JP2012070912A - Method for manufacturing stent delivery system - Google Patents

Method for manufacturing stent delivery system Download PDF

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JP2012070912A
JP2012070912A JP2010217657A JP2010217657A JP2012070912A JP 2012070912 A JP2012070912 A JP 2012070912A JP 2010217657 A JP2010217657 A JP 2010217657A JP 2010217657 A JP2010217657 A JP 2010217657A JP 2012070912 A JP2012070912 A JP 2012070912A
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stent
balloon
diameter
step
delivery system
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Tomoteru Takiguchi
滝口友輝
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Kaneka Corp
株式会社カネカ
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Abstract

PROBLEM TO BE SOLVED: To provide a method for manufacturing a stent delivery system capable of preventing a stent from coming off or moving when a balloon catheter with the stent attached thereto is inserted up to a stricture part by pre-processing the stent without causing the influence on the performance of an existing balloon catheter.SOLUTION: The method for manufacturing the stent delivery system includes the steps of: previously shrinking a prepared stent into a second diameter having an inner diameter the same as or smaller than the outside diameter of a folded balloon, inserting the folded balloon into the same, and applying a pressure toward the diameter direction inside from the outer surface of the stent to shrink the stent into a third diameter after the completion of crimping.

Description

  The present invention relates to a method for manufacturing a stent delivery system for crimping a stent to a balloon catheter, and in particular, a stent delivery system for crimping a stent to be placed on the balloon catheter for the purpose of expanding and maintaining the stenotic portion of the blood vessel. It relates to the manufacturing method.

  It is known that various diseases occur when a stenosis occurs in a blood vessel, which is a flow path for circulating blood in the body, and the circulation of blood is delayed. It is known that when a coronary artery that supplies blood to the heart, which is the source of blood circulation, is stenotic, it can cause serious diseases such as angina pectoris and myocardial infarction, resulting in an extremely high risk of death. Yes. One of the methods for treating such a stenotic portion of a blood vessel is angioplasty (PTA, PTCA) in which the stenotic portion is expanded using a balloon catheter, and is minimally invasive without requiring a thoracotomy such as a bypass operation. It is widely used because it is a therapy. However, in the case of angioplasty, restenosis occurs in a stenosis portion expanded at a frequency of about 40%, which has been pointed out as a major problem. As a treatment method for reducing the frequency of occurrence of restenosis (restenosis rate), stent placement is widely performed instead of angioplasty.

  A stent is a medical device that is placed for the purpose of expanding a stenotic site and maintaining the state when a living body lumen such as a blood vessel, a bile duct, or a urethra is stenotic. Generally, a stent is composed of a metal, a polymer, or a composite thereof, and is most commonly composed of a metal such as SUS316 steel, a Co—Cr alloy, or a Ni—Ti alloy.

  Stents are roughly classified into the following two types according to the mechanism when expanded to a predetermined size. One is a stent made of a shape memory alloy or the like, and is a self-expandable stent that does not need to be separately expanded by an external force. The other is a stent that needs to be expanded by an external force, and is generally a balloon expandable stent that is expanded by a balloon catheter such as that used to expand vessels, particularly arteries and veins. (Balloon-expandable tent).

  The balloon-expandable stent does not have an expansion function in the stent itself, and in order to place the stent in the desired stenosis, the stent attached to the balloon part of the balloon catheter is placed to the desired stenosis, and then the balloon is expanded. In general, a method of bringing the stent into close contact with the inner surface of the stenosis by plastically deforming the stent by the expansion force of the balloon is generally performed.

  When a balloon-expandable stent is placed by the above method, it is necessary to insert a balloon catheter with the stent attached to the balloon part to the stenosis part. At the time of insertion, there is a risk that the stent moves on the balloon and falls off the balloon catheter. is there.

  A balloon generally used for a balloon catheter has a shape in which a truncated cone-shaped tapered portion is formed before and after a straight tube portion that expands into a cylindrical shape, and a balloon expandable stent is formed on the outer surface of the straight tube portion. However, if the stent moves before and after the straight tube part, even if the stent moves on the balloon and does not fall off the balloon catheter during insertion, one end of the stent is attached to the outer surface of the tapered part of the balloon. Will be located. Since the balloon in this portion is expanded only in a tapered shape, the stent is insufficiently expanded, and there is an extremely high possibility that restenosis of the stenosis portion will occur.

  In recent years, it has been found from the clinical results of Non-Patent Document 1 and Non-Patent Document 2 that the thinner the stent design, the better the clinical results. Moreover, it is thought that the thing with a large surface area which contacts a blood vessel can suppress peeling | exfoliation of a thrombus more. Therefore, in order to be able to design thinner stents, new alloy materials and composite materials such as stronger cobalt chrome alloys have been used as the stent material from stainless steel, which has been the mainstream until now. It is coming. In addition, in order to increase the surface area of the stent, the stent has been designed to have a complicated meandering design. However, due to these design changes, the elastic deformation of the stent itself tends to be larger than before, making it difficult to stably contract the stent. For this reason, the difficulty level at the time of mounting (crimping) a stent on a balloon is further increased.

  From the above viewpoint, a prior art for preventing the stent from dropping or moving to a balloon catheter used for placement of a balloon expandable stent is disclosed.

  Patent Document 1 discloses an intravascular support device having a means for encapsulating a stent. In this prior art, encapsulation is achieved by heating, pressurizing, and cooling the balloon so that it expands around the stent in the folded state.

  Patent Document 2 discloses a method of inflating and crimping a balloon. In this prior art, the balloon is inflated within the stent, and the stent is compressed so that the stent contacts the balloon, thereby achieving uniform crimping of the stent.

  Patent Document 3 discloses a method of crimping a polymer stent to a catheter by adjusting to a target temperature during a crimping process.

  Patent Document 4 discloses a method of crimping a stent on a balloon, pressurizing and heating the balloon while suppressing radial expansion, and further crimping the stent.

  However, such a heating and pressurizing process for the balloon causes thermal and physical damage to the balloon, and there is a concern that the pressure strength may be lowered, and the crimping process may be complicated.

Japanese Patent No. 3408663 JP-T-2006-504470 Special table 2007-512908 gazette Special table 2009-539560

Criccation 2001; 103; 2816-21 JACC2003; 41; 8; 1283-8

  Therefore, in view of the above problems, the problem to be solved by the present invention does not greatly affect the performance of the balloon catheter. Further, when the balloon catheter equipped with the stent is inserted to the stenosis, the stent is dropped or moved. It is providing the manufacturing method of the stent delivery system which can prevent.

As a result of studying in view of the above problems, the present inventors are a method of manufacturing a stent delivery system for crimping a stent to a balloon catheter,
(A) preparing a balloon catheter and folding the balloon;
(B) preparing a stent having a first diameter;
(C) Second pressure having an inner diameter equal to or smaller than the outer diameter of the folded balloon prepared in the step (a) by applying a pressure radially inward from the outer surface of the stent. Shrinking to a diameter of
(However, the order of the steps (b) and (c) with respect to the step (a) does not matter),
(D) inserting the folded balloon into the lumen of the stent;
(E) further applying pressure toward the radially inner side from the outer surface of the stent to shrink the stent to a third diameter, which is the diameter that has been crimped;
A method for manufacturing a stent delivery system is provided. This can reduce the risk of the stent falling off or moving from the balloon without greatly affecting the performance of the balloon catheter.

  In addition, the present invention provides a method for manufacturing the stent delivery system in which the core material is inserted into the lumen of the stent and contracts to the second diameter in the step (c).

  Moreover, the manufacturing method of the said stent delivery system which implements the process of removing the residual stress of a stent after the process of (c) was provided.

  In addition, in the step (d), a method for manufacturing the stent delivery system is provided in which the stent is expanded by applying pressure from the inner surface of the stent toward the radially outer side by inserting a balloon.

  Further, the present invention provides a method for manufacturing the stent delivery system, wherein the stent used is made of a material having a wide elastic deformation region.

  Moreover, the manufacturing method of the said stent delivery system whose 2nd diameter is below 3rd diameter was provided.

  According to the present invention, since the balloon is inserted into the lumen of the stent after the stent is contracted from the first diameter to the second diameter, the insertion proceeds while the stent is in contact with the balloon. In this state, pressure is applied from the outer surface of the stent toward the inside of the diameter method to become the third diameter, so that the stent and the balloon are crimped in close contact with each other, and the stent is dropped from above the balloon. The risk of moving is reduced. Moreover, the performance of the balloon catheter is not greatly affected.

  The present invention relates to a method for manufacturing a stent delivery system for crimping a stent to a balloon catheter. Although the manufacturing method of the stent delivery system concerning the present invention is explained in detail below, the present invention is not limited to these specific examples.

  The stent used in the manufacturing method of the stent delivery system of the present invention is a balloon-expandable stent, which is usually obtained by being cut with a laser beam or the like, and is provided in a non-contracted first diameter before crimping. (Step (b)). The stent is mounted on a balloon catheter balloon with a third crimped diameter, delivered to the target site, and radially expandable to a fourth diameter implantable to the target site by balloon expansion. When compressed to a displacement equivalent to 30% of the outer diameter of the stent in the expanded state to the fourth diameter, the radial force per unit length of the stent is in the range of 0.05 to 0.50 N / mm. Is preferred in order to maintain expansion of the target site.

  The material of the stent used in the step (b) is made of iron, chromium, cobalt, nickel, titanium, molybdenum, manganese, aluminum, magnesium, calcium, zirconia, silicon, gold, silver, copper, platinum, lead, and tungsten. In order to secure a sufficient radial force, it is preferable to form the material including at least one material selected from the group. In particular, a stent made of a highly elastic material such as a cobalt chromium alloy is preferable because the radial force can be maintained high even in a thin stent design, and the degree of freedom in stent design is increased. In this case, since the elastic deformation of the stent also increases, the present invention is reduced to the second diameter without inserting the balloon, and the present invention, which is not easily affected by the elastic deformation during crimping, is particularly suitable for such a system. It is effective.

  In addition, the design of the stent used in the step (b) is not particularly limited, but the stent strut that is a linear element is included, and the thickness of the stent strut is thin in Non-Patent Document 1 and Non-Patent Document 2. It is said to be preferable to clinical results. When the thickness of the stent struts is reduced, in order to secure radial force, the width of the stent struts is inevitably larger than the thickness, and the adjacent stent struts easily come into contact with each other during the crimping of the stent. There is an increased likelihood of crimping into an abnormal stent shape. In this case, it is necessary to crimp the stent while controlling the shape of the stent, and the present invention in which the diameter of the stent is reduced in advance while controlling the shape is particularly effective.

  The balloon catheter used in the step (a) of the present invention is not particularly limited in shape, material and structure as long as it is a catheter having a balloon for delivering and expanding a stent. However, this balloon catheter preferably has a shaft, and the shaft has an inflation lumen connected to the balloon so as to be in fluid communication.

  In addition, the balloon of the balloon catheter is not particularly limited in shape, material, structure, etc., but a cylindrical straight tube portion and a truncated cone-shaped tapered portion on the front end side of the straight tube portion are arranged on the rear end side of the straight tube portion. It is preferable that the shape has a truncated cone-shaped tapered portion. In addition, the taper angle in these taper parts is not restrict | limited, An arbitrary angle can be selected. Moreover, it is preferable that the balloon can be expanded by being deformed into a contracted and expanded state by placing a stent on the balloon.

  In addition, the stent delivery system manufacturing method of the present invention includes the step (a) of folding the balloon of the prepared balloon catheter. In particular, the balloon needs to be in a folded state and is folded into several sheets. In this case, it is preferable to wind along the inner tube around the catheter axial direction. It is also possible to fold the balloon into two or more. On the other hand, the folded balloon is preferably once inserted into the lumen of the expansion restraining member in order to stabilize the outer diameter by attaching a curl to the folded balloon. The expansion restraining member is not particularly limited, but is preferably a tubular member having a total length larger than the total length of the balloon.

  In the present invention, before the prepared stent is crimped to the balloon, pressure is applied from the outer surface of the stent toward the radially inner side, and the first stent is prepared in the step (a). The step (c) is characterized in that it is contracted to a second diameter having an inner diameter equal to or smaller than the outer diameter of the folded balloon. The stent contraction means is not particularly limited, but it is preferable that the entire circumference of the stent is uniformly contracted, and a mechanical device (crimp device) invented to apply a uniform force to the entire circumference of the stent is used. Is preferred. The second diameter is equal to or smaller than the outer diameter of the folded balloon prepared in the step (a), which causes contact between the stent and the balloon in the step (d) described later. However, in order to further increase the degree of contact between the stent and the balloon, a smaller diameter is preferable, and a third diameter or less is particularly preferable.

  Moreover, it is preferable to perform contraction to the second diameter in the step (c) in a state where the core material is inserted into the lumen of the stent. By inserting the core material, the stent is contracted so as to be pressed against the core material, and the diameter and shape of the stent can be arbitrarily controlled with higher accuracy.

  Furthermore, it is possible to stabilize the residual stress caused by the contraction to the second diameter on the stent, and the third diameter can be made smaller by stabilizing the residual stress. It becomes. The method for removing the residual stress is not particularly limited, and examples thereof include heat treatment, ultrasonic treatment, and long-term storage at a constant temperature.

  In addition, the order of the process of (b) and (c) with respect to the process of (a) demonstrated so far shall not be ask | required. In the description so far, it has been essential to prepare a stent having the first diameter in the step (b). However, this is generally the case when the stent is first cut by a laser beam or the like. This corresponds to the fact that a stent can be obtained (that is, not in a completely contracted state). If the stent can be formed with the second diameter from the beginning, the step (b) can be omitted. .

  Moreover, in the manufacturing method of the stent delivery system of the present invention, a balloon folded into the lumen of the stent is inserted after the steps (a), (b), and (c) (step (d)), The stent is placed on the balloon, preferably on the straight tube of the balloon. When the balloon is inserted into the lumen of the stent, it is preferable that the diameter of the stent is expanded by receiving pressure from the radially inner side by the balloon in order to improve adhesion to the balloon. In addition, when the stent lumen is small and it is difficult to insert the balloon, it is possible to insert the balloon into the stent lumen by applying pressure from the inside in the radial direction of the stent with a tapered core or tube. The operation may be performed by temporarily expanding the stent to a certain diameter.

  In the present invention, next, pressure is applied from the outer surface of the stent on the balloon toward the inside in the radial direction, and the stent is contracted to the third diameter which is the crimped diameter (step (e)). ). The stent contraction means is not particularly limited, but it is preferable that the entire circumference of the stent is uniformly reduced in diameter by applying a uniform force to the entire circumference of the stent, and the invention is applied to press the stent onto the catheter. It is preferable to use a mechanical device (crimp device). In this way, after inserting the folded balloon into the lumen of the stent, the diameter of the expanded stent is reduced again, or the diameter is reduced to return to the original diameter, If the diameter is further reduced, or if it does not expand upon insertion, the diameter of the stent may be further reduced, causing the stent and the balloon to be crimped more closely, causing the stent to fall off or move from the balloon. Is reduced. In particular, the stent diameter is expanded when the folded balloon is inserted into the lumen of the stent, since the adhesion between the stent and the balloon is easy to improve and the balloon is less likely to be damaged by the operation. It is preferable to adopt a method of reducing a part of the diameter again, that is, a method for manufacturing a stent delivery system in which the second diameter is equal to or smaller than the third diameter.

  Specific examples and comparative examples according to the present invention will be described in detail below, but the present invention is not limited to the specific structures shown in the following examples. In addition, the stent holding force shown below was measured based on ASTM: F2394-04 (Standard Guide for Measuring Sequential of Balloon Expandable Stented on Delivery System). The outer diameter was measured using a laser outer diameter measuring instrument, and the average value was taken as the representative outer diameter value.

  The stent may be a stainless steel SUS316L closed cell design stent (first diameter x length φ1.8 mm x 18 mm, wall thickness 0.13 mm), or a cobalt chrome alloy open cell design stent ( The first diameter × length is φ1.8 mm × 18 mm and the wall thickness is 0.09 mm). The catheter used was a rapid exchange type balloon catheter having a balloon diameter of 3.5 mm at the rated expansion pressure and a straight tube portion length of 20 mm.

Example 1
The stent was crimped onto the catheter in the following manner.
(A) The balloon catheter was folded into three sheets.
(B) A closed cell design stent made of SUS316L was prepared.
(C-1) The stent was placed in a crimping device.
(C-2) The stent was contracted with a force of 30N.
(D) A folded balloon was inserted into the lumen of the stent.
(E-1) A balloon and a stent were placed in the crimping device.
(E-2) The stent was pressed against the balloon for 60 seconds with a force of 50N.
(F) Packaged and placed in a sterilizer.
(G) Heat treatment at about 55 degrees was performed for 78 hours.

  The outer diameter of the balloon after the step (a) was 1.15 mm. The outer diameter of the stent after the step (c-2) was 1.18 mm on average. The outer diameter after the step (d) was 1.21 mm on average. The outer diameter after the step (e) was 1.17 mm on average. The average stent retention after the step (g) was 2.8N.

(Example 2)
The stent was crimped onto the catheter in the following manner.
(A) The balloon catheter was folded into three sheets.
(B) A closed cell design stent made of SUS316L was prepared.
(C-1) A round core material having a diameter of 0.80 mm was disposed in the lumen of the stent.
(C-2) The stent was placed in the crimping device together with the core material.
(C-3) The stent was contracted with a force of 150N.
(C-4) The stent was placed in an oven and heat-treated at a temperature of 120 degrees for 8 hours.
(D) A stent was placed in the straight tube portion of the balloon.
(E-1) A balloon and a stent were placed in the crimping device.
(E-2) The stent was pressed against the balloon for 60 seconds with a force of 50N.
(F) Packaged and placed in a sterilizer.
(G) Heat treatment at about 55 degrees was performed for 78 hours.

  Measurements were taken at each step. The outer diameter of the balloon after the step (a) was 1.15 mm. The outer diameter of the stent after the step (c-4) was 1.10 mm on average. The outer diameter after the step (d) was 1.16 mm on average. After the step (e-2), the average outer diameter of the stent portion was 1.12 mm, and the stent holding force after the step (g) was 3.1 N on average.

(Example 3)
The stent was crimped onto the catheter in the following manner.
(A) The balloon catheter was folded into three sheets.
(B) A cobalt chromium alloy open cell design stent was prepared.
(C-1) The stent was placed in a crimping device.
(C-2) The stent was contracted with a force of 50N.
(D) A stent was placed in the straight tube portion of the balloon.
(E-1) A balloon and a stent were placed in the crimping device.
(E-2) The stent was pressed against the balloon for 60 seconds with a force of 200N.
(F) Packaged and placed in a sterilizer.
(G) Heat treatment at about 55 degrees was performed for 78 hours.

  Measurements were taken at each step. The outer diameter of the balloon after the step (a) was 1.05 mm. The outer diameter of the stent after the step (c-2) was 1.00 mm on average. The outer diameter after the step (d) was an average of 1.02 mm. After the step (e-2), the outer diameter of the stent part averaged 0.98 mm, and the stent holding force after the step (g) averaged 1.4 N.

Example 4
The stent was crimped onto the catheter in the following manner.
(A) The balloon catheter was folded into three sheets.
(B) A cobalt chromium alloy open cell design stent was prepared.
(C-1) A round core material having a diameter of 0.75 mm was placed in the lumen of the stent.
(C-2) The stent was placed in the crimping device together with the core material.
(C-3) The stent was contracted with a force of 200N.
(D) A stent was placed in the straight tube portion of the balloon.
(E-1) A balloon and a stent were placed in the crimping device.
(E-2) The stent was pressed against the balloon for 60 seconds with a force of 200N.
(F) Packaged and placed in a sterilizer.
(G) Heat treatment at about 55 degrees was performed for 78 hours.

  Measurements were taken at each step. The outer diameter of the balloon after the step (a) was 1.05 mm. The outer diameter of the stent after the step (c-3) was an average of 0.85 mm. The outer diameter after the step (d) was 0.95 mm on average. After the step (e-2), the average outer diameter of the stent portion was 0.92 mm, and the stent holding force after the step (g) was 1.9 N on average.

(Example 5)
The stent was crimped onto the catheter in the following manner.
(A) The balloon catheter was folded into three sheets.
(B) A cobalt chromium alloy open cell design stent was prepared.
(C-1) A round core material having a diameter of 0.75 mm was placed in the lumen of the stent.
(C-2) The stent was placed in the crimping device together with the core material.
(C-3) The stent was contracted with a force of 200N.
(C-4) The stent was placed in an oven and heat-treated at a temperature of 200 degrees for 24 hours.
(D) A stent was placed in the straight tube portion of the balloon.
(E-1) A balloon and a stent were placed in the crimping device.
(E-2) The stent was pressed against the balloon for 60 seconds with a force of 200N.
(F) Packaged and placed in a sterilizer.
(G) Heat treatment at about 55 degrees was performed for 78 hours.

  Measurements were taken at each step. The outer diameter of the balloon after the step (a) was 1.05 mm. The outer diameter of the stent after the step (c-4) was an average of 0.85 mm. The outer diameter after the step (d) was 0.93 mm on average. After the step (e-2), the outer diameter of the stent part averaged 0.89 mm, and the stent holding force after the step (g) averaged 2.2 N.

(Example 6)
The stent was crimped onto the catheter in the following manner.
(A) The balloon catheter was folded into three sheets.
(B) A cobalt chromium alloy open cell design stent was prepared.
(C-1) A round core material having a diameter of 0.75 mm was placed in the lumen of the stent.
(C-2) The stent was placed in the crimping device together with the core material.
(C-3) The stent was contracted with a force of 200N.
(C-4) The stent was put in a container containing a liquid and irradiated with ultrasonic waves for 1 hour.
(D) A stent was placed in the straight tube portion of the balloon.
(E-1) A balloon and a stent were placed in the crimping device.
(E-2) The stent was pressed against the balloon for 60 seconds with a force of 200N.
(F) Packaged and placed in a sterilizer.
(G) Heat treatment at about 55 degrees was performed for 78 hours.

  Measurements were taken at each step. The outer diameter of the balloon after the step (a) was 1.05 mm. The outer diameter of the stent after the step (c-4) was an average of 0.85 mm. The outer diameter after the step (d) was 0.94 mm on average. After the step (e-2), the average outer diameter of the stent portion was 0.91 mm, and the stent holding force after the step (g) was 2.0 N on average.

(Comparative Example 1)
The stent was crimped onto the catheter in the following manner.
(A) The balloon catheter balloon was folded in three.
(B) A closed cell design stent made of SUS316L was prepared.
(D) A stent was placed in the straight tube portion of the balloon.
(E-1) A balloon and a stent were placed in the crimping device.
(E-2) The stent was pressed against the balloon for 60 seconds with a force of 50N.
(F) Packaged and placed in a sterilizer.
(G) Heat treatment at about 55 degrees was performed for 78 hours.

  Measurements were taken at each step. The outer diameter of the balloon after the step (a) was 1.15 mm. After the step (e-2), the outer diameter of the stent part averaged 1.15 mm, and after the step (g), the stent holding force averaged 2.0 N.

(Comparative Example 2)
The stent was crimped onto the catheter in the following manner.
(A) The balloon catheter balloon was folded in three.
(B) A cobalt chromium alloy open cell design stent was prepared.
(D) A stent was placed in the straight tube portion of the balloon.
(E-1) A balloon and a stent were placed in the crimping device.
(E-2) The stent was pressed against the balloon for 60 seconds with a force of 200N.
(F) Packaged and placed in a sterilizer.
(G) Heat treatment at about 55 degrees was performed for 78 hours.

Measurements were taken at each step. The outer diameter of the balloon after the step (a) was 1.05 mm. After the step (e-2), the outer diameter of the stent portion averaged 1.00 mm, and after the step (g), the stent holding force averaged 0.9 N.

Claims (6)

  1. A method for manufacturing a stent delivery system for crimping a stent to a balloon catheter,
    (A) preparing a balloon catheter and folding the balloon;
    (B) providing a stent having a first diameter;
    (C) Second pressure having an inner diameter equal to or smaller than the outer diameter of the folded balloon prepared in the step (a) by applying a pressure radially inward from the outer surface of the stent. Shrinking to a diameter of
    (However, the order of the steps (b) and (c) with respect to the step (a) does not matter),
    (D) inserting the folded balloon into the lumen of the stent;
    (E) further applying pressure toward the radially inner side from the outer surface of the stent to shrink the stent to a third diameter, which is the diameter that has been crimped;
    A method for manufacturing a stent delivery system, comprising:
  2.   The manufacturing method of the stent delivery system according to claim 1, wherein the contraction to the second diameter in the step (c) is performed in a state where the core material is inserted into the lumen of the stent.
  3.   The manufacturing method of the stent delivery system of any one of Claim 1 or 2 which implements the process of removing the residual stress of a stent after the process of (c).
  4.   The method for manufacturing a stent delivery system according to any one of claims 1 to 3, wherein in step (d), pressure is applied from the inner surface of the stent toward the radially outer side by inserting a balloon to expand the stent.
  5.   The method for manufacturing a stent delivery system according to any one of claims 1 to 4, wherein the stent to be used is made of a material having a wide elastic deformation region.
  6. The method for manufacturing a stent delivery system according to any one of claims 1 to 5, wherein the second diameter is equal to or smaller than the third diameter.
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JP2008284019A (en) * 2007-05-15 2008-11-27 Kaneka Corp Medical balloon, stent delivery system, and method of manufacturing the same

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