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

Abstract

A stent kit (1) has: a stent (10); an insertion member (20) inserted through the lumen of the holder (10); and an outer cylindrical member (50) disposed on the outer side of the interposer member (20) and closer to the position side than the stent (10), in which the stent (10) has an arcuate portion bent in an arcuate shape, and in a state where the interposer member (20) is not disposed in the lumen of the stent (10), the minimum radius of curvature of the arcuate portion is smaller than the minimum radius of curvature of the interposer member (20).

Description

Technical Field

[0001] The present invention relates to a stent kit for delivering a stent in vivo, a stent system having the stent kit and a method for manufacturing the stent kit. Background Art

[0002] Medical tubular bodies represented by stents are medical instruments used to treat various diseases such as bile duct obstruction, jaundice, and bile duct cancer caused by stenosis or blockage of the bile duct, pancreatic duct, and other digestive tracts in the body. The medical tubular body is placed in the body lumen for the purpose of, for example, discharging bile from the bile duct to the duodenum and maintaining the inner diameter of the lumen by expanding the lesion of the stenosis or blockage from the inside. In the above-mentioned treatment, a stent made of a resin material is generally used.

[0003] As an example of treatment using a stent using an endoscope, the following describes a method for placing a stent in the bile duct for the purpose of discharging (draining) bile from the bile duct to the duodenal side in a bile duct blocked by bile duct cancer. First, insert an endoscope from the mouth to the entrance (nipple) of the bile duct in the duodenum. Next, a guide wire is delivered to the lesion through the endoscope. And, a stent kit is delivered to the lesion along the guide wire. Then, the stent kit is operated to leave the stent in the lesion.

[0004] For example, patent document 1 describes a component, which is a catheter component, and the component is characterized in that it includes a catheter main branch having a base end portion and a front end portion having an arc portion, the arc portion including: a curved portion having a first end and a second end and an outer surface, the arc portion maintaining the curved portion when in a rest state; an inner cavity, which is divided inside the arc portion and extends along the curved portion between the first end and the second end; an inwardly curved outer surface side portion of the curved portion; an outwardly curved outer surface side portion of the curved portion; and at least one remaining side portion, which is arranged 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 is arranged on a plane parallel to a projection plane, and the projection plane is arranged in a direction parallel to a plane from the inwardly curved side portion to the outwardly curved side portion. Patent document 2 describes a stent kit, which is composed of a tubular stent and an inner catheter, wherein at least one end of the tubular stent has a stent arc portion formed by at least a portion of an arc, and the inner catheter forms an inner arc portion of the same shape as the stent arc portion, and is inserted into the interior of the tubular stent in a manner such that the inner arc portion and the stent arc portion are aligned in position. Patent document 3 describes a method for manufacturing a stent delivery catheter, which comprises: a step of inserting a stent into a storage lumen of a storage tube; a step of reducing the diameter of the stent in the storage lumen by deforming the storage tube and reducing the diameter of the storage lumen; and a step of moving the reduced diameter stent from the storage lumen of the storage tube to the catheter lumen of the catheter tube. Patent document 4 describes a catheter, which comprises: 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, the detachable portion being in fluid communication with the tube at the second end and being removably mounted on the tube; an inner tube having at least one lumen, the inner tube being removably inserted into both the tube and the detachable portion; and a wire extending through at least a portion of at least one lumen of the inner tube, a portion of the wire being mounted on the tube. Patent document 5 describes a medical device, which comprises: a tubular retention member, and an inner catheter inserted through the retention member, wherein the retention member has a first curved portion pre-shaped into a curved shape, and the inner catheter has a second curved portion pre-shaped into a curved shape different from the first curved portion, and the second curved portion is inserted through the first curved portion.

[0005] Patent Document 1: Japanese Patent Application No. 2010-528768

[0006] Patent Document 2: Japanese Patent Application Publication No. 2015-8862

[0007] Patent Document 3: Japanese Patent Application Publication No. 2017-38792

[0008] Patent Document 4: Japanese Patent Application No. 2017-502818

[0009] Patent Document 5: Japanese Patent Application Publication No. 2022-52207

[0010] In catheters such as those disclosed in Patent Documents 1 to 5, a medical tubular body such as a stent is bent into an arc shape. By bending the stent into an arc shape, it is possible to prevent the stent from being displaced when it is placed in a lesion. However, in catheters such as those disclosed in Patent Documents 1 to 3, the insert component on which the stent is mounted is also bent along the stent, so that when the stent is delivered to the lesion, it is difficult to insert the guide wire disposed in the body into the insert component, it is difficult to insert the insert component into the body, and the load when the insert component is pulled out from the inner cavity of the stent becomes high. In addition, in catheters such as Patent Document 4, there is the following problem, namely: the insert component having a straight shape is inserted into the stent bent into an arc shape, and the shape of the stent is made straight to be delivered to the lesion, but the shape of the stent after being placed becomes straight or nearly straight, resulting in a weakened effect of preventing the stent from being displaced. In a medical device such as Patent Document 5, a tubular placement member is bent together with an inner catheter on which the placement member is mounted, so that it is difficult to insert a guide wire disposed in the body into the inner cavity of the inner catheter, which sometimes results in a problem of poor insertability of the placement member, or a problem of increased load when the inner catheter is pulled out from the inner cavity of the placement member. Summary of the invention

[0011] The present invention is completed in view of the above situation, and its purpose is to provide a stent kit that can easily transport the stent to the lesion and prevent the stent from being easily displaced after being placed, a stent system having the stent kit, and a method for manufacturing the stent kit.

[0012] The bracket kit according to the embodiment of the present invention that can solve the above-mentioned problems is as follows.

[0013] [1] A bracket kit comprising:

[0014] Bracket;

[0015] An insert component inserted into the inner cavity of the stent; and

[0016] The outer cylinder member is arranged outside the inner insert member and closer to the bracket.

[0017] in,

[0018] The bracket has an arc portion bent into an arc shape.

[0019] When the insert member is not disposed in the inner cavity of the stent, the minimum curvature radius of the arc portion is smaller than the minimum curvature radius of the insert member.

[0020] [2] A bracket kit according to [1], wherein:

[0021] When the above-mentioned insertion component is configured in the inner cavity of the above-mentioned bracket, the above-mentioned insertion component has a shaping section bent into a circular arc shape and a non-shaping section located on the front end side of the above-mentioned insertion component and in a straight line, and the length of the above-mentioned non-shaping section in the extension direction of the above-mentioned insertion component is longer than the length of the above-mentioned shaping section in the extension direction of the above-mentioned insertion component.

[0022] [3] The bracket kit according to [1] or [2], wherein:

[0023] When the insertion member is arranged in the inner cavity of the stent, the insertion member has a metal wire in at least a part of a portion located in the arc portion of the stent.

[0024] [4] A bracket kit according to [3], wherein:

[0025] The material constituting the above-mentioned metal wire is shape memory alloy.

[0026] [5] The bracket kit according to [3] or [4], wherein:

[0027] At least a portion of the metal wire is fixed to a wall portion of the interposer member.

[0028] [6] The bracket kit according to any one of [3] to [5], wherein:

[0029] The insert component has a pivot portion at the proximal end.

[0030] The metal wire is fixed to the pivot portion.

[0031] [7] The bracket kit according to any one of [1] to [6], wherein:

[0032] The bracket and the outer cylinder member are connected by a connection mechanism.

[0033] [8] A bracket kit according to [7], wherein:

[0034] The stent has a first side hole communicating with the inner cavity of the stent,

[0035] The outer tube component has a second side hole communicating with the inner cavity of the outer tube component.

[0036] The connecting mechanism is inserted into the first side hole and the second side hole.

[0037] [9] The bracket kit according to [7] or [8], wherein:

[0038] The connecting mechanism has an annular portion.

[0039] The insert member is disposed inside the annular portion.

[0040] The present invention includes the stent system described in the following

[10] to

[12] .

[0041]

[10] A support system comprising:

[0042] The stent kit according to any one of [1] to [9]; and

[0043] Keep the elements, keep the above bracket kit,

[0044] in,

[0045] The holding element holds the arc portion in a state in which the insertion member is inserted into the inner cavity of the stent.

[0046]

[11] A support system according to

[10] , wherein:

[0047] The retaining element includes at least one of a backing paper, a blister, a clip and a band.

[0048]

[12] The support system according to

[10] or

[11] , wherein:

[0049] It also has a protective tube.

[0050] The minimum curvature radius of the protective tube is greater than the minimum curvature radius of the arc portion.

[0051] The stent is inserted into the inner cavity of the protection tube.

[0052] A method for manufacturing a bracket kit according to an embodiment of the present invention that can solve the above-mentioned problems is as follows.

[0053]

[13] A method for manufacturing a stent kit, the stent kit comprising: a stent having an inner cavity extending from a proximal side to a distal side along a longitudinal direction and having an arc portion A curved in an arc shape; and an insertion member inserted into the inner cavity of the stent, wherein the insertion member comprises:

[0054] A preparation step for preparing the above-mentioned bracket;

[0055] A step of disposing the insert component in the inner cavity of the stent; and

[0056] A holding step of bringing a holding element into contact with the arc portion A of the stent.

[0057]

[14] The manufacturing method according to

[13] , wherein:

[0058] The interpolation component is in a straight line shape.

[0059]

[15] The manufacturing method according to

[14] , comprising:

[0060] A step of subjecting the insert member to a heat treatment and forming the insert member into a linear shape before arranging the insert member in the inner cavity of the stent.

[0061]

[16] The manufacturing method according to

[13] , wherein:

[0062] The insert member has an arc portion B curved in an arc shape, and a minimum curvature radius rB of the arc portion B is larger than a minimum curvature radius rA of the arc portion A of the stent.

[0063]

[17] The production method according to any one of

[13] to

[16] , wherein

[0064] The preparation step includes a step of bending a portion of the raw pipe into an arc shape to form the arc portion A.

[0065]

[18] The production method according to any one of

[13] to

[17] , comprising:

[0066] After the above-mentioned holding step, a sterilization step is performed.

[0067]

[19] The production method according to any one of

[13] to

[18] , wherein

[0068] In a state where the insertion member is arranged in the inner cavity of the stent, the insertion member has a metal wire in at least a portion of a portion located in the arc portion A of the stent.

[0069]

[20] The manufacturing method according to

[19] , wherein:

[0070] The material constituting the metal wire includes at least one selected from the group consisting of stainless steel, tungsten and shape memory alloy.

[0071] In addition, the method of using the bracket kit according to the present invention is as follows.

[0072]

[21] A method of use, which is a method of use of a stent kit, the stent kit comprising: a stent having an inner cavity extending from a proximal side to a distal side along a length direction and having an arc portion A bent into an arc shape; and an insert component inserted into the inner cavity of the stent, wherein before the stent is delivered into a lumen in a biological body, the stent is moved toward the distal side or the proximal side relative to the insert component.

[0073]

[22] The method of use according to

[21] , wherein:

[0074] The moving distance of the above-mentioned bracket is in the range of 1 mm to 50 mm.

[0075] According to the stent kit of the present invention, when the insert component is not arranged in the inner cavity of the stent, the minimum curvature radius of the arc portion is smaller than the minimum curvature radius of the insert component, so that the insert component is more linear than the arc portion of the stent, or has a curved shape close to a linear shape. Therefore, when the insert component is inserted into the inner cavity of the stent, the curved shape of the arc portion of the stent is made linear or close to a linear shape by the insert component, which facilitates the delivery of the stent to the lesion. In addition, when the insert component is pulled out of the stent and the stent is left in place, the minimum curvature radius of the arc portion of the stent becomes larger than the minimum curvature radius of the insert component, so that the position deviation of the stent after being left in place is not easily caused.

[0076] In addition, the manufacturing method of the stent kit of the present invention can provide a stent kit that is easily transported to the lesion. In addition, if the stent kit provided by the manufacturing method of the stent kit of the present invention is transported to the lesion and the stent is left in the lesion, the stent is not easily displaced from the left position. BRIEF DESCRIPTION OF THE DRAWINGS

[0077] Figure 1 This is an overall view showing a bracket kit according to one embodiment of the present invention.

[0078] Figure 2 express Figure 1 The stent kit shown is an overall view of the stent in a state where no insert component is arranged in the inner cavity.

[0079] Figure 3 express Figure 1 The illustrated diagram is a partial enlarged view of the insert component of the stent kit in a state where the insert component is not disposed in the inner cavity of the stent.

[0080] Figure 4 express Figure 1 A cross-sectional view IV-IV of the stent kit is shown.

[0081] Figure 5A cross-sectional view perpendicular to the extending direction of the stent shows a stent kit according to another embodiment of the present invention.

[0082] Figure 6 express Figure 1 The illustrated embodiment is a partial enlarged cross-sectional view of the bracket kit along the extension direction of the insert component.

[0083] Figure 7 Indicates that Figure 1 An overall view of the bracket system of the bracket kit is shown.

[0084] Figure 8 This is an overall view showing a rack system according to another embodiment of the present invention.

[0085] Fig. 9 express Figure 8 The shown figure is an overall view of the protective tube of the stent system in a state where no stent is arranged in the inner cavity.

[0086] Fig.10 This is an overall view showing a stent kit in which an insertion member is inserted into the inner lumen of a stent according to an embodiment of the present invention, and shows a state in which a holding element is brought into contact with an arc portion A of the stent.

[0087] Fig.11 The present invention shows a stent kit in which an insert component is inserted into the inner cavity of a stent according to an embodiment of the present invention. Fig.10 Schematic diagram of the state where different holding elements abut against the arc portion A of the stent.

[0088] Fig.12 A schematic diagram showing a state in which a holding element is brought into contact with an arc portion A of a stent in a stent kit in which an insertion member is inserted into the inner lumen of a stent according to another embodiment of the present invention is shown. DETAILED DESCRIPTION

[0089] The present invention is described in more detail below based on the following embodiments, but the present invention is of course not limited by the following embodiments, and can undoubtedly be implemented with appropriate changes within the scope of the above / below description, and they are all included in the technical scope of the present invention. In addition, in each of the drawings, for convenience, there are also cases where hatching, component figure marks, etc. are omitted. In this case, please refer to the specification and other drawings. In addition, the sizes of various components in the drawings are preferentially conducive to understanding the features of the present invention, and therefore there are cases where they are different from the actual sizes.

[0090] First, the bracket kit of the present invention will be described.

[0091] Figure 1 1 is an overall view of the bracket kit 1 according to an embodiment of the present invention. Figure 1As shown, the stent kit 1 comprises: a stent 10; an inner inserting member 20 inserted into the inner cavity of the stent 10; and an outer tube member 50 arranged outside the inner inserting member 20 and closer to the position than the stent 10. The stent kit 1 is a device for delivering the stent 10 to the lesion. The stent 10 is mounted on the inner inserting member 20 equipped with the outer tube member 50 and delivered to the lesion, and the inner inserting member 20 is pulled toward the hand side relative to the outer tube member 50, thereby pulling out the inner inserting member 20 from the inner cavity of the stent 10 and leaving the stent 10 in the lesion.

[0092] In the present invention, the proximal side refers to the user's hand side in the extension direction of the insertion component 20, and the distal side refers to the opposite side of the proximal side, that is, the side (lesion side) treated by the stent kit 1. In addition, the extension direction of the insertion component 20 is sometimes referred to as the long-axis direction. The long-axis direction of the insertion component 20 can be replaced by the distal direction of the insertion component 20.

[0093] Figure 2 The figure is a general view of the stent 10 in a state where the inner cavity of the stent 10 is not provided with the insert component 20. The stent 10 is a long object having one end and the other end and having an inner cavity. The stent 10 is preferably a plastic stent. In addition to the stent 10, a sealing member or the like can also be used.

[0094] As the material constituting the stent 10, for example, polyamide resin, polyester resin, polyurethane resin, polyolefin resin, fluorine resin, vinyl chloride resin, silicone resin, natural rubber, etc. can be cited. Only one of them can be used, or two or more of them can be used in combination. Among them, the resin constituting the stent 10 is preferably at least one of polyamide resin, polyester resin, polyurethane resin, polyolefin resin and fluorine resin. The material constituting the stent 10 is at least one of polyamide resin, polyester resin, polyurethane resin, polyolefin resin and fluorine resin, thereby improving the sliding property of the surface of the stent 10 and improving the insertability into the lumen in the biological body. The tube composed of resin, which is the raw material of the stent 10, can be manufactured using common methods such as extrusion molding and injection molding.

[0095] like Figure 2 As shown, the stent 10 has an arc portion A bent in an arc shape. The arc portion A refers to the portion of the stent 10 bent in an arc shape when the inner cavity of the stent 10 is not provided with an insert component 20 and no external force other than gravity is applied to the stent 10. The arc portion A contacts the lumen in the biological body and has the function of fixing the stent 10 to the lumen in the biological body. Specifically, in the case where the stent 10 is a bile duct stent, the arc portion A is sometimes arranged on the distal side of the stenosis (occlusion portion) of the bile duct in order to prevent the stent 10 from falling off from the bile duct to the duodenum, or the arc portion A is arranged near the duodenal papilla in order to prevent the stent 10 from mistakenly entering the bile duct.

[0096] The arc portion A only needs to be located at one end of the stent 10, and is preferably located at both ends of the stent 10. That is, the stent 10 preferably has an arc portion A curved in an arc shape at both ends at one end and the other end. By having the arc portion A at both ends of the stent 10, the effect of fixing the stent 10 to the lumen in the living body can be improved.

[0097] The shape of the arc portion A can be Figure 2 The closed circular shape as shown in the figure may also be an arc shape of a semicircular circle that is not closed. If the shape of the arc portion A is a closed circular shape, the effect of fixing the stent 10 at a predetermined position can be improved. In addition, if the shape of the arc portion A is an arc shape that is not closed, it can be formed into a stent 10 with high penetration into a lumen in a living body.

[0098] like Figure 1 As shown, the insertion component 20 is inserted into the inner cavity of the stent 10. The insertion component 20 is a long strip having one end and the other end. The stent 10 is transported to the lesion part while the stent 10 is installed in the insertion component 20, and the insertion component 20 is pulled out from the inner cavity of the stent 10, so that the stent 10 can be left in the lesion part.

[0099] The shape of the insert component 20 that is not disposed in the inner cavity of the stent 10 may be such that at least a portion of the extending direction of the insert component 20 is curved into an arc shape, or at least a portion of the extending direction of the insert component 20 is straight, or it may be straight from one end to the other end of the insert component 20. Figure 3 As shown, the shape of the insert component 20 disposed in front of the inner cavity of the stent 10 may also have an arc portion B bent in an arc shape. The arc portion B refers to the portion of the insert component 20 bent in an arc shape when the insert component 20 is not disposed in the inner cavity of the stent 10 and no external force other than gravity is applied to the insert component 20.

[0100] The insertion member 20 preferably has a lumen extending from one end to the other end. The insertion member 20 has a lumen, and when the stent 10 is delivered to a lesion, the guide wire is inserted through the lumen of the insertion member 20, thereby improving the insertability.

[0101] The cross-sectional shape of the outer shape of the insert component 20 in a cross section perpendicular to the extension direction of the insert component 20 is preferably circular. By making the cross-sectional shape of the outer shape of the insert component 20 circular, the surface of the insert component 20 becomes smooth, and even if it contacts other objects such as the inner surface of the stent 10 and the wall of the lumen of the biological body, it is not easy to damage other objects. In addition, in the case where the insert component 20 has an inner cavity extending from one end to the other end, the cross-sectional shape of the inner cavity of the insert component 20 in a cross section perpendicular to the extension direction of the insert component 20 is preferably circular. By making the cross-sectional shape of the inner cavity of the insert component 20 circular, the inner surface of the insert component 20 becomes smooth, and a guide wire or the like can be smoothly inserted into the inner cavity of the insert component 20.

[0102] As materials constituting the insert component 20, polyamide resins, polyester resins, polyurethane resins, polyolefin resins, fluorine resins, vinyl chloride resins, silicone resins, natural rubber, etc. can be cited. Only one of them can be used, or two or more of them can be used in combination. Among them, the material constituting the insert component 20 is preferably polyamide resin, polyester resin, polyurethane resin, polyolefin resin, and fluorine resin. The material constituting the insert component 20 is polyamide resin, polyester resin, polyurethane resin, polyolefin resin, and fluorine resin, thereby forming an insert component 20 with good surface sliding and high insertion performance.

[0103] The outer tube member 50 is a long object having one end and the other end and having an inner cavity. The inner insertion member 20 is inserted into the inner cavity of the outer tube member 50. The distal end of the outer tube member 50 is arranged on the side closer to the proximal end of the stent 10. That is, the outer tube member 50 is arranged on the outside of the inner insertion member 20 and on the side closer to the proximal end of the stent 10. The stent 10 is installed on the inner insertion member 20 equipped with the outer tube member 50 to be transported to the lesion, and the inner insertion member 20 is pulled out from the inner cavity of the stent 10 by pulling the inner insertion member 20 toward the hand side relative to the outer tube member 50, so that the stent 10 can be left in the lesion.

[0104] As 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, for example, a circle, a polygon, or a combination of these shapes can be cited. Among them, 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. Since the cross-sectional shape of the outer shape of the outer tube member 50 is a circle, the outer surface of the outer tube member 50 becomes smooth, and even if the outer surface of the outer tube member 50 contacts the wall of the lumen in the body, it is not easy to damage the wall of the lumen in the body. In addition, the cross-sectional shape of the inner cavity 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. Since the cross-sectional shape of the inner cavity of the outer tube member 50 is a circle, the surface of the inner cavity of the outer tube member 50 becomes smooth, and the sliding property of the outer tube member 50 relative to the insertion member 20 is easily improved.

[0105] As the material constituting the outer tube component 50, for example, polyamide resin, polyester resin, polyurethane resin, polyolefin resin, fluorine resin, vinyl chloride resin, silicone resin, natural rubber, etc. can be cited. Only one of them can be used, or two or more of them can be used in combination. Among them, the resin constituting the outer tube component 50 is preferably at least one of polyamide resin, polyester resin, polyurethane resin, polyolefin resin and fluorine resin. By using at least one of polyamide resin, polyester resin, polyurethane resin, polyolefin resin and fluorine resin as the material constituting the outer tube component 50, it is possible to form an outer tube component 50 with high surface sliding property and good insertion property. The tube made of resin that becomes the raw material of the outer tube component 50 can be manufactured using common methods such as extrusion molding and injection molding.

[0106] Figure 3 FIG. 2 is a partially enlarged view of the insert component 20 in a state where the insert component 20 is not disposed in the inner cavity of the stent 10. Figure 2 and Figure 3 As shown in FIG. 1 , when the insertion component 20 is not disposed in the inner cavity of the stent 10 , the minimum curvature radius rA of the arc portion A is smaller than the minimum curvature radius rB of the insertion component 20 . Figure 3As shown, when the insert component 20 has an arc portion B, the minimum curvature radius rB of the insert component 20 refers to the minimum curvature radius rB of the arc portion B of the insert component 20. When the insert component 20 is not arranged in the inner cavity of the stent 10, the minimum curvature radius rA of the arc portion A is smaller than the minimum curvature radius rB of the insert component 20, so that the degree of bending is different between the arc portion A of the stent 10 and the insert component 20, and the arc portion A of the stent 10 becomes a shape that is more curved than the insert component 20. When the insert component 20 is not arranged in the inner cavity of the stent 10, the arc portion A of the stent 10 is bent, and the arc portion A contacts the lumen in the body, so that the stent 10 can be fixed in the lumen in the body. As a result, it is difficult for the stent 10 to fall off from the lumen in the body and the position of the stent 10 to shift. In addition, when the insertion member 20 is inserted into the inner cavity of the stent 10 , the insertion member 20 can reduce the curvature of the arc portion A of the stent 10 and make the shape of the arc portion A close to a straight line. As a result, the insertability of the stent 10 can be improved.

[0107] Specifically, the stent 10 is inserted into the lumen of the body and delivered to the target site while the insertion member 20 is inserted into the lumen of the stent 10. Figure 1 As shown, the bending of the arc portion A of the stent 10 is reduced by the insertion component 20, so that the stent 10 becomes a straight line or a shape close to a straight line, which can improve the insertability. When the stent 10 reaches the target part of the lumen in the living body, the insertion component 20 is pulled out from the inner cavity of the stent 10. As a result, the shape of the arc portion A of the stent 10 returns to the shape before the insertion component 20 is inserted or a shape close to the shape before the insertion component 20 is inserted, and the arc portion A becomes a curved shape. The curved arc portion A contacts the lumen in the living body, so that the movement of the stent 10 can be prevented.

[0108] As a method for measuring the minimum curvature radius rA of the arc portion A and the minimum curvature radius rB of the inserted component 20 when the inserted component 20 is not arranged in the inner cavity of the bracket 10, for example, the inserted component 20 is pulled out from the inner cavity of the bracket 10, and a photo of the bracket 10 and the inserted component 20 is taken while the bracket 10 and the inserted component 20 are in a static state, and the minimum curvature radius rA of the arc portion A and the minimum curvature radius rB of the inserted component 20 are measured in the obtained image.

[0109] The minimum radius of curvature rA of the arc portion A when the insert component 20 is not arranged in the inner cavity of the stent 10 is preferably less than 70% of the minimum radius of curvature rB of the insert component 20, more preferably less than 60%, and further preferably less than 50%. By setting the upper limit of the ratio of the minimum radius of curvature rA of the arc portion A to the minimum radius of curvature rB of the insert component 20 to the above range, the insert component 20 can easily reduce the bending of the arc portion A of the stent 10 when the insert component 20 is arranged in the inner cavity of the stent 10. In addition, the lower limit of the ratio of the minimum radius of curvature rA of the arc portion A when the insert component 20 is not arranged in the inner cavity of the stent 10 to the minimum radius of curvature rB of the insert component 20 is not particularly limited, and can be set to, for example, more than 0%, more than 0.1%, or more than 1%.

[0110] The insertion component 20 preferably has a straight shape when not arranged in the inner cavity of the stent 10. The insertion component 20 has a straight shape, so that when the insertion component 20 is inserted into the inner cavity of the stent 10, the bending of the arc portion A of the stent 10 can be reduced, and the stent 10 can be made into a straight shape to improve the insertability.

[0111] like Figure 1 As shown, preferably, when the insert component 20 is arranged in the inner cavity of the stent 10, the insert component 20 has a shaping section s1 that is curved in an arc shape and a non-shaping section s2 that is located closer to the front end side of the insert component 20 than the shaping section s1 and is in a straight line, and the length L2 of the non-shaping section s2 in the extension direction of the insert component 20 is longer than the length L1 of the shaping section s1 in the extension direction of the insert component 20. The shaping section s1 is a section of the portion of the insert component 20 that is curved in an arc shape in the extension direction, and the non-shaping section s2 is a section of the portion of the insert component 20 that is in a straight line in the extension direction.

[0112] When the insertion component 20 is disposed in the inner cavity of the stent 10, the length L2 of the non-shaped section s2 is longer than the length L1 of the shaped section s1, so that a straight portion can be ensured at the front end of the insertion component 20. As a result, when the guide wire is inserted into the inner cavity of the insertion component 20, the step difference between the front end of the insertion component 20 and the guide wire can be reduced, and the insertability of the stent kit 1 can be improved.

[0113] The length L2 of the non-shaped section s2 in the extension direction of the insert component 20 is preferably more than twice the length L1 of the shaped section s1 in the extension direction of the insert component 20, more preferably more than 2.5 times, and further preferably more than 3 times. By setting the lower limit of the ratio of the length L2 of the non-shaped section s2 to the length L1 of the shaped section s1 to the above range, it is easy to make the length L2 of the non-shaped section s2 sufficiently long relative to the length L1 of the shaped section s1 at the front end of the insert component 20. As a result, when the guide wire is inserted into the inner cavity of the insert component 20, the step difference between the front end of the insert component 20 and the guide wire becomes smaller, and a stent kit 1 with good insertability can be formed. In addition, the length L2 of the non-shaped section s2 in the extension direction of the insert component 20 is preferably less than 30 times the length L1 of the shaped section s1 in the extension direction of the insert component 20, more preferably less than 25 times, and further preferably less than 20 times. By setting the upper limit of the ratio of the length L2 of the non-forming section s2 to the length L1 of the forming section s1 to the above range, the length of the insertion component 20 can be prevented from becoming too long, making it easier to configure the insertion component 20 in the inner cavity of the stent 10.

[0114] The length L2 of the non-shaped section s2 in the extension direction of the insert component 20 is preferably 50 mm or less, more preferably 45 mm or less, and further preferably 40 mm or less. By setting the upper limit of the length L2 of the non-shaped section s2 to the above range, the length of the insert component 20 in the extension direction is not easy to become too long, and the lumen in the body is not easy to be damaged when the stent 10 is arranged. In addition, the lower limit of the length L2 of the non-shaped section s2 in the extension direction of the insert component 20 is not particularly limited, and can be set to, for example, 5 mm or more, 7 mm or more, or 10 mm or more.

[0115] Figure 4 is a cross-sectional view of the bracket kit 1 perpendicular to the extension direction of the bracket 10, Figure 5 1 is a cross-sectional view of a bracket kit 1 according to another embodiment, taken along a direction perpendicular to the extension direction of the bracket 10 .

[0116] like Figure 4 and Figure 5 As shown, preferably, when the insert component 20 is arranged in the inner cavity of the stent 10, the insert component 20 has a metal wire 30 at least in a portion of the portion located at the arc portion A of the stent 10. Since the insert component 20 has the metal wire 30 at least in a portion of the portion located at the arc portion A, the rigidity of the portion of the insert component 20 having the metal wire 30 is improved. As a result, when the insert component 20 is arranged in the inner cavity of the stent 10, the effect of reducing the bending of the arc portion A of the stent 10 by the insert component 20 can be improved, and the insertability of the stent 10 can be easily improved.

[0117] When the insertion component 20 is arranged in the inner cavity of the stent 10, the metal wire 30 is preferably arranged to be 30% or more of the length of the arc portion A of the stent 10, more preferably 50% or more, further preferably 70% or more, further preferably 90% or more, and particularly preferably 100%. The metal wire 30 is arranged to be 100% of the length of the arc portion A of the stent 10 means that the metal wire 30 exists throughout the entire length of the arc portion A. By setting the lower limit of the length of the arc portion A where the metal wire 30 is arranged to the above range, when the insertion component 20 is arranged in the inner cavity of the stent 10, the metal wire 30 can easily reduce the bending of the arc portion A of the stent 10, and the insertion property of the stent 10 can be improved. In addition, the upper limit of the length of the arc portion A where the metal wire 30 is arranged is not particularly limited, and can be set to 100% or less, for example.

[0118] The length of the metal wire 30 in the extension direction of the insert component 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, further preferably 70% or more, further 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 to the above range, it is easy to arrange the metal wire 30 in the part of the arc portion A when the insert component 20 is arranged in the inner cavity of the stent 10. As a result, the bending of the arc portion A can be easily reduced by the insert component 20. In addition, 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, for example, it can be set to less than 500%, less than 400%, or less than 300%.

[0119] The number of metal wires 30 in the insert component 20 may be one, but preferably multiple. The insert component 20 having multiple metal wires 30 can further improve the rigidity of the portion where the metal wires 30 are provided in the insert component 20, and improve the effect of the insert component 20 in reducing the bending of the arc portion A of the stent 10.

[0120] As the cross-sectional shape of the metal wire 30 in the cross section perpendicular to the extending direction of the interpolation component 20, for example, a circle, a polygon, or a combination thereof can be cited. Among them, the cross-sectional shape of the metal wire 30 in the cross section perpendicular to the extending direction of the interpolation component 20 is preferably a circle. Since the cross-sectional shape of the metal wire 30 is a circle, when the interpolation component 20 is bent and the metal wire 30 is pressed by the interpolation component 20, it is possible to prevent the interpolation component 20 from being damaged such as rupture due to the metal wire 30.

[0121] Examples of the material constituting the metal wire 30 include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, copper, iron, manganese, aluminum, zinc, or alloys thereof.

[0122] The material constituting the metal wire 30 is preferably a shape memory alloy. By constituting the metal wire 30 with a shape memory alloy, the metal wire 30 is easily formed into a straight line or a shape with a large radius of curvature. Therefore, by inserting the insertion component 20 into the inner cavity of the stent 10, the bending of the arc portion A of the stent 10 can be easily reduced.

[0123] The shape memory alloy constituting the metal wire 30 preferably includes at least one selected from the group consisting of nickel-titanium alloy, β-type titanium alloy, iron-manganese-silicon alloy, and cobalt-chromium alloy. When the shape memory alloy constituting the metal wire 30 includes at least one selected from the above group, the metal wire 30 has excellent elasticity, and the effect of reducing the bending of the arc portion A of the stent 10 can be improved.

[0124] It is also preferred that the straightness of the metal wire 30 is higher than that of the stent 10. By making the straightness of the metal wire 30 higher than that of the stent 10, it is easy to make the insert component 20 into a straight or nearly straight shape through the metal wire 30. As a result, by arranging the insert component 20 in the inner cavity of the stent 10, the bending of the stent 10 is reduced, and the insertability of the stent 10 is easily improved. In addition, in the case where the insert component 20 has an inner cavity extending from one end to the other end, by making the insert component 20 into a straight or nearly straight shape, it is possible to easily insert a guide wire or the like into the inner cavity of the insert component 20.

[0125] It is also preferred that the metal wire 30 includes at least one of a stainless steel wire and a tungsten wire. Since the metal wire 30 includes at least one of a stainless steel wire and a tungsten wire, the straightness of the metal wire 30 is likely to be higher than that of the stent 10. Therefore, the straightness of the insertion component 20 is also improved, and the effect of reducing the bending of the stent 10 and the insertability of the insertion component 20 into the inner cavity can be improved.

[0126] like Figure 4 and Figure 5 As shown in FIG. 1 , the metal wire 30 is preferably fixed to the wall portion 21 of the insert component 20 at least in part. Figure 4 As shown, the metal wire 30 is fixed in a manner embedded in the wall portion 21 of the insert component 20, or as shown in FIG. Figure 5 As shown, the metal wire 30 is arranged in the inner cavity of the insert component 20 and is fixed to the surface of the wall portion 21 of the insert component 20. In addition, the metal wire 30 may be fixed to the wall portion 21 of the insert component 20 only in a portion in the extending direction of the metal wire 30, or the metal wire 30 may be fixed to the wall portion 21 of the insert component 20 in its entirety in the extending direction.

[0127] like Figure 1As shown in the figure, the insert component 20 has a pivot 40 at the proximal end portion, and although not shown, it is preferred that the metal wire 30 is fixed to the pivot 40. As a structure in which the metal wire 30 is fixed to the pivot 40, for example, a structure in which the proximal portion of the metal wire 30 is fixed to the pivot 40 can be cited. By fixing the metal wire 30 to the pivot 40, the proximal side of the metal wire 30 is fixed and supported by the pivot 40, and the effect of improving the rigidity and straightness of the insert component 20 as a whole by the metal wire 30 is more easily improved.

[0128] The pivot portion 40 has a guide wire port therein that communicates with the inner cavity of the insertion member 20 , and is used when introducing a guide wire into the inner cavity of the insertion member 20 , or when injecting a contrast agent, a drug solution, or the like.

[0129] Figure 6 FIG. 2 is a partial enlarged cross-sectional view of the bracket kit 1 along the extension direction of the insert component 20. Figure 6 As shown, it is preferred that the bracket 10 and the outer tube member 50 are connected by a connecting mechanism 60. Figure 6 In the bracket kit 1 shown, the connecting mechanism 60 is annular, and the insert component 20 is arranged inside the ring of the connecting mechanism 60. Figure 6 In the figure, the portion of the connection mechanism 60 existing on the front side of the paper is shown by a dotted line in order to facilitate understanding of the positional relationship between the connection mechanism 60 and the insertion member 20. Since the stent 10 and the outer tube member 50 are connected by the connection mechanism 60, the force applied from the hand side can be easily transmitted to the stent 10 through the outer tube member 50, and the operation of pushing the stent 10 to the distal side and delivering the stent 10 to the target site can be easily performed.

[0130] like Figure 6 As shown, preferably, the stent 10 has a first side hole 71 communicating with the inner cavity of the stent 10, the outer tube member 50 has a second side hole 72 communicating with the inner cavity of the outer tube member 50, and the connection mechanism 60 is inserted through the first side hole 71 and the second side hole 72. By inserting the connection mechanism 60 through the first side hole 71 of the stent 10 and the second side hole 72 of the outer tube member 50, the connection of the stent 10 and the outer tube member 50 using the connection mechanism 60 can be easily performed, and the connection between the stent 10 and the outer tube member 50 can also be easily released as needed.

[0131] The connection mechanism 60 may be any one as long as it can connect the stent 10 to the outer tube member 50. Examples of the structure of the connection mechanism 60 include a structure in which the connection mechanism 60 forms a ring and the insert member 20 and the outer tube member 50 are arranged inside the ring-shaped portion, a structure in which the connection mechanism 60 has a plurality of ring-shaped portions and the insert member 20 is arranged in one ring-shaped portion and the outer tube member 50 is arranged in another ring-shaped portion, and a structure in which the connection mechanism 60 is in the shape of a rod and the insert member 20 is fixed at one end and the outer tube member 50 is fixed at the other end.

[0132] like Figure 6 As shown, the connection mechanism 60 preferably has an annular portion, and the inserting member 20 is disposed inside the annular portion. Since the connection mechanism 60 has an annular portion and the inserting member 20 is disposed inside the annular portion, the connection between the stent 10 and the outer tube member 50 can be easily released by pulling out the inserting member 20 from the annular portion, cutting the annular portion, etc. Therefore, the stent 10 can be easily placed in the target area.

[0133] More preferably, the connection mechanism 60 is a suture. When the connection mechanism 60 is a suture, the connection mechanism 60 can be made flexible while maintaining its durability, and the connection mechanism 60 can be made less likely to damage the stent 10 or the wall of the lumen in the body.

[0134] like Figure 6 As shown, the connection mechanism 60 preferably forms an annular portion, and the inner insertion member 20 and a portion of the distal end of the outer cylinder member 50 are arranged inside the annular portion of the connection mechanism 60. Figure 6 As shown in the figure, the structure in which the inserting member 20 and a part of the distal end of the outer tube member 50 are arranged inside the annular portion of the connecting mechanism 60 can be changed to a structure in which two linear members constituting the connecting mechanism 60 are arranged in the first side hole 71 and one linear member constituting the connecting mechanism 60 is arranged in the second side hole 72. By arranging the inserting member 20 and a part of the distal end of the outer tube member 50 inside the annular portion of the connecting mechanism 60, the connecting mechanism 60 is fixed to the outer tube member 50 even after the inserting member 20 is pulled out from the inside of the annular portion of the connecting mechanism 60, so that the connecting mechanism 60 can be prevented from falling off, and the safety can be improved.

[0135] Figure 7 FIG. 1 is an overall diagram of a bracket system 100 having a bracket kit 1. Figure 7As shown, the stent system 100 preferably includes a stent kit 1 and a holding element 80 for holding the stent kit 1, wherein the holding element 80 holds the arc portion A in a state where the insert component 20 is inserted into the inner cavity of the stent 10. By holding the arc portion A in a state where the insert component 20 is inserted into the inner cavity of the stent 10, the holding element 80 can be used to maintain the shape of the arc portion A of the stent 10. That is, in the stent system 100, the curvature of the arc portion A of the stent 10 can be prevented from being excessively corrected to a straight line by the insert component 20, and the arc portion A of the stent 10 can be maintained by the holding element 80 to prevent the arc portion A of the stent 10 from disappearing when the insert component 20 is pulled out of the inner cavity of the stent 10. Therefore, the following stent system 100 can be formed, namely: when the stent 10 is transported, the stent 10 can be made into a straight or nearly straight shape by the insertion component 20 to improve the insertability, and after the insertion component 20 is pulled out from the inner cavity of the stent 10, the curvature of the arc portion A of the stent 10 is restored, and the arc portion A contacts the tubular cavity in the biological body and is not easily displaced.

[0136] Preferably, the retaining element 80 includes at least one of backing paper, a blister, a clip, and a belt. That is, the material constituting the retaining element 80 preferably includes at least one selected from the group consisting of backing paper, a blister, a clip, and a belt. The retaining element 80 may include one of the backing paper, the blister, the clip, and the belt, or may include two or more of them. Blister refers to a so-called blister pack, such as a structure in which a thin plate-like object with projections and depressions formed of a synthetic resin is assembled to a backing paper or a thin plate-like object, or a structure in which a groove is formed on a thin plate-like object made of a synthetic resin. By including at least one of the backing paper, the blister, the clip, and the belt, the retaining element 80 can be used to easily and firmly fix and retain the arc portion A of the bracket 10.

[0137] As a method for holding the arc portion A with the insert component 20 inserted into the inner cavity of the bracket 10, when the holding element 80 is a backing paper, a hole or cutout is formed in the paper material, and the bracket 10 is inserted into the hole or cutout to fix and hold the arc portion A, etc. When the holding element 80 is a blister, the bracket 10 is embedded in the concave and convex of a thin plate-like object formed of a synthetic resin to fix and hold the arc portion A, etc. When the holding element 80 is a clip, the clip is installed on the bracket 10 to fix and hold the arc portion A, etc. When the holding element 80 is a belt, the belt is attached to the bracket 10 to fix and hold the arc portion A, etc.

[0138] like Figure 7As shown, the stent system 100 may further include other retaining elements 81 for retaining the inserted component 20, the portion other than the arc portion A of the stent 10, etc. In the stent system 100, in addition to the retaining element 80 for retaining the arc portion A of the stent 10, other retaining elements 81 for retaining other portions are also included, thereby preventing the inserted component 20 from falling off the stent 10 and preventing the components from accidentally contacting each other and being damaged during storage or transportation of the stent system 100.

[0139] Figure 8 is an overall view of a support system 100 according to another embodiment. Fig. 9 FIG. 1 is an overall view of the protective tube 90 in a state where no stent 10 is arranged in the inner cavity. Figure 8 and Fig. 9 As shown, the stent system 100 preferably further comprises a protection tube 90, the minimum curvature radius rC of the protection tube 90 is greater than the minimum curvature radius rA of the arc portion A, and the stent 10 is inserted into the inner cavity of the protection tube 90. Fig. 9 As shown, when the protection tube 90 has an arc portion C, the minimum curvature radius rC of the protection tube 90 refers to the minimum curvature radius rC of the arc portion C of the protection tube 90. The arc portion C refers to a portion of the protection tube 90 that is curved into an arc shape when the stent 10 is not disposed in the inner cavity of the protection tube 90 and no external force other than gravity is applied to the protection tube 90.

[0140] In addition, the minimum radius of curvature rC of the protection tube 90 is measured in a state where the stent 10 is not inserted into the inner cavity of the protection tube 90. That is, it is preferable that the minimum radius of curvature rC of the protection tube 90 in a state where the stent 10 is not inserted into the inner cavity of the protection tube 90 is larger than the minimum radius of curvature rA of the arc portion A in a state where the insertion component 20 is not arranged in the inner cavity of the stent 10. Since the minimum radius of curvature rC of the protection tube 90 is larger than the minimum radius of curvature rA of the arc portion A, the degree of curvature is different between the protection tube 90 and the arc portion A of the stent 10, and the protection tube 90 has a shape with a smaller degree of curvature than the arc portion A of the stent 10. In other words, the protection tube 90 has a straight shape or a shape closer to a straight shape than the arc portion A of the stent 10. Therefore, by inserting the stent 10 through the inner cavity of the protection tube 90 , the stent 10 can be protected by the protection tube 90 , and the protection tube 90 reduces the bending of the arc portion A of the stent 10 , thereby improving the insertability of the stent 10 .

[0141] As 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, for example, the protective tube 90 is left stationary when no inserted component 20 is configured in the inner cavity of the protective tube 90, and a photograph of the protective tube 90 is taken, and the minimum radius of curvature rC of the protective tube 90 is measured in the obtained image.

[0142] The protection tube 90 is a long object having one end and the other end and having an inner cavity. Preferably, the length from one end to the other end of the protection tube 90 is longer than the length from one end to the other end of the stent 10. By making the protection tube 90 longer than the stent 10, it is easy to protect the entire stent 10.

[0143] As the cross-sectional shape of the protection tube 90 in the cross section perpendicular to the extension direction of the protection tube 90, for example, a circle, a polygon, or a combination of these shapes can be cited. Among them, the cross-sectional shape of the outer shape of the protection tube 90 in the cross section perpendicular to the extension direction of the protection tube 90 is preferably a circle. By making the cross-sectional shape of the outer shape of the protection tube 90 circular, the outer surface of the protection tube 90 becomes smooth, and even if the outer surface of the protection tube 90 contacts other objects, it is not easy to damage other objects. In addition, the cross-sectional shape of the inner cavity of the protection tube 90 in the cross section perpendicular to the extension direction of the protection tube 90 is preferably a circle. By making the cross-sectional shape of the inner cavity of the protection tube 90 circular, the sliding property of the inner surface of the protection tube 90 is improved, and the stent 10 can be easily and smoothly moved in the inner cavity of the protection tube 90.

[0144] As the material constituting the protection tube 90, for example, polyamide resin, polyester resin, polyurethane resin, polyolefin resin, fluorine resin, vinyl chloride resin, silicone resin, natural rubber, etc. can be cited. Only one of them can be used, or two or more of them can be used in combination. Among them, the resin constituting the protection tube 90 is preferably at least one of polyamide resin, polyester resin, polyurethane resin, polyolefin resin and fluorine resin. By using at least one of polyamide resin, polyester resin, polyurethane resin, polyolefin resin and fluorine resin as the material constituting the protection tube 90, a protection tube 90 with good sliding properties can be formed. The tube made of resin that is the raw material of the protection tube 90 can be manufactured using common methods such as extrusion molding and injection molding.

[0145] As described above, the delivery device of the present invention comprises: a stent; an insert component inserted into the inner cavity of the stent; and an outer tube component arranged outside the insert component and closer to the position side than the stent, wherein the stent has an arc portion bent into an arc shape, and when the insert component is not arranged in the inner cavity of the stent, the minimum curvature radius of the arc portion is smaller than the minimum curvature radius of the insert component. The delivery device of the present invention is structured such that the insert component is a shape that is more linear than the arc portion of the stent, or has a curved shape that is close to a linear shape. Therefore, when the insert component is inserted into the inner cavity of the stent, the curvature of the arc portion of the stent is made linear or close to a linear shape by the insert component, and the stent is easily delivered to the lesion. In addition, when the insert component is pulled out from the stent and the stent is left in place, the minimum curvature radius of the arc portion of the stent becomes larger than the minimum curvature radius of the insert component, so that the position deviation of the stent after leaving in place is not easy to occur.

[0146] Next, a method for manufacturing the bracket kit of the present invention will be described. In the following description, the parts overlapping with the above description will be omitted.

[0147] The manufacturing method of the stent kit involved in the present invention is a manufacturing method of a stent kit having a stent and an insert component, the stent having an inner cavity extending from the proximal side to the distal side along the length direction and having an arc portion A bent into an arc shape, and the insert component is inserted into the inner cavity of the stent, which includes: a preparation step of preparing the stent; a configuration step of configuring the insert component in the inner cavity of the stent; and a holding step of making a holding element abut against the arc portion A of the stent.

[0148] According to the manufacturing method of the stent kit of the present invention, since it includes a holding step of making the holding element contact the arc portion A of the stent in a state where the inner cavity of the stent having an inner cavity extending from the proximal side to the distal side in the longitudinal direction and having an arc portion A curved in an arc shape is arranged with an insert component, the stent can be maintained in a state where the arc portion A curved in an arc shape is formed even if the insert component is, for example, straight or has an arc portion B curved in an arc shape, and the minimum curvature radius rB of the arc portion B is larger than the minimum curvature radius rA of the arc portion A of the stent. Therefore, when the stent is delivered to the lesion, the arc portion A of the stent is curved in a straight or nearly straight shape by the insert component, so that the stent can be easily delivered to the lesion. In addition, after the stent is delivered to the lesion, when the insert component is pulled out from the stent and the stent is left in the lesion, the minimum curvature radius rA of the arc portion A of the stent is greater than the minimum curvature radius rB of the insert component, so that the stent left in the lesion is less likely to be displaced. Each process is described below.

[0149] [Preparation process]

[0150] In the preparation step, the stent 10 having a lumen extending in the longitudinal direction from the proximal side to the distal side and having an arc portion A curved in an arc shape is prepared.

[0151] exist Figure 2 An example of a configuration of an embodiment of the stent 10 prepared in the preparation step is shown in FIG. Figure 2 The inner cavity of the stent 10 shown is not provided with the insert component 20 .

[0152] In the preparation step, a stent 10 having an inner cavity extending in the longitudinal direction from the proximal side to the distal side and having an arc portion A bent in an arc shape may be prepared, and a step of preparing a tube (hereinafter sometimes referred to as a raw material tube) that is a raw material of the stent 10 and bending a part of the raw material tube in an arc shape to form the arc portion A may be included. As a method of bending a part of the raw material tube in an arc shape to form the arc portion A, for example, the following method can be cited, namely, inserting a long object into the inner cavity of the raw material tube, heating a part of the raw material tube in a state where the long object is bent in an arc shape together with the long object, and forming the arc portion A on the raw material tube.

[0153] [Configuration process]

[0154] The placement step is a step of placing the insert component 20 in the inner cavity of the stent 10. Figure 3 1 shows an example of a configuration of an embodiment of the insert component 20 disposed in the inner cavity of the stent 10. Figure 3 , a state in which the insert component 20 is not arranged in the inner cavity of the stent 10 is shown.

[0155] The manufacturing method of the present invention may also include a step of heat-treating the insert component 20 to form it into a straight shape before arranging the insert component 20 in the inner cavity of the stent 10. The heat treatment may be performed by heating the insert component 20 at 80 to 150° C. for 1 to 2 hours while pulling both ends of the insert component 20.

[0156] [Maintaining process]

[0157] In the holding step, the holding element 80 is brought into contact with the arc portion A of the stent 10 in which the insertion member 20 is disposed in the inner cavity. The holding element 80 is a member capable of holding the shape of the arc portion A of the stent 10 .

[0158] The material constituting the holding element 80 preferably includes at least one selected from the group consisting of backing paper, synthetic resin, clip, and tape. The holding element 80 includes at least one of backing paper, synthetic resin, clip, and tape, so that the arc portion A of the stent 10 can be easily and firmly held by the holding element 80.

[0159] The synthetic resin constituting the retaining element 80 is preferably at least one of polyamide resin, polyester resin, polyurethane resin, polyolefin resin and fluorine resin. When the material constituting the retaining element 80 is a synthetic resin, it is preferred to use a material that does not undergo a thermal process compared to the material constituting the stent 10. Not undergoing a thermal process means that it is not easy to deform. Since the synthetic resin constituting the retaining element 80 does not undergo a thermal process compared to the material constituting the stent 10, the retaining element 80 is less likely to deform than the stent 10 even if heated in the sterilization process as described later, and thus the shape of the arc portion A of the stent 10 can be easily maintained.

[0160] As a method of making the holding element 80 contact the arc portion A of the stent 10 in which the insert component 20 is arranged in the inner cavity, when the holding element 80 is a backing paper, a method of forming a hole or a cutout in the paper material and inserting the arc portion A of the stent 10 into the hole or the cutout to hold the shape of the arc portion A can be cited. When the holding element 80 is a synthetic resin, a method of embedding the arc portion A of the stent 10 into the concave and convex of a thin plate-like object formed of synthetic resin can be cited. When the holding element 80 is a clip, a method of attaching the clip to the arc portion A of the stent 10 to hold the arc portion A can be cited. When the holding element 80 is a belt, a method of attaching the belt to the arc portion A of the stent 10 to hold the arc portion A can be cited.

[0161] use Figure 10 to Figure 12 A state in which the holding element 80 is brought into contact with the arc portion A of the stent 10 will be described.

[0162] Fig.10 1 is a schematic diagram showing a state in which the holding element 80 is brought into contact with the stent kit 1 in which the insert component 20 is arranged in the inner cavity of the stent 10 . Fig.10 The stent 10 shown has closed circular arc portions A at one end and the other end, respectively. The holding element 80 abuts against each of the arc portions A to hold the shape of the arc portions A. Fig.10 The holding element 80 shown is a belt, and the shape of the circular arc portion A is held by bringing the belt into contact with the circular arc portion A of the stent 10 .

[0163] Fig.11 1 is a schematic diagram showing another state in which the holding element 80 is brought into contact with the stent kit 1 in which the insert component 20 is arranged in the inner cavity of the stent 10 . Fig.11 The bracket 10 shown is Fig.10 Similarly, closed circular arc portions A are provided at one end and the other end, respectively, and the holding element 80 abuts against each of the arc portions A to hold the shape of the arc portions A. Fig.11The holding element 80 shown is a bubble cap, and a groove 110 is formed in the bubble cap. The holder 10 is entirely embedded along the groove 110 of the bubble cap, so that the shape of the arc portion A is held.

[0164] Fig.12 1 is a schematic diagram showing still another state in which the holding element 80 is brought into contact with the stent kit 1 in which the insert component 20 is disposed in the inner cavity of the stent 10 . Fig.12 The stent 10 shown has semicircular arc portions A which are not closed circles at one end and the other end, respectively. The holding element 80 abuts against each of the arc portions A to hold the shape of the arc portions A. Fig.12 The holding element 80 shown is a bubble cap, and a groove 110 is formed in the bubble cap. The holder 10 is entirely embedded along the groove 110 of the bubble cap, so that the shape of the arc portion A is held.

[0165] The manufacturing method of the present invention preferably includes a sterilization step after the holding step. The sterilization process is performed in a state where the holding element 80 is in contact with the arc portion A of the stent 10, whereby the portion of the insert component 20 located at the arc portion A of the stent 10 is bent into a shape that approximates the minimum curvature radius rA of the arc portion A. Thus, even if the holding element 80 in contact with the stent 10 is removed after the sterilization process, the arc portion A of the stent 10 will not immediately become a straight line, 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.

[0166] In the sterilization step, the sterilization treatment conditions are not particularly limited, and may be, for example, 8 to 15 hours at 50 to 90°C.

[0167] Next, a method of using the bracket kit 1 according to the present invention will be described.

[0168] The stent kit 1 having the stent 10 and the inserting component 20 is preferably used after the stent 10 is moved to the distal side or the proximal side relative to the inserting component 20 before the stent 10 is delivered to the lumen in the living body. The stent 10 has an inner cavity extending from the proximal side to the distal side in the length direction and has an arc portion A curved in an arc shape, and the inserting component 20 is inserted into the inner cavity of the stent 10. By moving the position of the stent 10 relative to the inserting component 20, the shape of the arc portion A of the stent 10 can be made close to a straight line. As a result, the stent kit 1 can be easily inserted into the lumen in the living body.

[0169] The position of the stent 10 relative to the interposition member 20 can be moved by the doctor, but can also be moved by medical personnel other than the doctor. By having medical personnel other than the doctor move the stent 10 before the operation, the doctor can perform the operation quickly.

[0170] The moving distance of the stent 10 is preferably set to a range of, for example, 1 mm or more and 50 mm or less. By setting the moving distance of the stent 10 to the above range, the insertability of the stent 10 into the lumen in the living body is improved.

[0171] As described above, according to the manufacturing method of the stent kit of the present invention, the insert component is, for example, straight or has an arc portion B that is curved in an arc shape. Even if the minimum curvature radius rB of the arc portion B is greater than the minimum curvature radius rA of the arc portion A of the stent, the stent can maintain a state in which the arc portion A that is curved in an arc shape is formed. Therefore, when the stent is transported to the lesion, the arc portion A of the stent is curved into a straight line or a shape close to a straight line by the insert component, so that the stent is easily transported to the lesion. In addition, after the stent is transported to the lesion, when the insert component is pulled out from the stent and the stent is left in the lesion, the stent is not easily displaced when the minimum curvature radius rA of the arc portion A of the stent is greater than the minimum curvature radius rB of the insert component.

[0172] 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.

[0173] Description of Reference Numerals

[0174] 1…bracket kit; 10…bracket; 20…inserted component; 21…wall; 30…wire; 40…pivot; 50…outer tube component; 60…connecting mechanism; 71…first side hole; 72…second side hole; 80…retaining element; 81…other retaining elements; 90…protective tube; 100…bracket system; 110…slot; A…arc portion of bracket; rA…minimum radius of curvature of arc portion A; B…arc portion of inserted component; rB…minimum radius of curvature of arc portion B; C…arc portion of protective tube; rC…minimum radius of curvature of arc portion C; s1…shaping interval; s2…non-shaping interval; L1…length of shaping interval; L2…length of non-shaping interval.

Claims

1. A bracket kit, comprising: Bracket; an insert component inserted into the inner cavity of the stent; and The outer cylinder member is arranged outside the inner insert member and closer to the bracket. The bracket kit is characterized in that: The bracket has an arc portion bent into an arc shape, When the insert member is not disposed in the inner cavity of the stent, the minimum curvature radius of the arc portion is smaller than the minimum curvature radius of the insert member.

2. The bracket kit according to claim 1, characterized in that: When the insert component is arranged in the inner cavity of the stent, the insert component has a shaping section that is curved into an arc shape and a non-shaping section that is located closer to the front end side of the insert component than the shaping section and is linear. The length of the non-shaping section in the extending direction of the interpolation member is longer than the length of the shaping section in the extending direction of the interpolation member.

3. The bracket kit according to claim 1, characterized in that: When the insertion member is arranged in the inner cavity of the stent, the insertion member has a metal wire in at least a part of a portion located in the arc portion of the stent.

4. The bracket kit according to claim 3, characterized in that: The material constituting the metal wire is shape memory alloy.

5. The bracket kit according to claim 3, characterized in that: At least a portion of the metal wire is fixed to a wall portion of the interposer member.

6. The bracket kit according to claim 3, characterized in that: The insert component has a pivot portion at the proximal end. The metal wire is fixed to the pivot portion.

7. The bracket kit according to claim 1, characterized in that: The bracket and the outer tube member are connected by a connection mechanism.

8. The bracket kit according to claim 7, characterized in that: The stent has a first side hole communicating with the inner cavity of the stent, The outer tube component has a second side hole communicating with the inner cavity of the outer tube component, The connecting mechanism is inserted into the first side hole and the second side hole.

9. The bracket kit according to claim 8, characterized in that: The connecting mechanism has an annular portion, The insert member is disposed inside the annular portion.

10. A support system comprising: The bracket kit of claim 1; and retaining elements, retaining the bracket kit, The support system is characterized in that The holding element holds the arc portion in a state in which the insertion member is inserted into the inner cavity of the stent.

11. The support system according to claim 10, characterized in that: The retaining element includes at least one of a backing paper, a blister, a clip, and a strap.

12. The support system according to claim 10, characterized in that: It also has a protective tube. The minimum curvature radius of the protection tube is greater than the minimum curvature radius of the arc portion, The bracket is inserted into the inner cavity of the protection tube.

13. A method for manufacturing a stent kit, the stent kit comprising: a stent having an inner cavity extending from a proximal side to a distal side along a length direction and having an arc portion A bent into an arc shape; and an insert component inserted into the inner cavity of the stent, The manufacturing method of the bracket kit is characterized by comprising: A preparation step of preparing the support; A step of disposing the insert component in the inner cavity of the stent; and A holding step of bringing a holding element into contact with the arc portion A of the stent.

14. The manufacturing method according to claim 13, characterized in that: The insert component is in a straight line shape.

15. The manufacturing method according to claim 14, characterized in that: include: A step of subjecting the insert member to a heat treatment and forming the insert member into a linear shape before arranging the insert member in the inner cavity of the stent.

16. The manufacturing method according to claim 13, characterized in that: The insert member has an arc portion B curved in an arc shape, and a minimum curvature radius rB of the arc portion B is larger than a minimum curvature radius rA of the arc portion A of the stent.

17. The manufacturing method according to claim 13, characterized in that: The preparation step includes a step of bending a portion of the raw pipe into an arc shape to form the arc portion A.

18. The manufacturing method according to claim 13, characterized in that: include: After the maintaining step, a sterilization step is performed.

19. The manufacturing method according to claim 13, characterized in that: When the insertion member is arranged in the inner cavity of the stent, the insertion member has a metal wire in at least a part of a portion located in the arc portion A of the stent.

20. The manufacturing method according to claim 19, characterized in that: The material constituting the metal wire includes at least one selected from the group consisting of stainless steel, tungsten and shape memory alloy.

Images