WO2017177700A1 - 一种经心尖植入的二尖瓣气囊闭合板阻塞体及植入方法 - Google Patents

一种经心尖植入的二尖瓣气囊闭合板阻塞体及植入方法 Download PDF

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Publication number
WO2017177700A1
WO2017177700A1 PCT/CN2016/108784 CN2016108784W WO2017177700A1 WO 2017177700 A1 WO2017177700 A1 WO 2017177700A1 CN 2016108784 W CN2016108784 W CN 2016108784W WO 2017177700 A1 WO2017177700 A1 WO 2017177700A1
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Prior art keywords
closure plate
hook card
mitral
mitral valve
airbag
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PCT/CN2016/108784
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English (en)
French (fr)
Inventor
贺照明
荆腾
张凯亮
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江苏大学
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Application filed by 江苏大学 filed Critical 江苏大学
Priority to US16/093,926 priority Critical patent/US10799355B2/en
Publication of WO2017177700A1 publication Critical patent/WO2017177700A1/zh

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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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
    • 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
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • 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
    • A61B2017/00579—Barbed implements
    • 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
    • A61B2017/00592—Elastic or resilient implements
    • 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
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0464—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0085—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof hardenable in situ, e.g. epoxy resins
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas

Definitions

  • the invention relates to the field of human heart repair technology and medical instruments, in particular to a device capable of repairing mitral regurgitation of the heart.
  • the human heart and valve are shown in Figure 1.
  • the left ventricle 3 is located at the upper left of the apex 4, the mitral valve 2 is located between the left atrium 1 and the left ventricle 3, and the mitral valve 2 controls the flow of blood from the left atrium 1 into the left ventricle 3 .
  • the dysfunctional mitral valve 2 causes the two leaflets of the mitral valve 2 to be incompletely closed, causing blood to flow back from the left ventricle 3 back to the left atrium during systole. Mitral regurgitation will cause pulmonary congestion and left ventricular 3 hypertrophy, which ultimately leads to heart failure and death in the patient.
  • the structure of the mitral valve 2 is shown in Figure 2.
  • the mitral valve 2 is a complex one-way valve structure that withstands blood pressure, consisting of an annulus 2.1, a anterior leaflet 2.2, a posterior leaflet 2.3, a chordae 2.4, a papillary muscle 2.5. And the composition of the myocardium on the left ventricular wall.
  • the papillary muscle 2.5 is attached to the left ventricular wall, and the anterior leaflet 2.2 and the posterior leaflet 2.3 are attached to the annulus 2.1.
  • the annulus 2.1 is an internal tissue structure that connects the anterior leaflet 2.2, the posterior leaflet 2.3, and the left ventricular wall.
  • tissue structure of the annulus 2.1 it is divided into a fibrous layer of the anterior medial segment and a muscle layer of the posterolateral segment.
  • the chordae 2.4 starts from the papillary muscle 2.5 and attaches to the leaflets to prevent the anterior leaflet 2.2 and the posterior leaflet 2.3 from collapsing into the left atrium when the heart contracts.
  • Fig. 3 and Fig. 4 The state of the normal mitral valve closure is shown in Fig. 3 and Fig. 4. After the mitral valve is closed, there is no gap between the anterior leaflet 2.2 and the posterior leaflet 2.3, and the anterior and posterior leaflet junctions 5 are completely closed. There will be reflux.
  • Fig. 5 and Fig. 6 a gap exists between the anterior and posterior leaflet junctions 5 of the mitral valve 2, and the gap between the anterior and posterior leaflet junctions causes the blood to contract in the heart.
  • this reflux is called mitral regurgitation, which reduces heart efficiency and causes heart failure.
  • the object of the present invention is to solve the problems existing in the prior art mitral regurgitation treatment method, and provide a apical valve mitral valve balloon closure plate for repairing mitral regurgitation, obstructing mitral regurgitation Channel, effectively preventing the two tips
  • the regurgitation of the lobes the invention also provides a method for implanting the mitral airbag closure plate occlusion body, which is implanted into the regurgitation position of the mitral valve before and after the mitral valve is closed by minimally invasive surgery, without opening the chest, Happy, less trauma to the human body, no residual reflux occurs, and high reliability.
  • a apical valved mitral airbag closure plate occlusion body adopts a technical solution that the mitral valve balloon closure plate occlusion body includes a balloon closure plate, a guide wire, a guide ring, and a fixed plug fixedly implanted at the apex of the heart, the inside of the balloon closure plate being an air bag located at the junction of the anterior and posterior leaflets of the heart; the left and right mitral valves at the junction of the anterior and posterior leaflets
  • Each of the ring is fixedly implanted with a hook card, and the left and right guide wires respectively pass through the hook card on the same side and are fixedly connected to the upper side of the airbag closing plate, and the left lower part and the lower right part of the air bag closing board are fixedly connected.
  • the left and right guiding wires respectively pass through the guiding ring on the same side and fixedly connected to the fixing plug;
  • the infusion tube is connected to the lower bottom edge of the balloon closing plate and the infusion tube extends to the outside through the fixing plug, the infusion The tube communicates with the inside of the airbag closing plate, and a check valve is arranged on the infusion tube, and the inside of the air bag closing plate can be filled with gas or a curable liquid through the infusion tube.
  • the bottom edge of the airbag closing plate is fixedly connected to one end of the traction wire, and the other end of the traction wire is fixedly connected to the fixing plug.
  • the apical implanted mitral valve balloon closure plate is implanted in a technical solution: a small incision is made in the left apex of the chest to pass through the apex, and a sacral operation is performed at the apex of the apex. Inserting the left ventricle from the purse and tightening the pouch to fix the apical sleeve also includes the following steps:
  • the guide wire is placed on the hook card, and the hook card is placed in the hook card implantation catheter.
  • the hook card implants the catheter through the apical sleeve into the left ventricle to reach the joint of the front and rear leaflets, and the hook is pulled from the hook by the push rod.
  • the card is inserted into the catheter to insert the hook card into the mitral annulus; the two hooks are respectively implanted twice in the left and right mitral annulus at the junction of the anterior and posterior valvelets; After the hook card is implanted, the hook card is inserted into the catheter, and both ends of the two guiding wires passing through the hook card are led to the outside through the apical catheter;
  • the airbag closing plate, the guiding ring, the one-way valve and the end of the infusion tube are formed into one whole piece, and one end of the two guiding wires of the external body are respectively fixedly connected with the upper part of the same side of the airbag closing plate, and the other ends are respectively separated.
  • the guiding ring is worn on the same side; the balloon closing plate is curled into a cylinder, and the whole part of the cylinder is placed in the closed plate implantation catheter, and the closed plate is inserted into the catheter through the apical cannula into the left ventricle, and the balloon is pushed out.
  • the plate is closed to be deployed, the guiding wire passing through the guiding ring is guided to the outside of the body through the implantation catheter, and finally the guiding wire is tensioned so that the left upper part and the upper right part of the air bag closing plate are respectively located at the hook side of the same side, and the infusion tube is additionally One end is extended outside the body via a closed plate implantation catheter;
  • step B the lower end of the balloon closure plate is fixedly connected to one end of the traction wire in vitro, and after the balloon closure plate is fixed in the body, the other end of the traction wire is extended outside the body through the closure plate implantation catheter.
  • the airbag closing plate in the mitral airbag closing plate blocking body of the invention is made of an elastic plastic material which can be filled with gas or a curable liquid, and passes through the left chest of the human body.
  • a small incision is implanted through the apex into the left ventricle, placed and fixed to the position of the regurgitation of the mitral valve before and after the mitral valve is closed.
  • the mitral valve opens, and the blood passes through the anterior and posterior leaflets and the balloon closure plate.
  • the two channels between the left atrium flow into the left ventricle; when the heart contracts, the anterior and posterior leaflets close, the leaflet edge and the balloon closure plate fit snugly together, blocking the mitral valve regurgitation channel, effectively Prevents regurgitation of the mitral valve.
  • the balloon closure plate has a simple structure and high reliability, and the implantation method has little trauma to the human body, and the incidence of residual reflux is very low, and the treatment of functional mitral regurgitation and the like can be performed, and the functional apex can be repaired. The success rate of regurgitation is over 90%.
  • Figure 1 is a view of the structure of the heart and the position of the mitral valve
  • FIG. 2 is an enlarged view of the tissue structure of the mitral valve of Figure 1;
  • Figure 3 is a right side view of the mitral valve of Figure 2 when closed;
  • Figure 4 is a partial enlarged view of the atrium of Figure 2 when the mitral valve is closed;
  • Figure 5 is a right side view of the mitral regurgitation of the systolic mitral regurgitation in Figure 2;
  • Figure 6 is a partial enlarged view of the atrial mitral regurgitation in the systolic mitral regurgitation of Figure 2;
  • FIG. 7 is a schematic view of a transapical mitral valve balloon closure plate implant after implantation according to the present invention.
  • Figure 8 is an enlarged view of the hook card structure of Figure 7;
  • Figure 9 is a schematic view of the hook card of Figure 8 placed in the hook card implant catheter;
  • Figure 10 is a schematic view showing the implantation state of a mitral valve balloon closure plate occlusion body according to the present invention.
  • a structure of a apical valved mitral airbag closure plate occlusion body of the present invention includes a hook card 6, an airbag closure plate 7, a guide wire 8, a guide ring 13, and a fixation plug 12.
  • the fixation plug 12 is implanted at the apex 4 .
  • the hooks 6, respectively, are implanted at the left and right positions of the mitral annulus 2.1 at the anterior and posterior leaflet junctions 5, respectively.
  • the inside of the airbag closing plate 7 is an air bag, and the inside of the air bag is filled with a gas or a curable liquid.
  • the curable liquid is a liquid which is liquid when charged, and can be solid after a certain period of time or injection of a curing agent after being filled into the air bag. substance.
  • the longitudinal section of the airbag closing plate 7 has an inverted isosceles trapezoidal structure, and the length of the upper base of the isosceles trapezoid is longer than the length of the lower base, and the airbag closing plate 7 can be along itself before being filled with gas or solidified liquid outside the body.
  • the upper bottom edge or the lower bottom edge parallel to each other is tightly curled into an elongated cylinder.
  • the balloon closure plate 77 is placed between the anterior and posterior leaflets of the mitral valve 2 of the heart after implantation, and is located at the anterior and posterior leaflet junctions of the anterior leaflet 2.2 and the free edge of the posterior leaflet 2.3.
  • the balloon closure plate 7 is used to block the reflux passage formed by the incomplete closure of the two leaflets.
  • a guide ring 13 is fixedly connected to each of the lower left portion and the lower right portion of the airbag closing plate 7.
  • the upper left portion is fixedly connected to the hook card 6 on the left side via a first guiding line 8
  • the right upper portion of the flexible closing plate 7 is fixedly connected to the hook card 6 on the right side via a second guiding line 8.
  • the left and right guide wires 8 each pass through the guide ring 13 on the same side and then extend down to the apex 4 or the nipple muscle 2.5 at the position of the fixed plug 12, that is, the first guide wire 8 passes through the guide ring on the left side. 13 is fixed downward by the fixing plug 12, and the second guiding wire 8 passes through the guiding ring 13 on the right side and is lowered downward by the fixing plug 12.
  • the guide ring 13 serves to define the course of the guide wire 8.
  • the lower bottom edge of the airbag closing plate 7 is fixedly connected to one end of the pulling wire 14, and the other end of the pulling wire 14 is fixedly connected to the fixing plug 12.
  • the position of the airbag closing plate 7 is fixed by the pulling wire 14.
  • the airbag closing plate 7 is placed in the optimum position via the hook card 6, the pulling wire 14, and the fixing plug 12.
  • the lower bottom edge of the airbag closing plate 7 is connected to the infusion tube 10, the infusion tube 10 extends to the outside through the fixing plug 12, the infusion tube 10 communicates with the inside of the airbag closing plate 7, and a check valve 15 is arranged on the infusion tube 10, which can be unidirectional
  • the valve 15 is mounted at the junction of the infusion tube 10 and the balloon closure plate 7.
  • the one-way valve 15 is used to allow gas or liquid to enter the airbag closure panel 7 only in one direction.
  • the infusion tube 10 is a flexible medical hose for inflating the body or the curable liquid to the balloon closure panel 7.
  • the airbag closure panel 7 is made of an elastic plastic material, such as medical silicone or latex.
  • the hook card 6 is made of an alloy material, for example, a nickel-titanium memory alloy material.
  • the lead wire 8 and the pull wire 14 are made of ePTFE (expanded polytetrafluoroethylene) material.
  • the fixation plug 12 is made of a blood compatible material and the blood compatible material is a polyurethane or pericardial material. The fixation plug 12 is capable of locking the guide wire 8 and the traction wire 10 and is fixed at the apex 4 or the papillary muscle 2.5 position.
  • the hook card 6 is composed of two parts, a barb 6.1 and a connecting ring 6.2. One end is two barbs 6.1, and the other end is a connecting ring 6.2.
  • the barb 6.1 is partially fixed to the flap.
  • the guide wire 8 is worn
  • the airbag closing plate 7 is fixedly attached to the connecting ring 6.2, and the airbag closing plate 7 is fixed to the hook card 6 by the guiding wire 8.
  • the hook card 6 is first placed into the hook card implant catheter 9, and the inner diameter of the hook card implant catheter 9 is adapted to the outer diameter of the connecting ring 6.2 of the hook card 6.
  • the barb 6.1 portion is slightly bent and placed in the front end of the hook card implantation catheter 9.
  • the method of implanting the mitral balloon closure plate occlusion body into the heart is:
  • Step 1 First make a small incision in the left apex of the chest, straight through the apex 4, and do a purging operation at the apex 4 position, insert the apical sleeve into the left ventricle 3 from the purse, tighten the purse, and fix the apical sleeve. .
  • the apical cannula is clamped by a hemostat to prevent blood from flowing out of the implant site.
  • Step 2 In vitro, the two guiding wires 8 are placed on the connecting ring 6.2 of the hook card 6, and the two hook cards 6 on the connecting ring 6.2 through which the guiding wires 8 are respectively inserted are respectively implanted before and after.
  • the left and right mitral annuluses 2.1 of the leaflet junction 5 are in the middle.
  • the specific method is as follows: firstly, the first guiding wire 8 is placed on the connecting ring 6.2 of the first hook card 6, and then the first hook card 6 is placed in the hook card implanting catheter 9, which is loose and happy.
  • the second guiding wire 8 is placed on the connecting ring 6.2 of the second hook card 6, and the second hook card 6 is placed in the hook card implanting catheter 9, and the pillow is inserted.
  • the hemostat of the tube is inserted into the catheter 9 through the apical cannula into the left ventricle 3, and the barb 6.1 of the second hook card 6 is inserted into the right end position of the mitral annulus 2.1.
  • the hook card implantation catheter 9 is withdrawn.
  • both ends of each of the guide wires 8 passing through the hook card 6 are guided to the outside through the apical catheter, and the apex catheter is clamped with a hemostat to prevent bleeding of the heart.
  • Step 3 Externally, a left guide ring 13 is fixed to the left lower portion of the airbag closing plate 7, and a right guide ring 13 is fixedly coupled to the right lower portion.
  • One end of the plurality of traction wires 14 is evenly fixedly connected to the lower bottom edge of the airbag closing plate 7, and the middle of the lower bottom edge of the airbag closing plate 7 is fixedly connected to one end of the infusion tube 10, and a single table is installed at the connection of the infusion tube 10 and the airbag closing plate 7.
  • the airbag closing plate 7, the check valve 15, one end of the pulling wire 14, the one end of the infusion tube 10, and the left and right guide rings 13 are collectively formed as one piece.
  • the airbag closing plate 7 is manufactured, the lower edge thereof and the pulling wire 14 are evenly connected, and the guide ring 13 is fixed to the left and right lower portions, and the infusion tube 10 and the check valve 15 are provided to form an assembly.
  • Two guiding wires 8 are introduced to the outside of the body, and one end of each guiding wire 8 is respectively fixedly connected to the same upper side of the airbag closing plate 7, and the other end of each guiding wire 8 is respectively guided through the same side.
  • Ring 13 the first guide One end of the lead wire 8 is fixed to the upper left portion of the airbag closing plate 7, and the other end of the first guiding wire 8 passes through the left guiding ring 13 fixed to the flexible closing plate 7, and the second guiding wire 8 end and the air bag
  • the right upper portion of the closing plate 7 is fixed, and the other end of the second guiding wire 8 passes through the right guiding ring 13 fixed to the flexible closing plate 7.
  • the airbag closing plate 7 is tightly curled into an elongated cylinder along its mutually parallel upper bottom edge or lower bottom edge, and the curled airbag closing plate 7 is provided together with the guiding ring 13, the check valve 15, the end of the infusion tube 10, and One end of the traction wire 14 is placed together in the closure plate implantation catheter 11, the hemostasis of the cannula is loosened, and the closure plate is implanted into the catheter 11 by a small incision on the left side of the chest, through the apical cannula into the left ventricle 3 in.
  • Step 4 The balloon closure plate 7 is pushed out of the closure plate implantation catheter 11, and the balloon closure plate 7 is deployed inside the left ventricle 3.
  • the other end of the infusion tube 10, the other end of the pull wire 14 and the guide wire 8 passing through the guide ring 13 are all protruded from the apex 4 through the closed plate implantation catheter 11 outside the body. Adjusting the outer ends of the two guide wires 8 passing through the guide ring 13 and tightening the guide wire 8 so that the left upper portion and the upper right portion of the airbag closing plate 7 are respectively located at the hook card 6 on the same side, and the airbag closing plate is fixed. 7.
  • the pull wire 14 is adjusted such that the lower bottom edge of the air bag closure panel 7 is tensioned by the other end of the pull wire 14.
  • Step 5 exit the closed plate implant catheter 11, remove the apical cannula, and then tighten the purse to prevent bleeding.
  • the outer end of the infusion tube 10, the guiding wire 8 and the traction wire 14 are passed through the fixing plug 12.
  • the fixing plug 12 has a small end and protrudes into the apex 4, and the other end has a large area, close to the surface of the apex 4, and the fixing plug 12 has a middle
  • the central bore, the infusion tube 10, the guide wire 8 and the pull wire 14 are led out of the central bore of the fixed plug 12. Push the fixed plug 12 to the apex 4 position, release the purse, place the fixed plug 12 to the apex 4, and tighten the purse to fix.
  • the locking wire 14 and the guiding wire 8 are fixed by the fixing plug 12.
  • Step 6 The gas or curable liquid is introduced into the airbag closing plate 7 through the infusion tube 10 to be filled and formed.
  • the infusion tube 10, the traction line 14, and the guide wire 8 outside the fixed plug 12 are cut off by the fixing plug 12 locking the infusion tube 10.
  • Step 7 The small incision on the left side of the chest is sutured, and the implantation process of the mitral valve closure plate obstruction is completed.
  • the mitral valve 2 when the heart is dilated, the mitral valve 2 is opened, and blood flows from the left atrium 1 into the left ventricle 3 through the two channels between the anterior leaflet 2.2, the posterior leaflet 2.3, and the balloon closure plate 7; When contracted, the anterior leaflet 2.2 and the posterior leaflet 2.3 are closed, and the leaflet edge and the balloon closure plate 7 are closely attached together, blocking the regurgitation channel of the mitral valve 2, and effectively preventing the regurgitation of the mitral valve 2 .

Abstract

一种体心脏修复技术领域中经心尖植入的二尖瓣气囊闭合板阻塞体及植入方法，气囊闭合板（7）由可充入气体或可固化液体的弹性塑料材料制成，通过人体左侧胸部小切口植入，经心尖（4）进入左心室（3），放置并固定到二尖瓣（2）前后瓣叶闭合处（5）的反流孔位置，当心脏舒张时，二尖瓣（2）打开，血液通过前、后瓣叶（2.2、2.3）和气囊闭合板（7）之间的两条通道从左心房（1）流入左心室（3）；当心脏收缩时，前、后瓣叶（2.2、2.3）关闭，瓣叶边缘和气囊闭合板（7）紧密贴合到一起，阻塞了二尖瓣（2）的反流通道，有效地防止了二尖瓣（2）的反流；气囊闭合板阻塞体的结构简单，可靠性强，其植入方法对人体的创伤小，残余反流发生率很低，能够进行功能性二尖瓣关闭不全等疾病的治疗，修复功能型二尖瓣反流成功率达90％以上。

Description

一种经心尖植入的二尖瓣气囊闭合板阻塞体及植入方法 技术领域
本发明涉及人体心脏修复技术和医疗器械领域，尤其是一种能修复心脏二尖瓣反流的器械。
背景技术
人体心脏和瓣膜如图1所示，左心室3位于心尖4左上方，二尖瓣2位于左心房1和左心室3之间，二尖瓣2控制血液从左心房1单向流入左心室3。功能失调的二尖瓣2会导致二尖瓣2的两瓣叶关闭不全，使血液在心脏收缩期从左心室3反流回左心房1。二尖瓣反流将引起肺充血和左心室3肥大，最终导致病人的心衰和死亡。
二尖瓣2的结构如图2所示，二尖瓣2是一个复杂的承受血压的单向阀结构，由瓣环2.1、前瓣叶2.2、后瓣叶2.3、腱索2.4、乳头肌2.5和左心室壁上的心肌组成。乳头肌2.5附着于左心室壁上，前瓣叶2.2、后瓣叶2.3附着在瓣环2.1上。瓣环2.1是一个连接前瓣叶2.2、后瓣叶2.3和左心室壁的内部组织结构。根据瓣环2.1的组织结构，它被分成前内侧段的纤维层和后外侧段的肌肉层。腱索2.4起始于乳头肌2.5，附着于瓣叶上，能够防止心脏收缩时前瓣叶2.2、后瓣叶2.3塌陷进入左心房1。
功能正常的二尖瓣闭合时的状态如图3、图4所示，二尖瓣关闭后前瓣叶2.2、后瓣叶2.3之间没有间隙，前后瓣叶结合处5之间完全闭合，不会产生反流现象。当二尖瓣2闭合时的状态如图5、图6所示时，二尖瓣2的前后瓣叶结合处5之间有间隙出现，前后瓣叶结合处5间的间隙使血液在心脏收缩时从左心室3回流到左心房1(如图5中的箭头所示的反流方向)，这种回流称为二尖瓣反流，二尖瓣反流会降低心脏效率并导致心衰。
目前，对于二尖瓣反流的治疗方法，主要有瓣环整形术、机械二尖瓣或生物二尖瓣的移植等等，这些大多需要开胸、开心，对人体创伤大，可靠性不高，导致治疗后5年内50％的二尖瓣反流重新复发。现有的比较先进的微创治疗方法是通过二尖瓣钳夹，将前后瓣叶边缘的中点夹在一起，形成两个独立的血流通道，减少血液的反流，但是这种方法有残余反流发生。
发明内容
本发明的目的是解决现有二尖瓣反流治疗方法存在的问题，提供一种修复二尖瓣反流的经心尖植入的二尖瓣气囊闭合板阻塞体，阻塞二尖瓣的反流通道，有效防止二尖 瓣的反流；本发明同时还提供该二尖瓣气囊闭合板阻塞体的植入方法，经微创手术植入到二尖瓣前后瓣叶闭合处的反流孔位置，不需要开胸、开心，对人体创伤小，无残余反流发生，可靠性高。
为了达到以上目的，本发明一种经心尖植入的二尖瓣气囊闭合板阻塞体采用的技术方案是：所述二尖瓣气囊闭合板阻塞体包括气囊闭合板、导引线、导向环和固定塞，所述固定塞固定植入在心脏的心尖处，所述气囊闭合板内部是一个气囊，位于心脏的前后瓣叶结合处；在前后瓣叶结合处的左、右侧的二尖瓣环中各固定植入有一个钩卡，左、右两根导引线分别穿过同侧的钩卡且固定连接气囊闭合板的同侧上部，气囊闭合板的左下部和右下部各固定连接一个导向环，左、右两根导引线各自穿过同侧的导向环并固定连接到固定塞；在气囊闭合板的下底边连接有输液管且输液管通过固定塞延伸到体外，输液管与气囊闭合板内部相通，输液管上设置单向阀，经输液管能向气囊闭合板内部充入气体或可固化液体。
进一步地，气囊闭合板下底边缘固定连接牵引线一端，牵引线另一端固定连接固定塞。
所述经心尖植入的二尖瓣气囊闭合板阻塞体的植入方法采用的技术方案是：在胸部左侧心尖位置做一个小切口直通心尖，在心尖位置做一个荷包手术，将心尖套管从荷包中插入左心室，收紧荷包固定心尖套管，还包含以下步骤：
A、将导引线穿在钩卡上，钩卡放置在钩卡植入导管中，钩卡植入导管经心尖套管进入左心室到达前后瓣叶结合处，通过推杆将钩卡从钩卡植入导管中推出，使钩卡插入在二尖瓣环中；先后两次分别将两个钩卡分别植入在前后瓣叶结合处的左、右侧的二尖瓣环中；在两个钩卡植入后退出钩卡植入导管，穿过钩卡的两根导引线的两端都通过心尖导管引到体外；
B、在体外先将气囊闭合板、导向环、单向阀以及输液管一端组成一个整件，将体外的两根导引线一端各自分别和气囊闭合板同侧上部固定连接、另一端各自分别穿在同侧的导向环；再将气囊闭合板卷曲成圆柱体，将圆柱体的整件放入闭合板植入导管中，闭合板植入导管经心尖套管进入到左心室内部，推出气囊闭合板使其展开，穿过导向环的导引线经植入导管引向体外，最后拉紧导引线使气囊闭合板的左上部和右上部分别位于同侧的钩卡位置，输液管另一端则经闭合板植入导管伸出在体外；
C、退出闭合板植入导管，通过输液管将气体或可固化液体输入到气囊闭合板内部，使气囊闭合板充涨成型，通过固定塞锁紧输液管和导引线。
进一步地，步骤B中，在体外将气囊闭合板下底边固定连接牵引线一端，气囊闭合板在体内被固定好后，牵引线另一端则经闭合板植入导管伸出在体外。
本发明采用上述技术方案后具有的优点是：本发明所述二尖瓣气囊闭合板阻塞体中的气囊闭合板由可充入气体或可固化液体的弹性塑料材料制成，通过人体左侧胸部小切口植入，经心尖进入左心室，放置并固定到二尖瓣前后瓣叶闭合处的反流孔位置，当心脏舒张时，二尖瓣打开，血液通过前、后瓣叶和气囊闭合板之间的两条通道从左心房流入左心室；当心脏收缩时，前、后瓣叶关闭，瓣叶边缘和气囊闭合板紧密贴合到一起，阻塞了二尖瓣的反流通道，有效地防止了二尖瓣的反流。气囊闭合板阻塞体的结构简单，可靠性强，其植入方法对人体的创伤小，残余反流发生率很低，能够进行功能性二尖瓣关闭不全等疾病的治疗，修复功能型二尖瓣反流成功率达90％以上。
附图说明
下面结合附图以及具体实施方式对本发明作进一步的说明，但本发明的保护范围并不限于此。
图1为心脏的结构和二尖瓣位置图；
图2为图1中二尖瓣的组织结构放大图；
图3为图2中二尖瓣关闭时的右侧视图；
图4为图2中二尖瓣关闭时的心房局部放大图；
图5为图2中心脏收缩二尖瓣关闭不全时二尖瓣反流的右侧视图；
图6为图2中心脏收缩二尖瓣关闭不全时的二尖瓣反流的心房局部放大图；
图7为本发明所述一种经心尖植入的二尖瓣气囊闭合板阻塞体植入后的示意图；
图8为图7中钩卡结构放大图；
图9为图8中的钩卡放置在钩卡植入导管中的示意图；
图10为本发明一种经心尖植入的二尖瓣气囊闭合板阻塞体的植入状态示意图。
图中：1-左心房，2-二尖瓣，2.1-二尖瓣环，2.2-前瓣叶，2.3-后瓣叶，2.4-腱索，2.5-乳头肌，3-左心室，4-心尖，5-前后瓣叶结合处，6-钩卡，6.1-倒钩，6.2-连接环，7-气囊闭合板，8-导引线，9-钩卡植入导管，10-输液管，11-闭合板植入导管，12-固定塞，13-导向环，14-牵引线，15-单向阀。
具体实施方式
参见图7，本发明一种经心尖植入的二尖瓣气囊闭合板阻塞体的结构包括钩卡6、气囊闭合板7、导引线8、导向环13和固定塞12。固定塞12植入在心尖4处。有2个 钩卡6，分别植入在前后瓣叶结合处5的二尖瓣环2.1的左侧和右侧位置。气囊闭合板7内部是一个气囊，且气囊内部充有气体或者可固化液体，可固化液体是一种在充时是液体，充入气囊后经过一定的时间或注入固化剂后能够变成固体的物质。气囊闭合板7纵截面的形状为倒立的等腰梯形结构，等腰梯形的上底边长的长度大于下底边长，在体外充入气体或者固化液体之前，气囊闭合板7能够沿自身的相互平行的上底边或下底边紧密卷曲成细长的圆柱体。气囊闭合板77植入后放置在心脏的二尖瓣2的前后瓣叶之间，位于前瓣叶2.2和后瓣叶2.3游离边缘的前后瓣叶结合处5。
气囊闭合板7用于阻塞两瓣叶关闭不全形成的反流通道。气囊闭合板7的左下部和右下部各固定连接一个导向环13。有左、右两根导引线8，左、右两根导引线8各自穿过同侧的钩卡6，导引线8固定连接柔性闭合板7的同侧上部，即柔性闭合板7的左上部经第一根导引线8固定连接左侧的钩卡6，柔性闭合板7的右上部经第二根导引线8固定连接右侧的钩卡6。左、右两根导引线8各自穿过同侧的导向环13后向下延伸到心尖4或者乳头肌2.5处由固定塞12，即第一根导引线8穿过左侧的导向环13后向下由固定塞12固定，第二根导引线8穿过右侧的导向环13后向下由固定塞12处。导向环13用于限定导引线8的走向。
气囊闭合板7的下底边缘固定连接牵引线14一端，牵引线14另一端固定连接固定塞12。本发明中的牵引线14有多根，多根牵引线14一端沿气囊闭合板7下底边缘的长度方向均匀连接气囊闭合板7，多根牵引线14的另一端均固定连接于固定塞12，通过牵引线14固定气囊闭合板7的位置。这样，使气囊闭合板7经钩卡6、牵引线14和固定塞12放置在最佳位置。
气囊闭合板7的下底边连接输液管10，输液管10通过固定塞12延伸到体外，输液管10与气囊闭合板7内部相通，在输液管10上设置单向阀15，可将单向阀15安装在输液管10和气囊闭合板7的连接处。单向阀15用于使气体或液体只能单向进入气囊闭合板7。输液管10为柔软的医用软管，用于给气囊闭合板7内部充气体或可固化液体。
气囊闭合板7由弹性塑料材料制成，例如可用医用硅胶或乳胶制成。钩卡6由合金材料制成，例如采用镍钛记忆合金材料。导引线8和牵引线14均为ePTFE(膨体聚四氟乙烯)材料制成。固定塞12为血液相容性材料制成，血液相容性的材料为聚氨酯或心包膜材料。固定塞12能够锁定导引线8和牵引线10并固定在心尖4或乳头肌2.5位置。
参见图8，钩卡6由倒钩6.1和连接环6.2两部分组成，一端是两个倒钩6.1，另一端是一个连接环6.2，钩卡6植入时以倒钩6.1部分固定卡在瓣环2.1上，导引线8穿 在连接环6.2上并固定连接气囊闭合板7，通过导引线8使气囊闭合板7与钩卡6固定。
参见图9，钩卡6植入心脏前，要先将钩卡6置入钩卡植入导管9中，钩卡植入导管9的内径与钩卡6的连接环6.2的外径相适应。钩卡6置入时，将倒钩6.1部分略作弯曲变形后置入钩卡植入导管9的前端。
参见图1-10，将所述二尖瓣气囊闭合板阻塞体植入心脏内的方法是：
步骤1、首先在胸部左侧心尖位置做一个小的切口，直通心尖4，并在心尖4位置做一个荷包手术，将心尖套管从荷包中插入左心室3，收紧荷包，固定心尖套管。心尖套管通过止血钳夹住，防止心脏血液从植入位置流出。
步骤2、在体外，将两根导引线8穿在钩卡6的连接环6.2上，先后两次分别将连接环6.2上穿有导引线8的两个钩卡6分别植入在前后瓣叶结合处5的左、右侧的二尖瓣环2.1中。其具体方法为：先将第一根导引线8穿在第一个钩卡6的连接环6.2上，再将该第一个钩卡6放置在钩卡植入导管9中，松开心尖套管的止血钳，将钩卡植入导管9由左侧胸部小切口经心尖套管进入左心室3，到达二尖瓣的前瓣叶2.2和后瓣叶2.3间隙两端的二尖瓣环2.1位置，通过推杆将该第一个钩卡6从钩卡植入导管9的前端推出，倒钩6.1被推出展开后通过其弹性使倒钩6.1插入在二尖瓣环2.1的左端位置中。再退出钩卡植入导管9，心尖套管通过止血钳夹住。用同样的方法，将第二根导引线8穿在第二个钩卡6的连接环6.2上，再将该第二个钩卡6放置在钩卡植入导管9中，松开心尖套管的止血钳，将钩卡植入导管9经心尖套管进入左心室3，将第二个钩卡6的倒钩6.1插入在二尖瓣环2.1的右端位置中。这样，将两个钩卡6植入后，退出钩卡植入导管9。此时，穿过钩卡6的每根导引线8的两端都通过心尖导管引到体外，用止血钳夹紧心尖导管，防止心脏出血。
步骤3、在体外，将气囊闭合板7的左下部固定一个左侧导向环13、右下部固定连接一个右侧导向环13。在气囊闭合板7的下底边均匀固定连接多根牵引线14一端，气囊闭合板7的下底边的中间固定连接输液管10一端，在输液管10和气囊闭合板7的连接处安装单向阀15，使气囊闭合板7、单向阀15、牵引线14一端、输液管10一端以及左右两个导向环13共同成为一个整件。或者，在制造气囊闭合板7时，将其下边缘和牵引线14均匀连接，其左右下部固定好导向环13，并带有输液管10和单向阀15，形成一个组件。
引到体外的两根导引线8，每根导引线8的一端各自分别和气囊闭合板7的同侧上部固定连接，每根导引线8的另一端各自分别穿过同侧的导向环13。即：将第一根导 引线8一端和气囊闭合板7左上部固连，第一根导引线8另一端穿过固定在柔性闭合板7上的左侧的导向环13，将第二根导引线8一端和气囊闭合板7右上部固连，第二根导引线8另一端穿过固定在柔性闭合板7上的右侧的导向环13。再将气囊闭合板7沿自身的相互平行的上底边或下底边紧密卷曲成细长的圆柱体，将卷曲的气囊闭合板7连同导向环13、单向阀15、输液管10一端以及牵引线14一端一起放入闭合板植入导管11中，松开心尖套管的止血钳，将闭合板植入导管11由胸部左侧的小切口植入，经心尖套管进入到左心室3中。
步骤4、将气囊闭合板7从闭合板植入导管11中推出，气囊闭合板7在左心室3内部展开。此时，输液管10的另一端、牵引线14的另一端以及穿过导向环13的导引线8都从心尖4经闭合板植入导管11伸出在体外。调节两根穿过导向环13的导引线8的体外端，拉紧导引线8，使气囊闭合板7的左上部和右上部分别位于同侧的钩卡6位置，固定好气囊闭合板7。同时调节牵引线14，使气囊闭合板7下底边缘通过牵引线14另一端拉紧。
步骤5、退出闭合板植入导管11，将心尖套管取出，再收紧荷包，防止心脏出血。将输液管10、导引线8和牵引线14的体外端穿过固定塞12，固定塞12一端细小，伸入心尖4，另一端部面积较大，贴近心尖4表面，固定塞12中间有中心孔，输液管10、导引线8和牵引线14从固定塞12的中心孔中引出。将固定塞12推向心尖4位置，松开荷包，将固定塞12放置到心尖4后，收紧荷包固定。调整牵引线14和导引线8的拉力达到最佳后，通过固定塞12固定锁紧牵引线14和导引线8。
步骤6、将气体或可固化液体通过输液管10输入到气囊闭合板7，使其充涨成型。通过固定塞12锁紧输液管10，将固定塞12外面多余的输液管10、牵引线14和导引线8剪除。
步骤7、将胸部左侧小切口缝合，二尖瓣气囊闭合板阻塞体的植入过程结束。
参见图1-10，当心脏舒张时，二尖瓣2打开，血液通过前瓣叶2.2、后瓣叶2.3和气囊闭合板7之间的两条通道从左心房1流入左心室3；当心脏收缩时，前瓣叶2.2和后瓣叶2.3关闭，瓣叶边缘和气囊闭合板7紧密贴合到一起，阻塞了二尖瓣2的反流通道，能有效防止了二尖瓣2的反流。

Claims (9)

  1. 一种经心尖植入的二尖瓣气囊闭合板阻塞体，其特征是：包括气囊闭合板(7)、导引线(8)、导向环(13)和固定塞(12)，所述固定塞(12)固定植入在心脏的心尖(4)处，所述气囊闭合板(7)内部是一个气囊，位于心脏的前后瓣叶结合处；在前后瓣叶结合处的左、右侧的二尖瓣环(2.1)中各固定植入有一个钩卡(6)，左、右两根导引线(8)分别穿过同侧的钩卡(6)且固定连接气囊闭合板(7)的同侧上部，气囊闭合板(7)的左下部和右下部各固定连接一个导向环(13)，左、右两根导引线(8)各自穿过同侧的导向环(13)并固定连接到固定塞(12)；在气囊闭合板(7)的下底边连接有输液管(10)且输液管(10)通过固定塞(12)延伸到体外，输液管(10)与气囊闭合板(7)内部相通，输液管(10)上设置单向阀(15)，经输液管(10)能向气囊闭合板(7)内部充入气体或可固化液体。
  2. 根据权利要求1所述经心尖植入的二尖瓣柔性闭合板阻塞体，其特征是：气囊闭合板(7)下底边缘固定连接牵引线(14)一端，牵引线(14)另一端固定连接固定塞(12)。
  3. 根据权利要求2所述经心尖植入的二尖瓣柔性闭合板阻塞体，其特征是：所述牵引线(14)有多根，多根牵引线(14)一端沿气囊闭合板(7)下底边的长度方向均匀连接气囊闭合板(7)，多根牵引线(10)的另一端均固定连接于固定塞(12)。
  4. 根据权利要求1所述经心尖植入的二尖瓣柔性闭合板阻塞体，其特征是：所述气囊闭合板(7)的纵截面为倒等腰梯形结构，气囊闭合板(7)能够沿上底边或下底边卷曲成圆柱体。
  5. 根据权利要求1所述经心尖植入的二尖瓣柔性闭合板阻塞体，其特征是：气囊闭合板(7)由弹性塑料材料制成，钩卡(6)由合金材料制成，导引线(8)由膨体聚四氟乙烯材料制成，固定塞(12)由血液相容性材料制成。
  6. 根据权利要求1所述经心尖植入的二尖瓣柔性闭合板阻塞体，其特征是：钩卡(6)由倒钩(6.1)和连接环(6.2)两部分组成，导引线(8)穿在连接环(6.2)上。
  7. 一种如权利要求1所述经心尖植入的二尖瓣气囊闭合板阻塞体的植入方法，在胸部左侧心尖位置做一个小切口直通心尖(4)，在心尖(4)位置做一个荷包手术，将心尖套管从荷包中插入左心室(3)，收紧荷包固定心尖套管，其特征是还包含以下步骤：
    A、将导引线(8)穿在钩卡(6)上，钩卡(6)放置在钩卡植入导管(9)中，钩卡植入导管(9)经心尖套管进入左心室(3)到达前后瓣叶结合处，通过推杆将钩卡(6)从钩卡植入导管(9)中推出，使钩卡(6)插入在二尖瓣环(2.1)中；先后两次分别将两个 钩卡(6)分别植入在前后瓣叶结合处的左、右侧的二尖瓣环(2.1)中；在两个钩卡(6)植入后退出钩卡植入导管(9)，穿过钩卡(6)的两根导引线(8)的两端都通过心尖导管引到体外；
    B、在体外先将气囊闭合板(7)、导向环(13)、单向阀(15)以及输液管(10)一端组成一个整件，将体外的两根导引线(8)一端各自分别和气囊闭合板(7)同侧上部固定连接、另一端各自分别穿在同侧的导向环(13)；再将气囊闭合板(7)卷曲成圆柱体，将圆柱体的整件放入闭合板植入导管(11)中，闭合板植入导管(11)经心尖套管进入到左心室(3)内部，推出气囊闭合板(7)使其展开，穿过导向环(13)的导引线(8)经闭合板植入导管(11)引向体外，最后拉紧导引线(8)使气囊闭合板(7)的左上部和右上部分别位于同侧的钩卡(6)位置，输液管(10)另一端则经闭合板植入导管(11)伸出在体外；
    C、退出闭合板植入导管(11)，通过输液管(10)将气体或可固化液体输入到气囊闭合板(7)内部，使气囊闭合板(7)充涨成型，通过固定塞(12)锁紧输液管(10)和导引线(8)。
  8. 根据权利要求7所述经心尖植入的二尖瓣柔性闭合板阻塞体的植入方法，其特征是：步骤B中，在体外将气囊闭合板(7)下底边固定连接牵引线(14)一端，气囊闭合板(7)在体内被固定好后，牵引线(14)另一端则经闭合板植入导管(11)伸出在体外。
  9. 根据权利要求7所述经心尖植入的二尖瓣柔性闭合板阻塞体的植入方法，其特征是：步骤A中，导引线(8)一端穿在钩卡(6)的连接环(6.2)部分，钩卡(6)的倒钩(6.1)部分插入在心脏的二尖瓣环(2.1)中。
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