Presettable prosthetic bioprosthetic aortic valve

Abstract

A presettable biological prosthetic aortic valve includes a valve seat (1), a leaflet stent (2), and three leaflets (3) attached to the leaflet stent (2), in which the valve seat (1) is an annular metal seat that can be expanded with a position limit in one direction, and a first rivet (7), a position limiting protrusion (6), and a first oval groove (5) are provided at the tip of each seat body unit (4) in this order from outside to inside, and a second oval groove (8) that engages with the first rivet (7) at the tip of the adjacent seat body unit (4), a second position limiting hole (10) and a first position limiting hole (9) that respectively engage with the position limiting protrusion (6), and a second rivet (11) that engages with the first oval groove (5) are provided at the end of each seat body unit (4) in this order. The presettable biological prosthetic aortic valve has an initial preset state and a normal use state after being expanded with a position limit in one direction.

Description

[Technical field]

[0001] The present invention relates to prosthetic tissue valves, and in particular to pre-settable prosthetic tissue aortic valves. [Background technology]

[0002] With the advancement of valvular surgery, the problem of narrowing of the valve annulus or narrowing of the aortic root is increasingly being emphasized in AVR. AVR patients with stenosis such as congenital heart disease or rheumatic heart disease, small body size or overweight, stenosis of the valve annulus or stenosis of the combined left ventricular outflow tract or poor formation of the aortic root (sinus duct boundary-valve annulus-outflow tract) are limited by the local anatomical conditions of the aortic root, and therefore cannot always introduce a prosthetic valve of sufficient caliber. The use of an artificial valve prosthesis that is too small for surgery will cause the patient's high postoperative transvalvular pressure difference, failure to improve blood flow dynamics, and increased left ventricular postoperative load, which not only affects the patient's cardiac function recovery, but also affects the quality of long-term life and survival rate, and accelerates the deterioration of the biological valve.

[0003] Chinese patients are smaller than Westerners, so prosthetic valve-patient mismatch (PPM) is particularly serious. According to data from 93 large centers nationwide in the China Cardiac Surgery Registry System, recently, 50% of surgical AVR patients have been implanted with small prosthetic valves not exceeding size 21, so cardiac surgeons in China must first enlarge the valve annulus through surgery before performing AVR. Enlarging the valve annulus or aortic root is an effective solution to the problem of small aortic annulus, but it places high demands on the surgeon's surgical skills, and often leads to postoperative complications and even death. In fact, some patients are suitable for the use of biological valves due to their age or contraindications to anticoagulation, but they are concerned about the relatively small aortic annulus, so they are forced to choose the same type of mechanical valve.

[0004] In addition, with the recent research and application of transcatheter valve-in-valve, it has become feasible to introduce a transcatheter artificial biological valve into a previously implanted damaged biological valve via a catheter, so that these patients can receive treatment without the risk of undergoing surgery to replace the valve again. However, the specifications of the previously implanted damaged valve are too small, for example, size 21 or size 19, so that the inner diameter of the valve orifice is limited, making it difficult to intervene in transcatheter valve-in-valve treatment. Even if a relatively small valve-in-valve is intervened, the postoperative intervalve pressure difference is high, and its durability is significantly affected. At present, the industry has not yet proposed a satisfactory solution. Summary of the Invention

[0005] In view of the above, the present invention can provide a presettable prosthetic biological aortic valve with an initial preset state, the appearance of which is one size smaller than that of a conventional surgically implanted prosthetic biological heart valve. After the implantation operation is completed, it can be rotated in one direction by balloon pressurization, and the inner diameter of the valve orifice can be expanded by 1 or 1.5 sizes by position restriction, thereby avoiding the risk of PPM and achieving a better therapeutic effect.

[0006] In order to solve the above technical problems, the technical means adopted by the present invention is a presettable biological aortic valve prosthesis, including a valve seat, a leaflet stent, and three leaflets attached to the leaflet stent, the valve seat being an annular metal seat that can be expanded with a position limited in one direction, the annular metal seat being composed of three seat body units whose ends are connected in an alternating stacking manner, the end of each seat body unit being provided with a first rivet, a position limiting protrusion, and a first oval groove in order from the outside to the inside, the end of each seat body unit being provided with a second oval groove that engages with the first rivet at the end of the adjacent seat body unit, a second position limiting hole and a first position limiting hole that respectively engage with the position limiting protrusion, and a second rivet that engages with the first oval groove in order. a first oval groove of each seat body unit engages with a second rivet of an adjacent seat body unit to be movable in one direction, a second oval groove of each seat body unit engages with a first rivet of an adjacent seat body unit to be movable in one direction, a position limiting protrusion of each seat body unit engages with a first position limiting hole and a second position limiting hole of an adjacent seat body unit to be movable in one direction, and a wave-shaped protrusion is provided in the middle of each seat body unit, and the presettable prosthetic biological aortic valve has a preset initial state and a normal use state expanded with a position limited in one direction, and each seat body unit forms a normal use state similar to that of a conventional surgical biological aortic valve after being expanded outward by synchronous unidirectional rotation.

[0007] Here, the seat body units of the valves are expanded by a balloon of 5 atmospheres (atm) or more to rotate the valve seats synchronously in one direction and expand outward to form the expanded state limited in one direction, and the leaflet stent has a preset state and a normal application state, and the preset state matches the valve seat before expansion, and the normal function state matches the valve seat after expansion. The structure of each seat body unit is completely the same, and the tip of each seat body unit is disposed inside the end of the adjacent seat body unit. The position limiting protrusion has a semicircular protrusion inclined upward along the expansion direction, and the protrusion has a circular head along the expansion direction to suppress and stabilize the sliding resistance to the front, and the tail is a flat protrusion to prevent sliding in the reverse direction after sliding into the position limiting hole. The position limiting hole has a shape matching the position limiting protrusion. When the position limiting protrusions are in two positions on the valve seat before and after the expansion of the valve seat, the valve frame corresponds to two shapes before and after the expansion, respectively, and the shape after the expansion is the normal use shape. The leaflet stent has a preset shape and a normal use shape, and the normal use shape matches the normal use state after the presettable biological prosthetic aortic valve is expanded with position limiting in one direction. The specifications of the three leaflets match the normal use state after the aortic valve is expanded with position limiting in one direction. The outside of the valve seat is covered with a support belt made of a polymeric material, and the support belt matches the normal use state after the aortic valve is expanded with position limiting in one direction. The leaflets are modified bovine pericardium, porcine pericardium, porcine aortic valve, sheet-shaped animal tissue, or non-biosynthetic leaflet material. When the valve leaflet portion consisting of the three leaflets is in the normal use state after the valve leaflet portion is expanded with position limiting in one direction, the valve leaflet portion allows unidirectional blood flow through the valve leaflet portion. Materials for the valve seat and leaflet stent are Elgiloy alloy, cobalt chromium alloy, nickel titanium alloy and implantable stainless steel (316L, a cobalt chromium nickel molybdenum iron alloy).Before the valve leaflets are in an expanded state with their position restricted in one direction, the initial preset state is an abnormal use state, and only when the valve leaflets are changed from the expanded state with their position restricted in one direction by the external force of the balloon to a normal use state similar to that of a conventional surgical biological aortic valve can they exert their valve function of one-way blood flow.

[0008] The present invention relates to a presettable artificial biological aortic valve prosthesis. The artificial heart valve, which can be expanded in one direction with limited position, has two states, the first state of the product is a preset state, the implantation outer diameter of the product is similar to the appearance of the nominal artificial heart valve product on the market, but the model number of the specification of 1 or 1.5 is small, the type is the model number of the valve corresponding to the valve annulus size, and the valve in this state cannot be used normally and is not in the working state of the valve. After the product is implanted in the relatively small aortic annulus or the relatively small aortic root of the patient, the product can be expanded in one direction with limited position by the external force of balloon pressure, and it will be in the second state of normal use, that is, it is completely the same as the shape, structure and performance of the artificial heart valve already on the market by the enterprise, and the valve is in a completely normal functioning state in this state, except for the model number of the specification of 1 or 1.5. As can be seen, through this process, for patients whose aortic annulus is originally too small to implant a prosthetic biological valve or who are concerned about the mismatch of valve size (PPM), a small valve annulus leaflet can be implanted first, and then the annulus can be expanded by balloon expansion after implantation, thereby achieving the final effect and purpose of implanting a valve leaflet with a relatively large specification model, and the main meaning of "presetting" is to first implant a relatively small model of non-normal use valve leaflet and then expand it. The expansion of the valve annulus not only brings benefits to the treatment of the valve leaflet itself (e.g., reducing the transvalve pressure difference), but also provides the possibility of future transcatheter valve-in-valve treatment for patients with such small aortic root surgical valve replacement. [Brief description of the drawings]

[0009] [Figure 1] FIG. 1 is a perspective schematic diagram of a pre-settable prosthetic biological aortic valve body according to an embodiment of the present invention. [Diagram 2] 2A-E are schematic diagrams of the valve seat in FIG. 1 in an initial state and an expanded state. [Diagram 3] FIG. 3 is an exploded view of three seat body units of the valve seat in FIG. [Figure 4] FIG. 4 is a development view of the valve seat in FIG. 1 in an initial state after three seat body units are coupled together. [Diagram 5] FIG. 5 is a development view of the valve seat in FIG. 1 in an expanded state after three seat body units are coupled together. [Figure 6] 6A-B are schematic diagrams of unidirectional movement of the valve seat and diametric position limiting expansion of the valve seat. [Figure 7] 7A-C are schematic diagrams of the initial preset state of the prosthetic biological aortic valve of the present application and the normal use state in which the valve is expanded in one direction by an external force of a balloon intervention. [Figure 8] 8A-B are schematic diagrams of a predictable prosthetic aortic valve implantation procedure according to an embodiment of the present invention. [Figure 9] 9A-B are schematic diagrams showing accurate measurement of the initial inner diameter and the inner diameter after unidirectional dilation of the preset aortic valve leaflet by DSA angiography. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] The present invention will be described in more detail below with reference to the drawings and examples. Note that the specific examples described herein are merely for the purpose of interpreting the present invention and are not intended to limit the present invention.

[0011] 1 to 7, a presettable biological aortic valve prosthesis according to an embodiment of the present invention includes a valve seat 1, a leaflet stent 2, and three leaflets 3 attached to the leaflet stent. The valve seat is an annular metal seat that can be expanded with a position limit in one direction. The annular metal seat is composed of three seat body units 4 whose leading ends and ends are alternately stacked inside and outside and connected. The leading end of each seat body unit is provided with a first rivet 7, a position limiting protrusion 6, and a first oval groove 5 in that order, and the trailing end is provided with a second oval groove 8, a first position limiting hole 9, a second position limiting hole 10, and a second position limiting hole 12. The first oval groove 5 of each seat body unit 4 is engaged with the second rivet 11 of the adjacent seat body unit to be movable in one direction, the second oval groove 8 of each seat body unit is engaged with the first rivet 7 of the adjacent seat body unit to be movable in one direction, and the semicircular position limiting protrusion 6 of each seat body unit is engaged with the semicircular first position limiting hole 9 and the second position limiting hole 10 of the adjacent seat body unit to be movable in one direction, and each seat body unit has a wavy protrusion in the middle. In the initial state, the position limiting protrusion 6 is first positioned in the second position limiting hole 10, and after being expanded by position limiting in one direction, the position limiting protrusion 6 is displaced in one direction into the first position limiting hole 9 to be positioned. The position limiting protrusion has a semicircular protrusion inclined upward along the expansion direction, and the head of the protrusion is circular along the expansion direction, which suppresses and stabilizes the sliding resistance in the forward direction, and the tail is a flat protrusion, which prevents the reverse sliding after sliding into the position limiting hole. The position limiting hole has a shape matching the position limiting protrusion. When the position limiting protrusion is in two positions before and after the expansion of the valve seat on the valve seat, the valve frame corresponds to two shapes before and after the expansion, respectively, and the shape after the expansion is the normal use shape. The presettable biological aortic valve prosthesis has a preset initial state and a normal use state after being expanded by unidirectional position limiting, and each seat unit forms a normal use state similar to that of a conventional surgical biological aortic valve after being expanded outward by synchronous unidirectional rotation, and Figures 2A and 2C are the initial state, and Figures 2B and 2D are the expanded state.The arrangement of the oval groove and the rivet is not fixed, and their positions can be changed as necessary, as long as they cooperate with each other to restrict the rotational and expansive movement in one direction.

[0012] 6 and 7, the seat units are expanded by a balloon of 5 atm or more to rotate the valve seat synchronously in one direction and expand outward to form the expanded state limited in one direction, and the leaflet stent has a preset state and a normal application state, and the preset state matches the valve seat before expansion, and the normal function state matches the valve seat after expansion. The seat units have the same structure, and their tips are located inside or outside the end of the adjacent seat unit. The position limiting protrusion has a semicircular protrusion that slopes upward along the expansion direction, and the position limiting hole has a shape that matches the position limiting protrusion. The position limiting protrusion has a circular head along the expansion direction to suppress and stabilize the sliding resistance in the forward direction, and a flat protrusion at the tail to prevent sliding in the reverse direction after sliding into the position limiting hole. The position limiting hole has a shape matching the position limiting protrusion, and when the position limiting protrusion is in two positions on the valve seat before and after the expansion of the valve seat, the valve frame corresponds to two shapes before and after the expansion, respectively, and the shape after the expansion is the normal use shape, and the length of the first and second oval grooves is equal to the distance between the two position limiting holes. The leaflet stent has a preset shape and a normal use shape, and the normal use shape matches the normal use state after the presettable biological aortic valve prosthesis is expanded in one direction with a position limited. The specifications of the three leaflets match the normal use state after the expansion in one direction with a position limited. The outside of the valve seat is covered with a support belt made of a polymeric material, and the support belt matches the normal use state after the aortic valve is expanded in one direction with a position limited. The leaflets are modified bovine pericardium, porcine pericardium, porcine aortic valve, sheet-shaped animal tissue, or non-biosynthetic leaflet material. The three leaflet valve portion allows unidirectional blood flow through the valve portion when in normal use after being unidirectionally constrained and expanded. The materials of the valve seat and leaflet stent are Elgiloy, cobalt chromium, nickel titanium and implantable stainless steel (316L, a cobalt chromium nickel molybdenum iron alloy). The materials of the outer layers of the coatings are all conventional in the art and are not shown.Before the valve is in an expanded state restricted in one direction, the initial preset state is an abnormal use state, and when the valve is converted from the expanded state restricted in one direction by the external force of the balloon into a normal use state similar to the aortic valve of a conventional surgical organism, it can exert a valve function of one-way blood flow. In vitro validation

[0013] The presettable bioprosthetic aortic valve of the present invention is characterized by having an initial preset state and a normal use state in which it is expanded in one direction by the external force of balloon intervention (see FIG. 7). In an in vitro test, a normal balloon is used to expand the valve by balloon intervention, and when it reaches 5 atmospheres, the aortic valve is expanded in one direction from the initial preset state, and the inner diameter is increased by one size, so that it can be preset as the normal use state. When compared with the company's original commercially available bioprosthetic aortic valve, the appearance is exactly the same as the hydrodynamic performance even when the external diameter is restricted and measured, and after an in vitro hydrodynamic test. In vivo verification

[0014] Adult sheep were used as experimental animals, and in situ presettable artificial biological aortic valves were implanted under extracorporeal circulation. The implantation surgeries No. 19, No. 21, and No. 23 were performed (see Figures 8 and 9). Before expansion, the outer diameter of the valve was measured by DSA, and then a balloon from a company that expands the valve by balloon intervention was inserted, pressurized to 5.0-5.5 atmospheres, and maintained for 5 seconds, after which the pressure was released and the balloon was removed, and the heart and chest skin were sutured in order to complete the surgery.

[0015] DSA angiography was used to accurately measure the inner diameter of the implanted and expanded preset aortic valve (see Figure 9), and then esophageal ultrasound was used to measure the transvalvular pressure difference, effective opening area, and regurgitation status of the valve. When compared with the Company's commercially available prosthetic biological aortic valve, the normal operating state of the unidirectionally expanded preset bioprosthetic aortic valve was found to have exactly the same opening and closing function as the next larger model commercially available prosthetic biological aortic valve.

[0016] A total of three models were completed in the animal experiments, and the preset aortic valve was expanded in one direction using the same balloon expansion pressure, changing from the initial state to the normal operating state. Esophageal ultrasound examination showed no regurgitation of the valve, and the inner diameter and effective opening area were both the same as those of the next larger model of normal prosthetic aortic valve.

[0017] The design of the preset aortic valve provides a model with a smaller outer diameter for patients who need surgical valve replacement for aortic stenosis due to narrowing of their valve annulus or narrowing of the aortic root, but can obtain a normal valve that is 1 or 1.5 sizes larger by balloon expansion, and at the same time, it can avoid implanting a preset prosthetic aortic valve with a model with a larger specification for patients whose aortic annulus is originally too small to implant a prosthetic bioprosthetic valve or who are concerned about PPM due to complications from the root expansion operation. At the same time, it also provides the possibility that the patient will need transcatheter midvalve treatment in the future.

[0018] The above are only preferred embodiments of the present invention, and are not intended to limit the present invention. Any modifications, equivalent replacements, and improvements made within the spirit and principle of the present invention should be included within the protection scope of the present invention.

Claims

1. 1. A presettable bioprosthetic aortic valve comprising a valve seat, a leaflet stent, and three leaflets attached to the leaflet stent, The valve seat is an annular metal seat that can be expanded in one direction with its position limited, and the annular metal seat is composed of three seat body units whose leading ends are alternately stacked inside and outside and connected, and the leading end of each seat body unit is provided with a first rivet, a position limiting protrusion and a first oval groove, in this order from outside to inside, and the end of each seat body unit is provided with a second oval groove that engages with the first rivet at the leading end of the adjacent seat body unit, a second position limiting hole and a first position limiting hole that respectively engage with the position limiting protrusion, and a second rivet that engages with the first oval groove, in this order; The first oval groove of each seat body unit and the second rivet of the adjacent seat body unit are engaged with each other to be movable in one direction, the second oval groove of each seat body unit and the first rivet of the adjacent seat body unit are engaged with each other to be movable in one direction, the position limiting protrusions of each seat body unit are engaged with the first position limiting holes and the second position limiting holes of the adjacent seat body units respectively to be movable in one direction, and each seat body unit has a wave-shaped protrusion in the middle, The presettable prosthetic biological aortic valve has a preset initial state and a normal use state in which it is unidirectionally restricted and expanded, and each seat unit is synchronously rotated unidirectionally to expand outward, thereby forming the same normal use state as a conventional surgical biological aortic valve; The initial preset state before the valve consisting of the three leaflets is in an expanded state with its position restricted in one direction is an abnormal use state, and when the external force of the balloon causes it to change from the expanded state with its position restricted in one direction to a normal use state similar to that of a conventional surgical bioprosthetic aortic valve, it exhibits a valve function of one-way blood flow. A presettable prosthetic biological aortic valve.

2. The tip of each seat unit is disposed inside the end of the adjacent seat unit.

10. The presettable bioprosthetic aortic valve of claim 1.

3. Each seat unit is expanded by a balloon at 5 atmospheres or more to rotate the valve seat synchronously in one direction and expand outward, thereby forming the expanded state limited in one direction; and the leaflet stent has a preset state and a normal application state, and the preset state matches the state of the valve seat before expansion, and the normal function state matches the state of the valve seat after expansion.

10. The presettable bioprosthetic aortic valve of claim 1.

4. The position limiting protrusion has a semicircular protrusion inclined upward along the expansion direction, and the position limiting hole has a shape matching the position limiting protrusion.

10. The presettable bioprosthetic aortic valve of claim 1.

5. The position limiting protrusion has a semicircular protrusion that slopes upward along the expansion direction, and the head of the protrusion is round along the expansion direction, thereby reducing forward sliding resistance and stabilizing the protrusion, and the tail is flat, thereby preventing reverse sliding after sliding into the position limiting hole, and the position limiting hole has a shape that matches the position limiting protrusion, so that when the position limiting protrusion is in two positions on the valve seat before and after expansion of the valve seat, respectively, the valve frame corresponds to two shapes before and after expansion, and the shape after expansion is the normal use shape.

10. The presettable bioprosthetic aortic valve of claim 1.

6. the length of the first oblong groove, the length of the second oblong groove, and the distance between the two position limiting holes are all the same; 10. The presettable bioprosthetic aortic valve of claim 1.

7. The leaflet stent has a preset configuration and a normal use configuration, and the normal use configuration corresponds to the normal use state of the presettable prosthetic aortic valve after it is expanded in one direction and restricted in position.

10. The presettable bioprosthetic aortic valve of claim 1.

8. The specifications of the three leaflets are consistent with the normal use state after being expanded in one direction with limited positioning; 10. The presettable bioprosthetic aortic valve of claim 1.

9. The outside of the valve seat is covered with a support belt made of a polymeric material, and the support belt is configured to limit the position of the aortic valve in one direction and match the normal use state after expansion.

10. The presettable bioprosthetic aortic valve of claim 1.

10. The valve leaflets are modified bovine pericardium, porcine pericardium, porcine aortic valve, sheet-like animal tissue, or non-bio-synthetic valve leaflet material.

10. The presettable bioprosthetic aortic valve of claim 1.

11. The valve portion consisting of the three leaflets allows unidirectional blood flow through the valve portion when in a normal use state after being expanded with the unidirectional position restriction.

10. The presettable bioprosthetic aortic valve of claim 1.

12. The materials of the valve seat and leaflet stent are Elgiloy alloy, cobalt chromium alloy, nickel titanium alloy and implantable stainless steel.

10. The presettable bioprosthetic aortic valve of claim 1.

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