CN114177484B - Guide catheter capable of automatically demagnetizing and positioning in real time and system thereof - Google Patents
Guide catheter capable of automatically demagnetizing and positioning in real time and system thereof Download PDFInfo
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Abstract
The invention relates to the field of medical instruments, in particular to a guide catheter capable of automatically demagnetizing and positioning in real time and a system thereof. The invention includes a head end magnetizable catheter for access into a blood vessel, a plurality of receivers positioned on the body surface to detect and convert magnetic signals into electrical signals, a processor to process and convert the electrical signals, and a magnetic cup to create an adjustable magnetic field. In the invention, the head end of the catheter is coated with tiny magnetic particles, and the particles can be automatically demagnetized at the temperature of a human body. The invention can find out the dislocation of the catheter in time in the process of placing the catheter and accurately send the catheter into the preset position.
Description
Technical Field
The invention relates to the field of medical instruments, in particular to a guide catheter capable of automatically demagnetizing and positioning in real time and a system thereof.
Background
Central venous catheter (peripherally inserted central catheter, PICC) and central venous catheter (central venous catheter, CVC) technology has been widely used in clinical practice in recent years. The medicine liquid can be directly introduced into the superior vena cava by PICC/CVC infusion. Because the blood flow speed of the superior vena cava is high, the liquid medicine can be diluted as soon as possible, and the damage of the irritant medicine to tissues and blood vessels can be avoided. Problems such as puncture failure, difficult tube delivery, and catheter ectopic are often encountered in clinical PICC/CVC procedures, with catheter ectopic being the most important. Huang Liping, hu Qian are described in the journal of the protective science and the journal of the chinese nursing respectively: the incidence of ectopic sites in PICC catheterization is about 12.5% -25.0%, and the sites where ectopic sites may occur are wide ranging, including the axillary vein, internal jugular vein, brachiocephalic vein, subclavian vein, right atrium, etc. Trerotola published J Vasc Iterv Radiol states that the highest incidence of PICC catheterization is the internal jugular vein, which can be 3% -37%. Catheter ectopic may cause a number of complications, such as: complications such as seepage, limb swelling, pain, tube blockage, phlebitis, tube removal, deep vein thrombosis, and cranial nerve injury after thrombosis.
Currently, the ectopic vascular catheter is generally estimated through experience of doctors and uncomfortable response of patients in operation, and X-ray photographing is needed for diagnosis. DSA imaging guidance devices may be selected for use in some catheterization procedures. However, on one hand, DSA equipment is expensive, requires special intervention in an operating room, and is not suitable for emergency, sudden accidents or disasters and other situations; in addition, many patients, such as pregnant and parturients, infants, etc., do not adapt DSA guided catheter placement for radiation safety. Such populations are subject to doses of X-ray radiation, potentially irreversibly damaged, and cannot be operated using DSA-guided fluoroscopy. Other common positioning methods, such as intra-luminal electrocardiography, are directed to locating the final position of the catheter tip, which cannot discover catheter ectopic in time and take remedial action in time during the puncture.
The magnetic induction positioning has no damage to human body relative to X-ray positioning, and compared with other positioning modes, the magnetic induction positioning can realize the real-time tracking guiding function and reduce the occurrence of ectopic in operation.
CN209490094U provides a magnetic induction locator for assisting the surgical navigation system to quickly achieve fusion of images and physical space. The locator senses the body surface locating patch through the locating probe, sequentially obtains physical space coordinates of the locating patch, and provides operation guidance by combining the three-dimensional image of the patient and the space information of the patient; CN108158654a provides a portable magnetic induction positioning guiding device and method thereof, the device enters into the human body cavity through the cavity magnetic induction diagnosis and treatment catheter, the tiny magnet embedded on the head of the device emits magnetic signals, the catheter tracker located on the body surface senses the magnetic signals, the tracker is placed above the diagnosis and treatment position, and the catheter tracker prompts the patient to arrive at the appointed diagnosis and treatment position along the physiological cavity in the human body. The head of the cavity magnetic induction diagnosis and treatment catheter in the system is provided with a hydrophilic film coating.
The patent provides a but automatic demagnetizing real-time positioning guide catheter and system thereof, is applied to cavity way or endovascular catheter positioning navigation, reduces the risk of occurrence of the catheter dystopia in the art. Compared with the patents CN209490094U and CN108158654A, the catheter can realize automatic demagnetization at the human body temperature after the catheter is placed, and the later detection of a patient is not influenced; on the other hand, the catheter head end is a flexible head end, and special treatment is not needed; in the system, on one hand, not less than three signal receiving devices are provided, the signal receiving devices are placed at the joint of blood vessels, and can timely find out the ectopic position of the catheter in operation and judge the ectopic position of the catheter. This patent has apparent effect to reducing the ectopic risk in the catheterization, and reducible complication takes place to lengthen catheter retention time simultaneously, improves PICC's clinical application value, reduces patient's misery, protection patient life safety.
Disclosure of Invention
In order to reduce the ectopic risk in the intravascular catheter catheterization, the invention provides an automatically demagnetizing real-time positioning guide catheter and a system thereof, wherein the magnetizable catheter head end is magnetized through a magnetic cup, the magnetic signal transmitting capability of the catheter head end is endowed, a plurality of receivers positioned on the surface of a human body sense the magnetic signal and convert the magnetic signal into an electric signal, and a processor analyzes and processes the electric signal and tracks and positions the catheter through a display screen on the processor.
In order to achieve the above purpose, the present invention provides the following technical solutions.
The automatic demagnetizing real-time positioning guide catheter and the system thereof are characterized by comprising a catheter with a magnetizable head end entering a blood vessel, a plurality of receivers which are positioned on the body surface and detect magnetic signals and convert the magnetic signals into electric signals, a processor which processes and converts the electric signals and a magnetic cup which can manufacture an adjustable magnetic field; the head end of the catheter is coated with tiny soft magnetic particles which can be automatically demagnetized at 37 ℃, and the length of the head end of the catheter is 1-5 mm; the receiver may provide a light indication of the difference in intensity as the catheter reaches and directly below it.
Further, the soft magnetic particles may be soft magnetic ferrite;
preferably, the soft magnetic ferrite is Mn-Zn ferrite in which Fe 2 O 3 ：ZnO：MnO 2 Molar weight ratio 49-54:28-34:13-23;
preferably, fe 2 O 3 ：ZnO：MnO 2 Molar weight ratio 51-53:30-32:16-20.
Further, the micro magnetic particles are characterized in that the particle size ranges are as follows: 0.1-100 mu m, and the Curie temperature is 37-50 ℃.
Further, the micro soft magnetic particles are characterized in that after being treated by a silane coupling agent, the micro soft magnetic particles are uniformly dispersed in a magnetizable catheter head end main body material in a physical mixing or/and chemical bonding mode, and the mass ratio of the micro soft magnetic particles to main body glue is 0.3:1-1:1, molding by extrusion or injection molding.
Further, the automatic demagnetizing real-time positioning guide catheter and the system thereof are characterized in that the magnetizable catheter is provided with a flexible head end, and the Shore hardness is 50-85A.
Further, the receiver comprises a sucker, a box body, an electromagnetic sensor, an induction circuit, a magnetic control switch and a box body external indicator lamp, wherein the sucker, the box body and the electromagnetic sensor, the induction circuit, the magnetic control switch and the box body external indicator lamp are used for fixing the receiver.
Furthermore, the receiver is characterized in that the sucker is made of flexible materials and has a gecko bionic structure, and the receiver can be firmly adhered to a smooth and moist surface without adding other glue substances.
Further, the number of the receivers is not less than three, one of which is located at the expected final position of the catheter.
Furthermore, the magnetic cup is divided into a power supply and an unpowered power supply, so that magnetic fields with different intensities can be manufactured, and the magnetic induction intensity range at the central position is 0-2T.
Compared with the prior art, the guide catheter capable of automatically demagnetizing and positioning in real time and the system thereof have the following advantages:
1. the magnetic cup can provide an adjustable magnetic field and can endow the magnetic signal emission performance of different intensities at the head end of the positioning guide catheter;
2. after the catheter is placed, the magnetic performance of the catheter head is maintained for no more than 12 hours, and the catheter can be automatically demagnetized at body temperature, so that various later examination of a patient with the catheter is not influenced;
3. the tiny soft magnetic particles at the head end of the catheter are uniformly embedded at the head end of the catheter, so that the head end of the catheter is a flexible head end without special treatment;
4. the multiple receivers are distributed at the intersection of the vascular passages, so that the head end of the catheter can be positioned in time, and the catheter ectopic position in the operation can be effectively identified;
5. the Curie temperature of the micro soft magnetic particles is 37-50 ℃.
Drawings
In order to more clearly illustrate the technical solution of the present invention, the following drawings required for the description of the embodiments will be briefly described:
FIG. 1 is a schematic view of an automatically demagnetizable real-time positioning guide catheter;
FIG. 2 is a schematic diagram of a system receiver and a converter of an automatically demagnetizable real-time positioning guide catheter;
FIG. 3 is a schematic diagram of a magnetic cup with current-modulated magnetic field strength;
FIG. 4 is a schematic diagram of a magnetic cup for magnetically adjusting the magnetic field strength;
FIG. 5 is a plot of magnetization versus temperature for a head-end magnetizable catheter according to four embodiments under external magnetic field 1T;
FIG. 6 shows the time required for the magnetic induction of the head-end magnetizable catheter of the four embodiments to decrease to 0 at 37℃after magnetization with an external magnetic field of 0.5T;
in the figure, 1. A catheter; 2. tiny soft magnetic particles; 3. a signal receiver; 4. a signal processor; 5. a magnetic cup; 6. an indicator light; 7. a display screen; 8. a suction cup microstructure; 9. a current regulator; 10. a magnet clamping groove; 11. a metal shield.
Detailed Description
The present invention will be described in further detail with reference to the drawings and examples, for more clearly showing the objects, technical methods and advantages of the present invention. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the invention.
The method for testing the magnetic performance of the catheter in the embodiment comprises the following steps:
curie temperature: determining Curie temperature by measuring a relation curve of magnetization M and temperature T, wherein the magnetization is measured by a magnetic balance, and the temperature is measured by a DWT-702 temperature controller;
magnetic induction intensity: measured in gauss;
and (3) hardness detection: shore A durometer;
test criteria used in catheter biology in the examples:
cytotoxicity test: GBT 16886.5-2017 in vitro cytotoxicity assay;
delayed hypersensitivity and intradermal stimulation test: GB/T16886.10-2017 medical device biological evaluation part 10: irritation and skin sensitization test.
The following methods involve reagents, all AR-rated unless specified, purchased from chemical reagent websites.
(1) Automatically demagnetized real-time positioning guide catheter and system thereof, and Mn-Zn ferrite particles are prepared:
ZnSO is added to 4 ·7H 2 O、FeSO 4 ·7H 2 O、MnSO 4 ·H 2 O is dissolved in deionized water according to the proportion. Heating in water bath to 55+ -2deg.C, and slowly adding ammonium oxalate (NH) under mechanical stirring at 350 r/min 4 ) 2 C 2 O 4 ·H 2 And (3) regulating the pH value to 8.0+/-0.2. Settling 12h, cooling to room temperature, washing twice with deionized water and ethanol respectively, and drying at 80deg.C; then preserving heat at 1200+/-5 ℃ for 3h, and grinding to obtain Mn-Zn ferrite particles;
(2) An automatically demagnetized guide catheter capable of positioning in real time and a system thereof, wherein the silane coupling agent is used for treatment:
mixing and ball milling the obtained Mn-Zn ferrite particles with KH-570 or/and KH-560 to obtain Mn-Zn ferrite particles treated by a silane coupling agent;
(3) An automatically demagnetizable guide catheter capable of being positioned in real time and a system thereof, wherein the head end magnetizable catheter is prepared by the following steps:
the Mn-Zn ferrite particles obtained in the step (2) and the main body material are evenly mixed or mixed according to a set mass ratio, and are connected with the catheter main body through coextrusion, and the length of the head end is a preset value; the other parts of the catheter are made of main materials and are extruded independently to obtain a catheter 1;
(4) An automatically demagnetizing real-time positioning guide catheter and a system thereof, the application steps are as follows:
a) Before the tube is placed, the environment is clean and cool, and alcohol and iodophor disinfection are carried out on the operation area;
b) Probing the condition of the blood vessel by ultrasonic waves, and selecting a proper blood vessel; the receiver 3 is fixed by means of a bottom suction cup to the skin corresponding to the venous junction and the final position. Zero clearing and calibration are carried out on the receiver;
c) The catheter 1 is completely placed at its front end in a magnetic cup 5, the tiny soft magnetic particles 2 inside it are magnetized, and then the magnetized catheter 1 is fed into a preselected vein by a guiding device. The plurality of receivers 3 simultaneously locate the catheter head end and display the position and the walking route on the display screen 7 of the signal processor 4. When the catheter tip is close to the receiver 3, the indicator light 6 on the receiver 3 can emit light to indicate that the closer the distance is, the stronger the magnetic signal received by the receiver is, and the brighter the light is.
Example 1
(1) Automatically demagnetized real-time positioning guide catheter and system thereof, and Mn-Zn ferrite particles are prepared: znSO is added to 4 ·7H 2 O、FeSO 4 ·7H 2 O、MnSO 4 ·H 2 O is according to Fe 2 O 3 ：ZnO：MnO 2 The molar ratio is 52:31:17 is dissolved in deionized water. Heating in water bath to 55+ -2deg.C, and slowly adding ammonium oxalate (NH) under mechanical stirring at 350 r/min 4 ) 2 C 2 O 4 ·H 2 And (3) regulating the pH value to 8.0+/-0.2. Sinking for 12h, coolingAfter the temperature reaches room temperature, respectively washing twice by deionized water and ethanol, and drying at 80 ℃; then preserving heat for 3 hours at 1200+/-5 ℃ and grinding to obtain Mn-Zn ferrite particles with the particle size of 5 mu m;
(2) An automatically demagnetized guide catheter capable of positioning in real time and a system thereof, wherein the silane coupling agent is used for treatment: mixing and ball milling the obtained Mn-Zn ferrite particles with KH-560 to obtain Mn-Zn ferrite particles treated by a silane coupling agent;
(3) An automatically demagnetizable guide catheter capable of being positioned in real time and a system thereof, wherein the head end magnetizable catheter is prepared by the following steps: the Mn-Zn ferrite particles obtained in the step (2) and a main material are mixed according to the mass ratio of 0.7: 1, mixing the materials together through melt stirring, and connecting the materials with a catheter main body through coextrusion, wherein the length of the head end is 3 mm; the other parts of the catheter are made of main materials and are extruded independently to obtain a catheter 1;
(4) An automatically demagnetized guide catheter capable of being positioned in real time and a system thereof, and a catheter placement process are provided:
a) Before the tube is placed, the environment is clean and cool, and alcohol or/and iodophor is sterilized in the operation area;
b) Probing the vascular conditions by ultrasound, selecting an appropriate vessel, such as the head vein; the receiver 3 is fixed on the corresponding skin at the junction of the head vein and the subclavian vein, the subclavian vein and the jugular vein, and the jugular vein and 1/3 of the inferior vena cava by the bottom suction cup. Zero clearing and calibration are carried out on the receiver;
c) The head end of the catheter 1 is completely placed in a tubular coil magnetic cup, the magnetic cup 5 is used for controlling the magnetic field intensity by adjusting the current as shown in fig. 3, magnetizing tiny soft magnetic particles 2 in the head end of the catheter, and then the magnetized catheter 1 is sent into a head vein by using a guiding device. The plurality of receivers 3 simultaneously locate the catheter head end and display the position and the walking route on the display screen 7 of the signal processor 4. When the catheter head end is close to the receiver 3, the indicator light 6 on the receiver 3 can emit light to indicate that the closer the distance is, the stronger the magnetic signal received by the receiver is, and the brighter the light is;
the shore hardness of the head end of the detection catheter is 73A, and the Curie temperature is 47 ℃.
Example 2
Substantially the same as in example 1, except that:
(1) Automatically demagnetized real-time positioning guide catheter and system thereof, and Mn-Zn ferrite particles are prepared: fe in Mn-Zn ferrite 2 O 3 ：ZnO：MnO 2 The molar ratio was 49:28:23, the grain diameter is 1 mu m;
(2) An automatically demagnetized guide catheter capable of positioning in real time and a system thereof, wherein the silane coupling agent is used for treatment: mixing and ball milling KH-570 and KH-560;
(3) An automatically demagnetizable guide catheter capable of being positioned in real time and a system thereof, wherein the head end magnetizable catheter is prepared by the following steps: the mass ratio of the material to the main body material is 0.5: 1, fully and uniformly mixing, and connecting the pipe body with the joint extrusion, wherein the length of the head end is 5 mm;
(4) An automatically demagnetized guide catheter capable of being positioned in real time and a system thereof, and a catheter placement process are provided: selecting a suitable blood vessel, such as a noble vein; the receiver 3 is fixed on the corresponding skin at the junction of the great vein and the axillary vein, the axillary vein and the jugular vein, and the jugular vein and the innominate vein, and 1/3 of the inferior vena cava. Catheter 1 enters the blood vessel from the vein of the noble subject;
the shore hardness of the head end of the detection catheter is 60A, and the Curie temperature is 40 ℃.
Example 3
Substantially the same as in example 1, except that:
(1) Automatically demagnetized real-time positioning guide catheter and system thereof, and Mn-Zn ferrite particles are prepared: fe in Mn-Zn ferrite 2 O 3 ：ZnO：MnO 2 The molar ratio is 54:33:13, the grain diameter is 100 mu m;
(2) An automatically demagnetizable guide catheter capable of being positioned in real time and a system thereof, wherein the head end magnetizable catheter is prepared by the following steps: the mass ratio of the material to the main material is 0.3:1, connecting the catheter body together in an injection molding mode, wherein the length of the head end is 1mm;
(3) An automatically demagnetized guide catheter capable of being positioned in real time and a system thereof, and a catheter placement process are provided: the magnetic cup 5 is of a U-shaped structure, as shown in fig. 4, magnet placement grooves 10 are formed in two ends of the U-shaped structure, the strength of a magnetic field is controlled by changing magnets with different specifications under the condition of no power, and a rigid metal shielding cover 11 is arranged on the outer layer;
the shore hardness of the head end of the detection catheter is 50A, and the Curie temperature is 50 ℃.
Example 4
Substantially the same as in example 1, except that:
(1) Automatically demagnetized real-time positioning guide catheter and system thereof, and Mn-Zn ferrite particles are prepared: fe in Mn-Zn ferrite 2 O 3 ：ZnO：MnO 2 The molar ratio is 50:30:20, the grain diameter is 0.1 mu m;
(2) An automatically demagnetized guide catheter capable of positioning in real time and a system thereof, wherein the silane coupling agent is used for treatment: mixing and ball milling through KH-570;
(3) An automatically demagnetizable guide catheter capable of being positioned in real time and a system thereof, wherein the head end magnetizable catheter is prepared by the following steps: the mass ratio of the material to the main material is 1:1, a head end length of 3 mm;
(4) An automatically demagnetized guide catheter capable of being positioned in real time and a system thereof, and a catheter placement process are provided: selecting an appropriate blood vessel, such as the jugular vein; the receiver 3 is fixed on the corresponding skin at the junction of the great vein and the jugular vein and the innominate vein, and the junction of the innominate vein and the superior vena cava and 1/3 of the inferior vena cava by the bottom sucker. Catheter 1 enters the vessel from the jugular vein;
the shore hardness of the head end of the detection catheter is 85 and A, and the temperature is 37 ℃.
The hardness measurements for the four examples of catheter 1 of the present invention are shown in Table 1; the results of the safety performance tests for the four embodiments of catheter 1 of the present invention are shown in Table 2.
As is clear from Table 1, the hardness of the four examples of the catheter increases with the addition amount of the soft magnetic particles, because Mn-Zn ferrite as a polymer material having a hardness far greater than that of the catheter body as inorganic particles.
As can be seen from Table 2, the four examples of the catheter were tested for cytotoxicity, delayed hypersensitivity and internal stimulation, which indicated that the catheter provided by the invention was able to automatically demagnetize and locate the catheter in real time with good biocompatibility. In the present invention, the saturation magnetization and temperature relationship of the four embodiments of the head-end magnetizable catheter 1 under an external magnetic field 1T are shown in FIG. 5. The intersection of this curve with the m=0 transverse line is the curie temperature of the head end magnetizable catheter, as shown in table 3; four example head-end magnetizable catheters with magnetic induction of about 0.2T at 37 c, the time required for the induction to drop to 0, are shown in fig. 6.
As can be seen from FIGS. 5 and Table 3, the Curie temperatures of the four head-end magnetizable tubes are in the range of 37-50 ℃. As shown in FIG. 6, the four kinds of head end magnetizable tubes having magnetic induction intensity of about 0.2. 0.2T can be completely demagnetized within 12 hours at 37 ℃, and the lower the Curie temperature, the shorter the magnetizable tubes can be demagnetized, and when the temperature is not less than the Curie temperature, mn-Zn ferrite is instantaneously demagnetized.
The foregoing description of the preferred embodiments of the invention is not intended to be limiting, but rather is intended to cover all modifications, equivalents, and alternatives falling within the spirit and principles of the invention.
Claims (6)
1. The automatic demagnetizing real-time positioning and guiding system is characterized by comprising a guide tube with a magnetizable head end entering a blood vessel, a plurality of receivers which are positioned on the body surface and detect magnetic signals and convert the magnetic signals into electric signals, a processor which processes and converts the electric signals and a magnetic cup which can manufacture an adjustable magnetic field; the head end of the catheter is coated with tiny soft magnetic particles which can be automatically demagnetized in 12h at 37 ℃; the length of the head end of the catheter is 1-5 mm, and the magnetic induction intensity after magnetization is about 0.2T; the receiver can perform different light indications of intensity when the catheter reaches the vicinity and the right below the receiver;
the catheter process is as follows:
(1) Soft magnetic particle preparation:
according to Fe in soft magnetic particles 2 O 3 ：ZnO：MnO 2 The molar ratio is 51-53:30-32:16-20, znSO 4 ·7H 2 O、FeSO 4 ·7H 2 O、MnSO 4 H2O is dissolved in deionized water; heating in water bath to 55+ -2deg.C, and slowly adding ammonium oxalate (NH) under mechanical stirring at 350 r/min 4 ) 2 C 2 O 4 ·H 2 O solution, regulating the pH value to 8.0+/-0.2; settling 12h, cooling to room temperature, washing twice with deionized water and ethanol respectively, and drying at 80deg.C; then, the temperature is kept at 1200+/-5 ℃ for 3h, and Mn-Zn ferrite particles are obtained by grinding, wherein the particle size range is as follows: 0.1-5 mu m, and the Curie temperature is 37-50 ℃;
(2) Silane coupling agent treatment:
mixing and ball milling the obtained Mn-Zn ferrite particles with KH-570 or/and KH-560 to obtain Mn-Zn ferrite particles treated by a silane coupling agent;
(3) Preparing a catheter with a magnetizable head end:
the Mn-Zn ferrite particles obtained in the step (2) and the main body material are melted, stirred, mixed or uniformly mixed according to the mass ratio of 0.3:1-1:1, and are jointly extruded to be connected with the main body of the catheter, and the length of the head end is a preset value; and the other parts of the catheter are made of main materials which are extruded independently, so that the catheter is obtained.
2. The automatic demagnetizing real-time positioning and guiding system according to claim 1, wherein the magnetizable catheter has a flexible head end with shore hardness of 50-85A.
3. The automatic demagnetizing real-time positioning and guiding system according to claim 1, wherein the receiver comprises a sucker for fixing, a box body, an electromagnetic sensor, an induction circuit, a magnetic control switch and an indicator lamp on the outer surface of the box body.
4. The automatic demagnetizing real-time positioning and guiding system according to claim 3, wherein the sucker is made of flexible material and has a gecko bionic structure, and can be firmly adhered to a smooth and wet surface without adding other glue substances.
5. An automatically demagnetizable real-time positioning and guiding system according to claim 3, wherein the number of said receivers is not less than three, one of which is located at the desired final position of the catheter.
6. The automatic demagnetizing real-time positioning and guiding system according to claim 1, wherein the magnetic cup is divided into a power supply and an unpowered magnetic cup, so that magnetic fields with different intensities can be manufactured, and the magnetic induction intensity of the central position is in the range of 0-2T.
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| CN202111556714.7A CN114177484B (en) | 2021-12-18 | Guide catheter capable of automatically demagnetizing and positioning in real time and system thereof |
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| CN202111556714.7A CN114177484B (en) | 2021-12-18 | Guide catheter capable of automatically demagnetizing and positioning in real time and system thereof |
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| CN114177484A CN114177484A (en) | 2022-03-15 |
| CN114177484B true CN114177484B (en) | 2023-11-10 |
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