CN102961199A - Anti-displacement pulmonary valve stent - Google Patents

Anti-displacement pulmonary valve stent Download PDF

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Publication number
CN102961199A
CN102961199A CN2012105000418A CN201210500041A CN102961199A CN 102961199 A CN102961199 A CN 102961199A CN 2012105000418 A CN2012105000418 A CN 2012105000418A CN 201210500041 A CN201210500041 A CN 201210500041A CN 102961199 A CN102961199 A CN 102961199A
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Prior art keywords
valve
making
valve section
shifted
membrane support
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CN2012105000418A
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CN102961199B (en
Inventor
李毅斌
徐志云
孙建国
张鹏云
信朝华
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Jenscare Scientific Co Ltd
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Ningbo Jianshi Biological Science & Technology Co Ltd
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Abstract

The invention relates to an anti-displacement pulmonary valve stent which comprises a valve suture section (1) and an artificial valve (2), wherein the artificial valve (2) is connected with the valve suture section (1); and after the valve suture section (1) is released, the valve suture section (1) is located on an outflow tract of a right ventricle or a main pulmonary artery (10). The anti-displacement pulmonary valve stent further comprises a limiting mechanism (3), wherein a bottom end part of the limiting mechanism (3) is connected with a far end of the valve suture section (1); and after a top end part (31) of the limiting mechanism is released, the top end part is propped against an intersection (30) of the main pulmonary artery and a branch pulmonary artery. According to the anti-displacement pulmonary valve stent, the limiting mechanism is arranged at the far end of the pulmonary valve stent, and is propped against an inner wall of a blood vessel at the intersection of the main pulmonary artery and the branch pulmonary artery after the limiting mechanism is released, and the valve stent can be limited axially, so that the stability of the pulmonary valve stent is improved, and the displacement of the pulmonary valve stent is avoided.

Description

Prevent the valve of pulmonary trunk membrane support that is shifted
Technical field:
The invention belongs to medical instruments field, be specifically related to a kind of valve of pulmonary trunk membrane support of being shifted of preventing.
Background technology:
Percutaneous replacement of pulmonary valve (Percutaneous Pulmonary Valve Replacement, PPVR) refer to through the peripheral vein approach, to manually be with valve bracket to be implanted to the Pulmonary autograft place by conduit, replace having lost the valve of pulmonary trunk of function.In JIUYUE, 2000, Bonhoeffer etc. successfully are the patient of 12 years old right ventricular outflow-valve of pulmonary trunk Serious Stenosis of an example first, percutaneous at pulmonary artery position implantable artificial band valve bracket, has been started the beginning of PPVR by the femoral vein approach.To the end of the year 2008, the whole world has had the 600 routine patients of surpassing successfully to implement the PPVR art.
The subject matter that faces of PPVR comprises now: fixing, perivalvular leakage and the valve of valve bracket are released how to guarantee valvular function etc. in the process through conduit.The main pulmonary artery of expansion and right ventricular outflow make support insert rear the appearance easily and backflow and be shifted, and will cause patient to die suddenly in case right ventricle is fallen in the support displacement.The balloon expandable stent that generally uses now all can be in process of expansion easily to artificial valve's injury, and because Patients with Lung arterial blood tube wall is very thin, excessive radial support power also can cause the severe complications such as vascular tear.
Clinical effectiveness is told us at present, and a percutaneous intervention lung arterial support not yet occurring can thoroughly address the above problem, and the research staff constantly provides technical scheme and apparatus innovation, to improve patient's survival rate, improves patient's weather.
Patent US7025780 has described a pulmonary artery self-inflated valve bracket, and its artificial valve makes in the self-expandable stent stage casing, and support radial support power produces frictional force makes support be fixed in the target location.This valve bracket also is not suitable for main pulmonary artery and the right ventricular outflow of expansion, and support displacement risk occurs easily.
Patent US7470285 discloses a kind of band valve lung arterial support, and it is the little tubular expansile support broad in the middle in two, and its appearance profile can meet sinus of pulmonary trunk better, provides fixation for support on the structure.However, it does not still solve the problem of support displacement well.
Patent CN101057796 discloses a kind of band valve lung arterial support, it is the little tubular expansile braided support in large centre, two, its appearance profile can meet better and enlarged outflow tract of right ventricle, reduce support displacement risk, the relatively soft mesh grid blood vessel wall of fitting preferably, alleviate and backflow, and be not easy to cause vascular tear.
Propose a kind of compound support among the patent CN201110025943, it sews up or is bonded with the netted bare bracket of spherical in overlay film tubular scaffold bottom, in order to can be close to blood vessel wall after inserting it in tremulous pulse hole, prevents the overlay film frame displacement of cast part.
In sum, how to avoid the displacement of valve of pulmonary trunk membrane support and the solution problem of backflowing to become the primary study direction of many researcheres.
Summary of the invention:
The object of the invention is to improve and remedy the defective of prior art and propose a kind of valve of pulmonary trunk membrane support of being shifted of preventing that can effectively solve support displacement.The present invention is by arranging position-limit mechanism at the valve bracket far-end, the blood vessel of the intersection of conflict main pulmonary artery and branch after it discharges, so that valve bracket is able to axial limiting, significantly improved the steadiness of valve of pulmonary trunk membrane support, avoid the displacement of valve of pulmonary trunk membrane support.
To achieve these goals, the present invention adopts following concrete technical scheme:
A kind of valve of pulmonary trunk membrane support of being shifted of preventing, comprise the valve section of making and artificial valve, described artificial valve is connected on the described valve section of making, the described valve section of making is positioned on outflow tract of right ventricle or the main pulmonary artery when discharging, it is characterized in that, described valve bracket also comprises position-limit mechanism, the bottom part of described position-limit mechanism is connected with the far-end of the described valve section of making, the intersection of conflict main pulmonary artery and branch after the head portion of described position-limit mechanism discharges is to provide the axial limiting function.
Purpose of the present invention can also further realize by following technical scheme:
Preferably, the head portion of described position-limit mechanism is petal-like self-expandable stent; It perhaps is the netted self-expandable stent of bowl-type; Perhaps be the sacculus of inflation or topping up, be provided with the valve of inflation or topping up on the described sacculus.
Preferred, described petal-like self-expandable stent is comprised of multi-disc lobe leaf, described lobe leaf is shaped as rhombus or triangle, the integrant petal-like self-expandable stent of mode such as tie up to turn round around, seam between the skeleton of adjacent lobe leaf, the angle between the line at the top of described lobe leaf and petal center is between 100~160 °.
Preferred, in the described lobe leaf many bracing pieces are arranged, the benefit of design is the support force that provides enough like this, strengthens position-limiting action.
Preferably, the bottom part of described position-limit mechanism is many connecting elements, the far-end of described connecting elements is connected on the head portion of described position-limit mechanism, and the near-end of described connecting elements is connected with the valve section of making by modes such as welding, stitching, grapplings.
Preferred, described connecting elements is the postponing of skeleton of the lobe leaf of described petal-shaped support.
Preferably, the whole shape-memory material pipe one engraving that adopts of described position-limit mechanism and the valve section of making is made, or adopt shape-memory material silk integrated woven to form, described shape-memory material is preferably niti-shaped memorial alloy, the all or part of overlay film of the outer surface of the described valve section of making, the material of described position-limit mechanism and the described valve section of making is shape-memory material or elastomeric material, and the material of described film comprises politef, polyethylene, polypropylene, polyurethane, silica gel.
Preferably, the external circumferential of the described valve section of making be provided with the cryptomere member, described cryptomere member is in the outside of the described valve section of making continuous distribution or evenly spaced apart.
Preferably, described cryptomere member is connected with the valve section of making by modes such as stitching, stickup, welding.
Preferably, described cryptomere member is formed by the shape-memory alloy wire braiding, and perhaps described cryptomere member is inflation or topping up sacculus, and perhaps described cryptomere member is the inner hollow member that is filled with water uptake expansion material.Preferred, described water uptake expansion material is acrylic acid, propylene, acrylic amide, polyvinyl alcohol or cellulose family etc.
Preferably, the described valve section of making or cryptomere member arrange respectively or are provided with simultaneously a plurality of barbs, and an end of described barb is connected on the described valve section of making or the cryptomere member, and the other end outwards opens, and the angle of opening is 5~45 °.Barb discharges to thrust and plays the fixing effect of anticreep in the blood vessel wall.
Preferably, described artificial valve adopts three-lobed structure, is made by animal tissue or high molecular polymer, and described animal tissue is Cor Sus domestica bag, bovine pericardium, Cor Equi bag etc., and described high molecular polymer is politef, polyurethane, silica gel.
Compare with prior art, the invention has the advantages that:
1, the present invention is by arranging position-limit mechanism at the valve bracket far-end, the blood vessel of the intersection of conflict main pulmonary artery and branch was so that valve bracket is able to axial limiting after it discharged, can significantly improve the valve bracket steadiness, avoid the displacement of valve of pulmonary trunk membrane support.
2, the present invention can provide a supporting role when support discharges at the cryptomere member that the valve section of making periphery adopts, avoid the valve periphery to backflow and further avoid support to come off, and the shape of guaranteeing the artificial valve on the valve section of making do not change with peripheral blood vessel profile variations, makes it to open or close the maintenance ideal form.
3, the material of the valve section of making of the present invention and position limiting structure all adopts marmem, and the release mode of this self-inflated can mildly provide support power to blood vessel wall, avoids vascular tear.
4, the present invention effectively reduces perivalvular leakage by at all or part of overlay film of the outer surface of the valve section of making.
5, the valve section of making among the present invention or cryptomere member arrange respectively, or are provided with simultaneously a plurality of barbs, and barb discharges to thrust and plays anticreep and fixing effect in the blood vessel wall.
Description of drawings:
Fig. 1 is a kind of sketch map that prevents the valve of pulmonary trunk membrane support that is shifted of the present invention.
Fig. 2 a and 2b are a kind of sketch map preferred embodiment of the head portion of position-limit mechanism of the present invention.
Fig. 3 a-e is the sketch map of petal-shaped support of the present invention.
Fig. 4 a and 4b are lobe leaf preferred embodiment a kind of of petal-shaped support of the present invention.
Fig. 5 a and 5b are lobe leaf preferred embodiment a kind of of petal-shaped support of the present invention.
Fig. 6 a-d is the bottom part of position-limit mechanism of the present invention and the sketch map of the valve section of making connected mode.
Fig. 7 a is the sketch map of the valve section of making of the present invention.
Fig. 7 b is the carved pattern sketch map of the valve section of making of the present invention.
Fig. 7 c is the overlay film sketch map of the valve section of making of the present invention.
Fig. 8 is another preferred embodiment sketch map of the present invention.
Fig. 9 is another preferred embodiment sketch map of the present invention.
Figure 10 a-c is the preferred embodiment sketch map of cryptomere member of the present invention.
Figure 11 is a kind of carved pattern sketch map preferred embodiment of the present invention.
Figure 12 is another preferred embodiment sketch map of the present invention.
The specific embodiment:
For making purpose of the present invention, technical scheme and advantage clearer, referring to the accompanying drawing embodiment that develops simultaneously, the present invention is described in more detail.
Near-end of the present invention refers to the end near the outflow tract of right ventricle mouth, and described far-end refers to the end away from the outflow tract of right ventricle mouth.
Specific embodiment one:
As shown in Figure 1, a kind of valve of pulmonary trunk membrane support of being shifted of preventing, comprise the valve section of making 1 and artificial valve 2, described artificial valve 2 is connected on the described valve section of making 1, the described valve section of making 1 is positioned on outflow tract of right ventricle or the main pulmonary artery 10 when discharging, described valve bracket also comprises position-limit mechanism 3, the bottom part 32 of described position-limit mechanism 3 is connected with the far-end of the described valve section of making 1, the intersection 30 of conflict main pulmonary artery and branch provided the axial limiting function after the head portion 31 of described position-limit mechanism 3 discharged.
The head portion 31 of described position-limit mechanism is self-expandable stent, and material is shape-memory material or elastomeric material, more preferably niti-shaped memorial alloy.As preferred embodiment a kind of, shown in Fig. 2 a and 2b, the head portion 31 of described position-limit mechanism is petal-like self-expandable stent 4.Described petal-like self-expandable stent 4 is comprised of multi-disc lobe leaf 41, such as two leaves, SANYE, four leaves and seven leaves etc., shown in Fig. 3 a-e.The top of described lobe leaf 41 (p for example 1, p 2) and petal center (o) between the angle α of line between 100~160 °, such being designed with is beneficial to described petal-like self-expandable stent 4 and contacts blood vessel submissively, avoids the piercing blood vessel wall, and the stress equilibrium of described position-limit mechanism 3 is distributed.Preferred, in the described lobe leaf 41 many bracing pieces 42 are arranged, as shown in Figs. 4a and 4b, the benefit of design is the support force that provides enough like this, strengthens position-limiting action.Preferably, described lobe leaf 41 is shaped as rhombus or triangle, the integrant petal-like self-expandable stent 4 of mode such as ties up to turn round around, seam between the skeleton of adjacent lobe leaf 41, to improve the axial support power of described position-limit mechanism 3, shown in Fig. 5 a and 5b.The bottom part 32 of described position-limit mechanism is connecting elements 5, the far-end of described connecting elements 5 is connected on the head portion 31 of described position-limit mechanism, near-end is connected with the valve section of making 1 by welding (solder joint 53), the modes such as (suture 54), grappling (rivet 55) of sewing up, shown in Fig. 6 a-d.Preferably, the postponing for the skeleton of the lobe leaf 41 of described petal-shaped support 4 of described connecting elements 5.Preferred, described connecting elements 5 is many, and the benefit of design is to make the described valve section of making 1 suffered blood flow impact force to be delivered to better on the head portion 31 of described position-limit mechanism like this, improves the stability of valve bracket.
The described valve section of making 1 is self-expandable stent, and material is shape-memory material or elastomeric material, is preferably niti-shaped memorial alloy.The described valve section of making 1 adopts shape-memory material pipe one engraving to make, and is preferably niti-shaped memorial alloy pipe one engraving and makes, shown in Fig. 7 a and 7b.
As preferred embodiment a kind of, all or part of overlay film 11 of the outer surface of the described valve section of making 1 is shown in Fig. 7 c.The material of described film 11 comprises politef, polyethylene, polypropylene, polyurethane, silica gel etc., and overlay film can effectively prevent perivalvular leakage.
Specific embodiment two:
A kind of valve of pulmonary trunk membrane support of being shifted of preventing, comprise the valve section of making 1 and artificial valve 2, described artificial valve 2 is connected on the described valve section of making 1, the described valve section of making 1 is positioned on outflow tract of right ventricle or the main pulmonary artery 10 when discharging, described valve bracket also comprises position-limit mechanism 3, the bottom part 32 of described position-limit mechanism 3 is connected with the far-end of the described valve section of making 1, the intersection 30 of conflict main pulmonary artery and branch provided the axial limiting function after the head portion 31 of described position-limit mechanism 3 discharged.
The head portion 31 of described position-limit mechanism is self-expandable stent, and material is shape-memory material or elastomeric material, is preferably niti-shaped memorial alloy.As preferred embodiment a kind of, as shown in Figure 8, described self-expandable stent is bowl-type network 6, the target blood inwall so that it is mildly conflicted.
The bottom part 32 of described position-limit mechanism is connecting elements 5, and the far-end of described connecting elements 5 is connected on the head portion 31 of described position-limit mechanism, and near-end is connected with the valve section of making 1 by modes such as welding, stitching, grapplings.Preferred, described connecting elements 5 is many, and the benefit of design is to make the described valve section of making 1 suffered blood flow impact force to be delivered to better on the head portion 31 of described position-limit mechanism like this, improves the stability of valve bracket.
The described valve section of making 1 is self-expandable stent, and material is shape-memory material or elastomeric material, is preferably niti-shaped memorial alloy.Preferred, the described valve section of making 1 adopts shape-memory material pipe one engraving to make, and is preferably niti-shaped memorial alloy pipe one engraving and makes.
The all or part of overlay film 11 of the outer surface of the described valve section of making 1.The material of described film 11 comprises politef, polyethylene, polypropylene, polyurethane, silica gel etc., and overlay film can effectively prevent perivalvular leakage.
Be provided with cryptomere member 8 to the external circumferential of the described valve section of making, shown in Figure 10 a.This cryptomere member 8 can provide a supporting role when support discharges, avoid the valve periphery to backflow and further avoid support to come off, and the shape of guaranteeing the artificial valve 2 on the valve section of making 1 do not change with peripheral blood vessel profile variations, makes it to open or close the maintenance ideal form.Preferably, described cryptomere member 8 is in the external circumferential continuous distribution of the valve section of making 1 or evenly spaced apart.Preferably, described cryptomere member 8 is connected with the valve section of making 1 by modes such as stitching, stickup, welding.Described cryptomere member 8 is formed by shape-memory alloy wire 81 braidings.
As preferred embodiment a kind of, described cryptomere member 8 shown in Figure 10 b, is provided with the valve 82 of inflation or topping up for inflation or topping up sacculus on the sacculus.The described valve section of making 5 plays a supportive role inflation by inflation or topping up after the target location discharges.
As another preferred embodiment, described cryptomere member 8 is for the inner hollow member that is filled with water uptake expansion material 83, shown in Figure 10 c.Described water uptake expansion material is acrylic acid, propylene or acrylic amide; Polyvinyl alcohol; Cellulose family etc.The described valve section of making 1 after the target location discharges, the moisture in described water uptake expansion material 83 absorbing bloods and expanding, speed of expansion is controlled, can mildly support the valve section of making 1, avoids too fast expansion to cause vascular tear.
Described artificial valve 2 adopts three-lobed structure, is made by animal tissue or high molecular polymer.Preferred described animal tissue is Cor Sus domestica bag, bovine pericardium, Cor Equi bag etc., and described high molecular polymer is politef, polyurethane, silica gel.
Specific embodiment three:
The difference of present embodiment and specific embodiment two is, the head portion 31 of described position-limit mechanism is inflation or topping up sacculus 7, described sacculus is flat, to avoid blocking the pulmonary artery branch blood vessel after the collision, as shown in Figure 9, be provided with the valve 72 of inflation or topping up on the described sacculus 7, make sacculus 7 expanded buffer limit effects by inflation or topping up, avoid the top injured blood vessel wall of position-limit mechanism 3.In addition, described connecting elements 5 postponing for the skeleton of the lobe leaf 41 of described petal-shaped support 4.
Specific embodiment four:
The difference of present embodiment and specific embodiment two is that described position-limit mechanism 3 and the valve section of making 1 adopt shape-memory material pipe one engraving to make, and are more preferably niti-shaped memorial alloy pipe one engraving and make, as shown in figure 11.As preferred embodiment a kind of, described position-limit mechanism 3 and the valve section of making 1 adopt shape-memory material silk integrated woven to form (not shown).
Specific embodiment five:
Present embodiment is that from the different of specific embodiment two the described valve section of making 1 or cryptomere member 8 arrange respectively, or is provided with simultaneously a plurality of barbs 9, as shown in figure 12; Described barb 9 one ends are connected on the described valve section of making 1 or the cryptomere member 8, and the other end outwards opens, and the angle of opening is 5~45 °.Barb 9 discharges to thrust and plays anticreep and fixing effect in the blood vessel wall.
Should be noted that at last; the above only is preferred embodiment of the present invention; not in order to limiting the present invention, all any modifications of doing within the spirit and principles in the present invention, be equal to and replace and improvement etc., all should be included within protection scope of the present invention.

Claims (10)

1. valve of pulmonary trunk membrane support that prevents from being shifted, comprise the valve section of making and artificial valve, described artificial valve is connected on the described valve section of making, the described valve section of making is positioned on outflow tract of right ventricle or the main pulmonary artery after discharging, it is characterized in that, described valve of pulmonary trunk membrane support also comprises position-limit mechanism, the bottom part of described position-limit mechanism is connected with the far-end of the described valve section of making, the intersection of conflict main pulmonary artery and branch after the head portion of described position-limit mechanism discharges is to provide the axial limiting function.
2. the valve of pulmonary trunk membrane support that is shifted of preventing according to claim 1 is characterized in that the head portion of described position-limit mechanism is petal-like self-expandable stent; It perhaps is the netted self-expandable stent of bowl-type; Perhaps be the sacculus of inflation or topping up, be provided with the valve of inflation or topping up on the described sacculus.
3. the valve of pulmonary trunk membrane support that is shifted of preventing according to claim 2, it is characterized in that, described petal-like self-expandable stent is comprised of multi-disc lobe leaf, to turn round around, the integrant petal-like self-expandable stent of mode tied up of seam, the angle between the line at the top of described lobe leaf and petal center is between 100~160 ° between the skeleton of adjacent lobe leaf.
4. the valve of pulmonary trunk membrane support that is shifted of preventing according to claim 3 is characterized in that in the described lobe leaf many bracing pieces being arranged.
5. the valve of pulmonary trunk membrane support that is shifted of preventing according to claim 1, it is characterized in that, the bottom part of described position-limit mechanism is many connecting elements, the far-end of described connecting elements is connected on the head portion of described position-limit mechanism, and the near-end of described connecting elements is connected with the described valve section of making.
6. the valve of pulmonary trunk membrane support that is shifted of preventing according to claim 5 is characterized in that, described connecting elements is the postponing of lobe leaf of described petal-shaped support.
7. according to the described valve of pulmonary trunk membrane support that is shifted of preventing of aforementioned each claim, it is characterized in that, the described valve section of making is self-expandable stent, the whole shape-memory material pipe one engraving that adopts of described position-limit mechanism and the valve section of making makes or adopts shape-memory material silk integrated woven to form, all or part of overlay film of the outer surface of the described valve section of making.
8. the valve of pulmonary trunk membrane support that is shifted of preventing according to claim 7, it is characterized in that, the described valve section of making external circumferential be provided with the cryptomere member, described cryptomere member is in the outside of the described valve section of making continuous distribution or evenly spaced apart.
9. the valve of pulmonary trunk membrane support that is shifted of preventing according to claim 8, it is characterized in that, described cryptomere member is formed by the shape-memory alloy wire braiding, perhaps described cryptomere member is inflation or topping up sacculus, and perhaps described cryptomere member is the inner hollow member that is filled with water uptake expansion material.
10. the valve of pulmonary trunk membrane support that is shifted of preventing according to claim 1, it is characterized in that, the described valve section of making or cryptomere member arrange respectively or are provided with simultaneously a plurality of barbs, one end of described barb is connected on the described valve section of making or the cryptomere member, the other end outwards opens, and the angle of opening is 5~45 °.
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CN103598939A (en) * 2013-10-17 2014-02-26 杭州启明医疗器械有限公司 Safety improved pulmonary artery stent and pulmonary artery valve replacement device
CN104720936A (en) * 2015-03-26 2015-06-24 杭州启明医疗器械有限公司 Valve stent safe to use and valve replacement device with same
CN105455924A (en) * 2014-09-26 2016-04-06 Nvt股份公司 Implantable device for treating mitral valve regurgitation
CN110801312A (en) * 2019-10-21 2020-02-18 复旦大学附属中山医院 Intervene valve release stop device

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CN102639179A (en) * 2009-12-04 2012-08-15 爱德华兹生命科学公司 Prosthetic valve for replacing mitral valve
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US20040236411A1 (en) * 2001-07-19 2004-11-25 The Cleveland Clinic Foundation Prosthetic cardiac valve and method for making same
CN101184453A (en) * 2005-04-21 2008-05-21 爱德华兹生命科学股份公司 A blood flow controlling apparatus
US20070244544A1 (en) * 2006-04-14 2007-10-18 Medtronic Vascular, Inc. Seal for Enhanced Stented Valve Fixation
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CN103598939A (en) * 2013-10-17 2014-02-26 杭州启明医疗器械有限公司 Safety improved pulmonary artery stent and pulmonary artery valve replacement device
CN105455924A (en) * 2014-09-26 2016-04-06 Nvt股份公司 Implantable device for treating mitral valve regurgitation
CN104720936A (en) * 2015-03-26 2015-06-24 杭州启明医疗器械有限公司 Valve stent safe to use and valve replacement device with same
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CN110801312A (en) * 2019-10-21 2020-02-18 复旦大学附属中山医院 Intervene valve release stop device

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