JP2023042609A - Catheter for penetration - Google Patents

Abstract

To provide a catheter for penetration capable of improving a penetration property for a living body lumen.SOLUTION: A catheter 100 according to the present invention includes: a proximal shaft part 110; and a distal end member 120 connected to a distal end 110B of the proximal shaft part, extending toward a distal end side of the proximal shaft part, and including a guide wire lumen 120L through which a guide wire GW can be inserted. An outer diameter D1 of the proximal shaft part is larger than an outer diameter D2 of the distal end member.SELECTED DRAWING: Figure 1

Description

The present invention relates to penetrating catheters.

When performing various procedures in a biological lumen such as a blood vessel, an operator inserts a guiding catheter (parent catheter) along a guide wire that has been inserted into the blood vessel in advance to a lesion such as a coronary artery ostium (for example, , stenosis formed in the blood vessel). After guiding the tip of the guiding catheter to a location near the lesion such as the ostium of the coronary artery, the operator advances a therapeutic device such as a balloon catheter from the tip of the guiding catheter to treat the lesion. .

For example, when treating a lesion formed in a coronary artery, if the lesion is far from the entrance of the coronary artery, the treatment device will be subject to various resistances due to the effects of stenosis and tortuousness of the blood vessel. , it becomes difficult for the operator or the like to insert the treatment device into the lesion. In such cases, the operator should place the guiding catheter at a predetermined location in the blood vessel, insert a penetrating catheter (secondary catheter) into the guiding catheter, and place the penetrating catheter as close to the lesion as possible. Deliver to close locations. An operator or the like can relatively easily insert the treatment device into the lesion by supporting the delivery of the treatment device with the penetration catheter.

Patent Literature 1 below discloses a rapid exchange catheter including a base shaft portion, a tip member through which a treatment device can be inserted, and a hub fixed to the proximal end of the base shaft portion.

U.S. Pat. No. 8,048,032

In general, rapid exchange catheters have the advantage that the process of inserting or removing a treatment device or the like from the catheter can be performed efficiently.

However, the catheter described in Patent Document 1 has a base shaft formed by a C-shaped or U-shaped tube. Therefore, the cross-sectional area of the base shaft portion perpendicular to the axial direction is smaller than the cross-sectional area of the tip member perpendicular to the axial direction, making it difficult to transmit the operating force in the base shaft portion to the tip member. Therefore, the pushability (penetrability) of the catheter into a biological lumen may decrease.

In particular, when the catheter is a penetrating catheter, the catheter is used to ensure passage of the guidewire for patients in whom it is difficult to insert the guidewire to the lesion site. Therefore, the penetration of the catheter into the biological lumen is more required.

SUMMARY OF THE INVENTION Accordingly, an object of the present invention is to provide a penetrating catheter capable of improving penetrability through a body lumen.

A penetrating catheter according to the present invention includes a proximal shaft portion, and a guide wire lumen connected to the distal end of the proximal shaft portion, extending toward the distal end side of the proximal shaft portion, and through which a guide wire can be inserted. a tip member, wherein the outer diameter of the base shaft portion is greater than the outer diameter of the tip member.

The penetrating catheter configured as described above facilitates transmission of the operating force at the proximal shaft portion (the proximal end side of the penetrating catheter) to the tip member (the distal end side of the penetrating catheter). Therefore, it is possible to improve the penetrability of the penetrating catheter with respect to the biological lumen.

1 is a schematic diagram of a penetrating catheter according to an embodiment of the present invention; FIG. 1 is a perspective view schematically showing a penetrating catheter according to an embodiment; FIG. FIG. 4 is an enlarged cross-sectional view along the axial direction of the distal end side of the penetrating catheter.

Hereinafter, embodiments of the present invention will be described with reference to the attached drawings. The following description does not limit the technical scope or the meaning of terms described in the claims. Also, the dimensional ratios in the drawings are exaggerated for convenience of explanation, and may differ from the actual ratios.

1 to 3 are diagrams for explaining a penetration catheter (hereinafter referred to as a catheter) 100 according to an embodiment. The arrow X attached to each figure indicates the “longitudinal direction (axial direction)” of the catheter 100 , the arrow Y indicates the “width direction (depth direction)” of the catheter 100 , and the arrow Z indicates the “height direction” of the catheter 100 . direction.

As shown in FIGS. 1 and 2, the catheter 100 according to this embodiment includes a base shaft portion 110, a tip member 120 through which the guide wire GW can be inserted, and a hub 130 fixed to the proximal end of the base shaft portion 110. and a connection portion 140 that connects the base shaft portion 110 and the tip member 120 .

In this specification, the side to be inserted into the living body is called "distal end" or "distal end side", and the hand side where hub 130 is arranged is called "proximal end" or "proximal end side".

The base shaft portion 110 and the tip member 120 are substantially circular long members having a substantially constant outer shape (cross-sectional shape) from the base end side to the tip end side.

The outer diameter D1 of the base shaft portion 110 is formed larger than the outer diameter D2 of the tip member 120, as shown in FIG. That is, the cross-sectional area of the base shaft portion 110 orthogonal to the axial direction (X direction) is larger than the cross-sectional area of the tip member 120 orthogonal to the axial direction. Therefore, the catheter 100 can easily transmit the operating force on the proximal side of the catheter 100 to the distal side of the catheter 100, and the proximal shaft portion 110 can push the distal end of the catheter 100 toward the distal side more strongly. Therefore, it is possible to improve the penetrability of the catheter 100 with respect to the biological lumen.

The base shaft portion 110 is an axially extending solid member. Therefore, the base shaft portion 110 can be provided with greater rigidity, and the operating force on the proximal end side of the catheter 100 can be easily transmitted to the distal end side of the catheter 100 .

The base shaft portion 110 is composed of a core material 111 and a covering material 112 covering the core material 111 (see FIG. 3).

The constituent material of the core material 111 is not limited as long as it is a material having flexibility. , polyamides, polyetheretherketone (PEEK), polyesters, polycarbonates, hard plastics such as glass fibers, and composites thereof. Among the above, a metal wire can be preferably used. Although the cross-sectional shape of the core material 111 is not particularly limited, it can be formed substantially circular, for example.

As a constituent material of the covering material 112, for example, various elastomers such as polyamide, polyamide elastomer, polyester elastomer, polyurethane elastomer, polystyrene elastomer, silicone rubber, latex rubber, or any combination thereof can be used. The covering material 112 may have a multi-layer structure configured by laminating different resin materials. Also, the outer surface of the covering material 112 may have a hydrophilic coating layer (not shown) made of a hydrophilic polymer.

The tip member 120 is a hollow member (tube) connected to the tip 110B of the base shaft portion 110 and axially extending toward the tip side of the base shaft portion 110 . As shown in FIGS. 2 and 3, the tip member 120 has a distal opening 120Q and a proximal opening (guidewire port) 120P. As shown in FIGS. 1 and 3, the lumen of the tip member 120 is formed with a guide wire lumen 120L through which the guide wire GW can be inserted.

The catheter 100 according to this embodiment is configured as a so-called rapid exchange catheter. The catheter can improve the efficiency of a procedure when using a guide wire of a general length used in a PCI (Percutaneous Coronary Intervention) procedure, and contribute to medical economy. In particular, by using the catheter, the operator can quickly and efficiently perform the process of removing the guide wire used for penetrating the lesion from the catheter and inserting the treatment device into the catheter. can be done.

The length of the tip member 120 is preferably about 25 cm to 50 cm. For example, when the tip member 120 has a length of 25 cm, the operator can remove the guide wire GW inserted into the catheter 100 from the catheter 100 quickly and efficiently. Further, when the length of the tip member 120 is 50 cm, the efficiency of the process of removing the guide wire GW from the catheter 100 can be improved while ensuring the penetrability of the guide wire GW through the lesion.

A marker 120M having X-ray imaging properties for indicating the tip position of the tip member 120 is arranged on the tip side of the tip member 120 . As a constituent material of the marker 120M, for example, a metal coil or ring with high X-ray opacity such as Pt or Au can be used.

As shown in FIGS. 2 and 3, the tip member 120 according to this embodiment has a first tip member 121 having a distal opening 120Q and a second tip member 122 having a proximal opening 120P. ing. The 1st tip member 121 and the 2nd tip member 122 are connected by terminal area 140 mentioned below.

The first tip member 121 is composed of a flexible inner layer (not shown) and an outer layer (not shown).

Materials constituting the inner layer include, for example, PTFE (polytetrafluoroethylene), PFA (tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer), FEP (tetrafluoroethylene-hexafluoropropylene copolymer), ETFE (ethylene- Resins such as fluorine-containing ethylenic polymers such as tetrafluoroethylene copolymers, polyamides such as nylon, and polyamide elastomers such as nylon elastomers can be used. Among these, PTFE (polytetrafluoroethylene) or PFA (tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer) having high lubricity can be preferably used. By using these materials, sliding resistance to the guide wire GW inserted into the first tip member 121 can be suppressed. Therefore, it is possible to improve passability and operability of the guide wire GW inserted into the lumen of the first tip member 121 when the catheter 100 is used.

As the constituent material of the outer layer, for example, various elastomers such as polyamide, polyamide elastomer, polyester elastomer, polyurethane elastomer, polystyrene elastomer, silicone rubber, latex rubber, or a combination of two or more of these may be used. can. The outer layer may have a multilayer structure configured by laminating different resin materials. Moreover, the outer surface of the outer layer may have a hydrophilic coating layer (not shown) made of a hydrophilic polymer.

In addition, the first tip member 121 may include a braid formed by weaving a plurality of thin wire members. The first tip member 121 can ensure higher rigidity by including a blade. Examples of materials constituting the blade include titanium-based (Ti--Ni, Ti--Pd, Ti--Nb--Sn, etc.) or copper-based alloys, stainless steel, β-titanium steel, Co--Cr alloys, nickel-titanium alloys, and the like. A super-elastic alloy or other resin material or the like can be used.

The second tip member 122 is composed of multiple flexible layers.

Materials constituting the second tip member 122 include, for example, polyvinyl chloride, polyethylene, polypropylene, polybutadiene, polyolefins such as ethylene-vinyl acetate copolymer (EVA), polyethylene terephthalate (PET), and polybutylene terephthalate (PBT). Various thermoplastic elastomers such as polyester, polyvinylidene chloride, silicone, polyurethane, polyamide elastomer, polyurethane elastomer, polyester elastomer, or any combination thereof (blend resin, polymer alloy, laminate, etc.) be able to.

In addition, the 2nd tip member 122 may contain the blade mentioned above.

The hub 130 is fixed to the base shaft portion 110 by an adhesive, a fixture (not shown), or the like. Hub 130 functions as a grip when manipulating catheter 100 .

As a constituent material of the hub 130, for example, a thermoplastic resin such as polycarbonate, polyamide, polysulfone, polyarylate, methacrylate-butylene-styrene copolymer can be used.

The connecting portion 140 includes a first tube 141 that covers the base end 121A of the first tip member 121 and a second tube 142 that covers the tip 110B of the base shaft portion 110, as shown in FIGS.

The first tube 141 connects the base end 121A of the first tip member 121 and the tip 110B of the base shaft portion 110 so that the axial direction of the tip member 120 and the axial direction of the base shaft portion 110 are substantially parallel. . At this time, the proximal end 121A of the first distal end member 121 is connected to the distal end 110B of the proximal shaft portion 110 so as to at least partially overlap. Therefore, the rigidity of the connecting portion 140 can be ensured, and the occurrence of bending or kinking of the connecting portion 140 can be prevented.

In this embodiment, the distal end 110B of the proximal shaft portion 110 is connected to the proximal end 121A of the first distal member 121 with the covering material 112 removed and the core material 111 exposed. The exposed core material 111 is inserted from the proximal side opening 141P of the first tube 141, as shown in FIG. placed between surfaces. As a result, the proximal end 121A of the first distal end member 121 is arranged to at least partially overlap the distal end 110B of the proximal shaft portion 110 .

According to the connection method described above, the connection region between the proximal shaft portion 110 and the tip member 120 is reinforced by the core material 111 arranged to at least partially overlap the proximal end 121A of the first tip member 121 . Therefore, it is possible to prevent the diameter of the connection portion 140 from increasing while preventing the occurrence of folds and kinks in the connection region. Further, since the first tip member 121 and the first tube 141 are integrally connected by heat treatment, the core material 111 is sandwiched and fixed between the integral parts.

The second tube 142 is a reinforcing body that reinforces the distal end 110B of the base shaft portion 110. As shown in FIG. The second tube 142 can prevent the tip 110B of the base shaft portion 110 from being broken or kink.

As a constituent material of the first tube 141 and the second tube 142, for example, a flexible material can be used. For the first tube 141 and the second tube 142, members using the same constituent material as the second tip member 122 can be used.

In addition, each of the first tube 141 and the second tube 142 and the second tip member 122 are at least partially covered with a heat-shrinkable third tube (not shown), and heat-treated to be integrally formed. Connected.

Therefore, the proximal end 141A of the first tube 141 is fused to the distal end 122B of the second tip member 122 so that the lumen of the first tip member 121 and the lumen of the second tip member 122 are arranged coaxially. ing. As a result, the lumen of the distal end member 120 (the guidewire lumen 120L) extends from the proximal opening 120P of the first distal end member 121 to the distal opening 120Q of the second distal end member 122 at the proximal opening 120P and It is provided coaxially with the tip side opening 120Q. Therefore, the operator can linearly insert the guide wire GW along the axial direction of the catheter 100 . Therefore, it is possible to improve the passability and operability of the guide wire GW with respect to the catheter 100 . Further, since the second tip member 122 and the second tube 142 are integrally connected by heat treatment, the base shaft portion 110 is positionally fixed with respect to the tip member 120 .

Also, the second tube 142 is fused with the second tip member 122 and the first tube 141 . Thereby, the connecting region between the base shaft portion 110 and the tip member 120 can be reinforced, and the followability of the tip member 120 to the base shaft portion 110 can be improved.

Note that the third tube is removed when the heat treatment is completed. As a constituent material of the third tube, for example, silicon or the like can be used.

As described above, the catheter (catheter for penetration) 100 according to the present embodiment is connected to the base shaft portion 110 and the distal end 110B of the base shaft portion 110, and extends toward the distal end side of the base shaft portion 110. , and a tip member 120 having a guidewire lumen 120L through which the guidewire GW can be passed, wherein the outer diameter D1 of the proximal shaft portion 110 is greater than the outer diameter D2 of the tip member 120 .

According to the catheter 100 configured in this way, the cross-sectional area of the base shaft portion 110 orthogonal to the axial direction is larger than the cross-sectional area of the tip member 120 orthogonal to the axial direction. Therefore, the catheter 100 can easily transmit the operating force on the proximal side of the catheter 100 to the distal side of the catheter 100, and the proximal shaft portion 110 can push the distal end of the catheter 100 toward the distal side more strongly. Therefore, it is possible to improve the penetrability of the catheter 100 with respect to the biological lumen.

The distal member 120 also has a proximal opening 120P and a distal opening 120Q, and the guidewire lumen 120L extends from the proximal opening 120P to the distal opening 120Q. It is provided coaxially with 120P and distal opening 120Q. This allows the operator to linearly insert the guide wire GW along the axial direction of the catheter 100 . Therefore, it is possible to improve the passability and operability of the guide wire GW with respect to the catheter 100 .

Also, the base shaft portion 110 is made of a solid elongated member. As a result, the base shaft portion 110 can be provided with greater rigidity, and the operating force on the proximal end side of the catheter 100 can be easily transmitted to the distal end side of the catheter 100 .

It also has a connection portion 140 that connects the base shaft portion 110 and the tip member 120 , and the tip member 120 is connected to the base shaft portion 110 in a state where the connection portion 140 at least partially overlaps the base shaft portion 110 . As a result, the rigidity of the connecting portion 140 can be ensured, and the occurrence of bending or kinking of the connecting portion 140 can be prevented.

In addition, the base shaft portion 110 has a core material 111 and a covering material 112 covering the core material 111, and the connecting portion 140 has a first tube 141 that at least partially covers the tip member 120, Core material 111 is disposed between the outer surface of guidewire lumen 120L and the inner surface of first tube 141 . As a result, it is possible to prevent the connecting portion 140 from increasing in diameter while preventing the occurrence of a break or a kink in the connecting region between the base shaft portion 110 and the tip member 120 .

Connecting portion 140 also includes a second tube 142 that at least partially covers proximal shaft portion 110 , and second tube 142 is fused to tip member 120 . Thereby, the connecting region between the base shaft portion 110 and the tip member 120 can be reinforced, and the followability of the tip member 120 to the base shaft portion 110 can be improved.

The present invention is not limited to the above-described embodiments, and various modifications are possible within the scope of the claims.

For example, although the base shaft portion 110 and the tip member 120 have been described as elongated members having a substantially constant outer shape from the base end side to the tip end side, the cross section of the base shaft portion 110 orthogonal to the axial direction (X direction) may be used. The shape is not particularly limited as long as the area is larger than the cross-sectional area at any point of the tip member 120 (if the outer diameter of the base shaft portion 110 is larger than the outer diameter at any point of the tip member 120). For example, base shaft portion 110 may be a tapered member. Also, the base shaft portion 110 is not limited to a cylindrical shape, and may be C-shaped.

In addition, the proximal side opening 120P of the tip member 120 may be cut obliquely with respect to the axial direction (X direction) from the viewpoint of improving the insertability of the guide wire GW.

Moreover, the method of connecting each of the base shaft part 110, the 1st tip member 121, and the 2nd tip member 122 by the connection part 140 is not limited to heat fusion|bonding. For example, each of the base shaft portion 110, the first tip member 121, and the second tip member 122 may be adhered via an adhesive.

In addition, the thickness of the tube that constitutes tip member 120 and connecting portion 140 may not be uniform in the circumferential direction over the entire range in the longitudinal direction (X direction).

Also, the core material 111 that can be arranged in the gap between the first tube 141 and the first tip member 121 does not have to have a substantially constant outer shape (cross-sectional shape) as shown in FIG. For example, the tip of the core material 111 (the tip 110B of the base shaft portion 110) may be cut obliquely so as to taper off toward the tip side.

Moreover, although the third tube has been described as one tube, the third tube may be a plurality of tubes. In other words, after integrally connecting the first tube 141, the second tube 142, and the second tip member 122 by heat treatment using one third tube, another third The tubes may be stacked and heat treated again. By repeating the step of integrally connecting the first tube 141, the second tube 142, and the second tip member 122, between the lumen of the first tip member 121 and the lumen of the second tip member 122 (boundary) ) can be further suppressed from forming a step (uneven portion). Therefore, the catheter 100 can improve the insertability of the guide wire GW into the tip member 120 and further ensure the rigidity of the connecting portion 140 .

100 catheter (catheter for penetration),
110 base shaft,
110B the tip of the base shaft portion,
111 core material,
112 covering material,
120 tip member,
120L guidewire lumen,
120P proximal opening,
120Q tip side opening,
130 hub,
140 connections,
141 first tube,
142 second tube,
D1 the outer diameter of the base shaft,
D2 outer diameter of tip member,
GW guidewire.

Claims (6)

a base shaft;
a tip member connected to the tip of the base shaft portion, extending toward the tip side of the base shaft portion, and including a guide wire lumen through which a guide wire can be inserted;
A penetrating catheter, wherein the outer diameter of the proximal shaft portion is greater than the outer diameter of the tip member. the tip member has a proximal opening and a distal opening;
2. The penetrating catheter of claim 1, wherein the guidewire lumen is provided coaxially with the proximal side opening and the distal side opening between the proximal side opening and the distal side opening. . 3. The penetration catheter of claim 2, wherein the proximal shaft portion comprises a solid elongated member. Having a connecting portion that connects the base shaft portion and the tip member,
The penetrating catheter according to any one of claims 1 to 3, wherein the tip member is connected to the base shaft portion at the connection portion so as to at least partially overlap the base shaft portion. The base shaft portion has a core material and a covering material covering the core material,
the connecting portion has a first tube that at least partially covers the tip member;
5. The penetrating catheter of claim 4, wherein the core material is disposed between the outer surface of the guidewire lumen and the inner surface of the first tube. the connecting portion has a second tube that at least partially covers the base shaft;
6. The penetrating catheter of claim 4 or 5, wherein the second tube is fused to the tip member.

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