WO2023071022A1 - 植入式液体转运装置及液体转运控制系统 - Google Patents

植入式液体转运装置及液体转运控制系统 Download PDF

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Publication number
WO2023071022A1
WO2023071022A1 PCT/CN2022/080798 CN2022080798W WO2023071022A1 WO 2023071022 A1 WO2023071022 A1 WO 2023071022A1 CN 2022080798 W CN2022080798 W CN 2022080798W WO 2023071022 A1 WO2023071022 A1 WO 2023071022A1
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WIPO (PCT)
Prior art keywords
liquid
valve
magnetic
control valve
transfer device
Prior art date
Application number
PCT/CN2022/080798
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English (en)
French (fr)
Inventor
曾金
付际
王智勇
Original Assignee
浙江清华柔性电子技术研究院
上海歌瑞盟医疗器械技术有限公司
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Application filed by 浙江清华柔性电子技术研究院, 上海歌瑞盟医疗器械技术有限公司 filed Critical 浙江清华柔性电子技术研究院
Publication of WO2023071022A1 publication Critical patent/WO2023071022A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3379—Masses, volumes, levels of fluids in reservoirs, flow rates

Definitions

  • the present application relates to the technical field of medical devices, in particular to an implantable liquid transfer device and a liquid transfer control system.
  • Edema is a pathological process in which excessive body fluid accumulates in interstitial spaces or body cavities, such as cardiac edema induced by heart failure, renal edema caused by primary renal disease, and hepatic edema caused by abnormal accumulation of body fluid caused by liver disease , Pulmonary edema with excess fluid accumulation in the lung interstitium and/or overflow into the alveoli, Cerebral edema with increased brain volume and volume due to increased fluid content in the brain tissue.
  • the main causes of tissue edema include increased capillary blood pressure, decreased plasma colloid osmotic pressure, increased capillary permeability, and blocked lymphatic return.
  • Tissue edema can cause certain organ dysfunction, such as gastrointestinal mucosal edema can affect digestion and absorption, pulmonary edema can cause respiratory dysfunction, hydropericardium can affect heart pumping function, laryngeal edema can cause airway obstruction or even suffocation, cerebral edema Can lead to increased intracranial pressure, and even the formation of brain herniation, life-threatening.
  • organ dysfunction such as gastrointestinal mucosal edema can affect digestion and absorption
  • pulmonary edema can cause respiratory dysfunction
  • hydropericardium can affect heart pumping function
  • laryngeal edema can cause airway obstruction or even suffocation
  • cerebral edema Can lead to increased intracranial pressure, and even the formation of brain herniation, life-threatening.
  • the main clinical treatment for tissue edema includes the administration of drugs such as diuretics to strengthen the body's metabolism and treat edema.
  • drugs such as diuretics
  • it is necessary to drain the accumulated fluid implant a drainage tube under the skin, make a fistula, and regularly drain the fluid out of the body.
  • This method has a greater risk of infection.
  • There is also a drainage channel built in the body and a drainage tube with a valve is implanted to drain the cerebrospinal fluid to the abdominal cavity.
  • the scope of use of this type of product is limited, and the fluid transfer provided is limited, so it cannot be applied to other tissue edema.
  • liquid transport is changed from passive transport to active transport, and active micropumps are implanted to form transport channels in the body, but the application of active devices has caused MR incompatibility .
  • the blockage of the pump body and the pipeline is likely to cause product failure, and the product safety needs to be improved.
  • the body fluid is transported to the body to form a transport pathway in the body, and the blockage of the pipeline will cause the function of the transport system to fail. Frequent punctures can cause inflammation and infection, and seriously reduce the living standards of patients.
  • the properties of the transport liquid will be different.
  • the transport of large particles and viscous substances has higher requirements on the pump body and pipeline.
  • the existing transfer products have limited lifespan due to electronic products such as power supply, and also have certain restrictions on clinical MR detection (magnetic resonance examination), which affects the physiological health of patients and the diagnosis and treatment of diseases.
  • the purpose of this application is to provide an implantable liquid transfer device and a liquid transfer control system to solve the need for frequent punctures of the liquid transfer device in the prior art, and to take samples and inject drugs more difficult question.
  • the present application provides an implantable liquid transfer device, which includes a pump body, a control valve, a liquid inlet pipe, and a liquid outlet pipe.
  • the control valve includes a first control valve and a second control valve.
  • One end of the liquid inlet pipe is connected to the One end of the pump body is connected, one end of the liquid outlet pipe is connected to the other end of the pump body, and the pump body is used to drive body fluid to flow from the liquid inlet pipe to the liquid outlet pipe, and the liquid outlet pipe
  • the other end is provided with a plurality of branch pipes, the first control valve is arranged on the liquid inlet pipe, the second control valve is arranged on the liquid outlet pipe, and the second control valve is a multi-way valve And it is used to control the conduction between the liquid outlet pipe and the branch pipe, and a plurality of the branch pipes are respectively arranged at different tissues.
  • the pump body is a positive displacement pump
  • the positive displacement pump includes a pump casing and a magnetic plate connected to the pump casing
  • the pump casing has a cavity
  • the magnetic plate is arranged in the pump casing and
  • the cavity is divided into two chambers
  • the pump casing is provided with two first interfaces communicating with one of the chambers, and the magnetic plate can move or deform in a magnetic field and change the two first ports.
  • the volume of the chamber is a positive displacement pump
  • the positive displacement pump includes a pump casing and a magnetic plate connected to the pump casing
  • the pump casing has a cavity
  • the magnetic plate is arranged in the pump casing and
  • the cavity is divided into two chambers
  • the pump casing is provided with two first interfaces communicating with one of the chambers
  • the magnetic plate can move or deform in a magnetic field and change the two first ports.
  • the volume of the chamber is a positive displacement pump
  • a clamping block is provided on the edge of the magnetic plate, and the magnetic plate is clamped with the pump casing through the clamping block.
  • the two first interfaces are respectively detachably connected to the liquid inlet pipe and the liquid outlet pipe.
  • the implanted liquid transfer device further includes a pouch, the end of the liquid inlet tube away from the pump body is connected to the pouch, and the pouch is provided with a plurality of through holes.
  • a semipermeable membrane is provided at the through hole of the pouch, and body fluid can pass through the semipermeable membrane and enter the pouch.
  • the pouch has a plurality of branch structures, each of which is located in a different edema area, each of the branch structures is provided with a plurality of through holes, and each of the branch structures All communicate with the liquid inlet pipe.
  • the first control valve is a magnetic control valve
  • the first control valve includes a first valve housing, a first flexible pipe, and a first magnetic rotating member
  • the first valve housing has a first accommodation chamber and two second interfaces communicating with the first flexible pipe
  • the first magnetic rotating member is eccentrically arranged in the first accommodation chamber and can rotate in the first accommodation chamber
  • the first magnetic rotating member The rotating part can rotate in the magnetic field and adjust the flow rate of the first flexible pipe.
  • the end of the outlet pipe away from the pump body is provided with two branch pipes, the two branch pipes are respectively the first branch pipe and the second branch pipe, and the control valve also includes a single
  • the first branch pipe is provided with the one-way valve and the fixing device, and the fixing device is arranged at the end of the first branch pipe away from the liquid outlet pipe; the second branch pipe is provided with There are fixed points.
  • the second control valve is a magnetic control valve
  • the second control valve includes a second valve housing and a second magnetic rotating member
  • the second valve housing has a second accommodation chamber and is connected to the first
  • the three third interfaces communicated with the two accommodation chambers, the three third interfaces are respectively communicated with the liquid outlet pipe, the first branch pipe and the second branch pipe
  • the second magnetic rotating member is arranged on
  • the second accommodating cavity and the inner wall of the second valve housing form a liquid guide channel
  • the second magnetic rotating part can rotate in the second accommodating cavity
  • the second magnetic rotating part includes mutual The rotating part and the blocking part are connected, the second magnetic rotating part can rotate in a magnetic field and enable the blocking part to selectively block one of the third interfaces.
  • the one-way valve is a diaphragm valve
  • the diaphragm valve includes a valve tube and a plurality of magnetic flaps inside the valve tube, and the magnetic flaps can be unfolded or rolled up in a magnetic field.
  • the magnetic flap curls in the valve tube and blocks the conduction of the valve tube.
  • the magnetic flap unfolds and curls at intervals in the infusion direction.
  • the fixing device includes an injection port, a control tube and a plurality of microbubble structures, the injection port communicates with the plurality of microbubble structures through the control tube, and the microbubble structure is made of elastic material.
  • the implanted liquid transfer device further includes a data monitoring component, the data monitoring component is used to monitor body fluid information, and the data monitoring component includes at least one of a pressure sensor, a flow sensor or an inflammatory factor sensor, so
  • the pressure sensor is used to detect the hydraulic pressure of the edema area
  • the flow sensor is used to detect the flow of the liquid transported by the pump body
  • the inflammatory factor sensor is used to detect the inflammatory condition of the edema area.
  • the present application also provides a fluid transfer control system, comprising a transfer control device and the implanted fluid transfer device as described above, the transfer control device is used to control the implanted fluid transfer device to operate normally.
  • the transfer control device includes a power supply, a processor, a driving module and a data receiving module, and the power supply, the driving module and the data receiving module are all electrically connected to the processor;
  • the implantable The liquid transfer device includes a data monitoring component, the driving module is used to drive the pump body, the control valve and the data monitoring component to run, the data monitoring component is used to monitor body fluid information, and the data receiving module is used to After receiving the body fluid information, the processor controls the drive module to drive the working states of the pump body and the control valve according to the body fluid information.
  • the transfer control device further includes a communication module, which is used to send the body fluid information to a mobile terminal.
  • the pump body is set through the implanted liquid transfer device, and the pump body is implanted together with the implanted liquid transfer device, which can actively transfer the liquid to the natural cavity for discharge, maintain the balance of local tissue pressure, and avoid repeated puncture infection. It has good universal applicability to patients with ascites; the design of multiple branch tubes can be used for fluid transfer, drug treatment or sampling detection, and drainage of tumor deterioration and fluid containing inflammatory factors to the outside of the body to achieve fluid management multifunctional transfer.
  • Fig. 1 is a schematic structural view of the implantable liquid transfer device in the present application
  • Fig. 2 is the structural representation of pump body in the present application.
  • Fig. 3 is the structural representation of the first control valve in the present application.
  • Fig. 4 is the structural representation of the second control valve in the present application.
  • Fig. 5 is one of the structural representations of the pouch in the present application.
  • Fig. 6 is the second structural diagram of the pouch in the present application.
  • Fig. 7 is a schematic structural view of the fixing device in the present application.
  • Fig. 8 is the structural representation of check valve in the present application.
  • FIGS 9a-9d are schematic structural diagrams of the working principle of the check valve in the present application.
  • Fig. 10 is a structural block diagram of the liquid transfer control system in this application.
  • Fig. 1 is a schematic structural diagram of the implantable liquid transfer device in this application
  • Fig. 2 is a schematic structural diagram of a pump body in this application
  • Fig. 3 is a schematic structural diagram of the first control valve in this application
  • Fig. 4 is a schematic structural diagram of a second control valve in this application.
  • FIG. 1 Schematic diagram of the structure of the control valve
  • Figure 5 is one of the schematic diagrams of the pouch in this application
  • Figure 6 is the second schematic diagram of the pouch in this application
  • Figure 7 is a schematic diagram of the structure of the fixing device in this application
  • Figure 8 is a schematic diagram of the structure of the pouch in this application
  • Figures 9a-9d are schematic structural diagrams of the working principle of the one-way valve in the application
  • Figure 10 is a structural block diagram of the liquid transfer control system in the application.
  • an implantable liquid transfer device provided by the present application includes a pump body 11, a control valve 101, a liquid inlet pipe 15 and a liquid outlet pipe 16, and the control valve 101 includes a first control Valve 13 and second control valve 14, one end of inlet pipe 15 is connected to one end of pump body 11, one end of liquid outlet pipe 16 is connected to the other end of pump body 11, and pump body 11 is used to drive body fluid from inlet pipe 15 Flow to the liquid outlet pipe 16, the other end of the liquid outlet pipe 16 is provided with a plurality of branch pipes 160, the first control valve 13 is arranged on the liquid inlet pipe 15, the second control valve 14 is arranged on the liquid outlet pipe 16, and the second control valve 13 is arranged on the liquid outlet pipe 16.
  • the valve 14 is a multi-way valve and is used to control the conduction between the outlet pipe 16 and the branch pipe 160, and the multiple branch pipes 160 are respectively arranged at different tissues.
  • a pump body 11 is provided through an implanted liquid transfer device.
  • the pump body 11 is implanted together with the implanted liquid transfer device in the body, and can actively transfer the liquid to the natural cavity for discharge, maintain the balance of local tissue pressure, and avoid repeated Puncture infection is generally applicable to patients with ascites; the design of multiple branch pipes 160 of the liquid outlet pipe 16 can be used for liquid transfer, drug treatment or sampling detection, and for the deterioration of tumors and other diseases containing inflammatory factors. Fluid drainage outside the body for multifunctional transport for fluid management.
  • the interior of the liquid inlet pipe 15 and the liquid outlet pipe 16 contains a hydrophilic coating and a developing coating, which is convenient for X-ray detection.
  • the end of the outlet pipe 16 away from the pump body 11 is provided with two branch pipes 160, the two branch pipes 160 are respectively the first branch pipe 161 and the second branch pipe 162, and the control valve 101 also includes a one-way Valve 163, the first branch pipe 161 is provided with a one-way valve 163 and a fixing device 164, the fixing device 164 is located at the end of the first branch pipe 161 away from the liquid outlet pipe 16, the one-way valve 163 is used to prevent the liquid from flowing backward, the fixing device 164 is used to fix the first branch tube 161 to tissue, such as bladder or vein.
  • the second branch pipe 162 is provided with a fixed point 165, and the fixed point 165 is provided with a rubber structure, so as to facilitate the detection of injecting medicine or aspirating liquid, and the outer surface is provided with a wrapper, and the material of the wrapper is polyester with better biocompatibility , polyester, etc.
  • the fixing point 165 is used to fix the second branch tube 162 to the subcutaneous tissue.
  • branch pipes may be provided at the end of the liquid outlet pipe 16 away from the pump body 11 to realize multifunctional transfer of liquid management.
  • the type of the pump body 11 can be one of positive displacement pumps such as peristaltic pumps, gear pumps, piezoelectric pumps, diaphragm pumps, etc.
  • the composition of the pump body 11 contains at least flexible materials or memory metals. A volume change occurs under a certain driving force to generate a driving force.
  • the outer surface of the pump body 11 is provided with materials such as silica gel with better biocompatibility, so as to prevent the body's defense system from rejecting the pump body 11 .
  • the pump body 11 is a diaphragm pump in a positive displacement pump.
  • the diaphragm pump includes a pump case 111 and a magnetic plate 112 connected to the pump case 111.
  • the pump case 111 has a disc-shaped structure as a whole and has The cavity 111a, the magnetic plate 112 is arranged in the pump housing 111 and divides the cavity 111a into two chambers 111c, the pump housing 111 is provided with two first interfaces 111b communicating with one of the chambers 111c, the magnetic plate 112 can It moves or deforms in the magnetic field and changes the volumes of the two chambers 111c, so as to control the normal operation of the pump body 11 through the magnetic field outside the body.
  • the two first interfaces 111b are detachably connected to the liquid inlet pipe 15 and the liquid outlet pipe 16 respectively, so as to facilitate the assembly of the pump body 11 with the liquid inlet pipe 15 and the liquid outlet pipe 16, and the first interface 111b ensures the connection strength.
  • the first interface 111b ensures the connection strength.
  • a clamping block 113 is provided on the edge of the magnetic plate 112 , and the magnetic plate 112 is clamped with the pump casing 111 through the clamping block 113 .
  • a locking hole is provided on the side wall of the pump body 11 to facilitate the locking of the magnetic plate 112 and the pump casing 111 .
  • Block 113 can be made of polymer materials, such as flexible silicone, polyurethane, polyether, polysulfone and other materials, at least two or more materials can also be made of memory metal materials, magnetic plates 112 carries out the coating design, avoids sticking with the pump shell 111, can be close to but can not bond.
  • the magnetic plate 112 is made of flexible magnetic material and can be deformed in a magnetic field, for example, magnetic powder can be added into flexible silica gel.
  • the edge of the magnetic plate 112 can be fixed with the pump casing 111 to increase the sealing.
  • the magnetic plate 112 can be made of hard materials, but the edge of the magnetic plate 112 is movably connected with the pump housing 111, so that the volume of the two chambers 111c can be changed by the movement of the magnetic plate 112.
  • the pump body 11 is implanted in the subcutaneous tissue, the superficial layer, and the magnetic plate 112 can be used for the normal transfer of liquid, but the magnetic plate 112 in the pump body 11 can be taken out when the patient needs to do the MR examination.
  • the magnetic plate 112 is inserted into the pump body 11 to continue the liquid transfer work. Because the pump body 11 is minimally invasively implanted into the superficial layer, the implantation site of the pump body 11 is found by positioning, and the magnetic plate 112 is pulled out minimally invasively for MR detection. After the detection is completed, the magnetic plate 112 is packaged into the pump body 11 Inside, for fluid transport. Since the first control valve 13 , the second control valve 14 and the one-way valve 163 require relatively small magnetism, they will not have too much influence on the MR detection, so they do not need to be taken out.
  • the implantable liquid transfer device further includes a pouch 12 , the end of the inlet tube 15 away from the pump body 11 is connected to the pouch 12 , and the pouch 12 is provided with a plurality of through holes 121 .
  • large particles such as macromolecular proteins, cell fragments, and local soft tissue fragments
  • a semipermeable membrane 121 a is provided at the through hole 121 of the pouch 12 , and body fluid can pass through the semipermeable membrane 121 a and enter into the pouch 12 .
  • the semi-permeable membrane 121a can only allow liquid or small molecules to enter the pouch 12, further avoiding blockage of the pipeline.
  • the pouch 12 is a flexible material with a certain degree of shrinkage or expansion. Driven by the pump body 11, when the pouch 12 shrinks, the liquid in the edema area enters the pouch 12 and flows to the pump body 11 and the outlet through the liquid inlet tube 15. The direction of liquid pipe 16 flows.
  • the pouch 12 can be made of biodegradable materials, and the pouch 12 can be implanted in the target area when draining or monitoring physiological indicators within a required period of time.
  • the pouch 12 can be removed and is biodegradable in the body, leaving no harmful residues.
  • the pouch 12 has a plurality of branch structures 122, and each branch structure 122 is respectively arranged in a different edema area, and each branch structure 122 is provided with a plurality of through holes 121, and each branch structure 122 is It communicates with the liquid inlet pipe 15.
  • the multi-branch structure is beneficial to improve the management effect of effusion, and the interface after the collection of each branch structure 122 is connected with the liquid inlet pipe 15 .
  • Each branch structure 122 can be located in different tissues, such as the lungs, chest, brain, etc., controlled by a pump body 11, and the effusions of different tissues are sucked through the liquid inlet and transported to the abdominal cavity for absorption. Control valves can also be designed on each branch structure 122 to control each branch separately. Sensors can be set in each branch structure 122 to monitor the transport requirements and physiological conditions of each area.
  • both the first control valve 13 and the second control valve 14 are magnetic control valves, and both the first control valve 13 and the second control valve 14 can change the conduction state through magnetic force, so as to control the first control valve through a magnetic field outside the body.
  • Valve 13 and second control valve 14 function normally.
  • the first control valve 13 includes a first valve housing 131 , a first flexible tube 132 and a first magnetic rotating member 133 , and the first valve housing 131 has a disc-shaped structure as a whole.
  • the first valve housing 131 has a first accommodating chamber 131a and two second ports 131b communicating with the first flexible tube 132, and the first magnetic rotating member 133 is arranged eccentrically (that is, the center of rotation and the center of the first magnetic rotating member 133 not at the same position) in the first accommodation cavity 131a and can rotate in the first accommodation cavity 131a, the first magnetic rotating member 133 can rotate in a magnetic field and adjust the flow rate of the first flexible tube 132.
  • the first magnetic rotating part 133 rotates with the driving of the external magnetic field, and the extrusion of the first flexible tube 132 is different during the rotation. Within a certain range, the liquid can be allowed to pass through the liquid inlet tube 15 to continue the first magnetic rotation.
  • the rotating member 133 is in a closed state until no liquid passes through the first flexible tube 132, so that the flow rate of the transfer process can be adjusted to achieve safe and reliable transfer.
  • the second control valve 14 includes a second valve housing 141 and a second magnetic rotating member 142.
  • the second valve housing 141 has a second accommodation chamber 141a and is connected to the second accommodation chamber 141a.
  • the three third ports 141b communicate with each other, the three third ports 141b communicate with the liquid outlet pipe 16, the first branch pipe 161 and the second branch pipe 162 respectively, and the second magnetic rotating member 142 is arranged in the second housing chamber 141a and
  • the liquid guide channel 141c is formed with the inner wall of the second valve housing 141, and the second magnetic rotating member 142 can rotate in the second receiving chamber 141a.
  • the second magnetic rotating member 142 includes a rotating part 142a and a blocking part 142b connected to each other.
  • the two magnetic rotating parts 142 can rotate in a magnetic field and enable the blocking part 142b to selectively block one of the third interfaces 141b.
  • at least one of the rotating part 142a and the blocking part 142b is a magnetic part
  • the rotating part 142a is made of biocompatible elastic material
  • the blocking part 142b is a spherical structure, only when the blocking part 142b is rotated to the corresponding third interface 141b, At this time, the third interface 141b is closed by the blocking portion 142b.
  • the blocking part 142b can rotate independently, that is, the blocking part 142b is made of magnetic material.
  • the number of blocking parts 142b can be correspondingly increased according to actual application scenarios.
  • the one-way valve 163 includes a duckbill valve, a diaphragm valve, a ball valve or a retractable expansion tube valve.
  • the one-way valve 163 is a diaphragm valve
  • the diaphragm valve includes a valve tube 163a and a plurality of magnetic flaps 163b inside the valve tube 163a
  • the magnetic flaps 163b can be expanded in a magnetic field or Rewinding, in the initial state, the magnetic flap 163b is curled in the valve tube 163a and blocks the conduction of the valve tube 163a.
  • the magnetic flap 163b unfolds and curls at intervals in the infusion direction, that is, the next When the magnetic flap 163b is deployed, the last magnetic flap 163b is curled.
  • the magnetic flap 163b can be made of magnetically flexible material, such as silica gel mixed with magnetic powder, or a composite material formed of magnetic powder and polymer flexible material.
  • the magnetic flap 163b is in a curled shape without external drive, and applying a reverse magnetic field can accelerate the curling of the magnetic flap 163b. Under the stimulation of an external magnetic field, the curled state is transformed into an extended state, and the contracted state is transformed into an open state, so as to realize the directional flow of liquid.
  • the magnetic flap 163b when no liquid passes through, the magnetic flap 163b is curled.
  • the first magnetic flap 163b when the liquid enters, the first magnetic flap 163b is in an extended structure under the control of the external magnetic field, and the liquid enters between the first magnetic flap 163b and the second magnetic flap 163b, at this time , close the first magnetic valve 163b, open the second magnetic valve 163b, with the flow of liquid, close the second magnetic valve 163b, open the third magnetic valve 163b, in order to ensure that each magnetic valve
  • the closing sequence and operating time of 163b realize the directional flow of liquid.
  • the fixing device 164 includes an injection port 164a, a control tube 164b and a plurality of microbubble structures 164c, and the injection port 164a communicates with the plurality of microbubble structures 164c through the control tube 164b.
  • the microbubble structure 164c is made of elastic materials, such as flexible polymer materials, such as polyurethane, silica gel, etc., which have a certain elastic deformation, and the outer surface of the microbubble structure 164c is designed to be coated, such as heparin, to enhance tissue compatibility , for easy fixation in the body.
  • the fixing device 164 can be made into an integral structure with the first branch pipe 161 , and the channels of the control pipe 164b and the first branch pipe 161 are separated from each other.
  • the implantable liquid transfer device 10 further includes a data monitoring component 102, the data monitoring component 102 is used to monitor body fluid information, the data monitoring component 102 includes at least one of a pressure sensor, a flow sensor or an inflammatory factor sensor, and the pressure The sensor is used to detect the hydraulic pressure of the edema area, and the flow sensor is used to detect the flow rate of the liquid transported by the pump body 11 .
  • the pressure in the edema area reaches a certain limit
  • the pump body 11, the first control valve 13, and the second control valve 14 are opened.
  • the pressure in the target area decreases.
  • the pump body 11 and the first control valve 13 are closed.
  • the valve is closed; otherwise, the valve is opened.
  • the inflammatory factor sensor is used to detect the inflammatory condition in the edema area. If the inflammation is too severe, the communication module 25 is used to send the body fluid information to the mobile terminal to remind patients and medical staff.
  • the present application also provides a fluid transfer control system.
  • the fluid transfer control system includes a transfer control device 20 and the implanted fluid transfer device 10 described above.
  • the transfer device 10 is functioning normally.
  • the transport control device 20 can be located outside the body or inside the body, preferably placed outside the body, and controls the normal operation of the implanted liquid transport device 10 through the wireless transmission function.
  • the implantable liquid transfer device 10 has no electronic active components, and has a simple structure, which is convenient for the operation of the control system.
  • the transfer control device 20 includes a power supply 21 , a processor 22 , a driving module 23 and a data receiving module 24 , and the power supply 21 , the driving module 23 and the data receiving module 24 are all electrically connected to the processor 22 .
  • the power supply 21 is used to provide electric energy to the transfer control device 20;
  • the driving module 23 is used to drive the implantable liquid transfer device 10 to operate normally;
  • the data receiving module 24 is used to receive the data signal of the implantable liquid transfer device 10;
  • the processor 22 processes Body fluid information and control the normal operation of the entire transport control device 20 .
  • the implantable liquid transfer device 10 includes a pump body 11, a control valve 101 and a data monitoring component 102, the drive module 23 is used to drive the pump body 11, the control valve 101 and the data monitoring component 102 to run, and the data monitoring component 102 is used to The body fluid information is monitored, the data receiving module 24 is used to receive the body fluid information, and the processor 22 controls the driving module 23 to drive the working state of the pump body 11 and the control valve 101 according to the body fluid information.
  • the control valve 101 includes a first control valve 13, a second control valve 14, and a one-way valve 163;
  • the data monitoring component 102 includes a pressure sensor, a flow sensor, and an inflammatory factor sensor.
  • the sensor is used to detect the flow information of the liquid transported by the pump body 11, the inflammatory factor sensor is used to detect the inflammation information in the edema area, and the processor 22 controls the driving module 23 to drive the pump body 11 and the control valve 101 according to the hydraulic pressure information, flow information and inflammation information. working status.
  • the pressure sensor and the flow sensor can be set in the pump body 11, the liquid inlet pipe 15 and the liquid outlet pipe 16, and the inflammatory factor sensor can be set on the pouch 12 to monitor the inflammation of the tissue edema.
  • the drive module 23 can be set in multiples and correspond to the pump body 11, the first control valve 13, the second control valve 14, the one-way valve 163, the pressure sensor, the flow sensor and the inflammatory factor sensor respectively, so as to ensure that the drive module 23 and the pump body 11 , the control valve 101, and the data monitoring component 102 are coupled within a certain range.
  • the drive module 23 controls the normal operation of the pump body 11 , the first control valve 13 , the second control valve 14 , and the one-way valve 163 through magnetic force, and the drive module 23 supplies electric energy to the pressure sensor, flow sensor and inflammatory factor sensor through electromagnetic induction.
  • the data receiving module 24 receives body fluid information detected by the pressure sensor, flow sensor, and inflammatory factor sensor through a wireless receiving function.
  • the transfer control device 20 also includes a communication module 25 and a memory 26, both of which are also electrically connected to the processor 22, and the communication module 25 is used to collect the body fluid information monitored by the implantable liquid transfer device 10 sent to the mobile terminal; the memory 26 is used to store the control program and body fluid information.
  • the liquid transfer control system converts passive transfer into active transfer, manages the transfer of fluid in each tissue, and can realize functions such as monitoring, drug administration, sampling and detection, and is applicable to various transfers Scenarios can be applied to various tissues and symptoms in the body, such as drainage of cerebrospinal fluid, ascites in the abdominal cavity, drainage during glaucoma surgery, lymphatic drainage of limbs caused by lymphedema, etc.
  • the normal operation of the implanted fluid transfer device 10 is controlled by the transfer control device 20 to ensure that the transfer control device 20 and the implanted fluid transfer device 10 are coupled within a certain range, so that remote driving can be realized. Realize the safety and reliability of transporting body fluid or local tissue fluid.
  • the pump body is set through the implanted liquid transfer device, and the pump body is implanted together with the implanted liquid transfer device, which can actively transfer the liquid to the natural cavity for discharge, maintain the balance of local tissue pressure, and avoid repeated puncture infection. It has good universal applicability to patients with ascites; the design of multiple branch tubes can be used for fluid transfer, drug treatment or sampling detection, and drainage of tumor deterioration and fluid containing inflammatory factors to the outside of the body to achieve fluid management multifunctional transfer.

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Abstract

一种植入式液体转运装置及液体转运控制系统，植入式液体转运装置包括泵体(11)、控制阀(101)、进液管(15)以及出液管(16)，控制阀(101)包括第一控制阀(13)和第二控制阀(14)，进液管(15)的一端与泵体(11)的一端连接，出液管(16)的一端与泵体(11)的另一端连接，泵体(11)用于驱动体液从进液管(15)流向出液管(16)，出液管(16)的另一端设有多个分歧管(160)，第一控制阀(13)设于进液管(15)上，第二控制阀(14)设于出液管(16)上，第二控制阀(14)为多通阀并用于控制出液管(16)与分歧管(160)导通，多个分歧管(160)分别设于不同的组织处。植入式液体转运装置避免了反复穿刺的感染，对腹水患者的普适性较好；而且多个分歧管(160)的设计可用于转运液体，给药治疗或取样检测，及对肿瘤等恶化及含炎性因子的液体，引流至体外。

Description

植入式液体转运装置及液体转运控制系统
本申请要求了申请日为2021年10月27日，申请号为 202111258527.0，申请名称为“植入式液体转运装置及液体转运控制系统”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请涉及医疗器械技术领域，特别是涉及一种植入式液体转运装置及液体转运控制系统。
 背景技术
水肿是由过多的体液在组织间隙或体腔中积聚的病理过程，如心力衰竭诱发的心性水肿，因肾原发性疾病引起的肾性水肿，原发于肝病的体液异常积聚的肝性水肿，肺间质中有过量体液积聚和/或溢入肺泡的肺水肿，脑组织的液体含量增多引起的脑容量和容量增加的脑水肿。引起组织水肿的主要原因包括毛细血管血压增高，血浆胶体渗透压降低，毛细血管通透性增加，淋巴回流受阻。组织水肿会产生一定的器官功能障碍，如胃肠粘膜水肿可影响消化吸收，肺水肿可引起呼吸功能障碍，心包积水可影响心脏泵血功能，喉头水肿可致气道阻塞甚至窒息，脑水肿可致颅内压升高，甚至形成脑疝，危及生命。
目前临床对于组织水肿的主要治疗包括，从药物上给予利尿剂等药物，加强身体代谢，治疗水肿。针对药物治疗无效的顽固性水肿，需要将积累液体进行引流，将引流管植入皮下，造瘘，定期将液体引流到体外，该方法感染的风险较大。也有在体内搭建引流通道，植入带阀的引流管，将脑脊液等引流至腹腔，但是该类产品使用范围有限，提供的液体转运有限，在其他组织水肿中无法应用。基于实现更多的转运场景及更好地控制，将液体转运从被动转运转变为主动转运，植入有源的微泵，在体内形成转运通道，但是有源器件的应用造成了MR的不兼容，泵体及管路的堵塞容易造成产品失效，及在产品安全性上有待提高。而且将体液转运至体内，在体内形成转运通路，管路的堵塞会引起转运系统的功能失效。频繁的穿刺，会引发炎症及感染，并严重降低患者的生活水平。
 技术问题
在临床上，根据不同的转运场景，及同一种疾病在不同的发展阶段，转运液体的性质会有差别，如选择大颗粒和粘性物质的转运，对泵体及管路要求较高。且现有的很对转运产品由于具有电源等电子产品，寿命有限，对临床MR检测(磁共振检查)也有一定的限制，影响患者的生理健康及对疾病的诊疗。
 技术解决方案
为了克服现有技术中存在的缺点和不足，本申请的目的在于提供一种植入式液体转运装置及液体转运控制系统，以解决现有技术中液体转运装置的需要频繁穿刺，而且取样和注射药物比较困难的问题。
本申请的目的通过下述技术方案实现：
本申请提供一种植入式液体转运装置，包括泵体、控制阀、进液管以及出液管，所述控制阀包括第一控制阀和第二控制阀，所述进液管的一端与所述泵体的一端连接，所述出液管的一端与所述泵体的另一端连接，所述泵体用于驱动体液从所述进液管流向所述出液管，所述出液管的另一端设有多个分歧管，所述第一控制阀设于所述进液管上，所述第二控制阀设于所述出液管上，所述第二控制阀为多通阀并用于控制所述出液管与所述分歧管导通，多个所述分歧管分别设于不同的组织处。
进一步地，所述泵体为容积泵，所述容积泵包括泵壳以及与所述泵壳连接的磁性板，所述泵壳具有腔体，所述磁性板设于所述泵壳内并将所述腔体分割成两个腔室，所述泵壳设有与其中一个所述腔室连通的两个第一接口，所述磁性板能够在磁场中运动或发生形变并改变两个所述腔室的容积。
进一步地，所述磁性板的边缘设有卡块，所述磁性板通过所述卡块与所述泵壳卡接。
进一步地，两个所述第一接口分别与所述进液管和所述出液管可拆卸连接。
进一步地，所述植入式液体转运装置还包括囊袋，所述进液管远离所述泵体的一端与所述囊袋连接，所述囊袋上设有多个通孔。
进一步地，所述囊袋的所述通孔处设有半透膜，体液能够穿过所述半透膜并进入所述囊袋中。
进一步地，所述囊袋具有多个分支结构，每个所述分支结构分别设于不同的水肿区域，每个所述分支结构上均设有多个所述通孔，每个所述分支结构均与所述进液管相连通。
进一步地，所述第一控制阀为磁力控制阀，所述第一控制阀包括第一阀壳体、第一柔性管以及第一磁性转动件，所述第一阀壳体具有第一容纳腔以及与所述第一柔性管连通的两个第二接口，所述第一磁性转动件偏心设置于所述第一容纳腔内并能够在所述第一容纳腔内转动，所述第一磁性转动件能够在磁场中转动并调节所述第一柔性管的流量大小。
进一步地，所述出液管的远离所述泵体的一端设有两个所述分歧管，两个所述分歧管分别为第一分歧管和第二分歧管，所述控制阀还包括单向阀，所述第一分歧管上设有所述单向阀和固定装置，所述固定装置设于所述第一分歧管远离所述出液管的一端；所述第二分歧管上设有固定点。
进一步地，所述第二控制阀为磁力控制阀，所述第二控制阀包括第二阀壳体和第二磁性转动件，所述第二阀壳体具有第二容纳腔以及与所述第二容纳腔连通的三个第三接口，三个所述第三接口分别与所述出液管、所述第一分歧管和所述第二分歧管连通，所述第二磁性转动件设于所述第二容纳腔内并与所述第二阀壳体的内壁形成导液通道，所述第二磁性转动件能够在所述第二容纳腔内转动，所述第二磁性转动件包括相互连接的转动部和阻塞部，所述第二磁性转动件能够在磁场中转动并使所述阻塞部能够选择性地阻塞其中一个所述第三接口。
进一步地，所述单向阀为隔膜阀，所述隔膜阀包括阀管以及设有所述阀管内的多个磁性膜瓣，所述磁性膜瓣能够在磁场中展开或收卷，在初始状态时，所述磁性膜瓣卷曲于所述阀管内并阻断所述阀管导通，在输液状态时，所述磁性膜瓣在输液方向上间隔式的展开和卷曲。
进一步地，所述固定装置包括注射端口、控制管以及多个微泡结构，所述注射端口通过所述控制管与多个所述微泡结构连通，所述微泡结构采用弹性材料制成。
进一步地，所述植入式液体转运装置还包括数据监测组件，所述数据监测组件用于监测体液信息，所述数据监测组件包括压力传感器、流量传感器或炎症因子传感器中的至少一种，所述压力传感器用于检测水肿区域的液压大小，所述流量传感器用于检测所述泵体运输液体的流量，所述炎症因子传感器用于检测水肿区域的炎症状况。
本申请还提供一种液体转运控制系统，包括转运控制装置以及如上所述的植入式液体转运装置，所述转运控制装置用于控制所述植入式液体转运装置正常运作。
进一步地，所述转运控制装置包括电源、处理器、驱动模块以及数据接收模块，所述电源、所述驱动模块以及所述数据接收模块均与所述处理器电性连接；所述植入式液体转运装置包括数据监测组件，所述驱动模块用于驱动所述泵体、所述控制阀以及所述数据监测组件运行，所述数据监测组件用于监测体液信息，所述数据接收模块用于接收所述体液信息，所述处理器根据所述体液信息控制所述驱动模块驱动所述泵体和所述控制阀的工作状态。
进一步地，所述转运控制装置还包括通讯模块，所述通讯模块用于将所述体液信息发送至移动终端。
 有益效果
通过植入式液体转运装置设置泵体，泵体随植入式液体转运装置一同植入体内，可将液体主动转移至自然腔道排出，维持局部组织压力的平衡，避免了反复穿刺的感染，对腹水患者的普适性较好；多个分歧管的设计可分别用于转运液体，给药治疗或取样检测，及对肿瘤等恶化及含炎性因子的液体引流至体外，以实现液体管理的多功能转运。
 附图说明
图1是本申请中植入式液体转运装置的结构示意图；
图2是本申请中泵体的结构示意图；
图3是本申请中第一控制阀的结构示意图；
图4是本申请中第二控制阀的结构示意图；
图5是本申请中囊袋的结构示意图之一；
图6是本申请中囊袋的结构示意图之二；
图7是本申请中固定装置的结构示意图；
图8是本申请中单向阀的结构示意图；
图9a-9d是本申请中单向阀的工作原理结构示意图；
图10是本申请中液体转运控制系统的结构框图。
本申请的实施方式
为更进一步阐述本申请为达成预定申请目的所采取的技术手段及功效，以下结合附图及较佳实施例，对依据本申请提出的植入式液体转运装置及液体转运控制系统的具体实施方式、结构、特征及其功效，详细说明如下：
图1是本申请中植入式液体转运装置的结构示意图，图2是本申请中泵体的结构示意图，图3是本申请中第一控制阀的结构示意图，图4是本申请中第二控制阀的结构示意图，图5是本申请中囊袋的结构示意图之一，图6是本申请中囊袋的结构示意图之二，图7是本申请中固定装置的结构示意图，图8是本申请中单向阀的结构示意图，图9a-9d是本申请中单向阀的工作原理结构示意图，图10是本申请中液体转运控制系统的结构框图。
如图1至图8以及图10所示，本申请提供的一种植入式液体转运装置，包括泵体11、控制阀101、进液管15以及出液管16，控制阀101包括第一控制阀13和第二控制阀14，进液管15的一端与泵体11的一端连接，出液管16的一端与泵体11的另一端连接，泵体11用于驱动体液从进液管15流向出液管16，出液管16的另一端设有多个分歧管160，第一控制阀13设于进液管15上，第二控制阀14设于出液管16上，第二控制阀14为多通阀并用于控制出液管16与分歧管160导通，多个分歧管160分别设于不同的组织处。
本申请通过植入式液体转运装置设置泵体11，泵体11随植入式液体转运装置一同植入体内，可将液体主动转移至自然腔道排出，维持局部组织压力的平衡，避免了反复穿刺的感染，对腹水患者的普适性较好；出液管16的多个分歧管160设计可分别用于转运液体，给药治疗或取样检测，及对肿瘤等恶化及含炎性因子的液体引流至体外，以实现液体管理的多功能转运。
进一步地，进液管15和出液管16的内部含有亲水涂层，含有显影涂层，便于X射线检测。
本实施例中，出液管16的远离泵体11的一端设有两个分歧管160，两个分歧管160分别为第一分歧管161和第二分歧管162，控制阀101还包括单向阀163，第一分歧管161上设有单向阀163和固定装置164，固定装置164设于第一分歧管161远离出液管16的一端，单向阀163用于防止液体倒流，固定装置164用于将第一分歧管161固定与组织处，例如膀胱或静脉。第二分歧管162上设有固定点165，固定点165处设有橡胶结构，以便于注射药物或吸出液体检测，外表面设有包裹套，包裹套的材质为生物相容性较好的涤纶、聚酯等。固定点165用于将第二分歧管162固定于皮下组织。当第二控制阀14控制出液管16与第二分歧管162相通时，可通过第二分歧管162进行取样或药物给药，给药时，泵体呈关闭状态，第一控制阀13打开，通过经过第二分歧管162、出液管16、进液管15以及囊袋12将药物移送至水肿区域。当然，出液管16的远离泵体11的一端还可以设置更多的分歧管，以实现液体管理的多功能转运。
进一步地，泵体11的类型可以是蠕动泵、齿轮泵、压电泵、隔膜泵等容积泵中的一种，泵体11的组成材料中至少含有柔性材料或记忆金属等，泵体11在一定驱动下发生容积变化，产生驱动力。优选地，泵体11外表面设有生物相容性较好的硅胶等材质，以防止人体防御系统对泵体11的排斥反应。
本实施例中，如图2所示，泵体11为容积泵中的隔膜泵，隔膜泵包括泵壳111以及与泵壳111连接的磁性板112，泵壳111整体呈圆盘形结构并具有腔体111a，磁性板112设于泵壳111内并将腔体111a分割成两个腔室111c，泵壳111设有与其中一个腔室111c连通的两个第一接口111b，磁性板112能够在磁场中运动或发生形变并改变两个腔室111c的容积，以便于在体外通过磁场控制泵体11正常运作。其中，两个第一接口111b分别与进液管15和出液管16可拆卸连接，以便于泵体11与进液管15和出液管16的组装，且第一接口111b在保证连接强度的前提下实现密封性，形成液体的转运通路。
磁性板112的边缘设有卡块113，磁性板112通过卡块113与泵壳111卡接。当然，泵体11的侧壁上设有卡孔，便于磁性板112与泵壳111卡接。卡块113可以由高分子材料制成，如柔性硅胶、聚氨酯、聚醚、聚砜等材料中的至少为两种或两种以上的材料制成，也可以由记忆金属材料制成，磁性板112进行涂层设计，避免与泵壳111粘附，可紧贴但不会粘接。
本实施例中，磁性板112为柔性磁性材料制成并能够在磁场中发生形变，例如可在柔性硅胶里面参入磁粉。磁性板112的边缘可以与泵壳111固定，以增加密封性。当然，磁性板112可采用硬质材料制成，但磁性板112的边缘与泵壳111活动连接，以通过磁性板112的活动改变两个腔室111c的容积。
其中，泵体11植入皮下组织，浅表层，磁性板112可用于液体的正常转运，但需要患者在做MR检查时，可将泵体11内的磁性板112取出，待检查完成后，将磁性板112插入泵体11内，继续进行液体转运工作。因为泵体11微创植入浅表层，通过定位找到植入泵体11的位点，实行微创将磁性板112抽出，进行MR检测，检测完毕后，再将磁性板112封装入泵体11内，进行液体转运。由于第一控制阀13、第二控制阀14以及单向阀163中需要的磁性较小，在进行MR检测，不会有太大影响，因此可不用取出。
本实施例中，如图1所示，植入式液体转运装置还包括囊袋12，进液管15远离泵体11的一端与囊袋12连接，囊袋12上设有多个通孔121。通过设置囊袋12，且在囊袋12上设有多个通孔121，避免大颗粒物质(例如大分子蛋白、细胞碎片、局部软组织碎片)进入囊袋12中，而造成管路堵塞。
进一步地，如图5所示，囊袋12的通孔121处设有半透膜121a，体液能够穿过半透膜121a并进入囊袋12中。半透膜121a只能允许液体或小分子进入囊袋12中，进一步避免管路堵塞。其中，囊袋12为柔性材料，具有一定的收缩或扩张性，在泵体11驱动下，囊袋12收缩时水肿区域液体进入囊袋12内，并通过进液管15向泵体11、出液管16的方向流动。优选地，囊袋12可选择生物可降解的材料，在需要的时间内引流或监测生理指标时，可将囊袋12植入目标区域。当治疗完成后，囊袋12可不用取出并在体内生物可降解，没有伤害残留产生。
如图6所示，囊袋12具有多个分支结构122，每个分支结构122分别设于不同的水肿区域，每个分支结构122上均设有多个通孔121，每个分支结构122均与进液管15相连通。多分支结构有利于提高积液管理效果，各分支结构122汇总后的接口与进液管15相连通。每个分支结构122可单独位于不同的组织内，如分别位于肺部、胸部、脑部等，用一个泵体11进行控制，不同组织的积液经进液端吸入，转运至腹腔吸收。也可在每个分支结构122上分别设计控制阀，用于单独控制各支路。可在每个分支结构122中设置传感器，监测各个区域的转运需求及生理情况。
进一步地，第一控制阀13和第二控制阀14均为磁力控制阀，第一控制阀13和第二控制阀14均能够通过磁力改变导通状态，以便于在体外通过磁场控制第一控制阀13和第二控制阀14正常运作。
本实施例中，如图3所示，第一控制阀13包括第一阀壳体131、第一柔性管132以及第一磁性转动件133，第一阀壳体131整体呈圆盘形结构，第一阀壳体131具有第一容纳腔131a以及与第一柔性管132连通的两个第二接口131b，第一磁性转动件133偏心设置(即转动轴心与第一磁性转动件133的中心不在同一个位置)于第一容纳腔131a内并能够在第一容纳腔131a内转动，第一磁性转动件133能够在磁场中转动并调节第一柔性管132的流量大小。第一磁性转动件133随着体外磁场的驱动发生转动，转动中对第一柔性管132的挤压是不同的，在一定范围内，可允许液体从进液管15中通过，继续第一磁性转动件133，直到第一柔性管132无液体通过，此时为关闭状态，这样可以调节转运过程的流速，实现安全、可靠的转运。
本实施例中，如图4所示，第二控制阀14包括第二阀壳体141和第二磁性转动件142，第二阀壳体141具有第二容纳腔141a以及与第二容纳腔141a连通的三个第三接口141b，三个第三接口141b分别与出液管16、第一分歧管161和第二分歧管162连通，第二磁性转动件142设于第二容纳腔141a内并与第二阀壳体141的内壁形成导液通道141c，第二磁性转动件142能够在第二容纳腔141a内转动，第二磁性转动件142包括相互连接的转动部142a和阻塞部142b，第二磁性转动件142能够在磁场中转动并使阻塞部142b能够选择性地阻塞其中一个第三接口141b。其中，转动部142a和阻塞部142b至少其中之一为磁性件，转动部142a生物相容性的弹性材料，阻塞部142b为球形结构，只有当阻塞部142b转动至对应的第三接口141b处，此时该第三接口141b被阻塞部142b封闭。当然，阻塞部142b可单独转动，即阻塞部142b采用磁性材料制成。在其他实施例中，当出液管16的远离泵体11的一端还可以设置更多的分歧管时，阻塞部142b的数量可以根据实际应用场景对应增加。
进一步地，单向阀163包括鸭嘴阀、隔膜阀、球阀或收缩扩张管阀。
本实施例中，如图8所示，单向阀163为隔膜阀，隔膜阀包括阀管163a以及设有阀管163a内的多个磁性膜瓣163b，磁性膜瓣163b能够在磁场中展开或收卷，在初始状态时，磁性膜瓣163b卷曲于阀管163a内并阻断阀管163a导通，在输液状态时，磁性膜瓣163b在输液方向上间隔式的展开和卷曲，即下一个磁性膜瓣163b展开时，上一个磁性膜瓣163b卷曲。其中，磁性膜瓣163b可以为具有磁性的柔性材料制成，如参入磁粉的硅胶，也可是磁粉与高分子柔性材料形成的复合材料。磁性膜瓣163b在外界无驱动下，呈卷曲状，施加反向磁场可加快磁性膜瓣163b卷曲。在外界磁场刺激下，有卷曲转变为伸展状态，从收缩转化为开放状态，以此实现液体的定向流动。
如图8所示，当无液体通过时，磁性膜瓣163b呈卷曲状。如图9a-9d所示，当液体进入时，第一个磁性膜瓣163b在外磁场控制下呈伸展结构，液体进入第一个磁性膜瓣163b和第二个磁性膜瓣163b之间，此时，关闭第一个磁性膜瓣163b，打开第二个磁性膜瓣163b，随着液体的流动，关闭第二个磁性膜瓣163b，打开第三个磁性膜瓣163b，依次保证每个磁性膜瓣163b的关闭顺序及运作时长，实现液体的定向流动。
本实施例中，如图1和7所示，固定装置164包括注射端口164a、控制管164b以及多个微泡结构164c，注射端口164a通过控制管164b与多个微泡结构164c连通。微泡结构164c采用弹性材料制成，例如柔性高分子材料，如聚氨酯、硅胶等，有一定的弹性形变，在微泡结构164c的外表面进行涂层设计，如肝素等，增强组织相容性，便于在体内固定。通过注射端口164a向微泡结构164c中注入液体或气体，使得微泡结构164c膨胀并将第一分歧管161固定于目标组织处，例如膀胱30或静脉，从而避免在组织及液体环境中晃动，影响液体转运。其中，固定装置164可与第一分歧管161做成一体结构，控制管164b与第一分歧管161的通道相互隔开。
本实施例中，植入式液体转运装置10还包括数据监测组件102，数据监测组件102用于监测体液信息，数据监测组件102包括压力传感器、流量传感器或炎症因子传感器中的至少一种，压力传感器用于检测水肿区域的液压大小，流量传感器用于检测泵体11运输液体的流量。当水肿区域压力到达一定限值时，泵体11、第一控制阀13以及第二控制阀14开启，当随着液体的持续转运，目标区域压力降低，当低于预期的设定值时，泵体11和第一控制阀13关闭。确保在转运过程中的安全性，避免一次性转运过量，造成局部组织低压，电解质紊乱等不良事件。当流量传感器检测到泵体11完成目标转运量时，阀门关闭，否则，阀门开启。炎症因子传感器用于检测水肿区域的炎症状况。如果炎症过于严重，通过通讯模块25用于将体液信息发送至移动终端，以提醒患者和医护人员。
本申请还提供一种液体转运控制系统，如图10所示，液体转运控制系统包括转运控制装置20以及如上所述的植入式液体转运装置10，转运控制装置20用于控制植入式液体转运装置10正常运作。转运控制装置20可位于体外，也可位于体内，优选地设置于体外，并通过无线传输功能控制植入式液体转运装置10正常运作。而植入式液体转运装置10无电子有源部件，结构简单、便于控制系统的操作。
本实施例中，转运控制装置20包括电源21、处理器22、驱动模块23和数据接收模块24，电源21、驱动模块23以及数据接收模块24均与处理器22电性连接。电源21用于给转运控制装置20提供电能；驱动模块23用于驱动植入式液体转运装置10正常运作；数据接收模块24用于接收植入式液体转运装置10的数据信号；处理器22处理体液信息以及控制整个转运控制装置20正常运作。
进一步地，植入式液体转运装置10包括泵体11、控制阀101以及数据监测组件102，驱动模块23用于驱动泵体11、控制阀101以及数据监测组件102运行，数据监测组件102用于监测体液信息，数据接收模块24用于接收体液信息，处理器22根据体液信息控制驱动模块23驱动泵体11和控制阀101的工作状态。
其中，控制阀101包括第一控制阀13、第二控制阀14以及单向阀163；数据监测组件102包括压力传感器、流量传感器以及炎症因子传感器，压力传感器用于检测水肿区域的液压信息，流量传感器用于检测泵体11运输液体的流量信息，炎症因子传感器用于检测水肿区域的炎症信息，处理器22根据液压信息、流量信息以及炎症信息控制驱动模块23驱动泵体11和控制阀101的工作状态。其中，压力传感器和流量传感器可设于泵体11、进液管15和出液管16内，炎症因子传感器可设于囊袋12上以监测组织水肿处的炎症状况。
驱动模块23可以设置多个并分别与泵体11、第一控制阀13、第二控制阀14、单向阀163、压力传感器、流量传感器以及炎症因子传感器对应，确保驱动模块23与泵体11、控制阀101、数据监测组件102在一定范围内耦合。驱动模块23通过磁力控制泵体11、第一控制阀13、第二控制阀14、单向阀163正常运作，驱动模块23通过电磁感应给压力传感器、流量传感器以及炎症因子传感器提供电能。数据接收模块24也可以为多个并分别与压力传感器、流量传感器以及炎症因子传感器对应，数据接收模块24通过无线接收功能接收压力传感器、流量传感器以及炎症因子传感器检测到的体液信息。
进一步地，转运控制装置20还包括通讯模块25和存储器26，通讯模块25以及存储器26也均与处理器22电性连接，通讯模块25用于将植入式液体转运装置10监测到的体液信息发送至移动终端；存储器26用于存储控制程序以及体液信息。
本申请提供的液体转运控制系统将被动转运转化为主动转运，对各个组织处体内积液进行转运管理，并且可实现监测、给药、取样检测等功能，并且可适用于各种各样的转运场景，可适用于体内各个组织及症状，如脑脊液的引流，腹腔中腹水的引流，青光眼术中的引流，淋巴水肿引发的四肢淋巴液引流等。通过转运控制装置20控制植入式液体转运装置10正常运作，确保转运控制装置20和植入式液体转运装置10在一定范围内耦合，则可以实现远程驱动。实现转运体液或局部组织液的安全和可靠性。
在本文中，所涉及的上、下、左、右、前、后等方位词是以附图中的结构位于图中的位置以及结构相互之间的位置来定义的，只是为了表达技术方案的清楚及方便。应当理解，所述方位词的使用不应限制本申请请求保护的范围。还应当理解，本文中使用的术语“第一”和“第二”等，仅用于名称上的区分，并不用于限制数量和顺序。
以上所述，仅是本申请的较佳实施例而已，并非对本申请做任何形式上的限定，虽然本申请已以较佳实施例揭露如上，然而并非用以限定本申请，任何熟悉本专业的技术人员，在不脱离本申请技术方案范围内，当可利用上述揭示的技术内容作出些许更动或修饰，为等同变化的等效实施例，但凡是未脱离本申请技术方案内容，依据本申请的技术实质对以上实施例所作的任何简单修改、等同变化与修饰，均仍属于本申请技术方案的保护范围之内。
 工业实用性
通过植入式液体转运装置设置泵体，泵体随植入式液体转运装置一同植入体内，可将液体主动转移至自然腔道排出，维持局部组织压力的平衡，避免了反复穿刺的感染，对腹水患者的普适性较好；多个分歧管的设计可分别用于转运液体，给药治疗或取样检测，及对肿瘤等恶化及含炎性因子的液体引流至体外，以实现液体管理的多功能转运。

Claims (16)

  1. 一种植入式液体转运装置，包括泵体(11)、控制阀(101)、进液管(15)以及出液管(16)，所述控制阀(101)包括第一控制阀(13)和第二控制阀(14)，所述进液管(15)的一端与所述泵体(11)的一端连接，所述出液管(16)的一端与所述泵体(11)的另一端连接，所述泵体(11)用于驱动体液从所述进液管(15)流向所述出液管(16)，所述出液管(16)的另一端设有多个分歧管(160)，所述第一控制阀(13)设于所述进液管(15)上，所述第二控制阀(14)设于所述出液管(16)上，所述第二控制阀(14)为多通阀并用于控制所述出液管(16)与所述分歧管(160)导通，多个所述分歧管(160)分别设于不同的组织处。
  2. 根据权利要求1所述的植入式液体转运装置，其中，所述泵体(11)为容积泵，所述容积泵包括泵壳(111)以及与所述泵壳(111)连接的磁性板(112)，所述泵壳(111)具有腔体(111a)，所述磁性板(112)设于所述泵壳(111)内并将所述腔体(111a)分割成两个腔室(111c)，所述泵壳(111)设有与其中一个所述腔室(111c)连通的两个第一接口(111b)，所述磁性板(112)能够在磁场中运动或发生形变并改变两个所述腔室(111c)的容积。
  3. 根据权利要求2所述的植入式液体转运装置，其中，所述磁性板(112)的边缘设有卡块(113)，所述磁性板(112)通过所述卡块(113)与所述泵壳(111)卡接。
  4. 根据权利要求2所述的植入式液体转运装置，其中，两个所述第一接口(111b)分别与所述进液管(15)和所述出液管(16)可拆卸连接。
  5. 根据权利要求1所述的植入式液体转运装置，其中，所述植入式液体转运装置还包括囊袋(12)，所述进液管(15)远离所述泵体(11)的一端与所述囊袋(12)连接，所述囊袋(12)上设有多个通孔(121)。
  6. 根据权利要求5所述的植入式液体转运装置，其中，所述囊袋(12)的所述通孔(121)处设有半透膜(121a)，体液能够穿过所述半透膜(121a)并进入所述囊袋(12)中。
  7. 根据权利要求5所述的植入式液体转运装置，其中，所述囊袋(12)具有多个分支结构(122)，每个所述分支结构(122)分别设于不同的水肿区域，每个所述分支结构(122)上均设有多个所述通孔(121)，每个所述分支结构(122)均与所述进液管(15)相连通。
  8. 根据权利要求1所述的植入式液体转运装置，其中，所述第一控制阀(13)为磁力控制阀，所述第一控制阀(13)包括第一阀壳体(131)、第一柔性管(132)以及第一磁性转动件(133)，所述第一阀壳体(131)具有第一容纳腔(131a)以及与所述第一柔性管(132)连通的两个第二接口(131b)，所述第一磁性转动件(133)偏心设置于所述第一容纳腔(131a)内并能够在所述第一容纳腔(131a)内转动，所述第一磁性转动件(133)能够在磁场中转动并调节所述第一柔性管(132)的流量大小。
  9. 根据权利要求1所述的植入式液体转运装置，其中，所述出液管(16)的远离所述泵体(11)的一端设有两个所述分歧管(160)，两个所述分歧管(160)分别为第一分歧管(161)和第二分歧管(162)，所述控制阀(101)还包括单向阀(163)，所述第一分歧管(161)上设有所述单向阀(163)和固定装置(164)，所述固定装置(164)设于所述第一分歧管(161)远离所述出液管(16)的一端；所述第二分歧管(162)上设有固定点(165)。
  10. 根据权利要求9所述的植入式液体转运装置，其中，所述第二控制阀(14)为磁力控制阀，所述第二控制阀(14)包括第二阀壳体(141)和第二磁性转动件(142)，所述第二阀壳体(141)具有第二容纳腔(141a)以及与所述第二容纳腔(141a)连通的三个第三接口(141b)，三个所述第三接口(141b)分别与所述出液管(16)、所述第一分歧管(161)和所述第二分歧管(162)连通，所述第二磁性转动件(142)设于所述第二容纳腔(141a)内并与所述第二阀壳体(141)的内壁形成导液通道(141c)，所述第二磁性转动件(142)能够在所述第二容纳腔(141a)内转动，所述第二磁性转动件(142)包括相互连接的转动部(142a)和阻塞部(142b)，所述第二磁性转动件(142)能够在磁场中转动并使所述阻塞部(142b)能够选择性地阻塞其中一个所述第三接口(141b)。
  11. 根据权利要求9所述的植入式液体转运装置，其中，所述单向阀(163)为隔膜阀，所述隔膜阀包括阀管(163a)以及设有所述阀管(163a)内的多个磁性膜瓣(163b)，所述磁性膜瓣(163b)能够在磁场中展开或收卷，在初始状态时，所述磁性膜瓣(163b)卷曲于所述阀管(163a)内并阻断所述阀管(163a)导通，在输液状态时，所述磁性膜瓣(163b)在输液方向上间隔式的展开和卷曲。
  12. 根据权利要求9所述的植入式液体转运装置，其中，所述固定装置(164)包括注射端口(164a)、控制管(164b)以及多个微泡结构(164c)，所述注射端口(164a)通过所述控制管(164b)与多个所述微泡结构(164c)连通，所述微泡结构(164c)采用弹性材料制成。
  13. 根据权利要求1所述的植入式液体转运装置，其中，所述植入式液体转运装置(10)还包括数据监测组件(102)，所述数据监测组件(102)用于监测体液信息，所述数据监测组件(102)包括压力传感器、流量传感器或炎症因子传感器中的至少一种，所述压力传感器用于检测水肿区域的液压大小，所述流量传感器用于检测所述泵体(11)运输液体的流量，所述炎症因子传感器用于检测水肿区域的炎症状况。
  14. 一种液体转运控制系统，包括转运控制装置(20)以及如权利要求1-13任一项所述的植入式液体转运装置(10)，所述转运控制装置(20)用于控制所述植入式液体转运装置(10)正常运作。
  15. 根据权利要求14所述的液体转运控制系统，其中，所述转运控制装置(20)包括电源(21)、处理器(22)、驱动模块(23)以及数据接收模块(24)，所述电源(21)、所述驱动模块(23)以及所述数据接收模块(24)均与所述处理器(22)电性连接；所述植入式液体转运装置(10)包括数据监测组件(102)，所述驱动模块(23)用于驱动所述泵体(11)、所述控制阀(101)以及所述数据监测组件(102)运行，所述数据监测组件(102)用于监测体液信息，所述数据接收模块(24)用于接收所述体液信息，所述处理器(22)根据所述体液信息控制所述驱动模块(23)驱动所述泵体(11)和所述控制阀(101)的工作状态。
  16. 根据权利要求15所述的液体转运控制系统，其中，所述转运控制装置(20)还包括通讯模块(25)，所述通讯模块(25)用于将所述体液信息发送至移动终端。
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