CN114425125A

CN114425125A - Bubble detector for interventional catheter and vascular interventional therapy system

Info

Publication number: CN114425125A
Application number: CN202011103447.3A
Authority: CN
Inventors: 宋雷
Original assignee: Fuwai Hospital of CAMS and PUMC
Current assignee: Fuwai Hospital of CAMS and PUMC
Priority date: 2020-10-15
Filing date: 2020-10-15
Publication date: 2022-05-03

Abstract

The invention relates to a bubble detector for an interventional catheter and a vascular interventional therapy system. Specifically, the present invention provides a vascular interventional therapy system, comprising: monitoring a terminal; an interventional catheter; a syringe for delivering fluid through the interventional catheter; and the bubble detector, the bubble detector sets up intervene in the pipe and with monitor terminal connects, the bubble detector includes the body, the body includes input, output and communication end, and the bubble detector is right this is internal the input with fluid between the output carries out the bubble detection, the communication end with monitor terminal communicates.

Description

Bubble detector for interventional catheter and vascular interventional therapy system

Technical Field

The present invention relates to the field of vascular interventional therapy. More particularly, the present invention relates to a bubble detector for an interventional catheter and a vascular interventional therapy system.

Background

The statements in this section merely provide background information related to the present disclosure and may or may not constitute prior art.

The vascular interventional therapy technique is a catheter technique which does not require an operation nor general anesthesia relative to a surgical operation. The vascular interventional therapy technology utilizes an interventional catheter to reach a part to be treated at the far end in a body through a lumen of a blood vessel, and diagnoses and treats the part to be treated at the far end in the body by means of drug administration or placement of medical instruments. For example, an operator (also called an operator, such as a doctor or a medical care provider) can treat a lesion by delivering a light-tight medical instrument to a vascular lesion site by means of X-rays. Many diseases can be diagnosed and treated by vascular interventional therapy, such as coronary heart disease, peripheral vascular disease, congenital heart disease, valvular disease, arrhythmia, etc.

The vascular interventional therapy technology can be applied to the medical fields of angioplasty, angiography, thrombectomy and the like. The vascular interventional therapy technology has the advantages of low trauma to patients, patient pain relief (for example, cardiovascular interventional therapy does not need to open the chest of patients), easy wound healing, low treatment risk, low treatment cost and the like.

Vascular interventional therapy techniques may be aided by medical imaging techniques, such as intravascular imaging techniques using special catheters with ultrasound probes, optical probes attached at their distal ends.

For example, as a branch of vascular interventional therapy technology, cardiovascular interventional therapy is used for the diagnosis and treatment of cardiovascular related diseases. Cardiovascular interventional therapy with the aid of medical imaging techniques and other medical devices, interventional catheters are inserted through body surface vessels and delivered to the site where treatment is needed for diagnosis and treatment of cardiovascular related diseases.

Vascular interventional therapy techniques require the use of interventional catheters, such as angiographic interventional catheters, angioplasty interventional catheters, drug delivery interventional catheters, and the like. Interventional catheters generally have the characteristics of good blood compatibility, good lubricity, good mechanical properties and kink resistance, good processability, no toxicity or harm of materials and the like.

The purpose of using interventional catheters in vascular interventional techniques is to create a passageway through which medical devices (e.g., guidewires, stents, balloons, etc.) or drugs are delivered to a target organ. Coronary heart disease, for example, is a clinical condition in which myocardial insufficiency is caused by coronary luminal narrowing due to atherosclerosis (common symptoms are angina pectoris, myocardial infarction, heart failure, arrhythmia and sudden death). Treatment of coronary heart disease may be by delivering medical devices or drugs to the coronary arteries through interventional catheters.

Air bubbles (air or other gases) must be evacuated from the interventional catheter during the vascular interventional procedure, which is a necessary step during the vascular interventional procedure, since air entering the body can cause serious embolic complications and can even be life-threatening in severe cases. In the case of coronary heart disease interventional therapy, during the delivery of a medical device or drug to the coronary artery via an interventional catheter, an operator (e.g., a physician or a medical staff) may inject a bolus of contrast agent from the end of the catheter in order to visualize the target vessel. This procedure requires venting because air embolism can occur if air bubbles are pushed in, which can even lead to life risks for the patient in severe cases. During treatment, the interventional catheter is filled with blood, or a mixture of contrast agent, saline and blood, but no gas is present.

Although venting is performed before the beginning of the operation of the interventional catheter, in subsequent procedures, such as the introduction or removal of medical devices or the administration of drugs through the interventional catheter, small amounts of air are sometimes drawn into the interventional catheter due to the presence of negative pressure, and even small bubbles can pose a risk of being pushed into the blood vessel (particularly the coronary artery). In the prior art, the operator can only be relied on to perform the operation with extra care, and the operator is required to carefully observe the interventional catheter from time to determine whether air bubbles exist in the interventional catheter. Therefore, the prior art methods and devices are extremely demanding on the operator (e.g., a doctor or a medical care provider) and prone to visual and mental fatigue that affects the surgical procedure. In addition, the following disadvantages exist in the prior art: the visual blind area of the human eye observation, the low inspection precision, and the high requirements for the operator's service ability (for example, inexperienced operators sometimes have difficulty finding bubbles or may inadvertently bring bubbles in during operation).

Moreover, even with the extra care in the treatment process, a certain proportion of air embolism complications inevitably occur, which can have varying degrees of adverse consequences for the patient. In the prior art, a bubble detector and an alarm device for the vascular interventional therapy technology are not available.

It is therefore desirable to provide a bubble detector for an interventional catheter and a vascular interventional therapy system which automatically detects bubbles and alarms so that even inexperienced operators can use them normally.

Disclosure of Invention

Further areas of applicability of the present invention will become apparent from the description provided herein. It should be understood that the description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.

The bubble detector for interventional catheters and the vascular interventional therapy system according to the present invention solve the drawbacks of the prior art.

According to a preferred embodiment of the present invention, there is provided a vascular interventional therapy system, including: monitoring a terminal; an interventional catheter; a syringe for delivering fluid through the interventional catheter; and the bubble detector, the bubble detector sets up intervene in the pipe and with monitor terminal connects, the bubble detector includes the body, the body includes input, output and communication end, and the bubble detector is right this is internal the input with fluid between the output carries out the bubble detection, the communication end with monitor terminal communicates.

According to a preferred embodiment of the present invention, a communication plate is provided between the bubble detector and the syringe, a head end of the communicator is connected to the bubble detector, a tail end of the communicator is connected to the syringe, and the communication plate has a plurality of manifolds, one of which communicates with the monitoring terminal for monitoring pressure.

According to the preferred embodiment of the invention, the communication plate is a four-way four, wherein the four-way four.

According to the preferred embodiment of the invention, the communication plate is a triple tee, three manifolds are respectively arranged on the triple tee, the first manifold is connected with the pressure monitor, the second manifold is connected with saline, and the third manifold is connected with contrast medium.

According to a preferred embodiment of the present invention, a first hemostatic valve is disposed between the bubble detector and the communicating plate, the first hemostatic valve having three ports, wherein a first port of the first hemostatic valve is connected to the bubble detector, a second port of the first hemostatic valve is connected to the communicating plate, and a third port of the first hemostatic valve is connected to a balloon catheter for accessing a medical device.

According to a preferred embodiment of the present invention, further comprising a second hemostatic valve having three ports, wherein a first port of the second hemostatic valve is connected to a third port of the first hemostatic valve via a balloon catheter, a second port of the second hemostatic valve is connected to a pressure pump, and a medical device is delivered through the third port of the second hemostatic valve.

According to a preferred embodiment of the present invention, the bubble detector has a closed detection chamber therein for detecting whether bubbles exist in the fluid in the detection chamber, one end of the detection chamber is communicated with the input end of the bubble detector for receiving the fluid from the intervention conduit of the input end, and the other end of the detection chamber is communicated with the output end of the bubble detector for delivering the fluid to the intervention conduit of the output end.

According to a preferred embodiment of the invention, the interventional catheter enters from an input end of the bubble detector, extends through the bubble detector and protrudes from an output end of the bubble detector.

According to a preferred embodiment of the present invention, the bubble detector comprises a light source and a light sensor, the light source emits light to the light sensor, the light path passes through the interventional catheter or the detection chamber, and when no bubble exists, the light intensity received by the light sensor is a threshold value; when a bubble is present, the light intensity received by the light sensor is greater than a threshold value.

According to a preferred embodiment of the present invention, the bubble detector comprises a light source and a light sensor, the light source emits light to the light sensor, the light path passes through the interventional catheter or the detection chamber, and when no bubble exists, the light transmittance received by the light sensor is a threshold; when a bubble is present, the light transmittance received by the light sensor is greater than a threshold value.

According to a preferred embodiment of the invention, the bubble detector comprises a light source and a light sensor, wherein light from the light source is incident at an angle into the interventional catheter or detection chamber and refracted, and when no bubble is present, the refracted light exits in a first direction; when bubbles exist, the refracted light rays are emitted along a second direction, the first direction is different from the second direction, and the light sensor is arranged in the second direction to receive the light rays.

According to a preferred embodiment of the invention, the bubble detector has an ultrasound transmitter and an ultrasound receiver, wherein the ultrasound transmitter transmits an ultrasound signal to the ultrasound receiver, the ultrasound signal passing through the interventional catheter or the detection chamber, the ultrasound signal received by the ultrasound receiver being a threshold value when no bubble is present; when a bubble is present, the ultrasonic signal received by the ultrasonic receiver is below a threshold.

According to a preferred embodiment of the present invention, the bubble detector may further comprise a shut-off valve, and the monitoring terminal alarms and communicates to the bubble detector to shut off the shut-off valve when the presence of a bubble is detected, thereby shutting off the fluid containing the bubble.

According to a preferred embodiment of the present invention, there is provided a bubble detector for an interventional catheter, the bubble detector being arranged in the interventional catheter and connected to a monitoring terminal, the bubble detector comprising a body including an input end, an output end and a communication end, the bubble detector performing bubble detection on a fluid within the body between the input end and the output end, the communication end being in communication with the monitoring terminal.

Drawings

The drawings described herein are for illustration purposes only and are not intended to limit the scope of the present disclosure in any way.

FIG. 1 is a schematic view of an interventional catheter suite

Fig. 2 shows a vascular interventional therapy system.

Fig. 3 shows a perspective view of a hemostatic valve.

Fig. 4 shows a vascular interventional therapy system.

Fig. 5 shows a vascular interventional therapy system.

FIG. 6 is a schematic diagram of a bubble detector.

FIG. 7 is a perspective view of a bubble detector.

Figure 8 shows the bubble detector in an unassembled state.

FIG. 9 is a schematic view of one embodiment of a bubble detector.

FIG. 10 is a schematic view of one embodiment of a bubble detector.

Fig. 11 shows schematically the communication of the bubble detector with the monitoring terminal.

FIG. 12 is a schematic view of one embodiment of a bubble detector.

FIG. 13 is a schematic view of an embodiment of a bubble detector in which there are no bubbles within the interventional catheter.

Figure 14 is a schematic diagram of one embodiment of a bubble detector in which a bubble is present within the interventional catheter.

Figure 15 shows various cutaway shapes of the detection chamber.

FIG. 16 is a schematic view of one embodiment of a bubble detector.

Detailed Description

The following description of the variations is merely exemplary in nature and is in no way intended to limit the scope of the invention, its application, or uses.

Figure 1 schematically shows an interventional catheter chamber. As shown, the system used in the interventional catheter suite may be divided into a fluid-filled portion and an electronics portion, which are schematically separated by a dashed line in the figure. The fluid-filled portion of the system comprises a catheter system, wherein the catheter system may comprise a catheter (interventional catheter) and a manifold, at least a portion of the catheter being inserted into the body of the patient, for example into a cardiac site of the patient, as shown in fig. 1. The electronics portion of the system includes a sensor which is connected to the catheter, receives patient body parameter data, and transmits the parameter data as electrical signals to a computer with a display, where the parameter data can be printed out by a printer connected to the computer.

Fig. 2 shows a vascular interventional therapy system which may be used for balloon dilatation, stenting and other procedures in vascular interventional therapy techniques.

The left side of fig. 2 (the area outside the two dashed boxes) shows the guidewire, balloon, interventional catheter and arterial sheath. In use, the arterial sheath is placed into the artery to provide access to other vascular interventional devices. The arterial sheath may have a self-sealing feature to prevent backflow of arterial blood out of the body. An interventional catheter is delivered through an arterial sheath to the site to be treated. A guidewire is fed along the interventional catheter and a balloon may then be fed along the guidewire.

The area within the dashed box on the upper right side of figure 2 shows the hemostasis valve, extension tube, communication plate and syringe. The haemostatic valve shown in fig. 2 is a haemostatic valve in a Y-shape, which is also referred to as a Y-valve, although other forms of haemostatic valve may be used. In interventional procedures, a guidewire, interventional catheter, interventional device, etc. needs to be placed in a blood vessel. Due to the presence of blood pressure, blood within the vessel may travel along the interventional catheter and flow out of the patient. The provision of a haemostatic valve may restrict blood flow and may be used to vent air bubbles in the event they are found.

With reference to fig. 3 and with continuing reference to fig. 2, fig. 3 shows a perspective view of a hemostatic valve 100 having three ports, wherein a first port 110 is connected to an arterial sheath, and a bubble detector (not shown in fig. 2 and 3) may be disposed between the first port 110 and the arterial sheath, wherein the first port is connected to an input of the bubble detector, the bubble detector being described in detail below; the second port 120 is connected to the head end 200 of the communication plate via an extension pipe; the third port 130 may be connected to a balloon catheter for accessing a medical device such as a guidewire, balloon, stent, etc. The access plate is a manifold device that is used as a non-invasive aid to vascular interventional procedures.

In the embodiment shown in fig. 2, the communication plate is a four-way joint, the head end of the four-way joint is connected to one end of the extension tube, and the other end of the extension tube is connected to the second port 120 of the hemostatic valve. The head end 200 of the communicating plate is connected with the hemostatic valve and the tail end 250 of the communicating plate is connected with the injector. The injector may be a three-ring injector, which may be used to inject fluids such as saline or contrast media. The four-way junction shown in fig. 2 has four manifolds, a first manifold 210 connected to the arterial pressure monitor, a second manifold 220 connected to the contrast agent, a third manifold 230 connected to the saline, and a fourth manifold 240 for waste removal.

Other types of communication plates, such as triple tees, etc., may also be used. For example, fig. 4 shows a triple tee and syringe for a vascular interventional therapy system. Three manifolds are respectively arranged on the triple tee, the first manifold 410 is connected with a pressure monitor, the second manifold 420 is connected with saline, and the third manifold 430 is connected with contrast medium. The head end 400 of the triple tee is connected to one end of an extension tube, the other end of which is connected to a second port of a hemostasis valve (not shown). A syringe may be used to inject saline, contrast media, or other fluid, and the syringe is connected to the trailing end 440 of the triple tee.

Referring back to fig. 2, the third port 130 of the hemostasis valve may be connected to another hemostasis valve 300 by a balloon catheter. The other hemostasis valve 300 is also a Y-shaped hemostasis valve having three ports, wherein the first port 310 of the other hemostasis valve 300 is connected to the third port 130 of the hemostasis valve 100 through a balloon catheter, the second port 320 of the other hemostasis valve 300 is connected to a pressure pump through another extension tube, and a medical device such as a guide wire can be fed through the third port 330 of the other hemostasis valve 300.

During an interventional procedure, an arterial sheath is used to puncture an artery, such as the radial or femoral artery, and an interventional catheter is delivered into the patient via the arterial sheath. For example, in the treatment of coronary heart disease using vascular interventional techniques, an angiographic interventional catheter is advanced into either the left or right coronary artery and a bolus of contrast agent is administered for coronary angiography. The steering tool is used for pushing the guide wire, for example, as shown in fig. 2, the steering tool pushes the guide wire from the third port 330 of another hemostatic valve 300, passes through the balloon catheter to enter the third port of the hemostatic valve 100, then sends the guide wire to the site to be treated (such as a coronary stenosis site) through the interventional catheter, and sends the balloon along the guide wire to the coronary stenosis site, where the blood vessel is hardened and narrowed due to plaque, which may cause complete blockage of the artery. The balloon is inflated by pressurizing with a pressure pump to compress the stenotic plaque, enlarge the lumen and allow blood flow to be unobstructed. In addition, the stent can be implanted, namely, the stent is delivered to a vascular lesion, the balloon which is arranged in advance is expanded to open an arterial blood vessel, the medical device is withdrawn, and the stent is permanently left in the lesion blood vessel to keep the lumen unobstructed, improve the myocardial blood flow, relieve the chest pain and other symptoms.

Referring to fig. 5, a vascular interventional therapy system 1 according to one embodiment of the invention is shown. The vascular interventional therapy system 1 comprises a monitoring terminal 20, an interventional catheter 21, a bubble detector 22 and a syringe 23. The monitoring terminal 20 may be a catheterization laboratory electro-cardio-blood pressure monitoring terminal that may be used to monitor and display a patient's electro-cardiogram and blood pressure, and/or other body parameters. The monitoring terminal may also monitor various devices within the conduit chamber, for example the monitoring terminal may monitor a bubble detector and a communication board. The monitoring terminal may also be used as a controller for various devices within the catheter chamber, for example the monitoring terminal may be used to control a bubble detector. The monitoring terminal may also act as an alarm to alert when a bubble is detected. Preferably, the monitoring terminal may be in the form of a display. In addition, the monitoring terminal may also be connected to a printer or other device. In summary, the monitoring terminal may be used for monitoring a patient's body parameters, monitoring the operational state of the vascular interventional therapy system, controlling the operation of the vascular interventional therapy system, alarming upon detection of bubbles, etc. The injector 23 is preferably a controllable injector that may be used to deliver a medicament or the like into a patient through an interventional catheter.

The interventional catheter 21 is used to provide a stable operation platform for other medical instruments during treatment (surgery), plays a role in guidance, and can be used for imaging and measuring human body parameters such as blood pressure.

The venting process at the beginning of the interventional catheter procedure requires: (1) before the catheter enters the body, the catheter is flushed by normal saline containing heparin, and the air in the catheter is emptied as much as possible; (2) after the catheter is sent into the body, a hemostatic valve is opened (connected to the tail end of the interventional catheter), and tiny bubbles remained in the catheter are discharged by utilizing the natural pressure backflow of blood.

A bubble detector 22 may be disposed in the interventional catheter 21 and connected to the monitoring terminal 20. Specifically, the bubble detector 22 may have a plurality of input/output terminals, wherein one input terminal of the bubble detector 22 may be connected to a syringe 23 (e.g., a controllable syringe), and the syringe 23 may be controlled by the monitoring terminal 20 to deliver the medicament or other substances to the interventional catheter 21 through the bubble detector 22, and finally to deliver the medicament or other substances to the patient. Preferably, a communication plate, which may be a four-way or three-way connection, may be provided between the bubble detector and the injector. The communication plates may have a plurality of manifolds, one of the manifolds may be in communication with a monitoring terminal for monitoring pressure, a head end of the communication device may be connected to the bubble detector, and a tail end of the communication device may be connected to the syringe. Preferably, a hemostasis valve (not shown in fig. 5) may be provided between the bubble probe and the communication plate. Preferably, the bubble detector may be arranged between the arterial sheath and the hemostasis valve, i.e. the bubble detector is arranged in a section of the interventional catheter between the arterial sheath and the hemostasis valve, the first port of the hemostasis valve being connected to the input of the bubble detector. Alternatively, the bubble detector may be disposed between the arterial sheath and the communicating plate (not shown in fig. 5). Preferably, more than one bubble detector may be provided at a plurality of suitable locations.

The bubble detector 22 may also be connected to other input sources, or the bubble detector 22 may have additional inputs for inputting into the interventional catheter, the specific input source depending on the type of procedure, such as contrast, dilation, implantation, resection, etc.

FIG. 6 is a schematic view of a bubble probe having a fluid inlet and a fluid outlet, into and out of which a fluid (e.g., blood) flows for detection in the bubble probe. The bubble detector is communicated with the monitoring terminal through a cable, and alarms through the monitoring terminal when detecting bubbles.

Figure 7 shows a perspective view of a bubble detector which may have a box-like body with an input, an output and a communication terminal. The input end is used for enabling the fluid to flow in, flow through the body of the bubble detector and flow out from the output end. The communication terminal is used for communicating with the monitoring terminal, transmitting signals to the monitoring terminal to report the condition of bubble monitoring and receiving signals from the monitoring terminal to take action. FIG. 8 illustrates the bubble probe in an unassembled state, showing the bubble probe body, leads, fasteners, etc.

Fig. 9 schematically illustrates an embodiment of a bubble detector, wherein an input end of the bubble detector is connected to a segment of an interventional catheter that inputs a fluid (e.g., blood) into the bubble detector, the bubble detector having a sealed detection chamber therein for detecting the presence of bubbles in the fluid in the detection chamber, one end of the detection chamber being in communication with the input end of the bubble detector for receiving the fluid from the interventional catheter at the input end, and the other end of the detection chamber being in communication with an output end of the bubble detector for delivering the fluid to the interventional catheter at the output end. In other words, the interventional catheter is divided into two sections, the bubble detector is inserted into the two sections of interventional catheters, the detection chambers of the bubble detector are respectively connected with the two sections of interventional catheters to form sealed fluid channels with communicated interiors, and the bubble detector detects fluid in the detection chambers to determine whether bubbles exist.

Fig. 10 shows a further embodiment of a bubble detector in a schematic view, wherein an interventional catheter is passed through the bubble detector, i.e. the interventional catheter enters from one end (input end) of the bubble detector, extends through the bubble detector and protrudes from the other end (output end) of the bubble detector. In other words, the interventional catheter remains in a complete segment (not disconnected by the bubble detector) through which it passes, and the bubble detector detects the segment of the interventional catheter passing therethrough to determine whether a bubble is present.

Fig. 11 shows schematically the communication of the bubble detector with the monitoring terminal. In the process of blood vessel interventional therapy, the communication end of the bubble detector is communicated with a monitoring terminal (such as a catheter room electrocardio-blood pressure monitoring terminal) so as to detect bubbles in real time in the operation process and realize the function of automatic alarm under the condition of detecting the bubbles. Meanwhile, the monitoring terminal can also control the bubble detector.

Referring back to fig. 5, as mentioned above, air bubbles in the interventional catheter must be detected efficiently and in time during the vascular interventional procedure to ensure the health and life safety of the patient. Thus, the present invention provides a bubble detector 22 in interventional catheter 21 for detecting the presence of bubbles in real time. The communication end of the bubble detector 22 may be in communication with the monitoring terminal 20 for alarming via the monitoring terminal 20 upon detection of the presence of a bubble, and the alarm device may be an audible alarm device alone or an optical alarm device, or a combination thereof. For example, the alarm may be a beep or a flashing light.

Referring to FIG. 12, a bubble detector according to one embodiment of the present invention is shown. The bubble detector may be a light intensity based bubble detector. The bubble detector can comprise an upper shell and a lower shell, the two shells form a body of the bubble detector after being assembled, a light source and a light sensor can be arranged in the body, the bubble detector can further comprise a battery to supply power for components in the bubble detector, or the bubble detector can be powered by alternating current. The light source emits light to the light sensor, with the light path passing through the interventional catheter (or detection chamber). The light may be visible light or invisible light, such as ultraviolet light, infrared light, far infrared light, and the like. The light sensor may be used to detect light intensity, which changes when the fluid in the interventional catheter changes. For example, when no bubble is present, the light intensity received by the light sensor is a threshold value, i.e., a normal value. When bubbles pass through, light emitted by the light source penetrates through the bubbles and is received by the light sensor, and because the light intensity after the fluid and the gas penetrate through are different, the light intensity obtained when the bubbles exist is different from the threshold value, for example, the light intensity obtained when the bubbles exist is larger than the threshold value. The single chip microcomputer can be used for capturing the numerical value of the optical sensor in real time and judging the numerical value through a preset algorithm so as to determine whether bubbles exist. The bubble detector may further comprise an electronic processing unit for processing and analyzing the data of the light sensor to determine whether a bubble is present. Alternatively, the bubble detector may only transmit data to the monitoring terminal, and the data is stored, processed and judged by the processor of the monitoring terminal.

With continued reference to FIG. 12, in another embodiment of the present invention, the bubble detector may be a transmittance-based bubble detector. The bubble detector can comprise an upper shell and a lower shell, the two shells form a body of the bubble detector after being assembled, a light source and a light sensor can be arranged in the body, the bubble detector can further comprise a battery to supply power for components in the bubble detector, or the bubble detector can be powered by alternating current. The bubble detector can detect whether bubbles exist in the interventional catheter (or detection chamber) by using the light transmittance. For example, if the light transmittance is a normal value (threshold) when no bubble is present in the interventional catheter (or detection chamber), and if the light transmittance is above the normal value (threshold) when a bubble is present in the interventional catheter (or detection chamber), it may be determined that a bubble is present that causes the light transmittance to exceed the threshold. And the bubble detector communicated with the monitoring terminal gives an alarm through the monitoring terminal.

Fig. 12 shows an embodiment in which the interventional catheter extends through a bubble detector, which may also be adapted to embodiments comprising a detection chamber. In a preferred embodiment, multiple light sources and multiple light sensors may be provided within the bubble detector to improve detection accuracy.

Referring to FIG. 13, a bubble detector based on light refraction is shown according to one embodiment of the present invention. Note that fig. 13 is a schematic diagram showing the refraction of light rays, and does not represent that it is equivalent to an actual light path. The bubble detector can comprise an upper shell and a lower shell, the two shells form a body of the bubble detector after being assembled, a light source and a light sensor can be arranged in the body, the bubble detector can also comprise a battery to supply power for components in the bubble detector, or the bubble detector can be powered by alternating current.

The bubble detector can judge whether bubbles exist in the interventional catheter or not by utilizing refraction of light. Specifically, the bubble detector includes a light source and a light sensor. The light emitted from the light source may be visible light or invisible light, such as ultraviolet light, infrared light, far infrared light, etc. Light from the light source is directed into the interventional catheter at an angle, for example as shown in fig. 13, and in a cross section perpendicular to the direction of extension of the interventional catheter (i.e. perpendicular to the longitudinal axis of the interventional catheter), the light rays are at an angle of 15 to 75 degrees, preferably at an angle of 30 to 60 degrees, most preferably at an angle of 45 degrees, to the perpendicular axis. In another embodiment the light may be at an angle of 15 to 75 degrees, preferably 30 to 60 degrees, most preferably 45 degrees to the extension of the interventional catheter (not shown), i.e. the light source and the light are in the same horizontal plane as the interventional catheter. The light rays are refracted after irradiating the interventional catheter. When there are no bubbles in the interventional catheter, the refracted light will exit the interventional catheter in a first direction where no light sensor receives light, as shown in fig. 13, where the hatched lines within the circles indicate that the interventional catheter is filled with fluid and no bubbles.

Fig. 14 shows the presence of a bubble within the interventional catheter, in which case refracted light will emerge from the interventional catheter in a second direction, the first and second directions being different. And a light sensor is arranged in the second direction to receive the light. When the light sensor receives the light signal in the second direction, it can be determined that there is a bubble that causes the light to be refracted in the second direction. And the bubble detector communicated with the monitoring terminal gives an alarm through the monitoring terminal.

The bubble detector shown in fig. 13 and 14 may be adapted for embodiments in which the interventional catheter extends through the bubble detector, as well as embodiments that include a detection chamber. In a preferred embodiment, multiple light sources and multiple light sensors may be provided within the bubble detector to improve detection accuracy.

In embodiments comprising a detection chamber, it is preferred that the detection chamber has various cross-sectional shapes suitable for refraction of light, such as triangular, trapezoidal, diamond-shaped, rectangular, etc., in a cross-section perpendicular to the longitudinal axis of the detection chamber (i.e. perpendicular to the extension of the detection chamber). These cross-sectional shapes enable a clearer and more easily distinguishable light path to be formed when light is irradiated thereon to improve detection accuracy. Figure 15 shows various cutaway shapes of the detection chamber.

FIG. 16 illustrates a bubble detector according to an embodiment of the present invention. The bubble detector may be an ultrasound based bubble detector. The bubble detector can comprise an upper shell and a lower shell, the two shells form a body of the bubble detector after being assembled, the body can comprise an ultrasonic transmitter and an ultrasonic receiver, the bubble detector can also comprise a battery to supply power for components in the bubble detector, or the bubble detector can use alternating current to supply power. The bubble detector can judge whether bubbles exist in the interventional catheter by utilizing the difference of the transmission efficiency of the ultrasonic waves in different media. The bubble detector may have an ultrasonic transmitter and an ultrasonic receiver. The ultrasound transmitter transmits an ultrasound signal to the ultrasound receiver, which passes through the interventional catheter (or probe lumen). For example, when there is no bubble in the interventional catheter (or detection chamber), the transmitted signal is hardly attenuated, i.e. is a normal value (threshold), when there is a bubble in the interventional catheter (or detection chamber), the transmitted signal is attenuated, and below the normal value (threshold), it can be determined that there is a bubble causing attenuation of the transmitted signal. And the bubble detector communicated with the monitoring terminal gives an alarm through the monitoring terminal.

In another embodiment, the bubble detector may further comprise a built-in printed circuit board on which the microcontroller is integrally arranged. In operation, the ultrasound transmitter emits an ultrasound signal that is transmitted through the interventional catheter (or probe chamber) and the ultrasound receiver receives the ultrasound signal, thereby forming a loop. When there is no bubble in the interventional catheter (or detection chamber), the ultrasound receiver receives normal ultrasound signals; the ultrasound receiver receives an abnormal ultrasound signal when a bubble is present within the interventional catheter (or probe chamber). The ultrasonic loop detects the abnormality and sends a signal to the microcontroller, the microcontroller can give an alarm to the monitoring terminal, and the microcontroller can also stop the fluid delivery in the interventional catheter.

Fig. 16 shows an embodiment in which the interventional catheter extends through a bubble detector, which may also be adapted to embodiments comprising a detection chamber. In a preferred embodiment, multiple ultrasonic transmitters and multiple ultrasonic receivers may be provided within the bubble detector to improve detection accuracy.

In a preferred embodiment, the bubble detector may further include a power switch and a power indicator light to indicate the turning on and off of the power. The bubble detector may further comprise a power cord and a power plug. The bubble detector may further comprise a viewing window, preferably made of a transparent material, for viewing the conditions inside the bubble detector. The bubble detector may also include notches for receiving screws and nuts for fastening different parts of the bubble detector together, such as the upper and lower housings.

Of course, other devices and methods for detecting bubbles may be used.

When the bubble detector detects bubbles, the monitoring terminal automatically alarms. Additional alarm means may also be provided in communication with the bubble detector to automatically alarm when a bubble is detected. The alarm may inform the operator of the presence of air bubbles in the interventional catheter. The operator can pause the operation, open the hemostatic valve, and blood will automatically flow out of the catheter due to the pressure, thereby bringing air bubbles out.

Preferably, the bubble detector may further comprise a shut-off valve, and the monitoring terminal (or alarm device) alarms and communicates to the bubble detector to shut-off the shut-off valve when the presence of a bubble in the interventional catheter is detected, thereby shutting off the fluid containing the bubble. That is, the shut-off valve automatically shuts off when a bubble is detected, and fluid can no longer be injected into the blood vessel. The shut-off valve may be provided with a switch to control the activation of the shut-off valve as required. Prior to the interventional catheter entering the patient, there is a bubble-purging procedure in which the operator actively purges all residual gas in the catheter. During this time, the shut-off valve and the monitoring terminal (or the alarm device) may be closed. After the gas in the conduit is completely exhausted, the shut-off valve and the monitoring terminal (or alarm device) may be opened.

In a preferred embodiment, a side hole may be formed in the path of the bubble detection means, and may be opened when the gas needs to be discharged, so that the gas bubbles can be discharged from the side hole.

The bubble detector of the present invention can be used in all interventional catheter procedures, including vascular interventions, peripheral arterial interventions such as carotid arteries, renal arteries, lower extremity arterial interventions, interventional embolization of tumors, and the like. That is, the bubble detecting device of the present invention can be used in an interventional treatment requiring the use of a catheter.

The description of the invention is merely exemplary in nature and variations that do not depart from the gist of the invention are intended to be within the scope of the invention. Such variations are not to be regarded as a departure from the spirit and scope of the invention.

Claims

1. A vascular interventional therapy system, characterized in that it comprises:

monitoring a terminal;

an interventional catheter;

a syringe for delivering fluid through the interventional catheter; and

the bubble detector, the bubble detector sets up intervene in the pipe and with monitor terminal connects, the bubble detector includes the body, the body includes input, output and communication end, and the bubble detector is right this is internal the input with fluid between the output carries out the bubble detection, the communication end with monitor terminal intercommunication.

2. The vessel interventional therapy system of claim 1, wherein a communication plate is disposed between the bubble detector and the syringe, a head end of the communicator is connected to the bubble detector, a tail end of the communicator is connected to the syringe, and the communication plate has a plurality of manifolds, one of which communicates with the monitoring terminal for monitoring pressure.

3. The vessel interventional therapy system of claim 2, wherein the communication plate is a four-way four, the four-way.

4. The vessel interventional therapy system of claim 2, wherein the connecting plate is a triple tee, and three manifolds are respectively disposed on the triple tee, wherein a first manifold is connected to the pressure monitor, a second manifold is connected to saline, and a third manifold is connected to the contrast agent.

5. The vessel interventional therapy system of claim 2, wherein a first hemostasis valve is disposed between the bubble detector and the communication plate, the first hemostasis valve having three ports, wherein a first port of the first hemostasis valve is connected to the bubble detector, a second port of the first hemostasis valve is connected to the communication plate, and a third port of the first hemostasis valve is connected to a balloon catheter for accessing a medical instrument.

6. The vascular interventional therapy system of claim 5, further comprising a second hemostasis valve having three ports, wherein a first port of the second hemostasis valve is connected to a third port of the first hemostasis valve via a balloon catheter, a second port of the second hemostasis valve is connected to a pressure pump, and a medical device is delivered through the third port of the second hemostasis valve.

7. The vessel interventional therapy system of claim 1, wherein the bubble detector has a closed detection chamber therein for detecting whether a bubble is present in the fluid in the detection chamber, one end of the detection chamber is in communication with an input end of the bubble detector for receiving the fluid from an interventional catheter at the input end, and the other end of the detection chamber is in communication with an output end of the bubble detector for delivering the fluid to an interventional catheter at the output end.

8. The vascular interventional therapy system of claim 1, wherein the interventional catheter enters from an input end of the bubble detector, extends through the bubble detector, and exits from an output end of the bubble detector.

9. The vessel interventional therapy system according to claim 7 or 8, wherein the bubble detector comprises a light source and a light sensor, the light source emits light to the light sensor, the light path passes through the interventional catheter or the detection chamber, and when no bubble exists, the light intensity received by the light sensor is a threshold value; when a bubble is present, the light intensity received by the light sensor is greater than a threshold value.

10. The vessel interventional therapy system according to claim 7 or 8, wherein the bubble detector comprises a light source and a light sensor, the light source emits light to the light sensor, the light path passes through the interventional catheter or the detection chamber, and the light transmittance received by the light sensor is a threshold value when no bubble exists; when a bubble is present, the light transmittance received by the light sensor is greater than a threshold value.

11. Vessel interventional therapy system according to claim 7 or 8, characterized in that the bubble detector comprises a light source and a light sensor, wherein light from the light source is irradiated into the interventional catheter or the detection chamber at an angle and refracted, and when no bubble is present, the refracted light is emitted in a first direction; when bubbles exist, the refracted light rays are emitted along a second direction, the first direction is different from the second direction, and the light sensor is arranged in the second direction to receive the light rays.

12. Vessel interventional therapy system according to claim 7 or 8, characterized in that the bubble detector has an ultrasound transmitter and an ultrasound receiver, wherein the ultrasound transmitter transmits an ultrasound signal to the ultrasound receiver, the ultrasound signal passing through the interventional catheter or the detection chamber, the ultrasound signal received by the ultrasound receiver being a threshold value when no bubble is present; when a bubble is present, the ultrasonic signal received by the ultrasonic receiver is below a threshold.

13. The vessel interventional therapy system of claim 1, wherein the bubble detector further comprises a shut-off valve, the monitoring terminal alarming and communicating the bubble detector to shut off the shut-off valve when the presence of a bubble is detected, thereby blocking the fluid containing the bubble.

14. The utility model provides a bubble detector for interveneeing pipe which characterized in that, bubble detector sets up intervene in the pipe and be connected with monitor terminal, bubble detector includes the body, the body includes input, output and communication end, and bubble detector is right this is internal the input with fluid between the output carries out bubble detection, the communication end with monitor terminal communicates.

15. The vessel interventional therapy system of claim 14, wherein the bubble detector has a closed detection chamber therein for detecting whether a bubble is present in the fluid in the detection chamber, one end of the detection chamber is in communication with an input end of the bubble detector for receiving the fluid from the interventional catheter at the input end, and the other end of the detection chamber is in communication with an output end of the bubble detector for delivering the fluid to the interventional catheter at the output end.

16. The vascular interventional therapy system of claim 14, wherein the interventional catheter enters from an input end of the bubble detector, extends through the bubble detector, and exits from an output end of the bubble detector.

17. The vessel interventional therapy system according to claim 15 or 16, wherein the bubble detector comprises a light source and a light sensor, the light source emits light to the light sensor, the light path passes through the interventional catheter or the detection chamber, and when no bubble exists, the light intensity received by the light sensor is a threshold value; when a bubble is present, the light intensity received by the light sensor is greater than a threshold value.

18. The vessel interventional therapy system according to claim 15 or 16, wherein the bubble detector comprises a light source and a light sensor, the light source emits light to the light sensor, the light path passes through the interventional catheter or the detection chamber, and the light transmittance received by the light sensor is a threshold value when no bubble exists; when a bubble is present, the light transmittance received by the light sensor is greater than a threshold value.

19. The vessel interventional therapy system of claim 15 or 16, wherein the bubble detector comprises a light source and a light sensor, wherein light from the light source is incident into the interventional catheter or the detection chamber at an angle and refracted, and when no bubble is present, the refracted light is emitted in a first direction; when bubbles exist, the refracted light rays are emitted along a second direction, the first direction is different from the second direction, and the light sensor is arranged in the second direction to receive the light rays.

20. Vascular interventional therapy system according to claim 15 or 16, characterized in that the bubble detector has an ultrasound transmitter and an ultrasound receiver, wherein the ultrasound transmitter transmits an ultrasound signal to the ultrasound receiver, which ultrasound signal passes through an interventional catheter or a detection chamber, the ultrasound signal received by the ultrasound receiver being a threshold value when no bubble is present; when a bubble is present, the ultrasonic signal received by the ultrasonic receiver is below a threshold.

21. The vessel interventional therapy system of claim 14, wherein the bubble detector further comprises a shut-off valve, the monitoring terminal alarming and communicating the bubble detector to shut-off the shut-off valve when the presence of a bubble is detected, thereby blocking the fluid containing the bubble.