CN105342725B - Artificial biological heart valve support and artificial biological heart valve - Google Patents
Artificial biological heart valve support and artificial biological heart valve Download PDFInfo
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- CN105342725B CN105342725B CN201510845878.XA CN201510845878A CN105342725B CN 105342725 B CN105342725 B CN 105342725B CN 201510845878 A CN201510845878 A CN 201510845878A CN 105342725 B CN105342725 B CN 105342725B
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Abstract
The present invention provides a kind of artificial biological heart valve support and artificial biological heart valve.Artificial biological heart valve support is radially shrinkable and expansion tubular frame, it includes the sustainer supporting part, leaflet supporting part and support installation portion being fixedly connected sequentially vertically, the leaflet supporting part includes 3 support units, the support unit has V-arrangement brace rod, and outer circumference diameter of the outer circumference diameter more than support installation portion of sustainer supporting part.The prosthetic heart valve holder of the present invention is simple in construction, material is reduced on the basis of mechanical property is met, moreover it is possible to effectively reduce the compression diameter of artificial biological heart valve.Press-fit diameter when in use with above-mentioned prosthetic heart valve holder small, effectively the leakage of reduction half cycle, reduce and coronary artery mouthful is blocked.
Description
Technical Field
The invention relates to a biological heart valve prosthesis bracket and a biological heart valve prosthesis, belonging to the technical field of medical instruments.
Background
The heart valve is a core component of the heart, and is continuously opened and closed in the working process of the heart so as to realize normal blood circulation, when the valve is changed due to congenital or acquired diseases, the valve cannot be normally opened and closed, so that great influence is caused on the health and life of people, and the heart cannot normally work due to serious valve diseases, and the artificial heart valve needs to be replaced.
The artificial heart valves on the market at present mainly comprise two types, namely artificial mechanical heart valves and artificial biological heart valves. Because of the characteristics of the artificial mechanical heart valve, the mechanical heart valve is easy to cause thrombus to cause arterial embolism, so that a patient needs to take anticoagulant drugs for a lifetime, and the anticoagulant drugs have great influence on the body and economic conditions of the patient. The main material of the artificial biological heart valve is heart pericardium of animals such as pigs, cattle, sheep and the like which is finished by special process treatment. The valve has good biocompatibility, is not easy to cause thrombus, does not need to take anticoagulation medicines for a lifetime, and is popular with doctors and patients.
Bioprosthetic heart valves are mainly classified into two types, a surgical implantation type and a transcatheter intervention type, according to the characteristics of implantation into a human body. The surgical implantation type artificial biological heart valve needs general anesthesia to a patient, opens the chest and stops the heart to be jumped in the implantation process, and is introduced into an extracorporeal circulation system. The whole operation time is longer. Many weak patients present certain surgical risks in performing such procedures. The intervention type artificial biological heart valve is pre-pressed and installed in the catheter, and the valve is installed to a designated position through the valve conveying device through the aorta or the small apical opening and other paths.
A typical interventional bioprosthetic heart valve consists of a stent, leaflets, and a sewing skirt. The existing interventional artificial biological heart valve stent usually uses more materials in order to ensure the supporting strength, so that the press-fitting diameter of the valve stent is larger, the coronary orifice can be blocked, and the use of a patient with a thinner blood vessel is not facilitated. Especially, the contact position of the upper ascending aorta is made of more materials, so that the whole flexibility of the existing valve support is poor, the bending of the valve along with the ascending aorta is not facilitated, the poor adherence between the valve and the valve ring is easy to increase, and the backflow is increased.
Disclosure of Invention
The invention provides a biological heart valve prosthesis bracket and a biological heart valve prosthesis, which have simple structures, reduce materials on the basis of meeting mechanical properties, effectively reduce the compression diameter of the biological heart valve prosthesis and increase the flexibility of the biological heart valve prosthesis. The artificial biological heart valve with the artificial heart valve support has small pressing diameter when in use, reduces the blockage of coronary artery openings and reduces the backflow of the valve.
In order to achieve the above objects, in one aspect, the present invention provides a bioprosthetic heart valve stent, which is a tubular frame that is radially contractible and expandable, and includes an aorta supporting part, a leaflet supporting part, and a stent mounting part that are fixedly connected in this order in an axial direction, the number of beams of the aorta supporting part and the leaflet supporting part being smaller than that of the stent mounting part, and the peripheral diameter of the aorta supporting part being larger than that of the stent mounting part; wherein,
the aortic support part is provided with a continuous V-shaped unit formed by connecting a plurality of aortic support beams which are same in length and form an angle with each other end to end, the continuous V-shaped unit is connected with the valve leaflet support part through a first vertex, and a second vertex on the opposite side of the continuous V-shaped unit from the first vertex is provided with a connecting part used for being connected with a conveying device;
the leaflet support section includes 3 support units having V-shaped support ribs;
the support mounting part is of a grid structure consisting of a plurality of rhombic units, and two end parts of the V-shaped support rib are respectively connected with different vertexes of the rhombic units.
Further, the connecting part comprises a connecting rod and a fixing part matched with the conveying device, and two ends of the connecting rod are respectively connected with the fixing part matched with the conveying device and the second vertex.
Furthermore, a notch is arranged on the inner side of an included angle of the joint of the aortic support beams.
Further, the depth of the recess is less than 0.5 mm.
Further, the width of the aortic support beam is 0.4-1 mm.
Furthermore, the supporting unit is also provided with a hollow part, and the hollow part is connected with the vertex of the V-shaped supporting rib and the first vertex.
Further, the hollow-out part is a parallelogram, an ellipse or a circle.
Further, one end of the support mounting part, which is far away from the valve leaflet supporting part, is provided with a warping part which faces the periphery of the artificial biological heart valve support.
Further, the length of the warping portion is 3-5mm, and the radial distance between the edge of the warping portion and the support mounting portion is 1-4 mm.
Furthermore, the edge of the warping part is provided with a chamfer.
Further, the thickness of the warping portion is different from that of the bracket mounting portion.
Further, the diamond-shaped cells of the stent mounting portion are arranged in 6 rows, 9 rows, 12 rows or 15 rows in the circumferential direction.
Further, there is no free diamond-shaped unit apex on the side of the stent mounting portion near the leaflet support portion.
Furthermore, the artificial biological heart valve stent is in an expanded state, and the included angle of the cylindrical surfaces between the aorta support beams forming the continuous V-shaped units after the cylindrical surfaces are unfolded is 80-120 degrees.
Furthermore, the artificial biological heart valve stent is manufactured by cutting a pipe material by laser, then performing die pressing, then performing heat treatment, and finally shaping.
In another aspect, the present invention further provides a bioprosthetic heart valve, which includes the bioprosthetic heart valve stent, the leaflet structure and the sewing skirt as described above, wherein the sewing skirt is circumferentially disposed inside the bioprosthetic heart valve stent, two ends of the sewing skirt are respectively connected with the leaflet support part and the stent mounting part, a lower edge of the leaflet structure is connected to an inner surface of the sewing skirt, and a side edge of the leaflet structure is connected with the leaflet support part.
Further, the sewing skirt is sewn to the bracket mounting portion by a sewing thread.
Further, the artificial biological heart valve stent is a self-expanding stent.
The implementation of the scheme of the invention has at least the following advantages:
1. the artificial heart valve stent has a small pressing diameter when in use, effectively reduces perivalvular leakage and reduces the blockage of coronary artery openings.
2. The artificial biological heart valve stent can effectively prevent the position of the artificial biological heart valve from moving due to the impact force of blood.
Drawings
Fig. 1 is a schematic structural diagram of a bioprosthetic heart valve stent according to an embodiment of the present invention.
Fig. 2 is a schematic diagram illustrating the connection between the connection portion and the second vertex according to an embodiment of the present invention.
Fig. 3 is a schematic structural diagram of a bioprosthetic heart valve stent according to another embodiment of the present invention.
Fig. 4 is a schematic view of a leaflet support portion structure according to another embodiment of the invention.
Fig. 5 is a schematic view of a press-fit assembly of a sizing die in an embodiment of the present invention.
FIG. 6 is a schematic view of edge grinding of a clamping warpage portion in an embodiment of the present invention.
Fig. 7 is a schematic structural diagram of a bioprosthetic heart valve stent according to another embodiment of the present invention.
Fig. 8 is a partial expanded view of a bioprosthetic heart valve stent according to another embodiment of the present invention.
Fig. 9 is a front view of a bioprosthetic heart valve in an embodiment of the present invention.
Fig. 10 is a top view of the prosthetic biological heart valve of fig. 9.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below, and it is obvious that the described embodiments are a part of the embodiments of the present invention, but not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The invention provides a biological heart valve prosthesis support which is a tubular frame capable of being contracted and expanded in the radial direction, and comprises an aorta supporting part, a valve leaflet supporting part and a support mounting part which are fixedly connected in sequence along the axial direction, wherein the number of beams of the aorta supporting part and the valve leaflet supporting part is smaller than that of the support mounting part, so that the bending force is reduced and the compliance with the aorta is increased while the positioning and the supporting of the aortic arch part are kept, the fitting between a valve frame and an annulus is easily increased and the perivalvular leakage is reduced when the aorta is bent greatly, and the peripheral diameter of the aorta supporting part is larger than that of the support mounting part.
Wherein the aorta supporting part is provided with a plurality of continuous V-shaped units which are formed by connecting end to end aorta supporting beams with the same length and mutually forming an angle, the continuous V-shaped units are connected with the valve leaflet supporting part through a first vertex, and a second vertex on the opposite side of the continuous V-shaped units from the first vertex is provided with a connecting part used for being connected with a conveying device; the portion connected to delivery allows for controlled release and retrieval of the valve by manipulation of the delivery system.
The leaflet support section includes 3 support units having V-shaped support ribs.
The support mounting part is of a grid structure consisting of a plurality of rhombic units, and two end parts of the V-shaped support rib are respectively connected with different vertexes of the rhombic units.
In one embodiment, the connecting portion includes a connecting rod and a fixing portion engaged with the conveying device, and both ends of the connecting rod are respectively connected with the fixing portion and the second vertex. The conveying device of the artificial biological heart valve stent is provided with a groove matched with the connecting part. When the valve is implanted, the connecting part is arranged in the groove of the conveying device, the conveying sheath is sleeved outside the connecting part, the valve is pulled in the sheath, and the valve enters or exits the sheath, so that the valve conveying is realized. The depth of the groove profile of the conveying device is slightly larger than the thickness of the fixing part so as to realize effective connection.
In this embodiment, the aortic support beams are notched inward of the included angle at the connection. The notch has two functions, one is that the inner side of an included angle of the connecting part of the aorta supporting beam is in smooth transition, and the stress concentration of the part is avoided; secondly, the included angle between the aorta support beams of the artificial biological heart valve stent is reduced after the artificial biological heart valve stent is compressed, and the deformation caused by material accumulation can be reduced at the notch. As a further preference, the depth of the recess is less than 0.5 mm.
In general, the width of the aortic support beam is greater than or equal to the beam width of other structural parts, and the width of the aortic support beam is preferably 0.4mm to 1mm, and more preferably 0.5mm to 0.8 mm.
In this embodiment, the leaflet support portion is a revolving body structure taking a tangential arc as a generatrix, and the support unit may further include a hollow portion connecting a vertex of the V-shaped support rib and the first vertex. The hollow part and the V-shaped support rib play a supporting role together and are used for fixing the end of the valve leaflet, the hollow part is slightly larger than the vertex of the V-shaped structure, the fixing area of the valve leaflet is effectively increased, and the valve leaflet is easier and firmer to fix. The artificial biological heart valve stent is not basically deformed when the artificial biological heart valve stent expands and contracts. The specific shape of the hollowed-out portion is not limited in the present invention, and for example, the shape may be a parallelogram, an ellipse, or a circle. In one embodiment, the hollowed-out portion is a diamond structure with inner corners approximately rounded, and the structure is more beneficial to stent compression. The V-shaped supporting ribs are formed by connecting one ends of two supporting ribs which form an angle with each other, the connecting points are vertexes of the V-shaped supporting ribs, the vertexes are connected with the hollow parts, and the other end of each supporting rib (namely the end part of the V-shaped supporting rib) is connected to different vertexes of the rhombic grids of the support mounting part.
Furthermore, the tangent line of the arc section of the joint of the V-shaped supporting rib and the vertex of the diamond-shaped unit can be parallel to the axis of the artificial biological heart valve stent, so that the joint of each V-shaped supporting rib and the vertex of the diamond-shaped unit is centrosymmetric relative to the axis when the stent is expanded and contracted, and the expansion force or pressure can be favorably transmitted to the diamond-shaped unit.
Preferably, the stent mounting part in the embodiment has no free rhombic unit vertex on one side close to the valve leaflet supporting part, so that potential damage to the valve leaflet caused by the press fitting and recovering processes is avoided; the artificial biological heart valve stent is also beneficial to eliminating and reducing the blockage to the sheath of the delivery system in the retracting process in the implanting process, and is beneficial to the retracting and the repositioning of the valve.
The support installation part is composed of a plurality of rhombic units, and each rhombic unit is composed of four rhombic unit supporting ribs. The diamond-shaped units are distributed along the circumference of the tubular frame and can be arranged in a plurality of rows, and the number of each row is the same. In particular embodiments, the diamond-shaped cells may be 6, 9, 12, or 15 rows in the circumferential direction; the diamond shaped cells may be arranged in 1, 1.5, 2, 2.5, 3, or 4 rows, etc. As can be understood by those skilled in the art, when the number of the diamond-shaped units is smaller, the width of the supporting ribs of the diamond-shaped units can be increased appropriately to ensure the overall strength of the artificial biological heart valve stent.
Because the blood flowing through the aorta from the ventricle is oxygen-rich high-pressure blood which can cause certain impact force to the valve and the valve support, in the embodiment, the support mounting part can be further provided with a warping part at one end (namely at the position of the blood inflow end) far away from the valve leaf supporting part, the warping part warps outwards along the circumferential direction of the tubular frame, the warping part is preferably in an arc shape, the position of the artificial biological heart valve can be effectively prevented from moving due to the blood impact force, and the diameter of the warping part is slightly larger than that of other parts of the mounting part, so that the backflow of the blood is reduced, and the valve periphery leakage is reduced. The width of the beam of the buckling part is 0.5mm-1mm, preferably 0.6mm-0.8 mm. In one embodiment of the invention, the length of the warping part is 3-5mm, and the radial distance between the edge of the warping part and the bracket mounting part is 1-4mm, preferably 2-3 mm. The thickness of the warping part can be the same as or different from that of the bracket mounting part. The number of the warp end points can be the same as the arrangement number of the rhombic structure units in the circumferential direction, or can be one half or one quarter of the unit number, but the number is more than or equal to 3.
Further, when the buckling part is installed at the valve ring, the edge of the buckling part may touch the sinus node of the heart, and the sinus node sends out bioelectric current which is transmitted to the cardiac muscle so as to keep the heart beating with rhythm, and once the edge of the buckling part touches the sinus node, the bioelectric current which is transmitted to the cardiac muscle from the sinus node is unstable, so that sinus arrhythmia is caused, and the adverse effect is caused to the patient. To reduce this occurrence, the blood inflow end edge of the warped portion may be further provided with a chamfer. For example, the two sides of the edge of the warping part can be respectively provided with an outer chamfer and an inner chamfer, wherein the outer chamfer is larger than the inner chamfer, which is beneficial to reducing the conditions of touching the sinoatrial node and generating sinus arrhythmia.
The artificial biological heart valve stent is in an expanded state, and the expansion included angle of a cylinder between the aorta supporting beams forming the continuous V-shaped units is 80-120 degrees, so that the compression diameter of the artificial biological heart valve stent is favorably controlled within a proper range.
The joint of the artificial biological heart valve support connecting part and the aorta supporting beam can be provided with a destressing chamfer, and the joint of the V-shaped supporting rib and the rhombic unit can also be provided with a destressing fillet so as to reduce the strength reduction caused by stress concentration.
For the artificial biological heart valve stent provided by the invention, the width or thickness of each supporting beam or supporting rib, the number of rows of diamond-shaped units at the stent mounting part, the used material and the like are comprehensively considered so as to meet the requirement on the overall strength. For example, when the strength requirement is high, the width or thickness of the support beam or the support rib, the number of rows of the diamond-shaped units can be selectively increased, or the material with high strength can be selected.
The artificial biological heart valve stent is formed by molding and shaping a cylindrical tubular frame and then carrying out heat treatment; or the plate can be formed by cutting, then welding and reshaping.
The invention further provides a biological heart valve prosthesis, which comprises the biological heart valve prosthesis support, the valve leaflets and the sewing skirt, wherein the sewing skirt is arranged inside the biological heart valve prosthesis support along the circumferential direction, two ends of the sewing skirt are respectively sewn with the valve leaflet support and the support mounting part, the lower edge of the valve leaflet structure is connected to the inner surface of the sewing skirt, and the side edge of the valve leaflet structure is connected with the valve leaflet support.
The artificial biological heart valve aorta supporting part is used for supporting the aorta part. The valve leaflet support part is used for fixing most edges of the valve leaflets after the sewing skirt is sewn, and the side edges of the valve leaflets are fixed on the support mounting part. The support installation portion is in contact with the valve ring of the corresponding pathological change position in the heart and is fixed in the valve ring under the action of expansion force, the warping portion can be sewn with the sealing skirt along the circumferential direction, and the sealing skirt of the warping portion can prevent blood from flowing through a gap between the valve ring and the artificial biological heart valve support, so that the valve periphery leakage is avoided.
The material types of the artificial biological heart valve stent, the valve leaflet structure and the sewing skirt in the invention can refer to the prior art, wherein the artificial biological heart valve stent is made of plastic deformable materials, such as medical nickel-titanium alloy, stainless steel and the like; the valve leaflet can be made of animal pericardium materials or novel artificial materials; polyester fabric or the like can be used for the sewing skirt.
The invention is explained in detail below with reference to specific embodiments and the accompanying drawings.
Fig. 1 is a schematic view of a bioprosthetic heart valve stent provided by an embodiment of the present invention. As shown in fig. 1, the bioprosthetic heart valve stent 100 is a tubular frame that is radially contractible and expandable, and includes an aortic support part 20, a leaflet support part 30, and a stent mounting part 40 fixedly connected in this order in the axial direction, the leaflet support part 30 having a conical structure, and the aortic support part 20 having a larger outer circumferential diameter than the stent mounting part 40, wherein,
the aortic support section 20 has a continuous V-shaped unit formed by connecting end to end a plurality of aortic support beams 21 of the same length and angled to each other, the continuous V-shaped unit being connected to the leaflet support section 30 by a first apex 22, and a second apex 23 on the opposite side of the continuous V-shaped unit from the first apex being provided with a connection section 10 that can be mated with a delivery device. The connecting portion 10 is provided with a rounded corner 13 at the connecting portion with the aortic support beam 21 to reduce the strength reduction caused by stress concentration.
The width of the aortic support beam 21 is larger than the width of other support beams or support ribs, and is in contact with the inner wall of the ascending aorta vessel. Since the ascending aorta is generally of a curved configuration, the aortic support 20 will curve with the curvature of the ascending aorta vessels. The aorta support part 20 is composed of 6 continuous V-shaped units formed by connecting the aorta support beams 21 end to end, the inner angle of the connection is provided with a notch 24, and the first vertexes 22 of the 3 continuous V-shaped units are respectively connected with the connection parts 10.
As shown in FIG. 2, the connecting portion 10 includes a fixing portion 11 and a connecting rod 12 connected to each other, and the connecting portion 10 is connected to a valve delivery device through which the valve is delivered to an affected part of a patient. The conveying device is provided with a cylinder corresponding to the position, 3 grooves with the same profile as the fixing part 11 are uniformly distributed on the cylinder, the depth of each groove is slightly deeper than the thickness of the fixing part 11, and the bracket is conveyed to an affected part of a patient or is recovered and withdrawn by the aid of the fixing part 11 matched with the conveying device in the conveying and recovering processes to be conveyed again. The length of the connecting part 10 is 5-8 mm.
The leaflet support 30 comprises 3 support units with the same structure and evenly distributed in the circumferential direction, and the support units are provided with V-shaped support ribs 32; the two ends of the V-shaped support rib 32 are respectively connected with the vertexes 34 of different diamond-shaped units. The joints of the V-shaped supporting ribs 32 and the diamond-shaped units can also be provided with stress relief chamfers to reduce the strength reduction caused by stress concentration. Meanwhile, the tangent line A06 of the arc section 322 at the junction of the V-shaped support rib 32 and the vertex of the diamond-shaped unit is parallel to the axis of the artificial biological heart valve stent 100.
The valve leaflet support part 30 and a part of the support installation part 40 fix the valve leaflets together, most of the valve leaflets are distributed in the valve leaflet support part 30, and because the support material of the part is less, the redundant space just fills the valve leaflet structure, the valve leaflet support part is very favorable for reducing the press-fitting diameter of the valve.
The support installation part 40 is of a grid-shaped structure and is composed of 1.5 rows of rhombic units in the axial direction, 12 rhombic units are distributed in each row in the circumferential direction, two end parts of the V-shaped support ribs 32 are respectively connected with vertexes of different rhombic units, a warping part 50 warping towards the periphery of the artificial biological heart valve support 100 is arranged at one end, away from the valve leaflet support part 30, of the support installation part 40, the length of the warping part 50 is 3-5mm, the radial distance between the edge of the warping part and the support installation part is 1-4mm, and the beam width is 0.6-0.8 mm. A warp outer chamfer 511a and a warp inner chamfer 511b may be provided on both sides of the warp edge 51, respectively, wherein the warp outer chamfer 511a is larger than the warp inner chamfer 511 b.
Fig. 3 is a schematic structural diagram of a bioprosthetic heart valve stent 100 according to another embodiment of the present invention. As shown in fig. 3 and 4, the stent mounting portion 40 has 15 diamond-shaped cells arranged circumferentially, 2 rows of diamond-shaped cells distributed in a cross-connection in the axial direction, and free diamond-shaped cell vertices 34 between and on both sides of the V-shaped struts. The supporting unit is provided with a V-shaped supporting rib 32 and a hollow part 31 connected with the vertex of the V-shaped supporting rib 32, and one end of the hollow part 31 far away from the V-shaped supporting rib 32 is connected with the first vertex 22. The hollow part 31 is surrounded by two symmetrical rhombic unit supporting ribs similar to rounded corners, and a rhombic hollow similar to rounded corners is formed in the middle of the hollow part.
Fig. 7 is a schematic structural diagram of a bioprosthetic heart valve stent 100 according to still another embodiment of the present invention. Fig. 8 is a partial expanded view of a bioprosthetic heart valve stent according to another embodiment of the present invention.
As shown in fig. 7 and 8, unlike the previous embodiment: the number of diamond-shaped units of the leaflet mounting portion 40 in the circumferential direction is 12, the number of the V-shaped support ribs 32 is 3, 1 diamond-shaped unit vertex 34 exists between two end portions of the V-shaped support rib 32, 2 reinforcing ribs 33 are arranged between two end portions of each V-shaped support rib 32, and the two reinforcing ribs 33 are respectively connected with the diamond-shaped unit vertex 34 and two support ribs in the same V-shaped support rib to form a diamond-shaped grid structure together.
Due to the arrangement of the reinforcing ribs 33, the V-shaped supporting ribs 32 can better play a supporting role. In addition, the reinforcing ribs 33 can protect the valve leaflets when the stent is contracted, so that the valve leaflets are more effectively prevented from being exposed outside the artificial biological heart valve stent 100. Meanwhile, the free diamond-shaped unit vertexes 34 do not exist in the middle of the artificial biological heart valve stent 100 (the free diamond-shaped unit vertexes 34 refer to the diamond-shaped unit vertexes which are not connected with the two ends of the V-shaped support rib 32), so that potential damage to valve leaflets is avoided; and also facilitates the withdrawal and repositioning of the bioprosthetic heart valve stent 100 during implantation.
In the above embodiment, as shown by the dotted line in fig. 8, there is a case where there is a diamond-shaped unit vertex 34 between two adjacent V-shaped support ribs 32, and in this embodiment, two diamond-shaped unit support ribs forming the diamond-shaped unit vertex 34 may be eliminated, so as to avoid a case where there is a free diamond-shaped unit vertex 34 between two adjacent V-shaped support ribs 32.
In the above embodiments, the artificial biological heart valve stent 100 is manufactured by hollowing out a tube, molding, and removing stress caused by molding through heat treatment. The used mold has a cavity with the same contour as the artificial biological heart valve support, and consists of a mold core 60, a pressing block 70 and a pressing plate 80, wherein the pressing block 70 is formed by buckling two parts and is similar to a bearing bush structure.
The tubular frame obtained after the pipe hollowing treatment is mounted on the mold core 60, the press block 70 is fastened, and the two parts of the press block 70 are fastened and fixed through the press block fixing holes 71 by using bolts. Then, the pressure plate 80 is placed at the inflow end of the bracket and screwed with bolts through the pressure plate fixing center hole 81 to the core fixing screw 61. And then fixed with a corresponding hole (not shown) on the upper part of the pressing block 70 through a pressing plate fixing hole 82 by bolts. As shown in fig. 5, all parts of the tubular stent are completely fixed to form a press-fitting assembly of the shaping mold, and then heat treatment, solidification and stress relief are performed.
Thereafter, the warped portion edge 51 is ground to form a chamfer. As shown in fig. 6, the warpage fixing outer mold 61 and the warpage fixing inner mold 62 jointly clamp the outer wall and the inner wall of the warpage 50 to fix the warpage 50, grind the edge 51 of the warpage with a fine grinding wheel, and finally form a warpage outer chamfer 511a and a warpage inner chamfer 511b, with the fillet diameter of the warpage outer chamfer 511a being greater than that of the warpage inner chamfer 511b to reduce the occurrence of conduction block.
The artificial biological heart valve stent 100 provides effective supporting force, uses less implantation materials, is beneficial to increasing the compliance of the stent and the aorta and reducing perivalvular leakage, is beneficial to reducing the press-fitting diameter of the valve, and can effectively reduce the occurrence of coronary artery blockage; and meanwhile, the combination of the warping part and the valve skirt further effectively prevents the risk of the leakage around the valve.
As shown in fig. 9 to 10, an embodiment of the present invention further provides a bioprosthetic heart valve, including the bioprosthetic heart valve stent 100, the leaflet structure 200 and the sewing skirt 300 as described above, wherein the sewing skirt 300 is circumferentially disposed inside the bioprosthetic heart valve stent 100, two ends of the sewing skirt are respectively connected to the leaflet support portion 30 and the stent mounting portion 40, and a lower edge and a side edge of the leaflet structure 200 are connected to an inner surface of the sewing skirt 300. The sewing skirt 300 is attached to the diamond-shaped cells by sutures, and the sewing skirt 300 and leaflet structure 200 are sewn together by sutures.
The artificial biological heart valve stent 100 is made of medical nickel-titanium alloy, the valve leaflet structure 200 is an animal pericardium, and the sewing skirt 300 is polyester fiber fabric.
As shown in fig. 9, the bioprosthetic heart valve stent 100 adopted by this embodiment includes an aorta supporting section 20, a leaflet supporting section 30, and a stent mounting section 40 fixedly connected in this order along the axial direction, wherein the leaflet supporting section 30 has 3 supporting units, each of which has a hollow section 31 and a V-shaped supporting rib 32. And there are no free diamond-shaped cell vertices 34 on the side of the stent mounting portion 40 near the leaflet support portion 30.
The artificial biological heart valve that this embodiment provided is pressure equipment diameter less when using, reduces to flow into coronary artery mouth jam, and structural stability is strong simultaneously, reduces the emergence of valve week leakage.
Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.
Claims (16)
1. A kind of artificial biological heart valve support, characterized by, the said artificial biological heart valve support is a tubular frame that can be contracted and expanded radially, it includes aorta supporting part, valve leaflet supporting part, support mounting part fixedly connected sequentially along the axial, the number of the roof beam of the said aorta supporting part and said valve leaflet supporting part is smaller than the support mounting part, and the peripheral diameter of the said aorta supporting part is greater than the peripheral diameter of the said support mounting part; wherein,
the aortic support part is provided with a continuous V-shaped unit formed by connecting a plurality of aortic support beams which are same in length and form an angle with each other end to end, the continuous V-shaped unit is connected with the valve leaflet support part through a first vertex, and a second vertex on the opposite side of the continuous V-shaped unit from the first vertex is provided with a connecting part used for being connected with a conveying device;
the leaflet support part comprises 3 support units, each support unit is provided with a V-shaped support rib and a hollow part, and the hollow part is connected with the vertex of the V-shaped support rib and the first vertex;
the support mounting part is of a grid structure consisting of a plurality of rhombic units, and two end parts of the V-shaped support rib are respectively connected with vertexes of different rhombic units;
one side of the bracket mounting part close to the valve leaf supporting part is not provided with free rhombic unit vertexes.
2. The bioprosthetic heart valve stent of claim 1, wherein the connecting portion comprises a connecting rod and a delivery device-fitting fixing portion, and both ends of the connecting rod are respectively connected with the delivery device-fitting fixing portion and the second vertex.
3. The bioprosthetic heart valve stent of claim 1, wherein the aortic support beams are notched inward of the angle of connection.
4. The bioprosthetic heart valve stent of claim 3, wherein the depth of the notch is less than 0.5 mm.
5. The bioprosthetic heart valve stent of claim 1, wherein the width of the aortic support beam is 0.4-1 mm.
6. The bioprosthetic heart valve stent of claim 1, wherein the hollowed-out portion is parallelogram-shaped, oval-shaped, or circular.
7. The bioprosthetic heart valve stent of claim 1, wherein one end of the stent mounting portion away from the leaflet support portion is provided with a warping portion that warps toward the periphery of the bioprosthetic heart valve stent.
8. The bioprosthetic heart valve stent of claim 7, wherein the length of the warp is 3-5mm, and the radial distance between the warp edge and the stent mounting portion is 1-4 mm.
9. The bioprosthetic heart valve stent of claim 7, wherein edges of the warps are provided with chamfers.
10. The bioprosthetic heart valve stent of claim 7, wherein the thickness of the warp portion and the thickness of the stent mounting portion are not the same.
11. The bioprosthetic heart valve stent of claim 1, wherein the diamond-shaped cells of the stent mounting portion are 6, 9, 12, or 15 rows in the circumferential direction.
12. The bioprosthetic heart valve stent of any one of claims 1-11, wherein the bioprosthetic heart valve stent is in an expanded state with a post-deployment included angle of 80-120 ° of the cylindrical surface between the aortic support beams forming successive V-shaped units.
13. The bioprosthetic heart valve stent of any one of claims 1 to 11, wherein the bioprosthetic heart valve stent is manufactured by laser cutting a tube, die-pressing, and heat-treating.
14. A bioprosthetic heart valve comprising the bioprosthetic heart valve stent of any one of claims 1 to 13, a leaflet structure and a suturing skirt, wherein the suturing skirt is circumferentially disposed inside the bioprosthetic heart valve stent, both ends of the suturing skirt are respectively connected with a leaflet support part and a stent mounting part, the lower edge of the leaflet structure is connected with the inner surface of the suturing skirt, and the side edge is connected with the leaflet support part.
15. The bioprosthetic heart valve of claim 14, wherein the sewing skirt is sewn to the stent mounting portion and the leaflet support portion by sutures.
16. The bioprosthetic heart valve of claim 14, wherein the bioprosthetic heart valve stent is a self-expanding stent.
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| CN108720972A (en) * | 2017-04-19 | 2018-11-02 | 北京航空航天大学 | A kind of self expandable for avoiding coronary artery from blocking intervention valve bracket |
| CN109419571B (en) * | 2017-08-25 | 2024-09-20 | 上海微创心通医疗科技有限公司 | Delivery device for self-expanding prosthesis and delivery device for self-expanding heart valve prosthesis |
| CN108904101A (en) * | 2018-06-29 | 2018-11-30 | 金仕生物科技（常熟）有限公司 | Intervene valve component, the fixed device of intervention valve and its application |
| CN109124829A (en) * | 2018-06-29 | 2019-01-04 | 金仕生物科技（常熟）有限公司 | It is a kind of through conduit aortic valve and preparation method thereof |
| CN110731836B (en) * | 2018-07-20 | 2021-10-12 | 先健科技(深圳)有限公司 | Heart valve |
| CN110279495B (en) * | 2019-06-25 | 2022-08-26 | 陈翔 | Self-expanding heart valve prosthesis |
| CN112402058A (en) * | 2020-10-12 | 2021-02-26 | 金仕生物科技（常熟）有限公司 | Intervention mitral valve stent |
| CN114469446A (en) * | 2020-11-13 | 2022-05-13 | 上海微创心通医疗科技有限公司 | Valve stent and valve prosthesis |
| CN113331998B (en) * | 2021-06-07 | 2024-04-26 | 山东大学齐鲁医院 | Artificial heart valve |
| CN113599023A (en) * | 2021-07-16 | 2021-11-05 | 复旦大学附属中山医院 | Intervention type artificial heart valve |
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