WO2020162286A1 - Extension catheter and method for producing same - Google Patents

Extension catheter and method for producing same Download PDF

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Publication number
WO2020162286A1
WO2020162286A1 PCT/JP2020/003215 JP2020003215W WO2020162286A1 WO 2020162286 A1 WO2020162286 A1 WO 2020162286A1 JP 2020003215 W JP2020003215 W JP 2020003215W WO 2020162286 A1 WO2020162286 A1 WO 2020162286A1
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WO
WIPO (PCT)
Prior art keywords
tapered
taper
tubular
extension catheter
tapered surface
Prior art date
Application number
PCT/JP2020/003215
Other languages
French (fr)
Japanese (ja)
Inventor
俊哉 木佐
Original Assignee
株式会社カネカ
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 株式会社カネカ filed Critical 株式会社カネカ
Priority to JP2020571123A priority Critical patent/JPWO2020162286A1/en
Publication of WO2020162286A1 publication Critical patent/WO2020162286A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0004—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system

Definitions

  • the present invention relates to an extension catheter and a manufacturing method thereof.
  • Percutaneous coronary angioplasty for dilating stenosis of coronary artery of the heart and increasing blood flow using ischemic heart disease such as angina and myocardial infarction using endovascular treatment devices such as stents and balloons (PCI) is being performed.
  • the distal end of the tubular guiding catheter is inserted into the entrance of the coronary artery and left, and then the intravascular treatment device is delivered through the guiding catheter to insert the intravascular treatment device into the distal side of the coronary artery. It was improving the sex.
  • the tip of the guiding catheter sometimes comes off the entrance of the coronary artery.
  • an extension catheter having a small diameter is inserted into the guiding catheter so as to protrude from the opening on the distal side of the guiding catheter to improve the backup power.
  • a proximal member including an extension portion of Patent Document 1, a collar member attached to the extension portion, and a distal sheath member attached to the collar member.
  • Guide extension catheters having are known.
  • a push member including a portion having a grooved first surface and a second surface opposite thereto, and a distal shaft having a passage adjacent to the push member are provided.
  • Guide extension catheters are known.
  • the distal shaft of Patent Document 3 includes a distal shaft and a proximal shaft that constitutes a proximal end portion, and the proximal shaft is connected to the proximal end portion of the distal shaft by a modified polyolefin adhesive. Support catheters are known.
  • a coaxial guide catheter that can be delivered through the guide catheter by using the guide wire rail segment of Patent Document 4, a distal sheath of Patent Document 5, a proximal shaft, and a distal sheath on the proximal shaft.
  • a guide extension catheter including a coupling member for fixing is known.
  • a device for endovascular treatment such as a stent or a balloon has been inserted into an extension catheter through an opening on the proximal side of the extension catheter in an artery, but the device for endovascular treatment is inserted into the extension catheter. It was sometimes difficult.
  • the present invention has been made in view of the above problems, and an object thereof is to provide an extension catheter into which an endovascular treatment instrument can be easily inserted, and a manufacturing method thereof.
  • the extension catheter according to the present invention which has been able to solve the above problems, and the manufacturing method thereof are as follows.
  • An extension catheter that can be inserted into a tubular catheter and project from an opening on the distal side of the tubular catheter, A tubular portion, a first tapered portion located closer to the proximal side than the tubular portion, and a second tapered portion located closer to the proximal side than the first tapered portion,
  • the first tapered portion has an outer surface and a first tapered surface
  • the second taper portion has an outer surface and a second taper surface
  • An extension catheter characterized by satisfying the following formulas (1) and (2).
  • T shows the thickness (mm) of the said cylindrical part in the distal end of the said 1st taper part.
  • H 1 indicates a radial length (mm) between a point closest to the central axis of the tubular portion of the first tapered surface and a point farthest from the central axis.
  • H 2 indicates a radial length (mm) between a point closest to the central axis of the cylindrical portion of the second tapered surface and a point farthest from the central axis.
  • the extension catheter according to any one of [1] to [3], which satisfies the following formula (5).
  • D shows the outer diameter (mm) of the said cylindrical part in the distal end of the said 1st taper part.
  • D 2 indicates the radial length at the proximal end of the second tapered portion.
  • a third taper portion located closer to the proximal side than the second taper portion is provided, The third tapered portion has an outer side surface and a third tapered surface,
  • the extension catheter according to any one of [1] to [4], which satisfies the following formula (6). ⁇ 5° ⁇ 3 ⁇ 5° (6)
  • (theta) 3 shows the angle which the said 3rd taper surface and the said axial direction make.
  • a reinforcing layer is provided on the tubular portion,
  • the extension catheter according to any one of [1] to [5], which satisfies the following formula (7).
  • D ⁇ L 4 ⁇ 3D (7) [In Formula, D shows the outer diameter (mm) of the said cylindrical part in the distal end of the said 1st taper part.
  • L 4 represents the axial length (mm) from the proximal end of the reinforcing layer to the distal end of the first tapered portion.
  • a method of manufacturing an extension catheter comprising:
  • the present invention can provide an extension catheter into which an endovascular treatment instrument can be easily inserted, and a method of manufacturing the extension catheter having the above-described configuration.
  • FIG. 1 is a side view of an extension catheter according to an embodiment of the present invention.
  • 2 is an axial cross-sectional view of the R portion of FIG.
  • FIG. 3A is a side view of an extension catheter.
  • FIG. 3B is a side view when a part of the extension catheter is bent.
  • FIG. 3C is a side view of an extension catheter according to an embodiment of the present invention.
  • FIG. 3D is a side view when a part of the extension catheter according to the embodiment of the present invention is bent.
  • FIG. 4 shows a sectional view taken along the line IV-IV in FIG.
  • FIG. 5 shows a sectional view taken along line VV of FIG.
  • FIG. 6 shows a VI-VI sectional view of FIG.
  • FIG. 7 shows a sectional view taken along line VII-VII of FIG.
  • FIG. 8 is a figure which shows the state when the extension catheter which concerns on embodiment of this invention is inserted in a tubular catheter, and is made to project from the opening of the
  • FIG. 1 shows a side view of an extension catheter according to an embodiment of the present invention.
  • 2 is an axial cross-sectional view of the R portion of FIG.
  • FIG. 3A is a side view of an extension catheter.
  • FIG. 3B is a side view when a part of the extension catheter is bent.
  • FIG. 3C is a side view of an extension catheter according to an embodiment of the present invention.
  • FIG. 3D is a side view when a part of the extension catheter according to the embodiment of the present invention is bent.
  • 4 to 7 show a IV-IV sectional view, a VV sectional view, a VI-VI sectional view and a VII-VII sectional view of FIG. 1, respectively.
  • FIG. 1 shows a side view of an extension catheter according to an embodiment of the present invention.
  • 2 is an axial cross-sectional view of the R portion of FIG.
  • FIG. 3A is a side view of an extension catheter.
  • FIG. 3B is a side view when a part of the
  • FIG. 8 is a figure which shows the state when the extension catheter which concerns on embodiment of this invention is inserted in a tubular catheter, and is made to project from the opening of the distal side of a tubular catheter. Note that the radiopaque marker is omitted in FIG.
  • the extension catheter 30 is an extension catheter that can be inserted into a tubular catheter 40 as shown in FIG. 8 and can project from an opening a40 on the distal side of the tubular catheter 40. is there. Further, as shown in FIG. 2, the extension catheter 30 includes a tubular portion 4, a first tapered portion 1 located proximal to the tubular portion 4, and a proximal side of the first tapered portion 1. The second taper portion 2 is provided. The first taper portion 1 has an outer side surface S10 and a first taper surface S1, and the second taper portion 2 has an outer side surface S10 and a second taper surface S2. Further, the extension catheter 30 is formed so as to satisfy the following formulas (1) and (2).
  • (theta) 1 shows the angle which the 1st taper surface S1 and the axial direction X of the cylindrical part 4 make.
  • ⁇ 2 represents an angle formed by the second tapered surface S2 and the axial direction X of the tubular portion 4.
  • the proximal side means the direction of the operator's proximal side with respect to the extending direction of the extension catheter 30, and the distal side means the direction opposite to the proximal side, that is, the treatment target side. means.
  • the extension catheter 30 is most characterized in that the first tapered surface S1 and the second tapered surface S2 are formed so as to satisfy the above expressions (1) and (2). .. More specifically, in the conventional extension catheter, as in Patent Document 3, a tapered surface is provided at an angle of more than 90° with respect to the axial direction of the tubular portion to form an opening having a large opening area. Some have made it easy to insert an endovascular treatment instrument such as a stent or a balloon into an extension catheter.
  • the thin portion is reduced by forming the tapered surface having a small angle with respect to the axial direction of the tubular portion, that is, the first tapered surface S1 satisfying the above formula (1). Further, since the thin portion is reduced, the angle ⁇ 2 formed by the second tapered surface S2 and the axial direction X of the tubular portion 4 can be increased to the range defined by the above formula (2), The opening area of the opening can be easily increased. As a result, the endovascular treatment device can be easily inserted into the extension catheter.
  • (theta) 1 shows the angle which the 1st taper surface S1 and the axial direction X of the cylindrical part 4 make.
  • ⁇ 1 is preferably 140° or less, more preferably 130° or less, and further preferably 120° or less.
  • ⁇ 1 is preferably 95° or more, more preferably 100° or more, and further preferably 110° or more.
  • (theta) 2 shows the angle which the 2nd taper surface S2 and the axial direction X of the cylindrical part 4 make.
  • An angle ⁇ 2 formed by the second tapered surface S2 and the axial direction X of the tubular portion 4 is 120° or more. This makes it easy to increase the opening area of the opening for inserting the endovascular treatment instrument. Therefore, ⁇ 2 is preferably 130° or more, more preferably 140° or more, still more preferably 150° or more.
  • the upper limit of ⁇ 2 may be, for example, 175°, 170°, or 168°.
  • the extension catheter 30 preferably satisfies the following formula (3).
  • ⁇ 1 ⁇ 2 (3) [In the formula, ⁇ 1 and ⁇ 2 have the same meanings as described above. ]
  • the angle ⁇ 2 formed between the second tapered surface S2 and the axial direction X of the tubular portion 4 is preferably larger than the angle ⁇ 1 formed between the first tapered surface S1 and the axial direction X of the tubular portion 4.
  • theta 2 is more preferably theta 1 1.1 times or more, more preferably theta 1 1.2 times or more, and even more preferably theta 1 1.3 times or more.
  • the upper limit of theta 2 may be equal to or less than 1.5 times the example theta 1, may be not more than 1.4 times the theta 1.
  • the extension catheter 30 preferably satisfies the following formula (4).
  • T represents the thickness (mm) of the tubular portion 4 at the distal end A1 of the first tapered portion 1.
  • H 1 indicates a radial length (mm) between a point N 1 closest to the central axis C of the tubular portion 4 of the first tapered surface S 1 and a point F 1 farthest from the center axis C 1.
  • H 2 indicates a radial length (mm) between a point N 2 closest to the central axis C of the cylindrical portion 4 of the second tapered surface S 2 and a point F 2 farthest from the central axis C.
  • the radial length H 1 between the point N1 closest to the central axis C of the tubular portion 4 of the first tapered surface S1 and the farthest point F1 thereof is the tubular portion 4 at the distal end A1 of the first tapered portion 1. It is preferable that the thickness is equal to or more than T. As a result, the thin portion can be easily reduced. H 1 is more preferably 1.1 times or more T, still more preferably 1.2 times or more T, and even more preferably 1.3 times or more T.
  • H 1 is preferably equal to or less than the radial length H 2 between a point N2 closest to the central axis C of the tubular portion 4 of the second tapered surface S2 and a point F2 farthest from the center axis C. This makes it easy to avoid contact between the first tapered surface S1 and the endovascular treatment instrument. Therefore, H 1 is more preferably 0.5 times or less of H 2 and even more preferably 0.4 times or less of H 2 .
  • T is preferably 0.01 mm or more and 0.3 mm or less, more preferably 0.02 mm or more and 0.2 mm or less, and further preferably 0.05 mm or more and 0.1 mm or less.
  • H 1 is preferably 0.02 mm or more and 0.4 mm or less, more preferably 0.05 mm or more and 0.3 mm or less, and further preferably 0.1 mm or more and 0.25 mm or less.
  • H 2 is preferably 0.1 mm or more and 1.5 mm or less, more preferably 0.2 mm or more and 1 mm or less, still more preferably 0.4 mm or more and 0.7 mm or less.
  • the extension catheter 30 preferably satisfies the following formula (5).
  • 0.3D ⁇ D 2 (5) [In the formula, D indicates the outer diameter (mm) of the tubular portion 4 at the distal end A1 of the first tapered portion 1.
  • D 2 represents the radial length of the second tapered portion 2 at the proximal end B2.
  • the radial length D 2 at the proximal end B2 of the second tapered portion 2 is preferably 0.3 times or more the outer diameter D of the tubular portion 4 at the distal end A1 of the first tapered portion 1. .. This makes it easy to avoid local bending near the proximal end B2 of the second tapered portion 2.
  • D 2 is more preferably 0.4 times or more of D.
  • D 2 is preferably 0.8 times or less than D. This makes it easier to increase the opening area of the opening for inserting the endovascular treatment instrument. Therefore, D 2 is more preferably 0.7 times or less D, and even more preferably 0.6 times or less D.
  • D is preferably 0.5 mm or more and 4 mm or less, more preferably 1 mm or more and 2 mm or less, and further preferably 1.4 mm or more and 1.8 mm or less.
  • D 2 is preferably 0.2 mm or more and 2 mm or less, more preferably 0.5 mm or more and 1.5 mm or less, and further preferably 0.8 mm or more and 1.2 mm or less.
  • the extension catheter 30 preferably includes a third taper portion 3 located closer to the proximal side than the second taper portion 2.
  • the third tapered portion 3 has an outer side surface S10 and a third tapered surface S3.
  • the extension catheter 30 preferably satisfies the following formula (6).
  • ⁇ 5° ⁇ 3 ⁇ 5° (6) [In formula, (theta) 3 shows the angle which the 3rd taper surface S3 and the axial direction X of the cylindrical part 4 make. ]
  • the angle ⁇ 3 (not shown) formed by the third tapered surface S3 and the axial direction X of the tubular portion 4 is set to -5° or more and 5° or less, That is, since the third taper surface S3 and the axial direction X of the tubular portion 4 are substantially parallel to each other, the endovascular treatment instrument can be easily inserted into the opening along the third taper portion 3. It is more preferably -3° or more and 3° or less, still more preferably -2° or more and 2° or less, and even more preferably -1° or more and 1° or less.
  • D indicates the outer diameter (mm) of the tubular portion 4 at the distal end A1 of the first tapered portion 1.
  • L 4 indicates the length (mm) in the axial direction X from the proximal end B13 of the reinforcing layer 13 to the distal end A1 of the first tapered portion 1.
  • the length L 4 of the tubular portion 4 from the proximal end B13 of the reinforcing layer 13 to the distal end A1 of the first tapered portion 1 in the axial direction X is the tubular portion at the distal end A1 of the first tapered portion 1.
  • the outer diameter is 4 or more.
  • L 4 corresponds to the length in the axial direction X of the tubular portion 4 of the non-reinforcing portion 5 of the tubular portion 4 where the reinforcing layer 13 is not provided.
  • the deformation of the opening for inserting the internal treatment instrument can be easily avoided. Therefore, L 4 is preferably 1.5 times or more of D, and more preferably 2 times or more of D. On the other hand, when L 4 is 3 times or less than D, the deformation of the non-reinforced portion 5 can be easily avoided.
  • L 4 is more preferably 2.8 times or less than D.
  • Note L 4 are, specifically, preferably 0.5mm or more, 8 mm or less, more preferably 2mm or more, 6 mm or less, more preferably 3mm or more and 5mm or less.
  • the extension catheter 30 preferably satisfies the following formula (8). 10D ⁇ L 3 ⁇ 200D (8)
  • D indicates the outer diameter (mm) of the tubular portion 4 at the distal end A1 of the first tapered portion 1.
  • L 3 indicates the length (mm) in the axial direction X of the tubular portion 4 from the distal end of the third tapered portion 3 to the proximal end of the third tapered portion 3.
  • the length L 3 in the axial direction X of the tubular portion 4 from the distal end (not shown) of the third tapered portion 3 to the proximal end (not shown) of the third tapered portion 3 is the first tapered portion.
  • L 3 is more preferably 30 times or more the outer diameter D, and even more preferably 60 times or more the outer diameter D.
  • L 3 is preferably 200 times or less the outer diameter D. Thereby, the flexibility of the linear member 20 can be improved.
  • L 3 is more preferably 120 times or less the outer diameter D, and even more preferably 90 times or less the outer diameter D.
  • L 3 is specifically preferably 5 cm or more and 20 cm or less, more preferably 10 cm or more and 18 cm or less, and further preferably 12 cm or more and 15 cm or less.
  • the extension catheter 30 preferably satisfies the following formula (9). 120° ⁇ ⁇ 4 ⁇ 175° (9)
  • (theta) 4 shows the angle which the 2nd taper surface S2 and the 3rd taper surface S3 make.
  • the second taper at the curved portion in the artery as shown in FIG. 3B. Local bending is likely to occur at the proximal end B2 of the part.
  • ⁇ 4 is set to 120° or more, and the angle between the second tapered surface S2 and the third tapered surface S3 with respect to the axial direction X of the tubular portion 4 is smoothly changed, As shown in 3D, it is possible to easily avoid local bending at the proximal end B2 of the second tapered portion. As a result, it is possible to easily insert the endovascular treatment instrument. Therefore, ⁇ 4 is preferably 130° or more, more preferably 140° or more, and further preferably 150° or more. On the other hand, the upper limit of ⁇ 4 may be 175° or 168°, for example.
  • the radial length D 1 at the proximal end B1 of the first tapered portion 1 is preferably 0.5 mm or more and 2.5 mm or less, more preferably 1 mm or more and 2 mm or less, and further preferably 1.3 mm or more, 1 It is 0.7 mm or less.
  • the length of the tubular portion 4 from the distal end (not shown) to the proximal end (not shown) in the axial direction X is preferably 10 cm or more and 50 cm or less, more preferably 20 cm or more and 40 cm or less, and further It is preferably 25 cm or more and 35 cm or less.
  • the extension catheter 30 includes a tubular portion 4, a first tapered portion 1 located proximal to the tubular portion 4, and a proximal side of the first tapered portion 1.
  • the second taper portion 2 is provided.
  • the extension catheter 30 is inserted into the tubular catheter 40 through the opening b40 on the proximal side of the tubular catheter 40 shown in FIG. 8, for example.
  • the tubular catheter 40 has a distal end A40 and a proximal end B40, and has openings a40 and b40 at the distal end A40 and the proximal end B40, respectively.
  • the tubular catheter 40 may be a guiding catheter.
  • the extension catheter 30 has a distal end A30, and the distal end A30 of the extension catheter 30 is inserted through an opening b40 on the proximal side of the tubular catheter 40. As shown in FIG.
  • the distal portion of the extension catheter 30 can be projected from the opening a40 on the distal side of the tubular catheter 40, or can be pulled back.
  • the extension catheter 30 is inserted into the tubular catheter 40 that has been previously placed in the body cavity, in order to allow the device passing through the tubular catheter 40 and the extension catheter 30 to reach a more distal side in the body cavity. Used.
  • the inner diameter of the tubular catheter 40 is larger than the outer diameter of the extension catheter 30 in order to receive the extension catheter 30 in the lumen.
  • the extension catheter 30 preferably has a shape in which a rod-shaped linear member 20 and a distal member 10 including a tubular portion 4 or a tapered portion on the distal side are joined.
  • the linear member 20 of the extension catheter 30 is preferably used without protruding from the opening a40 on the distal side of the tubular catheter 40 as shown in FIG.
  • the length of the extension catheter 30 can be, for example, 1500 mm, and the length of the distal member 10 of the extension catheter 30 can be, for example, 350 mm.
  • the diameter of the distal end of the distal member 10 of the extension catheter 30 can be, for example, 1.5 mm.
  • the treatment device enters the tubular catheter 40 through the opening b40 on the proximal side of the tubular catheter 40, enters the extension catheter 30 through the opening on the proximal side of the extension catheter 30, and extends distally of the extension catheter 30. Can be projected from the opening a30.
  • the inner diameter of the tubular portion 4 is preferably 1.0 mm or more and 2.2 mm or less.
  • the thickness is more preferably 2.0 mm or less, still more preferably 1.8 mm or less.
  • the intravascular treatment instrument can easily pass through the tubular portion 4.
  • the thickness is more preferably 1.2 mm or more, still more preferably 1.4 mm or more.
  • the outer diameter of the tubular portion 4 is preferably 1.2 mm or more and 3 mm or less.
  • the tubular portion 4 can be easily inserted into the guiding catheter or the blood vessel. It is more preferably 2 mm or less, still more preferably 1.8 mm or less.
  • the outer diameter of the tubular portion 4 is more preferably 1.4 mm or more, and even more preferably 1.6 mm or more.
  • the tubular portion 4 preferably includes an inner layer 11.
  • a resin is used as a material forming the inner layer 11.
  • the resin for example, at least one selected from the group consisting of polyamide resin, polyester resin, polyurethane resin, polyolefin resin, fluorine resin, vinyl chloride resin, silicone resin, and natural rubber is preferable. Of these, at least one selected from the group consisting of polyester resins, polyolefin resins, fluorine resins, silicone resins, and natural rubber is more preferable. Of these, fluororesins are particularly preferable because they are excellent in chemical resistance, non-adhesiveness, and low friction.
  • polyamide resins include nylon 12, nylon 12 elastomer, nylon 6, aromatic polyamide, and the like.
  • polyester resin include polyethylene terephthalate.
  • polyurethane-based resin include an aliphatic polyurethane containing an aliphatic isocyanate as a monomer unit and an aromatic polyurethane containing an aromatic isocyanate as a monomer unit.
  • polyolefin resin examples include polyethylene and polypropylene.
  • fluorine-based resin include polytetrafluoroethylene, ethylene tetrafluoroethylene, and fluorinated ethylene propylene.
  • vinyl chloride resin include polyvinyl chloride and polyvinylidene chloride.
  • silicone-based resin examples include dimethylpolysiloxane, methylphenylpolysiloxane, methylvinylpolysiloxane, and fluoroalkylmethylpolysiloxane.
  • natural rubber examples include latex.
  • a part or all of the inner layer 11 may contain a radiopaque substance, which will be described later, for facilitating confirmation of the position of the tubular portion 4 under fluoroscopy or the like.
  • the tubular portion 4 preferably includes an outer layer 12.
  • a resin is used as a material forming the outer layer 12.
  • the resin for example, at least one selected from the group consisting of polyamide resin, polyester resin, polyurethane resin, polyolefin resin, fluorine resin, vinyl chloride resin, silicone resin, and natural rubber is preferable. Of these, at least one selected from the group consisting of a polyamide resin, a polyurethane resin, and a polyolefin resin is more preferable, and at least one selected from the group consisting of a polyamide resin and a polyurethane resin is further preferable, Polyurethane resins are even more preferred.
  • a part or all of the outer layer 12 may contain a radiopaque substance in order to easily confirm the position of the tubular portion 4 under fluoroscopy or the like.
  • the radiopaque substance include lead, barium, iodine, tungsten, gold, platinum, iridium, platinum iridium alloy, stainless steel, titanium, cobalt chrome alloy, palladium and tantalum.
  • the outer surface of the outer layer 12 is preferably coated with a hydrophilic polymer. This can facilitate the insertion of the tubular portion 4 into the guiding catheter or the blood vessel.
  • hydrophilic polymer examples include hydrophilic polymers such as poly-2-hydroxyethyl methacrylate, polyacrylamide, polyvinylpyrrolidone, and maleic anhydride copolymers such as methyl vinyl ether maleic anhydride copolymer.
  • the tubular portion 4 preferably includes a reinforcing layer 13.
  • the reinforcing layer 13 can improve the rigidity of the tubular portion 4.
  • the reinforcing layer 13 is provided in the outer layer 12 in FIGS. 2 and 4, the reinforcing layer 13 may be provided in the inner layer 11 or the reinforcing layer 13 may be provided between the inner layer 11 and the outer layer 12. .. Of these, it is particularly preferable to provide the reinforcing layer 13 in the outer layer 12 because the strength is easily improved by providing the reinforcing layer 13 in the outer layer 12.
  • the material forming the reinforcing layer 13 may be a metal wire, a fiber, or the like.
  • a material forming the metal wire for example, stainless steel, titanium, nickel titanium alloy, cobalt chromium alloy, tungsten alloy, etc. are preferable. Of these, stainless steel is more preferable.
  • the metal wire may be a single wire or a stranded wire.
  • the fiber include polyarylate fiber, aramid fiber, ultra high molecular weight polyethylene fiber, PBO fiber, carbon fiber and the like.
  • the fibers may be monofilaments or multifilaments.
  • the shape of the reinforcing layer 13 is not particularly limited, but a spiral shape, a mesh shape, and a braided shape are preferable. Among them, the braided shape is likely to improve the rigidity, and therefore, the shape of the reinforcing layer 13 is more preferably the braided shape.
  • the reinforcing layer 13 may include the above-mentioned radiopaque substance so that the position of the tubular portion 4 can be easily confirmed under fluoroscopy or the like.
  • a radiopaque marker 14 is preferably provided at the tip of the tubular portion 4.
  • the radiopaque marker 14 is preferably provided at a position within 50 mm from the distal end of the tubular portion 4 at a distance in the axial direction X of the tubular portion 4, and within 20 mm. Is more preferable, and it is further preferable that it is provided at a site within 5 mm. This makes it easier to confirm the position of the distal end of the tubular portion 4 in the artery.
  • a radiopaque marker 14 is preferably provided on the proximal side of the tubular portion 4.
  • the radiopaque marker 14 is preferably provided at a position within 50 mm from the proximal end B13 of the reinforcing layer 13 at a distance in the axial direction X of the tubular portion 4. It is more preferably within 20 mm from the proximal end B13 of the reinforcing layer 13, and even more preferably within 5 mm from the proximal end B13 of the reinforcing layer 13. This makes it easier to confirm the position of the proximal portion of the tubular portion 4 in the artery.
  • the shape of the radiopaque marker 14 is not particularly limited, and examples thereof include a band shape and a spiral shape.
  • Examples of the material forming the radiopaque marker 14 include the above radiopaque substances.
  • D indicates the outer diameter (mm) of the tubular portion 4 at the distal end A1 of the first tapered portion 1.
  • L 5 indicates the length (mm) in the axial direction X of the tubular portion 4 from the proximal end of the radiopaque marker 14 to the distal end A1 of the first tapered portion 1.
  • the length L 5 (not shown) in the axial direction X of the tubular portion 4 from the proximal end (not shown) of the radiopaque marker 14 to the distal end A1 of the first tapered portion 1 is the first taper.
  • the diameter is equal to or larger than the outer diameter D of the tubular portion 4 at the distal end A1 of the portion 1.
  • L 5 is preferably 1.5 times or more of D, and more preferably 2 times or more of D.
  • L 5 is more preferably 2.8 times or less than D.
  • the extension catheter 30 includes a third taper portion 3 located closer to the proximal side than the second taper portion 2.
  • the extension catheter 30 includes a distal member 10 including a tubular portion 4, a first tapered portion 1, a second tapered portion 2, and a third tapered portion 3.
  • the linear member 20 is fixed to the distal member 10, and the grip member 21 is provided on the proximal side of the linear member 20.
  • the first taper portion 1, the second taper portion 2, and the third taper portion 3 each have an outer side surface S10.
  • the radial cross-sectional shape of the outer side surface S10 in these taper portions is stepped from the first taper portion 1 to the third taper portion 3 from a circle as shown in FIG. 5 to an arcuate shape as shown in FIG. It is preferable that it is designed to change over time.
  • first tapered surface S1 and the second tapered surface S2 are preferably adjacent to each other.
  • another taper surface may be provided between the first taper surface S1 and the second taper surface S2.
  • the second tapered surface S2 and the third tapered surface S3 are preferably adjacent to each other.
  • another taper surface may be provided between the second taper surface S2 and the third taper surface S3.
  • the first taper portion 1, the second taper portion 2 and the third taper portion 3 preferably contain resin, and more preferably consist of resin.
  • the first taper portion 1, the second taper portion 2, and the third taper portion 3 preferably each include an inner layer 11.
  • the materials constituting these the materials of the inner layer 11 of the tubular portion 4 can be referred to.
  • the material of the inner layer 11 of the first tapered portion 1, the second tapered portion 2, and the third tapered portion 3 is preferably the same as the material of the inner layer 11 of the tubular portion 4.
  • the first taper portion 1, the second taper portion 2, and the third taper portion 3 preferably each include an outer layer 12.
  • the material of the outer layer 12 of the tubular portion 4 can be referred to.
  • the material of the outer layer 12 of the first taper portion 1, the second taper portion 2, and the third taper portion 3 may be the same as or different from the material of the outer layer 12 of the tubular portion 4.
  • the outer layers 12 of the first tapered portion 1, the second tapered portion 2, and the third tapered portion 3 preferably contain the same resin. This makes it easy to avoid local bending of the tapered portion.
  • the outer layer 12 of the first tapered portion 1, the outer layer 12 of the second tapered portion 2, and the outer layer 12 of the third tapered portion 3 are respectively included in the outer layer 12 of the tubular portion 4 where the reinforcing layer 13 is present. It is preferable that a resin having a Shore hardness higher than that of the resin is contained. This makes it possible to easily prevent the deformation of the opening for inserting the endovascular treatment instrument while ensuring the flexibility of the tubular portion 4.
  • the above Shore hardness can be measured based on the ISO 868:2003 plastic durometer hardness test method using a type D durometer.
  • the linear member 20 is a long wire.
  • the linear member 20 pushes the tubular portion 4 so that the tubular portion 4 projects from the opening of a tubular catheter (not shown).
  • a material forming the linear member 20 for example, stainless steel, titanium, nickel titanium alloy, cobalt chromium alloy, tungsten alloy, or the like is preferable. Of these, stainless steel is more preferable.
  • the cross-sectional shape of the linear member 20 in the thickness direction is not limited to the shapes shown in FIGS. 4 to 7, and examples thereof include square, rectangular, trapezoidal, and circular shapes. Of these, a rectangle is preferable.
  • the gripping member 21 is attached to the proximal end of the linear member 20 and has a shape that can be gripped by a practitioner with a finger.
  • a resin is used as a material forming the grip member 21, and a polyolefin resin such as polyethylene or polypropylene is used as the resin.
  • a method of manufacturing the extension catheter 30 As a method of manufacturing the extension catheter 30, a step of forming a notch in the tubular member to form the first tapered surface S1 and a second notch from the proximal side to the distal side of the first tapered surface S1 A manufacturing method including a step of forming the tapered surface S2 is included.
  • the step of forming the first tapered surface S1 it is preferable to make a cut at an angle that satisfies the above expression (1). This makes it easier to form the second tapered surface S2 so as to satisfy the above expression (2).
  • the second tapered surface S2 In the step of forming the second tapered surface S2, it is preferable to make a cut at an angle that satisfies the above formula (2).
  • the second tapered surface S2 In the step of forming the second tapered surface S2, the second tapered surface S2 is formed into a plane by forming a notch from the proximal side to the distal side with respect to the first tapered surface S1 to form the second tapered surface S2. It is possible to easily form S2. However, you may make a notch toward the proximal side from the distal end of the 1st taper surface S1. In this case, the first taper surface S1 and the second taper surface S2 can be formed by making continuous cuts. Further, in the step of forming the second tapered surface S2, it is more preferable to make a cut at an angle that satisfies the above expression (3).
  • the second tapered surface S2 and the third tapered surface S3 can be formed by making continuous cuts.
  • a cutting tool such as a cutter may be used.
  • the distal member 10 is obtained by forming the tapered surface as described above. It is preferable that each taper surface is formed after the linear member 20 is fixed to the tubular member.
  • the method of fixing the linear member 20 to the tubular member is not particularly limited, and examples include adhesive bonding, thermal bonding, brazing and the like. It is preferable to use a heat-shrinkable film for performing adhesive bonding and thermal bonding. When a heat shrink film is used, it is preferable to insert a metal core material into the distal member 10 and then heat the heat shrink film to shrink it.

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Abstract

Provided are an extension catheter into which an intra-blood vessel treatment instrument can be easily inserted, and a method for producing the same. This extension catheter can be inserted into a tubular catheter to protrude from an opening on the distal side of the tubular catheter and is characterized by: being provided with a tubular part, a first tapered part positioned proximally to the tubular part, and a second tapered part positioned proximally to the first tapered part, the first tapered part having an outer surface and a first tapered surface, the second tapered part having an outer surface and a second tapered surface; and satisfying the following formulae (1) and (2).　(1): 90° ≤ θ1 ≤ 145° (2): 120° ≤ θ2 ≤ 175° [In the formulae, θ1 represents the angle formed between the first tapered surface and the axial direction of the tubular part, and θ2 represents the angle formed between the second tapered surface and the axial direction.]

Description

延長カテーテル、及びその製造方法EXTENSION CATHETER AND METHOD OF MANUFACTURING THE SAME
　本発明は、延長カテーテル、及びその製造方法に関する。 The present invention relates to an extension catheter and a manufacturing method thereof.
　狭心症や心筋梗塞等の虚血性心疾患に対して、ステントやバルーン等の血管内治療用器具を用いて心臓の冠動脈の狭窄部を拡張し、血流を増加させる経皮的冠動脈形成術（ＰＣＩ）が行われている。この際、一般に筒状のガイディングカテーテルの先端を冠動脈の入口に挿入して留置した後、ガイディングカテーテル内を通じて血管内治療機器を送達することにより、血管内治療機器の冠動脈末梢側への挿入性を高めていた。しかしバックアップ力が小さく上記留置が不安定である場合には、ガイディングカテーテルの先端が冠動脈の入口から外れてしまうことがあった。その場合、ガイディングカテーテル内に径が小さい延長カテーテルを挿入して、ガイディングカテーテルの遠位側の開口から突出させることによりバックアップ力を向上させていた。 Percutaneous coronary angioplasty for dilating stenosis of coronary artery of the heart and increasing blood flow using ischemic heart disease such as angina and myocardial infarction using endovascular treatment devices such as stents and balloons (PCI) is being performed. At this time, generally, the distal end of the tubular guiding catheter is inserted into the entrance of the coronary artery and left, and then the intravascular treatment device is delivered through the guiding catheter to insert the intravascular treatment device into the distal side of the coronary artery. It was improving the sex. However, when the backup force is small and the placement is unstable, the tip of the guiding catheter sometimes comes off the entrance of the coronary artery. In that case, an extension catheter having a small diameter is inserted into the guiding catheter so as to protrude from the opening on the distal side of the guiding catheter to improve the backup power.
　このような延長カテーテルは種々知られており、例えば特許文献１の延長部分を含む近位部材と、延長部分に取り付けられているカラー部材と、カラー部材に取り付けられている遠位シース部材とを有するガイド延長カテーテルが知られている。その他に、特許文献２の溝が形成されている第１の面とその反対側の第２の面を有する部分を含むプッシュ部材と、プッシュ部材に隣接して通路を有する遠位シャフトとを備えるガイド延長カテーテルが知られている。また特許文献３の先端側部分を構成するディスタルシャフトと、基端側部分を構成するプロキシマルシャフトとを備え、プロキシマルシャフトは、ディスタルシャフトの基端側部分に変性ポリオレフィン系接着剤によって接続されているサポートカテーテルが知られている。更に、特許文献４のガイドワイヤレールセグメントを利用することによってガイドカテーテル内を通じて送達することが可能な同軸ガイドカテーテルや、特許文献５の先端シースと、基端シャフトと、基端シャフトに先端シースを固定する結合部材と、を備えるガイドエクステンションカテーテルが知られている。 Various extension catheters of this kind are known, for example, a proximal member including an extension portion of Patent Document 1, a collar member attached to the extension portion, and a distal sheath member attached to the collar member. Guide extension catheters having are known. In addition, a push member including a portion having a grooved first surface and a second surface opposite thereto, and a distal shaft having a passage adjacent to the push member are provided. Guide extension catheters are known. Moreover, the distal shaft of Patent Document 3 includes a distal shaft and a proximal shaft that constitutes a proximal end portion, and the proximal shaft is connected to the proximal end portion of the distal shaft by a modified polyolefin adhesive. Support catheters are known. Further, a coaxial guide catheter that can be delivered through the guide catheter by using the guide wire rail segment of Patent Document 4, a distal sheath of Patent Document 5, a proximal shaft, and a distal sheath on the proximal shaft. A guide extension catheter including a coupling member for fixing is known.
国際公開第２０１８／０７５７００号International Publication No. 2018/075700 国際公開第２０１７／２１４２０９号International Publication No. 2017/214209 国際公開第２０１８／０３００７５号International Publication No. 2018/030075 米国特許第８２９２８５０号U.S. Patent No. 8292850 特表２０１５－５２３１８６号公報Japanese Patent Publication No. 2015-523186
　従来、ステントやバルーン等の血管内治療用器具は、動脈内において、延長カテーテルの近位側の開口部から延長カテーテル内に挿入されていたが、血管内治療用器具を延長カテーテル内に挿入し難い場合があった。本発明は上記の様な問題に着目してなされたものであって、その目的は、血管内治療用器具を挿入し易い延長カテーテル、及びその製造方法を提供することにある。 Conventionally, a device for endovascular treatment such as a stent or a balloon has been inserted into an extension catheter through an opening on the proximal side of the extension catheter in an artery, but the device for endovascular treatment is inserted into the extension catheter. It was sometimes difficult. The present invention has been made in view of the above problems, and an object thereof is to provide an extension catheter into which an endovascular treatment instrument can be easily inserted, and a manufacturing method thereof.
　上記課題を解決することのできた本発明に係る延長カテーテル、及びその製造方法は、以下の通りである。
　［１］筒状カテーテル内に挿入し、上記筒状カテーテルの遠位側の開口から突出可能な延長カテーテルであって、
　筒状部と、上記筒状部よりも近位側に位置する第１テーパ部と、上記第１テーパ部よりも近位側に位置する第２テーパ部を備え、
　上記第１テーパ部は外側面と第１テーパ面とを有し、
　上記第２テーパ部は外側面と第２テーパ面とを有しており、
　下記式（１）、（２）を満たすことを特徴とする延長カテーテル。
　９０°≦θ１≦１４５°　・・・（１）
　１２０°≦θ２≦１７５°　・・・（２）
　［式中、θ１は、上記第１テーパ面と、上記筒状部の軸方向とのなす角度を示す。θ２は、上記第２テーパ面と上記軸方向とのなす角度を示す。］
　［２］下記式（３）を満たすものである［１］に記載の延長カテーテル。
　θ１＜θ２　・・・（３）
　［式中、θ１、θ２は、前と同じ意味である。］
　［３］下記式（４）を満たすものである［１］または［２］に記載の延長カテーテル。
　Ｔ≦Ｈ１≦Ｈ２・・・（４）
　［式中、Ｔは、上記第１テーパ部の遠位端における上記筒状部の厚さ（ｍｍ）を示す。Ｈ１は、上記第１テーパ面の上記筒状部の中心軸に最も近い点と最も遠い点との径方向の長さ（ｍｍ）を示す。Ｈ２は、上記第２テーパ面の上記筒状部の中心軸に最も近い点と最も遠い点との径方向の長さ（ｍｍ）を示す。］
　［４］下記式（５）を満たすものである［１］～［３］のいずれかに記載の延長カテーテル。
　０．３Ｄ≦Ｄ２　・・・（５）
　［式中、Ｄは、上記第１テーパ部の遠位端における上記筒状部の外径（ｍｍ）を示す。Ｄ２は、上記第２テーパ部の近位端における径方向の長さを示す。］
　［５］更に上記第２テーパ部よりも近位側に位置する第３テーパ部を備え、
　上記第３テーパ部は外側面と第３テーパ面とを有し、
　下記式（６）を満たすものである［１］～［４］のいずれかに記載の延長カテーテル。
　－５°≦θ３≦５°・・・（６）
　［式中、θ３は、上記第３テーパ面と上記軸方向とのなす角度を示す。］
　［６］上記筒状部には補強層が設けられており、
　下記式（７）を満たすものである［１］～［５］のいずれかに記載の延長カテーテル。
　Ｄ≦Ｌ４≦３Ｄ・・・（７）
　［式中、Ｄは、上記第１テーパ部の遠位端における上記筒状部の外径（ｍｍ）を示す。Ｌ４は、上記補強層の近位端から上記第１テーパ部の遠位端までの上記軸方向の長さ（ｍｍ）を示す。］
　［７］筒状部材に切り込みを入れて第１テーパ面を形成する工程、及び
　上記第１テーパ面よりも近位側から遠位側に向かって切り込みを入れて第２テーパ面を形成する工程、
　を含むことを特徴とする延長カテーテルの製造方法。 The extension catheter according to the present invention, which has been able to solve the above problems, and the manufacturing method thereof are as follows.
[1] An extension catheter that can be inserted into a tubular catheter and project from an opening on the distal side of the tubular catheter,
A tubular portion, a first tapered portion located closer to the proximal side than the tubular portion, and a second tapered portion located closer to the proximal side than the first tapered portion,
The first tapered portion has an outer surface and a first tapered surface,
The second taper portion has an outer surface and a second taper surface,
An extension catheter characterized by satisfying the following formulas (1) and (2).
90° ≤ θ 1 ≤ 145° (1)
120° ≤ θ 2 ≤ 175° (2)
[In formula, (theta) 1 shows the angle which the said 1st taper surface and the axial direction of the said cylindrical part make. θ 2 indicates an angle formed by the second tapered surface and the axial direction. ]
[2] The extension catheter according to [1], which satisfies the following formula (3).
θ 1 <θ 2 (3)
[In the formula, θ 1 and θ 2 have the same meanings as described above. ]
[3] The extension catheter according to [1] or [2], which satisfies the following formula (4).
T≦H 1 ≦H 2 (4)
[In formula, T shows the thickness (mm) of the said cylindrical part in the distal end of the said 1st taper part. H 1 indicates a radial length (mm) between a point closest to the central axis of the tubular portion of the first tapered surface and a point farthest from the central axis. H 2 indicates a radial length (mm) between a point closest to the central axis of the cylindrical portion of the second tapered surface and a point farthest from the central axis. ]
[4] The extension catheter according to any one of [1] to [3], which satisfies the following formula (5).
0.3D≦D 2 (5)
[In formula, D shows the outer diameter (mm) of the said cylindrical part in the distal end of the said 1st taper part. D 2 indicates the radial length at the proximal end of the second tapered portion. ]
[5] Furthermore, a third taper portion located closer to the proximal side than the second taper portion is provided,
The third tapered portion has an outer side surface and a third tapered surface,
The extension catheter according to any one of [1] to [4], which satisfies the following formula (6).
−5°≦θ 3 ≦5° (6)
[In formula, (theta) 3 shows the angle which the said 3rd taper surface and the said axial direction make. ]
[6] A reinforcing layer is provided on the tubular portion,
The extension catheter according to any one of [1] to [5], which satisfies the following formula (7).
D≦L 4 ≦3D (7)
[In Formula, D shows the outer diameter (mm) of the said cylindrical part in the distal end of the said 1st taper part. L 4 represents the axial length (mm) from the proximal end of the reinforcing layer to the distal end of the first tapered portion. ]
[7] A step of making a notch in the tubular member to form a first tapered surface, and a step of making a notch from the proximal side to the distal side of the first tapered surface to form the second tapered surface ,
A method of manufacturing an extension catheter, comprising:
　本発明は、上記構成により、血管内治療用器具を挿入し易い延長カテーテル、及びその製造方法を提供することができる。 The present invention can provide an extension catheter into which an endovascular treatment instrument can be easily inserted, and a method of manufacturing the extension catheter having the above-described configuration.
図１は、本発明の実施の形態に係る延長カテーテルの側面図である。FIG. 1 is a side view of an extension catheter according to an embodiment of the present invention. 図２は、図１のＲ部分の軸方向断面図である。2 is an axial cross-sectional view of the R portion of FIG. 図３Ａは、延長カテーテルの側面図である。FIG. 3A is a side view of an extension catheter. 図３Ｂは、延長カテーテルの一部を屈曲させたときの側面図である。FIG. 3B is a side view when a part of the extension catheter is bent. 図３Ｃは、本発明の実施の形態に係る延長カテーテルの側面図である。FIG. 3C is a side view of an extension catheter according to an embodiment of the present invention. 図３Ｄは、本発明の実施の形態に係る延長カテーテルの一部を屈曲させたときの側面図である。FIG. 3D is a side view when a part of the extension catheter according to the embodiment of the present invention is bent. 図４は、図１のＩＶ－ＩＶ断面図を示す。FIG. 4 shows a sectional view taken along the line IV-IV in FIG. 図５は、図１のＶ－Ｖ断面図を示す。FIG. 5 shows a sectional view taken along line VV of FIG. 図６は、図１のＶＩ－ＶＩ断面図を示す。FIG. 6 shows a VI-VI sectional view of FIG. 図７は、図１のＶＩＩ－ＶＩＩ断面図を示す。FIG. 7 shows a sectional view taken along line VII-VII of FIG. 図８は、本発明の実施の形態に係る延長カテーテルを筒状カテーテル内に挿入して筒状カテーテルの遠位側の開口から突出させたときの状態を示す図である。FIG. 8: is a figure which shows the state when the extension catheter which concerns on embodiment of this invention is inserted in a tubular catheter, and is made to project from the opening of the distal side of a tubular catheter.
　以下では、下記実施の形態に基づき本発明をより具体的に説明するが、本発明はもとより下記実施の形態によって制限を受けるものではなく、前・後記の趣旨に適合し得る範囲で適当に変更を加えて実施することも勿論可能であり、それらはいずれも本発明の技術的範囲に包含される。なお、各図面において、便宜上、部材符号等を省略する場合もあるが、かかる場合、明細書や他の図面を参照するものとする。また、図面における種々部材の寸法は、本発明の特徴の理解に資することを優先しているため、実際の寸法とは異なる場合がある。 Hereinafter, the present invention will be described in more detail based on the following embodiments, but the present invention is not limited by the following embodiments, and is appropriately modified within a range compatible with the gist of the preceding and following description. It is, of course, possible to add and carry out, and all of them are included in the technical scope of the present invention. Note that, in each drawing, member symbols and the like may be omitted for convenience, but in such a case, the specification and other drawings are referred to. Further, the dimensions of various members in the drawings may be different from the actual dimensions because priority is given to contributing to the understanding of the features of the present invention.
　まず図１～８を参照して、本発明の実施の形態に係る延長カテーテルについて説明する。図１は、本発明の実施の形態に係る延長カテーテルの側面図を示す。図２は、図１のＲ部分の軸方向断面図である。図３Ａは、延長カテーテルの側面図である。図３Ｂは、延長カテーテルの一部を屈曲させたときの側面図である。図３Ｃは、本発明の実施の形態に係る延長カテーテルの側面図である。図３Ｄは、本発明の実施の形態に係る延長カテーテルの一部を屈曲させたときの側面図である。図４～７は、それぞれ図１のＩＶ－ＩＶ断面図、Ｖ－Ｖ断面図、ＶＩ－ＶＩ断面図、ＶＩＩ－ＶＩＩ断面図を示す。図８は、本発明の実施の形態に係る延長カテーテルを筒状カテーテル内に挿入して筒状カテーテルの遠位側の開口から突出させたときの状態を示す図である。なお、図２では放射線不透過マーカーの記載は省略している。 First, an extension catheter according to an embodiment of the present invention will be described with reference to FIGS. FIG. 1 shows a side view of an extension catheter according to an embodiment of the present invention. 2 is an axial cross-sectional view of the R portion of FIG. FIG. 3A is a side view of an extension catheter. FIG. 3B is a side view when a part of the extension catheter is bent. FIG. 3C is a side view of an extension catheter according to an embodiment of the present invention. FIG. 3D is a side view when a part of the extension catheter according to the embodiment of the present invention is bent. 4 to 7 show a IV-IV sectional view, a VV sectional view, a VI-VI sectional view and a VII-VII sectional view of FIG. 1, respectively. FIG. 8: is a figure which shows the state when the extension catheter which concerns on embodiment of this invention is inserted in a tubular catheter, and is made to project from the opening of the distal side of a tubular catheter. Note that the radiopaque marker is omitted in FIG.
　図１に示す本発明の実施の形態に係る延長カテーテル３０は、図８に示すような筒状カテーテル４０内に挿入し、筒状カテーテル４０の遠位側の開口ａ４０から突出可能な延長カテーテルである。更に、図２に示す通り、延長カテーテル３０は、筒状部４と、筒状部４よりも近位側に位置する第１テーパ部１と、第１テーパ部１よりも近位側に位置する第２テーパ部２を備えるものである。第１テーパ部１は外側面Ｓ１０と第１テーパ面Ｓ１とを有しており、第２テーパ部２は外側面Ｓ１０と第２テーパ面Ｓ２とを有している。更に、延長カテーテル３０は、下記式（１）、（２）を満たすように形成されている。
　９０°≦θ１≦１４５°　・・・（１）
　１２０°≦θ２≦１７５°　・・・（２）
　［式中、θ１は、第１テーパ面Ｓ１と、筒状部４の軸方向Ｘとのなす角度を示す。式中、θ２は、第２テーパ面Ｓ２と筒状部４の軸方向Ｘとのなす角度を示す。］ The extension catheter 30 according to the embodiment of the present invention shown in FIG. 1 is an extension catheter that can be inserted into a tubular catheter 40 as shown in FIG. 8 and can project from an opening a40 on the distal side of the tubular catheter 40. is there. Further, as shown in FIG. 2, the extension catheter 30 includes a tubular portion 4, a first tapered portion 1 located proximal to the tubular portion 4, and a proximal side of the first tapered portion 1. The second taper portion 2 is provided. The first taper portion 1 has an outer side surface S10 and a first taper surface S1, and the second taper portion 2 has an outer side surface S10 and a second taper surface S2. Further, the extension catheter 30 is formed so as to satisfy the following formulas (1) and (2).
90° ≤ θ 1 ≤ 145° (1)
120° ≤ θ 2 ≤ 175° (2)
[In formula, (theta) 1 shows the angle which the 1st taper surface S1 and the axial direction X of the cylindrical part 4 make. In the formula, θ 2 represents an angle formed by the second tapered surface S2 and the axial direction X of the tubular portion 4. ]
　本発明において、近位側とは、延長カテーテル３０の延在方向に対して術者の手元側の方向を意味し、遠位側とは近位側の反対方向、すなわち処置対象側の方向を意味する。 In the present invention, the proximal side means the direction of the operator's proximal side with respect to the extending direction of the extension catheter 30, and the distal side means the direction opposite to the proximal side, that is, the treatment target side. means.
　本発明の実施の形態に係る延長カテーテル３０は、上記式（１）、（２）を満たすように第１テーパ面Ｓ１と第２テーパ面Ｓ２とが形成されている点に最大の特徴がある。詳細には、従来の延長カテーテルの中には特許文献３のように、筒状部の軸方向に対して９０°を超える角度でテーパ面を設けて開口面積の大きい開口部を形成することにより、ステントやバルーン等の血管内治療用器具を延長カテーテル内に挿入し易くしたものがあった。しかし、筒状部の軸方向に対するテーパ面の角度が大きくなり過ぎると、テーパ部の遠位端において筒状部に薄肉部分が生じてしまい、薄肉部分に血管内治療用器具が引っかかり易くなるという問題があった。これに対して本発明では、筒状部の軸方向に対する角度が小さいテーパ面、即ち上記式（１）を満たす第１テーパ面Ｓ１が形成されていることにより薄肉部分が低減されている。更に、薄肉部分が低減されていることにより、第２テーパ面Ｓ２と筒状部４の軸方向Ｘとのなす角度θ２を上記式（２）に規定する範囲にまで大きくすることができ、開口部の開口面積を大きくし易くすることができる。その結果、血管内治療用器具を延長カテーテル内に挿入し易くすることができる。 The extension catheter 30 according to the embodiment of the present invention is most characterized in that the first tapered surface S1 and the second tapered surface S2 are formed so as to satisfy the above expressions (1) and (2). .. More specifically, in the conventional extension catheter, as in Patent Document 3, a tapered surface is provided at an angle of more than 90° with respect to the axial direction of the tubular portion to form an opening having a large opening area. Some have made it easy to insert an endovascular treatment instrument such as a stent or a balloon into an extension catheter. However, when the angle of the tapered surface with respect to the axial direction of the tubular portion becomes too large, a thin portion is formed in the tubular portion at the distal end of the tapered portion, and the endovascular treatment device is easily caught in the thin portion. There was a problem. On the other hand, in the present invention, the thin portion is reduced by forming the tapered surface having a small angle with respect to the axial direction of the tubular portion, that is, the first tapered surface S1 satisfying the above formula (1). Further, since the thin portion is reduced, the angle θ 2 formed by the second tapered surface S2 and the axial direction X of the tubular portion 4 can be increased to the range defined by the above formula (2), The opening area of the opening can be easily increased. As a result, the endovascular treatment device can be easily inserted into the extension catheter.
　以下では、各式を中心に説明する。
　９０°≦θ１≦１４５°　・・・（１）
　［式中、θ１は、第１テーパ面Ｓ１と、筒状部４の軸方向Ｘとのなす角度を示す。］
　第１テーパ面Ｓ１と、筒状部４の軸方向Ｘとのなす角度θ１を１４５°以下とすることより、薄肉部分を低減して血管内治療用器具を引っかかり難くすることができる。そのため、θ１は、好ましくは１４０°以下、より好ましくは１３０°以下、更に好ましくは１２０°以下である。一方、θ１を９０°以上とすることにより、血管内治療用器具を挿入するための開口部の開口面積を大きくし易くすることができる。そのためθ１は、好ましくは９５°以上、より好ましくは１００°以上、更に好ましくは１１０°以上である。 Hereinafter, each expression will be mainly described.
90° ≤ θ 1 ≤ 145° (1)
[In formula, (theta) 1 shows the angle which the 1st taper surface S1 and the axial direction X of the cylindrical part 4 make. ]
By setting the angle θ 1 formed by the first tapered surface S1 and the axial direction X of the tubular portion 4 to be 145° or less, it is possible to reduce the thin portion and make it difficult for the endovascular treatment instrument to be caught. Therefore, θ 1 is preferably 140° or less, more preferably 130° or less, and further preferably 120° or less. On the other hand, when θ 1 is 90° or more, it is possible to easily increase the opening area of the opening for inserting the endovascular treatment instrument. Therefore, θ 1 is preferably 95° or more, more preferably 100° or more, and further preferably 110° or more.
　１２０°≦θ２≦１７５°　・・・（２）
　［式中、θ２は、第２テーパ面Ｓ２と筒状部４の軸方向Ｘとのなす角度を示す。］
　第２テーパ面Ｓ２と筒状部４の軸方向Ｘとのなす角度θ２は、１２０°以上である。これにより、血管内治療用器具を挿入するための開口部の開口面積を大きくし易くすることができる。そのためθ２は、好ましくは１３０°以上、より好ましくは１４０°以上、更に好ましくは１５０°以上である。一方、θ２の上限は、例えば１７５°であってもよく、１７０°であってもよく、１６８°であってもよい。 120° ≤ θ 2 ≤ 175° (2)
[In formula, (theta) 2 shows the angle which the 2nd taper surface S2 and the axial direction X of the cylindrical part 4 make. ]
An angle θ 2 formed by the second tapered surface S2 and the axial direction X of the tubular portion 4 is 120° or more. This makes it easy to increase the opening area of the opening for inserting the endovascular treatment instrument. Therefore, θ 2 is preferably 130° or more, more preferably 140° or more, still more preferably 150° or more. On the other hand, the upper limit of θ 2 may be, for example, 175°, 170°, or 168°.
　更に、延長カテーテル３０は、下記式（３）を満たすことが好ましい。
　θ１＜θ２　・・・（３）
　［式中、θ１、θ２は、前と同じ意味である。］
　第２テーパ面Ｓ２と筒状部４の軸方向Ｘとのなす角度θ２を、第１テーパ面Ｓ１と筒状部４の軸方向Ｘとのなす角度θ１よりも大きくすることが好ましい。これにより薄肉部分を低減しつつ、血管内治療用器具を挿入するための開口部の開口面積を大きくし易くすることができる。θ２は、より好ましくはθ１の１．１倍以上、更に好ましくはθ１の１．２倍以上、更により好ましくはθ１の１．３倍以上である。一方、θ２の上限は、例えばθ１の１．５倍以下であってもよく、θ１の１．４倍以下であってもよい。 Furthermore, the extension catheter 30 preferably satisfies the following formula (3).
θ 1 <θ 2 (3)
[In the formula, θ 1 and θ 2 have the same meanings as described above. ]
The angle θ 2 formed between the second tapered surface S2 and the axial direction X of the tubular portion 4 is preferably larger than the angle θ 1 formed between the first tapered surface S1 and the axial direction X of the tubular portion 4. As a result, it is possible to easily increase the opening area of the opening for inserting the endovascular treatment instrument while reducing the thin portion. theta 2 is more preferably theta 1 1.1 times or more, more preferably theta 1 1.2 times or more, and even more preferably theta 1 1.3 times or more. On the other hand, the upper limit of theta 2 may be equal to or less than 1.5 times the example theta 1, may be not more than 1.4 times the theta 1.
　更に、延長カテーテル３０は、下記式（４）を満たすことが好ましい。
　Ｔ≦Ｈ１≦Ｈ２・・・（４）
　［式中、Ｔは、第１テーパ部１の遠位端Ａ１における筒状部４の厚さ（ｍｍ）を示す。Ｈ１は、第１テーパ面Ｓ１の筒状部４の中心軸Ｃに最も近い点Ｎ１と最も遠い点Ｆ１との径方向の長さ（ｍｍ）を示す。Ｈ２は、第２テーパ面Ｓ２の筒状部４の中心軸Ｃに最も近い点Ｎ２と最も遠い点Ｆ２との径方向の長さ（ｍｍ）を示す。］
　第１テーパ面Ｓ１の筒状部４の中心軸Ｃに最も近い点Ｎ１と最も遠い点Ｆ１との径方向の長さＨ１は、第１テーパ部１の遠位端Ａ１における筒状部４の厚さＴ以上であることが好ましい。これにより薄肉部分を低減し易くすることができる。Ｈ１は、より好ましくはＴの１．１倍以上、更に好ましくはＴの１．２倍以上、更により好ましくはＴの１．３倍以上である。一方、Ｈ１は、第２テーパ面Ｓ２の筒状部４の中心軸Ｃに最も近い点Ｎ２と最も遠い点Ｆ２との径方向の長さＨ２以下であることが好ましい。これにより、第１テーパ面Ｓ１と血管内治療用器具との接触を回避し易くすることができる。そのため、Ｈ１は、より好ましくはＨ２の０．５倍以下、更に好ましくはＨ２の０．４倍以下である。 Furthermore, the extension catheter 30 preferably satisfies the following formula (4).
T≦H 1 ≦H 2 (4)
[In the formula, T represents the thickness (mm) of the tubular portion 4 at the distal end A1 of the first tapered portion 1. H 1 indicates a radial length (mm) between a point N 1 closest to the central axis C of the tubular portion 4 of the first tapered surface S 1 and a point F 1 farthest from the center axis C 1. H 2 indicates a radial length (mm) between a point N 2 closest to the central axis C of the cylindrical portion 4 of the second tapered surface S 2 and a point F 2 farthest from the central axis C. ]
The radial length H 1 between the point N1 closest to the central axis C of the tubular portion 4 of the first tapered surface S1 and the farthest point F1 thereof is the tubular portion 4 at the distal end A1 of the first tapered portion 1. It is preferable that the thickness is equal to or more than T. As a result, the thin portion can be easily reduced. H 1 is more preferably 1.1 times or more T, still more preferably 1.2 times or more T, and even more preferably 1.3 times or more T. On the other hand, H 1 is preferably equal to or less than the radial length H 2 between a point N2 closest to the central axis C of the tubular portion 4 of the second tapered surface S2 and a point F2 farthest from the center axis C. This makes it easy to avoid contact between the first tapered surface S1 and the endovascular treatment instrument. Therefore, H 1 is more preferably 0.5 times or less of H 2 and even more preferably 0.4 times or less of H 2 .
　なおＴは、好ましくは０．０１ｍｍ以上、０．３ｍｍ以下、より好ましくは０．０２ｍｍ以上、０．２ｍｍ以下、更に好ましくは０．０５ｍｍ以上、０．１ｍｍ以下である。Ｈ１は、好ましくは０．０２ｍｍ以上、０．４ｍｍ以下、より好ましくは０．０５ｍｍ以上、０．３ｍｍ以下、更に好ましくは０．１ｍｍ以上、０．２５ｍｍ以下である。Ｈ２は、好ましくは０．１ｍｍ以上、１．５ｍｍ以下、より好ましくは０．２ｍｍ以上、１ｍｍ以下、更に好ましくは０．４ｍｍ以上、０．７ｍｍ以下である。 In addition, T is preferably 0.01 mm or more and 0.3 mm or less, more preferably 0.02 mm or more and 0.2 mm or less, and further preferably 0.05 mm or more and 0.1 mm or less. H 1 is preferably 0.02 mm or more and 0.4 mm or less, more preferably 0.05 mm or more and 0.3 mm or less, and further preferably 0.1 mm or more and 0.25 mm or less. H 2 is preferably 0.1 mm or more and 1.5 mm or less, more preferably 0.2 mm or more and 1 mm or less, still more preferably 0.4 mm or more and 0.7 mm or less.
　更に、延長カテーテル３０は、下記式（５）を満たすことが好ましい。
　０．３Ｄ≦Ｄ２　・・・（５）
　［式中、Ｄは、第１テーパ部１の遠位端Ａ１における筒状部４の外径（ｍｍ）を示す。Ｄ２は、第２テーパ部２の近位端Ｂ２における径方向の長さを示す。］
　第２テーパ部２の近位端Ｂ２における径方向の長さＤ２は、第１テーパ部１の遠位端Ａ１における筒状部４の外径Ｄの０．３倍以上であることが好ましい。これにより第２テーパ部２の近位端Ｂ２近傍における局所的な屈曲を回避し易くすることができる。Ｄ２は、より好ましくはＤの０．４倍以上である。一方、Ｄ２は、Ｄの０．８倍以下であることが好ましい。これにより血管内治療用器具を挿入するための開口部の開口面積を大きくし易くすることができる。そのため、Ｄ２は、Ｄの０．７倍以下であることがより好ましく、Ｄの０．６倍以下であることが更に好ましい。 Furthermore, the extension catheter 30 preferably satisfies the following formula (5).
0.3D≦D 2 (5)
[In the formula, D indicates the outer diameter (mm) of the tubular portion 4 at the distal end A1 of the first tapered portion 1. D 2 represents the radial length of the second tapered portion 2 at the proximal end B2. ]
The radial length D 2 at the proximal end B2 of the second tapered portion 2 is preferably 0.3 times or more the outer diameter D of the tubular portion 4 at the distal end A1 of the first tapered portion 1. .. This makes it easy to avoid local bending near the proximal end B2 of the second tapered portion 2. D 2 is more preferably 0.4 times or more of D. On the other hand, D 2 is preferably 0.8 times or less than D. This makes it easier to increase the opening area of the opening for inserting the endovascular treatment instrument. Therefore, D 2 is more preferably 0.7 times or less D, and even more preferably 0.6 times or less D.
　なおＤは、好ましくは０．５ｍｍ以上、４ｍｍ以下、より好ましくは１ｍｍ以上、２ｍｍ以下、更に好ましくは１．４ｍｍ以上、１．８ｍｍ以下である。Ｄ２は、好ましくは０．２ｍｍ以上、２ｍｍ以下、より好ましくは０．５ｍｍ以上、１．５ｍｍ以下、更に好ましくは０．８ｍｍ以上、１．２ｍｍ以下である。 In addition, D is preferably 0.5 mm or more and 4 mm or less, more preferably 1 mm or more and 2 mm or less, and further preferably 1.4 mm or more and 1.8 mm or less. D 2 is preferably 0.2 mm or more and 2 mm or less, more preferably 0.5 mm or more and 1.5 mm or less, and further preferably 0.8 mm or more and 1.2 mm or less.
　更に、延長カテーテル３０は、第２テーパ部２よりも近位側に位置する第３テーパ部３を備えることが好ましい。第３テーパ部３は、外側面Ｓ１０と第３テーパ面Ｓ３とを有する。第３テーパ部３を備えることにより、第３テーパ部３に沿って血管内治療用器具を開口部に挿入し易くすることができる。 Further, the extension catheter 30 preferably includes a third taper portion 3 located closer to the proximal side than the second taper portion 2. The third tapered portion 3 has an outer side surface S10 and a third tapered surface S3. By providing the third taper portion 3, it is possible to easily insert the endovascular treatment instrument into the opening along the third taper portion 3.
　更に、延長カテーテル３０は、下記式（６）を満たすものであることが好ましい。
　－５°≦θ３≦５°・・・（６）
　［式中、θ３は、第３テーパ面Ｓ３と筒状部４の軸方向Ｘとのなす角度を示す。］
　上記式（６）に示されている通り、第３テーパ面Ｓ３と筒状部４の軸方向Ｘとのなす角度θ３（図示せず）を－５°以上、５°以下とすること、即ち第３テーパ面Ｓ３と筒状部４の軸方向Ｘが略平行になることにより、第３テーパ部３に沿って血管内治療用器具を開口部に挿入し易くすることができる。より好ましくは－３°以上、３°以下、更に好ましくは－２°以上、２°以下であり、更により好ましくは－１°以上、１°以下である。 Furthermore, the extension catheter 30 preferably satisfies the following formula (6).
−5°≦θ 3 ≦5° (6)
[In formula, (theta) 3 shows the angle which the 3rd taper surface S3 and the axial direction X of the cylindrical part 4 make. ]
As shown in the above formula (6), the angle θ 3 (not shown) formed by the third tapered surface S3 and the axial direction X of the tubular portion 4 is set to -5° or more and 5° or less, That is, since the third taper surface S3 and the axial direction X of the tubular portion 4 are substantially parallel to each other, the endovascular treatment instrument can be easily inserted into the opening along the third taper portion 3. It is more preferably -3° or more and 3° or less, still more preferably -2° or more and 2° or less, and even more preferably -1° or more and 1° or less.
　筒状部４が、後述する補強層１３を備える場合、下記式（７）を満たすことが好ましい。
　Ｄ≦Ｌ４≦３Ｄ・・・（７）
　［式中、Ｄは、第１テーパ部１の遠位端Ａ１における筒状部４の外径（ｍｍ）を示す。Ｌ４は、補強層１３の近位端Ｂ１３から第１テーパ部１の遠位端Ａ１までの軸方向Ｘの長さ（ｍｍ）を示す。］
　補強層１３の近位端Ｂ１３から第１テーパ部１の遠位端Ａ１までの筒状部４の軸方向Ｘの長さＬ４が、第１テーパ部１の遠位端Ａ１における筒状部４の外径Ｄ以上であることが好ましい。Ｌ４は、筒状部４のうち補強層１３が設けられていない非補強部５の筒状部４の軸方向Ｘの長さに相当するものであり、これがＤ以上であることにより、血管内治療用器具を挿入するための開口部の変形を回避し易くすることができる。そのため、Ｌ４は、Ｄの１．５倍以上であることが好ましく、Ｄの２倍以上であることがより好ましい。一方、Ｌ４がＤの３倍以下であることにより、非補強部５の変形を回避し易くすることができる。Ｌ４は、より好ましくはＤの２．８倍以下である。 When the tubular portion 4 includes the reinforcing layer 13 described below, it is preferable that the following formula (7) is satisfied.
D≦L 4 ≦3D (7)
[In the formula, D indicates the outer diameter (mm) of the tubular portion 4 at the distal end A1 of the first tapered portion 1. L 4 indicates the length (mm) in the axial direction X from the proximal end B13 of the reinforcing layer 13 to the distal end A1 of the first tapered portion 1. ]
The length L 4 of the tubular portion 4 from the proximal end B13 of the reinforcing layer 13 to the distal end A1 of the first tapered portion 1 in the axial direction X is the tubular portion at the distal end A1 of the first tapered portion 1. It is preferable that the outer diameter is 4 or more. L 4 corresponds to the length in the axial direction X of the tubular portion 4 of the non-reinforcing portion 5 of the tubular portion 4 where the reinforcing layer 13 is not provided. The deformation of the opening for inserting the internal treatment instrument can be easily avoided. Therefore, L 4 is preferably 1.5 times or more of D, and more preferably 2 times or more of D. On the other hand, when L 4 is 3 times or less than D, the deformation of the non-reinforced portion 5 can be easily avoided. L 4 is more preferably 2.8 times or less than D.
　なおＬ４は、具体的には、好ましくは０．５ｍｍ以上、８ｍｍ以下、より好ましくは２ｍｍ以上、６ｍｍ以下、更に好ましくは３ｍｍ以上、５ｍｍ以下である。 Note L 4 are, specifically, preferably 0.5mm or more, 8 mm or less, more preferably 2mm or more, 6 mm or less, more preferably 3mm or more and 5mm or less.
　更に、延長カテーテル３０は、下記式（８）を満たすものであることが好ましい。
　１０Ｄ≦Ｌ３≦２００Ｄ・・・（８）
　［式中、Ｄは、第１テーパ部１の遠位端Ａ１における筒状部４の外径（ｍｍ）を示す。Ｌ３は、第３テーパ部３の遠位端から第３テーパ部３の近位端までの筒状部４の軸方向Ｘの長さ（ｍｍ）を示す。］
　第３テーパ部３の遠位端（図示せず）から第３テーパ部３の近位端（図示せず）までの筒状部４の軸方向Ｘの長さＬ３が、第１テーパ部１の遠位端Ａ１における筒状部４の外径Ｄの１０倍以上であることが好ましい。これにより第３テーパ部３と線状部材２０との接触面積を大きくし易くすることができ、線状部材２０が強固に固定され易くなる。Ｌ３は、より好ましくは外径Ｄの３０倍以上、更に好ましくは外径Ｄの６０倍以上である。一方、Ｌ３は、外径Ｄの２００倍以下であることが好ましい。これにより線状部材２０の柔軟性を向上することができる。Ｌ３は、より好ましくは外径Ｄの１２０倍以下、更に好ましくは外径Ｄの９０倍以下である。 Further, the extension catheter 30 preferably satisfies the following formula (8).
10D≦L 3 ≦200D (8)
[In the formula, D indicates the outer diameter (mm) of the tubular portion 4 at the distal end A1 of the first tapered portion 1. L 3 indicates the length (mm) in the axial direction X of the tubular portion 4 from the distal end of the third tapered portion 3 to the proximal end of the third tapered portion 3. ]
The length L 3 in the axial direction X of the tubular portion 4 from the distal end (not shown) of the third tapered portion 3 to the proximal end (not shown) of the third tapered portion 3 is the first tapered portion. It is preferably 10 times or more the outer diameter D of the tubular portion 4 at the distal end A1. Thereby, the contact area between the third taper portion 3 and the linear member 20 can be easily increased, and the linear member 20 can be easily fixed firmly. L 3 is more preferably 30 times or more the outer diameter D, and even more preferably 60 times or more the outer diameter D. On the other hand, L 3 is preferably 200 times or less the outer diameter D. Thereby, the flexibility of the linear member 20 can be improved. L 3 is more preferably 120 times or less the outer diameter D, and even more preferably 90 times or less the outer diameter D.
　なおＬ３は、具体的には、好ましくは５ｃｍ以上、２０ｃｍ以下、より好ましくは１０ｃｍ以上、１８ｃｍ以下、更に好ましくは１２ｃｍ以上、１５ｃｍ以下である。 Note that L 3 is specifically preferably 5 cm or more and 20 cm or less, more preferably 10 cm or more and 18 cm or less, and further preferably 12 cm or more and 15 cm or less.
　更に、延長カテーテル３０は、下記式（９）を満たすものであることが好ましい。
　１２０°≦θ４≦１７５°・・・（９）
　［式中、θ４は、第２テーパ面Ｓ２と第３テーパ面Ｓ３とのなす角度を示す。］
　図３Ａに示すように、第２テーパ面Ｓ２と第３テーパ面Ｓ３とのなす角度θ４が１２０°未満の延長カテーテルでは、動脈内の湾曲部等において、図３Ｂに示すように第２テーパ部の近位端Ｂ２で局所的な屈曲が起き易い。これに対して、図３Ｃに示すようにθ４を１２０°以上として、筒状部４の軸方向Ｘに対する第２テーパ面Ｓ２と第３テーパ面Ｓ３の角度を滑らかに変化させることにより、図３Ｄに示すように、第２テーパ部の近位端Ｂ２における局所的な屈曲を回避し易くすることができる。その結果、血管内治療用器具を挿入し易くすることができる。そのため、θ４は、好ましくは１３０°以上、より好ましくは１４０°以上、更に好ましくは１５０°以上である。一方、θ４の上限は、例えば１７５°であってもよく、１６８°であってもよい。 Furthermore, the extension catheter 30 preferably satisfies the following formula (9).
120° ≤ θ 4 ≤ 175° (9)
[In formula, (theta) 4 shows the angle which the 2nd taper surface S2 and the 3rd taper surface S3 make. ]
As shown in FIG. 3A, in an extension catheter in which the angle θ 4 formed by the second tapered surface S2 and the third tapered surface S3 is less than 120°, the second taper at the curved portion in the artery as shown in FIG. 3B. Local bending is likely to occur at the proximal end B2 of the part. On the other hand, as shown in FIG. 3C, θ 4 is set to 120° or more, and the angle between the second tapered surface S2 and the third tapered surface S3 with respect to the axial direction X of the tubular portion 4 is smoothly changed, As shown in 3D, it is possible to easily avoid local bending at the proximal end B2 of the second tapered portion. As a result, it is possible to easily insert the endovascular treatment instrument. Therefore, θ 4 is preferably 130° or more, more preferably 140° or more, and further preferably 150° or more. On the other hand, the upper limit of θ 4 may be 175° or 168°, for example.
　その他の各部の好ましい寸法は、以下の通りである。第１テーパ面Ｓ１の筒状部４の中心軸Ｃに最も遠い点Ｆ１から、第１テーパ面Ｓ１の筒状部４の中心軸Ｃに最も近い点Ｎ１までの軸方向Ｘの長さＬ１は、好ましくは０ｍｍ以上、０．３ｍｍ以下、より好ましくは０．０２ｍｍ以上、０．２５ｍｍ以下、更に好ましくは０．０５ｍｍ以上、０．２ｍｍ以下である。 The preferred dimensions of the other parts are as follows. A length L 1 in the axial direction X from a point F1 farthest from the central axis C of the tubular portion 4 of the first tapered surface S1 to a point N1 closest to the central axis C of the tubular portion 4 of the first tapered surface S1. Is preferably 0 mm or more and 0.3 mm or less, more preferably 0.02 mm or more and 0.25 mm or less, and further preferably 0.05 mm or more and 0.2 mm or less.
　第２テーパ面Ｓ２の筒状部４の中心軸Ｃに最も遠い点Ｆ２から、第２テーパ面Ｓ２の筒状部４の中心軸Ｃに最も近い点Ｎ２までの軸方向Ｘの長さＬ２は、好ましくは０．５ｍｍ以上、６ｍｍ以下、より好ましくは１ｍｍ以上、４ｍｍ以下、更に好ましくは１．５ｍｍ以上、３ｍｍ以下である。 A length L 2 in the axial direction X from a point F2 farthest from the central axis C of the tubular portion 4 of the second tapered surface S2 to a point N2 closest to the central axis C of the tubular portion 4 of the second tapered surface S2. Is preferably 0.5 mm or more and 6 mm or less, more preferably 1 mm or more and 4 mm or less, still more preferably 1.5 mm or more and 3 mm or less.
　第１テーパ部１の近位端Ｂ１における径方向の長さＤ１は、好ましくは０．５ｍｍ以上、２．５ｍｍ以下、より好ましくは１ｍｍ以上、２ｍｍ以下、更に好ましくは１．３ｍｍ以上、１．７ｍｍ以下である。 The radial length D 1 at the proximal end B1 of the first tapered portion 1 is preferably 0.5 mm or more and 2.5 mm or less, more preferably 1 mm or more and 2 mm or less, and further preferably 1.3 mm or more, 1 It is 0.7 mm or less.
　筒状部４の遠位端（図示せず）から近位端（図示せず）までの軸方向Ｘの長さは、好ましくは１０ｃｍ以上、５０ｃｍ以下、より好ましくは２０ｃｍ以上、４０ｃｍ以下、更に好ましくは２５ｃｍ以上、３５ｃｍ以下である。 The length of the tubular portion 4 from the distal end (not shown) to the proximal end (not shown) in the axial direction X is preferably 10 cm or more and 50 cm or less, more preferably 20 cm or more and 40 cm or less, and further It is preferably 25 cm or more and 35 cm or less.
　次に、延長カテーテル３０の各部材について詳述する。図１、２に示す通り、延長カテーテル３０は、筒状部４と、筒状部４よりも近位側に位置する第１テーパ部１と、第１テーパ部１よりも近位側に位置する第２テーパ部２を備えるものである。 Next, each member of the extension catheter 30 will be described in detail. As shown in FIGS. 1 and 2, the extension catheter 30 includes a tubular portion 4, a first tapered portion 1 located proximal to the tubular portion 4, and a proximal side of the first tapered portion 1. The second taper portion 2 is provided.
　延長カテーテル３０は、例えば図８に示す筒状カテーテル４０の近位側の開口ｂ４０から、筒状カテーテル４０内に挿入される。筒状カテーテル４０は、遠位端Ａ４０と近位端Ｂ４０を有し、遠位端Ａ４０と近位端Ｂ４０のそれぞれに開口ａ４０、ｂ４０を備える。筒状カテーテル４０は、ガイディングカテーテルであってもよい。延長カテーテル３０は、遠位端Ａ３０を有し、筒状カテーテル４０の近位側の開口ｂ４０から延長カテーテル３０の遠位端Ａ３０が挿入される。図８に示すように筒状カテーテル４０の遠位側の開口ａ４０から延長カテーテル３０の遠位部を突出させることもできるし、引き戻すこともできる。延長カテーテル３０は、先に体腔内に配置されている筒状カテーテル４０内に挿入され、筒状カテーテル４０および延長カテーテル３０の中を通過するデバイスをより体腔内の遠位側へ到達させるために用いられる。筒状カテーテル４０の内径は、延長カテーテル３０を内腔に受け入れるために、延長カテーテル３０の外径よりも大きい。また延長カテーテル３０は、図１に示すように遠位側の筒状部４やテーパ部を含む遠位部材１０と、棒状の線状部材２０が結合された形状であることが好ましい。延長カテーテル３０の線状部材２０は、図８に示すように筒状カテーテル４０の遠位側の開口ａ４０から突出させずに用いることが好ましい。延長カテーテル３０の長さは、例えば１５００ｍｍとすることができ、延長カテーテル３０の遠位部材１０の長さは、例えば３５０ｍｍとすることができる。延長カテーテル３０の遠位部材１０の遠位端の直径は、例えば１．５ｍｍとすることができる。延長カテーテル３０を用いることにより、筒状カテーテル４０、延長カテーテル３０を経由して、処置用のデバイスを延長カテーテルの遠位端Ａ３０の開口ａ３０から突出させて用いることができる。処置用のデバイスは、筒状カテーテル４０の近位側の開口ｂ４０から筒状カテーテル４０内に入り、延長カテーテル３０の近位側の開口から延長カテーテル３０内に入り、延長カテーテル３０の遠位側の開口ａ３０から突出することができる。 The extension catheter 30 is inserted into the tubular catheter 40 through the opening b40 on the proximal side of the tubular catheter 40 shown in FIG. 8, for example. The tubular catheter 40 has a distal end A40 and a proximal end B40, and has openings a40 and b40 at the distal end A40 and the proximal end B40, respectively. The tubular catheter 40 may be a guiding catheter. The extension catheter 30 has a distal end A30, and the distal end A30 of the extension catheter 30 is inserted through an opening b40 on the proximal side of the tubular catheter 40. As shown in FIG. 8, the distal portion of the extension catheter 30 can be projected from the opening a40 on the distal side of the tubular catheter 40, or can be pulled back. The extension catheter 30 is inserted into the tubular catheter 40 that has been previously placed in the body cavity, in order to allow the device passing through the tubular catheter 40 and the extension catheter 30 to reach a more distal side in the body cavity. Used. The inner diameter of the tubular catheter 40 is larger than the outer diameter of the extension catheter 30 in order to receive the extension catheter 30 in the lumen. Further, as shown in FIG. 1, the extension catheter 30 preferably has a shape in which a rod-shaped linear member 20 and a distal member 10 including a tubular portion 4 or a tapered portion on the distal side are joined. The linear member 20 of the extension catheter 30 is preferably used without protruding from the opening a40 on the distal side of the tubular catheter 40 as shown in FIG. The length of the extension catheter 30 can be, for example, 1500 mm, and the length of the distal member 10 of the extension catheter 30 can be, for example, 350 mm. The diameter of the distal end of the distal member 10 of the extension catheter 30 can be, for example, 1.5 mm. By using the extension catheter 30, a treatment device can be used by protruding from the opening a30 of the distal end A30 of the extension catheter via the tubular catheter 40 and the extension catheter 30. The treatment device enters the tubular catheter 40 through the opening b40 on the proximal side of the tubular catheter 40, enters the extension catheter 30 through the opening on the proximal side of the extension catheter 30, and extends distally of the extension catheter 30. Can be projected from the opening a30.
　筒状部４の内径は、１．０ｍｍ以上、２．２ｍｍ以下であることが好ましい。筒状部４の内径が２．２ｍｍ以下であることにより、血管内治療用器具を挿入するための開口部の形状が変形し難くなる。より好ましくは２．０ｍｍ以下、更に好ましくは１．８ｍｍ以下である。一方、筒状部４の内径を１．０ｍｍ以上とすることにより、血管内治療用器具が筒状部４内を通過し易くなる。より好ましくは１．２ｍｍ以上、更に好ましくは１．４ｍｍ以上である。 The inner diameter of the tubular portion 4 is preferably 1.0 mm or more and 2.2 mm or less. When the inner diameter of the tubular portion 4 is 2.2 mm or less, the shape of the opening for inserting the endovascular treatment instrument becomes difficult to deform. The thickness is more preferably 2.0 mm or less, still more preferably 1.8 mm or less. On the other hand, by setting the inner diameter of the tubular portion 4 to be 1.0 mm or more, the intravascular treatment instrument can easily pass through the tubular portion 4. The thickness is more preferably 1.2 mm or more, still more preferably 1.4 mm or more.
　筒状部４の外径は、１．２ｍｍ以上、３ｍｍ以下であることが好ましい。筒状部４の外径が３ｍｍ以下であることにより、筒状部４をガイディングカテーテル内や血管内へ挿入し易くすることができる。より好ましくは２ｍｍ以下、更に好ましくは１．８ｍｍ以下である。一方、筒状部４の外径を１．２ｍｍ以上とすることにより、筒状部４の強度を向上し易くすることができる。より好ましくは１．４ｍｍ以上、更に好ましくは１．６ｍｍ以上である。 The outer diameter of the tubular portion 4 is preferably 1.2 mm or more and 3 mm or less. When the outer diameter of the tubular portion 4 is 3 mm or less, the tubular portion 4 can be easily inserted into the guiding catheter or the blood vessel. It is more preferably 2 mm or less, still more preferably 1.8 mm or less. On the other hand, by setting the outer diameter of the tubular portion 4 to be 1.2 mm or more, the strength of the tubular portion 4 can be easily improved. It is more preferably 1.4 mm or more, and even more preferably 1.6 mm or more.
　図２に示すように筒状部４は、内層１１を備えることが好ましい。内層１１を構成する素材として樹脂が挙げられる。樹脂として、例えばポリアミド系樹脂、ポリエステル系樹脂、ポリウレタン系樹脂、ポリオレフィン系樹脂、フッ素系樹脂、塩化ビニル系樹脂、シリコーン系樹脂、及び天然ゴムよりなる群から選択される少なくとも１種が好ましい。このうちポリエステル系樹脂、ポリオレフィン系樹脂、フッ素系樹脂、シリコーン系樹脂、及び天然ゴムよりなる群から選択される少なくとも１種がより好ましい。このうちフッ素系樹脂は、耐薬品性、非粘着性、低摩擦性に優れるため特に好ましい。 As shown in FIG. 2, the tubular portion 4 preferably includes an inner layer 11. A resin is used as a material forming the inner layer 11. As the resin, for example, at least one selected from the group consisting of polyamide resin, polyester resin, polyurethane resin, polyolefin resin, fluorine resin, vinyl chloride resin, silicone resin, and natural rubber is preferable. Of these, at least one selected from the group consisting of polyester resins, polyolefin resins, fluorine resins, silicone resins, and natural rubber is more preferable. Of these, fluororesins are particularly preferable because they are excellent in chemical resistance, non-adhesiveness, and low friction.
　ポリアミド系樹脂として、ナイロン１２、ナイロン１２エラストマー、ナイロン６、芳香族ポリアミド等が挙げられる。ポリエステル系樹脂として、ポリエチレンテレフタレート等が挙げられる。ポリウレタン系樹脂として、脂肪族イソシアネートをモノマー単位として含む脂肪族ポリウレタン、芳香族イソシアネートをモノマー単位として含む芳香族ポリウレタン等が挙げられる。ポリオレフィン系樹脂として、ポリエチレン、ポリプロピレン等が挙げられる。フッ素系樹脂として、ポリテトラフルオロエチレン、エチレンテトラフルオロエチレン、フッ素化エチレンプロピレン等が挙げられる。塩化ビニル系樹脂として、ポリ塩化ビニル、ポリ塩化ビニリデン等が挙げられる。シリコーン系樹脂として、ジメチルポリシロキサン、メチルフェニルポリシロキサン、メチルビニルポリシロキサン、フロロアルキルメチルポリシロキサン等が挙げられる。天然ゴムとして、ラテックス等が挙げられる。 Examples of polyamide resins include nylon 12, nylon 12 elastomer, nylon 6, aromatic polyamide, and the like. Examples of the polyester resin include polyethylene terephthalate. Examples of the polyurethane-based resin include an aliphatic polyurethane containing an aliphatic isocyanate as a monomer unit and an aromatic polyurethane containing an aromatic isocyanate as a monomer unit. Examples of the polyolefin resin include polyethylene and polypropylene. Examples of the fluorine-based resin include polytetrafluoroethylene, ethylene tetrafluoroethylene, and fluorinated ethylene propylene. Examples of the vinyl chloride resin include polyvinyl chloride and polyvinylidene chloride. Examples of the silicone-based resin include dimethylpolysiloxane, methylphenylpolysiloxane, methylvinylpolysiloxane, and fluoroalkylmethylpolysiloxane. Examples of natural rubber include latex.
　なお内層１１の一部、または全部には、筒状部４の位置をＸ線透視下等で確認し易くするために後記する放射線不透過物質が含まれていてもよい。 Incidentally, a part or all of the inner layer 11 may contain a radiopaque substance, which will be described later, for facilitating confirmation of the position of the tubular portion 4 under fluoroscopy or the like.
　筒状部４は、外層１２を備えることが好ましい。外層１２を構成する素材として樹脂が挙げられる。樹脂としては、例えばポリアミド系樹脂、ポリエステル系樹脂、ポリウレタン系樹脂、ポリオレフィン系樹脂、フッ素系樹脂、塩化ビニル系樹脂、シリコーン系樹脂、及び天然ゴムよりなる群から選択される少なくとも１種が好ましい。このうちポリアミド系樹脂、ポリウレタン系樹脂、及びポリオレフィン系樹脂よりなる群から選択される少なくとも１種がより好ましく、ポリアミド系樹脂、及びポリウレタン系樹脂よりなる群から選択される少なくとも１種が更に好ましく、ポリウレタン系樹脂が更により好ましい。 The tubular portion 4 preferably includes an outer layer 12. A resin is used as a material forming the outer layer 12. As the resin, for example, at least one selected from the group consisting of polyamide resin, polyester resin, polyurethane resin, polyolefin resin, fluorine resin, vinyl chloride resin, silicone resin, and natural rubber is preferable. Of these, at least one selected from the group consisting of a polyamide resin, a polyurethane resin, and a polyolefin resin is more preferable, and at least one selected from the group consisting of a polyamide resin and a polyurethane resin is further preferable, Polyurethane resins are even more preferred.
　なお外層１２の一部、または全部には、筒状部４の位置をＸ線透視下等で確認し易くするために放射線不透過物質が含まれていてもよい。放射線不透過物質としては、例えば、鉛、バリウム、ヨウ素、タングステン、金、白金、イリジウム、白金イリジウム合金、ステンレス、チタン、コバルトクロム合金、パラジウム、タンタル等が挙げられる。 Incidentally, a part or all of the outer layer 12 may contain a radiopaque substance in order to easily confirm the position of the tubular portion 4 under fluoroscopy or the like. Examples of the radiopaque substance include lead, barium, iodine, tungsten, gold, platinum, iridium, platinum iridium alloy, stainless steel, titanium, cobalt chrome alloy, palladium and tantalum.
　外層１２の外側面は、親水性ポリマーがコーティングされていることが好ましい。これにより筒状部４のガイディングカテーテル内や血管内への挿入を容易にし易くすることができる。親水性ポリマーとして、例えば、ポリ２－ヒドロキシエチルメタアクリレート、ポリアクリルアミド、ポリビニルピロリドン、メチルビニルエーテル無水マレイン酸共重合体等の無水マレイン酸共重合体等の親水性ポリマーが挙げられる。 The outer surface of the outer layer 12 is preferably coated with a hydrophilic polymer. This can facilitate the insertion of the tubular portion 4 into the guiding catheter or the blood vessel. Examples of the hydrophilic polymer include hydrophilic polymers such as poly-2-hydroxyethyl methacrylate, polyacrylamide, polyvinylpyrrolidone, and maleic anhydride copolymers such as methyl vinyl ether maleic anhydride copolymer.
　筒状部４は、補強層１３を備えることが好ましい。補強層１３により、筒状部４の剛性を向上することができる。図２や図４では、外層１２内に補強層１３を設けているが、内層１１内に補強層１３を設けてもよいし、内層１１と外層１２の間に補強層１３を設けてもよい。このうち特に外層１２内に補強層１３を設けると強度が向上し易いため、外層１２内に補強層１３が設けられていることが好ましい。 The tubular portion 4 preferably includes a reinforcing layer 13. The reinforcing layer 13 can improve the rigidity of the tubular portion 4. Although the reinforcing layer 13 is provided in the outer layer 12 in FIGS. 2 and 4, the reinforcing layer 13 may be provided in the inner layer 11 or the reinforcing layer 13 may be provided between the inner layer 11 and the outer layer 12. .. Of these, it is particularly preferable to provide the reinforcing layer 13 in the outer layer 12 because the strength is easily improved by providing the reinforcing layer 13 in the outer layer 12.
　補強層１３を構成する素材として、金属線、繊維等が挙げられる。金属線を構成する素材として、例えばステンレス鋼、チタン、ニッケルチタン合金、コバルトクロム合金等、タングステン合金等が好ましい。このうちステンレス鋼がより好ましい。金属線は、単線であってもよいし、撚線であってもよい。繊維として、例えばポリアリレート繊維、アラミド繊維、超高分子量ポリエチレン繊維、ＰＢＯ繊維、炭素繊維等が挙げられる。繊維は、モノフィラメントであってもよいし、マルチフィラメントであってもよい。 The material forming the reinforcing layer 13 may be a metal wire, a fiber, or the like. As a material forming the metal wire, for example, stainless steel, titanium, nickel titanium alloy, cobalt chromium alloy, tungsten alloy, etc. are preferable. Of these, stainless steel is more preferable. The metal wire may be a single wire or a stranded wire. Examples of the fiber include polyarylate fiber, aramid fiber, ultra high molecular weight polyethylene fiber, PBO fiber, carbon fiber and the like. The fibers may be monofilaments or multifilaments.
　補強層１３の形状は、特に限定されないが、らせん状、網目状、編組状が好ましい。このうち編組状が剛性を向上し易いため、補強層１３の形状は編組状であることがより好ましい。 The shape of the reinforcing layer 13 is not particularly limited, but a spiral shape, a mesh shape, and a braided shape are preferable. Among them, the braided shape is likely to improve the rigidity, and therefore, the shape of the reinforcing layer 13 is more preferably the braided shape.
　補強層１３には、筒状部４の位置をＸ線透視下等で確認し易くするため、上記放射線不透過物質が含まれていてもよい。 The reinforcing layer 13 may include the above-mentioned radiopaque substance so that the position of the tubular portion 4 can be easily confirmed under fluoroscopy or the like.
　図１に示すように、筒状部４の先端部には、放射線不透過マーカー１４が設けられていることが好ましい。具体的には、放射線不透過マーカー１４は、筒状部４の軸方向Ｘの距離で、筒状部４の遠位端から５０ｍｍ以内の部位に設けられていることが好ましく、２０ｍｍ以内の部位に設けられていることがより好ましく、５ｍｍ以内の部位に設けられていることが更に好ましい。これにより動脈内における筒状部４の遠位端の位置を確認し易くすることができる。 As shown in FIG. 1, a radiopaque marker 14 is preferably provided at the tip of the tubular portion 4. Specifically, the radiopaque marker 14 is preferably provided at a position within 50 mm from the distal end of the tubular portion 4 at a distance in the axial direction X of the tubular portion 4, and within 20 mm. Is more preferable, and it is further preferable that it is provided at a site within 5 mm. This makes it easier to confirm the position of the distal end of the tubular portion 4 in the artery.
　図１に示すように、筒状部４の近位側には、放射線不透過マーカー１４が設けられていることが好ましい。具体的には、放射線不透過マーカー１４は、筒状部４の軸方向Ｘの距離で、補強層１３の近位端Ｂ１３から５０ｍｍ以内の部位に設けることが好ましい。より好ましくは補強層１３の近位端Ｂ１３から２０ｍｍ以内であり、更に好ましくは補強層１３の近位端Ｂ１３から５ｍｍ以内である。これにより動脈内における筒状部４の近位部の位置を確認し易くすることができる。 As shown in FIG. 1, a radiopaque marker 14 is preferably provided on the proximal side of the tubular portion 4. Specifically, the radiopaque marker 14 is preferably provided at a position within 50 mm from the proximal end B13 of the reinforcing layer 13 at a distance in the axial direction X of the tubular portion 4. It is more preferably within 20 mm from the proximal end B13 of the reinforcing layer 13, and even more preferably within 5 mm from the proximal end B13 of the reinforcing layer 13. This makes it easier to confirm the position of the proximal portion of the tubular portion 4 in the artery.
　放射線不透過マーカー１４の形状は、特に限定されないが、帯状、らせん状等が挙げられる。放射線不透過マーカー１４を構成する素材として、上記放射線不透過物質が挙げられる。 The shape of the radiopaque marker 14 is not particularly limited, and examples thereof include a band shape and a spiral shape. Examples of the material forming the radiopaque marker 14 include the above radiopaque substances.
　筒状部４が、放射線不透過マーカー１４を備える場合、下記式（１０）を満たすことが好ましい。
　Ｄ≦Ｌ5≦３Ｄ・・・（１０）
　［式中、Ｄは、第１テーパ部１の遠位端Ａ１における筒状部４の外径（ｍｍ）を示す。Ｌ5は、放射線不透過マーカー１４の近位端から第１テーパ部１の遠位端Ａ１までの筒状部４の軸方向Ｘの長さ（ｍｍ）を示す。］
　放射線不透過マーカー１４の近位端（図示せず）から第１テーパ部１の遠位端Ａ１までの筒状部４の軸方向Ｘの長さＬ５（図示せず）が、第１テーパ部１の遠位端Ａ１における筒状部４の外径Ｄ以上であることが好ましい。Ｌ５がＤ以上であることにより、血管内治療用器具を挿入するための開口部の変形を回避し易くすることができる。そのため、Ｌ５は、Ｄの１．５倍以上であることが好ましく、Ｄの２倍以上であることがより好ましい。一方、Ｌ５がＤの３倍以下であることにより、非補強部５の変形を回避し易くすることができる。Ｌ５は、より好ましくはＤの２．８倍以下である。 When the tubular portion 4 includes the radiopaque marker 14, it is preferable that the following formula (10) is satisfied.
D≦L 5 ≦3D...(10)
[In the formula, D indicates the outer diameter (mm) of the tubular portion 4 at the distal end A1 of the first tapered portion 1. L 5 indicates the length (mm) in the axial direction X of the tubular portion 4 from the proximal end of the radiopaque marker 14 to the distal end A1 of the first tapered portion 1. ]
The length L 5 (not shown) in the axial direction X of the tubular portion 4 from the proximal end (not shown) of the radiopaque marker 14 to the distal end A1 of the first tapered portion 1 is the first taper. It is preferable that the diameter is equal to or larger than the outer diameter D of the tubular portion 4 at the distal end A1 of the portion 1. When L 5 is D or more, it is possible to easily avoid the deformation of the opening for inserting the endovascular treatment instrument. Therefore, L 5 is preferably 1.5 times or more of D, and more preferably 2 times or more of D. On the other hand, when L 5 is 3 times or less than D, the deformation of the non-reinforced portion 5 can be easily avoided. L 5 is more preferably 2.8 times or less than D.
　また図２では、延長カテーテル３０は、第２テーパ部２よりも近位側に位置する第３テーパ部３を備えている。詳細には、延長カテーテル３０は、筒状部４、第１テーパ部１、第２テーパ部２、及び第３テーパ部３を含む遠位部材１０を備えている。更に、遠位部材１０には線状部材２０が固定されており、線状部材２０の近位側には把持部材２１が設けられている。 Also, in FIG. 2, the extension catheter 30 includes a third taper portion 3 located closer to the proximal side than the second taper portion 2. Specifically, the extension catheter 30 includes a distal member 10 including a tubular portion 4, a first tapered portion 1, a second tapered portion 2, and a third tapered portion 3. Further, the linear member 20 is fixed to the distal member 10, and the grip member 21 is provided on the proximal side of the linear member 20.
　第１テーパ部１、第２テーパ部２、第３テーパ部３は、それぞれ外側面Ｓ１０を有する。これらのテーパ部における外側面Ｓ１０の径方向の断面形状は、第１テーパ部１から第３テーパ部３に向かって、図５に示す様な円形から図６に示す様な円孤状に段階的に変化するようになっていることが好ましい。 The first taper portion 1, the second taper portion 2, and the third taper portion 3 each have an outer side surface S10. The radial cross-sectional shape of the outer side surface S10 in these taper portions is stepped from the first taper portion 1 to the third taper portion 3 from a circle as shown in FIG. 5 to an arcuate shape as shown in FIG. It is preferable that it is designed to change over time.
　図２に示すように、第１テーパ面Ｓ１と第２テーパ面Ｓ２は隣接していることが好ましい。但し、第１テーパ面Ｓ１と第２テーパ面Ｓ２の間に他のテーパ面を有していてもよい。 As shown in FIG. 2, the first tapered surface S1 and the second tapered surface S2 are preferably adjacent to each other. However, another taper surface may be provided between the first taper surface S1 and the second taper surface S2.
　図２に示すように、第２テーパ面Ｓ２と第３テーパ面Ｓ３は隣接していることが好ましい。但し、第２テーパ面Ｓ２と第３テーパ面Ｓ３の間に他のテーパ面を有していてもよい。 As shown in FIG. 2, the second tapered surface S2 and the third tapered surface S3 are preferably adjacent to each other. However, another taper surface may be provided between the second taper surface S2 and the third taper surface S3.
　第１テーパ部１、第２テーパ部２、第３テーパ部３は、樹脂を含むことが好ましく、樹脂からなることがより好ましい。 The first taper portion 1, the second taper portion 2 and the third taper portion 3 preferably contain resin, and more preferably consist of resin.
　第１テーパ部１、第２テーパ部２、第３テーパ部３は、それぞれ内層１１を備えることが好ましい。これらを構成する素材としては、上記筒状部４の内層１１の素材を参照することができる。第１テーパ部１、第２テーパ部２、第３テーパ部３の内層１１の素材は、それぞれ、筒状部４の内層１１の素材と同じであることが好ましい。 The first taper portion 1, the second taper portion 2, and the third taper portion 3 preferably each include an inner layer 11. As the materials constituting these, the materials of the inner layer 11 of the tubular portion 4 can be referred to. The material of the inner layer 11 of the first tapered portion 1, the second tapered portion 2, and the third tapered portion 3 is preferably the same as the material of the inner layer 11 of the tubular portion 4.
　第１テーパ部１、第２テーパ部２、第３テーパ部３は、それぞれ外層１２を備えることが好ましい。これらを構成する素材としては、上記筒状部４の外層１２の素材を参照することができる。第１テーパ部１、第２テーパ部２、第３テーパ部３の外層１２の素材は、それぞれ、筒状部４の外層１２の素材と同じであってもよいし、異なっていてもよいが、第１テーパ部１、第２テーパ部２、第３テーパ部３の外層１２は、それぞれ同じ樹脂を含むことが好ましい。これによりテーパ部の局所的な屈曲を回避し易くすることができる。 The first taper portion 1, the second taper portion 2, and the third taper portion 3 preferably each include an outer layer 12. As the material constituting these, the material of the outer layer 12 of the tubular portion 4 can be referred to. The material of the outer layer 12 of the first taper portion 1, the second taper portion 2, and the third taper portion 3 may be the same as or different from the material of the outer layer 12 of the tubular portion 4. The outer layers 12 of the first tapered portion 1, the second tapered portion 2, and the third tapered portion 3 preferably contain the same resin. This makes it easy to avoid local bending of the tapered portion.
　第１テーパ部１の外層１２、第２テーパ部２の外層１２、第３テーパ部３の外層１２は、それぞれ筒状部４の外層１２のうち補強層１３が存在する部分に含まれている樹脂よりも、ショア硬度が高い樹脂が含まれていることが好ましい。これにより筒状部４の柔軟性を確保しつつ、血管内治療用器具を挿入するための開口部の変形を防止し易くすることができる。 The outer layer 12 of the first tapered portion 1, the outer layer 12 of the second tapered portion 2, and the outer layer 12 of the third tapered portion 3 are respectively included in the outer layer 12 of the tubular portion 4 where the reinforcing layer 13 is present. It is preferable that a resin having a Shore hardness higher than that of the resin is contained. This makes it possible to easily prevent the deformation of the opening for inserting the endovascular treatment instrument while ensuring the flexibility of the tubular portion 4.
　上記ショア硬度は、タイプＤデュロメータを用いたＩＳＯ８６８：２００３　プラスチック・デュロメータ硬さ試験方法に基づき計測することができる。 The above Shore hardness can be measured based on the ISO 868:2003 plastic durometer hardness test method using a type D durometer.
　線状部材２０は、長尺の線材である。線状部材２０は、筒状部４をプッシュして、筒状カテーテル（図示せず）の開口から筒状部４を突出させるものである。線状部材２０を構成する素材として、例えばステンレス鋼、チタン、ニッケルチタン合金、コバルトクロム合金等、タングステン合金等が好ましい。このうちステンレス鋼がより好ましい。線状部材２０は、厚さ方向の断面形状が図４～７に示す形状に限定されず、例えば、正方形、長方形、台形、円形等の形状が挙げられる。このうち長方形が好ましい。 The linear member 20 is a long wire. The linear member 20 pushes the tubular portion 4 so that the tubular portion 4 projects from the opening of a tubular catheter (not shown). As a material forming the linear member 20, for example, stainless steel, titanium, nickel titanium alloy, cobalt chromium alloy, tungsten alloy, or the like is preferable. Of these, stainless steel is more preferable. The cross-sectional shape of the linear member 20 in the thickness direction is not limited to the shapes shown in FIGS. 4 to 7, and examples thereof include square, rectangular, trapezoidal, and circular shapes. Of these, a rectangle is preferable.
　図１に示すように把持部材２１は、線状部材２０の近位端に取り付けられており、施術者が指で把持できるような形状になっている。把持部材２１を構成する素材として樹脂が挙げられ、樹脂としてポリエチレン、ポリプロピレン等のポリオレフィン系樹脂が挙げられる。 As shown in FIG. 1, the gripping member 21 is attached to the proximal end of the linear member 20 and has a shape that can be gripped by a practitioner with a finger. A resin is used as a material forming the grip member 21, and a polyolefin resin such as polyethylene or polypropylene is used as the resin.
　次に、実施の形態に係る延長カテーテル３０の製造方法について説明する。延長カテーテル３０の製造方法として、筒状部材に切り込みを入れて第１テーパ面Ｓ１を形成する工程、及び第１テーパ面Ｓ１よりも近位側から遠位側に向かって切り込みを入れて第２テーパ面Ｓ２を形成する工程、を含む製造方法が挙げられる。 Next, a method of manufacturing the extension catheter 30 according to the embodiment will be described. As a method of manufacturing the extension catheter 30, a step of forming a notch in the tubular member to form the first tapered surface S1 and a second notch from the proximal side to the distal side of the first tapered surface S1 A manufacturing method including a step of forming the tapered surface S2 is included.
　第１テーパ面Ｓ１を形成する工程において、上記式（１）を満たす角度で切り込みを入れることが好ましい。これにより、上記式（２）を満たすように第２テーパ面Ｓ２を形成し易くすることができる。 In the step of forming the first tapered surface S1, it is preferable to make a cut at an angle that satisfies the above expression (1). This makes it easier to form the second tapered surface S2 so as to satisfy the above expression (2).
　第２テーパ面Ｓ２を形成する工程において、上記式（２）を満たす角度で切り込みを入れることが好ましい。第２テーパ面Ｓ２を形成する工程において、第１テーパ面Ｓ１よりも近位側から遠位側に向かって切り込みを入れて第２テーパ面Ｓ２を形成することにより、平面状に第２テーパ面Ｓ２を形成し易くすることができる。但し、第１テーパ面Ｓ１の遠位端から近位側に向かって切り込みを入れてもよい。この場合、連続的に切り込みを入れて第１テーパ面Ｓ１と第２テーパ面Ｓ２を形成することができる。また、第２テーパ面Ｓ２を形成する工程において、上記式（３）を満たす角度で切り込みを入れることがより好ましい。 In the step of forming the second tapered surface S2, it is preferable to make a cut at an angle that satisfies the above formula (2). In the step of forming the second tapered surface S2, the second tapered surface S2 is formed into a plane by forming a notch from the proximal side to the distal side with respect to the first tapered surface S1 to form the second tapered surface S2. It is possible to easily form S2. However, you may make a notch toward the proximal side from the distal end of the 1st taper surface S1. In this case, the first taper surface S1 and the second taper surface S2 can be formed by making continuous cuts. Further, in the step of forming the second tapered surface S2, it is more preferable to make a cut at an angle that satisfies the above expression (3).
　更に、第２テーパ面Ｓ２よりも近位側から遠位側に向かって切り込みを入れて第３テーパ面Ｓ３を形成する工程を含むことが好ましい。第２テーパ面Ｓ２よりも近位側から遠位側に向かって切り込みを入れることにより、平面状に第３テーパ面Ｓ３を形成し易くすることができる。但し、第２テーパ面Ｓ２の遠位端から近位側に向かって切り込みを入れてもよい。この場合、連続的に切り込みを入れて第２テーパ面Ｓ２と第３テーパ面Ｓ３を形成することができる。 Further, it is preferable to include a step of forming a notch from the proximal side to the distal side of the second tapered surface S2 to form the third tapered surface S3. By making a notch from the proximal side to the distal side of the second tapered surface S2, it is possible to easily form the third tapered surface S3 in a planar shape. However, you may make a notch toward the proximal side from the distal end of the 2nd taper surface S2. In this case, the second tapered surface S2 and the third tapered surface S3 can be formed by making continuous cuts.
　これらの切り込みを入れるに当たっては、カッター等の切込器具を用いればよい。 When making these cuts, a cutting tool such as a cutter may be used.
　上記のようにテーパ面を形成することにより遠位部材１０が得られる。なお線状部材２０を筒状部材に固定してから、各テーパ面を形成することが好ましい。線状部材２０を筒状部材に固定する方法は特に限定されないが、接着接合、熱接合、ろう付け等が挙げられる。接着接合、熱接合を行うに当たっては、熱収縮フィルムを用いて行うことが好ましい。熱収縮フィルムを用いる場合、遠位部材１０内に金属製の芯材を挿入した後に熱収縮フィルムを加熱して収縮させることが好ましい。 The distal member 10 is obtained by forming the tapered surface as described above. It is preferable that each taper surface is formed after the linear member 20 is fixed to the tubular member. The method of fixing the linear member 20 to the tubular member is not particularly limited, and examples include adhesive bonding, thermal bonding, brazing and the like. It is preferable to use a heat-shrinkable film for performing adhesive bonding and thermal bonding. When a heat shrink film is used, it is preferable to insert a metal core material into the distal member 10 and then heat the heat shrink film to shrink it.
　本願は、２０１９年２月６日に出願された日本国特許出願第２０１９－０１９９９７号に基づく優先権の利益を主張するものである。２０１９年２月６日に出願された日本国特許出願第２０１９－０１９９９７号の明細書の全内容が、本願に参考のため援用される。 The present application claims the benefit of priority based on Japanese Patent Application No. 2019-0199997 filed on February 6, 2019. The entire content of the specification of Japanese Patent Application No. 2019-019997 filed on Feb. 6, 2019 is incorporated herein by reference.
　１　第１テーパ部
　２　第２テーパ部
　３　第３テーパ部
　４　筒状部
　５　非補強部
　１０　遠位部材
　１１　内層
　１２　外層
　１３　補強層
　１４　放射線不透過マーカー
　２０　線状部材
　２１　把持部材
　３０　延長カテーテル
　４０　筒状カテーテル
　Ｓ１　第１テーパ面
　Ｓ２　第２テーパ面
　Ｓ３　第３テーパ面
　Ｓ１０　外側面
　Ａ１　第１テーパ部の遠位端
　Ｂ１　第１テーパ部の近位端
　Ｂ２　第２テーパ部の近位端
　Ｂ１３　補強層の近位端
　Ｃ　筒状部の中心軸
　Ｆ１　第１テーパ面の筒状部の中心軸に最も遠い点
　Ｎ１　第１テーパ面の筒状部の中心軸に最も近い点
　Ｆ２　第２テーパ面の筒状部の中心軸に最も遠い点
　Ｎ２　第２テーパ面の筒状部の中心軸に最も近い点
　Ｘ　筒状部の軸方向
　Ａ３０　延長カテーテルの遠位端
　Ａ４０　筒状カテーテルの遠位端
　Ｂ４０　筒状カテーテルの近位端
　ａ３０　延長カテーテルの遠位側の開口
　ａ４０　筒状カテーテルの遠位側の開口
　ｂ４０　筒状カテーテルの近位側の開口
  1 1st taper part 2 2nd taper part 3 3rd taper part 4 Cylindrical part 5 Non-reinforcing part 10 Distal member 11 Inner layer 12 Outer layer 13 Reinforcing layer 14 Radiopaque marker 20 Linear member 21 Grasping member 30 Extension catheter 40 Tubular catheter S1 First tapered surface S2 Second tapered surface S3 Third tapered surface S10 Outer surface A1 Distal end of first tapered portion B1 Proximal end of first tapered portion B2 Proximal end of second tapered portion B13 Reinforcement Proximal end of layer C Central axis of tubular portion F1 Point farthest from central axis of tubular portion of first tapered surface N1 Point closest to central axis of tubular portion of first tapered surface F2 Of second tapered surface Point farthest from the central axis of the tubular portion N2 Point closest to the central axis of the tubular portion of the second tapered surface X Axial direction of the tubular portion A30 Distal end of the extension catheter A40 Distal end of the tubular catheter B40 Tube Proximal end of tubular catheter a30 distal opening of extension catheter a40 distal opening of tubular catheter b40 proximal opening of tubular catheter

Claims (7)

  1. 　筒状カテーテル内に挿入し、前記筒状カテーテルの遠位側の開口から突出可能な延長カテーテルであって、
    　筒状部と、前記筒状部よりも近位側に位置する第１テーパ部と、前記第１テーパ部よりも近位側に位置する第２テーパ部を備え、
    　前記第１テーパ部は外側面と第１テーパ面とを有し、
    　前記第２テーパ部は外側面と第２テーパ面とを有しており、
    　下記式（１）、（２）を満たすことを特徴とする延長カテーテル。
    　９０°≦θ１≦１４５°　・・・（１）
    　１２０°≦θ２≦１７５°　・・・（２）
    　［式中、θ１は、前記第１テーパ面と、前記筒状部の軸方向とのなす角度を示す。θ２は、前記第２テーパ面と前記軸方向とのなす角度を示す。］     An extension catheter that is inserted into a tubular catheter and can project from an opening on the distal side of the tubular catheter,
    A tubular portion, a first taper portion located proximal to the tubular portion, and a second taper portion located proximal to the first tapered portion,
    The first tapered portion has an outer surface and a first tapered surface,
    The second taper portion has an outer surface and a second taper surface,
    An extension catheter characterized by satisfying the following formulas (1) and (2).
    90° ≤ θ 1 ≤ 145° (1)
    120° ≤ θ 2 ≤ 175° (2)
    [In formula, (theta) 1 shows the angle which the said 1st taper surface and the axial direction of the said cylindrical part make. θ 2 indicates an angle formed by the second tapered surface and the axial direction. ]
  2. 　下記式（３）を満たすものである請求項１に記載の延長カテーテル。
    　θ１＜θ２　・・・（３）
    　［式中、θ１、θ２は、前と同じ意味である。］     The extension catheter according to claim 1, which satisfies the following formula (3).
    θ 1 <θ 2 (3)
    [In the formula, θ 1 and θ 2 have the same meanings as described above. ]
  3. 　下記式（４）を満たすものである請求項１または２に記載の延長カテーテル。
    　Ｔ≦Ｈ１≦Ｈ２・・・（４）
    　［式中、Ｔは、前記第１テーパ部の遠位端における前記筒状部の厚さ（ｍｍ）を示す。Ｈ１は、前記第１テーパ面の前記筒状部の中心軸に最も近い点と最も遠い点との径方向の長さ（ｍｍ）を示す。Ｈ２は、前記第２テーパ面の前記筒状部の中心軸に最も近い点と最も遠い点との径方向の長さ（ｍｍ）を示す。］     The extension catheter according to claim 1, which satisfies the following formula (4).
    T≦H 1 ≦H 2 (4)
    [In formula, T shows the thickness (mm) of the said cylindrical part in the distal end of the said 1st taper part. H 1 indicates a radial length (mm) between a point closest to the central axis of the cylindrical portion of the first tapered surface and a point farthest from the central axis. H 2 indicates a radial length (mm) between a point closest to the central axis of the cylindrical portion of the second tapered surface and a point farthest from the central axis. ]
  4. 　下記式（５）を満たすものである請求項１～３のいずれかに記載の延長カテーテル。
    　０．３Ｄ≦Ｄ２　・・・（５）
    　［式中、Ｄは、前記第１テーパ部の遠位端における前記筒状部の外径（ｍｍ）を示す。Ｄ２は、前記第２テーパ部の近位端における径方向の長さを示す。］     The extension catheter according to any one of claims 1 to 3, which satisfies the following formula (5).
    0.3D≦D 2 (5)
    [In formula, D shows the outer diameter (mm) of the said cylindrical part in the distal end of the said 1st taper part. D 2 indicates the radial length at the proximal end of the second tapered portion. ]
  5. 　更に前記第２テーパ部よりも近位側に位置する第３テーパ部を備え、
    　前記第３テーパ部は外側面と第３テーパ面とを有し、
    　下記式（６）を満たすものである請求項１～４のいずれかに記載の延長カテーテル。
    　－５°≦θ３≦５°・・・（６）
    　［式中、θ３は、前記第３テーパ面と前記軸方向とのなす角度を示す。］     Further, a third taper portion located proximal to the second taper portion is provided,
    The third tapered portion has an outer surface and a third tapered surface,
    The extension catheter according to any one of claims 1 to 4, which satisfies the following formula (6).
    −5°≦θ 3 ≦5° (6)
    [In formula, (theta) 3 shows the angle which the said 3rd taper surface and the said axial direction make. ]
  6. 　前記筒状部には補強層が設けられており、
    　下記式（７）を満たすものである請求項１～５のいずれかに記載の延長カテーテル。
    　Ｄ≦Ｌ４≦３Ｄ・・・（７）
    　［式中、Ｄは、前記第１テーパ部の遠位端における前記筒状部の外径（ｍｍ）を示す。Ｌ４は、前記補強層の近位端から前記第１テーパ部の遠位端までの前記軸方向の長さ（ｍｍ）を示す。］     The tubular portion is provided with a reinforcing layer,
    The extension catheter according to any one of claims 1 to 5, which satisfies the following formula (7).
    D≦L 4 ≦3D (7)
    [In formula, D shows the outer diameter (mm) of the said cylindrical part in the distal end of the said 1st taper part. L 4 indicates the axial length (mm) from the proximal end of the reinforcing layer to the distal end of the first tapered portion. ]
  7. 　筒状部材に切り込みを入れて第１テーパ面を形成する工程、及び
    　前記第１テーパ面よりも近位側から遠位側に向かって切り込みを入れて第２テーパ面を形成する工程、
    　を含むことを特徴とする延長カテーテルの製造方法。
          Forming a first tapered surface by making a cut in the tubular member, and making a second tapered surface by making a cut from the proximal side to the distal side of the first tapered surface,
    A method for manufacturing an extension catheter, comprising:
PCT/JP2020/003215 2019-02-06 2020-01-29 Extension catheter and method for producing same WO2020162286A1 (en)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016517320A (en) * 2013-03-15 2016-06-16 キューエックスメディカル リミテッド ライアビリティ カンパニー Boosting catheter and related systems and methods
JP2017533012A (en) * 2014-11-04 2017-11-09 オーバスネイチ メディカル、インコーポレイテッド Cumulative flexibility catheter support frame
US20180193042A1 (en) * 2017-01-10 2018-07-12 Route 92 Medical, Inc. Aspiration catheter systems and methods of use
US20180200480A1 (en) * 2017-01-13 2018-07-19 Turnstone Technologies, LLC Catheter extension device

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016517320A (en) * 2013-03-15 2016-06-16 キューエックスメディカル リミテッド ライアビリティ カンパニー Boosting catheter and related systems and methods
JP2017533012A (en) * 2014-11-04 2017-11-09 オーバスネイチ メディカル、インコーポレイテッド Cumulative flexibility catheter support frame
US20180193042A1 (en) * 2017-01-10 2018-07-12 Route 92 Medical, Inc. Aspiration catheter systems and methods of use
US20180200480A1 (en) * 2017-01-13 2018-07-19 Turnstone Technologies, LLC Catheter extension device

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