Medical devices and catheters

Abstract

The present invention provides a medical device that is thin in outer diameter, flexible, and offers improved visibility under X-ray images. [Solution] The medical device comprises a shaft, a reinforcing body covering the outer circumference of the shaft, having a dense portion in which radiopaque wires are wound around the shaft and a sparse portion in which the wires are wound more loosely around the shaft than in the dense portion, and a covering portion covering the outer circumference of the reinforcing body, having a first portion and a second portion having higher radiopaqueness than the first portion. The first portion is positioned on the outer circumference of the sparse portion, and the second portion is positioned on the outer circumference of the dense portion.

Description

Technical Field

[0004] , , , , , , , ,

[0005]

[0001] The present disclosure relates to medical devices and catheters.

Background Art

[0002] Medical devices used in percutaneous procedures are known. For example, Patent Document 1 describes a catheter having a braid formed of a radiopaque material as a reinforcing layer. For example, Patent Document 2 describes a catheter having a tube kneaded with a radiopaque material. For example, Patent Document 3 describes a catheter in which a braided member is covered with a polymer coating. Patent Document 3 describes that the braided member can be formed of a radiopaque material and that the polymer can contain a radiopaque material.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Patent Document 2

Patent Document 3

Summary of the Invention

Problems to be Solved by the Invention

[0004] In a percutaneous procedure, an operator inserts a catheter into a living body lumen such as a blood vessel and performs the procedure while confirming the position of the catheter in the living body lumen using an X-ray image. Therefore, as shown in Patent Documents 1 to 3, the catheter is visible under an X-ray image by including a member formed using a radiopaque material.

[0005] Furthermore, since catheters are inserted into narrow, complexly curved biological tubular lumens, they are required to have a small outer diameter, be flexible, and have improved visibility under X-ray imaging. In this regard, in the catheter described in Patent Document 1, if the braid is thinned to reduce the diameter of the catheter, visibility under X-ray imaging decreases. In the catheter described in Patent Document 2, if the tube is thinned to reduce the diameter of the catheter, visibility under X-ray imaging decreases. In the catheter described in Patent Document 3, since both the braid member and the polymer coating are made of radiopaque material, it is difficult to distinguish the catheter from the concomitant device, or to distinguish the concomitant devices from each other, under X-ray imaging.

[0006] These challenges are particularly pronounced in microcatheters used for the treatment and examination of cerebrovascular conditions. However, these challenges are not limited to microcatheters; they are common to all medical devices inserted into biological lumens, such as other catheters and guidewires. [Means for solving the problem]

[0007] This disclosure is made to solve at least some of the problems described above and can be implemented in the following forms.

[0008] According to one embodiment of the present disclosure, a medical device is provided. This medical device comprises a shaft; a reinforcing body covering the outer circumference of the shaft, having a dense portion in which radiopaque wires are wound around the shaft and a sparse portion in which the wires are wound more loosely around the shaft than in the dense portion; and a covering portion covering the outer circumference of the reinforcing body, having a first portion and a second portion having higher radiopaqueness than the first portion, wherein the first portion is positioned on the outer circumference of the sparse portion and the second portion is positioned on the outer circumference of the dense portion. [Brief explanation of the drawing]

[0009] [Figure 1] This is an explanatory diagram illustrating the configuration of a catheter. [Figure 2] This is a longitudinal cross-sectional view of the main body of a PA (Public Access Panel) in a portion of Figure 1. [Figure 3] This diagram shows a portion of the PA in Figure 1, with the inner shaft and reinforcing body extracted. [Figure 4] This is a cross-sectional view of the catheter along the line A1-A1 in Figure 1. [Figure 5] This is a cross-sectional view of the catheter along the line A2-A2 in Figure 1. [Figure 6] This is an explanatory diagram illustrating an example of a catheter according to the second embodiment. [Figure 7] This is an explanatory diagram illustrating an example of a catheter according to the third embodiment. [Figure 8] This is an explanatory diagram illustrating an example of a catheter according to the fourth embodiment. [Figure 9] This is an explanatory diagram illustrating an example of a catheter according to the fifth embodiment. [Figure 10] This is an explanatory diagram illustrating an example of a catheter according to the sixth embodiment. [Figure 11] This is an explanatory diagram illustrating the tip side of the guide wire in the seventh embodiment. [Modes for carrying out the invention]

[0010] <First Embodiment> Figure 1 is an explanatory diagram illustrating an example of a catheter 1. Catheter 1 is a medical device used in percutaneous procedures. Catheter 1 is inserted into the lumen of a living body, such as the vascular system, lymphatic system, biliary system, urinary tract system, airway system, digestive system, secretory glands, and reproductive organs. Catheter 1 comprises a main body 10, a marker 20, a tip 30, and a connector 90. In this embodiment, a single-lumen microcatheter is exemplified as catheter 1. Catheter 1 corresponds to a "medical device".

[0011] Figure 1 includes some parts where the relative sizes of the components differ from reality for the sake of explanation. Figure 1 also includes parts where some of the components are exaggerated. Figure 1 illustrates mutually orthogonal XYZ axes. The X-axis corresponds to the longitudinal direction of catheter 1 and each component. The X-axis corresponds to the axial direction of catheter 1 and each component. The Y-axis corresponds to the height direction of catheter 1 and each component. The Z-axis corresponds to the width direction of catheter 1 and each component. The direction along the -X axis is called the "tip side" of catheter 1 and each component. The direction along the +X axis is called the "proximal end side" of catheter 1 and each component. Hereafter, of the two ends of catheter 1 and each component in the longitudinal direction, the end located on the tip side will be called the "tip," and the other end located on the proximal end side will be called the "proximal end." The tip and its vicinity will be called the "tip portion," and the proximal end and its vicinity will be called the "proximal end portion." The tip side is inserted into the body, and the proximal end side is manipulated by a surgeon such as a physician. These points are also common in Figure 2 and beyond. In this embodiment, "same" and "equal" mean being approximately the same, and allow for variations due to manufacturing errors, etc. In this embodiment, "constant" also includes being approximately constant, and allow for variations due to manufacturing errors, etc.

[0012] The main body 10 has a cylindrical shape that extends in the longitudinal direction of the catheter 1. The main body 10 is tubular. A lumen is formed inside the main body 10 for inserting other medical devices into the catheter 1. As shown in Figure 1, the main body 10 has a second section S2, a first section S1, a second section S2, and a first section S1, from the tip to the proximal end. In other words, the first section S1 and the second section S2 are arranged alternately in the longitudinal direction of the catheter 1. In the example in Figure 1, the tip of the catheter 1 is the second section S2. In the example in Figure 1, the main body 10 is assumed to have two first sections S1 and two second sections S2. The number of first sections S1 and the number of second sections S2 in the main body 10 can be arbitrarily changed. The structure of the main body 10 differs between the first section S1 and the second section S2. In each first section S1, the structure of the main body 10 is the same. In each second section S2, the structure of the main body 10 is the same. The length L1 of the first section S1 in the longitudinal direction of the catheter 1 is longer than the length L2 of the second section S2. Lengths L1 and L2 may be determined arbitrarily.

[0013] Figure 2 is a longitudinal cross-sectional view of the main body 10 in a portion PA of Figure 1. The portion PA is the vicinity of the boundary between the second section S2 and the first section S1. As shown in Figure 2, the main body 10 comprises an inner shaft 110, a reinforcing body 120, and a covering portion 130.

[0014] The inner shaft 110 is disposed at the innermost side of the main body 10. The inner shaft 110 is a cylindrical member extending in the longitudinal direction of the catheter 1. The inner shaft 110 is a hollow shaft having a hollow shape. The distal end of the inner shaft 110 is located at the distal end of the main body 10. The proximal end of the inner shaft 110 is located at the proximal end of the main body 10. In other words, the inner shaft 110 is disposed over the entire length from the distal end to the proximal end of the main body 10 regardless of the first section S1 and the second section S2. The inner shaft 110 forms a lumen 1L for inserting another medical device into the catheter 1. The inner shaft 110 can be formed of, for example, a fluororesin such as PTFE or polyethylene. The inner shaft 110 corresponds to the "shaft", "hollow shaft", and "inner shaft".

[0015] Figure 3 is a diagram showing the inner shaft 110 and reinforcing body 120 extracted from a portion PA of Figure 1. The reinforcing body 120 covers the outer circumference of the inner shaft 110. In the example of Figure 2, the reinforcing body 120 is embedded in the covering portion 130. As shown in Figure 3, the reinforcing body 120 is a braided member formed of wires 40 arranged in a mesh-like pattern. The wires 40 are made of metal and are radiopaque. The wires 40 can be made of, for example, gold, platinum, tungsten, or alloys containing these elements. The reinforcing body 120 has sparse portions 121 and dense portions 122. The sparse portions 121 are portions in which the wires 40 are wound relatively loosely around the inner shaft 110. The sparse portions 121 are portions in which the wires 40 are wound loosely more loosely than in the dense portions 122. Therefore, the sparse portions 121 have lower radiopaqueness than the dense portions 122. The dense section 122 is the portion where the wire strands 40 are wound relatively tightly around the inner shaft 110. The dense section 122 is the portion where the wire strands 40 are wound more tightly than in the sparse section 121. Therefore, the dense section 122 has higher radiopaqueness than the sparse section 121. The amount of metal per unit area UA in the dense section 122 is greater than the amount of metal per unit area UA in the sparse section 121. The pitch P2 of the wire strands 40 in the dense section 122 is smaller than the pitch P1 of the wire strands 40 in the sparse section 121. Pitches P1 and P2 are the intervals between each rotation of the wire strands 40 around the outer surface of the inner shaft 110. In the illustrated example, the center of the wire strands 40 is taken as the starting point for pitches P1 and P2.

[0016] As shown in FIG. 2, the covering portion 130 is disposed on the outermost side of the main body portion 10. The covering portion 130 covers the outer periphery of the reinforcing body 120. The covering portion 130 is a cylindrical member extending in the longitudinal direction of the catheter 1. The covering portion 130 is a hollow shaft having a hollow shape. The covering portion 130 has a first portion 131 and a second portion 132. The first portion 131 is a portion having radiation transparency. The first portion 131 can be formed of, for example, at least any one of polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, and polyurethane elastomer. The second portion 132 is a portion having lower radiation transparency than the first portion 131. In other words, the second portion 132 has higher radiation opacity than the first portion 131. The second portion 132 can be formed of a resin material imparted with radiation opacity by mixing a radiation-opaque material such as bismuth trioxide, tungsten, and barium sulfate with the resin material exemplified in the first portion 131. The resin material of the first portion 131 and the resin material of the second portion 132 may be the same or different. In the example of FIG. 2, the thickness T130 of the covering portion 130 is larger than the thickness T110 of the inner shaft 110. The thicknesses T130 and T110 may be the same. The thickness T130 may be smaller than the thickness T110. The covering portion 130 corresponds to a "covering portion", a "hollow shaft", and an "outer shaft".

[0017] Figure 4 is a cross-sectional view of the catheter 1 along the line A1-A1 in Figure 1. Figure 4 shows a cross-section of the first section S1. As shown in Figures 2 and 4, in the first section S1, the first portion 131 of the covering portion 130 is positioned on the outer circumference of the sparse portion 121 of the reinforcing body 120. In the illustrated example, the sparse portion 121 of the reinforcing body 120 is embedded in the first portion 131 of the covering portion 130. In other words, the sparse portion 121 of the reinforcing body 120 is positioned in the longitudinal direction of the catheter 1 to correspond to the first portion 131 of the covering portion 130. In the longitudinal direction of the catheter 1, the area where the sparse portion 121 of the reinforcing body 120 is provided coincides with the area where the first portion 131 of the covering portion 130 is provided. In the example of Figure 4, the inner circumferential surface 121i of the sparse portion 121 is in contact with the outer circumferential surface 110o of the inner shaft 110. The inner circumferential surface 121i of the sparse portion 121 and the outer circumferential surface 110o of the inner shaft 110 may be separated.

[0018] Figure 5 is a cross-sectional view of the catheter 1 along the line A2-A2 in Figure 1. Figure 3 shows a cross-section of the second section S2. Figure 5 is an explanatory diagram of the reinforcing body 120. As shown in Figures 2 and 5, in the second section S2, the second portion 132 of the covering portion 130 is positioned on the outer circumference of the dense portion 122 of the reinforcing body 120. In the illustrated example, the dense portion 122 of the reinforcing body 120 is embedded in the second portion 132 of the covering portion 130. In other words, the dense portion 122 of the reinforcing body 120 is positioned in the longitudinal direction of the catheter 1 to correspond to the second portion 132 of the covering portion 130. In the longitudinal direction of the catheter 1, the area where the dense portion 122 of the reinforcing body 120 is provided and the area where the second portion 132 of the covering portion 130 is provided coincide. In the example of Figure 5, the inner circumferential surface 122i of the dense portion 122 is in contact with the outer circumferential surface 110o of the inner shaft 110. The inner circumferential surface 122i of the close-fitting portion 122 and the outer circumferential surface 110o of the inner shaft 110 may be separated.

[0019] The worker can form the main body 10 by placing the first tube, which will become the first part 131, and the second tube, which will become the second part 132, over the inner shaft 110, which is covered with the reinforcing body 120, and then melting the first and second tubes to form the covering part 130. When the worker places the first and second tubes, the worker places the first tube over the outer circumference of the sparse part 121 of the reinforcing body 120, and the second tube over the outer circumference of the dense part 122. The first tube is formed from one of the materials described above as the material for the first part 131. The second tube is formed from one of the materials described above as the material for the second part 132.

[0020] Returning to Figure 1, let's continue the explanation. The tip 30 is an annular member joined to the tip of the main body 10. The tip 30 is located at the very tip of the catheter 1. The tip of the tip 30 is provided with an opening 1a connected to the lumen 1L of the main body 10. The tip 30 can be formed from either a radiopaque resin material or a radiopaque metal material. As a radiopaque resin material, for example, a material can be used which is a mixture of at least one of polyamide, polyolefin, polyester, polyurethane, silicon, or fluororesin with a radiopaque material such as bismuth trioxide, tungsten, or barium sulfate. As a radiopaque metal material, for example, gold, platinum, tungsten, or alloys containing these elements can be used. If the tip 30 is formed from a radiopaque material, the operator can visually confirm the tip position of the catheter 1 under an X-ray image. The tip 30 may also be formed from a well-known resin material that is not radiopaque.

[0021] The marker 20 is an annular member joined to the tip of the main body 10, on the base end side of the tip 30. The marker 20 can be formed from either a radiopaque resin material or a radiopaque metal material. As the radiopaque resin material, the same material as exemplified for the tip 30 can be used. As the radiopaque metal material, the same material as exemplified for the tip 30 can be used. The marker 20 may be omitted.

[0022] The connector 90 is positioned at the proximal end of the main body 10 and is a component used by the operator when manipulating the catheter 1. The connector 90 has a cylindrical member 91 and a wing portion 92. The cylindrical member 91 is a cylindrical body having an outer shape in which the outer diameter decreases from the proximal end to the tip end. The proximal end of the main body 10 is inserted and fixed to the tip end of the cylindrical member 91. An opening 1b connected to the lumen 1L of the main body 10 is provided at the proximal end of the cylindrical member 91. The operator can insert other medical devices into the lumen 1L of the main body 10 through the opening 1b. The wing portion 92 is a portion extending in the ±Y axis direction from the outer surface of the cylindrical member 91. The wing portion 92 is used by the operator when grasping the catheter 1. The cylindrical member 91 and the wing portion 92 may be an integral part or may be separate components. The connector 90 can be formed from a resin material. Examples of resin materials include polycarbonate, polyamide, polysulfone, polyurethane, polypropylene, and rigid polyvinyl chloride.

[0023] As described above, in the catheter 1 of the first embodiment, the second portion 132 is arranged on the outer circumference of the dense portion 122. The dense portion 122 is a portion in which radiopaque wires 40 are wound relatively tightly around the inner shaft 110, and therefore is relatively easy to see in X-ray images. The second portion 132 has higher radiopaqueness than the first portion 131, and therefore is relatively easy to see in X-ray images. In other words, in the second section S2 of the catheter 1 in which the second portion 132 is arranged on the outer circumference of the dense portion 122, the portions that are relatively easy to see in X-ray images are arranged in overlapping positions, and thus the visibility under X-ray images is high. For this reason, even if the reinforcing body 120 is made relatively thin with the intention of reducing the diameter of the catheter 1, the visibility of the catheter 1 under X-ray images can be maintained.

[0024] The first section S1, in which the first portion 131 is positioned on the outer circumference of the sparse section 121, has lower radiopaqueness compared to the second section S2, in which the second portion 132 is positioned on the outer circumference of the dense section 122. Therefore, the catheter 1 having the first section S1 of the first embodiment is easier to distinguish from a device used in combination with the catheter 1 compared to a catheter that does not have the first section S1 and has only the second section S2 along its entire length.

[0025] As shown in Figure 3, when a braided member is used for the reinforcing body 120, in the dense portion 122, the acute angle θ2 of the angle that the strands 40 of the braided member make with respect to the longitudinal direction of the catheter 1 becomes relatively large, resulting in a relatively low bending rigidity of the dense portion 122. As shown in Figure 3, when a braided member is used for the reinforcing body 120, in the sparse portion 121, the acute angle θ1 of the angle that the strands 40 of the braided member make with respect to the longitudinal direction of the catheter 1 becomes relatively small, resulting in a relatively high bending rigidity of the sparse portion 121. Angle θ1 is smaller than angle θ2. As shown in Figure 2, the first portion 131 of the covering portion 130 is radiopaque, so its bending rigidity is relatively low. As shown in Figure 2, the second portion 132 of the covering portion 130 contains radiopaque metal powder to make it more radiopaque than the first portion 131, so its bending rigidity is relatively high. In the catheter 1 of the first embodiment, a first portion 131 with relatively low bending rigidity is positioned on the outer circumference of a sparse portion 121 with relatively high bending rigidity, and a second portion 132 with relatively high bending rigidity is positioned on the outer circumference of a dense portion 122 with relatively low bending rigidity. Therefore, it is possible to suppress the occurrence of a rigidity gap between the first section S1 of the catheter 1, in which the first portion 131 is positioned on the outer circumference of the sparse portion 121, and the second section S2, in which the second portion 132 is positioned on the outer circumference of the dense portion 122.

[0026] Furthermore, according to the catheter 1 of the first embodiment, the first section S1, which includes the sparse portion 121 and the first portion 131, and the second section S2, which includes the dense portion 122 and the second portion 132, are alternately arranged in the longitudinal direction of the catheter 1. The radiopaqueness of the second section S2 is higher than that of the first section S1. Therefore, the operator can more easily visualize the catheter 1 under X-ray images. Furthermore, the operator can easily distinguish the catheter 1 in the biological lumen from the concomitant devices inserted into the catheter 1 under X-ray images. Concomitant devices refer to medical devices other than the catheter 1, such as guidewires or other catheters.

[0027] Furthermore, according to the catheter 1 of the first embodiment, the tip of the catheter 1 is a second section S2 including a dense section 122 and a second section 132. Therefore, as shown in Figure 1, the tip of the catheter 1 has a radiopaque tip 30, a marker 20, and the second section S2 arranged in a continuous manner. Even if the marker 20 is omitted, the tip of the catheter 1 still has a radiopaque tip 30 and the second section S2 arranged in a continuous manner. As a result, the visibility of the tip of the catheter 1 under X-ray imaging can be further improved.

[0028] Furthermore, according to the catheter 1 of the first embodiment, an inner shaft 110 is provided inside the covering portion 130, which is a hollow shaft. Therefore, the inner shaft 110 can improve the liquid-tightness within the lumen 1L of the catheter 1 and the sliding properties of the device used in combination with the catheter 1.

[0029] <Second Embodiment> Figure 6 is an explanatory diagram illustrating an example of the catheter 1A of the second embodiment. The catheter 1A of the second embodiment includes a main body 10A in place of the main body 10, as described in the embodiment of the first embodiment. The main body 10A has a first section S1, a second section S2, a first section S1, and a second section S2, extending from the tip to the proximal end. That is, the tip of the catheter 1A is the first section S1. The details of the first section S1 are as described in the first embodiment. The details of the second section S2 are as described in the first embodiment. Thus, the configuration of the catheter 1A can be modified in various ways, and the first section S1 may be located at the tip. The catheter 1A of the second embodiment described above can also achieve the same effects as the first embodiment described above. Furthermore, according to the catheter 1A of the second embodiment, the tip of the catheter 1A is a first section S1 including the sparse portion 121 and the first portion 131, so the boundary between the first section S1 and the marker 20 becomes clear, and the position of the marker 20 becomes easier to see.

[0030] <Third Embodiment> Figure 7 is an explanatory diagram illustrating an example of the catheter 1B of the third embodiment. Figure 7 shows a longitudinal cross-section of a portion PA of Figure 1 for the main body 10B of the catheter 1B. The catheter 1B of the third embodiment includes a main body 10B instead of the main body 10 as described in the first embodiment. The main body 10B has a third section S3 between the first section S1 and the second section S2. The main body 10B has a covering section 130B instead of the covering section 130 described in the first embodiment. The covering range of the covering section 130B in the longitudinal direction of the catheter 1B differs from that of the first embodiment.

[0031] In the third section S3, the second portion 132 of the covering portion 130B is positioned around the outer circumference of the sparse portion 121 of the reinforcing body 120. In the illustrated example, in the third section S3, the sparse portion 121 of the reinforcing body 120 is embedded in the second portion 132 of the covering portion 130B. In other words, the tip of the sparse portion 121 is embedded in the second portion 132 of the covering portion 130B. The base end of the second portion 132 of the covering portion 130B is located more towards the base end than the base end of the dense portion 122. The length L3 of the third section S3 in the longitudinal direction of the catheter 1B is shorter than the length L1 of the first section S1 and shorter than the length L2 of the second section S2. The length L3 may be determined arbitrarily.

[0032] Thus, the configuration of the catheter 1B can be modified in various ways, and a third section S3 may be provided between the first section S1 and the second section S2. The third section S3 may be provided between the first section S1 and the second section S2 at the tip, between the first section S1 and the second section S2 at the proximal end, or in both directions, among the first section S1 and the second section S2 which are repeatedly provided in the longitudinal direction of the catheter 1B. The catheter 1B of the third embodiment described above can also achieve the same effects as the first embodiment described above. Furthermore, according to the catheter 1B of the third embodiment, since a third section S3 including a sparse portion 121 and a second portion 132 is provided between the first section S1 and the second section S2, the occurrence of a rigid gap in the catheter 1B can be further suppressed.

[0033] <Fourth Embodiment> Figure 8 is an explanatory diagram illustrating an example of the catheter 1C of the fourth embodiment. Figure 8 shows a longitudinal cross-section of a portion PA of Figure 1 for the main body portion 10C of the catheter 1C. The catheter 1C of the fourth embodiment includes a main body portion 10C in place of the main body portion 10, as described in the embodiment of the first embodiment. The main body portion 10C has a fourth section S4 between the first section S1 and the second section S2. The main body portion 10C has a covering portion 130C in place of the covering portion 130 described in the first embodiment. The covering range of the covering portion 130C in the longitudinal direction of the catheter 1C differs from that of the first embodiment.

[0034] In the fourth section S4, the first portion 131 of the covering portion 130C is positioned around the outer circumference of the dense portion 122 of the reinforcing body 120. In the illustrated example, in the fourth section S4, the dense portion 122 of the reinforcing body 120 is embedded in the first portion 131 of the covering portion 130C. In other words, the base end of the dense portion 122 is embedded in the first portion 131 of the covering portion 130C. The base end of the second portion 132 of the covering portion 130C is located closer to the tip than the base end of the dense portion 122. The length L4 of the fourth section S4 in the longitudinal direction of the catheter 1C is shorter than the length L1 of the first section S1 and shorter than the length L2 of the second section S2. The length L4 may be determined arbitrarily.

[0035] Thus, the configuration of the catheter 1C can be modified in various ways, and a fourth section S4 may be provided between the first section S1 and the second section S2. The fourth section S4 may be provided between the first section S1 and the second section S2 on the tip side of the first section S1 and the second section S2 which are repeatedly provided in the longitudinal direction of the catheter 1C, or between the first section S1 and the second section S2 on the proximal end side, or in both. The catheter 1C of the fourth embodiment described above can also achieve the same effects as the first embodiment described above. Furthermore, according to the catheter 1C of the fourth embodiment, since a fourth section S4 including a dense portion 122 and a first portion 131 is provided between the first section S1 and the second section S2, the occurrence of a rigid gap in the catheter 1C can be further suppressed.

[0036] <Fifth Embodiment> Figure 9 is an explanatory diagram illustrating an example of the catheter 1D of the fifth embodiment. Figure 9 shows a longitudinal cross-section of a portion PA of Figure 1 for the main body portion 10D of the catheter 1D. The catheter 1D of the fifth embodiment includes a main body portion 10D in place of the main body portion 10, as described in the embodiment of the first embodiment. The main body portion 10D includes an inner shaft 110D in place of the inner shaft 110, a reinforcing body 120D in place of the reinforcing body 120, and a covering portion 130D in place of the covering portion 130.

[0037] The inner shaft 110D is the same as in the first embodiment, except that a reinforcing body 120D is embedded inside it. The reinforcing body 120D is the same as in the first embodiment, except that it does not cover the inner shaft 110D and is embedded in the inner shaft 110D. The covering portion 130D is the same as in the first embodiment, except that a reinforcing body 120D is not embedded inside it. In the first section S1D, the first portion 131 of the covering portion 130D is positioned on the outer circumference of the sparse portion 121 of the reinforcing body 120D. In other words, the sparse portion 121 of the reinforcing body 120D is positioned in the longitudinal direction of the catheter 1D at a location corresponding to the first portion 131 of the covering portion 130D. In the second section S2D, the second portion 132 of the covering portion 130D is positioned on the outer circumference of the dense portion 122 of the reinforcing body 120D. In other words, the dense portion 122 of the reinforcing body 120D is positioned in the longitudinal direction of the catheter 1D to correspond to the second portion 132 of the covering portion 130D. In the example of Figure 9, the thickness T130D of the covering portion 130D is the same as the thickness T110D of the inner shaft 110D. The thicknesses T130D and T110D may be different.

[0038] Thus, the configuration of the catheter 1D can be modified in various ways, and the reinforcing body 120D may be embedded in the inner shaft 110D. Alternatively, the reinforcing body 120D may not be embedded in either the inner shaft 110D or the covering portion 130D, but may be laminated between the inner shaft 110D and the covering portion 130D. The catheter 1D of the fifth embodiment described above can also achieve the same effects as the first embodiment described above.

[0039] <Sixth Embodiment> Figure 10 is an explanatory diagram illustrating an example of the catheter 1E according to the sixth embodiment. Figure 10 shows a longitudinal cross-section of the main body portion 10E of the catheter 1E, a portion of Figure 1 PA. The catheter 1E of the sixth embodiment includes a main body portion 10E instead of the main body portion 10, as described in the embodiment of the first embodiment. The main body portion 10E does not include the inner shaft 110 described in the first embodiment. Thus, the configuration of the catheter 1E can be modified in various ways, and at least some of the above-mentioned components may be omitted. The catheter 1E of the sixth embodiment described above can also achieve the same effects as the first embodiment described above.

[0040] <Seventh Embodiment> Figure 11 is an explanatory diagram illustrating the tip side of the guide wire 1F according to the seventh embodiment. As shown in Figure 11, the guide wire 1F comprises a core shaft 110F, a coil body 120F, a covering portion 130F, and a tip 30F. The guide wire 1F corresponds to a "medical device".

[0041] The core shaft 110F has a larger diameter at the base end and a smaller diameter at the tip end. The core shaft 110F is a long, tapered member. The core shaft 110F is solid. The core shaft 110F can be made of, for example, a nickel-titanium alloy or an alloy of nickel-titanium with another metal. The core shaft 110F has a small diameter section 111, a tapered section 112, and a large diameter section 113 from the tip end to the base end. The small diameter section 111 is located at the very tip of the core shaft 110F. The small diameter section 111 is the part of the core shaft 110F with the smallest outer diameter and is a substantially cylindrical section with a substantially constant outer diameter. The tapered section 112 is located between the small diameter section 111 and the large diameter section 113. The tapered section 112 is a substantially frustoconical section whose outer diameter increases from the tip end to the base end. The large-diameter section 113 is located at the most proximal end of the core shaft 110F. The large-diameter section 113 is the part of the core shaft 110F with the largest outer diameter and is a substantially cylindrical part with a substantially constant outer diameter. The core shaft 110F corresponds to the "shaft".

[0042] The coil body 120F is formed by spirally winding individual wires 40F around a core shaft 110F. The coil body 120F is substantially cylindrical in shape. In the illustrated example, the coil body 120F is a single-strand coil formed by winding a single wire in a single strand. The material of the individual wire 40F can be the same as the material of the individual wire 40 described in the first embodiment. The coil body 120F has a sparse area 121F and a dense area 122F. In the sparse area 121F, there is a gap between adjacent individual wires 40. In the dense area 122F, adjacent individual wires 40 are in contact with each other. In the dense area 122F, there may be a gap between adjacent individual wires 40. In this case, the gap between adjacent individual wires 40 in the dense area 122F is smaller than that in the sparse area 121F. The coil body 120F may also be a multi-strand coil formed by winding multiple individual wires in multiple strands. The coil body 120F may be a single-strand stranded coil formed by twisting together multiple strands of wire and winding a stranded wire into a single strip. The coil body 120F may also be a multi-strand stranded coil formed by using multiple strands of wire and winding each strand into multiple strips. The coil body 120F may cover the entire core shaft 110F from the tip to the base, or it may cover only a portion of the tip side of the core shaft 110F. The coil body 120F corresponds to a "reinforcement body".

[0043] The covering portion 130F covers the outer circumferential surface 120o of the coil body 120F. In the illustrated example, the covering portion 130F does not cover the inner circumferential surface 120i of the coil body 120F. The covering portion 130F has a first portion 131F and a second portion 132F. The first portion 131F is a radiopaque portion. The material of the first portion 131F can be the same as the material of the first portion 131 described in the first embodiment. The second portion 132F is a portion that has higher radiopaqueness than the first portion 131F. In other words, the second portion 132F is a radiopaque portion. The material of the second portion 132F can be the same as the material of the second portion 132 described in the first embodiment. The covering portion 130F corresponds to the "covering portion".

[0044] In the first section S1F, the first portion 131F of the covering portion 130F is positioned around the outer circumference of the sparse portion 121F of the coil body 120F. In the illustrated example, a portion of the sparse portion 121F of the coil body 120F is embedded in the first portion 131F of the covering portion 130F. In other words, the sparse portion 121F of the coil body 120F is positioned in the longitudinal direction of the guide wire 1F at a location corresponding to the first portion 131F of the covering portion 130F. In the second section S2F, the second portion 132F of the covering portion 130F is positioned around the outer circumference of the dense portion 122F of the coil body 120F. In the illustrated example, the dense portion 122F of the coil body 120F is embedded in the second portion 132F of the covering portion 130F. In other words, the dense portion 122F of the coil body 120F is positioned in the longitudinal direction of the guide wire 1F at a location corresponding to the second portion 132F of the covering portion 130F.

[0045] The tip 30 is provided at the tip of the guide wire 1F. The tip 30 is a hemispherical member. The tip 30 connects the tip of the coil body 120F to the tip of the core shaft 110F. The guide wire 1F may further include a base end connecting member that connects the base end of the coil body 120F to a portion of the core shaft 110F.

[0046] Thus, the configuration of the medical device can be modified in various ways, and the medical device may be a guide wire 1F. In the guide wire 1F, multiple sets of the first section S1F and the second section S2F may be provided. In this case, the first section S1F and the second section S2F may be arranged alternately. The guide wire 1F of the seventh embodiment described above can also achieve the same effects as the first embodiment described above. According to the seventh embodiment, the medical device can be various devices other than catheters.

[0047] <Modified form of this embodiment> This disclosure is not limited to the embodiments described above, and can be implemented in various forms without departing from its essence, including, for example, the following modifications.

[0048] [Example 1] The first to sixth embodiments described above show examples of catheters 1, 1A to 1E. Various modifications are possible to the configuration of catheters 1, 1A to 1E. For example, catheter 1 may be a guiding catheter. For example, catheter 1 may be a balloon catheter having a balloon at the tip of the main body portion 10. For example, catheter 1 may be other types of catheters. For example, catheter 1 may be a double-lumen catheter or a multi-lumen catheter. In this case, two or more inner shafts 110 may be arranged inside the covering portion 130.

[0049] For example, the main body 10 of catheter 1 may include only one first section S1 and one second section S2. In this case, the tip of catheter 1 may have either the first section S1 or the second section S2. For example, the main body 10 of catheter 1 may have two or more first sections S1 and second sections S2. In this case, the lengths L1 of each first section S1 do not have to be the same. In this case, the lengths L2 of each second section S2 do not have to be the same.

[0050] For example, the reinforcing member 120 does not have to be a braided member. In this case, the reinforcing member 120 can be, for example, a coil. The coil may be a single-strand coil, a multi-strand coil, a single-strand stranded coil, or a multi-strand stranded coil. For example, the strands 40 forming the reinforcing member 120 may be made of a resin that is radiopaque.

[0051] [Differentiation 2] In the seventh embodiment described above, an example of the guide wire 1F is shown. The configuration of the guide wire 1F can be modified in various ways. For example, the core shaft 110F does not have to have at least a part of the small diameter portion 111, the tapered portion 112, and the large diameter portion 113. For example, the core shaft 110F may further include a second tapered portion, a second large diameter portion, etc. For example, the coil body 120F may be embedded in the covering portion 130F.

[0052] [Difference 3] The first to sixth embodiments 1, 1A to 1E, the guide wire 1F of the seventh embodiment, and the modified examples 1 and 2 may be combined as appropriate. For example, in the catheter 1, two or more of the following may be arbitrarily combined and adopted: the arrangement of the first section S1 and second section S2 described in the second embodiment, the third section S3 described in the third embodiment, the fourth section S4 described in the fourth embodiment, the inner shaft 110D having the reinforcing body 120D described in the fifth embodiment, and the configuration in which the inner shaft 110 is omitted as described in the sixth embodiment. For example, in the guide wire 1F of the seventh embodiment, one or more of the modifications described in the second to sixth embodiments may be combined and adopted.

[0053] This embodiment has been described above based on embodiments and modifications. The embodiments described above are for the purpose of facilitating understanding of this embodiment and do not limit it. This embodiment can be modified and improved without departing from its spirit and the scope of the claims, and equivalents thereof are included in this embodiment. Technical features that are not described as essential in this specification may be deleted as appropriate.

Claims

1. Medical devices (1, 1A to 1F), Shafts (110, 110D, 110F) and A reinforcing body (120, 120D, 120F) covering the outer circumference of the shaft (110, 110D, 110F), having a dense section (122, 122F) in which radiopaque wires are wound around the shaft (110, 110D, 110F), and a sparse section (121, 121F) in which the wires are wound more loosely around the shaft (110, 110D, 110F) than in the dense section (122, 122F), A covering portion (130, 130B, 130C, 130D, 130F) that covers the outer periphery of the reinforcing body (120, 120D, 120F), having a first portion (131, 131F) and a second portion (132, 132F) having higher radiopaqueness than the first portion (131, 131F), Equipped with, The first portion (131, 131F) is arranged on the outer periphery of the aforementioned sparse portion (121, 121F), A medical device (1, 1A to 1F) in which the second portion (132, 132F) is arranged on the outer periphery of the aforementioned dense portion (122, 122F).

2. A medical device (1,1A to 1F) according to claim 1, The reinforcing members (120, 120D, 120F) are formed from metal wires arranged in a mesh-like pattern, and are used in the medical device (1, 1A to 1F).

3. A medical device (1,1A to 1F) according to claim 1 or claim 2, A first section (S1, S1D, S1F) including the sparse portions (121, 121F) and the first portion (131, 131F), and a second section (S2, S2D, S2F) including the dense portions (122, 122F) and the second portion (132, 132F), are alternately arranged in the longitudinal direction of the medical device (1, 1A to 1F).

4. A medical device (1,1B to 1F) according to any one of claims 1 to 3, The tip of the medical device (1, 1B to 1F) is a second section (S2, S2D, S2F) including the dense portion (122, 122F) and the second portion (132, 132F), the medical device (1, 1B to 1F).

5. A medical device (1A) according to any one of claims 1 to 3, The tip of the medical device (1A) is a first section (S1) including the sparse portion (121, 121F) and the first portion (131, 131F), the medical device (1A).

6. A medical device (1B, 1C) according to any one of claims 1 to 5, Between the first section (S1) including the sparse portion (121, 121F) and the first portion (131, 131F), and the second section (S2) including the dense portion (122, 122F) and the second portion (132, 132F), A third section (S3) including the aforementioned sparse portion (121, 121F) and the second portion (132, 132F), A fourth section (S4) including the dense portion (122, 122F) and the first portion (131, 131F), A medical device (1B, 1C) having at least one of the following installed.

7. Catheters (1, 1A to 1E), A hollow shaft (110, 110D, 130, 130B, 130C, 130D) having a hollow shape, comprising a first portion (131) and a second portion (132) having higher radiopaqueness than the first portion (131), A reinforcing body (120, 120D) embedded in the hollow shaft (110, 110D, 130, 130B, 130C, 130D), having a dense section (122) in which radiopaque wires are wound around the hollow shaft (110, 110D, 130, 130B, 130C, 130D), and a sparse section (121) in which the wires are wound more loosely around the hollow shaft (110, 110D, 130, 130B, 130C, 130D) than in the dense section (122), Equipped with, The sparse portion (121) is positioned in the longitudinal direction of the catheter (1, 1A to 1E) at a location corresponding to the first portion (131), The sealed portion (122) is located in the longitudinal direction of the catheter (1, 1A to 1E) at a position corresponding to the second portion (132), wherein the catheters (1, 1A to 1E).

8. A catheter (1, 1A to 1C, 1E) according to claim 7, The hollow shaft (110, 130, 130B, 130C) has an inner shaft (110) and an outer shaft (130, 130B, 130C) that covers the outer circumference of the inner shaft (110). The first portion (131) and the second portion (132) are provided on the outer shaft (130, 130B, 130C), The reinforcing body (120) is a catheter (1, 1A to 1C, 1E) embedded in the outer shaft (130, 130B, 130C).

9. A catheter (1D) according to claim 7, The hollow shaft (110D, 130D) comprises an inner shaft (110D) and an outer shaft (130D) that covers the outer circumference of the inner shaft (110D). The first portion (131) and the second portion (132) are provided on the outer shaft (130D), The reinforcing body (120D) is a catheter (1D) embedded in the inner shaft (110D).

Images