WO2024113436A1 - Expandable valve seat and biological valve - Google Patents

Abstract

An expandable valve seat (1) and a biological valve. The valve seat (1) is of an annular structure formed by winding a strip-shaped plate having two free ends. When being subjected to an expansion acting force from inside to outside in a first use state, the valve seat (1) can be expanded to a second use state in which it is still annular, and the diameter in the second use state is greater than that in the first use state; in the first use state, the valve seat (1) forms a laminated structure at at least part of positions in the circumferential direction, and adjacent layers at the laminated positions are attached to each other; in the second use state, the valve seat (1) still forms a laminated structure at at least part of positions in the circumferential direction, and adjacent layers at the laminated positions are attached to each other. By means of the design of the structure of the valve seat (1), the valve seat (1) can still maintain a complete annular structure in an expanded state, and the valve seat (1) can always maintain good integrity and stability, so that the valve seat (1) has a simpler structure, and has better practicability during implantation and use in a human body.

Description

Expandable valve seat and bioprosthesis Technical Field

The invention belongs to the technical field of biological valves, and in particular relates to an expandable valve seat and a biological valve using the expandable valve seat.

Background technique

Heart valve disease is a common complication of heart disease. Surgery can be used to replace or repair a diseased or damaged valve; in a traditional valve replacement procedure, the damaged leaflets are usually removed and the annulus is shaped to accept a replacement artificial valve.

An artificial heart valve usually includes a support structure arranged in the valve assembly. The support structure usually adopts a rigid structure and can be made of various biocompatible materials such as metal, plastic, ceramic, etc. The life of a biological valve is usually 10-20 years. After reaching the service life, the valve performance will decline. At this time, the patient is often too old and his body function is difficult to accept surgical operations. At present, an interventional valve is usually implanted in the original implanted biological valve. However, due to the influence of the original biological valve leaflets, the interventional valve frame, etc., the implanted interventional valve model must be at least one model smaller than the original biological valve, which will greatly reduce the overall blood flow channel area (valve orifice area) of the implanted biological valve, so that the postoperative cardiac hemodynamic condition cannot meet the patient's physical needs, resulting in poor postoperative effects.

Summary of the invention

The object of the present invention is to provide an expandable valve seat and a biological valve, so as to solve the problems that the effect of the biological valve becomes poor and the valve seat structure becomes complicated after the interventional valve is implanted.

The present invention is achieved through the following technical solutions:

An expandable petal seat, the petal seat being a coiled annular structure with two free ends, and when the petal seat is subjected to an expansion force from inside to outside in a first use state, it can expand to a second use state that is still annular, and the diameter in the second use state is greater than the diameter in the first use state;

In the first usage state, the petal seat forms a stacked structure at least in part of the circumferential direction, and adjacent layers at the stacked position fit together; in the second usage state, the petal seat still forms a stacked structure at least in part of the circumferential direction, and adjacent layers at the stacked position fit together.

As a further improvement to the above technical solution, in the first use state, the petal seat forms a double-layer stacked structure over the entire circumference.

As a further improvement of the above technical solution, in the first usage state, the petal seat includes an inner ring wound in a complete circle and an outer ring wound outside the inner ring, one end of the inner ring is a free end, and the other end is connected to one end of the outer ring.

As a further improvement to the above technical solution, the width of the inner circle of the petal seat is different from the width of the outer circle.

As a further improvement to the above technical solution, the width of the outer ring of the petal seat is smaller than the width of the inner ring.

As a further improvement to the above technical solution, in the first use state, the petal seat presents a wave-shaped structure with multiple wave crests and multiple wave troughs in the circumferential direction.

As a further improvement to the above technical solution, the inner ring and the outer ring are in a wave-shaped structure in the circumferential direction.

As a further improvement to the above technical solution, adjacent layers on the petal seat are fixedly connected at at least one position by binding, welding or bonding.

On the other hand, the present invention also provides a biological valve with an expandable valve seat, wherein the valve seat is covered with a covering cloth, and the covering cloth is sutured along the circumferential direction of the valve seat to form a closed cylindrical structure, and the alignment of the sutures along the circumferential direction forms a contour structure in which the walls and the mouths are arranged in sequence at intervals.

As a further improvement of the above technical solution, the suture thread includes a needle-removing wiring portion and a return needle wiring portion which run in a clockwise or counterclockwise direction according to the wiring structure, and the needle-removing wiring portion and the return needle wiring portion cooperate with each other so that the position of the stack wall contour/stack mouth contour of the needle-removing wiring portion corresponds to the position of the stack mouth contour/stack wall contour of the return needle wiring portion; preferably, the return needle wiring portion and the needle-removing wiring portion are continuously sutured, and the routing direction of the return needle wiring portion is opposite to the routing direction of the needle-removing wiring portion.

Compared with the prior art, the present invention has the following beneficial effects:

The valve seat in the present invention is formed by winding a strip plate, so that the valve seat has good overall stability and can expand to the required diameter when subjected to an expansion force, thereby solving the limitation on the size of the interventional valve when the interventional valve is implanted; by designing the valve seat structure, the valve seat can still maintain a complete annular structure in the expanded state, so that the valve seat can always maintain good integrity and stability without the need to set other additional structures on the valve seat, making the structure of the valve seat simpler and having better practicality during implantation in the human body and use.

In the setting of the valve seat structure, the operability and stability of the expansion performance of the valve seat and the biological valve during use are very important for the use of the biological valve. Therefore, while realizing the expandability of the valve seat, it is necessary to ensure that the valve seat of the stacked structure can slide smoothly against each other and expand under the action of the expansion force, and to avoid the coating covering the outside of the valve seat from hindering the expansion of the valve seat during the expansion process. The valve seat is designed as a double-layer stacked structure consisting of an inner ring and an outer ring. The inner ring serves as the basic skeleton of the valve seat and is used as the connection basis between the valve seat and the valve frame, leaflets and other structures. The outer ring is arranged on the outside of the inner ring to provide a tensioning force for the inner ring, so that the inner ring can be in the initial state and the expanded state. Good structural stability can be maintained under all circumstances; on this basis, the width of the outer ring is designed to be smaller than that of the inner ring. Under the premise of meeting the above functions, the friction between the inner ring and the outer ring is reduced due to the smaller overlapping area of the inner ring and the outer ring, thereby facilitating the expansion of the valve seat; at the same time, when the valve seat based on the waveform structure forms a covering fit with the covering cloth, the setting of the width between the outer ring and the inner ring can reduce the demand of the valve seat for the internal space of the covering cloth in the expanded state when the valve seat expands, that is, it can reduce the restraint of the covering cloth on the valve seat during expansion, so as to facilitate the smooth expansion of the valve seat. These designs are undoubtedly very beneficial to the practical performance of the valve seat and the biological valve seat.

In terms of the practicality of the valve, the structural characteristics of the expandable valve seat are combined with the corresponding design of the suture routing method of the coating cloth in the biological valve, so that the suture line has better ductility in all directions, further reducing the obstruction caused by the coating cloth when the stacked structure valve seat is expanded, and facilitating the smooth expansion of the valve seat.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

FIG1 is a schematic structural diagram of an embodiment of an expandable valve seat of the present invention in a first use state.

FIG. 2 is a schematic structural diagram of an embodiment of an expandable valve seat of the present invention in a second use state.

FIG3 is a schematic structural diagram of another embodiment of the expandable valve seat of the present invention in a first use state.

FIG. 4 is a schematic structural diagram of another embodiment of the expandable valve seat of the present invention in a second use state.

FIG. 5 is a schematic diagram of the suture structure on the biological valve seat of the present invention.

FIG. 6 is a schematic diagram of a routing structure of sutures on a biological valve seat of the present invention.

FIG. 7 is a schematic diagram of a suture line structure of a biological valve seat in a suture state according to the present invention.

FIG. 8 is a schematic diagram of another routing structure of the suture thread on the biological valve seat of the present invention.

FIG. 9 is a schematic diagram of another wiring structure of the suture thread on the biological valve seat of the present invention in the suture state.

Wherein: 1, petal seat, 11, inner ring, 12, outer ring;

2. Binding thread, 3. Wing edge, 4. Covering cloth, 5. Suture thread, 5a. Needle and thread routing section, 5b. Back-needle and thread routing section.

Detailed ways

In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments.

As an important component of a biological valve, the valve seat meets the conventional functional properties and performance requirements of a biological valve. However, when a conventional biological valve needs to be implanted into an interventional valve, the valve seat structure cannot be deformed, resulting in the implanted interventional valve model being one size smaller than the previously implanted biological valve, thereby reducing the blood flow channel area after the interventional valve is implanted. To address this issue, the valve seat is set as an expandable structure, so that when the interventional valve is implanted, a balloon can be used to expand the valve seat structure in the original biological valve to increase the inner diameter of the valve seat structure. At this time, the size of the re-implanted interventional valve can be increased to ensure the performance of the biological valve after the interventional valve is implanted.

As an expandable valve seat, in the case of achieving its expandable performance, the integrity of the valve seat structure and the structural stability of the valve seat in different use states are also considered when achieving the performance of the biological valve. Usually, the valve seat and the biological valve need to achieve two use states. The first use state is the initial state or the unexpanded state of the valve seat. The second use state is to expand the valve seat to a size suitable for the implantation of the interventional valve by using a balloon when the interventional valve needs to be implanted, that is, the expanded state.

Based on the function to be achieved by the valve seat, as shown in Figures 1 and 2, this expandable valve seat 1 can be formed by winding a strip plate with two free ends, and wound into the annular structure required for the valve seat in the biological valve. At this time, the valve seat is actually a movable structure with two free ends. When the valve seat is subjected to an expansion force from the inside to the outside in the first use state, it can expand to a second use state that is still annular. Obviously, the diameter of the valve seat in the second use state is larger than the diameter in the first use state.

One of the design features of the petal seat is that, in the first use state, the petal seat forms a stacked structure at some or all positions in the circumferential direction, and the adjacent layers at the stacked positions form a tightly fitting structure, so that the petal seat has good integrity and structural stability based on the elasticity and other properties of the material (such as memory alloy, etc.) used and the structural characteristics. Of course, here, in order to further ensure the structural stability of the petal seat in the first use state, in the first use state, the adjacent layers on the petal seat are fixedly connected by means of binding wire 2, welding (such as spot welding, etc.) or bonding, and the fixed connection points can be set as needed, and the force of the fixed connection is generally able to withstand the expansion of the balloon 0-2 atmospheres without damage, so that the petal seat can maintain good integrity and stability before expansion, and should be able to be damaged and fail when subjected to the expansion force of 2-5 atmospheres. When the layers of the petal seat are fixed by binding wire, a corresponding binding wire groove can be set at the position where the binding wire is set on the petal seat to fix the position of the binding wire. Of course, the method of fixing and connecting adjacent layers on the petal seat is not limited to the above-mentioned methods. Other conventional connection methods that can be applied to fix the petal seats can also be applied to fix the petal seats.

In the second use state, the valve seat 1 still forms a stacked structure at least in some positions in the circumferential direction, and the adjacent layers at the stacked positions fit each other; at this time and in this state, the valve seat can still form a complete annular structure, and based on its own structure, the valve seat can have good integrity and stability in the expanded state, without the need to set other structures on the valve seat, such as setting a connecting structure or a limiting structure at its two free ends to connect the two free ends to form an integral structure of the valve seat. Obviously, the valve seat adopting this structural form has a simpler structure while meeting its expansion performance and use performance. This feature has a very obvious effect in the operation of implanting a biological valve into the human body.

As a better implementation method and also another design feature of the petal seat structure, in the first usage state, the petal seat forms a double-layer stacked structure on the entire circumference. The use of this structure can maximize the realization of better comprehensive performance of the petal seat in two usage states, such as structural stability, deployability, and petal seat quality.

As another preferred embodiment, in the first use state, the petal seat 1 is composed of an inner ring 11 wound in a complete circle and an outer ring 12 wound outside the inner ring, as shown in Figures 3 and 4, wherein one end of the inner ring 11 is one of the free ends of the petal seat, and the other end of the inner ring is connected to one end of the outer ring, and the outer ring 12 wraps around the inner ring for a circle, and the other end of the outer ring is the other free end of the petal seat. At this time, the inner ring forms the basic skeleton of the petal seat, and the outer ring is wound around the outer surface of the inner ring, which plays a role of holding the inner ring tightly, so as to improve the stability of the basic skeleton structure of the petal seat, so that the petal seat structure with two free ends still has good integrity.

As another better implementation, the inner ring 11 and the outer ring 12 of the petal seat are set to have different widths. This structure can reduce the area of contact between the outer ring and the inner ring through the differentiated design of the width of the outer ring and the inner ring of the petal seat, and can greatly reduce the friction resistance between the inner ring and the outer ring of the stacked winding arrangement during expansion, thereby making it easier for the petal seat to implement expansion operations and avoiding jamming.

As a more effective implementation method, the width of the outer ring 12 of the valve seat is designed to be smaller than the width of the inner ring 11. This improvement is based on the combined structural form of the outer ring and the inner ring of the valve seat. The large width of the inner ring makes it as a basic skeleton to make the valve seat structure more stable, so that the inner ring and the outer ring can play their respective roles in the valve seat. It can be imagined that the reliability of the valve seat expansion operation when the biological valve is implanted in the human body has an important impact on the operability of the operation and the safety of the operation. At the same time, when the valve seat is used in the biological valve, a layer of coating cloth is usually coated on the outside of the valve seat. Although the coating cloth adopts a certain elasticity of fabric, it still has a certain impact on the expansion of the valve seat when the valve seat expands, especially when the valve seat adopts a corrugated spiral structure. Therefore, reducing the impact of the coating cloth when the valve seat expands is also a consideration in the design of the valve seat structure; and here, by reducing the width of the outer ring, it can well solve the possible obstruction of the valve seat by the coating cloth when the valve seat expands.

As another embodiment, in the first use state, the petal seat 1 is a wave structure with multiple peaks and multiple troughs in the circumferential direction. Referring to the petal seat shown in Figures 1 and 2, the petal seat has three peaks and three troughs in the unexpanded state, wherein the inner ring 11 and the outer ring 12 are both wave structures in the circumferential direction, and the waveforms of the inner ring and the outer ring are set correspondingly. In the structure where the width of the outer ring is smaller than the width of the inner ring, the inner ring 11 serves as the basic skeleton of the petal seat, and the outer ring is a thin strip plate structure wrapped outside the inner ring. The outer ring also has a wave structure that matches the inner ring, so that the outer contour of the petal seat is basically the same as the outer contour of the inner ring. When the petal seat is expanded, the peaks and troughs of the inner and outer rings are separated. At this time, since the width of the outer ring is smaller than the width of the inner ring, that is, smaller than the width of the petal seat in the unexpanded state, the outer ring has a first activity space in the coating cloth during sliding expansion, reducing the influence of the coating cloth on the expansion of the petal seat.

On the other hand, the present invention also relates to a biological valve using the above-mentioned expandable valve seat, as shown in FIG5 . In general, a circle of wing edges 3 are arranged around the outside of the valve seat 1 in the biological valve, so as to fix the biological valve to the valve ring of the human body. At this time, a layer of wrapping cloth 4 is arranged outside the structure composed of the valve seat and the wing edges. The wrapping cloth 4 is usually made of external fabric to connect the valve frame and the leaflets. The wrapping cloth 4 is sutured with sutures 5 along the circumferential direction of the valve seat between the valve seat and the wing edges to form a closed cylindrical structure. As the wrapping cloth is a connecting structure for the valve seat and the wing edges and considering the expandability of the valve seat inside the wrapping cloth, the suture method of the wrapping cloth needs to have good structural strength and ductility of the suture position in all directions. The traditional suture method using sutures around the valve seat in a circular manner is obviously difficult to meet this functional requirement. Therefore, a jumping wiring method is adopted for this expandable valve seat structure, which is called radial suture method.

6 and 7, in this embodiment, the routing of the suture line along the circumferential direction of the petal seat presents a contour structure in which the wall and the crenel are arranged in sequence. It can be seen from the figure that the solid line part in FIG6 is the part of the suture line on the front side of the wrapping cloth, and the dotted line part is the part of the suture line on the back side of the wrapping cloth. The continuous solid line part and the dotted line part together form a contour structure of the wall and the crenel, and the suture position of the wrapping cloth is sutured and connected. With this structure, the suture operation of the wrapping cloth is realized by sewing a circle on the entire circumference. The use of this routing structure can well meet the requirements of the ductility of the wrapping cloth at the suture position.

In order to further meet the requirements of the structural strength of the suture position, as shown in Figures 8 and 9, the suture line includes a needle-removing wiring part 5a (shown by the dark lines in Figure 8) and a return needle wiring part 5b (shown by the light lines in Figure 8) that run in a clockwise or counterclockwise direction according to the wiring structure, and the needle-removing wiring part 5a and the return needle wiring part 5b cooperate with each other, so that the position of the wall contour/crenel contour of the needle-removing wiring part 5a corresponds to the position of the crenel contour/crenel contour of the return needle wiring part 5b. Among them, the return needle wiring part 5b and the needle-removing wiring part 5a are routed in a continuous suture manner, and at this time, the routing direction of the return needle wiring part 5b is opposite to the routing direction of the needle-removing wiring part 5a, so as to further improve the overall structural strength of the suture position of the covering cloth, and at the same time, it can prevent leakage of the biological valve at the suture position.

When the valve seat and the biological valve are in a first use state, the structure of the valve seat itself or a fixed connection method such as binding wires can withstand the normal diastolic force of the heart valve ring, and the valve seat can always maintain good integrity and stability.

The valve seat and the biological valve are in the second state of use, which is the state of use in which the valve seat structure in the biological valve is expanded. In this state, an interventional valve needs to be implanted in the biological valve. At this time, the force of the balloon can be used to make the fixed connection structure such as the binding wire invalid and expand the valve seat/biological valve to the required diameter of the interventional valve, so as to implant the interventional valve in the biological valve. Usually, the diameter of the valve seat in the second state of use is 1-4mm larger than the diameter in the first state of use.

In the description of the present invention, it should be noted that the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside", etc. used to indicate the orientation or position relationship are based on the orientation or position relationship shown in the accompanying drawings, or are the orientation or position relationship commonly placed when the product of the invention is used. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

In addition, if the terms "horizontal" or "vertical" appear in the description of the present invention, it does not mean that the components are required to be absolutely horizontal or suspended, but can be slightly tilted. For example, "horizontal" only means that its direction is more horizontal than "vertical", and does not mean that the structure must be completely horizontal, but can be slightly tilted.

In the description of the present invention, it is also necessary to explain that, unless otherwise clearly specified and limited, the terms "set", "install", "connect", and "connect" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

The above description is only a preferred embodiment of the present invention and does not limit the present invention in any form. Any simple modification or equivalent change made to the above embodiment based on the technical essence of the present invention shall fall within the protection scope of the present invention.

Claims (10)

The expandable petal seat is characterized in that the petal seat is a wound annular structure with two free ends, and when the petal seat is subjected to an expansion force from the inside to the outside in a first use state, it can be expanded to a second use state that is still annular, and the diameter in the second use state is greater than the diameter in the first use state; In the first usage state, the petal seat forms a stacked structure at least in part of the circumferential direction, and adjacent layers at the stacked position fit together; in the second usage state, the petal seat still forms a stacked structure at least in part of the circumferential direction, and adjacent layers at the stacked position fit together. The expandable petal seat according to claim 1 is characterized in that, in the first use state, the petal seat forms a double-layer stacked structure over the entire circumference. The expandable petal seat according to claim 1 or 2 is characterized in that, in a first usage state, the petal seat includes an inner ring wound in a complete circle and an outer ring wound outside the inner ring, one end of the inner ring is a free end, and the other end thereof is connected to one end of the outer ring. The expandable petal seat according to claim 3 is characterized in that the width of the inner circle of the petal seat is different from the width of the outer circle. The expandable petal seat according to claim 4 is characterized in that the width of the outer circle of the petal seat is smaller than the width of the inner circle. The expandable petal seat according to any one of claims 3 to 5 is characterized in that, in a first usage state, the petal seat presents a wave-shaped structure having a plurality of crests and a plurality of troughs in a circumferential direction. The expandable valve seat according to claim 6 is characterized in that the inner ring and the outer ring are in a wavy structure in the circumferential direction. The expandable petal seat according to claim 1 is characterized in that adjacent layers on the petal seat are fixedly connected at at least one position by binding, welding or bonding. A biological valve with an expandable valve seat as described in any one of claims 1 to 8 is characterized in that the valve seat is covered with a covering cloth, and the covering cloth is sutured along the circumferential direction of the valve seat to form a closed cylindrical structure, and the alignment of the sutures along the circumferential direction forms a contour structure in which the walls and the crenels are arranged in sequence at intervals. The biological valve according to claim 9 is characterized in that the suture thread includes a needle-removing wiring portion and a return-needle wiring portion that are routed in a clockwise or counterclockwise direction according to the routing structure, and the needle-removing wiring portion and the return-needle wiring portion cooperate with each other so that the position of the stack wall contour/stack mouth contour of the needle-removing wiring portion corresponds to the position of the stack mouth contour/stack wall contour of the return-needle wiring portion; preferably, the return-needle wiring portion and the needle-removing wiring portion are continuously sutured, and the routing direction of the return-needle wiring portion is opposite to the routing direction of the needle-removing wiring portion.

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