System and method for monitoring tip position of catheter through intravascular ultrasonic real-time puncture

Abstract

According to the system and method for monitoring the tip position of the catheter through intravascular ultrasonic real-time puncture, whether the tip of the catheter reaches the optimal placement position or not is judged in real time through a phased array intravascular ultrasonic probe carried by the tip of a supporting guide wire in the infusion port catheter, and the position of the tip of the catheter is accurately adjusted in real time. The infusion port catheter is a three-way valve catheter, the ultrasonic transducer is packaged at the tip of the infusion port catheter, a supporting guide wire is arranged in the center of the infusion port catheter, and 10 / 18 cables are led out from the rigid circuit board and packaged in the supporting guide wire to form the supporting guide wire containing the cables. The running head end of the Y-shaped interface is a hollow male seat which is designed to be matched with a catheter cavity of an infusion port, and a cable supporting guide wire penetrates through the hollow male seat; the interior of the operation tail end is connected with a cable supporting guide wire, and the exterior of the operation tail end is provided with an 18-channel male seat interface which is matched with a female seat interface of a disposable sterile ultrasonic interface connecting wire; the branch end is provided with a heparin cap; the disposable sterile ultrasonic interface is connected with the female seat interface adaptive operation tail end, and the male seat interface is adaptive to the female seat interface of the imager.

Description

Technical Field

[0001] This invention relates to the technical field of implantable medical devices, and more particularly to a system for real-time intravascular ultrasound puncture monitoring of catheter tip position, and a method of using such a system. Background Technology

[0002] A port-a-cath, also known as a totally implantable venous access device (TIVAD), is a central venous infusion device suitable for long-term, repeated drug infusions, chemotherapy drugs, blood products, parenteral nutrition, frequent blood sample collection, and patients with contraindications to other venous access routes. Over the past 40 years, port-a-cath implantation technology has evolved from primarily open surgical implantation to primarily puncture implantation, and from mainly chest wall ports to a combination of upper arm and chest wall ports.

[0003] To maintain the proper function of a fully implantable port-a-cath and avoid adverse reactions such as thrombosis and arrhythmia, the position of the catheter tip is crucial after port-a-cath implantation. The optimal placement is located in the middle and lower third of the superior vena cava, at the junction of the superior vena cava and the right atrium. Early methods for catheter tip positioning relied on surface localization or formula calculations; however, these methods are highly experience-dependent, significantly influenced by patient body size, and cannot accurately determine the catheter tip position, thus failing to guide clinical practice.

[0004] With the introduction of imaging technology, X-rays have become the gold standard and most commonly used method for clinically assessing the position of catheter tip. However, X-rays are limited by low temporal and spatial resolution, non-real-time imaging, and numerous image interferences, leading to a high reliance on experience in assessing catheter tip position. This is especially true when catheter position needs adjustment, resulting in lag and placing greater risks on patients, such as infection, bleeding, injury, and pain from secondary surgeries, and requiring them to undergo multiple X-ray radiation exposures. Summary of the Invention

[0005] To overcome the shortcomings of the prior art, the technical problem to be solved by the present invention is to provide a system for real-time intravascular ultrasound puncture monitoring of catheter tip position. The system uses a phased array intravascular ultrasound probe mounted on the guidewire tip inside the port catheter to evaluate in real time whether the catheter tip has reached the optimal placement position, and makes real-time and accurate adjustments to the position of the catheter tip, thereby reducing the risk of X-ray radiation exposure to patients and avoiding the risk of patients having to undergo a second surgery due to poor catheter position.

[0006] The technical solution of the present invention is: a system for real-time intravascular ultrasound puncture monitoring of catheter tip position, comprising: an ultrasound transducer (1), an infusion port catheter (2), a Y-type interface (4), a disposable sterile ultrasound interface connection cable (5), and a portable ultrasound imager (6). The ultrasonic transducer has a rigid circuit board (11). The infusion port catheter is a three-way valve catheter with an ultrasonic transducer encapsulated at its tip. The infusion port catheter is equipped with a support guidewire at its center. Ten or eighteen cables are led out from the rigid circuit board and encapsulated inside the support guidewire to form a cable-supported guidewire (3). The Y-type interface includes: a running head (41), a running tail (42), and a branch end (43); the running head is a hollow male connector designed to fit the lumen of the infusion port catheter, with a cable support guidewire passing through it; the running tail has an internal connection with a cable support guidewire and an external 18-channel male connector interface, which is compatible with a female connector for disposable sterile ultrasound interface cables; the branch end is equipped with a heparin cap. The disposable sterile ultrasound interface cable is an 18-channel interface cable with a male connector (51) and a female connector (52) at both ends. The female connector is adapted to the running end of the Y-type interface, and the male connector is adapted to the female connector of the portable ultrasound imager.

[0007] This invention uses a phased array intravascular ultrasound probe mounted on the tip of the guidewire inside the infusion port catheter to assess in real time whether the catheter tip has reached the optimal placement position, and makes real-time and accurate adjustments to the position of the catheter tip, reducing the risk of X-ray radiation exposure for patients and avoiding the risk of patients having to undergo a second surgery due to poor catheter placement.

[0008] A method for real-time intravascular ultrasound puncture monitoring of catheter tip position is also provided, comprising the following steps: (1) The patient is in a supine position, and the body surface is marked; (2) The operator opens the sterile infusion port catheter kit, prepares 100ml of 100IU / ml heparinized saline, and uses heparinized infusion port, straight non-traumatic needle, curved non-traumatic needle, puncture needle, vascular sheath, tunnel needle, disposable implantable drug delivery device indwelling needle, and J-type tip guidewire with heparinized saline. (3) The operator connects the male connector of the Y-type interface to the female connector of the disposable sterile ultrasound interface, unscrews the heparin cap of the branch end of the Y-type interface, connects the syringe containing heparinized saline, and injects heparinized saline to heparinize the lumen of the infusion port catheter and the periphery of the support guidewire. (4) The operator opens the portable ultrasound imaging device and connects the disposable sterile ultrasound interface cable to the male connector; (5) Routine disinfection and draping, sterile probe set with linear array ultrasound probe of neck vascular mode color Doppler ultrasound instrument, local infiltration anesthesia with 1% cocaine hydrochloride injection; (6) Install the puncture needle into the tip of the Raulerson spring guidewire syringe. Under the guidance of neck ultrasound, insert the puncture needle into the internal jugular vein or subclavian vein. Aspirate to see blood return. Insert the guidewire through the spring guidewire guide rail of the Raulerson spring guidewire syringe. Withdraw the puncture needle. Make a 2mm incision in the local skin at the guidewire insertion site. Widen the skin locally with a curved clamp. Insert the vascular sheath. Remove the guidewire and vascular sheath core. Insert the catheter along the vascular sheath. Under the monitoring of a portable ultrasound imaging device, place the catheter tip in the middle and lower 1 / 3 of the superior vena cava to the junction of the superior vena cava and the right atrium. At the same time, monitor whether there is obvious compression, abnormal course, or obvious thrombosis in the lumen of the internal jugular vein or subclavian vein to the superior vena cava. Aspirate to see blood to confirm that the catheter lumen is patent. Withdraw the vascular sheath. (7) Adjust the position of the catheter tip again using a portable ultrasound imaging device to the middle and lower 1 / 3 of the superior vena cava to the junction of the superior vena cava and the right atrium. Record the catheter depth scale. Aspirate to confirm that the catheter lumen is patent. Separate the infusion port catheter from the Y-type interface, remove the Y-type interface and the support guidewire, and temporarily fix the infusion port catheter on the drape. (8) Local infiltration anesthesia with 1% cocaine hydrochloride injection was performed. A subcutaneous pouch with a depth of about 1 cm was established 2 cm below the clavicle on the chest wall. The catheter was guided through the neck incision to the chest wall incision using a tunneling needle. The catheter at the puncture point was temporarily fixed with a vascular retractor. The recorded catheter depth was confirmed. The catheter on the tunneling needle was trimmed off. The catheter lock was put on the catheter. (9) Reconfirm the recorded catheter depth scale, precisely trim the excess catheter tip, align the catheter tip and the port handle parallel to each other, and place the catheter tip on the port handle for about 1 / 2. Simultaneously advance the locking buckle and catheter to the edge of the port body, pull the catheter with appropriate force to confirm that the catheter and port handle are firmly connected, insert a non-traumatic needle into the silicone diaphragm of the port body and aspirate to see blood, confirm that the port and catheter system are correctly connected and the lumen is patent; (10) Adjust the position of the infusion port and place it into the bag. Remove the vascular retractor. Suture the bag and puncture point. Wipe and bandage the area. Insert the disposable implantable drug delivery device indwelling needle vertically into the silicone diaphragm under the skin. Install the positive pressure connector and flush the tubing. Attached Figure Description

[0009] Figure 1 A schematic diagram of a system for real-time intravascular ultrasound puncture monitoring of catheter tip position according to the present invention is shown. The lengths of the infusion port catheter and the disposable sterile ultrasound interface connecting wire are shortened to more clearly illustrate the other parts; the actual lengths are... Figure 1 It is longer than in China.

[0010] Figure 2 An ultrasonic transducer is shown.

[0011] Figure 3 The infusion port catheter is shown.

[0012] Figure 4 This is a schematic diagram of the cross-section of the infusion port catheter.

[0013] Figure 5 A Y-type interface is shown.

[0014] Figure 6 A disposable sterile ultrasound interface cable is shown.

[0015] Figure 7 A portable ultrasound imaging device is shown. Detailed Implementation

[0016] To enable those skilled in the art to better understand the present invention, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of the present invention.

[0017] It should be noted that the term "comprising" and any variations thereof in the specification, claims and accompanying drawings of this invention are intended to cover non-exclusive inclusion. For example, a process, method, apparatus, product or device that includes a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products or devices.

[0018] like Figures 1-7 As shown, this system for real-time intravascular ultrasound puncture monitoring of catheter tip position includes: an ultrasound transducer 1, an infusion port catheter 2, a Y-type interface 4, a disposable sterile ultrasound interface connection cable 5, and a portable ultrasound imager 6. The ultrasonic transducer has a rigid circuit board 11; The infusion port catheter is a three-way valve catheter with an ultrasonic transducer encapsulated at its tip. The infusion port catheter is equipped with a support guidewire at its center. 10 or 18 cables are led out from the rigid circuit board and encapsulated inside the support guidewire to form a cable-supported guidewire 3. The Y-type interface includes: a running head end 41, a running tail end 42, and a branch end 43; the running head end is a hollow male connector design adapted to the lumen of the infusion port catheter, with a cable support guidewire passing through it; the running tail end has an internal connection with a cable support guidewire and an external 18-channel male connector interface adapted to a female connector interface for disposable sterile ultrasonic interface cables; the branch end is equipped with a heparin cap. The disposable sterile ultrasound interface cable is an 18-channel interface cable with a male connector 51 and a female connector 52 at both ends. The female connector is adapted to the end of the Y-type interface, and the male connector is adapted to the female connector of the portable ultrasound imager.

[0019] This invention uses a phased array intravascular ultrasound probe mounted on the tip of the guidewire inside the infusion port catheter to assess in real time whether the catheter tip has reached the optimal placement position, and makes real-time and accurate adjustments to the position of the catheter tip, reducing the risk of X-ray radiation exposure for patients and avoiding the risk of patients having to undergo a second surgery due to poor catheter placement.

[0020] Furthermore, the ultrasonic transducer is a ring-arranged phased array transducer composed of 64 piezoelectric micromechanical transducer (PMUT) elements, with an outer diameter < 5 Fr, a length < 1 mm, a center frequency of 18 MHz, an axial resolution > 70 μm, a lateral resolution of 80–100 μm, a side resolution of 50 μm, a frame rate of 30 fps, a signal-to-noise ratio (SNR) ≥ 25 dB, and a penetration depth of 25 mm.

[0021] Furthermore, the three-way valve catheter is 45cm long, with an outer diameter of 7Fr-9Fr, a wall thickness of 0.25mm-0.4mm, an inner diameter of 1.7-2.5mm, and an ultrasonic transducer and circuit board placed within a 10mm range of the catheter tip. The support guidewire is 48cm long and has a diameter of <5Fr.

[0022] Furthermore, the 10 0.1mm diameter cables include: 8 signal lines, 1 power line, and 1 ground line (the cable arrangement order for the 10-channel version is power line, signal line 1, empty channel, signal line 2, empty channel, signal line 3, empty channel, signal line 4, empty channel, ground line, signal line 5, empty channel, signal line 6, empty channel, signal line 7, empty channel, signal line 8, empty channel); the 18 0.1mm diameter cables include: 16 signal lines, 1 power line, and 1 ground line (the 18-channel version consists of 16 signal lines, 1 power line, and 1 ground line, arranged in the following order: power line, signal line 1, signal line 2, signal line 3, signal line 4, signal line 5, signal line 6, signal line 7, signal line 8, ground line, signal line 9, signal line 10, signal line 11, signal line 12, signal line 13, signal line 14, signal line 15, signal line 16).

[0023] Furthermore, the disposable sterile ultrasonic interface cable is a cable with a length of 1m or more and 18 channels; the male connector has a pin diameter of 0.5mm per channel, and the female connector has a pin hole diameter of 0.51mm per channel.

[0024] Furthermore, the Y-type interface features a 45° angled Y-type branch design.

[0025] Furthermore, the portable ultrasound imager employs synthetic aperture imaging technology, with a lateral resolution of 50-80μm, an SNR ≥ 30dB, and a frame rate of 30 fps. Each channel of the 18-channel female connector has a pinhole diameter of 0.51mm, and it is compatible with disposable sterile ultrasound interface cable male connectors. The interfaces are marked with power and grounding indicators and include at least an ultrasound operation keyboard, trackball, touchscreen, and display screen. When paired with ultrasound imaging software, it possesses at least the functions of frequency, depth, gain, time-compensated gain, dynamic range, and measurement, and also features automatic or manual image orientation calibration.

[0026] Furthermore, the conduit wall surface has insertion depth markings, the cable interface has power and grounding markings, and the male and female connectors have power and grounding markings.

[0027] A method for real-time intravascular ultrasound puncture monitoring of catheter tip position is also provided, comprising the following steps: (1) The patient is in a supine position, and the body surface is marked; (2) The operator opens the sterile infusion port catheter kit, prepares 100ml of 100IU / ml heparinized saline, and uses heparinized infusion port, straight non-traumatic needle, curved non-traumatic needle, puncture needle, vascular sheath, tunnel needle, disposable implantable drug delivery device indwelling needle, and J-type tip guidewire with heparinized saline. (3) The operator connects the male connector of the Y-type interface to the female connector of the disposable sterile ultrasound interface, unscrews the heparin cap of the branch end of the Y-type interface, connects the syringe containing heparinized saline, and injects heparinized saline to heparinize the lumen of the infusion port catheter and the periphery of the support guidewire. (4) The operator opens the portable ultrasound imaging device and connects the disposable sterile ultrasound interface cable to the male connector; (5) Routine disinfection and draping, sterile probe set with linear array ultrasound probe of neck vascular mode color Doppler ultrasound instrument, local infiltration anesthesia with 1% cocaine hydrochloride injection; (6) Install the puncture needle into the tip of the Raulerson spring guidewire syringe. Under the guidance of neck ultrasound, insert the puncture needle into the internal jugular vein or subclavian vein. Aspirate to see blood return. Insert the guidewire through the spring guidewire guide rail of the Raulerson spring guidewire syringe. Withdraw the puncture needle. Make a 2mm incision in the local skin at the guidewire insertion site. Widen the skin locally with a curved clamp. Insert the vascular sheath. Remove the guidewire and vascular sheath core. Insert the catheter along the vascular sheath. Under the monitoring of a portable ultrasound imaging device, place the catheter tip in the middle and lower 1 / 3 of the superior vena cava to the junction of the superior vena cava and the right atrium. At the same time, monitor whether there is obvious compression, abnormal course, or obvious thrombosis in the lumen of the internal jugular vein or subclavian vein to the superior vena cava. Aspirate to see blood to confirm that the catheter lumen is patent. Withdraw the vascular sheath. (7) Adjust the position of the catheter tip again using a portable ultrasound imaging device to the middle and lower 1 / 3 of the superior vena cava to the junction of the superior vena cava and the right atrium. Record the catheter depth scale. Aspirate to confirm that the catheter lumen is patent. Separate the infusion port catheter from the Y-type interface, remove the Y-type interface and the support guidewire, and temporarily fix the infusion port catheter on the drape. (8) Local infiltration anesthesia with 1% cocaine hydrochloride injection was performed. A subcutaneous pouch with a depth of about 1 cm was established 2 cm below the clavicle on the chest wall. The catheter was guided through the neck incision to the chest wall incision using a tunneling needle. The catheter at the puncture point was temporarily fixed with a vascular retractor. The recorded catheter depth was confirmed. The catheter on the tunneling needle was trimmed off. The catheter lock was put on the catheter. (9) Reconfirm the recorded catheter depth scale, precisely trim the excess catheter tip, align the catheter tip and the port handle parallel to each other, and place the catheter tip on the port handle for about 1 / 2. Simultaneously advance the locking buckle and catheter to the edge of the port body, pull the catheter with appropriate force to confirm that the catheter and port handle are firmly connected, insert a non-traumatic needle into the silicone diaphragm of the port body and aspirate to see blood, confirm that the port and catheter system are correctly connected and the lumen is patent; (10) Adjust the position of the infusion port and place it into the bag. Remove the vascular retractor. Suture the bag and puncture point. Wipe and bandage the area. Insert the disposable implantable drug delivery device indwelling needle vertically into the silicone diaphragm under the skin. Install the positive pressure connector and flush the tubing.

[0028] Furthermore, the method also includes training in ultrasound cross-sectional images of the catheter tip, including: a standard ultrasound cross-sectional image of the middle and lower 1 / 3 of the superior vena cava, a quasi-ultrasound cross-sectional image of the junction of the superior vena cava and the right atrium, and ultrasound images of whether there is clear compression, abnormal course, or clear thrombosis in the vein lumen from the internal jugular vein or subclavian vein catheterization site to the superior vena cava.

[0029] The beneficial effects of this invention are as follows: (1) The present invention uses a phased array intravascular ultrasound probe mounted on the tip of the guidewire inside the port catheter to evaluate the position of the catheter tip in real time, so that the port catheter tip can be accurately placed in the middle and lower 1 / 3 of the superior vena cava to the junction of the superior vena cava and the right atrium in different populations. The position of the catheter tip can be adjusted in real time during the operation, reducing the risk of X-ray radiation exposure for patients and avoiding the various risks of secondary surgery for patients due to catheter adjustment.

[0030] (2) The present invention uses a phased array intravascular ultrasound probe mounted on the tip of the guidewire inside the infusion port catheter to evaluate in real time whether there are anatomical variations in the course of the inserted vein, whether the lumen is compressed, and whether there are thrombi in the lumen, etc., to assess the risks of catheterization.

[0031] The following describes a specific example of the present invention in detail.

[0032] The components, overall structure, and operating procedures of this system for real-time intravascular ultrasound monitoring of catheter tip position are as follows: (1) Ultrasonic transducer: A phased array transducer arranged in a ring, for example, composed of 64 piezoelectric micromachined ultrasound transducer (PMUT) elements, using a rigid circuit board (3.5mm long, 1.5mm wide, and 0.6mm thick).

[0033] (2) Infusion port catheter and support guidewire: Three-way valve catheter (length 45cm, outer diameter 7Fr-9Fr, wall thickness 0.25mm-0.4mm, lumen inner diameter 1.7-2.5mm), with insertion depth markings on the catheter wall surface; support guidewire (length approximately 48cm, diameter <5Fr), with an ultrasonic transducer and circuit board encapsulated at the tip, and 10 / 18 0.1mm diameter cables inside the guidewire trunk; the catheter end interface is a 45° angled Y-type branch interface, the running head end is a hollow male connector design to fit the catheter lumen, through which the support guidewire can pass, the running tail end is internally connected to the support guidewire cable, and the outside is an 18-channel male connector interface (available in 10-channel and 18-channel versions), each channel pin diameter 0.5mm, the power and ground wire positions are marked at the interface, and it is compatible with the female connector of disposable sterile ultrasonic interface cable; the branch end is equipped with a heparin cap.

[0034] (3) Disposable sterile ultrasound interface cable: ≥1m long, 18-channel interface cable, with male and female connectors at both ends. The male connector has a pin diameter of 0.5mm per channel. It is compatible with the female connector of portable ultrasound imaging devices. The female connector has a pin diameter of 0.51mm per channel. It is compatible with the 18-channel male connector at the end of the Y-type interface of the infusion port catheter. All cable interfaces are marked with the power and ground wire orientations.

[0035] (4) Portable ultrasound imager: adopts synthetic aperture imaging technology; the instrument hardware is equipped with an 18-channel female connector (each channel pinhole diameter 0.51mm), and is compatible with disposable sterile ultrasound interface cable male connector, with the power and ground wire orientation marked on the interface; frame rate 30 fps; at least has a common ultrasound instrument operation keyboard, trackball, touch screen, display screen, etc.; equipped with ultrasound imaging software, at least has functions such as frequency, depth, gain, time compensation gain, dynamic range, measurement, etc., and also has automatic / manual image orientation calibration function (the 12 o'clock direction of the image is the front of the human body), etc.; has artificial intelligence image learning capability.

[0036] (5) Other infusion port kits: infusion port, catheter lock, straight non-traumatic needle, curved non-traumatic needle, vascular retractor, puncture needle (18G×70mm), vascular sheath (dilator and tear sheath), tunnel needle, disposable implantable drug delivery device indwelling needle, J-type tip guidewire (0.035 inches in diameter), Raulerson spring guidewire injector, 5ml syringe, 10ml syringe, 20ml syringe.

[0037] (6) Operating method: (a) Catheter insertion procedure: 1) The patient is placed in a supine position, and the body surface is marked; 2) The sterile infusion port catheter kit is opened, and 100 ml of 100 IU / ml heparinized saline is prepared. The infusion port catheter kit is heparinized with the heparinized saline; 3) The male connector of the Y-type interface at the end of the infusion port catheter is connected to the female connector of the disposable sterile ultrasound interface cable. The heparin cap of the branch end of the Y-type interface is unscrewed, and the syringe containing heparinized saline is connected. The heparinized saline is injected to heparinize the lumen of the infusion port catheter and the periphery of the support guidewire; 4) The portable ultrasound imaging device is turned on and connected to the male connector of the disposable sterile ultrasound interface cable; 5) Routine disinfection and draping are performed, and local infiltration anesthesia with 1% cocaine hydrochloride injection is administered; 6) The puncture needle is installed in the Rauler. Using the Raulerson spring guidewire syringe tip, under the guidance of a neck ultrasound, the puncture needle is inserted into the internal jugular vein or subclavian vein. Blood return is observed upon aspiration. The guidewire is then inserted through the Raulerson spring guidewire syringe using the spring guidewire guide rail. The puncture needle is withdrawn. A 2mm incision is made in the local skin at the guidewire insertion site, and the skin is widened with a curved clamp. A vascular sheath is inserted, and the guidewire and sheath core are removed. A catheter is then inserted along the vascular sheath. Under the monitoring of a portable ultrasound imaging device, the catheter tip is placed in the middle to lower third of the superior vena cava, extending to the junction of the superior vena cava and right atrium. Simultaneously, the internal jugular vein or subclavian vein is monitored for compression, abnormal course, or thrombosis within the vein lumen leading to the superior vena cava. Blood return confirms catheter patency. The vascular sheath is then withdrawn. 8) Using a portable ultrasound imaging device, adjust the catheter tip position again to the middle and lower 1 / 3 of the superior vena cava, to the junction of the superior vena cava and right atrium. Record the catheter depth scale, aspirate to confirm catheter patency, disconnect the port-infusion catheter from the Y-connector, remove the Y-connector and support guidewire, and temporarily fix the port-infusion catheter on the drape; 9) Perform local infiltration anesthesia with 1% cocaine hydrochloride injection, create a subcutaneous pouch about 1 cm deep 2 cm below the clavicle on the chest wall, and use a tunneling needle to guide the catheter through the neck incision into the chest wall incision (the angle of the tunnel should be carefully avoided to prevent acute angles). Temporarily fix the catheter at the puncture point with a vascular retractor, confirm the recorded catheter depth scale, trim the catheter off the tunneling needle, and put the catheter locking buckle on the catheter. (Black ring away from the port body); 9) Reconfirm the recorded catheter depth scale, precisely trim the excess catheter tip, align the catheter tip and port handle parallel to each other, and place it on the port handle for about 1 / 2. Simultaneously advance the locking buckle and catheter to the edge of the port body (a "click" sound can be heard). Pull the catheter with appropriate force to confirm that the catheter and port handle are firmly connected. Insert a non-traumatic needle into the silicone diaphragm of the port body and aspirate to see blood, confirming that the port and catheter system are correctly connected and the lumen is patent; 10) Adjust the position of the port body and place it into the pocket, remove the vascular retractor, suture the pocket and puncture point, wipe and bandage the area, vertically insert the disposable implantable drug delivery device indwelling needle into the silicone diaphragm under the skin, install the positive pressure connector, and flush the tubing.

[0038] (b) Training on ultrasound cross-sectional images of catheter tip: standard ultrasound cross-section of the middle and lower 1 / 3 of the superior vena cava, quasi-ultrasound cross-section of the junction of the superior vena cava and the right atrium, and ultrasound images of whether there is obvious compression, abnormal course, or obvious thrombosis in the lumen of the vein from the internal jugular vein or subclavian vein insertion site to the superior vena cava.

[0039] To address the issues of low spatial and temporal resolution in X-ray assessment of the position of the infusion port catheter tip, reduce the risk of complications caused by catheter adjustment lag, and minimize patient X-ray radiation exposure, this invention integrates intravascular ultrasound into the infusion port catheter to support the guidewire tip, enabling real-time, high-resolution monitoring of the catheter tip position and surrounding venous vessels.

[0040] The following describes a specific example of the present invention: S1.64 piezoelectric micromechanical transducer elements form a ring-arranged phased array transducer, which, together with a miniature rigid circuit board, forms the ultrasonic transducer structure supporting the guidewire tip inside the infusion port catheter.

[0041] S2. Support wire backbone internally encapsulates 10-channel / 18-channel cable.

[0042] S3. Design the catheter end with a 45° oblique Y-type branch interface, and the running end is an 18-channel male connector interface.

[0043] S4. Design a disposable sterile ultrasonic interface connection cable with male and female connectors and 18-channel cable.

[0044] S5. Design a portable ultrasound imager using synthetic aperture imaging technology; the hardware includes an 18-channel female interface, and at least a commonly used ultrasound instrument operation keyboard, trackball, touch screen, and display screen; frame rate of 30 fps; the ultrasound imaging software should have functions such as frequency, depth, gain, time-compensated gain, dynamic range, and measurement, as well as automatic / manual image orientation calibration (the 12 o'clock direction of the image is the front of the human body); gradually introduce an artificial intelligence system to indicate when the catheter tip reaches the plane.

[0045] S6. Other infusion port kits include: infusion port, catheter lock, straight non-traumatic needle, curved non-traumatic needle, vascular retractor, puncture needle (18G×70mm), vascular sheath (dilatator and tear sheath), tunnel needle, disposable implantable drug delivery device indwelling needle, J-tip guidewire (0.035 inches in diameter), Raulerson spring guidewire injector, 5ml syringe, 10ml syringe, and 20ml syringe.

[0046] S7. Catheter Placement Procedure: 1) Patient in supine position, body surface marked; 2) Heparinize the sterile infusion port catheter and related equipment; 3) Connect the ultrasound imaging device, disposable sterile ultrasound interface cable, and infusion port catheter, and heparinize the infusion port catheter; 4) Routine disinfection and draping, local infiltration anesthesia with 1% cocaine hydrochloride injection; 5) Under ultrasound guidance, puncture the internal jugular vein or subclavian vein, place the guidewire, make a local incision and skin dilation, insert the vascular sheath, and remove the guidewire and vascular sheath core; 6) Under the monitoring of a portable ultrasound imaging device, insert the infusion port catheter into the superior vena cava. 7) From the middle and lower 1 / 3 of the vein to the junction of the superior vena cava and the right atrium, remove the vascular sheath, mark the catheter depth, disconnect the catheter from the portable ultrasound imaging system, and remove the catheter support guidewire; 8) Local infiltration anesthesia with 1% cocaine hydrochloride injection, create a pocket and catheter tunnel, pass the catheter through the catheter tunnel to the pocket incision, and fix the catheter with a vascular retractor; 9) Put a catheter lock on the catheter, trim the catheter end, and securely connect the infusion port; 10) Place the infusion port in the pocket, remove the vascular retractor, suture the wound, and bandage the area; 11) Test the infusion port.

[0047] S8. Training on catheter tip ultrasound cross-sectional images: standard ultrasound cross-sectional image of the middle and lower 1 / 3 of the superior vena cava, quasi-ultrasound cross-sectional image of the junction of the superior vena cava and the right atrium, and ultrasound images of the vein lumen from the internal jugular vein or subclavian vein insertion site to the superior vena cava to show whether there is obvious compression, abnormal course, or obvious thrombosis.

[0048] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Any simple modifications, equivalent changes, and alterations made to the above embodiments based on the technical essence of the present invention shall still fall within the protection scope of the present invention.

Claims

1. A system for real-time intravascular ultrasound puncture monitoring of catheter tip position, characterized in that: It includes: Ultrasonic transducer (1), infusion port catheter (2), Y-type interface (4), disposable sterile ultrasonic interface connection cable (5), portable ultrasonic imager (6); The ultrasonic transducer has a rigid circuit board (11). The infusion port catheter is a three-way valve catheter with an ultrasonic transducer encapsulated at its tip. The infusion port catheter is equipped with a support guidewire at its center. Ten or eighteen cables are led out from the rigid circuit board and encapsulated inside the support guidewire to form a cable-supported guidewire (3). The Y-type interface includes: a running head end (41), a running tail end (42), and a branch end (43); the running head end is a hollow male seat design to adapt to the lumen of the infusion port catheter, including cable support guidewire passing through it; The internal connection at the tail end includes a cable support guidewire, and the external part is an 18-channel male connector, which is compatible with the female connector of a disposable sterile ultrasound interface cable; the branch end is equipped with a heparin cap. The disposable sterile ultrasound interface cable is an 18-channel interface cable with a male connector (51) and a female connector (52) at both ends. The female connector is adapted to the running end of the Y-type interface, and the male connector is adapted to the female connector of the portable ultrasound imager.

2. The system for real-time intravascular ultrasound puncture monitoring of catheter tip position according to claim 1, characterized in that: The ultrasonic transducer is a ring-arranged phased array transducer composed of 64 piezoelectric micromechanical transducer (PMUT) elements, with an outer diameter < 5 Fr, a length < 1 mm, a center frequency of 18 MHz, an axial resolution > 70 μm, a lateral resolution of 80–100 μm, a side resolution of 50 μm, a frame rate of 30 fps, a signal-to-noise ratio (SNR) ≥ 25 dB, and a penetration depth of 25 mm.

3. The system for real-time intravascular ultrasound puncture monitoring of catheter tip position according to claim 2, characterized in that: The three-way valve catheter is 45cm long, with an outer diameter of 7Fr-9Fr, a wall thickness of 0.25mm-0.4mm, and an inner diameter of 1.7-2.5mm. An ultrasound transducer and circuit board are placed within a 10mm range of the catheter tip. The support guidewire is 48cm long and has a diameter of <5Fr.

4. The system for real-time intravascular ultrasound puncture monitoring of catheter tip position according to claim 3, characterized in that: The 10 cables with a diameter of 0.1mm include: 8 signal cables, 1 power cable, and 1 ground cable; the 18 cables with a diameter of 0.1mm include: 16 signal cables, 1 power cable, and 1 ground cable.

5. The system for real-time intravascular ultrasound puncture monitoring of catheter tip position according to claim 4, characterized in that: The disposable sterile ultrasonic interface cable is a cable with a length of 1m or more and 18 channels; the male connector has a pin diameter of 0.5mm per channel, and the female connector has a pin hole diameter of 0.51mm per channel.

6. The system for real-time intravascular ultrasound puncture monitoring of catheter tip position according to claim 5, characterized in that: The Y-type interface features a 45° angled Y-type branch design.

7. The system for real-time intravascular ultrasound puncture monitoring of catheter tip position according to claim 6, characterized in that: The portable ultrasound imager employs synthetic aperture imaging technology, with a lateral resolution of 50-80μm, SNR ≥ 30dB, and a frame rate of 30fps. Each channel of the 18-channel female connector has a pinhole diameter of 0.51mm, and it is compatible with disposable sterile ultrasound interface cables. The interface is marked with power and grounding indicators and includes at least an ultrasound operation keyboard, trackball, touchscreen, and display screen. When paired with ultrasound imaging software, it should have functions for frequency, depth, gain, time-compensated gain, dynamic range, and measurement, as well as automatic or manual image orientation calibration.

8. The system for real-time intravascular ultrasound puncture monitoring of catheter tip position according to claim 7, characterized in that: The conduit wall surface has a tube insertion depth marking, the cable interface has power and grounding markings, and the male and female connector interfaces have power and grounding markings.

9. The method of using the system for real-time intravascular ultrasound puncture monitoring of catheter tip position according to claim 1, characterized in that: It includes the following steps: (1) The patient is in a supine position, and the body surface is marked; (2) The operator opens the sterile infusion port catheter kit, prepares 100ml of 100IU / ml heparinized saline, and uses heparinized infusion port, straight non-traumatic needle, curved non-traumatic needle, puncture needle, vascular sheath, tunnel needle, disposable implantable drug delivery device indwelling needle, and J-type tip guidewire with heparinized saline. (3) The operator connects the male connector of the Y-type interface to the female connector of the disposable sterile ultrasound interface, unscrews the heparin cap of the branch end of the Y-type interface, connects the syringe containing heparinized saline, and injects heparinized saline to heparinize the lumen of the infusion port catheter and the periphery of the support guidewire. (4) The operator opens the portable ultrasound imaging device and connects the disposable sterile ultrasound interface cable to the male connector; (5) Routine disinfection and draping, sterile probe set with linear array ultrasound probe of neck vascular mode color Doppler ultrasound instrument, local infiltration anesthesia with 1% cocaine hydrochloride injection; (6) Install the puncture needle into the tip of the Raulerson spring guidewire syringe. Under the guidance of neck ultrasound, insert the puncture needle into the internal jugular vein or subclavian vein. Aspirate to see blood return. Insert the guidewire through the spring guidewire guide rail of the Raulerson spring guidewire syringe. Withdraw the puncture needle. Make a 2mm incision in the local skin at the guidewire insertion site. Widen the skin locally with a curved clamp. Insert the vascular sheath. Remove the guidewire and vascular sheath core. Insert the catheter along the vascular sheath. Under the monitoring of a portable ultrasound imaging device, place the catheter tip in the middle and lower 1 / 3 of the superior vena cava to the junction of the superior vena cava and the right atrium. At the same time, monitor whether there is obvious compression, abnormal course, or obvious thrombosis in the lumen of the internal jugular vein or subclavian vein to the superior vena cava. Aspirate to see blood to confirm that the catheter lumen is patent. Withdraw the vascular sheath. (7) Adjust the position of the catheter tip again using a portable ultrasound imaging device to the middle and lower 1 / 3 of the superior vena cava to the junction of the superior vena cava and the right atrium. Record the catheter depth scale. Aspirate to confirm that the catheter lumen is patent. Separate the infusion port catheter from the Y-type interface, remove the Y-type interface and the support guidewire, and temporarily fix the infusion port catheter on the drape. (8) Local infiltration anesthesia with 1% cocaine hydrochloride injection was performed. A subcutaneous pouch with a depth of about 1 cm was established 2 cm below the clavicle on the chest wall. The catheter was guided through the neck incision to the chest wall incision using a tunneling needle. The catheter at the puncture point was temporarily fixed with a vascular retractor. The recorded catheter depth was confirmed. The catheter on the tunneling needle was trimmed off. The catheter lock was put on the catheter. (9) Reconfirm the recorded catheter depth scale, precisely trim the excess catheter tip, align the catheter tip and the port handle parallel to each other, and place the catheter tip on the port handle for about 1 / 2. Simultaneously advance the locking buckle and catheter to the edge of the port body, pull the catheter with appropriate force to confirm that the catheter and port handle are firmly connected, insert a non-traumatic needle into the silicone diaphragm of the port body and aspirate to see blood, confirm that the port and catheter system are correctly connected and the lumen is patent; (10) Adjust the position of the infusion port and place it into the bag. Remove the vascular retractor. Suture the bag and puncture point. Wipe and bandage the area. Insert the disposable implantable drug delivery device indwelling needle vertically into the silicone diaphragm under the skin. Install the positive pressure connector and flush the tubing.

10. The method of using the system for real-time intravascular ultrasound puncture monitoring of catheter tip position according to claim 9, characterized in that: The method also includes training in ultrasound cross-sectional imaging of the catheter tip, including: a standard ultrasound cross-sectional image of the middle and lower 1 / 3 of the superior vena cava, a quasi-ultrasound cross-sectional image of the junction of the superior vena cava and the right atrium, and ultrasound images of whether there is clear compression, abnormal course, or clear thrombosis in the lumen of the vein from the internal jugular vein or subclavian vein insertion site to the superior vena cava.

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