Guide wire insertion aid and medical device set

Abstract

A guide wire insertion aid 10 according to the present disclosure comprises: a wire body 11; and a flexible opening part 12 having an opening 121 for inserting a guide wire therethrough, the opening part 12 being provided at least to one end 11a of the wire body 11. A medical device set according to the present disclosure comprises a medical device 20 having a cylindrical body 21 through which a guide wire is inserted, and a guide wire insertion aid 10 inserted through the cylindrical body 21. According to the guide wire insertion aid and / or the medical device set described above, a guide wire in which a distal end section is shaped can be easily inserted from the distal end into a medical device such as an inserter.

Description

Guidewire insertion aid, medical device set

[0001] The present disclosure relates to a guidewire insertion aid used when inserting a guidewire into a tubular body, and a medical device set including the guidewire insertion aid and a medical device.

[0002] Conventionally, guidewires have been used to guide medical instruments, such as catheters, inserted into tubular organs of the human body, such as blood vessels and digestive organs, to target sites. Known guidewires have distal ends formed into curved shapes or the like to suit their intended use. When a physician inserts the guidewire into a tubular organ, catheter, or the like, he or she uses a medical device (insertion aid) called an inserter, which has a tubular portion through which the guidewire is inserted, so that the distal end can be inserted in a substantially straight state (see, for example, Patent Document 1).

[0003] Japanese Patent Application Laid-Open No. 2000-107297

[0004] In order to insert a guidewire into a small-diameter catheter such as a microcatheter, the outer and inner diameters of the inserter, which serves as an insertion aid, must also be small. This makes it difficult to insert a guidewire with a shaped tip into an inserter from the tip. The thinner the diameter of the guidewire, the more easily it bends, which creates the problem of difficulty in pushing a small-diameter guidewire with a shaped tip into a small-diameter inserter.

[0005] The present disclosure has been made in consideration of the above circumstances, and aims to provide a guidewire insertion aid that allows a guidewire with a shaped tip to be easily inserted from the tip into a medical device such as an inserter, and a medical device set that includes the guidewire insertion aid and the medical device.

[0006] In order to achieve the above object, the present disclosure provides a guidewire insertion aid comprising a filament and a flexible opening having an opening for inserting a guidewire, the opening being provided at at least one end of the filament.

[0007] According to this disclosure, when inserting a guidewire into a medical device having a tubular body, the filament of the guidewire insertion aid is inserted into the tubular body so that the opening is exposed to the outside of the tubular body, and the tip of the guidewire is hooked onto the opening and the filament is pulled toward the tip of the medical device, whereby the opening can be pulled into the tubular body together with the tip of the guidewire. Such a guidewire insertion aid allows a guidewire with a shaped tip to be easily inserted tip-first into a medical device such as an inserter.

[0008] The present disclosure relates to a guidewire insertion aid and an inserter, and is an explanatory diagram showing the overall structure of the guidewire insertion aid according to an embodiment of the present disclosure. The present disclosure also relates to a guidewire insertion aid and an inserter, and is an explanatory diagram showing the guidewire being inserted into the inserter using the guidewire insertion aid.

[0009] Hereinafter, embodiments of the present disclosure will be described with reference to the drawings. The present disclosure is not limited to the embodiments described below, and the described embodiments are merely examples for explaining the technical features of the present disclosure. The shapes and dimensions shown in each drawing are shown merely to facilitate understanding of the contents of the present disclosure, and do not accurately reflect the actual shapes and dimensions.

[0010] As used herein, "distal side" refers to the direction along the axial direction of an inserter (and a guidewire inserted into the inserter), which is an example of a guidewire insertion aid or medical device, and refers to the direction in which the guidewire to which the inserter is attached advances toward the target site. "Proximal side" refers to the direction along the axial direction of a guidewire insertion aid or inserter (and a guidewire), and refers to the direction opposite to the distal side. "Distal" refers to the distal end of any component or part. "Proximal end" refers to the proximal end of any component or part.

[0011] 1 is an explanatory diagram showing the overall structure of a guidewire insertion aid 10 according to one embodiment of the present disclosure. The guidewire insertion aid 10 is used to pull a guidewire having a bent shape, such as a J-shaped distal end or a shape with a round curve of 90 degrees or more, from its distal end into a medical device, such as an inserter or catheter, that has a tubular body through which the guidewire is inserted.

[0012] The guidewire insertion aid 10 includes a filament 11 and an opening 12 having an opening 121 for inserting a guidewire. The opening 12 is flexible and can be deformed, and is provided at one end (proximal end 11a) of the filament 11.

[0013] 2 is an explanatory diagram showing the guidewire insertion aid 10 combined with the inserter 20. The inserter 20 is an example of a medical device and has a tubular body 21 through which a guidewire is inserted. In the present disclosure, a set of a medical device (inserter 20) having a tubular body 21 through which a guidewire is inserted, and the above-mentioned guidewire insertion aid 10 inserted into the tubular body 21, is referred to as a medical device set.

[0014] 1, the filament 11 constituting the guidewire insertion aid 10 is a linear member that is substantially linear from the base end 11a to the tip 11b. The cross section of the filament 11 may be circular, elliptical, or rectangular.

[0015] Examples of materials for forming the filament 11 include metal materials such as stainless steel alloys (SUS302, SUS304, SUS316, etc.), superelastic alloys such as Ni-Ti alloys, piano wire, nickel-chromium alloys, cobalt alloys, and tungsten, as well as resin materials such as polyamide, polyamide elastomer, polyolefin, polyester, and polyester elastomer. The filament 11 may be formed entirely from the same material, or may be formed partially using different materials.

[0016] The opening 12 constituting the guidewire insertion aid 10 is formed by forming a wire 122 into a ring shape, and the area surrounded by the ring-shaped wire 122 forms the opening 121 for inserting the guidewire. The cross section of the wire 122 forming the opening 12 may be a perfect circle, an ellipse, or a rectangle.

[0017] Examples of materials that can be used to form the opening 12 include metal materials such as stainless steel alloys (SUS302, SUS304, SUS316, etc.), superelastic alloys such as Ni-Ti alloys, piano wire, nickel-chromium alloys, cobalt alloys, and tungsten, as well as resin materials such as polyamide, polyamide elastomer, polyolefin, polyester, and polyester elastomer. The entire opening 12 may be made of the same material, or portions may be made of different materials.

[0018] Since the opening 12 is formed by forming the wire 122 into a ring shape, the opening 12 can be formed from the same material as the filament 11, and the shape of the opening 12 can be easily processed.

[0019] For example, when forming the annular opening 12 from a single wire 122, it is necessary to provide a joint at the end of the wire 122. When connecting the opening 12 to the base end 11a of the filament 11, it is also necessary to provide a joint between the opening 12 and the filament 11. The joint may be formed by, for example, a metal solder such as silver solder, gold solder, zinc, a Sn—Ag alloy, or a Au—Sn alloy, or may be formed by an adhesive such as an epoxy adhesive.

[0020] When inserting a guidewire into an inserter 20 (medical device) having a tubular body 21, the filament 11 of the guidewire insertion aid 10 is inserted into the tubular body 21, leaving the opening 12 exposed to the outside of the tubular body 21 (the state shown in FIG. 2 ). Next, with the tip of the guidewire hooked on the opening 121 of the opening 12, the filament 11 is pulled toward the tip of the inserter 20, allowing the opening 12 to be pulled into the tubular body 21 together with the tip of the guidewire.

[0021] The opening 12 in this embodiment has a shape that is symmetrical with respect to the axis A of the filament 11. More specifically, the opening 12 has a hexagonal shape in a plan view, and a vertex 123 of the opening 12 is connected to the base end 11a of the filament 11. Since the flexible opening 12 has a shape that is symmetrical with respect to the axis A of the filament 11, the opening 12 can easily deform to fit the inner diameter of the tubular body, thereby allowing the guidewire to be smoothly drawn into the tubular body of the medical device. In particular, if the opening 12 has an even-sided shape, such as a square or hexagon, and is connected so that one of its vertices (vertex 123) is located at one end (base end 11a) of the filament 11, the vertex 124 opposite to vertex 123 will also be positioned on the axis A of the filament 11. Therefore, these vertices 123 and 124 can be used to realize a structure that allows the opening 12 to be easily folded, thereby allowing the opening 12 to more smoothly deform to fit the inner diameter of the tubular body 11.

[0022] The inserter 20 includes a cylindrical body 21 through which a guidewire is inserted, and a connector 22 is attached to the end of the cylindrical body 21. Examples of materials that can be used to form the cylindrical body 21 and the connector 22 of the inserter 20 include resin materials such as polyamide, polyamide elastomer, polyolefin, polyester, and polyester elastomer.

[0023] In the medical device set including the guidewire insertion aid 10 and the inserter 20 of this embodiment, the outer diameter of the opening 12 in the direction perpendicular to the axis of the filament 11 of the guidewire insertion aid 10 is larger than the inner diameter of the tubular body 21 of the inserter 20. By making the outer diameter of the opening 12 larger than the inner diameter of the tubular body 21 in this manner, it becomes easier to hook the tip of the guidewire onto the opening 121 of the opening 12.

[0024] In the medical device set including the guidewire insertion aid 10 and the inserter 20 of this embodiment, the filament 11 of the guidewire insertion aid 10 is longer than the tubular body 21 of the inserter 20. This allows the other end (distal end 11b) of the filament 11 to be exposed to the outside from the other end (distal end) of the tubular body 21 while the opening 12 connected to one end (proximal end 11a) of the filament 11 is exposed to the outside from one end (proximal end) of the tubular body 21 (the state shown in FIG. 2 ). This makes it easy to pull the filament 11 toward the distal end of the inserter 20.

[0025] 3 shows how the guidewire GW is inserted into the inserter 20 using the guidewire insertion aid 10. First, with the guidewire insertion aid 10 inserted into the inserter 20, the tip of the guidewire GW is inserted through the opening 121 of the opening 12 (FIG. 3(a)).

[0026] Next, the guidewire insertion aid 10 is pulled toward the distal end of the inserter 20, and the opening 12 is pulled into the tubular body 21 of the inserter 20 together with the distal end of the guidewire GW ( FIG. 3( b) ). At this time, the shape of the opening 12 is deformed so that the outer diameter of the opening 12 in a direction perpendicular to the axis of the filament 11 of the guidewire insertion aid 10 becomes smaller than the inner diameter of the tubular body 21 of the inserter 20. By configuring the opening 12 in this manner, the distal end of the guidewire GW hooked on the opening 121 of the opening 12 can be easily pulled into the tubular body 21.

[0027] By continuing to pull the guidewire insertion aid 10 toward the tip of the inserter 20, the guidewire GW is drawn into the tubular body 21 of the inserter 20 (Figure 3(c)), and eventually the opening 12 of the guidewire insertion aid 10, together with the tip of the guidewire GW, emerges from the tip of the tubular body 21 to the outside of the inserter 20 (Figure 3(d)).

[0028] When the distal end of the guidewire GW is exposed from the distal end of the tubular body 21, the guidewire insertion aid 10 is removed from the guidewire GW (FIG. 3(e)). Next, the guidewire GW is pulled back toward the proximal end of the inserter 20, and the shaped distal end of the guidewire GW is hooked onto the distal end of the tubular body 21 (FIG. 3(f)). In this state, when the guidewire GW is further pulled toward the proximal end of the inserter 20, the bent distal end of the guidewire GW becomes substantially straight and is housed within the tubular body 21 of the inserter 20 (FIG. 3(g)).

[0029] The guidewire insertion aid and medical device set according to the present disclosure have been described above with reference to the drawings. The present disclosure is not limited to the above-described embodiments, and various modifications are possible. For example, the medical device through which the guidewire is to be inserted may be a catheter instead of an inserter, or may be another medical device having a tubular body. The opening of the guidewire insertion aid may be circular or elliptical in plan view, or may have any other shape as long as it has an opening through which the guidewire is inserted. The opening of the guidewire insertion aid may have a certain width in the opening direction, as long as it is smaller than the inner diameter of the tubular body of the medical device through which the guidewire is to be inserted.

[0030] The present disclosure provides a guidewire insertion aid including a filament and a flexible opening having an opening for inserting a guidewire, the opening being provided at at least one end of the filament (Disclosure 1).

[0031] According to this disclosure (Disclosure 1), when inserting a guidewire into a medical device having a tubular body, the filament of the guidewire insertion aid is inserted into the tubular body so that the opening is exposed to the outside of the tubular body, and the tip of the guidewire is hooked onto the opening and the filament is pulled toward the tip of the medical device, whereby the opening can be pulled into the tubular body together with the tip of the guidewire. Such a guidewire insertion aid allows a guidewire with a shaped tip to be easily inserted tip-first into a medical device such as an inserter.

[0032] In the above disclosure (Disclosure 1), it is preferable that the opening has a shape that is symmetrical with respect to the axis of the filament (Disclosure 2).

[0033] According to this disclosure (Disclosure 2), the flexible opening is easily deformed to fit the inner diameter of the cylindrical body, allowing the guide wire to be smoothly pulled into the cylindrical body of the medical device.

[0034] In the above disclosures (Disclosures 1 and 2), it is preferable that the opening has an n-sided polygonal shape (n is an even number) in a planar view, and any vertex of the opening is connected to one end of the filament (Disclosure 3).

[0035] According to this disclosure (Disclosure 3), if the opening has an even-sided shape such as a rectangle or a hexagon, and one of its vertices is located at one end of the filament, the vertex opposite to that vertex will also be positioned on the axis of the filament, making it easier for the opening to be folded using those vertices and allowing the opening to deform more smoothly to fit the inner diameter of the tubular body.

[0036] In the above disclosures (Disclosures 1-3), it is preferable that the opening is formed by forming a wire into a ring shape (Disclosure 4).

[0037] According to this disclosure (Disclosure 4), the opening can be formed from the same material as the filament, and the shape of the opening can be easily processed.

[0038] Second, the present disclosure provides a medical device set comprising a medical device having a tubular body through which a guidewire is inserted, and a guidewire insertion aid of Disclosures 1-4 inserted into the tubular body (Disclosure 5).

[0039] In the above disclosure (Disclosure 5), it is preferable that the outer diameter of the opening in a direction perpendicular to the axis of the filament is larger than the inner diameter of the cylindrical body (Disclosure 6).

[0040] According to this disclosure (Disclosure 6), the outer diameter of the opening is larger than the inner diameter of the cylindrical body, so that the tip of the guide wire can be easily hooked onto the opening of the opening.

[0041] In the above disclosures (Disclosures 5 and 6), it is preferable that the shape of the opening be deformed so that the outer diameter of the opening in a direction perpendicular to the axis of the filament is smaller than the inner diameter of the cylindrical body (Disclosure 7).

[0042] According to this disclosure (Disclosure 7), the tip of the guide wire hooked on the opening of the opening can be easily pulled into the cylindrical body.

[0043] In the above disclosures (Disclosures 5-7), it is preferable that the filament is longer than the cylindrical body (Disclosure 8).

[0044] According to this disclosure (Disclosure 8), with the opening connected to one end of the filament exposed to the outside from one end of the tubular body, the other end of the filament can also be exposed to the outside from the other end of the tubular body, making it easier to pull the filament toward the tip of the medical device.

Claims

1. A guidewire insertion aid (10) comprising: a filament (11); and a flexible opening (12) having an opening (121) for inserting a guidewire, the opening (12) being provided at at least one end of the filament (11).

2. A guide wire insertion aid (10) according to claim 1, wherein the opening (12) has a shape that is symmetrical with respect to the axis of the filament (11).

3. A guidewire insertion aid (10) according to claim 1 or 2, wherein the opening (12) has an n-sided polygonal shape (n is an even number) in plan view, and one of the vertices (123) of the opening (12) is connected to one end (11a) of the filament (11).

4. A guide wire insertion aid (10) according to any one of claims 1 to 3, wherein the opening (12) is formed by forming a wire (122) into a ring shape.

5. A medical device set comprising: a medical device (20) having a tubular body (21) through which a guide wire is inserted; and a guide wire insertion aid (10) according to any one of claims 1 to 4, which is inserted into the tubular body (21).

6. A medical device set according to claim 5, wherein the outer diameter of the opening (12) in a direction perpendicular to the axis of the filament (11) is larger than the inner diameter of the tubular body (21).

7. A medical device set as described in claim 5 or 6, wherein the shape of the opening (12) is deformed so that the outer diameter of the opening (12) in a direction perpendicular to the axis of the filament (11) is smaller than the inner diameter of the tubular body (21).

8. A medical device set according to any one of claims 5 to 7, wherein the filament (11) is longer than the tubular body (21).

Images