Stent kit, stent system having stent kit, and method for manufacturing stent kit

Abstract

This stent kit (1) has a stent (10), an insertion member (20) inserted through the lumen of the stent (10), and an outer cylinder member (50) disposed at a position that is on the outer side of the insertion member (20) and on the proximal side of the stent (10), the stent (10) having an arcuate part curving in an arcuate shape, and the minimum curvature radius of the arcuate part being smaller than the minimum curvature radius of the insertion member (20) in a state in which the insertion member (20) is not disposed in the lumen of the stent (10).

Description

STENT KIT, STENT SYSTEM HAVING THE STENT KIT, AND METHOD FOR MANUFACTURING THE STENT KIT

[0001] The present invention relates to a stent kit for delivering a stent into the body, a stent system including the stent kit, and a method for manufacturing the stent kit.

[0002] Medical tubular bodies, typified by stents, are medical devices used to treat various diseases, such as biliary atresia, yellow bile, and biliary tract cancer, which occur due to stenosis or obstruction of biological lumens, such as the bile duct and the digestive tract, including the pancreatic duct. Medical tubular bodies are placed in biological lumens, for example, to drain bile from the bile duct to the duodenum, or to maintain the inner diameter of the lumen by dilating the lesion at the stenosis or obstruction from the inside. In such treatments, stents made of resin materials are generally used.

[0003] As an example of endoscopic stent treatment, the following describes a method for placing a stent in a biliary tract obstructed by bile duct cancer to drain bile from the bile duct to the duodenum. First, an endoscope is inserted from the mouth to the entrance (papilla) of the bile duct in the duodenum. Next, a guidewire is carried through the endoscope to the lesion. Next, a stent kit is carried along the guidewire to the lesion. The stent kit is then manipulated to place the stent in the lesion.

[0004] For example, Patent Document 1 describes a catheter assembly comprising a catheter main branch having a base end portion and a tip portion with an arc portion, the arc portion comprising a curved section having first and second ends and an outer surface, the arc portion maintaining the curved section when in a rest state, a lumen defined within the arc portion and extending along the curved section between the first and second ends, an inwardly curved outer surface side portion of the curved section, an outwardly curved outer surface side portion of the curved section, at least one remaining side portion disposed on the outer surface between the inwardly curved outer surface side portion and the outwardly curved outer surface side portion, and the at least one remaining side portion disposed on a plane parallel to a projection plane oriented parallel to a plane extending from the inwardly curved side portion to the outwardly curved side portion. Patent Document 2 describes a stent kit comprising a tube stent having a stent arc portion, at least one end of which is formed of at least a part of an arc, and an inner catheter having an inner arc portion formed with the same shape as the stent arc portion and inserted into the tube stent so that the inner arc portion and the stent arc portion are aligned. Patent Document 3 describes a method for manufacturing a stent delivery catheter, including the steps of: inserting a stent into a stock lumen of a stock tube;Patent document 4 describes a catheter comprising: a tube having a cylindrical wall, a first end, a second end, a first retention feature near the first end, and a second retention feature near the second end; a detachable portion that is fluidly connected to the tube at the second end and is removably attachable to the tube; an inner tube having at least one lumen that is removably insertable into both the tube and the detachable portion; and a wire that extends through at least a portion of at least one lumen of the inner tube, a portion of the wire being attached to the tube. Patent Document 5 describes a medical device having a tubular indwelling device and an inner catheter inserted into the indwelling device, wherein the indwelling device has a first bent portion that has been pre-formed into a bent shape, and the inner catheter has a second bent portion that has been pre-formed into a bent shape different from the first bent portion, and the second bent portion is inserted into the first bent portion.

[0005] JP-T-2010-528768 A JP-A-2015-8862 JP-A-2017-38792 JP-T-2017-502818 JP-A-2022-52207

[0006] In catheters such as those described in Patent Documents 1 to 5, medical tubular bodies such as stents are curved in an arc. The arc-shaped curve of the stent prevents the stent from shifting position when placed in a lesion. However, in catheters such as those described in Patent Documents 1 to 3, the insertion member to which the stent is attached is also curved along the stent, which makes it difficult to insert a guidewire placed inside the body through the insertion member and to insert the insertion member into the body when delivering the stent to the lesion, and also increases the load required to pull the insertion member out of the stent lumen. Furthermore, in catheters such as those described in Patent Document 4, a linear insertion member is inserted into a curved stent, which straightens the stent and delivers it to the lesion. However, the stent becomes linear or nearly linear after placement, which reduces the effectiveness of preventing stent shifting. In medical devices such as that disclosed in Patent Document 5, the tubular indwelling device and the inner catheter to which the indwelling device is attached are both bent, which makes it difficult to insert the guide wire placed inside the body into the lumen of the inner catheter, resulting in problems such as poor insertability of the indwelling device and a high load when pulling out the inner catheter from the lumen of the indwelling device.

[0007] The present invention has been made in view of the above circumstances, and its object is to provide a stent kit that allows for easy delivery of a stent to a lesion and is less likely to shift position after placement, a stent system including this stent kit, and a method for manufacturing this stent kit.

[0008] The following are stent kits according to embodiments of the present invention that can solve the above-mentioned problems. [1] A stent kit comprising a stent, an insert member inserted into the lumen of the stent, and an outer tubular member disposed outside the insert member and proximal to the stent, wherein the stent has an arcuate portion, and when the insert member is not disposed in the lumen of the stent, the minimum radius of curvature of the arcuate portion is smaller than the minimum radius of curvature of the insert member. [2] The stent kit according to [1], wherein when the insert member is disposed in the lumen of the stent, the insert member has a shaped section that is curved in an arcuate shape and a linear non-shaped section that is located distal to the insert member relative to the shaped section, and the length of the non-shaped section in the extension direction of the insert member is longer than the length of the shaped section in the extension direction of the insert member. [3] The stent kit according to [1] or [2], wherein, when the inserting member is disposed in the lumen of the stent, the inserting member has a metal wire in at least a portion of the portion located in the arc portion of the stent. [4] The stent kit according to [3], wherein the material constituting the metal wire is a shape memory alloy. [5] The stent kit according to [3] or [4], wherein at least a portion of the metal wire is fixed to a wall portion of the inserting member. [6] The stent kit according to any of [3] to [5], wherein the inserting member has a hub at a proximal end, and the metal wire is fixed to the hub. [7] The stent kit according to any of [1] to [6], wherein the stent and the outer tubular member are connected by a connecting means. [8] The stent kit according to [7], wherein the stent has a first side hole communicating with the lumen of the stent, the outer tubular member has a second side hole communicating with the lumen of the outer tubular member, and the connecting means is inserted through the first side hole and the second side hole. [9] The stent kit according to [7] or [8], wherein the connecting means has a ring-shaped portion, and the inserting member is disposed inside the ring-shaped portion.

[0009] The present invention includes stent systems described in the following

[10] to

[12] .

[10] A stent system comprising the stent kit described in any one of [1] to [9] and a retaining element that holds the stent kit, wherein the retaining element holds the arc portion with the insertion member inserted into the lumen of the stent.

[11] The stent system described in

[10] , wherein the retaining element includes at least one of a mount, a blister, a clip, and tape.

[12] The stent system described in

[10] or

[11] , further comprising a protective tube, wherein the minimum radius of curvature of the protective tube is greater than the minimum radius of curvature of the arc portion, and the stent is inserted into the lumen of the protective tube.

[0010] The following are methods for manufacturing a stent kit according to an embodiment of the present invention that can solve the above-mentioned problems.

[13] A method for manufacturing a stent kit having a stent with an inner lumen extending longitudinally from the proximal side to the distal side and having an arc portion A curved in an arc shape, and an inserting member inserted into the inner lumen of the stent, the method comprising: a preparation step of preparing the stent; an arrangement step of arranging the inserting member in the inner lumen of the stent; and a holding step of abutting a holding element against the arc portion A of the stent.

[14] The manufacturing method according to

[13] , in which the inserting member is straight.

[15] The manufacturing method according to

[14] , including a step of heat treating the inserting member to straighten it before arranging it in the inner lumen of the stent.

[16] The manufacturing method according to

[13] , wherein the inner insertion member has an arc-shaped portion B, and the minimum radius of curvature rB of the arc-shaped portion B is greater than the minimum radius of curvature rA of the arc-shaped portion A of the stent.

[17] The manufacturing method according to any one of

[13] to

[16] , wherein the preparation step includes a step of bending a portion of a raw material tube into an arc-shaped portion to form the arc-shaped portion A.

[18] The manufacturing method according to any one of

[13] to

[17] , wherein the holding step is followed by a sterilization step.

[19] The manufacturing method according to any one of

[13] to

[18] , wherein, when the inner insertion member is disposed in the lumen of the stent, the inner insertion member has a metal wire in at least a portion of the portion located in the arc-shaped portion A of the stent.

[20] The manufacturing method according to

[19] , wherein the material constituting the metal wire includes at least one selected from the group consisting of stainless steel, tungsten, and a shape memory alloy.

[0011] The method of using the stent kit according to the present invention is as follows:

[21] A method of using a stent kit including a stent having an inner lumen extending longitudinally from the proximal side to the distal side and having an arc portion A curved in an arc shape, and an insertion member inserted into the inner lumen of the stent, wherein the stent is moved distally or proximally relative to the insertion member prior to delivery of the stent to a lumen in a living body.

[22] The method of use according to

[21] , wherein the distance of movement of the stent is in the range of 1 mm or more and 50 mm or less.

[0012] According to the stent kit of the present invention, when the insertion member is not placed in the lumen of the stent, the minimum radius of curvature of the arcuate portion is smaller than the minimum radius of curvature of the insertion member, so that the insertion member has a more linear or nearly linear curve than the arcuate portion of the stent. Therefore, when the insertion member is inserted into the lumen of the stent, the insertion member causes the arcuate portion of the stent to become linear or nearly linear, facilitating delivery of the stent to the lesion. Furthermore, when the insertion member is removed from the stent and the stent is placed, the minimum radius of curvature of the arcuate portion of the stent becomes larger than the minimum radius of curvature of the insertion member, making it less likely for the stent to become displaced after placement.

[0013] Furthermore, the method for producing a stent kit of the present invention can provide a stent kit that is easy to deliver to a lesion. Furthermore, when the stent kit provided by the method for producing a stent kit of the present invention is delivered to a lesion and the stent is placed in the lesion, the stent is unlikely to move from the placed position.

[0014] 1 shows an overall view of a stent kit according to one embodiment of the present invention.

[0023] FIG. 1 shows an overall view of a stent in the stent kit shown in FIG. 1 when an insertion member is not placed in the lumen.

[0024] FIG. 2 shows a partially enlarged view of an insertion member in the stent kit shown in FIG. 1 when not placed in the lumen of the stent.

[0025] FIG. 3 shows a cross-sectional view of the stent kit shown in FIG. 1 taken along line IV-IV.

[0026] FIG. 4 shows a cross-sectional view perpendicular to the extension direction of the stent in another embodiment of the present invention.

[0027] FIG. 5 shows a partially enlarged cross-sectional view of the stent kit shown in FIG. 1 along the extension direction of the insertion member.

[0028] FIG. 6 shows an overall view of a stent system including the stent kit shown in FIG. 1.

[0029] FIG. 7 shows an overall view of a stent system according to another embodiment of the present invention.

[0029] FIG. 8 shows an overall view of a protective tube in the stent system shown in FIG. 8 when a stent is not placed in the lumen.

[0029] FIG. 9 shows an overall view of a stent kit in which an insertion member is inserted into the lumen of the stent in one embodiment of the present invention, showing a state in which a retaining element is abutting against the arc portion A of the stent. 11 is a schematic diagram showing a state in which a retaining element different from that shown in FIG. 10 is abutted against a circular arc portion A of a stent in a stent kit in which an inserting member is inserted into the inner lumen of a stent in one embodiment of the present invention. FIG. 12 is a schematic diagram showing a state in which a retaining element is abutted against a circular arc portion A of a stent in a stent kit in which an inserting member is inserted into the inner lumen of a stent in another embodiment of the present invention.

[0015] The present invention will be described in more detail below based on the following embodiments. However, the present invention is not limited to the following embodiments, and can be implemented with appropriate modifications within the scope of the above and below-described purposes, and all such modifications are included within the technical scope of the present invention. For convenience, hatching and component symbols may be omitted in the drawings. In such cases, reference should be made to the specification and other drawings. The dimensions of various components in the drawings may differ from their actual dimensions, as priority is given to helping understand the features of the present invention.

[0016] First, the stent kit of the present invention will be described.

[0017] Fig. 1 is an overall view of a stent kit 1 according to an embodiment of the present invention. As shown in Fig. 1, the stent kit 1 includes a stent 10, an inner insertion member 20 inserted into the lumen of the stent 10, and an outer tubular member 50 disposed outside the inner insertion member 20 and proximal to the stent 10. The stent kit 1 is a device for delivering the stent 10 to a lesion. The stent 10 is attached to the inner insertion member 20, on which the outer tubular member 50 is disposed, and delivered to the lesion. The inner insertion member 20 is then pulled proximally relative to the outer tubular member 50 to remove the inner insertion member 20 from the lumen of the stent 10, and the stent 10 is placed in the lesion.

[0018] In the present invention, the proximal side refers to the side closer to the user in the extending direction of the insertion member 20, and the distal side refers to the side opposite the proximal side, i.e., the side (the lesion side) where treatment is performed using the stent kit 1. The extending direction of the insertion member 20 is sometimes referred to as the longitudinal axis direction. The longitudinal axis direction of the insertion member 20 can also be referred to as the direction of approach and distance from the insertion member 20.

[0019] 2 is an overall view of the stent 10 without the insertion member 20 disposed in the lumen of the stent 10. The stent 10 is a long object having one end and the other end and an inner lumen. In particular, the stent 10 is preferably a plastic stent. In addition to the stent 10, an occluder or the like may also be used.

[0020] Examples of materials constituting the stent 10 include polyamide resins, polyester resins, polyurethane resins, polyolefin resins, fluorine-based resins, vinyl chloride resins, silicone resins, and natural rubber. These materials may be used alone or in combination. Among these, the resin constituting the stent 10 is preferably at least one of polyamide resins, polyester resins, polyurethane resins, polyolefin resins, and fluorine-based resins. By using at least one of polyamide resins, polyester resins, polyurethane resins, polyolefin resins, and fluorine-based resins as the material constituting the stent 10, the surface slipperiness of the stent 10 can be increased, thereby improving the insertability into a lumen in the body. The resin tube that serves as the raw material for the stent 10 can be manufactured using conventional methods such as extrusion molding and injection molding.

[0021] As shown in Figure 2, the stent 10 has an arc portion A that is curved in an arc shape. The arc portion A refers to the portion of the stent 10 that is curved in an arc shape when the insertion member 20 is not placed in the lumen of the stent 10 and no external force other than gravity is applied to the stent 10. The arc portion A comes into contact with the lumen of the body and functions to fix the stent 10 to the lumen of the body. Specifically, when the stent 10 is a biliary stent, the arc portion A may be placed distal to a narrowed portion (obstructed portion) of the bile duct to prevent the stent 10 from falling out of the bile duct toward the duodenum, or near the duodenal papilla to prevent the stent 10 from migrating into the bile duct.

[0022] The arc portion A may be present at one end of the stent 10, and is preferably present at both ends of the stent 10. In other words, the stent 10 preferably has arc portions A curved in an arc shape at both ends of the stent 10. The presence of arc portions A at both ends of the stent 10 can enhance the effect of fixing the stent 10 to a lumen in the body.

[0023] The shape of the arc portion A may be a closed circle as shown in Fig. 2, or may be a semicircular arc shape that is not a closed circle. If the arc portion A is a closed circle, the effect of fixing the stent 10 in a predetermined position can be improved. Furthermore, if the arc portion A is an unclosed arc shape, the stent 10 can be made to have high insertability into a lumen within a living body.

[0024] As shown in Fig. 1, an insertion member 20 is inserted into the lumen of a stent 10. The insertion member 20 is an elongated member having one end and the other end. With the stent 10 attached to the insertion member 20, the stent 10 is transported to the lesion, and the insertion member 20 is removed from the lumen of the stent 10, thereby leaving the stent 10 in the lesion.

[0025] The shape of the inserting member 20 when not placed in the lumen of the stent 10 may be such that at least a portion of the inserting member 20 is curved in an arc shape in the extending direction, or may be linear in the extending direction, or may be linear from one end to the other end of the inserting member 20. As shown in Fig. 3 , the shape of the inserting member 20 before being placed in the lumen of the stent 10 may have an arc portion B that is curved in an arc shape. The arc portion B refers to the portion of the inserting member 20 that is curved in an arc shape when the inserting member 20 is not placed in the lumen of the stent 10 and no external force other than gravity is applied to the inserting member 20.

[0026] The insertion member 20 preferably has an inner lumen extending from one end to the other end. By having the inner lumen, when the stent 10 is delivered to the lesion, a guide wire can be inserted through the inner lumen of the insertion member 20, thereby improving the insertability.

[0027] The cross-sectional shape of the outer shape of the inserting member 20 in a cross section perpendicular to the extension direction of the inserting member 20 is preferably circular. The circular cross-sectional shape of the outer shape of the inserting member 20 makes the surface of the inserting member 20 smooth, making it less likely to damage other objects, such as the inner surface of the stent 10 or the wall of a lumen in a living body, even when it comes into contact with those objects. Furthermore, when the inserting member 20 has an inner lumen extending from one end to the other end, the cross-sectional shape of the inner lumen of the inserting member 20 in a cross section perpendicular to the extension direction of the inserting member 20 is preferably circular. The circular cross-sectional shape of the inner lumen of the inserting member 20 makes the inner surface of the inserting member 20 smooth, allowing a guidewire or the like to be smoothly inserted into the inner lumen of the inserting member 20.

[0028] Examples of materials that can be used to form the insert member 20 include polyamide resins, polyester resins, polyurethane resins, polyolefin resins, fluorine-based resins, vinyl chloride resins, silicone resins, and natural rubber. These materials can be used alone or in combination. Among these, polyamide resins, polyester resins, polyurethane resins, polyolefin resins, and fluorine-based resins are preferred as the materials for the insert member 20. By using polyamide resins, polyester resins, polyurethane resins, polyolefin resins, and fluorine-based resins as the materials for the insert member 20, the insert member 20 can have a smooth surface and be highly insertable.

[0029] The outer tubular member 50 is an elongated member having one end and the other end and an inner lumen. The inner insertion member 20 is inserted into the inner lumen of the outer tubular member 50. The distal end of the outer tubular member 50 is disposed proximal to the proximal end of the stent 10. In other words, the outer tubular member 50 is disposed outside the inner insertion member 20 and proximal to the proximal end of the stent 10. The stent 10 is attached to the inner insertion member 20 on which the outer tubular member 50 is disposed and transported to the lesion. By pulling the inner insertion member 20 toward the operator relative to the outer tubular member 50, the inner insertion member 20 is removed from the inner lumen of the stent 10, and the stent 10 can be placed in the lesion.

[0030] The cross-sectional shape of the outer tube member 50 in a cross section perpendicular to the extension direction of the outer tube member 50 may be, for example, a circle, a polygon, or a combination of these. In particular, the cross-sectional shape of the outer shape of the outer tube member 50 in a cross section perpendicular to the extension direction of the outer tube member 50 is preferably a circle. The circular cross-sectional shape of the outer shape of the outer tube member 50 makes the outer surface of the outer tube member 50 smooth, making it less likely to damage the wall of a lumen in a living body even if the outer surface of the outer tube member 50 comes into contact with the wall of a lumen in a living body. Furthermore, the cross-sectional shape of the inner lumen of the outer tube member 50 in a cross section perpendicular to the extension direction of the outer tube member 50 is preferably a circle. The circular cross-sectional shape of the inner lumen of the outer tube member 50 makes the surface of the inner lumen of the outer tube member 50 smooth, making it easier to improve the sliding properties of the outer tube member 50 relative to the inner member 20.

[0031] Examples of materials constituting the outer tube member 50 include polyamide resins, polyester resins, polyurethane resins, polyolefin resins, fluorine-based resins, vinyl chloride resins, silicone resins, and natural rubber. These materials may be used alone or in combination. Among these, the resin constituting the outer tube member 50 is preferably at least one of polyamide resins, polyester resins, polyurethane resins, polyolefin resins, and fluorine-based resins. By using at least one of polyamide resins, polyester resins, polyurethane resins, polyolefin resins, and fluorine-based resins as the material constituting the outer tube member 50, the outer tube member 50 can have a highly slippery surface and excellent insertability. The resin tube that serves as the raw material for the outer tube member 50 can be manufactured using conventional methods such as extrusion molding and injection molding.

[0032] Fig. 3 is a partially enlarged view of the inserting member 20 when the inserting member 20 is not placed in the lumen of the stent 10. As shown in Figs. 2 and 3, when the inserting member 20 is not placed in the lumen of the stent 10, the minimum radius of curvature rA of the arc portion A is smaller than the minimum radius of curvature rB of the inserting member 20. When the inserting member 20 has an arc portion B as shown in Fig. 3, the minimum radius of curvature rB of the inserting member 20 means the minimum radius of curvature rB of the arc portion B of the inserting member 20. When the inserting member 20 is not placed in the lumen of the stent 10, the minimum radius of curvature rA of the arc portion A is smaller than the minimum radius of curvature rB of the inserting member 20, so that the arc portion A of the stent 10 and the inserting member 20 have different degrees of curvature, and the arc portion A of the stent 10 is more curved than the inserting member 20. When the insertion member 20 is not placed in the lumen of the stent 10, the arc portion A of the stent 10 curves, and the arc portion A comes into contact with the lumen of the living body, thereby fixing the stent 10 to the lumen of the living body. As a result, it is possible to prevent the stent 10 from falling off from the lumen of the living body or from shifting its position. Furthermore, when the insertion member 20 is inserted into the lumen of the stent 10, the insertion member 20 reduces the curvature of the arc portion A of the stent 10, allowing the shape of the arc portion A to approach a straight line. As a result, it is possible to improve the insertability of the stent 10.

[0033] Specifically, the stent 10 is fed into a lumen of the body with the insertion member 20 inserted into the lumen of the stent 10 and transported to the target site. At this time, as shown in FIG. 1 , the curvature of the arc portion A of the stent 10 is reduced by the insertion member 20, so the stent 10 assumes a straight or nearly straight shape, improving insertability. Once the stent 10 reaches the target site in the lumen of the body, the insertion member 20 is removed from the lumen of the stent 10. As a result, the shape of the arc portion A of the stent 10 returns to its shape before the insertion member 20 was inserted or becomes similar to its shape before the insertion member 20 was inserted, resulting in a curved arc portion A. The contact of the curved arc portion A with the lumen of the body prevents the stent 10 from moving.

[0034] A method for measuring the minimum radius of curvature rA of the arc portion A and the minimum radius of curvature rB of the inserting member 20 when the inserting member 20 is not placed in the inner cavity of the stent 10 includes, for example, removing the inserting member 20 from the inner cavity of the stent 10, taking a photograph of the stent 10 and the inserting member 20 while the stent 10 and the inserting member 20 are left stationary, and measuring the minimum radius of curvature rA of the arc portion A and the minimum radius of curvature rB of the inserting member 20 in the obtained image.

[0035] The minimum radius of curvature rA of the arc portion A when the inserting member 20 is not placed in the lumen of the stent 10 is preferably 70% or less, more preferably 60% or less, and even more preferably 50% or less of the minimum radius of curvature rB of the inserting member 20. By setting the upper limit of the ratio between the minimum radius of curvature rA of the arc portion A and the minimum radius of curvature rB of the inserting member 20 within the above range, the inserting member 20 can easily reduce the curvature of the arc portion A of the stent 10 when the inserting member 20 is placed in the lumen of the stent 10. Furthermore, the lower limit of the ratio between the minimum radius of curvature rA of the arc portion A when the inserting member 20 is not placed in the lumen of the stent 10 and the minimum radius of curvature rB of the inserting member 20 is not particularly limited, and can be, for example, more than 0%, 0.1% or more, or 1% or more.

[0036] The shape of the insertion member 20 is preferably linear when not placed in the lumen of the stent 10. By having the insertion member 20 linear, the effect of reducing the curvature of the arc portion A of the stent 10 can be enhanced when the insertion member 20 is inserted into the lumen of the stent 10, and the linear shape of the stent 10 can improve insertability.

[0037] 1, when the inserting member 20 is placed in the lumen of the stent 10, the inserting member 20 has a shaping section s1 that is curved in an arc shape and a straight non-shaping section s2 that is located closer to the tip of the inserting member 20 than the shaping section s1, and it is preferable that the length L2 of the non-shaping section s2 in the extension direction of the inserting member 20 is longer than the length L1 of the shaping section s1 in the extension direction of the inserting member 20. The shaping section s1 is the section where the extension direction of the inserting member 20 is curved in an arc shape, and the non-shaping section s2 is the section where the extension direction of the inserting member 20 is straight.

[0038] When the insertion member 20 is placed in the lumen of the stent 10, the length L2 of the non-shaping section s2 is longer than the length L1 of the shaping section s1, thereby ensuring a straight portion at the tip of the insertion member 20. As a result, when a guidewire is inserted into the lumen of the insertion member 20, the step that occurs between the tip of the insertion member 20 and the guidewire can be reduced, thereby improving the insertability of the stent kit 1.

[0039] The length L2 of the non-shaping section s2 in the extension direction of the insert member 20 is preferably at least twice, more preferably at least 2.5 times, and even more preferably at least 3 times the length L1 of the shaping section s1 in the extension direction of the insert member 20. By setting the lower limit of the ratio of the length L2 of the non-shaping section s2 to the length L1 of the shaping section s1 within the above range, it becomes easier to make the length L2 of the non-shaping section s2 at the distal end of the insert member 20 sufficiently longer than the length L1 of the shaping section s1. As a result, when a guidewire is inserted into the lumen of the insert member 20, the step between the distal end of the insert member 20 and the guidewire is reduced, resulting in a stent kit 1 with good insertability. Furthermore, the length L2 of the non-shaping section s2 in the extension direction of the insert member 20 is preferably at most 30 times, more preferably at most 25 times, and even more preferably at most 20 times the length L1 of the shaping section s1 in the extension direction of the insert member 20. By setting the upper limit value of the ratio between the length L2 of the non-shaping section s2 and the length L1 of the shaping section s1 within the above range, the length of the insertion member 20 can be prevented from becoming excessively long, making it easier to place the insertion member 20 into the lumen of the stent 10.

[0040] The length L2 of the non-shaping section s2 in the extension direction of the insertion member 20 is preferably 50 mm or less, more preferably 45 mm or less, and even more preferably 40 mm or less. By setting the upper limit of the length L2 of the non-shaping section s2 within the above range, the length of the insertion member 20 in the extension direction is less likely to become excessively long, making it less likely to damage the biological lumen during placement of the stent 10. Furthermore, the lower limit of the length L2 of the non-shaping section s2 in the extension direction of the insertion member 20 is not particularly limited, and can be, for example, 5 mm or more, 7 mm or more, or 10 mm or more.

[0041] FIG. 4 is a cross-sectional view of the stent kit 1 taken perpendicular to the direction in which the stent 10 extends, and FIG. 5 is a cross-sectional view of the stent kit 1 according to another embodiment taken perpendicular to the direction in which the stent 10 extends.

[0042] 4 and 5, when the inserting member 20 is placed in the lumen of the stent 10, the inserting member 20 preferably has a metal wire 30 in at least a portion of the portion located in the arc portion A of the stent 10. By having the metal wire 30 in at least a portion of the portion of the inserting member 20 located in the arc portion A, the rigidity of the portion of the inserting member 20 having the metal wire 30 is increased. As a result, when the inserting member 20 is placed in the lumen of the stent 10, the effect of the inserting member 20 in reducing the curvature of the arc portion A of the stent 10 can be enhanced, and the insertability of the stent 10 can be easily improved.

[0043] When the insertion member 20 is disposed in the lumen of the stent 10, the metal wire 30 is preferably disposed over 30% or more of the length of the arc portion A of the stent 10, more preferably over 50%, even more preferably over 70%, even more preferably over 90%, and particularly preferably over 100%. Disposing the metal wire 30 over 100% of the length of the arc portion A of the stent 10 means that the metal wire 30 is present over the entire length of the arc portion A. By setting the lower limit of the length of the metal wire 30 in the arc portion A within the above range, when the insertion member 20 is disposed in the lumen of the stent 10, the metal wire 30 can more easily reduce the curvature of the arc portion A of the stent 10, thereby improving the insertability of the stent 10. The upper limit of the length of the metal wire 30 in the arc portion A is not particularly limited, but may be, for example, 100% or less.

[0044] The length of the metal wire 30 in the extension direction of the insertion member 20 is preferably 30% or more of the length of the arc portion A in the extension direction of the stent 10, more preferably 50% or more, even more preferably 70% or more, even more preferably 90%, and particularly preferably 100% or more. By setting the lower limit of the ratio of the length of the metal wire 30 to the length of the arc portion A within the above range, the metal wire 30 is more likely to be positioned in the arc portion A when the insertion member 20 is placed in the lumen of the stent 10. As a result, the curvature of the arc portion A can be more easily reduced by the insertion member 20. The upper limit of the ratio of the length of the metal wire 30 to the length of the arc portion A is not particularly limited, and can be, for example, 500% or less, 400% or less, or 300% or less.

[0045] The number of metal wires 30 in the inserting member 20 may be one, but preferably is more than one. By having the inserting member 20 have more than one metal wire 30, the rigidity of the portion of the inserting member 20 where the metal wires 30 are provided can be increased, and the effect of reducing the curvature of the arc portion A of the stent 10 by the inserting member 20 can be improved.

[0046] The cross-sectional shape of the metal wire 30 in a cross section perpendicular to the extension direction of the insert member 20 may be, for example, a circle, a polygon, or a combination of these. In particular, the cross-sectional shape of the metal wire 30 in a cross section perpendicular to the extension direction of the insert member 20 is preferably a circle. By having the cross-sectional shape of the metal wire 30 be circular, it is possible to make the insert member 20 less likely to be damaged, such as to tear, by the metal wire 30 when the insert member 20 is bent or pressed against the insert member 20.

[0047] Examples of materials that can be used to form the metal wire 30 include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, copper, iron, manganese, aluminum, zinc, and alloys thereof.

[0048] The material constituting the metal wire 30 is preferably a shape memory alloy. When the material constituting the metal wire 30 is a shape memory alloy, the metal wire 30 is likely to be straight or have a shape with a large radius of curvature. Therefore, by inserting the insertion member 20 into the lumen of the stent 10, the curvature of the arc portion A of the stent 10 can be easily reduced.

[0049] The shape memory alloy constituting the metal wire 30 preferably contains at least one selected from the group consisting of a nickel-titanium alloy, a beta-titanium alloy, an iron-manganese-silicon alloy, and a cobalt-chromium alloy. When the shape memory alloy constituting the metal wire 30 contains at least one selected from the above group, the metal wire 30 has excellent elasticity, and the effect of reducing the curvature of the arc portion A of the stent 10 can be enhanced.

[0050] It is also preferable that the metal wire 30 has a higher straightness than the stent 10. Since the straightness of the metal wire 30 is higher than that of the stent 10, the metal wire 30 makes it easier for the insertion member 20 to have a straight or nearly straight shape. As a result, by placing the insertion member 20 in the lumen of the stent 10, the curvature of the stent 10 is reduced, making it easier to improve the insertability of the stent 10. Furthermore, when the insertion member 20 has a lumen extending from one end to the other end, the straight or nearly straight shape of the insertion member 20 makes it easier to insert a guide wire or the like into the lumen of the insertion member 20.

[0051] It is also preferable that the metal wire 30 contains at least one of a stainless steel wire and a tungsten wire. When the metal wire 30 contains at least one of a stainless steel wire and a tungsten wire, the straightness of the metal wire 30 tends to be higher than that of the stent 10. This also increases the straightness of the inner insertion member 20, which has the effect of reducing curvature of the stent 10 and making it possible to improve the insertability of the inner insertion member 20 into the lumen.

[0052] As shown in Figures 4 and 5, it is preferable that at least a portion of the metal wire 30 is fixed to the wall 21 of the insert member 20. Specifically, as shown in Figure 4, the metal wire 30 may be fixed so as to be embedded inside the wall 21 of the insert member 20, or as shown in Figure 5, the metal wire 30 may be disposed in the cavity of the insert member 20 and fixed to the surface of the wall 21 of the insert member 20. Furthermore, the metal wire 30 may be fixed to the wall 21 of the insert member 20 only partially in the extension direction of the metal wire 30, or may be fixed to the wall 21 of the insert member 20 over the entire extension direction of the metal wire 30.

[0053] 1 , the insertion member 20 has a hub 40 at the proximal end, and although not shown, the metal wire 30 is preferably fixed to the hub 40. An example of a configuration in which the metal wire 30 is fixed to the hub 40 is a configuration in which the proximal portion of the metal wire 30 is fixed to the hub 40. By fixing the metal wire 30 to the hub 40, the proximal side of the metal wire 30 is fixed to and supported by the hub 40, which makes it easier to enhance the effect of the metal wire 30 in increasing the rigidity and straightness of the entire insertion member 20.

[0054] The hub 40 has a guidewire port inside that is connected to the inner cavity of the insertion member 20, and is a component that is used when introducing a guidewire into the inner cavity of the insertion member 20 or when injecting contrast agent, medicinal liquid, etc.

[0055] Figure 6 is a partially enlarged cross-sectional view of the stent kit 1 taken along the extension direction of the inner insertion member 20. As shown in Figure 6, the stent 10 and the outer tubular member 50 are preferably connected by a connecting means 60. In the stent kit 1 shown in Figure 6, the connecting means 60 is annular, and the inner insertion member 20 is disposed inside the ring of the connecting means 60. In Figure 6, the portion of the connecting means 60 located on the front side of the page is indicated by a dashed line to make it easier to understand the positional relationship between the connecting means 60 and the inner insertion member 20. By connecting the stent 10 and the outer tubular member 50 by the connecting means 60, force applied from the proximal side is easily transmitted to the stent 10 through the outer tubular member 50, making it easier to push the stent 10 distally and deliver the stent 10 to the target site.

[0056] 6, it is preferable that the stent 10 has a first side hole 71 communicating with the lumen of the stent 10, the outer tubular member 50 has a second side hole 72 communicating with the lumen of the outer tubular member 50, and the connecting means 60 is inserted through the first side hole 71 and the second side hole 72. By inserting the connecting means 60 through the first side hole 71 of the stent 10 and the second side hole 72 of the outer tubular member 50, it becomes easier to connect the stent 10 and the outer tubular member 50 with the connecting means 60, and also makes it easier to release the connection between the stent 10 and the outer tubular member 50, if necessary.

[0057] The connecting means 60 may be any as long as it can connect the stent 10 and the outer tubular member 50. Examples of the configuration of the connecting means 60 include a configuration in which the connecting means 60 forms a single ring, with the inner insertion member 20 and the outer tubular member 50 disposed inside the ring portion, a configuration in which the connecting means 60 has multiple ring portions, with the inner insertion member 20 disposed in one ring portion and the outer tubular member 50 disposed in another ring portion, and a configuration in which the connecting means 60 is rod-shaped, with the inner insertion member 20 fixed to one end and the outer tubular member 50 fixed to the other end.

[0058] As shown in Figure 6, the connecting means 60 preferably has an annular portion, and the inner insertion member 20 is disposed inside the annular portion. Because the connecting means 60 has an annular portion and the inner insertion member 20 is disposed inside the annular portion, the connection between the stent 10 and the outer tubular member 50 can be easily released by removing the inner insertion member 20 from the annular portion or by cutting the annular portion, etc. This makes it easier to place the stent 10 at the target site.

[0059] It is more preferable that the connecting means 60 is a suture. By using a suture as the connecting means 60, the connecting means 60 can be made flexible while maintaining its durability, and the connecting means 60 can be made less likely to damage the stent 10, the lumen wall of the living body, etc.

[0060] As shown in Figure 6, the connecting means 60 preferably forms a single annular portion, and portions of the distal end portions of the inner insert member 20 and the outer tubular member 50 are preferably disposed inside the annular portion of the connecting means 60. The configuration in which portions of the distal end portions of the inner insert member 20 and the outer tubular member 50 are disposed inside the annular portion of the connecting means 60 can be rephrased as a configuration in which two linear members constituting the connecting means 60 are disposed in the first side hole 71 and one linear member constituting the connecting means 60 is disposed in the second side hole 72, as shown in Figure 6. By disposing portions of the distal end portions of the inner insert member 20 and the outer tubular member 50 inside the annular portion of the connecting means 60, the connecting means 60 remains fixed to the outer tubular member 50 even after the inner insert member 20 is removed from inside the annular portion of the connecting means 60, so that it is possible to prevent the connecting means 60 from falling off and improve safety.

[0061] Fig. 7 is an overall view of a stent system 100 including a stent kit 1. As shown in Fig. 7, the stent system 100 includes the stent kit 1 and a retaining element 80 that holds the stent kit 1. The retaining element 80 preferably holds the arc portion A of the stent 10 when the insertion member 20 is inserted into the lumen of the stent 10. By holding the arc portion A of the stent 10 when the insertion member 20 is inserted into the lumen of the stent 10, the retaining element 80 can maintain the shape of the arc portion A of the stent 10. In other words, in the stent system 100, the insertion member 20 is prevented from excessively correcting the curvature of the arc portion A of the stent 10 to a straight line, and the retaining element 80 maintains the arc portion A of the stent 10, thereby preventing the arc portion A of the stent 10 from disappearing when the insertion member 20 is removed from the lumen of the stent 10. Therefore, when the stent 10 is transported, the insertion member 20 causes the stent 10 to assume a straight or nearly straight shape, improving insertion ease. Furthermore, after the insertion member 20 is removed from the lumen of the stent 10, the curve of the arc portion A of the stent 10 returns to its original shape, making it possible to create a stent system 100 in which the arc portion A is less likely to come into contact with the lumen inside the body and become displaced.

[0062] The retaining element 80 preferably includes at least one of a mount, a blister, a clip, and a tape. That is, the material constituting the retaining element 80 preferably includes at least one selected from the group consisting of a mount, a blister, a clip, and a tape. The retaining element 80 may include one or more of a mount, a blister, a clip, and a tape. A blister refers to a so-called blister pack, such as a sheet-like object made of synthetic resin with an uneven surface attached to a mount or a thin sheet, or a sheet-like object made of synthetic resin with grooves. By including at least one of a mount, a blister, a clip, and a tape, the retaining element 80 can easily and firmly fix and hold the arc portion A of the stent 10.

[0063] When the insertion member 20 is inserted into the lumen of the stent 10, the arc portion A can be held by the holding element 80 by, for example, making holes or cuts in the paper material and inserting the stent 10 through the holes or cuts to fix and hold the arc portion A. When the holding element 80 is a backing, the arc portion A can be fixed and held by fitting the stent 10 into the recesses and protrusions of a thin plate-like material made of synthetic resin. When the holding element 80 is a clip, the arc portion A can be fixed and held by attaching the clip to the stent 10. When the holding element 80 is a tape, the arc portion A can be fixed and held by applying the tape to the stent 10.

[0064] 7, the stent system 100 may further include other holding elements 81 that hold the inner insertion member 20 and portions of the stent 10 other than the arc portion A. In the stent system 100, in addition to the holding element 80 that holds the arc portion A of the stent 10, the other holding elements 81 that hold other portions can be further included, thereby preventing the inner insertion member 20 from falling off the stent 10 and preventing the respective members from coming into unintentional contact with each other and being damaged during storage or transportation of the stent system 100.

[0065] Fig. 8 is an overall view of a stent system 100 according to another embodiment, and Fig. 9 is an overall view of a protective tube 90 without a stent 10 disposed in the lumen. As shown in Figs. 8 and 9, the stent system 100 further includes a protective tube 90. The minimum radius of curvature rC of the protective tube 90 is preferably greater than the minimum radius of curvature rA of the arc portion A, and the stent 10 is inserted into the lumen of the protective tube 90. As shown in Fig. 9, when the protective tube 90 has an arc portion C, the minimum radius of curvature rC of the protective tube 90 refers to the minimum radius of curvature rC of the arc portion C of the protective tube 90. The arc portion C refers to the portion of the protective tube 90 that is curved in an arc shape when the stent 10 is not disposed in the lumen of the protective tube 90 and no external force other than gravity is applied to the protective tube 90.

[0066] The minimum radius of curvature rC of the protective tube 90 is measured when the stent 10 is not inserted into the lumen of the protective tube 90. In other words, the minimum radius of curvature rC of the protective tube 90 when the stent 10 is not inserted into the lumen of the protective tube 90 is preferably larger than the minimum radius of curvature rA of the arc portion A when the inner insertion member 20 is not disposed in the lumen of the stent 10. When the minimum radius of curvature rC of the protective tube 90 is larger than the minimum radius of curvature rA of the arc portion A, the protective tube 90 and the arc portion A of the stent 10 have different degrees of curvature, and the protective tube 90 has a shape with a smaller degree of curvature than the arc portion A of the stent 10. In other words, the protective tube 90 has a linear shape or a shape closer to a linear shape than the arc portion A of the stent 10. Therefore, by inserting the stent 10 into the inner cavity of the protective tube 90, the stent 10 is protected by the protective tube 90, while the protective tube 90 reduces the curvature of the arc portion A of the stent 10, thereby improving the insertability of the stent 10.

[0067] A method for measuring the minimum radius of curvature rC of the protective tube 90 when the stent 10 is not inserted into the inner cavity of the protective tube 90 includes, for example, leaving the protective tube 90 stationary without the insertion member 20 placed in the inner cavity of the protective tube 90, taking a photograph of the protective tube 90, and measuring the minimum radius of curvature rC of the protective tube 90 in the obtained image.

[0068] The protective tube 90 is an elongated member having one end and the other end and an inner lumen. The length from one end to the other end of the protective tube 90 is preferably longer than the length from one end to the other end of the stent 10. By making the protective tube 90 longer than the stent 10, the entire stent 10 can be more easily protected.

[0069] The cross-sectional shape of the protective tube 90 in a cross section perpendicular to the extension direction of the protective tube 90 may be, for example, a circle, a polygon, or a combination of these. In particular, the cross-sectional shape of the outer shape of the protective tube 90 in a cross section perpendicular to the extension direction of the protective tube 90 is preferably a circle. The circular cross-sectional shape of the outer shape of the protective tube 90 makes the outer surface of the protective tube 90 smooth, making it less likely to be damaged even if the outer surface of the protective tube 90 comes into contact with other objects. Furthermore, the cross-sectional shape of the lumen of the protective tube 90 in a cross section perpendicular to the extension direction of the protective tube 90 is preferably a circle. The circular cross-sectional shape of the lumen of the protective tube 90 increases the slidability of the inner surface of the protective tube 90, making it possible for the stent 10 to move smoothly within the lumen of the protective tube 90.

[0070] Examples of materials constituting the protective tube 90 include polyamide-based resins, polyester-based resins, polyurethane-based resins, polyolefin-based resins, fluorine-based resins, vinyl chloride-based resins, silicone-based resins, and natural rubber. These materials may be used alone or in combination. Among these, the resin constituting the protective tube 90 is preferably at least one of polyamide-based resins, polyester-based resins, polyurethane-based resins, polyolefin-based resins, and fluorine-based resins. By using at least one of polyamide-based resins, polyester-based resins, polyurethane-based resins, polyolefin-based resins, and fluorine-based resins as the material constituting the protective tube 90, the protective tube 90 can have good slip properties. The resin-based tube that serves as the raw material for the protective tube 90 can be manufactured using a conventional method such as extrusion molding or injection molding.

[0071] As described above, the delivery device of the present invention includes a stent, an inserting member inserted into the lumen of the stent, and an outer tubular member disposed outside the inserting member and proximal to the stent. The stent has an arcuate portion, and when the inserting member is not disposed in the lumen of the stent, the minimum radius of curvature of the arcuate portion is smaller than the minimum radius of curvature of the inserting member. This configuration of the delivery device of the present invention allows the inserting member to have a more linear or nearly linear curve than the arcuate portion of the stent. Therefore, when the inserting member is inserted into the lumen of the stent, the inserting member causes the arcuate portion of the stent to become linear or nearly linear, facilitating delivery of the stent to the lesion. Furthermore, when the inserting member is removed from the stent and the stent is deployed, the minimum radius of curvature of the stent's arcuate portion is larger than the minimum radius of curvature of the inserting member, thereby reducing the likelihood of stent displacement after deployment.

[0072] Next, a method for producing the stent kit of the present invention will be described. In the following description, parts that overlap with the above description will be omitted.

[0073] The method for manufacturing a stent kit according to the present invention is a method for manufacturing a stent kit having a stent having an inner lumen extending longitudinally from the proximal side to the distal side and having an arc portion A that is curved in an arc shape, and an inserting member inserted into the inner lumen of the stent, and includes a preparation step for preparing the stent, an arrangement step for placing the inserting member in the inner lumen of the stent, and a holding step for abutting a holding element against the arc portion A of the stent.

[0074] The method for manufacturing a stent kit of the present invention includes a holding step of abutting a holding element against the arc portion A of a stent having an inner lumen extending longitudinally from the proximal side to the distal side and having an arc portion A curved in an arc shape while an insertion member is placed in the lumen of the stent. Therefore, even if the insertion member has, for example, a straight or arc portion B curved in an arc shape, and the minimum radius of curvature rB of the arc portion B is greater than the minimum radius of curvature rA of the arc portion A of the stent, the stent can maintain the state in which the arc portion A curved in an arc shape is formed. Therefore, when the stent is delivered to the lesion, the curvature of the arc portion A of the stent is linear or nearly linear due to the insertion member, making it easier to deliver the stent to the lesion. Furthermore, after the stent has been delivered to the lesion, the insertion member is removed from the stent and the stent is placed in the lesion, and since the minimum radius of curvature rA of the arc portion A of the stent is larger than the minimum radius of curvature rB of the insertion member, the stent placed in the lesion is less likely to become displaced.

[0075] [Preparation Step] In the preparation step, a stent 10 is prepared, which has an inner lumen extending in the longitudinal direction from the proximal side to the distal side and has an arc portion A that is curved in an arc shape.

[0076] An example of the configuration of an embodiment of the stent 10 prepared in the preparation step is shown in Fig. 2. Note that no insertion member 20 is disposed in the lumen of the stent 10 shown in Fig. 2.

[0077] The preparation step may include preparing a stent 10 having a lumen extending longitudinally from the proximal side to the distal side and having an arc portion A that is curved in an arc shape, or may include a step of preparing a tube (hereinafter sometimes referred to as a raw tube) that serves as a raw material for stent 10 and bending a portion of the raw tube into an arc shape to form the arc portion A. A method of bending a portion of the raw tube into an arc shape to form the arc portion A includes, for example, inserting a long object into the lumen of the raw tube and heating the portion of the raw tube together with the long object in a state where it is bent into an arc shape, thereby forming the arc portion A in the raw tube.

[0078] [Placement Step] The placement step is a step of placing the insertion member 20 in the lumen of the stent 10. Fig. 3 shows an example of the configuration of an embodiment of the insertion member 20 to be placed in the lumen of the stent 10. Note that Fig. 3 shows a state in which the insertion member 20 is not placed in the lumen of the stent 10.

[0079] The manufacturing method of the present invention may include a step of heat treating the inner insertion member 20 to straighten it before placing it in the lumen of the stent 10. The heat treatment may be performed by heating the inner insertion member 20 at 80 to 150°C for 1 to 2 hours while pulling both ends of the inner insertion member 20.

[0080] [Retaining Step] In the retaining step, the retaining element 80 is brought into contact with the arc portion A of the stent 10 with the insertion member 20 disposed in the lumen. The retaining element 80 is a member capable of retaining the shape of the arc portion A of the stent 10.

[0081] The material constituting the retaining element 80 preferably includes at least one selected from the group consisting of, for example, a mount, a synthetic resin, a clip, and a tape. By including at least one of the mount, the synthetic resin, the clip, and the tape in the retaining element 80, the retaining element 80 can easily and firmly hold the arc portion A of the stent 10.

[0082] The synthetic resin material constituting the retaining element 80 is preferably at least one of polyamide-based resin, polyester-based resin, polyurethane-based resin, polyolefin-based resin, and fluorine-based resin. When the material constituting the retaining element 80 is a synthetic resin, it is preferable to use a synthetic resin that is less subject to thermal history than the material constituting the stent 10. Not being subject to thermal history means that it is less likely to deform. If the synthetic resin constituting the retaining element 80 is less subject to thermal history than the material constituting the stent 10, the retaining element 80 will be less likely to deform than the stent 10 even when heated in the sterilization process, as described below, and this makes it easier to maintain the shape of the arc portion A of the stent 10.

[0083] As a method for abutting the holding element 80 against the arc portion A of the stent 10 with the insertion member 20 disposed in the lumen, if the holding element 80 is a backing paper, one method is to make holes or cuts in the paper material and insert the arc portion A of the stent 10 into the holes or cuts to hold the shape of the arc portion A. If the holding element 80 is a synthetic resin, one method is to fit the arc portion A of the stent 10 into the unevenness of a thin plate-like material formed from the synthetic resin to hold the arc portion A. If the holding element 80 is a clip, one method is to attach the clip to the arc portion A of the stent 10 to hold the arc portion A. If the holding element 80 is a tape, one method is to apply the tape to the arc portion A of the stent 10 to hold the arc portion A.

[0084] The state in which the holding element 80 is brought into contact with the arcuate portion A of the stent 10 will be described with reference to FIGS.

[0085] Fig. 10 is a schematic diagram showing a state in which a retaining element 80 is abutted against a stent kit 1 in which an insertion member 20 is disposed in the lumen of a stent 10. The stent 10 shown in Fig. 10 has closed circular arc portions A at one end and the other end, and a retaining element 80 abuts against each arc portion A, thereby maintaining the shape of the arc portion A. The retaining element 80 shown in Fig. 10 is a tape, and the shape of the arc portion A is maintained by abutting the tape against the arc portion A of the stent 10.

[0086] Fig. 11 is a schematic diagram showing another state in which a retaining element 80 is abutted against a stent kit 1 in which an insertion member 20 is disposed in the lumen of a stent 10. The stent 10 shown in Fig. 11 is the same as that shown in Fig. 10, and has closed circular arc portions A at one end and the other end, with retaining elements 80 abutting against each arc portion A to maintain the shape of the arc portion A. The retaining element 80 shown in Fig. 11 is a blister, and grooves 110 are formed in the blister. The stent 10 is entirely embedded along the blister grooves 110, thereby maintaining the shape of the arc portion A.

[0087] Fig. 12 is a schematic diagram showing another state in which a retaining element 80 is abutted against a stent kit 1 in which an insertion member 20 is disposed in the lumen of a stent 10. The stent 10 shown in Fig. 12 has semicircular arc portions A, which are not closed circles, at one end and the other end, and the retaining elements 80 abut against each arc portion A, thereby maintaining the shape of the arc portion A. The retaining element 80 shown in Fig. 12 is a blister, and a groove 110 is formed in the blister. The stent 10 is entirely embedded along the groove 110 of the blister, thereby maintaining the shape of the arc portion A.

[0088] The manufacturing method of the present invention preferably includes a sterilization step after the holding step. By performing sterilization with the holding element 80 abutting against the arc portion A of the stent 10, the portion of the insertion member 20 located at the arc portion A of the stent 10 is forced into a shape that approximates the smallest radius of curvature rA of the arc portion A. As a result, even if the holding element 80 abutting against the stent 10 is removed after sterilization, the arc portion A of the stent 10 does not immediately become straight, and the shape of the arc portion A of the stent 10 can be maintained for a certain period of time. Therefore, the stent 10 can be fixed to the lumen in the body.

[0089] In the sterilization step, the conditions for the sterilization treatment are not particularly limited, but may be, for example, 50 to 90° C. and 8 to 15 hours.

[0090] Next, a method of using the stent kit 1 according to the present invention will be described.

[0091] A stent kit 1 includes a stent 10 having a lumen extending longitudinally from the proximal side to the distal side and having an arcuate portion A that is curved in an arc shape, and an insertion member 20 inserted into the lumen of the stent 10. Prior to delivery of the stent 10 to a lumen in a living body, the stent 10 is preferably moved distally or proximally relative to the insertion member 20 before use. By moving the position of the stent 10 relative to the insertion member 20, the shape of the arcuate portion A of the stent 10 can be made closer to a straight line. This makes it easier to insert the stent kit 1 into a lumen in a living body.

[0092] The position of the stent 10 relative to the insertion member 20 may be moved by a doctor or by a medical professional other than a doctor. By having a medical professional other than a doctor move the stent 10 before surgery, the doctor can quickly perform the procedure.

[0093] The movement distance of the stent 10 is preferably set to, for example, a range of 1 mm to 50 mm. By setting the movement distance of the stent 10 within the above range, the insertability of the stent 10 into a lumen in a living body is improved.

[0094] As described above, according to the method for manufacturing a stent kit of the present invention, even if the insertion member has, for example, a linear or arc-shaped curved arc portion B, and the minimum radius of curvature rB of the arc portion B is greater than the minimum radius of curvature rA of the arc portion A of the stent, the stent can maintain the arc-shaped curved arc portion A. Therefore, when the stent is delivered to the lesion, the insertion member causes the arc portion A of the stent to be curved into a linear or nearly linear shape, making it easier to deliver the stent to the lesion. Furthermore, after the stent is delivered to the lesion, when the insertion member is removed from the stent and the stent is placed in the lesion, the minimum radius of curvature rA of the stent's arc portion A becomes larger than the minimum radius of curvature rB of the insertion member, making it less likely for the stent to become displaced after being placed in the lesion.

[0095] This application claims the benefit of priority based on Japanese Patent Application No. 2022-131982 filed on August 22, 2022, and Japanese Patent Application No. 2022-146169 filed on September 14, 2022. The entire contents of the specifications of Japanese Patent Application No. 2022-131982 filed on August 22, 2022, and Japanese Patent Application No. 2022-146169 filed on September 14, 2022 are incorporated herein by reference.

[0096] 1: Stent kit 10: Stent 20: Insertion member 21: Wall portion 30: Metal wire 40: Hub 50: Outer cylindrical member 60: Connecting means 71: First side hole 72: Second side hole 80: Retaining element 81: Other retaining element 90: Protective tube 100: Stent system 110: Groove A: Arc portion of stent rA: Minimum radius of curvature in arc portion A B: Arc portion of insertion member rB: Minimum radius of curvature in arc portion B C: Arc portion of protective tube rC: Minimum radius of curvature in arc portion C s1: Shaped section s2: Non-shaped section L1: Length of shaped section L2: Length of non-shaped section

Claims

1. A stent, An insertion member inserted into the lumen of the stent; and an outer tubular member disposed outside the inner insertion member and proximal to the stent, The stent has an arcuate portion that is curved in an arc shape, When the insertion member is not disposed in the lumen of the stent, the minimum radius of curvature of the arc portion is smaller than the minimum radius of curvature of the insertion member, A stent kit, wherein when the insertion member is placed in the inner lumen of the stent, the insertion member has a metal wire in at least a portion of the portion that is located in the arc portion of the stent.

2. When the insertion member is disposed in the lumen of the stent, the insertion member has a shaped section that is curved in an arc shape and a non-shaped section that is linear and is located on the distal end side of the insertion member relative to the shaped section, The stent kit according to claim 1 , wherein the length of the non-shaped section in the extension direction of the insertion member is longer than the length of the shaped section in the extension direction of the insertion member.

3. The stent kit according to claim 1 , wherein the material constituting the metal wire is a shape memory alloy.

4. The stent kit according to claim 1 , wherein at least a portion of the metal wire is fixed to the wall of the insertion member.

5. The insertion member has a hub at a proximal end; The stent kit of claim 1 , wherein the metal wire is fixed to the hub.

6. 2. The stent kit according to claim 1, wherein the stent and the outer tube member are connected by a connecting means.

7. The stent has a first side hole communicating with an inner lumen of the stent, the outer tube member has a second side hole communicating with an inner cavity of the outer tube member, The stent kit according to claim 6 , wherein the connecting means is inserted through the first side hole and the second side hole.

8. The connecting means has an annular portion, The stent kit according to claim 7 , wherein the insertion member is disposed inside the annular portion.

9. A stent kit according to claim 1 ; a retaining element for retaining the stent kit, A stent system, wherein the retaining element retains the arc portion while the insertion member is inserted into the inner cavity of the stent.

10. The stent system of claim 9 , wherein the retention element comprises at least one of a mount, a blister, a clip, and a tape.

11. Further, it has a protective tube, The minimum radius of curvature of the protective tube is greater than the minimum radius of curvature of the arc portion, The stent system according to claim 9 , wherein the stent is inserted through an inner lumen of the protective tube.

12. A method for manufacturing a stent kit including a stent having an inner lumen extending in a longitudinal direction from a proximal side to a distal side and having an arc portion A curved in an arc shape, and an insertion member inserted into the inner lumen of the stent, preparing the stent; a placement step of placing the insertion member in the lumen of the stent; a retaining step of abutting a retaining element against the arcuate portion A of the stent; Including, A method for manufacturing a stent kit, wherein, when the insertion member is placed in the inner cavity of the stent, the insertion member has a metal wire in at least a portion of the portion located in the arc portion A of the stent.

13. The method of claim 12, wherein the insert is straight.

14. The method of claim 13, further comprising the step of heat treating the insert to straighten it before placing it in the lumen of the stent.

15. The manufacturing method described in claim 12, wherein the insertion member has an arc portion B that is curved in an arc shape, and the minimum radius of curvature rB of the arc portion B is greater than the minimum radius of curvature rA of the arc portion A of the stent.

16. The manufacturing method according to claim 12 , wherein the preparing step includes a step of bending a part of the raw material tube into an arc shape to form the arc portion A.

17. The method of claim 12, further comprising a step of sterilizing after the holding step.

18. The method according to claim 12, wherein the material constituting the metal wire includes at least one selected from the group consisting of stainless steel, tungsten, and a shape memory alloy.