CN102961199B - Prevent the valve of pulmonary trunk membrane support be shifted - Google Patents
Prevent the valve of pulmonary trunk membrane support be shifted Download PDFInfo
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- CN102961199B CN102961199B CN201210500041.8A CN201210500041A CN102961199B CN 102961199 B CN102961199 B CN 102961199B CN 201210500041 A CN201210500041 A CN 201210500041A CN 102961199 B CN102961199 B CN 102961199B
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Abstract
The present invention relates to a kind of valve of pulmonary trunk membrane support preventing being shifted, comprise the valve section of making (1) and artificial valve (2), described artificial valve (2) is connected in the described valve section of making (1), be positioned on outflow tract of right ventricle or main pulmonary artery (10) after the described valve section of making (1) release, the described valve of pulmonary trunk membrane support be shifted that prevents also comprises position-limit mechanism (3), the bottom part 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 after tip portion (31) release of described position-limit mechanism.The present invention is provided with position-limit mechanism at cusps of pulmonary valve rack far end, after its release, the blood vessel of the intersection of conflict main pulmonary artery and branch, makes valve bracket be able to axial limiting, therefore, significantly improve the steadiness of valve of pulmonary trunk membrane support, avoid cusps of pulmonary valve stent migration.
Description
Technical field:
The invention belongs to medical instruments field, be specifically related to a kind of valve of pulmonary trunk membrane support preventing being shifted.
Background technology:
Percutaneous pulmonary valved prosthesis art (Percutaneous Pulmonary Valve Replacement, PPVR) refer to through peripheral vein approach, being implanted to Pulmonary autograft place by conduit by being manually with valve bracket, replacing the valve of pulmonary trunk having lost function.In JIUYUE, 2000, Bonhoeffer etc. are successfully the patient of an example 12 years old right ventricular outflow-valve of pulmonary trunk Serious Stenosis first, and percutaneous, by femoral vein approach, at pulmonary artery position implantable artificial band valve bracket, has started the beginning of PPVR.To the end of the year 2008, the whole world has had and has successfully implemented PPVR art more than 600 routine patients.
The subject matter that PPVR faces now comprises: fixing, perivalvular leakage and the valve of valve bracket are released in process how to ensure valvular function etc. through conduit.The main pulmonary artery of expansion and right ventricular outflow make support insert rear easily appearance to backflow and be shifted, patient will be caused to die suddenly once stent migration falls into right ventricle.The balloon expandable stent generally used now all easily can cause damage to artificial valve in process of expansion, and due to individual with pulmonary's blood vessel wall very thin, excessive radial support power also can cause the severe complications such as vascular tear.
Current clinical effectiveness tells us, and not yet occur that a percutaneous is got involved lung arterial support and can thoroughly be solved the problem, research staff constantly provides technical scheme and apparatus innovation, to improve patient's survival rate, improves minimal invasive treatment's situation.
Patent US7025780 describes a pulmonary artery self-inflated valve bracket, and its artificial valve makes in self-expandable stent stage casing, and support radial support power produces frictional force makes support be fixed on target location.This valve bracket is not also suitable for main pulmonary artery and the right ventricular outflow of expansion, easily stent migration risk occurs.
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, for support provides fixation structure.However, it does not still solve the problem of stent migration 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 expands outflow tract of right ventricle, reduce stent migration risk, the mesh grid of flexible relative can be fitted blood vessel wall preferably, alleviate and backflow, and be not easy to cause vascular tear.
Propose a kind of compound support in patent CN201110025943, it sews up or is bonded with the netted bare bracket of spherical bottom overlay film tubular scaffold, can be close to blood vessel wall to insert after in tremulous pulse hole, prevents the overlay film frame of cast part to be shifted.
In sum, how to avoid cusps of pulmonary valve stent migration and solve the primary study direction that reflux problem becomes many researcheres.
Summary of the invention:
The object of the invention is to improvement and make up the defect of prior art and propose a kind of valve of pulmonary trunk membrane support preventing being shifted that effectively can solve stent migration.The present invention is by arranging position-limit mechanism at valve bracket far-end, the blood vessel of the intersection of conflict main pulmonary artery and branch after its release, make valve bracket be able to axial limiting, significantly improve the steadiness of valve of pulmonary trunk membrane support, avoid cusps of pulmonary valve stent migration.
To achieve these goals, the present invention adopts following concrete technical scheme:
A kind of valve of pulmonary trunk membrane support preventing being shifted, comprise the valve section of making and artificial valve, described artificial valve is connected in the described valve section of making, the described valve section of making is positioned on outflow tract of right ventricle or 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 tip portion release of described position-limit mechanism, to provide axial limiting function.
Object of the present invention can also be realized further by following technical scheme:
Preferably, the tip portion of described position-limit mechanism is petal-like self-expandable stent; Or be the netted self-expandable stent of bowl-type; Or be the sacculus of inflation or topping up, described sacculus be provided with the valve of inflation or topping up.
Preferred, described petal-like self-expandable stent is made up of multi-disc lobe leaf, the leaf shape of described lobe is rhombus or triangle, the integrant petal-like self-expandable stent of mode such as to tie up to turn round around, seam between the skeleton of adjacent lobe leaf, the angle between the top of described lobe leaf and the line at petal center is between 100 ~ 160 °.
Preferred, have many bracing pieces in described lobe leaf, the benefit of design is like this to provide enough support forces, strengthening 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 in the tip portion of described position-limit mechanism, being connected with the valve section of making proximally by modes such as welding, stitching, grapplings of described connecting elements.
Preferred, described connecting elements is postponing of the skeleton of the lobe leaf of described petal-shaped support.
Preferably, described position-limit mechanism and the valve section of making entirety adopt shape-memory material pipe one engraving to make, 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 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 described valve section of making external circumferential be provided with cryptomere component, described cryptomere component is in the outside continuous distribution of the described valve section of making or uniform intervals distribution.
Preferably, described cryptomere component is connected with the valve section of making by modes such as stitching, stickup, welding.
Preferably, described cryptomere component is woven by shape-memory alloy wire and forms, or described cryptomere component is inflation or topping up sacculus, or described cryptomere component is the hollow member that inside 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 component arrange respectively or are provided with multiple barb simultaneously, and one end of described barb is connected on the described valve section of making or cryptomere component, and the other end outwards opens, and the angle of opening is 5 ~ 45 °.Barb release is thrust in blood vessel wall and is played the fixing effect of anticreep.
Preferably, described artificial valve adopts three-lobed structure, is made up of 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.
Compared with the existing technology, the invention has the advantages that:
1, the present invention is by arranging position-limit mechanism at valve bracket far-end, after its release, the blood vessel of the intersection of conflict main pulmonary artery and branch makes valve bracket be able to axial limiting, valve bracket steadiness can be significantly improved, avoid cusps of pulmonary valve stent migration.
2, the cryptomere component that the present invention adopts at the valve section of making periphery can provide a supporting role when support discharges, avoid valve periphery to backflow and avoid support to come off further, and guarantee that the shape of the artificial valve in the valve section of making does not change with periphery blood vessel profile variations, make it to open or close to keep 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 mildly can provide support power to blood vessel wall, avoids vascular tear.
4, the present invention is by all or part of overlay film of the outer surface of the valve section of making, and effectively reduces perivalvular leakage.
5, the valve section of making in the present invention or cryptomere component are arranged respectively, or are provided with multiple barb simultaneously, and barb release is thrust in blood vessel wall and played anticreep and fixing effect.
Accompanying drawing illustrates:
Fig. 1 is a kind of schematic diagram preventing the valve of pulmonary trunk membrane support be shifted of the present invention.
Fig. 2 a and 2b is a kind of schematic diagram preferred embodiment of the tip portion of position-limit mechanism of the present invention.
Fig. 3 a-e is the schematic diagram of petal-shaped support of the present invention.
Fig. 4 a and 4b be the one of the lobe leaf of petal-shaped support of the present invention preferred embodiment.
Fig. 5 a and 5b be the one of the lobe leaf of petal-shaped support of the present invention preferred embodiment.
Fig. 6 a-d is the bottom part of position-limit mechanism of the present invention and the schematic diagram of the valve section of making connected mode.
Fig. 7 a is the schematic diagram of the valve section of making of the present invention.
Fig. 7 b is the carved pattern schematic diagram of the valve section of making of the present invention.
Fig. 7 c is the overlay film schematic diagram of the valve section of making of the present invention.
Fig. 8 is another preferred embodiment schematic diagram of the present invention.
Fig. 9 is another preferred embodiment schematic diagram of the present invention.
Figure 10 a-c is the preferred embodiment schematic diagram of cryptomere component of the present invention.
Figure 11 is a kind of carved pattern schematic diagram preferred embodiment of the present invention.
Figure 12 is another preferred embodiment schematic diagram of the present invention.
Detailed description of the invention:
For making object of the present invention, technical scheme and advantage clearly understand, to develop simultaneously embodiment referring to accompanying drawing, the present invention is described in more detail.
Near-end of the present invention refers to the one end close to outflow tract of right ventricle mouth, and described far-end refers to the one end away from outflow tract of right ventricle mouth.
Specific embodiment one:
As shown in Figure 1, a kind of valve of pulmonary trunk membrane support preventing being shifted, comprise the valve section of making 1 and artificial valve 2, described artificial valve 2 is connected in the described valve section of making 1, the described valve section of making 1 is positioned on outflow tract of right ventricle or 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 tip portion 31 of described position-limit mechanism 3 discharges the intersection 30 of rear conflict main pulmonary artery and branch, provides axial limiting function.
The tip portion 31 of described position-limit mechanism is self-expandable stent, and material is shape-memory material or elastomeric material, is more preferably niti-shaped memorial alloy.As one preferred embodiment, as shown in figures 2 a and 2b, the tip portion 31 of described position-limit mechanism is petal-like self-expandable stent 4.Described petal-like self-expandable stent 4 is made up of multi-disc lobe leaf 41, as two leaves, SANYE, four leaves and seven leaves etc., as shown in Fig. 3 a-e.Top (the such as p of described lobe leaf 41
1, p
2) and petal center (o) between the angle α of line between 100 ~ 160 °, being designed with like this is beneficial to described petal-like self-expandable stent 4 and compliantly contacts blood vessel, avoid piercing blood vessel wall, the stress equilibrium of described position-limit mechanism 3 is distributed.Preferred, have many bracing pieces 42 in described lobe leaf 41, as shown in Figs. 4a and 4b, the benefit of design is like this to provide enough support forces, strengthening position-limiting action.Preferably, described lobe leaf 41 shape is rhombus or triangle, the integrant petal-like self-expandable stent 4 of mode such as to tie up, to improve the axial support power of described position-limit mechanism 3, as shown in figure 5a and 5b between the skeleton of adjacent lobe leaf 41 to turn round around, seam.The bottom part 32 of described position-limit mechanism is connecting elements 5, the far-end of described connecting elements 5 is connected in the tip portion 31 of described position-limit mechanism, be connected with the valve section of making 1, as shown in Fig. 6 a-d proximally by welding (solder joint 53), the mode such as (suture 54), grappling (rivet 55) of sewing up.Preferably, postponing of the skeleton of the lobe leaf 41 for described petal-shaped support 4 of described connecting elements 5.Preferred, described connecting elements 5 is many, and the benefit of design is like this to make the described blood flow impact force suffered by the valve section of making 1 be delivered in the tip portion 31 of described position-limit mechanism better, 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, as illustrated in figs. 7 a and 7b.
As one preferred embodiment, all or part of overlay film 11 of outer surface of the described valve section of making 1, as shown in Figure 7 c.The material of described film 11 comprises politef, polyethylene, polypropylene, polyurethane, silica gel etc., and overlay film effectively can prevent perivalvular leakage.
Specific embodiment two:
A kind of valve of pulmonary trunk membrane support preventing being shifted, comprise the valve section of making 1 and artificial valve 2, described artificial valve 2 is connected in the described valve section of making 1, the described valve section of making 1 is positioned at when discharging on outflow tract of right ventricle or main pulmonary artery 10, 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 tip portion 31 of described position-limit mechanism 3 discharges the intersection 30 of rear conflict main pulmonary artery and branch, provides axial limiting function.
The tip 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 one preferred embodiment, as shown in Figure 8, described self-expandable stent is bowl-type network 6, so that its mildly conflict target blood inwall.
The bottom part 32 of described position-limit mechanism is connecting elements 5, and the far-end of described connecting elements 5 is connected in the tip portion 31 of described position-limit mechanism, is connected with the valve section of making 1 proximally by modes such as welding, stitching, grapplings.Preferred, described connecting elements 5 is many, and the benefit of design is like this to make the described blood flow impact force suffered by the valve section of making 1 be delivered in the tip portion 31 of described position-limit mechanism better, 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 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 effectively can prevent perivalvular leakage.
Be provided with cryptomere component 8 to the external circumferential of the described valve section of making, as shown in Figure 10 a.This cryptomere component 8 can provide a supporting role when support discharges, avoid valve periphery to backflow and avoid support to come off further, and the shape of the artificial valve 2 guaranteed in the valve section of making 1 does not change with periphery blood vessel profile variations, make it to open or close to keep ideal form.Preferably, described cryptomere component 8 is in the external circumferential continuous distribution of the valve section of making 1 or uniform intervals distribution.Preferably, described cryptomere component 8 is connected with the valve section of making 1 by modes such as stitching, stickup, welding.Described cryptomere component 8 is woven by shape-memory alloy wire 81 and forms.
As one preferred embodiment, described cryptomere component 8 is inflation or topping up sacculus, as shown in fig. lob, sacculus is provided with the valve 82 of inflation or topping up.The described valve section of making 5, after the release of target location, makes inflation play a supportive role by inflation or topping up.
As another preferred embodiment, described cryptomere component 8 is the inner hollow member being filled with water uptake expansion material 83, as shown in figure l oc.Described water uptake expansion material is acrylic acid, propylene or acrylic amide; Polyvinyl alcohol; Cellulose family etc.The described valve section of making 1 is after the release of target location, and the moisture in described water uptake expansion material 83 absorbing blood and expanding, speed of expansion is controlled, mildly can 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 up of 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 the present embodiment and specific embodiment two is, the tip portion 31 of described position-limit mechanism is inflation or topping up sacculus 7, described sacculus is flat, to block pulmonary artery branch blood vessel after collision free, as shown in Figure 9, described sacculus 7 is provided with the valve 72 of inflation or topping up, makes the expanded buffer limit effect of sacculus 7 by inflation or topping up, avoid the top injured blood vessel wall of position-limit mechanism 3.In addition, described connecting elements 5 is postponing of the skeleton of the lobe leaf 41 of described petal-shaped support 4.
Specific embodiment four:
The difference of the present embodiment and specific embodiment two is, described position-limit mechanism 3 and the valve section of making 1 adopt shape-memory material pipe one engraving to make, and is more preferably niti-shaped memorial alloy pipe one engraving and makes, as shown in figure 11.As one preferred embodiment, 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:
The present embodiment is from the different of specific embodiment two, and the described valve section of making 1 or cryptomere component 8 are arranged respectively, or is provided with multiple barb 9 simultaneously, as shown in figure 12; Described barb 9 one end is connected on the described valve section of making 1 or cryptomere component 8, and the other end outwards opens, and the angle of opening is 5 ~ 45 °.Barb 9 release is thrust in blood vessel wall and is played anticreep and fixing effect.
Finally should be noted that; the foregoing is only preferred embodiment of the present invention; not in order to limit the present invention, all any amendments done within the spirit and principles in the present invention, equivalent replacement and improvement etc., all should be included within protection scope of the present invention.
Claims (8)
1. the valve of pulmonary trunk membrane support preventing from being shifted, comprise the valve section of making and artificial valve, described artificial valve is connected in the described valve section of making, be positioned on outflow tract of right ventricle or main pulmonary artery after the described valve section of making release, it is characterized in that, the described valve section of making is the self-expandable stent structure that two ends diameter is greater than the tubular of mid diameter, 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 tip portion of described position-limit mechanism is petal-like self-expandable stent, described petal-like self-expandable stent is made up of multi-disc lobe leaf, between the skeleton of adjacent lobe leaf with turn round around, stitch the integrant petal-like self-expandable stent of mode tied up, many bracing pieces are had in described lobe leaf, the intersection of conflict main pulmonary artery and branch after the tip portion release of described position-limit mechanism, to provide axial limiting function.
2. the valve of pulmonary trunk membrane support preventing being shifted according to claim 1, it is characterized in that, the angle between the top of described lobe leaf and the line at petal center is between 100 ~ 160 °.
3. the valve of pulmonary trunk membrane support preventing being shifted 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 in the tip portion of described position-limit mechanism, and the near-end of described connecting elements is connected with the described valve section of making.
4. the valve of pulmonary trunk membrane support preventing being shifted according to claim 3, it is characterized in that, described connecting elements is postponing of the lobe leaf of described petal-like self-expandable stent.
5. the valve of pulmonary trunk membrane support preventing being shifted according to aforementioned any one claim, it is characterized in that, the described valve section of making is self-expandable stent, described position-limit mechanism and the valve section of making entirety adopt shape-memory material pipe one engraving to make or adopt shape-memory material silk integrated woven to form, all or part of overlay film of outer surface of the described valve section of making.
6. the valve of pulmonary trunk membrane support preventing being shifted according to claim 5, it is characterized in that, the described valve section of making external circumferential be provided with cryptomere component, described cryptomere component is in the outside continuous distribution of the described valve section of making or uniform intervals distribution.
7. the valve of pulmonary trunk membrane support preventing being shifted according to claim 6, it is characterized in that, described cryptomere component is woven by shape-memory alloy wire and forms, or described cryptomere component is inflation or topping up sacculus, or described cryptomere component is the hollow member that inside is filled with water uptake expansion material.
8. the valve of pulmonary trunk membrane support preventing being shifted according to claim 7, it is characterized in that, the described valve section of making or cryptomere component arrange respectively or are provided with multiple barb simultaneously, one end of described barb is connected on the described valve section of making or cryptomere component, 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 |
ES2676060T3 (en) * | 2014-09-26 | 2018-07-16 | Nvt Ag | Implantable device for the treatment of mitral valve regurgitation |
CN104720936B (en) * | 2015-03-26 | 2017-07-07 | 杭州启明医疗器械有限公司 | Valve bracket using safety and the valve replacement device with the valve bracket |
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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US8845722B2 (en) * | 2009-08-03 | 2014-09-30 | Shlomo Gabbay | Heart valve prosthesis and method of implantation thereof |
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