CN104771249A - Intrusive type heart valve prosthesis and preparation method thereof - Google Patents

Abstract

The invention discloses an intrusive type heart valve prosthesis and a preparation method thereof, and belongs to the technical field of intrusive type medical apparatuses. The intrusive type heart valve prosthesis comprises an elastic bracket, a covering film and at least two valves, wherein the elastic bracket can extend and retract along the radial direction, the covering film is sewed onto the inner wall or the outer wall of the bracket, the valves are arranged in a cavity of the bracket, the lower edge of each valve is sewed onto the covering film, the adjacent sides of the two adjacent valves are mutually spliced, and the side edges of the valves are sewed onto the bracket. The intrusive type heart valve prosthesis has the advantages that the function of natural valves can be well replaced; by adopting the elastic bracket, the valve structure can be conveniently loaded into a conveying device, and can also be conveniently released to the target position to be tightly combined with the surrounding tissues of the target position; the bracket is coated by the covering film, so the surrounding leakage of the valves is effectively prevented; the bionic degree of the sewing structure of the valve and the covering film is high, the natural valves can be well simulated, and the function of the natural valves is replaced; the structure is stable and firm, the durability and firmness are realized, the elastic extending and retracting requirements in the loading and release processes can be met, and the damage is avoided.

Description

A kind of insertion type artificial cardiac valve and preparation method thereof

Technical field

The invention belongs to insertion type technical field of medical instruments, be specifically related to a kind of insertion type artificial cardiac valve and preparation method thereof.

Background technology

Heart is the very important organ of human body, for blood circulation of human body provides power, heart is divided into left and right two parts, every part comprises a ventricle and atrium, separated by interventricular septum and interatrial septum between ventricle and ventricle and between atrium and atrium, there is the valve preventing blood reflux between room, room, tremulous pulse.Valve wherein between left atrium and left ventricle is Bicuspid valve, and the valve between right atrium and right ventricle is Tricuspid valve, and the valve between left ventricle and large artery trunks is aortic valve, and the valve between right ventricle and pulmonary artery is valve of pulmonary trunk.

Above-mentioned valve can along with the contraction of heart and the corresponding open and close of diastole, and therefore the valve of heart must bear the extruding of blood and surrounding lobe ring and washing away of blood for a long time.If because disease or other reason cause valve to close completely or to open insufficient, then backflowing and supply of blood flow deficiency of blood will be caused.Such as: valvular stenosis causes the smooth or incompetence of blood circulation to cause cardiac blood supply deficiency, thus greatly increase the weight of the burden of heart, cause cardiac failure, for this type of valvular heart disease, traditional therapy is out cardiac arrest after breast, under cryotron circulatory support, opens heart and carries out the surgical repair of valve or the displacement of artificial valve, make recovering beat of heart again after having performed the operation, complete subsequent operation.Surgery prosthetic valve replacement operation wound is large, and the recovery time of patient is long, therefore to gerontal patient often because of advanced age, body constitution is weak, pathological changes is heavy or merging Other diseases and avoid performing the operation.

Min. traumatic surgery technology is at development, wherein, Cardiac valve prosthesis can adopt conduit to introduce in patient body, namely cardiac valve is placed by Wicresoft's intervene operation, operation is without the need to opening breast, thus wound is little, post-operative recovery fast, for the valvular stenosis patient that those current conventional therapy means can not extend its life or alleviate its misery, provides a kind of new solution.But because this technology time of occurrence is shorter, be also faced with more problem at present, result of use is still undesirable.

Summary of the invention

The present invention is directed to the problems referred to above, provide a kind of new insertion type artificial cardiac valve.

Object of the present invention is realized by following technical proposals:

A kind of insertion type artificial cardiac valve, comprise elastic support, overlay film and at least two pieces of lobe leaves that can radially stretch, described overlay film is sewn on described rack inner wall or outer wall, described lobe leaf is arranged in the cavity of described support, along being sewn on described overlay film under lobe leaf, the mutual split of adjacent side of adjacent two pieces of lobe leaves, described side seams is closed on the bracket.This structure can be good at replacing the function of natural valve effectively to avoid blood reflux, elastic support is adopted both to be convenient to be loaded in conveyer device, be convenient to again be discharged into target location fast and combine closely with target location surrounding tissue, when installing conveying, be convenient to support to tighten up in the conveyer device of loading finite volume, when strutting rapidly again after release from conveyer device, be convenient to fit tightly with destination organization, form sufficient channel of blood flow; Adopt overlay film coated stent effectively can prevent perivalvular leakage; The bionical degree of suture texture that described lobe leaf coordinates with overlay film is high, can be good at simulation natural valve and replace its function, enough channel of blood flow can be provided during blood following current, resistance is little, can close again and completely successfully prevent from backflowing, and described Stability Analysis of Structures is firm, durable in use, the elastic telescopic that can also well adapt in loading and dispose procedure requires and is not damaged.

Alternately, the quantity of described lobe leaf is 3 pieces.

Alternately, described lobe leaf comprises the rectangular portion of upper end and the curved portions of lower end, and the lower edge of described lobe leaf is arc.Adopt the lobe leaf of this shape to be convenient to coordinate described suture way, and the hemodynamic effect of gained valve is good.

Alternately, described overlay film is one or more layers.The material of described overlay film is one or more in PET, e-PTFE, pericardium material.

Alternately, described lobe leaf can be the one in biological tissue's (as Cor Sus domestica bag, bovine pericardium, Cor Sus domestica lobe, Cor Bovis seu Bubali lobe etc.), macromolecular material, tissue engineered heart valve.

Alternately, the end of described supporting structure is provided with conveying link.Be convenient to coordinate with corresponding conveyer device realize quick and precisely discharging.Alternately, described conveying link is the rod member with conveying connecting hole.Alternately, after sewing up overlay film, described conveying link is exposed at valve outer surface.

Alternately, described support comprises tubular structure portion and skirt hatch frame portion, and the diameter in described skirt hatch frame portion is greater than the diameter of described tube, and described tubular structure portion is coaxially fixedly connected with skirt hatch frame portion.As the blood inlet of blood behind described skirt hatch frame implantation position of valve, tubular structure is as the blood outlet of blood, the physiological structure of the structure that described tubular structure matches with skirt hatch frame and natural valve matches (especially matching with the native physiological structure of Bicuspid valve and tricuspid surrounding tissue), there is certain self-locating function, be convenient to locate release rapidly and accurately, and release after-poppet close structure laminating channel of blood flow, not easily be shifted, this structure coordinates with surrounding tissue and is convenient to overlay film and forms plugging structure simultaneously, be conducive to avoiding perivalvular leakage.

Alternately, described conveying link is positioned at support tubular structure side.As optional, its number is 2-6.When valve loads induction system, stand connection in described conveying link and conveyer device is connected, in operation process, first releasing bracket length 1/4 ~ 3/4, observe the placement location of support in heart, if off-position and pre-determined bit are equipped with deviation, interior pipe racks just can be pulled to move support to be withdrawn in interior pipe again, under the extruding of wall within the outer tube, support can draw in until got back to the state before release by epitheca parcel completely gradually, then reorientate again, release, like this just can first time support in place unsuccessful time, timely adjustment, until valve to be released in best position.

Alternately, the diameter of described support mid portion is less than both ends open, and support tube wall forms sunk structure, thus is reached the object be fixedly connected with lobe ring by the difference of physical form.

Alternately, described tubular structure portion internal diameter is between 20-32mm, selects the size of tubular structure in valve bracket further according to the size of patient's lobe ring.

Alternately, described support is also provided with overlay film sewing hole.By arranging overlay film sewing hole, the stitching of overlay film of being more convenient for, makes the inwall of overlay film and support or outer wall be combined more closely, firmly, more be conducive to avoiding occurring perivalvular leakage.Further, the two ends of described support are provided with overlay film sewing hole.As optional, the overlay film sewing hole number of described every one end is respectively 3-12, preferably 6 further.

Alternately, upper end, described tubular structure portion is provided with at least two group lobe leaf sewing holes.By arranging lobe leaf sewing hole, lobe leaf of being more convenient for is connected with the stitching of support, lobe leaf is combined with support more closely, firmly, not easily occurs damaged and tear.As optional, the group number of described lobe leaf sewing hole is 3 groups.As optional, described lobe leaf sewing hole is evenly distributed on upper end, tubular structure portion circumferentially.As optional, often organize the circular hole that lobe leaf sewing hole comprises two same diameter sizes.As optional, described lobe leaf sewing hole is positioned at the below of described conveying connecting hole.

Alternately, described support has network, is interconnected forms by lattice support unit.Described network is more conducive to realizing the elastic effect that support can radially stretch.

Alternately, described tubular structure portion has network.As optional, the support unit of described network assumes diamond in shape.This structure is conducive to the elasticity that formation support radially stretches.Further, described tubular structure portion and described skirt hatch frame portion are formed by interconnective support unit.

Alternately, the described skirt hatch frame portion support connecting piece that comprises the many skirt opening skeletons from described tubular structure subordinate end to downward-extension and be connected between adjacent two skirt opening skeletons.As optional, skirt opening skeleton lower end is provided with overlay film lower end sewing hole.As optional, described support connecting piece is in " V " type.

Alternately, the diameter of the junction in described tubular structure portion and described skirt hatch frame portion is less than the diameter at all the other positions of support, makes the lateral surface of described supporting structure form in the junction in described tubular structure portion and described skirt hatch frame portion structure of caving in.

Alternately, the tubular structure portion of described support and skirt hatch frame portion have integrated formed structure.

Alternately, described support material is Nitinol.

Alternately, described support is formed through cut and heat treatment shaping by a NiTi pipe, and laser cutting machine cuts out the shape of valve bracket on thin-walled Nitinol pipe, then is shaped into predetermined shape by difform mold hot.

Alternately, agnail is provided with in described support.Described agnail can thrust the tissue of valve periphery after cardiac valve is implanted to ad-hoc location, plays positioning action, is not easily shifted after the release of gained valve, can in blood stream pressure and washing away after long-lasting tolerance release.

Alternately, described agnail is by tubular structure portion to the extension of skirt hatch frame portion and to stent outer inclination, and after stitching overlay film, described agnail is exposed at valve outer surface.To be coordinated with skirt hatch frame portion by described agnail and realize antiskid function, reduce the damage to surrounding tissue.

Alternately, the angle between described agnail and rack outer surface is 10 ~ 80 degree.Adopt this angular range to be both convenient to agnail and thrust surrounding tissue smoothly, be conducive to again the quick and precisely release realizing valve.Further, described angle is 45 degree.

Alternately, described agnail is arranged at the one end near described skirt hatch frame portion in tubular structure portion.The agnail being arranged on this position just thrusts the position near lobe ring upon discharge, good antiskid effect and little to the damage of heart.

Alternately, described barbed ends is wedge shape or needle-like.Wedge shape or acicular texture is adopted to be convenient to thrust.Described wedge structure can be that described barbed ends thickness diminishes formation gradually, also can be that barbed ends width diminishes formation gradually.

Alternately, described agnail linearly type or " V " type or " U " type.Can according to the actual state flexible design of surrounding tissue.

Alternately, described support is provided with development site.By arranging development site, coordinating suitable shadowgraph technique to make operator can be clearly seen that the physical location of insertion type artificial cardiac valve when laying insertion type artificial cardiac valve, being conducive to accurate location when installing, improve the success rate of installing operation.As optional, described development site is positioned on described tubular structure portion outer wall.Further, described development site is positioned at lobe leaf minimum point corresponding position.

Alternately, described agnail is provided with development site.

Alternately, described conveying connector is provided with development site.

Alternately, described development site comprises development hole and the developing media that is filled in described development hole.

Alternately, described developing media is radiopaque metal medium.

Alternately, described developing media is bio-inert material.

Alternately, described developing media is one or more in platinum (Pt), platinumiridio (Pt/Ir), tantalum metal (Ta).

Alternately, described developing media is the development ball in the described development hole of press-in.

Present invention also offers a kind of preparation method of above-mentioned insertion type artificial cardiac valve, comprise the following steps: (1) adopts cut and heat treatment shaping preparation; (2) overlay film is sewn onto on support; (3) lobe leaf is sewn onto in the cavity of support.

Alternately, in above-mentioned preparation method, the preparation of described support comprises cut, heat treatment shaping step.Adopt laser cutting machine on Thin wall alloy tube, cut out the pore space structure of valve bracket, then be shaped into predetermined shape by difform mold hot.Support prepared by the method has integrated formed structure, and technique is simple, the support reliability that reproducible, cut global formation obtains and precision higher, reduce production cost and be easy to large-scale production.Further, above-mentioned Thin wall alloy tube is Nitinol pipe.As optional, the preparation method of described support comprises the steps such as cut, heat treatment shaping and interpolation developing media.Adopt laser cutting machine on Thin wall alloy tube, cut out the pore space structure of valve bracket, then be shaped into predetermined shape by difform mold hot, finally developing media (as to press-in development ball in development hole) is set in development site.

All features disclosed in this description, or the step in disclosed all methods or process, except mutually exclusive feature and/or step, all can combine by any way

Beneficial effect of the present invention:

Insertion type artificial cardiac valve of the present invention can be good at replacing the function of natural valve effectively to avoid blood reflux, elastic support is adopted both to be convenient to be loaded in conveyer device, be convenient to again be discharged into target location fast and combine closely with target location surrounding tissue, when installing conveying, be convenient to support to tighten up in the conveyer device of loading finite volume, when strutting rapidly again after release from conveyer device, be convenient to fit tightly with destination organization, form sufficient channel of blood flow; Adopt overlay film coated stent effectively can prevent perivalvular leakage; The bionical degree of suture texture that described lobe leaf coordinates with overlay film is high, can be good at simulation natural valve and replace its function, enough channel of blood flow can be provided during blood following current, resistance is little, can close again and completely successfully prevent from backflowing, and described Stability Analysis of Structures is firm, durable in use, the elastic telescopic that can also well adapt in loading and dispose procedure requires and is not damaged.

Accompanying drawing explanation

Fig. 1 is the schematic diagram of a kind of supporting structure described in embodiment 2;

Fig. 2 is the close-up schematic view of the conveying connection hole of a kind of supporting structure described in embodiment 2;

Fig. 3 is the close-up schematic view at the development hole place after press-in development ball in a kind of supporting structure described in embodiment 2;

Fig. 4 is for sewing up the front view after overlay film in a kind of supporting structure surface described in embodiment 2;

Fig. 5 is the upward view after a kind of supporting structure stitching lobe leaf described in embodiment 2;

Fig. 6 is the schematic diagram of a kind of supporting structure described in embodiment 3;

Fig. 7 is for sewing up the front view after overlay film in a kind of supporting structure surface described in embodiment 3;

Fig. 8 is the upward view after a kind of supporting structure stitching lobe leaf described in embodiment 3;

Three kinds of alternative shapes that Fig. 9 is the described agnail in the supporting structure described in embodiment 3.

Wherein, 1 for conveying link, 2 be lobe leaf sewing hole, 3 for development hole, 4 for upper end sewing hole, 5 for lower end sewing hole, 6 for support, 7 for support unit, 8 for development ball, 9 for overlay film, 10 be lobe leaf, 11 is agnail.

Detailed description of the invention

By the following examples the present invention is specifically described; what be necessary to herein means out is that the present embodiment is only used to further illustrate the present invention; but can not be interpreted as limiting the scope of the invention, the person skilled in the art in this field can make improvement and the adjustment of some non-intrinsically safes to the present invention according to the content of the invention described above.

embodiment 1

A kind of insertion type artificial cardiac valve, comprise elastic support, overlay film and at least two pieces of lobe leaves that can radially stretch, described overlay film is sewn on described rack inner wall or outer wall, described lobe leaf is arranged in the cavity of described support, along being sewn on described overlay film under lobe leaf, the mutual split of adjacent side of adjacent two pieces of lobe leaves, described side seams is closed on the bracket.This structure can be good at replacing the function of natural valve effectively to avoid blood reflux, elastic support is adopted both to be convenient to be loaded in conveyer device, be convenient to again be discharged into target location fast and combine closely with target location surrounding tissue, when installing conveying, be convenient to support to tighten up in the conveyer device of loading finite volume, when strutting rapidly again after release from conveyer device, be convenient to fit tightly with destination organization, form sufficient channel of blood flow; Adopt overlay film coated stent effectively can prevent perivalvular leakage; The bionical degree of suture texture that described lobe leaf coordinates with overlay film is high, can be good at simulation natural valve and replace its function, enough channel of blood flow can be provided during blood following current, resistance is little, can close again and completely successfully prevent from backflowing, and described Stability Analysis of Structures is firm, durable in use, the elastic telescopic that can also well adapt in loading and dispose procedure requires and is not damaged.

Alternately, the quantity of described lobe leaf is 3 pieces.

Alternately, described lobe leaf comprises the rectangular portion of upper end and the curved portions of lower end, and the lower edge of described lobe leaf is arc.Adopt the lobe leaf of this shape to be convenient to coordinate described suture way, and the hemodynamic effect of gained valve is good.

Alternately, described overlay film is one or more layers.The material of described overlay film is one or more in PET, e-PTFE, pericardium material.

Alternately, described lobe leaf can be the one in biological tissue's (as Cor Sus domestica bag, bovine pericardium, Cor Sus domestica lobe, Cor Bovis seu Bubali lobe etc.), macromolecular material, tissue engineered heart valve.

Alternately, the end of described supporting structure is provided with conveying link.Be convenient to coordinate with corresponding conveyer device realize quick and precisely discharging.Alternately, described conveying link is the rod member with conveying connecting hole.Alternately, after sewing up overlay film, described conveying link is exposed at valve outer surface.

Alternately, described support comprises tubular structure portion and skirt hatch frame portion, and the diameter in described skirt hatch frame portion is greater than the diameter of described tube, and described tubular structure portion is coaxially fixedly connected with skirt hatch frame portion.As the blood inlet of blood behind described skirt hatch frame implantation position of valve, tubular structure is as the blood outlet of blood, the physiological structure of the structure that described tubular structure matches with skirt hatch frame and natural valve matches (especially matching with the native physiological structure of Bicuspid valve and tricuspid surrounding tissue), there is certain self-locating function, be convenient to locate release rapidly and accurately, and release after-poppet close structure laminating channel of blood flow, not easily be shifted, this structure coordinates with surrounding tissue and is convenient to overlay film and forms plugging structure simultaneously, be conducive to avoiding perivalvular leakage.

Alternately, described conveying link is positioned at support tubular structure side.As optional, its number is 2-6.When valve loads induction system, stand connection in described conveying link and conveyer device is connected, in operation process, first releasing bracket length 1/4 ~ 3/4, observe the placement location of support in heart, if off-position and pre-determined bit are equipped with deviation, interior pipe racks just can be pulled to move support to be withdrawn in interior pipe again, under the extruding of wall within the outer tube, support can draw in until got back to the state before release by epitheca parcel completely gradually, then reorientate again, release, like this just can first time support in place unsuccessful time, timely adjustment, until valve to be released in best position.

Alternately, the diameter of described support mid portion is less than both ends open, and support tube wall forms sunk structure, thus is reached the object be fixedly connected with lobe ring by the difference of physical form.

Alternately, described tubular structure portion internal diameter is between 20-32mm, selects the size of tubular structure in valve bracket further according to the size of patient's lobe ring.

Alternately, described support is also provided with overlay film sewing hole.By arranging overlay film sewing hole, the stitching of overlay film of being more convenient for, makes the inwall of overlay film and support or outer wall be combined more closely, firmly, more be conducive to avoiding occurring perivalvular leakage.Further, the two ends of described support are provided with overlay film sewing hole.As optional, the overlay film sewing hole number of described every one end is respectively 3-12, preferably 6 further.

Alternately, upper end, described tubular structure portion is provided with at least two group lobe leaf sewing holes.By arranging lobe leaf sewing hole, lobe leaf of being more convenient for is connected with the stitching of support, lobe leaf is combined with support more closely, firmly, not easily occurs damaged and tear.As optional, the group number of described lobe leaf sewing hole is 3 groups.As optional, described lobe leaf sewing hole is evenly distributed on upper end, tubular structure portion circumferentially.As optional, often organize the circular hole that lobe leaf sewing hole comprises two same diameter sizes.As optional, described lobe leaf sewing hole is positioned at the below of described conveying connecting hole.

Alternately, described support has network, is interconnected forms by lattice support unit.Described network is more conducive to realizing the elastic effect that support can radially stretch.

Alternately, described tubular structure portion has network.As optional, the support unit of described network assumes diamond in shape.This structure is conducive to the elasticity that formation support radially stretches.Further, described tubular structure portion and described skirt hatch frame portion are formed by interconnective support unit.

Alternately, the described skirt hatch frame portion support connecting piece that comprises the many skirt opening skeletons from described tubular structure subordinate end to downward-extension and be connected between adjacent two skirt opening skeletons.As optional, skirt opening skeleton lower end is provided with overlay film lower end sewing hole.As optional, described support connecting piece is in " V " type.

Alternately, the diameter of the junction in described tubular structure portion and described skirt hatch frame portion is less than the diameter at all the other positions of support, makes the lateral surface of described supporting structure form in the junction in described tubular structure portion and described skirt hatch frame portion structure of caving in.

Alternately, the tubular structure portion of described support and skirt hatch frame portion have integrated formed structure.

Alternately, described support material is Nitinol.

Alternately, described support is formed through cut and heat treatment shaping by a NiTi pipe, and laser cutting machine cuts out the shape of valve bracket on thin-walled Nitinol pipe, then is shaped into predetermined shape by difform mold hot.Technique is simple, the support reliability that reproducible, cut global formation obtains and precision higher, reduce production cost and be easy to large-scale production.

Alternately, agnail is provided with in described support.Described agnail can thrust the tissue of valve periphery after cardiac valve is implanted to ad-hoc location, plays positioning action, is not easily shifted after the release of gained valve, can in blood stream pressure and washing away after long-lasting tolerance release.

Alternately, described agnail is by tubular structure portion to the extension of skirt hatch frame portion and to stent outer inclination, and after stitching overlay film, described agnail is exposed at valve outer surface.To be coordinated with skirt hatch frame portion by described agnail and realize antiskid function, reduce the damage to surrounding tissue.

Alternately, the angle between described agnail and rack outer surface is 10 ~ 80 degree.Adopt this angular range to be both convenient to agnail and thrust surrounding tissue smoothly, be conducive to again the quick and precisely release realizing valve.Further, described angle is 45 degree.

Alternately, described agnail is arranged at the one end near described skirt hatch frame portion in tubular structure portion.The agnail being arranged on this position just thrusts the position near lobe ring upon discharge, good antiskid effect and little to the damage of heart.

Alternately, described barbed ends is wedge shape or needle-like.Wedge shape or acicular texture is adopted to be convenient to thrust.Described wedge structure can be that described barbed ends thickness diminishes formation gradually, also can be that barbed ends width diminishes formation gradually.

Alternately, described agnail linearly type or " V " type or " U " type.Can according to the actual state flexible design of surrounding tissue.

Alternately, described support is provided with development site.By arranging development site, coordinating suitable shadowgraph technique to make operator can be clearly seen that the physical location of insertion type artificial cardiac valve when laying insertion type artificial cardiac valve, being conducive to accurate location when installing, improve the success rate of installing operation.As optional, described development site is positioned on described tubular structure portion outer wall.Further, described development site is positioned at lobe leaf minimum point corresponding position.

Alternately, described agnail is provided with development site.

Alternately, described conveying connector is provided with development site.

Alternately, described development site comprises development hole and the developing media that is filled in described development hole.

Alternately, described developing media is radiopaque metal medium.

Alternately, described developing media is bio-inert material.

Alternately, described developing media is one or more in platinum (Pt), platinumiridio (Pt/Ir), tantalum metal (Ta).

Alternately, described developing media is the development ball in the described development hole of press-in.

embodiment 2

A kind of insertion type artificial cardiac valve, comprise the elastic support that can radially stretch, overlay film and at least two pieces of lobe leaves, described overlay film is sewn on described rack inner wall or outer wall, described lobe leaf is arranged in the cavity of described support, along being sewn on described overlay film under lobe leaf, the mutual split of adjacent side of adjacent two pieces of lobe leaves, described side seams is closed on the bracket, described elastic support as shown in Figure 1 to Figure 3, supporting structure 6 is made up of the lattice support unit closed, support 6 comprises: conveying link 1, support unit 7, lobe leaf sewing hole 2, lobe leaf minimum point development hole 3, upper end sewing hole 4, lower end sewing hole 5, development ball 8, support 6 is formed through cut and heat treatment shaping by a NiTi pipe, laser cutting machine cuts out the original-shape of valve bracket on thin-walled Nitinol pipe, then predetermined shape is shaped into by difform mold hot, support 6 comprises two parts after having shaped, a part in tubular construction, another part is skirt hatch frame, two parts are interconnected by interconnective support unit 7, wherein skirt hatch frame section diameter is greater than the diameter of described tubular opening part, skirt hatch frame is implanted the postpone of heart mitral position and is positioned at the blood inlet that side, atrium is blood, tubular structure is positioned at the blood outlet that ventricle side is blood.Both are less than both ends open by mid portion diameter, thus the object be fixedly connected with heart mitral annulus is reached by the difference of physical form, described tubular structure internal diameter is between 20-32mm, and operation consent doctor selects the valve tubular structure of suitable diameter according to the size of patient's lobe ring.

Described upper end sewing hole and lower end sewing hole lay respectively at the end of tubular structure and skirt hatch frame, and its number is respectively 3-12, and for sewing up the overlay film of valve surface, preferred number is 6 further.

Figure 2 shows that the present invention carries the close-up schematic view of connection hole, conveying link 1 is positioned at tubular opening structure top end and can coordinates with induction system, for release valvular during operation process and recovery, when valve is loaded on conveyer device, the conveying connecting hole of tubular opening structure top end is needed to embed conveyer device top, the position that conveyer device is corresponding and shape size and conveying connecting hole cooperatively interact, then, in twitching, sheath makes epitheca be wrapped by valve again, also can be pushed away in loading outer tube by valve in skirt structure side by external force.

As optional, conveying link 1 is positioned at support tubular structure side, its number is 2-6, conveying link 1 is when valve implants induction system, pipe far-end in connecting hole and conveyer device is carried to be connected, in operation process, first the thin film of certain length is discharged, observe the placement location of valve in heart, if off-position and pre-determined bit are equipped with deviation, interior pipe racks just can be pulled to move support 6 from newly withdrawing interior pipe, under the extruding of wall within the outer tube, support 6 can draw in until got back to the state before release by epitheca parcel completely gradually, then reorientate again, release, so both can when first time, valve placement location be unsuccessful, timely adjustment, until valve to be released in best position.

Be lobe leaf sewing hole 2 below conveying connecting hole, comprise the circular hole of two same diameter sizes, its number is 4-12, lobe leaf 10 is sewn to one end of described tubular structure, it is positioned at the inwall of support, and lobe leaf 10 can adopt prior art and the seam method of putting to carry out, and makes it be fixed on support inner face.

Figure 3 shows that the present invention be pressed into development ball 8 after lobe leaf minimum point development hole 3 place close-up schematic view, lobe leaf minimum point development hole 3 is positioned on the support unit 7 of described support tubular structure side, its number is 2-6, preferably 4, the radiopaque metal ball of press-in in lobe leaf minimum point development hole 3, described lobe leaf minimum point development hole 3 is used to indicate the position of lobe leaf 10 in tubular structure, when indicating the position of lobe leaf 10 in heart in valve implant into body process and after implanting precalculated position, user discharges opportunity by the position judgment valve of development ball 8 in heart, valve surgery whether success and follow-up patient's health check-up time support whether be shifted, described development ball 8 is bio-inert material, its material can be platinum (Pt), platinumiridio (Pt/Ir), tantalum metal (Ta), further preferably platinum, preferred number is 4 further.

Figure 4 shows that the present invention sew up overlay film after front view, described overlay film 9 is sewn to the outer surface of support tubular structure and skirt structure, further described overlay film 9 is sewn to support 6 surface, the perivalvular leakage produced after preventing valve from implanting lobe ring, surface is sewed with one or more layers film, its material is PET, e-PTFE, pericardium material, and thickness is 0.05 ~ 0.2mm, further preferably 0.1mm.

Fig. 5 is the upward view after the present invention sews up valve, described lobe leaf 10 utilizes stitching thread to make to be fixed in described support tubular structure, and further described lobe leaf 10 can be biological tissue's (Cor Sus domestica bag, bovine pericardium, Cor Sus domestica lobe, Cor Bovis seu Bubali lobe), macromolecular material, tissue engineered heart valve.

Alternately, described lobe leaf comprises the rectangular portion of upper end and the curved portions of lower end, and the lower edge of described lobe leaf is arc.Adopt the lobe leaf of this shape to be convenient to coordinate described suture way, and the hemodynamic effect of gained valve is good.

embodiment 3

In the intervention-type heart valve described in embodiment 2, in described elastic support, increase barb structure, described agnail by tubular structure portion to skirt hatch frame portion extend and to stent outer tilt, as shown in Fig. 6 ~ 8.

Alternately, the angle between described agnail and rack outer surface is 10 ~ 80 degree, and further described angle is 45 degree.

Alternately, described agnail is arranged at the joint portion between row's network cells of bottom in tubular structure portion.

Alternately, described barbed ends is wedge shape or needle-like.

Alternately, described agnail linearly type or " V " type or " U " type.As shown in Figure 9.

Alternately, described agnail is provided with development site.As described in Figure 9.

Alternately, described development site comprises development hole and the developing media that is filled in described development hole.

Alternately, multiple described agnail is evenly distributed on described support periphery.

Insertion type artificial cardiac valve containing barb structure in this example with in embodiment 2 not containing agnail but compared with the identical Cardiac valve prosthesis of other structures, the stability after release and skidproof effect better.

The foregoing is only the preferred embodiments of the present invention, is only illustrative for the purpose of the present invention, and nonrestrictive; Those of ordinary skill in the art understand, and can carry out many changes in the spirit and scope that the present invention limits to it, amendment, and even equivalence is changed, but all will fall into protection scope of the present invention.

Claims (10)

1. an insertion type artificial cardiac valve, it is characterized in that, comprise elastic support, overlay film and at least two pieces of lobe leaves that can radially stretch, described overlay film is sewn on described rack inner wall or outer wall, described lobe leaf is arranged in the cavity of described support, along being sewn on described overlay film under lobe leaf, the mutual split of adjacent side of adjacent two pieces of lobe leaves, described side seams is closed on the bracket.

2. insertion type artificial cardiac valve according to claim 1, is characterized in that, the quantity of described lobe leaf is 3 pieces.

3. insertion type artificial cardiac valve according to claim 1, is characterized in that, described lobe leaf comprises the rectangular portion of upper end and the curved portions of lower end, and the lower edge of described lobe leaf is arc.

4. insertion type artificial cardiac valve according to claim 1, is characterized in that, the end of described supporting structure is provided with conveying link.

5. insertion type artificial cardiac valve according to claim 1, it is characterized in that, described support comprises tubular structure portion and skirt hatch frame portion, and the diameter in described skirt hatch frame portion is greater than the diameter of described tube, and described tubular structure portion is coaxially fixedly connected with skirt hatch frame portion.

6. insertion type artificial cardiac valve according to claim 5, it is characterized in that, also be provided with agnail in described support, described agnail to be extended to skirt hatch frame portion by tubular structure portion and tilts to stent outer, and it is exposed at valve outer surface to sew up described agnail after overlay film.

7. insertion type artificial cardiac valve according to claim 1, is characterized in that, described support is provided with development site.

8. insertion type artificial cardiac valve according to claim 7, is characterized in that, described development site comprises the development hole be arranged on support outer wall and the developing media be filled in described development hole.

9. the insertion type artificial cardiac valve according to claim 4 or 6, is characterized in that, described conveying link or described agnail are provided with development site.

10. a preparation method for insertion type artificial cardiac valve as claimed in claim 1, is characterized in that, comprises the following steps: (1) adopts cut and heat treatment shaping preparation; (2) overlay film is sewn onto on support; (3) lobe leaf is sewn onto in the cavity of support.