WO2015141094A1

WO2015141094A1 - Manufacturing method and manufacturing apparatus for long medical treatment object

Info

Publication number: WO2015141094A1
Application number: PCT/JP2014/084083
Authority: WO
Inventors: 力也小俣; 一貴宮城; 泰直大谷
Original assignee: テルモ株式会社
Priority date: 2014-03-18
Filing date: 2014-12-24
Publication date: 2015-09-24
Also published as: JP2017079808A

Abstract

Provided is a manufacturing method for a long medical treatment object, the method being capable of easily and quickly manufacturing long medical treatment objects for which surface lubrication is controlled according to use. The manufacturing method for a long medical treatment object (10) comprises: a forming step for forming a lubricating layer on at least a portion of the surface of a base material (11); a masking step for covering the base material on which the lubricating layer has been formed with a masking member (20), which is provided with permeable sections (21) through which energy rays (E) pass and non-permeable sections (22) through which energy rays do not pass; and an irradiation step for irradiating energy rays from outside of the masking member toward the base material that has been covered by the masking member.

Description

Manufacturing method and manufacturing apparatus for medical long body

The present invention relates to a method for manufacturing a medical long body and a manufacturing apparatus.

Medical elongated bodies inserted into living bodies such as catheters and guide wires have excellent lubricity on the surface to reduce tissue damage such as blood vessels during insertion and improve the operability of the operator. It is requested. For this reason, a method for coating a hydrophilic polymer having lubricity on the surface of a substrate has been developed.

On the other hand, depending on the intended use, adverse effects may occur due to improved surface lubricity. For example, when a medical long body is inserted into a living body and the leading edge of the medical long body hits a bent or narrowed portion of a blood vessel, if the surface has high lubricity, the insertion resistance may be Difficult to get to. For this reason, the operator does not realize that the surgeon has hit the bend or stenosis of the blood vessel, pushes the medical long body as it is, advances the device in an unexpected direction, or overlooks the target site There is a fear. In addition, when a medical long body is desired to be left at the target site, if the surface has high lubricity, the patient may slide and move from the target site due to the pulsation or body movement of the patient. Therefore, it is necessary to control the lubricity of the surface of the medical elongated body according to the intended use.

In this connection, for example, Patent Document 1 below describes a guide wire in which a lubricating resin film is coated at a high density from the proximal end side to the distal end side. According to this guide wire, the lubricity at the distal end side is high and the lubricity at the proximal end side is low, so that the sliding resistance during insertion into the body is reduced, and the operability of the surgeon is not impaired. Can be improved.

Also, in Patent Document 2 below, a guide wire is described in which a coil is foreseen at the tip, and the most advanced part of the coil is formed with low lubricity. According to this guide wire, since the lubricity at the distal end side is low and the lubricity at the proximal end side is high, the surgeon can sense the resistance at the most distal portion and the insertion resistance to the inner wall of a blood vessel or the like is low. Can be maintained.

Japanese Patent Laid-Open No. 2003-33438 JP 2002-17863 A

However, when manufacturing the guide wire of Patent Document 1, it is necessary to coat the lubricating resin so that the tip side has a higher density than the base end side, which takes time for the work and the manufacturing method is complicated. Further, when manufacturing the guide wire of Patent Document 2, it is necessary to provide a predetermined lubricity on the surface of the coil, and to enclose the coil on the tip of the guide wire. Is complicated.

The present invention has been invented in order to solve the above-mentioned problems, and can be used to produce a medical long body whose surface lubricity is controlled easily and quickly according to the intended use. It aims at providing the manufacturing method and manufacturing apparatus of a long body.

A method for producing a medical elongated body according to the present invention that achieves the above object is a manufacturing method for producing a medical elongated body by irradiating an elongated base with energy rays, A masking member provided with a forming step of forming a lubricating layer on at least a part of the surface, a transmitting portion through which the energy rays pass and a non-transmitting portion through which the energy rays do not pass through the base material on which the lubricating layer is formed A masking step of covering with the masking member, and an irradiation step of irradiating the energy beam from the outside of the masking member toward the base material covered with the masking member, and transmitting the transmitting portion of the masking member In the method for producing a long medical body, the energy beam is irradiated on the lubricating layer formed on the surface of the base material, and the lubricity of the region irradiated with the energy beam is lowered. That.

In addition, the medical long-body manufacturing apparatus according to the present invention that achieves the above-described object is provided with a medical length by irradiating an elongated base material having a lubricating layer formed on at least a part of the surface with an energy beam. A manufacturing apparatus for manufacturing a scale body, wherein the masking member is disposed so as to cover the base material, and is provided with a transmission part through which the energy rays pass and a non-transmission part through which the energy rays do not pass, and And an irradiating means for irradiating the energy beam toward the base material, and the energy beam transmitted through the transmission part of the masking member is formed on the surface of the base material. It is a manufacturing apparatus of the medical long body which reduces the lubricity of the area | region irradiated to the said lubricating layer and the said energy ray.

According to the above-described method and apparatus for manufacturing a medical elongated body, it is possible to transmit only by irradiating an energy beam toward a base material covered with a masking member having a transmission part and having a lubricating layer formed on the surface. Lubricity can be reduced in the region irradiated with the energy rays transmitted through the part. At this time, the lubricity of the surface of the medical elongated body can be controlled by appropriately changing the region irradiated with the energy beam that has passed through the transmission part. Therefore, it is possible to easily and quickly manufacture a medical long body whose surface lubricity is controlled according to the intended use.

It is a figure which shows a guide wire. It is a figure which shows the manufacturing apparatus which concerns on 1st Embodiment of this invention. FIG. 3 is a cross-sectional view taken along line 3-3 in FIG. It is a flowchart which shows the manufacturing method of a guide wire. It is a figure which shows the manufacturing apparatus which concerns on 2nd Embodiment. It is a figure which shows the manufacturing apparatus which concerns on 3rd Embodiment. It is a figure which shows the manufacturing apparatus which concerns on 4th Embodiment. It is a figure which shows a mode that the masking member which concerns on the modification 2 covers a base material. It is a figure which shows a mode that the masking member which concerns on the modification 3 covers a base material. It is a figure which shows a friction measuring machine. It is a graph which shows the result of having measured sliding resistance value. It is a figure which shows a mode that a guide wire is inserted in the meandering blood vessel model.

Hereinafter, embodiments of the present invention will be described with reference to the drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio. In the present embodiment, a guide wire 10 will be described as an example of a medical long body. Further, in the following description, the proximal operation side of the guide wire 10 manufactured by the method of manufacturing the guide wire 10 according to the first embodiment of the present invention is referred to as the “base end side”, and the side inserted into the living body lumen is referred to as the proximal insertion side. This is referred to as “tip side”.

<Guide wire>
First, an example of the structure of the guide wire 10 manufactured with the manufacturing method and manufacturing apparatus which concern on embodiment of this invention is demonstrated.

FIG. 1 is a view showing a guide wire 10. As shown in FIG. 1, the guide wire 10 includes an elongated base material 11, a lubrication portion 12 having a high lubricity composed of a lubrication layer formed on the surface of the base material 11, and the surface of the base material 11. And a low lubrication portion 13 having a lower lubricity than the lubrication portion 12 formed by irradiating an energy beam E, which will be described later, to the lubrication layer. For easy understanding, in FIG. 1, the lubrication part 12 is shown in white and the low lubrication part 13 is shown in dots.

The base material 11 extends in the vertical direction in FIG. Examples of the material constituting the substrate 11 include a metal material, a polymer material, and a ceramic material. The metal material is not particularly limited. For example, various stainless steels such as SUS304, SUS316, SUS316L, SUS420J2, and SUS630, gold, platinum, silver, copper, nickel, cobalt, titanium, iron, aluminum, tin, or Examples include various alloys such as nickel-titanium alloy, nickel-cobalt alloy, cobalt-chromium alloy, zinc-tungsten alloy. The polymer material is not particularly limited. For example, polyamide resin, polyolefin resin such as polyethylene resin or polypropylene resin, modified polyolefin resin, cyclic polyolefin resin, epoxy resin, urethane resin, diallyl phthalate resin (allyl resin) , Polycarbonate resin, fluorine resin, amino resin (urea resin, melamine resin, benzoguanamine resin), polyester resin, styrene resin, acrylic resin, polyacetal resin, vinyl acetate resin, phenol resin, vinyl chloride resin, silicone resin (silicon resin), A polyether resin, a polyimide resin, etc. are mentioned. These materials may be used alone or in combination of two or more. Further, a multilayer structure in which different materials are laminated in multiple layers, or a structure in which members formed of different materials for each portion of the guide wire 10 are joined together.

The lubrication part 12 is provided in a spiral shape, and the pitch continuously increases from the distal end side (lower side in FIG. 1) to the proximal end side (upper side in FIG. 1). The lubrication part 12 is composed of a lubrication layer formed on the outer periphery of the substrate 11.

The lubrication layer is not particularly limited as long as it is a hydrophilic material that exhibits lubricity when wet (water absorption). Examples of hydrophilic materials that form lubricity include cellulose polymer materials, hyaluronic acid, polyethylene oxide polymer materials, and maleic anhydride polymer materials (such as methyl vinyl ether-maleic anhydride copolymer). And maleic anhydride copolymer), acrylamide polymer (for example, polyacrylamide, polydimethylacrylamide-glycidyl methacrylate block copolymer), water-soluble nylon, polyvinyl alcohol, polyvinylpyrrolidone, and the like. The hydrophilic material (lubricating layer) of the present invention is preferably a glycidyl methacrylate-dimethylacrylamide copolymer. These hydrophilic materials are coated on the substrate 11 by a conventionally known technique such as dip coating, spray coating, or surface graft polymerization to form a lubricating layer.

The low lubrication part 13 is comprised by irradiating the surface of the base material 11 with the lubrication layer irradiated with energy rays E. The energy rays E are, for example, ultraviolet rays, gamma rays, electron beams and the like. The degree to which the lubricity is lowered when the energy beam E is irradiated onto the base material 11 having the lubrication layer formed on the surface varies depending on the type of the energy beam E. For example, when ultraviolet rays are used as the energy rays E, the friction coefficient increases by about 5 to 50 times by irradiating the lubricating layer with ultraviolet rays. The energy ray E of the present invention is preferably ultraviolet rays. The low lubrication part 13 is provided in a spiral shape, and is configured such that the width increases toward the base end side.

The line width of the lubrication part 12 and the low lubrication part 13 is preferably 0.01 to 10 mm. By reducing the line width, the lubricity of the entire guide wire 10 can be precisely controlled.

Lubrication part 12 and low lubrication part 13 are provided alternately. Thus, when the lubrication part 12 with high lubricity and the low lubrication part 13 with low lubricity are mixed in a micro area | region, the lubricity in the contact surface with the target object of the guide wire 10 is the area ratio of each area | region. Dependent. For example, the object is a living body lumen such as a blood vessel. In the above-described guide wire 10, the area occupied by the low lubrication portion 13 increases from the distal end side to the proximal end side with respect to the area occupied by the lubrication portion 12, so that the distal end side has high lubricity and the proximal end side is lubricated. It has the characteristic that property is low.

In the case of the guide wire 10 having such characteristics, the distal end side inserted into a complicated lesion site has high lubricity, so that the approach to the lesion portion is easy, and the proximal end side operated by the operator is lubricity. Since it is low, it is hard to slip and the operability is high. The guide wire 10 shown in FIG. 1 is an example of a guide wire manufactured by the manufacturing apparatus and the manufacturing method according to the present embodiment, and a position where the lubrication portion 12 and the low lubrication portion 13 are formed depending on usage. May be changed as appropriate. For example, the structure which the area which the lubrication part 12 occupies may become large with respect to the area which the low lubrication part 13 occupies from the front end side of the base material 11 to the base end side.

<First Embodiment>
<Manufacturing equipment>
Next, the manufacturing apparatus 1 of the guide wire 10 based on 1st Embodiment of this invention is demonstrated. FIG. 2 is a diagram illustrating the manufacturing apparatus 1 according to the first embodiment. FIG. 3 is a sectional view taken along line 3-3 in FIG. As shown in FIG. 2, the manufacturing apparatus 1 according to the present embodiment is configured such that the guide wire 10 can be arranged in the vertical direction.

The manufacturing apparatus 1 according to the present embodiment includes a masking member 20, an irradiation unit 30, an adjustment unit 40, and a cooling unit 50 as shown in FIG. In addition, the base material 11, the masking member 20, the irradiation means 30, the adjustment means 40, and the cooling means 50 are each fixed by the base part not shown.

The masking member 20 is arranged so as to cover the long base material 11 having a lubricating layer formed on the surface thereof, and is provided with a transmission part 21 through which energy rays E pass and a non-transmission part 22 through which energy rays E do not pass. .

The masking member 20 is formed by spirally winding a string-like tape member 24 that does not transmit the energy beam E around the outer periphery of the transmission member 23 that can transmit the energy beam E. That is, the transmission part 21 that transmits the energy beam E corresponds to a region of the transmission member 23 where the tape member 24 is not wound, and the non-transmission unit 22 that does not transmit the energy beam E corresponds to the tape of the transmission member 23. This corresponds to the region around which the member 24 is wound.

The transmitting member 23 covers the long base material 11 having a lubricating layer formed on the surface. As shown in FIG. 3, the transmission member 23 has a circular inner periphery and outer periphery. For this reason, even if the base material 11 interferes with the transmissive member 23, the base material 11 is almost in surface contact, so that the base material 11 is hardly scratched. The material which comprises the transmissive member 23 will not be specifically limited if it is a material which permeate | transmits the energy ray E, For example, it comprises with quartz glass. The inner periphery and the outer periphery of the transmission member 23 are not limited to a circular shape. Further, the transmission member 23 is preferably cylindrical in order to make the clearance CL between the inner periphery of the transmission member 23 and the outer periphery of the substrate 11 constant.

The tape member 24 has a uniform and uniform width, and is wound around the outer periphery of the transmission member 23 in a spiral shape so that the pitch increases toward the base end side (upper side in FIG. 2). Here, a region of the transmissive member 23 where the tape member 24 is not wound corresponds to the transmissive portion 21, and the energy rays E transmitted through the transmissive portion 21 are irradiated to the lubricating layer on the base material 11, The low lubrication part 13 is formed above. Therefore, the tape member 24 is wound around the outer periphery of the transmission member 23 so that the low lubrication portion 13 has a desired shape. Thus, since the tape member 24 is wound around the outer periphery of the transmission member 23, the energy ray E is irradiated from the outside of the masking member 20, so that the shape of the transmission portion 21 corresponds to the shape of the transmission portion 21. The low-lubrication part 13 is formed, and the guide wire 10 having the lubrication part 12 and the low-lubrication part 13 on the surface shown in FIG. 1 can be manufactured.

When the clearance CL between the inner periphery of the transmission member 23 and the outer periphery of the base material 11 shown in FIG. 3 becomes narrow, the base material 11 easily interferes with the transmission member 23. For this reason, it is preferable that clearance CL is 0.3 mm or more.

In addition, when the clearance CL increases, even if the tape member 24 is wound around the outer periphery of the transmission member 23 so that the low lubrication portion 13 has a desired shape, the transmission portion 21 is configured even if the transmission portion 21 is configured. Since the distance until E reaches the surface of the base material 11 is increased, the energy beam E having a shape slightly different from the shape of the transmission part 21 is irradiated on the base material 11, and the low lubrication part 13 is desired. It will deviate from the shape. For this reason, the clearance CL is preferably 5 mm or less.

The irradiation means 30 is provided outside the masking member 20 and irradiates the energy beam E toward the base material 11. For example, as shown in FIG. 2, two irradiation means 30 are provided with the masking member 20 interposed therebetween, but the present invention is not limited to this.

The adjusting means 40 adjusts the energy rays E irradiated by the irradiation means 30 so as to be parallel. The adjustment unit 40 is provided between the masking member 20 and the irradiation unit 30. The adjusting means 40 is, for example, a condenser lens, a Fresnel lens, or a Selfoc (registered trademark) lens. As described above, by arranging the adjusting unit 40 between the masking member 20 and the irradiation unit 30, the energy rays E irradiated by the irradiation unit 30 become parallel, and the parallel energy rays E are covered by the masking member 20. The substrate 11 is irradiated. Therefore, even when the clearance CL between the inner periphery of the transmissive member 23 and the outer periphery of the base material 11 is large, the surface of the base material 11 is irradiated with an energy beam E corresponding to the shape of the transmissive portion 21 to obtain a desired low The lubrication part 13 can be formed.

The cooling unit 50 cools the base material 11 irradiated with the energy beam E by the irradiation unit 30. The cooling means 50 air-cools the base material 11 by supplying air to the gap between the inner periphery of the transmission member 23 and the outer periphery of the base material 11. The cooling means 50 is not particularly limited as long as it can cool the substrate 11.

<Manufacturing method>
Next, a method for manufacturing the guide wire 10 according to the present embodiment will be described.

FIG. 4 is a flowchart showing a method for manufacturing the guide wire 10 according to the present embodiment.

First, a lubricating layer is formed on the surface of the long base 11 (forming process). At this time, a lubricating layer can be formed on all or part of the surface of the substrate 11. As described above, the lubricating layer is coated on the substrate 11 by a conventionally known technique such as dip coating, spray coating, or surface graft polymerization.

Next, the base material 11 having the lubricating layer formed on the surface in the forming step is covered with a masking member 20 provided with a transmitting portion 21 through which the energy rays E pass and a non-transmitting portion 22 through which the energy rays E do not pass (masking step). ). At this time, the masking member 20 may be moved with respect to the base material 11, or the base material 11 may be moved with respect to the masking member 20.

Next, the energy beam E is irradiated from the outside of the masking member 20 toward the base material 11 covered with the masking member 20 (irradiation process). The energy rays E irradiated in the irradiation process are adjusted so as to be parallel by the adjusting means 40, pass through the transmission part 21 of the masking member 20, and are formed on the base material 11 having the lubricating layer formed on the surface in the forming process. Irradiated. As a result, the low lubrication part 13 is formed on the base material 11 corresponding to the shape of the transmission part 21, and the guide wire 10 shown in FIG. 1 is manufactured. In the present embodiment, as described above, since the tape member 24 is spirally wound so that the pitch increases toward the proximal end side, the guide wire 10 shown in FIG. 1 is manufactured. Accordingly, by appropriately changing the winding method of the tape member 24 or changing the width of the tape member 24 as appropriate, the guide wire 10 whose surface lubricity is appropriately controlled can be provided.

In addition, while the energy beam E is irradiated in the irradiation step, the base material 11 is cooled by the cooling means 50 as necessary. Specifically, it is preferable that the cooling unit 50 cools the base material 11 by supplying air to the gap between the inner periphery of the transmission member 23 and the outer periphery of the base material 11.

Through the above steps, the guide wire 10 according to the present embodiment is manufactured. In addition, the structure in which the elongate base material 11 is conveyed by roll to roll may be sufficient. At this time, after performing each process mentioned above, after carrying out the predetermined distance by roll to roll, by performing each process mentioned above again, the guide wire 10 can be manufactured continuously, and mass production is carried out. It is suitable for.

As described above, the method of manufacturing the guide wire 10 according to the present embodiment is a method of manufacturing the guide wire 10 by irradiating the long base 11 with the energy beam E. The manufacturing method of the guide wire 10 includes a forming step of forming a lubricating layer on the surface of the base material 11, and the transmitting portion 21 through which the energy rays E pass and the energy rays E through the base material 11 on which the lubricating layers are formed. A masking step of covering with the masking member 20 provided with the non-transmissive portion 22 and an irradiation step of irradiating the energy beam E from the outside of the masking member 20 toward the base material 11 covered with the masking member 20. Further, the energy rays E transmitted through the transmission part 21 of the masking member 20 are irradiated to the lubricating layer formed on the surface of the substrate 11, and the lubricity of the region irradiated with the energy rays E is lowered. According to this manufacturing method, energy transmitted through the transmissive portion 21 can be obtained simply by irradiating the energy beam E toward the base material 11 covered with the masking member 20 having the transmissive portion 21 and having a lubricating layer formed on the surface. Lubricity in the region irradiated with the line E can be reduced. At this time, the lubricity of the surface of the guide wire 10 can be controlled by appropriately changing the shape of the transmission part 21. Therefore, the guide wire 10 whose surface lubricity is controlled can be manufactured easily and quickly according to the intended use.

In the masking step, the base material 11 is covered with a hollow cylindrical masking member 20. That is, the entire periphery of the base material 11 is covered with the masking member 20 in the base material 11 arranged in the internal space of the masking member 20. Therefore, the lubricity of the whole outer periphery of the surface of the base material 11 can be controlled only by irradiating the energy beam E once from the outside in the circumferential direction toward the base material 11 covered with the masking member 20.

Further, the transmission part 21 is provided in a spiral shape, and the energy beam E is irradiated spirally toward the base material 11 in the irradiation process. The configuration of the transmission part 21 is realized by winding a string-like tape member 24 that does not transmit the energy beam E around the outer periphery of the transmission member 23 that can transmit the energy beam E in a spiral shape. Therefore, the masking member 20 can be configured with a simple configuration.

Further, the energy beam E is adjusted by the adjusting means 40 so that the energy beam E irradiated in the irradiation process becomes parallel. For this reason, even if the clearance CL between the inner periphery of the transmissive member 23 and the outer periphery of the base material 11 is large, the surface of the base material 11 is irradiated with an energy beam E corresponding to the shape of the transmissive portion 21 to obtain a desired value. The low lubrication part 13 can be formed.

Further, if necessary, the substrate 11 to which the energy beam E is irradiated in the irradiation process is cooled by the cooling means 50. For this reason, the temperature rise of the base material 11 by irradiation with the energy beam E can be suppressed, and even a base material with low heat resistance can be easily processed.

In addition, as described above, the guide wire 10 manufacturing apparatus 1 according to the present embodiment manufactures the guide wire 10 by irradiating the long base material 11 having the lubricating layer formed on the surface with the energy beam E. The manufacturing apparatus 1 to The manufacturing apparatus 1 is disposed so as to cover the base material 11, and includes a masking member 20 provided with a transmission part 21 through which energy rays E pass and a non-transmission part 22 through which energy rays E do not pass, and outside the masking member 20. And an irradiation means 30 that irradiates the energy beam E toward the base material 11. Further, the energy rays E transmitted through the transmission part 21 of the masking member 20 are irradiated to the lubricating layer formed on the surface of the substrate 11, and the lubricity of the region irradiated with the energy rays E is lowered. According to this manufacturing apparatus 1, it is transmitted through the transmission part 21 only by irradiating the energy beam E toward the base material 11 covered with the masking member 20 having the transmission part 21 and having a lubricating layer formed on the surface. Lubricity in the region irradiated with the energy beam E can be reduced. At this time, the lubricity of the surface of the guide wire 10 can be controlled by appropriately changing the shape of the transmission part 21. Therefore, the guide wire 10 whose surface lubricity is controlled can be manufactured easily and quickly according to the intended use.

Further, it further has an adjustment means 40 for adjusting the energy rays E irradiated by the irradiation means 30 to be parallel. For this reason, even if the clearance CL between the inner periphery of the transmissive member 23 and the outer periphery of the base material 11 is large, the surface of the base material 11 is irradiated with an energy beam E corresponding to the shape of the transmissive portion 21 to obtain a desired value. The low lubrication part 13 can be formed.

Moreover, it further has a cooling means 50 for cooling the substrate 11 irradiated with the energy rays E by the irradiation means 30. For this reason, it is possible to cool the guide wire 10 that has been irradiated with the energy beam E and has reached a high temperature, and the safety of the work is improved.

Second Embodiment
<Manufacturing equipment>
Next, the manufacturing apparatus 2 of the guide wire 10 based on 2nd Embodiment of this invention is demonstrated. Description of parts common to the first embodiment will be omitted, and only features unique to the second embodiment will be described. The manufacturing apparatus 2 according to the second embodiment differs from the manufacturing apparatus 1 according to the first embodiment in the structure of the masking member 120.

FIG. 5 is a view showing the manufacturing apparatus 2 according to the second embodiment. As illustrated in FIG. 5, the manufacturing apparatus 2 according to the second embodiment includes a masking member 120, an irradiation unit 30, an adjustment unit 40, and a cooling unit 50. In addition, since the irradiation means 30, the adjustment means 40, and the cooling means 50 are the structures similar to the manufacturing apparatus 1 which concerns on 1st Embodiment, description is abbreviate | omitted.

The masking member 120 is disposed so as to cover the long base material 11 having a lubricating layer formed on the surface, and is provided with a transmission part through which the energy beam E is transmitted and a non-transmission part through which the energy beam E is not transmitted.

The masking member 120 is configured by uniformly arranging the tape member 124 on the outer periphery of the transmission member 23 that can transmit the energy beam E. Since the structure of the transmissive member 23 is the same as that of the transmissive member 23 according to the first embodiment, the description thereof is omitted.

The tape member 124 is uniformly arranged on the outer periphery of the transmission member 23. The tape member 124 is set so that the transmittance of the energy rays E continuously decreases from the base end side (upper side in FIG. 5) to the front end side (lower side in FIG. 5). Such a tape member 124 can be produced, for example, by printing ink having a low energy ray E permeability with gradation on a tape member having a high energy ray permeability. According to such a configuration, the proportion of the transmissive portion increases on the proximal end side, and the proportion of the non-transmissive portion increases on the distal end side. Since the masking member 120 has such a configuration, by irradiating the energy rays E from the outside of the masking member 120, many energy rays E are irradiated on the base material 11 toward the base end side, and as the base end side is reached. A guide wire 10 with reduced lubricity is manufactured.

Note that the masking member 120 is not limited to the one in which the tape member 124 is disposed on the transmission member 23. For example, the masking member 120 may be a transmissive member formed using a material in which a transmissive member is formed by applying a paint having low energy ray E permeability or a material in which a member having low energy ray permeability is mixed.

<Manufacturing method>
Next, a method for manufacturing the guide wire 10 according to the present embodiment will be described. Since the method for manufacturing the guide wire 10 according to the present embodiment differs from the method for manufacturing the guide wire 10 according to the first embodiment in the behavior of the energy beam E in the irradiation process, the irradiation process will be described here.

The energy rays E irradiated in the irradiation process and adjusted to be parallel by the adjusting means 40 are transmitted through the transmission part of the masking member 120 and irradiated to the base material 11 having a lubricating layer formed on the surface in the forming process. Is done. At this time, the tape member 124 formed on the surface of the masking member 120 has a large proportion of the transmissive portion on the proximal end side and a large proportion of the non-transmissive portion on the distal end side. E is irradiated onto the substrate 11. Therefore, the guide wire 10 whose lubricity decreases from the distal end side to the proximal end side is manufactured.

As described above, in the second embodiment, the masking member 120 of the manufacturing apparatus 2 uses the tape member 124 that is set so that the transmittance of the energy rays E continuously decreases from the proximal end side to the distal end side. Composed by placing on top. According to this configuration, the step of winding the tape member in a spiral shape is not necessary, and the masking member 120 can be easily prepared.

<Third Embodiment>
<Manufacturing equipment>
Next, the manufacturing apparatus 3 of the guide wire 10 based on 3rd Embodiment of this invention is demonstrated. Description of parts common to the first embodiment will be omitted, and only the features unique to the third embodiment will be described. The manufacturing apparatus 3 according to the third embodiment is different in the structure of the masking member 220 from the manufacturing apparatus 1 according to the first embodiment.

FIG. 6 is a view showing the manufacturing apparatus 3 according to the third embodiment. As illustrated in FIG. 6, the manufacturing apparatus 3 according to the third embodiment includes a masking member 220, an irradiation unit 30, an adjustment unit 40, and a cooling unit 50. In addition, since the irradiation means 30, the adjustment means 40, and the cooling means 50 are the structures similar to the manufacturing apparatus 1 which concerns on 1st Embodiment, description is abbreviate | omitted.

The masking member 220 is disposed so as to cover the elongated base material 11 having a lubricating layer formed on the surface thereof, and is provided with a transmission part 221 through which energy rays E pass and a non-transmission part 222 through which energy rays E do not pass. .

The masking member 220 is made of a resin or metal that does not transmit the energy beam E, and is formed in a cylindrical shape having an opening 223 that is provided in a spiral shape and has an opening area that increases toward the base end side (upper side in FIG. 6). . Note that the masking member 220 is preferably made of metal from the viewpoint of strength. The opening 223 corresponds to the transmission part 221, and the portion of the masking member 220 excluding the opening 223 corresponds to the non-transmission part 222. Since the masking member 220 has such a configuration, the low lubrication part 13 is formed on the base material 11 corresponding to the shape of the transmission part 221 by irradiating the energy rays E from the outside of the masking member 220. A guide wire 10 shown in FIG. 1 is manufactured.

The energy rays E irradiated in the irradiation process and adjusted so as to be parallel by the adjusting means 40 are transmitted through the transmission part 221 of the masking member 220 and are applied to the base material 11 on which the lubricating layer is formed on the surface in the forming process. Irradiated. At this time, since the masking member 220 has an opening 223 that is provided in a spiral shape and has an opening area that increases toward the base end side, the energy beam E is applied to many regions toward the base end side. Therefore, as shown in FIG. 1, the guide wire 10 whose lubricity decreases from the distal end side to the proximal end side is manufactured.

As described above, in the third embodiment, the masking member 220 of the manufacturing apparatus 3 has the opening 223 that is provided in a spiral shape and has an opening area that increases toward the base end side. According to this configuration, the step of disposing the tape member on the outer periphery of the transmission member 23 becomes unnecessary, and the masking member 220 can be easily prepared.

<Fourth embodiment>
<Manufacturing equipment>
Next, the manufacturing apparatus 4 of the guide wire 10 based on 4th Embodiment of this invention is demonstrated. Description of parts common to the first embodiment will be omitted, and only features that are unique to the fourth embodiment will be described.

FIG. 7 is a view showing the manufacturing apparatus 4 according to the fourth embodiment. As shown in FIG. 7, the manufacturing apparatus 4 according to the fourth embodiment includes a masking member 320, an irradiation unit 30, an adjustment unit 40, a cooling unit 50, and a motor 360. In addition, since the irradiation means 30, the adjustment means 40, and the cooling means 50 are the structures similar to the manufacturing apparatus 1 which concerns on 1st Embodiment, description is abbreviate | omitted. The motor 360 is fixed by a base portion (not shown).

The masking member 320 is disposed so as to cover the long base material 11 having a lubricating layer formed on the surface thereof, and is provided with a transmission part 321 through which energy rays E pass and a non-transmission part 322 through which energy rays E do not pass. .

The masking member 320 is made of a resin or metal that does not transmit the energy ray E, and has a cylindrical shape having a rectangular through hole 323. The through hole 323 corresponds to the transmission part 321, and the portion of the masking member 320 excluding the through hole 323 corresponds to the non-transmission part 322.

The motor 360 is connected to the base material 11 and is controlled by a control unit (not shown), so that the base material 11 can be moved in the extending direction or rotated around an axis in the extending direction. The control unit is configured mainly with, for example, a CPU and a memory. The motor 360 may be connected to the masking member 320 and may move the masking member 320 in the extending direction or rotate around the axis in the extending direction.

<Manufacturing method>
Next, a method for manufacturing the guide wire 10 according to the present embodiment will be described. Since the manufacturing method of the guide wire 10 according to the present embodiment differs from the manufacturing method of the guide wire 10 according to the first embodiment in the steps after the irradiation step, the steps after the irradiation step will be described here. .

The energy rays E irradiated in the irradiation step and adjusted to be parallel by the adjusting means 40 are transmitted through the transmission part 321 of the masking member 320, and the rectangular energy rays E have a lubricating layer on the surface in the forming step. The formed substrate 11 is irradiated. During this step, the control unit controls the motor 360 to move and rotate the base material 11 while irradiating the base material 11 with the energy beam E. At this time, the control unit controls the motor 360 so that the energy beam E irradiates many regions toward the base end side of the base material 11. As a result, the guide wire 10 whose lubricity decreases from the distal end side to the proximal end side is manufactured.

As described above, according to the fourth embodiment, the control unit controls the motor 360 so that the rectangular energy beam E transmitted through the rectangular through-hole 323 is irradiated to a large number of regions toward the base end side. Control. For this reason, by appropriately controlling the motor 360 by the control unit, it is possible to irradiate the energy beam E to an arbitrary region regardless of the shape of the masking member, and to easily control the lubricity of the surface of the guide wire 10. Become.

Hereinafter, modifications of the above-described embodiment will be exemplified.

<Modification 1>
In the first to fourth embodiments described above, the masking

members

20, 120, 220, and 320 have a hollow cylindrical shape. However, the masking member is not particularly limited as long as it has a transmission part through which the energy beam E passes and a non-transmission part through which the energy beam E does not pass. For example, the masking member has a plate shape and partially covers the masking member. It may be.

<Modification 2>
FIG. 8 is a diagram illustrating a state in which the masking member 420 according to the modification example 2 covers the base material 11. In the first embodiment described above, the masking member 20 is configured such that the string-like tape member 24 that does not transmit the energy beam E is spirally wound around the outer periphery of the transmission member 23 that can transmit the energy beam E. . However, as shown in FIG. 8, the masking member 420 has a plurality of string-like tape members 424 that do not transmit the energy beam E wound in a striped manner on the outer periphery of the transmission member 23 that can transmit the energy beam E. It may be configured.

<Modification 3>
FIG. 9 is a diagram illustrating a state in which the masking member 520 according to the modification example 3 covers the base material 11.
In 1st Embodiment mentioned above, the masking member 20 covered the outer periphery of the base material 11 arrange | positioned in the perpendicular direction. However, as shown in FIG. 9, the masking member 520 may cover the outer periphery of the base material 11 placed on the placement unit 570 in the horizontal direction. In FIG. 9, a tape member wound around the outer periphery of the masking member 520 is omitted for easy understanding. In the third modification, a groove 521 that passes when the guide wire 10 is accommodated in the masking member 520 is provided in the upper portion of the masking member 520 along the extending direction (see FIG. 9A). Further, after the guide wire 10 is accommodated in the masking member 520, the groove 521 is covered with a lid member 580 (see FIG. 9B).

<Modification 4>
In the first embodiment described above, the adjusting means 40 adjusts the energy rays E to be parallel. However, the adjustment means is not limited to this, and the adjustment means may adjust so as to focus the energy beam E.

<Modification 5>
The manufacturing apparatus and manufacturing method according to the first to fourth embodiments and the first to fourth modification examples described above are applied to the guide wire 10. However, it can also be applied to catheters.

<Example>
Hereinafter, the effect of the present invention will be described using examples and comparative examples. However, the technical scope of the present invention is not limited only to the following examples.

<Example 1>
For a 0.7 mm diameter catheter (outer layer material: polyester elastomer), a block copolymer (DMAA: GMA) having N, N-dimethylacrylamide (DMAA) as a hydrophilic domain and glycidyl methacrylate (GMA) as a reactive domain. A DMF solution in which a molar ratio) = 40: 1) was dissolved at a ratio of 4 wt% was dip-coated and reacted in an oven at 130 ° C. for 3 hours to form a surface lubricating layer on the catheter base layer surface.

A quartz glass tube with an inner diameter of 1.2 mm (masking), in which a tape-like tape member having a width of 0.5 mm from the front end is spirally wound at intervals of 0.1 mm, and the tape member is attached to the rear end side while gradually increasing the spiral interval. The catheter was inserted into the member. The interval between the tape members on the rear end side was 2.5 mm. Thereafter, as shown in FIG. 2, the irradiation means and the adjustment means are arranged, and the entire surface of the catheter is irradiated with ultraviolet rays (wavelength 365 nm, 250 mW / cm 2) for 30 seconds through a masking member wound with a tape member. In the surface lubricating layer formed on the surface of the material, ultraviolet rays were irradiated in a spiral shape. After the ultraviolet irradiation, the catheter was taken out from the masking member.

As a result of the above operation, lubricated portions with high lubricity and low-lubricated portions with low lubricity are alternately arranged on the surface with respect to the extending direction. A low catheter was obtained.

The surface lubricity of the obtained catheter C was evaluated with a friction measuring machine (Tribomaster TL201Ts, manufactured by Trinity Lab) 70 shown in FIG. The obtained catheter C was fixed in a container 71 filled with water, and the container 71 was fixed to the moving table 72 of the friction measuring device 70. A cylindrical rubber terminal (φ10 mm) 73 was brought into contact with the catheter C, and a load was applied to the terminal by a weight 74 of 200 g. The moving table 72 was moved horizontally from the distal end side to the proximal end side at a speed of 5 mm / sec, and the sliding resistance value was measured.

FIG. 11 is a graph showing the results of measuring the sliding measurement values. As shown in FIG. 11, the obtained catheter C had a smaller sliding resistance value toward the distal end side (about 4 gf), and a larger sliding resistance value toward the proximal end side (about 68 gf). In addition, the change in lubricity with respect to the extending direction is smooth, and the apparent lubricity of the entire device is precisely controlled by alternately arranging areas with high and low lubricity in the surface lubrication layer. It was shown that it can be done.

<Example 2>
Block copolymer (DMAA: GMA (molar ratio)) having N, N-dimethylacrylamide (DMAA) as a hydrophilic domain and glycidyl methacrylate (GMA) as a reactive domain against a metal coil guide wire having a diameter of 0.35 mm = 12: 1) was dissolved in a DMF solution at a rate of 8 wt% and reacted in an oven at 120 ° C. for 7 hours to form a surface lubricating layer on the surface of the guide wire base material layer.

Thereafter, a string-like tape member having a width of 0.5 mm was spirally wound at an interval of 0.5 mm with respect to a region 10 cm from the front end side, and the tape member was attached to the entire region after 10 cm from the most advanced side. A guide wire was inserted into a quartz glass tube (masking member) having an inner diameter of 1.2 mm. After that, ultraviolet rays (wavelength 365 nm, 250 mW / cm 2) are irradiated for 30 seconds to the entire surface of the guide wire through the masking member to which the tape member is attached in the same manner as in Example 1, so that only the region of the guide wire at the tip of 10 cm is irradiated with ultraviolet rays. Irradiated spirally. After the ultraviolet irradiation, the guide wire was taken out from the masking member.

By the above operation, a guide wire was obtained in which lubricated portions with high lubricity and low-lubricated portions with low lubricity were alternately arranged in the extending direction only in the surface lubrication layer region of the guide wire tip 10 cm.

The operability of the obtained guide wire was evaluated by the following method. FIG. 12 is a diagram showing how the guide wire 10 is inserted into the meandering blood vessel model M. FIG. The guide wire 10 is inserted into a meandering blood vessel model (inner diameter 2 mm silicone tube) M as shown in FIG. 12, and the insertion resistance when the tip of the guide wire 10 reaches the position P indicated by a circle is sensory evaluated. did. Thereafter, the distal end of the guide wire 10 was placed in alignment with the position P of the circle, and the extent to which the distal end position of the guide wire 10 was retracted when the hand was released was measured (guide wire 10 bent along the model). Is trying to return to a straight state, resulting in a force to retract the tip). Evaluation was carried out using the guide wire produced in Example 2, Comparative Example 1 in which no ultraviolet ray was irradiated after forming the surface lubricating layer, and Comparative Example 2 in which the surface lubricating layer was not formed. The results are shown in Table 1 below.

Comparative Example 2 had poor lubricity because no surface lubrication layer was formed, and was poor in insertability due to large resistance when a guide wire was inserted. In Comparative Example 1, a surface lubricating layer that expresses good lubricity was formed, so it could be easily inserted into the blood vessel model, but the device could move unintentionally after the guidewire was placed Sex was a concern. On the other hand, in Example 2 in which the lubricity was partially reduced, the guide wire was difficult to move even after the guide wire was placed while ensuring the same level of insertability as in Comparative Example 1. From the above results, it can be said that Example 2 is a guide wire that is easier to realize the operation intended by the operator than Comparative Example 1 and Comparative Example 2.

Furthermore, this application is based on Japanese Patent Application No. 2014-055460 filed on March 18, 2014, the disclosures of which are referenced and incorporated as a whole.

1,2,3,4 production equipment,
10 Guidewire (medical long body),
11 substrate,
12 Lubrication part,
13 Low lubrication part,
20, 120, 220, 320, 420, 520 masking member,
21, 221, 321 transmission part,
22, 222, 322 non-transparent part,
30 Irradiation means,
40 adjustment means,
50 cooling means,
C catheter (medical long body),
E Energy rays.

Claims

It is a production method for producing a medical long body by irradiating an elongated substrate with energy rays,
Forming a lubricating layer on at least part of the surface of the substrate;
A masking step of covering the base material on which the lubricating layer is formed with a masking member provided with a transmission part through which the energy rays pass and a non-transmission part through which the energy rays do not pass;
Irradiating the energy beam from the outside of the masking member toward the base material covered by the masking member, and
The energy beam transmitted through the transmission part of the masking member is irradiated to the lubricating layer formed on the surface of the base material, and the medical long body reduces the lubricity of the region irradiated with the energy beam. Manufacturing method.
The method for producing a medical elongated body according to claim 1, wherein, in the masking step, the base material is covered with a hollow cylindrical masking member.
The transmission part is provided in a spiral shape,
The manufacturing method of the medical elongate body of Claim 2 with which the said energy beam is irradiated helically toward the said base material in the said irradiation process.
The medical elongated body according to any one of claims 1 to 3, wherein the energy beam is adjusted by an adjusting unit so that the energy beam irradiated in the irradiation step is parallel or focused. Production method.
The method for producing a medical elongated body according to any one of claims 1 to 4, wherein the base material irradiated with the energy beam in the irradiation step is cooled by a cooling means.
A manufacturing apparatus for manufacturing a medical long body by irradiating an energy beam on a long base material having a lubricating layer formed on at least a part of a surface,
A masking member that is disposed so as to cover at least a part of the base material, and is provided with a transmission part through which the energy rays pass and a non-transmission part through which the energy rays do not pass;
An irradiation means that is provided outside the masking member and irradiates the energy beam toward the substrate;
The energy beam transmitted through the transmission part of the masking member is irradiated to the lubricating layer formed on the surface of the base material, and the medical long body reduces the lubricity of the region irradiated with the energy beam. Manufacturing equipment.
The medical long body manufacturing apparatus according to claim 6, further comprising adjusting means for adjusting the energy rays so as to be parallel or focused.
The apparatus for producing a medical elongated body according to claim 6 or 7, further comprising a cooling means for cooling the base material irradiated with the energy beam.