WO2015042938A1 - 一种用于超声引导下室间隔缺损封堵术的适配引导系统 - Google Patents

一种用于超声引导下室间隔缺损封堵术的适配引导系统 Download PDF

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Publication number
WO2015042938A1
WO2015042938A1 PCT/CN2013/084690 CN2013084690W WO2015042938A1 WO 2015042938 A1 WO2015042938 A1 WO 2015042938A1 CN 2013084690 W CN2013084690 W CN 2013084690W WO 2015042938 A1 WO2015042938 A1 WO 2015042938A1
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Prior art keywords
catheter
sheath
ultrasound
guide wire
straight
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PCT/CN2013/084690
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English (en)
French (fr)
Inventor
潘湘斌
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潘湘斌
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Priority to PCT/CN2013/084690 priority Critical patent/WO2015042938A1/zh
Priority to CN201380077799.8A priority patent/CN105339034B/zh
Publication of WO2015042938A1 publication Critical patent/WO2015042938A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A61B8/0841—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/00336—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means with a protective sleeve, e.g. retractable or slidable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00623—Introducing or retrieving devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound

Definitions

  • the invention belongs to the technical field of medicine, and particularly relates to a guiding system for ultrasound guided ventricular septal defect occlusion and its adaptation. Background technique
  • Ventricular septal defect refers to ventricular septal dysplasia during the embryonic period, which forms abnormal traffic and produces a left-to-right shunt at the ventricular level. Ventricular septal defect is the most common congenital heart disease, accounting for congenital heart disease
  • the defect is often 0.1-3cm, which is more common in the membrane. If the defect is ⁇ 0.3cm, the flow rate will be small and there will be no clinical symptoms. In the case of a small defect, the heart size can be normal, and the left ventricle is significantly enlarged in the large defect, and can cause pulmonary hypertension, leading to death of the patient. Since the percutaneous intervention in the last century, there have been cases of percutaneous transluminal septal occlusion, percutaneous ventricular septal defect occlusion, percutaneous patent ductus arteriosus occlusion, stent implantation, etc. A group of classic surgery.
  • the present invention provides a simple ultrasound guided or radiation and ultrasound The same is guided through the transfemoral ventricular septal defect occlusion, and an adapted guiding system for the simplex-guided or radiofrequency-ultrasonic guided transfemoral ventricular septal defect occlusion.
  • the present invention provides a novel guiding system for transfemoral ventricular septal defect occlusion combined with simple ultrasound guidance or radiation and ultrasound, the guiding system comprising a guide wire for guiding the inner catheter and delivering the occluder An outer catheter, an inner catheter for guiding the guide wire, and a loading sheath for receiving the occluder;
  • the outer catheter includes a sheath of a hollow structure and an inner core inserted into the sheath for guiding the outer catheter into the femoral vein, the sheath being adapted for insertion of the inner catheter and the inner core;
  • the sheath tube is sequentially divided into a first straight segment, a first arc segment and a second straight segment along a direction in which it is inserted into the blood vessel;
  • the first arc segment is an arc shape of 120-160°, and the first straight segment
  • the angle between the extension line and the extension line of the second straight section is 20-60°, and the second straight section is provided with a hemostatic width away from the end of the first arc section;
  • the inner core is a hollow, elongated structure adapted to be inserted and slid by the guide wire, the inner core being adapted to be inserted into the sheath tube of the outer catheter, the inner core being inserted into the sheath along the inner core
  • the insertion direction of the tube is divided into a head portion and a body, the head portion being tapered and bent at 0-45 ° with the main body;
  • the inner catheter is a hollow catheter adapted to be inserted into the sheath of the outer catheter and adapted to be inserted and passed through the guidewire along which the inner catheter is inserted into the sheath of the outer catheter
  • the insertion direction is divided into a head bending section and a tail straight section, and the head bending section and the tail straight section are at an angle of 45-90°;
  • the loading sheath is a hollow tubular structure whose outer diameter is adapted to the inner diameter of the sheath of the outer catheter, and can be inserted into the sheath of the outer catheter via the hemostatic, the loading sheath being on the outer wall
  • a symmetrical wing-like projection is provided at a position adjacent to the direction in which the loading sheath is inserted into the catheter.
  • the first straight segment is 1-6 cm long
  • the second straight segment is 100-120 cm long
  • the inner core is 130-140 cm long
  • the head of the inner core is 5-15 a centimeter
  • the head bending section is 0.5-2 cm long
  • the tail straight section is 148-152 cm long
  • the loading sheath is 6-10 cm long
  • the wing protrusion is disposed adjacent to the loading sheath.
  • the position of the outer catheter is 1.5-2.5 cm.
  • the first straight section is 4 cm long
  • the second straight section is 110 cm long
  • the inner core is 135 cm long
  • the head of the inner core is 10 cm
  • the folding section is 1 cm long
  • the tail straight section is 150 cm long
  • the loading sheath is 8 cm long
  • the wing protrusion is provided Positioned 2 cm away from the direction in which the loading sheath was inserted into the outer catheter.
  • the head bending section of the inner conduit is at an angle of 45°, 60° or 90° with the straight section of the tail.
  • the inner diameter of the sheath tube is 6F, 7F, 8F, 9F, 10F, and the outer wall of the second straight section of the sheath of the outer catheter is marked with a numerical mark every 1 cm in sequence, and the outer catheter is recorded into the body. depth.
  • the inner catheter has a diameter type of 6F, and the outer wall of the tail straight section of the inner conduit is numerically marked every 1 cm in sequence, and the depth of the inner conduit into the outer conduit is recorded.
  • the guidewire is a straight guidewire of 0.035 or 0.038 inches.
  • the invention also discloses an occlusion of the femoral vein ventricular septal defect under the guidance of ultrasound alone or under the guidance of radiation and ultrasound, which specifically includes:
  • the step of blocking the step (4) may further be: after the step (3), withdrawing the inner catheter, leaving the straight guide wire in the left ventricle or the aorta, along the straight
  • the head guide wire inserts the inner core into the sheath tube, pushes the entire outer catheter along the straight guide wire, passes through the chamber to reach the left chamber; and exits the inner core and the guide wire, and blocks the corresponding size
  • the device collects the loading sheath and delivers the hemostasis into the sheath tube for sealing.
  • the step of blocking the step (4) may further be: after the step (3), the straight guide wire is withdrawn, the inner catheter is left in the left chamber, and the inner catheter is inserted into the mud guide wire.
  • the muddy guide wire is kept in the left ventricle or the aorta, and the sheath of the inner catheter and the outer catheter is withdrawn, and the traditional ventricular septal defect occluder delivery system is sent along the muddy guide wire, and the ventricular occlusion device is closed by the corresponding occluder.
  • the ultrasonic operation is to display a four-chamber heart, a long axis of the aorta, etc. according to the specific situation, and the radiation operation is performed according to the specific situation, and the left and right oblique positions are projected according to the specific situation.
  • the indications and contraindications of the percutaneous transluminal septal defect occlusion guided by the simple transthoracic ultrasound according to the present invention are the same as the indications and contraindications of the current ray-guided surgery.
  • the occlusion technique of the present invention can use ultrasound as the only guiding means, completely independent of radiation, and after the puncture or incision of the femoral vein, under the guidance of ultrasound, the guide wire and the catheter are inserted into the heart, from the right ventricle surface. After passing through the ventricular septal defect, the occluder is placed in the lesion position through the catheter, which overcomes the problem of radiation and contrast agent damage caused by the radiation as the guiding medium in the prior art;
  • the guiding system of the guiding system of the invention has a diameter of more than 6F, and cooperates with a guide wire of more than 0.035 inches, so that the ultrasound can clearly show the position of the whole system in the heart.
  • the outer catheter head is 120-160 radians, which fits the angle between the inferior vena cava and the tricuspid opening. After the external catheter enters the right atrium through the inferior vena cava, the first straight segment can be passed through the outer catheter. The cusp is inserted into the right chamber. Since the direction of the ventricular septal defect is parallel to the direction of the first straight segment of the outer catheter, the inner catheter is designed to be bent at 45-90 degrees.
  • the opening direction is close to the chamber spacing, and the guide wire extends through the inner catheter.
  • the ventricular septal defect can be passed in a vertical direction. Due to the ventricular septal defect, the direction of blood flow in the right ventricular opening can be perpendicular to the interventricular septum, or slightly toward the apex, at an angle of 45-90 degrees to the interventricular septum, so the inner catheter is provided with three models, respectively 45, 60, 90 Degree of bending. It can be selected according to the opening direction of the right ventricular surface of the ventricular septal defect;
  • the external catheter of the system can be directly used as the delivery sheath of the occluder. It is not necessary to change the sheath tube back and forth. For special ventricular septal defect in some positions, the outer catheter may not easily pass through the ventricular septum. We also provide the guidance.
  • the method of using the traditional ventricular septal defect to transport the sheath tube is used as an alternative; 4, because the risk of femoral artery puncture in general surgery is much higher than femoral vein puncture, and the need to establish orbit, you need to take a guide wire from the left femoral artery ⁇ aortic valve ⁇ ventricular septal defect ⁇ tricuspid valve ⁇ right atrium ⁇
  • the inferior vena cava ⁇ right femoral vein is not only time-consuming and laborious, but also easy to damage important structures such as aortic valve and tricuspid valve.
  • the operation using this system does not require puncture of the femoral artery, and no need to establish an arteriovenous orbit, completely avoiding the above risks. Not only is it easy to operate but also has fewer complications.
  • the new guiding system has completed 30 animal experiments, of which the first 10 cases were completed under the guidance of ultrasound and radiation, and the last 20 cases were completed under ultrasound guidance. All the sealing was successful, and there was no serious occluder shedding or pericardial effusion. Complications, operation time and radiation exposure time were significantly less than conventional radiotherapy-guided ventricular occlusion, and the results were good.
  • FIG. 1 is a schematic structural view of a sheath tube of an outer catheter in a guiding system according to the present invention
  • FIG. 2 is a schematic structural view of an inner core of an outer catheter in the guiding system of the present invention
  • FIG. 3 is a schematic structural view of an inner catheter in the guiding system of the present invention.
  • FIG. 4 is a schematic view showing the structure of a loading sheath in the guiding system of the present invention. detailed description
  • the present invention relates to a novel guiding system for guiding transfemoral ventricular septal defect with simple ultrasound guided or radiation and ultrasound, including a guide wire, an outer catheter for guiding the inner catheter and conveying the occluder, and
  • the inner catheter FH for guiding the guide wire, and the loading sheath for accommodating the occluder are shown in Figs. 1, 2, and the outer catheter includes a sheath AD of a hollow structure as shown in Fig. 1 and as shown in Fig. 2.
  • An inner core inserted into the sheath tube AD for guiding the outer catheter into the femoral vein, the sheath tube being adapted for insertion of the inner catheter FH and the inner core IJ.
  • the sheath tube AD is sequentially divided into a first straight segment AB, a first arc segment BEC and a second straight segment CD along a direction in which it is inserted into a blood vessel;
  • the first arc segment BEC is 120-160 a circular arc shape, and preferably 135°;
  • the first straight segment AB is 1-6 cm long, and preferably 4 cm, and the second straight segment CD is 100-120 cm long, and preferably 115 cm;
  • the angle between the extension of the straight section AB and the extension of the second straight section CD is 20-60°, and preferably 45°.
  • the second The straight segment CD is provided with a hemostasis wide away from the end D of the first arc segment.
  • the inner diameter of the sheath tube AD is 6F, 7F, 8F, 9F, 10F, and the outer wall of the second straight segment CD of the sheath tube AD is marked with a numerical mark every 1 cm in sequence, and the outer catheter is recorded into the body. depth.
  • the inner core IJ is a hollow, elongated structure suitable for insertion and sliding of the guide wire, and the inner core IJ is adapted to be inserted into a sheath of the outer catheter, the inner core IJ is 130-140 cm long, and preferably 135 cm; the inner core IJ is divided into a head IN and a body JN along the insertion direction of the sheath into which the outer catheter is inserted, the head IN being tapered and It is bent at 0-45 ° with the main body JN, and the head is 5-15 cm, and preferably 10 cm.
  • the inner catheter FH is a hollow catheter adapted to be inserted into the sheath tube AD of the outer catheter, and is adapted to be inserted and passed along the hollow wire thereof, and the inner catheter FH is inserted along it
  • the insertion direction of the sheath tube AD of the outer catheter is divided into a head bending section FG and a tail straight section GH, and the head bending section FH and the tail straight section GH are at an angle of 45-90°
  • the head bending section FH is 0.5-1 cm long, and the tail straight section GH is 148-152 cm long; and preferably, the head bending section FG of the inner duct FH and the tail straight section GH are 45 °, 60 ° or 90 ° angle.
  • the inner duct FH has a diameter of 6F, and the outer wall of the tail straight section GH of the inner duct FH is numerically marked every 1 cm in order, and the depth of the inner duct entering the outer duct is recorded.
  • the loading sheath KM is a hollow tubular structure whose outer diameter is adapted to the inner diameter of the sheath tube AD of the outer catheter, and can be inserted into the sheath tube of the outer catheter through the hemostatic stem.
  • the loading sheath KM is provided at the outer wall L with a symmetrical wing-like protrusion, the wing-shaped protrusion being disposed at a position close to the loading sheath inserted into the duct, the loading sheath KM being 6-10 cm long, The wing is disposed adjacent to the loading sheath for insertion into the outer catheter at a position 1.5-2.5 cm KL.
  • the guidewire is a conventional 0.035 or 0.038 inch straight guidewire.
  • the system When using the system, first select the appropriate diameter occluder and the appropriate model of the system according to the size of the chamber. After successful puncture of the right femoral vein, the arterial sheath matched with the external catheter model was placed, and the distance from the intercostal sternum to the femoral vein puncture point was measured, which is the working distance of the outer catheter;
  • the wire is fed into the outer catheter sheath AD, and after reaching the working distance, the guide wire and the inner core IL are withdrawn, and the sheath AD recovers its curved curvature, and is guided under ultrasound guidance or under the guidance of ultrasound and radiation.
  • the inner catheter FH is sent from the hemostasis, and guided by ultrasound or ultrasound and radiation, until the head bending section FG extends out of the sheath tube AD through the first straight section AB; At this time, the straight guide wire is fed through the tail straight line segment GH; and the position of the sheath tube AD and the inner tube FH is adjusted by pushing and rotating under the guidance of ultrasound or ultrasound and radiation, so that the head is bent
  • the segment FG points to the opening of the right ventricular surface of the chamber.
  • the straight guide wire is fed into the left ventricle through the ventricle, and the inner catheter FH is fed into the left ventricle along the straight guide wire through the ventricle.
  • the sheath AD is then pushed forward to pass through the ventricular septal defect along the inner catheter FH, while exiting the inner catheter FH and the straight guide wire, and the corresponding size of the occluder is collected into the loading sheath by the transport cable.
  • the hemostasis is sent into the sheath tube AD, the delivery cable is pushed, and the occluder is sent to the ventricular septal defect through the sheath of the outer catheter for sealing.
  • the inner catheter FH can be withdrawn, the straight guide wire is kept in the left ventricle or the aorta, and the inner core IJ is inserted into the sheath AD along the straight guide wire. Pushing the entire sheath AD along the straight guide wire to pass through the ventricular septum to reach the left ventricle; and withdrawing the inner core and the guide wire, and the corresponding size occluder is collected into the loading sheath by the transport cable, and The hemostasis valve is sent into the sheath tube, the delivery cable is pushed, and the occluder is sent to the ventricular septal defect through the sheath of the outer catheter for sealing.
  • the straight guide wire can be withdrawn, and the inner catheter FH is left in the left chamber.
  • the inner guide tube FH is inserted into the mud guide wire, the mud guide wire is left in the left ventricle or the aorta, and exits.
  • the catheter FH and the sheath AD are fed along the muddy guide wire into the traditional ventricular septal defect occluder delivery system, and the occlusion chamber is closed with a corresponding occluder.
  • the new guidance system combined with simple ultrasound guided or radiation and ultrasound guided transfemoral ventricular septal defect closure, including external catheter, internal catheter FH, loading sheath KM and 0.035 Inches of guide wire;
  • the outer guide includes a sheath AD and an inner core IJ.
  • the sheath AD is a hollow structure and is adapted to be inserted into the inner tube FH and the inner core IJ.
  • the sheath tube AD is sequentially divided into a first straight segment AB, a first arc segment BEC and a second straight segment CD along a direction in which it is inserted into the blood vessel; the first arc segment BEC is 135°; the first straight segment AB is 4 cm long, and the second straight section CD is 115 cm long; the angle between the extension line of the first straight section AB and the extension line of the second straight section CD is 45°.
  • the second straight segment CD is provided with a hemostatic width away from the end portion D of the first arc segment.
  • the sheath has an AD inner diameter of 8F, and the outer wall of the second straight section CD of the sheath AD is marked with a numerical mark every 1 cm in order, and the depth of the outer catheter into the body is recorded.
  • the inner core is a hollow, elongated structure suitable for inserting and sliding the guide wire, and the inner core is suitable In the sheath tube, the inner core IJ is 135 cm long; the inner core IJ is divided into a head IN and a body JN along a direction in which it is inserted into the sheath, and the head IN is tapered It is in line with the main body JN, and the head IN is 10 cm long.
  • the inner catheter FH is a hollow catheter adapted to be inserted into the sheath tube AD, and is adapted to be inserted and passed through the guide wire thereof, the insertion direction of the inner catheter FH along the insertion direction of the sheath tube AD
  • the head bending section FH and the tail straight section GH are at an angle of 90° with the tail straight section GH, and the head bending section FH is 1 cm long, and the tail straight line
  • the segment GH is 150 cm long.
  • the inner duct FH has a diameter of 6F, and the outer wall of the tail straight section GH of the inner duct FH is numerically marked every 1 cm in order, and the depth of the inner duct entering the outer duct is recorded.
  • the loading sheath KM is a hollow tubular structure whose outer diameter is adapted to the inner diameter of the sheath of the outer catheter, and can be inserted into the outer catheter via the hemostasis, the loading sheath KM being on the outer wall a symmetrical wing-shaped protrusion is disposed at a position, the wing-shaped protrusion is disposed at a position adjacent to the loading sheath inserted into the conduit, the loading sheath KM is 8 cm long, and the wing-shaped protrusion is disposed adjacent to the loading sheath insertion The position of the KL at 2 cm in the direction of the outer catheter.
  • the new guidance system combined with ultrasound-guided or radiation-assisted guided transfemoral ventricular septal defect closure, including external catheter, internal catheter FH, loading sheath KM, and 0.038 Inches of guide wire;
  • the outer guide includes a sheath AD and an inner core IJ.
  • the sheath AD is a hollow structure and is adapted to be inserted into the inner tube FH and the inner core IJ.
  • the sheath tube AD is sequentially divided into a first straight segment AB, a first arc segment BEC and a second straight segment CD along a direction in which it is inserted into the blood vessel; the first arc segment BEC is an arc shape of 120°;
  • the first straight section AB is 1 cm long, and the second straight section CD is 100 cm long; the angle between the extension line of the first straight section AB and the extension line of the second straight section CD is 20°.
  • the second straight segment CD is provided with a hemostatic width away from the end portion D of the first arc segment.
  • the sheath has an AD inner diameter of 9F, and the outer wall of the second straight segment CD of the sheath AD is marked with a numerical mark every 1 cm in order, and the depth of the outer catheter AD into the body is recorded.
  • the inner core is a hollow, elongated structure suitable for insertion and sliding of the guide wire, the inner core is adapted to be inserted into the sheath tube, the inner core IJ is 130 cm long; the inner core IJ is along The insertion direction into which the sheath is inserted is divided into a head IN which is tapered and 20° curved with the main body JN, and a head portion 5 cm.
  • the inner catheter FH is a hollow catheter adapted to be inserted into the sheath tube AD, and is adapted to be inserted and passed through the guide wire thereof, the insertion direction of the inner catheter FH along the insertion direction of the sheath tube AD Divided into a head bending section FG and a tail straight section GH, the head bending section FH is at an angle of 45° with the tail straight section GH, and the head bending section FH is 0.5 cm long, the tail part The straight line segment GH is 148 cm long.
  • the inner duct FH has a diameter of 6F, and the outer wall of the tail straight section GH of the inner duct FH is numerically marked every 1 cm in order, and the depth of the inner duct entering the outer duct is recorded.
  • the loading sheath KM is a hollow tubular structure whose outer diameter is adapted to the inner diameter of the sheath AD, and can be inserted into the outer catheter via the hemostatic, the loading sheath KM is at the outer wall L a symmetrical wing-like protrusion is provided, the wing-like protrusion being disposed adjacent to a position in which the loading sheath is inserted into the catheter, the loading sheath KM is 6 cm long, and the wing-shaped protrusion is disposed adjacent to the loading sheath and inserted into the outer The position of the KL at 1.5 cm in the direction of the catheter.
  • the new guidance system combined with simple ultrasound guided or radiation and ultrasound guided transfemoral ventricular septal defect closure, including external catheter, internal catheter FH, loading sheath KM and 0.035 Inches of guide wire;
  • the outer guide includes a sheath AD and an inner core IJ.
  • the sheath AD is a hollow structure and is adapted to the insertion of the inner catheter FH and the inner core IJ.
  • the sheath tube AD is sequentially divided into a first straight segment AB, a first arc segment BEC and a second straight segment CD along a direction in which it is inserted into the blood vessel; the first arc segment BEC is an arc shape of 160°;
  • the first straight section AB is 6 cm long, and the second straight section CD is 120 cm long; the angle between the extension line of the first straight section AB and the extension line of the second straight section CD is 60°.
  • the second straight segment CD is provided with a hemostatic width away from the end portion D of the first arc segment.
  • the sheath has an AD inner diameter of 7F, and the outer wall of the second straight section CD of the sheath AD is numerically marked every 1 cm in order, and the depth of the sheath AD into the body is recorded.
  • the inner core is a hollow, elongated structure suitable for insertion and sliding of the guide wire, the inner core is adapted to be inserted into the sheath tube, the inner core IJ is 140 cm long; the inner core IJ is along The insertion direction into which the sheath is inserted is divided into a head IN which is tapered and which is bent at 45° with the main body JN, and a head portion 15 cm.
  • the inner catheter FH is a hollow catheter adapted to be inserted into the sheath tube AD, and is adapted to be inserted and passed through the guide wire thereof, the insertion direction of the inner catheter FH along the insertion direction of the sheath tube AD
  • the head bending section FH is at an angle of 60° with the tail straight section GH, and the head bending section FH is 0.8 cm long, and the tail straight line Segment GH is 152 cm long.
  • the inner duct FH has a diameter of 6F, and the outer wall of the tail straight section GH of the inner duct FH is numerically marked every 1 cm in order, and the depth of the inner duct entering the outer duct is recorded.
  • the loading sheath KM is a hollow tubular structure whose outer diameter is adapted to the inner diameter of the sheath AD, and can be inserted into the outer catheter via the hemostatic, the loading sheath KM is at the outer wall L a symmetrical wing-like protrusion is provided, the wing-like protrusion being disposed adjacent to a position in which the loading sheath is inserted into the catheter, the loading sheath KM is 10 cm long, and the wing-shaped protrusion is disposed adjacent to the loading sheath and inserted into the outer The position of the KL at 2.5 cm in the direction of the catheter.
  • the guide wire and the inner core are withdrawn, and the sheath tube recovers its curved curvature under ultrasound guidance.
  • the first straight segment is manipulated into the right ventricle through the tricuspid valve; the ultrasonic operation is to display the four-chamber heart according to the specific situation.
  • the long axis of the aorta and other aspects, the radiation operation should be based on the specific situation of the front and rear position, the left front oblique position projection;
  • the ultrasound operation is performed according to the specific situation, and the four-chamber heart, the long axis of the aorta and the like are displayed, and the radiation operation is performed according to the specific situation, and the left and right oblique positions are projected according to the specific situation;
  • Example 5 (4) pushing the sheath forward to pass the ventricular septal defect along the inner catheter, simultaneously withdrawing the inner catheter and the straight guide wire, and loading the corresponding size occluder into the sheath through the transport cable And the hemostasis is sent into the outer catheter, the delivery cable is pushed, and the occluder is sent to the ventricular septal defect through the sheath of the outer catheter for sealing.
  • Example 5
  • the transfemoral ventricular septal defect occlusion is performed by the system of the first embodiment, and the method includes the following:
  • the guide wire and the inner core are withdrawn, and the sheath tube recovers its curved curvature, and is guided by ultrasound.
  • the heart, the long axis of the aorta, etc., the radiation operation should be projected according to the specific situation, the left anterior position and the left anterior oblique position;
  • the ventricular deficiencies are sent to the left ventricle;
  • the ultrasonic operation is to display the four-chamber heart, the aorta long axis and the like according to the specific situation, and the radiation operation is to be performed according to the specific situation, and the left anterior oblique position is projected according to the specific situation;
  • the occlusion of the transfemoral ventricular septal defect by ultrasound alone is performed by using the system described in Embodiment 1, and specifically includes: (1) Preoperative routine examination, all patients underwent transthoracic ultrasonography before operation, measuring the diameter of ventricular septal defect and observing the marginal condition. Those who met the requirements were chest X-ray and electrocardiogram before operation, and blood was collected for infectious diseases and coagulation function. Biochemical complete set, blood routine;
  • the guide wire and the inner core are withdrawn, and the sheath tube recovers its curved curvature, and is guided by ultrasound.
  • the heart, the long axis of the aorta, etc., the radiation operation should be projected according to the specific situation, the left anterior position and the left anterior oblique position;
  • the ultrasound operation is performed according to the specific situation, and the four-chamber heart, the long axis of the aorta and the like are displayed, and the radiation operation is performed according to the specific situation, and the left and right oblique positions are projected according to the specific situation;

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Abstract

一种用于超声引导下室间隔缺损封堵术及其适配的引导系统。所述系统属于医学技术领域并包括导丝、用于引导内导管（FH）并输送封堵器的外导管、用于引导导丝的内导管（FH）、以及用于收纳封堵器的装载鞘（KM）。所述引导系统和所述封堵术可以以超声为唯一的引导手段，完全不依赖放射线，经股静脉穿刺或切开后，在超声的引导下，将导丝、导管插入心脏，从右室面通过室间隔缺损后，经导管将封堵器置于病变位置，克服了现有技术中以射线为引导介质导致辐射及造影剂损伤的问题。

Description

一种用于超声引导下室间隔缺损封堵术的适配引导系统 技术领域
本发明属于医学技术领域， 具体涉及一种用于超声引导下室间隔缺损 封堵术及其适配的引导系统。 背景技术
室间隔缺损指室间隔在胚胎时期发育不全， 形成异常交通， 在心室水 平产生左向右分流。 室间隔缺损是最常见的先天性心脏病， 约占先心病的
20%， 可单独存在， 也可与其他畸形并存。 缺损常在 0.1-3cm， 位于膜部者 多见。 缺损若 <0.3cm则分流量较小， 多无临床症状。 缺损小者心脏大小可 正常， 缺损大者左心室明显增大， 并可引起肺动脉高压， 导致患者死亡。 自上世纪出现经皮介入治疗以来， 出现了以经皮房间隔缺损封堵术、 经皮室间隔缺损封堵术、 经皮动脉导管未闭缺损封堵术、 支架植入术等为 代表的一批经典术式。 这些手术的共同特点是： 经外周血管穿刺后， 在放 射线的引导下， 将导丝及导管插入心脏， 并经导管将所需的封堵器或支架 置于病变位置进行治疗。 这一系列手术对于房间隔缺损或室间隔缺损等病 症起到了较好的手术治疗效果。 但以现有技术而言， 这些手术在术中必须使用放射线照射患者， 不仅 存在较大的辐射损伤， 会影响骨髓、 生殖器及甲状腺等器官的功能， 而且 对患者及医护人员也会造成医源性损伤。 鉴于辐射的危害巨大， 因此国家 专门立法规定医护人员必须在术中穿防护服来保护自己。 更为重要的是， 常规的放射线引导下的室间隔缺损封堵术需要先穿刺股动脉， 经左室面将 导丝、 导管穿过室间隔缺损， 再穿刺股静脉， 送入圈套器， 套住从股动脉 送入的导丝并从股静脉拉出来， 建立动静脉轨道后， 再经股静脉送入输送 鞘进行封堵。 传统技术不但操作复杂， 创伤大， 手术时间长， 放射线照射 时间长， 而且三尖瓣反流等并发症发生率高。 发明内容
为了克服上述缺点，本发明提供一种单纯超声引导下或放射线与超声共 同引导下经股静脉室间隔缺损封堵术，并提供一种用于所述单纯超声引导下 或放射线与超声共同引导下经股静脉室间隔缺损封堵术的适配的引导系统。
上述问题由如下技术方案实现：
本发明提供了一种配合单纯超声引导下或放射线与超声共同引导下经 股静脉室间隔缺损封堵术的新型引导系统，所述引导系统包括导丝、用于引 导内导管并输送封堵器的外导管、用于引导导丝的内导管、以及用于收纳封 堵器的装载鞘；
所述外导管包括中空结构的鞘管以及插入所述鞘管内的用于引导所述 外导管进入股静脉的内芯，所述鞘管适于所述内导管和所述内芯的插入；所 述鞘管沿其插入血管内的方向依次分为第一直段、第一弧段和第二直段；所 述第一弧段为 120-160° 的圆弧状， 所述第一直段的延长线和所述第二直段 的延长线的夹角为 20-60° ， 所述第二直段远离所述第一弧段的端部设有止 血阔；
所述内芯为适于所述导丝插入并滑动的中空、长条形结构，所述内芯适 于插入所述外导管的所述鞘管中，所述内芯沿其插入所述鞘管的插入方向分 为头部和主体， 所述头部呈锥形且与所述主体呈 0-45 ° 弯曲；
所述内导管为适于插入所述外导管的所述鞘管内的中空导管，且适于所 述导丝沿其中空插入并通过，所述内导管沿其插入所述外导管的鞘管的插入 方向分为头部弯折段及尾部直线段， 所述头部弯折段与所述尾部直线段呈 45-90° 夹角；
所述装载鞘为中空的管状结构， 其外径与所述外导管的鞘管的内径相适 配， 可以经所述止血阔插入所述外导管的鞘管内， 所述装载鞘在所述外壁处 设置有对称的翼状突起， 所述翼状突起设置于靠近所述装载鞘插入所述导管 方向的位置。
优选的， 所述第一直段长 1-6厘米， 所述第二直段长 100-120厘米； 所 述内芯长 130-140厘米， 所述内芯的所述头部长 5-15厘米； 所述头部弯折 段长 0.5-2厘米，所述尾部直线段长 148-152厘米；所述装载鞘长 6-10厘米， 所述翼状突起设置于靠近所述装载鞘插入所述外导管方向 1.5-2.5 厘米处的 位置。
进一步优选的， 所述第一直段长 4厘米， 所述第二直段长 110厘米； 所 述内芯长 135厘米， 所述内芯的所述头部长 10厘米； 所述头部弯折段长 1 厘米， 所述尾部直线段长 150厘米； 所述装载鞘长 8厘米， 所述翼状突起设 置于靠近所述装载鞘插入所述外导管方向 2厘米处的位置。
所述内导管的所述头部弯折段与所述尾部直线段呈 45° 、 60° 或 90° 夹角。
所述鞘管的内径型号为 6F、 7F、 8F、 9F、 10F， 所述外导管的鞘管的第 二直段的外壁上每隔 1厘米顺序标有数字标记， 记录所述外导管进入体内的 深度。
所述内导管的直径型号为 6F, 所述内导管的尾部直线段的外壁上每隔 1 厘米顺序标有数字标记， 记录所述内导管进入所述外导管的深度。
所述导丝为 0.035或 0.038英寸的直头导丝。
本发明还公开了一种单纯在超声引导下或在放射线与超声共同引导下 经股静脉室间隔缺损封堵术， 具体包括：
( 1 ) 术前常规超声检查， 所有患者术前进行经胸超声检查， 测量室间 隔缺损直径并观察边缘情况， 符合要求者术前行胸片、心电图检查， 并抽血 查传染疾病、 凝血功能、 生化全套、 血常规；
(2) 根据室间隔大小， 选择适宜直径的封堵器及以及适宜的本系统的 型号； 穿刺右侧股静脉成功后，置入与所述外导管的鞘管型号相匹配的下肢 动脉鞘，并测量同侧胸骨 3肋间到股静脉穿刺点的距离，此为外导管工作距 离；将所述内芯插入外导管的鞘管内备用，经下肢动脉鞘送入造影导管及导 丝到达右心房， 退出造影导管及下肢动脉鞘， 保留所述导丝位于右房内， 沿 导丝送入所述外导管， 达到工作距离后， 退出所述导丝及内芯， 所述鞘管恢 复其弯曲的弧度，在超声引导下或在超声及放射线的共同引导下通过推送及 旋转所述外导管的鞘管的第二直段，操纵所述第一直段通过三尖瓣进入右室;
(3 ) 根据室间隔缺损开口的方向， 选择合适的内导管的型号， 从止血 阔将所述内导管送入，并通过超声或超声及放射线的引导，至所述头部弯折 段通过所述外导管的第一直段伸出所述鞘管;此时经所述尾部直线段送入直 头导丝； 并在超声引或超声及放射线的引导下，通过推送及旋转同时调整外 导管及内导管的位置， 使所述内导管头部弯折段指向室缺在右室面的开口， 此时将直头导丝通过室缺送入左室，并将内导管沿直头导丝通过室缺送入左
(4) 向前推送所述鞘管， 使其沿内导管通过室间隔缺损， 同时退出所 述内导管及所述直头导丝，将相应大小的封堵器收入装载鞘内，并经所述止 血阔送入所述外导管内， 进行封堵。 作为可以替代的方式， 所述步骤 （4) 的封堵步骤还可以为： 在所述步 骤 （3 ) 之后， 退出所述内导管， 保留直头导丝位于左室或主动脉内， 沿直 头导丝将所述内芯插入所述鞘管内，沿直头导丝推送整个外导管，使其通过 室缺， 到达左室； 并退出所述内芯及导丝， 将相应大小的封堵器收入所述装 载鞘， 并经所述止血阔送入所述鞘管内， 进行封堵。
作为可以替代的方式， 所述步骤 （4) 的封堵步骤还可以为： 在所述步 骤 （3 ) 之后， 退出直头导丝， 保留内导管位于左室内， 沿内导管插入泥鳅 导丝后， 保留泥鳅导丝位于左室或主动脉内， 退出内导管、 外导管的鞘管， 沿泥鳅导丝送入传统室间隔缺损封堵器输送系统，并以相应封堵器封堵室缺。
整个手术过程中，所述超声操作要根据具体情况显示四腔心、主动脉长 轴等切面， 所述放射线操作要根据具体情况做前后位、 左前斜位投射。
本发明所述单纯经胸超声引导下经皮房间隔缺损封堵术的适应症及禁 忌症与目前射线引导下的手术的适应症及禁忌症相同。
本发明的上述技术方案相比现有技术具有以下优点：
1、 本发明所述封堵术可以以超声为唯一的引导手段， 完全不依赖放射 线， 经股静脉穿刺或切开后， 在超声的引导下， 将导丝、 导管插入心脏， 从 右室面通过室间隔缺损后，经导管将封堵器置于病变位置，克服了现有技术 中以射线为引导介质导致辐射及造影剂损伤的问题；
2、 本发明所述引导系统的导管直径在 6F以上， 配合 0.035英寸以上的 导丝，使超声能够清晰显示整个系统在心脏中的位置。外导管头部呈 120-160 弧度，契合下腔静脉与三尖瓣开口方向的夹角，外导管经下腔静脉进入右房 后， 只要回拉外导管即可使其第一直段通过三尖瓣， 插入右室内。 由于室间 隔缺损的方向与外导管第一直段的方向平行，所以设计内导管呈 45-90度弯 曲， 内导管伸出外导管后， 其开口方向与室间隔接近垂直， 导丝经内导管伸 出后，可以以垂直的方向通过室间隔缺损。由于室间隔缺损右室面开口的血 流方向可以与室间隔垂直， 也可以略朝向心尖， 与室间隔呈 45-90度夹角， 所以内导管设三个型号， 分别为 45、 60、 90度弯曲。 可以根据室间隔缺损 右室面的开口方向进行选择；
3、 本系统的外导管可以直接作为封堵器的输送鞘管使用， 无需来回更 换鞘管， 对于部分位置特殊的室间隔缺损， 可能外导管不容易通过室缺， 我 们亦提供在使用该引导系统的基础上，配合使用传统室间隔缺损输送鞘管的 方法作为备用方案； 4、 由于一般手术中股动脉穿刺的风险远远高于股静脉穿刺， 而且需要 建立轨道，需要将一个导丝从左侧股动脉→主动脉瓣→室间隔缺损→三尖瓣 →右心房→下腔静脉→右侧股静脉，不但费时费力，而且容易损伤主动脉瓣、 三尖瓣等重要结构，使用本系统进行治疗的手术无需穿刺股动脉，无需建立 动静脉轨道， 完全避免了上述风险， 不但操作简单而且并发症少。
实验例
该新型引导系统已经完成 30例动物实验，其中前 10例在超声及放射线 共同引导下完成， 后 20例在超声引导下完成， 全部封堵成功， 没有出现封 堵器脱落、心包积液等严重并发症，手术时间及放射照射时间明显小于常规 放射线引导下的室缺封堵术， 实验结果良好。 附图说明
为了使本发明的内容更容易被清楚的理解， 下面根据本发明的具体实 施例并结合附图， 对本发明作进一步详细的说明， 其中
图 1 为本发明所述引导系统中外导管的鞘管的结构示意图；
图 2为本发明所述引导系统中外导管的内芯的结构示意图；
图 3为本发明所述引导系统中内导管的结构示意图；
图 4为本发明所述引导系统中装载鞘的结构示意图。 具体实施方式
本发明所述的配合单纯超声引导下或放射线与超声共同引导下经股静 脉室间隔缺损封堵术的新型引导系统，包括导丝、用于引导内导管并输送封 堵器的外导管、 用于引导导丝的内导管 FH、 以及用于收纳封堵器的装载鞘 如图 1、 2所示， 所述外导管包括如图 1所示的中空结构的鞘管 AD以 及如图 2所示的插于所述鞘管 AD内的用于引导所述外导管进入股静脉的内 芯， 所述鞘管适于所述内导管 FH和所述内芯 IJ的插入。
如图 1所示， 所述鞘管 AD沿其插入血管内的方向依次分为第一直段 AB、 第一弧段 BEC和第二直段 CD; 所述第一弧段 BEC为 120-160° 的圆 弧状， 并优选 135° ； 所述第一直段 AB长 1-6厘米， 并优选 4厘米， 所述 第二直段 CD长 100-120厘米， 并优选 115厘米； 所述第一直段 AB的延长 线和所述第二直段 CD的延长线的夹角为 20-60° ， 并优选 45° 。 所述第二 直段 CD远离所述第一弧段的端部 D设有止血阔。 所述鞘管 AD的内径为 6F、 7F、 8F、 9F、 10F， 所述鞘管 AD的第二直段 CD的外壁上每隔 1厘米 顺序标有数字标记， 记录所述外导管进入体内的深度。
如图 2所示， 所述内芯 IJ为适于所述导丝插入并滑动的中空、 长条形 结构， 所述内芯 IJ适于插入所述外导管的鞘管中， 所述内芯 IJ长 130-140 厘米， 并优选 135厘米； 所述内芯 IJ沿其插入所述外导管的所述鞘管的插 入方向分为头部 IN和主体 JN,所述头部 IN呈锥形且与所述主体 JN呈 0-45 ° 弯曲， 所述头部长 5-15厘米， 并优选 10厘米。
如图 3所示， 所述内导管 FH为适于插入所述外导管的鞘管 AD内的中 空导管， 且适于所述导丝沿其中空插入并通过， 所述内导管 FH沿其插入所 述外导管的鞘管 AD的插入方向分为头部弯折段 FG及尾部直线段 GH， 所 述头部弯折段 FH与所述尾部直线段 GH呈 45-90° 夹角， 所述头部弯折段 FH长 0.5-1厘米， 所述尾部直线段 GH长 148-152厘米； 并优选的， 所述内 导管 FH的所述头部弯折段 FG与所述尾部直线段 GH呈 45 ° 、 60° 或 90° 夹角。 所述内导管 FH的直径为 6F, 所述内导管 FH的尾部直线段 GH的外 壁上每隔 1厘米顺序标有数字标记，记录所述内导管进入所述外导管的深度。
如图 4所示， 所述装载鞘 KM为中空的管状结构， 其外径与所述外导 管的鞘管 AD的内径相适配， 可以经所述止血阔插入所述外导管的鞘管内， 所述装载鞘 KM在所述外壁 L处设置有对称的翼状突起， 所述翼状突起设 置于靠近所述装载鞘插入所述导管方向的位置， 所述装载鞘 KM长 6-10厘 米， 所述翼状突起设置于靠近所述装载鞘插入所述外导管方向 1.5-2.5厘米 处 KL的位置。
所述导丝为常规的 0.035或 0.038英寸的直头导丝。
该系统使用时，首先根据室间隔大小，选择适宜直径的封堵器及以及适 宜的本系统的型号。穿刺右侧股静脉成功后，置入与所述外导管型号相匹配 的动脉鞘，并测量同侧胸骨 3肋间到股静脉穿刺点的距离，此为外导管的工 作距离；
将所述内芯 U插入外导管的鞘管 AD内备用， 经下肢动脉鞘送入造影 导管及导丝到达右心房，退出造影导管及动脉鞘，保留所述导丝位于右房内， 沿导丝送入所述外导管鞘管 AD，达到工作距离后，退出所述导丝及内芯 IL 所述鞘管 AD恢复其弯曲的弧度，在超声引导下或在超声及放射线的共同引 导下通过推送及旋转所述鞘管的第二直段 CD, 操纵所述第一直段 AB通过 三尖瓣进入右室； 然后根据室间隔缺损开口的方向， 选择合适的内导管 FH 的型号， 从止血阔将所述内导管 FH送入， 并通过超声或超声及放射线的引 导， 至所述头部弯折段 FG通过所述第一直段 AB伸出所述鞘管 AD; 此时 经所述尾部直线段 GH送入直头导丝；并在超声引或超声及放射线的引导下， 通过推送及旋转同时调整鞘管 AD及内导管 FH的位置，使所述头部弯折段 FG指向室缺在右室面的开口， 此时将直头导丝通过室缺送入左室， 并将内 导管 FH沿直头导丝通过室缺送入左室。 随后向前推送所述鞘管 AD， 使其 沿内导管 FH通过室间隔缺损， 同时退出所述内导管 FH及所述直头导丝， 通过输送钢缆将相应大小的封堵器收入装载鞘 KM 内， 并经所述止血阔送 入所述鞘管 AD内，推送输送钢缆，将封堵器经外导管的鞘管送到室间隔缺 损部位， 进行封堵。
也可以在将导丝送入左室后， 退出所述内导管 FH， 保留直头导丝位于 左室或主动脉内， 沿直头导丝将所述内芯 IJ插入所述鞘管 AD内， 沿直头 导丝推送整个鞘管 AD,使其通过室缺，到达左室；并退出所述内芯及导丝， 通过输送钢缆将相应大小的封堵器收入所述装载鞘，并经所述止血阀送入所 述鞘管内， 推送输送钢缆， 将封堵器经外导管的鞘管送到室间隔缺损部位， 进行封堵。
也可以在将导丝送入左室后， 退出直头导丝， 保留内导管 FH位于左室 内， 沿内导管 FH插入泥鳅导丝后， 保留泥鳅导丝位于左室或主动脉内， 退 出内导管 FH及鞘管 AD,沿泥鳅导丝送入传统室间隔缺损封堵器输送系统， 并以相应封堵器封堵室缺。
实施例 1
如图 1-4所示，所述的配合单纯超声引导下或放射线与超声共同引导下 经股静脉室间隔缺损封堵术的新型引导系统， 包括外导管、 内导管 FH、 装 载鞘 KM以及 0.035英寸的导丝； 所述外导包括鞘管 AD及内芯 IJ。
所述鞘管 AD为中空的结构，并适于所述内导管 FH和所述内芯 IJ的插 入。 所述鞘管 AD沿其插入血管内的方向依次分为第一直段 AB、 第一弧段 BEC和第二直段 CD; 所述第一弧段 BEC为 135° ； 所述第一直段 AB长 4 厘米， 所述第二直段 CD长 115厘米； 所述第一直段 AB的延长线和所述第 二直段 CD的延长线的夹角为 45° 。所述第二直段 CD远离所述第一弧段的 端部 D设有止血阔。 所述鞘管的 AD内径为 8F, 所述鞘管 AD的第二直段 CD的外壁上每隔 1厘米顺序标有数字标记， 记录所述外导管进入体内的深 度。
所述内芯为适于所述导丝插入并滑动的中空、长条形结构，所述内芯适 于插入所述鞘管中， 所述内芯 IJ长 135厘米； 所述内芯 IJ沿其插入所述鞘 管的插入方向分为头部 IN和主体 JN,所述头部 IN呈锥形且与所述主体 JN 呈一条直线， 所述头部 IN长 10厘米。
所述内导管 FH为适于插入所述鞘管 AD内的中空导管， 且适于所述导 丝沿其中空插入并通过， 所述内导管 FH沿其插入所述鞘管 AD的插入方向 分为头部弯折段 FG及尾部直线段 GH,所述头部弯折段 FH与所述尾部直线 段 GH呈 90° 夹角， 所述头部弯折段 FH长 1厘米， 所述尾部直线段 GH长 150厘米。 所述内导管 FH的直径为 6F, 所述内导管 FH的尾部直线段 GH 的外壁上每隔 1厘米顺序标有数字标记， 记录所述内导管进入所述外导管的 深度。
所述装载鞘 KM为中空的管状结构， 其外径与所述外导管的鞘管的内 径相适配， 可以经所述止血阔插入所述外导管内， 所述装载鞘 KM在所述 外壁 L处设置有对称的翼状突起， 所述翼状突起设置于靠近所述装载鞘插 入所述导管方向的位置， 所述装载鞘 KM长 8厘米， 所述翼状突起设置于 靠近所述装载鞘插入所述外导管方向 2厘米处 KL的位置。
实施例 2
如图 1-4所示，所述的配合单纯超声引导下或放射线与超声共同引导下 经股静脉室间隔缺损封堵术的新型引导系统， 包括外导管、 内导管 FH、 装 载鞘 KM以及 0.038英寸的导丝； 所述外导包括鞘管 AD及内芯 IJ。
所述鞘管 AD为中空的结构，并适于所述内导管 FH和所述内芯 IJ的插 入。 所述鞘管 AD沿其插入血管内的方向依次分为第一直段 AB、 第一弧段 BEC和第二直段 CD;所述第一弧段 BEC为 120° 的圆弧状；所述第一直段 AB长 1厘米， 所述第二直段 CD长 100厘米； 所述第一直段 AB的延长线 和所述第二直段 CD的延长线的夹角为 20° 。所述第二直段 CD远离所述第 一弧段的端部 D设有止血阔。 所述鞘管的 AD内径为 9F, 所述鞘管 AD的 第二直段 CD的外壁上每隔 1厘米顺序标有数字标记， 记录所述外导管 AD 进入体内的深度。
所述内芯为适于所述导丝插入并滑动的中空、长条形结构，所述内芯适 于插入所述鞘管中， 所述内芯 IJ长 130厘米； 所述内芯 IJ沿其插入所述鞘 管的插入方向分为头部 IN和主体 JN,所述头部 IN呈锥形且与所述主体 JN 呈 20° 弯曲， 所述头部长 5厘米。
所述内导管 FH为适于插入所述鞘管 AD内的中空导管， 且适于所述导 丝沿其中空插入并通过， 所述内导管 FH沿其插入所述鞘管 AD的插入方向 分为头部弯折段 FG及尾部直线段 GH,所述头部弯折段 FH与所述尾部直线 段 GH呈 45 ° 夹角，所述头部弯折段 FH长 0.5厘米，所述尾部直线段 GH长 148厘米。 所述内导管 FH的直径为 6F, 所述内导管 FH的尾部直线段 GH 的外壁上每隔 1厘米顺序标有数字标记， 记录所述内导管进入所述外导管的 深度。
所述装载鞘 KM为中空的管状结构， 其外径与所述鞘管 AD的内径相 适配，可以经所述止血阔插入所述外导管内，所述装载鞘 KM在所述外壁 L 处设置有对称的翼状突起，所述翼状突起设置于靠近所述装载鞘插入所述导 管方向的位置， 所述装载鞘 KM长 6厘米， 所述翼状突起设置于靠近所述 装载鞘插入所述外导管方向 1.5厘米处 KL的位置。
实施例 3
如图 1-4所示，所述的配合单纯超声引导下或放射线与超声共同引导下 经股静脉室间隔缺损封堵术的新型引导系统， 包括外导管、 内导管 FH、 装 载鞘 KM以及 0.035英寸的导丝； 所述外导包括鞘管 AD及内芯 IJ。
所述鞘管 AD为中空结构，并适于所述内导管 FH和所述内芯 IJ的插入。 所述鞘管 AD沿其插入血管内的方向依次分为第一直段 AB、第一弧段 BEC 和第二直段 CD; 所述第一弧段 BEC为 160° 的圆弧状； 所述第一直段 AB 长 6厘米， 所述第二直段 CD长 120厘米； 所述第一直段 AB的延长线和所 述第二直段 CD的延长线的夹角为 60° 。所述第二直段 CD远离所述第一弧 段的端部 D设有止血阔。 所述鞘管的 AD内径为 7F, 所述鞘管 AD的第二 直段 CD的外壁上每隔 1厘米顺序标有数字标记，记录所述鞘管 AD进入体 内的深度。
所述内芯为适于所述导丝插入并滑动的中空、长条形结构，所述内芯适 于插入所述鞘管中， 所述内芯 IJ长 140厘米； 所述内芯 IJ沿其插入所述鞘 管的插入方向分为头部 IN和主体 JN,所述头部 IN呈锥形且与所述主体 JN 呈 45 ° 弯曲， 所述头部长 15厘米。
所述内导管 FH为适于插入所述鞘管 AD内的中空导管， 且适于所述导 丝沿其中空插入并通过， 所述内导管 FH沿其插入所述鞘管 AD的插入方向 分为头部弯折段 FG及尾部直线段 GH,所述头部弯折段 FH与所述尾部直线 段 GH呈 60° 夹角，所述头部弯折段 FH长 0.8厘米，所述尾部直线段 GH长 152厘米。 所述内导管 FH的直径为 6F, 所述内导管 FH的尾部直线段 GH 的外壁上每隔 1厘米顺序标有数字标记， 记录所述内导管进入所述外导管的 深度。 所述装载鞘 KM为中空的管状结构， 其外径与所述鞘管 AD的内径相 适配，可以经所述止血阔插入所述外导管内，所述装载鞘 KM在所述外壁 L 处设置有对称的翼状突起，所述翼状突起设置于靠近所述装载鞘插入所述导 管方向的位置， 所述装载鞘 KM长 10厘米， 所述翼状突起设置于靠近所述 装载鞘插入所述外导管方向 2.5厘米处 KL的位置。
实施例 4
所述单纯在超声引导下经股静脉室间隔缺损封堵术依靠前述实施例 1 中的引导系统完成， 具体步骤包括：
( 1 ) 术前常规检查， 所有患者术前进行经胸超声检查， 测量室间隔缺 损直径并观察边缘情况， 符合要求者术前行胸片、心电图检查， 并抽血查传 染疾病、 凝血功能、 生化全套、 血常规；
(2) 根据室间隔大小， 选择适宜直径的封堵器及以及适宜的本系统的 型号； 穿刺右侧股静脉成功后， 置入与所述外导管型号相匹配的动脉鞘， 并 测量同侧胸骨 3肋间到股静脉穿刺点的距离，此为外导管工作距离；将所述 内芯插入鞘管内备用，经下肢动脉鞘送入造影导管及导丝到达右心房，退出 造影导管及下肢动脉鞘，保留所述导丝位于右房内，沿导丝送入所述外导管， 达到工作距离后， 退出所述导丝及内芯， 所述鞘管恢复其弯曲的弧度， 在超 声引导下或在超声及放射线的共同引导下通过推送及旋转所述鞘管的第二 直段，操纵所述第一直段通过三尖瓣进入右室；所述超声操作要根据具体情 况显示四腔心、主动脉长轴等切面，所述放射线操作要根据具体情况做前后 位、 左前斜位投射；
(3 ) 根据室间隔缺损开口的方向， 选择合适的内导管的型号， 从止血 阔将所述内导管送入，并通过超声的引导，至所述头部弯折段通过所述外导 管的第一直段伸出所述外导管；此时经所述尾部直线段送入直头导丝； 并在 超声引或超声及放射线的引导下，通过推送及旋转同时调整鞘管及内导管的 位置，使所述内导管的头部弯折段指向室缺在右室面的开口，此时将直头导 丝通过室缺送入左室，并将内导管沿直头导丝通过室缺送入左室；所述超声 操作要根据具体情况显示四腔心、主动脉长轴等切面，所述放射线操作要根 据具体情况做前后位、 左前斜位投射；
(4) 向前推送所述鞘管， 使其沿内导管通过室间隔缺损， 同时退出所 述内导管及所述直头导丝，通过输送钢缆将相应大小的封堵器收入装载鞘内， 并经所述止血阔送入所述外导管内，推送输送钢缆，将封堵器经外导管的鞘 管送到室间隔缺损部位， 进行封堵。 实施例 5
所述在放射线与超声共同引导下经股静脉室间隔缺损封堵术利用实施 例 1所述系统完成， 具体包括：
( 1 ) 术前常规检查， 所有患者术前进行经胸超声检查， 测量室间隔缺 损直径并观察边缘情况， 符合要求者术前行胸片、心电图检查， 并抽血查传 染疾病、 凝血功能、 生化全套、 血常规；
(2) 根据室间隔大小， 选择适宜直径的封堵器及以及适宜的本系统的 型号； 穿刺右侧股静脉成功后， 置入与所述外导管型号相匹配的动脉鞘， 并 测量同侧胸骨 3肋间到股静脉穿刺点的距离，此为外导管工作距离；将所述 内芯插入外导管内备用，经下肢动脉鞘送入造影导管及导丝到达右心房，退 出造影导管及下肢动脉鞘，保留所述导丝位于右房内，沿导丝送入所述外导 管， 达到工作距离后， 退出所述导丝及内芯， 所述鞘管恢复其弯曲的弧度， 在超声引导下或在超声及放射线的共同引导下通过推送及旋转所述外导管 的第二直段，操纵所述第一直段通过三尖瓣进入右室；所述超声操作要根据 具体情况显示四腔心、主动脉长轴等切面，所述放射线操作要根据具体情况 做前后位、 左前斜位投射；
(3 ) 根据室间隔缺损开口的方向， 选择合适的内导管的型号， 从止血 阔将所述内导管送入，并通过超声及放射线的引导，至所述头部弯折段通过 所述外导管的第一直段伸出所述外导管;此时经所述尾部直线段送入直头导 丝；并在超声引或超声及放射线的引导下，通过推送及旋转同时调整鞘管及 内导管的位置，使所述内导管的头部弯折段指向室缺在右室面的开口，此时 将直头导丝通过室缺送入左室， 并将内导管沿直头导丝通过室缺送入左室； 所述超声操作要根据具体情况显示四腔心、主动脉长轴等切面，所述放射线 操作要根据具体情况做前后位、 左前斜位投射；
(4) 退出所述内导管， 保留直头导丝位于左室或主动脉内， 沿直头导 丝将所述内芯插入所述鞘管内，沿直头导丝推送整个外导管，使其通过室缺， 到达左室；并退出所述内芯及导丝，通过输送钢缆将相应大小的封堵器收入 所述装载鞘， 并经所述止血阔送入所述外导管内， 推送输送钢缆， 将封堵器 经外导管的鞘管送到室间隔缺损部位， 进行封堵。
实施例 6
所述单纯在超声引导下经股静脉室间隔缺损封堵术是利用实施例 1 所 述系统完成， 具体包括： ( 1 ) 术前常规检查， 所有患者术前进行经胸超声检查， 测量室间隔缺 损直径并观察边缘情况， 符合要求者术前行胸片、心电图检查， 并抽血查传 染疾病、 凝血功能、 生化全套、 血常规；
( 2 ) 根据室间隔大小， 选择适宜直径的封堵器及以及适宜的本系统的 型号； 穿刺右侧股静脉成功后， 置入与所述外导管型号相匹配的动脉鞘， 并 测量同侧胸骨 3肋间到股静脉穿刺点的距离，此为外导管工作距离；将所述 内芯插入外导管内备用，经下肢动脉鞘送入造影导管及导丝到达右心房，退 出造影导管及下肢动脉鞘，保留所述导丝位于右房内，沿导丝送入所述外导 管， 达到工作距离后， 退出所述导丝及内芯， 所述鞘管恢复其弯曲的弧度， 在超声引导下或在超声及放射线的共同引导下通过推送及旋转所述外导管 的第二直段，操纵所述第一直段通过三尖瓣进入右室；所述超声操作要根据 具体情况显示四腔心、主动脉长轴等切面，所述放射线操作要根据具体情况 做前后位、 左前斜位投射；
( 3 ) 根据室间隔缺损开口的方向， 选择合适的内导管的型号， 从止血 阔将所述内导管送入，并通过超声的引导，至所述头部弯折段通过所述外导 管的第一直段伸出所述鞘管；此时经所述尾部直线段送入直头导丝； 并在超 声引或超声及放射线的引导下，通过推送及旋转同时调整外导管及内导管的 位置，使所述内导管的头部弯折段指向室缺在右室面的开口，此时将直头导 丝通过室缺送入左室，并将内导管沿直头导丝通过室缺送入左室；所述超声 操作要根据具体情况显示四腔心、主动脉长轴等切面，所述放射线操作要根 据具体情况做前后位、 左前斜位投射；
(4 ) 退出直头导丝， 保留内导管位于左室内， 沿内导管插入泥鳅导丝 后， 保留泥鳅导丝位于左室或主动脉内， 退出内导管、 外导管的鞘管， 沿泥 鳅导丝送入传统室间隔缺损封堵器输送系统， 并以相应封堵器封堵室缺。
显然， 上述实施例仅仅是为清楚地说明所作的举例， 而并非对实施方式 的限定。 对于所属领域的普通技术人员来说， 在上述说明的基础上还可以做 出其它不同形式的变化或变动。 这里无需也无法对所有的实施方式予以穷举。 而由此所引伸出的显而易见的变化或变动仍处于本发明创造的保护范围之 中。

Claims

权 利 要 求 书
1、 一种用于超声引导下室间隔缺损封堵术的适配引导系统， 其特征在 于：
包括导丝、用于引导内导管并输送封堵器的外导管、用于引导导丝的内 导管、 以及用于收纳封堵器的装载鞘；
所述外导管包括中空结构的鞘管以及插入所述鞘管内的用于引导所述 外导管进入股静脉的内芯，所述鞘管适于所述内导管和所述内芯的插入；所 述鞘管沿其插入血管内的方向依次分为第一直段、第一弧段和第二直段；所 述第一弧段为 120-160° 的圆弧状， 所述第一直段的延长线和所述第二直段 的延长线的夹角为 20-60° ， 所述第二直段远离所述第一弧段的端部设有止 血阔； 所述内芯为适于所述导丝插入并滑动的中空、长条形结构，所述内芯适 于插入所述外导管的所述鞘管中，所述内芯沿其插入所述鞘管的插入方向分 为头部和主体， 所述头部呈锥形且与所述主体呈 0-45 ° 弯曲； 所述内导管为适于插入所述外导管的所述鞘管内的中空导管，且适于所 述导丝沿其中空插入并通过，所述内导管沿其插入所述外导管的鞘管的插入 方向分为头部弯折段及尾部直线段， 所述头部弯折段与所述尾部直线段呈 45-90° 夹角； 所述装载鞘为中空的管状结构， 其外径与所述外导管的鞘管的内径相适 配， 可以经所述止血阔插入所述外导管的鞘管内， 所述装载鞘在所述外壁处 设置有对称的翼状突起， 所述翼状突起设置于靠近所述装载鞘插入所述导管 方向的位置。
2、 根据权利要求 1 所述的用于超声引导下室间隔缺损封堵术的适配引 导系统， 其特征在于：
所述鞘管的所述第一直段长 1-6厘米， 所述第二直段长 100-120厘米； 所述内芯长 130-140厘米， 所述内芯的所述头部长 5-15厘米； 所述内导管的头部弯折段长 0.5-2厘米， 所述尾部直线段长 148-152厘 米， 所述内导管的所述头部弯折段与所述尾部直线段呈 45 ° 、 60° 或 90° 夹角；
所述装载鞘长 6-10厘米，所述翼状突起设置于靠近所述装载鞘插入所述 外导管方向 1.5-2.5厘米处的位置。
3、 根据权利要求 1或 2所述的用于超声引导下室间隔缺损封堵术的适 配引导系统， 其特征在于：
所述鞘管的所述第一直段长 4厘米， 所述第二直段长 110厘米； 所述内芯长 135厘米， 所述内芯的所述头部长 10厘米；
所述内导管的头部弯折段长 1厘米， 所述尾部直线段长 150厘米； 所述装载鞘长 8厘米， 所述翼状突起设置于靠近所述装载鞘插入所述外 导管方向 2厘米处的位置。
4、根据权利要求 1-3任一所述的用于超声引导下室间隔缺损封堵术的适 配引导系统， 其特征在于：
所述鞘管的内径型号为 6F、 7F、 8F、 9F、 10F， 所述鞘管的所述第二直 段的外壁上每隔 1厘米顺序标有数字标记。
5、根据权利要求 1-4任一所述的用于超声引导下室间隔缺损封堵术的适 配引导系统， 其特征在于：
所述内导管的直径型号为 6F, 所述内导管的尾部直线段的外壁上每隔 1 厘米顺序标有数字标记。
6、根据权利要求 1-5任一所述的用于超声引导下室间隔缺损封堵术的适 配引导系统， 其特征在于：
所述导丝为 0.035或 0.038英寸的直头导丝。
7、一种利用权利要求 1-6任一所述系统实现的单纯在超声引导下或在放 射线与超声共同引导下经股静脉室间隔缺损封堵术， 其特征在于， 包括如下 步骤：
( 1 ) 术前常规超声检查检查， 测量室间隔缺损直径并观察边缘情况；
(2) 根据室间隔大小， 选择适宜直径的封堵器及以及适宜的本系统的 型号； 穿刺右侧股静脉成功后，置入与所述外导管的鞘管型号相匹配的下肢 动脉鞘，并测量同侧胸骨 3肋间到股静脉穿刺点的距离，此为外导管工作距 离；将所述内芯插入外导管的鞘管内备用，经下肢动脉鞘送入造影导管及导 丝到达右心房， 退出造影导管及下肢动脉鞘， 保留所述导丝位于右房内， 沿 导丝送入所述外导管， 达到工作距离后， 退出所述导丝及内芯， 所述鞘管恢 复其弯曲的弧度，在超声引导下或在超声及放射线的共同引导下通过推送及 旋转所述外导管的鞘管的第二直段，操纵所述第一直段通过三尖瓣进入右室;
( 3) 根据室间隔缺损开口的方向， 选择合适的内导管的型号， 从止血 阔将所述内导管送入，并通过超声或超声及放射线的引导，至所述头部弯折 段通过所述外导管第一直段伸出所述鞘管；此时经所述尾部直线段送入直头 导丝； 并在超声引或超声及放射线的引导下，通过推送及旋转同时调整外导 管及内导管的位置，使所述内导管头部弯折段指向室缺在右室面的开口，此 时将直头导丝通过室缺送入左室，并将内导管沿直头导丝通过室缺送入左室;
(4) 向前推送所述鞘管， 使其沿内导管通过室间隔缺损， 同时退出所 述内导管及所述直头导丝，将相应大小的封堵器收入装载鞘内，并经所述止 血阔送入所述外导管内， 进行封堵。
8、一种利用权利要求 1-6任一所述系统实现的单纯在超声引导下或在放 射线与超声共同引导下经股静脉室间隔缺损封堵术， 其特征在于， 包括如下 步骤：
( 1 ) 术前常规超声检查， 测量室间隔缺损直径并观察边缘情况；
(2) 根据室间隔大小， 选择适宜直径的封堵器及以及适宜的本系统的 型号； 穿刺右侧股静脉成功后，置入与所述外导管的鞘管型号相匹配的下肢 动脉鞘，并测量同侧胸骨 3肋间到股静脉穿刺点的距离，此为外导管工作距 离；将所述内芯插入外导管的鞘管内备用，经下肢动脉鞘送入造影导管及导 丝到达右心房， 退出造影导管及下肢动脉鞘， 保留所述导丝位于右房内， 沿 导丝送入所述外导管， 达到工作距离后， 退出所述导丝及内芯， 所述鞘管恢 复其弯曲的弧度，在超声引导下或在超声及放射线的共同引导下通过推送及 旋转所述外导管的鞘管的第二直段，操纵所述第一直段通过三尖瓣进入右室;
(3 ) 根据室间隔缺损开口的方向， 选择合适的内导管的型号， 从止血 阔将所述内导管送入，并通过超声或超声及放射线的引导，至所述头部弯折 段通过所述外导管第一直段伸出所述鞘管；此时经所述尾部直线段送入直头 导丝； 并在超声引或超声及放射线的引导下，通过推送及旋转同时调整外导 管及内导管的位置，使所述内导管头部弯折段指向室缺在右室面的开口，此 时将直头导丝通过室缺送入左室，并将内导管沿直头导丝通过室缺送入左室;
( 4) 退出所述内导管， 保留直头导丝位于左室或主动脉内， 沿直头导 丝将所述内芯插入所述鞘管内，沿直头导丝推送整个外导管，使其通过室缺， 到达左室； 并退出所述内芯及导丝， 将相应大小的封堵器收入所述装载鞘， 并经所述止血阔送入所述鞘管内， 进行封堵。
9、一种利用权利要求 1-6任一所述系统实现的单纯在超声引导下或在放 射线与超声共同引导下经股静脉室间隔缺损封堵术， 其特征在于， 包括如下 步骤：
( 1 ) 术前常规超声检查， 测量室间隔缺损直径并观察边缘情况；
( 2 ) 根据室间隔大小， 选择适宜直径的封堵器及以及适宜的本系统的 型号； 穿刺右侧股静脉成功后，置入与所述外导管的鞘管型号相匹配的下肢 动脉鞘，并测量同侧胸骨 3肋间到股静脉穿刺点的距离，此为外导管工作距 离；将所述内芯插入外导管的鞘管内备用，经下肢动脉鞘送入造影导管及导 丝到达右心房， 退出造影导管及下肢动脉鞘， 保留所述导丝位于右房内， 沿 导丝送入所述外导管， 达到工作距离后， 退出所述导丝及内芯， 所述鞘管恢 复其弯曲的弧度，在超声引导下或在超声及放射线的共同引导下通过推送及 旋转所述外导管的鞘管的第二直段，操纵所述第一直段通过三尖瓣进入右室;
( 3 ) 根据室间隔缺损开口的方向， 选择合适的内导管的型号， 从止血 阔将所述内导管送入，并通过超声或超声及放射线的引导，至所述头部弯折 段通过所述外导管第一直段伸出所述鞘管；此时经所述尾部直线段送入直头 导丝； 并在超声引或超声及放射线的引导下，通过推送及旋转同时调整外导 管及内导管的位置，使所述内导管头部弯折段指向室缺在右室面的开口，此 时将直头导丝通过室缺送入左室，并将内导管沿直头导丝通过室缺送入左室;
( 4 ) 退出直头导丝， 保留内导管位于左室内， 沿内导管插入泥鳅导丝 后， 保留泥鳅导丝位于左室或主动脉内， 退出内导管、 外导管的鞘管， 沿泥 鳅导丝送入传统室间隔缺损封堵器输送系统， 并以相应封堵器封堵室缺。
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