WO2018161620A1 - 一种静脉穿刺装置、系统及静脉穿刺控制方法 - Google Patents

一种静脉穿刺装置、系统及静脉穿刺控制方法 Download PDF

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Publication number
WO2018161620A1
WO2018161620A1 PCT/CN2017/108901 CN2017108901W WO2018161620A1 WO 2018161620 A1 WO2018161620 A1 WO 2018161620A1 CN 2017108901 W CN2017108901 W CN 2017108901W WO 2018161620 A1 WO2018161620 A1 WO 2018161620A1
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Prior art keywords
needle
venipuncture
control
outer cylinder
motor
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PCT/CN2017/108901
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English (en)
French (fr)
Inventor
王燕青
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王燕青
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Publication of WO2018161620A1 publication Critical patent/WO2018161620A1/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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Definitions

  • the invention relates to the field of automatic catheterization technology, in particular to a venipuncture device, a system and a venipuncture control method.
  • Venous puncture is a medical care method to relieve the pain of repeated puncture of patients and facilitate long-term infusion. Venous puncture can effectively avoid the pain caused by repeated puncture of superficial veins, and can effectively avoid the destruction of blood vessels by anti-tumor drugs and local tissue necrosis caused by drug extravasation.
  • the key points affecting the development of venipuncture catheterization techniques are the puncture guiding device and the control of the movement of the puncture needle.
  • the auxiliary medical robot applying mechanical force has high accuracy and stability, and can reduce the labor intensity of the operator. Therefore, in order to be able to perform soft tissue puncture surgery stably and accurately, robot-assisted puncture has received more and more attention.
  • an object of the embodiments of the present invention is to provide a venipuncture device, a system, and a venipuncture control method, which can automatically control the venipuncture device to perform needle insertion, catheterization, and needle withdrawal operations with high precision, thereby reducing operation.
  • the labor intensity and low cost are examples of the labor intensity and low cost.
  • an embodiment of the present invention provides a venipuncture device, including: a fixing device, a guiding device, and a driving device; the fixing device is slidably connected to the guiding device, and the fixing device is fixed to the driving device Connecting, the driving device is used for connecting with the control device;
  • the hose to be placed is fixed to the fixing device through the needle body to be pierced;
  • the guiding device is configured to guide the fixing device and the needle body to move in a fixed direction
  • the driving device is configured to drive the fixing device to move in a direction guided by the guiding device.
  • an embodiment of the present invention provides a first possible implementation manner of the first aspect, wherein the hose is fixedly disposed on the syringe through the needle body; the fixing device comprises: an inner cylinder, Outer tube, first connecting piece, fixing plate and needle card;
  • the syringe is fixedly connected to the inner cylinder in the inner cylinder, and the inner cylinder is disposed through the first connecting member In the outer cylinder, and the outer cylinder is slidably coupled to the inner cylinder; the outer cylinder is fixedly disposed on the fixing plate by the first connecting member;
  • the needle card cooperates with the needle withdrawal button for triggering the needle withdrawal button under the action of an external force to separate the needle body from the hose and retract into the syringe barrel.
  • the embodiment of the present invention provides the second possible implementation of the first aspect, wherein the venipuncture device further includes an ultrasonic probe; the guiding device includes : a needle guide and an outer cylinder guide;
  • the needle guide is fixedly disposed on the ultrasonic probe, and the needle is mounted on the needle guide;
  • the ultrasonic probe is configured to collect data information of a preselected target blood vessel by using ultrasonic waves, and the data information is Send to the control device;
  • the outer cylinder guide is fixedly disposed on the fixing plate, and the outer cylinder is disposed on the outer cylinder guide.
  • the embodiment of the present invention provides a third possible implementation manner of the first aspect, wherein the driving device comprises: a needle control motor and a second connecting member;
  • the needle control motor is fixedly disposed on the fixing plate, and is fixedly connected to the inner cylinder through the second connecting member.
  • the embodiment of the present invention provides a fourth possible implementation of the first aspect, wherein the driving device further
  • the utility model comprises: a tube motor, a third connecting piece, an outer tube connecting rod and a motor connecting rod;
  • the tube motor is fixedly disposed on the fixing plate by the motor connecting rod; the tube motor is fixedly connected with the third connecting member, and the third connecting member passes through the outer tube connecting rod and the The outer cylinder is connected.
  • the venipuncture device provided by the embodiment of the invention has the following advantages compared with the manual manual puncture or mechanical force assisted medical robot operation puncture in the prior art: 1.
  • the overall cost is low relative to the robot medical system, and is practical. Strong; 2, venipuncture device and ultrasonic probe form a puncture mechanical body, and with the control device to achieve automatic control of the venipuncture device for needle insertion, catheterization and withdrawal, reducing the labor intensity of the operator; 3, vein
  • Most of the components in the puncture device are made of polyethylene material, which has high strength, small volume and light weight, which makes the operator comfortable in hand; 4. It can cooperate with the ultrasonic probe under the guidance of the ultrasonic probe. , high positioning accuracy; 5, can achieve one-handed operation, reduce the operator's experience requirements, and can adapt to a certain dynamic environment.
  • the embodiment of the present invention further provides a venipuncture system, comprising: the control device and the venipuncture device according to any one of the first aspects; the venipuncture device is connected to the control device;
  • the venipuncture device is configured to collect data information of a preselected target blood vessel by using an ultrasonic probe, and send the data information to the control device;
  • the control device is configured to receive the data information, calculate position information of the target blood vessel according to the data information, and generate a control signal for controlling the operation of the venous puncturing device according to the position information;
  • the venipuncture device is further configured to control the needle body to be punctured which is fixed by itself and the skin to be inserted into the skin according to the control signal.
  • control device includes: an ultrasound system host, an image display device, a data acquisition component, an image processor, and a controller;
  • the ultrasonic probe is connected to the ultrasound host;
  • the image display and the data acquisition component are respectively connected to the ultrasound host;
  • the image processor is respectively connected to the data acquisition component and the controller ;
  • the ultrasound machine host is configured to receive the data information sent by the ultrasonic probe, perform image processing on the data information to generate image data, and send the image data to the image display device and the data acquisition card ;
  • the image display device is configured to display the image data, and send the image to be punctured image selected by an operator according to the image data to the ultrasound system host;
  • the ultrasound machine host is further configured to generate a control signal for controlling the data acquisition card to collect image data of the position of the image to be pierced, and send the signal to the data acquisition card;
  • the data acquisition card is configured to receive the control signal, collect image data of the position of the image to be pierced according to the control signal, and send the image data to the image processor;
  • the image processor is configured to receive the image data, calculate position information of the target blood vessel according to the image data, and send the position information to the controller;
  • the controller is configured to receive the location information, determine whether the location information matches the pre-stored standard location information, and if so, generate a control signal for controlling the operation of the venipuncture device according to the location information.
  • the embodiment of the present invention provides a second possible implementation of the second aspect, wherein the venipuncture device comprises: a needle control motor and a tube motor; a needle control motor and the tube motor are respectively connected to the controller;
  • the needle control motor is configured to control the rotation of the second connecting member according to the control signal to drive the whole direction of guiding the syringe, the inner cylinder and the outer cylinder to the guiding device;
  • the tube-splitting motor is configured to control the rotation of the third connecting member according to the control signal, and drive the outer tube to move in a direction guided by the guiding device through the outer cylinder connecting rod.
  • the embodiment of the present invention provides a third possible implementation manner of the second aspect, wherein the venipuncture system further includes a support frame;
  • the support frame includes: a bottom cover mold, a support rib, Supporting the bottom plate and the spacer;
  • the support bottom plate is fixedly disposed on the bottom cover mold at an acute angle through the support rib; the support base plate is provided with the spacer block; and the venipuncture device is fixedly disposed by the spacer block Said on the support floor.
  • the venipuncture system has the following advantages compared with the manual manual puncture or mechanical force assisted medical robot operation puncture in the prior art: 1.
  • the overall cost is low relative to the robot medical system, and is practical. Strong sex; 2, the venipuncture device and the ultrasonic probe form a puncture mechanical body, and with the control device to achieve automatic Control the venipuncture device to perform needle insertion, catheterization and needle withdrawal, reducing the labor intensity of the operator; 3.
  • Most of the components in the venipuncture device are made of polyethylene material, which has high strength and small volume. Light weight makes the operator comfortable in hand; 4, can cooperate with the ultrasonic probe, under the guidance of the ultrasonic probe, the positioning accuracy is high; 5, can realize one-hand operation, reduce the operator's experience requirements, and can Adapt to a certain dynamic environment.
  • the embodiment of the present invention further provides a venipuncture control method, which is the venipuncture system according to any one of the second aspect, the method comprising:
  • control needle motor When detecting that the position information matches the pre-stored standard position information, the control needle motor pushes the whole of the syringe, the inner cylinder and the outer cylinder to move along the guiding direction of the needle guide and the outer cylinder guide;
  • the needle withdrawal button is triggered by the needle card to control the needle body and the hose to separate and retract the needle body into the syringe barrel.
  • the venipuncture control method provided by the embodiment of the invention has the following advantages compared with the manual manual puncture or mechanical force assisted medical robot operation puncture in the prior art: 1.
  • the overall cost is lower than the cost of the robot medical system. Practicality is strong; 2.
  • the venipuncture device and the ultrasonic probe form a puncture mechanical body, and the control device is used to automatically control the venipuncture device for needle insertion, catheterization and needle withdrawal, thereby reducing the labor intensity of the operator;
  • Most of the components in the venipuncture device are made of polyethylene material, which has high strength, small volume and light weight, which makes the operator comfortable in hand; 4. It can cooperate with the ultrasonic probe and guide the ultrasonic probe. Under the high positioning accuracy; 5, can achieve one-hand operation, reduce the operator's experience requirements, and can adapt to a certain dynamic environment.
  • FIG. 1 is a front elevational view of a venipuncture device according to an embodiment of the present invention
  • FIG. 2 is a plan view showing a venipuncture device according to an embodiment of the present invention, in a state in which the advancement of the needle body reaches a preset position and then the catheter is advanced to the blood vessel;
  • FIG. 3 is a schematic diagram showing an image of an ultrasound guided vascular puncture in a horizontal axis position provided by an embodiment of the present invention
  • FIG. 4 is a schematic diagram showing an image of an ultrasound guided vascular puncture in a longitudinal axis position provided by an embodiment of the present invention
  • Fig. 5 is a schematic view showing the critical force of the needle entering different tissue layers at different puncture speeds according to an embodiment of the present invention.
  • FIG. 6 is a schematic structural view of a venipuncture system according to an embodiment of the present invention.
  • FIG. 7 shows a display image of a venous blood vessel collected by an ultrasonic probe (ie, a B-ultrasound probe) according to an embodiment of the present invention.
  • an ultrasonic probe ie, a B-ultrasound probe
  • FIG. 8 is a view showing a comparison of the needle insertion process and the speed control provided by the embodiment of the present invention.
  • FIG. 9 shows a host computer program debugging interface provided by an embodiment of the present invention.
  • FIG. 10 shows experimental test data of the needle control motor provided by the embodiment of the present invention.
  • FIG. 11 shows experimental test data of the tube-mounted motor provided by the embodiment of the present invention.
  • FIG. 12 is a schematic structural view of a support frame in a venipuncture device according to an embodiment of the present invention.
  • FIG. 13 is a flow chart showing a venipuncture control method according to an embodiment of the present invention.
  • Icon 1, venipuncture device; 2, control device; 3, support frame; 4, syringe; 5, needle body; 10, fixing device; 11, guiding device; 12, driving device; 13, ultrasonic probe; Inner cylinder; 101, outer cylinder; 102, first connecting member; 103, fixing plate; 104, needle card; 110, needle guiding member; 111, outer cylinder guiding member; 120, needle control motor; 121, second connection 122; tube motor; 123, third connector; 124, outer tube connecting rod; 125, motor connecting rod; 126, inner motor fixing plate; 20, ultrasound machine host; 21, image display device; Acquisition component; 23, image processor; 24, controller; 31, bottom sleeve; 32, support ribs; 33, support bottom plate; 34, spacer.
  • Venous puncture is a medical care method to relieve the pain of repeated puncture of patients and facilitate long-term infusion. Venous puncture can effectively avoid the pain caused by repeated puncture of superficial veins, and can effectively avoid the destruction of blood vessels by anti-tumor drugs and local tissue necrosis caused by drug extravasation.
  • the key points affecting the development of venipuncture catheterization technology are the puncture guiding device and the control of the movement of the puncture needle.
  • the auxiliary medical robot applying mechanical force has high accuracy and stability, and can reduce the operation.
  • robot-assisted puncture is difficult to reach. The extent of pan-application.
  • B-scan ultrasonography and CT Computed Tomography
  • the PICC Peripherally Inserted Central Catheter
  • B-ultrasound is a new type of venous catheterization in recent years. It uses ultrasonic non-invasive positioning technology to accurately locate blood vessels. A method of performing a venipuncture cannula is considered. The arteries, veins, nerves and surrounding tissues of the puncture site under ultrasound are clearly displayed.
  • the direction, angle and depth of the needle can be determined under B-ultrasound during puncture, making the puncture intuitive, accurate and targeted, which can avoid If you accidentally enter the artery, puncture the blood vessel or accidentally injure the surrounding tissue, you can improve the success rate of one puncture, prevent the occurrence of adverse symptoms such as hematoma and pneumothorax, and reduce the number of punctures and complications of catheterization.
  • the embodiment of the invention designs a venipuncture device, a system and a venipuncture control method, wherein the venipuncture device is a light and simple puncture guiding device, which adopts B-ultrasound image guidance and is controlled by a micro system to reach an automatic vein.
  • the effect of puncture catheterization is a light and simple puncture guiding device, which adopts B-ultrasound image guidance and is controlled by a micro system to reach an automatic vein.
  • the venipuncture device, the system and the venipuncture control method provided by the embodiment of the invention have the following characteristics: 1 automatically completing the needle insertion, tube placement and needle withdrawal according to the venous blood vessel B-ultrasound image; 2 positioning support frame (also called puncture The guide frame is flexibly combined with the ultrasonic probe (abbreviated as B-ultrasound) for easy disassembly and installation.
  • B-ultrasound ultrasonic probe
  • most of the components of the venipuncture device are made of polyethylene material, which is not only high in strength but also small in size ( 240mm ⁇ 80mm ⁇ 60mm), light weight, good hand-held comfort; 4 system through the B-ultrasound guided venipuncture device, high positioning accuracy, making the puncture more accurate; 5 from the original two-hand operation can be changed with one hand, the operation The experience requirements are reduced, and can adapt to a certain dynamic environment; 6 cost is much cheaper than robotic medical systems, greatly reducing costs.
  • a venipuncture device, a system, and a venipuncture control method according to an embodiment of the present invention are described in detail below with reference to FIG. 1 to FIG. 5 and a specific embodiment.
  • an embodiment of the present invention provides a venipuncture device 1 including: a fixing device 10, a guiding device 11 and a driving device 12; the fixing device 10 is slidably connected with the guiding device 11, the fixing device 10 and the driving device The device 12 is fixedly connected, and the driving device 12 is used for connecting with the control device 2;
  • the hose to be placed is fixed on the fixing device 10 through the needle to be pierced;
  • a guiding device 11 for guiding the fixing device 10 and the needle body 5 to move in a fixed direction
  • the driving device 12 is configured to drive the fixing device 10 to move in the direction in which the guiding device 11 is guided.
  • the fixing device 10 functions to fix the needle to be punctured (hereinafter referred to as the needle body 55) and the hose to be placed (hereinafter referred to as the hose). Specifically, the needle body 5 passes through the hose and the hose is fixed to the needle tube to form a unit.
  • the fixing device 10 functions to fix the needle tube in the whole body.
  • the fixing device 10 is slidably coupled to the guiding device 11 for the purpose of providing a direction of movement of the fixing device 10, and the fixing device 10 is moved along the guiding direction of movement of the guiding device 11.
  • the driving device 12 is connected to the fixing device 10 for the purpose of driving the movement of the fixing device 10, and the fixing device 10 is moved in the moving direction guided by the guiding device 11 under the driving of the driving device 12.
  • the driving device 12 can be connected to the control device 2 for receiving the control signal from the control device 2 and operating according to the control signal.
  • a venipuncture device 1 according to an embodiment of the present invention, a hose is fixedly disposed on the syringe 4 through a needle body 5;
  • the fixing device 10 includes: an inner cylinder 100, an outer cylinder 101, and a first Connecting member 102 and fixing plate 103;
  • the syringe 4 is disposed in the inner cylinder 100 in fixed connection with the inner cylinder 100.
  • the inner cylinder 100 is disposed in the outer cylinder 101 through the first connecting member 102, and the outer cylinder 101 is slidably coupled to the inner cylinder 100; the outer cylinder 101 passes the first
  • the connecting member 102 is fixedly disposed on the fixing plate 103.
  • the inner cylinder 100 and the outer cylinder 101 are both hollow cylindrical bodies, wherein the hollow portion of the inner cylinder 100 is a first chamber, and the hollow portion of the outer cylinder 101 is a second chamber.
  • the syringe 4 is disposed in the first chamber of the inner cylinder 100 and is fixedly connected with the inner cylinder 100 to form an integral body, and the whole movement and the overall stationary state during the puncturing process.
  • the inner cylinder 100 is disposed in the second chamber of the outer cylinder 101 through the first connecting member 102, the outer cylinder 101 is slidably coupled to the inner cylinder 100, and the outer cylinder 101 is also fixedly disposed on the fixing plate by the first connecting member 102.
  • the driving device 12 can separately drive the outer cylinder 101 to move, at this time, the inner cylinder 100 and the cylinder 4 are not moved integrally; the driving device 12 can also drive the inner cylinder 100 to move, at this time, the inner cylinder 100 and Both the entire barrel 4 and the outer cylinder 101 are moved.
  • a venipuncture device 1 according to an embodiment of the present invention further includes a needle card 104;
  • the needle card 104 cooperates with the withdrawal button for triggering the withdrawal button under the action of an external force to separate the needle body 5 from the hose and retract into the syringe 4.
  • the needle card 104 is a hose needle card.
  • the user can apply an external force to the needle card 104, and trigger the needle withdrawal button through the needle card 104, and finally, the needle body 5 is returned. Retreat into the syringe 4 and separate from the hose.
  • the venipuncture device 1 provided by the embodiment of the present invention further includes an ultrasonic probe 13;
  • the guiding device 11 includes: a needle body guiding member 110 and an outer cylinder guiding member 111;
  • the needle guide 110 is fixedly disposed on the ultrasonic probe 13, and the needle 5 is mounted on the needle guide 110.
  • the ultrasonic probe 13 is configured to collect data information of the preselected target blood vessel by ultrasonic waves, and send the data information to the control device 2 ;
  • the outer cylinder guide 111 is fixedly disposed on the fixed plate 103, and the outer cylinder 101 is erected on the outer cylinder guide 111.
  • the guiding device 11 specifically includes two components, namely a needle guiding member 110 and an outer cylinder guiding member 111.
  • the needle guiding member 110 is fixedly disposed on the ultrasonic probe 13 for erecting the needle body 5 and making the needle
  • the body 5 is located on the same plane as the ultrasonic probe 13 for the purpose of observing the puncture path of the needle body 5 through the ultrasonic probe 13 during the puncture of the needle body 5.
  • the puncture path is a so-called longitudinal section, see FIG. And Figure 4.
  • the ultrasound plane and the puncture needle can be divided into an in-plane technique and an out-of-plane technique.
  • the so-called in-plane technique is that the pointer and the probe are in the same plane, and the puncture path of the needle, that is, the longitudinal section, can be observed throughout the puncture process.
  • Figure 4 is an image of ultrasound guided vascular puncture in the vertical axis position.
  • the ultrasonic plane and the guiding needle it can be divided into in-plane technology and out-of-plane technology, see Figures 3 and 4.
  • the out-of-plane technique the direction of the pointer is perpendicular to the probe, and the image seen is the cross section.
  • (A) indicates an adjustment probe
  • (B) indicates an ultrasound screen image
  • Art indicates an artery
  • Vn indicates a vein
  • P indicates a probe
  • US indicates an ultrasound beam plane
  • a indicates a needle (ie, a needle) 5) into the vein
  • b is the puncture needle (ie needle body 5) and the ultrasound plane intersects
  • c is the puncture needle (ie needle body 5) through the vein.
  • the driving device 12 includes: a needle control motor 120 and a second connecting member 121; the needle adjusting motor 120 is fixedly disposed on the fixing plate 103, And being fixedly connected to the inner cylinder 100 through the second connecting member 121.
  • the function of the needle control motor 120 is to control the rotation of the second connecting member 121 to drive the entire cylinder 4, the inner cylinder 100 and the outer cylinder 101 to move in the direction in which the guiding device 11 is guided.
  • the needle control motor 120 is fixed on the fixing plate 103 by the inner motor fixing plate 126, and is fixedly connected to the inner cylinder 100 through the second connecting member 121.
  • the driving device 12 further includes: a tube motor 122, a third connecting member 123, an outer tube connecting rod 124 and a motor connecting rod 125; the tube motor 122 is fixedly disposed on the fixing plate 103 through the motor connecting rod 125; the tube motor 122 The third connector 123 is fixedly coupled to the third connector 123, and the third connector 123 is coupled to the outer cylinder 101 via the outer cylinder connecting rod 124.
  • the function of the tube placing motor 122 is to control the rotation of the third connecting member 123 according to the control signal, and to drive the outer tube 101 to move in the direction guided by the guiding device 11 by the outer cylinder connecting rod 124.
  • the second connecting member 121 and the third connecting member 123 are both screw nuts.
  • the load of the needle control motor 120 is mainly derived from the resistance of the puncturing skin, the frictional force of the needle body 5 and its guiding inner cylinder, and the second connecting member 121 (the screw nut in the embodiment of the present invention) ) Vice drive friction resistance, etc.
  • the mass of the needle body 5 is selected to be about 20 g, and the damping coefficient of the needle body 5 and the guide inner cylinder is 0.3, so the frictional resistance is 0.006 N.
  • the resistance of the puncture needle in the process of puncture the skin is more complicated.
  • the whole puncture process can be divided into the following three stages: before piercing the skin, after piercing the skin, and after entering the blood vessel.
  • the resistances encountered during the entire puncture process are mainly rigid force, friction force and cutting force, and the above three resistances of the needle body 5 at different tissues and different stages such as skin and blood vessels are also different.
  • Nonlinear force; at the same time, puncture resistance The force is also related to the puncture speed of the needle 5, and the resistance to the needle motor 120 is different because the puncture speed of the needle 5 is different.
  • the puncture needle Under normal circumstances, during the manual puncture, the puncture needle enters the skin and the blood vessel has a small puncture force, and the manual puncture speed is generally lower than 5 mm/s.
  • Figure 3 shows that the needle 5 enters different tissue layers at different puncture speeds.
  • the critical force. Therefore, the puncture force required for the needle is generally less than 4N, so that the theoretical maximum external load of the needle motor 120 can be estimated to be 4.006N.
  • the venipuncture device 1 adopts a linear motion to realize automatic puncture, and the transmission is stable, the positioning accuracy is high, and the control is convenient, and the self-wire is finally selected.
  • the micro motor of the bar slide is used as the needle control motor 120.
  • the basic parameters of the stepper motor are: 2-phase 4-wire system, drive voltage is 4-9V/100-500mA, screw length is 90mm, slider stroke is 80mm, motor diameter is 15mm, screw diameter is 3mm, optical axis The diameter is 3mm, the screw pitch is 0.5mm, and the step angle is 18°.
  • the theoretical maximum value of the external load of the tube motor 122 is estimated to be 6N by querying the data.
  • the accuracy requirement and the transmission requirement of the tube motor 122 are lower than those of the needle motor 120.
  • the micro screw stepping motor is used as the tube motor 122, and its parameters are as follows: 2-phase 4-wire system, driving voltage is 5V/100-500mA, screw length is 55mm, motor diameter is 10mm, screw diameter is 3mm, screw pitch It is 1.2mm and the step angle is 18°.
  • the venipuncture device provided by the embodiment of the invention has the following advantages compared with the manual manual puncture or mechanical force assisted medical robot operation puncture in the prior art: 1.
  • the overall cost is low relative to the robot medical system, and is practical. Strong; 2, venipuncture device and ultrasonic probe form a puncture mechanical body, and with the control device to achieve automatic control of the venipuncture device for needle insertion, catheterization and withdrawal, reducing the labor intensity of the operator; 3, vein
  • Most of the components in the puncture device are made of polyethylene material, which has high strength, small volume and light weight, which makes the operator comfortable in hand; 4. It can cooperate with the ultrasonic probe under the guidance of the ultrasonic probe. , high positioning accuracy; 5, can achieve one-handed operation, reduce the operator's experience requirements, and can adapt to a certain dynamic environment.
  • the embodiment of the present invention further provides a venipuncture system, and referring to FIG. 6, comprising: a control device 2 and the above-mentioned venipuncture device 1; the venipuncture device 1 is connected with the control device 2;
  • a venipuncture device 1 for collecting data information of a preselected target blood vessel through the ultrasonic probe 13, and transmitting the data information to the control device 2;
  • the control device 2 is configured to receive data information, calculate position information of the target blood vessel according to the data information, and generate a control signal for controlling the operation of the venous puncturing device 1 according to the position information;
  • the venipuncture device 1 is also used to control the needle body 5 to be punctured which is fixed by itself and the skin to be inserted into the skin according to the control signal.
  • the ultrasonic probe 13 is a B-ultrasound probe
  • the venipuncture device 1 transmits ultrasonic waves to the preselected target blood vessels through the B-ultrasound probe, and receives ultrasonic waves reflected by the preselected target blood vessels to collect the preselected target blood vessels. The data information is then sent to the control device 2.
  • control device 2 After receiving the data information, the control device 2 performs image processing on the data information to generate image data, and then calculates position information of the target blood vessel based on the image data, and after detecting that the position information of the target blood vessel conforms to the pre-stored standard position information, according to The position information generates a control signal for controlling the operation of the venipuncture device 1.
  • the control device 2 specifically includes: an ultrasound system host 20, an image display device 21, a data acquisition component 22, an image processor 23, and a controller 24;
  • the ultrasonic probe 13 is connected to the ultrasound host 20; the image display 21 and the data acquisition component 22 are respectively connected to the ultrasound host 20; the image processor 23 is connected to the data acquisition component 22 and the controller 24, respectively;
  • the ultrasonic probe 13 (ie, the B-ultrasound probe) transmits ultrasonic waves to the preselected target blood vessels, and receives the ultrasonic waves reflected by the preselected target blood vessels, and sends the received reflected ultrasonic waves to the ultrasound apparatus main body 20;
  • the ultrasound machine host 20 is configured to receive data information sent by the ultrasonic probe 13, perform image processing on the data information to generate image data, and send the image data to the image display device 21 and the data acquisition card;
  • the image display device 21 is configured to display image data, and send the image to be punctured image selected by the operator according to the image data to the ultrasound system host 20;
  • the ultrasound system host 20 is further configured to generate a control signal for controlling the data acquisition card to collect image data of the position of the image to be punctured, and send the data to the data acquisition card;
  • a data acquisition card for receiving a control signal, collecting image data of the position of the image to be pierced according to the control signal, and transmitting the image data to the image processor 23;
  • the image processor 23 is configured to receive image data, calculate position information of the target blood vessel based on the image data, and send it to the controller 24;
  • the controller 24 is configured to receive the position information, determine whether the position information matches the pre-stored standard position information, and if so, generate a control signal for controlling the operation of the venipuncture device 1 based on the position information.
  • the ultrasonic probe 13 (ie, the B-ultrasound probe) transmits ultrasonic waves to the preselected target blood vessels, and receives ultrasonic waves reflected by the preselected target blood vessels, and sends the received reflected ultrasonic waves to the ultrasound apparatus main body 20; the ultrasound apparatus main body 20 receives the reflected ultrasonic waves, And performing image processing on the reflected ultrasonic wave to generate image data, and then transmitting the image data to the image display device 21 and the data acquisition card; the image display device 21 displays the image data, and receives the operator to select the candidate according to the image data.
  • the ultrasonic probe 13 ie, the B-ultrasound probe
  • the ultrasound system host 20 controls the image data of the data acquisition card to be punctured image position; the data acquisition card collects the position of the image to be punctured under the control of the ultrasound system host 20 Image data, the collected image data is sent to the image processor 23; the image processor 23 receives the image data, calculates the position information of the target blood vessel based on the image data, and then transmits the calculated position information to the controller 24; The device 24 receives the location information, and determines that the location information and the pre-stored standard location information are Match, if match, based on the position information of an operating control signal generating means for controlling the venipuncture.
  • Fig. 7 is a display image of a venous blood vessel in a B-mode ultrasound, and the image processor 23 can calculate important gradation information such as the radius r of the blood vessel and the depth h of the skin from the center of the blood vessel by processing the gradation value of the image.
  • the circle in Fig. 7 is the range of blood vessels indicated by the image processor 23 based on the image data, and the central bright spot is the development of the puncture needle tip in the blood vessel.
  • the data acquisition unit 22 collects a large number of acquired venous blood vessel B-ultrasound images, and the image processor 23 calculates corresponding depth h values and inner diameter values to form a blood vessel image database.
  • the depth permission range of the needle is set to 5.95 to 10.91 mm based on the above data, and the allowable range of the blood vessel radius of the needle is set to 1.57 to 2.65 mm.
  • Fig. 8 Under the premise of safe needle insertion, in order to ensure the precise control of the distance of the needle and to reduce the time of the needle piercing the skin in order to reduce the pain of the patient, six key control points are set according to the entire needle insertion condition of the needle, as shown in Fig. 8.
  • the O, E, B, F, C, and D points in the needle process and speed control comparison chart represent the key turning points for controlling the needle speed.
  • the whole needle insertion process is divided into five control segments, each of which is a function of three variables of the origin of the needle tip from the skin height h, the vessel center depth d, and the vessel radius r.
  • the controller controls the speed control program design of the needle control motor and the tube-mounted motor:
  • the controller 24 used in the embodiment of the present invention adopts the MCU (Microcontroller Unit) of the ST company STM32F411, and adopts 64-bit.
  • the package has a 100MHz CPU frequency and operates from 1.7V to 3.6V.
  • the microcontroller is based on the ARM Cortex-M4 32-bit MCU core, single-cycle access, low power, low price, high performance.
  • the controller 24 uses the CodeWarrior development studio as the compiling environment for the control program, and the CodeWarrior has a rich STM32 firmware library built in, which can be easily programmed.
  • the modular control is used for the speed control program design. Since the control object only has a stepping motor, the PWM (Pulse Width Modulation) frequency modulation method is used to control the motor speed, given the duty of the PWM. In the case of the ratio, only the PWM pulse period is changed for speed regulation, and the STM32F411 accesses or rewrites the L6470 internal register through the SPI (Serial Peripheral Interface) interface to control the acceleration, deceleration and stop of the stepping motor.
  • PWM Pulse Width Modulation
  • SPI Serial Peripheral Interface
  • the venipuncture device 1 includes: a needle control motor 120 and a tube motor 122; the needle control motor 120 and the tube motor 122 are respectively connected to the controller 24;
  • the needle control motor 120 is configured to control the rotation of the second connecting member 121 according to the control signal, so as to drive the entire movement of the syringe 4, the inner cylinder 100 and the outer cylinder 101 to guide the device 11;
  • the tube motor 122 is configured to control the rotation of the third connecting member 123 according to the control signal, and connect the rod 124 through the outer cylinder
  • the outer cylinder 101 is driven to move in the direction in which the guiding device 11 is guided.
  • Fig. 10 is the experimental test data of the needle control motor 120 (large motor)
  • Fig. 11 is the experimental test data of the tube motor 122 (small motor).
  • the venipuncture device in the embodiment of the present invention takes the STM32F411 as the core, realizes the automatic control of the needle insertion and the needle withdrawal action through the modular design method, completes the entire expected action flow, and can realize the target through the B-mode image guidance.
  • the steps are lost, but both of them are within the error security allowable range. It is proved that the venipuncture device of the embodiment of the invention can accurately realize the automatic needle insertion function with good stability.
  • the front surface area of the ultrasonic probe 13 and the needle body 5 is small, and the curvature of the curved surface is large and irregular, and the venipuncture device is difficult to install; at the same time, the needle body 5 and the ultrasonic wave are required at the horizontal axis position.
  • the ultrasonic beam emitted by the probe 13 is in the same plane, and the pin body and the blood vessel are deformed by extrusion during the puncture, which is difficult to ensure.
  • the embodiment of the present invention adopts an out-of-plane technology with a large plane, that is, adopts a horizontal axis mounting manner, and according to the characteristics of the ultrasonic probe and the operator's hand-held habit, a support frame 3 having a hollow triangular structure is designed for puncture. Fixed installation of the device and probe.
  • Figure 12 is a schematic view of the support frame 3.
  • a venipuncture system further includes a support frame 3, which is used for positioning, that is, a positioning support frame;
  • the support frame 3 includes: a bottom cover mold 31 and a support rib plate. 32, supporting the bottom plate 33 and the block 34;
  • the support bottom plate 33 is fixedly disposed on the bottom cover mold 31 at an acute angle by the support ribs 32.
  • the support base plate 33 is provided with a spacer 34; the venipuncture device 1 is fixedly disposed on the support base plate 33 through the spacer 34.
  • the bottom cover mold 31 is used for placing the ultrasonic probe 13
  • the support bottom plate 33 is used for placing the venipuncture device 1 for adjusting the height of the venous puncturing device 1 on the support base plate 33
  • the support rib 32 is used for supporting
  • the support bottom plate 33 is configured to fix the support bottom plate 33 to the bottom cover mold 31.
  • the venipuncture device 1 includes an outer cylinder guide 111 fixedly disposed on the support bottom plate 33 of the support frame 3 to realize that the venipuncture device 1 is integrally disposed on the support frame 3.
  • the B-super probe model is used as a mold, and the bottom mold 31 made of polyethylene thermoforming technology is not only light in weight, high in strength, but also firmly integrated with the probe, and the operator's hand-held comfort is greatly improved.
  • the reference plane is machined on the bottom cover 31, and the adjustment of the spacer 34 ensures the positioning accuracy of the probe and the needle 5.
  • the venipuncture system provided by the embodiment of the present invention is generally described below with reference to FIG. 6 : the current modular design has been widely used in the global manufacturing product development process.
  • the embodiment of the invention designs a venipuncture device and a venipuncture system based on the modular design method and the functional requirements used by the system.
  • the overall scheme of the venipuncture system is shown in Fig. 6, which is composed of a venipuncture device 1, a support frame 3 and a control device 2.
  • the venipuncture device 1 includes a needle control motor 120, a tube motor 122 and other connecting components, and adopts a double motor screw nut transmission mode.
  • the needle control motor 120 pushes the puncture needle and the hose to puncture the skin into the blood vessel, and the tube motor 122 pushes the tube.
  • the hose is in place and triggers the withdrawal button to retract the needle 5 into the syringe 4.
  • the operator holds the automatic puncture device, moves the B-ultrasound probe to locate the target blood vessel, and locates the device posture.
  • the image processor 23 calculates the depth and inner diameter of the target blood vessel according to the image data returned by the B-ultrasound host, and the controller 24STM32F411 automatically calculates the number of PWM pulses according to the position signal, and selects the speed and acceleration, and drives the chip L6470 through the intelligent stepping motor. And control the order movement of the needle control motor and the tube motor separately.
  • the needle control motor 120 drives the needle body 5 so that both the needle tip and the PICC catheter pierce the skin.
  • the needle control motor 120 After accurately reaching the center position of the target blood vessel, the needle control motor 120 stops moving, and then the tube motor 122 pushes the catheter to continue to penetrate the blood vessel for a distance; After the blood vessel is set in length, the tube motor 122 stops moving, and at the same time, the needle withdrawal button is triggered, the catheter and the needle body 5 are automatically separated, and the indwelling needle is safely withdrawn; finally, the needle control motor 120 drives the needle body 5 to retreat and returns to the origin to stop.
  • the venipuncture system provided by the embodiment of the invention has the following advantages compared with the manual manual puncture or mechanical force assisted medical robot operation puncture in the prior art: 1.
  • the overall cost is low relative to the robot medical system, and is practical. Strong; 2, venipuncture device and ultrasonic probe form a puncture mechanical body, and with the control device to achieve automatic control of the venipuncture device for needle insertion, catheterization and withdrawal, reducing the labor intensity of the operator; 3, vein
  • Most of the components in the puncture device are made of polyethylene material, which has high strength, small volume and light weight, which makes the operator comfortable in hand; 4. It can cooperate with the ultrasonic probe under the guidance of the ultrasonic probe. , high positioning accuracy; 5, can achieve one-handed operation, reduce the operator's experience requirements, and can adapt to a certain dynamic environment.
  • the embodiment of the present invention further provides a venipuncture control method.
  • the method is based on the venipuncture system described above, and the method is performed by a controller in a venipuncture system, and specifically includes:
  • S101 Collect data information of the preselected target blood vessel.
  • control needle motor pushes the whole of the syringe, the inner cylinder and the outer cylinder to move along the guiding direction of the needle guide and the outer cylinder guide.
  • S104 When detecting the overall movement of the syringe, the inner cylinder and the outer cylinder by a first predetermined distance, controlling the tube motor to push the outer cylinder to continue to move along the direction in which the outer cylinder guide is guided.
  • the needle withdrawal button is triggered by the needle card to control the needle body and the hose to separate and retract the needle body into the syringe.
  • the first preset distance and the second preset distance are set according to the actual needle insertion, and the first preset distance and the second preset distance may be the same or different.
  • the venipuncture control method provided by the embodiment of the invention has the following advantages compared with the manual manual puncture or mechanical force assisted medical robot operation puncture in the prior art: 1.
  • the overall cost is lower than the cost of the robot medical system. Practicality is strong; 2.
  • the venipuncture device and the ultrasonic probe form a puncture mechanical body, and the control device is used to automatically control the venipuncture device for needle insertion, catheterization and needle withdrawal, thereby reducing the labor intensity of the operator;
  • Most of the components in the venipuncture device are made of polyethylene material, which has high strength, small volume and light weight, which makes the operator comfortable in hand; 4. It can cooperate with the ultrasonic probe and guide the ultrasonic probe. Under the high positioning accuracy; 5, can achieve one-hand operation, reduce the operator's experience requirements, and can adapt to a certain dynamic environment.
  • the control device provided by the embodiment of the present invention may be specific hardware on the device or software or firmware installed on the device.
  • the implementation principle and the technical effects of the device provided by the embodiments of the present invention are the same as those of the foregoing method embodiments.
  • a person skilled in the art can clearly understand that for the convenience and brevity of the description, the specific working processes of the foregoing system, the device and the unit can refer to the corresponding processes in the foregoing method embodiments, and details are not described herein again.
  • the disclosed apparatus and method may be implemented in other manners.
  • the device embodiments described above are merely illustrative.
  • the division of the unit is only a logical function division.
  • multiple units or components may be combined or Can be integrated into another system, or some features can be ignored or not executed.
  • the mutual coupling or direct coupling or communication connection shown or discussed may be an indirect coupling or communication connection through some communication interface, device or unit, and may be electrical, mechanical or otherwise.
  • the units described as separate components may or may not be physically separated, and the components displayed as units may or may not be physical units, that is, may be located in one place, or may be distributed to multiple network units. Some or all of the units may be selected according to actual needs to achieve the purpose of the solution of the embodiment.
  • each functional unit in the embodiment provided by the present invention may be integrated into one processing unit, or each unit may exist physically separately, or two or more units may be integrated into one unit.
  • the function can be stored if it is implemented in the form of a software functional unit and sold or used as a standalone product.
  • a computer readable storage medium Based on such understanding, the technical solution of the present invention, which is essential or contributes to the prior art, or a part of the technical solution, may be embodied in the form of a software product, which is stored in a storage medium, including The instructions are used to cause a computer device (which may be a personal computer, server, or network device, etc.) to perform all or part of the steps of the methods described in various embodiments of the present invention.
  • the foregoing storage medium includes: a U disk, a mobile hard disk, a read-only memory (ROM), a random access memory (RAM), a magnetic disk, or an optical disk, and the like. .

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Abstract

一种静脉穿刺装置（1）、系统及静脉穿刺控制方法，该系统包括：控制装置（2）和静脉穿刺装置（1）；静脉穿刺装置（1）和超声波探头（13）分别与控制装置（2）连接；静脉穿刺装置（1），用于通过超声波探头（13）采集预选靶血管的数据信息，并发送至控制装置（2）；控制装置（2），用于根据数据信息计算靶血管的位置信息，根据位置信息生成控制信号；静脉穿刺装置（1）还用于，根据控制信号控制自身固定的待穿刺针体（5）和待置入软管穿刺皮肤。该装置及系统整体造价相对机器人医疗系统成本低；能够自动控制静脉穿刺装置（1）进行进针、置管和退针的动作，减少了操作者的劳动强度；且与超声波探头（13）相配合，在超声波探头（13）的引导下，定位精度高；可实现单手操作，对操作者的经验要求降低且能适应动态环境。

Description

一种静脉穿刺装置、系统及静脉穿刺控制方法
相关申请的交叉引用
本申请要求于2017年03月10日提交中国专利局的申请号为CN201710142454.6、名称为“一种静脉穿刺装置、系统及静脉穿刺控制方法”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
本发明涉及自动置管技术领域，具体而言，涉及一种静脉穿刺装置、系统及静脉穿刺控制方法。
背景技术
静脉穿刺是为了减轻病人反复穿刺的痛苦，便于长期输液的一种医学护理手段。静脉穿刺能有效避免浅静脉反复穿刺造成的痛苦,也能有效避免抗肿瘤药物对血管的破坏及药物外渗引起的局部组织坏死。影响静脉穿刺置管技术发展的关键点就是穿刺引导装置和对穿刺针运动的控制。与人手操作相比，应用机械力的辅助医疗机器人具有很高的准确性和稳定性，并能降低操作者的劳动强度。因此，为了能够稳定且准确的实施软组织穿刺手术，机器人辅助穿刺受到越来越多的关注。
但是，由于机器人价格昂贵、机器人与病人的标定和配套方式比较复杂、机器人操作方式过于专业化等因素，机器人辅助穿刺还难以达到广泛应用的程度。
发明内容
有鉴于此，本发明实施例的目的在于提供一种静脉穿刺装置、系统及静脉穿刺控制方法，能够高精度的实现自动控制静脉穿刺装置进行进针、置管和退针的动作，减少了操作者的劳动强度且成本低。
第一方面，本发明实施例提供了一种静脉穿刺装置，包括：固定装置、导向装置和驱动装置；所述固定装置与所述导向装置可滑动连接，所述固定装置与所述驱动装置固定连接，所述驱动装置用于与控制装置连接；
待置入软管通过待穿刺针体固定在所述固定装置上；
所述导向装置，用于引导所述固定装置和所述针体以固定的方向运动；
所述驱动装置，用于驱动所述固定装置沿着所述导向装置引导的方向运动。
结合第一方面，本发明实施例提供了第一方面的第一种可能的实施方式，其中，所述软管通过所述针体固定设置在针筒上；所述固定装置包括：内筒、外筒、第一连接件、固定板和针卡；
所述针筒设置在所述内筒中与所述内筒固定连接，所述内筒通过所述第一连接件设置 在所述外筒中，且外筒可与所述内筒可滑动连接；所述外筒通过所述第一连接件固定设置在所述固定板上；
所述针卡与退针按钮相配合，用于在外力的作用下触发所述退针按钮，以使所述针体与所述软管分离并回退到所述针筒内。
结合第一方面的第一种可能的实施方式，本发明实施例提供了第一方面的第二种可能的实施方式，其中，所述的静脉穿刺装置，还包括超声波探头；所述导向装置包括：针体导向件和外筒导向件；
所述针体导向件固定设置在所述超声波探头上，所述针体架设在所述针体导向件上；所述超声波探头，用于通过超声波采集预选靶血管的数据信息，并将数据信息发送至控制装置；
所述外筒导向件固定设置在所述固定板上，所述外筒架设在所述外筒导向件上。
结合第一方面的第一种可能的实施方式，本发明实施例提供了第一方面的第三种可能的实施方式，其中，所述驱动装置包括：控针电机和第二连接件；
所述控针电机固定设置在所述固定板上，并通过所述第二连接件与所述内筒固定连接。
结合第一方面的第一种可能的实施方式或者第一方面的第三种可能的实施方式，本发明实施例提供了第一方面的第四种可能的实施方式，其中，所述驱动装置还包括：置管电机、第三连接件、外筒连接杆和电机连接杆；
所述置管电机通过所述电机连接杆固定设置在所述固定板上；所述置管电机与所述第三连接件固定连接，所述第三连接件通过所述外筒连接杆与所述外筒连接。
本发明实施例提供的一种静脉穿刺装置，与现有技术中的人工手动穿刺或者机械力的辅助医疗机器人操作穿刺相比，其具有以下优势：1、整体造价相对机器人医疗系统成本低，实用性较强；2、静脉穿刺装置与超声波探头形成穿刺机械本体，并配合控制装置实现自动控制静脉穿刺装置进行进针、置管和退针的动作，减少了操作者的劳动强度；3、静脉穿刺装置中的大部分构件均是采用聚乙烯材料加工而成，具有强度高、体积小、质量轻，使得操作者手持舒适度好；4、能够与超声波探头相配合，在超声波探头的引导下，定位精度高；5、可实现单手操作，对操作者的经验要求降低，且能适应一定的动态环境。
第二方面，本发明实施例还提供了一种静脉穿刺系统，包括：控制装置和第一方面任一项所述的静脉穿刺装置；所述静脉穿刺装置与所述控制装置连接；
所述静脉穿刺装置，用于通过超声波探头采集预选靶血管的数据信息，将所述数据信息发送至所述控制装置；
所述控制装置，用于接收所述数据信息，根据所述数据信息计算所述靶血管的位置信息，根据所述位置信息生成用于控制所述静脉穿刺装置工作的控制信号；
所述静脉穿刺装置还用于，根据所述控制信号控制自身固定的待穿刺针体和待置入软管穿刺皮肤。
结合第二方面，本发明实施例提供了第二方面的第一种可能的实施方式，其中，所述控制装置包括：超声仪主机、图像显示仪、数据采集部件、图像处理器和控制器；
所述超声波探头与所述超声仪主机连接；所述图像显示仪和所述数据采集部件分别与所述超声仪主机连接；所述图像处理器分别与所述数据采集部件和所述控制器连接；
所述超声仪主机，用于接收所述超声波探头发送的所述数据信息，对所述数据信息进行图像处理生成图像数据，将所述图像数据发送至所述图像显示仪和所述数据采集卡；
所述图像显示仪，用于显示所述图像数据，以及将操作者根据该图像数据选择的待穿刺图像位置发送给所述超声仪主机；
所述超声仪主机还用于，生成用于控制所述数据采集卡采集所述待穿刺图像位置的图像数据的控制信号，并发送给所述数据采集卡；
所述数据采集卡，用于接收所述控制信号，根据所述控制信号采集所述待穿刺图像位置的图像数据，将所述图像数据发送至所述图像处理器；
所述图像处理器，用于接收所述图像数据，根据所述图像数据计算所述靶血管的位置信息，并发送给所述控制器；
所述控制器，用于接收所述位置信息，判断所述位置信息与预存标准位置信息是否相匹配，若是，根据所述位置信息生成用于控制所述静脉穿刺装置工作的控制信号。
结合第二方面的第一种可能的实施方式，本发明实施例提供了第二方面的第二种可能的实施方式，其中，所述静脉穿刺装置包括：控针电机和置管电机；所述控针电机和所述置管电机分别与所述控制器连接；
所述控针电机，用于根据所述控制信号控制第二连接件转动，以带动针筒、内筒和外筒整体向所述导向装置引导的方向运动；
所述置管电机，用于根据所述控制信号控制第三连接件转动，并通过外筒连接杆带动外筒沿着导向装置引导的方向运动。
结合第二方面，本发明实施例提供了第二方面的第三种可能的实施方式，其中，所述静脉穿刺系统，还包括支撑架；所述支撑架包括：底面套模、支撑肋板、支撑底板和垫块；
所述支撑底板通过所述支撑肋板以一锐角角度固定设置在所述底面套模上；所述支撑底板上设置有所述垫块；所述静脉穿刺装置通过所述垫块固定设置在所述支撑底板上。
本发明实施例提供的一种静脉穿刺系统，与现有技术中的人工手动穿刺或者机械力的辅助医疗机器人操作穿刺相比，其具有以下优势：1、整体造价相对机器人医疗系统成本低，实用性较强；2、静脉穿刺装置与超声波探头形成穿刺机械本体，并配合控制装置实现自动 控制静脉穿刺装置进行进针、置管和退针的动作，减少了操作者的劳动强度；3、静脉穿刺装置中的大部分构件均是采用聚乙烯材料加工而成，具有强度高、体积小、质量轻，使得操作者手持舒适度好；4、能够与超声波探头相配合，在超声波探头的引导下，定位精度高；5、可实现单手操作，对操作者的经验要求降低，且能适应一定的动态环境。
第三方面，本发明实施例还提供了一种静脉穿刺控制方法，所述方法基于第二方面任一项所述的静脉穿刺系统，所述方法包括：
采集预选靶血管的数据信息；
根据所述数据信息计算所述靶血管的位置信息；
在检测到所述位置信息与预存标准位置信息相匹配时，控制控针电机推动针筒、内筒和外筒的整体沿着针体导向件和外筒导向件的导向方向移动；
在检测到所述针筒、内筒和外筒的整体移动第一预设距离时，控制置管电机推动所述外筒沿着外筒导向件导向的方向继续移动；
在检测到所述外筒移动第二预设距离时，通过针卡触发退针按钮，用以控制针体和软管分离且回退所述针体到所述针筒内。
本发明实施例提供的一种静脉穿刺控制方法，与现有技术中的人工手动穿刺或者机械力的辅助医疗机器人操作穿刺相比，其具有以下优势：1、整体造价相对机器人医疗系统成本低，实用性较强；2、静脉穿刺装置与超声波探头形成穿刺机械本体，并配合控制装置实现自动控制静脉穿刺装置进行进针、置管和退针的动作，减少了操作者的劳动强度；3、静脉穿刺装置中的大部分构件均是采用聚乙烯材料加工而成，具有强度高、体积小、质量轻，使得操作者手持舒适度好；4、能够与超声波探头相配合，在超声波探头的引导下，定位精度高；5、可实现单手操作，对操作者的经验要求降低，且能适应一定的动态环境。
为使本发明的上述目的、特征和优点能更明显易懂，下文特举较佳实施例，并配合所附附图，作详细说明如下。
附图说明
为了更清楚地说明本发明实施例的技术方案，下面将对实施例中所需要使用的附图作简单地介绍，应当理解，以下附图仅示出了本发明的某些实施例，因此不应被看作是对范围的限定，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他相关的附图。
图1示出了本发明实施例所提供的一种静脉穿刺装置的正视图；
图2示出了本发明实施例所提供的一种静脉穿刺装置在推进针体达到预设位置后又推进导管继续深入血管的状态下的俯视图；
图3示出了本发明实施例所提供的横轴位置时超声引导血管穿刺的图像的原理图；
图4示出了本发明实施例所提供的纵轴位置时超声引导血管穿刺的图像的原理图；
图5示出了本发明实施例所提供不同穿刺速度下针进入不同组织层的临界力的示意图。
图6示出了本发明实施例所提供的一种静脉穿刺系统的结构示意图。
图7示出了本发明实施例所提供的通过超声波探头(即B超探头)采集的静脉血管的显示图像。
图8示出了本发明实施例所提供的进针过程与速度控制对比图。
图9示出了本发明实施例所提供的上位机程序调试界面。
图10示出了本发明实施例所提供的控针电机实验测试数据。
图11示出了本发明实施例所提供的置管电机实验测试数据。
图12示出了本发明实施例所提供的一种静脉穿刺装置中支撑架的结构示意图。
图13示出了本发明实施例所提供的静脉穿刺控制方法的流程图。
图标：1、静脉穿刺装置；2、控制装置；3、支撑架；4、针筒；5、针体；10、固定装置；11、导向装置；12、驱动装置；13、超声波探头；100、内筒；101、外筒；102、第一连接件；103、固定板；104、针卡；110、针体导向件；111、外筒导向件；120、控针电机；121、第二连接件；122、置管电机；123、第三连接件；124、外筒连接杆；125、电机连接杆；126、内电机固定板；20、超声仪主机；21、图像显示仪；22、数据采集部件；23、图像处理器；24、控制器；31、底面套模；32、支撑肋板；33、支撑底板；34、垫块。
具体实施方式
为使本发明实施例的目的、技术方案和优点更加清楚，下面将结合本发明实施例中附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。通常在此处附图中描述和示出的本发明实施例的组件可以以各种不同的配置来布置和设计。因此，以下对在附图中提供的本发明的实施例的详细描述并非旨在限制要求保护的本发明的范围，而是仅仅表示本发明的选定实施例。基于本发明的实施例，本领域技术人员在没有做出创造性劳动的前提下所获得的所有其他实施例，都属于本发明保护的范围。
静脉穿刺是为了减轻病人反复穿刺的痛苦，便于长期输液的一种医学护理手段。静脉穿刺能有效避免浅静脉反复穿刺造成的痛苦,也能有效避免抗肿瘤药物对血管的破坏及药物外渗引起的局部组织坏死。影响静脉穿刺置管技术发展的关键点就是穿刺引导装置和对穿刺针运动的控制，这与人手操作相比，应用机械力的辅助医疗机器人具有很高的准确性和稳定性，并能降低操作者的劳动强度。因此，为了能够稳定且准确的实施软组织穿刺手术，机器人辅助穿刺受到越来越多的关注。但由于机器人价格昂贵、机器人与病人的标定和配套方式比较复杂、机器人操作方式过于专业化等因素，机器人辅助穿刺还难以达到广 泛应用的程度。
随着图像可视化技术的快速发展，B超(B-scan ultrasonography)和CT(Computed Tomography，计算机体层摄影)等技术在穿刺手术中得到越来越广泛的应用。B超引导下的PICC(Peripherally Inserted Central Catheter，经外周静脉置入中心静脉导管)技术，是近年来兴起的新型静脉穿刺置管术，其采用超声无创定位技术，对血管进行准确定位，在直视下进行静脉穿刺插管的方法。超声下穿刺部位的动脉、静脉、神经及周围组织显示清晰，穿刺时在B超下可以制定穿刺针的方向、角度和进针深度，让穿刺变得直观、准确、针对性强，既可避免穿刺时误入动脉、刺穿血管或误伤周围组织等弊端，又可提高一次穿刺的成功率，防止血肿、气胸等不良症状的发生，减少穿刺次数及置管并发症的发生。
虽然如此，但是要成为一名成功的PICC置管者，不仅需要掌握学习血管超声成像原理、了解超声下动静脉的特征及条件评估、如何测量血管内径、评估进针方式等专业知识，还需要进行针对性训练，掌握手眼协调的方法，特别是掌握超声下进针过程的判断，才能保证操作成功。由于培养周期长，条件严格，导致国内优秀的PICC置管者并不多，供不应求。同时在重大灾害或军事救援中，人在动态环境下完全依靠手动很难完成穿刺，在这种紧急状态中一次穿刺成功率很低，因此对该技术也提出了更高的要求。因此，本发明实施例设计了一种静脉穿刺装置、系统及静脉穿刺控制方法，上述静脉穿刺装置为一种轻便简易的穿刺引导装置，其采用B超图像引导，通过微型系统控制，达到自动静脉穿刺置管的效果。
本发明实施例提供的一种静脉穿刺装置、系统及静脉穿刺控制方法，具有如下特点：①根据静脉血管B超图像自动完成进针、置管和退针动作；②定位支撑架(也称穿刺引导架)与超声波探头(简称B超探头)灵活结合，方便拆卸与安装；③静脉穿刺装置中除电机外，绝大部分构件是采用聚乙烯材料加工而成，不仅强度高，而且体积小(240mm×80mm×60mm)，质量轻，手持舒适度好；④系统通过B超图像引导静脉穿刺装置，定位精度高，使穿刺更准确；⑤由原来的双手操作改为可单手操作，对操作者的经验要求降低，而且能适应一定的动态环境；⑥造价相对机器人医疗系统便宜得多，大大减少了成本。
下面结合图1-图5以及具体实施例对本发明实施例提供的一种静脉穿刺装置、系统及静脉穿刺控制方法进行详细描述。
参考图1和图2，本发明实施例提供了一种静脉穿刺装置1，包括：固定装置10、导向装置11和驱动装置12；固定装置10与导向装置11可滑动连接，固定装置10与驱动装置12固定连接，驱动装置12用于与控制装置2连接；
待置入软管通过待穿刺针体固定在固定装置10上；
导向装置11，用于引导固定装置10和针体5以固定的方向运动；
驱动装置12，用于驱动固定装置10沿着导向装置11引导的方向运动。
本发明实施例中，固定装置10的作用是固定待穿刺针体(下文简称针体55)和待置入软管(下文简称软管)。具体的，针体5穿过软管，并将软管固定在针管上，形成一个整体，固定装置10的作用是固定上述整体中的针管。固定装置10与导向装置11可滑动连接，导向装置11的目的是为固定装置10提供移动方向，固定装置10则沿着导向装置11的引导的移动方向进行移动。驱动装置12与固定装置10连接，目的是用于驱动固定装置10运动，固定装置10则在驱动装置12的驱动下沿着导向装置11引导的移动方向移动。
作为一种可选的实施方式，上述驱动装置12可以与控制装置2连接，用于接收控制装置2给予控制信号，并根据该控制信号进行工作。
进一步的，参考图1和图2，本发明实施例提供的静脉穿刺装置1，软管通过针体5固定设置在针筒4上；固定装置10包括：内筒100、外筒101、第一连接件102和固定板103；
针筒4设置在内筒100中与内筒100固定连接，内筒100通过第一连接件102设置在外筒101中，且外筒101可与内筒100可滑动连接；外筒101通过第一连接件102固定设置在固定板103上。
具体的，内筒100和外筒101均是为空心柱形体，其中，内筒100的空心部分为第一腔室，外筒101的空心部分为第二腔室。本发明实施例中，针筒4设置在内筒100的第一腔室中与内筒100固定连接，形成一个整体，在穿刺的过程中，整体移动以及整体静止。内筒100则通过第一连接件102设置在外筒101的第二腔室中，外筒101可与内筒100可滑动连接，并且，外筒101还通过第一连接件102固定设置在固定板103上；具体的，驱动装置12可单独驱动外筒101移动，此时，内筒100和针筒4的整体不动；驱动装置12也可驱动内筒100移动，此时，内筒100和针筒4的整体以及外筒101均移动。
进一步的，参考图1和图2，本发明实施例提供的静脉穿刺装置1，固定装置10还包括针卡104；
针卡104与退针按钮相配合，用于在外力的作用下触发退针按钮，以使针体5与软管分离并回退到针筒4内。
本发明实施例中，上述针卡104为软管针卡。作为一种具体的实施方式，在整个静脉穿刺装置1完成穿刺针体5和软管后，用户可向针卡104作用外力，并通过针卡104触发退针按钮，最终，使针体5回退到针筒4内且与软管分离。
进一步的，参考图1和图2，本发明实施例提供的静脉穿刺装置1中，还包括超声波探头13；导向装置11包括：针体导向件110和外筒导向件111；
针体导向件110固定设置在超声波探头13上，针体5架设在针体导向件110上；超声波探头13，用于通过超声波采集预选靶血管的数据信息，并将数据信息发送至控制装置2；
外筒导向件111固定设置在固定板103上，外筒101架设在外筒导向件111上。
本发明实施例中，导向装置11具体包括两个部件，即针体导向件110和外筒导向件111；针体导向件110固定设置在超声波探头13上，用于架设针体5且使针体5与超声波探头13位于同一平面，目的是在针体5的穿刺过程中，可通过超声波探头13全程观察到针体5的穿刺路径，该穿刺路径即通常所说的纵切面，参考图3和图4。
具体的，根据超声平面与穿刺针的位置关系，可分为平面内技术和平面外技术。所谓平面内技术，是指针与探头在同一平面内，穿刺过程中可全程观察到针的穿刺路径，即纵切面。图4为纵轴位置时超声引导血管穿刺的图像。根据超声平面与引导针的位置关系，可分为平面内技术和平面外技术，参见图3、图4。平面外技术，是指针的方向与探头垂直，看到的图像即横断面。其中，图3和图4中，(A)表示调整探头，(B)表示超声屏幕图像，Art表示动脉，Vn表示静脉，P表示探头，US表示超声波束平面，a表示穿刺针(即针体5)进入静脉，b为穿刺针(即针体5)与超声平面交叉，c为穿刺针(即针体5)穿过静脉。
进一步的，参考图1和图2，本发明实施例提供的静脉穿刺装置1中，驱动装置12包括：控针电机120和第二连接件121；控针电机120固定设置在固定板103上，并通过第二连接件121与内筒100固定连接。
具体的，控针电机120的作用是控制第二连接件121转动，以带动所述针筒4、所述内筒100和所述外筒101整体向所述导向装置11引导的方向运动。具体的，控针电机120通过内电机固定板126固定在固定板103上，并通过第二连接件121与内筒100固定连接。
上述驱动装置12还包括：置管电机122、第三连接件123、外筒连接杆124和电机连接杆125；置管电机122通过电机连接杆125固定设置在固定板103上；置管电机122与第三连接件123固定连接，第三连接件123通过外筒连接杆124与外筒101连接。
上述置管电机122的作用是根据控制信号控制第三连接件123转动，并通过外筒连接杆124带动外筒101沿着导向装置11引导的方向运动。
作为本发明实施例中的一种实施方式，上述第二连接件121和第三连接件123均为丝杆螺母。
在上述静脉穿刺装置1的设计中，控针电机120的负载主要来源于穿刺皮肤的阻力、针体5与其导向内筒的摩擦力以及第二连接件121(本发明实施例中为丝杠螺母)副传动摩擦阻力等。在本发明实施例中，选取针体5的质量约为20g，针体5与导向内筒的阻尼系数为0.3，故摩擦阻力为0.006N。穿刺针在穿刺皮肤的过程中所受的阻力比较复杂，整个穿刺过程可以分为以下三个阶段：刺破皮肤前、刺破皮肤后、进入血管后。在整个穿刺过程中受到的阻力主要是刚性力、摩擦力和切割力，并且针体5在皮肤和血管等不同的组织及不同的阶段受到的上述三种阻力也不相同，这三种阻力属于非线性力；同时，穿刺阻 力还与针体5的穿刺速度有关，由于针体5穿刺速度不同控针电机120所受到的阻力也不相同。
正常情况下，在手动穿刺过程中，穿刺针进入皮肤和血管的穿刺力较小，手动穿刺的速度一般都低于5mm/s，图3示出了不同穿刺速度下针体5进入不同组织层的临界力。故进针所需要的穿刺力一般都小于4N，由此可以估算控针电机120的外部负载理论最大值为4.006N。
参考图5，在保证控制精度的情况下，为了硬件部分尽可能的轻便简单，静脉穿刺装置1采用直线运动实现自动穿刺，要实现传动平稳，定位精度高，便于控制，最终选定自带丝杠滑台的微型电机作为控针电机120。该步进电机基本参数为：2相4线制，驱动电压为4-9V/100-500mA，丝杆长度为90mm，滑块行程为80mm，电机直径为15mm，丝杆直径为3mm，光轴直径为3mm，丝杆螺距为0.5mm，步距角为18°。同样，通过查询资料估算出置管电机122的外部负载理论最大值为6N，而实际上对置管电机122的精度要求和传动要求都比控针电机120要求低，综合考虑，最终选择单头微型螺杆步进电机作为置管电机122，其参数如下：2相4线制，驱动电压为5V/100-500mA，丝杆长度为55mm，电机直径为10mm，丝杆直径为3mm，丝杆螺距为1.2mm，步距角为18°。
本发明实施例提供的一种静脉穿刺装置，与现有技术中的人工手动穿刺或者机械力的辅助医疗机器人操作穿刺相比，其具有以下优势：1、整体造价相对机器人医疗系统成本低，实用性较强；2、静脉穿刺装置与超声波探头形成穿刺机械本体，并配合控制装置实现自动控制静脉穿刺装置进行进针、置管和退针的动作，减少了操作者的劳动强度；3、静脉穿刺装置中的大部分构件均是采用聚乙烯材料加工而成，具有强度高、体积小、质量轻，使得操作者手持舒适度好；4、能够与超声波探头相配合，在超声波探头的引导下，定位精度高；5、可实现单手操作，对操作者的经验要求降低，且能适应一定的动态环境。
本发明实施例还提供了一种静脉穿刺系统，参考图6，包括：控制装置2和上述静脉穿刺装置1；静脉穿刺装置1与控制装置2连接；
静脉穿刺装置1，用于通过超声波探头13采集预选靶血管的数据信息，将数据信息发送至控制装置2；
控制装置2，用于接收数据信息，根据数据信息计算靶血管的位置信息，根据位置信息生成用于控制静脉穿刺装置1工作的控制信号；
静脉穿刺装置1还用于，根据控制信号控制自身固定的待穿刺针体5和待置入软管穿刺皮肤。
本发明实施例中，上述超声波探头13即B超探头，静脉穿刺装置1通过上述B超探头向预选靶血管发射超声波，并接收经过预选靶血管反射的超声波，以采集预选靶血管的 数据信息，然后将该数据信息发给控制装置2。
控制装置2接收到上述数据信息后，对上述数据信息进行图像处理生成图像数据，然后根据图像数据计算靶血管的位置信息，并在检测到靶血管的位置信息符合预存的标准位置信息后，根据该位置信息生成用于控制静脉穿刺装置1工作的控制信号。
进一步的，参考图6，本发明实施例提供的静脉穿刺系统中，控制装置2具体包括：超声仪主机20、图像显示仪21、数据采集部件22、图像处理器23和控制器24；
超声波探头13与超声仪主机20连接；图像显示仪21和数据采集部件22分别与超声仪主机20连接；图像处理器23分别与数据采集部件22和控制器24连接；
超声波探头13(即B超探头)向预选靶血管发射超声波，并接收经过预选靶血管反射的超声波，将接收的反射超声波发给超声仪主机20；
超声仪主机20，用于接收超声波探头13发送的数据信息，对数据信息进行图像处理生成图像数据，将图像数据发送至图像显示仪21和数据采集卡；
图像显示仪21，用于显示图像数据，以及将操作者根据该图像数据选择的待穿刺图像位置发送给超声仪主机20；
超声仪主机20还用于，生成用于控制数据采集卡采集待穿刺图像位置的图像数据的控制信号，并发送给数据采集卡；
数据采集卡，用于接收控制信号，根据控制信号采集待穿刺图像位置的图像数据，将图像数据发送至图像处理器23；
图像处理器23，用于接收图像数据，根据图像数据计算靶血管的位置信息，并发送给控制器24；
控制器24，用于接收位置信息，判断位置信息与预存标准位置信息是否相匹配，若是，根据位置信息生成用于控制静脉穿刺装置1工作的控制信号。
具体的，超声波探头13(即B超探头)向预选靶血管发射超声波，并接收经过预选靶血管反射的超声波，将接收的反射超声波发给超声仪主机20；超声仪主机20接收该反射超声波，并对该反射超声波进行图像处理，生成图像数据，然后将该图像数据发送给图像显示仪21和数据采集卡；图像显示仪21显示图像数据，并接收操作者根据查看该图像数据触发选择的待穿刺位置，并将该待穿刺位置发送给超声仪主机20，超声仪主机20则控制数据采集卡该待穿刺图像位置的图像数据；数据采集卡在超声仪主机20的控制下采集待穿刺图像位置的图像数据，将采集的图像数据发送给图像处理器23；图像处理器23接收该图像数据，根据该图像数据计算靶血管的位置信息，然后将该计算的位置信息发送给控制器24；控制器24接收该位置信息，判断该位置信息与预存标准位置信息是否相匹配，若匹配，根据该位置信息生成用于控制静脉穿刺装置1工作的控制信号。
图7为静脉血管在B超中的显示图像，图像处理器23通过对图像的灰度值进行处理，可以计算出血管的半径r、血管中心距离皮肤的深度h等重要位置信息。图7中圆圈为图像处理器23根据图像数据标示出的血管范围，中心亮点即为穿刺针尖在血管中的显影。数据采集部件22采集大量采集静脉血管B超图像，由图像处理器23计算相应的深度h值和内径值，形成血管图像数据库。本发明实施例中，采集中国人民解放军307医院73例静脉穿刺成功的血管B超图像，计算出73组数据中，其中，静脉血管半径的最小值为1.23mm，最大值为3.22mm，平均值为2.06mm；静脉血管中心距离皮肤的深度最小值为3.06mm，最大值为14.21mm，平均值为8.51mm。为了安全考虑，本发明实施例中，根据上述数据将进针的深度许可范围设为5.95～10.91mm，将进针的血管半径许可范围设为1.57～2.65mm。
在安全进针的前提下，为了保证能够精确控制进针的距离以及为了减轻患者痛苦而减少针刺破皮肤的时间，根据穿刺针的整个进针情况设置6个关键控制点，如图8进针过程与速度控制对比图中的O、E、B、F、C和D点表示的是控制进针速度的关键转折点。通过这6个控制点将整个进针过程分为5个控制段，每一个控制段都是针尖原点距离皮肤高度h、血管中心深度d、血管半径r三个变量的函数。给定一组数值，就可以确定每段的进针距离，再根据步进电机的脉冲当量，就可以计算出每段需要的脉冲数。对所选的步进电机，为了提高控制精度，采取细分驱动的方法细分步距角，通过PWM脉宽调制，改变PWM周期来调整电机转速。
本发明实施例中，控制器控制控针电机和置管电机的速度控制程序设计：本发明实施例中使用的控制器24采用ST公司STM32F411的MCU(Microcontroller Unit，微控制单元)，采用64位封装，拥有100MHz CPU频率，工作电压为1.7V～3.6V。该单片机是基于ARMCortex-M4的32位MCU内核，单周期访问，低功耗、低价格、高性能。上述控制器24采用CodeWarrior开发工作室作为控制程序的编译环境，CodeWarrior内置有丰富STM32固件库，可以方便地进行程序设计。为简化程序开发难度，采用模块化思维进行速度控制程序设计，由于控制对象只有步进电机，故采用PWM(Pulse Width Modulation，脉冲宽度调制)调频调宽法控制电机转速，在给定PWM占空比的情况下，只改变PWM脉冲周期进行调速，STM32F411通过SPI(Serial Peripheral Interface，串行外设接口)接口访问或改写L6470内部寄存器对步进电机加速、减速和停止进行控制。
进一步的，参考图6，本发明实施例提供的静脉穿刺系统中，静脉穿刺装置1包括：控针电机120和置管电机122；控针电机120和置管电机122分别与控制器24连接；
控针电机120，用于根据控制信号控制第二连接件121转动，以带动针筒4、内筒100和外筒101整体向导向装置11引导的方向运动；
置管电机122，用于根据控制信号控制第三连接件123转动，并通过外筒连接杆124 带动外筒101沿着导向装置11引导的方向运动。
为了验证本发明实施例中控制器24的控制程序是否正确，需要对其包括的控制程序进行调试，具体的，为了控制器的程序的调试方便，编写了上位机程序调试界面，每给定一组直径d、深度h、内径r数值就可以计算出各控制段所需要的脉冲数和总行程脉冲数，从而精确控制进针距离。在调试界面只需要给出总行程所需的脉冲数，程序会自动分配各控制段所需的脉冲数，通过“进针”、“退针”及“进针测速”等按钮进行对装置进行调试和检测。图9为上位机程序调试界面。
在实验测试中，B超探头模型以及导针卡槽是唯一的，所以d值也是恒定的。通过采集不同的静脉血管B超图像，计算出每张图像中血管的深度h和半径r，上位机根据由这两个参数所给定的进针路程(脉冲数)和置管路程(脉冲数)，应用上述速度分段控制策略，自动进行进针和退针的速度控制。图10为控针电机120(大电机)实验测试数据，图11为置管电机122(小电机)实验测试数据。
本发明实施例中的静脉穿刺装置以STM32F411为核心，通过模块化设计方法，实现了进针和退针动作的自动控制，完成了整个预期的动作流程；能够通过B超图像引导，实现对靶血管的准确定位；在进针和置管测试实验中，两个电机的实际行程均比理论值偏小，说明针体5在血管模型行进的摩擦阻力比理论预设值要大，可能导致电机减速过程中丢步，但均在误差安全允许范围内，证明本发明实施例静脉穿刺装置能够准确地实现自动进针功能，稳定性良好。
进一步的，由于纵轴位置时，超声波探头13与针体5相对的正面面积小，而且曲面弧度变化大、不规则，静脉穿刺装置的安装难度大；同时横轴位置时需要针体5与超声波探头13发射的超声波束在同一平面内，而在穿刺过程中针体和血管都会产生挤压变形，这一点很难得到保证。综合考虑，本发明实施例采取有大平面的平面外技术，也就是采用横轴安装方式，根据超声波探头的特点和操作者的手持习惯，设计一种有空心三角结构的支撑架3用于穿刺装置与探头的固定安装。图12为支撑架3示意图。
参考图12，本发明实施例提供的静脉穿刺系统，还包括支撑架3，该支撑架3用于起到定位的作用，即定位支撑架；支撑架3包括：底面套模31、支撑肋板32、支撑底板33和垫块34；
支撑底板33通过支撑肋板32以一锐角角度固定设置在底面套模31上；支撑底板33上设置有垫块34；静脉穿刺装置1通过垫块34固定设置在支撑底板33上。
具体的，底面套模31用于放置超声波探头13，支撑底板33用于放置静脉穿刺装置1，垫块34用于调节静脉穿刺装置1在支撑底板33上的高度，支撑肋板32用于支撑上述支撑底板33，用以将支撑底板33固定在底面套模31上。
作为一种可选的实施方式，静脉穿刺装置1包括的外筒导向件111固定设置在该支撑架3的支撑底板33，以实现静脉穿刺装置1整体设置在支撑架3上。
本发明实施例中，以B超探头模型作为模具，运用聚乙烯热成型技术做成的底面套模31，不仅质量轻、强度高，而且与探头结合稳固，操作者手持的舒适度也大大提高。同时在底面套模31上加工基准平面，通过垫块34的调节作用，这样可保证探头与针体5的定位精度。
下面结合图6对本发明实施例提供的静脉穿刺系统进行整体说明：目前模块化设计已经被广泛应用于全球制造业产品开发过程中。本发明实施例基于模块化设计方法和系统使用的功能性要求设计了静脉穿刺装置及静脉穿刺系统。静脉穿刺系统的总体方案如图6所示，其由静脉穿刺装置1、支撑架3和控制装置2三部分组成。静脉穿刺装置1包括控针电机120、置管电机122等其他连接零部件，其采用双电机丝杠螺母传动方式，控针电机120推动穿刺针和软管穿刺皮肤进入血管，置管电机122推动软管到位并触发退针按钮，使针体5退回针筒4内。
操作者手持自动穿刺装置，移动B超探头找准靶血管位置，定位好装置姿势。图像处理器23根据B超主机传回的图像数据，计算靶血管的深度和内径，控制器24STM32F411根据该位置信号自动计算PWM脉冲数，并选定速度与加速度，经过智能步进电机驱动芯片L6470并分别控制控针电机和置管电机有序运动。控针电机120驱动针体5，使针尖和PICC导管均穿刺皮肤，在准确到达靶血管中心位置后，控针电机120停止运动，然后置管电机122推进导管继续深入血管一段距离；在导管进入血管设定长度后，置管电机122停止运动，同时触发退针按钮，导管与针体5自动分离，留置针安全退出；最后控针电机120驱动针体5后退，回到原点停止。
本发明实施例提供的一种静脉穿刺系统，与现有技术中的人工手动穿刺或者机械力的辅助医疗机器人操作穿刺相比，其具有以下优势：1、整体造价相对机器人医疗系统成本低，实用性较强；2、静脉穿刺装置与超声波探头形成穿刺机械本体，并配合控制装置实现自动控制静脉穿刺装置进行进针、置管和退针的动作，减少了操作者的劳动强度；3、静脉穿刺装置中的大部分构件均是采用聚乙烯材料加工而成，具有强度高、体积小、质量轻，使得操作者手持舒适度好；4、能够与超声波探头相配合，在超声波探头的引导下，定位精度高；5、可实现单手操作，对操作者的经验要求降低，且能适应一定的动态环境。
本发明实施例还提供了一种静脉穿刺控制方法，参考图13，所述方法基于上述的静脉穿刺系统，所述方法由静脉穿刺系统中的控制器执行，具体包括：
S101、采集预选靶血管的数据信息。
S102、根据所述数据信息计算所述靶血管的位置信息。
S103、在检测到所述位置信息与预存标准位置信息相匹配时，控制控针电机推动针筒、内筒和外筒的整体沿着针体导向件和外筒导向件的导向方向移动。
S104、在检测到所述针筒、内筒和外筒的整体移动第一预设距离时，控制置管电机推动所述外筒沿着外筒导向件导向的方向继续移动。
S105、在检测到所述外筒移动第二预设距离时，通过针卡触发退针按钮，用以控制针体和软管分离且回退所述针体到所述针筒内。其中，上述第一预设距离与上述第二预设距离是根据实际扎针需要进行设置，且第一预设距离与上述第二预设距离可以相同，也可以不同。
本发明实施例提供的一种静脉穿刺控制方法，与现有技术中的人工手动穿刺或者机械力的辅助医疗机器人操作穿刺相比，其具有以下优势：1、整体造价相对机器人医疗系统成本低，实用性较强；2、静脉穿刺装置与超声波探头形成穿刺机械本体，并配合控制装置实现自动控制静脉穿刺装置进行进针、置管和退针的动作，减少了操作者的劳动强度；3、静脉穿刺装置中的大部分构件均是采用聚乙烯材料加工而成，具有强度高、体积小、质量轻，使得操作者手持舒适度好；4、能够与超声波探头相配合，在超声波探头的引导下，定位精度高；5、可实现单手操作，对操作者的经验要求降低，且能适应一定的动态环境。
本发明实施例所提供的控制装置可以为设备上的特定硬件或者安装于设备上的软件或固件等。本发明实施例所提供的装置，其实现原理及产生的技术效果和前述方法实施例相同，为简要描述，装置实施例部分未提及之处，可参考前述方法实施例中相应内容。所属领域的技术人员可以清楚地了解到，为描述的方便和简洁，前述描述的系统、装置和单元的具体工作过程，均可以参考上述方法实施例中的对应过程，在此不再赘述。
在本发明所提供的实施例中，应该理解到，所揭露装置和方法，可以通过其它的方式实现。以上所描述的装置实施例仅仅是示意性的，例如，所述单元的划分，仅仅为一种逻辑功能划分，实际实现时可以有另外的划分方式，又例如，多个单元或组件可以结合或者可以集成到另一个系统，或一些特征可以忽略，或不执行。另一点，所显示或讨论的相互之间的耦合或直接耦合或通信连接可以是通过一些通信接口，装置或单元的间接耦合或通信连接，可以是电性，机械或其它的形式。
所述作为分离部件说明的单元可以是或者也可以不是物理上分开的，作为单元显示的部件可以是或者也可以不是物理单元，即可以位于一个地方，或者也可以分布到多个网络单元上。可以根据实际的需要选择其中的部分或者全部单元来实现本实施例方案的目的。
另外，在本发明提供的实施例中的各功能单元可以集成在一个处理单元中，也可以是各个单元单独物理存在，也可以两个或两个以上单元集成在一个单元中。
所述功能如果以软件功能单元的形式实现并作为独立的产品销售或使用时，可以存储 在一个计算机可读取存储介质中。基于这样的理解，本发明的技术方案本质上或者说对现有技术做出贡献的部分或者该技术方案的部分可以以软件产品的形式体现出来，该计算机软件产品存储在一个存储介质中，包括若干指令用以使得一台计算机设备(可以是个人计算机，服务器，或者网络设备等)执行本发明各个实施例所述方法的全部或部分步骤。而前述的存储介质包括：U盘、移动硬盘、只读存储器(ROM，Read-Only Memory)、随机存取存储器(RAM，Random Access Memory)、磁碟或者光盘等各种可以存储程序代码的介质。
应注意到：相似的标号和字母在下面的附图中表示类似项，因此，一旦某一项在一个附图中被定义，则在随后的附图中不需要对其进行进一步定义和解释，此外，术语“第一”、“第二”、“第三”等仅用于区分描述，而不能理解为指示或暗示相对重要性。
最后应说明的是：以上所述实施例，仅为本发明的具体实施方式，用以说明本发明的技术方案，而非对其限制，本发明的保护范围并不局限于此，尽管参照前述实施例对本发明进行了详细的说明，本领域的普通技术人员应当理解：任何熟悉本技术领域的技术人员在本发明揭露的技术范围内，其依然可以对前述实施例所记载的技术方案进行修改或可轻易想到变化，或者对其中部分技术特征进行等同替换；而这些修改、变化或者替换，并不使相应技术方案的本质脱离本发明实施例技术方案的精神和范围。都应涵盖在本发明的保护范围之内。因此，本发明的保护范围应以所述权利要求的保护范围为准。

Claims (10)

  1. 一种静脉穿刺装置，其特征在于，包括：固定装置、导向装置和驱动装置；所述固定装置与所述导向装置可滑动连接，所述固定装置与所述驱动装置固定连接，所述驱动装置被配置成与控制装置连接；
    待置入软管通过待穿刺针体固定在所述固定装置上；
    所述导向装置，被配置成引导所述固定装置和所述针体以固定的方向运动；
    所述驱动装置，被配置成驱动所述固定装置沿着所述导向装置引导的方向运动。
  2. 根据权利要求1所述的静脉穿刺装置，其特征在于，所述软管通过所述针体固定设置在针筒上；所述固定装置包括：内筒、外筒、第一连接件、固定板和针卡；
    所述针筒设置在所述内筒中与所述内筒固定连接，所述内筒通过所述第一连接件设置在所述外筒中，且外筒可与所述内筒可滑动连接；所述外筒通过所述第一连接件固定设置在所述固定板上；
    所述针卡与退针按钮相配合，被配置成在外力的作用下触发所述退针按钮，以使所述针体与所述软管分离并回退到所述针筒内。
  3. 根据权利要求2所述的静脉穿刺装置，其特征在于，还包括超声波探头；所述导向装置包括：针体导向件和外筒导向件；
    所述针体导向件固定设置在所述超声波探头上，所述针体架设在所述针体导向件上；所述超声波探头，被配置成通过超声波采集预选靶血管的数据信息，并将数据信息发送至控制装置；
    所述外筒导向件固定设置在所述固定板上，所述外筒架设在所述外筒导向件上。
  4. 根据权利要求2所述的静脉穿刺装置，其特征在于，所述驱动装置包括：控针电机和第二连接件；
    所述控针电机固定设置在所述固定板上，并通过所述第二连接件与所述内筒固定连接。
  5. 根据权利要求2或4所述的静脉穿刺装置，其特征在于，所述驱动装置还包括：置管电机、第三连接件、外筒连接杆和电机连接杆；
    所述置管电机通过所述电机连接杆固定设置在所述固定板上；所述置管电机与所述第三连接件固定连接，所述第三连接件通过所述外筒连接杆与所述外筒连接。
  6. 一种静脉穿刺系统，其特征在于，包括：控制装置和权利要求1-5任一项所述的静脉穿刺装置；所述静脉穿刺装置与所述控制装置连接；
    所述静脉穿刺装置，被配置成通过超声波探头采集预选靶血管的数据信息，将所述数据信息发送至所述控制装置；
    所述控制装置，被配置成接收所述数据信息，根据所述数据信息计算所述靶血管的位置信息，根据所述位置信息生成被配置成控制所述静脉穿刺装置工作的控制信号；
    所述静脉穿刺装置还被配置成，根据所述控制信号控制自身固定的待穿刺针体和待置入软管穿刺皮肤。
  7. 根据权利要求6所述的静脉穿刺系统，其特征在于，所述控制装置包括：超声仪主机、图像显示仪、数据采集部件、图像处理器和控制器；
    所述超声波探头与所述超声仪主机连接；所述图像显示仪和所述数据采集部件分别与所述超声仪主机连接；所述图像处理器分别与所述数据采集部件和所述控制器连接；
    所述超声仪主机，被配置成接收所述超声波探头发送的所述数据信息，对所述数据信息进行图像处理生成图像数据，将所述图像数据发送至所述图像显示仪和所述数据采集卡；
    所述图像显示仪，被配置成显示所述图像数据，以及将操作者根据该图像数据选择的待穿刺图像位置发送给所述超声仪主机；
    所述超声仪主机还被配置成，生成被配置成控制所述数据采集卡采集所述待穿刺图像位置的图像数据的控制信号，并发送给所述数据采集卡；
    所述数据采集卡，被配置成接收所述控制信号，根据所述控制信号采集所述待穿刺图像位置的图像数据，将所述图像数据发送至所述图像处理器；
    所述图像处理器，被配置成接收所述图像数据，根据所述图像数据计算所述靶血管的位置信息，并发送给所述控制器；
    所述控制器，被配置成接收所述位置信息，判断所述位置信息与预存标准位置信息是否相匹配，若是，根据所述位置信息生成被配置成控制所述静脉穿刺装置工作的控制信号。
  8. 根据权利要求7所述的静脉穿刺系统，其特征在于，所述静脉穿刺装置包括：控针电机和置管电机；所述控针电机和所述置管电机分别与所述控制器连接；
    所述控针电机，被配置成根据所述控制信号控制第二连接件转动，以带动针筒、内筒和外筒整体向所述导向装置引导的方向运动；
    所述置管电机，被配置成根据所述控制信号控制第三连接件转动，并通过外筒连接杆带动外筒沿着导向装置引导的方向运动。
  9. 根据权利要求6所述的静脉穿刺系统，其特征在于，还包括支撑架；所述支撑架包括：底面套模、支撑肋板、支撑底板和垫块；
    所述支撑底板通过所述支撑肋板以一锐角角度固定设置在所述底面套模上；所述支撑底板上设置有所述垫块；所述静脉穿刺装置通过所述垫块固定设置在所述支撑底板上。
  10. 一种静脉穿刺控制方法，其特征在于，所述方法基于权利要求6-9任一项所述的静脉穿刺系统，所述方法包括：
    采集预选靶血管的数据信息；
    根据所述数据信息计算所述靶血管的位置信息；
    在检测到所述位置信息与预存标准位置信息相匹配时，控制控针电机推动针筒、内筒和外筒的整体沿着针体导向件和外筒导向件的导向方向移动；
    在检测到所述针筒、内筒和外筒的整体移动第一预设距离时，控制置管电机推动 所述外筒沿着外筒导向件导向的方向继续移动；
    在检测到所述外筒移动第二预设距离时，通过针卡触发退针按钮，用以控制针体和软管分离且回退所述针体到所述针筒内。
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