Catheter

Abstract

To provide a catheter capable of determining an insertion path of a guide wire at a real time when inserting the guide wire into a blood vessel and a body cavity.SOLUTION: A catheter includes: a shaft having a lumen extending in a longitudinal axis direction; and a cylindrical member arranged in the lumen of the shaft, and having a lumen extending in the longitudinal axis direction, and a proximal side opening and a distal side opening. A hole for providing communication between the lumen of the cylindrical member and the lumen of the shaft is arranged in a lateral wall of the cylindrical member, and the shaft has a supply port for supplying fluid to the lumen of the shaft.SELECTED DRAWING: Figure 2

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 the tip of the catheter to the target location, treatments such as administering or injecting medicines or contrast agents or performing diagnoses can be performed.

[0003] As an example of a system including such a catheter, Patent Document 1 discloses a system for adjusting the flow characteristics of a fluid medium supplied to a delivery site inside the body, the system including: a delivery catheter having a lumen and capable of delivering a medium from outside the body to the delivery site inside the body; a syringe operable to supply a fluid medium to the delivery catheter, the syringe including an optical sensor module; and a regulator disposed between the syringe and the delivery catheter, the regulator configured to limit the pressure of the fluid medium supplied to the delivery catheter to a set maximum pressure value when the syringe is actuated. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Special Publication No. 2018-512986 Summary of the Invention [Problem to be solved by the invention]

[0005] A catheter is inserted along a guidewire inserted into a blood vessel or body cavity. When inserting a guidewire into a blood vessel or body cavity, a contrast agent is injected and the insertion path of the guidewire is determined. When injecting the contrast agent, the guidewire must be removed from the catheter shaft and the contrast agent must be injected through the hub. Therefore, the state when the contrast agent is injected must be recorded with an imaging device, the guidewire must be reinserted into the catheter shaft, and the insertion path of the guidewire must be determined based on the image recorded earlier. Therefore, it was necessary to insert and remove the guidewire multiple times until the tip of the catheter reached the target position.

[0006] The present invention has been made in light of the above-mentioned circumstances, and its object is to provide a catheter that can determine the insertion path of a guidewire in real time when inserting the guidewire into a blood vessel or a body cavity. [Means for solving the problem]

[0007] The present invention is as follows. [1] A shaft having an inner cavity extending in a longitudinal direction; a catheter including a tubular member disposed in a lumen of the shaft, having a lumen extending in the longitudinal axis direction, and having a proximal opening and a distal opening, a hole is provided in a side wall of the cylindrical member, which allows the inner cavity of the cylindrical member to communicate with the inner cavity of the shaft; The catheter has a shaft having a supply port for supplying fluid to the lumen of the shaft. [2] A catheter as described in [1], wherein the inner surface of the shaft and the outer surface of the tubular member abut in the longitudinal axis direction of the shaft at a position distal to the most distal hole and supply port, and at a position proximal to the most proximal hole and supply port. [3] A catheter described in [1] or [2], wherein the shaft and the tubular member are fixed at a position distal to the most distal hole and supply port and at a position proximal to the most proximal hole and supply port in the longitudinal axis direction of the shaft. [4] The catheter according to any one of [1] to [3], wherein a braided tube or a coil is disposed on at least a portion of the radially outer side of the tubular member. [5] A catheter according to [4], in which an outer layer is disposed radially outward from at least the braided tube or the coil. [6] The catheter according to any one of [1] to [5], wherein the fluid contains a contrast agent. [7] The catheter according to any one of [1] to [6], wherein a radiopaque ring is disposed at the distal end of the tubular member. [Effects of the Invention]

[0008] The catheter according to the present invention has a tubular member in the lumen of the shaft, a hole in the sidewall of the tubular member that connects the lumen of the tubular member to the lumen of the shaft, and the shaft has a supply port for supplying fluid to the lumen of the shaft. Therefore, even if a guidewire is placed in the lumen of the tubular member, fluid supplied from the supply port travels from the lumen of the shaft through the hole to the lumen of the tubular member and is released into a blood vessel or body cavity from the distal opening of the tubular member. As a result, the insertion path of the guidewire can be determined in real time. [Brief explanation of the drawings]

[0009] [Figure 1] FIG. 1 is a schematic diagram showing an embodiment of a catheter. [Figure 2] FIG. 2 is a cross-sectional view of the main part II in FIG. [Figure 3] FIG. 3 is a cross-sectional view of the main part III in FIG. DETAILED DESCRIPTION OF THE INVENTION

[0010] An embodiment of a catheter according to the present invention is a catheter having a shaft having an inner lumen extending in the longitudinal direction, and a tubular member disposed in the inner lumen of the shaft, having an inner lumen extending in the longitudinal direction, and having a proximal opening and a distal opening, wherein a hole is disposed in the side wall of the tubular member to connect the inner lumen of the tubular member with the inner lumen of the shaft, and the shaft has a supply port for supplying fluid to the inner lumen of the shaft.

[0011] 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.

[0012] 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 periphery. That is, the distal end of each component refers to the portion including the distal end of each component and its periphery, and the proximal end of each component refers to the portion including the proximal end of each component and its periphery.

[0013] Fig. 1 is a schematic diagram showing an embodiment of a catheter, Fig. 2 is a cross-sectional view of a main part II of the catheter of Fig. 1, and Fig. 3 is a cross-sectional view of a main part III of the catheter of Fig. 1.

[0014] As shown in FIGS. 1 to 3 , the catheter 1 has a shaft 80 and a tubular member 10. The shaft 80 has a lumen extending in the longitudinal direction. The shaft 80 has a supply port 81 for supplying fluid to the lumen of the shaft 80. The tubular member 10 has a lumen extending in the longitudinal direction, and has a proximal opening 10aP and a distal opening 10bP. The tubular member 10 is disposed in the lumen of the shaft 80. A hole 15 is disposed in the side wall of the tubular member 10, which communicates the lumen of the tubular member 10 with the lumen of the shaft 80. Fluid supplied from the supply port 81 of the shaft 80 to the lumen of the shaft 80 passes through the hole 15 disposed in the side wall of the tubular member 10, moves from the lumen of the shaft 80 to the lumen of the tubular member 10, and is released from the distal opening 10bP of the tubular member 10. At this time, even if the guidewire 40 is inserted into the lumen of the tubular member 10, the fluid can be released from the distal opening 10bP of the tubular member 10. Therefore, if the fluid contains, for example, a contrast agent, the insertion path of the guidewire 40 can be determined in real time without removing the guidewire 40 from the tubular member 10.

[0015] The number of holes 15 arranged in the side wall of the cylindrical member 10 may be one or more, and may be 1 to 10, 2 to 9, or 3 to 8.

[0016] The position of the hole 15 arranged on the side wall of the tubular member 10 is not particularly limited, and may be arranged, for example, in a section from the distal end 10b of the tubular member 10 to a position 100 mm away in the longitudinal direction proximally, or in a section from the distal end 10b of the tubular member 10 to a position 80 mm away in the longitudinal direction proximally, or in a section from the distal end 10b of the tubular member 10 to a position 60 mm away in the longitudinal direction proximally.

[0017] The position of the hole 15 arranged on the side wall of the tubular member 10 and the supply port 81 of the shaft 80 may be such that, in the longitudinal axis direction of the tubular member 10, the hole 15 arranged on the side wall of the tubular member 10 is closer to the supply port 81 of the shaft 80, or may be in the same position as the supply port 81 of the shaft 80, but it is preferable that the hole 15 be closer to the supply port 81 of the shaft 80.

[0018] When there are multiple holes 15 arranged on the side wall of the tubular member 10, the holes 15 may be arranged in a row in the longitudinal axis direction of the tubular member 10, in a row in the circumferential direction of the tubular member 10, in a spiral arrangement around the tubular member 10, or in a random arrangement.

[0019] The size of the holes 15 arranged in the side wall of the tubular member 10 is not particularly limited as long as the size allows the fluid supplied to the lumen of the shaft 80 to flow from the outside to the inside of the tubular member 10. When multiple holes 15 are arranged in the side wall of the tubular member 10, all of the holes 15 may be the same size or different sizes.

[0020] The opening shape of the hole 15 arranged in the side wall of the tubular member 10 is not particularly limited, and may be, for example, circular, elliptical, oval, egg-shaped, triangular, square, rectangular, trapezoidal, rhombus, polygonal, or a combination thereof when viewed from the side of the tubular member 10.

[0021] The catheter 1 is preferably configured such that, with respect to the longitudinal axis direction of the shaft 80, (1) the inner surface of the shaft 80 and the outer surface of the tubular member 10 abut at a position distal to the most distally arranged hole 15 and supply port 81 and a position proximal to the most proximal arranged hole 15 and supply port 81, or (2) the shaft 80 and the tubular member 10 are fixed at a position distal to the most distally arranged hole 15 and supply port 81 and a position proximal to the most proximal arranged hole 15 and supply port 81. By the abutment of the inner surface of the shaft 80 and the outer surface of the tubular member 10 or by fixing the shaft 80 and the tubular member 10, a closed space is formed in the lumen of the shaft 80, which is sealed outside the tubular member 10. As a result, fluid supplied to the lumen of the shaft 80 is supplied from the closed space to the lumen of the tubular member 10 through the hole 15 arranged in the side wall of the tubular member 10.

[0022] (1) When the inner surface of the shaft 80 and the outer surface of the tubular member 10 abut against each other, it is sufficient that a portion of the inner surface of the shaft 80 abuts against a portion of the outer surface of the tubular member 10, and they are not fixed to each other. The inner surface of the shaft 80 and the outer surface of the tubular member 10 abut against each other at a position distal to the most distal position of the hole 15 arranged in the side wall of the tubular member 10 and the supply port 81 that the shaft 80 has, and at a position proximal to the most proximal position of the hole 15 arranged in the side wall of the tubular member 10 and the supply port 81 that the shaft 80 has.

[0023] (2) When the shaft 80 and the tubular member 10 are fixed, it is sufficient that a part of the shaft 80 and a part of the tubular member 10 are fixed. The shaft 80 and the tubular member 10 may be fixed at a position distal to the most distal position of the hole 15 arranged in the side wall of the tubular member 10 and the supply port 81 that the shaft 80 has, and at a position proximal to the most proximal position of the hole 15 arranged in the side wall of the tubular member 10 and the supply port 81 that the shaft 80 has.

[0024] The shaft 80 and the cylindrical member 10 may be fixed to each other, for example, via an adhesive or by heat fusion.

[0025] The catheter 1 may have a braided tube or a coil disposed on at least a portion of the radially outer side of the tubular member 10 .

[0026] The braided tube may have 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 may be made up of one or more wires.

[0027] The wires of the braided tube may be metal wires, fibers, or a combination thereof, 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.

[0028] The strands of the braided tube may contain a radiopaque material, which allows the position of the braided tube 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.

[0029] The cross-sectional shape of the braided tube perpendicular to the longitudinal axis of the wire is not particularly limited, and may be, for example, circular, elliptical, oblong, oval, D-shaped, triangular, rectangular, polygonal, or a combination thereof. The braided tube may also be made of round or flat wire. Flat wire is a round wire with both sides scraped off.

[0030] The wire diameter of the braided tube 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 perpendicular to the longitudinal axis direction of the wire.

[0031] The coil may be a solid wire or a stranded wire.

[0032] The coil may include metal wire, fiber, or a combination thereof, and preferably includes metal wire. The metal wire 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. The fiber preferably includes, for example, polyarylate fiber, aramid fiber, ultra-high molecular weight polyethylene fiber, polyparaphenylene benzobisoxazole fiber (PBO fiber), carbon fiber, or a combination thereof. The fiber may be monofilament or multifilament.

[0033] 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.

[0034] The shape of the cross section perpendicular to the longitudinal axis of the coil is not particularly limited, and examples include circular, elliptical, oblong, egg-shaped, D-shaped, triangular, rectangular, polygonal, and combinations thereof. The coil may also be made of round or flat wire. Flat wire is a round wire with both sides shaved.

[0035] The wire diameter of the coil is, for example, preferably 3 to 300 μm, more preferably 5 to 200 μm, and even more preferably 10 to 100 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 of the coil.

[0036] When a braided tube or coil is disposed on at least a portion of the radially outer side of the tubular member 10, an outer layer may be disposed at least radially outer than the braided tube or coil.

[0037] The outer layer may contain, 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 preferably contains a polyamide resin, a polyurethane resin, or a combination thereof. The resin may 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.

[0038] The outer layer may have a single layer structure, or may have a structure in which multiple layers are laminated in the radial direction of the tubular member 10. When the outer layer has a laminated structure, layers adjacent to each other in the radial direction of the tubular member 10 may contain different types of resins, or may contain the same type of resin.

[0039] When a braided tube or coil is disposed on at least a portion of the radially outer side of the tubular member 10 and an outer layer is disposed at least radially outer than the braided tube or coil, the braided tube or coil may be disposed within the outer layer, or an intermediate layer may be disposed on the radially outer side of the tubular member 10, the outer layer may be disposed outside the intermediate layer, and the braided tube or coil may be disposed within the intermediate layer. By forming a layered structure of the intermediate layer and the outer layer, it is possible to vary the stiffness of the tubular member 10 in the radial direction.

[0040] The intermediate layer may contain, 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 preferably contains a polyamide resin, a polyurethane resin, or a combination thereof. The resin may 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.

[0041] The intermediate layer may have a single layer structure, or may have a structure in which multiple layers are stacked in the radial direction of the tubular member 10. When the intermediate layer has a stacked structure, the layers adjacent to each other in the radial direction of the tubular member 10 may contain different types of resins, or may contain the same type of resin.

[0042] The outer layer may be disposed on the radially outside of the tubular member 10, or may be disposed in a section where no braided tube or coil is disposed.

[0043] The fluid may include, for example, a contrast agent, or may include, for example, saline or a drug.

[0044] The resin material constituting the cylindrical member 10 can be any known resin, including, for example, polyamide resins such as nylon; polyether polyamide resins; polyimide resins; polyester resins such as polyethylene terephthalate (PET); polyurethane resins; polyolefin resins such as polyethylene and polypropylene; fluorine-based resins such as polytetrafluoroethylene (PTFE), perfluoroalkoxyalkane (PFA), and ethylene tetrafluoroethylene copolymer (ETFE); polyvinyl chloride resins; silicone resins; and natural rubber. These may be used alone or in combination of two or more. Among these, polyamide resins, polyester resins, polyurethane resins, polyolefin resins, and fluorine-based resins are preferred.

[0045] When a braided tube or coil is disposed on at least a portion of the radially outer side of the tubular member 10 and an outer layer is disposed at least radially outer than the braided tube or coil, it is preferable to use a fluorine-based resin such as polytetrafluoroethylene (PTFE), perfluoroalkoxyalkane (PFA), or ethylene tetrafluoroethylene copolymer (ETFE) from among the known resins described above as the resin material constituting the tubular member 10. These may be used alone or in combination of two or more.

[0046] A radiopaque ring may be disposed at the distal end of the tubular member 10. This allows the position of the distal end 10b of the tubular member 10 to be confirmed under X-ray fluoroscopy. The radiopaque ring is a ring containing a radiopaque material, and may be a ring made of a radiopaque material. The radiopaque materials exemplified above can be used.

[0047] The resin material constituting the shaft 80 can be any known resin, including, for example, polyamide resins such as nylon; polyether polyamide resins; polyimide resins; polyester resins such as polyethylene terephthalate (PET); polyurethane resins; polyolefin resins such as polyethylene and polypropylene; fluorine-based resins such as polytetrafluoroethylene (PTFE), perfluoroalkoxyalkane (PFA), and ethylene tetrafluoroethylene copolymer (ETFE); polyvinyl chloride resins; silicone resins; and natural rubber. These resins may be used alone or in combination. Among these, polyamide resins, polyester resins, polyurethane resins, polyolefin resins, and fluorine-based resins are preferred.

[0048] The shaft 80 may have a single-layer structure or a multi-layer structure, with a single-layer structure being preferred. A single-layer structure allows for easier manufacturing. If the shaft has a multi-layer structure, the resin materials constituting each layer may be the same or different.

[0049] The shaft 80 may be constructed from a single tube from the proximal end to the distal end, or may be constructed by joining multiple tubes. By constructing the shaft 80 from multiple tubes, the bending rigidity of the shaft 80 in the longitudinal direction can be changed.

[0050] The resin material forming the shaft 80 and the resin material forming the inner cylindrical member 10 may be the same or different, and by using different resin materials, the strength of each can be controlled. [Explanation of symbols]

[0051] 1 catheter 10 Cylindrical member 10a Proximal end of tubular member 10b distal end of tubular member 10aP Proximal opening of tubular member 10bP Distal opening of tubular member 15 holes 40 Guidewire 80 shaft 80b Distal end of shaft 81 Supply port

Claims

1. a shaft having a longitudinally extending lumen; a catheter including a tubular member disposed in a lumen of the shaft, having a lumen extending in the longitudinal axis direction, and having a proximal opening and a distal opening, a hole is provided in a side wall of the cylindrical member, which allows the inner cavity of the cylindrical member to communicate with the inner cavity of the shaft; The catheter has a shaft having a supply port for supplying fluid to the lumen of the shaft.

2. 2. The catheter of claim 1, wherein the inner surface of the shaft and the outer surface of the tubular member abut in the longitudinal axis direction of the shaft at a position distal to the most distal hole and supply port, and at a position proximal to the most proximal hole and supply port.

3. 2. The catheter of claim 1, wherein the shaft and the tubular member are fixed in the longitudinal axis direction of the shaft at a position distal to the most distal hole and supply port and at a position proximal to the most proximal hole and supply port.

4. The catheter according to claim 1, wherein a braided tube or a coil is disposed on at least a portion of the radially outer side of the tubular member.

5. The catheter according to claim 4, wherein an outer layer is disposed radially outward from at least the braided tube or the coil.

6. The catheter of claim 1 , wherein the fluid includes a contrast agent.

7. 2. The catheter according to claim 1, wherein a radiopaque ring is disposed at the distal end of the tubular member.

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