WO2023062984A1

WO2023062984A1 - Extension guide catheter

Info

Publication number: WO2023062984A1
Application number: PCT/JP2022/033695
Authority: WO
Inventors: 知也加藤
Original assignee: 株式会社カネカ
Priority date: 2021-10-14
Filing date: 2022-09-08
Publication date: 2023-04-20

Abstract

Provided is an extension guide catheter for a guide catheter, the extension guide catheter having a tubular body (2) having a lumen (4) extending in the longitudinal direction of the guide catheter, and a linear member (13) extending on the proximal side of the tubular body (2), wherein: a proximal-side opening (5) of the tubular body (2) has, from the distal side thereof, a first section (7), a second section (8), and a third section (9); and the proximal-side opening (5) is formed so that, when the tubular body (2) is viewed from below, the width of the tubular body gradually increases from the distal side toward the proximal side in the first section (7), the width gradually decreases from the distal side toward the proximal side in the second section (8), and the width gradually increases from the distal side toward the proximal side in the third section (9).

Description

extension guide catheter

The present invention relates to an extension guide catheter for a guide catheter, and more particularly to an extension guide catheter that is used by being inserted into the guide catheter and extending from an opening on the distal side of the guide catheter.

Percutaneous coronary angioplasty, in which endovascular treatment devices such as stents and balloons are used to expand coronary artery stenosis and increase blood flow for ischemic heart diseases such as angina pectoris and myocardial infarction. (PCI) is done. At this time, after inserting the tip of a cylindrical guide catheter into the entrance of the coronary artery and indwelling it, the endovascular treatment instrument is delivered through the guide catheter, thereby improving the ease of insertion of the endovascular treatment instrument into the peripheral side of the coronary artery. is commonly practiced. However, if the backup force is small and the placement is unstable, the tip of the guide catheter may come off the entrance of the coronary artery. In that case, an extension guide catheter having a smaller diameter may be inserted within the guide catheter to extend through the distal opening of the guide catheter to improve backup force.

Various such extension guide catheters are known. For example, U.S. Pat. No. 6,200,000 discloses a guide extension guide catheter having a proximal member including an extension portion, a collar member attached to the extension portion, and a distal sheath member attached to the collar member. . U.S. Patent No. 6,000,000 discloses a guide comprising a push member including a portion having a grooved first surface and an opposite second surface, and a distal shaft having a passageway adjacent the push member. An extension catheter is disclosed. In Patent Document 3, a tubular portion, a first tapered portion located on the proximal side of the tubular portion, and a second tapered portion located on the proximal side of the first tapered portion are provided. The angle formed between the first tapered surface of the portion and the axial direction of the cylindrical portion is 90° to 145°, and the angle formed between the second tapered surface of the second tapered portion and the axial direction of the cylindrical portion is 120° to 120°. An extension catheter is disclosed that is 175°.

WO2018/075700 WO2017/214209 WO2020/162286

The extension guide catheter is used by inserting it into the guide catheter. When a treatment device such as an endovascular treatment instrument is delivered from the guide catheter through the extension guide catheter, the extension guide catheter is positioned in a body cavity or a curved portion of the guide catheter. Sometimes. In this case, there is a concern that it will be difficult to insert a treatment device such as an intravascular treatment instrument into the extension guide catheter in a body cavity or a curved portion of the guide catheter. SUMMARY OF THE INVENTION The present invention has been made in view of the above circumstances, and an object thereof is to provide an extension guide catheter that facilitates the insertion of treatment devices such as instruments for endovascular treatment.

The extension guide catheter of the present invention is as follows.
[1] An extension guide catheter for a guide catheter, comprising a tubular body having a lumen extending in the longitudinal direction and having a proximal side opening and a distal side opening; and a linear member extending proximally from a proximal opening of the cylindrical body, wherein the cylindrical body has an upper side to which the linear member is fixed with respect to the radial direction. and an opposite lower side thereof, and the proximal opening includes a first section, a second section that is proximal to the first section, and a second section that is closer to the second section than the second section. It has a third section on the proximal side, and when the tubular body is viewed from below, the width of the proximal opening gradually increases from the distal side to the proximal side in the first section, and the width increases in the second section. The extension guide catheter is formed so that the width gradually decreases from the distal side to the proximal side in the third section and the width gradually increases from the distal side to the proximal side in the third section.

Since the extension guide catheter of the present invention has the first section, the second section, and the third section formed at the proximal side opening as described above, the proximal end of the cylindrical body can be bent in the body cavity or the guide catheter. When a force is applied to the proximal end of the cylindrical body in the bending direction, the cylindrical body is deformed so that the proximal side opening opens when viewed from below, and the proximal side opening of the cylindrical body is deformed. expands in size. In addition, even if the proximal end of the cylindrical body is bent, distortion is unlikely to occur at that part, and the lumen of the cylindrical body is prevented from being crushed or the cross-sectional shape of the lumen is distorted and the cross-sectional area is greatly narrowed. be done. Therefore, it becomes easier to insert the treatment device into the lumen of the tubular body through the proximal opening of the tubular body.

[2] The extension guide according to [1], wherein from the distal end of the first section to the proximal end of the second section, the outer edge of the proximal opening is formed in the lower half of the cylindrical body. catheter.
[3] The length in the longitudinal direction from the distal end of the first section to the proximal end of the second section is 0.3 to 15 times the width of the proximal opening at the proximal end of the third section The extension guide catheter according to [1] or [2], which is the following.
[4] The width of the proximal opening at the distal end of the third section is 0.3 times or more and 0.9 times or less than the width of the proximal opening at the proximal end of the third section [1]- The extension guide catheter according to any one of [3].
[5] The longitudinal length of the first section and/or the longitudinal length of the second section is equal to or less than the longitudinal length of the third section [1]-[4] An extension guide catheter according to any one of the preceding claims.
[6] The extension guide catheter according to any one of [1] to [5], which satisfies one or both of the following formulas (1) and (2).
(A1-A2)/B1≧(A3-A2)/B3 (1)
(A1-A2)/B2≧(A3-A2)/B3 (2)
[In the above formula, A1 represents the width of the proximal opening at the proximal end of the first section, A2 represents the width of the proximal opening at the proximal end of the second section, and A3 represents the width of the third Represents the width of the proximal opening at the proximal end of the section, where B1 is the longitudinal length from the proximal end of the first section to the point in the first section where the width of the proximal opening is A2. B2 represents the longitudinal length of the second section, and B3 represents the longitudinal length of the third section. ]
[7] The extension guide catheter according to any one of [1] to [6], wherein the distal end of the linear member is located on the distal side of the distal end of the proximal opening.

In the extension guide catheter according to the embodiment of the present invention, when the proximal end portion of the tubular body is positioned at the curved portion of the body cavity such as a blood vessel or the curved portion of the guide catheter, the tubular body can be seen from below. deformed so that the proximal side opening opens, and the size of the proximal side opening widens. In addition, even if the proximal end of the cylindrical body is bent, distortion is unlikely to occur at that part, and the lumen of the cylindrical body is prevented from being crushed or the cross-sectional shape of the lumen is distorted and the cross-sectional area is greatly narrowed. be done. Therefore, it becomes easier to insert the treatment device into the lumen of the tubular body through the proximal opening of the tubular body.

1 illustrates an extension guide catheter according to an embodiment of the present invention, and illustrates an overall view of the extension guide catheter; FIG. 2 depicts a side view of the proximal end of the tubular body of the extension guide catheter shown in FIG. 1; FIG. Figure 3 shows a bottom view of the proximal end of the tubular body of the extension guide catheter shown in Figure 2; Figure 4 shows an enlarged view of the proximal end barrel of the extension guide catheter shown in Figure 3; Fig. 3 shows a side view of the proximal end of the tubular body of the extension guide catheter shown in Fig. 2, with the proximal end of the tubular body being bent; FIG. 4 is a diagram showing a state in which an extension guide catheter according to an embodiment of the present invention is inserted into a guide catheter placed in a blood vessel and extended from an opening on the distal side of the guide catheter; FIG. 10B shows a side view of the proximal end of the tubular body of the extension guide catheter according to the comparative embodiment. Fig. 8 shows a side view of the proximal end of the tubular body of the extension guide catheter shown in Fig. 7 in a state where the proximal end of the tubular body is bent;

Hereinafter, the extension guide catheter of the present invention will be specifically described based on the following embodiments, but the present invention is not limited by the following embodiments, and is suitable within the scope that can conform to the gist of the above and later descriptions. Of course, it is also possible to implement by adding changes to, and all of them are included in the technical scope of the present invention. In each drawing, for the sake of convenience, hatching, member numbers, etc. may be omitted. In such cases, the specification and other drawings shall be referred to. In addition, the dimensions of various members in the drawings may differ from the actual dimensions, since priority is given to helping to understand the features of the present invention.

An extension guide catheter according to an embodiment of the present invention will be described with reference to FIGS. 1 to 6. FIG. FIG. 1 is an extension guide catheter according to an embodiment of the present invention, showing an overall view of the extension guide catheter, and FIG. 2 is a view of the proximal end of the tubular body of the extension guide catheter shown in FIG. 3 shows a view from below of the proximal end of the tubular body of the extension guide catheter shown in FIG. 2, and FIG. 4 shows the tubular body of the extension guide catheter shown in FIG. 5 depicts an enlarged view of the tubular body at the proximal end of the tubular body, FIG. 5 is the proximal end of the tubular body of the extension guide catheter shown in FIG. is bent, and FIG. 6 shows that the extension guide catheter according to the embodiment of the present invention is inserted into the guide catheter placed in the blood vessel, and the opening on the distal side of the guide catheter is opened FIG. 10 shows a view showing a state extended from .

The extension guide catheter is used in combination with the guide catheter. Specifically, it is inserted into the guide catheter and extended from the opening on the distal side of the guide catheter. By using the extension guide catheter, it is possible to stably deliver a treatment device such as an instrument for intravascular treatment to a farther periphery. Devices for endovascular treatment include stents and balloons.

As shown in FIGS. 1 and 2, an extension guide catheter 1 according to an embodiment of the present invention includes a tubular body 2 having a lumen 4 extending in the longitudinal direction x, and a tube fixed to the tubular body 2. and a linear member 13 extending proximally from the proximal side opening 5 of the tubular body 2 .

As shown in FIG. 6, the extension guide catheter 1 is used by inserting it into the guide catheter 21 previously placed in the body cavity during the operation. Specifically, the extension guide catheter 1 is inserted into the guide catheter 21 from the opening on the proximal side of the guide catheter 21, and the extension guide catheter 1 is extended distally from the opening 22 on the distal side of the guide catheter 21. It can be taken out and used. FIG. 6 shows a state in which the extension guide catheter 1 is placed inside the guide catheter 21 placed in the ascending aorta, and the extension guide catheter 1 extends from the opening 22 on the distal side of the guide catheter 21 .

By pushing or pulling the linear member 13, the extension guide catheter 1 advances or retracts the cylindrical body 2 within the guide catheter 21, or extends distally from the distal opening 22 of the guide catheter 21. can be pulled back into the guide catheter 21. By delivering a treatment device such as an instrument for intravascular treatment through the guide catheter 21 and the extension guide catheter 1, the treatment device can reach a more distal end within the body cavity. The inner diameter of the guide catheter 21 is larger than the outer diameter of the extension guide catheter 1 to accommodate the extension guide catheter 1 . The treatment device enters the guide catheter 21 from the proximal side opening of the guide catheter 21, passes through the guide catheter 21, and further enters the extension guide catheter 1 from the proximal side opening 5 of the extension guide catheter 1 to be the extension guide. By passing it through the inside of the catheter 1, it can be extended distally from the distal side opening 6 of the tubular body 2 of the extension guide catheter 1. As shown in FIG.

In the extension guide catheter 1 , the longitudinal axis direction x is defined as the extension direction of the extension guide catheter 1 , specifically the extension direction of the tubular body 2 and the linear member 13 . The extension guide catheter 1 has a proximal side and a distal side as one side and the other side with respect to the longitudinal axis direction x. In the extension guide catheter 1, the proximal side refers to the direction toward the hand side of the user, that is, the operator with respect to the extending direction of the extension guide catheter 1, and the distal side is the opposite direction to the proximal side, that is, Point in the direction of the side to be treated. The cylindrical body 2 has a radial direction as a direction orthogonal to the longitudinal axis direction x.

The length of the extension guide catheter 1 in the longitudinal direction x is, for example, preferably 800 mm or more, more preferably 1000 mm or more, still more preferably 1200 mm or more, and preferably 2200 mm or less, more preferably 2000 mm or less, and even more preferably 1800 mm or less. . The length of the cylindrical body 2 in the longitudinal direction x is, for example, preferably 100 mm or more, more preferably 200 mm or more, still more preferably 250 mm or more, preferably 600 mm or less, more preferably 500 mm or less, and even more preferably 450 mm or less. .

From the viewpoint of ensuring the insertability of the extension guide catheter 1 through the guide catheter and the insertability of the treatment device inside the extension guide catheter 1, the diameter of the lumen 4 of the cylindrical body 2 is preferably 1.0 mm or more. 2 mm or more is more preferable, 1.3 mm or more is still more preferable, 2.2 mm or less is preferable, 2.0 mm or less is more preferable, and 1.9 mm or less is even more preferable. The outer diameter of the cylindrical body 2 is preferably 1.2 mm or more, more preferably 1.3 mm or more, still more preferably 1.4 mm or more, and preferably 3.5 mm or less, more preferably 3.0 mm or less, and 2.5 mm. More preferred are: The thickness of the cylindrical body 2 is preferably 0.01 mm or more, more preferably 0.02 mm or more, still more preferably 0.05 mm or more, and preferably 0.4 mm or less, more preferably 0.3 mm or less, and 0.01 mm or more. 2 mm or less is more preferable.

In the cross section perpendicular to the longitudinal axis direction x of the tubular body 2, the shape of the lumen 4 of the tubular body 2 and the shape of the outer edge of the tubular body 2 are not particularly limited, and may be circular, elliptical, oval, or polygonal. , irregular shapes, and the like. When the shape of the lumen 4 and the shape of the outer edge of the tubular body 2 are other than circular, the diameter of the lumen 4 of the tubular body 2 and the outer diameter of the tubular body 2 described above mean equivalent circle diameters. . That is, it means the diameter of a circle having the same length as the circumference of the lumen 4 of the tubular body 2 or the circumference of the outer edge of the tubular body 2 . The shape of the lumen 4 of the cylindrical body 2 and the shape of the outer edge of the cylindrical body 2 are preferably circular or elliptical. is preferred, 0.90 or more is more preferred, and 0.95 or more is even more preferred.

The cylindrical body 2 can be made of resin, for example. Examples of resins include polyamide resins, polyester resins, polyurethane resins, polyolefin resins, fluorine-based resins, vinyl chloride-based resins, silicone resins, and natural rubber. Polyamide resins include nylon 12, nylon 12 elastomer, nylon 6, aromatic polyamides, and the like. Polyethylene terephthalate etc. are mentioned as a polyester resin. Examples of polyurethane resins include aliphatic polyurethanes containing aliphatic isocyanates as monomer units, aromatic polyurethanes containing aromatic isocyanates as monomer units, and the like. Examples of polyolefin resins include polyethylene and polypropylene. Examples of the fluororesin include polytetrafluoroethylene, ethylenetetrafluoroethylene, fluorinated ethylenepropylene, and the like. Examples of vinyl chloride-based resins include polyvinyl chloride and polyvinylidene chloride. Examples of silicone resins include dimethylpolysiloxane, methylphenylpolysiloxane, methylvinylpolysiloxane, and fluoroalkylmethylpolysiloxane. Latex etc. are mentioned as natural rubber.

The tubular body 2 may be composed of a single layer, or may be composed of multiple layers. Moreover, in the longitudinal direction x, part of the cylindrical body 2 may be composed of a single layer, and the other part may be composed of multiple layers.

The tubular body 2 preferably has a reinforcing layer. The reinforcement layer can increase the rigidity of the cylindrical body 2 . The reinforcing layer may be provided on the inner surface of the tubular body 2 , may be provided on the outer surface, or may be provided between the inner and outer surfaces of the tubular body 2 .

The reinforcing layer can be composed of metal wires, fibers, or the like. Materials constituting the metal wire include, for example, stainless steel, titanium, nickel-titanium alloys, cobalt-chromium alloys, and tungsten alloys. Among them, stainless steel is preferable. The metal wire may be a single wire or a twisted wire. Examples of fibers include polyarylate fibers, aramid fibers, ultra-high molecular weight polyethylene fibers, PBO (polyparaphenylenebenzoxazole) fibers, and carbon fibers. The fibers may be monofilaments or multifilaments.

Although the shape of the reinforcing layer is not particularly limited, it is preferably spiral, mesh, or braided. In particular, the shape of the reinforcing layer is more preferably braided because the reinforcing layer can effectively increase the rigidity of the cylindrical body 2 .

The cylindrical body 2 may contain a radiopaque material in order to facilitate confirmation of the position under X-ray fluoroscopy. Radiopaque materials include, for example, lead, barium, iodine, tungsten, gold, platinum, iridium, platinum-iridium alloys, stainless steel, titanium, cobalt-chromium alloys, palladium, tantalum, and the like. For example, radiopaque markers are preferably provided at the proximal end and the distal end of the tubular body 2, so that the position of the tubular body 2 within the body cavity can be confirmed under X-ray fluoroscopy. can.

The cylindrical body 2 may have its outer surface coated with a hydrophilic polymer. This facilitates insertion of the cylindrical body 2 into the guide catheter or blood vessel. Examples of hydrophilic polymers include hydrophilic polymers such as poly-2-hydroxyethyl methacrylate, polyacrylamide, polyvinylpyrrolidone, and maleic anhydride copolymers such as methyl vinyl ether maleic anhydride copolymers.

The tubular body 2 preferably has an inner layer and an outer layer. The inner and outer layers can be composed of the resins described above. Among others, the inner layer is preferably composed of at least one selected from the group consisting of polyester resins, polyolefin resins, fluororesins, silicone resins, and natural rubbers. In particular, from the viewpoint of excellent chemical resistance, non-adhesiveness, and low friction, the inner layer is preferably composed of a fluororesin. The outer layer is preferably composed of at least one resin selected from the group consisting of polyamide resins, polyurethane resins, and polyolefin resins, and is composed of at least one resin selected from the group consisting of polyamide resins and polyurethane resins. More preferably, it is made of a polyurethane resin.

The tubular body 2 preferably has a reinforcing layer in addition to the inner layer and the outer layer. The reinforcing layer may be provided on the outer layer, on the inner layer, or between the inner layer and the outer layer. It is preferably provided between outer layers.

The linear member 13 is an elongated wire and fixed to the proximal end of the cylindrical body 2 . By pushing or pulling the linear member 13, the tubular body 2 can be advanced or retracted, thereby causing the tubular body 2 to protrude from the opening on the distal side of the guide catheter or to move the tubular body 2 forward. It can be pulled back into the guide catheter.

The linear member 13 is preferably made of metal. Examples of the metal forming the linear member 13 include stainless steel, titanium, nickel-titanium alloys, cobalt-chromium alloys, tungsten alloys, etc. Among them, stainless steel is more preferable. The cross-sectional shape of the linear member 13 in the direction perpendicular to the longitudinal axis direction x is not particularly limited. Especially, it is preferable that the cross-sectional shape of the linear member 13 is a square.

The extension guide catheter 1 is preferably provided with a grasping member 14 at the proximal end of the linear member 13 . By gripping the gripping member 14 with fingers, the operator can easily push in and pull out the extension guide catheter 1 . Examples of materials for the grip member 14 include resins, and examples of resins include polyolefin resins such as polyethylene and polypropylene.

The linear member 13 may be fixed to the inner surface of the tubular body 2, may be fixed to the outer surface of the tubular body 2, or may be fixed between the inner and outer surfaces of the tubular body 2. good too. When the cylindrical body 2 has an inner layer and an outer layer, the linear member 13 may be fixed to the inner layer of the cylindrical body 2, the outer layer, or between the inner layer and the outer layer. . The linear member 13 is fixed to one side of the cylindrical body 2 in the radial direction, and the cylindrical body 2 is defined such that the side to which the linear member 13 is fixed is the upper side and the opposite side is the lower side with respect to the radial direction. be done. That is, the cylindrical body 2 has an upper side to which the linear member 13 is fixed and a lower side opposite to the upper side with respect to the radial direction. In addition, among the radial directions, the direction extending from the upper side to the lower side is referred to as the vertical direction, and the direction orthogonal thereto is referred to as the width direction.

The cylindrical body 2 has a proximal opening 5 and a distal opening 6. The proximal opening 5 of the tubular body 2 means the opening on the proximal side of the lumen 4 of the tubular body 2 , and the distal opening 6 of the tubular body 2 means the inside of the tubular body 2 . It means the distal opening of cavity 4 . The proximal side opening 5 of the cylindrical body 2 has a portion inclined with respect to the longitudinal axis direction x. The cylindrical body 2 has a cylindrical portion 3 formed in a cylindrical shape and a non-cylindrical proximal extension portion 11 extending proximally from the cylindrical portion 3, and the outer edge of the proximal side opening 5 is It is formed on the proximal extension portion 11 . A bore 4 of the tubular body 2 is formed in the tubular portion 3 .

The proximal opening 5 has a first section 7, a second section 8 proximal to the first section 7, and a third section proximal to the second section 8 with respect to the longitudinal axis direction x. 9. In the tubular body 2, a proximal extension portion 11 formed with the outer edge of the proximal side opening 5, specifically, a longitudinal portion in which the first section 7 to the third section 9 of the proximal extension portion 11 are formed A portion within the range in the axial direction x and a portion adjacent to the distal side thereof are referred to as a proximal end portion of the tubular body 2 . For example, the portion of the proximal extension portion 11 in which the first section 7 to the third section 9 are formed and the portion within 20 mm distally from the proximal end of the tubular portion 3 adjacent thereto are formed into a tubular shape. It can be the proximal end of body 2 . Also, in the proximal extension portion 11 , the portion of the longitudinal axis direction x where the first section 7 is formed is referred to as the first section 7 of the proximal extension portion 11 . Similarly, for the portion of the proximal extension portion 11 that is closer to the proximal side than the first section 7, the section with respect to the longitudinal axis direction x is defined based on each section.

As shown in FIG. 3 , when the tubular body 2 is viewed from below, the width of the proximal opening 5 gradually increases from the distal side to the proximal side in the first section 7 and increases in the second section 8 . The width gradually decreases from the distal side to the proximal side, and the width of the third section 9 gradually increases from the distal side to the proximal side. In the extension guide catheter 1 according to the embodiment of the present invention, the proximal opening 5 of the tubular body 2 is formed in this way, so that the proximal end portion of the tubular body 2 is bent in a body cavity such as a blood vessel. The tubular body 2 is deformed so that the size of the proximal side opening 5 expands when positioned at a bent portion of the guide catheter, and a treatment device such as an endovascular treatment instrument is placed near the tubular body 2. It becomes easy to insert into the lumen 4 of the cylindrical body 2 from the position side opening 5 .

To explain this in detail, the extension guide catheter 1 is used by inserting it into the guide catheter and the body cavity. , the proximal end of the tubular body 2 may be located in a body cavity or a bent portion of the guide catheter. In this case, the proximal end of the tubular body 2 is bent with the lower side of the tubular body 2 inside along the bent portion of the body cavity or the guide catheter. 4 may be crushed, or the cross-sectional shape of the lumen 4 may be distorted to narrow the cross-sectional area. However, since the extension guide catheter 1 has the first section 7, the second section 8, and the third section 9 formed in the proximal side opening 5 as described above, the proximal end of the cylindrical body 2 extends into the body cavity. or at the bent portion of the guide catheter, when a force in the bending direction is applied to the proximal end of the tubular body 2, the tubular body 2 opens the proximal side opening 5 when viewed from below. It deforms and the size of the proximal side opening 5 expands. In addition, even if the proximal end portion of the cylindrical body 2 is bent, distortion is unlikely to occur in this portion, and the lumen 4 of the cylindrical body 2 may be crushed or the cross-sectional shape of the lumen 4 may be distorted to increase the cross-sectional area. Narrowing can be suppressed. Therefore, it becomes easier to insert the treatment device into the lumen 4 of the tubular body 2 from the proximal opening 5 of the tubular body 2 .

For example, as shown in FIG. 7, when the outer edge of the proximal side opening 5 is formed to simply extend obliquely with respect to the longitudinal axis direction x, when the proximal end portion of the cylindrical body 2 is bent, As shown in 8, the distal end of the proximal opening 5 is distorted and tends to bend inward in a distorted shape. As a result, the lower portion of the lumen 4 of the tubular body 2 is distorted, the cross-sectional area of the lumen 4 is narrowed, and the insertion of the treatment device into the proximal opening 5 of the tubular body 2 is hindered. There is a risk of On the other hand, when the proximal opening 5 is provided with the first section 7, the second section 8, and the third section 9, when the force in the bending direction is applied to the third section 9 of the proximal extension portion 11, , the force is transmitted to the second section 8, which can be deformed so that the lower portion of the proximal opening 5 opens at the second section 8, as shown in FIG. In addition, the proximal extension portion 11 can be easily bent from the first section 7 to the second section 8, and at that time, along with the bending, the proximal extension portion 11 can be bent from the second section 8 to the third section 9. The lower part of the side opening 5 can be deformed to open. Furthermore, even if the proximal extension portion 11 is bent from the first section 7 to the second section 8, distortion is less likely to occur in this section, and the proximal end portion of the tubular body 2 is bent with a larger curvature. can be made Since the proximal opening 5 is widened from the first section 7 to the second section 8, the lower portion of the proximal opening 5 opens from the second section 8 to the third section 9. By doing so, a large opening is formed on the lower side of the tubular body 2 . Therefore, when the treatment device is inserted from the proximal opening 5 of the tubular body 2 , the treatment device is less likely to be caught on the outer edge of the proximal opening 5 of the tubular body 2 , and the treatment device is inserted proximally of the tubular body 2 . Insertion into the side opening 5 is facilitated.

The width of the proximal side opening 5 is determined based on the projected shape of the outer edge of the proximal side opening 5 when the cylindrical body 2 is viewed from below, and the width It is obtained by measuring the length between both ends of the outer edge of the proximal opening 5 with respect to the direction. The outer edge of the proximal opening 5, when viewed from the bottom side of the tubular body 2, may be formed in a straight line shape, may be formed in a curved shape, or may be formed in a combination of these shapes. may be

From the first section 7 to the third section 9, the outer edge of the proximal side opening 5 is preferably formed line-symmetrically in the width direction. In this case, the width of the proximal opening 5 is the length in the width direction between both ends of the outer edge of the proximal opening 5 at the same position in the vertical direction in the vertical cross section of the proximal opening 5 in the longitudinal axis direction x. It can be obtained by measuring. If the proximal side opening 5 is formed in this way, the proximal end portion of the tubular body 2 is greatly distorted when the proximal end portion of the tubular body 2 is positioned in the body cavity or the bent portion of the guide catheter. It becomes easy to bend smoothly without causing Further, when the proximal end portion of the cylindrical body 2 is bent, the proximal side opening 5 tends to expand substantially evenly in the width direction on one side and the other side in the width direction. In addition, forming symmetrically in the width direction means forming symmetrically with respect to a plane defined by the longitudinal axis direction x and the vertical direction.

The distal end of the first section 7 of the proximal opening 5 is preferably the distal end of the proximal opening 5 . Therefore, first section 7 is preferably formed including the distal end of proximal opening 5 . On the other hand, the proximal opening 5 may also be present on the proximal side of the proximal end of the third section 9, for example, on the proximal side of the third section 9, from the distal side to the proximal side. You may have the 4th section 10 formed so that width may taper toward a side.

The outer edge of the proximal opening 5 is preferably formed in the lower half portion of the cylindrical body 2 from the distal end of the first section 7 to the proximal end of the second section 8 . This prevents the proximal extension portion 11 from excessively bending from the first section 7 to the second section 8 when the proximal end portion of the cylindrical body 2 is positioned in a body cavity or a bent portion of the guide catheter. can be suppressed. Therefore, when inserting the treatment device through the proximal opening 5 , it is possible to prevent the treatment device from being caught on the outer edge of the proximal opening 5 . In addition, force in the bending direction is likely to be applied to the third section 9 of the proximal extension portion 11, the force is transmitted to the second section 8, and the lower portion of the proximal side opening 5 is opened in the second section 8. It becomes easy to transform like this. Alternatively, as the proximal extension portion 11 is bent from the first section 7 to the second section 8, the lower portion of the proximal side opening 5 is deformed from the second section 8 to the third section 9 so that the lower portion opens. easier.

The outer edge of the proximal opening 5 is preferably formed in the lower half portion of the tubular body 2 also in the third section 9 . Therefore, the outer edge of the proximal opening 5 is preferably formed in the lower half portion of the cylindrical body 2 in the first section 7 to the third section 9 . In this case, the proximal end of the third section 9 preferably coincides with the proximal end of the lower half portion of the tubular body 2 . Moreover, in the fourth section 10 on the proximal side of the third section 9 , the outer edge of the proximal opening 5 is preferably formed in the upper half portion of the tubular body 2 .

The length in the longitudinal direction x from the distal end of the first section 7 to the proximal end of the second section 8 is 0.3 times or more the width of the proximal side opening 5 at the proximal end of the third section 9 is preferred, 0.6 times or more is more preferred, and 1 time or more is even more preferred. As a result, when the proximal end portion of the cylindrical body 2 is bent, the lower portion of the proximal side opening 5 can be smoothly deformed so as to widen. In addition, when the lower portion of the proximal opening 5 is opened, the treatment device moves toward the outer edge of the proximal opening 5 of the tubular body 2, particularly the second section 8 to the third section 9 of the proximal extending portion 11. It becomes difficult to get caught on the protruding part. On the other hand, the length of the longitudinal axis direction x from the distal end of the first section 7 to the proximal end of the second section 8 is 15 times or less the width of the proximal opening 5 at the proximal end of the third section 9. is preferred, 12 times or less is more preferred, and 10 times or less is even more preferred. As a result, the lengths of the first section 7 and the second section 8 in the longitudinal axis direction x of the proximal extension portion 11 are not excessively long, and the proximal end portion of the tubular body 2 is positioned in a body cavity or a guide catheter. When positioned at the bent portion, the force in the bending direction is likely to be applied to the third section 9 of the proximal extension portion 11 . Therefore, the force applied to the third section 9 of the proximal extension portion 11 is transmitted to the second section 8 , and the second section 8 easily deforms so that the lower portion of the proximal side opening 5 opens.

The length of the first section 7 in the longitudinal direction x and/or the length of the second section 8 in the longitudinal direction x is preferably equal to or less than the length of the third section 9 in the longitudinal direction x. If the proximal side opening 5 is formed in this way, when the proximal extending portion 11 is bent from the first section 7 to the second section 8, distortion is less likely to occur in that portion. Therefore, when inserting the treatment device from the proximal opening 5 of the tubular body 2 , the treatment device is less likely to get caught on the outer edge of the proximal opening 5 of the tubular body 2 . In this case, even if one of the length in the longitudinal axis direction x of the first section 7 and the length in the longitudinal axis direction x of the second section 8 is longer than the length in the longitudinal axis direction x of the third section 9 . However, in that case, it is preferably 2.0 times or less, more preferably 1.5 times or less, the length of the third section 9 in the longitudinal direction x. Also, both the length in the longitudinal axis direction x of the first section 7 and the length in the longitudinal axis direction x of the second section 8 may be less than or equal to the length in the longitudinal axis direction x of the third section 9 .

The width of the proximal opening 5 at the distal end of the third section 9 is preferably 0.3 times or more the width of the proximal opening 5 at the proximal end of the third section 9, such as 0.4 times. 0.5 times or more is more preferable. If the proximal side opening 5 is formed in this way, when the treatment device is inserted through the proximal side opening 5 of the tubular body 2, the treatment device is inserted through the second section 8 of the proximal extension portion 11. It becomes difficult to get caught on the protruding part over the third section 9. - 特許庁On the other hand, the width of the proximal opening 5 at the distal end of the third section 9 is preferably 0.9 times or less than the width of the proximal opening 5 at the proximal end of the third section 9. The length of the third section 9 in the longitudinal direction x is ensured. Therefore, when the proximal end portion of the cylindrical body 2 is positioned in the body cavity or the bent portion of the guide catheter, the force applied to the third section 9 of the proximal extension portion 11 is transmitted to the second section 8, The two sections 8 facilitate deformation so that the lower portion of the proximal opening 5 opens.

The width of the proximal opening 5 at the distal end of the second section 8 is preferably 0.4 to 1.0 times the width of the proximal opening 5 at the proximal end of the third section 9. , is more preferably 0.5 times or more, and more preferably 0.6 times or more. As a result, when a force in the bending direction is applied to the proximal end portion of the tubular body 2 , the lower portion of the proximal side opening 5 spreads so as to form a large opening, and the treatment device is positioned near the tubular body 2 . It becomes easy to insert from the postural side opening 5.例文帳に追加In addition, the proximal extension portion 11 can easily bend smoothly from the first section 7 to the second section 8 .

The first section 7, the second section 8 and the third section 9 are preferably formed so as to satisfy one or both of the following formulas (1) and (2).
(A1-A2)/B1≧(A3-A2)/B3 (1)
(A1-A2)/B2≧(A3-A2)/B3 (2)

In the above formula, A1 to A3 and B1 to B3 mean the length of each part shown in FIG. 4, specifically, A1 represents the width of the proximal opening 5 at the proximal end of the first section 7. , A2 represents the width of the proximal opening 5 at the proximal end of the second section 8, A3 represents the width of the proximal opening 5 at the proximal end of the third section 9, and B1 represents the width of the first represents the length in the longitudinal direction x from the proximal end of the section 7 to the point in the first section 7 where the width of the proximal opening 5 is A2, where B2 is the longitudinal direction x of the second section 8 and B3 represents the length of the third section 9 in the longitudinal direction x.

If the proximal side opening 5 is formed in this way, the proximal extension portion 11 can be smoothly bent from the first section 7 to the second section 8, and the proximal end portion of the cylindrical body 2 can be enlarged. Easier to bend. The first section 7, the second section 8 and the third section 9 are preferably formed so as to satisfy at least one of the above formulas (1) and (2), but more preferably the above formula (1) and Equation (2).

When the cylindrical body 2 is viewed from below, the outer edge of the proximal side opening 5 extends so that the angle formed by the longitudinal axis direction x is 60° or less in the second section 8 and the third section 9. is preferably 50° or less, and even more preferably 45° or less. Regarding the first section 7, the angle formed by the outer edge of the proximal side opening 5 with the longitudinal axis direction x in the range of the proximal side 1/2 of the first section 7, preferably in the range of the proximal side 2/3 is preferably 60° or less, more preferably 50° or less, and even more preferably 45° or less. If the outer edge of the proximal opening 5 is formed in this way, the treatment device is less likely to get caught on the outer edge of the proximal opening 5 when the treatment device is inserted through the proximal opening 5 of the tubular body 2 . Become.

The outer edge of the proximal opening 5 has a portion extending parallel to the longitudinal direction x between the first section 7 and the second section 8 and/or between the second section 8 and the third section 9. may be That is, the proximal opening 5 does not vary in width from distal to proximal between the first section 7 and the second section 8 and/or between the second section 8 and the third section 9. It may have a portion extending to The length of the portion where the proximal side opening 5 extends in the longitudinal direction x with a constant width is the length of the length in the longitudinal direction x from the distal end of the first section 7 to the proximal end of the third section 9 . It is preferably 1/3 or less of the height, more preferably 1/4 or less. As a result, when the proximal end portion of the tubular body 2 is positioned at the bent portion of the body cavity or the guide catheter, the proximal end portion of the tubular body 2 can be smoothly bent along the bent portion. The outer edge of the proximal opening 5 may also have a portion extending parallel to the longitudinal axis direction x between the third section 9 and the fourth section 10, in which case the proximal opening 5 The length of the portion extending in the longitudinal direction x with a constant width is 1/3 or less of the length in the longitudinal direction x from the distal end of the first section 7 to the proximal end of the fourth section 10 It is preferably 1/4 or less, more preferably 1/4 or less.

The linear member 13 is preferably fixed to the tubular body 2 at the proximal extension portion 11 . The linear member 13 preferably extends further distally than the distal end of the proximal opening 5 . Therefore, it is preferable that the distal end of the linear member 13 be located on the distal side of the distal end of the proximal opening 5 . By providing the linear member 13 in this manner, the cylindrical body 2 can be smoothly bent from the cylindrical portion 3 to the first section 7 , the second section 8 and the third section 9 . The linear member 13 is also preferably fixed to the tubular body 2 on the distal side of the distal end of the proximal opening 5 . By fixing the linear member 13 to the cylindrical body 2 in this way, it becomes easy to move the cylindrical body 2 forward by pushing the linear member 13 . In addition, the lumen 4 of the cylindrical body 2 is less likely to be crushed at the body cavity or the bent portion of the guide catheter.

The proximal extending portion 11 preferably has a belt-like portion 12 that is positioned proximally relative to the third section 9 or the fourth section 10 and extends parallel to the longitudinal axis direction x. By providing the band-shaped portion 12 in this way, it becomes easy to insert the treatment device from the proximal side opening 5 of the tubular body 2 along the band-shaped portion 12 .

It is preferable that the band-shaped portion 12 is formed on the upper portion of the cylindrical body 2 and the linear member 13 is arranged along the band-shaped portion 12 and fixed to the band-shaped portion 12 . The length in the longitudinal direction x of the belt-like portion 12 is, for example, preferably 50 mm or longer, more preferably 80 mm or longer, still more preferably 100 mm or longer, preferably 200 mm or shorter, more preferably 180 mm or shorter, and even more preferably 150 mm or shorter. Thereby, the linear member 13 can be stably fixed to the cylindrical body 2 .

The tubular portion 3 of the tubular body 2 has a resin layer and a reinforcing layer in which metal wires or fibers are arranged in a spiral, mesh, or braid, and the proximal end of the reinforcing layer faces the proximal side. It is preferably within 15 mm distally from the distal end of the opening 5, more preferably within 10 mm, and even more preferably within 8 mm. By providing the reinforcing layer in this manner, the lumen 4 of the tubular body 2 is less likely to be crushed, making it easier to insert a treatment device into the lumen 4 of the tubular body 2 . The resin layer of the tubular portion 3 preferably includes the inner layer and the outer layer described above.

The proximal extension portion 11 of the tubular body 2 preferably has the inner layer and the outer layer described above. In addition, it is preferable that the proximal extension portion 11 is not provided with a reinforcing layer. In addition, the proximal extending portion 11 of the tubular body 2 tends to bend more preferentially than the tubular portion 3 , so that the tubular portion 3 is prevented from being largely distorted or kinked.

This application claims the benefit of priority based on Japanese Patent Application No. 2021-169116 filed on October 14, 2021. The entire contents of the specification of Japanese Patent Application No. 2021-169116 filed on October 14, 2021 are incorporated herein by reference.

1: Extension guide catheter 2: Tubular body 3: Tubular portion 4: Lumen 5: Proximal side opening 6: Distal side opening 7: First section 8: Second section 9: Third section 10: Fourth Section 11: Proximal extending portion 12: Band-shaped portion 13: Linear member 14: Grasping member 21: Guide catheter

Claims

An extension guide catheter for a guide catheter, comprising:
a tubular body having a longitudinally extending lumen and having a proximal opening and a distal opening;
a linear member fixed to the tubular body and extending proximally from a proximal opening of the tubular body;
The cylindrical body has an upper side to which the linear member is fixed and a lower side opposite to the upper side with respect to the radial direction,
The proximal opening has a first section, a second section proximal to the first section, and a third section proximal to the second section with respect to the longitudinal axis direction. death,
When the cylindrical body is viewed from below, the width of the proximal opening gradually increases from the distal side to the proximal side in the first section, and the width increases from the distal side to the proximal side in the second section. an extension guide catheter formed to gradually decrease in width toward the third section and gradually increase in width from the distal side to the proximal side in the third section.
2. The extension of claim 1, wherein from the distal end of the first section to the proximal end of the second section, the outer edge of the proximal opening is formed in a lower half portion of the tubular body. guide catheter.
The longitudinal length from the distal end of the first section to the proximal end of the second section is 0.3 times or more the width of the proximal opening at the proximal end of the third section The extension guide catheter of claim 1, which is 15 times or less.
2. The width of the proximal side opening at the distal end of the third section is 0.3 times or more and 0.9 times or less than the width of the proximal side opening at the proximal end of the third section. An extension guide catheter as described in .
2. The length of the first section in the longitudinal direction and/or the length of the second section in the longitudinal direction is equal to or less than the length of the third section in the longitudinal direction according to claim 1. extension guide catheter.
The extension guide catheter according to claim 1, which satisfies one or both of the following formulas (1) and (2).
(A1-A2)/B1≧(A3-A2)/B3 (1)
(A1-A2)/B2≧(A3-A2)/B3 (2)
[In the formula,
A1 represents the width of the proximal opening at the proximal end of the first section;
A2 represents the width of the proximal opening at the proximal end of the second section,
A3 represents the width of the proximal opening at the proximal end of the third section,
B1 represents the length in the longitudinal direction from the proximal end of the first section to a point in the first section where the width of the proximal opening is A2;
B2 represents the length of the second section in the longitudinal direction,
B3 represents the length of the third section in the longitudinal direction. ]
The extension guide catheter according to claim 1, wherein the distal end of the linear member is located on the distal side of the distal end of the proximal opening.