WO2016011602A1 - New type of balloon catheter used for ultrasound-guided percutaneous pulmonary valve balloon angioplasty - Google Patents

Abstract

Provided is a new type of balloon catheter used for ultrasound-guided percutaneous pulmonary valve balloon angioplasty, belonging to the field of interventional treatment. The balloon catheter comprises a catheter and three balloons arranged on the outer side of said catheter; the balloons are sleeved on said catheter, achieving a seal; the three balloons are, in sequence, a guide balloon (1), a dilation balloon (2), and a positioning balloon (3); inside the catheter are provided four separate passageways arranged in parallel along the length of the catheter; each of the balloons corresponds to a unique seal and is sleeved on the outer side of the opening of each passageway located at the side wall, forming expandable sealed spaces which are separate from each other and which do not interfere with each other. The guide balloon expands after inflation, and its cross-sectional area increases significantly in comparison with the cross-sectional area of the catheter; at that time, an ultrasound probe can easily detect the position of the balloon, facilitating the determination of the position of the top end of the catheter. Therefore, when using the above balloon catheter structure to perform angioplasty, ultrasound can be effectively used for guidance, preventing the harm caused by using radiation for guidance.

Description

 BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to the field of interventional therapy, and more particularly to a novel balloon catheter for ultrasound guided percutaneous pulmonary balloon balloon dilatation. Background technique

 The ercutaneous balloon pulmonary valvulopla STy (PBPV) is an early treatment for interventional congenital heart disease. The first successful report was 1982. Domestically, it also started in the late 1980s. At present, it has accumulated more mature experience and become the first choice for simple pulmonary stenosis. At present, percutaneous balloon pulmonary valvuloplasty requires the use of radiation and contrast agents, which not only has a greater risk of radiation damage, but also affects the function of organs such as bone marrow, genitals and thyroid, and the risk of causing allergies and renal failure in contrast agents. . Therefore, it is intended to develop a safe surgical method and adapting device based on ultrasound to reduce injury and medical expenses.

However, since ultrasound is a scan of a slice and a slice, unlike radiation, which is a projection detection, the biggest difficulty when ultrasound is the only guide is that ultrasound cannot accurately determine the position of the catheter tip in the heart like radiation. It is difficult to accurately locate the surgical procedure. SUMMARY OF THE INVENTION To overcome the above problems, the present invention provides an ultrasound-guided percutaneous pulmonary balloon balloon dilatation and a novel balloon catheter suitable for ultrasound-guided percutaneous pulmonary balloon balloon dilatation. In order to solve the above technical problems, the present invention provides a novel balloon catheter for ultrasound guided percutaneous pulmonary balloon balloon dilatation, comprising a catheter and a plurality of expandable balloons disposed outside the catheter, the balloon Sealing with the conduit to achieve sealing;

 The duct is provided with a plurality of channels parallel and independent of each other in the longitudinal direction thereof, wherein a main passage is formed through the entire duct, and one side opening of the main passage is disposed at one end of the duct to form a main opening ;

 Openings on the same side of the other end passages and the end openings of the main passages are respectively disposed at the side walls of the ducts, and the only corresponding seals of the respective sleeves are respectively connected to the passage openings at the side walls. On the outside, forming an expandable sealed space that is independent of each other and does not interfere with each other;

 The other side opening of each of the passages is connected to a filling valve for injecting or pumping a gas or liquid into each of the passages to expand or suck the balloon.

 The catheter has a length dimension of 100-130 cm.

 The primary channel is sized to pass a 0.035 inch guidewire.

 Further, the catheter is a four-channel catheter, and the other three channels except the main channel are respectively sleeved with the corresponding balloons, and the guiding balloon, the expanding balloon and the positioning ball are respectively formed according to the distance from the main opening. Pouch, where

The diameter of the guiding balloon is 1-3 cm, and the guiding balloon is sleeved to the outer wall of the catheter by a length of 0.5-1.5 cm _;

 The dilatation balloon has a diameter of l-<2 cm, and the length of the dilatation balloon being sleeved with the outer wall of the catheter is 2-3 cm;

 The positioning balloon has a diameter of l-3 cm, and the positioning balloon is sleeved to the outer wall of the catheter by a length of 0.5-1.5 cm.

As a convertible structure, the catheter is a four-channel catheter, and the other three channels except the main channel are respectively sleeved with the corresponding balloons, and the guiding balloon and the dilating balloon are respectively formed in parallel according to the distance from the main opening. And positioning the balloon, wherein The guiding balloon has a diameter of l-3 cm, the length of the guiding balloon being sleeved with the outer wall of the catheter is 0.5-1.5 cm _; the diameter of the expanding balloon is 2-<3 cm, the expanding ball The length of the balloon sleeved with the outer wall of the catheter is 2.5-4.5 cm _; the diameter of the positioning balloon is 1-3 cm, and the length of the positioning balloon sleeved with the outer wall of the catheter is 0.5-1.5 cm. The distance of the guiding balloon closest to the distal end portion of the catheter in which the main opening is opened is 0.8-1.2 cm. The diameter of the dilatation balloon is one model for each 0.2 cm increase. The present invention also provides a method of using the above-described novel balloon catheter for ultrasound guided percutaneous pulmonary valve balloon dilatation, which is suitable for a patient who is a child patient or a patient with severe pulmonary stenosis Specifically, the following steps are included:

 (1) taking the balloon, penetrating through the femoral vein, and inserting an arterial sheath that matches the outer diameter of the catheter of the balloon, and delivering the balloon through the arterial sheath into the body under ultrasound detection a vena cava section, after the catheter enters the right atrium through the inferior vena cava, injecting gas into the guiding balloon through the filling valve to fully expand the guiding balloon, the catheter will follow the blood flow through the three The cusps reach the right ventricular outflow tract, and the position of the balloon is detected by ultrasound, thereby determining the position of the tip of the catheter;

 (2) Due to the narrow opening of the pulmonary valve, the guiding balloon cannot pass through the pulmonary valve and stay in the right ventricular outflow tract, at which time a straight guide wire of 0.035 inch can be fed through the main channel of the catheter. After the guide wire extends out of the catheter, it can reach the pulmonary artery through the pulmonary valve. At this time, the guiding balloon is sucked, and the balloon catheter is further advanced along the guide wire. After passing through the pulmonary valve, the balloon can be refilled. Auxiliary positioning

(3) after filling the balloon, adjusting the catheter insertion depth according to the position of the guiding balloon and the positioning balloon, especially paying attention to placing the guiding balloon slightly higher than the position of the pulmonary valve leaflet, but not Reaching the left pulmonary artery opening; moving the positioning balloon away from the tricuspid valve to avoid expansion of the expansion The balloon is damaged by the tricuspid valve; here, only the positioning balloon can be filled and pushed to the position under the pulmonary valve;

 (4) fixing the position of the catheter, and expanding the expansion balloon with physiological saline to reach a working pressure for 5 to 10 seconds, sucking the guiding balloon, expanding the balloon, and positioning the balloon, and withdrawing The catheter, the guide wire is retained in the patient, and the end-hole catheter is fed to measure the pressure difference of the pulmonary valve, and the pressure difference is used to determine whether to select a larger balloon to expand again.

 The present invention also provides a method of using the above-described novel balloon catheter for ultrasound guided percutaneous pulmonary valve balloon dilatation, which is used for an adult patient or a patient with mild pulmonary stenosis, specifically Including the following steps:

 (1) taking the balloon catheter, penetrating through the femoral vein, and inserting an arterial sheath matching the outer diameter of the catheter of the balloon, and delivering the balloon catheter into the body through the arterial sheath, ultrasound Detecting the inferior vena cava section, after the catheter enters the right atrium through the inferior vena cava, injecting gas into the guiding balloon through the filling valve to fully expand the guiding balloon, the catheter will follow the blood flow Through the tricuspid valve, reaching the pulmonary valve, and detecting the position of the balloon by ultrasound, thereby determining the position of the tip of the catheter;

 (2) After the guiding balloon reaches the pulmonary artery through the pulmonary valve, the guiding balloon can be kept in a filled state, and the guiding balloon is placed slightly higher than the pulmonary valve leaflet, but the left pulmonary artery cannot be reached. Opening; inserting a guide wire through the main channel to provide a supporting force, and then expanding the positioning balloon for positioning, so that the positioning balloon is away from the tricuspid valve, so as not to damage the tricuspid valve when the expansion balloon is expanded, after positioning Expanding the balloon with saline to reach working pressure and lasting

5~10 seconds, sucking the guiding balloon, dilating the balloon and positioning the balloon, withdrawing the catheter, retaining the guide wire in the patient, feeding the end-hole catheter to measure the pressure difference of the pulmonary valve, and determining whether to choose larger according to the pressure difference The balloon expands again.

The present invention also provides an ultrasound-guided percutaneous pulmonary balloon balloon dilatation using the above-mentioned novel balloon catheter, which is suitable for a patient who is a child patient or a patient with severe pulmonary stenosis, and specifically includes the following steps: (1) taking the balloon, penetrating through the femoral vein, and inserting an arterial sheath that matches the outer diameter of the catheter of the balloon, and delivering the balloon through the arterial sheath into the body under ultrasound detection a vena cava section, after the catheter enters the right atrium through the inferior vena cava, injecting gas into the guiding balloon through the filling valve to fully expand the guiding balloon, the catheter will follow the blood flow through the three The cusps reach the right ventricular outflow tract, and the position of the balloon is detected by ultrasound, thereby determining the position of the tip of the catheter;

 (2) Due to the narrow opening of the pulmonary valve, the guiding balloon cannot pass through the pulmonary valve and stay in the right ventricular outflow tract, at which time a straight guide wire of 0.035 inch can be fed through the main channel of the catheter. After the guide wire extends out of the catheter, it can reach the pulmonary artery through the pulmonary valve. At this time, the guiding balloon is sucked, and the balloon catheter is further advanced along the guide wire. After passing through the pulmonary valve, the balloon can be refilled. Auxiliary positioning

(3) after filling the balloon, adjusting the catheter insertion depth according to the position of the guiding balloon and the positioning balloon, especially paying attention to placing the guiding balloon slightly higher than the position of the pulmonary valve leaflet, but not Reaching the left pulmonary artery opening; moving the positioning balloon away from the tricuspid valve to avoid damage to the tricuspid valve when the expansion balloon is expanded; here, only the positioning balloon can be filled and pushed to the pulmonary valve s position;

 (4) fixing the position of the catheter, and expanding the expansion balloon with physiological saline to reach a working pressure for 5 to 10 seconds, sucking the guiding balloon, expanding the balloon, and positioning the balloon, and withdrawing Catheter, retaining the guide wire in the patient, feeding the end-hole catheter to measure the pressure difference of the pulmonary valve, determining whether to select a larger balloon to expand again according to the pressure difference, and preparing for balloon dilatation;

(5) The balloon dilatation is performed according to a conventional method. The present invention also provides an ultrasound-guided percutaneous pulmonary balloon balloon dilatation using the above-mentioned novel balloon catheter, which is suitable for patients with adult patients or patients with mild pulmonary stenosis, and specifically includes the following steps: (1) Taking the balloon catheter, penetrating through the femoral vein, and inserting an arterial sheath matching the outer diameter of the catheter of the balloon, and delivering the balloon catheter into the body through the arterial sheath, under ultrasound detection Cavity a venous section, after the catheter enters the right atrium through the inferior vena cava, injecting gas into the guiding balloon through the filling valve to fully expand the guiding balloon, the catheter will follow the blood flow through the three-pointed a flap, reaching the pulmonary valve, detecting the position of the balloon by ultrasound, thereby determining the position of the tip of the catheter;

 (2) After the guiding balloon reaches the pulmonary artery through the pulmonary valve, the guiding balloon can be kept in a filled state, and the guiding balloon is placed slightly higher than the pulmonary valve leaflet, but the left pulmonary artery cannot be reached. Opening; inserting a guide wire through the main channel to provide a supporting force, and then expanding the positioning balloon for positioning, so that the positioning balloon is away from the tricuspid valve, so as not to damage the tricuspid valve when the expansion balloon is expanded, after positioning Expanding the balloon with saline to reach working pressure and lasting

5~10 seconds, sucking the guiding balloon, dilating the balloon and positioning the balloon, withdrawing the catheter, retaining the guide wire in the patient, feeding the end-hole catheter to measure the pressure difference of the pulmonary valve, and determining whether to choose larger according to the pressure difference The balloon expands again and is ready for balloon dilation;

 (3) The balloon dilatation is performed according to a conventional method. According to the novel balloon catheter of the present invention, since the guiding balloon and the positioning balloon will expand after inflation, the cross-sectional area thereof is greatly increased compared with the cross-sectional area of the catheter, and the application of ultrasonic detection can easily detect the ball. The position of the capsule not only facilitates the delivery of the catheter into the pulmonary artery, but positioning the balloon can help adjust the insertion depth of the balloon during surgery to avoid accidental injury to the tricuspid valve. Therefore, the expansion using this structure balloon can effectively perform guided detection by ultrasound to avoid the potential hazard caused by ray guidance in the prior art.

 The novel balloon catheter of the present invention can be operated by selecting an appropriate structure according to the condition of the patient. The four-channel balloon is suitable for patients whose patients are children or severe pulmonary stenosis, and further uses the positioning balloon to determine the position of the catheter, thereby ensuring the accuracy of the operation.

The expansion method provided by the invention effectively utilizes the novel balloon catheter to realize ultrasonic guidance and detection, and effectively solves the harm in the existing surgery. BRIEF DESCRIPTION OF THE DRAWINGS In order to make the content of the present invention easier to understand, the following is a specific embodiment of the present invention. The present invention will be further described in detail with reference to the accompanying drawings, in which

 1 is a schematic view showing the structure of a balloon in which the catheter is a four-channel catheter according to the present invention. DETAILED DESCRIPTION OF THE INVENTION A novel balloon catheter for ultrasound guided percutaneous pulmonary valve balloon dilatation includes a catheter and a plurality of expandable balloons disposed outside the catheter, the balloon and the balloon The sleeve is sleeved to achieve sealing;

 The duct is provided with a plurality of channels parallel and independent of each other in the longitudinal direction thereof, wherein a main passage is formed through the entire duct, and one side opening of the main passage is disposed at one end of the duct to form a main opening ;

 Openings on the same side of the other end passages and the end openings of the main passages are respectively disposed at the side walls of the ducts, and the only corresponding seals of the respective sleeves are respectively connected to the passage openings at the side walls. On the outside, forming an expandable sealed space that is independent of each other and does not interfere with each other;

 The other side opening of each of the passages is connected to a filling valve for injecting or pumping a gas or liquid into each of the passages to expand or suck the balloon.

 Further, the catheter has a length dimension of the AF segment of 100-130 cm, and the diameter of the main passage is adapted to pass through a 0.035 inch guide wire.

 In order to accommodate the surgical equipment requirements of a child patient or a patient with severe pulmonary stenosis, the novel balloon catheter of the present invention can be designed as a four-channel catheter balloon.

Example 1

As shown in Figure 1, the balloon catheter is a balloon catheter structure having four channels for the catheter. Wherein, the duct is provided with four channels parallel and independent of each other in the longitudinal direction thereof, wherein the main passage of the entire duct is penetrated, and one side opening of the main passage is disposed at one end of the duct to form a main opening; an opening of the other three channels respectively on the same side as the main opening of the main channel is respectively disposed at a side wall of the duct, and the only corresponding sealing sleeve of the balloon is sleeved at each channel at the side wall The outside of the opening forms an inflatable seal that is independent of each other and does not interfere with each other. And forming a juxtaposed guiding balloon, an expanding balloon, and a positioning balloon respectively according to a distance from the main opening, wherein

 The guiding balloon has a diameter of l-3 cm, and the length BC of the guiding balloon is sleeved with the outer wall of the catheter is 0.5-1.5 cm, and preferably lcm;

 The dilatation balloon has a diameter of l-<2 cm, and the length CD of the dilatation balloon is sleeved from the outer wall of the catheter to be 1.8-2.2 cm, and preferably 2 cm; or the diameter of the dilatation balloon is 2- <3cm, the length CD of the dilatation balloon being sleeved with the outer wall of the catheter is 2.8-3.2 cm, and preferably 3 cm; the diameter of the dilatation balloon is one model for each 0.2 cm increase;

 The positioning balloon has a diameter of l-3 cm, and the length DE of the positioning balloon being sleeved with the outer wall of the catheter is 0.5-1.5 cm, and preferably lcm. The other side openings of the four passages are respectively connected with filling valves for injecting or pumping gas or liquid into each of the passages to expand or suck the balloon. The primary channel has a diameter dimension suitable for passing a 0.035 inch guidewire.

Example 2

 The novel balloon catheter of the present embodiment has the same structure as that of the embodiment 1, except that the diameter of the dilatation balloon is 2-<3 cm, and the length of the dilatation balloon is sleeved with the outer wall of the catheter. The segment is 2.8-3.2 cm, and preferably 3 cm; the diameter of the dilatation balloon is still a model of 0.2 cm per increment.

Example 3

 The four-channel catheter balloon described in the above embodiments 1 and 2 can be applied to a conventional adult patient or a patient with mild pulmonary stenosis, and is also applicable to a child patient or a patient with severe pulmonary stenosis.

 When the four-channel catheter balloon is used in a child patient or a patient with severe pulmonary stenosis, the method of using the above four-channel balloon specifically includes the following steps:

(1) taking the balloon, penetrating through the femoral vein, and inserting an arterial sheath that matches the outer diameter of the catheter of the balloon, and delivering the balloon through the arterial sheath into the body under ultrasound detection Vena cava section, After the catheter enters the right atrium through the inferior vena cava, gas is injected into the guiding balloon through the filling valve to fully expand the guiding balloon, and the catheter will follow the blood flow through the tricuspid valve to reach a right ventricular outflow tract, wherein the position of the balloon is detected by ultrasound, thereby determining the position of the tip of the catheter;

 (2) Due to the narrow opening of the pulmonary valve, the guiding balloon cannot pass through the pulmonary valve and stay in the right ventricular outflow tract, at which time a straight guide wire of 0.035 inch can be fed through the main channel of the catheter. After the guide wire extends out of the catheter, it can reach the pulmonary artery through the pulmonary valve. At this time, the guiding balloon is sucked, and the catheter of the balloon is continuously sent forward along the guide wire. After passing through the pulmonary valve, the guiding ball can be refilled. Capsule assisted positioning;

(3) after filling the balloon, adjusting the catheter insertion depth according to the position of the guiding balloon and the positioning balloon, especially paying attention to placing the guiding balloon slightly higher than the position of the pulmonary valve leaflet, but not Reaching the left pulmonary artery opening; moving the positioning balloon away from the tricuspid valve to avoid damage to the tricuspid valve when the expansion balloon is expanded; here, only the positioning balloon can be filled and pushed to the pulmonary valve s position;

 (4) fixing the position of the catheter, and expanding the expansion balloon with physiological saline to reach a working pressure for 5 to 10 seconds, sucking the guiding balloon, expanding the balloon, and positioning the balloon, and withdrawing The catheter, the guide wire is retained in the patient, and the end-hole catheter is fed to measure the pressure difference of the pulmonary valve, and the pressure difference is used to determine whether to select a larger balloon to expand again. When the four-channel catheter balloon is used in an adult patient or a patient with mild pulmonary stenosis, the method of using the above four-channel balloon specifically includes the following steps:

(1) taking the balloon catheter, penetrating through the femoral vein, and inserting an arterial sheath matching the outer diameter of the catheter of the balloon, and delivering the balloon catheter into the body through the arterial sheath, ultrasound Detecting the inferior vena cava section, after the catheter enters the right atrium through the inferior vena cava, injecting gas into the guiding balloon through the filling valve to fully expand the guiding balloon, the catheter will follow the blood flow Through the tricuspid valve, reaching the pulmonary valve, and detecting the position of the balloon by ultrasound, thereby determining the position of the tip of the catheter; (2) After the guiding balloon reaches the pulmonary artery through the pulmonary valve, the guiding balloon can be kept in a filled state, and the guiding balloon is placed slightly higher than the pulmonary valve leaflet, but the left pulmonary artery cannot be reached. Opening; inserting a guide wire through the main channel to provide a supporting force, and then expanding the positioning balloon for positioning, so that the positioning balloon is away from the tricuspid valve, so as not to damage the tricuspid valve when the expansion balloon is expanded, after positioning Expanding the balloon with saline to reach working pressure and lasting

5~10 seconds, sucking the guiding balloon, dilating the balloon and positioning the balloon, withdrawing the catheter, retaining the guide wire in the patient, feeding the end-hole catheter to measure the pressure difference of the pulmonary valve, and determining whether to choose larger according to the pressure difference The balloon expands again.

Embodiment 4 The present invention also provides an ultrasound-guided percutaneous pulmonary balloon balloon dilatation in a patient or a patient with severe pulmonary stenosis using a balloon catheter of the above four-channel catheter, and specifically includes the following steps:

(1) taking the balloon, penetrating through the femoral vein, and inserting an arterial sheath that matches the outer diameter of the catheter of the balloon, and delivering the balloon through the arterial sheath into the body under ultrasound detection a vena cava section, after the catheter enters the right atrium through the inferior vena cava, injecting gas into the guiding balloon through the filling valve to fully expand the guiding balloon, the catheter will follow the blood flow through the three The cusps reach the right ventricular outflow tract, and the position of the balloon is detected by ultrasound, thereby determining the position of the tip of the catheter;

 (2) Due to the narrow opening of the pulmonary valve, the guiding balloon cannot pass through the pulmonary valve and stay in the right ventricular outflow tract, at which time a straight guide wire of 0.035 inch can be fed through the main channel of the catheter. After the guide wire extends out of the catheter, it can reach the pulmonary artery through the pulmonary valve. At this time, the guiding balloon is sucked, and the catheter of the balloon is continuously sent forward along the guide wire. After passing through the pulmonary valve, the guiding ball can be refilled. Capsule assisted positioning;

(3) after filling the balloon, adjusting the catheter insertion depth according to the position of the guiding balloon and the positioning balloon, especially paying attention to placing the guiding balloon slightly higher than the position of the pulmonary valve leaflet, but not Reaching the left pulmonary artery opening; moving the positioning balloon away from the tricuspid valve to avoid damage to the tricuspid valve when the expansion balloon is expanded; here, only the positioning balloon can be filled and pushed to the lung The position under the aortic valve;

 (4) fixing the position of the catheter, and expanding the expansion balloon with physiological saline to reach a working pressure for 5 to 10 seconds, sucking the guiding balloon, expanding the balloon, and positioning the balloon, and withdrawing Catheter, retaining the guide wire in the patient, feeding the end-hole catheter to measure the pressure difference of the pulmonary valve, determining whether to select a larger balloon to expand again according to the pressure difference, and preparing for balloon dilatation;

 (5) The balloon dilatation is performed according to a conventional method.

Example 5

 The present invention also provides an ultrasound-guided percutaneous pulmonary balloon balloon dilatation for an adult patient or a patient with mild pulmonary stenosis using a balloon catheter of the above four-channel catheter, specifically comprising the following steps:

 (1) taking the balloon catheter, penetrating through the femoral vein, and inserting an arterial sheath matching the outer diameter of the catheter of the balloon, and delivering the balloon catheter into the body through the arterial sheath, ultrasound Detecting the inferior vena cava section, after the catheter enters the right atrium through the inferior vena cava, injecting gas into the guiding balloon through the filling valve to fully expand the guiding balloon, the catheter will follow the blood flow Through the tricuspid valve, reaching the pulmonary valve, and detecting the position of the balloon by ultrasound, thereby determining the position of the tip of the catheter;

 (2) After the guiding balloon reaches the pulmonary artery through the pulmonary valve, the guiding balloon can be kept in a filled state, and the guiding balloon is placed slightly higher than the pulmonary valve leaflet, but the left pulmonary artery cannot be reached. Opening; inserting a guide wire through the main channel to provide a supporting force, and then expanding the positioning balloon for positioning, so that the positioning balloon is away from the tricuspid valve, so as not to damage the tricuspid valve when the expansion balloon is expanded, after positioning Expanding the dilatation balloon with saline to reach working pressure for 5-10 seconds, sucking the guiding balloon, dilating the balloon and positioning the balloon, withdrawing the catheter, retaining the guide wire in the patient, and feeding the end hole The catheter measures the pressure difference of the pulmonary valve, and determines whether to select a larger balloon to expand again according to the pressure difference, and prepare for balloon dilatation;

 (3) The balloon dilatation is performed according to a conventional method.

The novel balloon catheter of the present invention will be inflated after guiding the balloon and positioning the balloon The expansion, the cross-sectional area of the catheter will be greatly increased compared to the cross-sectional area of the catheter. At this time, the application of ultrasound detection will very easy to detect the position of the balloon, not only can easily send the catheter into the pulmonary artery, and positioning the balloon can help during surgery. Adjust the depth of insertion of the balloon to avoid accidental injury to the tricuspid valve. Therefore, the expansion using the structural balloon can effectively perform guided detection by ultrasonic means to avoid potential harm caused by ray guiding in the prior art. It is apparent that the above-described embodiments are merely illustrative of the examples, and are not intended to limit the embodiments. Other variations or modifications of the various forms may be made by those skilled in the art in light of the above description. There is no need and no way to exhaust all of the implementations. Obvious changes or variations resulting therefrom are still within the scope of the invention.

Claims

Claim  What is claimed is: 1. A novel balloon catheter for ultrasound guided percutaneous pulmonary balloon balloon dilatation, comprising: a catheter and a plurality of expandable balloons disposed outside said catheter, said balloon being said The sleeve is sleeved to achieve sealing;  The duct is provided with a plurality of channels parallel and independent of each other in the longitudinal direction thereof, wherein a main passage is formed through the entire duct, and one side opening of the main passage is disposed at one end of the duct to form a main opening ;  Openings of the other respective passages on the same side of the end opening of the main passage are respectively disposed at the side walls of the duct, and the only corresponding seals of the respective sleeves are respectively connected to the passage openings at the side walls. On the outside, forming an expandable sealed space that is independent of each other and does not interfere with each other;  The other side opening of each of the passages is connected to a filling valve for injecting or pumping a gas or liquid into each of the passages to expand or suck the balloon.  2. A novel balloon catheter for ultrasound guided percutaneous pulmonary balloon balloon dilatation according to claim 1 wherein said catheter has a length dimension of from 100 to 130 cm.  3. A novel balloon catheter for ultrasound guided percutaneous pulmonary valve balloon dilatation according to claim 1 or 2, wherein said main channel has a diameter dimension adapted to pass a 0.035 inch guidewire.  4. A novel balloon catheter for ultrasound guided percutaneous pulmonary balloon balloon augmentation according to any of claims 1-3, wherein:  The catheter is a four-channel catheter, and the other three channels except the main channel are respectively sleeved with the corresponding balloons, and a juxtaposed guiding balloon, an expanding balloon and a positioning balloon are respectively formed according to the distance from the main opening, wherein ,  The guide balloon has a diameter of l-3 cm, and the length (BC) of the guiding balloon to the outer wall of the catheter is 0.5-1.5 cm; The dilatation balloon has a diameter of l-<2 cm, and the dilatation balloon is sleeved with the outer wall of the catheter The length (CD) is 2-3 cm;  The positioning balloon has a diameter of l-3 cm, and the length (DE) of the positioning balloon to the outer wall of the catheter is 0.5-1.5 cm.  5. A novel balloon catheter for ultrasound guided percutaneous pulmonary balloon balloon augmentation according to any of claims 1-3, wherein:  The catheter is a four-channel catheter, and the other three channels except the main channel are respectively sleeved with the corresponding balloons, and a juxtaposed guiding balloon, an expanding balloon and a positioning balloon are respectively formed according to the distance from the main opening, wherein ,  The diameter of the guiding balloon is 1-3 cm, the length of the guiding balloon being sleeved with the outer wall of the catheter (BC) is 0.5-1.5 cm; the diameter of the expanding balloon is 2-<3 cm, The length (CD) of the expansion balloon being sleeved with the outer wall of the catheter is 2.5-4.5 cm;  The positioning balloon has a diameter of l-3 cm, and the length (DE) of the positioning balloon to the outer wall of the catheter is 0.5-1.5 cm.  6. A novel balloon catheter for ultrasound guided percutaneous pulmonary valve balloon dilatation according to claim 4 or 5, wherein:  The distance (AB) of the guiding balloon closest to the distal end portion of the catheter in which the main opening is opened is 0.8 - 1.2 cm.  7. A novel balloon catheter for ultrasound guided percutaneous pulmonary balloon balloon expansion according to any of claims 4-6, wherein:  The diameter of the dilatation balloon is one model for every 0.2 cm increase.  8. A method of using a novel balloon catheter for ultrasound guided percutaneous pulmonary valve balloon dilatation according to any of claims 1-7, wherein said novel balloon catheter is for use in a child patient Or patients with severe pulmonary stenosis, including the following steps: (1) taking the balloon, penetrating through the femoral vein, and placing it into the outer diameter of the catheter of the balloon An arterial sheath tube is provided, the balloon is delivered into the body through the arterial sheath, and the inferior vena cava section is ultrasonically detected. After the catheter enters the right atrium through the inferior vena cava, the guiding balloon is guided through the filling valve. Injecting a gas to fully expand the guiding balloon, the catheter will follow the blood flow through the tricuspid valve to the right ventricular outflow tract, and the position of the balloon is detected by ultrasound to determine the position of the tip of the catheter. ;  (2) Due to the narrow opening of the pulmonary valve, the guiding balloon cannot pass through the pulmonary valve and stay in the right ventricular outflow tract, at which time a straight guide wire of 0.035 inch can be fed through the main channel of the catheter. After the guide wire extends out of the catheter, it can reach the pulmonary artery through the pulmonary valve. At this time, the guiding balloon is sucked, and the balloon catheter is further advanced along the guide wire. After passing through the pulmonary valve, the balloon can be refilled. Auxiliary positioning (3) after filling the balloon, adjusting the catheter insertion depth according to the position of the guiding balloon and the positioning balloon, especially paying attention to placing the guiding balloon slightly higher than the position of the pulmonary valve leaflet, but not Reaching the left pulmonary artery opening; moving the positioning balloon away from the tricuspid valve to avoid damage to the tricuspid valve when the expansion balloon is expanded; here, only the positioning balloon can be filled and pushed to the pulmonary valve s position;  (4) fixing the position of the catheter, and expanding the expansion balloon with physiological saline to reach a working pressure for 5 to 10 seconds, sucking the guiding balloon, expanding the balloon, and positioning the balloon, and withdrawing The catheter, the guide wire is retained in the patient, and the end-hole catheter is fed to measure the pressure difference of the pulmonary valve, and the pressure difference is used to determine whether to select a larger balloon to expand again.  9. A method of using a novel balloon catheter for ultrasound guided percutaneous pulmonary valve balloon dilatation according to any of claims 1-7, wherein said novel balloon catheter is for use in an adult patient Or patients with mild pulmonary stenosis, including the following steps: (1) taking the balloon catheter, penetrating through the femoral vein, and inserting an arterial sheath matching the outer diameter of the catheter of the balloon, and delivering the balloon catheter into the body through the arterial sheath, ultrasound Detecting the inferior vena cava section, after the catheter enters the right atrium through the inferior vena cava, injecting gas into the guiding balloon through the filling valve to fully expand the guiding balloon, the catheter will follow the blood flow Through the tricuspid valve, reach the pulmonary valve, use ultrasound to detect the position of the balloon, and then determine the location The position of the tip of the catheter;  (2) After the guiding balloon reaches the pulmonary artery through the pulmonary valve, the guiding balloon can be kept in a filled state, and the guiding balloon is placed slightly higher than the pulmonary valve leaflet, but the left pulmonary artery cannot be reached. Opening; inserting a guide wire through the main channel to provide a supporting force, and then expanding the positioning balloon for positioning, so that the positioning balloon is away from the tricuspid valve, so as not to damage the tricuspid valve when the expansion balloon is expanded, after positioning Expanding the balloon with saline to reach working pressure and lasting 5~10 seconds, sucking the guiding balloon, dilating the balloon and positioning the balloon, withdrawing the catheter, retaining the guide wire in the patient, feeding the end-hole catheter to measure the pressure difference of the pulmonary valve, and determining whether to choose larger according to the pressure difference The balloon expands again.  10. An ultrasound-guided percutaneous pulmonary balloon balloon dilatation using the novel balloon catheter of any of claims 1-7, wherein the patient is a child patient or a patient with severe pulmonary stenosis, characterized in that Specifically, the following steps are included: (1) taking the balloon, penetrating through the femoral vein, and inserting an arterial sheath that matches the outer diameter of the catheter of the balloon, and delivering the balloon through the arterial sheath into the body under ultrasound detection a vena cava section, after the catheter enters the right atrium through the inferior vena cava, injecting gas into the guiding balloon through the filling valve to fully expand the guiding balloon, the catheter will follow the blood flow through the three The cusps reach the right ventricular outflow tract, and the position of the balloon is detected by ultrasound, thereby determining the position of the tip of the catheter;  (2) Due to the narrow opening of the pulmonary valve, the guiding balloon cannot pass through the pulmonary valve and stay in the right ventricular outflow tract, at which time a straight guide wire of 0.035 inch can be fed through the main channel of the catheter. After the guide wire extends out of the catheter, it can reach the pulmonary artery through the pulmonary valve. At this time, the guiding balloon is sucked, and the catheter of the balloon is continuously sent forward along the guide wire. After passing through the pulmonary valve, the guiding ball can be refilled. Capsule assisted positioning; (3) after filling the balloon, adjusting the catheter insertion depth according to the position of the guiding balloon and the positioning balloon, especially paying attention to placing the guiding balloon slightly higher than the position of the pulmonary valve leaflet, but not Reaching the left pulmonary artery opening; moving the positioning balloon away from the tricuspid valve to avoid damage to the tricuspid valve when the expansion balloon is expanded; here, only the positioning balloon can be filled and pushed to the lung The position under the aortic valve;  (4) fixing the position of the catheter, and expanding the expansion balloon with physiological saline to reach a working pressure for 5 to 10 seconds, sucking the guiding balloon, expanding the balloon, and positioning the balloon, and withdrawing Catheter, retaining the guide wire in the patient, feeding the end-hole catheter to measure the pressure difference of the pulmonary valve, determining whether to select a larger balloon to expand again according to the pressure difference, and preparing for balloon dilatation;  (5) The balloon dilatation is performed according to a conventional method.  11. An ultrasound-guided percutaneous pulmonary balloon balloon dilatation using the novel balloon catheter of any of claims 1-7, wherein the patient is an adult patient or a patient with mild pulmonary stenosis, characterized Therefore, the specific steps include the following steps:  (1) taking the balloon catheter, penetrating through the femoral vein, and inserting an arterial sheath matching the outer diameter of the catheter of the balloon, and delivering the balloon catheter into the body through the arterial sheath, ultrasound Detecting the inferior vena cava section, after the catheter enters the right atrium through the inferior vena cava, injecting gas into the guiding balloon through the filling valve to fully expand the guiding balloon, the catheter will follow the blood flow Through the tricuspid valve, reaching the pulmonary valve, and detecting the position of the balloon by ultrasound, thereby determining the position of the tip of the catheter;  (2) After the guiding balloon reaches the pulmonary artery through the pulmonary valve, the guiding balloon can be kept in a filled state, and the guiding balloon is placed slightly higher than the pulmonary valve leaflet, but the left pulmonary artery cannot be reached. Opening; inserting a guide wire through the main channel to provide a supporting force, and then expanding the positioning balloon for positioning, so that the positioning balloon is away from the tricuspid valve, so as not to damage the tricuspid valve when the expansion balloon is expanded, after positioning Expanding the dilatation balloon with saline to reach working pressure for 5-10 seconds, sucking the guiding balloon, dilating the balloon and positioning the balloon, withdrawing the catheter, retaining the guide wire in the patient, and feeding the end hole The catheter measures the pressure difference of the pulmonary valve, and determines whether to select a larger balloon to expand again according to the pressure difference, and prepare for balloon dilatation;  (3) The balloon dilatation is performed according to a conventional method.