UNILATERAL-DRIVEN MEDICAL DEVICE WITH INFUSION AND DETECTION INTEGRATED

The invention discloses a unilateral-driven medical device with infusion and detection integrated, comprising: drug infusion unit; program unit comprising input end and output end, and the input end comprises a plurality of electrically connective regions for receiving signals of analyte data in the body fluid, after the output end is electrically connected to the power unit, the program unit controls whether the drug infusion unit delivers drugs; and an infusion cannula provided with at least two detecting electrodes, the infusion cannula is the drug infusion channel, the electrodes are disposed on the cannula wall. It takes only one insertion to perform both analyte detection and drug infusion.

TECHNICAL FIELD

The present invention mainly relates to the field of medical instruments, in particular to a unilateral-driven medical device with infusion and detection integrated.

BACKGROUND

Diabetes is mainly a metabolic disease caused by abnormal human pancreatic function. Diabetes is a lifelong disease. At present, medical technology cannot cure diabetes. It can only control the occurrence and development of diabetes and its complications by stabilizing blood glucose. The normal human pancreas automatically monitors changes in the body's blood glucose levels and automatically secretes the required insulin. At present, the medical device for stabilizing blood glucose works by dynamically monitoring the blood glucose changes of the human body by a glucose sensor implanted in the subcutaneous tissue of the human body; and continuously accurately infusing insulin into the subcutaneous tissue of the human body through a medical cannula implanted in the subcutaneous tissue of the human body.

This method requires separately inserting glucose sensor and infusion cannula under the human skin. Even though there are some devices that can integrate the sensor probe and the infusion cannula into one device, the sensor and cannula still need to be separately inserted at different positions, increasing the risk of infection.

Therefore, there is a need in the prior art for a unilateral-driven medical device with infusion and detection integrated that can perform both detection and infusion at the same time.

BRIEF SUMMARY OF THE INVENTION

Embodiments of the present invention disclose a unilateral-driven medical device with infusion and detection integrated in which multiple electrodes are disposed on an infusion cannula also acted as an infusion channel. It takes only one insertion to perform both analyte detection and drug infusion, thus reducing the risk of infection.

The invention discloses a unilateral-driven medical device with infusion and detection integrated, comprising: a drug infusion unit, including: at least one drug storage unit; a screw connected to a piston and a driving wheel provided with wheel teeth, respectively, the driving wheel drives the screw to move by rotation, pushing the piston, provided in the drug storage unit, forward; at least one driving unit cooperating with the driving wheel, the driving unit includes at least one driving portion; a power unit and a reset unit connected to the driving unit, wherein: when the power unit exerts a force on the driving unit, the driving unit rotates around a pivot shaft, driving the driving portion to push the wheel teeth, thus rotating the driving wheel; when the reset unit exerts a force on the driving unit alone, the driving unit performs a reset rotation without the driving portion pushing the wheel teeth, thus making the driving wheel stop rotating; a program unit comprising input end and output end, and the input end comprises a plurality of electrically connective regions for receiving signals of analyte data in the body fluid, after the output end is electrically connected to the power unit or the reset unit, according to the received signals of analyte data in the body fluid, the program unit, through the power unit or the reset unit, controls the rotation of the driving unit to implement drug infusion; and an infusion cannula provided with at least two detecting electrodes, the infusion cannula is the drug infusion channel, the electrodes are disposed on/in the cannula wall, when the infusion cannula is installed to the working position, the infusion cannula is connected with the drug infusion unit, the drug can then be injected into the body through the infusion cannula, and the different electrodes are electrically connected to different electrically connective regions respectively, inputting signal of analyte data in the body fluid to the program unit.

According to one aspect of this invention, the electrodes are located on the outer surface of the cannula wall or in the cannula wall.

According to one aspect of this invention, the electrodes are located on the outer surface of the cannula wall, and when the infusion cannula is installed to the working position, different electrodes are directly electrically connected to different electrically connective regions, respectively.

According to one aspect of this invention, the electrodes are located on the subcutaneous part of the outer surface of the cannula wall, and the outer surface of the cannula wall is further provided with electrode leads electrically connected to the electrodes, and when the infusion cannula is installed to the working position, different electrode leads are electrically connected to different electrically connective regions, respectively.

According to one aspect of this invention, the infusion cannula includes an inner layer cannula and at least one outer layer cannula, and the outer layer cannulas are disposed outside the inner layer cannula, and the inner layer cannula is used for drug infusion.

According to one aspect of this invention, at least one electrode is provided between the outer wall of the inner layer cannula and the outermost cannula.

According to one aspect of this invention, when the infusion cannula is installed to the working position, the electrode located on the outer wall surface of the inner layer cannula is entirely exposed in the subcutaneous tissue fluid, or covered in whole or in part by the outer layer cannulas.

According to one aspect of this invention, when the electrode located on the outer wall surface of the inner layer cannula is covered in whole or in part by the outer layer cannulas, the material of the outer layer cannula walls is permeable membrane or a semi-permeable membrane.

According to one aspect of this invention, the electrodes include working electrode and auxiliary electrode, and the number of the working electrode(s) and the auxiliary electrode(s) is one or more than one, respectively.

According to one aspect of this invention, the auxiliary electrode is counter electrode, or the auxiliary electrode includes counter electrode and reference electrode.

According to one aspect of this invention, a plurality of electrodes form one or more electrode combinations, each electrode combination comprising working electrode and auxiliary electrode, the program unit choosing one or more electrode combinations to detect analyte data in body fluid.

According to one aspect of this invention, the input end is an elastic member, and the elastic member comprises one of or a combination of conductive strip, oriented conductive silica gel, conductive ring and conductive ball.

According to one aspect of this invention, the drug infusion unit includes a plurality of infusion subunits, the plurality of infusion subunits being electrically connected to the output ends, respectively, and the program unit controlling whether each infusion subunit delivers drugs.

According to one aspect of this invention, the unilateral-driven medical device with infusion and detection integrated is composed of a plurality of parts, the drug infusion unit and the program unit are arranged in different parts, and the different parts are connected by waterproof plugs.

According to one aspect of this invention, the driving unit includes two driving portions, and under the cooperative operation of the power unit and the reset unit, the two driving portions can alternately push the wheel teeth.

According to one aspect of this invention, the two driving portions alternately push the wheel teeth disposed on the same driving wheel.

According to one aspect of the present invention, the driving wheel includes two sub-wheels provided with wheel teeth, and the two driving portions respectively alternately push the wheel teeth disposed on different sub-wheels.

According to one aspect of the invention, the power unit and the reset unit are linear actuators.

According to one aspect of the invention, the linear actuator includes a shape memory alloy.

According to one aspect of the present invention, the reset unit at least includes a spring, an elastic sheet, an elastic plate, an elastic rod, or elastic reset rubber.

Compared with the prior arts, the technical solution of the present invention has the following advantages:

In the unilateral-driven medical device with infusion and detection integrated disclosed herein, an infusion cannula provided with at least two detecting electrodes. The infusion cannula performs analyte detection and drug infusion at the same time. Once the puncture is performed at one position, the analyte detection and the drug infusion can be completed simultaneously, reducing the risk of the user's infection. Secondly, when the infusion cannula is installed to the working position, the infusion cannula connects with the drug infusion unit to allow the drugs to flow through the infusion cannula into the body, and the different electrodes are electrically connected to different electrically connective regions inputting the analyte data signal to the program unit. With this design method, after the user attaches the medical device to the skin surface, the mounting unit for installing the infusion cannula is pressed. When the infusion cannula is installed to the working position, the medical device can begin to work. This approach reduces the user's pre-using steps and improves the user experience.

Furthermore, when the electrode located on the outer wall surface of the inner layer cannula is covered in whole or in part by the outer layer cannulas, the material of the outer layer cannulas wall is permeable membrane or a semi-permeable membrane. The cannula wall material is selected from a permeable membrane or a semi-permeable membrane to ensure the required analyte passes through the cannula wall to the electrode surface. It can improve the flexibility of electrode position design without affecting the detection.

Furthermore, a plurality of electrodes constitute one or more electrode combinations, each electrode combination includes working electrode and auxiliary electrode, and the program unit selects one or more electrode combinations to detect the body fluid analyte data. On the one hand, when a combination of electrodes fails to detect, the program unit can select other electrode combinations for detection according to the situation to ensure the detection process of the body fluid signal is uninterrupted. On the other hand, the program unit can select multiple electrode combinations to work at the same time, performing statistical analysis on multiple sets of data of the same parameter at the same time, improving the detection accuracy of the analyte data, and then issue a more accurate infusion signal.

Furthermore, the drug infusion unit comprises a plurality of infusion subunits, the plurality of infusion subunits being electrically connected to the output end respectively, and the program unit controlling whether each infusion subunit delivers drugs. Different drugs are reserved in different infusion subunits, and the program unit sends different drug infusion instructions to different infusion subunits to achieve precise control of the analyte level in body fluid.

Furthermore, the power unit and the reset unit are linear actuators. The force of the linear actuator can be controlled by current. When the current is constant, the force exerted by the linear actuator is constant. Therefore, the linear actuator can exert stable and controllable force, thus making the drug infusion proceed smoothly.

Furthermore, the reset unit at least includes a spring, an elastic sheet, an elastic plate, an elastic rod, or an elastic reset rubber. When the reset unit is an elastic member, the reset unit can work without consuming additional energy, which reduces the power consumption of the medical device and saves the production cost.

DETAILED DESCRIPTION

As described above, in the prior art device, the detection and the infusion are performed separately to control the analyte level in the body fluid, and it is necessary to puncture at multiple positions on the skin, thereby increasing the pain of the user and increasing the risk of infection.

The study found that the cause of the above problems is that the sensor detection device and the drug medical device are two independent units. Or even if the two are designed into a single structure, multiple puncture positions are still required on the body surface.

In order to solve this problem, the present invention provides a unilateral-driven medical device with infusion and detection integrated, the infusion cannula is used for detecting analyte data and a drug infusion channel. And it can perform detection and infusion with only one puncture.

Various exemplary embodiments of the present invention will now be described in detail with reference to the drawings. The relative arrangement of the components and the steps, numerical expressions and numerical values set forth in the embodiments are not to be construed as limiting the scope of the invention.

In addition, it should be understood that, for ease of description, the dimensions of the various components shown in the figures are not necessarily drawn in the actual scale relationship, for example, the thickness, width, length or distance of certain units may be exaggerated relative to other structures.

The following description of the exemplary embodiments is merely illustrative, and is not intended to be in any way limiting the invention and its application or use. The techniques, methods and devices that are known to those of ordinary skill in the art may not be discussed in detail, but such techniques, methods and devices should be considered as part of the specification.

It should be noted that similar reference numerals and letters indicate similar items in the following figures. Therefore, once an item is defined or illustrated in a drawing, it will not be discussed further in the following description of the drawings.

FIG. 1is a flow chart showing the operation of a unilateral-driven medical device with infusion and detection integrated according to an embodiment of the present invention.

The unilateral-driven medical device with infusion and detection integrated of the embodiment of the invention comprises three basic parts: electrodes, a program unit and a drug infusion unit. The body fluid analyte data is obtained by the electrodes and converted into an electrical signal. Electrical signals are passed to the program unit via electrodes and/or electrode leads. After analyzing the body fluid analyte data signal, the program unit, through the power unit or the reset unit, sends a signal to the drug infusion unit controlling whether to perform a drug infusion, thereby stabilizing the body fluid parameters. The body fluid analyte data are detected by the electrodes in real time, and the cycle of detection and infusion is without interruption. This process does not require human intervention and is done directly through program analysis to control the stability of body fluid parameters.

FIG. 2is a schematic view of main structures in the infusion unit according to an embodiment of the present invention.

The internal structure of the infusion unit mainly includes at least one drug storage unit1110, a piston1120, a screw1130, a driving wheel1140, at least one driving unit1150, a pivot shaft1160, a reset unit1170and a power unit1180. In the embodiment of this present invention, the driving unit1150is connected to the reset unit1170and the power unit1180, respectively. It should be noted that the connection herein includes mechanical connection or electrical connection.

The drug storage unit1110is used for storing liquid drug. Drugs include, but are not limited to, insulin, glucagon, antibiotics, nutrient solutions, analgesics, morphine, anticoagulants, gene therapy drugs, cardiovascular drugs or chemotherapy drugs, etc.

The piston1120is used to infuse liquid drug into the body.

The screw1130is connected to the piston1120and the driving wheel1140, respectively. In the embodiment of the present invention, the driving wheel1140advances the screw1130forward by screwing, the screw1130then forces the piston1120, arranged in the drug storage unit1110, to move forward, so as to achieve the purpose of drug infusion.

The peripheral surface of the driving wheel1140is provided with wheel teeth1141. The wheel teeth1141are gear teeth or ratchet teeth. Specifically, in the embodiment of the present invention, for improving driving efficiency, the wheel teeth1141are ratchet teeth which can be pushed more easily.

At least one driving portion1151is provided on the driving unit1150to push the wheel teeth1141, thereby rotating the driving wheel1140. The driving unit1150is movably connected to the pivot shaft1160.

The power unit1180and the reset unit1170cooperate with each other to make the driving unit1150rotate reciprocally around the pivot shaft1160, as shown in the R direction inFIG. 2, thereby making the driving portion1151move in the advancing direction and reset direction. When the driving unit1150performs one reciprocating rotation, the driving wheel1140drives the screw1130forward one step, and the screw1130engages the piston1120to infuse one unit of drug.

It should be noted here that the advancing direction of the driving portion1151refers to the direction in which the wheel teeth1141moves, while the reset direction of the driving portion1151is opposite to the advancing direction. During the reset movement, the driving portion1151only slides on the surface of the wheel teeth1141without pushing them.

In some embodiments of the present invention, the reset unit1170at least includes a spring, an elastic piece, an elastic plate, an elastic rod, rubber and other elastic members. It should be noted that the spring herein includes a compression spring, an extension spring, or a torsion spring, etc. Specifically, in the embodiment of the present invention, the reset unit1170is a torsion spring which is more conducive to the reset of the driving unit1150. When the reset unit1170is an elastic member, it can work without consuming additional energy, which reduces the power consumption of the medical device and saves the production cost.

In other embodiments of the present invention, the reset unit1170includes an electrically driven linear actuator or an electrically heated linear actuator, such as a shape memory alloy. After being energized, the physical form of the material of the linear actuator, like shape memory alloy, changes, which makes shrinkage deformation of the shape memory alloy occur, thereby outputting the driving force. The higher the current is, the larger the shrinkage deformation of the shape memory alloy occurs, and the greater the driving force outputs. Obviously, when the current is constant, the shrinkage deformation of the linear actuator is also constant, so the driving force is. Therefore, the shape memory alloy can output stable and controllable driving force for drug infusion.

The type, material selection or the position of the reset unit1170are not specifically limited herein, as long as it can satisfy the condition of making the driving unit1150rotate in the reset direction.

The power unit1180is an electrically driven linear actuator or an electrically heated linear actuator. By alternately turning on and off, the power unit1180outputs force in pulses. Specifically, in the embodiment of the present invention, the power unit1180is a shape memory alloy.

FIG. 3a-FIG. 3care top views of the driving portion1151pushing the wheel teeth1141in different embodiments of the present invention.FIG. 4a-FIG. 4care schematic views of the power unit1180, the reset unit1170and the driving unit1150cooperating with each other in different embodiments of the present invention.

As shown inFIG. 3aandFIG. 3b, the principle of the reciprocating rotation of the driving unit1150in the embodiment of the present invention is as follows. When the power unit1180pulls the driving unit1150by force FP, the driving unit1150rotates counter-clockwise (advancing direction) around the pivot shaft1160, driving the driving portion1151to push the wheel teeth1141forward, and thereby making the driving wheel1140rotate. The driving wheel1140then moves the screw1130forward in DAdirection. The reset unit1170, as an elastic member, builds a gradually increasing elastic force FR. When the power unit1180stops applying force and under the action of only the elastic force FR, the driving unit1150will rotate clockwise (reset direction) around the pivot shaft1160. At this time, the driving portion1151just slides on the surface of the wheel teeth1141instead of pushing them, therefore the driving wheel1140stops rotating. The driving unit1150completes one reciprocating rotation.

As shown inFIG. 3b, in another embodiment of the present invention, the reset unit1170and the power unit1180are disposed on the same side of the pivot shaft1160. And according to the general technical principles, those skilled in the art can arbitrarily adjust the positional relationship and the connection relationship of the reset unit1170, the driving unit1150, and the power unit1180, which is not specifically limited herein, as long as the above-mentioned rotation processes can be achieved.

As shown inFIG. 3c, in yet another embodiment of the present invention, the reset unit1170includes an electrically driven linear actuator or an electrically heated linear actuator, such as a shape memory alloy. Although the technical principle that the driving portion1151pushes the wheel teeth1141is consistent with the foregoing, the driving unit1150cannot automatically reset after the driving portion1151stops advancing, therefore, the reset unit1170is required to provide the reset force FBwhose direction is opposite with that of FP, thereby making the driving unit1150rotate reciprocally with the cooperation of the reset unit1170and the power unit1180.

Preferably, as shown inFIG. 3atoFIG. 3c, in the embodiment of the present invention, the directions of FP, FR(or FB) and DAare parallel to one another. This parallel design can make full use of space and optimize the structural relationships inside the infusion unit, making internal structure more compact.

Obviously, those skilled in the art can arbitrarily adjust the directions of the FPand FBas needed, as long as the conditions for reciprocating rotation of the driving unit1150are satisfied, as shown inFIG. 4a-FIG. 4c.

In other embodiments of the present invention, the direction of FPand the direction of FR(or FB) or the direction of DAmay not be parallel, which is not specifically limited herein, as long as the purpose of the reciprocating rotation of the driving unit1150can be achieved.

FIG. 5a-FIG. 5bare schematic views of that the pulling direction of the power unit1180is not parallel to the advancing direction of the screw1130.FIG. 5bis the top view ofFIG. 5a.

The FPdirection of the power unit1180is perpendicular to the forward direction DAof the screw1130. The pivot shaft1160and the reset unit1170are disposed on the base. As described above, the driving unit1150, rotating reciprocally in the R direction, drives the driving portion1151to push the wheel teeth1141, making the driving wheel1140rotate in the W direction and driving the screw1130to advance in the DAdirection. The driving principle of the driving unit1150is consistent with the foregoing embodiment.

In the embodiment of the present invention, blocking walls1171and1172(as shown inFIG. 2andFIG. 3a) that can stop the driving unit1150from rotating are also provided in the infusion unit. And an electrical signal may be triggered when the driving unit1150contacts the blocking wall1171or1172, allowing the program unit to control the driving force output of the power unit1180. In another embodiment of the present invention, only the blocking wall1171or only the blocking wall1172may be provided, so that the rotating terminal in either direction of the driving unit1150is controlled by the program unit. The position of the blocking wall1171or1172is not specifically limited herein, as long as the condition that the driving unit1150stops rotating can be satisfied.

In another embodiment of the present invention, no blocking wall is provided (as shown inFIG. 3btoFIG. 5b), and the rotating terminal of the driving unit1150is completely controlled by the program unit.

FIG. 6andFIG. 7are schematic views of a driving unit including two driving units according to different embodiments of the present invention.

As shown inFIG. 6, the driving unit1250arotates reciprocally in the R direction around the pivot shaft1260under the action of the linear actuator1280aand the reset unit1270a. Similarly, the driving unit1250brotates reciprocally in the R direction around the pivot shaft1260under the action of the linear actuator1280band the reset unit1270b. In the embodiment of the present invention, the reciprocating rotations of the two driving units do not interfere with each other. Therefore, both the driving unit1250aand the driving unit1250bcan independently implement the driving method or principle described above.

Preferably, in the embodiment of the present invention, the driving unit1250aand the driving unit1250brotate asynchronously. That is, when the driving portion1251aof the driving unit1250apushes the wheel teeth1241to move, the driving portion1251bof the driving unit1250bslides on the surface of the wheel teeth1241. When the driving portion1251bslides to one position, the program unit controls the linear actuator1280ato stop outputting driving power to the driving unit1250a, and in turn controls the linear actuator1280bto output power to the driving unit1250b. At this time, the driving unit1250arotates in the clockwise direction under the action of the reset unit1270a, and the driving portion1251aslides on the surface of the wheel teeth, while the driving portion1251bpushes the wheel teeth1241. The driving units1250aand1250bare alternately powered to push the same driving wheels1240.

In the embodiment of the present invention, the pulling force FPof the linear actuators1280aand1280b, the elastic force FRof the reset units1270aand1270band the forward direction DAof the screw1230are shown in the figures. Like foregoing statement, the direction of the pulling force FPis parallel to the forward direction DAof the screw1230.

In the embodiment of the present invention, the types of the reset units1270aand1270bcan be referred to the above, which will not be repeated herein.

As shown inFIG. 7, the driving portions1351aand1351balternately push the wheel teeth1341, respectively, and the force output by the linear actuators1380aand1380bare both controlled by the program unit.

It should be noted that, in the embodiment of the present invention, the direction of the pulling force FP′ of the linear actuator1380aand that of the pulling force FP″ of the linear actuator1380bare opposite. Obviously, the direction of the resetting force FR′ of the reset unit1370aand that of the resetting force FR″ of the reset unit1370bare also opposite.

Also, in the embodiment of the present invention, the driving units1350aand1350brotate asynchronously. That is, when the driving portion1351aof the driving unit1350apushes the wheel teeth1341forward, the driving portion1351bof the driving unit1350bslides on the surface of the wheel teeth1341. When the driving portion1351bslides to one position, the program unit controls the linear actuator1380ato stop outputting power to the driving unit1350a, and in turn controls the linear actuator1380bto output power to the driving unit1350b. The driving unit1350aresets to the clockwise rotation by the reset unit1370a, while the driving portion1351aslides on the surface of the wheel teeth1341, and the driving portion1351bpushes the wheel teeth1341. The driving units1350aand1350balternately pushes the driving wheels1340.

Similarly, both the driving unit1350aand the driving unit1350bcan independently implement the driving method or principle described above. And the types of the reset units1370aand1370bcan be referred to the above, which will not be repeated herein.

It should be noted that, in other embodiments of the present invention, more driving units can be arranged in the driving unit, or more driving portions are disposed on each driving unit, or the driving wheel includes more sub-wheels. Therefore, different driving units respectively push the corresponding sub-wheel to rotate.

FIG. 8aandFIG. 8bare schematic views of two driving portions1451aand1451bof a driving unit1450cooperating with two sub-wheels1440aand1440b, respectively according to yet another embodiment of the present invention.FIG. 8bis a right view of the partial teeth structure of the sub-wheels1440aand1440binFIG. 8a.

As shown inFIG. 8aandFIG. 8b, in the embodiment of the present invention, the driving unit1450includes two driving portions1451aand1451bdisposed left and right, while the driving wheel includes two fixedly connected sub-wheels1440aand1440bdisposed on the left and right (that is, two sub-wheels can move simultaneously). The driving portions1451aand1451bcooperate with the sub-wheels1440aand1440b, respectively, and the pivot shaft1460is disposed on the same side of two sub-wheels1440aand1440b. Both the linear actuator1480and the reset unit1470of the embodiment of the present invention are shape memory alloys, and the driving portion1451aor1451bcan respectively push the wheel teeth1441aor1441bforward. Their working principles and operating modes are consistent with the foregoing embodiments.

In addition to driving portion1451aor1451boperating independently, the embodiment of the present invention can also adjust the distance between the front ends of the driving portions1451aand1451b, or adjust the offset degree of the wheel teeth1441aand1441bto make two driving portions1451aand1451bcooperate with each other. Preferably, in the embodiment of the present invention, the wheel teeth1441aand1441bare offset with degree t, as shown inFIG. 8aandFIG. 8b.

Obviously, in the embodiment of the present invention, two driving portions1451aand1451breciprocate synchronously. As shown inFIG. 8a, when the previous forward movement is completed, the driving unit1450starts a reset rotation, the driving portion1451areaches the driving position before the driving portion1451b, so the driving portion1451acan be used to start the next forward movement instead. Or the driving unit1450continues the reset movement until the driving portion1451breaches the next driving position to start the next forward movement.

FIG. 9aandFIG. 9bare still another embodiment of the present invention in which the driving unit1550includes two driving portions1551aand1551bdisposed up and down, and driving portions1551aand1551bcooperate with the same driving wheel1540.FIG. 9bis a schematic view of the driving unit1550inFIG. 9a.

As shown inFIG. 9aandFIG. 9b, the driving unit1550includes two driving portions1551aand1551bdisposed up and down cooperating with the same driving wheel1540, so the driving portions1551aand1551breciprocate synchronously. The front ends of the driving portions1551aand1551bare not level with a certain distance m, therefore, the two cannot simultaneously push the wheel teeth1541forward, as shown inFIG. 9a. When the driving portion1551bfinishes the last forward movement, the driving unit1550performs a reset movement, obviously making the driving portion1551areach the next driving position before the driving portion1551b. The driving portion1551acan be used to push the wheel teeth1541forward to start the next forward movement.

In other embodiments of the present invention, the driving unit may further include more driving portions, such as 3, 4 or more, which is not specifically limited herein.

FIG. 10a-FIG. 10bare views of a medical device100according to an embodiment of the present invention, and the medical device100is an integral structure.FIG. 10ashows the infusion cannula130in the pre-installation position whileFIG. 10bshows the infusion cannula130in the working position.

Program unit120includes an input end121and an output end122. The input end121is used for receiving a body fluid analyte data signal. In the embodiment of the invention, the input end121includes electrically connective regions121aand121b. When in operation, the electrically connective region is electrically connected to the electrode or electrode lead to receive the analyte signal. In other embodiments of the invention, the input end121may also include more electrically connective regions depending on the number of electrodes. The output end122is electrically coupled to the power unit or the reset unit, allowing the program unit120to effectively control the drug infusion unit110.

During the use of the unilateral-driven medical device with infusion and detection integrated of the embodiment of the present invention, the infusion cannula130can slid relative to the input end121, while the input end121is provided as an elastic member. The elastic member is to ensure an interference fit between the infusion cannula130and the input end121to avoid poor electrical contact. The elastic member includes: conductive rubber strip, oriented conductive silica gel, conductive ring, conductive ball, etc. When the number of electrodes is relatively large, the electrically connective regions are relatively dense. In this case, according to different structural designs, the elastic members may be one or more combinations of the above.

In an embodiment of the invention, the infusion cannula130is mounted on the mounting unit150. When the infusion cannula130is in the pre-installation position, the mounting unit150protrudes from the outer surface of the medical device100, as shown inFIG. 10a. When the infusion cannula130is installed to the working position, the mounting unit150is pressed into the medical device100with the top portion integral with the medical device100housing, as shown inFIG. 10b. Prior to use by users, the mounting unit150holds the infusion cannula130in the pre-installation position. After the medical device100is attached on the surface of the human body, the mounting unit150is pressed to insert the infusion cannula under the skin, and the unilateral-driven medical device with infusion and detection integrated can start operation. Compared with other infusion cannula installation methods, the installation method of the embodiment of the invention reduces the steps required for installation, makes the installation more convenient and flexible and improves the user experience.

The manner of setting the infusion cannula130in the mounting unit150can be various, and is not specifically limited herein. Specifically, in the embodiment of the present invention, the other side of the mounting unit150also protrudes from the partial infusion cannula130(shown by a dotted line inFIG. 10aandFIG. 10b) for subsequent connection with the outlet of the drug infusion unit110to achieve drug circulation.

In other embodiments of the invention, the infusion cannula130further includes an electrical contact region140coupled to the input end121. As shown inFIG. 10a, the electrical contact region140is not electrically coupled to the input end121when the infusion cannula130is in the pre-installation position. And the other end of the infusion cannula130is also not connected with the drug infusion unit110outlet. As shown inFIG. 10b, when the infusion cannula130is mounted to the working position, one end of the infusion cannula130is inserted subcutaneously (indicated by the solid line portion of the infusion cannula inFIG. 10b) and the other end (illustrated by the dotted portion of the infusion cannula inFIG. 10b) is connected with the outlet of the drug infusion unit110, thereby establishing a flow path for the drug from the drug infusion unit110to the body tissue fluid. At the same time, the electrical contact region140reaches the electrically connective region of the input end121, enabling electrical connection between the program unit120and the electrical contact region140.

It should be noted that even if the infusion cannula130and the drug infusion unit110are connected, and the input end121and the electrical contact region140of the infusion cannula130are electrically connected, as long as the infusion cannula130does not penetrate the skin, the program unit120will not enter working mode, so that the unilateral-driven medical device with infusion and detection integrated does not generate any analyte data signal, nor does it issue an instruction to inject drug. Therefore, in other embodiments of the present invention, when the infusion cannula130is in the pre-installation position, the electrical contact region140may also be electrically connected to the electrically connective region of the input end121or the infusion cannula130may be coupled to the outlet of the drug infusion unit110. And there are no specific restrictions herein.

In an embodiment of the invention, a medical tape160for attaching the medical device100to the skin surface is used to paste the program unit120, the drug infusion unit110, the electrode and the infusion cannula130as a whole on the skin. When the infusion cannula130is installed to the working position, the portion of the infusion cannula130that is inserted into the skin is13.

FIG. 11ais a top view of a medical device100in accordance with another embodiment of the present invention.

In one embodiment of the invention, the medical device100comprises two parts. The program unit120is disposed in one part, the drug infusion unit110is disposed in another part, and the two parts are electrically connected by the waterproof electrical plug123. The part of the drug infusion unit110can be discarded after being used once, and the part of the program unit120can be reused, saving the users cost.

In other embodiments of the present invention, the medical device100may also be composed of more parts, and parts that do not require electrical connection may be connected using a common waterproof plug.

FIG. 11bis a top view of a medical device100in accordance with another embodiment of the present invention.

In an embodiment of the invention, the medical device100comprises two parts, and the drug infusion unit110comprises two infusion subunits110aand110b. The drug storage units of the infusion subunits110aand110bcan be used to reserve different drugs, respectively. Infusion subunits110aand110bare electrically coupled to outputs122aand122b, respectively, allowing the program unit120to effectively control the drug infusion unit110. The outlets of infusion subunits110aand110bcan be connected with the130aportion and130bportion of infusion cannula respectively.130aand130bare connected with the130cportion of infusion cannula, respectively. The130cportion of the infusion cannula is used to penetrate the skin, thereby establishing a path for the two drugs to flow from the drug infusion unit110into the body fluid. That is, the medical device still penetrates the skin only in one position. In the embodiment of the present invention, after the body fluid analyte data signal is transmitted to the program unit120, program unit120can output different infusion signals to different infusion subunits to control whether infusion of drug is required. This method realizes accurate detection and control of body fluid analyte level to stabilize the physiological state of the user.

In other embodiments of the present invention, there may be more infusion subunits according to actual needs, and multiple infusion subunits may be disposed in different parts of the medical device100. There are no specific restrictions herein.

FIG. 12a-FIG. 12bare partial longitudinal views of the infusion cannula130including two electrodes.

In the embodiment of the invention, the medical device100includes at least two detecting electrodes that are disposed on the wall of the infusion cannula130, as shown inFIG. 12a. The different electrodes are electrically connected to the electrically connective regions at the position of the dotted frame140. The cavity131of the infusion cannula130is used for drug infusion.

In the embodiment of the present invention, the electrodes, such as electrode171and electrode172, are plated on the outer surface of the cannula wall of the infusion cannula130. The electrode171and the electrode172, electrically insulated from each other, are directly electrically connected to the electrically connective regions121aand121bof the input end, respectively, which allows electrical signals of the body fluid analyte data to be transmitted to program unit120, as shown inFIG. 12b. Once the puncture is performed at one position, the analyte detection and the drug infusion can be completed simultaneously, reducing the risk of the user's infection.

It should be noted that, in the embodiment of the present invention, when the infusion cannula130is mounted to the working position, a part of the electrode171or the electrode172is located in the subcutaneous tissue fluid, while another part is located above the skin, so that electrical signals can be transmitted on the electrode. The corresponding electrode arrangements in the other embodiments below have the same function and will not be described in detail later.

In the embodiment of the present invention, the medical device100has only two electrodes, the electrode171is a working electrode while the electrode172is an auxiliary electrode. In another embodiment of the invention, the electrode171is an auxiliary electrode while the electrode172is a working electrode. The auxiliary electrode is a counter electrode.

In other embodiments of the present invention, more electrodes, which are electrically insulated from each other, may be provided on the surface of the infusion cannula130.

FIG. 13a-FIG. 13care partial longitudinal views of an infusion cannula130in accordance with another embodiment of the present invention.

It should be noted that the electrodes or electrode leads in all embodiments of the present invention are coated or plated on the infusion cannula130, but for ease of marking and description, the electrode leads or electrodes and the infusion cannula will be depicted separately in the FIGs. The following related structural views are the same as those here, which will not be described in detail below.

In this embodiment, the cannula wall132of the infusion cannula130provides with the electrode271and the electrode272. And the electrode271is directly electrically connected to the electrically connective regions121a, such as the electrode171inFIG. 12a. The electrode272is disposed at the front end of the infusion cannula130. And an electrode lead2720is used to electrically connect to the electrode272and the electrically connective regions121b. When the infusion cannula130is mounted to the working position, the electrode272is located on the subcutaneous part of the outer surface of the cannula wall132, while a part of the electrode272is located in the subcutaneous tissue fluid and another part is located above the skin. At this time, the electrode272is indirectly electrically connected to the electrically connective regions121b, sending parameter information to the program unit.

The embodiment of the present invention does not specifically limit the shape of the electrode272. If the electrode272may be ring-shaped, the electrode272surrounds the front end of the infusion cannula130, as shown inFIG. 13b. At this time, an insulation layer is provided between the electrode272and the electrode271. As shown inFIG. 13c, in yet another embodiment of the present invention, the electrode271and the electrode272are both provided at the front end of the infusion cannula130, that is, on the subcutaneous part of the outer surface of the cannula wall. The outer surface of the cannula wall132is also provided with an electrode lead2710and an electrode lead2720that are electrically connected to the electrode271and the electrode272, respectively. When the infusion cannula130is installed to the working position, the electrically connective regions121aand121bat the input end are electrically connected to the electrode lead2710and the electrode lead2720, respectively. Therefore, the electrode271and the electrode272are indirectly electrically connected to the input end, transmitting the body fluid parameter signal to the program unit. During detection, both the electrode271and the electrode272are located in the subcutaneous tissue fluid.

As shown inFIG. 13c, the electrode272is arranged in a ring shape surrounding a part of the outer surface of the cannula wall132. The electrode271and the electrode272may have other shapes, which is not specifically limited herein.

FIG. 14is a partial longitudinal view of an infusion cannula130provided with three electrodes in accordance with yet another embodiment of the present invention.

In the embodiment of the present invention, three electrodes are disposed on the infusion cannula130: the electrode371,372and373which are all disposed on the outer surface of the cannula wall132. Similarly, the surface of the cannula wall132is also provided with electrode leads3720and3730which are electrically connected to the electrode372and the electrode373, respectively. Similarly, the outer surface of the cannula wall132is also provided with an electrode lead electrically connected to the electrode371, but it is not shown in order to simplify the marking. When the infusion cannula130is installed to the working position, the electrode lead of the electrode371, electrode lead3720and electrode lead3730are electrically connected to the electrically connective regions121a,121b, and121cof the input end, respectively, connecting the input end to each electrode. The shapes of the three electrodes can be various, and there is no specific limitation herein.

In the embodiment of the present invention, in order to simplify the design of the electrically connective region, the elastic member at the input end is an oriented conductive silica gel or a conductive ring. By doping different elements in the silica gel, it is possible to achieve directional conduction, such as horizontal conduction or vertical conductivity. Thus, even if121aand121care adjacent to each other, the two can still be electrically insulated from each other. The electrically connective region121bmay be a conductive rubber strip or a conductive ball or the like, and is not specifically limited herein.

In the embodiment of the present invention, the electrode371is a working electrode, and the electrode372and the electrode373are both auxiliary electrodes. At this time, the electrode371and the electrode372or the electrode373may constitute a different electrode combination, that is, the two electrode combinations share the electrode371. The program unit120can select different electrode combinations to detect body fluid analyte data. After the electrode combination is formed, on the one hand, when a working electrode combination fails to detect, the program unit120can select other electrode combinations for detection according to the situation to ensure that the detection process of the body fluid signal is uninterrupted. On the other hand, the program unit120can select a plurality of electrode combinations to work simultaneously, perform statistical analysis on multiple sets of data of the same parameter at the same time, improve the accuracy of the analyte data, and thereby output a more accurate drug infusion signal.

In another embodiment of the present invention, the electrode371, electrode372, and electrode373include an auxiliary electrode and two working electrodes, which can also be arbitrarily selected according to actual needs, which are not specifically limited herein.

As an embodiment of the present invention, the electrode371is a working electrode, the electrodes372and373are auxiliary electrodes which are used as a counter electrode and a reference electrode, respectively, thereby forming a three-electrode system. Similarly, the three electrodes can be arbitrarily selected according to actual needs, which are not specifically limited herein.

Also, in other embodiments of the invention, more electrodes may be provided. The system includes a plurality of working electrodes and a plurality of auxiliary electrodes. At this time, each electrode combination includes at least a working electrode and an auxiliary electrode, and thus a plurality of electrodes may constitute a plurality of electrode combinations. The program unit120may select one or more electrode combinations to detect body fluid analyte data, as desired.

FIG. 15is a partial longitudinal view of an infusion cannula130including an inner layer cannula170and one outer layer cannula180in accordance with yet another embodiment of the present invention.

The cavity131of the inner layer cannula170is used as a drug infusion channel. The cannula wall of the infusion cannula130includes the inner layer cannula wall and the outer layer cannula wall. The electrode472is disposed outside the cannula wall of the inner layer cannula170, while the electrode471is provided on the outer surface of the wall of the outer layer cannula180. At this time, the electrode472is disposed in the wall of the infusion cannula130, that is, the electrode472is embedded between the outer layer cannula180and the inner layer cannula170.

In the embodiment of the present invention, the electrode472may be partially covered by the outer layer cannula180(as shown inFIG. 15), or completely covered by the outer layer cannula180. The electrode472is electrically connected to the electrically connective region121bthrough an electrode lead4720, while the electrode471is electrically connected to the electrically connective region121athrough an electrode wire4710. When the electrode472is partially or completely covered by the outer layer cannula180, the wall material of the outer layer cannula180is a permeable membrane or a semi-permeable membrane. Such selection can facilitate the body fluid analyte to pass through the wall of the outer layer cannula180and to be detected by the electrode, thereby improving the flexibility of electrode position design without affecting the detection.

In another embodiment of the present invention, the electrode471and the electrode472are both disposed in the wall of the infusion cannula130, that is, the electrode471and the electrode472, which are completely covered by the outer layer cannula180, are both embedded between the inner layer cannula170and the outer layer cannula180. At this time, the material of the outer layer cannula180is as described above, which makes analytes detected by the electrode through the outer layer cannula180.

It should be noted that, in other embodiments of the present invention, more layers of outer layer cannulas may be arranged outside the inner layer cannula170. And as described above, more electrodes can be provided on the infusion cannula130. According to actual needs, different electrodes can be arranged between different outer layer cannulas. And at least one electrode is disposed between the wall of the inner layer cannula and the outermost cannula.

In addition to embedding electrodes into the wall of the infusion cannula130, some embodiments of the present invention can also reduce the length of the outer layer cannula180inFIG. 15, directly exposing the electrode472disposed on the outer surface of the inner layer cannula170in tissue fluid.

In summary, the present invention discloses a unilateral-driven medical device with infusion and detection integrated that has both infusion and detection functions to reduce the number of punctures on the skin. With only one puncture at one position, analyte detection and drug infusion can be completed, reducing the risk of infection.

While the invention has been described in detail with reference to the specific embodiments of the present invention, it should be understood that it will be appreciated by those skilled in the art that the above embodiments may be modified without departing from the scope and spirit of the invention. The scope of the invention is defined by the appended claims.