WO2020162286A1 - Cathéter prolongé, et procédé de fabrication de celui-ci - Google Patents

Cathéter prolongé, et procédé de fabrication de celui-ci 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
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English (en)
Japanese (ja)
Inventor
俊哉 木佐
Original Assignee
株式会社カネカ
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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/ja
Publication of WO2020162286A1 publication Critical patent/WO2020162286A1/fr

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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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  • Life Sciences & Earth Sciences (AREA)
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  • Biomedical Technology (AREA)
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Abstract

L'invention fournit un cathéter prolongé destiné à l'insertion facile d'un instrument pour radiologie interventionnelle vasculaire, et un procédé de fabrication de ce cathéter prolongé. Plus précisément, l'invention concerne un cathéter prolongé qui est inséré à l'intérieur d'un cathéter de forme tubulaire, et qui peut dépasser par une ouverture côté distal dudit cathéter de forme tubulaire. Lequel cathéter prolongé est caractéristique en ce qu'il est équipé d'une partie tubulaire, d'une première partie évasée positionnée côté proximal par rapport à ladite partie tubulaire, et d'une seconde partie évasée positionnée côté proximal par rapport à ladite première partie évasée. En outre, ladite première partie évasée possède une face côté externe et une première face évasée, et ladite seconde partie évasée possède une face côté externe et une seconde face évasée. Enfin, les formules (1) et (2) suivantes sont satisfaites.　９０°≦θ１≦１４５°　・・・（１）　１２０°≦θ２≦１７５°　・・・（２） [Dans la formule, θ１ représente un angle formé par ladite première face évasée et la direction axiale de ladite partie tubulaire. θ２ représente un angle formé par ladite seconde face évasée et ladite direction axiale.]
PCT/JP2020/003215 2019-02-06 2020-01-29 Cathéter prolongé, et procédé de fabrication de celui-ci WO2020162286A1 (fr)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016517320A (ja) * 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 ブースティングカテーテルおよび関連するシステムおよび方法
JP2017533012A (ja) * 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 累加柔軟性カテーテル支持フレーム
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 (ja) * 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 ブースティングカテーテルおよび関連するシステムおよび方法
JP2017533012A (ja) * 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 累加柔軟性カテーテル支持フレーム
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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