JP5834536B2 - Catheter having tapered structure with different lumen and outer circumference - Google Patents

Description

  The present invention relates to a catheter such as a balloon catheter used for endovascular treatment.

At present, an intravascular treatment method using a catheter or the like is known as a less invasive treatment method for an intravascular lesion such as an aneurysm. For example, in this endovascular treatment method, a balloon catheter is used in a blood vessel, and is used for assisting treatment with a dilation of a blood vessel, another endovascular treatment device, occlusion of a blood vessel, or the like. Therefore, the balloon catheter is required to have a characteristic that the balloon can be quickly expanded and contracted, and at the same time, an excessive load is applied to an application site such as a blood vessel or an aneurysm, so that the wall of the blood vessel or the aneurysm can be obtained. The flexibility and placement capability required to perform the indwelling operation without causing problems such as damage to the surface are also required.
In addition, a catheter other than a balloon catheter, for example, a catheter for injecting a drug or the like, or a catheter for aspirating an in-vivo substance such as a thrombus, can quickly inject a drug or aspirate an in-vivo substance, and a blood vessel Therefore, the flexibility and placement capability required to perform the indwelling operation without causing problems such as applying an excessive load on the machine are also required.

  As a contrivance for realizing the characteristics that can quickly suck in-vivo substances etc., it is proposed to provide a taper structure in the lumen of the shaft having a guide wire lumen at the tip as described in Patent Document 1. Has been. Moreover, as a device for realizing the characteristic that balloon expansion / contraction can be performed quickly, a high suction function is provided by, for example, providing a suction-only lumen or a taper structure of the shaft disclosed in Patent Document 1. It is possible.

  However, due to the above structure, the shaft becomes thicker or the thickness balance of the shaft is lost, so that the flexibility and placement ability necessary for smooth placement operation cannot be realized, and balloon expansion / While it is possible to achieve the flexibility and placement capability required for smooth placement operation as well as the property of being able to contract quickly, there is a demand for a more moist placement operation. is there.

JP 2010-57831 A

  An object of the present invention is to provide a catheter such as a balloon catheter that has high delivery performance and can quickly perform fluid injection and suction operations such as balloon expansion and contraction.

  As a result of intensive studies, the present inventors have solved the above problem by focusing on the tapered structure of the outer peripheral portion of the cylindrical body constituting the shaft of the catheter and the inner peripheral portion forming the lumen portion of the shaft. As a result, the present invention has been completed. That is, the gist of the present invention is as follows.

(1) having a shaft with a lumen communicating from the distal part to the proximal part;
A taper portion that decreases in diameter from the proximal portion toward the distal portion is formed on part or all of the entire shaft length of the outer peripheral portion of the shaft and the inner peripheral portion that forms the lumen portion,
The proximal portion side end portion of the tapered portion formed on the inner peripheral portion is disposed on the distal portion side with respect to the proximal portion side end portion of the tapered portion formed on the outer peripheral portion, and the inner peripheral portion The catheter is characterized in that the proximal end portion of the tapered portion is arranged closer to the proximal portion side than the distal end portion of the tapered portion of the outer peripheral portion .
(2) having a shaft with a single lumen communicating from the distal portion to the proximal portion;
A taper portion that decreases in diameter from the proximal portion toward the distal portion is formed on part or all of the entire shaft length of the outer peripheral portion of the shaft and the inner peripheral portion that forms the lumen portion,
The proximal portion side end portion of the tapered portion formed on the inner peripheral portion is disposed on the distal portion side with respect to the proximal portion side end portion of the tapered portion formed on the outer peripheral portion. And catheter.
( 3 ) The catheter according to (1) or (2) , wherein a balloon is provided on an outer peripheral portion in the vicinity of the distal end portion of the shaft.
( 4 ) The shaft includes a small hole portion that communicates the inside of the balloon and the lumen portion of the shaft, and a guide wire inserted into the lumen portion on the distal side of the small hole portion. A catheter that is slidably held in an airtight or liquid-tight state, and the catheter according to ( 3 ) .
( 5 ) having a shaft provided with a lumen communicating from the distal part to the proximal part;
A taper portion that decreases in diameter from the proximal portion toward the distal portion is formed on part or all of the entire shaft length of the outer peripheral portion of the shaft and the inner peripheral portion that forms the lumen portion,
A balloon is provided on the outer periphery near the distal end of the shaft,
The shaft includes an outer tube and an inner tube disposed inside the outer tube;
The outer periphery of the shaft is formed by the outer periphery of the outer tube, and the lumen of the shaft is formed by the inner periphery of the inner tube;
The outer tube and the inner tube are joined in the vicinity of the end on the distal side, respectively, and a balloon lumen that communicates with the inside of the balloon is formed by the inner periphery of the outer tube and the outer periphery of the inner tube. It is,
The proximal portion side end portion of the tapered portion of the inner peripheral portion is disposed closer to the proximal portion side than the proximal portion side end portion of the tapered portion of the outer peripheral portion,
Proximal end portion, catheters arranged on the proximal side from the distal end of the tapered portion of the inner peripheral portion of the tapered portion of the outer peripheral portion.

  According to the present invention, it is possible to provide a catheter that has high delivery performance and can quickly perform fluid injection and suction operations. In addition, according to the present invention, it is possible to provide a balloon catheter that has a particularly high delivery performance and can rapidly expand and contract the balloon. In particular, in a balloon catheter of which the tip is sealed by a guide wire with a single lumen, the balloon can be expanded and contracted at a sufficient speed even when the outermost diameter of the catheter shaft is very thin.

It is an axial sectional view showing the outline of the structure of an example of the first embodiment of the catheter of the present invention. It is an axial sectional view which shows the outline of the use condition of the other example of 1st Embodiment of the catheter of this invention. It is an axial direction sectional view showing an outline of an example of a 2nd embodiment of a catering of the present invention. It is explanatory drawing which shows the outline of the evaluation apparatus used for the slipperiness evaluation of an Example and a comparative example. (A) It is an axial direction fragmentary sectional view which shows typically the structure of the front-end | tip part of the shaft of Example 1. FIG. (B) It is an axial direction fragmentary sectional view which shows typically the structure of the front-end | tip part of the shaft of the comparative example 1. FIG. (C) It is an axial direction fragmentary sectional view which shows the structure of the front-end | tip part of the shaft of the comparative example 2 typically.

  The catheter of the present invention has a shaft having a lumen portion communicating from the distal portion to the proximal portion, and a part of the entire shaft length of the outer peripheral portion of the shaft and the inner peripheral portion forming the lumen portion Alternatively, a taper portion that decreases in diameter from the proximal portion toward the distal portion is formed in all, and the proximal portion side end portion of the tapered portion formed in the inner peripheral portion is the outer peripheral portion. The taper portion is formed at a position different from the proximal end portion of the tapered portion in the entire length of the shaft.

  As described above, in the catheter of the present invention, since the tapered portion is arranged on the outer peripheral portion and the inner peripheral portion forming the lumen portion, a wider lumen is formed compared to a catheter having no tapered portion on the inner peripheral portion. Therefore, it is possible to quickly inject and suck the fluid passing through the lumen. Further, when the catheter is a balloon catheter, as will be described later, it is possible to quickly suck and inject a liquid used for balloon expansion / contraction, and balloon expansion / contraction can be performed quickly.

  In addition, by making a part or all of the outer peripheral part and inner peripheral part of the shaft have a taper structure, the thickness and hardness of the distal part and the proximal part of the shaft are compared with a straight tube catheter without a tapered part. It is possible to change the balance. Therefore, the catheter can be easily inserted into a part deeper in the lumen of a living body circulatory organ or digestive organ (part farther from the insertion part of the catheter outside the living body). In the present invention, the ability of the catheter to reach a predetermined part of the lumen of the living body is referred to as delivery performance or delivery performance.

  When forming a taper part in the predetermined part of a shaft, generally the method of extending | stretching the straight tubular tube previously shape | molded and providing the taper part gradually reduced in diameter in the straight tubular tube is employ | adopted.

  Therefore, for example, in the case of a straight tube having a single lumen portion, it is formed on the inner peripheral portion of the shaft having the tapered portion obtained by extending the tube and on the outer peripheral portion of the shaft. The tapered portion is disposed at the same position in the entire shaft length. As a result, the thickness of the shaft having a single lumen portion and the volume of the shaft lumen portion cannot be controlled, and the fluid is injected and sucked through the lumen portion while having high delivery performance. It was difficult to perform the operation promptly.

  In addition, for example, in a balloon catheter having a shaft having an inner tube and an outer tube, the inner tube is constituted by the inner tube lumen, the inner tube outer peripheral surface, and the outer tube inner peripheral surface. In the case of having another lumen portion, generally, the inner tube uses a straight tube, and the tapered portion is formed only on the outer tube. Therefore, as in the case of the tube having the single lumen portion, the outer peripheral portion of the outer tube and the tapered portion formed on the inner peripheral portion are arranged at the same position in the entire shaft length. As a result, although there is no change in the lumen volume of the inner tube, the wall thickness of the outer tube and the volume of the lumen portion of the outer tube cannot be controlled and pass through the one or two lumens. It has been difficult to ensure high delivery performance while quickly performing fluid injection and suction operations.

  On the other hand, according to the present invention, the proximal end of the tapered portion of the inner peripheral portion of the shaft and the proximal end of the tapered portion of the outer peripheral portion of the shaft are arranged at different positions in the overall shaft length. In addition to ensuring flexibility based on control of thickness and structure, it is possible to control the volume of the desired lumen of the shaft, and when the inner and outer tapered portions of the shaft are arranged at the same position In addition to having a delivery performance of a catheter that cannot be achieved, it is possible to quickly perform injection and suction operations of fluid passing through a desired lumen. In the case of a balloon catheter, the balloon catheter has the delivery performance described above, and can quickly expand and contract the balloon.

  Embodiments of the present invention will be described below with reference to the drawings, but the present invention is not limited to these embodiments.

FIG. 1 is an axial cutaway cross-sectional view showing an outline of an example of the first embodiment of the present invention.
The catheter 1 of this example is a balloon catheter that includes a shaft 10, a balloon 20, and a hub 30. The shaft 10 has a single lumen 50 that communicates from its distal portion 11 to its proximal portion 12. Further, the distal end portion of the distal portion 11 of the shaft 10 is opened to form the distal end opening portion 13, and the rearmost end portion of the proximal portion 12 is also opened to form the rearmost end opening portion 14. ing.

In this example, on the distal portion side of the shaft 10, a tapered portion 42 that decreases in diameter from the proximal portion side toward the distal portion side is formed on the outer peripheral portion 40, and the lumen portion 50 is formed. The inner peripheral portion 51 is formed with a tapered portion 52 that decreases in diameter from the proximal portion side toward the distal portion side. Further, the proximal portion side end portion 43 of the tapered portion 42 formed on the outer peripheral portion 40 and the proximal portion side end portion 53 of the tapered portion 52 formed on the inner peripheral portion 51 are located at different positions in the entire length of the shaft 10. It is arranged. In the present example, the proximal portion side end portion 53 of the tapered portion 52 of the inner peripheral portion 51 is arranged on the distal portion side of the proximal portion side end portion 43 of the tapered portion 42 of the outer peripheral portion 40. By arranging the proximal end 53 of the tapered portion 52 of the inner peripheral portion 51 at such a position, in this example, when the tapered portion is provided on the inner peripheral portion and the outer peripheral portion of the shaft 10, Compared to the case where the tapered portion and the tapered portion of the inner peripheral portion are arranged at the same position, it is possible to secure a larger volume of the lumen portion 50. Further, in this example, the proximal portion side end portion 54 of the tapered portion 52 of the inner peripheral portion 51 is disposed closer to the proximal portion side than the distal portion side end portion 44 of the tapered portion 42 of the outer peripheral portion 40. . Thereby, in this example, while ensuring the volume of the lumen | bore part 50 larger, the thickness of the wall part 16 of the shaft 10 formed of the taper part 42 of the outer peripheral part 40 and the inner peripheral part taper part 52 is adjusted. Thus, the portion where the tapered portion is formed can have a smaller diameter and a more flexible structure.
Further, the taper angle between the inner peripheral portion and the outer peripheral portion (the angle (acute angle side) formed by the taper portion with respect to the axial direction in the axial cross section of the catheter) is not particularly limited, and the range in which the effects of the present invention can be obtained. Thus, it can be appropriately selected.

  The material that can be used for the shaft 10 is not particularly limited, but a resin is preferable from the viewpoint of easily forming a desired tapered portion. For example, polyolefin, polyolefin elastomer, polyester, polyester elastomer, polyamide, polyamide elastomer, polyurethane , Polyurethane elastomer, fluorine-based resin (polytetrafluoroethylene (PTFE), PFA, etc.), a blend material in which two or more of these resins are mixed, and the like, but are not limited thereto. Moreover, it is good also as a single layer structure selected from various materials, and it is good also considering a multiple types of material as a multilayer structure.

In the present invention, a reinforcing layer (not shown) may be provided to reinforce the shaft. When the shaft has a multilayer structure, the reinforcing layer may be disposed so as to be the innermost side, or may be disposed between the innermost layer and the outermost layer. As such a reinforcing layer, for example, a densely wound coil or a pitch wound coil using strands, a braided strand, or a strand arranged parallel to the axial direction of the shaft can be used. Is not limited to these.
Examples of the strand include a single wire made of metal or resin, or a stranded wire obtained by using a plurality of these single wires.
Examples of the metal that can be used for the element wire include stainless steel, copper, tungsten, nickel, titanium, piano wire, Ni—Ti alloy, Ni—Ti—Co alloy, Ni—Al alloy, Cu—Zn alloy, Cu— Various metals such as a superelastic alloy such as a Zn-X alloy (for example, X = Be, Si, Sn, Al, Ga), and an amorphous alloy can be used. Examples of the resin that can be used for the strands include polyesters such as polyethylene terephthalate, polybutylene terephthalate, and polymethylene terephthalate, polyolefins such as polyethylene and polypropylene, rigid polyvinyl chloride, polyamide, polyimide, polystyrene, heat, and the like. Plastic polyurethane, polycarbonate, ABS resin, acrylic resin, polymethyl methacrylate, polyacetal, polyarylate, polyoxymethylene, high tensile polyvinyl alcohol, fluororesin, polyvinylidene fluoride, polytetrafluoroethylene, ethylene-vinyl acetate saponified product, polysulfone, poly Aromatic polymers represented by ether sulfone, polyether ketone, polyphenylene oxide, polyphenylene sulfide, and Kevlar Such as bromide, a polymer alloy containing any of these, carbon fiber and glass fiber.

  Furthermore, in the present invention, the axial flexibility of the shaft may be changed from the viewpoint of further improving the delivery property. As such a configuration, resins having different hardnesses are arranged in the axial direction of the shaft, the thickness of the shaft in the axial direction is changed, or the reinforcing layer is different in the axial direction of the shaft (for example, pitch winding coil) In this case, the pitch interval is changed in the axial direction). In addition, when changing the axial thickness of the shaft, there is no particular limitation on how to change the thickness, but in order to achieve both the flexibility of the distal end of the shaft and the rigidity capable of securing the pushing force of the catheter. The distal end portion is preferably thin and the proximal portion (hand side) of the catheter is preferably thick.

Such a shaft 10 can be manufactured as follows, for example.
As a first example, a straight tube having a single lumen is first formed by extrusion. Further, in order to insert the tube into the lumen portion of the tube and give a desired tapered portion shape to the inner peripheral portion, a core material having the corresponding tapered portion shape as an external shape is prepared in advance. And after arranging a core material in the lumen part of a straight tube, after arranging a heat contraction tube on the outside of a tube if necessary, by extending or shrinking the tube while heating, It is possible to obtain the shaft 10 in which a tapered portion having a desired shape is formed at a desired position on the outer peripheral portion.
In this case, instead of the heat-shrinkable tube used as necessary, it may be molded using a mold having an inner wall surface having a shape corresponding to the structure of the tapered portion formed on the outer peripheral portion of the tube.

  A second example is a method of molding by injection molding using a mold having a desired structure. In the case of injection molding, the entire length may be injection molded, or a tube including only a portion having a tapered portion or a portion having a tapered portion and a straight tubular portion having a predetermined length is injection molded, The shaft may be produced by bonding and fixing to the tube by adhesion or welding.

A third example is an example in which a reinforcing layer is provided.
In this example, first, a resin is continuously coated on the surface of a core material (no tapered shape) having a substantially constant outer diameter such as an annealed copper wire. The method of coating is not particularly limited, and examples thereof include a method of inserting a core material into a pre-formed tube, a method of applying a resin dispersion solution, a resin solution, etc., and drying to coat. In this way, the inner tube is formed.
Next, a reinforcing layer is formed on the surface of the inner layer tube. For example, the metal braid (blade) is formed using a known knitting machine. After cutting if necessary, the core material is pulled out.
Then, another core material (taper core material) having a desired taper shape is inserted, and one end portion is stretched while being heated, and the lumen portion of the inner tube is shaped into a desired taper shape.
Furthermore, an outer layer tube is disposed so that the reinforcing layer is covered, and a heat shrinkable tube is further disposed thereon, and the inner layer tube, the reinforcing layer, and the outer layer tube are brought into close contact with each other by heating. At this time, the outer layer tube may be provided with a tube of a different type (for example, different in material, thickness, etc.) in the axial direction of the shaft.
Then, the taper core material is removed to obtain a shaft having a desired taper shape.

The fourth example is an example in which a reinforcing layer is provided as in the third example.
In this example, first, a taper-shaped core material having a predetermined length is coated with a resin to form an inner tube having a desired tapered shape. The method for coating is not particularly limited, and examples thereof include a method in which a resin dispersion solution or resin solution is applied and then dried and coated. In addition, you may use the method of inserting a core material in the tube shape | molded previously, However, In this case, it is good to shape by heating extending | stretching etc. so that it may have a desired taper shape.
Next, a reinforcing layer is formed on the surface of the inner layer tube in the same manner as in the third example. Furthermore, an outer layer tube is disposed so that the reinforcing layer is covered, and a heat shrinkable tube is further disposed thereon, and the inner layer tube, the reinforcing layer, and the outer layer tube are brought into close contact with each other by heating. As in the case of the third example, the outer layer tube may be a tube of a different type (for example, different in material, thickness, etc.) in the axial direction of the shaft.
Then, the taper core material is removed to obtain a shaft having a desired taper shape.

The balloon 20 is disposed on the outer peripheral portion on the distal side of the shaft 10. In this example, the entire portion of the balloon 20 that is inflated and deflated is disposed on a tapered portion 42 formed on the outer peripheral portion 40 of the shaft 10. However, the arrangement of the balloon 20 is not limited to the position of this example, and the position of the tapered portion formed on the inner and outer peripheral portions of the shaft is taken into consideration within the range where the effects of the present invention can be exhibited. It can be determined as appropriate. The wall portion 16 of the shaft 10 is provided with at least one small hole portion 15 that communicates the lumen portion 50 of the shaft 10 and the interior 21 of the balloon 20.
The positional relationship between the proximal end 53 of the tapered portion 52 of the inner peripheral portion 50 of the shaft 10 and the balloon 20 attached to the outer peripheral portion 40 of the shaft 10 is not particularly limited. The balloon 20 may be disposed on the outer peripheral portion 40 of the shaft 10 so that the end portion 53 is on the distal portion side of the small hole portion 15. As a result, the lumen 50 of the shaft 10 from the proximal portion side of the shaft 10 to the balloon 20 can be further secured, and the fluid passing through the lumen 50, in this example, for example, expansion of the balloon 20 -The liquid required for contraction can be quickly delivered to and removed from the interior 21 of the balloon 20.

  The shape, structure, and material used of the balloon 20 are not particularly limited, and can be appropriately selected depending on the use, such as for expanding a stenotic part of a living body lumen or embolizing a living body lumen part. As the shape and structure, for example, a shape preliminarily shaped in an expanded state such as an oval shape or a circular shape, a straight tubular shape in a contracted state, or the like can be given. The former shaped balloon can be formed, for example, by blow molding a straight tubular parison formed by extrusion or the like. In addition, the latter balloon-shaped balloon in a contracted state can be formed as a straight-tube tube by, for example, extrusion molding. In addition, these shapes, structures, and molding methods are examples, and are not limited to these. In addition, examples of usable materials for balloons include polyolefins, polyolefin elastomers, polyesters, polyester elastomers, polyamides, polyamide elastomers, polyurethanes, polyurethane elastomers, and the like, and blend materials obtained by mixing two or more of these resins. However, it is not necessarily limited to these.

  In this example, the hub 30 is connected to the proximal portion 12 of the shaft 10. A hollow portion 31 is formed in the hub 30 so as to communicate with the lumen portion 50 of the shaft 10, and an opening portion 32 is formed at the rearmost end portion. In this example, the hollow portion 31 of the hub 30 is formed with a tapered portion so that a syringe and a connector can be connected, and a protruding portion 33 is provided on the outer peripheral portion thereof so as to enable a luer lock with the syringe and the connector. I have. However, the structure of the hub 30 is not limited to that of the present example, and a structure having another known structure can be adopted. The material that can be used for the hub 30 is not particularly limited, and a material that can be generally used in this field, such as polycarbonate, polyamide, polyurethane, polysulfone, polyarylate, styrene-butadiene copolymer, and polyolefin, is appropriately selected. Can do. Moreover, the joining method with the shaft 10 considers the material of the shaft 10 and the hub 30, and can connect by methods, such as an adhesive agent and welding.

  In this example, the balloon catheter has been described as an example. However, it is obvious that a catheter without the balloon 20 and the small hole portion 15 can be used as a catheter for suction or injection, and has a similar function. is there.

FIG. 2 is an axial cross-sectional view showing an outline of another use state of the first embodiment of the present invention.
The catheter 2 of this example is a balloon catheter configured with a shaft 100, a balloon 120, and a hub 130. FIG. 2 shows a use state in which the guide wire 60 is inserted through the catheter 2. The shaft 100 has a single lumen 150 that communicates from its distal portion 111 to the proximal portion 112. In addition, the distal end portion of the distal portion 111 of the shaft 100 is opened to form the distal end opening portion 113, and the rearmost end portion of the proximal portion 112 is also opened to form the rearmost end opening portion 114. ing.
The main difference between the catheter 2 shown in FIG. 2 and the catheter 1 shown in FIG. 1 is that the guide wire 60 is airtight or liquid in the inner peripheral portion 151 in the vicinity of the distal end opening 113 of the shaft 100 of the catheter 2. The seal portion 160 that is slidably held in a dense state is formed, and the hub 130 is a so-called Y connector.

  Therefore, the structure of the tapered portion 142 of the outer peripheral portion 140 of the shaft 110 and the tapered portion 152 of the inner peripheral portion 151 constituting the lumen portion 150 of the shaft 110 in FIG. 2 is the outer peripheral portion of the shaft 10 in the example shown in FIG. 40 is the same as the structure of the taper part 52 of the inner peripheral part 51 which comprises the lumen | bore part 50 of the shaft 10, and the code | symbol (111-116 attached | subjected to the site | part relevant to the shaft 110 in FIG. 140 to 154) The portions where the last two digits are the same as those in FIG.

  In the catheter 2 of this example, the seal portion 160 is disposed at a predetermined position of the shaft 110 as described above. The arrangement position of the seal portion 160 may be on the distal portion side of the small hole portion 115 communicating the interior 121 of the balloon 120 and the lumen portion 150 of the shaft 100. Further, as shown in FIG. 2, the seal portion 160 allows the guide wire 60 inserted into the lumen portion 150 to protrude from the most advanced opening 113, that is, the guide wire 60 can slide. And it is comprised so that an airtight or liquid-tight state can be maintained in the state by which the guide wire 60 was penetrated. As a result, while holding the guide wire 60, the fluid for inflating and deflating the balloon 120 injected and discharged from the hub 130 with a syringe (not shown) or the like passes through the lumen 150 more reliably and easily. Thus, it is possible to inject into and discharge from the interior 121 of the balloon 120.

  The configuration of the seal portion 160 is not particularly limited as long as the guide wire 60 can be slidably held in an airtight or liquid tight state. The inner peripheral surface 151 may be formed with a continuous protrusion so as to contact the outer peripheral surface of the guide wire 60 with at least one line, or the inner peripheral surface 151 may be in contact with the outer peripheral surface of the guide wire 60 with the surface. One round continuous protrusion may be formed, or other shapes and structures may be employed. Moreover, there is no limitation in particular also as a material, Resin etc. which were illustrated in the material of the shaft can be used. Further, the seal portion may be formed integrally when the shaft is molded, or a previously molded member may be joined to the inner peripheral portion 151 of the shaft 100 by an adhesive, welding, or the like.

  Since the balloon 120 in this example can also be configured in the same manner as in the example shown in FIG. 1, detailed description thereof is omitted in this example. 2 have the same structure, and the detailed description thereof will be omitted.

  The hub 130 in this example is connected to the proximal portion 112 of the shaft 100. The hub 130 is a Y connector having hollow portions 131 and 132 so as to communicate with the lumen portion 150 of the shaft 100 and having openings 133 and 134 at the rearmost ends thereof. In this example, as shown in FIG. 2, the guide wire 60 is inserted into the lumen portion 150 of the shaft 100 through the hollow portion 131 from the opening portion 133. Further, a protrusion 133 is provided on the outer periphery of the hub 130 near the opening 133 so that a luer lock with a connector (such as a connector having a structure for holding the guide wire 60 in an airtight or liquid tight manner) is possible. Yes. The hollow portion 132 is formed with a tapered portion so that a syringe and a connector (both not shown) can be connected, and the outer peripheral portion has a protrusion 136 so that the syringe and the connector can be connected with a luer lock. It has. In addition, the structure of the hub 130 is not limited to the thing of this example, The thing which has another well-known structure is employable. Moreover, since the material which can be used for the hub 130 and the joining method with the shaft 100 are the same as in the case of the example of FIG.

FIG. 3 is an axial cutaway cross-sectional view showing an outline of an example of the second embodiment of the present invention.
The catheter 3 of this example is a balloon catheter configured with a shaft 200, a balloon 220, and a hub 230.
The shaft 200 includes an outer tube 240 and an inner tube 250, and differs from the first embodiment in that the inner tube 250 is coaxially arranged inside the outer tube 240. The outer peripheral portion of the shaft 200 in this example is formed by the outer peripheral portion 241 of the outer tube 240, and the lumen portion of the shaft 200 is formed by the inner peripheral portion 251 of the inner tube 250. Further, the outer tube 240 and the inner tube 250 are joined in the vicinity of the distal end side of the outer tube 240 and the end of the inner tube 250 on the distal side, and the inner peripheral portion 245 of the outer tube 240 is joined. The outer lumen 255 of the inner tube 250 forms a balloon lumen 270 that communicates with the interior 221 of the balloon 220 via the small hole 215.

In this example, attention is paid to the positional relationship between the tapered portion 242 formed on the outer peripheral portion 241 of the outer tube 240 and the tapered portion 252 formed on the inner peripheral portion 251 of the inner tube 250.
In the case of the configuration of this example, the fluid for inflating and deflating the balloon 220 passes through the balloon lumen 270, and the medicine to be injected as needed and the contents sucked from the living body are contained in the inner tube 250. Although passing through the cavity 260, the operation of inflating and deflating the balloon 220 is basically prioritized. Therefore, it is required to secure a larger balloon lumen 270. From this point of view, the proximal end 253 of the tapered portion 252 of the inner peripheral portion 251 of the inner tube 250 is closer to the proximal end 243 of the tapered portion 242 of the outer peripheral portion 241 of the outer tube 240. It is preferable to be disposed on the side of the position part. Thus, when the outer tube 240 is provided with a tapered portion so that the diameter thereof is reduced, the inner peripheral portion 245 is also reduced in diameter, and the volume of the balloon lumen 270 is reduced, so that the inner peripheral portion of the inner tube 250 is reduced. By adjusting the position of the proximal end 253 of the tapered portion 252 of the H.245, the taper portion of the outer peripheral portion 255 of the inner tube 250 is suppressed as much as possible while reducing the inner volume of the inner lumen portion 260 of the inner tube 250. The positional relationship between the tapered portion 242 of the outer peripheral portion 241 of the outer tube 240 and the tapered portion 252 of the inner peripheral portion 251 of the inner tube 250 is prevented. By adjusting the thickness, the thickness and inner / outer diameter change of the outer tube and the inner tube are different, thereby providing flexibility while reducing the tapered portion of the shaft 200. Theft is possible. As a result, the balloon 220 can be quickly inflated and deflated, and can also inject drugs and the like, and can quickly inhale contents in the living body, and achieves high delivery performance. It is also possible to do.

In this example, the outer tube 240 and the inner tube 250 have the same positions of the outer peripheral portion and the tapered portion of the inner peripheral portion. Therefore, both the outer tube and the inner tube can be obtained by performing a general stretching process using a tube formed in a straight tube shape. However, it can be molded by other known methods such as injection molding.
Further, in this example, a tube having a single lumen portion, such as the shaft 10 or 100 shown in FIG. 1 or FIG. 2, or other configurations, as the outer tube and / or the inner tube. You may use what differs in the position of the taper part of an outer peripheral part and an inner peripheral part. The outer tube and the inner tube having such a tapered portion structure can be manufactured as described above.
Further, in this example, the outer tube 240 and the inner tube 250 are joined to each other in the vicinity of the distal end portion of the outer tube 240 and the distal end portion of the inner tube 250 to thereby form the sealing portion 280. Forming. The sealing part 280 may be formed by an adhesive or the like, or may be formed by directly joining the outer tube 240 and the inner tube 250 by welding or the like, or other methods may be employed.

  Since the balloon 220 in this example can be configured in the same manner as in the example shown in FIG. 1, detailed description thereof is omitted in this example. 3 have the same structure, and the detailed description is omitted, since the lower two digits of the reference numerals (220, 221) attached to the parts related to the balloon 220 in FIG. 3 have the same structure.

  The hub 230 in this example is connected to the proximal portion 212 of the shaft 200. The hub 230 is a Y connector having a hollow portion 231 that communicates with the lumen portion 260 of the inner tube 250 that constitutes the shaft 200 and a hollow portion 232 that communicates only with the balloon lumen 270. In addition, opening portions 233 and 234 are provided at the rearmost ends of the hollow portions 231 and 232, respectively, and syringes and connectors (both not shown) can be connected to the hollow portions 231 and 232, respectively. In addition to forming a tapered portion, the outer peripheral portion is provided with protrusions 235 and 236 so that a luer lock can be made with a syringe or a connector. Note that the structure of the hub 230 is not limited to that of the present example, and a structure having another known structure can be employed. Moreover, since the material which can be used for the hub 230 and the joining method with the shaft 200 are the same as those in the case of the example of FIG.

Hereinafter, of the catheters of the present invention, a balloon catheter will be described as an example in more detail based on examples.
Example 1
Using a polyamide-based elastomer, a shaft (500) having a single lumen having the following structure was obtained.
A tube having a single lumen having an outer diameter of 0.7 mm and an inner diameter of 0.5 mm was formed by extrusion molding. Next, the tapered portion was shaped according to the method described above.
The shaft (500) has a distal end portion (501) outer diameter of 0.7 mm, an inner diameter of 0.5 mm, and a proximal end rear end portion (502) of an outer diameter of 0.9 mm. Was 0.6 mm and the total length was 1500 mm. Further, the distal end portion (503) of the tapered portion of the outer peripheral portion is disposed at a position 50 mm from the tip portion (501), and the proximal end portion (504) thereof is 300 mm from the tip portion (501). The structure is arranged such that the diameter gradually decreases from the proximal end (504) to the distal end (503). Further, the distal end portion (505) of the tapered portion of the inner peripheral portion is arranged at a position of 0 mm from the tip portion (501), and the proximal end portion (506) thereof is from the tip portion (501). Arranged at a position of 150 mm, the diameter gradually decreased from the proximal end (506) to the distal end (505).
A plurality of small hole portions (508) having a diameter of 140 μm that communicate the lumen (507) and the outside were formed at a position of about 3 to 43 mm from the tip portion (501) of the shaft 500. Furthermore, the hub which can fit a syringe was joined to the proximal part side edge part of the shaft. In addition, the outline of the cross-section of the taper part of a shaft (500) is shown to Fig.5 (a).
In addition, using a styrene-based elastomer, a parison produced by extrusion molding was blow-molded according to a conventional method to produce a balloon. The shape of the balloon was an oval shape having a distal gradient portion, a straight tube portion, and a proximal gradient portion in order from the distal side in the axial direction of the balloon.
The balloon was joined by heat welding so that the small hole portion (508) was located inside the outer periphery of 5 mm to 35 mm from the distal end portion of the shaft formed as described above.
As described above, a balloon catheter having an opening at the most distal end and a single lumen communicating with the opening over its entire length was produced.

(Comparative Example 1)
The shaft (600) has an outer diameter of the distal end portion (601) of 0.7mm, an inner diameter of 0.5mm, an outer diameter of the rear end portion (602) of the proximal portion, 0.9mm, and an inner diameter. Was 0.6 mm and the total length was 1500 mm. Further, the distal end portion (603) of the tapered portion of the outer peripheral portion is disposed at a position 50 mm from the tip portion (601), and the proximal end portion (604) thereof is 300 mm from the tip portion (501). The structure is arranged such that the diameter gradually decreases from the proximal end (604) to the distal end (603). Further, the distal end portion (605) of the tapered portion of the inner peripheral portion is also arranged at a position 50 mm from the tip portion (601), and the proximal end portion (606) thereof is also located from the tip portion (601). Arranged at a position of 300 mm, the diameter gradually decreased from the proximal end (606) to the distal end (605).
A balloon catheter was produced in the same manner as in Example 1 except that the above shaft structure was used. In addition, the outline of the cross-sectional structure of the taper part of a shaft (600) is shown in FIG.5 (b).

(Comparative Example 2)
The shaft (700) has an outer diameter of the distal end portion (701) of 0.7 mm, an inner diameter of 0.5 mm, and an outer diameter of the rear end portion (702) of the proximal portion side of 0.9 mm. Was 0.6 mm and the total length was 1500 mm. Further, the distal end portion (703) of the tapered portion of the outer peripheral portion is arranged at a position 0 mm from the tip portion (701), and the proximal end portion (704) thereof is 150 mm from the tip portion (701). The structure is arranged such that the diameter gradually decreases from the proximal end (704) to the distal end (703). Further, the distal end portion (705) of the tapered portion of the inner peripheral portion is also arranged at a position of 0 mm from the tip portion (701), and the proximal end portion (706) thereof is also extended from the tip portion (701). The structure was arranged at a position of 150 mm and gradually decreased in diameter from the proximal side end (706) to the distal side end (705).
A balloon catheter was produced in the same manner as in Example 1 except that the above shaft structure was used. In addition, the outline of the cross-section of the taper part of a shaft (700) is shown in FIG.5 (c).

Using the balloon catheter prepared in Example 1 and Comparative Examples 1 and 2 above, the distal end opening of the distal end of the shaft is closed with a guide wire, and the balloon is expanded inside the balloon and the lumen of the shaft. Filled with liquid. Next, a syringe (capacity 1 mL) is attached to the hub of each balloon catheter, and when the pressure is reduced by pulling the plunger of the syringe, the time required for sucking up 1 mL of the balloon expansion liquid from the balloon catheter balloon (balloon contraction time) )It was confirmed. The shorter the balloon contraction time, the better the expansion / contraction performance.
In addition, using the balloon catheters prepared in Examples and Comparative Examples, the evaluation apparatus for evaluating the slipperiness shown in FIG. 4 was used, and when the balloon catheter was reciprocated in the catheter provided in the evaluation apparatus, The force applied to the vicinity of the proximal end was measured with a force gauge and used as a slip evaluation value. The lower the slip evaluation value, the better the delivery. Each measurement result is shown in Table 1.

  The evaluation apparatus used for evaluating the slipperiness of the balloon catheter and the arrangement of the balloon catheter relative to the apparatus will be briefly described with reference to the drawings. As shown in FIG. 4, the evaluation device 400 includes a delivery evaluation circuit 401 and a digital force gauge 402. The delivery evaluation circuit 401 has an evaluation catheter in a groove formed on a flat plate 403 so as to have a first substantially waveform shape portion 404 having about eight irregularities and a second substantially waveform shape portion 405 having about two irregularities. 406 is arranged. The first substantially waveform shape is configured such that the radii have R1 to R8 in order from the farthest from the digital force gauge 402, and the center of each radius formation is on a straight line. In this evaluation system, R1 was 4 mm, and was increased sequentially, and R8 was 12 mm. Further, the digital force gauge 402 can hold the balloon catheter 407 by a holding portion (not shown), and the moving speed is controlled by a linear actuator (not shown). In this evaluation system, the balloon catheter 407 was moved back and forth within the evaluation catheter 406 so as to linearly advance and retreat in the left-right direction (arrow 408) in FIG. The moving speed at this time was 10 mm / second.

From the results shown in Table 1, it was confirmed that in Example 1, the balloon could be quickly expanded and contracted. Moreover, it was confirmed that deterioration of the slip evaluation value can be prevented. On the other hand, in Comparative Examples 1 and 2, when the shaft proximal portion side end portion of the tapered structure of the shaft lumen and the shaft proximal portion side end portion of the tapered structure of the shaft outer periphery are arranged at the same position of the entire shaft length, It was confirmed that delivery performance deteriorates when priority is given to expansion / contraction performance (Comparative Example 2), and expansion / contraction performance of the balloon deteriorates (Comparative Example 1) when priority is given to delivery performance.
In the above-described examples and comparative examples, the balloon catheter has been described as an example. However, from the above evaluation results, the same result can be obtained with a catheter other than the balloon catheter, for example, a suction catheter or an injection catheter. I can expect.

1 Catheter 1
2 Catheter 2
3 Catheter 3
10, 100, 200 Shaft 11, 111, 211 Distal portion 12, 112, 212 Proximal portion 13, 113, 213 Front end opening portion 14, 114, 214 End opening portion 15, 115, 215 Small hole portion 16, 116 Wall part 20, 120, 220 Balloon 21, 121, 221 Balloon inner part 30, 130, 230 Hub 40, 140 Inner peripheral part 42, 142 Taper part 43, 143 Proximal part side end part 44, 144 Distal part side end Portions 50, 150 lumen portions 51, 151 inner peripheral portions 52, 152 taper portions 53, 153 proximal portion side ends 54, 154 distal portion side ends 60 guide wire 240 outer tube 250 inner tube

Claims (5)

A shaft having a lumen communicating from the distal portion to the proximal portion;
A taper portion that decreases in diameter from the proximal portion toward the distal portion is formed on part or all of the entire shaft length of the outer peripheral portion of the shaft and the inner peripheral portion that forms the lumen portion,
The proximal portion side end portion of the tapered portion formed on the inner peripheral portion is disposed on the distal portion side with respect to the proximal portion side end portion of the tapered portion formed on the outer peripheral portion, and the inner peripheral portion The catheter is characterized in that the proximal end portion of the tapered portion is arranged closer to the proximal portion side than the distal end portion of the tapered portion of the outer peripheral portion .   Having a shaft with a single lumen communicating from the distal portion to the proximal portion;
  A taper portion that decreases in diameter from the proximal portion toward the distal portion is formed on part or all of the entire shaft length of the outer peripheral portion of the shaft and the inner peripheral portion that forms the lumen portion,
  The proximal portion side end portion of the tapered portion formed on the inner peripheral portion is disposed on the distal portion side with respect to the proximal portion side end portion of the tapered portion formed on the outer peripheral portion. And catheter. The catheter according to claim 1 or 2, wherein a balloon is provided on an outer peripheral portion in the vicinity of the distal end portion of the shaft. The shaft has a small hole portion that communicates the inside of the balloon and the lumen portion of the shaft, and a guide wire inserted into the lumen portion on the distal side of the small hole portion. The catheter according to claim 3 , further comprising a seal portion that is slidably held in a dense state. A shaft having a lumen communicating from the distal portion to the proximal portion;
A taper portion that decreases in diameter from the proximal portion toward the distal portion is formed on part or all of the entire shaft length of the outer peripheral portion of the shaft and the inner peripheral portion that forms the lumen portion,
A balloon is provided on the outer periphery near the distal end of the shaft,
The shaft includes an outer tube and an inner tube disposed inside the outer tube;
The outer periphery of the shaft is formed by the outer periphery of the outer tube, and the lumen of the shaft is formed by the inner periphery of the inner tube;
The outer tube and the inner tube are joined in the vicinity of the end on the distal side, respectively, and a balloon lumen that communicates with the inside of the balloon is formed by the inner periphery of the outer tube and the outer periphery of the inner tube. It is,
The proximal portion side end portion of the tapered portion of the inner peripheral portion is disposed closer to the proximal portion side than the proximal portion side end portion of the tapered portion of the outer peripheral portion,
The catheter in which the proximal part side edge part of the taper part of the said outer peripheral part is distribute | arranged to the proximal part side from the distal part side edge part of the taper part of the said inner peripheral part .

Images