WO2021043011A1 - 反馈式智能注射器 - Google Patents

反馈式智能注射器 Download PDF

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Publication number
WO2021043011A1
WO2021043011A1 PCT/CN2020/110611 CN2020110611W WO2021043011A1 WO 2021043011 A1 WO2021043011 A1 WO 2021043011A1 CN 2020110611 W CN2020110611 W CN 2020110611W WO 2021043011 A1 WO2021043011 A1 WO 2021043011A1
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WIPO (PCT)
Prior art keywords
electrode
electrically connected
needle
main control
control device
Prior art date
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PCT/CN2020/110611
Other languages
English (en)
French (fr)
Inventor
燕自保
陈柳青
董朝阳
陈鹏飞
刘泉
殷波
Original Assignee
武汉中针智能科技有限公司
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Application filed by 武汉中针智能科技有限公司 filed Critical 武汉中针智能科技有限公司
Priority to JP2021538852A priority Critical patent/JP7185359B2/ja
Priority to DE112020000445.7T priority patent/DE112020000445B4/de
Priority to US17/267,793 priority patent/US20220369946A1/en
Publication of WO2021043011A1 publication Critical patent/WO2021043011A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/42—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
    • A61M5/427—Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0538—Measuring electrical impedance or conductance of a portion of the body invasively, e.g. using a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4887—Locating particular structures in or on the body
    • A61M1/0023—
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/73—Suction drainage systems comprising sensors or indicators for physical values
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/329—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles characterised by features of the needle shaft
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/65—Impedance, e.g. conductivity, capacity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3286—Needle tip design, e.g. for improved penetration

Definitions

  • the invention relates to the field of medical equipment, in particular to a feedback type smart injector.
  • Chinese patent document CN205163829U describes a fully automatic injection device that automatically scans blood vessels, which scans a three-dimensional image of blood vessels in the human body through a blood vessel scanner provided, but the document does not describe the structure and specific workflow of the blood vessel scanner in detail.
  • Chinese patent document CN101564294A records an electrical impedance tomography method based on structural information fusion, and provides a technical solution based on electrodes to detect the electrical impedance of the internal tissue of the organism to obtain human tissue imaging, but the structure and application of the solution It is more complicated and limits the value of clinical use.
  • the technical problem to be solved by the present invention is to provide a feedback type smart injector and method, which can quickly and accurately detect and locate skin, muscle, body fluid and blood impedance, and can perform intelligent injection or suction according to changes in impedance.
  • a feedback type smart injector including a needle and a needle seat, the needle is provided with a first electrode and a second electrode for detecting the impedance of human tissue, the first electrode and The second electrode is electrically connected with the main control device, and the main control device is electrically connected with the display or reminder device.
  • the needle is made of insulating material or the needle is made of metal material, and the outer layer of the needle is covered with an inner insulating layer;
  • the first electrode and the second electrode are arranged along the length of the needle;
  • the outer layer of the first electrode and the second electrode is covered with an outer insulating layer, and one end of the first electrode and the second electrode is exposed only at a position close to the needle tip.
  • the other ends of the first electrode and the second electrode extend to the outer wall of the needle hub, the main control device is sleeved with the needle hub, and the inner wall of the main control device is provided with a first lead-in electrode and a second lead-in electrode.
  • the lead-in electrode and the second lead-in electrode are electrically connected to the first electrode and the second electrode, respectively.
  • the main control system is electrically connected to the reference signal source, the reference signal source is electrically connected to the band pass filter, the band pass filter is electrically connected to the micro signal amplifying circuit, and the micro signal amplifying circuit Electrically connected to the first electrode and the second electrode;
  • the current detection circuit is electrically connected to the second electrode.
  • the micro signal amplifier circuit is an instrument amplifier circuit
  • the reference signal passes through the output end of the band-pass filter, and is directly electrically connected to the input of the micro signal amplifier circuit and the first electrode after being amplified and modulated by the signal control;
  • the other input of the micro signal amplifier circuit is electrically connected with the second electrode and the current detection circuit.
  • the structure of the main control device is as follows: the main control system is electrically connected to the reference signal source, the reference signal source is electrically connected to the band pass filter, and the reference signal passes through the band pass filter and then passes through the signal control module as the first electrode And the second electrode to provide a detection current;
  • the first electrode and the second electrode are respectively electrically connected to the micro-signal amplifying circuit and the current detection circuit, and the micro-signal amplifying circuit and the current detection circuit are respectively electrically connected to at least two sets of A/D conversion modules, and the A/D conversion module and digital signal processing The module is electrically connected, and the digital signal processing module is electrically connected to the main control system.
  • a third electrode is also provided at the position of the needle seat, and the third electrode is used for reliable contact with the skin.
  • the third electrode is electrically connected to the main control device through a micro-signal amplifying circuit.
  • the third electrode and the needle seat are rotatable
  • the third electrode and one of the first electrode and the second electrode form a variable frequency impedance detection circuit.
  • an array electrode is further provided at the position of the needle seat, and the array electrode is electrically connected to the main control device through a micro-signal amplifying circuit.
  • the array electrode and one of the first electrode and the second electrode form a variable frequency impedance detection circuit.
  • the plurality of array electrodes are arranged on a flexible fixing belt, and the flexible fixing belt is provided with glue or a buckle with the ends connected to each other, so that the array electrode can be reliably contacted with the skin.
  • the flexible fixing belt is provided with glue or a buckle with the ends connected to each other, so that the array electrode can be reliably contacted with the skin.
  • a 0-100Hz low-frequency current signal is connected between the first electrode and the second electrode to determine the position of the tip of the needle;
  • a medium and low frequency signal of 100 Hz to 50 kHz is connected to scan different tissues of the human body;
  • the display or reminder device includes a display screen, an LED indicator or a buzzer.
  • the present invention provides a feedback type smart injector.
  • the impedance of tissues and organs such as skin, muscle, effusion, blood, etc.
  • the dual detection method of direct current and medium and low frequency micro-current is adopted.
  • accurate detection and flexible setting are adopted.
  • the needle can easily and accurately detect the injection site or draw
  • the reconstructed image is restored through a specific algorithm or a prompt is given to make the injection or extraction process more accurate.
  • Figure 1 is a schematic diagram of the structure of the present invention.
  • Figure 2 is a schematic diagram of the structure of the needle in the present invention.
  • Figure 3 is a schematic cross-sectional view of the needle of the present invention.
  • Fig. 4 is a schematic diagram of another preferred structure in the present invention.
  • Fig. 5 is a schematic diagram of another preferred mechanism in the present invention.
  • Fig. 6 is a schematic diagram of the connection between the main control device and the needle base in the present invention.
  • Figure 7 is a schematic diagram of the present invention in use.
  • Fig. 8 is a frame diagram of the detection system of the present invention.
  • Fig. 9 is a schematic diagram of the micro signal amplifying circuit in the present invention.
  • Fig. 10 is a schematic diagram of the human body impedance detection circuit in the present invention.
  • needle holder 1 needle holder 1, main control device 2, needle 3, inner insulating layer 31, syringe 4, first electrode 5, second electrode 6, third electrode 7, array electrode 8, flexible fixing band 9, skin 10 , Arterial blood vessel 11, outer insulating layer 12, first lead-in electrode 13, second lead-in electrode 14, measured tissue equivalent circuit 15, current detection circuit OP3.
  • a feedback type smart injector includes a needle 3 and a needle seat 1.
  • the needle 3 is provided with a first electrode 5 and a second electrode 6 for detecting the impedance of human tissue, and the first electrode 5 and the second electrode
  • the electrode 6 is electrically connected to the main control device 2, and the main control device 2 is electrically connected to the display or reminder device.
  • electrical signals are connected to the first electrode 5 and the second electrode 6 through the main control device 2, so as to determine the specific position of the needle tip in the human tissue according to the impedance.
  • Cerebrospinal fluid 0.555; serum 0.714; blood 1.85; nerves 25.0; liver 80.0; muscle 90.0; brain 107; fat 10.8 ⁇ 10 2 ; moist skin 38.0 ⁇ 10 2 ; dry skin 40.0 ⁇ 10 3 ; non-membranous bone 20 ⁇ 10 5 .
  • the needle 3 is made of an insulating material, such as an insulating material made of alumina ceramic, and then a biocompatible coating is applied to the surface of the alumina ceramic.
  • a flexible glass material is used, and then a biocompatible polymer film is coated on the surface of the flexible glass.
  • Insulating layers such as silk fibroin film, polyvinylpyrrolidone, quaternary ammonium salt, Teflon and heparin compound, and other coatings produced by physical vapor deposition (PVD) and chemical vapor deposition (CVD).
  • the needle 3 is made of a metal material, the outer layer of the needle 3 is covered with an inner insulating layer 31, and the inner insulating layer 31 adopts an insulating layer with biocompatibility;
  • the first electrode 5 and the second electrode 6 are arranged along the length direction of the needle 3;
  • Fig. 6 The preferred solution is shown in Fig. 6, where the outer layers of the first electrode 5 and the second electrode 6 are covered with an outer insulating layer 12, and one end of the first electrode 5 and the second electrode 6 is exposed only at a position close to the needle tip.
  • This structure ensures that only the position of the needle tip can conduct current to the tissue contacted by the needle tip, while other positions are insulated, and will not interfere with the detection result of the needle tip position, thereby improving the accuracy of human tissue detection.
  • the other ends of the first electrode 5 and the second electrode 6 extend to the outer wall of the needle hub 1, the main control device 2 is sleeved with the needle hub 1, and the inner wall of the main control device 2 is provided with a first lead-in
  • the electrode 13 and the second lead-in electrode 14, and the first lead-in electrode 13 and the second lead-in electrode 14 are electrically connected to the first electrode 5 and the second electrode 6, respectively.
  • the first lead-in electrode 13 and the second lead-in electrode 14 adopt the structure of flexible electrodes.
  • the electrode 14 is electrically connected to the second electrode 6.
  • the main control system is electrically connected to the reference signal source, the reference signal source is electrically connected to the band-pass filter, and the band-pass filter is electrically connected to the micro-signal amplifying circuit.
  • the micro signal amplifier circuit is electrically connected to the first electrode 5 and the second electrode 6;
  • the current detection circuit OP3 is electrically connected to the second electrode 6.
  • the dashed box in FIG. 9 represents the equivalent circuit 15 of the tissue under test.
  • the micro signal amplifier circuit is an instrument amplifier circuit
  • the reference signal source passes through the output end of the band-pass filter, and is directly electrically connected to the first electrode 5 and one input of the micro-signal amplifying circuit after signal control amplification and modulation;
  • the other input of the micro signal amplifier circuit is electrically connected to the second electrode 6 and the current detection circuit OP3.
  • the structure of the main control device 2 is: the main control system is electrically connected to the reference signal source, the reference signal source is electrically connected to the band pass filter, and the signal after the band pass filter passes through the signal control module as the first electrode 5 and the second electrode 6 provide detection current;
  • the first electrode 5 and the second electrode 6 are respectively electrically connected to a micro-signal amplifying circuit and a current detection circuit.
  • the micro-signal amplifying circuit and the current detection circuit are respectively electrically connected to at least two sets of A/D conversion modules.
  • the signal processing module is electrically connected, and the digital signal processing module is electrically connected with the main control system.
  • the digital signal processing module in this example uses embedded processor stm32f103c8, and the A/D conversion module uses AD7476.
  • the main control system adopts intel or ARM series CPU.
  • a third electrode 7 is further provided at the position of the needle seat 1, and the third electrode 7 is electrically connected to the main control device 2 through a micro signal amplifying circuit, and the third electrode 7 is rotatably connected with the needle base 1, and the third electrode 7 and one of the first electrode 5 and the second electrode 6 form a variable frequency impedance detection circuit.
  • the third electrode 7 Taking the third electrode 7 as the center and rotating the direction of the needle 3, the third electrode 7 and the first electrode 5 or the second electrode 6 on the needle 3 are in reliable contact with the skin.
  • An alternating current is given between one of the two electrodes 6, and the positions of muscles and blood vessels are determined according to impedance detection.
  • a direct current is connected between the first electrode 5 and the second electrode 6 to determine the location of the tissue punctured by the needle tip. So as to realize the intelligent feedback of the syringe.
  • an array electrode 8 is also provided at the position of the needle seat 1.
  • the array electrode 8 is electrically connected to the main control device 2 through a micro-signal amplifying circuit, and the array electrode 8 is connected to the first electrode 5 and the second electrode.
  • One of the electrodes 6 constitutes a variable frequency impedance detection circuit.
  • An alternating current is connected between the array electrode 8 and the first electrode 5 or the second electrode 6, and the position and structure of the subcutaneous tissue are judged through impedance detection.
  • the positions of fat, body fluids, muscles, and blood vessels are displayed by a display or reminder, and the display or reminder includes a display screen, an LED indicator or a buzzer.
  • the structure of the array electrode 8 can further improve the scanning detection accuracy. For example, the scanning method described in Chinese Patent Document CN101564294A.
  • the preferred solution is shown in Fig. 5, there are multiple array electrodes 8, and multiple array electrodes 8 are arranged on a flexible fixing belt 9, and the flexible fixing belt 9 is provided with glue or buckles connecting the ends to each other to make The array electrode 8 is reliably in contact with the skin. This solution reduces the interference caused by poor contact between the array electrode 8 and the skin.
  • a 0-100 Hz low-frequency current signal is connected between the first electrode 5 and the second electrode 6 to determine the position of the tip of the needle 3;
  • a medium and low frequency signal of 100Hz to 50k Hz which is used to scan different tissues of the human body; the sensitivity of different human tissues to currents of different frequencies is used To further improve the accuracy of detection.
  • Fu Feng, Zang Yimin and other papers on the measurement of blood complex impedance frequency characteristics it is recorded that the blood position can be scanned on the body surface through the graph of the blood complex impedance characteristics at 0.5mA and the frequency of 100Hz ⁇ 10MHz. , And then determine the position of the blood vessel.
  • a switching circuit is also provided for switching the low frequency current signal and the medium and low frequency signal; the switching circuit preferably adopts a soft switching circuit. That is, the switching circuit controlled by software.
  • the arterial blood collection is taken as an example.
  • the array electrode 8 is attached to the patient's skin 10, and the third electrode 7 and the first electrode 5 are also in reliable contact with the skin.
  • the main control system of the main control device 2 issues an instruction, and the reference signal source sends out an alternating current.
  • an alternating current is sent from the first electrode 5 with a frequency of 100 Hz-50 kHz.
  • the needle 3 is rotated along the surface of the skin in the direction in which the first electrode 5 is in reliable contact with the skin during the rotation. According to impedance detection, the position of muscles and blood vessels is judged through the image.
  • the circuit is switched during the puncture process, and a direct current is connected between the first electrode 5 and the second electrode 6, and the position of the human tissue reached by the needle puncture is accurately judged through impedance, so as to realize the intelligent feedback of the syringe.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
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  • Molecular Biology (AREA)
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  • Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Radiology & Medical Imaging (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

一种反馈式智能注射器，包括针头(3)和针座(1)，在针头(3)设有用于检测人体组织阻抗的第一电极(5)和第二电极(6)，第一电极(5)和第二电极(6)与主控装置(2)电连接，主控装置(2)与显示或提醒装置电连接。通过采用以上的结构，能够精确的测量得到皮肤、肌肉、积液以及血液等组织和器官的阻抗，为智能化注射和抽取设置提供依据。在注射过程中，避免错位、栓塞等伤害，准确给药；或者在脂肪抽取过程中进行精确监控，避免抽错造成的伤害；又或者在进行肿瘤积液、脑脊髓液抽取时，通过准确扫描预测、精准定位降低医疗风险，大幅提高医生治疗效率。

Description

反馈式智能注射器 技术领域
本发明涉及医疗器械领域，特别是一种反馈式智能注射器。
背景技术
现有的注射器使用过程中均依靠人工判断注射和抽吸的位置，这依靠对医护人员长期的训练，而即便是熟练的医护人员也很难保证，每次均能使针头位于预定的位置。 首先是在涉及需要抽吸的操作中，例如动脉血、肿瘤积水、脑脊髓液、脂肪组织等过程中，有些还需要其他辅助设备的帮助才能完成工作，例如床边CT机等。其次每年都有很多医生在给人体注射填充物时，都有因填充物注射到血管内造成栓塞后周围组织迅速坏死等，造成了重大医疗事故而无法科学避免，有时候靶向给药无法准确到位，造成治疗效果打折，反馈式的注射器技术可以弥补这样的缺陷，为全球医生注射和抽取提供了智能的眼睛，为患者的病灶治疗提供了精准的工具。中国专利文献CN205163829U记载了一种自动扫描血管的全自动注射装置，通过设置的血管扫描仪扫描人体部位内血管的三维图像，但是该文献中并未详细记载血管扫描仪的结构和具体工作流程。中国专利文献CN101564294A记载了一种结构信息融合的电阻抗断层成像方法，给出了一种基于电极检测生物体内部组织电阻抗性从而得出人体组织成像的技术方案，但是该方案的结构和应用较为复杂，限制了临床使用价值。
发明内容
本发明所要解决的技术问题是提供一种反馈式智能注射器及方法，能够快捷精准地检测定位皮肤、肌肉、体液和血液阻抗，并能够根据阻抗的变化进行智能化注射或者抽吸。
为解决上述技术问题，本发明所采用的技术方案是：一种反馈式智能注射器，包括针头和针座，在针头设有用于检测人体组织阻抗的第一电极和第二电极，第一电极和第二电极与主控装置电连接，主控装置与显示或提醒装置电连接。
优选的方案中，所述的针头为绝缘材料或针头为金属材料，在针头外层包覆有内绝缘层；
第一电极和第二电极沿着针头长度方向布置；
在第一电极和第二电极外层包覆有外绝缘层，第一电极和第二电极的一端仅靠近针尖的位置裸露在外。
优选的方案中，第一电极和第二电极另一端延伸至针座的外壁，主控装置与针座套接，在主控装置的内壁设有第一引入电极和第二引入电极，第一引入电极和第二引入电极分 别与第一电极和第二电极电连接。
优选的方案中，所述的主控装置中，主控系统与基准信号源电连接，基准信号源与带通滤波器电连接，带通滤波器与微信号放大电路电连接，微信号放大电路与第一电极和第二电极电连接；
电流检测电路与第二电极电连接。
优选的方案中，微信号放大电路为仪用放大器电路；
基准信号通过带通滤波器的输出端，经信号控制放大与调制后直接与微信号放大电路的一路输入和第一电极电连接；
微信号放大电路的另一路输入与第二电极和电流检测电路电连接。
优选的方案中，主控装置的结构为：主控系统与基准信号源电连接，基准信号源与带通滤波器电连接，基准信号通过带通滤波器后，通过信号控制模块为第一电极和第二电极提供检测电流；
第一电极和第二电极分别与微信号放大电路和电流检测电路电连接，微信号放大电路和电流检测电路分别与至少两组A/D转换模块电连接，A/D转换模块与数字信号处理模块电连接，数字信号处理模块与主控系统电连接。
优选的方案中，在针座的位置还设有第三电极，第三电极用于与皮肤可靠接触，第三电极通过微信号放大电路与主控装置电连接，第三电极与针座可转动的连接，第三电极与第一电极和第二电极中的一个组成变频阻抗检测电路。
优选的方案中，在针座的位置还设有阵列电极，阵列电极通过微信号放大电路与主控装置电连接，阵列电极与第一电极和第二电极中的一个组成变频阻抗检测电路。
优选的方案中，所述的阵列电极有多个，多个阵列电极布置在柔性固定带上，柔性固定带设有粘胶或端头互相连接的粘扣，以使阵列电极可靠与皮肤接触，以在皮肤之外判断肌肉和血管的位置。
优选的方案中，第一电极与第二电极之间接入0～100Hz低频电流信号，用以确定针头尖端的位置；
第一电极和第二电极中的一个与第三电极或阵列电极之间接入100Hz至50k Hz的中低频信号，用于扫描人体不同组织；
还设有切换电路，用于切换低频电流信号和中低频频信号；
所述的显示或提醒装置包括显示屏、LED指示灯或蜂鸣器。
本发明提供了一种反馈式智能注射器，通过采用以上的结构，能够精确的测量得到 皮肤、肌肉、积液以及血液等组织和器官的阻抗，为智能化注射和抽取设置提供依据。本发明的中，采用直流和中低频微电流双重检测的方式，根据脂肪、肌肉、体液、血液、脊髓液等组织的阻抗变化，精确检测，灵活设置，针头很容易准确探测到注射部位或抽取的组织，同时通过特定算法还原重建图像或者给出提示，使注射或抽取过程更准确。例如，在注射过程中，避免错位、栓塞等伤害，准确给药；或者在脂肪抽取过程中进行精确监控，避免抽错造成的伤害；又或者在进行肿瘤积液、脑脊髓液抽取时，通过准确扫描预测、精准定位降低医疗风险，大幅提高医生治疗效率。
附图说明
下面结合附图和实施例对本发明作进一步说明：
图1为本发明的结构示意图。
图2为本发明中针头的结构示意图。
图3为本发明中针头的横截面示意图。
图4为本发明中另一优选的结构示意图。
图5为本发明中另一优选的机构示意图。
图6为本发明中主控装置与针座连接的结构示意图。
图7为本发明使用时的示意图。
图8为本发明的检测系统框架图。
图9为本发明中的微信号放大电路示意图。
图10为本发明中的人体阻抗检测电路示意图。
图中：针座1，主控装置2，针头3，内绝缘层31，针筒4，第一电极5，第二电极6，第三电极7，阵列电极8，柔性固定带9，皮肤10，动脉血管11，外绝缘层12，第一引入电极13，第二引入电极14，被测组织等效电路15，电流检测电路OP3。
具体实施方式
实施例1：
如图1～7中，一种反馈式智能注射器，包括针头3和针座1，在针头3设有用于检测人体组织阻抗的第一电极5和第二电极6，第一电极5和第二电极6与主控装置2电连接，主控装置2与显示或提醒装置电连接。由此结构，通过主控装置2给第一电极5和第二电极6接入电信号，从而根据阻抗判断针尖处于人体组织的具体位置。
经检测，人体组织的直流电阻率(Ω·m)如下：
脑脊液0.555；血清0.714；血液1.85；神经25.0；肝脏80.0；肌肉90.0；脑107；脂肪10.8 ×10 2；湿润皮肤38.0×10 2；干燥皮肤40.0×10 3；无膜骨20×10 5。
在本例中，通过接入直流电流，即可准确的判断针尖所处的人体的位置。该方案在血液或体液的抽吸操作过程中具有较高应用价值。例如动脉血的采集、淋巴液、脑脊液和肿瘤积液的抽取。
优选的方案如图2、3、6中，所述的针头3为绝缘材料，例如以氧化铝陶瓷制成的绝缘材料，然后再在氧化铝陶瓷表面涂覆具有生物相容性涂层。或者，采用柔性玻璃材质，再在柔性玻璃表面涂覆具有生物相容性的高分子膜。绝缘层例如丝素蛋白膜、聚乙烯吡咯烷酮、季铵盐、特氟龙和肝素复合物，以及其他采用物理气相沉积(PVD)、化学气相沉积(CVD)生成的涂层。
或针头3为金属材料，在针头3外层包覆有内绝缘层31，内绝缘层31采用具有生物相容性的绝缘层；
第一电极5和第二电极6沿着针头3长度方向布置；
优选的方案如图6中，在第一电极5和第二电极6外层包覆有外绝缘层12，第一电极5和第二电极6的一端仅靠近针尖的位置裸露在外。由此结构，以确保仅有针尖的位置能够传导电流至针尖所接触的组织，而其他位置则绝缘，不会干扰针尖位置的检测结果，从而提高对人体组织检测的精确度。
优选的方案如图6中，第一电极5和第二电极6另一端延伸至针座1的外壁，主控装置2与针座1套接，在主控装置2的内壁设有第一引入电极13和第二引入电极14，第一引入电极13和第二引入电极14分别与第一电极5和第二电极6电连接。进一步优选的，第一引入电极13和第二引入电极14采用柔性电极的结构，当主控装置2与针座1套接时，第一引入电极13与第一电极5导通，第二引入电极14与第二电极6导通。通过采用主控装置2与针座1套接的结构，价格较为昂贵的主控装置2部分能够通过拆除实现重复使用，而仅在针头3上通过镀层增加第一电极5和第二电极6的成本也能够被接受。
优选的方案如图9中，所述的主控装置2中，主控系统与基准信号源电连接，基准信号源与带通滤波器电连接，带通滤波器与微信号放大电路电连接，微信号放大电路与第一电极5和第二电极6电连接；
电流检测电路OP3与第二电极6电连接。图9中的虚线框代表被测组织等效电路15。
优选的方案中，微信号放大电路为仪用放大器电路；
基准信号源通过带通滤波器的输出端，经信号控制放大与调制后直接与微信号放大电路的一路输入和第一电极5电连接；
微信号放大电路的另一路输入与第二电极6和电流检测电路OP3电连接。
优选的方案中，主控装置2的结构为：主控系统与基准信号源电连接，基准信号源与带通滤波器电连接，经过带通滤波器后的信号通过信号控制模块为第一电极5和第二电极6提供检测电流；
第一电极5和第二电极6分别与微信号放大电路和电流检测电路电连接，微信号放大电路和电流检测电路分别与至少两组A/D转换模块电连接，A/D转换模块与数字信号处理模块电连接，数字信号处理模块与主控系统电连接。本例中的数字信号处理模块采用嵌入式处理器stm32f103c8，A/D转换模块采用AD7476。主控系统采用intel或ARM系列CPU。
实施例2：
在实施例1的基础上，优选的方案如图4中，在针座1的位置还设有第三电极7，第三电极7通过微信号放大电路与主控装置2电连接，第三电极7与针座1可转动的连接，第三电极7与第一电极5和第二电极6中的一个组成变频阻抗检测电路。以第三电极7为圆心，转动针头3的方向，第三电极7和针头3上的第一电极5或第二电极6均与皮肤可靠接触，在第三电极7与第一电极5和第二电极6中的一个之间给出交流电，根据阻抗检测，判断肌肉和血管的位置，然后在穿刺过程中，第一电极5与第二电极6之间接入直流电，判断针尖穿刺的组织位置，从而实现注射器的智能反馈。
另一优选的方案如图5中，在针座1的位置还设有阵列电极8，阵列电极8通过微信号放大电路与主控装置2电连接，阵列电极8与第一电极5和第二电极6中的一个组成变频阻抗检测电路。在阵列电极8与第一电极5或第二电极6之间接入交流电流，通过阻抗检测，判断皮下组织的位置结构。例如脂肪、体液、肌肉和血管的位置，优选的，皮下组织的位置结构的信息通过显示或提醒装置显示，所述的显示或提醒装置包括显示屏、LED指示灯或蜂鸣器。通过显示屏显示，或者通过不同颜色或不同亮度的LED灯提示，或者通过蜂鸣器加以提示。然后在穿刺过程中，通过施加在第一电极5与第二电极6之间的直流电，判断针尖在人体组织的位置。采用阵列电极8的结构，能够进一步提高扫描检测精度。例如中国专利文献CN101564294A中记载的扫描方式。
优选的方案如图5中，所述的阵列电极8有多个，多个阵列电极8布置在柔性固定带9上，柔性固定带9设有粘胶或端头互相连接的粘扣，以使阵列电极8可靠与皮肤接触。由此方案，以减少因为阵列电极8与皮肤接触不良而造成的干扰。
优选的方案中，第一电极5与第二电极6之间接入0～100Hz低频电流信号，用以确定针头3尖端的位置；
第一电极5和第二电极6中的一个与第三电极7或阵列电极8之间接入100Hz至50k Hz的中低频信号，用于扫描人体不同组织；利用人体不同组织对不同频率电流的敏感性，以进一步提高检测的精度。例如在付峰、臧益民等论文血液复阻抗频率特性的测量中，即记载了在0.5mA，频率100Hz～10MHz条件下，通过血液复电阻抗特性的图形，即可在体表扫描出血液的位置，进而判断出血管所处的位置。
还设有切换电路，用于切换低频电流信号和中低频频信号；切换电路优选采用软切换电路。即由软件控制的切换电路。
实施例3：
在实施例2的基础上，如图7中，以进行动脉血采集为例。使用时，将阵列电极8贴附在患者的皮肤10上，第三电极7和第一电极5也与皮肤可靠接触。主控装置2的主控系统发出指令，基准信号源发出交流电流，优选的，从第一电极5发出交流电流，频率为100Hz～50kHz。以第三电极7或针座1为圆心，沿着皮肤表面转动针头3的方向，在转动过程中，确保第一电极5与皮肤可靠接触。根据阻抗检测，通过图像判断肌肉和血管的位置。确定目标位置后，在穿刺过程中，电路切换，在第一电极5与第二电极6之间接入直流电，通过阻抗精确判断针尖穿刺到达的人体组织位置，从而实现注射器的智能反馈。
上述的实施例仅为本发明的优选技术方案，而不应视为对于本发明的限制，本申请中的实施例及实施例中的特征在不冲突的情况下，可以相互任意组合。本发明的保护范围应以权利要求记载的技术方案，包括权利要求记载的技术方案中技术特征的等同替换方案为保护范围。即在此范围内的等同替换改进，也在本发明的保护范围之内。

Claims (7)

  1. 一种反馈式智能注射器，包括针头(3)和针座(1)，其特征是：在针头(3)设有用于检测人体组织阻抗的第一电极(5)和第二电极(6)，第一电极(5)和第二电极(6)与主控装置(2)电连接，主控装置(2)与显示或提醒装置电连接；所述的针头(3)为绝缘材料或针头(3)为金属材料，在针头(3)外层包覆有内绝缘层(31)；
    第一电极(5)和第二电极(6)沿着针头(3)长度方向布置；
    在第一电极(5)和第二电极(6)外层包覆有外绝缘层(12)，第一电极(5)和第二电极(6)的一端仅靠近针尖的位置裸露在外；
    在针座(1)的位置还设有第三电极(7)，第三电极(7)用于与皮肤可靠接触，第三电极(7)通过微信号放大电路与主控装置(2)电连接，第三电极(7)与针座(1)可转动的连接，第三电极(7)与第一电极(5)和第二电极(6)中的一个组成变频阻抗检测电路；
    第一电极(5)与第二电极(6)之间接入0～100Hz低频电流信号，用以确定针头(3)尖端的位置；
    第一电极(5)和第二电极(6)中的一个与第三电极(7)之间接入100Hz至50kHz的中低频信号，用于扫描人体不同组织；
    所述的主控装置(2)中，主控系统与基准信号源电连接，基准信号源与带通滤波器电连接，带通滤波器与微信号放大电路电连接，微信号放大电路与第一电极(5)和第二电极(6)电连接；
    电流检测电路(OP3)与第二电极(6)电连接；
    还设有切换电路，用于切换低频电流信号和中低频信号；
    所述的显示或提醒装置包括显示屏、LED指示灯或蜂鸣器。
  2. 根据权利要求1所述的一种反馈式智能注射器，其特征是：第一电极(5)和第二电极(6)另一端延伸至针座(1)的外壁，主控装置(2)与针座(1)套接，在主控装置(2)的内壁设有第一引入电极(13)和第二引入电极(14)，第一引入电极(13)和第二引入电极(14)分别与第一电极(5)和第二电极(6)电连接。
  3. 根据权利要求1所述的一种反馈式智能注射器，其特征是：微信号放大电路为仪用放大器电路；
    基准信号通过带通滤波器的输出端，经信号控制放大与调制后直接与微信号放大电路的一路输入和第一电极(5)电连接；
    微信号放大电路的另一路输入与第二电极(6)和电流检测电路(OP3)电连接。
  4. 根据权利要求1所述的一种反馈式智能注射器，其特征是：主控装置(2)的结构为：主 控系统与基准信号源电连接，基准信号源与带通滤波器电连接，基准信号通过带通滤波器后，通过信号控制模块为第一电极(5)和第二电极(6)提供检测电流；
    第一电极(5)和第二电极(6)分别与微信号放大电路和电流检测电路电连接，微信号放大电路和电流检测电路分别与至少两组A/D转换模块电连接，A/D转换模块与数字信号处理模块电连接，数字信号处理模块与主控系统电连接。
  5. 根据权利要求1所述的一种反馈式智能注射器，其特征是：在针座(1)的位置还设有阵列电极(8)，阵列电极(8)通过微信号放大电路与主控装置(2)电连接，阵列电极(8)与第一电极(5)和第二电极(6)中的一个组成变频阻抗检测电路。
  6. 根据权利要求5所述的一种反馈式智能注射器，其特征是：所述的阵列电极(8)有多个，多个阵列电极(8)布置在柔性固定带(9)上，柔性固定带(9)设有粘胶或端头互相连接的粘扣，以使阵列电极(8)可靠与皮肤接触，以在皮肤之外判断肌肉和血管的位置。
  7. 根据权利要求5～6任一项所述的一种反馈式智能注射器，其特征是：
    第一电极(5)和第二电极(6)中的一个与阵列电极(8)之间接入100Hz至50kHz的中低频信号，用于扫描人体不同组织。
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