JP2006218070A - Catheter - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a catheter sustainably or temporarily indwelled in a tubular organ such as the blood vessel, smoothly moved along the outer circumference of a guide wire, and efficiently indwelling a blood vessel occluding instrument. <P>SOLUTION: This catheter 10 is provided with an inside resin layer 22 forming an internal circumference, a cylindrical reinforcing body 23 disposed at least at a distal end outer circumference of the inside resin layer 22, a coil 24 made of shape memory alloy and disposed at the distal end outer circumference of the inside resin layer, and an outside resin layer 26 disposed in the outermost circumference. The coil 24 made of the shape memory alloy is formed into a curved shape so that the distal end 21 of the catheter 10 is formed into the curved shape. This constitution can form the internal circumference of the catheter 10 into a smooth face without any recesses/projections so as to smoothly move the catheter 10 and efficiently indwell the blood vessel occluding instrument in an objective site. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to a catheter that is placed in a tubular organ such as a blood vessel continuously or temporarily, injecting a chemical solution such as an anticancer agent, or placing a blood vessel obturator or the like.

  In recent years, a catheter is inserted into a tubular organ such as a blood vessel, and a medical solution such as a contrast agent or an anticancer agent is administered, or a coiled vascular occlusion device is placed through the catheter.

  That is, after a thin and flexible guide wire is inserted into a tubular organ such as a blood vessel in advance, the tip of the guide wire reaches the target location, and a catheter is inserted along the outer periphery of the guide wire to reach the target location. The guide wire is withdrawn and the catheter is placed in the tubular organ. Then, a chemical solution is injected from the proximal end of the catheter, or a blood vessel obturator is placed in the tubular organ through the catheter, and one of the branch pipes of the tubular organ is blocked to effectively administer the chemical solution. ing.

  As such a catheter, in Patent Document 1 below, a shaping member made of a coil or a mesh tube is disposed along at least the inner periphery of the distal end portion of the tubular catheter body, and the distal end portion of the catheter body is bent. A catheter is disclosed in which a lumen is secured along the central axis of the shaping member.

In the above catheter, since the distal end portion of the catheter is shaped in a bent shape, the distal end portion is pressed and fixed to the inner wall of a blood vessel or the like. Therefore, since the tip of the catheter is not displaced, a drug solution such as an anticancer drug can be administered only to the target site.
JP 2000-185102 A

  However, since the coil or mesh tube is arrange | positioned at the front-end | tip part inner periphery of the catheter main body in the said patent document 1, the inner periphery of a catheter is not smooth and the unevenness | corrugation has arisen.

  Therefore, when the catheter is moved along the outer periphery of the guide wire, the catheter is easily caught. When the guide wire is moved along the inner periphery of the catheter, the guide wire is easily caught. Even when the coiled vascular occlusion device is placed in a tubular organ, the vascular occlusion device is easily caught, which may hinder the placement of the catheter or vascular occlusion device. Furthermore, there is a possibility that the hydrophilic resin film coated on the surface of the guide wire may be scraped off due to the irregularities on the inner circumference of the catheter.

  Therefore, the object of the present invention is to be able to be continuously or temporarily placed in a tubular organ such as a blood vessel, and to be smoothly moved along the outer periphery of the guide wire. An object of the present invention is to provide a catheter in which a guide wire can be moved smoothly and a vascular obturator can be efficiently placed.

  In order to achieve the above object, a first aspect of the present invention is a tube-shaped catheter, which is an inner resin layer that forms an inner periphery, and a cylindrical reinforcement that is disposed at least on the outer periphery of the base end of the inner resin layer. A shape memory alloy coil disposed on the outer periphery of the tip end portion of the inner resin layer, and an outer resin layer disposed on the outermost periphery, and the shape memory alloy coil is shaped into a bent shape. Thus, the catheter is characterized in that the distal end portion of the catheter is shaped in a bent shape.

  According to the first invention, the coil made of shape memory alloy is disposed on the outer periphery of the inner resin layer forming the inner periphery, and the guide inner wire becomes a smooth surface without any irregularities. The catheter can be moved smoothly along the outer periphery of the catheter, the guide wire can be moved smoothly along the inner periphery of the catheter, and the blood vessel obturator can be smoothly passed through the catheter to form a tubular shape. It can be efficiently placed at the target location in the organ.

  In addition, since the distal end of the catheter is shaped in a bent shape, when the catheter reaches the target location, the shape of the distal end of the catheter is restored by pulling out the guide wire and is fixed to the inner wall of the tubular organ. Thus, the catheter can be placed in the tubular organ continuously or temporarily. Therefore, it is possible to reliably and effectively perform drug solution administration, placement of a blood vessel obturator, and the like at a target location. Moreover, since the bent shape of the distal end of the catheter is maintained by the coil made of the shape memory alloy, it does not extend straight even after repeated use, and can always be in a predetermined bent shape, stably It can be placed in a tubular organ. The distal end of the catheter means the vicinity of the end of the catheter on the opposite side of the proximal end of the catheter (the part to be gripped when using the catheter), and only the most distal end of the catheter. It is not a thing.

  Furthermore, since the inner circumference of the catheter is flat, the guide wire is easy to slip in the catheter, the guide wire can be smoothly inserted and removed from the catheter, the operability of the guide wire and the catheter can be improved, and the surface of the guide wire is coated. The hydrophilic resin film or the like is not scraped off.

  In addition, since a reinforcing body is disposed on the outer periphery of the proximal end of the inner resin layer, that is, on the proximal end side of the catheter, torque transmission required when selecting a blood vessel, kink resistance to prevent twisting / bending, Improve the push ability required at the time of insertion.

  According to a second aspect of the present invention, there is provided the catheter according to the first aspect, wherein the outer resin layer is also shaped by heat treatment into the same bent shape as the shape memory alloy coil.

  According to the second aspect of the invention, not only the coil made of shape memory alloy but also the outer resin layer is shaped into a bent shape by heat treatment. The bent shape of the distal end portion of the catheter can be stabilized, and the shape restoring property of the distal end portion of the catheter can be further improved when the guide wire is pulled out.

  According to a third aspect of the present invention, there is provided the catheter according to the first or second aspect, wherein the inner resin layer is made of a fluororesin.

  According to the third aspect, since the inner resin layer is made of a fluorine-based resin having a small friction coefficient, the guide wire can be more easily slipped in the catheter, and the operability of the guide wire and the catheter can be further improved. it can.

  According to the catheter of the present invention, a coil made of a shape memory alloy is arranged on the outer periphery of the inner resin layer forming the inner periphery, and the catheter inner periphery becomes a smooth surface without unevenness. The blood vessel can be moved smoothly, and the blood vessel obturator can be efficiently placed at the target location. Further, since the distal end portion of the catheter is bent by a coil made of shape memory alloy, the catheter can be stably or temporarily placed in a tubular organ, such as drug solution administration or placement of a vascular occlusion device. Can be reliably and effectively performed. Furthermore, since the inner circumference of the catheter is flat, the guide wire is easy to slip, the operability of the guide wire and the catheter can be improved, and the reinforcement is disposed at the proximal end portion of the catheter, thereby improving pushability and the like.

  Hereinafter, with reference to FIGS. 1-8, one Embodiment of the catheter of this invention is described.

  As shown in FIG. 1, the catheter 10 of the present invention includes a catheter main body 20 having a tube shape and a catheter hub 30 connected to the proximal end of the catheter main body 20.

  The catheter hub 30 is made of a synthetic resin such as polypropylene or nylon, and has a flat shape so that it can be easily grasped by hand. The catheter hub 30 has an introduction tube 31 that communicates with the catheter body 20. The introduction tube 31 has an inner diameter that tapers toward the opening, and serves as a guide for introducing a guide wire 40 or a coil-shaped obturator described later into the catheter body 20.

  The catheter body 20 has a tubular shape extending with a constant outer diameter, and the proximal end is connected to the catheter hub 30. And the front-end | tip part 21 of the catheter main body 20 is shaped in the bending shape. That is, the distal end portion of the catheter 10 has a bent shape.

The catheter body 20 has a multilayer structure in which a plurality of layers are stacked. Referring also to FIG. 2 (for convenience, the distal end portion 21 is not bent), for example, polytetrafluoroethylene (PTFE), perfluoroalkoxy resin (PFA) is formed on the inner periphery of the catheter body 20. ), Fluororesins such as tetrafluoroethylene-hexafluoropropylene copolymer (FEP), tetrafluoroethylene-ethylene copolymer (ETFE), polyurethane, nylon elastomer, polyether block amide, polyethylene, poly A tubular inner resin layer 22 made of a synthetic resin such as vinyl chloride or vinyl acetate is disposed. The inner resin layer 22 may contain X-ray opaqueness by containing powders such as BaSO ₄ , Bi, and W. In the case of this embodiment, the inner resin layer 22 is made of a fluorine resin.

  A cylindrical reinforcing body 23 is disposed on the outer periphery of the inner resin layer 22 on the proximal end side of the catheter body 20. As the reinforcing body 23, for example, a metal wire made of a metal such as stainless steel, W, W plated with Au, or a Ni-Ti alloy, or a wire made of a synthetic resin such as nylon or polyester is alternately crossed. It consists of a so-called braided shape, a coil or the like.

  In addition, a coil 24 made of a shape memory alloy (hereinafter referred to as a coil 24) is disposed on the distal end 21 side of the catheter body 20 on the outer periphery of the inner resin layer 22. Examples of shape memory alloys include Ni-Ti alloys, Ni-Ti-X (X = Fe, Cu, V, Co, etc.) alloys, Cu-Zn-X (X = Al, Fe, etc.) alloys, Cu-Al -Ni alloy etc. are preferably used. Furthermore, the coil 24 is shaped in a bent shape, and accordingly, the distal end portion 21 of the catheter body 20 is shaped in a bent shape. With this coil 24, the distal end portion 21 of the catheter body 20 ensures both moderate flexibility and shape restoration.

  An annular marker 25 made of a radiopaque material is provided in the vicinity of the distal end portion 21 of the catheter body 20. Thereby, the position when the catheter 10 is inserted can be visually recognized by an X-ray monitor or the like. As the marker 25, for example, a metal such as Pt, Pt alloy, W, Au plated W, Au or the like is preferably used. The marker 25 is preferably arranged at a distance of 0.3 to 2.0 mm (distance A) from the distal end surface of the catheter body 20, thereby stably ensuring the marker action during X-ray imaging. is doing.

The outer periphery of the inner resin layer 22, the reinforcing body 23, the coil 24, and the marker 25 is covered with a tubular outer resin layer 26. Examples of the outer resin layer 26 include heat-shrinkable synthetic resins such as polyurethane, nylon elastomer, polyether block amide, polyethylene, polyvinyl chloride, and vinyl acetate, polytetrafluoroethylene (PTFE), perfluoroalkoxy resin (PFA). ), Fluorine-based resins such as tetrafluoroethylene-hexafluoropropylene copolymer (FEP) and tetrafluoroethylene-ethylene copolymer (ETFE). The outer resin layer 26 may contain X-ray opaqueness by containing powders such as BaSO ₄ , Bi, and W. In the case of this embodiment, the outer resin layer 26 is made of the above synthetic resin.

  Further, polyvinyl pyrrolidone, polyethylene glycol, methyl vinyl ether maleic anhydride copolymer is provided on the outer periphery of the outer resin layer 26 so as to improve the lubricity of the catheter body 20 with respect to the inner wall of the blood vessel and to prevent the thrombus from adhering as much as possible. It is preferable that a hydrophilic resin such as is coated.

  In this embodiment, the outer resin layer 26 is also shaped into the same bent shape as the coil 24 by heat treatment.

  As shown in FIGS. 1 and 3, the catheter body 20 composed of the above-described components has a shape in which a distal end portion 21 is bent. In the case of this embodiment, the distal end portion 21 of the catheter body 20 is shaped in a bent shape by both the coil 24 and the outer resin layer 26, but the distal end portion 21 is shaped in a bent shape only by the coil 24. You may let them. Further, the distal end portion 21 of the catheter body 20 may be shaped into various shapes as shown in FIG. 4A shows a shape in which the distal end portion 21 is obliquely bent at a predetermined angle with respect to the catheter body 20, and FIG. 4B shows that the distal end portion 21 of FIG. A bent shape is formed by bending toward the base end side. FIG. 4C shows a shape in which the tip 21 is bent in a J shape, and FIG. 4D shows a shape in which the tip of the tip 21 in FIG. There is no. Further, FIG. 4E shows a shape in which the tip 21 is bent into a loop shape.

  Next, an example of the manufacturing method of the catheter 10 of the present invention will be described.

  First, the coil 24 is shaped into a predetermined bent shape. That is, as shown in FIG. 5B, a shaping metal core 50 formed by shaping a metal or the like into a predetermined bent shape is covered with the coil 24 and subjected to shape memory processing in that state, and thereafter shaped. The core metal 50 is pulled out to form the coil 24 having a bent shape as shown in FIG.

  Next, a tube-shaped inner resin layer made of a fluororesin is formed by immersing the wire in a melted fluororesin, heating the wire with a predetermined thickness of the fluororesin, and then pulling out the core wire. 22 is formed.

  Then, with the mandrel inserted into the inner periphery of the inner resin layer 22, the reinforcing body 23 is braided into a braided shape with a stainless wire or the like from the base end to the middle in the axial direction on the outer periphery of the inner resin layer 22.

  Next, a coil 24 shaped in a bent shape is placed on the tip of the inner resin layer 22 so as not to overlap the reinforcing body 23, and a marker 25 is placed so as not to overlap the coil 24.

  Then, a tubular outer resin layer 26 made of a heat-shrinkable synthetic resin having an inner diameter larger than the outer diameter of the marker 25, coil 24, and reinforcing body 23 is further connected to the outer periphery of the marker 25, coil 24, and reinforcing body 23. Put on.

  Next, the outer resin layer 26 is heated and contracted by heating means such as a heater, so that the outer resin layer 26 is attached to the outer periphery of the marker 25, the coil 24, the reinforcing body 23, and the inner resin layer 22.

  Note that the outer resin layer 26 may be covered with a plurality of tubes instead of a single layer. For example, the base end side is coated with a hard resin layer, the soft resin layer is coated adjacent to the base resin, and the soft resin layer is further coated adjacent to the soft resin layer. You may coat the resin layer in which hardness becomes soft in steps. If it carries out like this, the hardness of the catheter main body 20 will become soft gradually toward a front-end | tip, and since a hardness gradient can be made smooth, the kink resistance and pushability of the catheter 10 can be improved. Further, only the distal end portion 21 of the catheter body 20 may be covered with another resin layer, for example, a more flexible resin layer than the outer resin layer 26.

  In this way, when the outer resin layer 26 is attached to the outer periphery of the marker 25, the coil 24, the reinforcing body 23, and the inner resin layer 22, the mandrel is extracted. Then, the distal end portion 21 of the catheter body 20 is heat-treated by a heating means such as a heater in a state where the distal end portion 21 of the catheter body 20 is shaped into a predetermined bent shape by the shaping core metal 50, the formwork, or the like. Then, since the outer resin layer 26 on the outer periphery is softened, the shape of the coil 24 that has been constrained by the outer resin layer 26 returns to the original bent shape, and the outer resin layer 26 is also shaped in the same bent shape as the coil 24. The Rukoto. Thus, the distal end portion 21 of the catheter body 20 is shaped into a bent shape.

  Then, the distal end of the catheter hub 30 is inserted and attached to the proximal end of the catheter body 20, and the catheter 10 is formed by protecting the connecting portion by the protective tube 32.

  In the case of the above embodiment, a fluororesin is selected as the inner resin layer 22 and a heat-shrinkable synthetic resin is selected from the outer resin layer 26. However, a synthetic resin such as nylon is used as the inner resin layer 22 and the outer resin. A fluorine-based resin layer may be selected for the layer 26, and the combination is not particularly limited.

  Next, an example of a method for using the catheter 10 of the present invention and its operation and effect will be described with reference to FIGS. Here, a method of administering a drug solution such as an anticancer drug using the catheter 10 will be described. 6 and 8, S is skin and V is blood vessel.

  In addition, as the guide wire 40 used at this time, various known ones can be used. That is, a superelastic alloy, a core wire made of stainless steel, etc., coated with a synthetic resin film, a coil attached to the outer periphery of the core wire, and the outer periphery of this coil further covered with a synthetic resin film, etc. are used.

  First, as shown in FIG. 6A, a sheath-like sheath 41 is inserted into the blood vessel V through the skin S by a well-known Seldinger method. Next, the guide wire 40 is inserted from the proximal end of the sheath 41, the distal end of the guide wire 40 reaches the target location of the blood vessel V, and then the catheter 10 is inserted and moved along the outer periphery of the guide wire 40. To reach the destination.

  Alternatively, as shown in FIG. 6A, with the guide wire 40 inserted from the introduction tube 31 of the catheter hub 30 and the catheter 10 being disposed on the outer periphery of the guide wire 40, the tip of the guide wire 40 is slightly moved. Once moved, the operation of moving the catheter 10 by following it may be repeated to bring the catheter 10 to the target location.

  At this time, as shown in FIG. 7, the catheter 10 of the present invention has the coil 24 disposed on the outer periphery of the inner resin layer 22, and the inner periphery of the catheter 10 has a smooth surface without any unevenness. Therefore, unlike the catheter described above, the guide wire 40 is not caught in the catheter 10, and the catheter 10 can be smoothly moved along the outer periphery of the guide wire 40. In addition, since the guide wire 40 is not caught in the catheter 10, the guide wire 40 can be smoothly moved along the inner periphery of the catheter 10. Similarly, although not illustrated, even when a vascular occlusion device is indwelled, the vascular occlusion device is not caught in the catheter 10, and the vascular occlusion device is smoothly passed through the catheter 10 to form a tubular shape. It can be efficiently placed at the target location in the organ. At this time, the distal end portion 21 of the catheter 10 is stretched linearly by the rigidity of the guide wire 40.

  And if the catheter 10 is detained in the target location, the guide wire 40 will be gradually pulled out. Then, the distal end portion of the catheter 10 is expanded by the shape restoring force of the coil 24, and the outer diameter thereof becomes larger than the inner diameter of the blood vessel V, so that it begins to be pressed against the inner wall of the blood vessel V. Further, as shown in FIG. 6B, when the guide wire 40 is completely pulled out, the coil 24 returns to its original bent shape and is pressed and fixed to the inner wall of the blood vessel V.

  Thus, since the distal end portion 21 of the catheter 10 is shaped in a bent shape, when the catheter 10 reaches the target location, the distal end portion 21 of the catheter 10 returns to its shape by pulling out the guide wire 40. The catheter 10 can be placed in the blood vessel V continuously or temporarily by being pressed and fixed to the inner wall of the blood vessel V. Therefore, it is possible to reliably and effectively perform drug solution administration, placement of a blood vessel obturator, and the like at a target location. In addition, since the bent shape of the distal end portion 21 of the catheter 10 is maintained by the coil 24, even if it is repeatedly used, it does not extend straight and can always have a predetermined bent shape, and the blood vessel V can be stably formed. It becomes possible to place it inside.

  Furthermore, since the inner periphery of the catheter 10 is flat, the guide wire 40 is easily slipped in the catheter 10, and the guide wire 40 can be smoothly inserted and removed from the catheter 10, and the operability of the guide wire 40 and the catheter 10 can be improved. The hydrophilic resin film coated on the surface of the wire 40 is not scraped off.

  Further, since the reinforcing body 23 is disposed on the outer periphery of the proximal end portion of the inner resin layer 22, that is, on the proximal end side of the catheter 10, torque transmission properties necessary for blood vessel selection, resistance to twisting and bending, and the like are prevented. Improves kink and pushability required for insertion.

  Furthermore, in the case of this embodiment, the outer resin layer 26 is also shaped in the same bent shape as the coil 24 by heat treatment. For this reason, not only the coil 24 but also the outer resin layer 26 is shaped into a bent shape by heat treatment, so that the bent shape of the distal end portion 21 of the catheter 10 is combined with the coil 24 shaped into the bent shape. While being able to stabilize, when the guide wire 40 is pulled out, the shape restoring property of the distal end portion 21 of the catheter 10 can be further improved.

  Furthermore, in the case of this embodiment, since the inner resin layer 22 is made of a fluorine-based resin having a small friction coefficient, the guide wire 40 can be made more slippery in the catheter 10, and the guide wire 40 and the catheter 10 The operability can be further improved.

  As described above, when the distal end portion 21 of the catheter 10 is disposed at the target location of the blood vessel V and the guide wire 40 is completely pulled out, the sheath 41 is also pulled out and the drug solution injection port 42 is implanted. This chemical solution injection port 42 is provided with a rubber film (not shown) into which an injection needle or the like can be inserted in the upper surface opening of a synthetic resin or metal frustum-shaped container 43, and a chemical solution outlet 44 is provided on the side wall of the container 43. It is provided and configured. The separated proximal end of the catheter 10 is connected to the chemical solution outlet 44, and as shown in FIG. 8, the skin S is incised, and the chemical solution injection port 42 is embedded in the lower part of the skin S, and a thread or the like is used. The placement of the catheter 10 is completed by tightening and fixing.

  When periodically administering the anticancer drug, an injection needle of a syringe (not shown) is inserted into the rubber film (not shown) of the drug solution injection port 42 through the skin S, and a drug solution in which the cancer drug is dissolved is injected into the drug solution injection port 42. The drug solution can pass through the catheter 10 from the drug solution outlet 44 and flow out of the distal end opening of the catheter 10 to be selectively injected into an organ affected by cancer.

  The present invention is a catheter that can be continuously or temporarily placed in a tubular organ such as a blood vessel, can be smoothly moved along the outer periphery of a guide wire, and can effectively place a blood vessel obturator. Can be used.

It is a perspective view which shows one Embodiment of the catheter of this invention. It is sectional drawing in the tip part vicinity when the front-end | tip part of the catheter is not shaped. It is the perspective view which expanded the vicinity of the front-end | tip part of the catheter partially. There are various bent shapes of the distal end portion of the catheter, (a) is an obliquely bent shape, (b) is a shape where the distal end of the distal end portion of (a) is folded, and (c) is bent into a J-shape. (D) is an explanatory view showing a shape in which the tip of the tip portion 21 of (c) is folded and bent into a J shape, and (e) is a shape bent in a loop shape. The coil of the catheter is shown, (a) is a perspective view which shows the state which bent the coil, (b) is a perspective view which shows the metal core for shaping for shaping a coil. The example which indwells the catheter in the body is shown, (a) is explanatory drawing which shows the state which inserted the guide wire and catheter using the sheath, (b) is the state which pulled out the guide wire and indwelled the catheter. It is explanatory drawing shown. It is sectional drawing which shows the state which is moving the catheter along the guide wire outer periphery. It is explanatory drawing which shows the state which connected the chemical | medical solution injection | pouring port to the catheter and indwelled in the body.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 Catheter 20 Catheter main body 21 Tip part 22 Inner resin layer 23 Reinforcement body 24 Coil 25 made of shape memory alloy Marker 26 Outer resin layer 30 Catheter hub 31 Introducing tube 32 Protective tube 40 Guide wire 41 Sheath 42 Drug solution injection port 43 Container 44 Drug solution Outflow port 50 Core metal for shaping S Skin V Blood vessel

Claims (3)

  A tube-shaped catheter, which is disposed on the inner resin layer forming the inner periphery, a cylindrical reinforcing body disposed on at least a base end outer periphery of the inner resin layer, and a distal end outer periphery of the inner resin layer. A shape memory alloy coil and an outer resin layer disposed on the outermost periphery, and the shape memory alloy coil is shaped in a bent shape, whereby the distal end of the catheter is attached in a bent shape. A catheter characterized by being shaped.   The catheter according to claim 1, wherein the outer resin layer is also shaped into the same bent shape as the shape memory alloy coil by heat treatment.   The catheter according to claim 1 or 2, wherein the inner resin layer is made of a fluororesin.

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