WO2014115479A1 - Stent, and stent-equipped prosthetic valve - Google Patents

Abstract

The purpose of the present invention is to provide a stent for a prosthetic valve and a stent-equipped prosthetic valve, with which a prosthetic valve can be indwelled in a stable state inside a body. A stent-equipped prosthetic valve (10) is provided with a stent (11), and a valve forming part (12) held by the stent (11). The stent (11) is provided with: a plurality of column parts (14) which extend in an axial direction, and which are provided at a prescribed spacing in a peripheral direction; and coupling parts (15) with which adjacent column parts (14) in the peripheral direction are coupled to each other. The column parts (14) are each provided with: a pair of column members (17) which extend in the axial direction, and which are provided side by side in the peripheral direction; and a plurality of joining members (18) which join each of the column members (17) to the other. Different coupling parts (15) are coupled to each of the pair of column members (17) in the peripheral direction. The plurality of joining members (18) include: first oblique joining members (18a) which extend obliquely with respect to the axial direction; second oblique joining members (18b) which extend obliquely with respect to the axial direction towards an opposite side to that of the first oblique joining members (18a); and orthogonal joining members (18c) which extend in a direction orthogonal with respect to the axial direction.

Description

Stent and prosthetic valve with stent

The present invention relates to a stent and a prosthetic valve with a stent.

In recent years, as a method for treating a diseased heart valve (for example, an aortic valve), a method has been proposed in which an artificial heart valve (artificial valve) is transported to a site where the heart valve is located using a delivery device such as a catheter. . According to this method, the burden on the patient can be greatly reduced as compared with a conventional surgical method in which a prosthetic valve is replaced with a diseased heart valve by heart valve surgery.

As this type of transcatheter heart valve treatment method, for example, Patent Document 1 discloses a method in which a prosthetic valve is integrated with a stent and delivered to a predetermined indwelling site. In this case, an artificial valve having a cylindrical portion and a plurality of valve membranes provided on the inner peripheral side of the cylindrical portion is used. In addition, the stent is formed into a tubular shape by a plurality of linear elements, extends in the axial direction and is provided at predetermined intervals in the circumferential direction, and a connecting portion that connects adjacent column portions to each other. Those having the following are used. More specifically, the pillar portion has a pair of pillar members that extend in the axial direction and are arranged in the circumferential direction, and a plurality of connecting members that connect the respective pillar members, and the connecting portion is In the adjacent column members, the column members on the sides close to each other are connected to each other. The prosthetic valve is integrated with the stent by joining the cylindrical portion to each column portion of the stent by sewing or the like in a state where the cylindrical portion is arranged coaxially with the stent. In addition, each connecting material of the column portion extends in a direction orthogonal to the axial direction.

The artificial valve placed in the body (specifically the valve membrane) opens and closes according to the heartbeat of the heart. Specifically, when the heart contracts and blood is pumped from the heart, the valve is pushed by the blood flow to open, while the heart relaxes and blood pumping is finished. The valve membrane closes and closes.

Special table 2011-509805 gazette

By the way, when the prosthetic valve is in the open state, the valve membrane is pressed and opened to the downstream side in the axial direction by the blood flow, so that a force directed toward the downstream side acts on the prosthetic valve. Further, when the artificial valve is in the closed state, the blood that is going to flow back to the upstream side hits the valve membrane in the closed state, and the upstream valve acts on the artificial valve. That is, in the indwelling state of the artificial valve, a force in the axial direction acts on the artificial valve. Therefore, a force in the axial direction also acts on each column portion of the stent to which the artificial valve is joined.

More specifically in this regard, each valve membrane of the artificial valve is made of, for example, a living tissue, and its shape and size are not necessarily the same but are considered to be different from each other. The sizes may be different from each other. Then, it is considered that the axial force acting on the artificial valve is different in the circumferential direction, and consequently the magnitude of the axial force acting on each column portion of the stent is also different. In this case, it is assumed that the column parts try to be displaced from each other in the axial direction, and as a result, a tensile force in the axial direction is generated in each connection part that connects adjacent column parts.

Here, in the configuration of Patent Document 1 in which the column members on the side close to each other in the adjacent column portions are connected by the connection portion, different connection portions are connected to the pair of column materials of the column portion in the circumferential direction. . Therefore, when a tensile force in the axial direction is generated in the connecting portion as described above, it is assumed that each column material of the column portion is pulled by a different connecting portion in a direction that causes a positional shift in the axial direction. Is done.

In this respect, in the stent of Patent Document 1 described above, the connecting material that connects the column members extends in a direction orthogonal to the axial direction, and therefore exhibits sufficient resistance against the force in the axial direction. It seems difficult. For this reason, there is a possibility that the column portion may be deformed by causing a shift in the axial direction of each column material. In that case, it may be difficult to place the artificial valve in a stable state.

The present invention has been made in view of the above circumstances, and has as its main object to provide a stent for an artificial valve and a prosthetic valve with a stent that allow the artificial valve to be stably placed in the body. Is.

In order to solve the above-mentioned problem, the stent of the first invention is formed into a tubular shape by a plurality of linear elements, and has a tubular portion and a plurality of valve membranes provided on the inner peripheral side of the tubular portion. A stent for a prosthetic valve for holding a forming portion, which extends in the axial direction of the stent, is disposed at a predetermined interval in the circumferential direction of the stent, and is integrated with the tubular portion, respectively. A plurality of pillars and a connecting part that connects the pillars adjacent to each other in the circumferential direction, and the pillars extend in the axial direction and are arranged in a row in the circumferential direction. Each of the pair of column members is connected to the different connecting portions in the circumferential direction, and the plurality of connection members are connected to each other. The material is inclined with respect to the axial direction A first oblique connecting member extending in a direction, a second oblique connecting member extending obliquely opposite to the first oblique connecting member with respect to the axial direction, and an orthogonal connecting member extending in a direction orthogonal to the axial direction. At least any two of the materials are included.

According to the present invention, at least the diagonal connecting material (specifically, at least one of the first diagonal connecting material and the second diagonal connecting material) is included in the plurality of connecting materials connecting the column materials in the column portion. Since the diagonal connecting member extends in a direction inclined with respect to the axial direction, in other words, extends in a predetermined direction including a component in the axial direction, each column member of the column portion is connected to each column member. When the portion is pulled in a direction that causes a positional shift in the axial direction, a resistance force can be applied to the tensile force. Thereby, the position shift to the axial direction of each pillar material can be suppressed, and as a result, a deformation | transformation of a column part can be suppressed. Therefore, the stented artificial valve can be placed in a stable state in the body.

The stent of the second invention is characterized in that, in the first invention, the plurality of connecting materials include an orthogonal connecting material extending in a direction orthogonal to the axial direction in addition to the oblique connecting material. To do.

In order to suppress the deformation of the column part, it is desirable to arrange a large number of diagonal connecting materials as connecting materials between a pair of column materials, but the diagonal connecting materials cannot be arranged so much between the column materials. Therefore, in the present invention, as the connecting material, an orthogonal connecting material is provided in addition to the oblique connecting material. In this case, it is possible to arrange a large number of connecting materials between the column members as compared with the case where only the oblique connecting materials are provided between the column members. Therefore, the strength of the pillar part can be suitably increased, and as a result, the deformation of the pillar part can be favorably suppressed.

The stent of the third invention is characterized in that, in the second invention, the orthogonal connecting material is formed of a linear element thicker than the oblique connecting material.

In order to suppress the deformation of the column part, it is desirable to increase the strength of the column part by forming the connecting material with a thick linear element. However, if the connecting material is thickened, the proportion of the connecting material between the column members increases, and the size of the gap formed between the connecting materials between the column members decreases. If it does so, it will become inconvenient when integrating a valve formation part in a pillar part using this crevice. For example, inconvenience occurs when the valve forming portion is partially integrated with the column portion through the gap, or when the valve forming portion is stitched and integrated with the column portion using the gap.

Therefore, in the present invention, in view of this point, in the second invention in which both the diagonal connecting material and the orthogonal connecting material are provided as the connecting material, the shorter side of the orthogonal connecting material and the diagonal connecting material is provided. The orthogonal connecting material is formed with a linear element thicker than the oblique connecting material. In this case, it is possible to increase the strength of the column portion while suppressing an increase in the ratio of the connecting material between the column members, that is, suppressing a decrease in the gap between the connecting members.

The stent of the 4th invention is the 2nd or 3rd invention. WHEREIN: The connection location with the said connection part in one pillar material among each pillar material of the said pillar part, and the said connection part in the other pillar material The connection location is set at the same position in the axial direction, and the orthogonal connecting material is provided so as to connect the connection locations.

In this type of stent, it is conceivable that the connecting portions respectively arranged between the pillar portions are arranged side by side in the circumferential direction. In this case, it is conceivable that the connecting portions connected to the connecting portions in the column members of the column portions are in the same position in the axial direction. Therefore, in the present invention, in such a configuration, an orthogonal connecting member is provided so as to connect the connecting portions of the respective column members with the connecting portions. In this case, since the adjacent connecting portions can be connected via the orthogonal connecting member with the pillar portion interposed therebetween, it is possible to suppress the displacement of the connecting portions. As a result, it is possible to increase the effect of suppressing the displacement between the column members to which the respective connecting portions are connected, and consequently to increase the effect of suppressing the deformation of the column portions.

The stent according to a fifth aspect of the present invention is the stent according to any one of the first to fourth aspects, wherein the plurality of connecting members include any one of the first oblique connecting member, the second oblique connecting member, and the orthogonal connecting member. A plurality of first linking materials and a plurality of second linking materials are included, and the first linking material and the second linking material are arranged so as to be alternately arranged in the axial direction. It is characterized by being continuous by being joined at the ends.

According to the present invention, since the truss made of the first connecting material, the second connecting material, and the column material can be continuously formed in the axial direction in the column portion, the column portion can be extremely strengthened. Thereby, a deformation | transformation of a pillar part can be suppressed notably and the indwelling state of an artificial valve can be made extremely stable.

A stent of a sixth invention is characterized in that, in any one of the first to fifth inventions, the oblique connecting material is arranged so as not to cross each other connecting material.

In the configuration in which the diagonal connecting material and the other connecting material are arranged so as to cross each other, there is a possibility that the gap formed between the connecting materials between the column members becomes very small. In that case, it may be difficult to integrate the valve forming portion using the gap. In that respect, in the present invention, since the diagonal connecting material is arranged so as not to intersect with other connecting materials, it is possible to suppress the gap between them from becoming small, and the column using the gap can be suppressed. This is a convenient configuration for integrating the valve forming part with the part.

A stent according to a seventh aspect is the stent according to any one of the first to sixth aspects, wherein the stent is formed of a material having radiopacity, and the stent is placed under X-ray projection on the column portion. When visually recognizing, the identification display part for discriminating whether the said pillar part is seen from the radial direction outer side and the inner side of the said stent is provided.

By the way, since each column part of the stent is provided side by side in the circumferential direction, when the stent is viewed under X-ray projection when the artificial valve is placed, the column part is arranged on the outer side (front side) and the inner side (back side) in the radial direction. It is assumed that it is difficult to determine from which side of Therefore, it is assumed that it is difficult to grasp the front and rear positions (specifically, the positions in the viewing direction) of the pillars in the body. Therefore, for example, when an artificial valve is placed in the body as a replacement valve for an aortic valve, the column portion is disposed at a position overlapping the inlet portion of the coronary artery in the vicinity of the aortic valve in the circumferential direction, and the column portion There is concern that the entrance may be blocked.

Therefore, in the present invention, in view of this point, it is possible to determine whether the column portion is viewed from the radially outer side or the inner side of the stent by providing the column with an identification display portion. I have to. In this case, when the artificial valve is indwelled, it becomes easy to grasp the front and rear positions of the column part, and it is possible to suppress or avoid the situation where the column part closes the inlet part of the coronary artery.

An artificial valve with a stent according to an eighth invention is a prosthetic valve with a stent comprising the stent according to any one of the first to seventh inventions and the artificial valve held by the stent, wherein the valve forming part Is formed so that at least a part of the stent is embedded by a tissue of a living body, and is thereby integrated with the stent.

According to the present invention, since the valve forming portion is formed so as to embed at least a part of the stent with a living tissue body, the stent is placed on the tube wall in the body while the artificial valve with the stent is placed in the body. Contact can be suppressed or prevented. Thereby, it is possible to suppress or prevent the occurrence of symptoms such as thrombosis.

An artificial valve with a stent according to a ninth aspect of the present invention is a prosthetic valve with a stent comprising the stent according to any one of the first to seventh aspects of the invention and the valve forming part held by the stent, wherein the valve forming The portion is integrated with each column portion of the stent, and in the integrated state, each column portion is provided with an extending portion extending in the axial direction from the cylindrical portion. It is characterized by being.

By the way, the entrance of the left coronary artery and the right coronary artery is present around the aortic valve of the heart in the body. Therefore, when an artificial valve with a stent is to be placed in the body as a replacement valve for an aortic valve, if the axial length of the artificial valve is long, the inlet portion is formed by the artificial valve, more specifically by the tubular portion of the valve forming portion. There is a risk of blocking. In contrast, if the axial length of the artificial valve is not secured to some extent, it becomes difficult to place the artificial valve in a stable state. Therefore, in the present invention, in view of these points, each column portion of the stent is provided with an extending portion extending in the axial direction from the tubular portion. In this case, the axial length of the stent column can be secured while keeping the axial length of the cylindrical portion short, so that the situation where the left coronary artery or the right coronary artery is blocked by the entrance is avoided. It becomes possible to place the artificial valve in a stable state.

It is a perspective view which shows the artificial valve with a stent in 1st Embodiment, (a) has shown the valve closing state of the artificial valve, (b) has shown the valve opening state. The front view which looked at the artificial valve with a stent from the axial direction. The perspective view which shows a stent. The expanded view shown in the state which expand | deployed the stent. It is explanatory drawing for demonstrating a mode that the artificial valve was detained in the body as a replacement valve of an aortic valve, (a) is the figure which looked at the state from the front, (b) becomes the figure which looked at from the top. Yes. The perspective view which shows the stent in 2nd Embodiment. The expanded view shown in the state which expand | deployed the stent. Explanatory drawing for demonstrating a state that the artificial valve was detained in the body as a replacement valve of an aortic valve. Explanatory drawing for demonstrating the arrangement | positioning state of the artificial valve in other embodiment. The expanded view which shows the stent in other embodiment.

[First Embodiment]
Hereinafter, an embodiment of the present invention will be described with reference to the drawings. In this embodiment, the stented prosthetic valve is embodied as a replacement valve that can be replaced with a diseased heart aortic valve. FIG. 1 is a perspective view showing a prosthetic valve with a stent according to the present embodiment, in which (a) shows a closed state of the artificial valve, and (b) shows a valve open state. Moreover, FIG. 2 is the front view which looked at the artificial valve with a stent from the axial direction. FIG. 3 is a perspective view of a stent constituting the prosthetic valve with a stent, and FIG. 4 is a developed view showing the expanded state of the stent.

As shown in FIGS. 1 and 2, the stented artificial valve 10 (hereinafter simply referred to as the artificial valve 10) includes a stent 11 and a valve forming portion 12 held by the stent 11. As shown in FIGS. 3 and 4, the stent 11 is formed into a tubular shape (circular tubular shape) as a whole by a plurality of linear elements. The stent 11 is formed of a metal material that can be plastically deformed, and is specifically formed of a cobalt chromium alloy. The stent 11 can transition between a contracted state and an expanded state in which the outer diameter is larger than that by performing plastic deformation. FIGS. 3 and 4 both show the expanded state of the stent 11. Yes. Moreover, the cobalt chromium alloy which is a forming material of the stent 11 is a material having a contrast function (X-ray opacity), and the stent 11 can be visually recognized under X-ray projection.

In addition, the stent 11 is manufactured by laser-cutting a cylindrical body (tube) made of, for example, a cobalt chromium alloy. Moreover, the stent 11 does not necessarily need to be formed with a cobalt chromium alloy, and may be formed with other metal materials, such as stainless steel and titanium.

The stent 11 includes a plurality of (specifically three) column portions 14 extending in the axial direction and provided at predetermined intervals (specifically, equal intervals) in the circumferential direction, and column portions 14 adjacent to each other in the circumferential direction. And a plurality of connecting portions 15 connected to each other. The column portion 14 includes a pair of column members 17 provided in the axial direction and extending in the axial direction, and a plurality of connecting members 18 that connect the column members 17 to each other. Both the column member 17 and the connecting member 18 are formed of linear elements.

The connecting portion 15 is formed in a wavy shape extending in the circumferential direction by a linear element, and has a shape that is alternately folded at both ends in the axial direction. The connection part 15 is arrange | positioned between the adjacent pillar parts 14, and the both ends of the circumferential direction are each connected with these each pillar part 14. As shown in FIG. Specifically, the connecting portion 15 is connected to each column member 17 on the side close to each other in the circumferential direction in the column portions 14 whose both ends are adjacent to each other.

A plurality of connecting portions 15 are arranged at predetermined intervals (specifically, equally spaced) in the axial direction for each of the adjacent column portions 14, and three connecting portions 15 are arranged in this embodiment. Further, the positions (relationships) of the connecting portions 15 in the axial direction between the adjacent column portions 14 are the same between the column portions 14. Accordingly, when viewed in the circumferential direction, the plurality of connecting portions 15 are arranged along the same direction, and the rows of the plurality of connecting portions 15 arranged in the circumferential direction are provided over three rows. Yes. Note that the number of columns of the connecting portion 15 is not necessarily limited to three, and may be one, two, or four or more.

All the connecting portions 15 have the same configuration and are arranged in the same direction. Both end portions of the connecting portion 15 in the circumferential direction correspond to the wavy line apex portion 15a of the connecting portion 15, and specifically correspond to the apex portion 15a on the same side in the axial direction. In this case, both end portions in the circumferential direction of the connecting portion 15 are positioned at the same position in the axial direction, and accordingly, the connecting portions with the column portions 14 at both ends of the connecting portion 15 are positioned at the same position in the axial direction. ing.

In the column portion 14, each of the connection portions 15 adjacent to each other in the circumferential direction is connected to the pair of column members 17 with the column portion 14 interposed therebetween. In this case, the connection location with the connection part 15 in one pillar material 17 and the connection location with the connection part 15 in the other pillar material 17 are set to the same position in the axial direction.

Subsequently, the column portion 14 will be described in detail.

As described above, the column portion 14 is provided with a plurality of connecting members 18 that connect the pair of column members 17 to each other. The plurality of connecting members 18 are provided side by side in the axial direction (in other words, the longitudinal direction of the column member 17) between the pair of column members 17.

The plurality of connecting members 18 include a first oblique connecting member 18a extending obliquely toward a predetermined side with respect to the axial direction (in other words, the longitudinal direction of the column member 17), and a first oblique connecting member 18a with respect to the axial direction. The 2nd diagonal joining material 18b which inclines in the opposite side and is extended, and the orthogonal joining material 18c extended in the direction orthogonal to an axial direction are contained. Each of the connecting members 18a to 18c is formed of a linear element having a substantially square cross section.

The first diagonal connecting member 18a extends incline toward one side in the axial direction from one column member 17 to the other column member 17 between the respective column members 17, and the second diagonal connecting member 18b As it goes from the column member 17 to the other column member 17, the column member 17 is inclined to the other side in the axial direction. A plurality of first oblique connecting members 18a and a plurality of second oblique connecting members 18b are provided. The first diagonal connecting members 18a and the second diagonal connecting members 18b are arranged so as to be alternately arranged in the axial direction, and the adjacent first diagonal connecting members 18a and the second diagonal connecting members 18b are mutually end portions. It is connected with. As a result, the plurality of first oblique connecting members 18a and the plurality of second oblique connecting members 18b are continuous in a zigzag shape in the axial direction. In this case, the first diagonal connecting material 18a corresponds to the first connecting material, and the second diagonal connecting material 18b corresponds to the second connecting material. In addition, the diagonal connecting members 18 a and 18 b are disposed across the entire longitudinal direction of the column member 17 between the pair of column members 17.

The adjacent first diagonal connecting material 18a and second diagonal connecting material 18b are connected to the column member 17 at a connecting end portion 28 where the diagonal connecting materials 18a and 18b are connected to each other. Thereby, in the pillar part 14, the truss (triangle) which consists of the 1st diagonal connection material 18a, the 2nd diagonal connection material 18b, and the pillar material 17 is formed continuously in the axial direction.

The inclination angle α (specifically, the inclination angle α on the acute angle side) with respect to the axial direction of the first oblique connecting member 18a is set in a range of 30 ° to 60 °, and specifically, set to 45 °. On the other hand, the second oblique connecting member 18b also has an inclination angle β (specifically, an acute angle side inclination angle β) in the range of 30 ° to 60 ° with respect to the axial direction, like the first oblique connecting member 18a. Specifically, it is set to 45 °. Therefore, in the present embodiment, the inclination angle α of the first oblique connecting member 18a and the inclination angle β of the second oblique connecting member 18b are respectively set to the same angle.

However, the inclination angle α of the first oblique connecting member 18a and the inclination angle β of the second oblique connecting member 18b are not necessarily the same angle, and may be different angles. In addition, the inclination angle α of the first diagonal connecting member 18a may be different for each first diagonal connecting member 18a, and the inclination angle β of the second diagonal connecting member 18b may be different for each second diagonal connecting member 18b. It may be allowed.

Further, the first diagonal connecting material 18a and the second diagonal connecting material 18b are each formed by linear elements having the same thickness. Accordingly, the line widths of the diagonal connecting members 18a and 18b are all the same line width D1, and in the present embodiment, the line width D1 is set to 0.254 mm. Note that the diagonal connecting members 18a and 18b are not necessarily formed by linear elements having the same thickness, and may be formed by linear elements having different thicknesses.

A plurality of orthogonal connecting members 18c are provided at predetermined intervals in the axial direction between the pair of column members 17. The orthogonal connecting members 18c are respectively arranged between the connecting portions 15 adjacent in the circumferential direction with the column portion 14 interposed therebetween. The orthogonal connecting member 18 c connects the connecting portion of the one pillar member 17 with the connecting portion 15 and the connecting portion of the other pillar member 17 with the connecting portion 15 among the pillar members 17 of the pillar portion 14. Is provided.

The orthogonal connecting member 18c is disposed at a boundary portion between the adjacent first oblique connecting member 18a and the second oblique connecting member 18b, and one end portion of the orthogonal connecting member 18c connects the oblique connecting members 18a and 18b. 28. Therefore, at the connection end portion 28, the four members of the first diagonal connecting member 18a, the second diagonal connecting member 18b, the orthogonal connecting member 18c, and the column member 17 are connected.

The orthogonal connecting member 18c is formed of a linear element that is thicker than the oblique connecting members 18a and 18b. Therefore, the line width D2 of the orthogonal connecting member 18c is larger than the line width D1 of the oblique connecting members 18a and 18b, and is set to 0.439 mm in this embodiment. However, the orthogonal connecting material 18c is not necessarily formed by a linear element thicker than the oblique connecting materials 18a and 18b, and may be formed by a linear element thinner than the oblique connecting materials 18a and 18b, or the oblique connecting material 18a. , 18b may be formed by linear elements having the same thickness.

A predetermined gap 23 is formed between the adjacent connecting members 18a to 18c between the pair of column members 17. The gap 23 is a portion into which a part of the valve forming portion 12 enters as will be described later.

In addition to the connecting members 18a to 18c, the column portion 14 is provided with a pair of end connecting members 18d and 18e as the connecting members 18. The end connecting member 18d connects one end portions of the column members 17 in the axial direction, and the end connecting member 18e connects the other end portions of the column members 17 in the axial direction. Each of the end connecting members 18d and 18e has an arc shape that is convex on the opposite side in the axial direction.

Each pillar part 14 has the extension part 19 extended to the one side of an axial direction rather than the some connection part 15, respectively. The extension length of the extension part 19 is set to be the same as or larger than the interval (pitch) between the connecting parts 15 adjacent in the axial direction. On the other hand, each column portion 14 does not extend to the other side in the axial direction from the plurality of connecting portions 15. Specifically, each column portion 14 has an end portion on the other side in the axial direction, the end portion on the other side in the plurality of connecting portions 15 (more specifically, the top portion on the other side in the connecting portion 15 on the other side). ).

The above is an explanation of the stent 11.

Next, the valve forming unit 12 will be described with reference to FIGS.

The valve forming part 12 is formed of an animal tissue. In this embodiment, the valve forming part 12 is formed of a human body, and specifically, is formed of a patient's own (self) tissue (that is, a self tissue). Therefore, the valve forming part 12 has excellent biocompatibility and blood compatibility. As shown in FIGS. 1 and 2, the valve forming portion 12 is formed so as to cover (embed) the entire stent 11, and thereby integrated with the stent 11.

The valve forming portion 12 includes a cylindrical tubular portion 21 and a plurality (three in the present embodiment) of valve membranes 22 provided on the inner peripheral side of the tubular portion 21. The cylindrical portion 21 and each valve membrane 22 are integrally formed by the tissue body. The cylindrical portion 21 is disposed coaxially with the stent 11 (the center position is the same), and ranges from one end portion to the other end portion (in other words, the column portion 14) in the plurality of connecting portions 15 in the axial direction. In the entire region except for the extending portion 19). Each connecting portion 15 and each column portion 14 are embedded in the inside of the cylindrical portion 21, whereby the cylindrical portion 21 is integrated with each connecting portion 15 and each column portion 14.

In particular, in the column portion 14, a part of the tissue body of the cylindrical portion 21 (valve forming portion 12) enters each gap 23 of the column portion 14, and the tissue body that enters the gap 23 corresponds to the column portion. The tissues covering 14 from both sides (front and back) are connected to each other. Therefore, the cylindrical portion 21 is in a state of being relatively firmly integrated with each column portion 14. Further, in the column part 14, the extending part 19 extends to one side in the axial direction from the cylindrical part 21, and is not embedded in the cylindrical part 21.

The valve membrane 22 is a movable part that opens and closes in accordance with the pulsation of the heart. When the heart contracts and blood is pumped from the heart, the valve membrane 22 is pushed by the blood flow to open the valve (FIG. 1). (See (b)). When the heart relaxes and blood delivery from the heart ends, the valve is closed (see FIG. 1 (a)). The valve membrane 22 has a fan shape when viewed from the axial direction, and a plurality of the valve membranes 22 are arranged around the axial line of the cylindrical portion 21 (see FIG. 2).

Each valve membrane 22 extends in a fan shape from the tubular portion 21 toward the inner peripheral side, and further toward one side in the axial direction (extending side of the extending portion 19) at the boundary portion with the adjacent valve membrane 22. It extends. A portion extending to the one side in the valve membrane 22 is an opening / closing portion 22a. At the boundary between adjacent valve membranes 22, the opening / closing portions 22 a of the respective valve membranes 22 are arranged to face each other, and the opening / closing portions 22 a come in contact with each other so that the valve membrane 22 is in a closed state and an opened state. It is designed to open and close. The opening / closing part 22a extends in the axial direction to the one side with respect to the tubular part 21, and more specifically, the extension length is substantially the same as the extension length of the extension part 19 in the column part 14. It has become.

Each boundary between adjacent valve membranes 22 is located at the same position as each column 14 of the stent 11 in the circumferential direction. Each of the opening / closing portions 22a of the adjacent valve membranes 22 is joined to the extending portion 19 of the column portion 14 at its radially outer end. Specifically, each opening / closing portion 22a is formed so as to cover the extending portion 19 at the end portion, and thereby integrated with the extending portion 19 (and thus the column portion 14). In this case, each valve membrane 22 has a shape recessed inward in the radial direction between adjacent column portions 14 (extension portions 19). Note that the tissue body also enters the gap 23 in the extended portion 19, and the tissue bodies on both sides of the extended portion 19 are connected to each other by the inserted tissue body.

Note that the valve forming portion 12 of the present embodiment is integrated with the stent 11 without being sutured to the stent 11 at all. Further, the valve forming portion 12 does not include any artificial object, and is formed only by a human tissue.

Next, a manufacturing procedure for manufacturing the artificial valve 10 will be briefly described.

First, the expanded stent 11 is extrapolated and assembled to a mold (mold member) formed in accordance with the shape of the valve forming portion 12. Then, in this assembled state, the stent 11 is implanted into the patient's (self) body together with the mold. At this time, the stent 11 is embedded in a site having a certain size (volume) such as an abdominal cavity or an extremity. The stent 11 may be implanted subcutaneously.

When the stent 11 is embedded in the body, the tissue around the stent 11 starts to grow on the mold surface so as to cover the stent 11. The growth of the tissue progresses with time, and eventually the entire stent 11 is covered with the tissue. Thereafter, the stent 11 is taken out from the body together with the mold.

After the stent 11 is taken out, the valve forming portion 12 is formed by cutting the tissue body formed in a state of covering the stent 11 or cutting unnecessary portions of the tissue body. Thereafter, the mold is pulled out from the stent 11. Thereby, manufacture of the artificial valve 10 is completed.

Next, how the artificial valve 10 is placed in the body as a replacement valve for a diseased aortic valve will be described with reference to FIG. FIGS. 5A and 5B are explanatory views for explaining a state in which the artificial valve 10 is placed in the body as a replacement valve for an aortic valve. FIG. 5A is a front view of the artificial valve 10 and FIG. It is a figure.

In this embodiment, as described above, the artificial valve 10 is transported to a predetermined indwelling site where the aortic valve is located using a balloon catheter. Although not shown, the balloon catheter has a balloon that can be inflated and deflated on the distal end side, as is well known. The artificial valve 10 is transported to the indwelling site while being mounted on the outer peripheral surface of the balloon in a deflated state. Specifically, the artificial valve 10 is mounted on the balloon by the stent 11 being crimped onto the balloon to be in a contracted state. In this mounted state, a balloon is inserted inside the valve forming portion 12 (tubular portion 21) and the valve membrane 22 is opened.

As an approach for delivering the artificial valve 10 to a predetermined indwelling site having an aortic valve using a balloon catheter, various approaches can be considered. For example, an approach is conceivable in which a hole is provided in the lower wall of the left ventricle of the heart and the artificial valve 10 is introduced into the indwelling site through the hole through the left ventricle. In this case, a guide wire G is introduced to the ascending aorta BV1 (see FIG. 5A) in advance through the hole, and a balloon catheter on which the artificial valve 10 is mounted is introduced along the guide wire G. And the artificial valve 10 on a balloon is conveyed to the indwelling site | part in Valsalva sinus BV2 (refer Fig.5 (a)) located in the origin part of the ascending aorta BV1.

After transportation, the balloon is inflated by injecting a compressed fluid into the balloon, and the stent 11 (and thus the artificial valve 10) is deformed from the contracted state to the expanded state. Thereby, as shown in FIG. 5A, the artificial valve 10 is indwelled at a predetermined indwelling site in the expanded state of the stent 11. After the artificial valve 10 is placed, the balloon is deflated by extracting the compressed fluid injected into the balloon, and the balloon catheter is extracted from the body. Thereby, the indwelling work of the artificial valve 10 is completed.

Subsequently, the indwelling state of the artificial valve 10 in the body will be described.

As shown in FIG. 5 (a), the prosthetic valve 10 is indwelled at a site where a diseased aortic valve BV3 is formed in Valsalva sinus V2. The prosthetic valve 10 is disposed in the inner part of the aortic valve BV3, and the aortic valve BV3 is swollen upward by the arrangement. In the ascending aorta BV1, an inlet of the left coronary artery BV4 and an inlet of the right coronary artery BV5 are provided above the aortic valve BV3 (downstream in the blood flow direction). As shown in FIG. 5B, the entrance portion of the left coronary artery BV4 and the entrance portion of the right coronary artery BV5 are positioned so as to face each other across the Valsalva sinus V2.

The artificial valve 10 is indwelled in a state in which the extending portions 19 of the column portions 14 of the stent 11 face upward (in other words, the inlet portions of the coronary arteries BV4 and BV5). In this case, the artificial valve 10 is disposed such that the cylindrical portion 21 is located below the inlet portions of the coronary arteries BV4 and BV5. Thereby, it is avoided that the inlet part of each coronary artery BV4, BV5 will be obstruct | occluded by the cylindrical part 21. FIG.

Further, the artificial valve 10 is arranged such that each column portion 14 does not overlap with the inlet portions of the coronary arteries BV4 and BV5 in the circumferential direction (see FIG. 5B). Thereby, it is avoided that the entrance part of each coronary artery BV4, BV5 is obstruct | occluded by the extension part 19 of the pillar part 14. FIG. Therefore, in the indwelling state of the artificial valve 10, the blood flow from the Valsalva sinus V2 into the coronary arteries BV4 and BV5 is not inhibited by the artificial valve 10.

In addition, when placing the artificial valve 10 so that each column portion 14 does not overlap with the entrance portion of each coronary artery BV4, BV5, the placement operation is performed while confirming the position of each column portion 14 under X-ray projection. It will be.

Moreover, since the extension part 19 is provided in the column part 14 in the artificial valve 10, the axial direction length of the stent 11 (column part 14) can be reduced while keeping the axial direction length of the cylindrical part 21 short. It is possible to secure to some extent. For this reason, the artificial valve 10 can be placed in a stable state while avoiding a situation where the inlet portions of the coronary arteries BV4 and BV5 are blocked when the artificial valve 10 is placed.

As described above, according to the configuration of this embodiment described in detail, the following excellent effects can be obtained.

As the connecting member 18 that connects the pair of column members 17 to the column part 14 of the stent 11, the first oblique connecting member 18 a extending obliquely with respect to the axial direction, and the first oblique connecting member 18 a with respect to the axial direction. A second oblique connecting member 18b extending inclined to the opposite side and an orthogonal connecting member 18c extending in a direction orthogonal to the axial direction were provided. The oblique connecting members 18a and 18b extend in a predetermined direction including a component in the axial direction. Therefore, when each column member 17 of the column portion 14 is pulled in a direction that causes a positional shift in the axial direction by a different connecting portion 15 connected to each column member 17, the tensile force is reduced. Resistance can be imparted. Thereby, position shift to the direction of an axis of each pillar material 17 can be controlled, and as a result, deformation of pillar part 14 can be controlled. Therefore, it becomes possible to place the artificial valve 10 in a stable state in the body.

In order to suppress the deformation of the column part 14, it is desirable to arrange a large number of diagonal connecting members 18 a and 18 b as connecting members 18 between the pair of column members 17, but the diagonal connecting members 18 a and 18 b are arranged between the column members 17. It is not possible to place so much in In this regard, by providing the orthogonal connecting material 18c in addition to the oblique connecting materials 18a and 18b as the connecting material 18, a relatively large number of the connecting materials 18 can be arranged between the column materials 17, and the strength of the column portion 14 is increased. Can be suitably increased. Accordingly, it is possible to enhance the effect of suppressing the deformation of the column portion 14.

Among the orthogonal connecting members 18c and the oblique connecting members 18a and 18b, the orthogonal connecting member 18c having a shorter length was formed by a linear element thicker than the oblique connecting members 18a and 18b. In this case, the strength of the column portion 14 is increased while suppressing the proportion of the connecting material 18 occupying between the pair of column materials 17, that is, while suppressing the gap 23 between the connecting materials 18 from becoming small. Is possible.

Of each column member 17 of the column part 14, the connecting part with the connecting part 15 in one column member 17 and the connecting part with the connecting part 15 in the other column member 17 are set at the same position in the axial direction. In the configuration, an orthogonal connecting member 18c is provided so as to connect these connecting portions. In this case, the connecting portions 15 adjacent to each other with the pillar portion 14 interposed therebetween can be connected via the orthogonal connecting member 18c, so that the positional deviation between the connecting portions 15 can be suppressed. As a result, it is possible to increase the effect of suppressing the displacement between the column members 17 to which the respective connecting portions 15 are connected, and as a result, the effect of suppressing the deformation of the column portions 14 can be increased.

A plurality of first oblique joining members 18a and a plurality of second oblique joining members 18b are provided as the joining members 18, and the first oblique joining members 18a and the second oblique joining members 18b are alternately arranged in the axial direction. It was made to connect by connecting the edge parts of. In this case, since the truss by the 1st diagonal connection material 18a, the 2nd diagonal connection material 18b, and the column material 17 can be continuously formed in the axial direction in the column part 14, the column part 14 is made very strong. be able to. Thereby, a deformation | transformation of the pillar part 14 can be suppressed notably and the indwelling state of the artificial valve 10 can be made extremely stable.

Since the diagonal connecting members 18a and 18b are arranged so as not to cross each other connecting member 18, it is possible to avoid the gaps 23 formed between the column members 17 from being remarkably reduced. . In this case, the configuration is convenient when the valve forming portion 12 is integrated with the column portion 14 using the gap 23.

Since the valve forming portion 12 is formed so as to cover (embed) the entire stent 11 with a tissue of a human body, the stent 11 is prevented from directly contacting the tube wall in the body in a state where the artificial valve 10 is placed in the body. be able to. Thereby, it is possible to prevent the occurrence of symptoms such as thrombosis.

[Second Embodiment]
In the present embodiment, the configuration of the stent that constitutes the prosthetic valve with a stent is different from that of the first embodiment. Hereinafter, the configuration of the prosthetic valve with a stent in the present embodiment will be described with reference to FIGS. 6 and 7. FIG. 6 is a perspective view showing a stent in the present embodiment, and FIG. 7 is a development view showing the stent in a developed state. 6 and 7 each show an expanded state of the stent.

The artificial valve 30 (see FIG. 8) in the present embodiment includes a stent 31 and a valve forming portion 32 held by the stent 31. Since the valve formation part 32 is fundamentally the same structure as the valve formation part 12 in 1st Embodiment, detailed description is omitted here. Briefly, the valve forming part 32 is formed so as to cover the stent 31 with a human tissue like the valve forming part 12, and is provided on the inner peripheral side of the cylindrical part 33 and the cylindrical part 33. A plurality of valve membranes (not shown). In FIG. 7, for convenience, only the tubular portion 33 of the valve forming portion 32 is illustrated by a one-dot chain line.

As shown in FIGS. 6 and 7, the stent 31 is formed into a tubular shape (circular tubular shape) as a whole by a plurality of linear elements. The stent 31 is formed of a metal material having elasticity, and specifically, is formed of a nickel titanium (Ni—Ti) alloy which is a kind of superelastic alloy. The stent 31 is a so-called self-expanding stent that is deformed from a contracted state to an expanded state by its own elasticity. The stent 31 may be formed of another superelastic alloy such as an Au—Cd alloy, a Cu—Al—Ni alloy, or a Ni—Ti—Co alloy.

The stent 31 extends in the axial direction and is arranged side by side in the circumferential direction, and a plurality of (specifically three) column portions 34 and a plurality of coupling portions 35 that couple the circumferential column portions 34 to each other. And a pair of holding portions 36 and 37 provided on both end sides of each column portion 34 in the axial direction. The column portion 34 includes a pair of column members 38 that extend in the axial direction and are arranged in the circumferential direction, and a plurality of connecting members 39 that connect the column members 38 to each other. Both the column member 38 and the connecting member 39 are formed of linear elements.

The connecting portion 35 is formed in a wavy line extending in the circumferential direction by a linear element. The connecting portions 35 are respectively connected to the column members 38 on the sides close to each other in the circumferential direction in the column portions 34 whose both ends in the circumferential direction are adjacent to each other. The connection part 35 is arrange | positioned for every between each pillar part 34, respectively, and these each connection part 35 is arrange | positioned along with the circumferential direction at 1 row. In addition, the row | line | column of the connection part 35 does not necessarily need to be 1 row, and may be 2 or more rows.

The holding portion 36 is provided at one end portion in the axial direction of each column portion 34, and the holding portion 37 is provided at the other end portion in the axial direction in each column portion 34. Each of the holding portions 36 and 37 is a portion that holds the stent 31 (and thus the artificial valve 30) by being pressed against the tube wall in the body when the artificial valve 30 is placed in the body. Each of the holding portions 36 and 37 is formed by a linear element.

The holding portion 36 includes a connecting portion 41 that connects the end portions on one side in the axial direction of the column portions 34 adjacent in the circumferential direction. The connecting portion 41 connects the column members 38 on the sides close to each other in the circumferential direction in the adjacent column portions 34. The connecting portions 41 are respectively provided between adjacent column portions 34, and the connecting portions 41 are arranged side by side in the circumferential direction. 6 and 7, two connecting portions 41 are provided for each column portion 34, but may be provided one by one or three or more.

Each connecting portion 41 extends to one side in the axial direction from the column portion 34 and has a folded shape that is folded to the other side at an end portion on one side. Each connecting portion 41 is formed so as to be displaced radially outward as it goes to the one side, and is located radially outside the column portion 34 at the end portion on the one side. Accordingly, the holding portion 36 has a flare shape that expands toward the end portion on the one side as a whole. In FIG. 6, for convenience, the holding unit 36 is illustrated in a state where it is not flare (the holding unit 37 is also the same).

On the other hand, the holding portion 37 is provided on the other side in the axial direction with respect to each column portion 34 and each connecting portion 35, and has an annular shape (annular shape) around the axis of the stent 31 and has a wavy shape. . The holding portion 37 is connected to each column portion 34 and each connecting portion 35 via a linear intermediate member 43. The holding part 37 is formed so as to be displaced radially outward as it goes to the other side in the axial direction, and is located radially outside the column part 34 at the other end. Therefore, the holding portion 37 has a flare shape that expands toward the other end portion as a whole. 6 and 7, only one holding portion 37 is provided, but a plurality (two or more) holding portions 37 may be provided at predetermined intervals in the axial direction. Further, the number of holding portions 37, the number of connecting portions 41, and the number of rows of connecting portions 35 may be arbitrarily set as long as the target expansion performance can be obtained in the stent 31.

Subsequently, the column portion 34 will be described in detail.

The column part 34 is provided with a plurality of oblique connecting members 39a extending obliquely to a predetermined side with respect to the axial direction and a plurality of orthogonal connecting members 39b extending in a direction orthogonal to the axial direction as connecting members 39. It has been. The oblique connecting members 39a and the orthogonal connecting members 39b are alternately arranged in the axial direction, and the adjacent oblique connecting members 39a and the orthogonal connecting members 39b are connected to each other at their ends. Thereby, the diagonal connecting material 39a and the orthogonal connecting material 39b are continuously zigzag in the axial direction. Further, the adjacent diagonal connecting member 39a and the orthogonal connecting member 39b are connected to the column member 38 at the end portions where they are connected to each other. Thereby, the truss by the diagonal connection material 39a, the orthogonal connection material 39b, and the pillar material 38 is formed continuously in the axial direction. Here, the diagonal connecting material 39a corresponds to the first connecting material, and the orthogonal connecting material 39b corresponds to the second connecting material.

The orthogonal connecting members 39b are respectively disposed between the connecting portions 35 adjacent in the circumferential direction with the pillar portion 34 interposed therebetween, and are respectively disposed between the connecting portions 41 adjacent in the circumferential direction with the pillar portion 34 interposed therebetween. ing. These orthogonal connecting members 39b are connected to the connecting portion 35 (41) in one column member 38 and the connecting portion 35 (41) in the other column member 38 among the column members 38 of the column portion 34. It is provided so that a connection location may be connected mutually. A predetermined gap 45 is formed between the connecting members 39a and 39b adjacent to each other between the pair of column members 38.

This completes the description of the stent 31.

The valve forming part 32 is arranged coaxially with the stent 31 with respect to the stent 31, and the cylindrical part 33 is formed so as to extend over the entire area of each column part 34 of the stent 31 in the axial direction. Each cylindrical portion 34 and each connecting portion 35 of the stent 31 are embedded in the cylindrical portion 33, and thereby the cylindrical portion 33 is integrated with each column portion 34 and each connecting portion 35. . In this case, in the column part 34, a part of the structure body of the cylindrical part 33 has entered each gap 45 of the column part 34, and the structure body that has entered the gap 45 has the column part 34 as its (front and back). Tissues covering each side are connected to each other. Therefore, the cylindrical portion 33 is relatively firmly integrated with each column portion 34. The holding portions 36 and 37 of the stent 31 are exposed from the cylindrical portion 33 on both sides in the axial direction.

Although the illustration of the valve membrane of the valve forming portion 32 is omitted, the valve membrane is arranged so that the boundary portion between adjacent valve membranes is located at the same position as each column portion 34 of the stent 31 in the circumferential direction. It is integrated with the column part 34 in the boundary part.

Next, how the artificial valve 30 is placed in the body as a replacement valve for a diseased aortic valve will be described with reference to FIG. FIG. 8 is an explanatory diagram for explaining a state in which the artificial valve 30 is placed in the body as a replacement valve for the aortic valve.

In this embodiment, when the artificial valve 30 is transported to a predetermined indwelling site, it is transported using a dedicated delivery catheter. An example of such a delivery catheter is a double catheter structure composed of an inner tube and an outer tube. In this case, the artificial valve 30 is disposed in a contracted state of the stent 31 between the inner tube and the outer tube on the distal end side of the catheter, and the artificial valve 30 is transported to the indwelling site in the disposed state. Then, after the conveyance, the artificial valve 30 is removed from the outer tube by pulling the outer tube to the proximal side while restricting the movement of the artificial valve 30 to the proximal side with a stopper provided on the outer peripheral surface of the inner tube. Derived to the position side. Thereby, the stent 31 is deformed from the contracted state to the expanded state by its own elasticity, and the artificial valve 30 is indwelled at the indwelling site in the stent expanded state.

Subsequently, the indwelling state of the artificial valve 30 will be described.

As shown in FIG. 8, the artificial valve 30 is placed at a predetermined placement site in the Valsalva sinus V2 with the holding part 36 of the stent 31 on the upper side and the holding part 37 on the lower side. The artificial valve 30 is disposed such that the valve forming portion 32 (cylindrical portion 33) is located below the inlet portions of the coronary arteries BV4 and BV5, whereby the cylindrical portion 33 causes the inlets of the coronary arteries BV4 and BV5. It is avoided that the part is blocked. Further, in the indwelling state of the artificial valve 30, the holding portion 36 is pressed against the tube wall of the Valsalva sinus VB2 by its own elasticity, thereby holding the stent 31 and the artificial valve 30 in a stable state.

As described above, according to the configuration of this embodiment described in detail, the following excellent effects can be obtained.

As a connecting member 39 for connecting a pair of column members 38 to the column portion 34 of the stent 31, an oblique connecting member 39a extending obliquely with respect to the axial direction, and an orthogonal connecting member 39b extending in a direction orthogonal to the axial direction, Was provided. The diagonal connecting member 39a extends in a predetermined direction including a component in the axial direction. Therefore, when each column member 38 of the column part 34 is pulled in a direction that causes a positional shift in the axial direction by different connecting portions 35 and 41 connected to the respective column members 38, Resistance. Thereby, position shift to the axial direction of each pillar material 38 can be controlled, and as a result, deformation of pillar part 34 can be controlled. Therefore, it becomes possible to place the artificial valve 30 in a stable state in the body.

As the connecting material 39, since the orthogonal connecting material 39b is provided in addition to the oblique connecting material 39a, a large number of connecting materials 39 can be arranged between the column members 38 as compared with the case where only the oblique connecting material 39a is provided between the column members 38. it can. Therefore, the strength of the column part 34 can be suitably increased, and as a result, the deformation of the column part 34 can be suitably suppressed.

Of each column member 38 of the column part 34, the connection part with the connection part 35 in one column member 38 and the connection part with the connection part 35 in the other column member 38 are set at the same position in the axial direction. In the configuration, an orthogonal connecting member 39b is provided so as to connect these connecting portions. In this case, the connecting portions 35 adjacent to each other with the pillar portion 34 interposed therebetween can be connected via the orthogonal connecting member 39b, so that the positional deviation between the connecting portions 35 can be suppressed. As a result, the effect of suppressing the displacement between the column members 38 to which the respective connecting portions 35 are connected can be enhanced, and as a result, the effect of suppressing the deformation of the column portions 34 can be enhanced.

A plurality of oblique connecting members 39a and orthogonal connecting members 39b are provided as connecting members 39, and the oblique connecting members 39a and the orthogonal connecting members 39b are alternately arranged in the axial direction and connected to each other at the ends. It was continued with. In this case, since the truss made of the diagonal connecting member 39a, the orthogonal connecting member 39b, and the column member 38 can be continuously formed in the axial direction on the column portion 34, the column portion 34 can be extremely strengthened. Thereby, a deformation | transformation of the pillar part 34 can be suppressed notably and the indwelling state of the artificial valve 30 can be made extremely stable.

Since the diagonal connecting members 39a are arranged so as not to intersect with the other connecting members 39, it is possible to avoid the gap 45 formed between the column members 38 from being remarkably reduced. In this case, the configuration is advantageous in integrating the valve forming portion 32 with the column portion 34 using the gap 45.

[Other Embodiments]
The present invention is not limited to the above embodiment, and may be implemented as follows, for example.

(1) In the first embodiment, only the diagonal connecting members 18 a and 18 b may be provided as the connecting member 18 between the pair of pillar members 17. That is, the orthogonal connecting member 18c may be omitted. Also in this case, by providing the diagonal connecting members 18a and 18b, a resistance force can be applied to a tensile force that attempts to shift the position of each column member 17 in the axial direction. Therefore, the deformation of the column portion 14 can be suppressed, and the artificial valve 10 can be placed in a stable state.

Also in the second embodiment, only the diagonal connecting material may be provided as the connecting material 39 between the pair of column members 38 in the same manner. That is, as the connecting material 39, only the oblique connecting material 39a and the oblique connecting material extending obliquely on the opposite side of the oblique connecting material 39a with respect to the axial direction may be provided.

(2) In each of the above embodiments, the diagonal connecting members 18a, 18b, 39a and the other connecting members 18, 39 are arranged so as to intersect each other, and the two are connected at the intersecting portion. May be.

(3) The adjacent connecting members 18 and 39 may be arranged apart from each other in the axial direction, and the connecting members 18 and 39 may be disconnected. In this case, since a relatively large gap 23 can be formed between the column members 17, it is even more convenient when the valve forming portion 12 is integrated using the gap 23.

(4) In the above embodiment, the valve forming portion 12 is formed so as to cover the entire stent 11, but may be formed so as to cover only a part of the stent 11. Even in that case, the stent 11 can be prevented from coming into contact with the tube wall in the body in the indwelling state of the artificial valve 10, and the occurrence of thrombosis can be suppressed.

(5) The valve forming part 12 does not necessarily have to be formed by its own tissue body, but may be formed by another person's tissue body. In this case, the stent 11 is embedded in another person's body, and the valve forming part 12 is formed around the stent 11. Moreover, you may form the valve formation part 12 with the structure | tissue body of animals (heterogeneous animals) other than a person. In this case, the stent 11 is implanted in the body of a different animal, and the valve forming portion 12 is formed around the stent 11. Examples of such heterologous animals include pigs, cows, goats, dogs, rabbits and the like. In addition, when forming the valve formation part 12 with the tissue body of a different animal, it is desirable to perform a decellularization process.

In the above embodiment, the valve forming portion 12 is integrally formed around the stent 11 by embedding the stent 11 in the body, but the valve forming portion 12 may be formed separately from the stent 11. For example, it is conceivable to form a tissue body around the artificial body by embedding a cylindrical artificial body (for example, a mandrel) in the body of the living body, and to form a valve forming portion by the tissue body. In this case, the valve forming portion can be integrated with the stent 11 by sewing or the like to each column portion 14 of the stent 11 using the gap 23.

Further, the valve forming part is not necessarily formed of a living body tissue, and may be formed of another material such as a polymer material. Also in that case, the valve forming portion can be integrated with the stent 11 by sewing or the like to each column portion 14.

(6) In the above embodiment, the stented prosthetic valve 10 of the present invention is used as a replacement valve for the aortic valve of the heart, but other valves (heart valves) provided in the heart, specifically, mitral valves, It can also be used as a replacement valve for tricuspid or pulmonary valve. Further, the artificial valve of the present invention is not necessarily used as a replacement valve, and may be used as a vascular valve by being placed in a blood vessel, for example. In this case, efficient blood flow can be secured by suppressing the backflow of blood. Alternatively, it may be placed in a tube other than a blood vessel. For example, if it is placed in the esophagus, reflux esophagitis can be treated.

(7) By the way, when the artificial valve 10 is placed in the body as a replacement valve for the aortic valve, the artificial valve 10 is arranged in the orientation shown in FIG. 9A and the orientation shown in FIG. 9B. In this case, when each column 14 of the stent 11 is visually recognized from the front under X-ray projection, it is considered that the position of each column 14 appears to be in the same position in any case. Therefore, when the artificial valve 10 is indwelled, even though it is assumed that the artificial valve 10 is arranged in such a direction that each column portion 14 does not overlap with the inlet portions of the coronary arteries BV4 and BV5 (that is, the direction shown in FIG. 9A) Each column 14 is arranged in a direction that overlaps with the inlet portions of the coronary arteries BV4 and BV5 (that is, the direction shown in FIG. 9B), and the inlet portions are blocked by the extending portions 19 of the column portions 14. It is conceivable that a situation such as that occurred.

Therefore, in view of this point, the column portion 14 may be provided with an identification display unit for determining whether the column portion 14 is viewed from the radially inner side or the outer side of the stent 11. That is, the columnar portion 14 may be provided with an identification display portion that looks different when viewed from the outside in the radial direction and when viewed from the inside. Specifically, it is conceivable to provide an asymmetric marker having an asymmetric shape as the identification display unit. FIG. 10 shows a configuration in which a marker 48 made of a letter “G” is provided as an asymmetric marker on the extending portion 19 of the column portion 14. In FIG. 10, the marker 48 is provided so that it can be seen correctly when viewed from the outside in the radial direction. That is, it is provided so that the letter “G” appears to be reversed when viewed from the inside in the radial direction. The marker 48 may be provided at a portion other than the extending portion 19 in the column portion 14.

According to such a configuration, when the artificial valve 10 is arranged in the orientation shown in FIG. 9A, the marker 48 on the front pillar portion 14A looks correct and is arranged in the orientation shown in FIG. 9B. In this case, the marker 48 on the front pillar portion 14A appears to be reversed. In this case, it becomes possible to grasp the front-rear position of the marker 48 in the body, and as a result, the artificial valve 10 is arranged in either the direction shown in FIG. 9A or the direction shown in FIG. 9B. It is possible to determine whether or not. As a result, when the artificial valve 10 is indwelled, it is possible to avoid a situation where the inlet portions of the coronary arteries BV4 and BV5 are blocked by the column portion 14 (specifically, the extending portion 19).

DESCRIPTION OF SYMBOLS 10 ... Artificial valve, 11 ... Stent, 12 ... Valve formation part, 14 ... Column part, 15 ... Connection part, 17 ... Column material, 18 ... Connecting material, 18a ... 1st diagonal connection material, 18b ... 2nd diagonal connection material 18c ... Orthogonal connecting material, 19 ... Extension part, 30 ... Artificial valve, 31 ... Stent, 32 ... Valve forming part, 34 ... Column part, 35 ... Connecting part, 38 ... Column material, 39 ... Connecting material, 39a ... Oblique connecting material, 39b ... orthogonal connecting material, 48 ... marker as an identification display section.

Claims (9)

1. A stent for a prosthetic valve for holding a valve forming portion which is formed into a tubular shape by a plurality of linear elements and has a tubular portion and a plurality of valve membranes provided on the inner peripheral side of the tubular portion. ,
   A plurality of pillars extending in the axial direction of the stent and arranged at predetermined intervals in the circumferential direction of the stent, and integrated with the cylindrical part,
   A connecting portion that connects the column portions adjacent to each other in the circumferential direction;
   With
   The column portion is
   A pair of pillars extending in the axial direction and arranged side by side in the circumferential direction;
   A plurality of connecting materials that connect these pillar materials,
   Have
   Each of the pair of column members is connected to the different connecting portions in the circumferential direction,
   The plurality of connecting members include a first oblique connecting member extending obliquely with respect to the axial direction, and a second oblique connecting member extending inclined to the opposite side of the first oblique connecting member with respect to the axial direction. A stent comprising at least any two of a material and an orthogonal connecting material extending in a direction orthogonal to the axial direction.
2. The stent according to claim 1, wherein the plurality of connecting members include the orthogonal connecting member.
3. In addition to the orthogonal joining material, the plurality of joining materials include any one of the first oblique joining material and the second oblique joining material,
   The stent according to claim 2, wherein the orthogonal connecting material is formed by a linear element that is thicker than the oblique connecting material.
4. In the column part, the connection part with the connection part in one column member of the pair of column members and the connection part with the connection part in the other column member are set at the same position in the axial direction. And
   The stent according to claim 2 or 3, wherein the orthogonal connecting member is provided so as to connect the connecting portions.
5. The plurality of connecting members include a plurality of first connecting members and second connecting members that are any two of the first oblique connecting member, the second oblique connecting member, and the orthogonal connecting member. And
   The first connecting material and the second connecting material are arranged so as to be alternately arranged in the axial direction, and are joined to each other at positions corresponding to the respective end portions thereof. The stent according to any one of claims 1 to 4.
6. The diagonal connecting material of any one of the first diagonal connecting material and the second diagonal connecting material is arranged so as not to intersect with other connecting materials at an intermediate portion thereof. The stent according to any one of 5.
7. A stent formed of a radiopaque material;
   In the column part, when the stent is visually recognized under X-ray projection, an identification display unit for determining which side of the stent is viewed from the radially outer side or the inner side of the stent is provided. The stent according to any one of claims 1 to 6, wherein the stent is provided.
8. A stent according to any one of claims 1 to 7;
   The annuloplasty part held by the stent;
   A prosthetic valve with a stent comprising:
   The prosthetic valve with a stent, wherein the valve forming part is formed so as to embed at least a part of the stent by a living tissue, and thereby integrated with the stent.
9. A stent according to any one of claims 1 to 7;
   The annuloplasty part held by the stent;
   A prosthetic valve with a stent comprising:
   The valve forming part is integrated with each column part of the stent,
   The prosthetic valve with a stent, wherein in each integrated state, each column part is provided with an extension part extending in the axial direction from the cylindrical part.

Images