JP2014039610A - Shaping device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a shaping device capable of easily performing shaping of a tip of a guide wire and capable of being also easily used on a medical site.SOLUTION: A shaping device 1 includes a body part 2 that has a hole part 3 into which a tip of a guide wire can be inserted, and a holding part 4 that is formed in a shape elongated from the body part 2. The hole part 3 assumes a shape elongated in the longitudinal direction of the body part 2. The hole part 3 has a first surface into which the tip of the guide wire is to be inserted, and a second surface from which the tip of the guide wire is to be ejected. An area of the first surface is larger than an area of the second surface.

Description

  The present invention relates to a shaping device for shaping a distal end portion of a guide wire.

  One method for treating a blockage occurring in a tubular organ such as a blood vessel is percutaneous coronary intervention (hereinafter referred to as PCI), which is a medical treatment using a catheter, a stent, or the like. In PCI, the success or failure of PCI depends on whether or not a guide wire used for treatment passes through a stenosis part such as a blood vessel. In addition, in PCI, when the shape of the distal end portion of the guide wire is a straight shape, a branching portion such as a blood vessel cannot be selected. Therefore, an operator uses a shaping device to perform a narrowing portion before PCI. A shape (curved shape or bent shape) suitable for the shape of the occurring blood vessel is applied to the distal end portion of the guide wire. In view of such a background, various apparatuses and methods for shaping the tip of the guide wire have been proposed.

  For example, Patent Document 1 discloses that a guide wire is formed on a holding surface for pressing and holding a distal end portion of a guide wire and a side surface continuous with the holding surface, and the distal end portion of the guide wire held by the holding surface is bent. A guide wire shaping aid that includes a flat plate portion including a pressing surface for forming a bending start point is described.

  Further, in Patent Document 2, by winding around the outer periphery of the shaping shaft while pressing the distal end portion of the guide wire along the outer periphery of the shaping shaft of the shaping tool for attaching the shape to the distal end portion of the guide wire. A guide wire manufacturing method is described in which a curved shape is formed at the tip of the guide wire.

JP2012-65913 JP2008-1555053

  The auxiliary tool for shaping a guide wire described in the cited document 1 requires the use of the operator's finger when pressing the distal end of the guide wire against the flat plate portion of the auxiliary tool. Because the size of the person's finger and how to apply the force when pressing are different, there is a risk that even if the same auxiliary tool is used, the tip of the guide wire may be shaped differently or the tip of the guide wire may be damaged. In addition, when shaping the tip of the guide wire with an auxiliary tool, it depends on the skill level of the operator, and it is not easy to shape the tip of the guide wire.

  Further, in the guide wire manufacturing method described in the cited document 2, although the same shape can be applied to the distal end portion of the guide wire regardless of the skill level of the operator, the apparatus becomes large and easy in the medical field. It was difficult to use.

  The present invention has been made in view of such problems, and an object of the present invention is to provide a shaping device that can easily shape the distal end portion of a guide wire and can be easily used in a medical field. To do.

  <1> The invention according to claim 1 of the present application is a shaping device including a main body having a hole portion into which a distal end portion of a guide wire can be inserted, and a grip portion formed to extend from the main body portion. Features.

  <2> The invention according to claim 2 is the shaping device according to claim 1, characterized in that the shape of the hole is a shape extending in a major axis direction of the main body. .

  <3> The invention according to claim 3 is the shaping device according to claim 1 or 2, wherein the hole includes a first surface into which a distal end portion of the guide wire is inserted, and a distal end portion of the guide wire. And a second surface from which the first surface is discharged, wherein the area of the first surface is larger than the area of the second surface.

  <4> The invention according to claim 4 is the shaping device according to any one of claims 1 to 3, wherein the hole has at least two different widths.

  <5> The invention according to claim 5 is the shaping device according to any one of claims 1 to 4, wherein at least a part of the hole portion has a constant width and at least two different thicknesses. A shaping device having:

  <6> The invention according to claim 6 is the shaping device according to claim 5, wherein the surface of the main body is colored differently according to the thickness of the hole. Features.

  <7> The invention according to claim 7 is the shaping device according to any one of claims 1 to 6, wherein at least a part of the inner peripheral surface of the main body portion forming the hole portion is provided on the surface. The shaping device is provided with a coating layer formed of a material having a lower hardness than a material forming the main body.

  <1> The shaping device according to claim 1 has a simple configuration including a main body having a hole into which a distal end portion of the guide wire can be inserted, and a grip formed by extending from the main body. Therefore, the tip of the guide wire can be easily shaped by simply inserting the tip of the guide wire into the hole of the main body and rotating the gripping portion. be able to.

  <2> In the shaping device according to claim 2, since the shape of the hole is a shape extending in the long axis direction of the main body, the tip of the guide wire can be easily inserted into the hole, The tip portion of the guide wire can be shaped more easily.

  <3> The shaping device according to claim 3, wherein the hole has a first surface into which the tip of the guide wire is inserted, and a second surface from which the tip of the guide wire is discharged. Since the area of the surface of 1 is larger than the area of the second surface, it is possible to enhance the insertability of the distal end portion of the guide wire into the hole and shape the distal end portion of the guide wire more easily.

  <4> In the shaping device according to claim 4, since the hole portion has at least two different widths, the distal end portion of the guide wire is inserted from the hole portion having a large width, and then the guide wire The tip of the guide wire can be moved to a hole having a small width, so that the tip of the guide wire can be easily inserted into the hole, and thus, the tip of the guide wire can be easily shaped. It can be carried out.

  <5> In the shaping device according to claim 5, since the hole portion has a constant width and at least two different thicknesses, the shape of the tip portion of the guide wire is different with one shaping device. Shape shaping can be performed.

  <6> In the shaping device according to claim 6, since the surface of the main body portion is colored differently depending on the thickness of the hole portion, the surgeon can arbitrarily shape the distal end portion of the guide wire. When performing, it is possible to visually confirm the body portion corresponding to the hole portions having different thicknesses, so that it is easy to quickly select a hole portion that can be arbitrarily shaped, and as a result, a guide wire Arbitrary shaping can be quickly performed on the tip of the slab.

  <7> The shaping device according to claim 7 is formed of a material having a lower hardness than a material forming the main body on at least a part of the inner peripheral surface of the main body forming the hole. Because the coating layer is provided, when the tip of the guide wire is inserted into the hole and shaped, the tip of the guide wire is damaged by the contact between the surface of the guide wire and the coating layer. Can be prevented and shaping can be performed more safely.

BRIEF DESCRIPTION OF THE DRAWINGS It is a block diagram of the shaping device which shows 1st Embodiment of this invention, (a) is a whole figure of a shaping device, (b) is a cross-sectional view of the shaping device in the AA cross section of (a). , (C) and (d) are modified examples of the first embodiment. It is a block diagram of the shaping device which shows 2nd Embodiment of this invention, (a) is a whole figure of a shaping device, (b) is a cross-sectional view of the shaping device in the AA cross section of (a). . It is a block diagram of the shaping device which shows 3rd Embodiment of this invention, (a) is a whole figure of a shaping device, (b) is a cross-sectional view of the shaping device in the AA cross section of (a). (C) is a cross-sectional view of the shaping device in the BB cross section of (a). It is a block diagram of the shaping device which shows 4th Embodiment of this invention, (a) is a whole figure of a shaping device, (b) is a longitudinal cross-sectional view of the main-body part of a shaping device, (c) is ( It is a cross-sectional view of the shaping device in the AA cross section of a), (d) is a cross-sectional view of the shaping device in the BB cross section of (a). It is a block diagram of the shaping device which shows 5th Embodiment of this invention, (a) is a whole figure of a shaping device, (b) is a longitudinal cross-sectional view of the main-body part of a shaping device. It is a block diagram of the shaping device which shows 6th Embodiment of this invention, (a) is a whole figure of a shaping device, (b) is a cross-sectional view of the shaping device in the AA cross section of (a). , (C) is a modification of the sixth embodiment.

  Hereinafter, a guide wire of the present invention will be described based on a preferred embodiment shown in the drawings.

<First Embodiment>
FIG. 1A is an overall view of a shaping device, and FIG. 1B is a cross-sectional view of the shaping device taken along the line AA in FIG.

In FIG. 1A, for convenience of explanation, the left side is described as “tip” and the right side as “base end”.
Further, in FIG. 1A, in order to facilitate understanding, the length direction of the shaping device 1 is shortened and the entire shaping device 1 is schematically illustrated, so that the dimensional ratio is different from the actual one.

1A and 1B, a shaping device 1 includes a main body portion 2 having a thickness t1 and a cylindrical gripping portion 4 formed to extend to the proximal end side of the main body portion 2. A shaft portion 5 is provided between the main body portion 2 and the grip portion 4.
The main body 2 has a width W1 into which the distal end portion of the guide wire can be inserted, and has a hole 3 that penetrates in the thickness direction of the main body 2.
In addition, the grasping portion 4 has a plurality of rib portions 6 on the outer periphery in order to make it easy for an operator to grasp the grasping portion 4 and to rotate the grasping portion 4.

  As described above, the shaping device 1 has a simple configuration including the main body portion 2 having the hole portion 3 into which the distal end portion of the guide wire can be inserted and the grip portion 4 formed extending from the main body portion 2. It can be used easily in the medical field. Also, when shaping the tip of the guide wire, the operator's finger does not touch the guide wire directly, so the guide wire's tip is not affected by the skill level of the operator. The tip of the guide wire can be easily shaped by simply rotating the grasping portion 4 while the operator is inserted into the hole 3 of the portion 2.

  The material constituting the shaping device 1 is not particularly limited, but metals such as stainless steel, chromium alloy, titanium alloy such as nickel-titanium alloy, polyamide, polymethacrylate, polyethylene, polypropylene, polycarbonate It can be formed from a resin such as polyacetal, polysulfone, or polyethersulfone.

  In addition, the main body 2, the grip 4 and the shaft 5 may be formed of different materials. However, from the viewpoint of the strength of the shaping device 1, the same material and the joints between the elements are provided. It is preferably formed so as to have a one-piece structure.

  As a method for producing the shaping device 1, there are a method of injecting a resin material such as polyacetal into a mold, and a method of cutting and grinding a metal or a resin material. Moreover, it is not limited to this, You may form the shaping device 1 by employ | adopting well-known methods other than these.

  Moreover, as described in FIG. 1B, in the cross-sectional view of the main body 2, the outer periphery of the main body 2 and the inner periphery of the main body 2 constituting the hole 3 are rounded. It is preferable that it is chamfered. Since the outer periphery and the inner periphery of the main body 2 are chamfered, when the tip of the guide wire is shaped, the bending start point of the tip of the guide wire becomes gentle, so that the tip of the guide wire is damaged. Can be prevented.

1 (c) and 1 (d) show a modification of the present embodiment, and the main body portion 2 has a shape of the main body portion 12 having the same width W2 and length L1. Alternatively, the main body 22 may have an elliptical shape, but it is preferable to take into account the insertion property of the distal end portion of the guide wire into the hole 3 as will be described later.
In consideration of the insertion property of the guide wire into the hole 3, the shape of the hole 3 is greater than that of the hole 13 having a substantially square shape as illustrated in FIG. c) A shape such as the hole 3 and the hole 23 extending in the major axis direction of the shaping device is preferable. Since the shape of the hole portion extends in the long axis direction of the main body portion, the tip of the guide wire can be easily inserted into the hole portion, and the tip portion of the guide wire can be shaped more easily. be able to.

  In addition, the shape of the grip portion 4 is not particularly limited. However, if it is considered that the distal end portion of the guide wire is inserted into the hole portion 3 of the main body portion 2 and the grip portion 4 is rotated, the grip portion 4. In order to transmit the rotational force to the main body 2, the outer diameter φ1 of the grip 4 is preferably larger than the width W1 of the hole 3 of the main body 2, as shown in FIG. . As a result, the rotational force can be sufficiently transmitted to the main body 2 by slightly rotating the grip 4, so that the tip of the guide wire can be shaped more easily.

  Moreover, although the shaft 5 located between the main-body part 2 and the holding part 4 is formed thinner than the outer diameter of the main-body part 2 and the holding part 4, it is the same as the holding part 4 without being limited to this. It may have an outer diameter, and the shaping device 1 may be provided directly on the grip portion 4 without having the shaft 5.

Second Embodiment
Next, the shaping device 11 according to the second embodiment will be described with reference to FIG. 2 focusing on differences from the first embodiment. Portions common to the first embodiment are denoted by the same reference numerals in the drawing.
In FIG. 2A, the length direction of the shaping device 11 is shortened and the entire shape of the shaping device 11 is schematically shown for easy understanding, so the overall dimensions are different from the actual dimensions. . Moreover, FIG.2 (b) is a cross section of the main-body part 32 in the AA cross section of (a).

  2A and 2B, the hole 33 of the shaping device 11 includes a first surface 7 into which the distal end portion of the guide wire is inserted, and a second surface 8 into which the distal end portion of the guide wire is discharged. And an inclined portion 320 from the first surface 7 toward the second surface 8 so that the width W3 of the first surface 7 is larger than the width W1 of the second surface 8. Thereby, the area of the first surface 7 is larger than the area of the second surface 8.

  As described above, the shaping device 11 includes the first surface 7 into which the hole portion 33 is inserted with the distal end portion of the guide wire, and the second surface 8 through which the distal end portion of the guide wire is discharged. Since the area of the surface 7 is larger than the area of the second surface 8, it is possible to improve the insertability of the distal end portion of the guide wire into the hole 33 and further easily shape the distal end portion of the guide wire. it can.

  In the cross-sectional view of the main body 32 of the shaping device 11 illustrated in FIG. 2B, the shape of the hole 33 is such that the inclined portion 320 of the hole 33 is connected to the second surface 8. That is, it can be provided so that the cross-sectional view of the main body 32 is substantially triangular. However, in order to reliably shape the distal end portion of the guide wire, the width W1 for supporting the distal end portion of the guide wire. Is preferably provided in the hole 33. That is, the starting end of the inclined portion 320 exists on the first surface 7 as in the present embodiment, and the terminal end does not contact the second surface 8, so that it is between the first surface 7 and the second surface 8. It is preferable that a certain width W1 is ensured in at least a part of the hole 33 at the position.

<Third Embodiment>
Next, the shaping device 21 according to the third embodiment will be described with reference to FIG. 3 focusing on differences from the first embodiment. Portions common to the first embodiment are denoted by the same reference numerals in the drawing.
In FIG. 3A, the length direction of the shaping device 21 is shortened and the entire shape of the shaping device 21 is schematically shown for easy understanding, and therefore the overall dimensions are different from the actual dimensions. . Moreover, (b) is a cross-sectional view of the main body 42 in the AA cross section of (a), and (c) is a cross-sectional view of the main body 42 in the BB cross section of (a).

  3A, 3 </ b> B, and 3 </ b> C, the hole 43 of the shaping device 21 is located on the base end side, and has a first hole 431 having a width W <b> 1 and a width larger than the width W <b> 1. And a second hole portion 432 arranged so as to be continuous with the distal end side of the first hole portion 431. In the present embodiment, the hole 43 has a width W1 and a width W3, but is not limited thereto, and further includes a third hole having a width larger than the width W3. As long as it has at least two different widths.

  Thus, since the hole portion 43 has at least two different widths (W1 and W3), the distal end portion of the guide wire is inserted from the second hole portion 432 having a large width W3, and then Since the distal end portion of the guide wire can be moved to the first hole portion 431 having the small width W1, the distal end portion of the guide wire can be easily inserted into the hole portion 43. The tip portion can be easily shaped.

  In the present embodiment, the first hole portion 431 is located on the proximal end side of the hole portion 43 and the second hole portion 432 is located on the distal end side of the hole portion 43. However, the present invention is not limited to this. Instead, the first hole portion 431 may be positioned on the distal end side of the hole portion, and the second hole portion 432 may be positioned on the proximal end side of the hole portion 43.

<Fourth embodiment>
Next, the shaping device 31 according to the fourth embodiment will be described with reference to FIG. 4 focusing on differences from the first embodiment. Portions common to the first embodiment are denoted by the same reference numerals in the drawing.
In FIG. 4A, the length direction of the shaping device 31 is shortened and the entire shape of the shaping device 31 is schematically shown for easy understanding, and therefore the overall dimensions are different from the actual dimensions. . Moreover, (b) is a side view of the main body 52 of (a), (c) is a cross-sectional view of the main body 52 in the AA cross section of (a), and (d) is a cross-sectional view of (a). It is a cross-sectional view of the main-body part 52 in a BB cross section.

  In FIG. 5A, the hole 53 of the shaping device 31 has a certain width W1. Further, in FIG. 5B, the main body 53 is located on the proximal end side and is located on the distal end side of the first main body 521 having the thickness t1, and the thickness t1. And a second main body portion 522 having a thinner thickness t2. Accordingly, the hole 53 provided in the main body 52 has a thickness t1 as shown in FIGS. 5A, 5C, and 5D, and the base of the hole 53 The first hole portion 531 located on the end side and the second hole portion 532 located on the distal end side of the first hole portion 531 and having a thickness t2 smaller than the thickness t1 are formed.

  Under the condition that the width of the hole 53 is constant, the tip of the guide wire is inserted into the first hole 531 and the tip of the guide wire is shaped. In the case where the distal end portion of the guide wire is shaped and the distal end portion of the guide wire is shaped, the distal end portion of the guide wire can be relatively curved or bent in the former case, and the distal end portion of the guide wire in the latter case. A relatively small curved or bent shape can be applied.

  Thus, since the hole 53 has a constant width W1 and two different thicknesses (t1 and t2), the size of the tip of the guide wire is different with one shaping device 31. Shape shaping can be performed easily.

  In this embodiment, the main body 52 (hole 53) is provided with two different thicknesses (t1 and t2). However, the present invention is not limited to this, and the main body 52 has three or more different thicknesses. Can also be provided.

<Fifth Embodiment>
Next, a shaping device 41 according to the fifth embodiment will be described with reference to FIG. 5 focusing on differences from the fourth embodiment. Parts common to the fourth embodiment are denoted by the same reference numerals in the drawing.
In FIG. 5A, the length of the shaping device 41 is shortened and the entire shape of the shaping device 41 is schematically shown in order to facilitate understanding. . Moreover, (b) is a side view of the main body 62 of (a).

  5 (a) and 5 (b), the surface of the first main body portion 621 having the thickness t1 and provided with the first hole portion 631 positioned on the proximal end side of the hole portion 63 has 1 is colored (black in this embodiment), has a thickness t2 smaller than the thickness t1, and is provided with a second hole 632 positioned on the tip side of the first hole 631. The surface of the second main body 622 is colored in the second color (yellow in this embodiment). Thereby, the surface of the main body 62 of the shaping device 41 is colored differently (black and yellow) depending on the thickness (t1 and t2) of the hole 63.

  Thus, since the surface of the main body 62 is colored differently depending on the thickness of the hole 63, when the surgeon performs arbitrary shaping on the distal end portion of the guide wire, the different thickness Since the main body 62 corresponding to the hole 63 can be visually confirmed, it becomes easy to quickly select the hole 63 that can be arbitrarily shaped, and in the end, the guide wire has an arbitrary shape. It can be done quickly.

  In addition, although the hole part 63 of this embodiment has two different thickness (t1 and t2), it is not limited to this, 3rd which has thickness t3 thinner than thickness t2. You may further have a hole. In this case, the surface of the main body 62 provided with the third hole can be colored (for example, blue) different from the first coloring and the second coloring described above.

  As a method of manufacturing the main body 62 having different coloring, the main body 62 having a plurality of different thickness holes 63 is prepared in advance, and different colorants are used depending on the thickness of the holes 63. When the main body portion 62 is formed of a resin material, the portion constituting the main body portion 62 from resin molding raw materials having different colors (for example, the first main body portion 621 and There is a method in which the second main body portion 622) is manufactured and the portions constituting the main body portion 62 are bonded or welded. Moreover, it is not limited to this, A well-known method is employable suitably.

<Sixth Embodiment>
Finally, the shaping device 51 according to the sixth embodiment will be described with reference to FIG. 6 focusing on differences from the first embodiment. Portions common to the first embodiment are denoted by the same reference numerals in the drawing.
In FIG. 6A, the length direction of the shaping device 51 is shortened and the entire shape of the shaping device 51 is schematically shown for easy understanding, and therefore the overall dimensions are different from the actual dimensions. . Moreover, (b) is a cross-sectional view of the main body 72 of (a). (C) is a modification of the present embodiment.

  In FIG. 6A, the coating layer 9 made of a material having a lower hardness than the material forming the main body 72 is provided on the inner peripheral surface of the main body 72 forming the hole 73. In addition, the hardness said by a present Example means Rockwell hardness, durometer hardness, and Shore hardness.

  Thus, the coating layer 9 formed of a material having a lower hardness than the material forming the main body 72 is provided on the inner peripheral surface of the main body 72 that forms the hole 73. When the tip portion of the guide wire is inserted into the hole 73 for shaping, the guide wire surface and the coating layer 9 come into contact with each other, thereby preventing the tip portion of the guide wire from being damaged and shaping. Can be done more safely.

As a combination of the main body 72 and the covering layer 9, the main body 72 is formed of stainless steel having a Rockwell hardness (C scale) 50, and the covering layer 9 is formed of polytetrafluoroethylene having a Rockwell hardness (R scale) 80. And a combination in which the main body 72 is formed of polyacetal having a Rockwell hardness (R scale) 120 and the coating layer 9 is formed of a polyamide elastomer having a Rockwell hardness (R scale) 55.
The C scale of Rockwell hardness is used for metal and is a scale for measuring a material having high hardness. The M scale of Rockwell hardness is for measuring a flexible material such as a resin material. It is a scale.

  Further, the combination of the main body portion 72 and the covering layer 9 is not limited to the above-described combination, and may be a combination in which the hardness of the material forming the covering layer 9 is lower than the hardness of the material forming the main body portion 72. .

  The covering range of the covering layer 9 may be provided on at least a part of the inner peripheral surface of the main body portion 72. However, in view of contact with the distal end portion of the guide wire, it is described in FIG. 6B. As shown, it is preferable that the covering layer 9 is provided on the entire inner peripheral surface of the main body 72 forming the hole 73 so as to have the width W4. Further, as shown in FIG. 6C described as a modification of the present embodiment, the entire surface of the main body 82 having the hole 83 may be covered with the coating layer 19.

Further, the present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical idea of the present invention.
For example, the shape of the main body 32 of the shaping device 11 according to the second embodiment of the present invention and the shape of the main body 42 of the shaping device 21 according to the third embodiment of the present invention are the same as the main body of the shaping device 31 according to the fourth embodiment of the present invention. 52 shapes can be combined.
Further, the main body 62 of the shaping device 41 of Embodiment 5 is made of stainless steel, and the colored portion covered with the first main body 621 has a lower hardness than stainless steel and is colored black. The colored portion covered with the second main body portion 622 may be made of polytetrafluoroethylene having a lower hardness than stainless steel and colored yellow.

1, 11, 21, 31, 41, 51 Shaping devices 2, 12, 22, 32, 42, 52,
62, 72, 82 Main body 3, 13, 23, 33, 43, 53,
63, 73, 83 Hole 4 Holding part 5 Shaft 6 Rib 7 First surface 8 Second surface 9, 19 Covering

Claims (7)

A main body having a hole into which the tip of the guide wire can be inserted;
A shaping device comprising: a grip portion extending from the main body portion. The shaping device according to claim 1.
The shape of the said hole is a shaping device which is the shape extended toward the major axis direction of the said main-body part. The shaping device according to claim 1 or 2,
The hole has a first surface into which the tip of the guide wire is inserted and a second surface from which the tip of the guide wire is discharged. The area of the first surface is the second surface. A shaping device that is larger than the surface area. The shaping device according to any one of claims 1 to 3,
The shaping device, wherein the hole has at least two different widths. The shaping device according to any one of claims 1 to 4,
A shaping device, wherein at least some of the holes have a constant width and at least two different thicknesses. The shaping device according to claim 5,
A shaping device in which the surface of the main body is colored differently depending on the thickness of the hole. The shaping device according to any one of claims 1 to 6,
A shaping layer formed of a material having a lower hardness than a material forming the main body is provided on at least a part of the inner peripheral surface of the main body forming the hole. device.