Medical device set and catheter molding instrument

Abstract

To facilitate the insertion of a catheter shaping device into the catheter. [Solution] The medical device set comprises a catheter and a catheter shaping tool. The catheter has a tip opening. The catheter shaping tool is inserted into the catheter through the tip opening. The catheter shaping tool has a first linear portion and a second linear portion. The first outer diameter of the first linear portion is smaller than the diameter of the tip opening. The second outer diameter of the second linear portion is smaller than the diameter of the tip opening and larger than the first outer diameter of the first linear portion. The second linear portion is located proximal to the first linear portion.

Description

Technical Field

[0001] The technology disclosed in this specification relates to a medical device set and a catheter shaper.

Background Art

[0002] A medical device set has a catheter and a catheter shaper. The catheter is used, for example, when treating a lesion in a living body lumen such as a blood vessel.

[0003] When the catheter is used, shaping may be performed on the tip of the catheter. A catheter shaper is used for shaping the catheter (see, for example, Non-Patent Document 1).

Prior Art Documents

Non-Patent Documents

[0004]

Non-Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] In a known medical device set, the inner diameter of the tip of the catheter is small. Therefore, it may be difficult for a technician to insert a catheter shaper into the catheter.

[0006] This specification discloses a technology capable of solving the above-described problems.

Means for Solving the Problems

[0007] The technologies disclosed herein can be implemented, for example, in the following forms:

[0008] The medical device set disclosed herein comprises a catheter and a catheter shaping device. The catheter has a tip opening. The catheter shaping device is inserted into the catheter through the tip opening. The catheter shaping device has a first linear portion and a second linear portion. The first outer diameter of the first linear portion is smaller than the diameter of the tip opening. The second outer diameter of the second linear portion is smaller than the diameter of the tip opening and larger than the first outer diameter of the first linear portion. The second linear portion is located proximal to the first linear portion. [Brief explanation of the drawing]

[0009] [Figure 1] Side view of the medical device set 500 in the first embodiment [Figure 2] An explanatory diagram showing a longitudinal section of the medical device set 500 in the first embodiment. [Figure 3] A schematic diagram illustrating the first method of use of medical device set 500. [Figure 4] A schematic diagram illustrating the first method of use of medical device set 500. [Figure 5] A schematic diagram illustrating the first method of use of medical device set 500. [Figure 6] A schematic diagram illustrating the second method of use for the medical device set 500. [Figure 7] A schematic diagram illustrating the second method of use for the medical device set 500. [Figure 8] A schematic diagram illustrating the third method of use for the medical device set 500. [Figure 9] A schematic diagram illustrating the third method of use for the medical device set 500. [Figure 10] An explanatory diagram showing a longitudinal section of the medical device set 500a in the second embodiment. [Figure 11] This is an explanatory diagram showing a longitudinal cross-section of the medical device set 500a in the second embodiment when the catheter shaping tool 10a is inserted into the catheter 100. [Figure 12] Perspective view of the medical device set 500b in the third embodiment [Figure 13] Explanatory drawing showing a longitudinal section of the medical device set 500b in the third embodiment at the position XIII - XIII in FIG. 12 [Figure 14] Perspective view of the medical device set 500e in the fourth embodiment [Figure 15] Explanatory drawing showing a cross - section of the medical device set 500e in the fourth embodiment at the position XV - XV in FIG. 14 [Figure 16] Explanatory drawing showing a cross - section of the medical device set 500e in the fourth embodiment at the position XVI - XVI in FIG. 14 [Figure 17] Explanatory drawing showing a longitudinal section of the medical device set 500c in the fifth embodiment [Figure 18] Explanatory drawing showing a perspective view of the mold insertion assist tool 300 in the fifth embodiment [Figure 19] Explanatory drawing showing a longitudinal section schematically showing the operation method of the medical device set 500c in the fifth embodiment [Figure 20] Explanatory drawing showing a longitudinal section schematically showing the operation method of the medical device set 500c in the fifth embodiment [Figure 21] Explanatory drawing showing a longitudinal section schematically showing the operation method of the medical device set 500c in the fifth embodiment [Figure 22] Explanatory drawing showing a longitudinal section schematically showing the operation method of the medical device set 500c in the fifth embodiment

Modes for Carrying Out the Invention

[0010] (First Embodiment) (Configuration of the medical device set 500) FIG. 1 is a side view of the medical device set 500 in the first embodiment. FIG. 2 is an explanatory drawing showing a longitudinal section (YZ section) of the medical device set 500 in the first embodiment.

[0011] Medical device set 500 is used, for example, when treating lesions in biological lumens. Biological lumens include blood vessels, the digestive tract, ureters, organs, and bile ducts.

[0012] The medical device set 500 includes a catheter 100 and a catheter molding tool 10.

[0013] (Components of Catheter 100) In this specification, the positive Z-axis direction is the direction indicated by the arrow labeled "Z" in each drawing. In Figures 1 and 2, the positive Z-axis side of the catheter 100 is the tip side (distal side) that is inserted into the body. The negative Z-axis direction is the direction opposite to the positive Z-axis direction. The negative Z-axis side of the catheter 100 is the proximal end (proximal side) that is manipulated by the operator. In the catheter 100 and its components, tip means the end on the tip side, tip portion means the tip and its vicinity, proximal end means the end on the proximal side, and proximal end means the proximal end and its vicinity. In the catheter 100 and its components, longitudinal section means a section along the central axis Ax of the catheter 100, and transverse section means a section perpendicular to the central axis Ax.

[0014] The catheter 100 is a tubular medical device. The catheter 100 includes a shaft 140, a protector 120, and a connector 130. The connector 130 is connected to the proximal end of the shaft 140. The protector 120 covers the area around the connection between the connector 130 and the shaft 140. The wall thickness of the catheter 100 is uniform in the circumferential direction.

[0015] The shaft portion 140 is an elongated member extending in the longitudinal direction of the catheter 100. The shaft portion has a lumen S that extends from the tip to the base of the shaft portion 140. For example, other medical devices are inserted into the lumen S. A tip opening 150 is located at the tip of the lumen S. The tip of the lumen S opens at the tip 140d of the shaft portion 140. The position of the tip 140d of the shaft portion 140 is the same as the position of the tip 100d of the catheter 100.

[0016] The shaft portion 140 includes a tip 110, an upper layer 144, an intermediate layer 146, a reinforcing body 145, a lower layer 147, and a marker 148.

[0017] The tip 110 is a cylindrical member extending in the longitudinal direction of the catheter 100. The tip 110 is positioned at the very tip of the shaft portion 140. The proximal end of the tip 110 is connected to the tip of the upper layer 144, the tip of the intermediate layer 146, and the tip of the lower layer 147. The tip 110 is formed of, for example, resin or metal.

[0018] The upper layer 144 extends along the long axis of the catheter 100 from the proximal end of the tip 110 to the proximal end 140p of the shaft portion 140. The upper layer 144 is located on the outermost side in the radial direction of the catheter 100. The shape of the outer edge of the cross-section of the upper layer 144 is, for example, approximately circular. The upper layer 144 is formed of, for example, a resin material.

[0019] The intermediate layer 146 extends along the long axis of the catheter 100 from the proximal end of the tip 110 to the proximal end 140p of the shaft portion 140. In the radial direction of the catheter 100, the intermediate layer 146 is located inside the upper layer 144. The outer circumferential surface of the intermediate layer 146 is in contact with the upper layer 144. The shape of the outer edge of the cross-section of the intermediate layer 146 is, for example, approximately circular. The intermediate layer 146 is formed of, for example, a resin material.

[0020] The reinforcing body 145 extends in the longitudinal direction of the catheter 100 from the base end of the tip 110 to the base end 140p of the shaft portion 140. The reinforcing body 145 is, for example, a braided body having a mesh-like structure in which multiple strands are woven together so as to intersect with each other. The reinforcing body 145 is embedded in the intermediate layer 146. The shape of the outer edge of the cross-section of the reinforcing body 145 is, for example, approximately circular. The reinforcing body 145 is formed of, for example, a metallic material. Examples of materials for forming the reinforcing body 145 include tungsten and stainless steel (SUS302, SUS304, SUS316, etc.). The reinforcing body 145 may be formed of the same material throughout. The reinforcing body 145 may be formed of different materials in each part.

[0021] The lower layer 147 extends in the longitudinal direction of the catheter 100 from the proximal end of the tip 110 to the proximal end 140p of the shaft portion 140. In the radial direction of the catheter 100, the lower layer 147 is located inside the intermediate layer 146. The outer circumferential surface of the lower layer 147 is in contact with the intermediate layer 146. The inner circumferential surface of the lower layer 147 forms the lumen S. The shape of the outer edge of the cross-section of the lower layer 147 is, for example, approximately circular. The lower layer 147 is formed of, for example, a resin material.

[0022] The marker 148 is a cylindrical member positioned at the tip of the shaft portion 140. The marker 148 is positioned, for example, at the base end of the tip 110, surrounding the intermediate layer 146 from the outer circumference. The marker 148 is made of a radiopaque material (e.g., an X-ray opaque material). Examples of radiopaque materials include platinum, gold, silver, tin, tungsten, bismuth, rhenium, tantalum, palladium, iridium, barium, and their alloys.

[0023] The shaft portion 140 includes a tip portion 149 and a base portion 143.

[0024] The tip portion 149 constitutes the tip of the shaft portion 140. The tip portion 149 includes the very tip portion 141 and the tapered portion 142. The inner diameter id141 of the very tip portion 141 is equal to the diameter D150 of the tip opening 150. The tapered portion 142 is adjacent to the proximal end of the very tip portion 141. The outer and inner diameters of the tapered portion 142 gradually increase from the tip to the proximal end of the catheter 100. The outer diameter of the tip of the tapered portion 142 is equal to the outer diameter od141 of the very tip portion 141.

[0025] The inner diameter id141 of the leading edge 141 may be, for example, 0.10 mm or more and 1.00 mm or less. The inner diameter id141 may be 0.20 mm or more and 0.40 mm or less, or 0.21 mm or more and 0.36 mm or less. The outer diameter od141 of the leading edge 141 may be, for example, 0.10 mm or more and 1.00 mm or less. The outer diameter od141 may be 0.20 mm or more and 0.55 mm or less, or 0.35 mm or more and 0.52 mm or less.

[0026] The base portion 143 is adjacent to the base side of the tip portion 149. The outer diameter od143 of the base portion 143 is larger than the outer diameter of the tip portion 149. Specifically, the outer diameter od143 of the base portion 143 is larger than the outer diameter od141 of the tip portion 141. The inner diameter id143 of the base portion 143 is larger than the inner diameter id141 of the tip portion 141.

[0027] (Configuration of the catheter forming device 10) In Figures 1 and 2, the positive Z-axis side of the catheter forming tool 10 is the proximal end (proximal side) manipulated by the operator. The negative Z-axis side of the catheter forming tool 10 is the distal end (tip side) inserted into the catheter 100. In the catheter forming tool 10 and its components, "tip" means the tip end, "tip portion" means the tip and its vicinity, "proximal end" means the proximal end, and "proximal end portion" means the proximal end and its vicinity. In the catheter forming tool 10 and its components, "longitudinal section" means a section along the central axis Ax of the catheter forming tool 10, and "transverse section" means a section perpendicular to the central axis Ax.

[0028] The catheter shaping tool 10 is a long, rectangular component. The catheter shaping tool 10 is used to shape the tip of the catheter 100. The catheter shaping tool 10 is inserted into the catheter 100 through the tip opening 150. The catheter shaping tool 10 is formed from, for example, a metal material. Examples of materials for forming the catheter shaping tool 10 include stainless steel (SUS302, SUS304, SUS316, etc.) and Ni-Ti alloy. The catheter shaping tool 10 may be formed from the same material throughout. The catheter shaping tool 10 may be formed from different materials in different parts.

[0029] The catheter molding tool 10 has a linear portion 15 and a gripping portion 14.

[0030] The gripping portion 14 is located at the base end of the catheter forming tool 10. The outer diameter od14 of the gripping portion 14 is the maximum outer diameter of the catheter forming tool 10. The gripping portion 14 has a curved shape from the linear portion 15. The longitudinal cross-section of the gripping portion 14 is, for example, approximately circular. The shape of the outer edge of the cross-section of the gripping portion 14 is, for example, approximately circular. The shape of the cross-section may differ for each part of the gripping portion 14.

[0031] The linear portion 15 is a rod-shaped member extending in the longitudinal direction of the catheter forming tool 10. The linear portion 15 is located on the tip side of the gripping portion 14 in the longitudinal direction of the catheter forming tool 10. The shape of the outer edge of the cross-section of the linear portion 15 is, for example, approximately circular. The shape of the outer edge of the cross-section may differ for each part of the linear portion 15. The linear portion 15 has a first linear portion 11 and a second linear portion 12.

[0032] The first linear portion 11 is located at the tip of the catheter forming tool 10. The second linear portion 12 is adjacent to the first linear portion 11 on the proximal side. The first outer diameter od11 of the first linear portion 11 is smaller than the diameter D150 of the tip opening 150 of the catheter 100. The first outer diameter od11 of the first linear portion 11 is approximately constant from the tip to the proximal end of the first linear portion 11. The length L11 of the first linear portion 11 is longer than the second outer diameter od12 of the second linear portion 12. The second outer diameter od12 of the second linear portion 12 is smaller than the diameter D150 of the tip opening 150 of the catheter 100. The second outer diameter od12 of the second linear portion 12 is larger than the first outer diameter od11 of the first linear portion 11. The second outer diameter od12 of the second linear portion 12 is approximately constant from the tip to the proximal end of the second linear portion 12. The first outer diameter od11 of the first linear portion 11 is, for example, 0.10 mm or more and 1.00 mm or less. The first outer diameter od11 may also be 0.11 mm or more and 0.50 mm or less, or 0.12 mm or more and 0.27 mm or less. The second outer diameter od12 of the second linear portion 12 is, for example, 0.10 mm or more and 1.00 mm or less. The second outer diameter od12 may also be 0.12 mm or more and 0.40 mm or less, or 0.15 mm or more and 0.32 mm or less. The length L11 of the first linear portion 11 is, for example, 0.50 mm or more and 20 mm or less. The length L11 may also be 1.0 mm or more and 10 mm or less, or 3.0 mm or more and 8.0 mm or less. The length L12 of the second linear portion 12 is, for example, 1 mm or more and 150 mm or less. The length L12 mentioned above may be 20 mm or more and 100 mm or less. The difference between the inner diameter id141 of the tip 141 of the catheter 100 and the outer diameter od11 of the first linear portion 11 (hereinafter referred to as the "first difference") is greater than the difference between the inner diameter id141 of the tip 141 of the catheter 100 and the outer diameter od12 of the second linear portion 12 (hereinafter referred to as the "second difference"). The magnitude of the first difference is, for example, 0.01 mm or more and 1.00 mm or less. The magnitude of the first difference may also be 0.03 mm or more and 0.50 mm or less, or 0.04 mm or more and 0.20 mm or less. The magnitude of the second difference is, for example, 0.01 mm or more and 1.00 mm or less.The magnitude of the second difference may be 0.015 mm or more and 0.55 mm or less, or 0.02 mm or more and 0.20 mm or less. The central axis Ax of the first linear portion 11 and the second linear portion 12 are the same.

[0033] The sum of the length L11 of the first linear portion 11 and the length L12 of the second linear portion 12 is shorter than the length L100 of the catheter 100. The sum of the length L11 of the first linear portion 11 and the length L12 of the second linear portion 12 is shorter than the length L149 of the tip portion 149 of the catheter 100. That is, when the catheter shaping tool 10 is inserted into the catheter 100, the first linear portion 11 is located tipward of the proximal end 149p of the tip portion 149 in the longitudinal axis direction of the catheter 100. The length of the portion of the tip portion 149 of the catheter 100 that is shaped by the catheter shaping tool 10 is, for example, 150 mm or less.

[0034] (Instructions for using Medical Device Set 500) There are three methods for bending the catheter 100 using the catheter shaping tool 10. Figures 3 to 5 are schematic diagrams illustrating the first method of using the medical device set 500. Figures 6 and 7 are schematic diagrams illustrating the second method of using the medical device set 500. Figures 8 and 9 are schematic diagrams illustrating the third method of using the medical device set 500. In Figures 3 to 5 and Figures 6 to 9 described later, the catheter 100 is shown in a cross-sectional view, and the catheter shaping tool 10 is shown in a side view.

[0035] In the first method of use, the operator first bends the second linear portion 12 of the catheter shaping tool 10 (Figure 3). At this time, the operator may or may not bend the first linear portion 11 of the catheter shaping tool 10. Next, the operator inserts the catheter shaping tool 10 into the catheter 100 through the tip opening 150 of the catheter 100 (Figures 4 and 5). As a result, the shape of the tip portion 149 of the catheter 100 becomes the same as the shape of the bent second linear portion 12 of the catheter shaping tool 10. At this time, the tip 11d of the first linear portion 11 is located on the tip side of the proximal end 149p of the tip portion 149 of the catheter 100 in the longitudinal axis direction of the catheter 100. Next, the operator applies heat to the catheter 100 and the catheter shaping tool 10 (Figure 5). Next, the operator removes the catheter shaping tool 10 from the catheter 100. By using the method described above, a catheter 100 with a curved tip is manufactured.

[0036] In the second method of use, first, the operator inserts the catheter shaping tool 10 into the catheter 100 through the tip opening 150 of the catheter 100 (Figure 6). At this time, the catheter 100 and the catheter shaping tool 10 are not curved. Next, the operator curves the catheter 100 and the second linear portion 12 of the catheter shaping tool 10 at the second linear portion 12 of the catheter shaping tool 10 (Figure 7). At this time, the operator may or may not curve the first linear portion 11 of the catheter shaping tool 10. As a result, the shape of the tip portion 149 of the catheter 100 becomes the same as the shape of the curved second linear portion 12 of the catheter shaping tool 10. At this time, the tip 11d of the first linear portion 11 is located on the tip side of the proximal end 149p of the tip portion 149 of the catheter 100 in the longitudinal axis direction of the catheter 100. Next, the operator applies heat to the catheter 100 and the catheter shaping tool 10 (Figure 5). Next, the technician removes the catheter shaping tool 10 from the catheter 100. By using the above method, a catheter 100 with a curved tip is manufactured.

[0037] In the third method of use, first, the operator inserts a portion of the first linear portion 11 of the catheter shaping tool 10 into the catheter 100 through the tip opening 150 of the catheter 100 (Figure 8). At this time, the catheter 100 and the catheter shaping tool 10 are not curved. The tip 12d of the second linear portion 12 is located more distal to the tip 100d of the catheter 100 in the longitudinal axis direction of the catheter 100. Next, the operator curves the second linear portion 12 of the catheter shaping tool 10 (Figure 9). At this time, the operator may or may not curve the first linear portion 11 of the catheter shaping tool 10. Next, the operator inserts the second linear portion 12 of the catheter shaping tool 10 into the catheter 100 through the tip opening 150 of the catheter 100. As a result, the shape of the tip portion 149 of the catheter 100 becomes the same as the shape of the curved second linear portion 12 of the catheter shaping tool 10. At this time, the tip 11d of the first linear portion 11 is located on the tip side of the proximal end 149p of the tip portion 149 of the catheter 100 in the longitudinal axis direction of the catheter 100. Next, the operator applies heat to the catheter 100 and the catheter shaping tool 10 (Figure 5). Next, the operator removes the catheter shaping tool 10 from the catheter 100. By using the above method, a catheter 100 with a curved tip is manufactured.

[0038] (Effects of the first embodiment) As described above, the medical device set 500 of this embodiment includes a catheter 100 and a catheter shaping tool 10. The catheter 100 has a tip opening 150. The catheter shaping tool 10 is inserted into the catheter 100 through the tip opening 150. The catheter shaping tool 10 has a first linear portion 11 and a second linear portion 12. The first outer diameter od11 of the first linear portion 11 is smaller than the diameter D150 of the tip opening 150. The second outer diameter od12 of the second linear portion 12 is smaller than the diameter D150 of the tip opening 150 and larger than the first outer diameter od11 of the first linear portion 11. The second linear portion 12 is located on the proximal end side of the first linear portion 11. Compared to a catheter forming tool having a second linear portion 12 extending to the tip, the catheter forming tool 10 of this embodiment has a large difference between the first outer diameter od11 of the first linear portion 11 of the catheter forming tool 10 and the inner diameter id141 of the leading edge 141 of the catheter 100. Therefore, in this embodiment, the operator can easily insert the tip of the catheter forming tool 10 into the tip opening 150 of the catheter 100. In the catheter forming tool 10 of this embodiment, the difference between the second outer diameter od12 of the second linear portion 12 of the catheter forming tool 10 and the inner diameter id141 of the leading edge 141 of the catheter 100 is small. Therefore, the tip of the catheter 100 can be formed with high precision. In other words, the catheter forming tool 10 of this embodiment facilitates insertion into the tip opening 150 of the catheter 100 and achieves high-precision forming of the tip of the catheter 100.

[0039] In this embodiment, the length L11 of the first linear portion 11 is longer than the second outer diameter od12. Therefore, the length L11 of the first linear portion 11 is sufficiently long. Thus, the operator can more easily insert the tip of the catheter shaping tool 10 into the tip opening 150 of the catheter 100.

[0040] In this embodiment, the sum of the length L11 of the first linear portion 11 and the length L12 of the second linear portion 12 is shorter than the length L100 of the catheter 100. Therefore, the operator can shape a portion of the catheter 100 near the tip using the catheter shaping tool 10. In other words, the operator can limit the area of ​​the catheter 100 that is shaped.

[0041] In this embodiment, the catheter 100 has a tip portion 149 and a proximal portion 143. The length L149 of the tip portion 149 is longer than the sum of the length L11 of the first linear portion 11 and the length L12 of the second linear portion 12. The proximal portion 143 is located proximal to the tip portion 149. The outer diameter od143 of the proximal portion 143 is larger than the outer diameter of the tip portion 149. Therefore, the operator can shape only the tip portion 149 of the catheter 100 using the catheter shaping tool 10. In other words, the operator can limit the area of ​​the catheter 100 that is shaped.

[0042] In this embodiment, the catheter shaping tool 10 further has a gripping portion 14. The gripping portion 14 is located at the base end of the catheter shaping tool 10. The gripping portion 14 has the largest outer diameter in the catheter shaping tool 10. When the catheter shaping tool 10 is inserted into the catheter 100, the tip 11d of the first linear portion 11 is located on the tip side of the base end 149p of the tip portion 149 of the catheter 100 in the longitudinal axis direction of the catheter 100. When inserting the catheter shaping tool 10 into the catheter 100, the operator can adjust the position of the tip 11d of the first linear portion 11 in the lumen of the catheter 100 by using the gripping portion 14 of the catheter shaping tool 10.

[0043] The catheter forming tool 10 of this embodiment has a first linear portion 11 and a second linear portion 12. The first outer diameter od11 of the first linear portion 11 is smaller than the diameter D150 of the tip opening 150 located at the tip of the catheter 100. The second outer diameter od12 of the second linear portion 12 is smaller than the diameter D150 of the tip opening 150 and larger than the first outer diameter od11 of the first linear portion 11. The second linear portion 12 is located on the proximal end side of the first linear portion 11. Therefore, when the catheter forming tool 10 of this embodiment is used together with the catheter 100, the catheter forming tool 10 can be easily inserted into the tip opening 150 of the catheter 100. When the catheter forming tool 10 of this embodiment is used together with the catheter 100, accurate forming of the tip of the catheter 100 can be achieved.

[0044] (Second Embodiment) Figure 10 is an explanatory diagram showing a longitudinal section (YZ section) of the medical device set 500a in the second embodiment. Figure 11 is an explanatory diagram showing a longitudinal section (XZ section) of the medical device set 500a in the second embodiment when the catheter forming tool 10a is inserted into the catheter 100. In the following, for components of the medical device set 500a in the second embodiment that are the same as those of the medical device set 500 in the first embodiment described above, the same reference numerals are used, and their explanations will be omitted as appropriate.

[0045] The catheter forming tool 10a of the second embodiment differs from the catheter forming tool 10 of the first embodiment in that it has a third linear portion 13 in addition to the first linear portion 11 and the second linear portion 12. The third linear portion 13 is a rod-shaped member that extends in the direction of the long axis of the catheter forming tool 10a. The shape of the outer edge of the cross-section of the third linear portion 13 is, for example, approximately circular. The third linear portion 13 is adjacent to the proximal end of the second linear portion 12. The third linear portion 13 is adjacent to the tip side of the gripping portion 14. The central axis Ax of the first linear portion 11, the second linear portion 12, and the third linear portion 13 of the catheter forming tool 10a is the same. The third outer diameter od13 of the third linear portion 13 is larger than the diameter D150 of the tip opening 150 of the catheter 100. The third outer diameter od13 of the third linear portion 13 is approximately constant from the tip to the proximal end of the third linear portion 13. The third outer diameter od13 of the third linear portion 13 is, for example, 0.10 mm or more and 1.10 mm or less. The length L13 of the third linear portion 13 is, for example, 1 mm or more and 100 mm or less.

[0046] The third outer diameter od13 of the third linear portion 13 is set to satisfy the following equation (1): The outer diameter of the tip 141 of the catheter 100 is od141, the inner diameter of the tip 141 of the catheter 100 is id141, the outer diameter of the second linear portion 12 is od12, and the outer diameter of the third linear portion 13 is od13. Formula (1): od141-id141+od12≦od13≦od141+id141-od12 The derivation method of equation (1) will now be explained. As shown in Figure 11, the operator places the tip of the catheter 100 and the catheter shaping tool 10a on the same plane PL, brings the catheter shaping tool 10a close to the catheter 100, and inserts the catheter shaping tool 10a into the catheter 100. The plane PL is perpendicular to the X-axis. Hereafter, the positive X-axis direction will be considered upward, and the negative X-axis direction will be considered downward. At this time, if equation (2) below is satisfied, then in Figure 11, the upper end of the second linear portion 12 is located below the upper end of the lumen S of the catheter 100. That is, the distance between the upper end of the second linear portion 12 and the lower end of the third linear portion 13 is shorter than the distance between the upper end of the lumen S of the catheter 100 and the lower end of the outer surface of the catheter 100. Formula (2): od13 / 2+od12 / 2≦od141-(od141-id141) / 2 If equation (3) below is satisfied, then in Figure 11, the lower end of the second linear portion 12 is located above the lower end of the lumen S of the catheter 100. That is, the distance between the lower end of the second linear portion 12 and the lower end of the third linear portion 13 is longer than the thickness of the catheter 100. Formula (3): od13 / 2-od12 / 2≧(od141-id141) / 2 Equation (1) is derived from equations (2) and (3) above.

[0047] In other words, in this embodiment, when the tip of the catheter 100 and the third linear portion 13 of the catheter forming tool 10a are placed on a plane PL, the tip opening 150 of the catheter 100 is in a position to encompass the second linear portion 12 of the catheter forming tool 10a when viewed in the direction of the central axis Ax.

[0048] (Effects of the second embodiment) In this embodiment, the catheter shaping tool 10a has a third linear portion 13. The third linear portion 13 is located proximal to the second linear portion 12. The third outer diameter od 13 of the third linear portion 13 is larger than the diameter D 150 of the tip opening 150. Therefore, the third linear portion 13 is not inserted into the lumen of the catheter 100. The tip 11d of the first linear portion 11 is located proximal to the proximal end 149p of the tip portion 149 of the catheter 100 in the longitudinal axis direction of the catheter 100. In the first embodiment, when inserting the catheter shaping tool 10 into the catheter 100, the operator needs to adjust the position of the tip 11d of the first linear portion 11 in the lumen of the catheter 100 by using the gripping portion 14 of the catheter shaping tool 10. In the third embodiment, the operator can determine the position of the tip 11d of the first linear portion 11 in the lumen of the catheter 100 by aligning the position of the tip 13d of the third linear portion 13 with the position of the tip 100d of the catheter 100. Therefore, when inserting the catheter shaping tool 10a into the catheter 100, the operator can easily determine the position of the tip 11d of the first linear portion 11 in the lumen of the catheter 100. As a result, the time required for the operator to shape the catheter 100 is reduced.

[0049] In this embodiment, when the outer diameter of the tip 141 of the catheter 100 is od141, the inner diameter of the tip 141 of the catheter 100 is id141, the outer diameter of the second linear portion 12 is od12, and the outer diameter of the third linear portion 13 is od13, the condition od141-id141+od12≦od13≦od141+id141-od12 is satisfied. Therefore, when the outer circumferential surface of the tip of the catheter 100 and the outer circumferential surface of the third linear portion 13 of the catheter shaping tool 10a are positioned on a plane PL, the operator can reliably insert the second linear portion 12 of the catheter shaping tool 10a into the tip opening 150 of the catheter 100. As a result, the time required for the operator to shape the catheter 100 is further reduced.

[0050] (Third embodiment) Figure 12 is a perspective view of the medical device set 500b in the third embodiment. Figure 13 is an explanatory diagram showing a longitudinal section (XZ section) of the medical device set 500b of the third embodiment at position XIII-XIII in Figure 12. In the following, for components of the medical device set 500b of the third embodiment that are the same as those of the medical device set 500 of the first embodiment described above, the same reference numerals are used, and their descriptions will be omitted as appropriate.

[0051] The third embodiment differs from the first embodiment in that the medical device set 500b includes a jig 200.

[0052] In Figures 12 and 13, the positive Z-axis side of the jig 200 is the distal end (tip side) into which the catheter forming tool 10 is inserted. The negative Z-axis side of the jig 200 is the proximal end (proximal side) into which the catheter 100 is inserted. In the jig 200 and its components, "tip" means the end on the tip side, "tip portion" means the tip and its vicinity, "proximal end" means the end on the proximal end side, and "proximal end portion" means the proximal end and its vicinity. In the jig 200 and its components, "longitudinal section" means a section along the central axis Ax of the jig 200, and "transverse section" means a section perpendicular to the central axis Ax.

[0053] The jig 200 has a rectangular parallelepiped shape. The jig 200 is formed of, for example, resin. Examples of materials for forming the jig 200 include polyamide resin, acrylic resin, polyethylene, polypropylene, etc. The jig 200 may be formed from the same material throughout. The jig 200 may be formed from different materials in different parts.

[0054] The jig 200 has a first surface portion 210 and a second surface portion 220. The first surface portion 210 and the second surface portion 220 are aligned in a predetermined alignment direction (in this embodiment, the direction of the central axis Ax). The first surface portion 210 is the surface portion of the jig 200 that contacts the outer circumferential surface of the catheter 100. The second surface portion 220 is the surface portion of the jig 200 that contacts the outer circumferential surface of the catheter molding tool 10.

[0055] The magnitude Δh of the step formed by the first surface portion 210 and the second surface portion 220 is set to satisfy the following equation (4). The outer diameter of the tip 141 of the catheter 100 is od141, the inner diameter of the tip 141 of the catheter 100 is id141, and the outer diameter of the second linear portion 12 is od12. Formula (4): (od141-id141) / 2≦Δh≦(od141+id141-2od12) / 2 The method for deriving equation (4) will now be explained. As shown in Figure 13, the operator places the tip of the catheter 100 and the catheter shaping tool 10 on the jig 200. The operator brings the catheter 100 into contact with the first surface portion 210 and the catheter shaping tool 10 into contact with the second surface portion 220. The operator brings the catheter shaping tool 10 closer to the catheter 100 and inserts the catheter shaping tool 10 into the catheter 100. Hereafter, the positive X-axis direction will be considered upward and the negative X-axis direction will be considered downward. At this time, if equation (5) below is satisfied, the upper end of the second linear portion 12 is located below the upper end of the lumen S of the catheter 100 in Figure 13. That is, the sum of the second outer diameter od12 of the second linear portion 12 and the step size Δh is shorter than the distance between the upper end of the lumen S of the catheter 100 and the lower end of the first surface portion 210. Formula (5): od12+Δh≦od141-(od141-id141) / 2 If condition (6) below is met, then in Figure 13, the lower end of the second surface portion 220 is located above the lower end of the lumen S of the catheter 100. That is, the step size Δh is greater than the wall thickness of the catheter 100. Formula (6):Δh≧(od141-id141) / 2 Equation (4) above is derived from (5) and (6) above.

[0056] In other words, in this embodiment, when the tip of the catheter 100 and the second linear portion 12 of the catheter forming tool 10 are placed on the jig 200, the medical device set 500b has a relationship in which, when viewed in the direction of the central axis Ax, the tip opening 150 of the catheter 100 encloses the second linear portion 12 of the catheter forming tool 10.

[0057] The first surface portion 210 has an inner surface 215 of the first groove. The inner surface 215 of the first groove is in contact with the outer circumferential surface of the catheter 100. The inner surface 215 of the first groove extends along the Z-axis from the base end to the middle part of the jig 200. The shape of the outer edge of the cross-section (XY section) of the inner surface 215 of the first groove is, for example, semicircular. The shape of the outer edge of the cross-section may differ for each part of the inner surface 215 of the first groove. The inner diameter of the first groove is approximately the same as the outer diameter of the catheter 100.

[0058] The second surface portion 220 has an inner surface 225 of the second groove. The inner surface 225 of the second groove is in contact with the outer circumferential surface of the catheter forming tool 10. The inner surface 225 of the second groove is connected to the inner surface 215 of the first groove. The inner surface 225 of the second groove extends along the Z-axis from the middle of the jig 200 to the tip of the jig 200. The shape of the outer edge of the cross-section (XY cross-section) of the inner surface 225 of the second groove is, for example, semicircular. The shape of the outer edge of the cross-section may differ for each part of the inner surface 225 of the second groove. The inner diameter of the second groove is approximately the same as the outer diameter of the catheter forming tool 10.

[0059] (Effects of the third embodiment) In this embodiment, the jig 200 of the third embodiment has a first surface portion 210 and a second surface portion 220. The outer diameter of the tip 141 of the catheter 100 is od141, the inner diameter of the tip 141 of the catheter 100 is id141, and the outer diameter of the second linear portion 12 is od12. The size of the step formed by the first surface portion 210 and the second surface portion 220 is Δh. At this time, (od141-id141) / 2≦Δh≦(od141+id141-2od12) / 2 is satisfied. By using the jig 200, the position of the catheter 100 and the position of the catheter shaping tool 10 are stabilized. Therefore, the second linear portion 12 of the catheter shaping tool 10 can be reliably inserted into the tip opening 150 of the catheter 100. Therefore, the time required for the operator to shape the catheter 100 is further reduced.

[0060] In this embodiment, the first surface portion 210 has an inner surface 215 of the first groove. That is, the inner surface 215 of the first groove supports the catheter 100. Therefore, when the operator inserts the catheter shaping tool 10 into the catheter 100, the position of the tip of the catheter 100 is stable. Consequently, the operator can insert the catheter shaping tool 10 into the catheter 100 more accurately.

[0061] In this embodiment, the second surface portion 220 has an inner surface 225 of the second groove. That is, the inner surface 225 of the second groove supports the second linear portion 12 of the catheter shaping tool 10. Therefore, when the operator inserts the catheter shaping tool 10 into the catheter 100, the position of the tip of the catheter shaping tool 10 is stable. Consequently, the operator can insert the catheter shaping tool 10 into the catheter 100 more accurately.

[0062] (Fourth Embodiment) Figure 14 is a perspective view of the medical device set 500e in the fourth embodiment. Figure 15 is an explanatory diagram showing a cross-section (XY section) of the medical device set 500e in the fourth embodiment at position XV-XV in Figure 14. Figure 16 is an explanatory diagram showing a cross-section (XY section) of the medical device set 500e in the fourth embodiment at position XVI-XVI in Figure 14. In the following, for components of the medical device set 500e in the fourth embodiment that are the same as those of the medical device set 500b in the third embodiment described above, the same reference numerals are used, and their descriptions will be omitted as appropriate.

[0063] The fourth embodiment differs from the third embodiment in that the medical device set 500e includes a jig 200e.

[0064] In Figures 14, 15, and 16, the positive Z-axis side of the jig 200e is the distal end (tip side) into which the catheter forming tool 10 is inserted. The negative Z-axis side of the jig 200e is the proximal end (proximal side) into which the catheter 100 is inserted. In the jig 200e and its components, "tip" means the end on the tip side, "tip portion" means the tip and its vicinity, "proximal end" means the end on the proximal end side, and "proximal end portion" means the proximal end and its vicinity. In the jig 200e and its components, "longitudinal section" means a section along the central axis Ax of the jig 200e, and "transverse section" means a section perpendicular to the central axis Ax.

[0065] In the fourth embodiment, the jig 200e has a first surface portion 210. More specifically, the jig 200e has a first portion P1 and a second portion P2 as the first surface portion 210. The first portion P1 and the second portion P2 are in contact with the outer circumferential surface of the catheter 100. The positions of the first portion P1 and the second portion P2 are different in the circumferential direction of the catheter 100. The first portion P1 is located on the first surface 211. The second portion P2 is located on the second surface 212. The first surface 211 and the second surface 212 are orthogonal to each other.

[0066] In the fourth embodiment, the jig 200e has a second surface portion 220. More specifically, the jig 200e has a third portion P3 and a fourth portion P4 as the second surface portion 220. The third portion P3 and the fourth portion P4 are in contact with the outer circumferential surface of the second linear portion 12 of the catheter forming tool 10. The positions of the third portion P3 and the fourth portion P4 are different in the circumferential direction of the second linear portion 12 of the catheter forming tool 10. The third portion P3 is located on the third surface 223. The fourth portion P4 is located on the fourth surface 224. The third surface 223 and the fourth surface 224 are perpendicular to each other.

[0067] In this embodiment, the first surface portion 210 has a first portion P1 and a second portion P2. The first portion P1 and the second portion P2 are in contact with the outer circumferential surface of the catheter 100. The positions of the first portion P1 and the second portion P2 are different in the circumferential direction of the catheter 100. Therefore, the position of the catheter 100 is stable between the first portion P1 and the second portion P2. Consequently, the operator can insert the catheter shaping tool 10 into the catheter 100 more accurately.

[0068] In this embodiment, the second surface portion 220 has a third portion P3 and a fourth portion P4. The third portion P3 and the fourth portion P4 are in contact with the outer circumferential surface of the second linear portion 12 of the catheter forming tool 10. The positions of the third portion P3 and the fourth portion P4 are different in the circumferential direction of the second linear portion 12 of the catheter forming tool 10. Therefore, the position of the catheter forming tool 10 is stable in the third portion P3 and the fourth portion P4. Consequently, the operator can insert the catheter forming tool 10 into the catheter 100 more accurately.

[0069] (Fifth embodiment) Figure 17 is an explanatory diagram showing a longitudinal section (YZ section) of the medical device set 500c in the fifth embodiment. Figure 18 is an explanatory diagram showing a perspective view of the molding tool insertion aid 300 in the fifth embodiment. In the following, for components of the medical device set 500c of the fifth embodiment that are the same as those of the medical device set 500 of the first embodiment described above, the same reference numerals will be used, and their explanations will be omitted as appropriate.

[0070] The medical device set 500c of the fifth embodiment differs from the first embodiment in that it further includes a molding instrument insertion aid 300.

[0071] The positive Z-axis side of the molding instrument insertion aid 300 is the distal end (tip side) into which the catheter molding instrument 10 is inserted. The negative Z-axis side of the molding instrument insertion aid 300 is the proximal end (proximal side) into which the catheter 100 is inserted. In the molding instrument insertion aid 300 and its components, "tip" means the end on the tip side, "tip portion" means the tip and its vicinity, "proximal end" means the end on the proximal end side, and "proximal end portion" means the proximal end and its vicinity. In the molding instrument insertion aid 300 and its components, "longitudinal section" means a section along the central axis Ax of the molding instrument insertion aid 300, and "transverse section" means a section perpendicular to the central axis Ax.

[0072] The molding tool insertion aid 300 of the fifth embodiment is a cylindrical member with openings at its tip and base. The molding tool insertion aid 300 is used to position the catheter 100 and the catheter molding tool 10. The molding tool insertion aid 300 has a first opening 310, a second opening 320, and a diameter-reducing portion 330. The first opening 310 is located at the tip of the molding tool insertion aid 300. The second opening 320 is located at the base of the molding tool insertion aid 300. The operator inserts the catheter molding tool 10 through the first opening 310. The operator inserts the catheter 100 through the second opening 320. The diameter id320 of the second opening is larger than the outer diameter of the tip of the catheter 100. The diameter id320 of the second opening is smaller than the diameter id310 of the first opening. The diameter-reducing portion 330 is located in the middle of the molding tool insertion aid 300. The inner diameter id330 of the reduced diameter portion 330 is the smallest of the inner diameters of the molding tool insertion aid 300, and is larger than the second outer diameter od12 of the second linear portion 12. The wall thickness of the reduced diameter portion 330 is the largest of the wall thicknesses of the molding tool insertion aid 300. The wall thickness of the molding tool insertion aid 300 gradually decreases from the reduced diameter portion 330 to the tip of the molding tool insertion aid 300. The wall thickness of the molding tool insertion aid 300 gradually decreases from the reduced diameter portion 330 to the base end of the molding tool insertion aid 300. The shape of the outer edge of the cross-section of the molding tool insertion aid 300 is, for example, approximately circular. The shape of the outer edge of the cross-section may differ for each part of the molding tool insertion aid 300. The molding tool insertion aid 300 is formed of, for example, resin. Examples of materials for forming the molding tool insertion aid 300 include polyamide resin, acrylic resin, polyethylene, polypropylene, etc. The molding tool insertion aid 300 may be formed from the same material throughout. The molding tool insertion aid 300 may be formed from different materials in each part.

[0073] (Instructions for using Medical Device Set 500c) The following methods can be used to position the catheter 100 and the catheter molding device 10 using the medical device set 500c. Figures 19, 20, 21, and 22 are explanatory diagrams showing a schematic longitudinal section (YZ section) illustrating the method of using the medical device set 500c in the fifth embodiment.

[0074] The procedure for using the medical device set 500c is as follows: First, the technician brings the catheter 100 close to the proximal end of the shaping device insertion aid 300. Next, the technician inserts the catheter 100 into the lumen of the shaping device insertion aid 300 through the second opening 320 of the shaping device insertion aid 300. Next, the technician brings the tip of the catheter 100 into contact with the inner surface of the shaping device insertion aid 300 (Figure 19). At this point, the outer diameter of the tip of the catheter 100 and the inner diameter of the shaping device insertion aid 300 coincide at the point where the tip of the catheter 100 and the inner surface of the shaping device insertion aid 300 come into contact. Next, the technician inserts the catheter shaping device 10 into the lumen of the shaping device insertion aid 300 through the first opening 310 of the shaping device insertion aid 300 (Figure 20). At this time, the inner diameter id330 of the reduced diameter portion 330 is larger than the second outer diameter od12 of the second linear portion 12 of the catheter shaping tool 10. Therefore, the first linear portion 11 and the second linear portion 12 of the catheter shaping tool 10 can pass through the lumen of the shaping tool insertion aid 300. Next, the operator inserts the catheter shaping tool 10 into the catheter 100 (Figure 21). At this time, the tip 11d of the first linear portion 11 is located on the tip side of the proximal end 149p of the tip portion 149 of the catheter 100 in the longitudinal axis direction of the catheter 100. Next, the operator removes the shaping tool insertion aid 300 by, for example, dividing it into two parts (Figure 22). The catheter 100 and the catheter shaping tool 10 are positioned by the above procedure.

[0075] (Effects of the fifth embodiment) In this embodiment, the medical device set 500c further comprises a molding tool insertion aid 300. The molding tool insertion aid 300 has a first opening 310, a second opening 320, and a reduced diameter portion 330. The first opening 310 is located at the tip of the molding tool insertion aid 300. The second opening 320 is located at the base end of the molding tool insertion aid 300. The diameter id320 of the second opening 320 is larger than the diameter of the tip of the catheter 100. The inner diameter id330 of the reduced diameter portion 330 is the smallest of the inner diameters of the molding tool insertion aid 300 and is larger than the second outer diameter od12 of the second linear portion 12. By using the molding tool insertion aid 300, the position of the catheter 100 and the position of the catheter molding tool 10 are further stabilized. Therefore, the second linear portion 12 of the catheter molding tool 10 can be reliably inserted into the tip opening 150 of the catheter 100. Therefore, the time required for the technician to shape the catheter 100 is further reduced.

[0076] In this embodiment, the diameter id310 of the first opening 310 of the molding instrument insertion aid 300 is larger than the diameter id320 of the second opening 320 of the molding instrument insertion aid 300. Therefore, when using the molding instrument insertion aid 300, the operator can easily distinguish between the first opening 310 and the second opening 320. Furthermore, because the diameter id310 of the first opening 310 is large, the operator can easily insert the catheter molding instrument 10 into the molding instrument insertion aid 300.

[0077] (modified version) The technologies disclosed herein are not limited to the embodiments described above and can be modified in various forms without departing from their essence, for example, the following modifications are possible.

[0078] In the above embodiment, the length L11 of the first linear portion 11 does not have to be longer than the second outer diameter od12. In the above embodiment, the sum of the length L11 of the first linear portion 11 and the length L12 of the second linear portion 12 does not have to be shorter than the length L100 of the catheter 100. In the above embodiment, the length L149 of the tip portion 149 of the catheter 100 does not have to be longer than the sum of the length L11 of the first linear portion 11 and the length L12 of the second linear portion 12.

[0079] In the above embodiment, the first outer diameter od11 of the first linear portion 11 does not have to be substantially constant from the tip to the base of the first linear portion 11. In the above embodiment, the first linear portion 11 may have a shape in which the outer diameter gradually decreases from the base to the tip of the catheter forming tool 10, 10a (hereinafter referred to as a "tapered shape"). In the above embodiment, the second outer diameter od12 of the second linear portion 12 does not have to be substantially constant from the tip to the base of the second linear portion 12. In the above embodiment, the second linear portion 12 may have a tapered shape. In the above second embodiment, the third outer diameter od13 of the third linear portion 13 does not have to be substantially constant from the tip to the base of the third linear portion 13. In the above second embodiment, the third linear portion 13 may have a tapered shape. In the above embodiment, the boundary between the first linear portion 11 and the second linear portion 12 may have a tapered shape. In the above second embodiment, the boundary between the second linear portion 12 and the third linear portion 13 may have a tapered shape.

[0080] In the above embodiment, the gripping portion 14 does not need to have the maximum outer diameter in the catheter molding instrument 10, 10a.

[0081] In the above embodiment, the central axes of the first linear portion 11 and the second linear portion 12 of the catheter forming tool 10, 10a do not have to be the same. In the second embodiment, the central axes of the first linear portion 11, the second linear portion 12 and the third linear portion 13 of the catheter forming tool 10a do not have to be the same. In this case, in the medical device set 500a in the second embodiment, with the tip of the catheter 100 and the third linear portion 13 of the catheter forming tool 10a placed on a plane PL, the tip opening 150 of the catheter 100 has a relationship in which it encloses the second linear portion 12 of the catheter forming tool 10a when viewed in the direction of the central axis Ax.

[0082] In the third embodiment described above, the jig 200 does not have to have a rectangular parallelepiped shape. In the jig 200 in the third embodiment described above, the position of the tip of the inner surface 215 of the first groove does not have to be the same as the middle part of the jig 200. In the third embodiment described above, the shape of the outer edge of the cross-section (XY section) of the inner surface 215 of the first groove is such that when the catheter 100 is placed on the jig 200, it can be positioned in such a way that the relative relationship between the catheter 100 and the jig 200 is determined. In the jig 200 in the third embodiment described above, the position of the base end of the inner surface 225 of the second groove does not have to be the same as the middle part of the jig 200. In the third embodiment described above, the shape of the outer edge of the cross-section (XY section) of the inner surface 225 of the second groove is such that when the catheter forming tool 10 is placed on the jig 200, it can be positioned in such a way that the relative relationship between the catheter forming tool 10 and the jig 200 is determined. In the fourth embodiment described above, the first surface 211 and the second surface 212 do not have to be orthogonal. In the fourth embodiment described above, the third surface 223 and the fourth surface 224 do not have to be orthogonal.

[0083] In the molding tool insertion aid 300 of the fifth embodiment described above, the diameter id310 of the first opening 310 does not have to be larger than the diameter id320 of the second opening 320. In the fifth embodiment described above, the wall thickness of the molding tool insertion aid 300 may be constant throughout the entire molding tool insertion aid 300. In the fifth embodiment described above, the wall thickness of the molding tool insertion aid 300 may gradually increase from the reduced diameter portion 330 to the tip of the molding tool insertion aid 300. In the fifth embodiment described above, the wall thickness of the molding tool insertion aid 300 may gradually increase from the reduced diameter portion 330 to the base end of the molding tool insertion aid 300. In the fifth embodiment described above, the wall thickness of the reduced diameter portion 330 does not have to be the largest of the wall thicknesses of the molding tool insertion aid 300.

[0084] The configuration of the catheter 100 in the above embodiment is merely an example and can be modified in various ways. For example, the reinforcing body 145 may be a configuration other than a braided body (for example, a coil). The catheter 100 in the above embodiment may not have a reinforcing body 145. The catheter 100 in the above embodiment may have other layers arranged on the outer circumference of the upper layer 144.

[0085] In the above embodiment, the wall thickness of the catheter 100 does not have to be the same in the circumferential direction of the catheter 100.

[0086] The forming materials of each component constituting the medical device sets 500, 500a, 500b, 500c, and 500e in the above embodiment are merely examples and can be modified in various ways.

Claims

1. A medical device set (500a, 500, 500b, 500c, 500e), A catheter (100) having a tip opening (150), A catheter shaping device (10a, 10) inserted into the catheter (100) from the tip opening (150), comprising: a first linear portion (11) having a first outer diameter (od11) smaller than the diameter of the tip opening (150); and a second linear portion (12) having a second outer diameter (od12) smaller than the diameter of the tip opening (150) and larger than the first outer diameter (od11), and located on the proximal end side of the first linear portion (11); A medical device set (500a, 500, 500b, 500c, 500e) equipped with the following.

2. A medical device set (500a, 500, 500b, 500c, 500e) according to claim 1, The length of the first linear portion (11) is longer than the second outer diameter (od12) of the medical device set (500a, 500, 500b, 500c, 500e).

3. A medical device set (500a, 500, 500b, 500c, 500e) according to claim 1 or claim 2, A medical device set (500a, 500, 500b, 500c, 500e) wherein the sum of the lengths of the first linear portion (11) and the second linear portion (12) is shorter than the length of the catheter (100).

4. A medical device set (500a, 500, 500b, 500c, 500e) according to any one of claims 1 to 3, The catheter (100) is A tip portion (149) that is longer than the sum of the length of the first linear portion (11) and the length of the second linear portion (12), A base end portion (143) is located on the base end side of the tip end portion (149) and has an outer diameter larger than the outer diameter of the tip end portion (149), A medical device set (500a, 500, 500b, 500c, 500e) having the following features.

5. A medical device set (500a) according to any one of claims 1 to 4, The catheter forming device (10a) further has a third linear portion (13) located proximal to the second linear portion (12) and having a third outer diameter (od13) larger than the diameter of the tip opening (150), in a medical device set (500a).

6. A medical device set (500a) according to claim 5, When the outer diameter of the catheter (100) is od141, the inner diameter of the catheter (100) is id141, the outer diameter of the second linear portion (12) is od12, and the outer diameter of the third linear portion (13) is od13, od141-id141+od12≦od13≦od141+id141-od12 A medical device set (500a) that satisfies the requirements.

7. A medical device set (500a, 500, 500b, 500c, 500e) according to any one of claims 1 to 6, The catheter forming tools (10a, 10) further have a gripping portion (14) located at the base end of the catheter forming tools (10a, 10) and having the largest outer diameter of the catheter forming tools (10a, 10), in a medical device set (500a, 500, 500b, 500c, 500e).

8. A medical device set (500b, 500e) according to any one of claims 1 to 7, The medical device set (500b, 500e) further comprises jigs (200, 200e) having a first surface portion (210) and a second surface portion (220), When the outer diameter of the catheter (100) is od141, the inner diameter of the catheter (100) is id141, and the outer diameter of the second linear portion (12) is od12, If the magnitude of the step difference between the first surface portion (210) and the second surface portion (220) is Δh, (od141-id141) / 2≦Δh≦(od141+id141-2od12) / 2 A medical device set (500b, 500e) that meets the requirements.

9. A medical device set (500b) according to claim 8, A medical device set (500b) wherein the first surface portion (210) has an inner surface (215) of the first groove.

10. A medical device set (500b) according to claim 8 or claim 9, A medical device set (500b) wherein the second surface portion (220) has an inner surface (225) of a second groove.

11. A medical device set (500e) according to any one of claims 8 to 10, The first surface portion (210) comprises a first portion (P1) that contacts the outer surface of the catheter (100) and a second portion (P2) that contacts the outer surface of the catheter (100) and is located at a different position from the first portion (P1) in the circumferential direction of the catheter (100), in the medical device set (500e).

12. A medical device set (500e) according to any one of claims 8 to 11, The medical device set (500e) has a second surface portion (220) which is in contact with the outer circumferential surface of the second linear portion (12) of the catheter forming tool (10), and a fourth portion (P4) which is in contact with the outer circumferential surface of the second linear portion (12) of the catheter forming tool (10) and is located at a different position from the third portion (P3) in the circumferential direction of the second linear portion (12) of the catheter forming tool (10).

13. A medical device set (500c) according to any one of claims 1 to 12, The aforementioned medical device set (500c) further comprises a molding tool insertion aid (300), The molding tool insertion aid (300) has a first opening (310) located at the tip of the molding tool insertion aid (300), a second opening (320) located at the base end of the molding tool insertion aid (300) and having a diameter larger than the outer diameter of the tip of the catheter (100), and a reduced diameter portion (330) which is the smallest of the inner diameters of the molding tool insertion aid (300) and has an inner diameter larger than the outer diameter of the second linear portion (12), as a medical device set (500c).

14. A medical device set (500c) according to claim 13, A medical device set (500c) wherein the first opening (310) of the molding tool insertion aid (300) has a diameter larger than the diameter of the second opening (320) of the molding tool insertion aid (300).

15. Catheter forming device (10a, 10), A first linear portion (11) having a first outer diameter (od11) smaller than the diameter of the tip opening (150) located at the tip of the catheter (100), The second linear portion (12) has a second outer diameter (od12) that is smaller than the diameter of the tip opening (150) and larger than the first outer diameter (od11), and is located on the base end side of the first linear portion (11), A catheter molding device (10a, 10) having the following features.

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