CN203662942U - Aorta mechanical valve with expandable suture ring - Google Patents

Abstract

The utility model relates to an aorta mechanical valve with an expandable suture ring. The aorta mechanical valve with the expandable suture ring can be rapidly implanted under the direct view of cardiothoracic surgeons. The aorta mechanical valve with the expandable suture ring comprises a valve frame, wherein an annular valve groove is formed in one side of the external circle of the valve frame; the annular spring suture ring is fixed into the annular valve groove; an open cavity formed inside the spring suture ring is filled with polyester fiber filling; forming threads are bundled on the waist portion of the outer side of the spring suture ring. As the forming threads are bundled on the waist portion of the outer side of the spring suture ring, the annular diameter of the spring suture ring is decreased, and the spring suture ring resets and the valve expands after the forming threads are untied. Three needle noninvasive stitches are fixed on the spring suture ring in advance. The aorta mechanical valve can be replaced only by triple-needle stitching, the clinical effects of greatly shortening the time of extracorporeal circulation and cardiac arrest, placing the large mechanical valve and significantly reducing the perivalvular leakage complication in an operation are achieved, and the curative effect of replacement of the aorta mechanical valve is improved effectively.

Description

Expanding petal skirt aorta mechanical valve prosthesis

Technical field

This utility model belongs to technical field of medical instruments, relates 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 exceeded 3,000,000.

There are four valves in mankind's normal heart, wherein aortic valve is to be made up of three lobe leaves and corresponding lobe hole, and it is around Connective tissue ring, between left ventricle and ascending aorta.Due to its blood flow impact of feeling concerned about system on a left side and bearing elevated pressures and speed, therefore sickness rate is higher.Once pathological changes appears in aortic valve, due to its space structure complexity, without the lobe such as papillary muscles, chordae tendineae lower device, and it is high to bear pressure, so surgical repair difficulty 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 one is biovalve, is mainly the cardiac valve that porcine aortic valve or bovine pericardium are made through special process processing; 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, mechanical prosthetic valve use amount exceedes 90%, and 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 use 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, is cutting ascending aorta apart from the about 2cm of aortic root place, 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 divides three quadrants according to aortic valve 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, the CPB parallel time in later stage in addition, and general operation needs about 4 hours.But due to the 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, therefore operation itself is for the each internal organs of human body, and especially cardiac function hits very large.The particularly aortic valve disease patient of China, 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 even 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.But these are not only faced with the serious problems of valve failure taking bioprosthetic valve 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 due to the special tectonic of 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 exempt to sew up that 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 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.But, much China Small aortic root patient, particularly middle and aged women patient, after aortic valve replacement, there is pressure gradient more than 50mmHg toward contact in these patients, and surgical effect is undesirable.In a lot of situations, have to implement aortic root Enlargement in order to implant the valve of larger model, 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 can realize contraction in the urgent need to one---the aorta mechanical prosthetic valve of expanding petal skirt is realized and while implantation, 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.When 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 the object that reaches fixing artificial valve 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, also can increase the probability of postoperative perivalvular leakage even if reproduce lobe ring, 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 sew up) direct-view implants through conduit at present and be bioprosthetic valve, not only easily failure, be suitable for that patient group is narrow, post-operative complication is many, long-term effect is not good, and technical matters complexity, expensive, is not suitable for the most patients of China.China exceedes 90% patient and selects mechanical valve prosthesis, 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, needs 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. destroy or residual very few and connective tissue pathological changes patient for aortic valvular ring, 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 problems to be solved in the utility model is to provide a kind of expanding petal skirt aorta mechanical valve prosthesis, can implant fast relatively large mechanical valve prosthesis to realize under surgeon's direct-view through a little stitching, 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, this utility model has been done further improvement on the basis of existing machinery bilobate valve.

A kind of expanding petal skirt aorta mechanical valve prosthesis described in the utility model, 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.

Compared with existing machinery lobe, the utlity model has lobe skirt " expansion " function, after lobe skirt contracting shape, be the actual measurement valve lobe ring footpath of changing, 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, can restore to the original state once remove external force, can increase No. 2～3, former survey valve diameter, make lobe skirt contact more closely with lobe ring tissue, more firm, can reduce the generation of postoperative perivalvular leakage in conjunction with 100% polyester fiber filling.

Manufacturing process of the present utility model is simple, easily manufactures, and clinical practice indication is wide.

Adopt operation technique of the present utility model easy, fast; sew up and can complete valve implantation with 3 suture with needle, reach the fixed effect that valve is good, obviously shortened CPB and cardiac arrest time; the protection of the each system organ function of favourable whole body, significantly reduces operation risk.

Brief description of the drawings

Fig. 1 is the structural representation of this utility model expanding petal skirt aorta mechanical valve prosthesis.

Fig. 2 is the schematic diagram in circular flap groove before this utility model spring lobe skirt 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 this utility model lobe frame schematic diagram.

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.

Detailed description of the invention

In order to make those skilled in the art better understand this utility model, below in conjunction with accompanying drawing, this utility model is done to further clear, complete explanation.

A kind of expanding petal skirt aorta mechanical valve prosthesis described in the utility model, 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, when 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, the each compacting of the each spring wire waist of spring lobe skirt 3 lateral surface one 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 this utility model expanding petal skirt aorta mechanical valve prosthesis 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 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.Survey aortic valvular ring footpath with aorta valve gage, 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 claimed scope of this utility model is not limited to above detailed description of the invention; to those skilled in the art; this utility model can have various deformation and change, all be any amendment of doing within expandable mechanical prosthetic valve lobe skirt in design of the present utility model and principle, improve and be equal within replacement all should be included in protection domain of the present utility model.

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), 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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