:
in the integrated drug infusion device disclosed by the invention, the infusion tube comprises a conductive area. The conductive area is directly used as a detection electrode, so that the infusion tube has the functions of electrode detection and drug infusion at the same time, and the analyte detection and the drug infusion can be completed by puncturing at one position at one time, thereby reducing the risk of infection of a user. Secondly, the integrated drug infusion device is provided with a plurality of electrodes for detecting body fluid analyte parameters, the conductive area of the infusion tube is at least one conductive area electrode, and one or more tube wall electrodes are arranged on the tube wall of the infusion tube. The conductive area of the infusion tube is used as an electrode, so that the infusion tube is used as the electrode, and the process difficulty of electrode design is reduced. Meanwhile, the plurality of electrodes arranged on the infusion tube can form a specific electrode combination while completing detection of analyte parameters, so that a program unit or a user can conveniently select according to actual requirements. In addition, when the infusion tube is mounted to the operating position, the infusion tube communicates with the infusion unit to allow the drug to flow into the body through the infusion tube, and the different electrodes are electrically connected to the different electrical connection areas, respectively, to input the body fluid analyte parameter signal into the program unit. With this arrangement, the user presses the mounting device for mounting the infusion tube after attaching the integrated medication infusion device to the skin surface. When the infusion tube is mounted to the working position, the integrated medication infusion device may begin to operate. The method reduces the operation steps before the use of the user and improves the experience of the user.
Further, the infusion tube comprises an infusion steel needle and a hose sleeved on the outer wall surface of the infusion steel needle, and the needle cavity of the infusion steel needle is used for infusing the medicine. The process of designing the electrode on the surface of the hose is relatively simple, so that the design reduces the process difficulty of electrode manufacturing and improves the preparation efficiency. And secondly, the tube wall material of the hose can be selected according to the requirement, and the tube wall of the hose only allows a specific analyte to permeate through the hose, so that the interference of other substances is weakened, and the detection accuracy of the analyte parameters is improved.
Further, when the tube wall electrode positioned on the outer wall surface of the infusion steel needle is completely or partially covered by the hose or the tube wall electrode is arranged on the inner surface of the tube wall of the hose, the tube wall of the hose is a permeable membrane or a semi-permeable membrane. The material of the tube wall of the hose is a permeable membrane or a semi-permeable membrane, so that the required analyte can smoothly permeate the tube wall to reach the surface of the electrode. Under the condition of not influencing detection, the flexibility of electrode position design is improved.
Further, the infusion tube comprises a plurality of conductive areas which are mutually electrically insulated, the infusion tube comprises a plurality of conductive area electrodes, and the electrodes in different conductive areas are different conductive areas of the infusion tube. Different conductive areas of the infusion tube are used as electrodes, so that the design quantity of the electrodes on the surface of the tube wall can be further reduced, and the flow of the production process of the infusion tube is reduced.
Further, the plurality of electrodes are configured as one or more electrode combinations, each electrode combination including a working electrode and an auxiliary electrode, and the program element selects one or more of the electrode combinations for detecting the bodily fluid analyte parameter. On one hand, when one electrode combination fails, the program unit can select other electrode combinations to detect according to the situation, and the detection process of the body fluid signal is ensured to be uninterrupted. On the other hand, the program unit can select a plurality of electrode combinations to work simultaneously, and perform statistical analysis on a plurality of groups of data of the same parameter at the same time, so that the detection accuracy of the analyte parameter is improved, and a more accurate infusion signal is sent out.
Furthermore, the infusion unit comprises a plurality of infusion subunits which are respectively electrically connected with the output end, and the program unit selectively controls the infusion subunits to output the medicines. Different drugs are placed in the subunits, and the program unit selects to send drug infusion instructions to different infusion subunits, so that accurate control of body fluid analyte parameters is realized.
Drawings
FIG. 1 is a flowchart illustrating operation of an integrated drug infusion device in accordance with one embodiment of the present invention;
fig. 2a is a schematic cross-sectional view of an infusion tube of an integrated medication infusion device in an installed position in accordance with an embodiment of the present invention;
FIG. 2b is a schematic cross-sectional view of an infusion tube of an integrated medication infusion device in an operative position, in accordance with an embodiment of the present invention;
fig. 3 a-3 b are schematic top views of an integrated drug infusion device according to another embodiment of the present invention;
FIGS. 4 a-4 b are partial longitudinal cross-sectional views of an infusion tube and electrodes according to one embodiment of the present invention;
FIGS. 5 a-5 b are partial longitudinal cross-sectional views of an infusion tube and electrodes according to another embodiment of the present invention;
FIG. 6 is a partial longitudinal cross-sectional view of an infusion tube and a tri-electrode in accordance with yet another embodiment of the present invention;
FIG. 7 is a partial longitudinal cross-sectional view of an infusion steel needle sheath hose according to yet another embodiment of the present invention;
FIG. 8a is a partial longitudinal cross-sectional view of an infusion tube having a plurality of conductive regions in accordance with yet another embodiment of the disclosures made herein;
FIGS. 8 b-8 c are partial transverse cross-sectional views of an infusion tube having multiple conductive areas in accordance with yet another embodiment of the disclosures made herein;
fig. 9 is a schematic structural view of an integrated medication infusion device and a remote apparatus according to yet another embodiment of the present invention.
Detailed Description
As mentioned above, the prior art devices separate detection and infusion when maintaining stable parameters of body fluids, and require multiple punctures on the surface of the body, which increases the pain of the user and also increases the risk of infection of the user.
The research finds that the reasons causing the problems are as follows: the sensor detection device and the drug infusion device are two separate units. Or even if both are integrated into a single structure, a plurality of puncture sites may be formed on the body surface.
In order to solve the problem, the invention provides an integrated drug infusion device, an infusion tube with a conductive area is used as an electrode for detecting analyte parameters and a drug infusion channel, and the detection and infusion can be realized by puncturing one position at a time.
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 present 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 description.
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 specification as 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 subsequent figure descriptions.
Fig. 1 is a flowchart illustrating the operation of an integrated drug infusion device according to an embodiment of the present invention.
The integrated drug infusion device of the embodiment of the invention comprises three basic parts: electrodes, a program unit and an infusion unit. Body fluid analyte parameter information is acquired by the electrodes and converted into electrical signals. The electrical signals are transmitted to the program unit via the electrodes and/or electrode leads. After analyzing the body fluid analyte parameter signal, the program unit sends a signal whether to perform drug infusion to the infusion unit to control whether to perform drug infusion by the infusion unit, thereby stabilizing the body fluid parameter. The body fluid analyte parameters are detected by the electrodes in real time, and detection infusion cycles are continuously performed. The process is directly completed through program analysis without human intervention so as to control the stability of the parameters of the body fluid.
Fig. 2 a-2 b are cross-sectional views of an integrated drug infusion device 100 according to an embodiment of the present invention, where the integrated drug infusion device 100 is a unitary structure. Fig. 2a shows the infusion tube 130 in the mounted position and fig. 2b shows the infusion tube 130 in the operating position.
The program element 120 comprises an input 121 and an output 122. Input 121 is for receiving a bodily fluid analyte parameter signal. In the embodiment of the present invention, the input terminal 121 includes electrical connection regions 121a and 121b. In the working state, the electric connection area is electrically connected with the electrode or the electrode lead so as to receive the parameter signal. In other embodiments of the present invention, the input terminal 121 may further include more electrical connection regions according to the number of electrodes. The output 122 is electrically connected to the infusion unit 110 to enable the program unit 120 to control the infusion unit 110.
During use of the integrated drug infusion device according to the embodiment of the present invention, the infusion tube 130 and the input end 121 slide relatively, so that the input end 121 is configured as an elastic member. The elastomeric member is selected to ensure an interference fit between the infusion tube 130 and the input end 121 to avoid poor electrical contact. The elastic member includes: conductive adhesive tape, conductive silica gel with directional conductivity, conductive ring, conductive ball, etc. When the number of the electrodes is more, the electric connection area is relatively dense, and at this time, the elastic member may be designed according to different structures, and one or more combinations of the above may be selected.
In an embodiment of the present invention, the infusion tube 130 is mounted on a mounting device 150. When the infusion tube 130 is in the mounting position, the mounting means 150 protrudes from the housing surface of the integrated drug infusion device 100, as shown in fig. 2 a. When the infusion tube 130 is mounted to the operating position, the mounting means 150 enters the integrated drug infusion device 100 with its top integrated with the integrated drug infusion device 100 housing as shown in fig. 2 b. The user carries the infusion tube 130 with the mounting device 150 in the mounted position prior to use. When the user uses the integrated drug infusion device 100, he or she can press the mounting device 150 to complete the mounting operation after the integrated drug infusion device is attached to the surface of the human body, and the integrated drug infusion device can start to work normally. Compared with other infusion tube installation methods, the installation method provided by the embodiment of the invention reduces the operation steps of a user during installation, enables the installation to be more convenient and flexible, and improves the user experience.
The manner in which the infusion tube 130 is disposed in the mounting device 150 may be various and is not particularly limited herein. Specifically, in the embodiment of the present invention, the other side of the mounting device 150 further protrudes a portion of the infusion tube 130 (shown in phantom in fig. 2a and 2 b) for subsequent connection with the outlet of the infusion unit 110 for drug communication.
In an embodiment of the present invention, infusion tube 130 includes one or more electrically conductive regions. As used herein, conductive regions refer to the walls of the infusion tube 130 at various locations, which may themselves be conductive. The material of the conductive region includes stainless steel, metal alloy, or other conductive material, and is not particularly limited herein. Specifically, in the present embodiment, the infusion tube 130 is made of stainless steel. The infusion tube 130 now acts as a conductive area in its entirety. The infusion tube 130 itself serves as an electrode, which can reduce the number of electrode designs and reduce the process difficulty of electrode design.
In other embodiments of the present invention, infusion tube 130 further includes an electrical contact area 140 coupled to input end 121. As shown in fig. 2a, when the infusion tube 130 is in the mounted position, the electrical contact area 140 is not electrically connected to the input 121. And the other end of the infusion tube 130 is also not in communication with the infusion unit 110 outlet. As shown in FIG. 2b, when the infusion tube 130 is installed in the working position, one end of the infusion tube 130 is penetrated subcutaneously (indicated in FIG. 2b by the solid line of the infusion tube) and the other end (indicated in FIG. 2b by the dotted line of the infusion tube) is in communication with the outlet of the infusion unit 110, thereby establishing a flow path for the drug from the infusion unit 110 to the body tissue fluid. At the same time, electrical contact area 140 reaches the location of the electrical contact area of input 121, and an electrical connection between program unit 120 and electrical contact area 140 is realized.
It should be noted that even though the input end 121 is electrically connected to the electrical contact area 140 of the infusion tube 130 while the infusion tube 130 is in communication with the infusion unit 110, the program unit 120 will be in a non-operating state as long as the infusion tube 130 is not penetrated subcutaneously, and the integrated drug infusion device will not generate an analyte parameter signal and will not issue a command for performing an infusion. Thus, in other embodiments of the present invention, the electrical contact area 140 may also be electrically connected to the electrical connection area of the input end 121 when the infusion tube 130 is in the installed position, or the infusion tube 130 may also be in communication with the outlet of the infusion unit 110, and is not particularly limited herein.
In the embodiment of the present invention, a medical adhesive plaster 160 for attaching the integrated type medicine infusion device 100 to the skin surface is further included to attach the program unit 120, the infusion unit 110, the electrodes and the infusion tube 130 to the skin as a whole. When the infusion tube 130 is mounted in the operative position, the infusion tube 130 penetrates the subcutaneous portion 13.
Fig. 3a is a top view of an integrated drug infusion device 100 in accordance with another embodiment of the present invention.
In one embodiment of the present invention, the integrated drug infusion device 100 comprises two parts. The program unit 120 is provided in one part and the infusion unit 110 is provided in the other part, the two parts being electrically connected by a waterproof electrical plug 123. The part of the infusion unit 110 where used once can be discarded and the part of the program unit 120 where used repeatedly, saving the cost of the user.
In other embodiments of the present invention, the integrated drug infusion device 100 may also be made up of more than one part, with the parts not requiring electrical connections to be connected using a common waterproof plug.
Fig. 3b is a top view of an integrated medication infusion device 100 in accordance with another embodiment of the present invention.
In an embodiment of the present invention, the integrated drug infusion device 100 comprises two parts, and the infusion unit 110 comprises two infusion sub-units 110a and 110b. The infusion subunits 110a and 110b may be placed with different drugs, such as insulin, glucagon, antibiotics, nutritional fluids, analgesics, morphine, anticoagulants, gene therapy drugs, cardiovascular drugs, or chemotherapy drugs, etc. The infusion subunits 110a and 110b are electrically connected to output terminals 122a and 122b, respectively, to enable control of the infusion unit 110 by the programming unit 120. The outlets of infusion subunits 110a and 110b are adapted to be in partial communication with infusion tubes 130a and 130b, respectively. Portions of infusion tubes 130a, 130b are in communication with portions of infusion tube 130c, respectively. The infusion tube 130c is used partially to pierce the skin and thereby establish a path for the two drugs to flow from the infusion unit 110 into the body fluid. I.e. the integrated drug infusion device still penetrates the subcutaneous tissue at only one location. In the embodiment of the present invention, after the body fluid analyte parameter signal is transmitted to the program unit 120, the program unit 120 may output different infusion signals to different infusion subunits to control whether to infuse a drug, so as to realize accurate detection and control of the body fluid analyte parameter, so as to stabilize the physiological state of the user.
In other embodiments of the present invention, there may be more infusion subunits, and multiple infusion subunits may be disposed in different parts of the integrated drug infusion device 100, according to actual needs, and are not limited herein.
Fig. 4 a-4 b are partial longitudinal cross-sectional views of the infusion tube 130.
In an embodiment of the present invention, the integrated drug infusion device 100 includes a plurality of electrodes for detecting an analyte parameter, the electrodes being electrically conductive regions of the infusion tube, the electrodes being electrically conductive region electrodes. Or the electrode is arranged on the wall of the infusion tube 130, and the electrode is a tube wall electrode.
In one embodiment of the present invention, wall electrode 172 is plated on the outer surface of the wall of infusion tube 130, the wall 132 of infusion tube 130 itself serves as a conductive area electrode 171, and lumen 131 is used for infusing drugs. Typically, an insulating layer (not shown) is disposed between the conductive-area electrode 171 and the tube-wall electrode 172 to isolate the conductive-area electrode 171 and the tube-wall electrode 172. Notably, in the present embodiment, the infusion tube 130 itself acts as both an electrode and an infusion line. The design reduces the skin piercing position of the integrated drug infusion device, can finish analyte detection and drug infusion by piercing at the same position once, and reduces the risk of infection of a user. Meanwhile, the method for integrally electroplating the electrode layer on the tube wall 132 of the infusion tube 130 can simplify the process flow of the infusion tube 130 preparation and is convenient for process implementation.
In order to facilitate electrical connection between the electrodes and the electrical connection regions 121a and 121b, the stainless steel tube wall 132 is exposed at the electrical contact region 140 (dotted line position in fig. 4 a), and the other positions of the infusion tube 130 are plated with electrode layers. When the infusion tube 130 is mounted in the operative position, as shown in fig. 4b, the conductive area electrodes 171 and the tube wall electrodes 172 are electrically connected directly to the electrical connection areas 121a and 121b, respectively, of the input end, and transmit the bodily fluid analyte parameter information as electrical signals to the program unit 120.
It should be noted that, when the infusion tube 130 is installed to the working position, a part of the tube wall electrode 172 is located in subcutaneous tissue fluid, and a part of the tube wall electrode 172 is located on the skin, so that the transmission of the electrical signal on the tube wall electrode 172 can be realized. The corresponding electrode arrangements in the other embodiments below have the same function and will not be described in detail later.
In the present embodiment, the integrated drug infusion device 100 has only two electrodes, the conductive area electrode 171 is a working electrode, and the tube wall electrode 172 is an auxiliary electrode. In another embodiment of the present invention, the conductive area electrode 171 is an auxiliary electrode and the wall electrode 172 is a working electrode. The auxiliary electrode is a counter electrode.
Fig. 5 a-5 b are partial longitudinal cross-sectional views of an infusion tube 130 in accordance with another embodiment of the invention. For ease of reference and description, the electrode lead and the infusion tube are shown separately in fig. 5a, and the following related structural illustrations are the same as those herein and will not be described further.
In this embodiment, the vessel wall 132 itself is the conductive area electrode 271, the vessel wall electrode 272 is disposed on a portion of the surface of the vessel wall 132, and the surface of the vessel wall 132 is further provided with an electrode lead 2720 electrically connected to the vessel wall electrode 272. A layer of insulating material (not shown) is formed between the electrode lead 2720 and the tube wall 132. When the infusion tube 130 is mounted in the operative position, the input electrical connection areas 121a, 121b are electrically connected to the conductive area electrode 271 and the electrode lead 2720, respectively. In this case, the tube wall electrode 272 is indirectly electrically connected to the input terminal, and may also transmit the body fluid parameter signal to the program unit.
The tube wall electrode 272 in fig. 5b is arranged in a ring shape, the ring-shaped tube wall electrode 272 surrounding a portion of the outer surface of the tube wall 132. The tube wall electrode 272 may also have other shapes, and is not particularly limited herein.
Fig. 6 is a partial longitudinal cross-sectional view of an infusion tube 130 in accordance with yet another embodiment of the invention.
In an embodiment of the present invention, three electrodes are disposed on the infusion tube 130: conductive area electrode 371, tube wall electrode 372 and tube wall electrode 373. The wall 132 of the infusion tube 130 itself serves as the conductive area electrode 371, and the wall electrode 372 and the wall electrode 373 are respectively disposed on a portion of the outer surface of the wall 132. Meanwhile, the surface of the tube wall 132 is further provided with electrode leads 3720 and 3730 electrically connected to the tube wall electrode 372 and the tube wall electrode 373, respectively. When the infusion tube 130 is mounted to the working position, the conductive area electrode 371, the electrode lead 3720, and the electrode lead 3730 are electrically connected to the input end electrical connection areas 121a, 121b, and 121c, respectively, thereby achieving electrical connection of the input end to each of the electrodes. The shapes of the tube wall electrode 372 and the tube wall electrode 373 may be various, and are not particularly limited.
In the embodiment of the invention, in order to simplify the design of the electrical connection region, the elastic member of the input end is a conductive silicone or a conductive ring. Different elements are doped in the silica gel, so that the directional conduction of the silica gel can be realized, for example, the conduction in the horizontal direction is realized, and the conduction in the vertical direction is not realized. By this design, even if 121a and 121c are adjacent to each other, they are insulated from each other. And the electrical connection region 121b may use a conductive adhesive tape or a conductive ball, etc., which is not particularly limited herein.
In the embodiment of the present invention, the conductive area electrode 371 is a working electrode, and the tube wall electrode 372 and the tube wall electrode 373 are both auxiliary electrodes. At this time, the conducting area electrode 371 and the tube wall electrode 372 or 373 can be combined into different electrode combinations, i.e. the conducting area electrode 371 is shared by the two electrode combinations. Program element 120 may select different electrode combinations to detect bodily fluid analyte parameter information. After the electrode combinations are formed, on one hand, when one working electrode combination fails, the program unit 120 may select another electrode combination for detection according to the situation, so as to ensure that the detection process of the body fluid signal is uninterrupted. On the other hand, the program unit 120 may select a plurality of electrode combinations to work simultaneously, and perform statistical analysis on a plurality of sets of data of the same parameter at the same time, so as to improve the accuracy of the analyte parameter, and further output a more accurate drug infusion signal.
Similarly, the conductive area electrode 371, the tube wall electrode 372 and the tube wall electrode 373 include a working electrode and two auxiliary electrodes, and can be arbitrarily selected according to actual requirements. In another embodiment of the present invention, the conductive area electrode 371, the tube wall electrode 372 and the tube wall electrode 373 include an auxiliary electrode and two working electrodes, which can be arbitrarily selected according to practical requirements and are not limited herein.
As an embodiment of the present invention, the conductive region electrode 371 is a working electrode, the tube wall electrodes 372 and 373 are auxiliary electrodes, and the tube wall electrodes 372 and 373 are used as a counter electrode and a reference electrode, respectively, to form a three-electrode system. Likewise, the three electrodes can be arbitrarily selected according to practical requirements, and are not particularly limited herein.
Likewise, in other embodiments of the invention, more electrodes may be provided. The electrodes include a plurality of working electrodes and a plurality of auxiliary electrodes, but it is ensured that the conductive region of the infusion tube 130 serves as at least one electrode. At this time, each electrode combination includes the working electrode and the auxiliary electrode, and thus a plurality of electrodes may constitute a plurality of electrode combinations. Depending on the requirements, the program element 120 may select one or more electrode combinations for detecting the bodily fluid analyte parameter.
Fig. 7 is a partial longitudinal cross-sectional view of an infusion tube 130 in accordance with yet another embodiment of the disclosures made herein. For ease of labeling and description, the wall of the hose 180 is shown separated from the outer wall of the infusion needle 170 in fig. 7.
In an embodiment of the present invention, the infusion tube 130 includes an infusion steel needle 170 and a flexible tube 180 fitted over an outer wall of the infusion steel needle 170. The outer sleeve of the hose 180 is provided with the electrode more easily on the surface of the hose 180, so that the difficulty of the electrode manufacturing process is reduced, and the preparation efficiency is improved. In addition, the wall material of the tube 180 can be selected as desired, for example, the wall can only allow a specific analyte to permeate, thereby reducing the interference of other substances and improving the detection accuracy of analyte parameters.
The needle cavity 131 of the infusion steel needle serves as a drug infusion channel, and the wall of the infusion tube 130 comprises the outer wall of the steel needle and the wall of the soft tube. The infusion needle 170 itself is integrally formed as a conductive region electrode 471, the wall electrode 472 is disposed on the outer wall surface of the infusion needle 170, and the wall electrode 473 is disposed on the outer surface of the tube 180. At this time, the tube wall electrode 472 is disposed in the tube wall of the infusion tube 130.
In the above embodiments, wall electrode 472 may be partially covered, fully covered, or wall electrode 472 may be exposed to interstitial fluid by flexible tube 180. The tube wall electrode 473 may also be disposed on the inner surface of the tube 180, i.e., between the steel needle wall and the tube wall, and the tube wall electrode 473 is electrically connected to the electrical connection region 121c via the electrode lead 4730. When the tube wall electrode 472 (the electrode lead of the tube wall electrode 472 is not shown) is partially or completely covered by the tube 180, or the tube wall electrode 473 is disposed on the inner surface of the tube 180, the tube wall material of the tube 180 is a permeable membrane or a semi-permeable membrane. Such a selection can facilitate the body fluid analyte to permeate the tube wall of the hose 180 and be detected by the electrode, thereby improving the flexibility of the electrode position design without affecting the detection.
In an embodiment of the present invention, when the infusion tube 130 is mounted in the working position, the flexible tubing 180 and the infusion steel needle 170 penetrate the subcutaneous depth in a certain relationship. Here, the depth refers to the distance from the subcutaneous distal end of the hose 180 or the infusion steel needle 170, respectively, to the skin surface, as shown in FIG. 7. Typically, the infusion steel needle 170 has a hardness greater than that of the hose 180. As shown in FIG. 7, the depth d of the tube 180 into the subcutaneous space within the subcutaneous portion 13 is shown 1 The depth of the injection steel needle 170 into the subcutaneous space is d 2 ，d 1 ≤d 2 . This design allows for a smooth penetration of the infusion tube 130 into the skin.
Fig. 8 a-8 c are partial longitudinal cross-sectional views of an infusion tube 130 in accordance with yet another embodiment of the invention. Fig. 8a is a longitudinal sectional view of the infusion tube 130, and fig. 8b and 8c are transverse sectional views of the infusion tube 130.
Referring to fig. 8a and 8b, fig. 8b is a schematic cross-sectional view of the infusion tube 130 of fig. 8 a.
In an embodiment of the present invention, the wall 132 of the infusion tube 130 includes a plurality of conductive areas, one or more of which act as electrodes. Such as when the tube wall 132 includes two conductive regions that act as a conductive-region electrode 571 and a conductive-region electrode 572, respectively. The conductive-area electrode 571 and the conductive-area electrode 572 may be a working electrode and an auxiliary electrode, respectively, and are electrically connected to the electrical connection regions 121a and 121b, respectively, for electrical signal transmission. Different conductive areas of the infusion tube are used as electrodes, so that the design of the electrodes on the surface of the tube wall can be further reduced, and the production flow of the infusion tube is reduced. The insulation 190 provides electrical insulation between the two conductive regions of the infusion tube 130.
Referring to fig. 8c, the infusion tube 130 is entirely made up of three conductive areas, with adjacent conductive areas separated by insulating portions 190. The infusion tube 130 itself acts as three electrodes: conductive area electrodes 671, 672, 673. Conductive-area electrode 671 is a working electrode and conductive- area electrodes 672 and 673 are auxiliary electrodes, or are selected according to actual requirements as described above.
Referring to fig. 9, signal transmission between the remote device 200 and the integrated medication infusion device 100.
Embodiments of the present invention also include a remote device 200. Remote device 200 includes, but is not limited to, a handset, mobile terminal, etc. The remote device 200 and the program unit 120 transmit wireless signals to each other. The program element 120 may transmit body fluid analyte parameter information or drug infusion information (including infusion or non-infusion) to the remote device 200. Remote device 200 may receive, record, store, display fluid parameter information or infusion information, as well as include other functional options. The user may view historical or real-time information at any time via the remote device 200. Through the remote device 200, the user can also select infusion information manually and remotely, and wirelessly transmit the information to the program unit 120, and on the premise that the program unit 120 determines safety, the user controls whether the infusion unit performs drug infusion, thereby realizing remote manual operation.
In some embodiments of the present invention, the integrated drug infusion device 100 further comprises more electrodes, thereby forming a plurality of electrode combinations as described above. The user can manually select different electrode combinations to detect the body fluid parameters according to the situation.
In summary, the present invention discloses an integrated drug infusion device, wherein the infusion tube has the functions of infusion and detection, so as to reduce the number of times of skin surface puncture. Analyte detection and drug infusion can be completed by puncturing one position at a time, and the risk of infection of a user is reduced.
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 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 (17)
1. An integrated medication infusion device, comprising:
an infusion unit for delivering a drug;
a program unit, wherein the program unit comprises an input end and an output end, the input end comprises a plurality of electric connection areas for receiving the body fluid analyte parameter signals, and the program unit controls the infusion unit to output the medicine or not according to the received body fluid analyte parameter signals after the output end is electrically connected with the infusion unit;
the infusion tube is a medicine infusion channel and is arranged on the mounting device, and a user presses the mounting device to complete mounting work;
the infusion tube comprises a plurality of electrically conductive regions electrically insulated from each other; and
the electrodes comprise a plurality of conductive area electrodes and tube wall electrodes, the conductive area electrodes are a plurality of mutually electrically insulated conductive areas on the infusion tube, one or more tube wall electrodes are arranged on the tube wall of the infusion tube, when the infusion tube is installed at a working position, the infusion tube is communicated with the infusion unit, so that the medicine can flow into the body through the infusion tube, and the different electrodes are respectively electrically connected with different electric connection areas so as to input the body fluid analyte parameter signals into the program unit.
2. The integrated drug infusion device of claim 1, wherein the tube wall electrode is disposed on an outer surface of the infusion tube wall or in the infusion tube wall.
3. The integrated drug infusion device of claim 2, wherein the wall electrode is disposed on an outer surface of the infusion tube wall, and the conductive area electrode and the wall electrode are each directly electrically connected to a different one of the electrical connection areas when the infusion tube is installed in the operating position.
4. The integrated drug infusion device according to claim 3, wherein the wall electrode is disposed on an outer surface of a subcutaneous wall of the infusion tube, and an electrode wire electrically connected to the wall electrode is further disposed on the outer surface of the wall of the infusion tube, and when the infusion tube is installed in the working position, the electrode wire and the conductive area electrode are electrically connected to different electrical connection areas, respectively.
5. The integrated drug infusion device according to claim 2, wherein the infusion tube comprises an infusion steel needle and a hose covering the outer wall surface of the infusion steel needle, and the needle cavity of the infusion steel needle is used for infusing drugs.
6. The integrated drug infusion device of claim 5, wherein the flexible tubing has a subcutaneous depth d when the infusion tube is installed in the operating position 1 The depth of the injection steel needle entering into the subcutaneous space is d 2 ，d 1 ≤d 2 。
7. The integrated drug infusion device according to claim 6, wherein the infusion steel needle is a conductive area electrode, and the tube wall electrode is arranged on the outer surface or the inner surface of the tube wall of the hose or on the outer wall surface of the infusion steel needle.
8. The integrated drug infusion device of claim 7, wherein the tube wall electrode on the outer wall surface of the infusion steel needle is exposed in subcutaneous tissue fluid or is covered in whole or in part by the flexible tube when the infusion tube is mounted in the working position.
9. The integrated drug infusion device according to claim 8, wherein when the tube wall electrode on the outer wall surface of the infusion steel needle is covered by the hose in whole or in part, or the tube wall electrode is arranged on the inner wall surface of the hose, the material of the tube wall of the hose is a permeable membrane or a semi-permeable membrane.
10. The integrated drug infusion device according to claim 7 or 9, wherein the electrodes comprise a working electrode and an auxiliary electrode, and the number of the working electrode and the auxiliary electrode is one or more.
11. The integrated drug infusion device of claim 10, wherein the conductive area electrode is a working electrode or an auxiliary electrode.
12. The integrated drug infusion device according to claim 10, wherein the auxiliary electrode is a counter electrode, or the auxiliary electrode comprises a counter electrode and a reference electrode.
13. The integrated drug infusion device of claim 11, wherein a plurality of the electrodes comprise one or more electrode combinations, each electrode combination comprising the working electrode and the auxiliary electrode, and the program unit selects one or more of the electrode combinations for detecting a bodily fluid analyte parameter.
14. The integrated drug infusion device of claim 13, further comprising a remote device, wherein the remote device and the program unit communicate wireless signals to each other, wherein the program unit transmits bodily fluid analyte parameters or drug infusion information to the remote device, and wherein the remote device transmits the manually selected electrode combinations or drug infusion information to the program unit.
15. The integrated drug infusion device according to claim 1, wherein the input end is an elastic member comprising one or more of a conductive adhesive strip, a directional conductive silicone, a conductive ring, and a conductive ball.
16. The integrated drug infusion device of claim 1, wherein the infusion unit comprises a plurality of infusion subunits, the plurality of infusion subunits are electrically connected with the output terminals respectively, and the program unit selectively controls whether the infusion subunits output drugs or not.
17. The integrated drug infusion device according to claim 1, wherein the integrated drug infusion device is composed of a plurality of parts, the infusion unit and the program unit are disposed in different parts, and the different parts are connected by a waterproof plug.
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| CN201910655142.4A CN112237658B (en) | 2019-07-19 | 2019-07-19 | Integrated drug infusion device |
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| CN201910655142.4A CN112237658B (en) | 2019-07-19 | 2019-07-19 | Integrated drug infusion device |
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| US7248912B2 (en) * | 2002-10-31 | 2007-07-24 | The Regents Of The University Of California | Tissue implantable sensors for measurement of blood solutes |
| JP5624322B2 (en) * | 2006-12-22 | 2014-11-12 | エフ．ホフマン−ラ ロシュアーゲーＦ．Ｈｏｆｆｍａｎｎ−Ｌａ Ｒｏｃｈｅ Ａｋｔｉｅｎｇｅｓｅｌｌｓｃｈａｆｔ | Liquid supply with in-vivo electrochemical analyte sensing |
| CN102711898B (en) * | 2009-11-30 | 2014-07-09 | F·霍夫曼-拉罗氏股份公司 | Analyte monitoring and fluid dispensing system |
| EP2802370B1 (en) * | 2012-01-09 | 2016-12-21 | Sanofi-Aventis Deutschland GmbH | Cartridge hub with active valve |
| CN104622480B (en) * | 2013-11-12 | 2017-12-05 | 上海移宇科技股份有限公司 | Single needle integrated-type artificial pancreas |
| US20150273146A1 (en) * | 2014-03-31 | 2015-10-01 | Pacific Diabetes Technologies, Inc. | Hollow Infusion Catheter with Multiple Analyte-Sensing Electrodes |
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