Method for manufacturing a medical tubular transport device
The manufacturing method for medical tubular body conveying devices addresses followability and frictional resistance issues by using core material portions of varying thicknesses to reduce the inner diameter selectively, ensuring improved guide wire followability and reduced friction, enhancing procedural efficiency.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- KANEKA CORP
- Filing Date
- 2022-03-07
- Publication Date
- 2026-07-24
AI Technical Summary
Existing medical tubular body conveying devices face issues with followability and increased frictional resistance when navigating through complex body lumens due to limited resin options and increased contact area with guide wires, leading to potential sticking and procedural delays.
A manufacturing method involving the use of core material portions of varying thicknesses to reduce the inner diameter selectively at the distal end of the device, ensuring good followability and minimizing frictional resistance by maintaining a smaller clearance with the guide wire at the distal end while allowing a larger clearance proximally.
The method enhances the device's ability to follow a guide wire without excessive friction, preventing rattling and improving operability by reducing the contact area and frictional resistance, thereby facilitating smoother navigation through bodily lumens.
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Abstract
Description
Technical Field
[0001] The present invention relates to a method for manufacturing a medical tubular body conveying device.
Background Art
[0002] In recent years, minimally invasive treatment techniques for transporting and placing medical tubular bodies in the body have been developed. As medical tubular bodies, for example, stents, stent grafts, occluders, injection catheters, prosthetic valves, etc. are used. Among these, a stent is generally a medical tubular body used for treating various diseases caused by stenosis or occlusion of an internal body lumen.
[0003] A medical tubular body is transported into the body through an internal body lumen using a conveying device. The conveying device includes an outer tube, and with the medical tubular body held in the lumen of this outer tube, it is inserted into the internal body lumen. The medical tubular body transported to a predetermined position in the body is placed (retained) at the predetermined position in the body by being released from the lumen of the outer tube.
[0004] When transporting a medical tubular body into the body using a conveying device, first, a guide wire is passed through the internal body lumen, and then, with the tip of the medical tubular body conveying device inserted along the guide wire until it reaches the lesion. However, even when the guide wire is advanced in this way, due to a stent pre - placed in the internal body lumen, a stenosis part of the internal body lumen, a sharp bend part of the internal body lumen, etc., the medical tubular body conveying device may not be able to proceed, and the followability with respect to the guide wire may deteriorate.
[0005] A catheter with improved followability of the catheter (conveying device) with respect to the guide wire is described in Patent Document 1. The catheter described in Patent Document 1 is tapered and reduced in diameter so that the inner diameter of its tip part is narrowed. Thereby, the clearance between the inner periphery of the tip part and the outer periphery of the guide wire becomes small, the guide wire is prevented from being eccentric and rattling at the tip part of the catheter. As a result, the followability of the catheter with respect to the guide wire is improved. [Prior art documents] [Patent Documents]
[0006] [Patent Document 1] Japanese Patent Publication No. 2006-149442 [Overview of the Initiative] [Problems that the invention aims to solve]
[0007] Incidentally, the tip of the catheter is made of a resin that is easy to heat-process and provides high flexibility. Resins used to provide flexibility generally have high tackiness, so if the diameter of the entire tip is tapered to narrow the inner diameter, the contact area between the tip and the guidewire increases, and consequently the frictional resistance increases. As a result, the operability of the catheter may worsen, or the tip and guidewire may get stuck, leading to delays in the procedure. In the above-mentioned Patent Document 1, a resin layer is placed at the tip of the catheter, and the inner diameter of the tip is tapered to narrow by utilizing the difference in the thermal shrinkage rate of this resin layer, but the type of resin that can be used at the tip of the catheter is limited, and it is not versatile.
[0008] This invention has been made in view of these circumstances, and its purpose is to provide a method for manufacturing a medical tubular material transport device that has good followability with respect to a guide wire and can reduce frictional resistance with respect to the guide wire. [Means for solving the problem]
[0009] The present invention is as follows: [1] A method for manufacturing a medical tubular body transport device for transporting a medical tubular body into the body, comprising the steps of: placing a first core material portion in the lumen of a tube; placing a cylindrical member on the outside of the distal end of the tube; fixing the distal end of the tube and the cylindrical member; placing a second core material portion, which is thinner than the first core material portion, at least at the distal end of the cylindrical member; and reducing the inner diameter at the distal end of the cylindrical member. [2] The distal end of the cylindrical member is the region from the distal end of the cylindrical member in the longitudinal direction up to 15 mm. [1] The manufacturing method. [3] The manufacturing method according to [1], wherein the cylindrical member is composed of a proximal cylindrical member and a distal cylindrical member, and the manufacturing method comprises the steps of: placing the first core material portion in the lumen of the tube; placing the proximal cylindrical member outside the distal end of the tube; fixing the distal end of the tube and the proximal cylindrical member; placing the distal cylindrical member distal to the proximal cylindrical member; fixing the proximal cylindrical member and the distal cylindrical member; placing a second core material portion, which is thinner than the first core material portion, at least at the distal end of the distal cylindrical member; and reducing the inner diameter at the distal end of the distal cylindrical member. [4] The distal end of the distal cylindrical member is the region from the distal end of the distal cylindrical member in the longitudinal direction up to 15 mm. [3] The manufacturing method. [5] The manufacturing method according to [3] or [4], wherein the maximum outer diameter of the distal cylindrical member is smaller than the maximum outer diameter of the proximal cylindrical member. [6] A manufacturing method according to any one of [1] to [5], using a single core material having the first core material portion and the second core material portion. [7] The manufacturing method according to [6], wherein the first core material has the second core material portion distal to the first core material portion, and the second core material portion is positioned at the distal end by moving the first core material from the distal side to the proximal side. [8] The manufacturing method according to 6, wherein the first core material has the second core material portion on a side more proximal to the first core material portion, and the second core material portion is positioned at the distal end by moving the first core material from the proximal side to the distal side. [9] A manufacturing method according to [1] or [2], comprising the steps of preparing a first core material having the first core material portion and a second core material having the second core material portion, and removing the first core material from the lumen of the tube prior to the step of placing the second core material portion, which is thinner than the first core material portion, at least at the distal end of the cylindrical member.
[10] A manufacturing method according to any one of [3] to [5], comprising the step of removing the first core material from the lumen of the tube prior to the step of preparing a first core material having the first core material portion and a second core material having the second core material portion, and arranging the second core material portion, which is thinner than the first core material portion, at least at the distal end of the distal cylindrical member. [Effects of the Invention]
[0010] According to the present invention, a medical tubular material transport device can be manufactured that exhibits good followability with respect to a guide wire while minimizing frictional resistance. [Brief explanation of the drawing]
[0011] [Figure 1] Figure 1 is a cross-sectional view showing a cylindrical member positioned on the outside of the distal end of the tube. [Figure 2] Figure 2 is a cross-sectional view showing the state in which the inner diameter at the distal end of the cylindrical member is reduced after the second core material portion has been placed at the distal end of the cylindrical member. [Figure 3] Figure 3 is a cross-sectional view showing a cylindrical member positioned on the outside of the distal end of the tube. [Figure 4] Figure 4 is a cross-sectional view showing the second core portion of the core material positioned at the distal end of the cylindrical member. [Figure 5] Figure 5 is a cross-sectional view showing a cylindrical member positioned on the outside of the distal end of the tube. [Figure 6] Figure 6 is a cross-sectional view showing the second core portion of the core material positioned at the distal end of the cylindrical member. [Figure 7] Figure 7 is a cross-sectional view showing the proximal cylindrical member positioned outside the distal end of the tube. [Figure 8]Figure 8 is a cross-sectional view showing the state after the second core material portion has been placed at the distal end of the distal cylindrical member, and the inner diameter at the distal end of the distal cylindrical member has been reduced. [Modes for carrying out the invention]
[0012] An embodiment of the manufacturing method for a medical tubular body transport device according to the present invention includes the steps of: placing a first core material portion in the lumen of a tube (hereinafter sometimes referred to as the first core material portion placement step); placing a cylindrical member on the outside of the distal end of the tube (hereinafter sometimes referred to as the cylindrical member placement step); fixing the distal end of the tube and the cylindrical member (hereinafter sometimes referred to as the cylindrical member fixing step); placing a second core material portion, which is thinner than the first core material portion, at least at the distal end of the cylindrical member (hereinafter sometimes referred to as the second core material portion placement step); and reducing the inner diameter at the distal end of the cylindrical member (hereinafter sometimes referred to as the inner diameter reduction step). By using core material portions of different thicknesses, the inner diameter at the distal end of the cylindrical member can be made smaller than the inner diameter at the proximal end of the cylindrical member. As a result, as described in Patent Document 1 above, a medical tubular transport device with good followability to the guide wire can be manufactured regardless of the type of resin used for the tip of the catheter (transport device). Furthermore, since it is not necessary to tapere the diameter to narrow the entire inner diameter of the tip, the contact area between the tip and the guide wire does not become excessively large, and frictional resistance with the guide wire can be reduced.
[0013] That is, according to the manufacturing method of the present invention, a medical tubular body conveying device can be obtained in which the clearance between the inner periphery of the distal end portion and the outer periphery of the guide wire is small, and the clearance with the outer periphery of the guide wire is large on the proximal side of the distal end portion. Since the clearance between the inner diameter at the distal end of the tubular member and the outer periphery of the guide wire is smaller than the clearance between the inner diameter and the outer periphery of the guide wire on the proximal side of the distal end of the tubular member, at the distal end of the tubular member, the guide wire is held at the distal end of the tubular member, so that rattling of the guide wire can be prevented. As a result, the followability with respect to the guide wire is improved. On the other hand, on the proximal side of the distal end of the tubular member, since the clearance between the inner diameter and the outer periphery of the guide wire is large, the sliding load during the operation of the guide wire is reduced, and the operability of the guide wire can be enhanced. In addition, since the contact area between the distal end portion and the guide wire can be reduced, the frictional resistance with the guide wire can be reduced.
[0014] Hereinafter, the present invention will be described more specifically based on embodiments. However, the present invention is not limited by the following embodiments, and it is of course possible to make modifications within the scope that can conform to the above and below gists and implement them, and all of them are included in the technical scope of the present invention. In each drawing, for convenience, hatching, member symbols, etc. may be omitted, but in such a case, reference shall be made to the specification and other drawings. In addition, the dimensions of various members in the drawings may differ from the actual dimensions because priority is given to facilitating the understanding of the features of the present invention. Hereinafter, the proximal side refers to the side closer to the user (surgeon)'s hand, and the distal side refers to the opposite side of the proximal side (i.e., the treatment target side). Also, the direction from the proximal side to the distal side is referred to as the long axis direction or the proximal-distal direction.
[0015] [First Core Material Portion Arrangement Step] In the first core material portion arrangement step, a first core material portion is arranged in the lumen of the tube. The tube extends in the proximal-distal direction, and the first core material portion is arranged in the lumen at least at the distal end of the tube. By arranging the first core material portion in the lumen of the tube, the workability in the subsequent steps is improved. In addition, it is possible to prevent the lumen of the tube from decreasing.
[0016] The tube may be formed of a resin material. As the resin material for forming the tube, known resins can be used. For example, polyamide resins such as nylon; polyether polyamide resins; polyimide resins; polyester resins such as polyethylene terephthalate (PET); polyurethane resins; polyolefin resins such as polyethylene and polypropylene; fluorine-based resins such as polytetrafluoroethylene (PTFE), perfluoroalkoxy alkane (PFA), and ethylene tetrafluoroethylene copolymer (ETFE); polyvinyl chloride resins; silicone resins; natural rubber, etc. may be mentioned. These may be used alone or in combination of two or more. Among them, polyamide resins, polyurethane resins, polyolefin resins, and fluorine-based resins are preferably used as the resin material for forming the tube. By containing at least one of polyamide resins, polyurethane resins, polyolefin resins, and fluorine-based resins, the flexibility of the tube becomes good.
[0017] The first core material part may constitute a part of the core material or the whole of the core material.
[0018] The material of the core material is not particularly limited. For example, metal materials such as copper, silver, aluminum, and stainless steel can be used. The core material may be hollow or solid. The cross-sectional shape perpendicular to the long axis direction of the core material is preferably circular.
[0019] [Cylindrical member arrangement step] In the cylindrical member arrangement step, a cylindrical member is arranged outside the distal end portion of the tube. The cylindrical member extends in the proximal-distal direction and has a lumen. The cylindrical member arranged at the distal end portion of the tube becomes a tip, and by arranging the tip, it becomes easier for the medical tubular body conveying device to pass through the stenosis of the body lumen.
[0020] Examples of the shape of the cross-section perpendicular to the long axis direction of the cylindrical member include a circular shape, a C shape, an elliptical shape, a polygonal shape, etc.
[0021] Figure 1 shows the state in which a cylindrical member is placed on the outside of the distal end of the tube. The arrow x in Figure 1 indicates the distal direction (long axis direction), with the right side of the arrow in Figure 1 being the proximal side and the left side being the distal side. The first core material portion 2 is placed inside the lumen of the tube 1, and the cylindrical member 3 is placed on the outside of the distal end of the tube 1. In Figure 1, the first core material portion 2 is also placed inside the lumen of the cylindrical member 3.
[0022] The distal end of the cylindrical member 3 is distal to the distal end of the tube 1, and the cylindrical member 3 has a tube placement region 31 in which the tube 1 is placed in the lumen, and a tube non-placement region 32 in which the tube 1 is not placed in the lumen.
[0023] The inner diameter of the cylindrical member 3 differs between the distal and proximal sides of the cylindrical member 3. The maximum inner diameter d1 in the tube-free region 32 of the cylindrical member 3 (hereinafter sometimes referred to as the maximum inner diameter d1 of the cylindrical member 3) is smaller than the maximum inner diameter d2 in the tube-placed region 31 of the cylindrical member 3 (hereinafter sometimes referred to as the maximum inner diameter d2 of the cylindrical member 3). Preferably, the maximum inner diameter d1 of the cylindrical member 3 is 97% or less of the maximum inner diameter d2 of the cylindrical member 3. More preferably, the maximum inner diameter d1 of the cylindrical member 3 is 95% or less of the maximum inner diameter d2 of the cylindrical member 3, and even more preferably 93% or less. The maximum inner diameter d1 of the cylindrical member 3 only needs to be larger than the outer diameter D3 of the first core material portion 2.
[0024] The maximum inner diameter d2 of the cylindrical member 3 should be larger than the outer diameter of the tube 1, and the maximum inner diameter d1 of the cylindrical member 3 should be the same as the inner diameter of the tube 1 or smaller than the inner diameter of the tube 1.
[0025] The minimum outer diameter D1 of the cylindrical member 3 in the tube-free region 32 (hereinafter sometimes referred to as the minimum outer diameter D1 of the cylindrical member 3) may be larger than, the same as, or smaller than the maximum outer diameter D2 of the cylindrical member 3 in the tube-placed region 31 (hereinafter sometimes referred to as the maximum outer diameter D2 of the cylindrical member 3), and is more preferably smaller. When the minimum outer diameter D1 of the cylindrical member 3 is smaller than the maximum outer diameter D2 of the cylindrical member 3, the passage of the tip of the medical tubular body transport device is improved.
[0026] The cylindrical member 3 may be composed of one member or of two or more members. Preferably, the cylindrical member 3 is composed of two or more members (particularly two members).
[0027] Preferably, the cylindrical member 3 has a taper in which the outer diameter decreases from the proximal side to the distal side. This makes the minimum outer diameter D1 of the cylindrical member 3 smaller than the maximum outer diameter D2 of the cylindrical member 3, thereby improving the passage of the medical tubular body transport device into the biological lumen.
[0028] Examples of materials that make up the cylindrical member 3 include synthetic resins such as: polyamide resins such as nylon; polyether polyamide resins; polyimide resins; polyester resins such as PET; polyurethane resins; polyolefin resins such as polyethylene and polypropylene; fluororesins such as PTFE, PFA, and ETFE; polyvinyl chloride resins; aromatic polyether ketone resins such as polyether ether ketone resin (PEEK); and others.
[0029] The material constituting the cylindrical member 3 is preferably a polyamide resin or a fluororesin, and more preferably nylon or PTFE.
[0030] The cylindrical member 3 may contain an X-ray opaque material. Examples of X-ray opaque materials include lead, barium, iodine, tungsten, gold, platinum, iridium, stainless steel, titanium, and cobalt-chromium alloy. Among these, platinum is preferred. With the cylindrical member 3 configured in this way, the position of the cylindrical member 3 can be confirmed by X-ray transmission.
[0031] An X-ray opaque marker may be placed on the outside of tube 1. Placing the X-ray opaque marker at the proximal end of the cylindrical member 3 makes it easier to determine the proximal end position of the cylindrical member 3. The shape of the X-ray opaque marker is not particularly limited; it may be cylindrical, or it may be a cylindrical shape with a C-shaped cross-section perpendicular to the long axis. The X-ray opaque marker contains an X-ray opaque material, and the materials exemplified above can be used as the X-ray opaque material.
[0032] [Cylindrical member fixing process] In the tubular member fixing process, the distal end of tube 1 and the tubular member 3 are fixed together. The distal end of tube 1 and the tubular member 3 can be fixed together, for example, using an adhesive or by heat fusion.
[0033] [Second core material placement process] In the second core material placement step, a second core material, which is thinner than the first core material 2, is placed at least at the distal end of the cylindrical member 3. Preferably, the distal end of the cylindrical member 3 is the region extending 15 mm in the longitudinal direction from the distal end of the cylindrical member 3.
[0034] The second core material portion may be positioned at least at the distal end of the cylindrical member 3, or it may be positioned along the entire length of the cylindrical member 3 in the longitudinal direction. That is, the second core material portion may be positioned at least 15 mm from the distal end of the cylindrical member 3 in the longitudinal direction, or it may be positioned more proximal to 15 mm from the distal end of the cylindrical member 3 in the longitudinal direction.
[0035] In an embodiment of the manufacturing method according to the present invention, after the cylindrical member fixing step and prior to the second core material placement step, the method may further include a step of cutting a portion of the distal end of the cylindrical member 3. By cutting a portion of the distal end of the cylindrical member 3, the length of the cylindrical member 3 can be adjusted.
[0036] [Inner diameter reduction process] In the inner diameter reduction process, the inner diameter at the distal end of the cylindrical member 3 is reduced. Figure 2 shows the state after the second core material portion has been placed at the distal end of the cylindrical member 3 and the inner diameter at the distal end of the cylindrical member 3 has been reduced. The same reference numerals are used for the same members as in Figure 1 to avoid redundant explanations (the same applies below).
[0037] As shown in Figure 2, by reducing the inner diameter of the cylindrical member 3 at its distal end from d1 to d4, the clearance between the inner circumference of the tip of the cylindrical member 3 and the outer circumference of the guide wire is reduced. As a result, the guide wire is held at the distal end of the cylindrical member 3, preventing rattling of the guide wire. Consequently, the ability to follow the guide wire is improved. Furthermore, since it is not necessary to tapere the inner diameter of the entire tip, the contact area between the tip and the guide wire does not become excessively large, and frictional resistance with the guide wire can be reduced.
[0038] The outer diameter D4 of the second core material portion 7 should be smaller than the outer diameter D3 of the first core material portion 2 shown in Figure 1. Preferably, the outer diameter D4 of the second core material portion 7 is 94% or less of the outer diameter D3 of the first core material portion 2. More preferably, the outer diameter D4 of the second core material portion 7 is 81% or less of the outer diameter D3 of the first core material portion 2, and even more preferably, 70% or less. The lower limit of the outer diameter D4 of the second core material portion 7 is preferably 0.48 mm or more, more preferably 0.57 mm or more, and even more preferably 0.66 mm or more.
[0039] When reducing the inner diameter of the cylindrical member 3 at its distal end from d1 to d4, it is preferable to also reduce the outer diameter of the cylindrical member 3 at its distal end. This improves the passage of the medical tubular body transport device into the lumen of a living organism.
[0040] In the inner diameter reduction process, the percentage by which the inner diameter at the distal end of the cylindrical member 3 is reduced from d1 to d4 is not particularly limited, but it is preferable, more preferable, to reduce the maximum inner diameter d1 at the distal end of the cylindrical member 3 before reduction to 60% or less, for example, 58% or less, and even more preferable to 56% or less. The lower limit of the percentage by which the inner diameter at the distal end of the cylindrical member 3 is reduced from d1 to d4 is preferably 50% or more, more preferable to 51% or more, and even more preferable to 52% or more, relative to the maximum inner diameter d1 at the distal end of the cylindrical member 3 before reduction.
[0041] The inner diameter at the distal end of the cylindrical member 3 can be reduced, for example, by heating the distal end of the cylindrical member 3 and rounding it.
[0042] In an embodiment of the medical tubular body transport device according to the present invention, it is preferable that an outer tube (not shown) is provided on the outside of the tube 1, and the proximal end of the cylindrical member 3 is positioned in the lumen of the outer tube. Furthermore, the medical tubular body can be held in the lumen of the outer tube.
[0043] The maximum outer diameter of the outer tube may be larger than, the same as, or smaller than the maximum outer diameter D2 of the cylindrical member 3, and is preferably the same as or smaller. Having them the same as or smaller improves the passage of the medical tubular body transport device. The absolute value of the difference between the maximum outer diameter of the outer tube and the maximum outer diameter D2 of the cylindrical member 3 is preferably 0.05 mm or less, more preferably 0.03 mm or less, and even more preferably 0 mm.
[0044] Figures 1 and 2 show an example configuration in which a first core material having a first core material portion 2 and a second core material having a second core material portion 7 are prepared, and in the first core material portion placement step, the first core material is placed in the lumen of the tube, and in the second core material portion placement step, the second core material is placed at least at the distal end of the cylindrical member. Specifically, the present invention illustrates a configuration example that includes the steps of: placing a first core material having a first core material portion inside the lumen of a tube (hereinafter sometimes referred to as the first core material placement step); placing a cylindrical member outside the distal end of the tube (cylindrical member placement step); fixing the distal end of the tube and the cylindrical member (cylindrical member fixing step); removing the first core material from the lumen of the tube (hereinafter sometimes referred to as the first core material removal step); placing a second core material having a second core material portion 7 that is thinner than the first core material portion 2 at at least the distal end of the cylindrical member (hereinafter sometimes referred to as the second core material placement step); and reducing the inner diameter at the distal end of the cylindrical member (inner diameter reduction step).
[0045] Figures 1 and 2 show embodiments using two core materials, but the present invention is not limited to these embodiments, and a single core material having a first core material portion and a second core material portion may be used as the core material. That is, (1) the single core material has the second core material portion distal to the first core material portion, and the second core material portion may be positioned at the distal end by moving the single core material from the distal end to the proximal end, or (2) the single core material has the second core material portion proximal to the first core material portion, and the second core material portion may be positioned at the distal end by moving the single core material from the proximal end to the distal end. Embodiment (1) will be explained using Figures 3 and 4, and embodiment (2) will be explained using Figures 5 and 6.
[0046] (1) In Figures 3 and 4, a core material 11 is used which has a second core material portion 7 distal to the first core material portion 2. In Figure 3, a cylindrical member 3 is placed outside the distal end of the tube 1, and the first core material portion 2 of the core material 11 is placed inside the lumen of the tube 1. In Figure 3, the first core material portion 2 of the core material 11 is also placed inside the lumen of the cylindrical member 3, and the second core material portion 7 of the core material 11 is placed distal to the distal end of the cylindrical member 3. In the state shown in Figure 3, the distal end of the tube 1 and the cylindrical member 3 are fixed (cylindrical member fixing step). After fixing the distal end of the tube 1 and the cylindrical member 3, the core material 11 can be moved from the distal side to the proximal side to position the second core material portion 7 of the core material 11 at the distal end of the cylindrical member 3. Figure 4 shows the state in which the second core material portion 7 of the core material 11 is positioned at the distal end of the cylindrical member 3. After placing the second core material portion 7 of the core material 11 at the distal end of the cylindrical member 3, the inner diameter at the distal end of the cylindrical member 3 can be reduced (inner diameter reduction process).
[0047] (2) In Figures 5 and 6, a core material 12 is used which has a second core material portion 7 located proximal to the first core material portion 2. In Figure 5, a cylindrical member 3 is positioned outside the distal end of the tube 1, and the first core material portion 2 of the core material 12 is positioned inside the lumen of the tube 1. In Figure 5, the first core material portion 2 of the core material 12 is also positioned inside the lumen of the cylindrical member 3, and the second core material portion 7 of the core material 12 is positioned inside the lumen of the tube 1. In the state shown in Figure 5, the distal end of the tube 1 and the cylindrical member 3 are fixed (cylindrical member fixing step). After fixing the distal end of the tube 1 and the cylindrical member 3, the core material 12 can be moved from the proximal side to the distal side to position the second core material portion 7 of the core material 12 at the distal end of the cylindrical member 3. Figure 6 shows the state in which the second core material portion 7 of the core material 12 is positioned at the distal end of the cylindrical member 3. After positioning the second core material portion 7 of the core material 12 at the distal end of the cylindrical member 3, the inner diameter at the distal end of the cylindrical member 3 can be reduced (inner diameter reduction process).
[0048] Figures 3 to 6 show an embodiment using a single core material in which a first core material portion 2 and a second core material portion 7, which have different outer diameters, are connected in the longitudinal direction. However, the shape of the single core material may be, for example, tapered between the first core material portion 2 and the second core material portion 7 to eliminate the step difference caused by the difference in outer diameter between the first core material portion 2 and the second core material portion 7.
[0049] As shown in Figures 1 and 2 above, the cylindrical member 3 may be composed of a single member, but it is preferable that it be composed of two or more members. Composing it of two or more members (especially two members) makes it easier to mold even if the shape of the cylindrical member 3 is complex. Furthermore, by composing the cylindrical member 3 of multiple members, the rigidity can be adjusted for each member, thereby improving conformability and operability. Below, an embodiment in which the cylindrical member 3 is composed of two members will be described.
[0050] Another embodiment of the method for manufacturing a medical tubular body transport device according to the present invention is a tubular member composed of a proximal tubular member and a distal tubular member, comprising the steps of: placing a first core material portion in the lumen of the tube (hereinafter sometimes referred to as the first core material portion placement step); placing a proximal tubular member on the outside of the distal end of the tube (hereinafter sometimes referred to as the proximal tubular member placement step); fixing the distal end of the tube and the proximal tubular member (hereinafter sometimes referred to as the proximal tubular member fixing step); and the proximal tubular member The process includes: placing the distal cylindrical member distal to the first core member (hereinafter sometimes referred to as the distal cylindrical member placement process); fixing the proximal cylindrical member and the distal cylindrical member (hereinafter sometimes referred to as the proximal and distal cylindrical member fixing process); placing a second core member, which is thinner than the first core member, at least at the distal end of the distal cylindrical member (hereinafter sometimes referred to as the second core member placement process); and reducing the inner diameter at the distal end of the distal cylindrical member (hereinafter sometimes referred to as the inner diameter reduction process).
[0051] [First core material placement process] In the first core material placement step, the first core material is placed inside the lumen of the tube. For a description of the first core material placement step, please refer to the description of the first core material placement step described above.
[0052] [Proximal cylindrical member arrangement process] In the proximal cylindrical member placement process, the proximal cylindrical member is positioned on the outside of the distal end of the tube. The proximal cylindrical member extends in the distal direction and has a lumen. The proximal cylindrical member positioned at the distal end of the tube serves as the base for the tip, and when a force is applied from distal to proximal to the distal cylindrical member positioned distal to the proximal cylindrical member, the proximal cylindrical member pushes back against the distal cylindrical member, improving the passage of the distal cylindrical member.
[0053] The shape of the cross-section perpendicular to the long axis of the proximal cylindrical member can be, for example, circular, C-shaped, elliptical, polygonal, or the like.
[0054] Figure 7 shows the proximal cylindrical member positioned outside the distal end of the tube. The same reference numerals are used for the same members as in other drawings to avoid redundant explanations. The arrow x in Figure 7 indicates the distal direction (long axis direction), with the right side of the arrow being the proximal end and the left side being the distal end.
[0055] The first core material portion 2 is located inside the lumen of the tube 1, and the proximal cylindrical member 3a is located outside the distal end of the tube 1.
[0056] The distal end of the proximal cylindrical member 3a is distal to the distal end of the tube 1, and the proximal cylindrical member 3a has a tube placement region 31 in which the tube 1 is placed in the lumen, and a tube non-placement region 32a in which the tube 1 is not placed in the lumen.
[0057] The inner diameter of the proximal cylindrical member 3a differs between the distal and proximal sides of the proximal cylindrical member 3a. The maximum inner diameter d1 in the tube-free region 32a of the proximal cylindrical member 3a (hereinafter sometimes referred to as the maximum inner diameter d1 of the proximal cylindrical member 3a) is smaller than the maximum inner diameter d2 in the tube-placed region 31 of the proximal cylindrical member 3a (hereinafter sometimes referred to as the maximum inner diameter d2 of the proximal cylindrical member 3a).
[0058] The maximum inner diameter d1 of the proximal cylindrical member 3a is preferably 97% or less of the maximum inner diameter d2 of the proximal cylindrical member 3a. More preferably, the maximum inner diameter d1 of the proximal cylindrical member 3a is 95% or less of the maximum inner diameter d2 of the proximal cylindrical member 3a, and even more preferably, 93% or less. The maximum inner diameter d1 of the proximal cylindrical member 3a is sufficient if it is larger than the outer diameter D3 of the first core material portion 2.
[0059] The maximum inner diameter d2 of the proximal cylindrical member 3a should be greater than the outer diameter of the tube 1, and the maximum inner diameter d1 of the proximal cylindrical member 3a should be the same as the inner diameter of the tube 1 or smaller than the inner diameter of the tube 1.
[0060] The minimum outer diameter D1 of the proximal cylindrical member 3a in the tube-free region 32a (hereinafter sometimes referred to as the minimum outer diameter D1 of the proximal cylindrical member 3a) may be larger than, the same as, or smaller than the maximum outer diameter D2 of the proximal cylindrical member 3a in the tube-placed region 31 (hereinafter sometimes referred to as the maximum outer diameter D2 of the proximal cylindrical member 3a), and is more preferably smaller. When the minimum outer diameter D1 of the proximal cylindrical member 3a is smaller than the maximum outer diameter D2 of the proximal cylindrical member 3a, the passage of the tip of the medical tubular body transport device is improved.
[0061] The proximal cylindrical member 3a preferably has a taper in which its outer diameter decreases from the proximal to the distal side. This makes the minimum outer diameter D1 of the proximal cylindrical member 3a smaller than the maximum outer diameter D2 of the proximal cylindrical member 3a, thereby improving the passage of the medical tubular body transport device into the biological lumen.
[0062] The material constituting the proximal cylindrical member 3a can be one of the materials exemplified as constituting the cylindrical member 3.
[0063] The proximal cylindrical member 3a may contain an X-ray opaque material, but it is preferable that it does not contain an X-ray opaque material. If the proximal cylindrical member 3a contains an X-ray opaque material, the example X-ray opaque material included in the cylindrical member 3 can be used.
[0064] An X-ray opaque marker may be placed on the outside of tube 1. Placing the X-ray opaque marker at the proximal end of the proximal cylindrical member 3a makes it easier to determine the proximal end position of the proximal cylindrical member 3a. The shape of the X-ray opaque marker is not particularly limited; it may be cylindrical, or it may be a cylindrical shape with a C-shaped cross-section perpendicular to the long axis. The X-ray opaque marker contains an X-ray opaque material, and the materials exemplified above can be used as the X-ray opaque material.
[0065] [Proximal cylindrical member fixing process] In the proximal cylindrical member fixing step, the distal end of tube 1 and the proximal cylindrical member 3a are fixed together. The distal end of tube 1 and the proximal cylindrical member 3a can be fixed together, for example, using an adhesive or by heat fusion.
[0066] [Distal cylindrical member arrangement process] In the distal cylindrical member arrangement process, the distal cylindrical member 3b is positioned distal to the proximal cylindrical member 3a. The distal cylindrical member 3b becomes the tip of the tip. By dividing the cylindrical member 3 into a proximal cylindrical member 3a and a distal cylindrical member 3b, it becomes easier to adjust the outer diameter of the distal and proximal sides of the cylindrical member, respectively. Furthermore, it is possible to change the rigidity of the proximal cylindrical member 3a and the distal cylindrical member 3b.
[0067] The maximum outer diameter D5 of the distal cylindrical member 3b may be larger than, the same as, or smaller than the maximum outer diameter D2 of the proximal cylindrical member 3a in the tube arrangement region 31, and is more preferably smaller. When the maximum outer diameter D5 of the distal cylindrical member 3b is smaller than the maximum outer diameter D2 of the proximal cylindrical member 3a, the passage of the tip of the medical tubular transport device is improved.
[0068] The inner diameter d5 of the distal cylindrical member 3b should be the same on both the distal and proximal sides of the distal cylindrical member 3b. The inner diameter d5 of the distal cylindrical member 3b may be larger or smaller than the maximum inner diameter d1 in the tube-less region 32a of the proximal cylindrical member 3a, but it is preferable that they be the same. The inner diameter d5 of the distal cylindrical member 3b should be larger than the outer diameter D3 of the first core material portion 2.
[0069] The shape of the cross-section perpendicular to the long axis of the distal cylindrical member 3b can be, for example, circular, C-shaped, elliptical, polygonal, etc. The shape of the cross-section perpendicular to the long axis of the distal cylindrical member and the shape of the cross-section perpendicular to the long axis of the proximal cylindrical member may be different, but it is preferable that they be the same.
[0070] The material constituting the distal cylindrical member 3b can be one of the materials exemplified for the cylindrical member 3. The material constituting the distal cylindrical member 3b and the material constituting the proximal cylindrical member 3a may be different, but it is preferable that they be the same. By being the same, the connection strength between the distal cylindrical member 3b and the proximal cylindrical member 3a is improved in later processes.
[0071] The rigidity of the distal cylindrical member 3b may be the same as or different from the rigidity of the distal cylindrical member 3a on the proximal side, and it is preferable that they are different. If the rigidity of the distal cylindrical member 3b and the rigidity of the proximal cylindrical member 3a are different, it is preferable that the rigidity of the distal cylindrical member 3b is greater than the rigidity of the distal cylindrical member 3a on the proximal side. This makes it easier to add the tip of the medical tubular transport device to the constricted section.
[0072] The distal cylindrical member 3b preferably contains an X-ray opaque material. As the X-ray opaque material, those exemplified as X-ray opaque materials contained in the cylindrical member 3 can be used.
[0073] [Process for fixing cylindrical members at different distances] In the process of fixing the proximal and distal cylindrical members, the proximal cylindrical member 3a and the distal cylindrical member 3b are fixed together. The proximal cylindrical member 3a and the distal cylindrical member 3b can be fixed together, for example, using an adhesive or by heat fusion.
[0074] [Second core material placement process] In the second core material placement step, a second core material, which is thinner than the first core material 2, is placed at least at the distal end of the distal cylindrical member 3b. The distal end of the distal cylindrical member 3b is defined as the region extending 15 mm in the longitudinal direction from the distal end of the distal cylindrical member 3b.
[0075] The second core material portion may be positioned at least at the distal end of the distal cylindrical member 3b, or it may be positioned along the entire length of the distal cylindrical member 3b in the longitudinal direction. That is, the second core material portion may be positioned at least 15 mm from the distal end of the distal cylindrical member 3b in the longitudinal direction, or it may be positioned more proximal to the position 15 mm from the distal end of the distal cylindrical member 3b in the longitudinal direction.
[0076] In an embodiment of the manufacturing method according to the present invention, a step of cutting a portion of the distal end of the distal cylindrical member 3b may be further included after the second core material placement step and prior to the second core material placement step. By cutting a portion of the distal end of the distal cylindrical member 3b, the length of the distal cylindrical member 3b can be adjusted.
[0077] [Inner diameter reduction process] In the inner diameter reduction process, the inner diameter at the distal end of the distal cylindrical member 3b is reduced. Figure 8 shows the state after the second core material portion 7 has been placed at the distal end of the distal cylindrical member 3b and the inner diameter at the distal end of the distal cylindrical member 3b has been reduced. The same reference numerals are used for the same components as in other drawings to avoid redundant explanations.
[0078] The outer diameter D4 of the second core material portion 7 should be smaller than the outer diameter D3 of the first core material portion 2 shown in Figure 7, and preferably the outer diameter D4 of the second core material portion 7 is 94% or less of the outer diameter D3 of the first core material portion 2. More preferably the outer diameter D4 of the second core material portion 7 is 81% or less of the outer diameter D3 of the first core material portion 2, and even more preferably 70% or less. The lower limit of the outer diameter D4 of the second core material portion 7 is preferably 0.48 mm or more, more preferably 0.57 mm or more, and even more preferably 0.66 mm or more.
[0079] As shown in Figure 8, by reducing the inner diameter of the distal end of the distal cylindrical member 3b from d1 to d4, the clearance between the inner circumference of the tip of the distal cylindrical member 3b and the outer circumference of the guide wire is reduced. As a result, the guide wire is held at the distal end of the distal cylindrical member 3b, preventing rattling of the guide wire. Consequently, the ability to follow the guide wire is improved. Furthermore, since it is not necessary to tapere the inner diameter of the entire tip, the contact area between the tip and the guide wire does not become excessively large, and frictional resistance with the guide wire can be reduced.
[0080] When reducing the inner diameter of the distal end of the distal cylindrical member 3b from d1 to d4, it is preferable to also reduce the outer diameter of the distal end of the cylindrical member 3. This improves the passage of the medical tubular body transport device into the biological lumen.
[0081] In the inner diameter reduction process, the percentage by which the inner diameter at the distal end of the distal cylindrical member 3b is reduced from d1 to d4 is not particularly limited, but it is preferable, more preferable, to reduce the maximum inner diameter d5 at the distal end of the distal cylindrical member 3b before reduction to 60% or less, for example, 58% or less, and even more preferable to 56% or less. The lower limit of the percentage by which the inner diameter at the distal end of the distal cylindrical member 3b is reduced from d1 to d4 is preferably 50% or more, more preferable, 51% or more, and even more preferable to 52% or more, relative to the maximum inner diameter d1 at the distal end of the cylindrical member 3 before reduction.
[0082] The inner diameter d4 at the distal end of the distal cylindrical member 3b can be reduced by, for example, heating the distal end of the distal cylindrical member 3b to round it and reduce its diameter.
[0083] It is preferable that the maximum outer diameter D5 of the distal cylindrical member 3b is smaller than the maximum outer diameter D2 of the proximal cylindrical member 3a. By reducing the maximum outer diameter D5 of the distal cylindrical member 3b, it becomes easier to pass through even narrow stenoses. Also, if a mesh-like stent is already placed in the lesion, if the tip of the distal cylindrical member 3b is narrow, it can pass through the mesh.
[0084] If the cylindrical member 3 is composed of a proximal cylindrical member and a distal cylindrical member, it is preferable that the tube 1 has an outer tube (not shown) on its outside, and that the proximal end of the proximal cylindrical member 3a is positioned in the lumen of the outer tube. Furthermore, a medical tubular body can be held in the lumen of the outer tube.
[0085] The maximum outer diameter of the outer tube may be larger than, the same as, or smaller than the maximum outer diameter D2 of the proximal cylindrical member 3a, and is preferably the same or smaller. Having them the same or smaller improves the passage of the medical tubular body transport device. The absolute value of the difference between the maximum outer diameter of the outer tube and the maximum outer diameter D2 of the proximal cylindrical member 3a is preferably 0.05 mm or less, more preferably 0.03 mm or less, and even more preferably 0 mm.
[0086] Figures 7 and 8 show an embodiment in which a first core material having a first core material portion 2 and a second core material having a second core material portion 7 are prepared, the first core material is placed in the lumen of the tube in the first core material portion placement step, and the second core material is placed at least at the distal end of the cylindrical member in the second core material portion placement step. Specifically, the steps are: placing the first core material having the first core material portion in the lumen of the tube (hereinafter sometimes referred to as the first core material placement step); placing the proximal cylindrical member outside the distal end of the tube (proximal cylindrical member placement step); fixing the distal end of the tube and the proximal cylindrical member (proximal cylindrical member fixing step); placing the distal cylindrical member distal to the proximal cylindrical member (distal cylindrical member placement step); and the proximal cylindrical member and This embodiment includes the steps of fixing the distal cylindrical member (distant cylindrical member fixing step), removing the first core material from the lumen of the tube (hereinafter sometimes referred to as the first core material removal step), arranging a second core material having a second core material portion that is thinner than the first core material portion at least at the distal end of the distal cylindrical member (second core material portion arrangement step), and reducing the inner diameter at the distal end of the distal cylindrical member (inner diameter reduction step).
[0087] Figures 7 and 8 show embodiments using two core materials, but the present invention is not limited to these embodiments. As with Figures 3 to 6, a single core material having a first core material portion and a second core material portion may be used as the core material. [Explanation of Symbols]
[0088] 1 tube 2. First core material section 3. Cylindrical member 7. Second core material section 31 Tube placement area 32, 32a Area without tube placement D1 Minimum outer diameter of the tube-less region 32 of the cylindrical member 3, or minimum outer diameter of the tube-less region 32a of the proximal cylindrical member 3a D2 Maximum outer diameter of the cylindrical member 3 in the tube arrangement region 31, or the maximum outer diameter of the proximal cylindrical member 3a in the tube arrangement region 31 D3 Outer diameter of the first core material part 2 D4 Outer diameter of the second core material part 7 D5 Maximum outer diameter of distal cylindrical member 3b d1 Maximum inner diameter in the tube-less region 32 of the cylindrical member 3 d2 Maximum inner diameter in the tube arrangement region 31 of the cylindrical member 3 d5 Inner diameter of distal cylindrical member 3b
Claims
1. A method for manufacturing a medical tubular body transport device for transporting medical tubular bodies into the body, The process involves placing the first core material portion inside the lumen of the tube, A step of placing a cylindrical member on the outside of the distal end of the tube, A step of fixing the distal end of the tube to the cylindrical member, A step of placing a second core material portion, which is thinner than the first core material portion, at least at the distal end of the cylindrical member, A step of reducing the inner diameter at the distal end of the cylindrical member, Includes, Using a core material having the first core material portion and the second core material portion, The first core material has the second core material portion distal to the first core material portion, A method for manufacturing a medical tubular body transport device, wherein the second core material portion is positioned at the distal end by moving the first core material from the distal end to the proximal end.
2. A method for manufacturing a medical tubular body transport device for transporting medical tubular bodies into the body, The process involves placing the first core material portion inside the lumen of the tube, A step of placing a cylindrical member on the outside of the distal end of the tube, A step of fixing the distal end of the tube to the cylindrical member, A step of placing a second core material portion, which is thinner than the first core material portion, at least at the distal end of the cylindrical member, A step of reducing the inner diameter at the distal end of the cylindrical member, Includes, Using a core material having the first core material portion and the second core material portion, The first core material has the second core material portion located proximal to the first core material portion. A method for manufacturing a medical tubular body transport device, wherein the second core material portion is positioned at the distal end by moving the first core material from the proximal side to the distal side.
3. The manufacturing method according to claim 1 or 2, wherein the distal end of the cylindrical member is the region from the distal end of the cylindrical member in the longitudinal direction up to 15 mm.
4. The cylindrical member is composed of a proximal cylindrical member and a distal cylindrical member. The process involves placing the first core material portion inside the lumen of the tube, The steps include: arranging the proximal cylindrical member on the outside of the distal end of the tube; A step of fixing the distal end of the tube to the proximal cylindrical member, A step of positioning the distal cylindrical member distal to the proximal cylindrical member, A step of fixing the proximal cylindrical member and the distal cylindrical member, A step of placing a second core material portion, which is thinner than the first core material portion, at least at the distal end of the distal cylindrical member, A step of reducing the inner diameter at the distal end of the distal cylindrical member, A manufacturing method according to claim 1 or 2, comprising:
5. The manufacturing method according to claim 4, wherein the distal end of the distal cylindrical member is a region extending 15 mm in the longitudinal direction from the distal end of the distal cylindrical member.
6. The manufacturing method according to claim 4 or 5, wherein the maximum outer diameter of the distal cylindrical member is smaller than the maximum outer diameter of the proximal cylindrical member.