A medical device

By using a combination of catheter and controller, the delivery parameters of the drug solution are adjusted by intracranial electrical signals, which solves the accuracy problem of intracranial injection therapy in existing technologies and achieves precise drug delivery and improved treatment efficacy for Parkinson's disease.

CN115105675BActive Publication Date: 2025-12-05SHANGHAI NEURAZING CO LTD
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Patent Information

Application Number
CN202110291870.9
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2021-03-18
Publication Date
2025-12-05
Estimated Expiration
2041-03-18

AI Technical Summary

Technical Problem

Current methods of intracerebral injection for Parkinson's disease require professionals to regularly adjust the drug dosage, making it difficult to ensure accurate medication and affecting treatment outcomes.

Method used

The device employs a combination of catheter, pump, and controller. By sensing intracranial electrical signals through electrodes at the distal end of the catheter, the controller adjusts the drug delivery parameters based on the electrical signals, enabling automatic or manual adjustment of drug delivery.

Benefits of technology

It improves the accuracy of drug injection and treatment effectiveness, reduces reliance on the experience of professionals, and enhances the precision and flexibility of treatment.

✦ Generated by Eureka AI based on patent content.

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Abstract

The application provides a medical device, comprising: a catheter, comprising a tube body and a first electrode, the tube body is arranged on a predetermined object and used for delivering a drug liquid to a target area; the first electrode is arranged at a distal end of the tube body and used for sensing an electrical signal of the target area; a pump is connected with a proximal end of the tube body and used for delivering the drug liquid to the tube body; and a controller is connected with the first electrode and the pump in communication and configured to receive the electrical signal, adjust a delivery parameter of the drug liquid according to the electrical signal, and control the pump to deliver the drug liquid to the tube body according to the delivery parameter. The application has the advantages of adjusting the delivery parameter of the drug liquid according to the electrical signal of the target area, improving the accuracy of drug delivery, and improving the treatment effect.
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Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a medical device. BACKGROUND

[0002] Parkinson patients mostly have symptoms such as resting tremor, muscle rigidity, bradykinesia, gait freezing, etc. The treatment of Parkinson patients in the prior art mainly includes deep brain stimulation combined with rehabilitation training, oral drug treatment and intracerebral injection treatment. Among them, deep brain stimulation combined with rehabilitation training and oral drug treatment can only improve the symptoms of patients in the early and middle stages of the disease, but cannot avoid the degeneration or death of brain dopamine neurons and cannot completely prevent the deterioration of the disease. Intracerebral injection treatment points to the injection of dopamine neurotrophic factor (CDNF) into the brain. CDNF is a protein that can protect and restore the function of dopamine neurons, and it is of great significance for the treatment of Parkinson's disease.

[0003] The intracerebral injection treatment scheme in the prior art can be achieved by implanting a long-term implantable catheter in the brain and directly injecting CDNF into the target area in the brain through the catheter, or placing a drug capsule in the brain to release CDNF to the target area through the drug capsule. This treatment scheme requires a professional with certain medical knowledge to regularly supplement the injection, or a professional to adjust the dosage of CDNF according to the patient's symptoms and experience, which is difficult to ensure accurate medication and is not conducive to improving the treatment effect. SUMMARY

[0004] The purpose of the present application is to provide a medical device which can be used for the treatment of Parkinson's disease and accurately control the dosage of intracerebral injection according to the actual situation of the patient to improve the treatment effect.

[0005] To achieve the above-mentioned purpose, the present application provides a medical device, characterized in that it comprises:

[0006] a catheter comprising a catheter body and a first electrode, the catheter body being arranged on a predetermined object and being used to deliver a drug liquid to a target area, and the first electrode being arranged at the distal end of the catheter body and being used to sense an electrical signal of the target area;

[0007] a pump connected to the proximal end of the catheter body and used to deliver a drug liquid to the catheter body; and

[0008] a controller in communication connection with the first electrode and the pump and configured to receive the electrical signal and adjust the delivery parameters of the drug liquid according to the electrical signal, and control the pump to deliver the drug liquid to the catheter body according to the delivery parameters.

[0009] Optionally, the number of the first electrodes is at least one; when the number of the first electrodes is more than two, the more than two first electrodes are arranged in an axial direction on the outer surface of the distal end of the tube body.

[0010] Optionally, each of the first electrodes extends in a circumferential direction of the tube body.

[0011] Optionally, the number of the first electrodes is one, and the first electrode is arranged at the distal end of the tube body; the tube body has a liquid flow channel extending in an axial direction thereof, and a liquid outlet arranged on a distal side wall of the tube body and in communication with the liquid flow channel.

[0012] Optionally, the first electrode has a conical, semi-elliptical or semi-spherical shape. Optionally, the number of the pumps is one, and the delivery parameter includes at least one of a frequency of delivery of the liquid, a volume of the liquid delivered each time, and a delivery rate.

[0013] Optionally, the number of the pumps is more than one, and the more than one pump is connected to the proximal end of the tube body through a connecting tube and used to deliver different liquids to the tube body, and the delivery parameter includes at least one of a frequency of delivery of the liquid, a volume of the liquid delivered by each of the pumps each time, and a delivery rate.

[0014] Optionally, the controller is configured to have a first control mode and / or a second control mode.

[0015] When the controller executes the first control mode, the controller is configured to automatically adjust the delivery parameter according to the electrical signal.

[0016] When the controller executes the second control mode, the controller is configured to further display the electrical signal, and to receive and execute an adjustment instruction based on the electrical signal, to adjust the delivery parameter according to the adjustment instruction.

[0017] Optionally, the controller has both the first control mode and the second control mode, and includes a first sub-controller and a second sub-controller arranged separately and in communication with each other; the first sub-controller is in communication with the first electrode and the pump, and configured to control the pump to deliver the liquid to the tube body according to the delivery parameter.

[0018] When the controller executes the first control mode, the first sub-controller is further configured to automatically adjust the delivery parameter according to the electrical signal.

[0019] When the controller executes the second control mode, the second sub-controller is configured to display the electrical signal, and to input and send the adjustment instruction to the first sub-controller; the first sub-controller is further configured to execute the adjustment instruction.

[0020] Optionally, the second sub-controller is further configured to receive a selection instruction, and to execute the first control mode or the second control mode according to the selection instruction.

[0021] Optionally, the first sub-controller is arranged on the predetermined object.

[0022] Optionally, the first sub-controller is an adaptive controller, and the first sub-controller and the pump are integrated into an adaptive pumping system.

[0023] Optionally, a catheter interface is arranged on the adaptive pumping system, and a third electrode in communication with the first sub-controller is arranged at the catheter interface; the catheter further comprises a second electrode arranged at the proximal end of the tube body and in communication with the first electrode; the proximal end of the tube body is inserted into the electrode interface and extends to be connected with the pump, and the second electrode is electrically connected with the third electrode, so that the first electrode is in communication with the first sub-controller.

[0024] Optionally, a catheter interface is arranged on the adaptive pumping system; the proximal end of the tube body is inserted into the catheter interface and connected with the pump; the catheter further comprises a wire, which is partially arranged in the side wall of the tube body, and the distal end of the wire is connected with the first electrode, and the proximal end of the wire extends out of the proximal end of the tube body and into the adaptive pumping system and is electrically connected with the first sub-controller.

[0025] Optionally, the first sub-controller comprises a control module, a wireless communication module, a battery and a charging coil; the control module is in communication with the first electrode and the pump, for receiving the electrical signal, and for adjusting the delivery parameter and controlling the pump to deliver the liquid medicine to the tube body according to the delivery parameter; the wireless communication module is used to connect the control module with the second sub-controller; the battery is used to supply power to the control module and the wireless communication module; and the charging coil is used to wirelessly charge the battery.

[0026] Optionally, the pump includes a drug liquid tank and a pushing unit; the drug liquid tank is configured to store drug liquid and has an output interface connected with the proximal end of the tube; the pushing unit is at least partially arranged in the drug liquid tank and is in communication with the controller, and is configured to move in a direction close to the output interface under the control of the controller to push drug liquid into the tube.

[0027] Optionally, the pump further includes a first one-way valve arranged at the output interface, and configured to open to allow drug liquid to enter the tube when the pump delivers drug liquid to the tube.

[0028] Optionally, the controller is in communication with the first one-way valve and is configured to adjust a valve parameter according to the delivery parameter.

[0029] Optionally, the drug liquid tank further has an input interface; and the medical device further includes an infusion port configured to be fixed on the predetermined object and connected with the input interface to supplement drug liquid to the drug liquid tank.

[0030] Optionally, the medical device further includes a second one-way valve arranged at the input interface and configured to open to allow drug liquid to enter the drug liquid tank when the infusion port supplements drug liquid to the drug liquid tank.

[0031] Compared with the prior art, the medical device has the following advantages:

[0032] First, the aforementioned medical device includes a catheter, a pump and a controller; the catheter includes a tube and a first electrode, the tube is configured to be arranged on a predetermined object and to deliver drug liquid to a target region; the first electrode is arranged at the distal end of the tube and is configured to sense an electrical signal of the target region; the pump is connected with the proximal end of the tube and is configured to deliver drug liquid to the tube; the controller is in communication with the first electrode and the pump, configured to receive the electrical signal and adjust a delivery parameter of drug liquid according to the electrical signal, and control the pump to deliver drug liquid to the tube according to the delivery parameter. By sensing the electrical signal by the first electrode and feeding back to the controller, the delivery parameter of drug liquid can be adjusted according to the electrical signal, the accuracy of drug delivery is improved, and the treatment effect is improved.

[0033] Second, the controller can automatically adjust the delivery parameter of drug liquid according to the electrical signal, or can display the electrical signal, so that professionals can obtain the electrical signal and issue an adjustment instruction based on the electrical signal, so that the controller executes the adjustment instruction to realize the adjustment of the delivery parameter of drug liquid. That is, the medical device has multiple control modes, which can be selected according to actual needs, and is convenient and flexible to use. BRIEF DESCRIPTION OF DRAWINGS

[0034] The accompanying drawings are used to better understand the present application, and do not constitute undue limitations on the present application. Among them:

[0035] Figure 1 is a schematic diagram of a use scenario of a medical device provided by the present application according to an embodiment, in which a second sub-controller is not shown;

[0036] Figure 2 is a schematic diagram of a use scenario of a medical device provided by the present application according to an embodiment, in which a second sub-controller is shown;

[0037] Figure 3 is a schematic diagram of a structure of a catheter of a medical device provided by the present application according to an embodiment;

[0038] Figure 4 is a schematic diagram of a structure of a catheter of a medical device provided by the present application according to another embodiment;

[0039] Figure 5 is a schematic diagram of a structure of a catheter of a medical device provided by the present application according to an embodiment; Figure 4 is an A-A sectional view of a catheter of a medical device shown in the figure;

[0040] Figure 6 is a schematic diagram of a control logic relationship of a medical device provided by the present application according to an embodiment in which a second control mode is executed;

[0041] Figure 7 is a schematic diagram of a structure of an adaptive pumping system of a medical device provided by the present application according to an embodiment in one direction;

[0042] Figure 8 is a schematic diagram of a structure of an adaptive pumping system of a medical device provided by the present application according to an embodiment in another direction;

[0043] Figure 9 is a schematic diagram of a partial structure of an adaptive pumping system of a medical device provided by the present application according to an embodiment;

[0044] Figure 10 is a more detailed schematic diagram of a control logic relationship of a medical device provided by the present application according to an embodiment;

[0045] Figure 11 is a schematic diagram of a structure of an infusion port of a medical device provided by the present application according to an embodiment.

[0046] [The following reference signs are used in the drawings:]

[0047] 100 - catheter, 110 - tube body, 111 - drug liquid flow channel, 112 - drug liquid outlet, 120 - first electrode, 130 - second electrode;

[0048] 200 - pump, 210 - liquid medicine tank, 211 - output interface, 212 - input interface, 220 - pushing part, 230 - first one-way valve;

[0049] 310 - first controller, 311 - control module, 311a - adaptive control circuit, 311b - storage unit, 312 - wireless communication module, 313 - battery, 314 - charging coil, 320 - second sub-controller;

[0050] 400 - infusion port, 410 - subcutaneous catheter, 420 - injection part on skin, 421 - support, 422 - blocking diaphragm, 423 - end cap;

[0051] 10 - adaptive pumping system;

[0052] 1 - fixing frame. DETAILED DESCRIPTION

[0053] Other advantages and benefits of the present application will become apparent to those skilled in the art upon consideration of the disclosure or can be learned by practice of the application. The application can be realized and achieved by means of the structures and combinations described in this specification and it is therefore to be understood that various modifications and changes can be made by those skilled in the art without departing from the spirit and scope of the present application. It is to be understood that the drawings herein are only intended to illustrate the essential characteristics of the application, and therefore the design, number, shape and arrangement of the components shown in the drawings are not to be construed as limiting the scope of the application. In fact, the components shown in the drawings can be arbitrarily changed in shape, size and arrangement, and the layout of the components can be more complex.

[0054] In addition, each of the embodiments described below has one or more technical features, but this does not mean that the user of the present application must simultaneously implement all the technical features in any embodiment, or can only separately implement one or all technical features in different embodiments. In other words, under the premise of implementation, those skilled in the art can selectively implement part or all of the technical features in any embodiment according to the disclosure of the present application, and according to the design specification or implementation requirements, or selectively implement a combination of part or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present application.

[0055] As used in this specification, the singular forms "a," "an" and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense of "and / or" unless the content clearly dictates otherwise. As used in this specification, the terms "have," "has," "have been," "has been," "having" or variants thereof are used in the sense of possession and affiliation, such that "A has B" means that A can possibly possess B or be affiliated with B. The terms "mounting," "connected," "connecting," should be interpreted broadly, for example, can be fixed connection, can also be detachable connection, or integral connection. It can be mechanical connection, can also be electrical connection. It can be directly connected, can also be indirectly connected through an intermediate medium, can be internal communication of two elements or interaction relationship of two elements. The specific meaning of the above terms in the present application can be understood according to the specific circumstances by those skilled in the art.

[0056] As described in the background, in the prior art, when treating Parkinson's disease by intracerebral injection, the professional personnel mainly supplements the drug solution or adjusts the drug injection dose according to the symptoms of the patient and combined with personal experience, which is subjective and difficult to accurately deliver the drug to the patient. The applicant found that the local field potential (LFP) in the brain as an extracellular field potential, including but not limited to Delta (0-4 Hz), Theta (4-8 Hz), Alpha (8-12 Hz), Beta (12-30 Hz), Gamma (30-80 Hz) and other electrical wave signals near the target point in the brain. The severity of the motor symptoms of Parkinson's patients has a statistical correlation with the signal strength of LFP. Therefore, the applicant proposes to adjust the relevant parameters of intracerebral injection according to the strength of LFP signal at the target point in the brain, so as to improve the accuracy of drug delivery and improve the treatment effect.

[0057] To achieve the above object, the core idea of the present application is to provide a medical device, comprising a catheter, a pump and a controller. The catheter comprises a tube and a first electrode, the tube is arranged on a predetermined object and used to deliver a drug to a target area; the first electrode is arranged at the distal end of the tube and used to sense the electrical signal of the target area. The pump is connected to the proximal end of the tube and used to deliver the drug to the tube. The controller is in communication connection with the first electrode and the pump, used to receive the electrical signal and adjust the delivery parameters of the drug according to the electrical signal, and control the pump to deliver the drug to the tube according to the delivery parameters. The medical device can be used for various intracerebral injection treatments such as intracerebral injection treatment of Parkinson's disease, or injection treatment of other parts of the patient. For the treatment of Parkinson's disease, the predetermined object refers to the skull, the target area refers to the target area in the brain, and the electrical signal refers to the LFP signal. That is, in the present application, the LFP signal of the target area in the brain sensed by the first electrode is adjusted according to the LFP signal to improve the accuracy of drug delivery and improve the treatment effect.

[0058] The term "distal end of the tube" herein refers to the end of the tube close to the target area during use, and the distal end has a certain length, and the proximal end is the end of the tube close to the pump and also has a certain length.

[0059] To make the object, advantages and features of the present application clearer, the following will further illustrate the present application with reference to the accompanying drawings. It should be noted that the drawings are very simplified and all use non-precise proportions, only to facilitate and clearly assist the purpose of illustrating the embodiments of the present application. The same or similar reference signs in the drawings represent the same or similar parts.

[0060] Figure 1 and Figure 2 The use scenario of the medical device provided by the present application is shown, Figure 3 and Figure 4 The structure of the catheter of the medical device is shown. Herein, the use of the medical device for intracerebral injection of patients to treat intracranial brain tissue lesions such as Parkinson's disease is taken as an example for illustration. In this way, the medical device is used to be at least partially fixed on the skull (i.e. the aforementioned predetermined object).

[0061] Please refer to Figures 1 to 4 The medical device comprises a catheter 100, a pump 200 (such as Figure 7The medical device comprises a catheter, a pump and a controller. The catheter 100 comprises a tube 110 and a first electrode 120. The tube 110 is arranged on the skull and is used to deliver a drug solution to a target site in the brain (i.e. the target region mentioned above). The first electrode 120 is arranged at the distal end of the tube 110 and is used to sense an electrical signal at the target site. The pump 200 is connected to the proximal end of the tube 110 and is used to deliver the drug solution to the tube 110. The controller is communicatively connected to the first electrode 120 and the pump 200, receives the electrical signal and adjusts the delivery parameters of the drug solution according to the electrical signal, and controls the pump to deliver the drug solution to the tube 110 according to the delivery parameters. Here, the electrical signal is preferably an LFP signal. The drug solution includes, but is not limited to, dopamine neurotrophic factor (CDNF), ventricular antibiotics, prazosin, urokinase and other drug solutions that can be directly used for intracranial brain tissue lesion treatment.

[0062] By arranging the first electrode 120 on the tube 110 to collect the electrical signal at the target site in the brain and feed back to the controller, the delivery parameters of the drug solution can be adjusted according to the electrical signal to achieve the purpose of accurate drug delivery and improved treatment effect. It can be understood that in some embodiments, in order to make the structure of the medical device more compact, the number of pumps 200 is one and is used to deliver a single drug solution or a mixture of multiple drug solutions to the tube 110. At this time, the delivery parameters include at least one of the delivery frequency of the drug solution, the dose of the drug solution delivered each time and the delivery rate. In actual use, if the actual electrical signal deviates from the normal electrical signal, the delivery frequency of the drug solution, the dose of the drug solution delivered each time and the delivery rate can be increased accordingly. If the actual electrical signal tends to be normal, the delivery frequency of the drug solution, the dose of the drug solution delivered each time can be reduced, and the specific setting is according to the actual needs. In other embodiments, the number of pumps 200 is multiple, and multiple pumps 200 are respectively connected to the proximal end of the tube 110 through connecting tubes (not shown in the figure) and are used to deliver different drug solutions to the tube 110. In this case, the delivery parameters include at least one of the frequency of delivering the drug solution, the volume of the drug solution delivered by each pump each time and the delivery rate. By arranging multiple pumps 200, the accuracy of drug delivery can be further improved and the treatment effect can be improved.

[0063] The controller can automatically adjust the delivery parameter according to the electrical signal, or adjust the delivery parameter under intervention of a professional. The two control modes are referred to as a first control mode and a second control mode herein. That is, when the controller executes the first control mode, the controller automatically adjusts the delivery parameter according to the electrical signal, and when the controller executes the second control mode, the controller is further configured to display the electrical signal, so that a professional can intuitively obtain the electrical signal, and then can make an adjustment instruction according to the electrical signal, and then the controller receives and executes the adjustment instruction to realize adjustment of the delivery parameter. It should be noted that the controller displays the electrical signal, which not only includes displaying the actual value of the electrical signal, but also can include displaying parameter information related to the electrical signal, such as a related curve of the electrical signal, a deviation curve of the actual value of the electrical signal from a normal electrical signal, and the like.

[0064] Preferably, the controller has both the first control mode and the second control mode, and is further configured to receive a selection instruction and determine to execute the first control mode or the second control mode according to the selection instruction.

[0065] Please refer to Figure 1 , Figure 2 and in combination with Figure 7 , the controller can include a first sub-controller 310 and a second sub-controller 320 arranged separately, wherein the first sub-controller 310 is arranged on the skull and is in communication connection with the first electrode 120 and the pump 200, that is, the first sub-controller 310 is configured to receive the electrical signal collected by the first electrode 120 and control the pump to deliver the drug liquid to the tube 110 according to the delivery parameter. The first sub-controller 310 is preferably a self-adaptive controller. The second sub-controller 320 is in communication connection with the first sub-controller 310, and the second sub-controller 320 is provided with an input module and a display module. The input module is configured to input the selection instruction and the adjustment instruction, and the display module is configured to display the electrical signal. It should be understood that the second sub-controller 320 can be a mobile phone, an IPAD, a computer, or a special control mechanism, and the like various intelligent control devices, and the input module can be a keyboard or a virtual input key on the display module, which is not limited in the present application.

[0066] When the controller executes the first control mode, the second sub-controller 320 can be used no more after inputting the corresponding selection instruction, and then the first sub-controller 310 receives the electrical signal and directly adjusts the delivery parameter according to the electrical signal. When the controller executes the second control mode, as Figure 6As shown, the first electrode 120 collects the electrical signal, which is received by the first sub-controller 310 and sent to the second sub-controller 320 for display. Then, the professional makes adjustment instructions according to the electrical signal, which are input into the second sub-controller 320, and then sent to the first sub-controller 310 by the second sub-controller 320. Finally, the first sub-controller 310 executes the adjustment instructions to complete the adjustment of the delivery parameters and performs drug delivery according to the delivery parameters. It should be known that when the controller only has the first control mode, the second sub-controller can be omitted.

[0067] Next, the preferred structure of the medical device will be described in detail in combination with the drawings, but the preferred structure is only an optional specific implementation manner of the medical device of the present application, which is not necessarily selected, and thus should not constitute a limitation to the present application.

[0068] Please refer to Figure 7 and Figure 8 , preferably, the first sub-controller 310 and the pump 200 are integrated into a self-adaptive pumping system 10, and are arranged integrally on the skull, reducing the implantation procedure of the medical device and shortening the time of implantation surgery.

[0069] Please continue to refer to Figure 7 , Figure 8 and in combination with Figure 10 , the first sub-controller 310 and the second sub-controller 320 are preferably connected in a wireless manner. Thus, the first sub-controller 310 can include a control module 311, a wireless communication module 312, a battery 313, and a charging coil 314. Among them, the control module 311 can specifically include an adaptive control circuit 311a and a storage unit 311b, the adaptive control circuit 311a can be connected in communication with the first electrode 120 in a wired manner, connected in communication with the pump 200 in a wired or wireless manner, and connected in communication with the second sub-controller 320 through the wireless communication module 312. That is, the adaptive control circuit 311a is used to receive the electrical signal, adjust the delivery parameters (automatic adjustment or adjustment according to adjustment instructions), and control the pump 200 to deliver the drug liquid to the tube body 110. The storage unit 311b is connected in communication with the adaptive control circuit 311a, which is used to store the delivery parameters. The battery 313 is used to supply power to the control module 311 and the wireless communication module. The charging coil 314 is used for wireless charging of the battery 313, so that the self-adaptive pumping system 10 can work for a long time. The specific arrangement of the first sub-controller 310 is known to those skilled in the art, which will not be described here.

[0070] Please refer to Figure 9 , the overall configuration of the pump 200 can be similar to a syringe, which includes a drug reservoir 210 and a pusher 220. The drug reservoir 210 is used to store drug liquid and has an output interface 211 connected with the proximal end of the tube 110. The pusher 220 is at least partially disposed in the drug reservoir 210 and is in communication with the first sub-controller 310, and the pusher 220 is used to move in the direction close to the output interface 211 under the control of the first sub-controller 310 (in particular, the adaptive control circuit 311a) and push drug liquid to the tube 110 to deliver drug liquid to the target point.

[0071] It should be understood that the pump 200 further includes a first one-way valve 230 (as shown in Figure 10 ) disposed at the output interface 211, and the first one-way valve 230 is used to open when the pump 200 delivers drug liquid to the tube 110 to allow drug liquid to enter the tube 110. In some embodiments, the first one-way valve 230 is a membrane structure, and the opening degree thereof is determined by the pressure generated by the pusher 220 when pushing drug liquid, so that the first sub-controller 310 can determine the pusher parameters of the pusher 220 according to the delivery parameters to make drug liquid be delivered to the target point at a predetermined delivery rate and delivery amount. The pusher parameters include but are not limited to the push rate and the push time. In other embodiments, the first one-way valve 230 is a mechanical valve driven by a micro motor, and the motor is in communication with the adaptive control circuit 311a of the first sub-controller 310, and the adaptive control circuit 311a can control the motor to work according to the output parameters to control the valve parameters of the mechanical valve, and the valve parameters include but are not limited to the opening degree and the opening time of the first one-way valve 230. Therefore, the adaptive control circuit 311a can determine the valve parameters and the pusher parameters of the pusher 220 according to the delivery parameters to control the delivery of drug liquid.

[0072] Further, please refer to Figure 9 and combine with Figure 7The medicine liquid tank 210 also has an input interface 212, which can be arranged on the end of the medicine liquid tank 210 provided with the output interface 211, i.e. the input interface 212 is located on the same side of the pushing part 220 as the output interface 211. The medical device also comprises infusion ports 400, which are used to be fixed on the skull and connected with the input interface 212, for supplementing medicine liquid to the medicine liquid tank 210. The infusion ports 400 are arranged in one-to-one correspondence with the pumps 200. In other words, when the medical device comprises only one pump 200, the number of the infusion ports 400 is also one. When the medical device comprises a plurality of pumps 200, the number of the infusion ports 400 is also a plurality, one infusion port 400 communicates with the medicine liquid tank 210 of one pump 200, i.e. each infusion port 400 is used to supplement medicine liquid to the corresponding medicine liquid tank 210.

[0073] The structure of the infusion port 400 can refer to Figure 11 which comprises a subcutaneous catheter 410 and a skin injection part 420, two ends of the subcutaneous catheter 410 are connected with the skin injection part 410 and the input interface 212 respectively. The skin injection part 420 comprises a support 421, a blocking diaphragm 422 and an end cover 423, the support 421 is used to be fixed on the skin of the patient by any suitable method such as medical tape bonding method, and the support 421 is provided with an injection hole in communication with the subcutaneous catheter 410. The blocking diaphragm 422 is arranged at the injection hole, and the blocking diaphragm 422 can be pierced by a butterfly needle multiple times and still keep liquid tight, the material of the blocking diaphragm 422 is the existing material, which will not be described in detail. The end cover 423 is used to cover the injection hole.

[0074] In some embodiments, when it is needed to supplement medicine liquid to the medicine liquid tank 210, the operator can input a reset instruction on the second sub-controller 320, the reset instruction is an instruction for moving the pushing part 220 in the direction away from the output interface 211. After the second sub-controller 320 sends the reset instruction to the first sub-controller 310, the first sub-controller 310 drives the pushing part 220 to move to the side of the medicine liquid tank 210 away from the output interface 211, and then the user can supplement medicine liquid to the medicine liquid tank 210 by using the infusion port 400. Alternatively, in other embodiments, when the operator supplements medicine liquid to the medicine liquid tank 210 by using the infusion port 400, the pushing part 220 moves in the direction away from the output interface 211 under the pressure of the input medicine liquid. It should be known that the first one-way valve 230 is in the closed state during the process of supplementing medicine liquid.

[0075] Preferably, the medical device further comprises a second one-way valve (not shown in the figure) disposed at the input interface 212 for opening to allow the drug solution to enter the drug solution compartment 210 when the infusion port 400 supplements the drug solution to the drug solution compartment 210. Further, the second one-way valve is also configured to have a bacteria filtering function. Specifically, the second one-way valve comprises at least one layer of one-way hydrophilic membrane and at least one layer of bacteria filtering membrane, wherein the one-way hydrophilic membrane allows the drug solution to enter the drug solution compartment 210 in one direction and not to flow out in the opposite direction, and the bacteria filtering membrane can prevent bacteria from invading the drug solution compartment 210. The bacteria filtering membrane is made of collodion immersed in isopentyl alcohol and acetone and then dried.

[0076] In addition, the structure of the catheter 100 is not particularly limited in the present application. Please refer back to Figure 3 In an exemplary embodiment, the tube body 110 has a drug solution flow channel 111 extending axially therethrough, and the drug solution flows from the pump 200 into the tube body 110 and along the drug solution flow channel 111 until it flows out at the distal end of the drug solution flow channel 111 to be applied at the target site. The first electrode 120 is at least one, and when the number of first electrodes 120 is multiple, the multiple first electrodes 120 are arranged at intervals along the axial direction of the tube body 110 at the distal end of the tube body 110. Each of the first electrodes 120 extends circumferentially along the tube body 110, and preferably the first electrode 120 extends 360° circumferentially along the tube body 110 to form a ring structure. Of course, the first electrode 120 can also extend 90° or 120° or other degrees circumferentially along the tube body 110, and the present application does not limit the embodiments thereof.

[0077] Alternatively, in an alternative embodiment, as shown in Figure 4 and Figure 5 the first electrode 120 is only one and is disposed at the distal end of the tube body 110, at which time the first electrode 120 can be a conical structure, a semi-elliptical structure, or a hemispherical structure. In this way, the drug solution flow channel 111 of the tube body 110 extends axially along the tube body 110, and its proximal end communicates with the pump 200 to receive the drug solution from the pump 200, and its distal end is a closed end. At the same time, the distal end side wall of the tube body 110 is also provided with a drug solution outlet 112, which communicates with the drug solution flow channel 111 to allow the drug solution to flow out and be applied at the target site.

[0078] Further, the first electrode 120 and the first sub-controller 310 can be connected by wire. Specifically, the adaptive pumping system 10 is provided with a catheter interface (not shown in the figure), and the catheter interface is provided with a third electrode, which can be connected with the adaptive control circuit 311a of the first sub-controller 310 by wire. The catheter 100 further comprises a second electrode 130 (as shown in Figure 3 and Figure 4 The second electrode 130 is arranged at the proximal end of the tube body 110. The wire is embedded in the tube wall of the tube body 110, and the two ends of the wire are connected with the first electrode 120 and the second electrode 130, respectively. The proximal end of the catheter 100 is inserted into the catheter interface, and the proximal end of the tube body 110 is connected with the pump 200, while the second electrode 130 is electrically connected with the third electrode, so as to realize the communication connection between the first electrode 120 and the first sub-controller 310. It should be known that the second electrode and the third electrode are not necessary, for example, when the proximal end of the wire extends from the proximal end of the tube body 110, the proximal end of the wire can be directly electrically connected with the adaptive control circuit 311a when the proximal end of the catheter 100 is inserted into the catheter interface.

[0079] It should be further explained that the adaptive pumping system 10 and the catheter 100 are not limited in the fixing manner on the skull, but generally the catheter 100 can be fixed on the skull by the fixing frame 1, so as to avoid the displacement of the catheter 100 and ensure the relative fixation between the catheter 100 and the target position.

[0080] In the technical scheme provided by the embodiment of the present application, the catheter integrates the functions of drug solution delivery and electric signal collection, the electric signal of the target region is sensed by the first electrode and fed back to the controller, and then the drug solution delivery parameter can be adjusted according to the electric signal, so as to improve the drug delivery accuracy and improve the treatment effect.

[0081] Although the present application has been disclosed as above, it is not limited thereto. Those skilled in the art can make various modifications and variations to the present application without departing from the spirit and scope of the present application. Thus, if these modifications and variations of the present application fall within the scope of the claims of the present application and equivalent technologies thereof, the present application also intends to include these modifications and variations.

Claims

1. A medical device, characterized by The catheter comprises a tube body, a first electrode and a second electrode, the tube body is arranged on a predetermined object and used for delivering a drug liquid to a target area; the first electrode is arranged at a distal end of the tube body and used for sensing an electrical signal of the target area; the second electrode is arranged at a proximal end of the tube body and connected with the first electrode in communication; a pump is connected with the proximal end of the tube body and used for delivering the drug liquid to the tube body; and a controller comprising a first sub-controller connected with the first electrode and the pump in communication, the controller is configured to receive the electrical signal and adjust a delivery parameter of the drug liquid according to the electrical signal, and the first sub-controller is configured to control the pump to deliver the drug liquid to the tube body according to the delivery parameter; the first sub-controller is an adaptive controller and integrated with the pump as an integrated adaptive pumping system, the integrated adaptive pumping system is provided with a catheter interface, and a third electrode connected with the first sub-controller in communication is arranged at the catheter interface; the proximal end of the tube body is inserted into the electrode interface and extended to be connected with the pump, and the second electrode is electrically connected with the third electrode to make the first electrode connected with the first sub-controller in communication. The number of the first electrodes is at least one; when the number of the first electrodes is more than two, the more than two first electrodes are arranged in an axial direction on an outer surface of the distal end of the tube body. Each of the first electrodes extends in a circumferential direction of the tube body.

2. The medical device of claim 1, wherein, The number of the first electrodes is one and arranged at a distal end of the tube body; the tube body has a drug liquid flow channel extending in an axial direction thereof, and a drug liquid outlet arranged on a distal end sidewall of the tube body and communicated with the drug liquid flow channel.

3. The medical device of claim 2, wherein, The first electrode has a shape of a cone, a semi-ellipse or a hemisphere.

4. The medical device of claim 1, wherein, The number of the pump is one, and the delivery parameter comprises at least one of a frequency of delivering the drug liquid, a volume of the drug liquid delivered each time, and a delivery rate.

5. The medical device of claim 4, wherein, The number of the pump is more than one, the more than one pump is connected with the proximal end of the tube body through a connecting tube and used for delivering different drug liquids to the tube body, and the delivery parameter comprises at least one of a frequency of delivering the drug liquid, a volume of the drug liquid delivered by each pump each time, and a delivery rate.

6. The medical device of claim 1, wherein, The controller is configured to have a first control mode and / or a second control mode; 7. The medical device of claim 1, wherein, when the controller executes the first control mode, the controller is configured to automatically adjust the delivery parameter according to the electrical signal; 8. The medical device of claim 1, wherein, when the controller executes the second control mode, the controller is configured to further display the electrical signal, and receive and execute an adjustment instruction based on the electrical signal to adjust the delivery parameter according to the adjustment instruction. The controller has both the first control mode and the second control mode, and further comprises a second sub-controller arranged separately from the first sub-controller and connected with each other in communication. ​ 9. The medical device of claim 8, wherein, ​ when the controller executes the first control mode, the first sub-controller is further configured to automatically adjust the delivery parameter according to the electrical signal; when the controller executes the second control mode, the second sub-controller is configured to display the electrical signal, and to input and send the adjustment instruction to the first sub-controller; the first sub-controller is further configured to execute the adjustment instruction.

10. The medical device of claim 9, wherein, The second sub-controller is further configured to receive a selection instruction, and to execute the first control mode or the second control mode according to the selection instruction.

11. The medical device of claim 9, wherein, The first sub-controller is arranged on the predetermined object.

12. The medical device of claim 11, wherein, The first sub-controller comprises a control module, a wireless communication module, a battery and a charging coil; the control module is in communication connection with the first electrode and the pump, and is configured to receive the electrical signal, to adjust the delivery parameter, and to control the pump to deliver the medical fluid to the tube according to the delivery parameter; the wireless communication module is configured to connect the control module with the second sub-controller; the battery is configured to supply power to the control module and the wireless communication module; and the charging coil is configured to wirelessly charge the battery.

13. The medical device of claim 1, wherein, The pump comprises a medical fluid cabin and a pushing part; the medical fluid cabin is configured to store medical fluid, and has an output interface connected with the proximal end of the tube; the pushing part is at least partially arranged in the medical fluid cabin, and is in communication connection with the controller; the pushing part is configured to move in the direction close to the output interface under the control of the controller, so as to push the medical fluid to the tube.

14. The medical device of claim 13, wherein, The pump further comprises a first one-way valve arranged at the output interface, and configured to open to allow the medical fluid to enter the tube when the pump delivers the medical fluid to the tube.

15. The medical device of claim 14, wherein, The controller is in communication connection with the first one-way valve, and is configured to adjust the valve parameter according to the delivery parameter.

16. The medical device of claim 13 or 14, wherein, The medical fluid cabin further has an input interface; and the medical device further comprises an infusion port arranged on the predetermined object, and connected with the input interface, and configured to supplement the medical fluid to the medical fluid cabin.

17. The medical device of claim 16, wherein, The medical device further comprises a second one-way valve arranged at the input interface, and configured to open to allow the medical fluid to enter the medical fluid cabin when the infusion port supplements the medical fluid to the medical fluid cabin.

Citation Information

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