WO2018133175A1 - Slidable multi-lumen drainage tube - Google Patents
Slidable multi-lumen drainage tube Download PDFInfo
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- WO2018133175A1 WO2018133175A1 PCT/CN2017/075187 CN2017075187W WO2018133175A1 WO 2018133175 A1 WO2018133175 A1 WO 2018133175A1 CN 2017075187 W CN2017075187 W CN 2017075187W WO 2018133175 A1 WO2018133175 A1 WO 2018133175A1
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- WIPO (PCT)
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- tube
- pressure measuring
- drainage tube
- inner catheter
- guiding
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Classifications
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- 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
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
-
- 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
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
-
- 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
- A61M25/0043—Catheters; Hollow probes characterised by structural features
-
- 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
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
- A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
-
- 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
- A61M2025/0001—Catheters; Hollow probes for pressure measurement
- A61M2025/0002—Catheters; Hollow probes for pressure measurement with a pressure sensor at the distal end
-
- 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
- A61M2210/00—Anatomical parts of the body
- A61M2210/12—Blood circulatory system
- A61M2210/125—Heart
Definitions
- the present invention relates to medical surgical instruments, and more particularly to a slidable multi-cavity drainage tube.
- a mechanical aid that is, after the blood is taken out of the body, with or without artificial lung oxygenation, and then driven by a pump (artificial heart) Blood is injected into the body.
- This technique is called “buying life to God.” It is the most common way to withdraw blood from the body through the femoral vein.
- this method can not effectively reduce the left ventricular preload and increase the left ventricular afterload, which will lead to increased left ventricular oxygen consumption and delayed recovery. Therefore, this model is not suitable for patients with left ventricular failure.
- Left atrial drainage can reduce left ventricular preload to a certain extent, thereby reducing cardiac work.
- left ventricular drainage can directly reduce the left ventricular preload and reduce the intracardiac pressure, which not only reduces myocardial oxygen consumption, but also increases coronary blood supply, thereby promoting left ventricular function recovery. Therefore, left ventricular drainage is extremely important for patients with severe left ventricular failure.
- a kind of left ventricular drainage tube used in clinical practice needs to be placed in the thoracic cavity, and the left ventricle is directly incision. Such surgery has great trauma to the myocardium and more bleeding, so it is not commonly used in clinical practice.
- the other type uses a longer drainage tube that passes through other arterial vessels, such as the femoral artery, retrogradely through the aortic valve to the left ventricle.
- the left ventricular drainage tube will severely compress the aortic valve (especially without the coronary valve), causing severe aortic regurgitation, which not only reduces the effect of left ventricular drainage, but also is not conducive to The recovery of left ventricular function, and long-term compression of the aortic valve, may result in severe valvular dysfunction, and even adhesion and loss of valve function, resulting in permanent aortic regurgitation.
- the invention aims to provide a slidable multi-cavity drainage tube, which can be inserted into the left ventricle of a patient through a subclavian artery or a radial artery or a femoral artery, and the target of left ventricular drainage can be achieved without opening the chest. Not only can the patient's pain be alleviated, but also reduce the amount of bleeding and shorten the operation time; it will not cause damage to the aortic valve, and measure the left ventricular pressure change.
- a slidable multi-lumen drainage tube includes an outer cannula and an inner catheter located in the inner cannula lumen, the inner catheter lumen is provided with a guiding die; and the outer cannula and the inner catheter are further provided with a blood vessel stent, the blood vessel stent Fixed on the outer wall of the inner catheter.
- the inner catheter is implanted in the outer cannula, and the inner catheter can slide in the outer cannula as needed. After the outer cannula is retracted, the vascular stent fixed on the inner catheter can be released, thereby supporting the inner catheter in the middle of the blood vessel to prevent the inner catheter from compressing the aortic valve. This results in aortic regurgitation and destruction of the aortic valve (long-term compression).
- the guiding die guides the outer cannula and the inner catheter during the placement of the drainage tube, thereby retrograde into the ascending aorta via the peripheral artery.
- the inner catheter rear opening is connected to the drive system (such as a centrifugal pump, a roller pump, etc.), and the left ventricular blood is drained to the outside through a drive system.
- the drive system such as a centrifugal pump, a roller pump, etc.
- the inner wall of the inner tube is provided with a pressure measuring channel
- the front opening of the pressure measuring channel is located at the outer wall of the front end of the inner tube
- the rear opening of the pressure measuring channel is located at the outer wall of the rear end of the inner tube.
- the utility model further comprises a pressure measuring tube, and one end of the pressure measuring tube is connected to the rear opening of the pressure measuring channel.
- the piezometer can be directly inserted into the rear opening of the pressure measuring channel.
- the rear opening position of the pressure measuring passage can be provided with a connecting head, and the pressure measuring tube is connected to the pressure measuring passage through the joint; when the pressure measuring is not required, the connecting head There is also a closed head to prevent blood from flowing out of the pressure measuring channel.
- the left end chamber pressure can be continuously measured after the other end of the piezometer is connected to the pressure sensor.
- the pressure measuring tube is also provided with a pipe clamp, which can block the passage of the pressure measuring tube and the pressure measuring channel.
- the inner tube front wall has a side hole formed therein, and the side hole communicates with the inner tube inner cavity and close to the inner tube front opening.
- the front end of the inner catheter body is provided with a plurality of side holes to avoid being blocked during the drainage process.
- the pressure measuring tube is further provided with a pipe clamp for blocking the pressure measuring tube.
- the vascular stent is secured to the front of the inner catheter.
- the vascular stent at the front of the inner catheter allows the inner catheter to be located in the center of the three aortic valves, preventing the inner catheter from compressing the aortic valve and causing aortic regurgitation and destruction of the aortic valve.
- the blood vessel support comprises a support rib and a connecting rib, the support rib is a cutting support, the support rib has a large cross section, the connecting rib part is a woven support, the woven support is woven by a thin metal wire, the wire cross section is small, and the support rib is between
- the braided stents are connected to form repeating units of different lengths to form a blood vessel stent.
- the basic structure of the supporting rib is a ring structure surrounded by a sinusoidal curve.
- the supporting rib has a plurality of basic structural repeats. The valleys and troughs of the sinusoidal valleys of the two adjacent basic structures are opposite, and the peaks and peaks are opposite;
- the basic structure of the support rib is divided into the straight line of the support rib and the corner of the support rib.
- the basic structure of the support rib and the basic structure of the support rib are alternately transformed into a ring structure.
- the cross section of the basic structure of the support rib is designed with variable cross section.
- the cross-sectional area of the basic structure of the support rib is small, and the cross-sectional area of the basic structure of the support rib is large.
- the cross-sectional area of the support rib from the straight line to the bend gradually becomes larger, and then gradually decreases from the bend to the straight line. And repeat the changes accordingly.
- the top of the basic structure of the support rib has a protruding joint at the top, and the main function of the support rib joint is for the connection of the support rib and the connecting rib; the connecting rib adopts a woven bracket and a woven bracket
- the connection with the support ribs is through the connection between the braided support wire and the support rib joint, and the connection method is a fusion welding method.
- the connecting rib adopts a woven bracket, and the wire is taken out from the joint of the basic structure of one supporting rib, and is connected by a connecting angle of a basic structure of another supporting rib by rotating a certain angle, and the rotation is divided into left-handed and right-handed, left-handed and The right-handed rotation is alternately distributed.
- the connecting ribs are made of woven brackets and 6 wires are respectively taken out from 6 joints of the basic structure of one supporting rib.
- 3 are left-handed, 3 are right-handed, and left-handed and right-handed are alternately distributed, and the rotation angle is 240 degrees. It is in turn connected to the six connectors of the basic structure of the other support rib.
- the wire of the braided bracket portion is made of a memory alloy material, and the support support portion is made of stainless steel or alloy.
- the guiding die comprises a guiding wire and a guiding tube fitted on the guiding wire, and the guiding wire is slidably connected with the guiding tube.
- the slidable multi-lumen drainage tube is placed into the left ventricle under the guidance of the guiding wick.
- the guiding wick is withdrawn, and the retracting outer cannula releases the vascular stent at the front of the inner catheter such that the inner catheter is centered in the three aortic valves.
- the inner conduit is connected to the drive system (such as a centrifugal pump, a roller pump, etc.), and the pressure tube on the inner catheter opens the tube clamp, connects the pressure sensor, and continuously measures the left ventricular pressure.
- the invention can achieve the goal of left ventricular drainage without opening the chest, so the use is convenient, not only can reduce the pain of the patient, but also can reduce the bleeding, shorten the operation time; does not cause damage to the aortic valve; and simultaneously measures the left ventricular pressure change, available The evaluation of the left ventricular function and feedback control the flow of the pump.
- the invention is suitable for patients with severe left ventricular dysfunction, and these patients can only effectively reduce the left ventricular front by using the currently used venous-arterial heart assist or venous-venous lung assist.
- the load which seriously affects the recovery of left ventricular function.
- blood in the left ventricle can be discharged, and the left ventricular preload can be lowered.
- the intracardiac pressure drops, the blood supply to the heart muscle improves, thereby promoting recovery of the heart.
- Figure 1 is a schematic view of the structure of the present invention.
- Figure 2 is a cross-sectional view of the inner catheter.
- Figure 3 is a cross-sectional view of the inner conduit.
- Figure 4 is a cross-sectional view of the present invention.
- Figure 5 is a diagram of an embodiment.
- Figure 6 is an ultrasound diagram A.
- Figure 7 is an ultrasound diagram B.
- Figure 8 is a Doppler A.
- Figure 9 is an ultrasound image C.
- Figure 10 is a Doppler plot B.
- Figure 11 is a Doppler plot C.
- Figure 12 is an ultrasound image D.
- Figure 13 is a Doppler map D.
- a slidable multi-cavity drainage tube comprises an outer cannula 1 and an inner catheter 2 located in the inner lumen of the outer cannula 1.
- the inner catheter 2 is provided with a guiding die 3; the outer cannula 1 and the inner cannula
- a blood vessel support 4 is also disposed between the catheters 2, and the blood vessel support 4 is fixed to the outer wall of the inner catheter 2.
- the inner wall of the inner tube 2 is provided with a pressure measuring channel 5, the front opening 6 of the pressure measuring channel is located at the outer wall of the front end of the inner tube 2, and the rear opening 7 of the pressure measuring channel is located at the inner tube 2 The outer wall of the rear end.
- a pressure measuring tube 8 is also included, one end of which is connected to the pressure measuring channel rear opening 7.
- a side hole 9 is formed in the front end wall of the inner tube 2, and the side hole 9 communicates with the inner tube 2 inner cavity and is adjacent to the inner tube front opening 13.
- the pressure measuring tube 8 is further provided with a pipe clamp 10 for blocking the pressure measuring tube 8.
- the blood vessel stent 4 is fixed to the front of the inner catheter 2.
- the guiding die 3 comprises a guiding wire 11 and a guiding tube 12 fitted over the guiding wire 11, the guiding wire 11 being slidably connected to the guiding tube 12.
- the inner tube rear opening 14 and the outer wall of the outer sleeve rear opening 15 are fixed with a crown 16 which is made of a hard plastic.
- a crown 16 which is made of a hard plastic.
- the slidable multi-lumen drainage tube of the present invention is used to successfully puncture the left iliac artery, or other suitable artery, such as the right subclavian artery and the femoral artery, first placing the guiding wire, and fitting the guiding tube The outer end of the wire is guided, the guide tube is slowly implanted, and the slidable multi-lumen drainage tube of the present invention is placed through the guide tube to reach above the aortic sinus. Then, the outer sleeve is kept stationary, and the inner cannula is pushed into the proper position of the left ventricle, then the outer cannula is retracted, the blood vessel stent is released, and the vascular sinus is fixed.
- the drainage tube is maintained to maintain its center position within the aorta.
- the inner catheter is connected to the ECMO into the blood end, and the ECMO is activated.
- blood is passed from the left ventricle - through the inner catheter of the present invention.
- the ultrasound can be seen that the multi-lumen drainage tube is fixed in position, located in the middle of the three valve leaflets of the aortic valve. There is no obvious compression on the aortic valve, and the aortic valve regurgitation is reduced, and the blood can be drained from the left ventricle.
- the tube reaches the artificial pump and the left ventricular drainage is completed.
- cardiac color Doppler ultrasound shows left ventricular failure using a left heart drainage tube for drainage, regardless of whether the aortic valve 18 is closed or open, the aortic valve without a coronary valve 17 on the long axis of the left ventricle is compressed. Another valve is open and free.
- color Doppler suggests: aortic valve 18 moderate eccentric regurgitation.
- the aortic short axis 20 indicates that the position of the left cardiac drainage tube 19 is not in the middle of the three leaflets of the aortic valve 18, but rather that one side of the aortic valve is forced to be compressed.
- color Doppler suggests: eccentric regurgitation of the aortic short axis 20.
- the left iliac artery is successfully punctured, the guiding wick is placed, and the slidable multi-cavity drainage tube of the present invention is placed through the guiding wick to reach the aortic sinus Above.
- the color Doppler image suggests that when the present invention is located in the median position of the aortic valve, there is no compression of the coronary valve, and the aortic regurgitation is significantly reduced.
- the aortic valve short-axis color Doppler shows that the slidable multi-lumen drainage tube of the present invention is located in the median position of the three aortic valves.
- the aortic valve short-axis image suggests a central regurgitation of the aortic valve.
- the experimental results are as follows: after placing the vascular stent, the device of the present invention is lifted up, located in the middle of the aorta and the aortic valve, avoiding the drainage tube pressing the aortic valve, and then the heart color ultrasound prompts that the originally compressed valve is opened and closed. Freely, there are no signs of oppression, and the left ventricular long axis and short axis images respectively indicate that the aortic valve eccentric regurgitation is converted into a central regurgitation, and the return flow is reduced or even disappeared.
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Abstract
A slidable multi-lumen drainage tube comprises an outer cannula (1) and an inner catheter (2) positioned inside the outer cannula (1). The inner catheter (2) is provided with a tubular guiding core (3) therein. An intravascular stent (4) is provided between the outer cannula (1) and the inner catheter (2). The intravascular stent (4) is fixed to an outer wall of the inner catheter (2). A user can implant the drainage tube in the left ventricle of a patient by means of a subclavian artery, an axillary artery or a femoral artery, such that a fluid can be removed from the left ventricle without having to perform a thoracic surgery, thereby easing the pain of a patient, reducing blood loss, shortening operation time, causing no damage to the aortic valve, and measuring a pressure variation in the left ventricle.
Description
本发明涉及医疗手术器械,尤其涉及一种可滑动多腔引流管。The present invention relates to medical surgical instruments, and more particularly to a slidable multi-cavity drainage tube.
对于严重心脏衰竭患者,在其他手段治疗无效后,为了维持患者生命,一般选择使用机械辅助装置,即将血液从机体引出后,经或不经人工肺氧合,再经驱动泵(人工心脏)将血液注入至人体。这种技术被称为“向上帝买生命”。经股静脉从机体内引出血液是最常用的途径,然而这种方式却不能够有效减轻左心室的前负荷,且能增加左心室后负荷,这将导致左心室耗氧量增加,恢复延迟。因此对于左心室衰竭的患者,这种模式并不适合。经左心房引流能够在一定程度上降低左心室前负荷,从而减少心脏做功。然而,对于严重左心室功能衰竭的患者,其作用有限。加之经左心房引流的途径需要开胸手术,因此临床上并不常用。经左心室引流能直接减轻左心室前负荷,使心内压力下降,这不仅能够减少心肌氧耗,而且能增加冠脉血液供应量,从而促进左心室功能恢复。因此左心室引流对于严重左心室衰竭患者极其重要。目前临床上使用的一类左心室引流管需要开胸安置,直接切开左心室安置,此类手术对心肌的创伤大、出血多,因此临床上并不常用。另一类则使用较长引流管,通过其他动脉血管,如股动脉,逆行经主动脉瓣到达左心室。然而心脏功能衰竭时,左心室引流管将会严重压迫主动脉瓣瓣膜(特别是无冠瓣),造成严重的主动脉瓣返流,不仅使左心室引流的效果下降,不利于
左心室功能的恢复,而且主动脉瓣膜长期受压,可能出现严重的瓣膜功能受损变形,甚至粘连而丧失瓣膜功能,从而导致主动脉瓣的永久返流。For patients with severe heart failure, in order to maintain the life of the patient after other means of treatment is ineffective, it is generally preferred to use a mechanical aid, that is, after the blood is taken out of the body, with or without artificial lung oxygenation, and then driven by a pump (artificial heart) Blood is injected into the body. This technique is called "buying life to God." It is the most common way to withdraw blood from the body through the femoral vein. However, this method can not effectively reduce the left ventricular preload and increase the left ventricular afterload, which will lead to increased left ventricular oxygen consumption and delayed recovery. Therefore, this model is not suitable for patients with left ventricular failure. Left atrial drainage can reduce left ventricular preload to a certain extent, thereby reducing cardiac work. However, for patients with severe left ventricular failure, its role is limited. In addition, the route of left atrial drainage requires thoracotomy, so it is not commonly used clinically. Left ventricular drainage can directly reduce the left ventricular preload and reduce the intracardiac pressure, which not only reduces myocardial oxygen consumption, but also increases coronary blood supply, thereby promoting left ventricular function recovery. Therefore, left ventricular drainage is extremely important for patients with severe left ventricular failure. At present, a kind of left ventricular drainage tube used in clinical practice needs to be placed in the thoracic cavity, and the left ventricle is directly incision. Such surgery has great trauma to the myocardium and more bleeding, so it is not commonly used in clinical practice. The other type uses a longer drainage tube that passes through other arterial vessels, such as the femoral artery, retrogradely through the aortic valve to the left ventricle. However, in heart failure, the left ventricular drainage tube will severely compress the aortic valve (especially without the coronary valve), causing severe aortic regurgitation, which not only reduces the effect of left ventricular drainage, but also is not conducive to
The recovery of left ventricular function, and long-term compression of the aortic valve, may result in severe valvular dysfunction, and even adhesion and loss of valve function, resulting in permanent aortic regurgitation.
发明内容Summary of the invention
本发明旨在提供一种可滑动多腔引流管,使用者可以经锁骨下动脉或腋动脉或股动脉,将引流管植入患者左心室中,无需开胸,即可达到左心室引流的目标;不仅可以减轻病人痛苦,还能减少出血量,缩短操作时间;且不会对主动脉瓣造成损伤,同时测量左心室压力变化。The invention aims to provide a slidable multi-cavity drainage tube, which can be inserted into the left ventricle of a patient through a subclavian artery or a radial artery or a femoral artery, and the target of left ventricular drainage can be achieved without opening the chest. Not only can the patient's pain be alleviated, but also reduce the amount of bleeding and shorten the operation time; it will not cause damage to the aortic valve, and measure the left ventricular pressure change.
为达到上述目的,本发明采用的技术方案如下:In order to achieve the above object, the technical solution adopted by the present invention is as follows:
一种可滑动多腔引流管,包括外套管和位于外套管内腔的内导管,内导管内腔设有引导管芯;所述外套管与内导管之间还设有血管支架,所述血管支架固定在内导管外壁上。A slidable multi-lumen drainage tube includes an outer cannula and an inner catheter located in the inner cannula lumen, the inner catheter lumen is provided with a guiding die; and the outer cannula and the inner catheter are further provided with a blood vessel stent, the blood vessel stent Fixed on the outer wall of the inner catheter.
内导管植入外套管内,内导管可以根据需要,在外套管内滑动,后退外套管后可释放固定在内导管上的血管支架,从而支撑内导管于血管正中位置,以避免内导管压迫主动脉瓣膜而导致主动脉瓣返流和主动脉瓣膜的毁损(长时间压迫)。引导管芯在引流管置入过程中引导外套管和内导管,从而经外周动脉逆行进入升主动脉。The inner catheter is implanted in the outer cannula, and the inner catheter can slide in the outer cannula as needed. After the outer cannula is retracted, the vascular stent fixed on the inner catheter can be released, thereby supporting the inner catheter in the middle of the blood vessel to prevent the inner catheter from compressing the aortic valve. This results in aortic regurgitation and destruction of the aortic valve (long-term compression). The guiding die guides the outer cannula and the inner catheter during the placement of the drainage tube, thereby retrograde into the ascending aorta via the peripheral artery.
内导管后开口与驱动系统相连(如离心泵、滚压泵等),通过驱动系统将左心室血液引流至体外。The inner catheter rear opening is connected to the drive system (such as a centrifugal pump, a roller pump, etc.), and the left ventricular blood is drained to the outside through a drive system.
优选的,所述内导管的管壁内开有测压通道,所述测压通道前开口位于内导管前端外壁,测压通道后开口位于内导管后端外壁。Preferably, the inner wall of the inner tube is provided with a pressure measuring channel, the front opening of the pressure measuring channel is located at the outer wall of the front end of the inner tube, and the rear opening of the pressure measuring channel is located at the outer wall of the rear end of the inner tube.
优选的,还包括测压管,所述测压管的一端与测压通道后开口连接。测压管可以直接插装在测压通道后开口上。当然,测压通道后开口位置可以设有一个连接头,测压管通过接头与测压通道连通;在不需要测压时,连接头
上还设有封闭头,避免血液从测压通道流出。Preferably, the utility model further comprises a pressure measuring tube, and one end of the pressure measuring tube is connected to the rear opening of the pressure measuring channel. The piezometer can be directly inserted into the rear opening of the pressure measuring channel. Of course, the rear opening position of the pressure measuring passage can be provided with a connecting head, and the pressure measuring tube is connected to the pressure measuring passage through the joint; when the pressure measuring is not required, the connecting head
There is also a closed head to prevent blood from flowing out of the pressure measuring channel.
测压管的另一端连接压力传感器后可连续测量左心室压力。测压管上还设有管夹,管夹能阻断测压管与测压通道的通路。The left end chamber pressure can be continuously measured after the other end of the piezometer is connected to the pressure sensor. The pressure measuring tube is also provided with a pipe clamp, which can block the passage of the pressure measuring tube and the pressure measuring channel.
优选的,所述内导管前端管壁上开有侧孔,所述侧孔与内导管内腔连通并靠近内导管前开口。Preferably, the inner tube front wall has a side hole formed therein, and the side hole communicates with the inner tube inner cavity and close to the inner tube front opening.
内导管本体前端设有数个侧孔,避免在引流过程中被阻塞。The front end of the inner catheter body is provided with a plurality of side holes to avoid being blocked during the drainage process.
优选的,所述测压管上还设有阻断测压管的管夹。Preferably, the pressure measuring tube is further provided with a pipe clamp for blocking the pressure measuring tube.
优选的,所述血管支架固定在内导管前部。内导管前部的血管支架,可以使内导管位于3个主动脉瓣膜的中央,避免内导管压迫主动脉瓣膜而导致主动脉瓣返流和主动脉瓣膜的毁损。Preferably, the vascular stent is secured to the front of the inner catheter. The vascular stent at the front of the inner catheter allows the inner catheter to be located in the center of the three aortic valves, preventing the inner catheter from compressing the aortic valve and causing aortic regurgitation and destruction of the aortic valve.
血管支架包括支撑筋和连接筋,其支撑筋是切割支架,支撑筋的截面较大,连接筋部分采用编织支架,编织支架由细金属丝编织而成,金属丝截面小,支撑筋之间由编织支架连接,组成不同长度的重复单元,构成血管支架。The blood vessel support comprises a support rib and a connecting rib, the support rib is a cutting support, the support rib has a large cross section, the connecting rib part is a woven support, the woven support is woven by a thin metal wire, the wire cross section is small, and the support rib is between The braided stents are connected to form repeating units of different lengths to form a blood vessel stent.
支撑筋的基本结构为正弦曲线型围成的环状结构,支撑筋有多个基本结构重复组成,相邻两个基本结构正弦波谷的波谷和波谷相对,波峰和波峰相对;The basic structure of the supporting rib is a ring structure surrounded by a sinusoidal curve. The supporting rib has a plurality of basic structural repeats. The valleys and troughs of the sinusoidal valleys of the two adjacent basic structures are opposite, and the peaks and peaks are opposite;
支撑筋的基本结构划分为支撑筋直线处和支撑筋拐弯处,支撑筋基本结构直线处和支撑筋基本结构拐弯处交替变换最终围成环状结构;支撑筋基本结构的截面采用变截面的设计,在支撑筋基本结构直线处截面面积较小,支撑筋基本结构拐弯处截面面积较大,从直线处到拐弯处支撑筋的截面面积逐渐变大,然后再从拐弯处到直线处逐渐变小,依此重复变化。The basic structure of the support rib is divided into the straight line of the support rib and the corner of the support rib. The basic structure of the support rib and the basic structure of the support rib are alternately transformed into a ring structure. The cross section of the basic structure of the support rib is designed with variable cross section. The cross-sectional area of the basic structure of the support rib is small, and the cross-sectional area of the basic structure of the support rib is large. The cross-sectional area of the support rib from the straight line to the bend gradually becomes larger, and then gradually decreases from the bend to the straight line. And repeat the changes accordingly.
支撑筋基本结构拐弯处的顶部都有一个突出的连接头,该支撑筋连接头的主要功能是用于支撑筋与连接筋的连接;连接筋采用编织支架,编织支架
与支撑筋之间的连接通过编织支架金属丝与支撑筋连接头之间的连接,连接方式采用熔焊的方法。The top of the basic structure of the support rib has a protruding joint at the top, and the main function of the support rib joint is for the connection of the support rib and the connecting rib; the connecting rib adopts a woven bracket and a woven bracket
The connection with the support ribs is through the connection between the braided support wire and the support rib joint, and the connection method is a fusion welding method.
连接筋采用编织支架,选用金属丝从一个支撑筋基本结构的连接头引出,通过旋转一定角度与相邻的另一个支撑筋基本结构的连接头进行连接,旋转分为左旋和右旋,左旋和右旋交替分布。The connecting rib adopts a woven bracket, and the wire is taken out from the joint of the basic structure of one supporting rib, and is connected by a connecting angle of a basic structure of another supporting rib by rotating a certain angle, and the rotation is divided into left-handed and right-handed, left-handed and The right-handed rotation is alternately distributed.
连接筋采用编织支架选用6根金属丝分别从一个支撑筋基本结构的6个连接头引出,3根采用左旋,两外3根采用右旋,左旋和右旋交替分布,旋转角度为240度,依次与另一个支撑筋基本结构的6个连接头相连。The connecting ribs are made of woven brackets and 6 wires are respectively taken out from 6 joints of the basic structure of one supporting rib. 3 are left-handed, 3 are right-handed, and left-handed and right-handed are alternately distributed, and the rotation angle is 240 degrees. It is in turn connected to the six connectors of the basic structure of the other support rib.
编织支架部分的金属丝采用记忆合金材料,支架支撑筋部分采用不锈钢或合金。The wire of the braided bracket portion is made of a memory alloy material, and the support support portion is made of stainless steel or alloy.
优选的,所述引导管芯包括引导钢丝和套装在引导钢丝上的引导管,引导钢丝与引导管滑动连接。Preferably, the guiding die comprises a guiding wire and a guiding tube fitted on the guiding wire, and the guiding wire is slidably connected with the guiding tube.
本发明的目的是要提供用于左心室引流的导管,使用者可以经锁骨下动脉或腋动脉或股动脉,将引导管芯放入左心室内。在引导管芯的引导下,将可滑动多腔引流管放入左心室。当较长的内导管到达左心室正确位置后,拔出引导管芯,后退外套管释放内导管前部的血管支架,使内导管位于3个主动脉瓣膜的中央。内导管与驱动系统相连(如离心泵、滚压泵等),同时内导管上的测压管打开管夹,连接压力传感器,连续测量左心室压力。使用本发明无需开胸,即可达到左心室引流的目标,因此使用方便,不仅可以减轻病人痛苦,还能减少出血,缩短操作时间;不对主动脉瓣造成损伤;同时测量左心室压力变化,可用于左心室功能的评估和反馈控制泵的流量。It is an object of the present invention to provide a catheter for left ventricular drainage that can be placed into the left ventricle by a user via a subclavian artery or a radial or femoral artery. The slidable multi-lumen drainage tube is placed into the left ventricle under the guidance of the guiding wick. When the longer inner catheter reaches the correct position of the left ventricle, the guiding wick is withdrawn, and the retracting outer cannula releases the vascular stent at the front of the inner catheter such that the inner catheter is centered in the three aortic valves. The inner conduit is connected to the drive system (such as a centrifugal pump, a roller pump, etc.), and the pressure tube on the inner catheter opens the tube clamp, connects the pressure sensor, and continuously measures the left ventricular pressure. The invention can achieve the goal of left ventricular drainage without opening the chest, so the use is convenient, not only can reduce the pain of the patient, but also can reduce the bleeding, shorten the operation time; does not cause damage to the aortic valve; and simultaneously measures the left ventricular pressure change, available The evaluation of the left ventricular function and feedback control the flow of the pump.
本发明适用于合并严重左心室功能障碍患者,这些患者仅使用目前常用的静脉-动脉心脏辅助,或者静脉-静脉肺脏辅助,均不能有效减轻左心室前
负荷,从而严重影响左心室功能恢复。而使用本发明,即可将左心室内血液排出,使左心室前负荷下降。随着心内压力的下降,心肌血液供应改善,从而促进心脏的恢复。The invention is suitable for patients with severe left ventricular dysfunction, and these patients can only effectively reduce the left ventricular front by using the currently used venous-arterial heart assist or venous-venous lung assist.
The load, which seriously affects the recovery of left ventricular function. By using the present invention, blood in the left ventricle can be discharged, and the left ventricular preload can be lowered. As the intracardiac pressure drops, the blood supply to the heart muscle improves, thereby promoting recovery of the heart.
图1为本发明结构示意图。Figure 1 is a schematic view of the structure of the present invention.
图2为内导管剖面图。Figure 2 is a cross-sectional view of the inner catheter.
图3为内导管截面图。Figure 3 is a cross-sectional view of the inner conduit.
图4为本发明截面图。Figure 4 is a cross-sectional view of the present invention.
图5为实施例图。Figure 5 is a diagram of an embodiment.
图6为超声图A。Figure 6 is an ultrasound diagram A.
图7为超声图B。Figure 7 is an ultrasound diagram B.
图8为多普勒图A。Figure 8 is a Doppler A.
图9为超声图C。Figure 9 is an ultrasound image C.
图10为多普勒图B。Figure 10 is a Doppler plot B.
图11为多普勒图C。Figure 11 is a Doppler plot C.
图12为超声图D。Figure 12 is an ultrasound image D.
图13为多普勒图D。Figure 13 is a Doppler map D.
图中:1-外套管、2-内导管、3-引导管芯、4-血管支架、5-测压通道、6-测压通道前开口、7-测压通道后开口、8-测压管、9-侧孔、10-管夹、11-引导钢丝、12-引导管、13-内导管前开口、14-内导管后开口、15-外套管后开口、16-柄头、17-无冠瓣、18-主动脉瓣、19-左心引流管、20-主动脉短轴、21-可滑动多腔引流管。In the figure: 1-outer cannula, 2-inner catheter, 3-guided wick, 4-vascular stent, 5-pressure channel, 6-pressure channel front opening, 7-pressure channel rear opening, 8-pressure Tube, 9-side hole, 10-tube clamp, 11-guide wire, 12-guide tube, 13-inner catheter front opening, 14-inner catheter rear opening, 15-outer casing rear opening, 16-handle, 17- Non-crown valve, 18-aortic valve, 19-left heart drainage tube, 20-aortic short axis, 21-slidable multi-lumen drainage tube.
为了使本发明的目的、技术方案及优点更加清楚明白,以下结合附图,对本发明进行进一步详细说明。In order to make the objects, technical solutions and advantages of the present invention more comprehensible, the present invention will be further described in detail with reference to the accompanying drawings.
如图1所示,一种可滑动多腔引流管,包括外套管1和位于外套管1内腔的内导管2,内导管2内腔设有引导管芯3;所述外套管1与内导管2之间还设有血管支架4,所述血管支架4固定在内导管2外壁上。As shown in Figure 1, a slidable multi-cavity drainage tube comprises an outer cannula 1 and an inner catheter 2 located in the inner lumen of the outer cannula 1. The inner catheter 2 is provided with a guiding die 3; the outer cannula 1 and the inner cannula A blood vessel support 4 is also disposed between the catheters 2, and the blood vessel support 4 is fixed to the outer wall of the inner catheter 2.
如图2和图3所示,所述内导管2的管壁内开有测压通道5,所述测压通道前开口6位于内导管2前端外壁,测压通道后开口7位于内导管2后端外壁。还包括测压管8,所述测压管8的一端与测压通道后开口7连接。所述内导管2前端管壁上开有侧孔9,所述侧孔9与内导管2内腔连通并靠近内导管前开口13。所述测压管8上还设有阻断测压管8的管夹10。As shown in FIG. 2 and FIG. 3, the inner wall of the inner tube 2 is provided with a pressure measuring channel 5, the front opening 6 of the pressure measuring channel is located at the outer wall of the front end of the inner tube 2, and the rear opening 7 of the pressure measuring channel is located at the inner tube 2 The outer wall of the rear end. A pressure measuring tube 8 is also included, one end of which is connected to the pressure measuring channel rear opening 7. A side hole 9 is formed in the front end wall of the inner tube 2, and the side hole 9 communicates with the inner tube 2 inner cavity and is adjacent to the inner tube front opening 13. The pressure measuring tube 8 is further provided with a pipe clamp 10 for blocking the pressure measuring tube 8.
如图4所示,所述血管支架4固定在内导管2前部。所述引导管芯3包括引导钢丝11和套装在引导钢丝11上的引导管12,引导钢丝11与引导管12滑动连接。As shown in FIG. 4, the blood vessel stent 4 is fixed to the front of the inner catheter 2. The guiding die 3 comprises a guiding wire 11 and a guiding tube 12 fitted over the guiding wire 11, the guiding wire 11 being slidably connected to the guiding tube 12.
为方便操作和固定,内导管后开口14和外套管后开口15的外壁上均固定有柄头16,柄头16材料为硬质塑料,在操作内导管2和外套管1滑动时,能够在柄头16位置施加力量,便于滑动;同时在使内导管2与与驱动系统相连时,可以在内导管柄头设置螺纹,也可以不设置螺纹,采用插接连接的方式,方便固定。For ease of operation and fixation, the inner tube rear opening 14 and the outer wall of the outer sleeve rear opening 15 are fixed with a crown 16 which is made of a hard plastic. When the inner tube 2 and the outer sleeve 1 are slid in operation, The position of the handle 16 is applied with force to facilitate sliding; at the same time, when the inner tube 2 is connected with the driving system, the inner tube can be provided with a thread or a thread, and the plug connection is convenient for fixing.
如图5所示,使用本发明的可滑动多腔引流管成功穿刺左侧腋动脉,或其他部位合适的动脉,如右锁骨下动脉,股动脉,首先置入引导钢丝,将引导管套装在引导钢丝外端,缓慢植入引导管,经引导管芯置入本发明的可滑动多腔引流管,到达主动脉窦部上方。随后保持外套管不动,推送内套管进入左心室合适位置后,后退外套管,释放血管支架,固定于主动脉窦部上方,
支撑引流管维持其在主动脉内正中位置。取出引导管芯,使内导管连接ECMO入血端后,启动ECMO,在人工泵的驱动下,血液从左心室-经本发明的内导管。在血流的作用下,超声可见多腔引流管位置固定,位于主动脉瓣三个瓣叶中间,对主动脉瓣无明显压迫,同时主动脉瓣返流减少,血液即可从左心室经引流管到达人工泵,完成实施左心室引流。As shown in FIG. 5, the slidable multi-lumen drainage tube of the present invention is used to successfully puncture the left iliac artery, or other suitable artery, such as the right subclavian artery and the femoral artery, first placing the guiding wire, and fitting the guiding tube The outer end of the wire is guided, the guide tube is slowly implanted, and the slidable multi-lumen drainage tube of the present invention is placed through the guide tube to reach above the aortic sinus. Then, the outer sleeve is kept stationary, and the inner cannula is pushed into the proper position of the left ventricle, then the outer cannula is retracted, the blood vessel stent is released, and the vascular sinus is fixed.
The drainage tube is maintained to maintain its center position within the aorta. After the guide wick is removed, the inner catheter is connected to the ECMO into the blood end, and the ECMO is activated. Under the drive of the artificial pump, blood is passed from the left ventricle - through the inner catheter of the present invention. Under the action of blood flow, the ultrasound can be seen that the multi-lumen drainage tube is fixed in position, located in the middle of the three valve leaflets of the aortic valve. There is no obvious compression on the aortic valve, and the aortic valve regurgitation is reduced, and the blood can be drained from the left ventricle. The tube reaches the artificial pump and the left ventricular drainage is completed.
在使用常规左心室引流管19进行的动物实验中,通过心脏彩超观测主动脉情况:In an animal experiment using a conventional left ventricular drainage tube 19, the aortic condition was observed by echocardiography:
如图6和7所示,心脏彩超显示急性左心室衰竭时,使用左心引流管进行引流,无论主动脉瓣18关闭或者开放状态下,左心室长轴的主动脉瓣膜无冠瓣17被压,另外一个瓣膜开放自如。As shown in Figures 6 and 7, cardiac color Doppler ultrasound shows left ventricular failure using a left heart drainage tube for drainage, regardless of whether the aortic valve 18 is closed or open, the aortic valve without a coronary valve 17 on the long axis of the left ventricle is compressed. Another valve is open and free.
如图8所示,彩色多普勒提示:主动脉瓣18中度偏心性返流。As shown in Figure 8, color Doppler suggests: aortic valve 18 moderate eccentric regurgitation.
如图9所示,主动脉短轴20提示左心引流管19位置不在主动脉瓣18三个瓣叶正中间,而是偏向一侧导致主动脉瓣的无冠瓣17被压迫。As shown in Fig. 9, the aortic short axis 20 indicates that the position of the left cardiac drainage tube 19 is not in the middle of the three leaflets of the aortic valve 18, but rather that one side of the aortic valve is forced to be compressed.
如图10所示,彩色多普勒提示:主动脉短轴20偏心性返流。As shown in Figure 10, color Doppler suggests: eccentric regurgitation of the aortic short axis 20.
实验结果为:左心室衰竭时,心脏超声显示左心室短轴和长轴分别看到被左心引流管压迫的无冠瓣,多普勒彩色超声显示左心引流管压迫主动脉瓣瓣膜造成瓣膜(主要是无冠瓣)中度偏心返流。The results of the experiment were: In the left ventricular failure, echocardiography showed that the left ventricular short axis and the long axis saw the unsupervised flap compressed by the left cardiac drainage tube respectively. Doppler color ultrasound showed that the left cardiac drainage tube compressed the aortic valve to cause the valve. (mainly without crown flap) moderate eccentric return.
在使用本发明的可滑动多腔引流管进行的动物实验中,通过心脏彩超观测主动脉返流情况:In an animal experiment using a slidable multi-lumen drain tube of the present invention, aortic regurgitation was observed by echocardiography:
如图11所示,使用本发明的可滑动多腔引流管,成功穿刺左侧腋动脉,置入引导管芯,经引导管芯放置本发明的可滑动多腔引流管,到达主动脉窦部上方。彩色多普勒图像提示,本发明位于主动脉瓣正中位置的时候,无冠瓣无压迫现象,主动脉返流明显减少。
As shown in FIG. 11, using the slidable multi-lumen drainage tube of the present invention, the left iliac artery is successfully punctured, the guiding wick is placed, and the slidable multi-cavity drainage tube of the present invention is placed through the guiding wick to reach the aortic sinus Above. The color Doppler image suggests that when the present invention is located in the median position of the aortic valve, there is no compression of the coronary valve, and the aortic regurgitation is significantly reduced.
如图12所示,主动脉瓣短轴彩超显示,本发明的可滑动多腔引流管位于主动脉三个瓣叶正中位。As shown in Fig. 12, the aortic valve short-axis color Doppler shows that the slidable multi-lumen drainage tube of the present invention is located in the median position of the three aortic valves.
如图13所示,主动脉瓣短轴图像提示,主动脉瓣微量的中心性返流。As shown in Figure 13, the aortic valve short-axis image suggests a central regurgitation of the aortic valve.
实验结果为:放置血管支架后,将本发明的装置抬起,位于主动脉及主动脉瓣的正中位置,避免了引流管压迫主动脉瓣瓣膜,之后心脏彩超提示,原来被压迫的瓣膜开闭自如,无被压迫迹象,左心室长轴和短轴图像分别提示主动脉瓣偏心返流转变为中心返流,同时返流量减少,甚至消失。The experimental results are as follows: after placing the vascular stent, the device of the present invention is lifted up, located in the middle of the aorta and the aortic valve, avoiding the drainage tube pressing the aortic valve, and then the heart color ultrasound prompts that the originally compressed valve is opened and closed. Freely, there are no signs of oppression, and the left ventricular long axis and short axis images respectively indicate that the aortic valve eccentric regurgitation is converted into a central regurgitation, and the return flow is reduced or even disappeared.
当然,本发明还可有其它多种实施例,在不背离本发明精神及其实质的情况下,熟悉本领域的技术人员可根据本发明作出各种相应的改变和变形,但这些相应的改变和变形都应属于本发明所附的权利要求的保护范围。
The invention may, of course, be embodied in a variety of other embodiments, and various changes and modifications can be made in accordance with the present invention without departing from the spirit and scope of the invention. And modifications are intended to fall within the scope of the appended claims.
Claims (7)
- 一种可滑动多腔引流管,其特征在于:包括外套管和位于外套管内腔的内导管,内导管内腔设有引导管芯;所述外套管与内导管之间还设有血管支架,所述血管支架固定在内导管外壁上。A slidable multi-lumen drainage tube, comprising: an outer sleeve and an inner tube located in the inner sleeve inner cavity; the inner tube inner cavity is provided with a guiding die; and the outer sleeve and the inner tube are further provided with a blood vessel bracket, The blood vessel stent is fixed to the outer wall of the inner catheter.
- 根据权利要求1所述的一种可滑动多腔引流管,其特征在于:所述内导管的管壁内开有测压通道,所述测压通道前开口位于内导管前端外壁,测压通道后开口位于内导管后端外壁。The slidable multi-cavity drainage tube according to claim 1, wherein the inner wall of the inner tube has a pressure measuring channel, and the front opening of the pressure measuring channel is located at the outer wall of the front end of the inner tube, and the pressure measuring channel The rear opening is located at the outer wall of the rear end of the inner conduit.
- 根据权利要求2所述的一种可滑动多腔引流管,其特征在于:还包括测压管,所述测压管的一端测压通道后开口连接。The slidable multi-cavity drainage tube according to claim 2, further comprising a pressure measuring tube, wherein the pressure measuring tube has a pressure measuring channel at one end and is connected to the opening.
- 根据权利要求1所述的一种可滑动多腔引流管,其特征在于:所述内导管前端管壁上开有侧孔,所述侧孔与内导管内腔连通并靠近内导管前开口。A slidable multi-cavity drainage tube according to claim 1, wherein a side hole is formed in the wall of the front end of the inner tube, and the side hole communicates with the inner tube inner cavity and close to the front opening of the inner tube.
- 根据权利要求3所述的一种可滑动多腔引流管,其特征在于:所述测压管上还设有阻断测压管的管夹。A slidable multi-cavity drainage tube according to claim 3, wherein the pressure measuring tube is further provided with a tube clamp for blocking the pressure measuring tube.
- 根据权利要求1所述的一种可滑动多腔引流管,其特征在于:所述血管支架固定在内导管前部。A slidable multi-lumen drainage tube according to claim 1 wherein said vascular stent is secured to the front of the inner catheter.
- 根据权利要求1-6任一所述的一种可滑动多腔引流管,其特征在于:所述引导管芯包括引导钢丝和套装在引导钢丝上的引导管,引导钢丝与引导管滑动连接。 A slidable multi-cavity draft tube according to any of claims 1-6, wherein the guiding die comprises a guiding wire and a guiding tube fitted over the guiding wire, the guiding wire being slidably connected to the guiding tube.
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CN201710035459.9A CN107441614A (en) | 2017-01-18 | 2017-01-18 | Slidable multi-cavity drainage tube |
CN201710035459.9 | 2017-01-18 |
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PCT/CN2017/075187 WO2018133175A1 (en) | 2017-01-18 | 2017-02-28 | Slidable multi-lumen drainage tube |
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WO (1) | WO2018133175A1 (en) |
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CN109009591B (en) * | 2018-08-24 | 2024-02-27 | 四川大学 | Bioabsorbable stent |
CN114305323B (en) * | 2020-09-27 | 2023-10-31 | 四川大学华西医院 | Method, device and equipment for predicting complications after transcatheter aortic valve replacement operation |
CN114081674B (en) * | 2021-09-28 | 2023-08-15 | 四川大学华西医院 | Valve leaf segmentation device |
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- 2017-02-28 WO PCT/CN2017/075187 patent/WO2018133175A1/en active Application Filing
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CN205759114U (en) * | 2016-06-17 | 2016-12-07 | 韩宇 | Ultrasound guidance pulmonary stenosis Nephrolithotomy Percutaneous is with guiding conduit |
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