Catheter

Abstract

To provide a catheter which further easily bites into a narrow part.SOLUTION: A catheter having a cylindrical member with a lumen extending in a longitudinal axis direction includes a protrusion outside a radial direction of the cylindrical member.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a catheter. [Background technology]

[0002] Various catheters are used in medical settings. By inserting a catheter into a blood vessel or a body cavity and reaching a target location with its distal end, treatments and diagnoses, such as administering or injecting a drug or contrast agent, can be performed. Patent Document 1 (JP-A-2005-102626) discloses a rapid exchange type secondary catheter that is inserted into a proximal opening of a parent catheter and protrudes from a distal opening of the parent catheter. The secondary catheter has a proximal shaft extending from the proximal end to the distal end, a distal shaft attached to the distal end of the proximal shaft, a linear member disposed along the proximal shaft, and a contact portion that protrudes from the outer circumferential surface of the distal shaft at the distal end by manipulating the linear member from the proximal end, and is pressed against the inner circumferential surface of the parent catheter. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Patent No. 6268673 Summary of the Invention [Problem to be solved by the invention]

[0004] Because cylindrical catheters such as microcatheters and guide extension catheters have difficulty penetrating into stenotic areas, pushing a guidewire or a combination device into the cylindrical catheter can cause the cylindrical catheter to kick back due to a reaction, making it impossible to push the guidewire or combination device all the way into the distal area.

[0005] The present invention has been made in view of the above circumstances, and an object of the present invention is to provide a catheter that can easily penetrate into a stricture. [Means for solving the problem]

[0006] The present invention is as follows. [1] A catheter having a tubular member with an inner lumen extending in the longitudinal axis direction, the catheter having a convex portion on the radially outer side of the tubular member. [2] A catheter as described in [1], which has a braided tube or a coil radially outside the tubular member, and the convex portion is arranged radially outside the braided tube or the coil. [3] A catheter according to [2], which has an outer layer radially outside the braided tube or the coil, and the convex portion is arranged radially outside the outer layer. [4] The catheter according to any one of [1] to [3], wherein the convex portion extends from the proximal side to the distal side in the longitudinal axis direction of the tubular member. [5] The catheter according to [4], wherein the extension direction of the convex portion is parallel to the longitudinal axis direction. [6] The catheter according to [5], wherein the convex portion has an inner cavity extending in the longitudinal axis direction. [7] The catheter according to [4], wherein the extension direction of the convex portion is non-parallel to the longitudinal axis direction. [8] A catheter described in any one of [1] to [7], wherein the shape of the outer edge of the convex portion in a vertical cross section of the tubular member in the longitudinal axis direction is circular, elliptical, oblong, egg-shaped, polygonal, or a combination thereof. [9] The catheter according to any one of [1] to [8], wherein the protrusions are arranged at equal intervals in the circumferential direction of the tubular member.

[10] The catheter according to any one of [1] to [8], wherein the protrusions are arranged at non-equidistant intervals in the circumferential direction of the tubular member.

[11] The catheter according to any one of [1] to

[10] , wherein the protrusion contains metal and / or resin.

[12] The catheter according to any one of [1] to

[11] , further comprising a linear member fixed to the tubular member and extending proximally from the tubular member.

[13] The catheter described in

[12] is an extension catheter that has an inner cavity extending in the longitudinal axis direction of the tubular member, is inserted into a second catheter having an opening at its distal end, and can protrude from the opening of the second catheter. [Effects of the Invention]

[0007] The catheter of the present invention has a convex portion arranged on the radially outer side of the tubular member that constitutes the catheter, making it easier for the convex portion to bite into the narrowed portion, making it easier to push the guide wire or combination device distally. [Brief explanation of the drawings]

[0008] [Figure 1] FIG. 1 is a side view of an embodiment of a catheter. [Figure 2] FIG. 2 is a cross-sectional view taken along line II-II of FIG. [Figure 3] FIG. 3 is a cross-sectional view showing another example of the cross-sectional view taken along line II-II of FIG. [Figure 4] FIG. 4 is a side view showing another embodiment of the catheter. [Figure 5] FIG. 5 is a side view showing the catheter shown in FIG. 4 inserted into a second catheter with a portion of the catheter protruding from an opening at the distal end of the second catheter. DETAILED DESCRIPTION OF THE INVENTION

[0009] A catheter according to the present invention is a catheter having a tubular member with a lumen extending in the longitudinal axis direction, and having a convex portion on the radially outer side of the tubular member.

[0010] The present invention will be described in more detail below based on the embodiments, but the present invention is not limited to the following embodiments. Of course, modifications can be made within the scope of the above and below-described purposes, and all such modifications are included within the technical scope of the present invention. In addition, hatching and component symbols may be omitted in the drawings for convenience. In such cases, reference should be made to the specification and other drawings. Furthermore, the dimensions of various components in the drawings may differ from actual dimensions, as priority is given to helping understand the features of the present invention.

[0011] In this specification, the proximal side refers to the direction toward the user's hand in the longitudinal direction, and the distal side refers to the opposite side of the proximal side, i.e., the direction toward the treatment target. Furthermore, when each component is divided into two equal parts along the longitudinal axis, the distal portion of each component is referred to as the distal section, and the proximal portion of each component is referred to as the proximal section. The distal end of each component is the most distal end of each component, and the proximal end of each component is the most proximal end of each component. The end of each component refers to the portion including the end of each component and its surroundings. That is, the distal end of each component refers to the portion including the distal end of each component and its surroundings, and the proximal end of each component refers to the portion including the proximal end of each component and its surroundings. The longitudinal axis direction may be designated x, the radial direction y, and the circumferential direction z.

[0012] Fig. 1 is a side view showing an embodiment of a catheter. Fig. 2 is a cross-sectional view taken along line II-II in Fig. 1. As shown in Figs. 1 and 2, the catheter 1 has a tubular member 10 and protrusions 90 (90a, 90b). Note that Fig. 1 shows only one wire as the protrusion 90.

[0013] The tubular member 10 has an inner cavity extending in the longitudinal axis direction x. The protrusions 90 are disposed on the outer side of the tubular member 10 in the radial direction y. By providing the protrusions 90 on the outer side of the tubular member 10 in the radial direction y, the protrusions 90 can bite into the stenosis, making it less likely for the catheter to kick back even when a guidewire or a combination device is pushed into the catheter. As a result, the guidewire or combination device can be pushed distally.

[0014] The external shape of the convex portions 90 may be linear in a side view of the catheter 1, and may be curved or straight as shown in Fig. 1. The external shape of all the convex portions 90 may be the same, or some of the convex portions 90 may be different.

[0015] The shape of the outer edge of the protrusions 90 in a cross section perpendicular to the longitudinal axis direction x of the tubular member 10 is not particularly limited, and may be, for example, a circle, an ellipse, an oval, an oval, a polygon, or a combination thereof. Examples of polygons include a triangle, a rectangle, a pentagon, and a hexagon. Examples of quadrilaterals include a square, a rectangle, and a trapezoid. The shape of the outer edge of all the protrusions 90 may be the same, or may be different for some of the protrusions 90.

[0016] The protrusions 90 may extend from the proximal side to the distal side in the longitudinal axis direction x of the tubular member 10. This makes it easier for the protrusions 90 to bite into the stricture.

[0017] When the convex portion 90 extends from the proximal side to the distal side in the longitudinal axis direction x of the tubular member 10, the convex portion 90 may extend continuously or may extend intermittently.

[0018] When the protrusions 90 extend from the proximal side to the distal side in the longitudinal axis direction x of the tubular member 10, the extension direction of the protrusions 90 may be parallel to the longitudinal axis direction x or non-parallel to the longitudinal axis direction x. When the extension direction of the protrusions 90 is parallel to the longitudinal axis direction x, the protrusions 90 may have an inner cavity extending in the longitudinal axis direction x. This allows, for example, a guidewire to be inserted into the inner cavity of the protrusions 90. When the extension direction of the protrusions 90 is non-parallel to the longitudinal axis direction x, it is preferable that the extension direction of the protrusions 90 is non-perpendicular to the longitudinal axis direction x of the tubular member 10. A non-perpendicular extension makes it easier for the protrusions 90 to bite into the stricture. When the extension direction of the protrusions 90 is non-parallel to the longitudinal axis direction x, the protrusions 90 may be arranged, for example, in a spiral shape around the tubular member 10.

[0019] The length of the convex portion 90 is not particularly limited, and may be K×0.1 to K×0.9, K×0.2 to K×0.8, or K×0.3 to K×0.7, where K is the length from the proximal end to the distal end of the tubular member 10 when viewed from the side of the catheter 1.

[0020] The number of protrusions 90 is not particularly limited and may be one or two or more. When the catheter 1 has multiple protrusions 90 on the outer side of the cylindrical member 10 in the radial direction y, the protrusions 90 may be arranged at equal intervals or at non-equidistant intervals in the circumferential direction z of the cylindrical member 10. By arranging the protrusions at equal intervals, it is possible to cut evenly into the stenotic portion. By arranging the protrusions at non-equidistant intervals, it is possible to cut only at desired positions in the stenotic portion.

[0021] The position where the convex portion 90 is arranged is not particularly limited, and may be, for example, the proximal end, the central portion, or the distal end with respect to the longitudinal axis direction x of the tubular member 10, and it is preferable that the convex portion 90 is arranged at least at the distal end. By arranging the convex portion 90 at the distal end, the convex portion 90 can easily bite into the narrowed portion.

[0022] The material that constitutes the protrusions 90 is not particularly limited, but preferably contains, for example, metal and / or resin.

[0023] The metal preferably includes, for example, stainless steel, titanium, nickel-titanium alloy, nickel-chromium alloy, cobalt-chromium alloy, tungsten alloy, or a combination thereof, and more preferably includes stainless steel.

[0024] The resin preferably contains, for example, a polyamide resin, a polyester resin, a polyurethane resin, a polyolefin resin, a vinyl chloride resin, a silicone resin, a natural rubber, or a combination thereof, and more preferably a polyamide resin, a polyurethane resin, or a combination thereof. The resin may also contain an elastomer having rubber elasticity, for example, a polyamide resin may contain a polyamide elastomer, and a polyurethane resin may contain a polyurethane elastomer.

[0025] The material constituting the protrusions 90 may be the same for all of the protrusions 90, or may be different for some of the protrusions 90.

[0026] The method for forming the protrusions 90 is not particularly limited, and they may be fixed to the surface of the cylindrical member 10 or the surface of the outer layer 40 via an adhesive, or may be fixed by heat fusion.

[0027] The cylindrical member 10 may be any resin tube, preferably containing a fluororesin, and more preferably made of a fluororesin. Fluororesin has excellent chemical resistance, non-stickiness, and low friction. The fluororesin preferably contains, for example, polytetrafluoroethylene, ethylene tetrafluoroethylene, fluorinated ethylene propylene, or a combination thereof.

[0028] The catheter 1 may have an outer layer on the outside of the tubular member 10 in the radial direction y. The outer layer preferably contains, for example, a polyamide resin, a polyester resin, a polyurethane resin, a polyolefin resin, a vinyl chloride resin, a silicone resin, a natural rubber, or a combination thereof, and more preferably contains a polyamide resin, a polyurethane resin, or a combination thereof. The resin may contain an elastomer having rubber elasticity; for example, the polyamide resin may contain a polyamide elastomer, and the polyurethane resin may contain a polyurethane elastomer.

[0029] The outer layer may be a single layer, or may have a structure in which multiple layers are laminated in the radial direction y of the tubular member 10. When the outer layer has a laminated structure, adjacent layers in the radial direction y of the tubular member 10 may contain different types of resins or may contain the same type of resin.

[0030] When the catheter 1 has an outer layer on the outside of the cylindrical member 10 in the radial direction y, the convex portion 90 may be disposed on the outside of the outer layer in the radial direction y.

[0031] Fig. 3 is a cross-sectional view showing another example of the configuration of the II-II cross-section view of Fig. 1. The catheter 1 has a braided tube 20 on the radially outer side of the tubular member 10, an outer layer 40 on the radially outer side of the braided tube 20 in the radial direction y, and a protrusion 90 on the radially outer side of the outer layer 40 in the radial direction y. Fig. 3 shows an example of a configuration in which four wires are arranged as the protrusion 90. Also, in Fig. 3, the braided tube 20 is arranged within the outer layer 40. Also, although Fig. 3 shows an example of a configuration in which the braided tube 20 is arranged, a coil may be arranged instead of the braided tube 20.

[0032] As shown in Fig. 3, when the catheter 1 has the braided tube 20 on the radially outer side of the tubular member 10 in the y direction, the protrusions 90 may be disposed on the radially outer side of the braided tube 20 in the y direction. When the catheter 1 has the braided tube 20 on the radially outer side of the tubular member 10 in the y direction, the catheter 1 may have an outer layer 40 on the radially outer side of the tubular member 10 and on the radially outer side of the braided tube 20 in the y direction. The braided tube 20 may be disposed within the outer layer 40. When the catheter 1 has the outer layer 40 on the radially outer side of the braided tube 20 in the y direction, the protrusions 90 may be disposed on the radially outer side of the outer layer 40 in the y direction.

[0033] The braided tube 20 preferably has a mesh structure in which wires are woven so that they cross each other. The wires may be solid wires or twisted wires. The braided tube 20 may be made up of one or more wires.

[0034] The wires of the braided tube 20 preferably include metal wires, fibers, or a combination thereof, more preferably metal wires. The metal wires preferably include, for example, stainless steel, titanium, nickel-titanium alloys, nickel-chromium alloys, cobalt-chromium alloys, tungsten alloys, or a combination thereof, more preferably stainless steel. The fibers preferably include, for example, polyarylate fibers, aramid fibers, ultra-high molecular weight polyethylene fibers, polyparaphenylene benzobisoxazole fibers (PBO fibers), carbon fibers, or a combination thereof. The fibers may be monofilaments or multifilaments.

[0035] The strands of the braided tube 20 may contain a radiopaque material, which allows the position of the braided tube 20 to be confirmed under X-ray fluoroscopy. The radiopaque material preferably contains, for example, lead, barium, iodine, tungsten, gold, platinum, iridium, platinum-iridium alloy, stainless steel, titanium, cobalt-chromium alloy, palladium, tantalum, or a combination thereof.

[0036] The shape of the cross section perpendicular to the longitudinal axis direction x of the wire of the braided tube 20 is not particularly limited, and may be, for example, a circle, an ellipse, an oval, an egg, a D-shape, a triangle, a rectangle, a polygon, or a combination thereof. The braided tube 20 may also be made of a round wire or a flat wire. A flat wire is a wire material with both sides scraped off from a round wire.

[0037] The wire diameter of the wire of the braided tube 20 is, for example, preferably 5 to 110 μm, more preferably 10 to 100 μm, and even more preferably 15 to 90 μm. The wire diameter refers to the maximum length (maximum width) of the wire in a cross section of the braided tube 20 perpendicular to the longitudinal axis direction x of the wire.

[0038] The coil may be a solid wire or a stranded wire.

[0039] The coil preferably comprises a metal wire, a fiber, or a combination thereof, more preferably a metal wire. The metal wire preferably comprises, for example, stainless steel, titanium, a nickel-titanium alloy, a nickel-chromium alloy, a cobalt-chromium alloy, a tungsten alloy, or a combination thereof, more preferably stainless steel. The fiber preferably comprises, for example, a polyarylate fiber, an aramid fiber, an ultra-high molecular weight polyethylene fiber, a polyparaphenylene benzobisoxazole fiber (PBO fiber), a carbon fiber, or a combination thereof. The fiber may be a monofilament or a multifilament.

[0040] The coil may include a radiopaque material, which allows the coil's position to be confirmed under fluoroscopy. The radiopaque material preferably includes, for example, lead, barium, iodine, tungsten, gold, platinum, iridium, platinum-iridium alloy, stainless steel, titanium, cobalt-chromium alloy, palladium, tantalum, or a combination thereof.

[0041] The shape of the cross section perpendicular to the longitudinal axis direction x of the coil is not particularly limited, and examples thereof include a circle, an ellipse, an oval, an egg, a D-shape, a triangle, a rectangle, a polygon, or a combination thereof. The coil may also be made of a round wire or a flat wire. A flat wire is a round wire with both sides scraped off.

[0042] The wire diameter of the coil is, for example, preferably 3 to 300 μm, more preferably 5 to 250 μm, and even more preferably 10 to 200 μm. The wire diameter of the coil refers to the maximum length (maximum width) of the coil in a cross section perpendicular to the longitudinal axis direction x of the coil.

[0043] The catheter 1 may have a radiopaque ring. The proximal or distal end of the braided tube 20 may be located inside the radiopaque ring in the radial direction y. This allows the position of the proximal or distal end of the braided tube 20 to be confirmed under X-ray fluoroscopy. The radiopaque ring may be located between the braided tube 20 or the coil and the outer layer 40 in the radial direction y of the tubular member 10. This prevents the end of the braided tube 20 from opening, thereby preventing the braided tube 20 or the coil from being exposed from the outer surface of the outer layer 40. The radiopaque ring is a ring containing a radiopaque material, and may be a ring made of a radiopaque material. The radiopaque materials listed above can be used.

[0044] The use of the catheter is not particularly limited as long as it can be inserted into a blood vessel or a body cavity, and may be, for example, a blood vessel, a ureter, a bile duct, a fallopian tube, or a hepatic duct.

[0045] Fig. 4 is a side view showing another embodiment of the catheter. Fig. 5 is a side view showing the catheter shown in Fig. 4 inserted into a second catheter with a portion of the catheter protruding from the opening at the distal end of the second catheter.

[0046] The catheter 1 may further include a linear member 60 fixed to the tubular member 10 and extending proximally from the tubular member 10. This allows the operator to push the tubular member 10 distally or pull it back proximally via the linear member 60.

[0047] The linear member 60 may have a lumen extending in the longitudinal axis direction x, but is preferably solid and does not have a lumen, which allows the thickness of the linear member 60 to be reduced.

[0048] The material of the linear member 60 is not particularly limited as long as it can push the tubular member 10 distally and pull it back proximally, but examples thereof include metal. Metals preferably include, for example, stainless steel, titanium, nickel-titanium alloys, cobalt-chromium alloys, tungsten alloys, or combinations thereof, and more preferably include stainless steel.

[0049] The shape of the linear member 60 in a cross section perpendicular to the longitudinal axis direction x is preferably, for example, a square, rectangle, trapezoid, circle, D-shape, ellipse, egg shape, or oval shape, and more preferably a rectangle. The shape of the linear member 60 in a cross section perpendicular to the longitudinal axis direction x may be the same regardless of the position in the longitudinal axis direction x, or may be different depending on the position in the longitudinal axis direction x.

[0050] The wire diameter of the linear member 60 is, for example, preferably 100 to 650 μm, more preferably 150 to 600 μm, and even more preferably 200 to 550 μm. The wire diameter of the linear member 60 refers to the maximum length (maximum width) of the linear member 60 in a cross section perpendicular to the longitudinal axis direction x of the linear member 60. The wire diameter of the linear member 60 may be the same regardless of the position in the longitudinal axis direction x, or may be different depending on the position in the longitudinal axis direction x, and may have, for example, a portion that tapers from the proximal side to the distal side.

[0051] When the catheter 1 further has a linear member 60, the catheter 1 may be an extension catheter 1A, as shown in Fig. 5. As shown in Fig. 5, the extension catheter 1A has a lumen extending in the longitudinal axis direction of the tubular member 10, and is a catheter to be inserted into a second catheter 2 having an opening 2bP at its distal end 2b, and is a catheter that can protrude from the opening 2bP at the distal end 2b of the second catheter 2.

[0052] For example, after inserting the distal end of the second catheter 2 into the entrance of the coronary artery, the extension catheter 1A is inserted into the second catheter 2 from an opening 2aP on the proximal side of the second catheter 2, and then inserted into the coronary artery with a portion of the extension catheter 1A protruding from an opening 2bP at the distal end 2b of the second catheter 2, thereby enabling delivery of, for example, an intravascular treatment device to an affected area in the coronary artery via the second catheter 2 and the extension catheter 1A. Examples of intravascular treatment devices include a balloon and a stent.

[0053] The second catheter 2 is preferably a so-called guiding catheter. A guiding catheter has a lumen into which a treatment catheter such as a balloon catheter or a stent delivery catheter is inserted. The treatment catheter is preferably one that is inserted into a coronary artery, but may also be one that is inserted into other arteries such as a cerebral artery, or into internal ducts such as veins, pancreatic ducts, bile ducts, ureters, and bronchi.

[0054] The catheter 1 may further have a handle member 70 fixed to the proximal end of the tubular member 10. When the catheter 1 is an extension catheter 1A having a linear member 60, the extension catheter 1A may further have a handle member 70 fixed to the proximal end of the linear member 60, as shown in Fig. 5. The operator can grasp the handle member 70 to move the tubular member 10 or the linear member 60 distally or proximally.

[0055] The handle member 70 preferably contains a resin, such as a polyolefin resin, which preferably contains, for example, polyethylene, polypropylene, or a combination thereof. [Explanation of symbols]

[0056] 1 catheter 1A Extension Catheter 2. Second catheter 2a Proximal end of second catheter 2b Distal end of second catheter 2aP Opening at the proximal end of the second catheter 2bP Opening at the distal end of the second catheter 10 Cylindrical member 10a Proximal end of tubular member 10b distal end of tubular member 20 braided tube 40 outer layer 60 Linear members 60b Distal end of linear member 70 Handle 90, 90a~90d Convex part x longitudinal axis y radial direction z Circumferential direction

Claims

1. A catheter having a tubular member with a lumen extending in a longitudinal direction, A catheter having a convex portion on the radially outer side of the tubular member.

2. a braided tube or coil is provided on the radially outer side of the cylindrical member; The catheter according to claim 1 , wherein the protrusion is disposed radially outward of the braided tube or the coil.

3. an outer layer on the radially outer side of the braided tube or the coil; The catheter according to claim 2 , wherein the protrusions are disposed radially outward of the outer layer.

4. The catheter according to claim 1 , wherein the protrusion extends from a proximal side to a distal side in the longitudinal axis direction of the tubular member.

5. The catheter according to claim 4 , wherein the extending direction of the protrusion is parallel to the longitudinal axis direction.

6. The catheter according to claim 5 , wherein the protrusion has an inner cavity extending in the longitudinal axis direction.

7. The catheter according to claim 4 , wherein the extending direction of the convex portion is non-parallel to the longitudinal axis direction.

8. The catheter according to claim 1, wherein the shape of the outer edge of the convex portion in a cross section perpendicular to the longitudinal axis direction of the tubular member is a circle, an ellipse, an oval, an egg, a polygon, or a combination thereof.

9. The catheter according to claim 1 , wherein the protrusions are arranged at equal intervals in the circumferential direction of the tubular member.

10. The catheter according to claim 1 , wherein the protrusions are arranged at non-equidistant intervals in the circumferential direction of the tubular member.

11. The catheter according to claim 1 , wherein the protrusion includes a metal and / or a resin.

12. The catheter according to claim 1, further comprising a linear member fixed to the tubular member and extending proximally from the tubular member.

13. 13. The catheter according to claim 12, wherein the catheter is an extension catheter that has an inner cavity extending in the longitudinal axis direction of the tubular member, is inserted into a second catheter having an opening at its distal end, and is capable of protruding from the opening of the second catheter.

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