CN103690272A - Mechanical valve prosthesis of expansion valve skirt aorta - Google Patents
Mechanical valve prosthesis of expansion valve skirt aorta Download PDFInfo
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- CN103690272A CN103690272A CN201410017395.6A CN201410017395A CN103690272A CN 103690272 A CN103690272 A CN 103690272A CN 201410017395 A CN201410017395 A CN 201410017395A CN 103690272 A CN103690272 A CN 103690272A
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Abstract
The invention relates to mechanical valve prosthesis of expansion valve skirt aorta, which can be quickly implanted by a cardiac surgeon under direct vision. The mechanical valve prosthesis of the expansion valve skirt aorta comprises a valve frame; one side of the outer circle of the valve frame forms an annular valve groove; an annular spring valve skirt is fixed within the annular valve groove; an open chamber formed inside the spring valve skirt is filled with polyester fiber fillers; shaping sutures are bundled up at the waist part of the outer side of the spring valve skirt. The shaping sutures are bundled up at the waist part of the outer side of the spring valve skirt to reduce the ring size of the spring valve skirt, and after the shaping sutures are released, the spring recovers and the valve groups are expanded. Three noninvasive sutures with needles are preset and fixed on the spring valve skirt. The mechanical valve prosthesis disclosed by the invention can fulfill the aim of replacing the mechanical valve prosthesis of the aorta by only three-needle suture, realizes clinical effects of greatly shortening extracorporeal circulation and cardiac arrest time in operation, implanting large-size mechanical valve prosthesis and remarkably reducing perivalvular leakage complication, and effectively improves the curative effect on replacement of a mechanical valve of the aorta.
Description
Technical field
The invention belongs to technical field of medical instruments, relate to a kind of aorta mechanical valve prosthesis of novel inflatable lobe skirt.
Background technology
Cardiac valve is the device of a kind of similar " one-way cock ", makes blood in heart, keep the one-way flow of right atrium-right ventricle-pulmonary circulation-left atrium-left ventricle-body circulation.Cardiac valve is brought into play vital effect for the cardiac function and the hemodynamic stability that maintain human normal.Valvular heart disease is one of modal heart disease, huge to human health risk, is one of most important reason causing cardiac failure, especially in China: 1. the valvular heart disease sickness rate of China is far above American-European countries; 2. China progressively enters aging society, and population-based is large, degenerative cardiac valve disease patient rapid development; 3. because economic level is relative with social environment backward, the cardiac valve patient group that China is caused by infective endocarditis or syphilitic arteritis is huge.Therefore, China is the country occurred frequently of valvular heart disease, it is estimated need to row surgical intervention cardiac valve patient surpass 3,000,000.
There are four valves in mankind's normal heart, wherein aortic valve is to consist of three lobe leaves and corresponding lobe hole, and it is around Connective tissue ring, between left ventricle and ascending aorta.Because it feels concerned about the blood flow impact that system bears elevated pressures and speed on a left side, so sickness rate is higher.Once pathological changes appears in aortic valve, because its space structure is complicated, without lobe lower devices such as papillary muscles, chordae tendineaes, and it is high to bear pressure, so surgical repair difficulty is maximum, annuloplasty band effect is undesirable.Therefore, valvular prosthetic replacement to perform the operation be often unique effective treatment approach.Artificial valve can be divided into two kinds, and a kind of is biovalve, is mainly porcine aortic valve or bovine pericardium are processed to the cardiac valve of making through special process; Another kind is mechanical valve prosthesis, is stock at present mainly with RESEARCH OF PYROCARBON, is around the suture ring that synthetic polyester fibers (Dacron) or politef (Telfon) are made, i.e. lobe skirt.In China's mechanical prosthetic valve use amount, surpass 90%, main cause is that China's valvular heart disease patient age is relatively little, how between 40～60 years old.Due to bioprosthetic valve poor durability, about 10 years, there is failure, be especially implanted in the bioprosthetic valve of aortic valve position, under the blood flow of high pressure, high speed impacts, valve failure phenomenon is more general, process is more rapid, and patient often need carry out heart valve replacement surgery for the second time.But second operation not only expense is high, and has a big risk.And mechanical prosthetic valve can be used all the life, it is that biovalve cannot replace.
The basic process of traditional aortic valve replacement is: in vitro under the support of circulation (CPB), patient's ascending aorta is closed in resistance, and perfused hearts stops jumping liquid and makes cardiac arrest, apart from the about 2cm of aortic root place, is cutting ascending aorta, appear pathological changes aortic valve, excise original pathological changes valve.Because suture ring (lobe skirt) has certain thickness, so must select to be less than the artificial valve of No. 1, aortic valve ring diameter or No. 2, on lobe skirt, after interrupted mattress suture 12～15 pins, hypovalve is tied a knot or according to aortic valve, divides three quadrants and sew up continuously respectively rear hypovalve knotting, artificial valve is fixed on aortic valvular ring to open ascending aorta recovering beat of heart.This process generally needs 30～60 min, and the CPB parallel time in later stage, generally performs the operation and need about 4 hours in addition.Yet due to each system organ function of CPB system damage human body itself, while replacing aortic valve, heart is in stoping jumping the state of ischemia in addition, so operation itself is for each internal organs of human body, and especially cardiac function strike is very large.The aortic valve disease patient of China particularly, when medical, cardiac function is often in losing the compensatory stage for they, thereby the damage being caused by CPB and cardiac arrest is even more serious, is often fatal.Research at present clearly shows that the CPB time becomes positive correlation with cardiac arrest time length with operative mortality.Therefore, reduce the effective way of this type of operation risk and simplify exactly modus operandi, shorten CPB and cardiac arrest time and even do not use CPB and cardiac arrest technology.Just for the above reasons, western developed country has developed the multiple aortic valve prosthesis who exempts from stitching or only need a little stitching to implant under conduit aortic valve implanted prosthetics (TAVI) and direct-view at present.The application of these technology and device can be avoided CPB and cardiac arrest or significantly shorten CPB and the cardiac arrest time, reaches the object that reduces operation risk.But, current TAVI technology is all to develop on the basis of biovalve with exempting to sew up aortic valve, this is because biovalve itself is soft, can take in special sheath pipe or in implanting device, but mechanical valve prosthesis is the rigid structure that RESEARCH OF PYROCARBON is made, cannot realizes through conduit and implant or exempt to sew up to implant by current technology.Yet these be take bioprosthetic valve and are not only faced with the serious problems of valve failure as basic technology, and also there are many still unsolved defects in clinical practice: the clinical indication of TAVI technology is strict, under non-direct-view, operate valve and be difficult to accurate location; pathological changes lobe cannot excise that incidence rates such as causing perivalvular leakage is higher, malignant arrhythmia incidence rate is high in art, and postoperative pressure gradient is larger etc.Exempt to sew up or few initiatively valve of sewing up for three kinds of clinical practice at present: ATS3f Enable, Perceval S and Edwards INTUITY, although it can be implanted rapidly by surgeon under direct-view, but the special tectonic due to bioprosthetic valve, the severe complications such as the displacement of postoperative easy generation valve, perivalvular leakage, conduction block, clinical use has certain limitation, and involves great expense, is difficult to promote.So these based on bioprosthetic valve through conduit or to exempt from sew up to implant valve technology very narrow and small the applicable patient group of China, we in the urgent need to a kind of can short time CPB support and cardiac arrest under can complete the aorta mechanical valve prosthesis of implantation.In addition, current aortic valve mechanical prosthetic valve is because suture ring (lobe skirt) itself has certain thickness and there is no dilatancy, has to implant the artificial valve who is less than No. 1～2, aortic valve ring diameter while therefore performing the operation, otherwise cannot hypovalve knotting.But surgical principle requires aortic valve prosthesis's model to be the bigger the better, if artificial valve's effective vent area and patient body-surface mismatch of cross-sectional area will form obvious pressure gradient, cause cardiac overload, be unfavorable for heart function recovery, appreciable impact operation long-term effect.Yet, much China Small aortic root patient, middle and aged women patient particularly, after aortic valve replacement, toward contact, there is pressure gradient more than 50mmHg in these patients, and surgical effect is undesirable.In a lot of situations, in order to implant the valve of larger model, have to implement aortic root Enlargement, but aortic root expands the not only technical sophistication of performing the operation, time-consuming is long, and the complication rate such as hemorrhage, conduction block is high.Therefore in the urgent need to a kind of, realize contraction---the aorta mechanical prosthetic valve of expanding petal skirt is realized and while implanting, can be selected the valve of relatively large number to improve operative effect.Finally, manyly need patient's lobe ring destroyed of row aorta valved prosthesis serious, this situation is more common in old people's Aortic valve degeneration and calcification, connective tissue disease, rupture of aortic sinusal aneurysm, each age group endocarditis, particularly involves case and the secondary of lobe root or repeatedly changes the patient of lobe.After excision pathological changes valve or original artificial valve, noresidue lobe ring or residual fraction are very few, lobe ring just can not be born suture tractive or cannot sew up and reach fixedly artificial valve's object with mechanical prosthetic valve skirt at all, and suture is easily torn lobe ring tissue and caused postoperative perivalvular leakage.Once generation perivalvular leakage, patient often has that the performance of left heart insufficiency or left heart insufficiency obviously increase the weight of, anemia or haemolysis, aortic area diastolic murmur etc., is a kind of fatal severe complication.For above-mentioned patient, existing artificial valve cannot meet requirements of operation: on the one hand, on aorta wall, stitching can cause hemorrhage and easily cause postoperative perivalvular leakage; On the other hand, even if reproduce lobe ring, also can increase the probability of postoperative perivalvular leakage, and extend and be unfavorable for obviously increasing operative mortality and complication rate by myocardial preservation while causing CPB time and cardiac arrest.Therefore, for this type of patient in the urgent need to a kind of aorta mechanical valve prosthesis of well fix and reducing perivalvular leakage generation of realizing.
In sum, can implant or exempt to sew up the aortic valve that (few stitching) direct-view implants through conduit at present and be bioprosthetic valve, not only easily failure, applicable patient group is narrow, post-operative complication is many, long-term effect is not good, and technical matters is complicated, expensive, is not suitable for the most patients of China.Mechanical valve prosthesis is selected over 90% patient by China, but existing mechanical aortic valve also has the following disadvantages: 1. in operation, valve stitching, hypovalve, knotting process are consuming time, cannot realize under direct-view and exempt to sew up or few stitching implantation, therefore CPB and cardiac arrest time are long, be unfavorable for whole body organ protection, operation risk is relatively large; 2. mechanical prosthetic valve lobe skirt (suture ring) does not have dilatancy, need to implant the artificial valve who is less than No. 1, measured aortic valve ring diameter or No. 2, has limited the effective vent area of implanting valve, has increased pressure gradient and cardiac load, is unfavorable for the recovery of cardiac function; 3. for aortic valvular ring, destroy or residual very few and connective tissue pathological changes patient, mechanical prosthetic valve skirt is difficult to realize firmly and sew up and fix with original lobe ring tissue, and not only operating difficulty is large, and postoperative easy generation perivalvular leakage.
Summary of the invention
The technical problem to be solved in the present invention is to provide a kind of expanding petal skirt aorta mechanical valve prosthesis, to realize under surgeon's direct-view, through a little stitching, can implant fast relatively large mechanical valve prosthesis, CPB time and cardiac arrest time in desmopyknosis, and lower postoperative pressure gradient, reduce the generation of postoperative perivalvular leakage, effectively improve operative effect.
For solving above technical problem, the present invention has done further improvement on the basis of existing machinery bilobate valve.
A kind of expanding petal skirt aorta mechanical valve prosthesis of the present invention, comprise lobe frame, cylindrical one side of lobe frame forms circular flap groove, in circular flap groove, be fixed with ring-spring lobe skirt, in the inner open cavity forming of spring lobe skirt, be filled with polyester fiber obturator, spring lobe skirt outer side waist is tied up shaped wire.
" spring " of spring lobe skirt selects Nitinol wire material, and shaped wire is selected polyester thread, binds in spring lobe skirt outer side waist, can reduce spring lobe hoop footpath, unties after shaped wire, and spring restores to the original state.Polyester fiber obturator adopts 100% polyester fiber, can select 100% commercially available nonwoven polyester sheet, and it not only works the object that stops abnormal blood flow, and very thin, can reduce the diameter of spring lobe skirt.
Spring lobe skirt outer side waist forms ring-type holddown groove, and shaped wire is banded in holddown groove, makes shaped wire difficult drop-off.
Spring lobe skirt inner side waist has static line, and static line is connected and fixed in the circular flap groove of metal bilobate valve.Static line adopts tinsel, and tinsel is nickel-titanium alloy material.
Presetly on spring lobe skirt 3 be fixed with some suture with needle, preferably, the quantity of described suture with needle is 3.This suture is selected noinvasive suture with needle, after excision pathological changes valve, can with the preset stitching of lobe ring, the secure valve of tiing a knot after hypovalve.
Compare with existing machinery lobe, the present invention has lobe skirt " expansion " function, is the actual measurement valve lobe ring footpath of changing after lobe skirt contracting shape, namely the actual diameter of inserting of this valve, realizes implantable relatively large valve, increases effective orifice area, reduce pressure gradient, be conducive to postoperative heart function recovery.
Because Nitinol has memory characteristic, once remove external force, can restore to the original state, can increase No. 2～3, former survey valve diameter, make lobe skirt contact more closely with lobe ring tissue, more firm, in conjunction with 100% polyester fiber filling, can reduce the generation of postoperative perivalvular leakage.
Manufacturing process of the present invention is simple, easily manufactures, and clinical practice indication is wide.
Adopt operation technique of the present invention easy, fast; with 3 suture with needle, sew up and can complete valve implantation, reach the fixed effect that valve is good, obviously shortened CPB and cardiac arrest time; the protection of each system organ function of favourable whole body, significantly reduces operation risk.
Accompanying drawing explanation
Fig. 1 is the structural representation of expanding petal skirt aorta mechanical valve prosthesis of the present invention.
Fig. 2 is the schematic diagram in circular flap groove before spring lobe skirt of the present invention is shaped.
Fig. 3 is after spring lobe skirt is shaped and the connection diagram of circular flap groove.
Fig. 4 is spring lobe skirt.
Fig. 5 is the side schematic view of spring lobe skirt spring repetitive.
Fig. 6 is lobe frame schematic diagram of the present invention.
In figure, 1-lobe frame, 2-circular flap groove, 3-spring lobe skirt, 4-polyester fiber obturator, 5-shaped wire, 6-static line, 7-suture with needle, 8-lobe leaf.
The specific embodiment
In order to make those skilled in the art better understand the present invention, below in conjunction with accompanying drawing, the present invention is done to further clear, complete explanation.
A kind of expanding petal skirt aorta mechanical valve prosthesis of the present invention, as shown in Figure 1, Figure 2 and Figure 3, comprise lobe frame 1, lobe leaf 8,, cylindrical one side of lobe frame 1 forms circular flap groove 2(Fig. 6), in circular flap groove 2, be fixed with ring-spring lobe skirt 3(Fig. 4), in the inner open cavity forming of spring lobe skirt 3, be filled with polyester fiber obturator 4, spring lobe skirt 3 outer side waist are tied up shaped wire 5.
" spring " of spring lobe skirt 3 selects Nitinol wire material, during making, nickel-titanium metal filament winding is shaped on the model designing, and is spring-like, and shaped wire 5 binds in spring lobe skirt 3 outer side waist.Polyester fiber obturator 4 is selected 100% commercially available nonwoven polyester sheet.
As shown in Figure 5, spring lobe skirt 3 inner side waist are made convex, to snap in circular flap groove 2.Spring lobe skirt 3 inner side waist have static line 6, and static line 6 is connected and fixed in the circular flap groove 2 of lobe frame 1.Static line 6 adopts tinsel, and tinsel is Nitinol line, binds in the periphery of circular flap groove 2.Spring lobe skirt 3 outer side waist form ring-type holddown groove, shaped wire 5 is bound in holddown groove, and shaped wire 5 is selected polyester thread, as shown in Figure 5, each spring wire waist of spring lobe skirt 3 lateral surface is respectively suppressed a little groove, form holddown groove, shaped wire 5 is fixing shaping in little groove, reduced lobe ring footpath, shaped wire 5 difficult drop-offs, when untiing shaped wire 5, after external pressure is removed, spring lobe skirt 3 restores to the original state.
As shown in Figure 1, Figure 2 and Figure 3, on spring lobe skirt 3, the preset some suture with needle 7 that are fixed with, select noinvasive suture with needle, and preferably, the quantity of suture with needle 7 is 3.
The patient of the applicable all aortic valve of expanding petal skirt aorta mechanical valve prosthesis of the present invention and aortic valve, Mitral displacement, under generalized anesthetic state, adopt median incision, set up extracorporeal circulation, aorta clamping, perfused hearts cardioplegic solution makes asystole, conventional at ascending aorta antetheca employing right low left high angular cut or transverse incision, the aortic valve of excision pathological changes or lose the artificial valve of function, as the row mitral valve replacement same period, also can first excise pathological changes Bicuspid valve, displacement PM is change owner arterial valve again.
The lower expandable implant lobe skirt aortic valve of surgery direct-view is put into normal saline to drench 100% polyester fiber before not using, and drains wherein gas.With aorta valve gage, survey aortic valvular ring footpath, the model of surveying is expandable implant lobe skirt valve model, if valve gage is easily by lobe ring also optional bigger inflatable lobe skirt valve.3 preset suture with needle 7 are sewn on the appropriate location of aortic valvular ring, it is fixing that valve is placed in the knotting of aortic valve lobe ring relevant position, cut off shaped wire 5, removing external force back lobe skirt expansion reinstatement, rinse aorta lumen, the conventional aorta otch of sewing up, open ascending aorta after aerofluxus, recovering beat of heart.Remove extracorporeal circulation, close breast and performed the operation.
The scope of protection of present invention is not limited to the above specific embodiment; to those skilled in the art; the present invention can have various deformation and change, all in design of the present invention and principle, be any modification of doing within expandable mechanical prosthetic valve lobe skirt, improve and be equal within replacement all should be included in protection scope of the present invention.
Claims (5)
1. an expanding petal skirt aorta mechanical valve prosthesis, comprise lobe frame (1), cylindrical one side of lobe frame (1) forms circular flap groove (2), it is characterized in that: in circular flap groove (2), be fixed with ring-spring lobe skirt (3), in the inner open cavity forming of spring lobe skirt (3), be filled with polyester fiber obturator (4), spring lobe skirt (3) outer side waist is tied up shaped wire (5).
2. expanding petal skirt aorta mechanical valve prosthesis according to claim 1, is characterized in that: spring lobe skirt (3) outer side waist forms ring-type holddown groove, and shaped wire (5) is bound in holddown groove.
3. expanding petal skirt aorta mechanical valve prosthesis according to claim 1 and 2, is characterized in that: spring lobe skirt (3) inner side waist has static line (6), and static line (6) is connected and fixed in the circular flap groove (2) of lobe frame (1).
4. expanding petal skirt aorta mechanical valve prosthesis according to claim 1 and 2, is characterized in that: at the upper preset some suture with needle (7) that are fixed with of spring lobe skirt (3).
5. expanding petal skirt aorta mechanical valve prosthesis according to claim 4, is characterized in that: the quantity of described suture with needle (7) is 3.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410017395.6A CN103690272B (en) | 2014-01-15 | 2014-01-15 | Expanding petal skirt aorta mechanical valve prosthesis |
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| CN201410017395.6A CN103690272B (en) | 2014-01-15 | 2014-01-15 | Expanding petal skirt aorta mechanical valve prosthesis |
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| CN103690272B CN103690272B (en) | 2016-08-17 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107411849A (en) * | 2017-08-24 | 2017-12-01 | 北京航空航天大学 | Anti- perivalvular leakage is through conduit valve system and method for implantation |
| CN111163730A (en) * | 2017-08-21 | 2020-05-15 | 爱德华兹生命科学公司 | Sealing member for prosthetic heart valve |
Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB1160008A (en) * | 1967-12-21 | 1969-07-30 | Rhone Poulenc Sa | Cardiac Valvular Prosthesis |
| CN1161644A (en) * | 1994-10-21 | 1997-10-08 | 圣朱德医疗有限公司 | Rotatable sewing cuff for heart valve prosthesis |
| US20060206203A1 (en) * | 2005-03-10 | 2006-09-14 | Jun Yang | Valvular support prosthesis |
| WO2008065678A2 (en) * | 2006-11-29 | 2008-06-05 | Aparna Thirumalai Anandampilla | An improved heart valve |
| 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 |
| ES1078330U (en) * | 2012-07-03 | 2012-12-28 | Ramón ARCAS MECA | Fixation device for mechanical valves in aortic position without sutures (Machine-translation by Google Translate, not legally binding) |
| CN203662942U (en) * | 2014-01-15 | 2014-06-25 | 梁宏亮 | Aorta mechanical valve with expandable suture ring |
-
2014
- 2014-01-15 CN CN201410017395.6A patent/CN103690272B/en not_active Expired - Fee Related
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB1160008A (en) * | 1967-12-21 | 1969-07-30 | Rhone Poulenc Sa | Cardiac Valvular Prosthesis |
| CN1161644A (en) * | 1994-10-21 | 1997-10-08 | 圣朱德医疗有限公司 | Rotatable sewing cuff for heart valve prosthesis |
| US20060206203A1 (en) * | 2005-03-10 | 2006-09-14 | Jun Yang | Valvular support prosthesis |
| WO2008065678A2 (en) * | 2006-11-29 | 2008-06-05 | Aparna Thirumalai Anandampilla | An improved heart valve |
| 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 |
| ES1078330U (en) * | 2012-07-03 | 2012-12-28 | Ramón ARCAS MECA | Fixation device for mechanical valves in aortic position without sutures (Machine-translation by Google Translate, not legally binding) |
| CN203662942U (en) * | 2014-01-15 | 2014-06-25 | 梁宏亮 | Aorta mechanical valve with expandable suture ring |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111163730A (en) * | 2017-08-21 | 2020-05-15 | 爱德华兹生命科学公司 | Sealing member for prosthetic heart valve |
| CN111163730B (en) * | 2017-08-21 | 2021-10-01 | 爱德华兹生命科学公司 | Sealing member for prosthetic heart valve |
| CN107411849A (en) * | 2017-08-24 | 2017-12-01 | 北京航空航天大学 | Anti- perivalvular leakage is through conduit valve system and method for implantation |
| CN107411849B (en) * | 2017-08-24 | 2018-11-30 | 北京航空航天大学 | Anti- perivalvular leakage is through conduit valve system and method for implantation |
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