CN103536377B - It is a kind of that the heart biology valve for replacing leaflet is repeated by Minimally Invasive Surgery - Google Patents

It is a kind of that the heart biology valve for replacing leaflet is repeated by Minimally Invasive Surgery Download PDF

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CN103536377B
CN103536377B CN201210247085.4A CN201210247085A CN103536377B CN 103536377 B CN103536377 B CN 103536377B CN 201210247085 A CN201210247085 A CN 201210247085A CN 103536377 B CN103536377 B CN 103536377B
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valve
leaflet
frame
valve frame
heart biology
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CN103536377A (en
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李莉
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Abstract

The embodiment of the invention discloses a kind of heart biology valve that replacement leaflet is repeated by Minimally Invasive Surgery, including for the valve frame with tissue apposition(1)With replaceable leaflet(2), its mesopetalum frame(1)With replaceable leaflet(2)Pass through the card slot on valve frame(3)And seal groove(4)Realize close connection.When patient is implanted into the heart biology valve by open chest surgery, when there is functional deterioration and need to replace biovalve again in leaflet, Minimally Invasive Surgery can be passed through, by the conveying device equipped with new valve leaflet under visualization device guiding, the leaflet to break down is removed into device by the leaflet of conveying device and is removed, while opens new valve leaflet, by leaflet on valve frame, the replacement of leaflet is completed, and loads conveying device after the leaflet to break down is compressed and withdraws from vitro, completes cardiac valve replacement.Because service life reason causes to open the risk that chest replaces valve and bring huge wound to patient again after implanting present invention reduces biovalve.

Description

It is a kind of that the heart biology valve for replacing leaflet is repeated by Minimally Invasive Surgery
Technical field
The present invention relates to the field of medical instrument technology, and replacement is repeated by Minimally Invasive Surgery more specifically to one kind The heart biology valve of leaflet.
Background technology
Valvulopathy is one of most common heart disease in China, and current most effective treatment method is to pass through surgical operation Valve replacement is carried out, common displacement apparatus there are two kinds:Mechanical valve prosthesis and biovalve.Replacement operation is needed in cardiac arrest, Carried out under the mode of extracorporal circulatory system, operating time length, loses blood more, while the damage to patient is larger.In recent years, it is external for height The huge wound that age patient is difficult to bear to perform the operation have developed the intervention heart biology valve by apex of the heart puncture or femoral artery puncture Film, obtains the SAPIEN balloon-expandables aortic valves and Medtronic that have Edwards of CE certifications at present CoreValve self-expanding aortic valves, there is the operation dosage of tens thousand of.
The above-mentioned each have their own advantage and disadvantage of three classes cardiac valves:Mechanical valve prosthesis durability is good, it is not necessary to replaces, but is implanted into patient After in vivo, thrombus is easily formed, so anticoagulant need to be taken throughout one's life, thrombus and bleeding etc. caused by anticoagulation improper use are concurrent Disease carrys out many security risks to the health care belt of patient.The valve of biovalve haemodynamics and people itself is similar, and effect is preferable, And without using anticoagulation, but the durability of biovalve is poor compared with mechanical valve prosthesis, and valve can calcification after being typically implanted internal 10 years Cause disabler, it is necessary to re-replace cardiac valves, the huge wound of open chest surgery is difficult to bear to many patients again.It is situated between Entering the replacement operation of heart biology valve without being carried out under cardiac arrest and the mode of extracorporal circulatory system, operating time is short, loses blood few, Damage to patient is smaller, but intervene valve structure in itself result in valve service life it is short, haemodynamics is not opened The biovalve of chest is good, while intervenes that valve application time is short, and long-term validity also needs further clinical observation, at present only Suitable for high-risk patient.
CN 101601611A disclose the assembled artificial heart biovalve treatment replaced repeatedly under a kind of Minimally Invasive Surgery Device, valve frame and leaflet split-type design, are implanted biovalve by open chest surgery, can be passed through after valvular function failure Minimally Invasive Surgery carries out valve replacement, reduces the difficulty performed the operation again, reduces operation risk.But the solution party of the disclosure of the invention The tie point of case, valve frame and leaflet is protruded inwardly from the bottom of valve frame, when blood passes through valve, prominent position meeting Change the state of haemodynamics, while can cause the rupture of haemocyte during haemocyte contact and haemolysis occurs.The vertex of leaflet With valve frame without effective fixing point, causing leaflet, leaflet shape distortion, accelerates the infringement of leaflet, shadow in long-term operation Ring its service life.
The content of the invention
In view of this, the technical problem to be solved in the present invention is to provide a kind of repeated by Minimally Invasive Surgery to replace leaflet Heart biology valve, mainly by the improvement on valve frame and leaflet structure, with the excellent hemodynamic of biovalve Learn, biocompatibility and service life, at the same have the advantages that again Minimally Invasive Surgery replacement valve wound is small, operating time is short.
To achieve the above object, the present invention provides following technical solution:
It is a kind of that the heart biology valve for replacing leaflet is repeated by Minimally Invasive Surgery, including for the valve frame with tissue apposition With replaceable leaflet, its mesopetalum frame and leaflet are two independent components, can assemble, dismantle.
Wherein described valve frame includes card slot, seal groove and suture ring.Card slot has three, outstanding, respectively positioned at valve frame Three vertex, on valve frame in 120 degree be distributed;Seal groove is " u "-shaped, positioned at the outside of valve frame, is connected two-by-two, and outside Highly it is less than the height of inner side;Suture ring is outstanding, positioned at the outer side bottom surface of valve frame, the suture for being used for and organizing.
The framework material of the valve frame can be one kind of cochrome, stainless steel, Nitinol or macromolecule PEEK.Institute The material for stating the outer layer covers of valve frame is the preferable woven dacron of biocompatibility.
Wherein described leaflet includes bayonet, valve frame and valve.The bayonet includes activity template, fixinig plate and spring, this Three component combinations together, apply certain power at one end, can open the other end, and the other end can be realized again after releasing power Clamp.The valve frame by a nitinol alloy wire by being in three " u "-shapeds after sizing, two free ends by laser welding or The ring for being joined together to form closing is mechanically fixed, the arc of valve frame is consistent with the arc of seal groove.The fixation of the bayonet Piece and valve frame are fixed together.The outer layer covers of the valve frame have woven dacron or PTFE material.
The valve can be one kind of bovine pericardium, Pigs Hearts bag, horse pericardium or Pigs Hearts valve, be sewn on valve frame.It is above-mentioned Material is all the common material of biovalve, has long-term Clinical practice history.
The leaflet is realized by the card slot on valve frame and seal groove and is closely connected with valve frame, while the leaflet can pass through Bayonet is operated to realize and the separation with valve frame.
When patient is implanted into the heart biology valve by open chest surgery, functional deterioration, which occurs, in leaflet need to replace bioprosthetic valves again During film, by the conveying device equipped with new valve leaflet under the guiding of DSA equipment, the leaflet to break down can be passed through defeated by Minimally Invasive Surgery Send the leaflet of device to remove device to remove, while open new valve leaflet, by leaflet on valve frame, complete the replacement of leaflet, and will Load conveying device after the leaflet compression to break down to withdraw from vitro, complete cardiac valve replacement.
It can be seen from the above technical scheme that the present invention's has the following advantages:
1st, compared with mechanical valve prosthesis, the present invention avoids thrombus caused by anticoagulation improper use without using anticoagulation Carry out security risk to the health care belt of patient with complication such as bleedings;
2nd, compared with biovalve, the present invention maintains biovalve excellent haemodynamics and service life, at the same time In view of the minimally invasive permutation function after valve failure, the huge wound that open chest surgery is brought to patient again is avoided, and this hair Bright offer repeats the design for replacing leaflet by Minimally Invasive Surgery, solves the problems, such as the Long Service Life of biovalve;
3rd, compared with intervening valve, the present invention have Minimally Invasive Surgery without under cardiac arrest and the mode of extracorporal circulatory system into OK, operating time is short, loses blood less, the less advantage of the damage to patient, while avoids valve after intervention valve implants The risk of haemodynamics and service life is reduced caused by shape distortion.Intervention valve is only applicable to elderly patient at present, its Because the reasons such as service life cannot use, the present invention solves the problems, such as the age limit of minimally invasive replacement valve by his patient.
Brief description of the drawings
In order to illustrate more clearly about the embodiment of the present invention or technical scheme of the prior art, below will be to embodiment or existing There is attached drawing needed in technology description to be briefly described, it should be apparent that, drawings in the following description are only this Some embodiments of invention, for those of ordinary skill in the art, without creative efforts, can be with Other attached drawings are obtained according to these attached drawings.
Fig. 1 is heart biology valve schematic diagram of the embodiment of the present invention.
Fig. 2 is heart biology valve assembling schematic diagram of the embodiment of the present invention.
Fig. 3 is heart biology valve valve frame schematic diagram of the embodiment of the present invention.
Fig. 4 is heart biology valve valve frame card slot diagrammatic cross-section of the embodiment of the present invention.
Fig. 5 is heart biology valve valve frame seal groove diagrammatic cross-section of the embodiment of the present invention.
Fig. 6 is heart biology valve leaflets schematic diagram of the embodiment of the present invention.
Fig. 7 is heart biology valve leaflets bayonet schematic diagram of the embodiment of the present invention.
Fig. 8 is the leaflet frame schematic diagram of heart biology valve leaflets of the embodiment of the present invention.
Figure label explanation:
1st, valve frame;2nd, leaflet;3rd, card slot;4th, seal groove;5th, suture ring;6th, bayonet;7th, leaflet frame;8th, valve;9th, it is movable Piece;10th, fixinig plate;11st, spring.
Embodiment
The invention discloses a kind of heart biology valve that replacement leaflet is repeated by Minimally Invasive Surgery, biovalve is solved Because service life reason causes to open the risk that chest replaces valve and bring huge wound to patient again after implanting.
Below in conjunction with the attached drawing in the embodiment of the present invention, the technical solution in the embodiment of the present invention is carried out clear, complete Site preparation describes, it is clear that described embodiment is only part of the embodiment of the present invention, instead of all the embodiments.It is based on Embodiment in the present invention, those of ordinary skill in the art are obtained every other without making creative work Embodiment, belongs to the scope of protection of the invention.
Fig. 1 is heart biology valve schematic diagram of the embodiment of the present invention, including valve frame 1 and leaflet 2, Fig. 2 are present invention implementation Example heart biology valve assembling schematic diagram, valve frame 1 and leaflet 2 are two independent components, can assemble, dismantle.
Fig. 3 is heart biology valve valve frame schematic diagram of the embodiment of the present invention, and valve frame 1 includes card slot 3, seal groove 4 and suture Ring 5.Fig. 4 is heart biology valve valve frame card slot diagrammatic cross-section of the embodiment of the present invention, and card slot 3 has three, outstanding, difference Positioned at three vertex of valve frame, in 120 degree of distributions on valve frame.Fig. 5 seals for heart biology valve valve of embodiment of the present invention frame Grooved profile schematic diagram.Seal groove 4 is " u "-shaped, positioned at the outside of valve frame 1, is connected two-by-two, and the height in outside is less than the height of inner side Degree.Suture ring 5 is outstanding, positioned at the outer side bottom surface of valve frame 1, the suture for being used for and organizing.The framework material of valve frame 1 can be Cochrome, stainless steel, one kind of Nitinol or macromolecule PEEK, the material of outer layer covers are preferably washed for biocompatibility Synthetic fibre cloth.
Fig. 6 is heart biology valve leaflets schematic diagram of the embodiment of the present invention, and leaflet 2 includes bayonet 6, valve frame 7 and valve 8.Fig. 7 is heart biology valve leaflets bayonet schematic diagram of the embodiment of the present invention, and bayonet 6 includes activity template 9, fixinig plate 10 and spring 11 three parts, these three component combinations together, apply certain power, can open the other end at one end, another after releasing power One end can realize clamping again.Fig. 8 is the leaflet frame schematic diagram of heart biology valve leaflets of the embodiment of the present invention, and valve frame 7 is by one By being in three " u "-shapeds after sizing, two free ends are linked together root nitinol alloy wire by laser welding or be mechanically fixed The ring of closing is formed, the arc of valve frame 7 is consistent with the arc of seal groove 4.The fixinig plate 10 of three bayonets respectively with valve frame 7 Three vertex linked together by laser welding or be mechanically fixed, after one end of bayonet 6 applies certain power, can make The other end of activity template 9 expands outwardly, and fixinig plate 10 does not have relative motion with respect to leaflet frame 7.The outer layer covers of leaflet frame 7 have Woven dacron or PTFE material, can improve the blood compatibility of leaflet frame 7, while opposite slip when preventing from suturing with valve 8. Valve 8 can be one kind of bovine pericardium, Pigs Hearts bag, horse pericardium or Pigs Hearts valve, be sewn on leaflet frame 7.Above-mentioned material is all raw The common material of thing valve, has long-term Clinical practice history.
When leaflet 2 and valve frame 1 are installed, using leaflet erecting device, by three pawls of leaflet erecting device and leaflet 2 three One end connection of bayonet 6, while applying certain power makes the other end of bayonet 6 open certain angle, while by the three of leaflet A bayonet 6 is directed at three card slots 3 of valve frame, depresses leaflet 2 after alignment, the leaflet frame 7 of leaflet 2 is loaded the sealing of valve frame 1 In groove 4, the erecting device of three bayonets 6 is unclamped, bayonet 6 and card slot 3 is realized and is fixed, completes the installation of leaflet 2 and valve frame 1.
Heart biology valve is installed, device is removed, it can be achieved that the separation of valve frame 1 and leaflet 2 using leaflet.Leaflet is moved Except one end of three bayonets 6 of three pawls and leaflet of device is connected, while applying certain power makes the other end of bayonet 6 open one Fixed angle, fixed lobes frame 1, leaflet removal device is carried upwards, leaflet 2 is departed from valve frame 1, completes point of leaflet 2 and valve frame 1 From.
The process that implantation to heart biology valve below and Minimally Invasive Surgery replace leaflet is briefly described.
The program for routinely opening chest cardiac valve replacement carries out cardiac arrest and extracorporal circulatory system, by the valve frame and valve of the present invention Leaflet is installed on valve frame by ring tissue apposition, valve frame after suturing by leaflet erecting device, completes heart biology valve Implantation.
After patient is implanted into the heart biology valve of the present invention for a period of time, functional deterioration, which occurs, in leaflet need to replace life again During thing valve, there are a variety of methods to replace leaflet.
Method one, can carry out cardiac arrest and extracorporal circulatory system by the program of conventional Thoracotomy in Management cardiac valve replacement, look at straight Under, the leaflet of the present invention is removed into device by leaflet and removes the leaflet to break down, and uses leaflet erecting device by new valve leaflet On valve frame, the replacement of leaflet is completed.Need to remove cardiac valves because the operation eliminates conventional replacement valve, then seam Close valvular program so that operating time greatly shortens, and reduces amount of bleeding and operating difficulty, makes patient is postoperative can be extensive as early as possible It is multiple.
Method two, can open a small notch, while puncture the blood of aortic arch by Minimally Invasive Surgery in the chest of patient Pipe, under visualization device guiding, new valve leaflet is compressed in the conveying device supporting with the operation method, and inverse blood flow enters master Artery valve site, removes device by the leaflet in conveying device and removes the leaflet to break down, while by conveying device Leaflet erecting device new valve leaflet is installed on valve frame, complete the replacement of leaflet, and load after the leaflet to break down is compressed defeated Device is sent to withdraw from the replacement in vitro, completing leaflet.Chest cardiac arrest need to be opened and follow in vitro by saving conventional valve replacement because of the operation The program of ring, makes patient's bleeding few, and wound is small, it is postoperative can rehabilitation as early as possible.
Method three, can open a small notch, while puncture the portion in the heart of left ventricle by Minimally Invasive Surgery in the chest of patient Position, under visualization device guiding, new valve leaflet is compressed in the conveying device supporting with the operation method, antegrade blood flow enters master Artery valve site, removes device by the leaflet in conveying device and removes the leaflet to break down, while by conveying device Leaflet erecting device new valve leaflet is installed on valve frame, complete the replacement of leaflet, and load after the leaflet to break down is compressed defeated Device is sent to withdraw from the replacement in vitro, completing leaflet.Chest cardiac arrest need to be opened and follow in vitro by saving conventional valve replacement because of the operation The program of ring, makes patient's bleeding few, and wound is small, it is postoperative can rehabilitation as early as possible.
Method four, in the thigh root row Femoral artery puncture of patient, can be guided by Minimally Invasive Surgery in visualization device Under, new valve leaflet is compressed in the conveying device supporting with the operation method, inverse blood flow enters aortic valve site, by defeated Send leaflet in device to remove device to remove the leaflet to break down, while by the leaflet erecting device in conveying device by new valve Leaf is installed on valve frame, completes the replacement of leaflet, and is loaded conveying device after the leaflet to break down is compressed and withdrawn from vitro, completes valve The replacement of leaf.Chest cardiac arrest and the program of extracorporal circulatory system need to be opened by saving conventional valve replacement because of the operation, make patient's bleeding few, Wound is small, it is postoperative can rehabilitation as early as possible.
What each embodiment stressed is the difference with other embodiment in this specification, each embodiment it Between identical similar portion mutually referring to.
The foregoing description of the disclosed embodiments, enables professional and technical personnel in the field to realize or use the present invention. A variety of modifications to these embodiments will be apparent for those skilled in the art, as defined herein General Principle can be realized in other embodiments without departing from the spirit or scope of the present invention.Therefore, it is of the invention The embodiments shown herein is not intended to be limited to, and is to fit to and the principles and novel features disclosed herein phase one The most wide scope caused.

Claims (10)

1. a kind of repeat the heart biology valve for replacing leaflet by Minimally Invasive Surgery, it is characterised in that including being used for and organizing The valve frame of suture and replaceable leaflet, its mesopetalum frame and leaflet are two independent components, can assemble, dismantle;
The valve frame includes card slot, seal groove and suture ring, and the card slot is located at valve frame vertex, and the seal groove is " u "-shaped, position In the outside of valve frame, the suture ring is outstanding, positioned at the outer side bottom surface of valve frame, the suture for being used for and organizing;
The leaflet includes bayonet, valve frame and valve, and the bayonet includes activity template, fixinig plate and spring, the bayonet Fixinig plate and valve frame are fixed together, and apply one in the one end for the bayonet arrangement that the activity template, fixinig plate and spring are formed Fixed power, can open the other end, and the other end can realize clamping again after releasing power, and the valve frame contains and the seal groove The "u"-shaped to match, the fixinig plate and valve frame of the bayonet are fixed together, and the valve is sewn on leaflet frame;
Achievable leaflet is engaged with the bayonet in the leaflet, valve frame by the card slot on the valve frame and seal groove respectively Close with valve frame is connected, while can realize the separation of leaflet and valve frame by operating bayonet;
When patient is implanted into the heart biology valve by open chest surgery, functional deterioration, which occurs, in leaflet need to replace biovalve again When, by Minimally Invasive Surgery, by the conveying device equipped with new valve leaflet under visualization device guiding, the leaflet to break down is passed through into conveying The leaflet of device removes device and removes, while opens new valve leaflet, by leaflet on valve frame, completes the replacement of leaflet, and will be bad Load conveying device after the leaflet compression fallen to withdraw from vitro, complete cardiac valve replacement.
2. the heart biology valve as described in claim 1, it is characterised in that the height on the outside of the seal groove is less than inner side Height.
3. the heart biology valve as described in claim 1, it is characterised in that the valve is bovine pericardium, Pigs Hearts bag, Ma Xin One kind of bag or Pigs Hearts valve.
4. the heart biology valve as described in claim 1, it is characterised in that the framework material of the valve frame be cochrome, One kind in stainless steel, Nitinol or macromolecule PEEK.
5. the heart biology valve as described in claim 1, it is characterised in that the material of the outer layer covers of the valve frame is made a living The preferable woven dacron of thing compatibility.
6. the heart biology valve as described in claim 1, it is characterised in that the outer layer covers of the valve frame have woven dacron Or PTFE materials.
7. the heart biology valve as described in claim 1, it is characterised in that the card slot is three, outstanding, respectively Positioned at three vertex of valve frame, in 120 degree of distributions on valve frame.
8. the heart biology valve as described in claim 1, it is characterised in that the seal groove has three, is connected two-by-two.
9. heart biology valve as claimed in claim 7, it is characterised in that the valve frame is passed through by a nitinol alloy wire It is in three " u "-shapeds after sizing, two free ends are joined together to form the ring of closing, valve by laser welding or be mechanically fixed The arc of frame is consistent with the arc of seal groove.
10. the heart biology valve as described in claim 1, it is characterised in that card slot has three, outstanding,
It is located at three vertex of valve frame respectively, is distributed on valve frame in 120 degree, seal groove is " u "-shaped, positioned at the outside of valve frame, It is connected two-by-two, and the height in outside is less than the height of inner side, valve frame is by a nitinol alloy wire by being in three " U " after sizing Shape, two free ends are joined together to form the ring of closing, the arc of valve frame and sealing by laser welding or be mechanically fixed The arc of groove is consistent, and three vertex of the fixinig plates of three bayonets respectively with valve frame by laser welding or are mechanically fixed connection Together, it after one end of bayonet applies certain power, can expand outwardly the other end of activity template, and fixinig plate is with respect to valve Leaf frame does not have relative motion.
CN201210247085.4A 2012-07-17 2012-07-17 It is a kind of that the heart biology valve for replacing leaflet is repeated by Minimally Invasive Surgery Active CN103536377B (en)

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CN109431656B (en) * 2018-12-17 2020-10-23 山东省千佛山医院 Aortic valve upper forming and fixing device
CN111265332B (en) * 2020-02-27 2022-03-25 上海理工大学 Artificial heart prosthesis valve
CN111249036B (en) * 2020-02-27 2022-03-25 上海理工大学 Artificial heart prosthesis valve with movable support
CN112773567A (en) * 2021-02-26 2021-05-11 复旦大学 Heart valve test fixture and use method thereof
CN115462934B (en) * 2022-10-08 2023-07-14 浙江归创医疗科技有限公司 Detachable venous valve
CN117503430A (en) * 2023-12-12 2024-02-06 苏州心岭迈德医疗科技有限公司 Valve prosthesis

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US7758640B2 (en) * 2004-12-16 2010-07-20 Valvexchange Inc. Cardiovascular valve assembly
US7776084B2 (en) * 2005-07-13 2010-08-17 Edwards Lifesciences Corporation Prosthetic mitral heart valve having a contoured sewing ring
EP2076215A4 (en) * 2006-10-23 2014-07-23 Valvexchange Inc Cardiovascular valve and assembly
US8092523B2 (en) * 2007-03-12 2012-01-10 St. Jude Medical, Inc. Prosthetic heart valves with flexible leaflets
CN101601611B (en) * 2009-04-03 2012-02-01 中国人民解放军第二军医大学 Therapeutic device for repeatedly replacing assembled artificial heart biovalve in mini-invasive surgery

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