CN103536377A - Heart bioprosthetic valve with valve leaflet capable of being repeatedly replaced through minimally invasive surgery - Google Patents

Heart bioprosthetic valve with valve leaflet capable of being repeatedly replaced through minimally invasive surgery Download PDF

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

The embodiment of the invention discloses a heart bioprosthetic valve with a valve leaflet capable of being repeatedly replaced through a minimally invasive surgery. The heart bioprosthetic valve comprises a valve support (1) and the replaceable valve leaflet (2), wherein the valve support (1) is used for being sewed with the tissue, and the valve support (1) and the replaceable valve leaflet (2) are in tight connection through a clamping groove (3) and a sealing groove (4) in the valve support (1). When the heart bioprosthetic valve is implanted in a patient through a thoracic surgery, the function of the valve leaflet degenerates, and the heart bioprosthetic valve is required to be replaced, through the minimally invasive surgery, a conveying device with a new valve leaflet can be guided by a visualization device to take down the damaged valve leaflet by a valve leaflet removing device of the conveying device, meanwhile, the new valve leaflet is expanded to be installed on the valve support to complete replacement of the valve leaflet, the damaged valve leaflet can be compressed to be installed in the conveying device which is pulled out of the human body, and replacement of the heart bioprosthetic valve is finished. According to the heart bioprosthetic valve, the risk of huge traumas caused by the fact that the thoracic surgery is required to be carried out on the patient again to replace the heart bioprosthetic valve due to the reason of the service life after the heart bioprosthetic valve is implanted in the human body is reduced.

Description

A kind of heart biology valve that can repeat to change lobe leaf by Minimally Invasive Surgery
Technical field
The present invention relates to technical field of medical instruments, more particularly, relate to a kind of heart biology valve that can repeat to change lobe leaf by Minimally Invasive Surgery.
Background technology
Valvular heart disease is one of modal heart disease of China, and the most effective Therapeutic Method is to carry out valve replacement by surgical operation at present, and conventional displacement apparatus has two kinds: mechanical valve prosthesis and biovalve.Replacement operation need to be in cardiac arrest, under the mode of extracorporeal circulation, carries out, and operating time is long, loses blood many, simultaneously larger to patient's damage.In recent years, the huge wound that is abroad difficult to bear operation for elderly patient has been developed by the apex of the heart and has been punctured or the intervention heart biology valve of femoral artery puncture, obtain at present the SAPIEN balloon expandable formula aortic valve that has Edwards of CE authentication and the CoreValve self expandable formula aortic valve of Medtronic, have the operation consumption of tens thousand of examples.
The each have their own pluses and minuses of above-mentioned three class cardiac valve: mechanical valve prosthesis good endurance, do not need to change, but after in patients with implantation body, easily form thrombosis, so need take throughout one's life anticoagulant, the thrombosis that anticoagulation improper use causes and the complication such as hemorrhage are brought a lot of potential safety hazards to patient's health.Biovalve hemodynamics and people's self valve is similar, effect is better, and without using anticoagulation, but the durability of biovalve is poor compared with mechanical valve prosthesis, after generally implanting 10 years, valve can calcification cause disabler, need to again change cardiac valve, the huge wound of open chest surgery is difficult to bear to a lot of patients again.Get involved the replacement operation of heart biology valve without carrying out under the mode of cardiac arrest and extracorporeal circulation; operating time is short; lose blood few; damage to patient is less; but the structure that gets involved valve itself has caused the service life of valve short, and the biovalve that hemodynamics is not opened breast is good, gets involved valve Applicative time short simultaneously; long-term effectiveness also needs further clinical observation, is only applicable at present high-risk patient.
[0005]cN 101601611A discloses the assembled artificial heart biovalve therapy equipment of displacement repeatedly under a kind of Minimally Invasive Surgery, lobe frame and lobe leaf split-type design, by open chest surgery, biovalve is implanted, valvular function can carry out Cardiac Valve Replacement by Minimally Invasive Surgery after losing efficacy, reduced the difficulty of operation again, operation risk is reduced.But the solution of this disclosure of the invention, the junction point of lobe frame and lobe leaf is in the bottom of lobe frame, and inwardly outstanding, when blood is during by valve, outstanding position can change hemodynamic state, and the while can cause breaking of hemocyte when hemocyte contacts and haemolysis occurs.The summit of lobe leaf and lobe frame be without effective fixing point, can cause lobe leaf long-term in service, and the leaf shape distortion of lobe, accelerates the infringement of lobe leaf, affects its service life.
Summary of the invention
In view of this, the technical problem to be solved in the present invention is to provide a kind of heart biology valve that can repeat to change lobe leaf by Minimally Invasive Surgery, main passing through the improvement on lobe frame and lobe impeller structure, make it to have the good hemodynamics of biovalve, biocompatibility and service life, have advantages of again that the wound of Minimally Invasive Surgery replacing valve is little, operating time is short simultaneously.
For achieving the above object, the invention provides following technical scheme:
Minimally Invasive Surgery can repeat to change a heart biology valve for lobe leaf, comprises that its mesopetalum frame and lobe leaf are two independently parts, can assemble, dismantle for the lobe frame with tissue apposition and removable lobe leaf.
Wherein said lobe frame comprises draw-in groove, seal groove and suture ring.Draw-in groove has three, outwards outstanding, lays respectively at three summits of lobe frame, is 120 degree and distributes on lobe frame; Seal groove is " U " shape, is positioned at the outside of lobe frame, be connected between two, and the height in outside is lower than the height of inner side; Suture ring is outwards outstanding, is positioned at the outside, bottom surface of lobe frame, for the stitching with tissue.
The framework material of described lobe frame can be a kind of of cochrome, rustless steel, Nitinol or macromolecule PEEK.The material of the skin parcel of described lobe frame is the good woven dacron of biocompatibility.
Wherein said lobe leaf comprises bayonet socket, valve frame and valve.Described bayonet socket comprises activity template, stator and spring, and these three unit constructions together, at one end apply certain power, can make the other end open, and after releasing power, the other end can be realized clamping again.Described valve frame is three " U " shapes by a nitinol alloy wire after shaping, and two free ends are fixed together by laser weld or machinery the ring that forms sealing, and the arc of valve frame is consistent with the arc of seal groove.The stator of described bayonet socket and valve frame are fixed together.The skin of described valve frame is enclosed with woven dacron or PTFE material.
Described valve can be a kind of of bovine pericardium, Cor Sus domestica bag, Cor Equi bag or Cor Sus domestica lobe, is sewn on valve frame.Above-mentioned material is all the material that biovalve is conventional, has long-term clinical use historical.
Described lobe leaf is realized and being closely connected with lobe frame by the draw-in groove on lobe frame and seal groove, and described lobe leaf can show separated with lobe frame by operation sheet cause for gossip simultaneously.
When patient implants this heart biology valve by open chest surgery, when lobe leaf occurs that functional deterioration need be replaced biovalve again, can pass through Minimally Invasive Surgery, by the conveyer device that new valve leaflet is housed, under the guiding of DSA equipment, the lobe leaf apparatus for removing by the lobe leaf breaking down by conveyer device takes off, and opens new valve leaflet simultaneously, lobe leaf is contained on lobe frame, complete the replacing of lobe leaf, and withdraw from externally by packing conveyer device after the lobe leaf compression breaking down into, complete cardiac valve replacement.
From above-mentioned technical scheme, can find out of the present invention having the following advantages:
1, compare with mechanical valve prosthesis, the present invention is without using anticoagulation, avoided thrombosis that anticoagulation improper use causes and the complication such as hemorrhage to bring potential safety hazard to patient's health;
2, compare with biovalve, the present invention has kept the good hemodynamics of biovalve and service life, consider the Wicresoft's permutation function after valve failure simultaneously, avoided the huge wound that open chest surgery brings to patient again, and the design that can repeat to change lobe leaf by Minimally Invasive Surgery provided by the invention has solved the Long Service Life problem of biovalve;
3, compare with intervention valve, the present invention has Minimally Invasive Surgery without carrying out under the mode of cardiac arrest and extracorporeal circulation, operating time is short, lose blood less, the advantage less to patient's damage, the reduction hemodynamics that after having avoided getting involved valve simultaneously and implanting, valve shape distortion causes and the risk in service life.Get involved at present valve and be only applicable to elderly patient, other patients can not use because of reasons such as service lifes, the invention solves the age limit problem of Wicresoft's replacement valve.
Accompanying drawing explanation
In order to be illustrated more clearly in the embodiment of the present invention or technical scheme of the prior art, to the accompanying drawing of required use in embodiment or description of the Prior Art be briefly described below, apparently, accompanying drawing in the following describes is only some embodiments of the present invention, for those of ordinary skills, do not paying under the prerequisite of creative work, can also obtain according to these accompanying drawings other accompanying drawing.
Fig. 1 is embodiment of the present invention heart biology valve schematic diagram.
Fig. 2 is embodiment of the present invention heart biology valve assembling schematic diagram.
Fig. 3 is embodiment of the present invention heart biology valve lobe frame schematic diagram.
Fig. 4 is embodiment of the present invention heart biology valve lobe frame draw-in groove generalized section.
Fig. 5 is embodiment of the present invention heart biology valve lobe frame seal groove generalized section.
Fig. 6 is embodiment of the present invention heart biology valve lobe leaf schematic diagram.
Fig. 7 is embodiment of the present invention heart biology valve lobe leaf bayonet socket schematic diagram.
Fig. 8 is the lobe leaf frame schematic diagram of embodiment of the present invention heart biology valve lobe leaf.
Number in the figure explanation:
1, lobe frame; 2, lobe leaf; 3, draw-in groove; 4, seal groove; 5, suture ring; 6, bayonet socket; 7, lobe leaf frame; 8, valve; 9, activity template; 10, stator; 11, spring.
The specific embodiment
The invention discloses a kind of heart biology valve that can repeat to change lobe leaf by Minimally Invasive Surgery, after solving biovalve and implanting because of service life reason cause again opening breast and change valve and to patient, bring the risk of huge wound.
Below in conjunction with the accompanying drawing in the embodiment of the present invention, the technical scheme in the embodiment of the present invention is clearly and completely described, obviously, described embodiment is only the present invention's part embodiment, rather than whole embodiment.Embodiment based in the present invention, those of ordinary skills, not making the every other embodiment obtaining under creative work prerequisite, belong to the scope of protection of the invention.
Fig. 1 is embodiment of the present invention heart biology valve schematic diagram, comprises lobe frame 1 and lobe leaf 2, and Fig. 2 is embodiment of the present invention heart biology valve assembling schematic diagram, and lobe frame 1 and lobe leaf 2 are two independently parts, can assemble, dismantle.
Fig. 3 is embodiment of the present invention heart biology valve lobe frame schematic diagram, and lobe frame 1 comprises draw-in groove 3, seal groove 4 and suture ring 5.Fig. 4 is embodiment of the present invention heart biology valve lobe frame draw-in groove generalized section, and draw-in groove 3 has three, outwards outstanding, lays respectively at three summits of lobe frame, is 120 degree and distributes on lobe frame.Fig. 5 is embodiment of the present invention heart biology valve lobe frame seal groove generalized section.Seal groove 4 is " U " shape, is positioned at the outside of lobe frame 1, be connected between two, and the height in outside is lower than the height of inner side.Suture ring 5 is outwards outstanding, is positioned at the outside, bottom surface of lobe frame 1, for the stitching with tissue.The framework material of lobe frame 1 can be a kind of of cochrome, rustless steel, Nitinol or macromolecule PEEK, and the material of outer parcel is the good woven dacron of biocompatibility.
Fig. 6 is embodiment of the present invention heart biology valve lobe leaf schematic diagram, and lobe leaf 2 comprises bayonet socket 6, valve frame 7 and valve 8.Fig. 7 is embodiment of the present invention heart biology valve lobe leaf bayonet socket schematic diagram, and bayonet socket 6 comprises activity template 9, stator 10 and spring 11 3 parts, these three unit constructions together, at one end apply certain power, can make the other end open, after releasing power, the other end can be realized clamping again.Fig. 8 is the lobe leaf frame schematic diagram of embodiment of the present invention heart biology valve lobe leaf, valve frame 7 is three " U " shapes by a nitinol alloy wire after shaping, two free ends are fixed together by laser weld or machinery the ring that forms sealing, and the arc of valve frame 7 is consistent with the arc of seal groove 4.The stator 10 of three bayonet sockets is fixed together by laser weld or machinery with three summits of valve frame 7 respectively, when one end of bayonet socket 6 applies after certain power, can make the other end of activity template 9 expand outwardly, and the relative lobe leaf frame 7 of stator 10 does not have relative motion.The skin of lobe leaf frame 7 is enclosed with woven dacron or PTFE material, can improve the blood compatibility of lobe leaf frame 7, the relative sliding while simultaneously preventing from sewing up with valve 8.Valve 8 can be a kind of of bovine pericardium, Cor Sus domestica bag, Cor Equi bag or Cor Sus domestica lobe, is sewn on lobe leaf frame 7.Above-mentioned material is all the material that biovalve is conventional, has long-term clinical use historical.
When lobe leaf 2 and lobe frame 1 are installed, use lobe leaf erecting device, one end of 2 three bayonet sockets 6 of three pawls and lobe leaves of lobe leaf erecting device is connected, apply the other end that certain power makes bayonet socket 6 simultaneously and open certain angle, three bayonet sockets of lobe leaf 6 are aimed to three draw-in grooves 3 of lobe framves simultaneously, after aligning, lobe leaf 2 is depressed, the lobe leaf frame 7 of lobe leaf 2 is packed in the seal groove 4 of lobe frame 1, unclamp the erecting device of three bayonet sockets 6, bayonet socket 6 and draw-in groove 3 are realized fixing, complete the installation of lobe leaf 2 and lobe frame 1.
Install heart biology valve, use lobe leaf apparatus for removing, can realize the separated of lobe frame 1 and lobe leaf 2.One end of three bayonet sockets 6 of three pawls and lobe leaves of lobe leaf apparatus for removing is connected, apply the other end that certain power makes bayonet socket 6 simultaneously and open certain angle, fixed lobes frame 1, upwards carries lobe leaf apparatus for removing, make lobe leaf 2 depart from lobe frame 1, complete the separated of lobe leaf 2 and lobe frame 1.
Below the process of the implantation of heart biology valve and Minimally Invasive Surgery replacing lobe leaf is briefly described.
Open routinely the program of breast cardiac valve replacement and carry out cardiac arrest and extracorporeal circulation, by lobe frame of the present invention and lobe ring tissue apposition, lobe frame is installed to lobe leaf on lobe frame by lobe leaf erecting device after sewing up, and completes the implantation of heart biology valve.
When patient implanted after heart biology valve a period of time of the present invention, when lobe leaf occurs that functional deterioration need be replaced biovalve again, there is several different methods can replace lobe leaf.
Method one, can carry out cardiac arrest and extracorporeal circulation by the program of conventional Thoracotomy in Management cardiac valve replacement, under direct-view, lobe leaf of the present invention be taken off by lobe leaf apparatus for removing the lobe leaf breaking down, and use lobe leaf erecting device that new valve leaflet is arranged on lobe frame, complete the replacing of lobe leaf.Because of this operation, saved conventional replacement valve and need to remove cardiac valve, sewed up subsequently valvular program, operating time is shortened greatly, reduced amount of bleeding and operating difficulty, made can recover as early as possible after operation in patients.
Method two, can pass through Minimally Invasive Surgery, at patient's chest, open a little otch, the blood vessel of aortic arch punctures simultaneously, under visualization device guiding, new valve leaflet is compressed in the conveyer device supporting with this operation method, contrary blood flow enters aortic valve position, by the lobe leaf apparatus for removing in conveyer device, the lobe leaf breaking down is taken off, by the lobe leaf erecting device in conveyer device, new valve leaflet is arranged on lobe frame simultaneously, complete the replacing of lobe leaf, and withdraw from externally by packing conveyer device after the lobe leaf compression breaking down into, complete the replacing of lobe leaf.Because of this operation, save the program that conventional valve replacement need be opened breast cardiac arrest and extracorporeal circulation, make patient's bleeding few, wound is little, postoperative rehabilitation as early as possible.
Method three, can pass through Minimally Invasive Surgery, at patient's chest, open a little otch, the position in the heart of the left ventricle that simultaneously punctures, under visualization device guiding, new valve leaflet is compressed in the conveyer device supporting with this operation method, antegrade blood flow enters aortic valve position, by the lobe leaf apparatus for removing in conveyer device, the lobe leaf breaking down is taken off, by the lobe leaf erecting device in conveyer device, new valve leaflet is arranged on lobe frame simultaneously, complete the replacing of lobe leaf, and withdraw from externally by packing conveyer device after the lobe leaf compression breaking down into, complete the replacing of lobe leaf.Because of this operation, save the program that conventional valve replacement need be opened breast cardiac arrest and extracorporeal circulation, make patient's bleeding few, wound is little, postoperative rehabilitation as early as possible.
Method four, can pass through Minimally Invasive Surgery, the capable Femoral artery puncture of thigh root patient, under visualization device guiding, new valve leaflet is compressed in the conveyer device supporting with this operation method, contrary blood flow enters aortic valve position, by the lobe leaf apparatus for removing in conveyer device, the lobe leaf breaking down is taken off, by the lobe leaf erecting device in conveyer device, new valve leaflet is arranged on lobe frame simultaneously, complete the replacing of lobe leaf, and withdraw from externally by packing conveyer device after the lobe leaf compression breaking down into, complete the replacing of lobe leaf.Because of this operation, save the program that conventional valve replacement need be opened breast cardiac arrest and extracorporeal circulation, make patient's bleeding few, wound is little, postoperative rehabilitation as early as possible.
In this description, each embodiment stresses is the difference with other embodiment, between each embodiment identical similar part mutually referring to.
Above-mentioned explanation to the disclosed embodiments, makes professional and technical personnel in the field can realize or use the present invention.To the multiple modification of these embodiment, will be apparent for those skilled in the art, General Principle as defined herein can, in the situation that not departing from the spirit or scope of the present invention, realize in other embodiments.Therefore, the present invention will can not be restricted to these embodiment shown in this article, but will meet the widest scope consistent with principle disclosed herein and features of novelty.

Claims (10)

1. the heart biology valve that can repeat to change lobe leaf by Minimally Invasive Surgery, it is characterized in that, comprise that, for the lobe frame (1) with tissue apposition and removable lobe leaf (2), its mesopetalum frame (1) and lobe leaf (2) are two independently parts, can assemble, dismantle.
2. heart biology valve as claimed in claim 1, is characterized in that, described lobe frame (1) comprises draw-in groove (3), seal groove (4) and suture ring (5).
3. heart biology valve as claimed in claim 2, is characterized in that, described draw-in groove (3) is three, outwards outstanding, lays respectively at three summits of lobe frame, is 120 degree and distributes on lobe frame.
4. heart biology valve as claimed in claim 2, is characterized in that, described seal groove (4) is positioned at the outside of lobe frame, and seal groove (4) is " U " shape, be connected between two, and the height in outside is lower than the height of inner side.
5. heart biology valve as claimed in claim 2, is characterized in that, described suture ring (5) is positioned at the outside, bottom surface of lobe frame, outwards outstanding, for the stitching with tissue.
6. heart biology valve as claimed in claim 1, is characterized in that, described lobe leaf (2) comprises bayonet socket (6), valve frame (7) and valve (8).
7. heart biology valve as claimed in claim 6, is characterized in that, described bayonet socket (6) comprises activity template (9), stator (10) and spring (11).
8. heart biology valve as claimed in claim 6, it is characterized in that, described valve frame (7) is three " U " shapes by a nitinol alloy wire after shaping, two free ends are fixed together by laser weld or machinery the ring that forms sealing, and the arc of valve frame (7) is consistent with the arc of seal groove (4).
9. heart biology valve as claimed in claim 6, is characterized in that, stator (10) and the valve frame (7) of described bayonet socket (6) are fixed together.
10. heart biology valve as claimed in claim 6, is characterized in that, described valve (8) can be a kind of of bovine pericardium, Cor Sus domestica bag, Cor Equi bag or Cor Sus domestica lobe, is sewn on valve frame (7).
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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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109431656A (en) * 2018-12-17 2019-03-08 山东省千佛山医院 Fixed device is formed on a kind of aorta petal
CN111249036A (en) * 2020-02-27 2020-06-09 上海理工大学 Artificial heart prosthesis valve with movable support
CN111265332A (en) * 2020-02-27 2020-06-12 上海理工大学 Artificial heart prosthesis valve
CN112773567A (en) * 2021-02-26 2021-05-11 复旦大学 Heart valve test fixture and use method thereof
CN115462934A (en) * 2022-10-08 2022-12-13 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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US20080228264A1 (en) * 2007-03-12 2008-09-18 St. Jude Medical, Inc. Prosthetic heart valves with flexible leaflets
CN101601611A (en) * 2009-04-03 2009-12-16 中国人民解放军第二军医大学 Metathetical repeatedly assembled artificial heart biovalve therapy equipment under the Minimally Invasive Surgery
US20100087918A1 (en) * 2006-10-23 2010-04-08 Ivan Vesely Cardiovascular valve and assembly

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US20060136052A1 (en) * 2004-12-16 2006-06-22 Valvexchange Inc. Cardiovascular valve assembly
CN101217920A (en) * 2005-07-13 2008-07-09 爱德华兹生命科学公司 Prosthetic mitral heart valve having a contoured sewing ring
US20100087918A1 (en) * 2006-10-23 2010-04-08 Ivan Vesely Cardiovascular valve and assembly
US20080228264A1 (en) * 2007-03-12 2008-09-18 St. Jude Medical, Inc. Prosthetic heart valves with flexible leaflets
CN101601611A (en) * 2009-04-03 2009-12-16 中国人民解放军第二军医大学 Metathetical repeatedly assembled artificial heart biovalve therapy equipment under the Minimally Invasive Surgery

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109431656A (en) * 2018-12-17 2019-03-08 山东省千佛山医院 Fixed device is formed on a kind of aorta petal
CN111249036A (en) * 2020-02-27 2020-06-09 上海理工大学 Artificial heart prosthesis valve with movable support
CN111265332A (en) * 2020-02-27 2020-06-12 上海理工大学 Artificial heart prosthesis valve
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
CN115462934A (en) * 2022-10-08 2022-12-13 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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