CN201333112Y - Non-support heterologous bioprosthetic heart valve - Google Patents

Abstract

The utility model discloses a non-support heterologous bioprosthetic heart valve, which comprises valve leaflets and coronary artery ostia of a porcine aortic valve, wherein, the valve leaflets are sutured in a valve seat; a polyester fabric layer is wrapped outside an inflow tract of the valve seat and seals the coronary artery ostia; and a suture ring is sewed at the periphery of the polyester fabric to form an aortic root-type non-support valve structure. Compared with a valve with a support of the same model, the non-support heterologous bioprosthetic heart valve has the following advantages: the aortic root-type non-support valve structure can provide a larger valve ostium area and a lower transvalvular pressure gradient, therebying favoring the gradual recovery of the heart function of a patient after operation and the inhibition of the development of cardiac hypertrophy and cardiac failure. The utility model can be used for the replacement of the valve and the aortic root and is particularly suitable for patients suffering from the complex lesions of the aortic root, the calcification of the valve sinus, and the serious expansion of the aortic root.

Description

A kind of unsupported heterogeneity biological cardiac valve

Technical field

This utility model belongs to field of medical technology, relates to a kind of heterogeneity biological cardiac valve (porcine aorta) of novel non-bracket design, is used to replace the human heart valve.The innovation that is specifically related to the design of novel non-bracket lobe and prevents the calcification method.

Background technology

Valvular heart disease is modal heart disease, and valve replacement is the unique therapy measure of serious valvular heart disease.China is high one of the country of suffering from of valvular heart disease, estimates that existing rheumatic heart disease patient surpasses 2,500,000.But still there is not ideal artificial valve so far.

The Cardiac valve prosthesis that uses mainly contains mechanical prosthetic valve and bioprosthetic valve two big classes at present.Domestic employed artificial valve is still mainly based on imported mechanical lobe (accounting for more than 95%).Though mechanical prosthetic valve good endurance, postoperative need lifelong anticoagulant, postoperative patient to face the danger of thrombosis, thromboembolism and many complication such as hemorrhage.Biomaterial is the main component of biovalve, and the source is generally porcine aortic valve or bovine pericardium valve, and the minority valve is an organizational project valve and from the body lobe.The xenogenesis valve that glutaraldehyde is handled is the main source of biovalve.At present, most pig lobes all are (Hancock lobe 0.2%, the Carpentier-Edwards lobes 0.6%) handled through the glutaraldehyde of variable concentrations.Standoff pig lobe is the same with mechanical prosthetic valve, and a suture ring is all arranged, and can cause partial pressure reduction, makes still to have the problem of changing before the lobe that is similar to behind the valve replacement.Effective vent area that the advantage of no support lobe is to provide bigger and lower pressure gradient, be more suitable for intrinsic aortic root, reproduce the physiological structure of normal aortic valve one aortic root complex, improve the hemodynamics performance of valve theoretically.At present external commercial no stent valve mainly contains: CryoLife does not have support pig lobe, CryoLife organizational project and does not have support pig lobe (SynerGraft lobe), Edwards Prima Plus does not have support pig lobe, the unsupported pig lobe of T-SPV (St.Jude Medical) and is specifically designed to the mitral no support four leaf pericardium lobe SJM Quattro lobes of displacement etc.Domestic still do not have a standard compliant commercial no support bioprosthetic valve.

Also adopt certain method to prevent calcification processing though be used to make up the biomaterial of no stent valve abroad, still had the calcification problem behind the long-term implant into body, influenced the long-term effect of valve.Use alpha-amido oleic acid as U.S. Ming Niabo Nice city Medtronic cardiac valve company and handle the fixed porcine aortic valve of glutaraldehyde, handle by tissue surface and to prevent that the sedimentary mechanism of calcium from slowing down valvular calcification, experimentation and clinical practice are good, but long-term effect is undesirable.The employing of Brazil Biocor company is a kind of to be carried out crosslinked with acetaldehyde, then the No-react method of carrying out attenuation treatment and surfactant processing with multiple material is produced multiple biological cardiac valves, can slow down biomaterial calcification and failure in vivo, but the calcification that can not effectively slow down aorta wall.The method that U.S. St.Jude Medical (SJM) adopts the Epic of alcoholic acid pretreatment glutaraldehyde cross-linking not have the support bioprosthetic valve prevents valvular calcification by compositions such as lipids in the removal valve, further tests showed that, this kind method and methanol, isopropyl alcohol pretreatment porcine aortic valve or bovine pericardial tissue, the effect that slows down calcification is all arranged, but the preservation of glutaraldehyde can reduce anti-calcification effect again before implanting.Although these anti-calcification methods have certain advantage, alleviate valvular calcification by certain mechanism, do not reach desired level.

The applicant at first uses the method for epoxychloropropane chemical modification bioprosthetic valve, seal the collagen molecules terminal carboxyl group effectively, the lobe leaf adopts the anti-calcification processing of epoxychloropropane, has better hemodynamics performance and anti-calcification performance, thereby plays obvious calcification effect.On the basis of this research, the applicant does not have the support lobe to the aortic root type and has done further investigation, in the hope of a normal valvular function and better quality of life are provided for the patient, be particularly suitable for to be subjected to the anticoagulant therapy case, or be difficult for adhering to the outlying district patient and the elderly patients of anticoagulant therapy.

Summary of the invention

This utility model aims to provide a kind of unsupported heterogeneity biological cardiac valve, mainly by no support biological cardiac valves being designed and preventing the improvement of calcification method, makes it to have good hemodynamics performance and anti-calcification performance.

In order to realize above-mentioned task, technical solution adopted in the utility model is:

A kind of unsupported heterogeneity biological cardiac valve, the lobe leaf and the arteria coronaria mouth that comprise porcine aortic valve, it is characterized in that, described lobe leaf is sutured in the lobe seat, at the inflow road of lobe seat coated outside one deck polyester textile and seal the arteria coronaria mouth, make suture ring around polyester textile, forming the aortic root type does not have the support valve structure.

The technique effect that unsupported heterogeneity biological cardiac valve of the present utility model brings is:

1, have the support lobe to compare with same model, the aortic root type does not have the support lobe can provide bigger valve orifice area and lower pressure gradient, and the progressively recovery of patient's cardiac function helps to reverse the development of myocardial hypertrophy and heart failure after helping performing the operation.

2, the aortic root type does not have support lobe design and can go valve and aortic root replacement art, is particularly suitable for the patient of aortic root complex lesions, the calcification of lobe hole portion, the serious expansion of aortic root.

Description of drawings

Fig. 1 is a no support biological cardiac valves structural representation of the present utility model;

The utility model is described in further detail below in conjunction with accompanying drawing.

The specific embodiment

Referring to Fig. 1, unsupported heterogeneity biological cardiac valve of the present utility model, the lobe leaf 2 and the arteria coronaria mouth 4 that comprise porcine aortic valve, lobe leaf 2 is sutured in the lobe seat 1, at the inflow road of lobe seat 1 coated outside one deck polyester textile 5 and seal arteria coronaria mouth 4, make suture ring 3 around polyester textile 5, forming the aortic root type does not have the support valve structure.

Concrete method for making is as follows:

The porcine aortic valve of taking fresh anosis damage under the gnotobasis comprises the lobe leaf 2 and the arteria coronaria mouth 4 of porcine aortic valve as raw material, and warm ischemia time placed Hank ' s liquid to preserve in 2 hours.Prune incidental muscle of porcine aortic valve and fatty tissue, Hank ' s liquid rinsing 3 times.Place 0.5% glutaraldehyde solution mesolow to soak back Hank ' s liquid rinsing 3 times 24 hours valve.Soak in the 2% epoxychloropropane solution and carried out chemical modification in 72 hours.Lobe leaf 2 is sutured in the lobe seat 1, and efferent tract can be pruned according to the operation needs, flows into road coated outside one deck polyester textile 5, and seam closes arteria coronaria mouth 4, makes suture ring 3 around polyester textile 5.

The unsupported heterogeneity biological cardiac valve of making does not have the suture ring of hard, on the fixed basis of glutaraldehyde low pressure, adopts the anti-calcification chemical modification of epoxychloropropane to handle, and seals the collagen molecules terminal carboxyl group effectively.

In the operation process, this utility model aortic root type does not have the support lobe can be pruned according to patient's situation, adopts implantation, tubing string shape implantation, three kinds of methods of aortic root replacement under the coronary ostium.Implantation adopt to flow into the engage in this profession method of fan-shaped stitching of diatom groove part interflow under the coronary ostium, is the most frequently used method for implantation up to now.Modification method comprises different aorta incision process (transverse incision, annular incision, vertical incision, angular cut), the hole pipe jointing part dwindle or fixing, do not have the reservation of hat coronary sinus.Tubing string shape implantation only will not have the left and right coronary artery of stent valve and will be the excision of button shape, valve can well be kept original form, valve inflow, outflow end and crown tremulous pulse opening portion and patient's aorta corresponding site coincide get final product, and this modus operandi can make the minimizing of valve replacement after strain incidence rate.Aortic root replacement becomes button shape to cut together with the part aorta wall left and right sides coronary ostium in the cross-section patient's aorta of hole pipe intersection, keeps with no stent valve and coincide.The residue aorta wall is removed in the lump together with the pathological changes valvular tissue.After no support aortic valve and left ventricular outflow tract view coincide, promptly coincide with coronary artery and distal aorta.

Claims (1)

1, a kind of unsupported heterogeneity biological cardiac valve, the lobe leaf (2) and the arteria coronaria mouth (4) that comprise porcine aortic valve, it is characterized in that, lobe leaf (2) is sutured in the lobe seat (1), at the inflow road of lobe seat (1) coated outside one deck polyester textile (5) and seal arteria coronaria mouth (4), make suture ring (3) around polyester textile (5), forming the aortic root type does not have the support valve structure.