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WO2016011602A1 - Nouveau type de catheter a ballonnet utilise pour l'angioplastie percutanee par ballonnet de valve pulmonaire guidee par ultrasons - Google Patents

Nouveau type de catheter a ballonnet utilise pour l'angioplastie percutanee par ballonnet de valve pulmonaire guidee par ultrasons Download PDF

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Publication number
WO2016011602A1
WO2016011602A1 PCT/CN2014/082727 CN2014082727W WO2016011602A1 WO 2016011602 A1 WO2016011602 A1 WO 2016011602A1 CN 2014082727 W CN2014082727 W CN 2014082727W WO 2016011602 A1 WO2016011602 A1 WO 2016011602A1
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WO
WIPO (PCT)
Prior art keywords
balloon
catheter
guiding
pulmonary
positioning
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2014/082727
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English (en)
Chinese (zh)
Inventor
潘湘斌
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Individual
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Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to CN201480061386.5A priority Critical patent/CN105705192A/zh
Priority to PCT/CN2014/082727 priority patent/WO2016011602A1/fr
Publication of WO2016011602A1 publication Critical patent/WO2016011602A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes

Definitions

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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:
  • 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
  • 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:
  • the guiding balloon 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
  • 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;
  • 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
  • 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;
  • the guiding balloon 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
  • the balloon dilatation is performed according to a conventional method.
  • 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.
  • 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.
  • 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 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.
  • the novel balloon catheter of the present invention can be designed as a four-channel catheter balloon.
  • the balloon catheter is a balloon catheter structure having four channels for the catheter.
  • 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.
  • 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.
  • 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.
  • 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.
  • the method of using the above four-channel balloon specifically includes the following steps:
  • 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;
  • the method of using the above four-channel balloon specifically includes the following steps:
  • Embodiment 4 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:
  • 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;
  • the balloon dilatation is performed according to a conventional method.
  • 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:
  • the guiding balloon 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;
  • 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.
  • 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.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)

Abstract

La présente invention concerne un nouveau type de cathéter à ballonnet utilisé l'angioplastie percutanée par ballonnet de valve pulmonaire guidée par ultrasons, ayant trait au domaine de traitement interventionnel. Le cathéter à ballonnet comporte un cathéter et trois ballonnets disposés sur le côté extérieur dudit cathéter; les ballonnets sont manchonnés sur ledit cathéter, produisant un joint d'étanchéité; les trois ballonnets sont, consécutivement, un ballonnet de guidage (1), un ballonnet de dilatation (2), et un ballonnet de positionnement (3); à l'intérieur du cathéter sont prévus quatre passages séparés disposés en parallèle dans le sens longitudinal du cathéter; chacun des ballonnets correspond à un joint d'étanchéité unique et est manchonné sur le côté extérieur de l'ouverture de chaque passage situé au niveau de la paroi latérale, formant des espaces étanches expansibles qui sont séparés les uns des autres et n'entraînent pas d'interférence mutuelle. Le ballonnet de guidage se dilate après le gonflage, et sa superficie de section transversale augmente de manière significative en comparaison avec la superficie de la section transversale du cathéter; à ce moment, une sonde à ultrasons peut facilement détecter la position du ballonnet, ce qui facilite la détermination de la position de l'extrémité supérieure du cathéter. Par conséquent, lors de l'utilisation de la structure de cathéter à ballonnet selon la présente invention pour effectuer une angioplastie, des ultrasons peuvent être efficacement utilisés pour le guidage, évitant les effets nuisibles entraînés par l'utilisation de rayonnement pour le guidage.
PCT/CN2014/082727 2014-07-22 2014-07-22 Nouveau type de catheter a ballonnet utilise pour l'angioplastie percutanee par ballonnet de valve pulmonaire guidee par ultrasons Ceased WO2016011602A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN201480061386.5A CN105705192A (zh) 2014-07-22 2014-07-22 用于超声引导下经皮肺动脉瓣球囊扩张术的新型球囊导管
PCT/CN2014/082727 WO2016011602A1 (fr) 2014-07-22 2014-07-22 Nouveau type de catheter a ballonnet utilise pour l'angioplastie percutanee par ballonnet de valve pulmonaire guidee par ultrasons

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CN2014/082727 WO2016011602A1 (fr) 2014-07-22 2014-07-22 Nouveau type de catheter a ballonnet utilise pour l'angioplastie percutanee par ballonnet de valve pulmonaire guidee par ultrasons

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WO2016011602A1 true WO2016011602A1 (fr) 2016-01-28

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PCT/CN2014/082727 Ceased WO2016011602A1 (fr) 2014-07-22 2014-07-22 Nouveau type de catheter a ballonnet utilise pour l'angioplastie percutanee par ballonnet de valve pulmonaire guidee par ultrasons

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WO (1) WO2016011602A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109954199A (zh) * 2019-05-08 2019-07-02 山东百多安医疗器械有限公司 一种超声控释的前列腺扩张载药球囊系统及其制备方法
CN112843436A (zh) * 2020-02-16 2021-05-28 东莞天天向上医疗科技有限公司 一种体内肺膜氧合多功能球囊扩张导管及使用方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002005887A2 (fr) * 2000-07-13 2002-01-24 Edwards Lifesciences Corporation Catheter multi-ballonnet pour administration de medicaments contre l'angiogenese
WO2002056772A2 (fr) * 2001-01-16 2002-07-25 Novacept Appareil et methode de traitement du reflux veineux
CN1651107A (zh) * 2005-02-24 2005-08-10 四川大学华西医院 多球囊血管内导管
CN201244281Y (zh) * 2008-08-27 2009-05-27 兖矿集团有限公司 三腔双球囊导管
CN102813994A (zh) * 2011-04-08 2012-12-12 劳伦斯.J.格兰斯 用于载送药物递送装置的球囊导管

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002005887A2 (fr) * 2000-07-13 2002-01-24 Edwards Lifesciences Corporation Catheter multi-ballonnet pour administration de medicaments contre l'angiogenese
WO2002056772A2 (fr) * 2001-01-16 2002-07-25 Novacept Appareil et methode de traitement du reflux veineux
CN1651107A (zh) * 2005-02-24 2005-08-10 四川大学华西医院 多球囊血管内导管
CN201244281Y (zh) * 2008-08-27 2009-05-27 兖矿集团有限公司 三腔双球囊导管
CN102813994A (zh) * 2011-04-08 2012-12-12 劳伦斯.J.格兰斯 用于载送药物递送装置的球囊导管

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Publication number Publication date
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