JP6940053B2 - Medical needle - Google Patents

Description

The present invention relates to a needle.

Generally, the injection needle used for subcutaneous injection is made of a metal such as stainless steel. It is not easy for this injection needle to sufficiently smooth the outer peripheral surface. Therefore, when the injection needle is punctured into the human body, the surface friction becomes large, which tends to cause pain and discomfort to the patient.

Therefore, today, an injection needle that reduces the risk of causing pain or discomfort to the patient when puncturing the human body has been proposed. As such an injection needle, Japanese Patent Application Laid-Open No. 2008-200258 proposes to reduce the outer diameter of the tip portion punctured by the human body. Further, Japanese Patent Application Laid-Open No. 7-178159 proposes laminating a silicone film on the outer periphery of a metal main body.

Japanese Unexamined Patent Publication No. 2008-200258 Japanese Unexamined Patent Publication No. 7-178159

However, according to the configuration described in Patent Document 1, since the inner diameter is reduced in accordance with the outer diameter of the needle, the flow path resistance when injecting the drug solution into the human body is increased. Therefore, it is difficult for the injection needle described in Patent Document 1 to inject a highly viscous chemical solution into the human body.

Further, according to the configuration described in Patent Document 2, there is a concern in terms of safety, such as the silicone contained in the coating film may be eluted into the body fluid and adversely affect the human body and the drug.

The present invention has been made based on such circumstances, and an object of the present invention is to provide a needle having excellent slidability and high safety.

The needle according to one aspect of the present invention, which has been made to solve the above problems, has a main body containing a metal as a main component and a crosslinked fluororesin as a main component, and is laminated at least on the outer surface side of the tip portion of the main body. The fluororesin is a polytetrafluoroethylene, tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer or tetrafluoroethylene-hexafluoropropylene copolymer, and the friction coefficient of the surface of the coating layer is high. It is 0.5 or less.

The needle according to the present invention has excellent slidability and high safety.

It is a schematic cross-sectional view which shows the needle which concerns on one Embodiment of this invention. FIG. 5 is a schematic side view showing a syringe provided with the needle of FIG. It is a schematic side view which shows the needle which concerns on embodiment different from the needle of FIG. FIG. 3 is an enlarged cross-sectional view taken along the line AA of the needle of FIG. It is a schematic cross-sectional view which shows the needle which concerns on embodiment different from the needle of FIG. 1 and FIG.

[Explanation of Embodiments of the Present Invention]
First, embodiments of the present invention will be listed and described.

The needle according to one aspect of the present invention includes a main body containing a metal as a main component and a coating layer containing a crosslinked fluororesin as a main component and laminated at least on the outer surface side of the tip portion of the main body. The resin is polytetrafluoroethylene, tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer or tetrafluoroethylene-hexafluoropropylene copolymer, and the friction coefficient of the surface of the coating layer is 0.5 or less.

The needle has a coating layer mainly composed of a crosslinked fluororesin laminated on the outer surface side of the tip of the main body, and the fluororesin is a polytetrafluoroethylene or tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer. Alternatively, since it is a tetrafluoroethylene-hexafluoropropylene copolymer, the outer surface of the coating layer can be smoothed, and the friction coefficient of the outer surface of the coating layer can be set to the upper limit or less. Therefore, the needle is excellent in slidability. Further, in the needle, since the coating layer is mainly composed of the crosslinked fluororesin, the adhesion between the main body and the coating layers can be enhanced, and the abrasion resistance of the coating layer is excellent. Therefore, the needle is highly safe because it can suppress the dissociation of the coating layer from the main body.

The peel strength between the main body and the coating layer is preferably 5 N / cm or more. As described above, when the peel strength between the main body and the coating layers is equal to or higher than the above lower limit, the adhesion between the main body and the coating layers can be sufficiently increased.

It is preferable that the main body and the coating layer are directly laminated. By directly laminating the main body and the coating layer in this way, it is possible to prevent other layers from interposing between the main body and the coating layers, and to easily and surely enhance the adhesion between the main body and the coating layers. be able to. Further, according to this configuration, it is possible to prevent deterioration of quality, safety, etc. due to leakage of the components contained in the other layers.

The maximum height Rz of the surface laminated with the coating layer of the main body is preferably 20 μm or less. As described above, even when the maximum height Rz of the surface laminated with the coating layer of the main body is set to be equal to or less than the upper limit, the adhesion between the main body and the coating layers can be sufficiently enhanced.

The needle may be a medical needle. Since the needle is a medical needle, it is possible to suppress causing pain and discomfort to the patient.

In the present invention, the "main component" means a component having the highest content ratio in terms of mass, for example, a component having a content of 50% by mass or more. "Outer surface" refers to the outer surface in the radial direction. The "coefficient of friction" refers to the coefficient of dynamic friction measured by a thrust wear test (ring-on-disk type wear evaluation) in accordance with the "plastic slip wear test method" of JIS-K7218 (1986). "Peeling strength" refers to the peeling strength obtained by a test method based on "Adhesive-Peeling Adhesive Strength Test Method-Part 2: 180 Degree Peeling" of JIS-K6854-2 (1999). The "maximum height Rz" means a value measured with a cutoff value (λc) of 0.25 mm and an evaluation length (l) of 10 mm according to JIS-B0601 (2001).

[Details of Embodiments of the present invention]
A preferred embodiment of the present invention will be described below with reference to the drawings.

[First Embodiment]
<Needle>
The needle 1 in FIG. 1 is a medical needle, and more specifically, an injection needle used for subcutaneous injection. The needle 1 includes a main body 2 containing a metal as a main component and a coating layer 3 containing a crosslinked fluororesin as a main component and laminated at least on the outer surface side of the tip end portion X1 of the main body 2. The fluororesin is polytetrafluoroethylene (PTFE), tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer (PFA) or tetrafluoroethylene-hexafluoropropylene copolymer (FEP). Further, the friction coefficient of the outer surface of the coating layer 3 is 0.5 or less.

The needle 1 has a coating layer 3 containing a crosslinked fluororesin as a main component laminated on the outer surface side of the tip portion X1 of the main body 2, and the fluororesin is PTFE, PFA or FEP. The outer surface can be smoothed. Further, since the fluororesin is excellent in slipperiness, the needle 1 can make the friction coefficient of the outer surface of the coating layer 3 equal to or less than the upper limit by smoothing the outer surface of the coating layer 3. Therefore, the needle 1 is excellent in slidability. Further, in the needle 1, since the coating layer 3 contains the crosslinked fluororesin as a main component, the adhesion between the main body 2 and the coating layer 3 can be enhanced, and the abrasion resistance of the coating layer 3 is excellent. .. Therefore, the needle 1 can suppress the dissociation of the coating layer 3 from the main body 2, and is highly safe for the human body.

Since the needle 1 is a medical needle, it is unlikely to cause pain or discomfort to the patient.

(Main body)
The main body 2 is a hollow needle whose main component is metal. The metal is not particularly limited, and examples thereof include stainless steel and nickel-chromium steel. The main body 2 has a tip portion X1 in which a blade surface inclined in the radial direction (direction perpendicular to the axial direction) is formed on the edge on the tip side, and the tip portion X1 is continuous from the proximal end edge to the proximal end side. It has a base end portion Y1 and the like. It is preferable that the tip portion X1 has a uniform outer diameter from the tip edge to the base end edge. By having a uniform outer diameter from the tip edge to the proximal edge of the tip X1, when the needle 1 is punctured into the human body, the patient's pain and discomfort due to the undulations of the outer diameter of the tip X1 are prevented. can do. Further, it is preferable that the inner diameter of the tip portion X1 from the tip edge to the base end edge is uniform. Since the inner diameter from the tip edge to the proximal edge of the tip X1 is uniform, the flow path resistance when injecting the drug solution into the human body can be suppressed to a low level. The "tip side" means the side to be inserted into the object, and in the present embodiment, the side to be punctured by the human body at the time of injection. Further, the "base end side" means the opposite side of the "tip end side".

As the lower limit of the outer diameter of the tip portion X1, 3.0 mm is preferable, 4.0 mm is more preferable, and 4.5 mm is further preferable. On the other hand, as the upper limit of the outer diameter of the tip portion X1, 7.0 mm is preferable, 6.0 mm is more preferable, and 5.5 mm is further preferable. Since the needle 1 has improved slidability due to the coating layer 3 laminated on the outer surface of the main body 2, it is unlikely to cause pain or discomfort to the patient even if the outer diameter of the tip portion X1 is relatively large. If the outer diameter of the tip portion X1 is smaller than the above lower limit, the inner diameter of the tip portion X1 cannot be sufficiently increased, and the flow path resistance when injecting the drug solution into the human body may increase. On the contrary, when the outer diameter of the tip portion X1 exceeds the above upper limit, the outer diameter of the tip portion X1 becomes unnecessarily large, which may limit the injection site or give the patient a sense of discomfort.

The inner diameter of the tip portion X1 is a value obtained by subtracting the thickness of the main body 2 (more specifically, a value twice the thickness) from the above-mentioned outer diameter. The lower limit of the inner diameter of the tip portion X1 is preferably 2.5 mm, more preferably 3.5 mm, and even more preferably 4.0 mm. On the other hand, the upper limit of the inner diameter of the tip portion X1 is preferably 6.5 mm, more preferably 5.5 mm, and even more preferably 5.0 mm. If the inner diameter of the tip portion X1 is smaller than the above lower limit, the flow path resistance when injecting the chemical solution into the human body may increase. On the contrary, when the inner diameter of the tip portion X1 exceeds the above upper limit, the outer diameter of the tip portion X1 becomes unnecessarily large with the size of the inner diameter, which may limit the injection site or give the patient a sense of discomfort.

As the lower limit of the axial length of the tip portion X1, 5 mm is preferable, and 10 mm is more preferable. It is preferable that the needle 1 is inserted into the human body only in the region where the coating layer 3 is laminated at the time of subcutaneous injection. On the other hand, if the axial length of the tip portion X1 is smaller than the above lower limit, when the needle 1 is punctured into the human body, it may be inserted into the human body to a region where the coating layer 3 is not laminated. The upper limit of the axial length of the tip portion X1 is not particularly limited and may be, for example, 50 mm.

The upper limit of the maximum height Rz of the surface laminated with the coating layer 3 of the main body 2 (that is, the outer surface of the main body 2) is preferably 20 μm, more preferably 10 μm, still more preferably 1 μm. The needle 1 can sufficiently increase the adhesion between the main body 2 and the coating layer 3 even when the maximum height Rz is set to the upper limit or less. On the other hand, when the maximum height Rz exceeds the upper limit, the maximum height Rz of the inner surface of the main body 2 tends to be high, and the slidability when punctured by the human body is poor due to the unevenness on the inner surface side of the main body 2. May be sufficient. The lower limit of the maximum height Rz is not particularly limited and may be 0 μm.

(Coating layer)
As described above, the coating layer 3 is laminated on the outer surface side of at least the tip portion X1 of the main body 2. The coating layer 3 covers the entire surface of the tip portion X1 on the outer surface side. The coating layer 3 may be laminated only on the outer surface side of the tip end portion X1 or may be laminated on the outer surface side of the base end portion Y1. That is, the coating layer 3 may be laminated on the entire surface of the main body 2 on the outer surface side.

The main body 2 and the coating layer 3 are directly laminated. That is, no other layer such as an adhesive layer is interposed between the main body 2 and the coating layer 3. Since the needle 1 does not have another layer interposed between the main body 2 and the coating layer 3, the quality of the needle 1 deteriorates due to leakage of components contained in other layers such as an adhesive layer, and the needle 1 reaches the human body. The effect can be prevented. Further, the needle 1 can easily and surely increase the adhesion between the main body 2 and the coating layer 3 by not interposing another layer between the main body 2 and the coating layer 3.

The coating layer 3 contains a crosslinked fluororesin as a main component. Since the fluororesin is crosslinked in the coating layer 3, the abrasion resistance is enhanced while maintaining the non-adhesiveness of the fluororesin. Examples of the fluororesin include the above-mentioned PTFE, PFA and FEP, and these can be used alone or in combination of two or more.

The fluororesin may contain a polymerization unit derived from another copolymerizable monomer as long as the effect of the present invention is not impaired. For example, PTFE may contain polymerization units such as perfluoro (alkyl vinyl ether), hexafluoropropylene, (perfluoroalkyl) ethylene, and chlorotrifluoroethylene. The upper limit of the content ratio of the polymerization unit derived from the other copolymerizable monomer is, for example, 3 mol% with respect to the total polymerization units constituting the fluororesin.

The lower limit of the content of the fluororesin in the coating layer 3 is preferably 60% by mass, more preferably 85% by mass, and even more preferably 98% by mass. Further, the content is particularly preferably 100% by mass. If the content does not reach the lower limit, the characteristics such as adhesion to the main body 2 and wear resistance may not be sufficiently improved.

The upper limit of the crystal melting point of the crosslinked fluororesin in the coating layer 3 varies depending on the type of the fluororesin. For example, in the case of PTFE, 325 ° C. is preferable, 320 ° C. is more preferable, and 310 ° C. is even more preferable. The crystal melting point decreases with the degree of cross-linking of the cross-linked fluororesin. Therefore, if the melting point of the crystal exceeds the upper limit, the wear resistance may be insufficient due to insufficient degree of cross-linking. The lower limit of the crystal melting point of the crosslinked fluororesin can be, for example, 290 ° C. The "crystal melting point" refers to the melting point peak temperature measured by a differential scanning calorimeter (DSC) in accordance with JIS-K7121: 2012 "Method for measuring transition temperature of plastics".

The coating layer 3 may contain other fluororesins, other optional components, and the like as long as the effects of the present invention are not impaired. Examples of the other fluororesins include polyvinylidene fluoride (PVDF), tetrafluoroethylene-ethylene copolymer (ETFE), polychlorotrifluoroethylene (PCTFE), and chlorotrifluoroethylene-ethylene copolymer (ECTFE). Examples thereof include polyvinyl fluoride (PVF), fluoroolefin-vinyl ether copolymer, vinylidene fluoride-tetrafluoroethylene copolymer, vinylidene fluoride-hexafluoropropylene copolymer and the like.

The coating layer 3 is formed to have a substantially uniform thickness. The lower limit of the average thickness of the coating layer 3 is preferably 10 μm, more preferably 15 μm. On the other hand, the upper limit of the average thickness of the coating layer 3 is preferably 50 μm, more preferably 30 μm. If the average thickness is smaller than the lower limit, the strength of the coating layer 3 may be insufficient, or the outer surface of the needle 1 may not be sufficiently smoothed. On the contrary, when the average thickness exceeds the upper limit, the coating layer 3 becomes unnecessarily thick and the outer diameter of the needle 1 becomes unnecessarily large, which gives the patient a sense of discomfort when the needle 1 is punctured. There is a risk.

As the lower limit of the peel strength between the main body 2 and the coating layer 3, 5 N / cm is preferable, and 10 N / cm is more preferable. If the peel strength does not reach the lower limit, the adhesion between the main body 2 and the coating layer 3 may not be sufficiently increased. On the other hand, the upper limit of the peel strength between the main body 2 and the coating layer 3 is not particularly limited, but can be set to, for example, 50 N / cm from the viewpoint of preventing production from becoming difficult. The peel strength between the main body 2 and the coating layer 3 can be controlled by, for example, adjusting the degree of cross-linking of the fluororesin.

As described above, the upper limit of the friction coefficient of the outer surface of the coating layer 3 is 0.5, preferably 0.2, and more preferably 0.1. If the friction coefficient of the outer surface of the coating layer 3 exceeds the above upper limit, the patient may feel pain or discomfort when the needle 1 is punctured. On the other hand, the lower the friction coefficient of the outer surface of the coating layer 3, the more preferable it is, and the lower limit thereof is not particularly limited, but for example, it can be 0.01 from the viewpoint of preventing production from becoming difficult. Since the needle 1 is mainly composed of a fluororesin in which the coating layer 3 is crosslinked as described above, the friction coefficient of the outer surface of the coating layer 3 can be reduced, and the space between the main body 2 and the coating layer 3 can be reduced. Adhesion is enhanced and there is less risk of fluorine remaining in the patient's body. On the other hand, the coefficient of friction of the outer surface of the needle can be reduced to a certain extent by applying silicone oil to the main body 2 or coating the outer surface of the main body 2 with a non-crosslinked fluororesin. However, according to these configurations, there is a risk of adversely affecting the human body, such as a safety problem of the silicone itself, a reaction between the silicone and a chemical, and peeling of the non-crosslinked fluororesin from the main body 2.

The upper limit of the maximum height Rz of the outer surface of the coating layer 3 is preferably 5 μm, more preferably 1 μm. If the maximum height Rz exceeds the upper limit, the patient may feel pain or discomfort when the needle 1 is punctured. On the other hand, the smaller the maximum height Rz is, the more preferable it is, and the lower limit thereof is not particularly limited, but for example, it can be 0.00001 μm from the viewpoint of preventing production from becoming difficult.

<Manufacturing method>
Next, a method of manufacturing the needle 1 will be described. The method for manufacturing the needle includes a main body preparing step of preparing the main body 2 and a covering layer laminating step of laminating the covering layer 3 on the outer surface side of at least the tip end portion X1 of the main body 2 prepared in the main body preparing step. The method for manufacturing the needle can easily and reliably manufacture the needle 1 shown in FIG.

(Coating layer laminating process)
The coating layer laminating step is a coating step of applying the coating layer forming composition containing the above-mentioned PTFE, PFA and FEP to at least the outer surface side of the tip portion X1 of the main body 2, and a coating step formed by the coating step. It is provided with an irradiation step of irradiating ionizing radiation.

<Applying process>
Examples of the coating method in the coating step include an electrostatic powder coating method in which the fluororesin powder is coated on the outer surface side of the main body 2, and a dispersion liquid in which the fluororesin powder is uniformly dispersed in a dispersant. Examples thereof include a method of applying (dispersion) to the outer surface side of the main body 2 to dry the dispersion medium.

Examples of the dispersion medium of the dispersion include a mixed solution of water and an emulsifier, a mixed solution of water and alcohol, a mixed solution of water and acetone, a mixed solution of water, alcohol and acetone, and the like.

<Irradiation process>
In the irradiation step, the fluororesin coated in the coating step is crosslinked. As a result, the mechanical properties, wear resistance, adhesion to the main body 2 and the like of the obtained coating layer 3 are improved.

In the irradiation step, it is preferable to heat the coating film to a temperature equal to or higher than the crystal melting point of the fluororesin. As the lower limit of the heating temperature, a temperature 5 ° C. higher than the melting point of the crystal is preferable. On the other hand, as the upper limit of the heating temperature, a temperature 50 ° C. higher than the crystal melting point is preferable, and a temperature 20 ° C. higher than the crystal melting point is more preferable. By irradiating ionizing radiation under the above conditions, it is possible to promote cross-linking between molecules while suppressing cleavage of the main chain of the fluororesin.

As the upper limit of the oxygen concentration in the irradiation step, 100 volume ppm is preferable, 10 volume ppm is more preferable, and 5 volume ppm is further preferable. If the oxygen concentration exceeds the upper limit, the fluororesin may be decomposed.

Examples of the ionizing radiation include γ-rays, electron beams, X-rays, neutron rays, high-energy ionizing rays and the like. The lower limit of the irradiation dose of ionizing radiation is preferably 10 kGy, more preferably 70 kGy, and even more preferably 200 kGy. On the other hand, as the upper limit of the irradiation dose, 2000 kGy is preferable, 1200 kGy is more preferable, and 400 kGy is further preferable. If the irradiation dose is smaller than the lower limit, the cross-linking reaction of the fluororesin may not proceed sufficiently. On the contrary, when the irradiation dose exceeds the upper limit, the main chain of the fluororesin may be easily cut.

<Syringe>
Next, an example of the syringe 11 provided with the needle 1 will be described with reference to FIG. The syringe 11 is connected to the needle 1, the needle base 12 that supports the outer surface side of the end end side of the needle base 1, and the needle base 12, and extends to the base end side of the needle base 12. A cylindrical chemical solution container 13 and a gasket (not shown) capable of sealing the internal space of the chemical solution container 13 are provided at the tip thereof, and a plunger 14 slidable in the axial direction of the chemical solution container 13 is provided. The syringe 11 is configured so that the drug solution can be injected into the human body from the tip of the needle 1 by pushing the plunger 14 toward the tip side while the drug solution is contained in the drug solution container 13.

Since the syringe 11 includes the needle 1, the needle 1 has excellent slidability and is highly safe for the human body.

[Second Embodiment]
<Needle>
The needle 21 in FIG. 3 is a sewing machine needle, and more specifically, an industrial sewing machine needle. As shown in FIG. 4, the needle 21 includes a main body 22 containing a metal as a main component and a coating layer 23 containing a crosslinked fluororesin as a main component and laminated at least on the outer surface side of the tip end portion X2 of the main body 2. To be equipped with. The fluororesin is PTFE, PFA or FEP. Further, the friction coefficient of the outer surface of the coating layer 23 is 0.5 or less.

The needle 21 is laminated with a coating layer 23 containing a crosslinked fluororesin as a main component on the outer surface side of the tip portion X2 of the main body 22, and the fluororesin is PTFE, PFA or FEP, so that the coating layer 23 The outer surface can be smoothed. Further, since the fluororesin is excellent in slipperiness, the needle 21 can make the friction coefficient of the outer surface of the coating layer 23 equal to or less than the upper limit by smoothing the outer surface of the coating layer 23. Therefore, the needle 21 is excellent in slidability. Further, since the coating layer 23 is mainly composed of the crosslinked fluororesin, the needle 21 can enhance the adhesion between the main body 22 and the coating layer 23 and is excellent in the abrasion resistance of the coating layer 23. .. Therefore, the needle 21 is highly safe because it can suppress the dissociation of the coating layer 23 from the main body 22.

In general, sewing machine needles, especially industrial sewing machine needles, have a high risk of generating heat during use. In this regard, the needle 21 is laminated with a coating layer 23 containing the above-mentioned fluororesin as a main component, which is crosslinked on the outer surface side of the tip portion X2 of the main body 22, and the above-mentioned fluororesin is PTFE, PFA or FEP. Therefore, heat generation can be suppressed as compared with the conventional needle made of metal. Further, since the coating layer 23 of the needle 21 is mainly composed of the above-mentioned fluororesin in which the coating layer 23 is crosslinked, the needle 21 is excellent in adhesion at a high temperature. Therefore, the needle 21 can suppress damage to the sewing object due to heat generation and peeling of the coating layer 23.

(Main body)
The main body 22 is mainly composed of metal. The metal is not particularly limited, and examples thereof include steel and the like. The tip portion X2 includes a needle tip provided on the edge on the tip side and gradually narrowing toward the tip side. The tip portion X2 is a region to be inserted into the sewing object at the time of sewing, and can be, for example, from the tip of the needle tip to the base end of the needle stem. The maximum height Rz of the surface laminated with the coating layer 23 of the main body 22 can be the same as that of the needle 1 in FIG.

(Coating layer)
As described above, the coating layer 23 is laminated on the outer surface side of at least the tip end portion X2 of the main body 22. The coating layer 23 covers the entire surface of the tip portion X2 on the outer surface side. The coating layer 23 may be laminated only on the outer surface side of the tip portion X2, or may be laminated on the proximal end side of the distal end portion X2 as well as on the proximal end side.

The main body 22 and the coating layer 23 are directly laminated. That is, no other layer such as an adhesive layer is interposed between the main body 22 and the coating layer 23.

The coating layer 23 contains a crosslinked fluororesin as a main component. Since the fluororesin is crosslinked in the coating layer 23, the abrasion resistance is enhanced while maintaining the non-adhesiveness of the fluororesin. Examples of the fluororesin include the above-mentioned PTFE, PFA and FEP, and these can be used alone or in combination of two or more.

As in the case of the coating layer 3 of FIG. 1, the fluororesin may contain a polymerization unit derived from another copolymerizable monomer as long as the effect of the present invention is not impaired. The content of the fluororesin in the coating layer 23 and the crystal melting point of the fluororesin can be the same as those of the needle 1 in FIG. Further, the coating layer 23 may contain other fluororesins, other optional components, and the like as long as the effects of the present invention are not impaired, as in the case of the coating layer 3 of FIG.

The coating layer 23 is formed to have a substantially uniform thickness. The average thickness of the coating layer 23 can be the same as that of the needle 1 in FIG. Further, the peel strength between the main body 22 and the coating layer 23, the friction coefficient of the outer surface of the coating layer 23, the ratio of the friction coefficient of the outer surface of the coating layer 23 to the friction coefficient of the outer surface of the main body 22, the maximum height Rz of the outer surface of the coating layer 23 and the main body 22 The ratio of the maximum height Rz of the outer surface of the covering layer 23 to the maximum height Rz of the outer surface can be the same as that of the needle 1 in FIG.

<Manufacturing method>
Similar to the needle 1 of FIG. 1, the needle 21 is laminated with a coating layer 23 in which the main body 22 is prepared and the coating layer 23 is laminated on the outer surface side of at least the tip portion X2 of the main body 22 prepared in the main body preparing step. It has a process. The method for manufacturing the needle can easily and reliably manufacture the needle 21 of FIG.

[Third Embodiment]
<Needle>
The needle 31 in FIG. 5 is a medical needle, and more specifically, an injection needle used for subcutaneous injection. The needle 31 has a main body 2 containing a metal as a main component, a first coating layer 33 containing a crosslinked fluororesin as a main component and laminated on the outer surface side of at least the tip end portion X1 of the main body 2, and crosslinked fluorine. It contains a resin as a main component, and includes at least a second coating layer 34 laminated on the inner surface side of the tip end portion X1 of the main body 2. The fluororesin is PTFE, PFA or FEP. Further, the friction coefficient of the outer surface of the coating layer 33 is 0.5 or less. The main body 2 of the needle 31 can have the same configuration as the main body 2 of the needle 1 of FIG. 1, and the first coating layer 33 of the needle 31 has the same configuration as the coating layer 3 of FIG. Can be done. Therefore, the description of the main body 2 and the first coating layer 33 of the needle 31 will be omitted.

Since the second coating layer 34 of the needle 31 is mainly composed of the crosslinked fluororesin, the adhesion between the main body 2 and the second coating layer 34 can be enhanced. Further, in the needle 31, since the second coating layer 34 contains the above-mentioned fluororesin as a main component, the second coating layer 34 is excellent in abrasion resistance. Therefore, the needle 31 is highly safe for the human body. Since the needle 31 includes the second coating layer 34, it is excellent in slidability on the inner surface side of the main body 2 in addition to the outer surface side of the main body 2.

(Second coating layer)
As described above, the second coating layer 34 is laminated on the inner surface side of at least the tip end portion X1 of the main body 2. The second coating layer 34 covers the entire surface of the tip portion X1 on the inner surface side. The second coating layer 34 may be laminated only on the inner surface side of the tip end portion X1 or may be laminated on the inner surface side of the base end portion Y1. That is, the second coating layer 34 may be laminated on the entire surface of the main body 2 on the inner surface side.

The main body 2 and the second coating layer 34 are directly laminated. The second coating layer 34 can have the same configuration as the first coating layer 33, except that the laminated surfaces of the main body 2 are reversed.

<Manufacturing method>
The method for manufacturing the needle 31 includes a main body preparation step of preparing the main body 2 and a first coating layer laminating step of laminating the first coating layer 33 on the outer surface side of at least the tip end portion X1 of the main body 2 prepared in the main body preparation step. And a second coating layer laminating step of laminating the second coating layer 34 on the inner surface side of at least the tip end portion X1 of the main body 2 prepared in the main body preparing step. The main body preparation step in the method for manufacturing the needle is the same as the main body preparation step in the method for manufacturing the needle 1 in FIG. Further, the first coating layer laminating step in the method for manufacturing the needle can be performed in the same procedure as the coating layer laminating step in the method for manufacturing the needle 1 in FIG.

The second coating layer laminating step may be performed before or after the first coating layer laminating step, or may be performed at the same time as the first coating layer laminating step. The second coating layer laminating step includes a coating step of applying the coating layer forming composition containing the above-mentioned PTFE, PFA and FEP to at least the inner surface side of the tip portion X1 of the main body 2, and a coating step formed by the coating step. It is provided with an irradiation step of irradiating the film with ionizing radiation. The coating step can be performed in the same procedure as the coating step in the manufacturing method of the needle 1 of FIG. 1 except that the coating surface with respect to the main body 2 is reversed. Further, the irradiation step can be performed in the same procedure as the irradiation step in the method for manufacturing the needle 1 of FIG.

The method for manufacturing the needle can easily and reliably manufacture the needle 31 shown in FIG.

[Other Embodiments]
It should be considered that the embodiments disclosed this time are exemplary in all respects and not restrictive. The scope of the present invention is not limited to the configuration of the above embodiment, but is indicated by the scope of claims, and is intended to include all modifications within the meaning and scope equivalent to the scope of claims. NS.

Hereinafter, the present invention will be described in more detail with reference to Examples, but the present invention is not limited to these Examples.

<Preparation of sample>
[Example]
[No. 1]
A needle body made of stainless steel (SUS304) having a maximum height Rz of 1 μm on the outer surface and a friction coefficient of 0.5 on the outer surface was prepared. A dispersion liquid in which powdered PTFE was uniformly dispersed in a dispersant was applied to the outer surface of the needle body. Next, the outer surface of the needle body is heated to 350 ° C. in a low oxygen atmosphere having an oxygen concentration of 10 volume ppm or less and irradiated with an electron beam at an irradiation amount of 300 kGy using an electron beam accelerator manufactured by NHV Corporation. A sample was prepared in which a coating layer having an average thickness of 30 μm, which was mainly composed of a fluororesin crosslinked with, was laminated.

In this example, the maximum height Rz and the coefficient of friction were measured by the following procedure.

(Maximum height Rz)
The maximum height Rz [μm] is based on JIS-B0601 (2001), using "SURFCOM 130A" manufactured by Tokyo Seimitsu Co., Ltd., with a cutoff value (λc) of 0.25 mm and an evaluation length of (l) of 10 mm. It was measured.

(Coefficient of friction)
The coefficient of friction was measured based on the thrust wear test (ring-on-disk type wear evaluation) in accordance with the "plastic slip wear test method" of JIS-K7218 (1986). Specifically, a metal (SUS304) cylinder (outer shape / inner diameter = 11.5 / 7.4) is placed on the test sample, and the test sample is subjected to a load of 5 kg under dry lubrication conditions. It was rotated at a rotation speed of V = 100 rpm, and the coefficient of dynamic friction was measured by the reaction torque generated in the cylinder. Leather was used as the mating material.

[No. 2]
No. Silicone oil (“KF-96-350cs” manufactured by Shin-Etsu Chemical Co., Ltd.) was applied to the outer surface of the sample No. 1.

[Comparison example]
[No. 3]
No. The needle body of No. 1 was used as a sample.

[No. 4]
No. By applying a dispersion liquid in which powdered PTFE is uniformly dispersed in a dispersant to the outer surface of the needle body 1 and drying it, the outer surface of the needle body has an average thickness of non-crosslinked fluororesin as a main component. A sample in which a coating layer of 30 μm was laminated was prepared.

[No. 5]
No. No. 3 on the outer surface of the sample. The same silicone oil as in 2 was applied.

<Quality evaluation>
(Coefficient of friction)
No. 1, No. 2. No. 4 and No. The coefficient of friction of the outer surface of the sample of 5 was measured by the above-mentioned measuring method. The measurement results are shown in Table 1. In addition, No. The coefficient of friction of the outer surface of the sample of No. 3 is No. It is the same as the coefficient of friction of the outer surface of the needle body of 1.

(Adhesion)
No. 1, No. 2 and No. For No. 4, the time until peeling between the needle body and the coating layer occurred was measured by the above-mentioned thrust wear test. The measurement results are shown in Table 1.

(Peeling strength)
No. 1, No. 2 and No. For sample 4, the peel strength between the needle body and the coating layer was determined by Shimadzu by a test method based on JIS-K6854-2 (1999) "Adhesive-Peeling Adhesive Strength Test Method-Part 2: 180 Degree Peeling". The measurement was performed using "AGS 1KNX" manufactured by Mfg. Co., Ltd. The measurement results are shown in Table 1.

密着性について、「１０ｍｉｎ＜」とは、１０分を超えても剥離が生じなかったことを意味し、「＜１０ｓ」とは、１０秒未満で剥離が生じたことを意味する。

Regarding the adhesion, "10 min <" means that the peeling did not occur even after 10 minutes, and "<10s" means that the peeling occurred in less than 10 seconds.

<Evaluation result>
As shown in Table 1, No. 1 in which a coating layer containing a crosslinked fluororesin as a main component was laminated on the outer surface of the needle body. 1 and No. No. 2 is a No. 2 composed of a needle body. No. 3 has a coefficient of friction smaller than that of No. 3 and has a coating layer containing a non-crosslinked fluororesin as a main component laminated on the outer surface of the needle body. Adhesion and peel strength between the needle body and the coating layers are higher than in 4. In addition, No. As shown in 2, by applying silicone oil to the outer surface of the coating layer containing the crosslinked fluororesin as the main component, the friction coefficient is further reduced while maintaining the adhesion and peel strength between the needle body and the coating layers. Can be done.

As described above, the needle according to the present invention has excellent slidability and high safety, and is therefore suitable as a medical needle and a sewing machine needle.

1,1,31 Needle 2,22 Body 3,23 Coating layer 11 Syringe 12 Needle base 13 Chemical solution container 14 Plunger 33 First coating layer 34 Second coating layer X1, X2 Tip Y1 Base end

Claims (2)

The main body, which is mainly composed of metal,
The main component is crosslinked fluororesin, and at least a coating layer laminated on the outer surface side of the tip of the main body is provided.
The fluororesin is a polytetrafluoroethylene, a tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer or a tetrafluoroethylene-hexafluoropropylene copolymer.
Friction coefficient of the coating layer outer surface Ri der 0.5 or less,
The outer diameter of the tip of the main body is 3.0 mm or more and 7.0 mm or less.
A medical needle in which the main body and the coating layer are directly laminated, and the maximum height Rz of the surface to be laminated with the coating layer of the main body is 20 μm or less. The medical needle according to claim 1, wherein the peel strength between the main body and the coating layer is 5 N / cm or more.

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