Method for manufacturing stent with wire, stent with wire, and stent transport device

Abstract

A method for manufacturing a bracket (4) with a wire includes: a first knot forming step of forming a first bent portion (12a) on a wire (6), and forming a first knot (11a) by passing a portion located closer to the other end side (6h) of the wire (6) than the first bent portion (12a) between the first bent portion (12a) and the bracket (5) in one direction of the direction of encirclement of the bracket (5); and a second knot buckle forming step of forming a second bent part (12b) at a position passing between the first bent part (12a) and the stent (5), and forming a second knot buckle (11b) by passing a position located closer to the other end side (6h) of the wire (6) than the second bent part (12b) between the second bent part (12b) and the stent (5) in the direction opposite to the direction of passing through the first bent part (12a), i.e., in the other direction of the encircling direction of the stent (5). When viewed in the axial direction (AX) of the holder (5), a first knot (11a) is formed on a first side (5x), and a second knot (11b) is formed on a second side (5y) located on the opposite side from the first side (5x).

Description

Technical Field

[0001] The present invention relates to a stent with a wire placed in a living body lumen, and also relates to a manufacturing method of the stent with a wire, the stent with a wire, and a stent delivery device. Background Art

[0002] Stents are placed and used in areas such as stenosis, occlusion, and adhesions (hereinafter sometimes referred to as "stenosis" or the like) that occur within a living body lumen. Stents are typically formed as small, expandable, mesh-like metal tubes. Among these stents, there are self-expanding stents made of superelastic metal. These stents are delivered to an adhesion or other site in a reduced diameter by being bound with a wire from the periphery. The stent then expands by releasing the wire's restraints.

[0003] For example, Patent Document 1 describes a stent held in a reduced diameter by a wire (referred to as a wire rod in Patent Document 1), and discloses a wire-binding method that facilitates stent expansion by pulling the wire rod at the active end of the wire. The stent-binding wire in Patent Document 1 comprises: a portion extending along the stent's axis; a portion extending along the stent's circumference; and a cross-shaped intersection where these portions are intertwined. In Reference 1, multiple intersections are arranged linearly along the axial direction at one location along the stent's circumference.

[0004] Previous technical literature

[0005] Patent Literature

[0006] Patent Document 1: Japanese Patent Application Laid-Open No. 2005-304792 Summary of the Invention

[0007] Technical issues to be solved by the invention

[0008] When the stent is expanded, a reaction force is applied to the stent from a stenosis in contact with the stent. As described above, in the wire of Patent Document 1, a plurality of intersections are linearly arranged along the axial direction at one location in the circumferential direction of the stent.

[0009] Therefore, according to the wire-to-stent bundling method of Patent Document 1, when the stent is expanded, one portion of the stent is expanded first in the circumferential direction. Therefore, the first expanded portion of the stent presses the stenosis first, and the stenosis exerts a reaction force on the portion.

[0010] Therefore, the technology of Patent Document 1 has room for improvement in accurately placing the stent at the target placement position without being affected by the reaction force from a stenosis or the like.

[0011] The present invention has been made in view of the above-mentioned problems, and provides a method for manufacturing a stent with a string, a stent with a string, and a stent delivery device that can accurately place a stent at a target placement position.

[0012] Means for solving technical problems

[0013] In the manufacturing method of the stent with a wire of the present invention, a stent and a wire are prepared, and a plurality of knots are formed from one end side of the wire to the other end side of the wire. The stent passes through the tubular portion in the subject's body and can be retained in the tubular portion by utilizing its own elastic expansion. The wire is bundled around the stent to limit the expansion of the contracted stent and maintain the contracted state when the stent is inserted into the tubular portion. The manufacturing method of the stent with a wire is characterized in that it includes: a first knot forming step, forming a first bent portion on the wire, and making the first bent portion along the stent, passing a portion located closer to the other end side of the wire than the first bent portion, around the stent in one direction of the circumferential direction of the stent, and forming a first knot between the first bent portion and the stent. 1 knot; and a second knot forming process, forming a second bent portion at a portion passing through the first bent portion and the bracket, and winding a portion located closer to the other end side of the wire than the second bent portion in a direction opposite to the direction passing through the first bent portion, that is, another direction of the winding direction of the bracket, through the second bent portion and the bracket to form a second knot, in the first knot forming process, forming the first knot on the first side when observed in the axial direction of the bracket, and in the second knot forming process, forming the second knot on the second side located on the opposite side to the first side when observed in the axial direction of the bracket, and repeating the first knot forming process and the second knot forming process alternately to bundle the bracket with the wire.

[0014] The stent with a wire of the present invention is characterized in that it comprises: a stent composed of a mesh, which passes through a tubular portion in a subject's body and can be retained in the tubular portion by expanding using its own elasticity; and a wire that is tied around the stent to limit the expansion of the contracted stent and maintain the contracted state when the stent is inserted into the tubular portion, the wire comprising: a first knot formed on the first side when observed in the axial direction of the stent; and a second knot formed on the second side located on the opposite side to the first side when observed in the axial direction of the stent.

[0015] The stent delivery device of the present invention is characterized by comprising: the stent with a wire; and a delivery unit that delivers the stent with a wire.

[0016] Effects of the Invention

[0017] According to the method for manufacturing a stent with a wire, the stent with a wire, and the stent delivery device of the present invention, the stent can be accurately placed at a target placement position. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 1 is a schematic overall view showing the stent delivery device according to this embodiment.

[0019] Figure 2 It is a schematic diagram showing the bundling area of ​​the wires for the stent.

[0020] Figure 3 It is a schematic diagram showing a state where the temporary fixing portion having the first bent portion is formed.

[0021] Figure 4 It means in Figure 3 Schematic diagram of a state in which a second bent portion is formed after the state shown.

[0022] Figure 5 It means in Figure 4 Schematic diagram of a state in which the first bent portion is formed after the state shown.

[0023] Figure 6 It means in Figure 5 Schematic diagram of a state in which a second bent portion is formed after the state shown.

[0024] Figure 7 It means in Figure 6 Schematic diagram of a state in which the first bent portion is formed after the state shown.

[0025] Figure 8 1 is a diagram showing a step of forming a temporary fixing portion and is a schematic diagram showing a state where a wire having a first curved portion is arranged along the stent.

[0026] Figure 9 It means when viewed from the axis direction Figure 8 Schematic diagram of the diagram.

[0027] Figure 10 It means in Figure 8 Schematic diagram of a state in which a third bent portion is formed after the state shown.

[0028] Figure 11 Observed from the axis Figure 10 Schematic diagram of .

[0029] Figure 12 It means in Figure 10 Schematic diagram of a state in which the first bent portion is formed after the state shown.

[0030] Figure 13 Observed from the axis Figure 12 Schematic diagram of .

[0031] Figure 14 is a diagram showing steps for forming a temporary fixing portion according to a modification example, and Figure 8 Schematic diagram of a state in which a fourth bent portion is formed after the state shown.

[0032] Figure 15 Observed from the axis Figure 14 Schematic diagram of . DETAILED DESCRIPTION

[0033] The following describes an embodiment of the present invention using the accompanying drawings. The embodiments described below are merely examples for facilitating understanding of the present invention and do not limit the present invention. Specifically, the shapes, dimensions, and configurations of the components described below may be modified or improved without departing from the spirit of the present invention, and the present invention naturally encompasses equivalents thereof.

[0034] In addition, the various constituent elements of the present invention do not need to exist independently. It is allowed that multiple constituent elements are constituted as a single constituent element, one constituent element is divided into multiple constituent elements, a certain constituent element is part of other constituent elements, a part of a certain constituent element overlaps with a part of other constituent elements, etc.

[0035] In addition, in all the drawings, the same components are denoted by the same reference numerals, and repeated descriptions are omitted as appropriate.

[0036] The thickness and size of each part described in the drawings of the present application are modified as appropriate for the convenience of explanation and are not limited to the scale of the actual objects.

[0037] Furthermore, the side closer to the operator who uses the transport device 1 is referred to as the proximal side, and the side farther from the operator is referred to as the distal side.

[0038] The stent 5 described later is formed by a plurality of steel wires crossing each other in a mesh shape, but for simplicity of illustration, the mesh-like portion is omitted and only the overall outer shape is shown.

[0039] <Outline>

[0040] First, the main reference Figures 1 to 7 Next, an overview of a method for manufacturing the stent with wire 4 according to this embodiment will be described.

[0041] Figure 1 It is a schematic overall view showing the stent delivery device (delivery device 1 ) according to this embodiment.

[0042] Figure 2Schematic diagram showing a bundling region R of the wires 6 with respect to the stent 5 .

[0043] Figure 3 It is a schematic diagram showing a state where the temporary fixing portion 13 having the first bent portion 12 a is formed. Figure 4 It means in Figure 3 The schematic diagram shows a state in which the second bent portion 12b is formed after the state shown.

[0044] Figure 5 It means in Figure 4 The schematic diagram shows a state in which the first bent portion 12a is formed after the state shown. Figure 6 It means in Figure 5 The schematic diagram shows a state in which the second bent portion 12b is formed after the state shown. Figure 7 It means in Figure 6 The schematic diagram shows a state in which the first bent portion 12a is formed after the state shown.

[0045] In addition, Figure 1 In order to clearly distinguish the plurality of lines 6, the proximal side line 6a is shown by a dotted line, the middle line 6b is shown by a broken line, and the distal side line 6c is shown by a solid line.

[0046] And, in Figure 1 In FIG. 1 , the bundled shape of the wires 6 is simplified and represented as a rhombus lattice.

[0047] And, in Figure 2 In the figure, the stent 5 is shown as having its diameter selectively reduced at the locations where it is tied by the temporary fixing portions 13 provided at both ends. However, in reality, the stent 5 is reduced in diameter as a whole by the wire 6. One method of reducing the diameter of the stent 5 as a whole is to pull the other end 6h of the wire 6 before forming the second temporary fixing portion 13, thereby shortening the length of the wire 6 in the tied region R and increasing the tied load.

[0048] like Figure 1 and Figure 2 As shown, in the manufacturing method of a stent 4 with a wire according to this embodiment, a stent 5 and a wire 6 are prepared. The stent 5 is composed of a mesh and is passed through a tubular portion within a subject's body. It expands due to its own elasticity and can remain in the tubular portion. The wire 6 is tied around the stent 5 to restrict expansion of the stent 5 during insertion into the tubular portion, maintaining the stent's contracted state. In this manufacturing method, multiple knots are formed from one end 6g of the wire 6 to the other end 6h of the wire 6.

[0049] like Figures 3 to 5As shown, the manufacturing method of the stent 4 with a wire includes a first knot forming step and a second knot forming step. In the first knot forming step, a first bent portion 12a is formed on the wire 6. Then, the first bent portion 12a is made to extend along the stent 5, and a portion located closer to the other end side 6h of the wire 6 than the first bent portion 12a is passed between the first bent portion 12a and the stent 5 in a counterclockwise direction (around one direction) of the winding direction of the stent 5 to form a first knot 11a. In the second knot forming step, as shown in FIG. Figure 4 As shown in FIG. 1 , a second curved portion 12b is formed at a portion passing through the first curved portion 12a and the bracket 5. Figure 5 and Figure 6 As shown, the portion located closer to the other end side 6h of the line 6 than the second bend 12b is passed between the second bend 12b and the bracket 5 in a direction opposite to the direction of passing through the first bend 12a, that is, in a clockwise direction (around the other direction) of the circumferential direction of the bracket 5 to form the second knot 11b.

[0050] like Figure 5 As shown, in the first knot forming step, the first knot 11 a is formed on the first side 5 x when viewed in the axial direction AX of the stent 5 .

[0051] like Figure 6 As shown, in the second knot forming step, the second knot 11 b is formed on the second side 5 y located on the opposite side to the first side 5 x when viewed in the axial direction AX of the stent 5 .

[0052] like Figure 2 and Figure 7 As shown, the method for manufacturing the stent 4 with a wire is characterized in that the first knot forming step and the second knot forming step are repeated alternately to bundle the stent 5 with the wire 6 .

[0053] In this embodiment, the large intestine is described as the above-mentioned "tubular portion", but the bile duct, digestive tracts such as the large intestine and small intestine, and other blood vessels may also be used.

[0054] And, specifically, the second knot 11b is formed on the second side 5y opposite to the first side 5x on which the first knot 11a is formed, which means that, when observed in the axial direction AX of the bracket 5, the center angle connecting the second knot 11b, the center axis of the bracket 5 and the first knot 11a just formed is not within the range of ±90 degrees (the center angle is greater than ±90 degrees and within ±180 degrees).

[0055] In other words, the first knot 11a and the second knot 11b, which are adjacent to each other in the axial direction of the stent 5, are arranged at different positions in the circumferential direction of the stent 5. Furthermore, when viewed in the axial direction AX of the stent 5, the angle formed by the line segment connecting the center of the stent 5 and the first knot 11a (a line segment extending in the radial direction of the stent 5) and the line segment connecting the center of the stent 5 and the second knot 11b (a line segment extending in the radial direction of the stent 5) exceeds 90 degrees.

[0056] In the present embodiment, the “first knot 11 a ” and the “second knot 11 b ” are structures in which portions of the wire 6 are folded back and wound together.

[0057] In other words, the "first knot 11a" and the "second knot 11b" are formed by passing a portion of the loop-shaped wire 6 and another portion of the loop-shaped wire 6 through each other's loops, and hooking (entwining) each other at the locations where their respective extending directions are reversed.

[0058] Specifically, “between the first curved portion 12 a and the stent 5 ” refers to a space defined by a portion where the stent 5 and the wire 6 wound around the stent 5 come into contact with each other, and the first curved portion 12 a .

[0059] Similarly, specifically, “between the second curved portion 12 b and the stent 5 ” refers to a space defined by a portion where the stent 5 and the wire 6 wound around the stent 5 come into contact with each other, and the second curved portion 12 b .

[0060] The above-mentioned method for manufacturing the stent 4 with a wire stipulates that the first knot forming step and the second knot forming step are performed alternately.

[0061] Therefore, the method of manufacturing the stent 4 with a wire is not necessarily limited to the order of the first knot forming step to the second knot forming step, and may be performed in the order of the second knot forming step to the first knot forming step.

[0062] According to the above structure, the first knot 11a is formed on the first side 5x when viewed in the axial direction AX of the stent 5, and the second knot 11b is formed on the second side 5y when viewed in the axial direction AX of the stent 5. As a result, the stent 5 can be deployed (expanded) alternately on the first side 5x and the second side 5y by the traction wire 6. Therefore, the direction of the reaction force applied to the stent 5 from the stenosis or the like will alternate between the second side 5y and the first side 5x. Therefore, compared with the case where the direction of the reaction force is constant, it is possible to suppress the stent 5 from being displaced relative to the target position of the stent 5 during expansion.

[0063] And, as Figure 2As shown, the stent 4 with wire involved in this embodiment comprises: a stent 5, which is composed of a mesh, passes through the tubular portion in the subject's body, and can be retained in the tubular portion by expanding using its own elasticity; and a wire 6, which is tied around the stent 5 to limit the expansion of the contracted stent 5 when the stent 5 is inserted into the tubular portion and maintain the contracted state.

[0064] It is characterized in that the wire 6 has: a first knot 11a formed on the first side 5x when viewed in the axial direction AX of the bracket 5; and a second knot 11b formed on the second side 5y located on the side opposite to the first side 5x when viewed in the axial direction AX of the bracket 5.

[0065] According to the above structure, since the first knot 11a is formed on the first side 5x of the stent 5 and the second knot 11b is formed on the second side 5y of the stent 5, the stent 5 can be deployed on the first side 5x and the second side 5y, as described in the method for manufacturing the stent 4 with a thread. Therefore, it is possible to suppress the stent 5 from being displaced relative to its intended placement position during expansion due to reaction forces applied to the stent 5 from a stenosis or the like.

[0066] like Figure 1 As shown in FIG. 1 , the stent conveying device (conveyor device 1 ) according to the present embodiment includes the above-mentioned stent 4 with a wire and a conveying unit 10 that conveys the stent 4 with a wire.

[0067] According to the above configuration, the transport device 1 can provide the effect of the stent 4 with a wire.

[0068] Stent delivery device

[0069] Next, the main reference Figure 1 , a stent delivery device (delivery device 1) for delivering a stent 5 into a living body vessel will be described.

[0070] As described above, the conveying device 1 includes the holder 4 with a wire and the conveying unit 10 that conveys the holder 4 with a wire.

[0071] The transport unit 10 mainly includes an inner sheath 2 around which a stent 4 with a wire is attached, and an outer sheath 3 covering the inner sheath 2 and the stent 4 with a wire and being movable relative to the inner sheath 2 in the axial direction.

[0072] The transport unit 10 further includes a stopper 7 for limiting the proximal movement of the stent 5 , a handle 8 for the operator to hold, and a slider 9 to which the outer sheath 3 is fixed and which is slidable relative to the handle 8 along the axial direction.

[0073] The inner sheath 2 is formed of a PEEK (polyetheretherketone) tube.

[0074] The stent 5 in this embodiment is a bare stent without a resin coating, but may also be a coated stent with a resin coating. The length of the stent 5 in its natural state in this embodiment is, for example, 120 mm, and the outer diameter of the stent 5 in its natural state is, for example, 22 mm. The diameter of the steel wire of the stent 5 is, for example, 0.17 mm.

[0075] The length of the bracket 5 can be any length such as 60 mm, 80 mm or 100 mm, and the outer diameter of the bracket 5 can be any size other than 22 mm, such as 18 mm.

[0076] <Line>

[0077] The wire 6 is used to bundle the stent 5 in a reduced diameter state so that the stent 5 can be housed in the outer sheath 3 when the stent 5 is delivered. When the stent 5 is expanded, the wire 6 is pulled by the operator to release the bundle of the stent 5.

[0078] The wire 6 is a wire formed by twisting together natural fibers or chemical fibers, or one of them. However, the wire 6 is not limited to this structure, and the wire 6 may be made of metal as long as it is a linear shape capable of tying up the stent 5.

[0079] like Figure 1 As shown, the wires 6 according to this embodiment are provided in plurality (a proximal wire 6a, an intermediate wire 6b, and a distal wire 6c). At least a portion of the plurality of wires 6 binds different regions of the stent 5 in the axial direction AX.

[0080] The proximal wire 6 a ties the proximal side of the stent 5 , the middle wire 6 b ties the middle portion of the stent 5 , and the distal wire 6 c ties the distal side of the stent 5 .

[0081] As described above, by binding different regions of the stent 5 with multiple wires 6 and releasing the wires 6 at different times, the stent 5 can be released in stages. This makes it easier to properly place the stent 5 in the stenosis.

[0082] In particular, providing three wires 6 is preferred because it allows for expansion of the distal and proximal ends of the wires 6, followed by expansion of the intermediate portion, while clamping a narrowed portion (not shown). However, this configuration is not limiting. For example, the wires 6 may be composed of two wires, a proximal wire 6a and a distal wire 6c. Furthermore, if stepwise release is not required, the wire 6 may be composed of a single wire.

[0083] In this embodiment, the distal end portion of the bundling region R of the proximal side wire 6a and the proximal end portion of the bundling region R of the intermediate wire 6b are adjacent to each other in the axial direction of the stent 5. Similarly, the distal end portion of the bundling region R of the intermediate wire 6b and the proximal end portion of the bundling region R of the distal side wire 6c are adjacent to each other in the axial direction of the stent 5.

[0084] The wired stent 4 of this embodiment is placed in the digestive tract (e.g., the large intestine). The plurality of wires 6 constituting the wired stent 4 of this embodiment are formed with first and second knots 11a and 11b so as to untie when pulled, e.g., from the anus toward the oral cavity.

[0085] In other words, the manufacturer Figure 1 The delivery device 1 shown here is constructed by tying multiple threads 6 to the stent 5 from the distal end (or oral side) toward the proximal end (anal side) on the opposite side, forming a first knot 11a and a second knot 11b. As will be described later, the manufacturer then places a temporary fixing portion 13, formed at the end of the thread tying process on the stent 5, on the anal side. This allows the threads 6 to untie from the anal side toward the oral side.

[0086] That is, the proximal line 6a, the intermediate line 6b, and the distal line 6c are configured such that the bundling end point is located on the proximal side of the bundling region R, and the stent 5 is opened from the proximal side of each bundling region R.

[0087] According to the above configuration, by untying the string 6 from the anus side, the string 6 can be taken out from the anus without being folded back along the axial direction AX of the stent 5 , thereby shortening the string 6 .

[0088] In addition, “untying from the anus side to the oral side” is only an example, and does not exclude a structure in which the untying is done in the opposite direction.

[0089] That is, the end point of the bundling of the stent 5 can also be set to the distal side of the bundling area R, and the wire 6 can be arranged on the inner sheath 2 in a manner such that a U-shape is turned, and the stent 5 can be opened from the distal side of the bundling area (i.e., untied from the oral side to the anal side).

[0090] For example, in the case of a structure having a plurality of wires 6 arranged at different positions in the axial direction AX as in the wired stent 4 involved in the present embodiment, it is preferred that the oral side (distal side) of the stent 5 is opened from the very end (distal side) and the anal side is opened from the base side (proximal side).

[0091] [Structure related to the central part of the line]

[0092] Next, take line 6 as an example, mainly refer to Figure 2 The structure of the distal side line 6c related to the central portion and the structure of the distal side line 6c related to the end portion will be described. The proximal side line 6a and the intermediate line 6b are constructed in the same manner as the distal side line 6c.

[0093] In the wired bracket 4 of this embodiment, as shown in FIG. Figure 2 As shown, a plurality of first knots 11 a and second knots 11 b provided on the distal side line 6 c are alternately formed and arranged along the axial direction AX of the stent 5 .

[0094] Note that details of the first knot 11 a and the second knot 11 b will be described later in the method of tying the wire 6 .

[0095] That is, the plurality of first knots 11a are on the first side 5x (at Figure 2 The second knots 11b are arranged along the axial direction AX. The second side 5y (in the axial direction AX) of the plurality of second knots 11b is arranged along the axial direction AX. Figure 2 The lower side is shown in the side view) and are arranged along the axial direction AX.

[0096] The phrase "arranged along the axial direction AX" is not limited to being arranged completely parallel to the axial direction AX. Specifically, when viewed in the axial direction AX of the bracket 5, first knots 11a connecting adjacent first knots 11a in the axial direction AX and the central axis of the bracket 5 are within a range of 60 degrees, and are considered to be arranged along the axial direction AX.

[0097] That is, when a plurality of first knots 11a are provided along the axial direction AX of the stent 5, the angle formed by the line segment connecting the axial center of the stent 5 and one first knot 11a (a line segment extending in the radial direction of the stent 5) and the line segment connecting the axial center of the stent 5 and another first knot 11a (a line segment extending in the radial direction of the stent 5) may be 60 degrees or less, as viewed in the axial direction AX of the stent 5. The "one first knot 11a" and "another first knot 11a" referred to herein are first knots 11a that are adjacent to each other in the axial direction AX of the stent 5 among the plurality of first knots 11a.

[0098] The above configuration allows the first knots 11a and the second knots 11b to be alternately deployed along the axial direction AX of the stent 5. Therefore, when the stent 5 is deployed, the stent 5 can be prevented from being displaced from the target placement position due to a reaction force from a stenosis (not shown).

[0099] like Figure 2 As shown, a portion of the line 6 extending linearly along the axial direction AX of the stent 5 is not formed between the first knot 11 a and the second knot 11 b in the line 6 .

[0100] That is, the wire 6 extends obliquely between the first knot 11 a and the second knot 11 b with a component in the circumferential direction of the stent 5 and a component in the axial direction AX (that is, the wire 6 is threaded along the outer peripheral surface of the stent 5 ).

[0101] According to the above configuration, the wire 6 does not have a portion extending linearly along the axial direction AX of the stent 5 and not functioning as a binding stent 5. Therefore, the length of the wire 6 for binding the stent 5 in the circumferential direction can be shortened.

[0102] [Structure related to both ends of the line]

[0103] like Figure 2 As shown, the temporary fixing portions 13 of the wire 6 are provided at the ends (in this embodiment, both ends) of the binding region R where the plurality of first knots 11a and the plurality of second knots 11b are provided. The temporary fixing portions 13 are not fixed in a manner that prevents the wire 6 from being untied even when it is pulled, but rather are fixed in a manner that prevents it from being untied in its natural state but is untied when the operator pulls the wire 6.

[0104] Note that the temporary fixing portion 13 will be described in detail in the later-described method of bundling the wires 6 .

[0105] According to the above configuration, by temporarily fixing the wire 6 at different positions in the axial direction AX of the stent 5 , the wire 6 can be easily released.

[0106] As described above, the temporary fixing portions 13 are preferably formed at both ends of the bundling region R of the bracket 5, but are not limited to this configuration. The temporary fixing portions 13 can be formed at any position on the bracket 5. For example, if the bundling region R of the wire 6 is long in the axial direction AX, an additional temporary fixing portion 13 may be provided in the center portion between the two ends of the bundling region R.

[0107] <Bundling Method>

[0108] Then, except Figures 2 to 7 In addition, the main reference Figures 8 to 13 Next, a method for bundling the wire 6 (distal-end side wire 6 c ) of the stent 5 will be described.

[0109] Figure 8 1 and 2 are diagrams showing a step of forming the temporary fixing portion 13 , and schematically showing a state in which the wire 6 having the first curved portion 12 a is guided along the stent 5 . Figure 9 It means when viewed from the axis direction Figure 8 Schematic diagram of the diagram. Figure 10 It means in Figure 8 The schematic diagram shows a state in which the third bent portion 12c is formed after the state shown. Figure 11 It means when viewed from the axis direction AX Figure 10 Schematic diagram of the diagram. Figure 12 It means in Figure 10 The schematic diagram shows a state in which the first bent portion 12a is formed after the state shown. Figure 13 It means when viewed from the axis direction AX Figure 12 Schematic diagram of the diagram.

[0110] In addition, during each step described below, it is preferable to keep the one end side 6g and the other end side 6h of the wire 6 always on the same side relative to the bracket 5 (at Figures 2 to 15The state of the upper side is shown in the middle.

[0111] [How to tie one end of the wire]

[0112] like Figure 3 and Figures 8 to 13 As shown, the method for manufacturing the stent 4 with wires includes a temporary fixing step of temporarily fixing the wires 6 to the stent 5 .

[0113] First, if Figure 8 and Figure 9 As shown, in the temporary fixing process, the wire 6 is made to run along the side surface of the bracket 5. Figure 8 In the side view shown, the wire 6 is arranged so that the bent portion 12 (first bent portion 12 a ) of the wire 6 protrudes outward from the stent 5 .

[0114] In the bundling method of one end side 6g of wire 6, one direction around the circumference of bracket 5 is set to be clockwise and the other direction around the circumference of bracket 5 is set to be counterclockwise (described later). However, this is only an example and is not limited to this.

[0115] like Figure 10 and Figure 11 As shown, the portion located closer to the other end side 6h of the wire 6 than the first bending portion 12a is rotated in the clockwise direction of the winding direction of the stent 5 (for example, Figure 11 The first bending portion 12a and the bracket 5 are connected to form a first knot 11a.

[0116] After forming the first knot 11a, Figure 10 As shown, a third curved portion 12 c is formed at a portion of the wire 6 passing between the first curved portion 12 a and the bracket 5 .

[0117] like Figure 12 and Figure 13 As shown, the portion located closer to the other end side 6h of the line 6 than the third curved portion 12c is rotated in the same direction as the direction passing through the first curved portion 12a, that is, in the clockwise direction of the circumferential direction of the stent 5 (for example, Figure 13 The first bent portion 12a is formed again at the portion passing between the third bent portion 12c and the bracket 5 (in the clockwise direction shown in FIG).

[0118] More strictly speaking, when forming the temporary fixing portion 13, a portion located closer to the other end 6h of the wire 6 than the third bent portion 12c and closer to the other end 6h than the first knot 11a passes between the third bent portion 12c and the first knot 11a.

[0119] Thus, forming Figure 3The temporary fixing portion 13 is shown.

[0120] Through the above process, for example, the middle portion between one end and the other end of the wire 6 is wound around the stent 5 in the other direction of the circumference of the stent 5 (for example, about half a circle), and the end side portion of the wound portion ( Figure 8 The lower end portion of the wire 6 becomes the curved portion 12 (the first curved portion 12a: hereinafter sometimes referred to as the first loop portion). Furthermore, for example, the portion of the wire 6 closer to the other end side 6h than the first loop portion is wound around the stent 5 in one direction in the circumferential direction of the stent 5 (for example, wound around once), and passes between the first loop portion and the stent 5, and the portion passed through becomes a new curved portion 12 ( Figure 10 The third curved portion 12c shown: hereinafter sometimes referred to as the second loop portion). Moreover, for example, the portion of the wire 6 closer to the other end side 6h than the second loop portion passes through the second loop portion, and the portion passed through becomes a new curved portion 12 ( Figure 12 、 Figure 13 The first bent portion 12a on the lower side is shown: hereinafter sometimes referred to as the third loop portion. In this manner, the wire 6 wound around the stent 5 is tied to the stent 5 so as to leave the third loop portion, thereby forming a temporary fixing portion 13.

[0121] According to the above configuration, by forming the temporary fixing portion 13 , the workability of bundling the wires 6 can be improved.

[0122] [How to tie the center of the line]

[0123] Then, if Figure 4 As shown, the first curved portion 12a (third ring portion) provided on the temporary fixing portion 13 and protruding from the first knot 11a is aligned along the axial direction of the stent 5. Then, a portion located closer to the other end 6h of the wire 6 than the first curved portion 12a is passed between the first curved portion 12a and the stent 5 in a counterclockwise direction relative to the winding direction of the stent 5, thereby forming the first knot 11a (first knot forming step).

[0124] In the method of bundling the central portion of the wire 6 , one direction around the circumference of the bracket 5 is set to the counterclockwise direction, and the other direction around the circumference of the bracket 5 is set to the clockwise direction. However, this is only an example and is not limited to this.

[0125] like Figure 4 As shown, the second bent portion 12 b is formed at a portion passing between the first bent portion 12 a and the bracket 5 .

[0126] like Figure 5 and Figure 6As shown, the portion located closer to the other end side 6h of the line 6 than the second bend 12b is passed between the second bend 12b and the bracket 5 in a direction opposite to the direction of passing through the first bend 12a, that is, in a clockwise direction of the circumferential direction of the bracket 5, to form the second knot 11b (second knot forming process).

[0127] Through the above process, for example, the portion of the wire 6 closer to the other end side 6h than the third loop portion is wound around the stent 5 while being screwed in the other direction of the circumference of the stent 5 by less than one turn, and passes between the third loop portion and the stent 5. The passed portion becomes a new curved portion 12 (second curved portion 12b: hereinafter sometimes referred to as the fourth loop portion) ( Figure 4 ).

[0128] Furthermore, for example, the portion of the wire 6 closer to the other end side 6h than the fourth ring portion is wound around the stent 5 while being screwed less than one turn in one direction in the circumferential direction of the stent 5, and passes between the fourth ring portion and the stent 5, and the portion passed through becomes a new curved portion 12 ( Figure 5 The first curved portion 12a on the lower side shown in the figure is sometimes referred to as the fifth ring portion below. Figure 5 The first knot 11a is shown.

[0129] Furthermore, for example, the portion of the wire 6 closer to the other end side 6h than the fifth ring portion is wound around the stent 5 while being screwed less than one turn in the other direction on the circumference of the stent 5, and passes between the fifth ring portion and the stent 5, and the portion passed through becomes a new curved portion 12 ( Figure 6 The second curved portion 12b on the right side shown: hereinafter sometimes referred to as the sixth loop portion), at this time, also forms Figure 6 The second knot 11b is shown.

[0130] Then, if Figure 6 and Figure 7 As shown, the stent 5 is bound with the central portion of the wire 6 by repeating the first knot forming step and the second knot forming step toward the proximal end side (the other end side) of the stent 5 .

[0131] In addition, the number of times the first knot forming process is performed (the number of first knots 11a in the central portion of the thread 6) and the number of times the second knot forming process is performed (the number of second knots 11b in the central portion of the thread 6) can be the same as each other, or one of them can be 1 more (1) than the other.

[0132] [Temporary fixation of the other end]

[0133] The same temporary fixing portion 13 as the temporary fixing portion 13 on the one end side described above is also formed on the other end side of the wire 6 (the temporary fixing portion 13 on the other end side is not shown in the figure).

[0134] The other end 6h pulled out from the temporary fixing portion 13 extends to the handle 8. Therefore, the operator can untie the temporary fixing portion 13, the first knot 11a, and the second knot 11b by pulling the other end 6h of the wire 6 in the handle 8, thereby expanding the stent 5. More specifically, by pulling the other end 6h of the wire 6, the temporary fixing portion 13 at the other end 6h of the two temporary fixing portions 13 is first untied, then the central portion of the wire 6 is untied, and finally, the temporary fixing portion 13 at the one end 6g is untied.

[0135] In particular, in this embodiment, the handle 8 is configured so that the proximal side wire 6a, the intermediate wire 6b, and the distal side wire 6c can be pulled independently of each other.

[0136] Modifications

[0137] The method of bundling the wires 6 according to the above embodiment is merely an example, and various modifications are possible.

[0138] As an example, the main reference Figure 14 and Figure 15 , the temporary fixing portion involved in the modification example is explained.

[0139] Figure 14 is a diagram showing steps for forming a temporary fixing portion according to a modification example, and Figure 8 The schematic diagram shows a state in which the fourth bent portion 12d is formed after the state shown. Figure 15 It means when viewed from the axis direction AX Figure 14 Schematic diagram of the diagram.

[0140] In the process of forming the temporary fixing portion according to the modification, Figure 10 and Figure 11 The steps shown are similar to those in Figure 8 After the state shown, in the space between the first bending portion 12a and the bracket 5, Figure 15 When viewed in the axial direction AX shown in FIG. 1 , the portion located closer to the other end side 6h of the line 6 than the first bent portion 12a is passed through in a clockwise direction to form the first knot 11a. The second bent portion 12b (which is the same as the first knot 11a) is formed at the same time as the first knot 11a. Figure 10 Furthermore, in the space between the second curved portion 12b and the bracket 5, Figure 15 When viewed in the axial direction AX shown, the portion located closer to the other end 6h of the wire 6 than the second bent portion 12b is passed through in a counterclockwise direction to form the second knot 11b.

[0141] like Figure 14 and Figure 15As shown in FIG. 1 , after forming the second knot 11b, the fourth bent portion 12d is formed at the portion passing through the second bent portion 12b and the bracket 5. Then, the portion located closer to the other end 6h of the wire 6 than the fourth bent portion 12d is wound in the same direction as the direction passing through the second bent portion 12b, that is, in the counterclockwise direction of the winding direction of the bracket 5 ( FIG. 1 ). Figure 15 counterclockwise direction shown), passing through the fourth bent portion 12d and the second knot 11b to form a temporary fixing portion ( Figure 12 and Figure 13 The temporary fixing portion 13 shown is the same temporary fixing portion except for the direction of passing through the portion located on the other end side 6h of the wire 6). Furthermore, the second bent portion 12b is formed again at the portion passing between the fourth bent portion 12d and the bracket 5.

[0142] More strictly speaking, when forming the temporary fixing portion, a portion located closer to the other end 6h of the wire 6 than the fourth bent portion 12d and closer to the other end 6h than the second knot 11b passes between the fourth bent portion 12d and the first knot 11a.

[0143] like Figure 14 and Figure 15 As shown, the temporary fixing step is performed after one or more first knots 11 a and second knots 11 b are alternately formed at the same position in the axial direction AX of the stent 5 .

[0144] The “same position in the axial direction AX” as the position where one or more first knots 11a and second knots 11b are alternately formed refers to the same position in the fixing area where the binding force of the temporary fixing portion is applied and the same position over a certain length.

[0145] According to the above configuration, by alternately forming one or more first knots 11 a and second knots 11 b at the same position and then temporarily fixing them, the binding strength can be locally increased.

[0146] As described above, the temporary fixing portion 13 and the temporary fixing portions according to the modified examples are formed by continuously passing the portion located on the other end side 6h of the wire 6 through the curved portion 12 and the first knot 11a or the second knot 11b in the same direction as the direction of winding of the stent 5. Therefore, the number of times the first knot 11a and the second knot 11b are formed before continuously passing the portion located on the other end side 6h of the wire 6 through these can be arbitrarily set. While forming a larger number of first knots 11a and second knots 11b increases the labor involved, the binding force of the temporary fixing portion becomes stronger.

[0147] Furthermore, if the wire 6 is fixed by the temporary fixing portion 13 and the temporary fixing portion according to the modified example, it is preferable because it does not require more work hours than when using other methods. However, the temporary fixing portion 13 and the temporary fixing portion according to the modified example are not limited to being formed in this manner and may also be formed using an adhesive or the like.

[0148] The above-mentioned embodiment includes the following technical ideas. (1)

[0150] A method for manufacturing a stent with wires, wherein:

[0151] Prepare a bracket and a wire, and form a plurality of knots from one end of the wire to the other end of the wire.

[0152] The stent passes through the tubular portion in the subject's body and expands by its own elasticity to be retained in the tubular portion.

[0153] The wire is tied around the stent to restrict expansion of the stent when the stent is inserted into the tubular portion and to maintain the stent in a contracted state.

[0154] The method for manufacturing the stent with wires is characterized by comprising:

[0155] a first knot forming step of forming a first curved portion on the wire and causing the first curved portion to extend along the stent, with a portion of the wire located closer to the other end of the wire than the first curved portion passing between the first curved portion and the stent in one direction around the stent to form a first knot; and

[0156] The second knot forming step is to form a second bent portion at a portion passing through the first bent portion and the bracket, and to form a second knot by passing a portion located closer to the other end of the wire than the second bent portion in a direction opposite to the direction passing through the first bent portion, that is, in another direction of the winding direction of the bracket, through the second bent portion and the bracket.

[0157] In the first knot forming step, a first knot is formed on a first side of the stent when viewed in the axial direction.

[0158] In the second knot forming step, a second knot is formed on a second side located opposite to the first side when viewed in the axial direction of the stent.

[0159] The first knot forming step and the second knot forming step are repeated alternately to bundle the stent with the wire. (2)

[0161] The method for manufacturing a stent with a wire according to (1) further comprises: a temporary fixing step of temporarily fixing the wire to the stent,

[0162] In this temporary fixing process,

[0163] After forming the first knot, forming a third bend in the wire at a portion passing between the first bend and the bracket.

[0164] The portion located closer to the other end side of the line than the third bend is passed between the third bend and the first knot in the same direction as the direction passing through the first bend, that is, one direction of the circumferential direction of the bracket to form a temporary fixing portion, and the first bend is formed again at the portion passing between the third bend and the bracket. (3)

[0166] The method for manufacturing a stent with a wire according to (1) further comprises: a temporary fixing step of temporarily fixing the wire to the stent,

[0167] In this temporary fixing process,

[0168] After forming the second knot, forming a fourth bend in the wire at a portion passing between the second bend and the bracket.

[0169] A portion located closer to the other end of the line than the fourth bending portion is passed through between the fourth bending portion and the second knot in the same direction as the direction passing through the second bending portion, that is, another direction of the circumferential direction of the bracket to form a temporary fixing portion, and the second bending portion is formed again at the portion passing between the fourth bending portion and the bracket. (4)

[0171] The method for manufacturing a stent with a wire according to (2) or (3), wherein:

[0172] The temporary fixing step is performed after alternately forming one or more of the first knots and the second knots at the same position in the axial direction of the stent. (5)

[0174] A bracket with a wire, characterized by having:

[0175] A stent, which passes through a tubular portion in a subject's body and expands by its own elasticity to be retained in the tubular portion; and

[0176] a wire, which is tied around the stent to restrict expansion of the stent when the stent is inserted into the tubular portion and to maintain the stent in a contracted state;

[0177] The line has:

[0178] a first knot formed on a first side of the stent when viewed in the axial direction; and

[0179] The second knot is formed on a second side that is opposite to the first side when viewed in the axial direction of the stent. (6)

[0181] The wired stent according to (5), wherein

[0182] A plurality of the first knots and the second knots are alternately formed and arranged along the axial direction of the stent. (7)

[0184] The wired stent according to (5) or (6), wherein:

[0185] No portion extending linearly along the axial direction of the stent is formed between the first knot and the second knot in the wire. (8)

[0187] The stent with wire according to (7) is manufactured by the method for manufacturing a stent with wire according to (4), wherein:

[0188] The temporary fixing portion is provided at an end portion of a region where the plurality of first knots and the plurality of second knots are provided. (9)

[0190] A stent delivery device, characterized by comprising:

[0191] The bracket with wires as described in any one of (5) to (8); and

[0192] The conveying part conveys the bracket with the wire. (10)

[0194] The stent delivery device according to (9), wherein

[0195] The line is provided with a plurality of

[0196] At least a portion of the plurality of wires binds different regions in the axial direction of the stent. (11)

[0198] The stent delivery device according to (9) or (10), wherein:

[0199] The stent with wire is left in the digestive tract.

[0200] The plurality of threads are formed with the first knot and the second knot so as to be untied from the anus side to the oral side when being pulled.

[0201] Explanation of symbols

[0202] 1-delivery device (stent delivery device), 2-inner sheath, 3-outer sheath, 4-stent with wire, 5-stent, 5x-first side, 5y-second side, 6-wire, 6a-proximal side wire, 6b-middle wire, 6c-distal side wire, 6g-one end side, 6h-other end side, 7-stopper, 8-handle, 9-slider, 10-delivery part, 11a-first knot, 11b-second knot, 12-bending part, 12a-first bending part, 12b-second bending part, 12c-third bending part, 12d-fourth bending part, 13-temporary fixing part, AX-axial direction, R-region.

Claims

1. A method for manufacturing a stent with a wire, wherein: Prepare a bracket and a wire, and form a plurality of knots from one end of the wire to the other end of the wire. The stent passes through the tubular portion in the subject's body and expands by its own elasticity to be retained in the tubular portion. The wire is tied around the stent to restrict expansion of the stent when the stent is inserted into the tubular portion and to maintain the stent in a contracted state. The method for manufacturing the stent with wires is characterized by comprising: a first knot forming step of forming a first curved portion on the wire and causing the first curved portion to extend along the stent, with a portion of the wire located closer to the other end of the wire than the first curved portion passing between the first curved portion and the stent in one direction around the stent to form a first knot; and The second knot forming step is to form a second bent portion at a portion passing through the first bent portion and the bracket, and to form a second knot by passing a portion located closer to the other end of the wire than the second bent portion in a direction opposite to the direction passing through the first bent portion, that is, in another direction of the winding direction of the bracket, through the second bent portion and the bracket. In the first knot forming step, a first knot is formed on a first side of the stent when viewed in the axial direction. In the second knot forming step, a second knot is formed on a second side located opposite to the first side when viewed in the axial direction of the stent. The first knot forming step and the second knot forming step are repeated alternately to bundle the stent with the wire.

2. The method for manufacturing a stent with wires according to claim 1, wherein: Also includes: A temporary fixing step of temporarily fixing the wire to the bracket, In this temporary fixing process, After forming the first knot, forming a third bend in the wire at a portion passing between the first bend and the bracket. The portion located closer to the other end side of the line than the third bend is passed between the third bend and the first knot in the same direction as the direction passing through the first bend, that is, one direction of the circumferential direction of the bracket to form a temporary fixing portion, and the first bend is formed again at the portion passing between the third bend and the bracket.

3. The method for manufacturing a stent with wires according to claim 1, wherein: Also includes: A temporary fixing step of temporarily fixing the wire to the bracket, In this temporary fixing process, After forming the second knot, forming a fourth bend in the wire at a portion passing between the second bend and the bracket. A portion located closer to the other end of the line than the fourth bending portion is passed through between the fourth bending portion and the second knot in the same direction as the direction passing through the second bending portion, that is, another direction of the circumferential direction of the bracket to form a temporary fixing portion, and the second bending portion is formed again at the portion passing between the fourth bending portion and the bracket.

4. The method for manufacturing a stent with wires according to claim 2 or 3, wherein: The temporary fixing step is performed after alternately forming one or more of the first knots and the second knots at the same position in the axial direction of the stent.

5. A bracket with a wire, characterized in that: have: A stent, which passes through a tubular portion in a subject's body and expands by its own elasticity to be retained in the tubular portion; and a wire, which is tied around the stent to restrict expansion of the stent when the stent is inserted into the tubular portion and to maintain the stent in a contracted state; The line has: a first knot formed on a first side of the stent when viewed in the axial direction; and The second knot is formed on a second side that is opposite to the first side when viewed in the axial direction of the stent.

6. The wired bracket according to claim 5, wherein: A plurality of the first knots and the second knots are alternately formed and arranged along the axial direction of the stent.

7. The wired bracket according to claim 6, wherein: No portion extending linearly along the axial direction of the stent is formed between the first knot and the second knot in the wire.

8. The stent with wires according to claim 7, which is manufactured by the method for manufacturing a stent with wires according to claim 4, wherein: The temporary fixing portion is provided at an end portion of a region where the plurality of first knots and the plurality of second knots are provided.

9. A stent delivery device, characterized in that: have: The bracket with wires according to any one of claims 5 to 7; and The conveying part conveys the bracket with the wire.

10. The stent delivery device according to claim 9, wherein: The line is provided with a plurality of At least a portion of the plurality of wires binds different regions in the axial direction of the stent.

11. The stent delivery device according to claim 9, wherein: The stent with wire is left in the digestive tract. The plurality of threads are formed with the first knot and the second knot so as to be untied from the anus side to the oral side when being pulled.

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