CN206777422U - The mould that sewn by hand valved external conduit and its U-shaped unit use - Google Patents

Abstract

The utility model discloses the mould that sewn by hand valved external conduit and its U-shaped unit use, wherein valved external conduit includes outer tube body and PTFE valves；PTFE is made up of three U-shaped units, and each U-shaped unit includes film lobe point and coupling part, and each U-shaped cell edges is sewed on the inwall of outer tube body；The film valve of each U-shaped unit is partially toward the central axis direction extension of outer tube body, and the marginal portion of several film lobes point mutually freely overlaps；U-shaped unit is provided with the bisector of whole U-shaped and pre-fixes line with the suture of outer tube body Along ent.The mould that U-shaped unit uses is included by hard clamp body, and the continuous U-shaped unit corresponding from different Outer Tube sizes engraves groove, on hard clamp body, engraved positioned at U-shaped unit described in each group and a positioning hole is further respectively had at the left and right end positions of groove.Valved external conduit of the present utility model, its stability is high, and persistence is strong, and anti-reflux effect is good, and the rate that decays is lower.

Description

The mould that sewn by hand valved external conduit and its U-shaped unit use

Technical field

Technical field is the utility model is related to, more particularly to sewn by hand valved external conduit.

Background technology

Expanded PTFE (ePTFE) is a kind of extremely stable using physicochemical property porous made of special process Medical macromolecular materials, there is the chemical stability of extremely inert surface and height^【1】, 0.1mm ePTFE thin slices are very fine Thin, pliability and mobility are good, and these all provide possibility for 0.1mm ePTFE thin slices as new artificial valve material.

1993, Yamagishi^【2】Pulmonary artery single-lobe is made in first Application 0.1mm polytetrafluoroethylene (PTFE) (PTFE) thin slice, should For the outflow tract of right ventricle of tetralogy of Fallot, good anti-reflux effect, subsequent Turrentine MW are achieved^【3】And Brown JW^【4】Report 0.1mmPTFE single-lobes mobility is good in succession, and follow-up does not find thrombus and calcification.2008, Nunn GR^【5】Describe The durability of PTFE bivalve anti-refluxs is more preferable compared with single-lobe, and the calcification of leaflet is equally had not seen in follow-up and is thickened.In recent years, day This scholar, which using 0.1mmPTFE is fabricated to three valves and is sutured in Dacron or Gore-tex artificial blood vessels, forms new band valve pipe Road, for rebuilding outflow tract of right ventricle, achieve good effect.Ando M^【6】139 patient's applications were reported in 2009 should After valved conduit, 10 years follow-up Outer Tubes from replacement rate be 88.0% ± 6.8%, 70% patient still maintain it is slight or slightly with Under pulmonary incompetence.MiyazakiT in 2011^【7】More soul-stirring result is brought, by the big of multicenter 794 Sample analysis, the Outer Tube including PTFE valves and the application with PTFE single-lobes, bivalve sticking patch, 10 years re-treatm ent rates are very Low, Outer Tube is only 4.6%, sticking patch 7.7%.

The Hemodynamic characteristics of system are felt concerned about according to the right side, the built-in valve of valved external conduit is mostly biovalve.Source master There are allogeneic aorta petal or pulmonary valve, bovine jugular vein valve, preparation of bovine pericardium or Pigs Hearts bag etc.. Homograft and Contegra is clinically the most commonly used valved external conduit at present, for right ventricle in cardiac operation The reconstruction of efferent tract.Although valved external conduit clinically achieves the effect of definite anti-reflux, calcification^【8】, fiber Change, infectious endocarditis^【9,10】The caused high rate of decaying is the defects of it can not avoid^【11】.2005, Brown JW^【12】 Report 117 and apply homograft, the rate that decays of 5 years and 15 years is 40%, 57%, and the rate that decayed in infancy is higher, respectively For 75%, 84%.Oosterhof T etc.^【13】Patients with tetralogy of Fallot is treated using homograft in report 158 in 2006, Postoperative 10 years pipeline rates of decaying are up to 53%.Report 38 infants within 5 years old and receive contegra reconstructions Outflow tract of right ventricle, follow-up 18 months, 13.2% performs the operation changed Outer Tube again because of obstruction.

Karamlou T^【15】Report 17, North America Heart center 241 and receive the trouble that valved external conduit is performed the operation and survived Person, found after follow-up because valved external conduit lesion intervenes rate for 1 year 25%, 3 years 58% again.Lee C in 2011^【16】Follow-up in 10 years The patient of 181 biological valved prosthesis pulmonary valves, 80% occur significantly decaying, it is necessary to perform the operation again.

O'Keefe KL^【17】It is the main reason for causing biovalve to be decayed to point out immune-mediated inflammatory reaction.2000 Year Grabenwoger M^【18】Find that substantial amounts of inflammatory cell infiltration in the biovalve decayed be present, and apply from body and mind Packing the valve of work does not have this phenomenon, thus it is speculated that immune response is probably one of basic reason that valve is decayed.PompilioG^【19】By situation after 6 years follow-up aorta petal homograft transplanting, it is found that 31.5% valve insufficiency occurs, 21% needs Re-treatm ent is wanted, hla antibody be present in 73.6% patient；Wojtalik^【20】It was found that using B cell amount after contegra, T cell The CD69 and CD71 of mediation substantially rise.Park CS^【21】A- galactosyls are detected in the patient of application pig pericardium heart valve (a-Gal) specific antibody, and a-Gal antigens are present in pig pericardium heart valve, and it is found that monokaryon in the valve decayed The infiltration of cell and macrophage.Hereafter, substantial amounts of zoopery confirms this viewpoint.

Therefore, most scholars attempt the antigen for removing or changing in biovalve, reduce immune response^【22】.It is main at present The method wanted have one's mother's sister's protease method, go to refuse agent method, enzyme-linked conjunction goes to refuse agent method etc., but its effect is still imprecise.Cicha I^【23】 Report, there have been the inflammatory reaction of valve and fibrosis, causes serious obstruction venereal disease using decellularization valve early stage Become.To find out its cause, Cissell DD^【24】Think mainly there are two, first, the above method can not remove all antigen, residual Antigen can still cause immune response, another aspect decellularization can also destroy valve structure, accelerate declining for valve on the contrary Lose.Although carry out Cultured endothelial cell and be planted on the valve of decellularization to attempt to solve using people's marrow or Cord blood in recent years Certainly above mentioned problem^【25】, but animal experiment stage is only stayed in, still face many uncertainties.

Therefore, " congenital defect " of biovalve result in the certainty that valved external conduit is decayed, and limit its application Prospect^【26】, the application particularly in heart disease in children, because decaying for biovalve is closely related with the age^【27】。 Siddiqui RF^【26】It was found that in Children and teenager patient, biovalve is decayed in early stage can, compared to big Age group and the old group of rate highest that decays.Chen PC^【27】227 patients with tetralogy of Fallot of Boston children's hospital are analyzed, Receive after biovalve displacement technique after 2~10 years, the rate that decays of valve is 25%, and independent danger that to be valve decay of low age Dangerous factor, this is consistent with the valved external conduit factor of decaying.It it is not immediately clear its reason, the Gao Min of the immune response of children Perception is considered as one of possible factor^【20】.And for children, the high rate of decaying of valved external conduit means that and needed Repeated multiple times operation is wanted, considerably increases the pain of infant, also increases the financial burden of whole family.

Utility model content

In order to overcome the above-mentioned deficiencies of the prior art, the utility model provides 0.1mmPTFE sewn by hand band valve outer tube Road, it is a kind of new valved external conduit, rebuild right ventricular outflow, for treat children's complexity CMH and The complication such as postoperative pulmonary incompetence.Tested by external fluidics, zoopery and clinical practice, 0.1mmPTFE is stitched by hand The characteristics of valved external conduit processed has embodied stability height, and persistence is strong, and anti-reflux effect is good.Not only solve outside domestic band valve The predicament that pipeline lacks, and provide that a kind of performance is more superior, the low valved external conduit of the rate that decays.

Technical scheme is used by the utility model：Sewn by hand valved external conduit, including outer tube body and PTFE valves；

PTFE valves are made up of three U-shaped units, and each U-shaped unit includes film lobe point and coupling part, each U-shaped Cell edges are sewed on the inwall of outer tube body；

The film valve of each U-shaped unit is partially toward the central axis direction extension of outer tube body, and several film lobes point Marginal portion mutually freely overlap；

At the lines of 5-0prolene from left to right of whole PTFE valves and at the 5-0prolene lines that the right side is turned left, it is provided with " u "-shaped unit pre-fixes line with the suture of outer tube body Along ent.

Further, three U-shaped units of PTFE valves, which are connected with each other, turns into an entirety, and directly sewing is in Outer Tube Face forms.

Further, the U-shaped structure in each coupling part of PTFE valves.

Further, PTFE valves are provided with three U-shaped blade units, and it has a common boundary sutures with the trisection line of Outer Tube inner face.

The valve for making valved external conduit makes mould, including by hard clamp body, and from different Outer Tube sizes The corresponding continuous U-shaped unit of size engraves groove, and on hard clamp body, the left and right both ends of groove are engraved positioned at U-shaped unit described in each group Opening position further respectively has a positioning hole.

Further, hard clamp body is made of clear material.

Compared with prior art, the beneficial effects of the utility model are：0.1mmPTFE sewn by hand valved external conduits are one The new valved external conduit of kind, rebuilds right ventricular outflow, is moved for treating children's complexity CMH and postoperative pulmonary Arteries and veins such as backflows at the complication.Tested by external fluidics, zoopery and clinical practice, outside 0.1mmPTFE sewn by hand band valve The characteristics of pipeline has embodied stability height, and persistence is strong, and anti-reflux effect is good.Domestic valved external conduit is not only solved to lack Predicament, and provide that a kind of performance is more superior, the low valved external conduit of the rate that decays.

Brief description of the drawings

Fig. 1 is the front view of one embodiment of 0.1mmPTFE sewn by hand valved external conduits；

Fig. 2 is the left view of Fig. 1 embodiment；

Fig. 3 is the sewing step structural representation of Fig. 1 embodiment；

Fig. 4 is the structural representation of the one embodiment for the valve making mould for making valved external conduit；

Wherein：1- outer tube bodies, 2-PTFE valves, 21- " u "-shaped units, 211- films lobe point, 212- connecting portions；3- oblique lines, At the lines of 5-0prolene from left to right of 4-PTFE valves, 5-PTFE valves are turned left at 5-0prolene lines from the right side, 6- Along ents seam Conjunction pre-fixes line, 7- trisection lines, 8- hard clamp bodies, and 9-U shape units engrave groove, 10- positioning holes.

Embodiment

In order to deepen to understanding of the present utility model, with reference to the accompanying drawings and examples to the utility model furtherly Bright, the embodiment is only used for explaining the utility model, and the scope of protection of the utility model is not formed and limited.

As shown in figure 1,0.1mmPTFE sewn by hand valved external conduits, including outer tube body 1 and PTFE valves 2；PTFE valves are by three The individual U-shaped unit 21 being continuously connected forms, and each U-shaped unit 21 includes film lobe point 211 and coupling part 212, each The edge sewing of " u "-shaped unit 21 is on the inwall of outer tube body 1；As shown in Fig. 3 process F and step G states, each U The film lobe point 211 of shape unit 21 extends towards the central axis direction of outer tube body 1, and the edge of several film lobes point 211 Part mutually freely overlaps；4 and from the 5- that turns left of the right side at the lines of 5-0prolene from left to right of whole PTFE valves 2 5 at 0prolene lines, line 6 is pre-fixed provided with " u "-shaped unit 21 and the suture of the Along ent of outer tube body 1.

As described in Figure 3, it is accurate including outer tube body material successively to sew the process sequence diagram of 0.1mmPTFE valved external conduits Standby technique A, overturns outer tube body processing step B, and outer tube body trisection line processing step C, PTFE valve material prepares and using valve Film production mould Outer Tube size required for draws out corresponding U-shaped unit, cuts U-shaped cell process step needed for being formed D, U-shaped unit coupling part and outer tube body inner surface trisection line interrupted suture technique for fixing step E, the sewing of U-shaped unit is existed The inner surface of outer tube body forms the PTFE valve technique F and last outward appearance technique G replied after outer tube body.Wherein shown in technique D, lead to Cross valve and make mould and describe so as to the PTFE valves cut, be connected with each other by three U-shaped units 21 as an entirety, just In being fixed on outer tube body inner face, U-shaped cell edges are continuously directly sutured in outer tube body inner face and form PTFE valves.From the process Shown in state diagram, each 212 U-shaped structure of coupling part of PTFE valves 2.

In the above-described embodiments, PTFE valves 2 are provided with three U-shaped units 21.

As shown in Figure 4, corresponding U-shaped can be cut according to different Outer Tube sizes by making mould using valve Unit, valve, which makes mould, to be included by hard clamp body 8, and the continuous U-shaped corresponding from different Outer Tube sizes Unit engraves groove, and 9, on hard clamp body 8, one is further respectively had at each group of 9 left and right end positions of U-shaped unit sample groove Individual positioning hole 10.Mould is made using valve and is pressed in PTFE valve materials surface, is fixed at positioning hole 10, outside required Duct size selects corresponding U-shaped to engrave groove 9 and describe, and then directly cuts out, and valve makes mold use, not only side Just, Production Time is saved, and the more specification shape of U-shaped unit so that its size in different Outer Tube manufacturing process It is more accurate, ensure the anti-reflux of valved external conduit valve.

In the above-described embodiments, hard clamp body 8 is provided with the corresponding continuous U-shaped list of different Outer Tube sizes Member engraves groove 9, can save the making of model, easy to use.Hard clamp body 8 is made of clear material, and having preferably makes With effect, ensure that operating personnel can fully observe the flatness of material when cutting out.

Sewn by hand valved external conduit of the present utility model is when being sewed, after Outer Tube inner face is turned to outside pipeline, point Not Biao Ji Outer Tube week footpath trisection line, 5-0prolene lines stitch the coupling part of U-shaped unit with corresponding bisector in advance Close and fix, be so advantageous to the uniformity of each leaflet size, keep valve edge not easily cause the distortion of leaflet in same level. Sewing step has been unified in the design of the structure and the use of the method for sewing, using most suitable manufactured size, application template Change specification and enormously simplify Making programme.The durability of new valved external conduit can avoid Repeated Operation from changing and lose the outer of work( Pipeline, New-support valved external conduit can avoid open chest surgery, mitigate operation wound, and the economy for mitigating infant family significantly is born Load, has very high economic benefit.

What embodiment of the present utility model was announced is preferred embodiment, but is not limited thereto, the common skill of this area Art personnel, easily according to above-described embodiment, understand spirit of the present utility model, and make different amplification and change, but as long as Spirit of the present utility model is not departed from, all in the scope of protection of the utility model.

Bibliography

1.Ito T,MaekawaA,YamanaK,et al.Use of an Expanded Polytetrafluoroethylene Patch as an Artificial Leaflet in Mitral Valve Plasty:An Early Experience.The Annals of Thoracic Surgery.2010；89(5):1620- 1624.

2.Yamagishi M,Kurosawa H.Outflow reconstruction of tetralogy ofFallot using a Gore-Tex valve.Ann Thorac Surg.1993；56:1414-7.

3.TurrentineMW,Rodefeld MD,Brown JW.PolytetrafluoroethyleneMonocusp Valve Reconstruction of the Right Ventricular Outflow Tract.Ann ThoracSurg.2002；73(3):871-9.

4.Brown JW,Ruzmetov M,Vijay P,et al.Right ventricular outflow tract reconstruction with apolytetrafluoroethylenemonocusp valve:A twelve- yearexperience.J ThoracCardiovasc Surg.2007；133:1336-43.

5.NunnGR,MBBS,BennettsJ,et al.Durability of hand-sewn valves in the right ventricularoutlet.J ThoracCardiovasc Surg.2008；136:290-7.

6.Ando M,TakahashiY.Ten-year experience with handmade trileafletpolytetrafluoroethylenevalved conduit used for pulmonary reconstruction.J ThoracCardiovasc Surg.2009；137:124-31.

7.Miyazaki T,YamagishiM,Maeda Y,et al.Expanded polytetrafluoroethylene conduits and patches with bulgingsinuses and fan- shaped valves in right ventricular outflow tractreconstruction:Multicenter study in Japan.J ThoracCardiovasc Surg.2011；142:1122-9.

8.IyerA,Malik P,Malik R,et al.Early Postoperative BioprostheticValveCalcification.Heart,Lung and Circulation.2013；22:873–874.

9.Cheung G,VejlstrupN,IhlemannN,et al.Infective endocarditis following percutaneous pulmonary valvereplacement:Diagnostic challenges and application ofintra-cardiac echocardiography.International Journal of Cardiology.2013；169:425–429.

10.Malekzadeh-MilaniS,LadouceurM,IserinL,et al.Incidence and outcomes of right-sided endocarditis in patients with congenital heart disease after surgical or transcatheter pulmonary valve implantation.The Journal of Thoracic and Cardiovascular Surgery.2014；148(5):2253-2259.

11.Nair V,Law KB,Li AY,et al.Characterizing the inflammatory reaction in explanted Medtronic Freestylestentless porcine aortic bioprosthesis over a 6-year period.Cardiovascular Pathology.2012；21:158–168.

12.Brown JW,Ruzmetov M,Rodefeld MD,et al.Right Ventricular Outflow Tract ReconstructionWith an Allograft Conduit in Non-Ross Patients:Risk Factors for Allograft Dysfunction and Failu re.AnnThorac Surg.2005；80:655–64.

13.Oosterhof T,Meijboom FJ,Vliegen HW,et al.Long-term follow-up of homograftfunction after pulmonary valve replacement in patients with tetralogy ofFallot.Eur Heart J.2006；27(12):1478-1484.

14.V,Berdat P,Pavlovic M,et al.Adverse Mid-Term Outcome Following RVOTReconstruction Using the ContegraValvedBovineJugular Vein.Ann Thorac Surg.2005；79:625–31.

15.Karamlou T,Blackstone EH,Hawkins JA,et al.Can pulmonary conduit dysfunction and failure bereduced in infants and children less than age 2years at initial implantation.J ThoracCardiovascSurg.2006；132:829-38.

16.Lee C,Park CS,Lee CH,et al.Durability of bioprosthetic valves in the pulmonary position:Long-term follow-up of 181 implants in patients with congenitalheart disease.J ThoracCardiovasc Surg.2011；142:351-8.

17.O'Keefe KL,CohleSD,McNamara JE,et al.Early Catastrophic Stentless Valve Failure Secondary to Possible Immune Reaction.The Annals of Thoracic Surgery.2011；91(4):1269-1272.

18.Grabenwoger M,Fitzal F,Gross C,et al.Different modes ofdegeneration in autologous and heterologous heart valve prostheses.J Heart Valve Dis.2000；9:104-9[discussion 110-1].

19.Pompilio G,Polvani G,Piccolo G,et al.Six-year monitoring of the donor-specific immune response to cryopreserved aortic allograft valves: implications with valve dysfunction.Ann Thorac Surg.2004 Aug；78(2):557-63.

20.Wojtalik M,Mrowczynski W,Zeromski J,etal.Doescontegraxenograft implantation evoke cellular immunityin childrenInteractive CardiovascThorac Surg.2003；2:273–8.

21.Park CS,Park SS,Choi SY,et al.Anti alpha-gal immune responsefollowingporcinebioprosthesis implantation in children.J HeartValve Dis.2010；19:124-30.

22.Lisy M,Pennecke J,Brockbank K,et al.The performance of ice-free cryopreserved heart valve allografts in an orthotopicpulmonary sheep model.Biomaterials.2010；31:5306-5311.

23.Cicha I,Rüffer A,Cesnjevar R,et al.Early obstruction of decellularizedxenogenic valves in pediatric patients:involvement of inflammatory and fibroproliferative processes.Cardiovascular Pathology.2011； 20:222-231.

24.Cissell DD,Hu JC,Griffiths LG,et al.Antigen removal for the production of biomechanically functional,xenogeneic tissue grafts.Journal ofBiomechanics.2014；47:1987-1996.

25.Apte SS,Paul A,Prakash S,et al.Current developments in the tissue engineering of autologous heart valves:moving towards clinical use.Future Cardiol.2011；7(1):77-97.

26.Siddiqui RF,Abraham JR,Butany J.Bioprosthetic heart valves:modesof failure.Histopathology.2009；55:135-44.

27.Chen PC,Sager MS,Zurakowski D,et al.You nger age and valve oversizing are predictors of structural valve deterioration after pulmonary valve replacement in patients with tetralogy of Fallot.The Journal of Thoracic and Cardiovascular Surgery.2012；143(2):352-360.

Claims (6)

1. sewn by hand valved external conduit, it is characterised in that including outer tube body (1) and PTFE valves (2)；The PTFE valves (2) by Three U-shaped unit (21) compositions, each U-shaped unit (21) include valve member (211) and coupling part (212), each U Shape blade unit (21) edge sewing is on the inwall of outer tube body (1)；

The film lobe point (211) of each U-shaped blade unit (21) extends towards the central axis direction of outer tube body (1), and some The marginal portion of the individual film lobe point (211) mutually freely overlaps；

At the lines of 5-0prolene from left to right of whole PTFE valves (2) (4) and at the 5-0prolene lines turned left of the right side (5), line (6) is pre-fixed provided with U-shaped blade unit (21) and the suture of outer tube body (1) Along ent.

2. sewn by hand valved external conduit according to claim 1, it is characterised in that three U-shapeds of the PTFE valves (2) Blade unit (21), which is connected with each other, turns into an entirety, and directly sewing forms in the inner face of Outer Tube.

3. sewn by hand valved external conduit according to claim 1 or 2, it is characterised in that the PTFE valves (2) it is each The U-shaped structure of individual coupling part (212).

4. sewn by hand valved external conduit according to claim 2, it is characterised in that the PTFE valves (2) are provided with three U Shape inner membrance blade unit (21), the wherein inner face of outer tube body (1) are provided with trisection line (7), each two U-shaped PTFE units have a common boundary with it is outer Trisection line (7) suture of body (1) inner face.

5. the U-shaped unit of the valved external conduit according to claim 1 or 2 or 4 makes mould, including hard clamp body (8), and the continuous U-shaped unit corresponding from different Outer Tube sizes engraves groove (9)；Wherein on hard clamp body (8) Engraved positioned at U-shaped unit described in each group and a positioning hole (10) is further respectively had at groove (9) left and right end positions.

6. the mould of the U-shaped unit of valved external conduit according to claim 5, it is characterised in that the hard clamp sheet Body (8) is made of clear material.