CN103690272B - Expanding petal skirt aorta mechanical valve prosthesis - Google Patents
Expanding petal skirt aorta mechanical valve prosthesis Download PDFInfo
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- CN103690272B CN103690272B CN201410017395.6A CN201410017395A CN103690272B CN 103690272 B CN103690272 B CN 103690272B CN 201410017395 A CN201410017395 A CN 201410017395A CN 103690272 B CN103690272 B CN 103690272B
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Abstract
The present invention relates to a kind of expanding petal skirt aorta mechanical valve prosthesis can quickly implanted under direct-view for cardiac surgeon, including lobe frame, the cylindrical side of lobe frame forms circular flap groove, ring-spring lobe skirt it is fixed with in circular flap groove, being filled with polyester fiber obturator in the open cavity body that spring lobe skirt is internally formed, spring lobe skirt outer side waist ties up shaped wire.Shaped wire binds in spring lobe skirt outer side waist, reduces spring lobe hoop footpath, and after untiing shaped wire, spring reinstatement lobe group expands.Preset on spring lobe skirt fix 3 band pin noinvasive sutures.The present invention can reach only to sew up three pins and i.e. complete the purpose of aorta mechanical prosthesis replacement, realize operation significantly being shortened extracorporeal circulation and cardiac arrest time, inserting relatively large mechanical valve prosthesis and the clinical effectiveness substantially reducing perivalvular leakage complication, be effectively improved aorta mechanical prosthetic valve replacement curative effect.
Description
Technical field
The invention belongs to technical field of medical instruments, relate to the aorta mechanical valve prosthesis of a kind of novel inflatable lobe skirt.
Background technology
Cardiac valve is the device of a kind of similar " one-way cock ", makes blood keep the one-way flow of right atrium-right ventricle-pulmonary circulation-left atrium-left ventricle-body circulation in heart.Cardiac valve plays vital effect for maintaining the cardiac function of human normal with hemodynamic stability.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 has stepped into aging society, and population-based is big, degenerative cardiac valve disease patient's rapid development；3. relative with social environment backward due to economic level, the valvular heart disease patient population 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 that the cardiac valve patient needing row surgical intervention is more than 3,000,000.
There are four valves in mankind's normal heart, wherein aortic valve is to be made up of with corresponding lobe hole three leaflets, is connective tissue annulus about, between left ventricle and ascending aorta.Feeling concerned about system due to it on a left side and bear the blood flow impact of elevated pressures and speed, therefore sickness rate is higher.Once there is pathological changes in aortic valve, and owing to its space structure is complicated, without device under the lobe such as papillary muscles, chordae tendineae, and it is high to bear pressure, so surgical repair difficulty is maximum, annuloplasty band effect is undesirable.Therefore, valvular prosthetic replacement performs the operation is often unique effectively therapy approach.Artificial valve can be divided into two kinds, and one is biovalve, mainly porcine aortic valve or bovine pericardium is processed through special process the cardiac valve made；Another kind is mechanical valve prosthesis, at present many with pyrolytic carbon as stock, is around synthetic polyester fibers (Dacron) or suture ring that politef (Telfon) is made, i.e. lobe skirt.In China's mechanical prosthetic valve usage amount more than 90%, main cause is that China's valvular heart disease patient age is relatively small, how between 40～60 years old.Due to bioprosthetic valve poor durability, failure i.e. occurring for about 10 years, is especially implanted in the bioprosthetic valve of aortic valve position, under the blood flow of high pressure, high speed impacts, valve failure phenomenon is the most universal, process is the rapidest, and patient often need to carry out second time heart valve replacement surgery.But second operation is the most costly, and risk is big.And mechanical prosthetic valve can use all the life, it is that biovalve cannot be substituted.
The basic process of traditional aortic valve replacement is: in vitro under the support of circulation (CPB), blocking patient's ascending aorta, perfused hearts stops jumping liquid and makes cardiac arrest, cuts ascending aorta at distance aortic root about 2cm, appear diseased aortic, excise original diseased valve.Because suture ring (lobe skirt) has certain thickness, so must select less than aortic annular diameter 1 or the artificial valve of No. 2, after on lobe skirt, after interrupted mattress suture 12～15 pin, hypovalve is tied a knot or divided the stitching the most continuously of three quadrants according to aortic valve, hypovalve is tied a knot, artificial valve is fixed on aortic valvular ring, open ascending aorta recovering beat of heart.This process is it is generally required to 30～60 min, in addition the CPB parallel time in later stage, and general operation needs about 4 hours.But, owing to CPB system itself damages human body each system organ function, during displacement aortic valve, heart is in the state stoping jumping ischemia, therefore operation internal organs each for human body itself in addition, and especially cardiac function strike is the biggest.The particularly aortic valve disease patient of China, their cardiac function when medical has the most been in and has lost the compensatory stage, thus even more serious with the damage that cardiac arrest causes by CPB, is often fatal.Research at present has clearly indicated that the CPB time becomes positive correlation with cardiac arrest time length with operative mortality.Therefore, the most effective approach reducing this type of operation risk simplifies modus operandi exactly, shortens CPB and does not even use CPB and cardiac arrest technology with the cardiac arrest time.The most for the above reasons, current western developed country has developed the multiple aortic valve prosthesis exempting to sew up or only need to sew up a little implantation under conduit aortic valve implanted prosthetics (TAVI) with direct-view.The application of these technology and device can be avoided CPB and cardiac arrest or CPB and cardiac arrest time are greatly shortened, and reduces the purpose of operation risk.But, current TAVI technology is all developed with exempting from stitching aortic valve on the basis of biovalve, this is because biovalve itself is soft, in special sheath pipe can be taken in or in implanting device, but mechanical valve prosthesis is the rigid structure that pyrolytic carbon is made, it is impossible to realize implanting through conduit or exempting to sew up implanting by current technology.But these technology based on bioprosthetic valve are not only faced with the serious problems of valve failure, and clinical practice there is also the most unsolved defect of many: the clinical indication of TAVI technology is strict, operate valve under non-direct-view to be difficult to be accurately positioned; 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 bigger.Three kinds of clinical practice at present exempt to sew up or few actively valve of sewing up: ATS3f Enable, Perceval S and Edwards INTUITY, although it can be implanted rapidly under direct-view by surgeon, but the special tectonic due to bioprosthetic valve, the severe complications such as postoperative easy generation valve displacement, perivalvular leakage, conduction block, Clinical practice has certain limitation, and involves great expense, is difficult to promote.So these based on bioprosthetic valve through conduit or exempt from sew up implant valve technology the narrowest and small in the applicable patient population of China, we in the urgent need to a kind of can short time CPB support and cardiac arrest under can complete implant aorta mechanical valve prosthesis.Additionally, current aortic valve mechanical prosthetic valve itself has certain thickness due to suture ring (lobe skirt) and do not has dilatancy, therefore have to during operation implant less than aortic annular diameter 1～the artificial valve of No. 2, otherwise cannot hypovalve knotting.But the model that surgical principle requires aortic valve prosthesis is the bigger the better, if the effective vent area of artificial valve does not mate obvious for formation pressure gradient with patient body surface areas, 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, these patients often there is also the pressure gradient of more than 50mmHg after aortic valve replacement, and surgical effect is undesirable.Having to implement aortic root Enlargement to implant the valve of larger number in the case of a lot, but aortic root expands and performs the operation not only technical sophistication, time-consuming is long, and the complication rates such as hemorrhage, conduction block are high.The valve of relatively large number is may select to improve operative effect when therefore realizing implanting in the urgent need to a kind of aorta mechanical prosthetic valve realizing convergent-divergent lobe skirt.Finally, many needs patient's annulus 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 the case of lobe root and secondary or repeatedly changes the patient of lobe.When after excision diseased valve or original artificial valve, noresidue annulus or residual fraction are very few, annulus cannot undertake suture tractive or cannot sew up the purpose reaching fixing artificial valve at all with mechanical prosthetic valve skirt, and suture easily tears annulus tissue and causes postoperative perivalvular leakage.Perivalvular leakage once occurs, and patient often has the performance of left heart insufficiency or left heart insufficiency substantially to 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 operation and require: on the one hand, on aorta wall, stitching can cause hemorrhage and easily cause postoperative perivalvular leakage；On the other hand, even if reproducing annulus also can increase the probability of postoperative perivalvular leakage, and extend when causing CPB time and cardiac arrest and be unfavorable for myocardial preservation, hence it is evident that increase operative mortality and complication rate.Therefore, this type of patient is realized good fixing in the urgent need to a kind of and reduce the aorta mechanical valve prosthesis that perivalvular leakage occurs.
In sum, can implant or exempt to sew up, through conduit, the aortic valve that (few sew up) direct-view implants at present and be bioprosthetic valve, not only easily failure, be suitable for that patient population is narrow, post-operative complication is many, long-term effect is the best, and technical matters is complicated, expensive, is not suitable for China's Most patients.The China patient more than 90% selects mechanical valve prosthesis; but existing machinery aortic valve there is also following deficiency: 1. valve stitching in operation, hypovalve, knotting process are time-consuming; cannot realize exempting under direct-view sew up or sew up implantation less; therefore CPB is long with the cardiac arrest time; being unfavorable for whole body organ protection, operation risk is relatively large；2. mechanical prosthetic valve lobe skirt (suture ring) does not has dilatancy, need to implant less than measured aortic annular diameter 1 or the artificial valve of No. 2, limit the effective vent area implanting valve, add pressure gradient and cardiac load, be unfavorable for the recovery of cardiac function；3. destroying for aortic valvular ring or remain very few and connective tissue pathological changes patient, mechanical prosthetic valve skirt is difficult to realize firmly sewing up fixing with original annulus tissue, and not only operating difficulty is big, 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, look at lower warp straight and sew up a little and can quickly implant relatively large mechanical valve prosthesis realizing surgeon, CPB time and cardiac arrest time in desmopyknosis, and lower postoperative pressure gradient, reduce the generation of postoperative perivalvular leakage, be effectively improved operative effect.
For solving above technical problem, the present invention has made further improvement on the basis of existing machinery bilobate valve.
A kind of expanding petal skirt aorta mechanical valve prosthesis of the present invention, including lobe frame, the cylindrical side of lobe frame forms circular flap groove, ring-spring lobe skirt it is fixed with in circular flap groove, being filled with polyester fiber obturator in the open cavity body that spring lobe skirt is internally formed, spring lobe skirt outer side waist ties up shaped wire.
Nitinol wire material selected by " spring " of spring lobe skirt, and shaped wire selects polyester thread, binds in spring lobe skirt outer side waist, can reduce spring lobe hoop footpath, and after untiing shaped wire, spring restores to the original state.Polyester fiber obturator uses 100% polyester fiber, can be selected for 100% commercially available nonwoven polyester sheet, and it not only acts the purpose stopping abnormal blood flow, and the thinnest, can reduce the diameter of spring lobe skirt.
Spring lobe skirt outer side waist forms annular retaining grooves, and shaped wire is banded in fixing groove, makes shaped wire difficult drop-off.
Spring lobe skirt inner side waist has fixing line, fixing line to be connected and fixed in the circular flap groove of metal bilobate valve.Fixing line uses tinsel, and tinsel is nickel-titanium alloy material.
Preset on spring lobe skirt 3 it is fixed with some suture with needle, it is preferable that the quantity of described suture with needle is 3.This suture select noinvasive suture with needle, excision diseased valve after, can stitching preset with annulus, after hypovalve tie a knot secure valve.
Compared with existing machinery lobe, the present invention has lobe skirt and " expands " function, is to survey changed valve annulus footpath after lobe skirt contracting shape, namely this valve is actual inserts diameter, it is achieved implantable relatively large valve, increases effective orifice area, reduce pressure gradient, the most postoperative heart function recovery.
Owing to Nitinol has memory characteristic, once removing external force can restore to the original state, and can increase former survey valve diameter 2～No. 3, makes lobe skirt contact more closely with annulus tissue, more firm, can reduce the generation of postoperative perivalvular leakage in conjunction with 100% polyester fiber filling.
The manufacturing process of the present invention is simple, easily manufactures, and clinical practice indication is wide.
The operation technique using the present invention is easy, fast; sew up with 3 suture with needle and can complete valve implantation, reach the fixed effect that valve is good, hence it is evident that shorten CPB and cardiac arrest time; the protection of favourable whole body each system organ function, 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 before spring lobe skirt of the present invention shapes in circular flap groove.
Fig. 3 is the connection diagram after spring lobe skirt shapes with 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-fixes line, 7-suture with needle, 8-leaflet.
Detailed description of the invention
In order to make those skilled in the art be better understood from the present invention, below in conjunction with accompanying drawing, the present invention made the clearest, 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, including lobe frame 1, leaflet 8, the cylindrical side of lobe frame 1 forms circular flap groove 2(Fig. 6), ring-spring lobe skirt 3(Fig. 4 it is fixed with) in circular flap groove 2, being filled with polyester fiber obturator 4 in the open cavity body that spring lobe skirt 3 is internally formed, spring lobe skirt 3 outer side waist ties up shaped wire 5.
Nitinol wire material selected by " spring " of spring lobe skirt 3, during making, is shaped by nickel-titanium metal filament winding on the model designed, and in spring-like, shaped wire 5 binds in spring lobe skirt 3 outer side waist.Polyester fiber obturator 4 selects 100% commercially available nonwoven polyester sheet.
As it is shown in figure 5, spring lobe skirt 3 inner side waist makes convex, in order to snap in circular flap groove 2.Spring lobe skirt 3 inner side waist has fixing line 6, and fixing line 6 is connected and fixed in the circular flap groove 2 of lobe frame 1.Fixing line 6 uses tinsel, and tinsel is Nitinol line, binds in the periphery of circular flap groove 2.Spring lobe skirt 3 outer side waist forms annular retaining grooves, shaped wire 5 is bound in fixing groove, and shaped wire 5 selects polyester thread, as shown in Figure 5, spring lobe skirt 3 lateral surface each spring wire waist respectively suppresses a little groove, forming fixing groove, shaped wire 5 is fixing in little groove to be shaped, and decreases annulus footpath, shaped wire 5 difficult drop-off, when untiing shaped wire 5, after external pressure releases, spring lobe skirt 3 restores to the original state.
As shown in Figure 1, Figure 2 and Figure 3, preset on spring lobe skirt 3 it is fixed with some suture with needle 7, selects noinvasive suture with needle, it is preferable that the quantity of suture with needle 7 is 3.
Expanding petal skirt aorta mechanical valve prosthesis of the present invention is suitable for all aortic valve and aortic valve, the patient of Mitral displacement, median incision is used under generalized anesthetic state, 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, excise the aortic valve of pathological changes or lose the artificial valve of function, as the row Bicuspid valve same period is replaced, also can first excise pathological changes Bicuspid valve, replace PM change owner arterial valve again.
The lower expandable implant lobe skirt aortic valve of surgery direct-view is put in normal saline with drenched 100% polyester fiber before not using, and drains wherein gas.Surveying aortic valvular ring footpath with aorta valve gage, surveyed model is i.e. expandable implant lobe skirt valve model, such as valve gage easily by the most optional bigger inflatable lobe skirt valve of annulus.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 annulus relevant position, cut off shaped wire 5, reinstatement is expanded removing external force back lobe skirt, rinse aorta lumen, conventional stitching aorta otch, open ascending aorta, recovering beat of heart after aerofluxus.Remove extracorporeal circulation, close breast and performed the operation.
The scope of protection of present invention is not limited to above detailed description of the invention; to those skilled in the art; within any amendment, improvement and the equivalent that the present invention is made within can having various deformation and change, all designs in the present invention and principle the most expandable mechanical prosthetic valve lobe skirt all should be included in protection scope of the present invention.
Claims (3)
1. an expanding petal skirt aorta mechanical valve prosthesis, including lobe frame (1), the cylindrical 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), being filled with polyester fiber obturator (4) in the open cavity body that spring lobe skirt (3) is internally formed, spring lobe skirt (3) outer side waist ties up shaped wire (5)；Spring lobe skirt (3) inner side waist has fixing line (6), and fixing line (6) is connected and fixed in the circular flap groove (2) of lobe frame (1)；The most preset it is fixed with some suture with needle (7) spring lobe skirt (3) is upper.
Expanding petal skirt aorta mechanical valve prosthesis the most according to claim 1, it is characterised in that: spring lobe skirt (3) outer side waist forms annular retaining grooves, and shaped wire (5) is bound in fixing groove.
Expanding petal skirt aorta mechanical valve prosthesis the most according to claim 1 and 2, it is characterised in that: the quantity of described suture with needle (7) is 3.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410017395.6A CN103690272B (en) | 2014-01-15 | 2014-01-15 | Expanding petal skirt aorta mechanical valve prosthesis |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410017395.6A CN103690272B (en) | 2014-01-15 | 2014-01-15 | Expanding petal skirt aorta mechanical valve prosthesis |
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| Publication Number | Publication Date |
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| CN103690272A CN103690272A (en) | 2014-04-02 |
| CN103690272B true CN103690272B (en) | 2016-08-17 |
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| CN201410017395.6A Expired - Fee Related CN103690272B (en) | 2014-01-15 | 2014-01-15 | Expanding petal skirt aorta mechanical valve prosthesis |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10722353B2 (en) * | 2017-08-21 | 2020-07-28 | Edwards Lifesciences Corporation | Sealing member for prosthetic heart valve |
| 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 |
Citations (4)
| 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 |
| 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 |
| CN203662942U (en) * | 2014-01-15 | 2014-06-25 | 梁宏亮 | Aorta mechanical valve with expandable suture ring |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20060206203A1 (en) * | 2005-03-10 | 2006-09-14 | Jun Yang | Valvular support prosthesis |
| US20110060406A1 (en) * | 2006-11-29 | 2011-03-10 | Aparna Thirumalai Anandampillai | Heart valve |
| ES1078330Y (en) * | 2012-07-03 | 2013-04-05 | Meca Ramon Arcas | Fixing device for mechanical valves in aortic position without sutures |
-
2014
- 2014-01-15 CN CN201410017395.6A patent/CN103690272B/en not_active Expired - Fee Related
Patent Citations (4)
| 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 |
| 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 |
| CN203662942U (en) * | 2014-01-15 | 2014-06-25 | 梁宏亮 | Aorta mechanical valve with expandable suture ring |
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| CN103690272A (en) | 2014-04-02 |
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