catheter

The catheter's innovative wire groove configuration addresses the challenge of balancing flexibility and pushability by allowing for adjustable flexibility through strategic groove positioning and configuration.

JP7860127B2Active Publication Date: 2026-05-15TERUMO KK
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Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
TERUMO KK
Filing Date
2022-08-25
Publication Date
2026-05-15

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Abstract

This catheter comprises an elongated tubular catheter body wall and at least one strand provided within the catheter body wall, the at least one strand having at least one groove.
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Description

Technical Field

[0001] The present disclosure relates to a catheter.

Background Art

[0002] Catheters such as contrast catheters, guiding catheters, or microcatheters (for example, see Patent Document 1) have a long tubular catheter body wall and at least one wire provided within the catheter body wall to form a coil body, a braided body, or the like as a contrast marker or a reinforcing body.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] It is necessary to appropriately set the flexibility of the catheter while ensuring its pushability.

[0005] Therefore, an object of the present disclosure is to provide a catheter with easily adjustable flexibility.

Means for Solving the Problems

[0006] As one aspect of the present disclosure, a catheter has a long tubular catheter body wall and at least one wire provided within the catheter body wall, and the at least one wire has at least one groove.

[0007] As one embodiment of the present disclosure, the catheter is a catheter in which the at least one groove is provided only at the tip of the catheter.

[0008] In one embodiment of the present disclosure, the catheter is a catheter in which the at least one groove has a pitch that decreases from the proximal end to the distal end of the catheter.

[0009] In one embodiment of the present disclosure, the catheter is a catheter in which the width or depth of the at least one groove increases from the proximal end to the distal end of the catheter.

[0010] In one embodiment of the present disclosure, the catheter is a catheter in which the at least one strand forms a contrast marker or reinforcement.

[0011] In one embodiment of the present disclosure, the catheter is a catheter in which the at least one strand is provided around the entire circumference within the wall of the catheter body.

[0012] In one embodiment of the present disclosure, the catheter is a catheter in which the at least one strand forms a coil or a braid.

[0013] In one embodiment of the present disclosure, the catheter is a catheter in which the at least one groove is provided on the portion of the catheter body wall of the at least one strand that extends around the entire circumference.

[0014] In one embodiment of the present disclosure, the catheter is such that the at least one groove is not provided in a portion of the at least one strand that is aligned in a first direction perpendicular to the axial direction of the catheter body wall, but is provided in a portion of the at least one strand that is aligned in a second direction perpendicular to both the axial direction and the first direction of the catheter body wall.

[0015] In one embodiment of the present disclosure, the catheter is a catheter in which the at least one groove is provided on only both sides or only one side of the at least one strand itself in the second direction.

[0016] As one embodiment of the present disclosure, the catheter is a catheter in which the at least one groove is provided only on both axial surfaces or only on one axial surface of the catheter body wall in the at least one wire itself.

[0017] As one embodiment of the present disclosure, the catheter is a catheter in which the at least one groove extends in the axial direction of the catheter body wall.

[0018] As one embodiment of the present disclosure, the catheter is a catheter in which the at least one groove is provided only in a portion of the at least one wire located radially outside the catheter body wall.

[0019] As one embodiment of the present disclosure, the catheter is a catheter in which the at least one groove is provided in a spiral or annular shape on the outer peripheral surface of the at least one wire itself.

[0020] As one embodiment of the manufacturing method of the catheter of the present disclosure, the manufacturing method of the catheter has an irradiation step of forming the at least one groove by irradiating the at least one wire with laser light in a state where the at least one wire is provided in the catheter body wall.

Advantages of the Invention

[0021] According to the present disclosure, a catheter with an easily set flexibility can be provided.

Brief Description of the Drawings

[0022] [Figure 1] It is a side view showing a catheter according to one embodiment. [Figure 2] It is a partial cross-sectional side view shown along the line A-A of FIG. 1. [Figure 3] It is a cross-sectional view shown along the line B-B of FIG. 2., [Figure 4] It is a side view showing a modification of the reinforcing body shown in FIG. 1. [Figure 5]It is a side view showing a modified example of the groove portion shown in FIG. 1. [Figure 6] It is a side view showing a modified example of the groove portion shown in FIG. 1. [Figure 7] It is a side view showing a modified example of the groove portion shown in FIG. 1. [Figure 8] It is a side view showing a modified example of the groove portion shown in FIG. 1.

Embodiments for Carrying Out the Invention

[0023] Hereinafter, embodiments of the present disclosure will be exemplified and described in detail with reference to the drawings.

[0024] As shown in FIGS. 1 to 3, a catheter 1 according to an embodiment of the present disclosure includes a long tubular catheter body wall 2 centered on an axis O and at least one wire 3 provided within the catheter body wall 2, and at least one wire 3 has at least one groove 4. The catheter 1 may be a contrast catheter, a guiding catheter, a microcatheter, or the like.

[0025] More specifically, the catheter 1 has a catheter body wall 2, a hub 5, a first wire portion 6a, a second wire portion 6b, and a groove portion 7. The hub 5 is continuous with the proximal end of the catheter body wall 2. In this embodiment, when the catheter 1 is introduced into the body cavity, the end located forward is referred to as the distal end, and the opposite end is referred to as the proximal end. The hub 5 forms a tube centered on the axis O, and the inner cavity of the hub 5 communicates with the inner cavity of the catheter body wall 2.

[0026] The catheter body wall 2 has an inner layer 2a and an outer layer 2b. The inner layer 2a and the outer layer 2b each form a long tube centered on the axis O, and the outer layer 2b is provided on the radially outer side of the inner layer 2a. The inner layer 2a and the outer layer 2b are each formed of a synthetic resin material. The materials forming the inner layer 2a and the outer layer 2b can be appropriately set according to the use of the catheter 1 and the like. The first wire portion 6a and the second wire portion 6b are respectively provided between the inner layer 2a and the outer layer 2b. The first wire portion 6a and the second wire portion 6b are each embedded in the outer layer 2b on the radially outer side of the inner layer 2a.

[0027] The first wire portion 6a is formed from two wires 3 and is a double helix coil body centered on the axis O. In other words, the first wire portion 6a is provided around the entire circumference within the catheter body wall 2. The first wire portion 6a forms a contrast marker. In other words, the first wire portion 6a is made of a material with low X-ray transparency, such as Pt or Au. The cross-sectional shape (shape in a cross-section perpendicular to the axial direction) of each wire 3 that forms the first wire portion 6a is circular. The first wire portion 6a is provided only at the tip 1a of the catheter 1. The first wire portion 6a is provided closer to the tip than the second wire portion 6b.

[0028] The second wire portion 6b is formed from a single wire 3 and is a single helix coil body centered on the axis O. In other words, the second wire portion 6b is provided around the entire circumference within the catheter body wall 2. The second wire portion 6b forms a reinforcing body. In other words, the second wire portion 6b is made of a highly rigid material such as metal. The cross-sectional shape of the wire 3 that forms the second wire portion 6b is circular. The second wire portion 6b is provided over the entire portion of the catheter body wall 2 except for the tip.

[0029] The outer surface of each individual wire 3 forming the first wire portion 6a has a double helix groove 4 formed by two grooves 4. Therefore, the first wire portion 6a has a grooved portion 7 formed by four grooves 4. Each groove 4 extends helically along the axial direction (longitudinal direction) of the wire 3 itself. Each groove 4 has two opposing side surfaces 4a and a bottom surface 4b connecting these side surfaces 4a. The material forming the outer layer 2b enters into each groove 4, resulting in strong adhesive strength between the outer layer 2b and the first wire portion 6a.

[0030] Each groove 4 has a constant width W (distance between both sides 4a) and a constant depth D (depth D of the bottom surface 4b). The groove portion 7 forms a predetermined pattern in which a part of the groove 4 is arranged at a predetermined pitch P in the width direction of the groove 4. The pitch P of the groove portion 7 is constant.

[0031] Each groove 4 is provided along the entire axial length of the wire 3 itself. Therefore, the groove portion 7 is provided on the entire circumference of the first wire portion 6a centered on the axis O.

[0032] The method for forming each groove 4 is not particularly limited. For example, each groove 4 can be formed by rotating the wire itself, which is straightened out before being coiled, in the circumferential direction while feeding it in the axial direction, and then using a laser or the like, which is irradiated perpendicular to the axial direction, to shave the outer surface of the wire itself.

[0033] The outer surface of each individual wire 3 that forms the second wire portion 6b does not have grooves 4. In other words, grooves 4 are provided only in the first wire portion 6a. Therefore, grooves 4 are provided only in the tip portion 1a of the catheter 1.

[0034] According to this embodiment, by providing the groove portion 7, the flexibility of the first wire portion 6a can be increased while ensuring its X-ray contrastability. Furthermore, by appropriately setting the width W, depth D, and pitch P of the groove 4 of the groove portion 7, the flexibility of the tip portion 1a of the catheter 1 can be easily adjusted.

[0035] The first wire portion 6a may be a helical coil body other than a double helix, for example, a single helix coil body or a multi-helix coil body with three or more helices. The cross-sectional shape of each wire 3 that forms the first wire portion 6a may be other than circular, for example, an ellipse, rectangle, square, polygon, etc.

[0036] The second wire portion 6b may be a helical coil body other than a single helix, for example, a double helix coil body or a multi-helix coil body with three or more helices. The cross-sectional shape of each wire 3 that forms the second wire portion 6b may be other than circular, for example, an ellipse, rectangle, square, polygon, etc.

[0037] The second wire portion 6b may not be a coil but a braided body formed by weaving together multiple wires 3 into a cylindrical shape. For example, as shown in the modified example in Figure 4, the second wire portion 6b may be a mesh-tube braided body that serves as a reinforcing body, also called a blade. In the modified example in Figure 4, the cross-sectional shape of each wire 3 forming the braided body is circular. However, the cross-sectional shape of each wire 3 forming the braided body may be other than circular, for example, it may be elliptical, rectangular, square, polygonal, etc.

[0038] The first wire portion 6a does not necessarily have to be located closer to the tip than the second wire portion 6b; for example, the tip of the second wire portion 6b may be located between the first wire portion 6a and the inner layer 2a.

[0039] The outer surface of each individual wire 3 that forms the first wire portion 6a may have a helical groove 4 other than a double helix; for example, it may have a single helix groove 4, or it may have three or more helical grooves 4.

[0040] Each groove 4 forming the groove portion 7 may be annular rather than helical. For example, as shown in the modified example in Figure 5, the outer surface of each strand 3 forming the first strand portion 6a may have a plurality of annular grooves 4 arranged at a predetermined pitch P in the axial direction of the strand 3 itself. In Figure 5, only one groove 4 is denoted by a reference numeral.

[0041] The groove portion 7 may be provided not only in the first wire portion 6a but also in the second wire portion 6b. In this case, each groove 4 forming the groove portion 7 of the second wire portion 6b may be provided in a helical or annular shape.

[0042] Alternatively, a configuration may be provided in which a first wire portion 6a having a groove portion 7 is provided, and a second wire portion 6b is not provided. Alternatively, a configuration may be provided in which the first wire portion 6a is not provided, but a second wire portion 6b having a groove portion 7 is provided. By adopting such a configuration, appropriate flexibility can be achieved without impairing the reinforcing effect of the second wire portion 6b, such as kink resistance.

[0043] The configuration may be such that only some of the strands 3 forming the first strand portion 6a have at least one groove 4, rather than each of them. The configuration may also be such that only some of the strands 3 forming the second strand portion 6b have at least one groove 4, rather than each of them.

[0044] Hereinafter, at least one of the first wire portion 6a and the second wire portion 6b will be referred to as the wire portion 6. Each groove 4 that forms the groove portion 7 provided in the wire portion 6 may be provided in a shape that is neither helical nor annular. For example, as shown in the modified example in Figure 6, each groove 4 that forms the groove portion 7 provided in the wire portion 6 may extend along the axial direction (direction along the axis O) of the catheter body wall 2. In this case, each groove 4 may be provided only in the portion of the wire portion 6 located radially outward from the catheter body wall 2 (radially outward from the axis O). In Figure 6, only one groove 4 is indicated by a reference numeral. With this configuration, the groove portion 7 can be easily formed by an irradiation step in which at least one groove 4 is formed by irradiating the wire portion 6 (at least one wire 3) with laser light while the wire portion 6 (at least one wire 3) is provided inside the catheter body wall 2. The wavelength of the laser light used in the irradiation process is set to a wavelength at which the metal or other wire portion 6 readily absorbs heat, while the synthetic resin or other catheter body wall 2 does not readily absorb heat. Alternatively, the irradiation process may be performed after the wire portion 6 has been placed on the outer surface of the inner layer 2a of the catheter body wall 2, but before the outer layer 2b is formed.

[0045] Each groove 4 forming the groove portion 7 in the wire portion 6 may extend in the axial direction of the catheter body wall 2 or in other directions. Each groove 4 forming the groove portion 7 in the wire portion 6 may be provided in a portion of the wire portion 6 located radially inward of the catheter body wall 2, in addition to or instead of a portion of the wire portion 6 located radially outward of the catheter body wall 2. The groove portion 7 in the wire portion 6 may be provided on both or one of the axial sides of the catheter body wall 2 on at least one wire 3 itself.

[0046] Instead of providing grooves 7 around the entire circumference of the catheter body wall 2 in the wire portion 6, the grooves 7 may be provided not in the portion of the wire portion 6 aligned in a first direction perpendicular to the axial direction of the catheter body wall 2 (the vertical direction in Figure 7 or Figure 8), but in the portion of the wire portion 6 aligned in a second direction perpendicular to both the axial direction and the first direction (the direction perpendicular to the plane of the paper in Figure 7 or Figure 8), as shown in the modified example in Figure 7 or Figure 8. In Figure 7 or Figure 8, only one groove 4 is denoted by a reference numeral. With such a configuration, it is possible to increase flexibility in a specific direction while ensuring the pushability of the wire portion 6.

[0047] The grooves 7 provided in the portion of the wire strand 6 aligned in the second direction may be provided only on both axial sides of the catheter body wall 2 on at least one wire strand 3 itself, as shown in the modified example in Figure 7. Alternatively, the grooves 7 provided in the portion of the wire strand 6 aligned in the second direction may be provided only on one axial side of the catheter body wall 2 on at least one wire strand 3 itself. With such a configuration, flexibility in the first direction can be increased while ensuring the pushability of the wire strand 6.

[0048] The grooves 7 provided in the portion of the wire strand 6 aligned in the second direction may be provided on only one or both sides of at least one wire strand 3 itself in the second direction, as shown in the modified example in Figure 8. With such a configuration, it is possible to increase flexibility in the second direction while ensuring the pushability of the wire strand 6.

[0049] The groove portion 7 provided in the wire portion 6 is not limited to a configuration in which the width W, depth D, and pitch P of the groove 4 are constant. For example, the groove portion 7 provided in the wire portion 6 may be configured such that the pitch P of the groove 4 decreases from the proximal end to the tip end of the catheter 1, or the width W or depth D of the groove 4 may increase from the proximal end to the tip end of the catheter 1. Such a configuration can efficiently increase the flexibility of the tip portion 1a of the catheter 1 while ensuring the pushability of the wire portion 6.

[0050] This disclosure is not limited to the embodiments described above and can be modified in various ways without departing from its essence.

[0051] Therefore, the catheter 1 according to the above embodiment can be modified in various ways, such as those described below.

[0052] The catheter 1 according to the above-described embodiment has a long tubular catheter body wall 2 and at least one strand 3 provided within the catheter body wall 2, and can be modified in various ways as long as the catheter 1 has at least one groove 4 in the at least one strand 3.

[0053] For example, the catheter 1 is not limited to having a hub 5. The catheter body wall 2 is not limited to having an inner layer 2a and an outer layer 2b. The first wire portion 6a is not limited to a coil. The first wire portion 6a is not limited to a contrast marker. The second wire portion 6b may have a form other than a coil or a braid. The second wire portion 6b is not limited to a reinforcing body.

[0054] In addition, it is preferable that the catheter 1 according to the above embodiment is a catheter 1 in which at least one groove 4 is provided only at the tip portion 1a of the catheter 1.

[0055] In the aforementioned embodiment, it is preferable that the catheter 1 has at least one groove 4 having a pitch P that decreases from the proximal end to the distal end of the catheter 1.

[0056] In the aforementioned embodiment, it is preferable that the catheter 1 is such that the width W or depth D of at least one groove 4 increases from the proximal end to the distal end of the catheter 1.

[0057] In the aforementioned embodiment, the catheter 1 is preferably a catheter 1 in which at least one strand 3 forms a contrast marker or reinforcement.

[0058] The catheter 1 according to the above-described embodiment is preferably a catheter 1 in which at least one strand 3 is provided around the entire circumference within the catheter body wall 2.

[0059] In the aforementioned embodiment, the catheter 1 is preferably a catheter 1 in which at least one strand 3 forms a coil or braided body.

[0060] In the aforementioned embodiment, it is preferable that the catheter 1 is such that at least one groove 4 is provided on the entire circumference of at least one strand 3 of the catheter body wall 2.

[0061] In the aforementioned embodiment, it is also preferable that the catheter 1 is such that at least one groove 4 is not provided in the portion of at least one strand 3 that is aligned in a first direction perpendicular to the axial direction of the catheter body wall 2, but is provided in the portion of at least one strand 3 that is aligned in a second direction perpendicular to both the axial direction and the first direction of the catheter body wall 2.

[0062] In this case, it is preferable that the catheter 1 is such that at least one groove 4 is provided on only one or both sides in the second direction of at least one strand 3 itself. It is also preferable that the catheter 1 is such that at least one groove 4 is provided on only one or both sides in the axial direction of the catheter body wall 2 of at least one strand 3 itself.

[0063] In the embodiment described above, it is preferable that the catheter 1 has at least one groove 4 extending in the axial direction of the catheter body wall 2. In this case, it is preferable that the catheter 1 has at least one groove 4 provided only in the portion of at least one strand 3 located radially outward from the catheter body wall 2.

[0064] In the aforementioned embodiment, it is also preferable that the catheter 1 is such that at least one groove 4 is provided in a helical or annular manner on the outer circumferential surface of at least one strand 3 itself.

[0065] The method for manufacturing the catheter 1 according to the above-described embodiment is preferably a method for manufacturing the catheter 1 that includes an irradiation step of forming at least one groove 4 by irradiating at least one strand 3 with laser light while at least one strand 3 is provided inside the catheter body wall 2. [Explanation of Symbols]

[0066] 1 Catheter 1a Tip of the catheter 2 Catheter body wall 2a Inner layer 2b outer layer 3 strands 4 grooves 4a side 4b Bottom 5 Hubs 6 Element wire part 6a First strand part 6b Second strand part 7 Groove section D Depth O axis Pitch W width

Claims

1. It has a long, tubular catheter body wall and at least one strand provided within the catheter body wall, wherein the at least one strand has at least one groove, The at least one strand is provided within the catheter body wall around its entire circumference. A catheter in which the at least one groove is not provided in a portion of the at least one strand that is aligned in a first direction perpendicular to the axial direction of the catheter body wall, but is provided in a portion of the at least one strand that is aligned in a second direction perpendicular to both the axial direction and the first direction of the catheter body wall.

2. The catheter according to claim 1, wherein the at least one groove is provided only at the tip of the catheter.

3. The catheter according to claim 1, wherein the at least one groove has a pitch that decreases from the proximal end to the distal end of the catheter.

4. The catheter according to claim 1, wherein the width or depth of the at least one groove increases from the proximal end to the distal end of the catheter.

5. The catheter according to claim 1, wherein the at least one strand forms a contrast marker or a reinforcing body.

6. The catheter according to claim 1, wherein the at least one strand forms a coil or a braid.

7. The catheter according to claim 1, wherein the at least one groove is provided on only both sides or only one side of the at least one strand itself in the second direction.

8. The catheter according to claim 1, wherein the at least one groove is provided on only one or only one of the axial sides of the catheter body wall on the at least one strand itself.

9. The catheter according to claim 1, wherein the at least one groove extends in the axial direction of the catheter body wall.

10. The catheter according to claim 9, wherein the at least one groove is provided only in the portion of the at least one strand that is located radially outward from the catheter body wall.

11. A method for manufacturing a catheter according to any one of claims 1 to 7, 9 and 10, comprising an irradiation step of irradiating the at least one strand with laser light while the at least one strand is provided within the wall of the catheter body to form the at least one groove.