CN115553979A

CN115553979A - Expandable valve seat and biological valve

Info

Publication number: CN115553979A
Application number: CN202211498084.7A
Authority: CN
Inventors: 钟生平; 刘静; 靳永富
Original assignee: Kingstronbio Changshu Co ltd
Current assignee: Kingstronbio Changshu Co ltd
Priority date: 2022-11-28
Filing date: 2022-11-28
Publication date: 2023-01-03
Also published as: WO2024113436A1

Abstract

The invention discloses an expandable valve seat and a biological valve, wherein the valve seat is of an annular structure formed by winding a strip-shaped plate with two free ends, and can be expanded to a second annular use state when the valve seat is subjected to an expansion acting force from inside to outside in a first use state, and the diameter of the valve seat in the second use state is larger than that of the valve seat in the first use state; in a first use state, the petal seats form a laminated structure at least at partial positions in the circumferential direction, and adjacent layers are mutually attached at the laminated position; in the second use state, the petal seat forms a laminated structure in the circumferential direction at least at partial position, and adjacent layers at the laminated position are mutually attached. Through designing the petal seat structure, the petal seat still can keep complete annular structure under the expansion state, and the petal seat can keep better wholeness and stability all the time, makes the structure of petal seat simpler, has better practicality in implanting human body and use.

Description

Expandable valve seat and biological valve

Technical Field

The invention belongs to the technical field of biological valves, and particularly relates to an expandable valve seat and a biological valve adopting the expandable valve seat.

Background

Valvular heart disease is a common disease in heart disease. Replacement or repair of diseased or damaged valves may be employed in surgery; in conventional valve replacement procedures, the damaged leaflets are typically excised and the annulus sculpted to receive a replacement prosthetic valve.

Prosthetic heart valves typically include a support structure disposed within a valve assembly, which is typically a rigid structure and may be made of various biocompatible materials, such as metal, plastic, ceramic, and the like. Typically, biological valves have a life span of 10-20 years, and after the life span is reached, the valve performance will decline; at this time, the body functions are difficult to be operated due to the high annual condition of the patient, and an intervention valve is usually implanted in the originally implanted biological valve. However, under the influence of the original biological valve leaflet and the intervention valve frame, the implanted intervention valve model is smaller than the original biological valve by at least one model, which greatly reduces the whole blood flow channel area (valve orifice area) of the implanted biological valve, so that the postoperative cardiac blood flow dynamic condition can not meet the requirement of the body of a patient, and the postoperative effect is poor.

Disclosure of Invention

The invention aims to provide an expandable valve seat and a biological valve, and solves the problems that the effect of the biological valve is poor and the structure of the valve seat is complex after an intervention valve is implanted.

The invention is realized by the following technical scheme:

the valve seat is of a winding annular structure with two free ends, and can be expanded to a second annular use state when subjected to expansion acting force from inside to outside in the first use state, and the diameter of the valve seat in the second use state is larger than that in the first use state;

in a first use state, the petal seats form a laminated structure at least at partial positions in the circumferential direction, and adjacent layers are mutually attached at the laminated position; in the second use state, the petal seat forms a laminated structure in the circumferential direction at least at partial position, and adjacent layers at the laminated position are mutually attached.

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

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

As a further improvement to the technical scheme, the width of the inner ring of the petal seat is different from that of the outer ring.

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

As a further improvement to the above technical solution, in the first use state, the petal seat has a waveform structure having a plurality of wave crests and a plurality of wave troughs in the circumferential direction.

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

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

On the other hand, the invention also provides a biological valve adopting the expandable valve seat, the valve seat is externally coated with wrapping cloth, the wrapping cloth is sewn by adopting a suture in the circumferential direction of the valve seat to form a closed cylindrical structure, and the routing of the suture in the circumferential direction is in a contour structure that buttress walls and buttress openings are sequentially arranged at intervals.

As a further improvement to the above technical solution, the suture thread includes a needle-removing thread-routing portion and a needle-returning thread-routing portion that are routed in a clockwise or counterclockwise direction according to a routing structure, and the needle-removing thread-routing portion and the needle-returning thread-routing portion are mutually matched, so that positions of a buttress wall contour/buttress wall contour of the needle-removing thread-routing portion respectively correspond to positions of a buttress wall contour/buttress wall contour of the needle-returning thread-routing portion; preferably, the back needle running part and the needle removing running part are continuously sewn, and the running direction of the back needle running part is opposite to the running direction of the needle removing running part.

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

the valve seat is formed by winding a strip-shaped plate, so that the valve seat has better overall stability and can be expanded to a required specification diameter when subjected to expansion acting force, and the limitation to the specification and size of an intervention valve when the intervention valve is implanted is solved; through designing the petal seat structure, the petal seat still can keep complete annular structure under the expansion state, need not set up under the condition of other additional structures on the petal seat like this, and the petal seat can keep better wholeness and stability all the time, makes the structure of petal seat simpler, has better practicality in implanting human body and use.

In the arrangement of the valve seat structure, the operability and stability of the expansion performance of the valve seat and the biological valve in the use process are very important for the use of the biological valve, so that the valve seat can expand while ensuring that the valve seat of the laminated structure can smoothly slide and expand under the action of expansion force, and the problem that the valve seat is expanded by coating cloth coated outside the valve seat in the expansion process to form obstruction is avoided; on the basis, the width of the outer ring is designed to be smaller than that of the inner ring, so that the friction force between the valve seat and the outer ring is reduced when the valve seat is unfolded on the premise of meeting the functions because the laminated area of the inner ring and the outer ring is reduced invisibly, and the valve seat is convenient to expand; simultaneously, the petal seat based on wave structure forms the cladding when cooperating with between the involucrum cloth, and setting up of width can be when the petal seat expands between outer lane and the inner circle, reduces under the expansion state the petal seat to the demand of involucrum cloth inner space, can reduce the constraint of involucrum cloth to the petal seat when expanding promptly to make things convenient for the smooth extension of petal seat, these designs are very profitable to the practicality of petal seat and biological petal seat undoubtedly.

Combine this kind of extensible valve seat structural feature in the practicality of valve, walk the stylolite to the coating cloth in the biological valve and walk the line mode and carry out corresponding design, make the stylolite have better ductility in all directions, the hindrance that the coating cloth brought when the expansion of the valve seat that further reduces stacked structure makes things convenient for smooth extension of valve seat.

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 described below, it should be understood that the following drawings only illustrate some embodiments of the present invention, and therefore should not be considered as limiting the scope, and for those skilled in the art, other related drawings can be obtained according to the drawings without inventive efforts.

FIG. 1 is a schematic view of an embodiment of an expandable flap seat of the present invention in a first use configuration.

Fig. 2 is a schematic structural view of an embodiment of the expandable flap seat of the present invention in a second use state.

Fig. 3 is a schematic view of another embodiment of an expandable seat of the present invention in a first use configuration.

Fig. 4 is a schematic structural view of another embodiment of the expandable flap seat of the present invention in a second use condition.

Fig. 5 is a schematic view of the structure of the suture on the biologic valve seat of the invention.

Fig. 6 is a schematic view of a routing structure of a suture on a biologic valve seat according to the invention.

Fig. 7 is a structural diagram of a suture state of a suture structure of the suture line on the biological valve seat of the invention.

Fig. 8 is a schematic view of another routing structure of the suture on the biologic valve seat of the invention.

Fig. 9 is a structural diagram of another suture state of the suture structure on the biologic valve seat according to the invention.

Wherein: 1. a petal seat 11, an inner ring 12 and an outer ring;

2. binding thread 3, wing edge 4, coating cloth 5, sewing thread 5a, needle removing thread part 5b and needle returning thread part.

Detailed Description

In order to make the objects, 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 with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention.

The valve seat is used as an important component of the biological valve, the conventional functional attribute and performance requirement of the biological valve are met, and meanwhile, when the intervention valve needs to be implanted based on the conventional biological valve, the structure of the valve seat cannot deform, so that the model of the implanted intervention valve is smaller than that of the previously implanted biological valve, and the area of a blood flow channel after the intervention valve is implanted can be reduced. To this problem, set up the valve seat into expandable structure, when implanting and intervene the valve like this, can adopt the sacculus to strut the valve seat structure in the original biological valve, increase the internal diameter size of valve seat structure, can increase the model size of the intervention valve of implanting again this moment, guarantee to implant the performance of intervene valve back biological valve.

As an expandable valve seat, the structural integrity of the valve seat and the structural stability of the valve seat in different use states are also considerations in achieving the performance of a biological valve while achieving its expandable performance. Generally, a valve seat and a biological valve need to achieve two use states, wherein the first use state is an initial state or an unexpanded state of the valve seat, and the second use state is an expanded state which is a size suitable for the implantation of the intervention valve by using a balloon when the intervention valve needs to be implanted.

Based on the function to be achieved by the valve seat, referring to fig. 1 and 2, such an expandable valve seat 1 can be formed by winding a strip-shaped plate with two free ends, and is wound into an annular structure required by the valve seat in the biological valve, where the valve seat is actually a movable structure with two free ends, and when the valve seat is subjected to an expanding force from inside to outside in a first use state, the valve seat can be expanded to a second use state which is still annular, and obviously, the diameter of the valve seat in the second use state is larger than that 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 laminated structure in partial or all positions in the circumferential direction, and adjacent layers in the laminated position form a tightly-clasping structure, so that the petal seat has good integrity and structural stability based on the elasticity and other properties of the adopted materials (such as memory alloy and the like) and the structural features. Of course, in order to further ensure the structural stability of the valve seat in the first use state, the adjacent layers are fixedly connected by using the binding wires 2, welding (such as spot welding and the like) or bonding and the like between the adjacent layers on the valve seat, the fixed connection points can be arranged as required, and the acting force of the fixed connection can not be damaged under the expansion action of 0-2 atmospheric pressure of the balloon, so that the valve seat can keep better integrity and stability before expansion, and can be damaged and failed under the expansion action of 2-5 atmospheric pressure. When the tying wire is adopted to fix the valve seat layers, the corresponding wire tying groove can be arranged at the position of the valve seat where the tying wire is arranged to fix the position of the tying wire. Of course, the manner of fixedly connecting the adjacent layers on the flap seat is not limited to the above-listed manner, and other conventional connection manners that can be applied to the fixed connection between the flap seats can be applied to the fixation of the flap seat.

In the second use state, the valve seat 1 still forms a laminated structure at least at partial position in the circumferential direction, and adjacent layers at the laminated position are mutually attached; at this moment, under this state, the petal seat still can form a complete ring structure, just can make the petal seat have better wholeness and stability under the expansion state based on its own structure, and need not set up other structures on the petal seat, for example set up connection structure or limit structure at its two free ends and make the petal seat form monolithic structure to connect the mode of two free ends. Obviously, the valve seat adopting the structure has simpler structure under the condition of meeting the expansion performance and the use performance, and the effect of the characteristic in the operation of implanting the biological valve into the human body is very obvious.

As a better implementation mode, the valve seat structure has another design characteristic, in the first use state, the valve seat just forms a double-layer laminated structure on the whole circumference, and by adopting the structure, the better comprehensive performances of the valve seat, such as structural stability, developability, valve seat quality and the like in the two use states can be realized to the greatest extent.

As another preferred embodiment, in the first usage 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 fig. 3 and 4, wherein one end of the inner ring 11 is one of the free ends of the petal seat, the other end of the inner ring is connected with one end of the outer ring, the outer ring 12 surrounds the inner ring for one circle, and the other end is the other free end of the petal seat. At this moment, the inner circle forms the basic skeleton of valve seat, and the outer lane is convoluteed the cladding in the inner circle surface, plays the effect of holding tightly to the inner circle to improve valve seat basic skeleton structure's stability, make this kind of valve seat structure that has two free ends still have fine wholeness.

As another preferred embodiment, the inner ring 11 and the outer ring 12 of the petal seat are set to have different widths, and in this structure, through the design of difference of the widths of the outer ring and the inner ring of the petal seat, the area of attachment between the outer ring and the inner ring can be reduced, and the frictional resistance between the inner ring and the outer ring in the stacked winding arrangement during expansion can be reduced to a great extent, so that the petal seat can be more convenient when the expansion operation is realized, and the occurrence of clamping stagnation is avoided.

As an embodiment with better effect, the width of the outer ring 12 of the petal seat is designed to be smaller than that of the inner ring 11, the improvement is based on the combination structure form of the outer ring and the inner ring of the petal seat, the inner ring with large width is used as a basic framework to enable the structure of the petal seat to be more stable, and therefore the inner ring and the outer ring respectively play the roles of the inner ring and the outer ring in the petal seat. It is conceivable that the reliability of the valve seat expanding operation when the biological valve is implanted in the human body is of great importance in terms of both the operability of the operation and the safety during the operation. Meanwhile, when the valve seat is used in a biological valve, a layer of coating cloth is usually coated outside the valve seat, although the coating cloth has certain elasticity due to the adoption of fabric, the coating cloth still has certain influence on the expansion of the valve seat when the valve seat is expanded, and particularly when the valve seat adopts a wave-shaped spiral structure, the influence caused by the coating cloth when the valve seat is expanded is also required to be considered in the design of the valve seat structure; and the problem that the coating cloth possibly obstructs the valve seat when the valve seat expands can be well solved by reducing the width of the outer ring.

As another embodiment, in the first usage state, the petal seat 1 has a wave structure with a plurality of wave crests and a plurality of wave troughs in the circumferential direction, and referring to the petal seat shown in fig. 1 and 2, the petal seat has three wave crests and three wave troughs in the non-expanded state, wherein the inner ring 11 and the outer ring 12 both have a wave structure in the circumferential direction, and the wave forms of the inner ring and the outer ring are correspondingly arranged. In the structure that the width of the outer ring is smaller than that of the inner ring, the inner ring 11 is used as a basic framework of the petal seat, the outer ring is of a thin strip plate-shaped structure and covers the outer part of the inner ring, and the outer ring is also of a wave structure matched with the inner ring, so that the outline of the petal seat is basically the same as that of the inner ring. The petal seat is when the expansion, and the crest, the trough phase separation of inner circle, outer lane, because the width that the outer lane width is less than the inner circle also is less than the width of petal seat when not expanding the state this moment, consequently the outer lane has first activity space in the coating cloth when the expansion that slides, has reduced the influence that the coating cloth brought the expansion of petal seat.

On the other hand, the invention also relates to a biological valve using the expandable valve seat, as shown in fig. 5, in general, a circle of flanges 3 is arranged around the outside of the valve seat 1 in the biological valve for fixing the biological valve to the annulus of the human body, at this time, a layer of coating cloth 4 is coated outside the structure formed by the valve seat and the flanges, and the coating cloth 4 usually adopts an external fabric for connecting the valve frame and the valve leaflets. The coating cloth 4 is sewed by a sewing thread 5 along the circumferential direction of the valve seat between the valve seat and the wing edge to form a closed cylindrical structure. The coating cloth is used as a connecting structure for the valve seat and the wing edge, the expandability of the valve seat in the coating cloth is considered, the sewing mode of the coating cloth can have good structural strength and the extensibility of the sewing position in all directions, the traditional sewing mode of the suture line which is circularly wired around the valve seat is obviously difficult to meet the functional requirements, and therefore, a jumping wiring mode is adopted for the expandable valve seat structure, and the mode is called as a radial sewing method.

Referring to fig. 6 and 7, in the present embodiment, the running line of the suture along the circumferential direction of the flap seat is a contour structure in which the buttress wall and the buttress gap are sequentially arranged at intervals, as can be seen from the figure, the solid line part in fig. 6 is the part of the suture on the front side of the coating cloth, the dotted line part is the part of the suture on the back side of the coating cloth, the continuous solid line part and the dotted line part together form the contour structure of the buttress wall and the buttress gap, the suture position of the coating cloth is connected by suturing, and the suture operation of the coating cloth is realized by sewing one circle on the whole circumference by adopting the structure. The requirement of the coating cloth on the extensibility of the sewing position can be well met by adopting the routing structure.

To further satisfy the structural strength requirement of the suture site, as shown in fig. 8 and 9, the suture includes a needle-removing thread portion 5a (indicated by dark lines in fig. 8) and a needle-returning thread portion 5b (indicated by light lines in fig. 8) which are routed in a clockwise or counterclockwise direction according to a routing structure, and the needle-removing thread portion 5a and the needle-returning thread portion 5b are engaged with each other such that the position of the buttress contour/crenellation contour of the needle-removing thread portion 5a corresponds to the position of the buttress contour/buttress contour of the needle-returning thread portion 5b, respectively. The back needle routing part 5b and the needle removing routing part 5a are routed in a continuous sewing mode, and the routing direction of the back needle routing part 5b is opposite to that of the needle removing routing part 5a, so that the overall structural strength of the sewing position of the wrapping cloth is further improved, and meanwhile, the condition of liquid leakage at the sewing position of the biological valve can be prevented.

This valve seat, biological valve are under first user state, and normal diastolic effort of heart valve ring can be born to valve seat structure itself or the mode that adopts fixed connection such as ligature line, and better wholeness and stability can be kept throughout to the valve seat.

The valve seat and the biological valve are in a second use state, namely an expansion use state of the valve seat structure in the biological valve, in the second use state, an intervention valve needs to be implanted in the biological valve, and at the moment, the valve seat/the biological valve can be expanded to the required specification diameter of the intervention valve by enabling a fixing connection structure such as a binding wire to be invalid through the acting force of the saccule so as to implant the intervention valve in the biological valve. Typically the diameter of the valve seat in the second condition of use is 1-4mm greater than the diameter in the first condition of use.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. used herein refer to the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the products of the present invention are used, and are used for convenience of description and simplicity of description, but do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be construed as limiting the present invention.

Furthermore, the terms "horizontal", "vertical" and the like when used in the description of the present invention do not require that the components be absolutely horizontal or overhanging, but may be slightly inclined. For example, "horizontal" merely means that the direction is more horizontal than "vertical" and does not mean that the structure must be perfectly horizontal, but may be slightly inclined.

In the description of the present invention, it should be further noted that unless otherwise explicitly stated or limited, the terms "disposed," "mounted," "connected," and "connected" should be interpreted broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

The above description is only a preferred embodiment of the present invention, and is not intended to limit the present invention in any way, and any simple modifications and equivalent variations of the above embodiment according to the technical spirit of the present invention are within the scope of the present invention.

Claims

1. The expandable valve seat is characterized in that the valve seat is of a winding annular structure with two free ends, when the valve seat is subjected to expansion acting force from inside to outside in a first use state, the valve seat can be expanded to a second use state which is still annular, and the diameter of the valve seat in the second use state is larger than that of the valve seat in the first use state;

in a first use state, the petal seats form a laminated structure at least at partial positions in the circumferential direction, and adjacent layers are mutually attached at the laminated position; in the second use state, the petal seat forms a lamination structure in the circumferential direction at least at partial positions, and adjacent layers at the lamination position are mutually attached.

2. The expandable petal seat according to claim 1, wherein in the first use state, the petal seat forms a double-layer lamination structure over exactly the entire circumference.

3. The expandable petal seat according to claim 1 or 2, wherein in the first use state, the petal seat comprises an inner ring wound as 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 of the inner ring is connected with one end of the outer ring.

4. The expandable seat of claim 3, wherein the inner ring of the seat has a different width than the outer ring.

5. The expandable petal seat according to claim 4, wherein the outer race of the petal seat has a width that is less than a width of the inner race.

6. The expandable petal seat according to any one of claims 3-5, wherein in the first use condition, the petal seat has a wave-shaped configuration with a plurality of wave crests and a plurality of wave troughs in the circumferential direction.

7. The expandable petal seat according to claim 6, wherein the inner ring and the outer ring have a wave-shaped configuration in a circumferential direction.

8. The expandable valve seat of claim 1, wherein adjacent layers on the valve seat are fixedly attached at least one location using a ligature, weld, or adhesive.

9. The biological valve with the expandable valve seat according to any one of claims 1 to 8, wherein the valve seat is coated with a coating cloth, the coating cloth is sewn by using a suture in the circumferential direction of the valve seat to form a closed cylindrical structure, and the suture is routed in the circumferential direction to form a contour structure with buttress walls and buttress openings arranged at intervals in sequence.

10. The biological valve according to claim 9, wherein the suture line comprises a needle removing routing portion and a needle returning routing portion which are routed according to a routing structure in a clockwise or counterclockwise direction, and the needle removing routing portion and the needle returning routing portion are matched with each other, so that the positions of the buttress contours/buttress contours of the needle removing routing portion correspond to the positions of the buttress contours/buttress contours of the needle returning routing portion respectively; preferably, the back needle running part and the needle removing running part are continuously sewn, and the running direction of the back needle running part is opposite to the running direction of the needle removing running part.