JP2019126643A - needle - Google Patents

Abstract

To provide a needle with excellent slidability and high safety property.SOLUTION: A needle includes: a main body mainly composed of metal; and a coating layer mainly composed of a crosslinked fluororesin, that is to be laminated on at least an outer surface side of a tip of the main body. The fluororesin is a polytetrafluoroethylene, tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer or a tetrafluoroethylene/hexafluoropropylene type copolymer. A friction coefficient of an outer surface of the coating layer is equal to or less than 0.5.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a needle.

  Generally, the injection needle used for subcutaneous injection is formed of metal such as stainless steel. With this injection needle, it is not easy to sufficiently smooth the outer peripheral surface. Therefore, when the injection needle punctures the human body, the surface friction becomes large, and it is easy for the patient to feel pain and discomfort.

  Therefore, today, there has been proposed an injection needle which is less likely to cause pain and discomfort to the patient when puncturing the human body. As such an injection needle, it is proposed by Unexamined-Japanese-Patent No. 2008-200528 that the outer diameter of the front-end | tip part punctured by a human body is made small. Japanese Patent Application Laid-Open No. 7-178159 proposes that a silicone film is laminated on the outer periphery of a metal body.

JP 2008-200908 A JP 7-178159 A

  However, according to the configuration described in Patent Document 1, since the inner diameter of the needle decreases to the inner diameter, the flow path resistance when the drug solution is injected into the human body increases. Therefore, the injection needle described in Patent Document 1 is difficult to inject a high-viscosity chemical into the human body.

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

  This invention is made | formed based on such a situation, and makes it a subject to be excellent in slidability and to provide a highly safe needle | hook.

  The needle according to one aspect of the present invention made to solve the above problems is mainly composed of a metal as a main component and a cross-linked fluorocarbon resin as a main component, and is laminated on at least the outer surface side of the tip of the main body And the fluorine resin is polytetrafluoroethylene, tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer or tetrafluoroethylene-hexafluoropropylene copolymer, and the coefficient of friction of the surface of the coating layer is 0.5 or less.

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

It is a typical sectional view showing the needle concerning one embodiment of the present invention. It is a typical side view which shows a syringe provided with the needle | hook of FIG. It is a typical side view showing the needle concerning an embodiment different from the needle of FIG. It is the AA line expanded sectional view of the needle of FIG. It is a schematic cross section which shows the needle | hook which concerns on embodiment different from the needle | hook of FIG.1 and FIG.

Description of the embodiment of the present invention
First, the embodiments of the present invention will be listed and described.

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

  The said needle | hook is laminated | stacked on the outer surface side of the front-end | tip part of the main body the coating layer which has the crosslinked fluororesin as a main component, The said fluororesin is a polytetrafluoroethylene, tetrafluoroethylene- perfluoroalkyl vinyl ether copolymer Or since it is a tetrafluoroethylene-hexafluoropropylene copolymer, smoothing of the said coating layer outer surface can be achieved, and the friction coefficient of the said coating layer outer surface can be made into the said upper limit or less. Therefore, the said needle is excellent in slidability. Moreover, since the said coating layer is based on the said crosslinked said fluorine resin as a main component, while the said needle | hook can improve the adhesiveness between the said main body and a coating layer, it is excellent in the abrasion resistance of the said coating layer. 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. Thus, when the peel strength between the main body and the coating layer is equal to or higher than the lower limit, the adhesion between the main body and the coating layer can be sufficiently increased.

  The body and the covering layer may be directly laminated. Thus, by directly laminating the main body and the covering layer, it is possible to prevent the interposition of another layer between the main body and the covering layer, and to easily and reliably enhance the adhesion between the main body and the covering layer. be able to. Moreover, according to this configuration, it is possible to prevent the deterioration in quality, safety and the like due to the leakage of the component contained in the other layer.

  The maximum height Rz of the surface laminated with the coating layer of the main body is preferably 20 μm or less. Thus, even when the maximum height Rz of the surface laminated with the coating layer of the main body is set to the upper limit or less, the adhesion between the main body and the coating layer can be sufficiently increased.

  The needle may be a medical needle. When the needle is a medical needle, it is possible to suppress giving pain or 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. The "outer surface" refers to the outer surface in the radial direction. The "friction coefficient" refers to a dynamic friction coefficient measured by a thrust wear test (ring-on-disk type wear evaluation) in accordance with JIS-K 7218 (1986) "sliding wear test method for plastic". "Peel strength" refers to the peel strength obtained by the test method according to "adhesive-peel adhesion strength test method-part 2: 180 degree peel" of JIS-K6854-2 (1999). “Maximum height Rz” refers to a value measured with a cutoff value (λc) of 0.25 mm and an evaluation length (l) of 10 mm in accordance with JIS-B0601 (2001).

Details of the Embodiment of the Present Invention
Preferred embodiments of the present invention will be described below with reference to the drawings.

First Embodiment
<Needle>
The needle 1 of FIG. 1 is a medical needle, more specifically, an injection needle used for subcutaneous injection. The needle 1 includes a main body 2 mainly composed of a metal, and a covering layer 3 mainly composed of a cross-linked fluorocarbon resin and laminated on the outer surface side of at least a tip portion X1 of the main body 2. The fluorine resin is polytetrafluoroethylene (PTFE), tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer (PFA) or tetrafluoroethylene-hexafluoropropylene copolymer (FEP). Moreover, the friction coefficient of the coating layer 3 outer surface is 0.5 or less.

  The needle 1 has a cover layer 3 mainly composed of a cross-linked fluorine resin laminated on the outer surface side of the distal end portion X1 of the main body 2, and the fluorine resin is PTFE, PFA or FEP. The outer surface can be smoothed. Moreover, since the said fluorine resin is excellent in slipperiness, the said needle 1 can make the friction coefficient of the coating layer 3 outer surface below the said upper limit by aiming at smoothing of the coating layer 3 outer surface. Therefore, the needle 1 is excellent in slidability. In addition, since the coating layer 3 contains the crosslinked fluorocarbon resin as a main component, the needle 1 can enhance the adhesion between the main body 2 and the coating layer 3 and is excellent in the wear resistance of the coating layer 3 . Therefore, since the needle 1 can suppress the dissociation of the coating layer 3 from the main body 2, the safety to the human body is high.

  Since the needle 1 is a medical needle, it is difficult to give pain and discomfort to the patient.

(Body)
The main body 2 is a hollow needle whose main component is metal. Although it does not specifically limit as said metal, For example, stainless steel, nickel chromium steel, etc. are mentioned. The main body 2 has a distal end X1 in which a blade surface inclined with respect to a radial direction (direction perpendicular to the axial direction) is formed at an end edge on the distal end side, and the base end edge of the distal end X1 is continuous from the proximal end And a base end portion Y1. The distal end portion X1 preferably has a uniform outer diameter from the distal end edge to the proximal end edge. The uniform outer diameter from the distal end edge to the proximal end edge of the distal end portion X1 prevents the patient from feeling pain and discomfort due to the undulation of the outer diameter of the distal end portion X1 when the needle 1 is punctured into the human body. can do. Moreover, it is preferable that the internal diameter from the front-end | tip edge of the front-end | tip part X1 to a base end edge is uniform. Since the inner diameter from the tip end edge to the base end edge of the tip end portion X1 is uniform, it is possible to suppress the flow path resistance at the time of injecting the drug solution into the human body low. 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. Also, "proximal side" means the opposite side of "distal side".

  As a minimum of the outside diameter of tip part X1, 3.0 mm is preferred, 4.0 mm is more preferred, and 4.5 mm is still more preferred. On the other hand, the upper limit of the outer diameter of the tip portion X1 is preferably 7.0 mm, more preferably 6.0 mm, and even more preferably 5.5 mm. The sliding property of the needle 1 is enhanced by the covering layer 3 laminated on the outer surface of the main body 2 and therefore, it is difficult for the patient to feel pain or discomfort even if the outer diameter of the distal end portion X1 is relatively large. If the outer diameter of the tip end portion X1 is smaller than the above lower limit, the inner diameter of the tip end portion X1 can not be made sufficiently large, and there is a possibility that the flow path resistance at the time of injecting the drug solution into the human body may be high. On the other hand, if the outer diameter of the distal end portion X1 exceeds the upper limit, the outer diameter of the distal end portion X1 becomes unnecessarily large, and there is a possibility that the site that can be injected is limited or that the patient feels uncomfortable.

  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-described 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 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 end portion X1 is smaller than the above lower limit, there is a possibility that the flow path resistance at the time of injecting the drug solution into the human body may be increased. Conversely, if the inner diameter of the distal end X1 exceeds the upper limit, the outer diameter of the distal end X1 becomes unnecessarily large with the size of the inner diameter, and there is a possibility that the site that can be injected is limited or the patient feels uncomfortable.

  As a minimum of the axial direction length of tip part X1, 5 mm is preferred and 10 mm is more preferred. The needle 1 is preferably inserted into the human body only in the region where the coating layer 3 is laminated during subcutaneous injection. On the other hand, when the axial length of the distal end portion X1 is smaller than the above-mentioned lower limit, when the needle 1 is punctured into the human body, the region where the covering layer 3 is not laminated may be inserted into the human body. In addition, as an upper limit of the axial direction length of the front-end | tip part X1, it does not specifically limit, For example, it can be set to 50 mm.

  The upper limit of the maximum height Rz of the surface of the main body 2 laminated with the coating layer 3 (that is, the outer surface of the main body 2) is preferably 20 μm, more preferably 10 μm, and even more preferably 1 μm. The needle 1 can sufficiently enhance the adhesion between the main body 2 and the coating layer 3 even when the maximum height Rz is not more than the upper limit. 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 at the time of puncturing the human body is not good due to the unevenness on the inner surface 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.

(Cover layer)
The covering layer 3 is laminated on at least the outer surface side of the distal end portion X1 of the main body 2 as described above. The coating layer 3 is coated on the entire outer surface side of the tip end portion X1. The covering layer 3 may be laminated only on the outer surface side of the distal end portion X1, or may be laminated also on the outer surface side of the base end portion Y1. That is, the covering 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 covering layer 3 are directly laminated. That is, no other layer such as an adhesive layer is interposed between the main body 2 and the covering layer 3. Since the needle 1 is free from other layers between the main body 2 and the covering layer 3, the needle 1 is deteriorated in quality due to leakage of components contained in other layers such as an adhesive layer, and the human body. The influence can be prevented. Moreover, the said needle 1 can raise the contact | adhesion power between the main body 2 and the coating layer 3 easily and reliably by the other layer not interposing between the main body 2 and the coating layer 3. FIG.

  The covering layer 3 is mainly composed of a cross-linked fluororesin. The coating layer 3 is enhanced in the abrasion resistance while maintaining the non-adhesiveness of the fluorine resin because the fluorine resin is crosslinked. As said fluororesin, the above-mentioned PTFE, PFA, and FEP are mentioned, These can be used individually by 1 type or in combination of 2 or more types.

  In addition, the said fluorine resin may contain the polymer unit derived from another copolymerizable monomer in the range which does not impair the effect of this invention. For example, PTFE may contain polymerized 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 all the polymerization units constituting the above-mentioned fluororesin.

  As a minimum of content of the above-mentioned fluoro-resin in covering layer 3, 60 mass% is preferred, 85 mass% is more preferred, and 98 mass% is still more preferred. Further, the content is particularly preferably 100% by mass. If the above content is less than the above lower limit, there is a possibility that the characteristics such as the adhesion to the main body 2 and the wear resistance do not become sufficiently high.

  The upper limit of the crystal melting point of the crosslinked fluorine resin in the covering layer 3 varies depending on the kind of the fluorine resin. For example, in the case of PTFE, 325 ° C. is preferable, 320 ° C. is more preferable, and 310 ° C. is more preferable. The crystal melting point decreases with the degree of crosslinking of the crosslinked fluororesin. Therefore, when the crystalline melting point exceeds the upper limit, the abrasion resistance may be insufficient due to the insufficient degree of crosslinking. The lower limit of the crystal melting point of the crosslinked fluororesin can be 290 ° C., for example. In addition, "crystal melting | fusing point" points out melting | fusing point peak temperature measured by a differential scanning calorimeter (DSC) based on JIS-K7121: 2012 "the transition temperature measurement method of a plastics."

  The coating layer 3 may contain other fluororesin, other arbitrary components, and the like as long as the effects of the present invention are not impaired. Examples of the other fluorine resin include polyvinylidene fluoride (PVDF), tetrafluoroethylene-ethylene copolymer (ETFE), polychlorotrifluoroethylene (PCTFE), chlorotrifluoroethylene-ethylene copolymer (ECTFE), Polyvinyl fluoride (PVF), fluoroolefin-vinyl ether copolymer, vinylidene fluoride-tetrafluoroethylene copolymer, vinylidene fluoride-hexafluoropropylene copolymer, etc. may be mentioned.

  The covering layer 3 is formed to have a substantially uniform thickness. As a minimum of average thickness of coating layer 3, 10 micrometers is preferred and 15 micrometers is more preferred. On the other hand, as an upper limit of average thickness of covering layer 3, 50 micrometers is preferred and 30 micrometers is more preferred. When the average thickness is smaller than the lower limit, the strength of the covering layer 3 may be insufficient, or the outer surface of the needle 1 may not be sufficiently smoothed. Conversely, 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, giving the patient a sense of discomfort when puncturing the needle 1 There is a fear.

  The lower limit of the peel strength between the main body 2 and the coating layer 3 is preferably 5 N / cm, and more preferably 10 N / cm. If the said peeling strength is less than the said minimum, there exists a possibility that the contact | adhesion power between the main body 2 and the coating layer 3 can not fully be improved. 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 the manufacture from becoming difficult. The peel strength between the main body 2 and the coating layer 3 can be controlled by adjusting the degree of crosslinking of the fluororesin, for example.

  The upper limit of the friction coefficient of the outer surface of the coating layer 3 is 0.5 as described above, preferably 0.2, and more preferably 0.1. If the friction coefficient of the outer surface of the coating layer 3 exceeds the upper limit, there is a risk of giving pain or discomfort to the patient 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 better. The lower limit is not particularly limited, but for example, it can be set to 0.01 from the viewpoint of preventing the manufacture from becoming difficult. In addition, since the said needle 1 is based on the fluorine resin which the coating layer 3 bridge | crosslinked as mentioned above, while being able to make the friction coefficient of the coating layer 3 outer surface small, between the main body 2 and the coating layer 3 The adhesion is increased and the risk of fluorine remaining in the patient's body is low. On the other hand, the friction coefficient of the outer surface of the needle can be reduced to a certain degree 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 possibility that the safety of the silicone itself, the reaction between the silicone and the drug, the peeling of the non-crosslinked fluororesin from the main body 2 and the like may adversely affect the human body.

  The upper limit of the maximum height Rz of the outer surface of the coating layer 3 is preferably 5 μm and more preferably 1 μm. If the maximum height Rz exceeds the upper limit, there is a risk of giving pain or discomfort to the patient when the needle 1 is punctured. On the other hand, the maximum height Rz is preferably as small as possible, and the lower limit thereof is not particularly limited. However, for example, it can be set to 0.00001 μm from the viewpoint of preventing difficulty in manufacturing.

<Manufacturing method>
Next, a method for 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 at least the outer surface side of the tip portion X1 of the main body 2 prepared in the main body preparing step. The needle manufacturing method can easily and reliably manufacture the needle 1 shown in FIG.

(Cover layer laminating process)
In the coating layer laminating step, a coating step of coating the composition for forming a coating layer containing the above-mentioned PTFE, PFA and FEP on the outer surface side of at least the front end portion X1 of the main body 2, and the coating film formed in the coating step An irradiation step of irradiating with ionizing radiation.

<Application process>
As a coating method in the coating step, for example, an electrostatic powder coating method in which the powder of the above-mentioned fluorocarbon resin is coated on the outer surface side of the main body 2, a dispersion liquid in which the powder of the above-mentioned fluorocarbon resin is uniformly dispersed in a dispersant (Dispersion) may be applied to the outer surface side of the main body 2 to dry the dispersion medium.

  Examples of the dispersion medium 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.

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

  In the irradiation step, the coating film is preferably heated to a temperature equal to or higher than the crystalline melting point of the fluororesin. The lower limit of the heating temperature is preferably a temperature 5 ° C. higher than the crystal melting point. On the other hand, the upper limit of the heating temperature is preferably 50 ° C. higher than the crystal melting point, more preferably 20 ° C. higher than the crystal melting point. By irradiating ionizing radiation under the above conditions, cross-linking between molecules can be promoted while suppressing breakage of the main chain of the fluororesin.

  As an upper limit of the oxygen concentration in the said irradiation process, 100 volume ppm is preferable, 10 volume ppm is more preferable, and 5 volume ppm is further more preferable. When the oxygen concentration exceeds the upper limit, decomposition of the fluororesin may occur.

  Examples of the ionizing radiation include γ rays, electron beams, X rays, neutron rays, high energy ion rays, and the like. Moreover, as a minimum of the irradiation dose of ionizing radiation, 10 kGy is preferable, 70 kGy is more preferable, 200 kGy is further more preferable. On the other hand, the upper limit of the irradiation dose is preferably 2000 kGy, more preferably 1200 kGy, and still more preferably 400 kGy. When the said irradiation dose is smaller than the said minimum, there exists a possibility that the crosslinking reaction of the said fluororesin may not fully advance. 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 including the needle 1 will be described with reference to FIG. The syringe 11 includes the needle 1, a needle base 12 that supports the outer surface side of the proximal end of the needle 1, and a cylinder that is connected to the needle base 12 and extends to the proximal end side of the needle base 12. The liquid medicine container 13 in the shape of a circle, and a gasket (not shown) capable of sealing the internal space of the medicine liquid container 13 is provided at the tip and includes a plunger 14 slidable in the axial direction of the medicine liquid container 13. The syringe 11 is configured to be able to inject a drug solution from the tip of the needle 1 into the human body by pushing the plunger 14 to the tip side in a state where the drug solution is stored in the drug solution container 13.

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

Second Embodiment
<Needle>
The needle 21 of FIG. 3 is a sewing needle, more specifically, an industrial sewing needle. The needle 21 is, as shown in FIG. 4, a main body 22 mainly composed of a metal, and a covering layer 23 mainly composed of a cross-linked fluorine resin and laminated on the outer surface side of at least the tip portion X2 of the main body 2 Is provided. The fluorine resin is PTFE, PFA or FEP. Moreover, the friction coefficient of the coating layer 23 outer surface is 0.5 or less.

  The needle 21 has a cover layer 23 mainly composed of a cross-linked fluorocarbon resin laminated on the outer surface side of the tip end portion X2 of the main body 22, and the fluorocarbon resin is PTFE, PFA or FEP. The outer surface can be smoothed. Moreover, since the said fluorine resin is excellent in slipperiness, the said needle 21 can make the friction coefficient of the coating layer 23 outer surface below the said upper limit by aiming at smoothing of the coating layer 23 outer surface. Therefore, the needle 21 is excellent in slidability. Further, since the coating layer 23 contains the crosslinked fluorocarbon resin as a main component, the needle 21 can enhance the adhesion between the main body 22 and the coating layer 23 and is excellent in the wear 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 needles, particularly industrial sewing needles, are likely to generate heat during use. In this regard, the needle 21 has the covering layer 23 mainly composed of the crosslinked fluororesin, which is cross-linked on the outer surface side of the distal end portion X2 of the main body 22, and the fluororesin is PTFE, PFA or FEP. Therefore, heat generation can be suppressed as compared with a conventional needle made of metal. Further, the needle 21 is excellent in adhesion at high temperature because the coating layer 23 contains the crosslinked fluorine resin as a main component. Therefore, the needle 21 can suppress damage to the sewing object due to heat generation and peeling of the covering layer 23.

(Body)
The main body 22 is mainly composed of metal. Although it does not specifically limit as said metal, For example, steel etc. are mentioned. The distal end portion X2 is provided at the end edge on the distal end side, and includes a needle tip that is gradually narrowed toward the distal end side. The distal end portion X2 is an area to be inserted into the sewing target at the time of sewing, and can be, for example, from the distal end of the needle tip to the proximal end of the needle trunk. The maximum height Rz of the surface laminated with the covering layer 23 of the main body 22 can be the same as that of the needle 1 of FIG.

(Cover layer)
The covering layer 23 is laminated on the outer surface side of at least the tip portion X2 of the main body 22 as described above. The covering layer 23 is covered on the entire outer surface side of the tip end portion X2. The covering layer 23 may be laminated only on the outer surface side of the distal end portion X2, or may be laminated also on the proximal side of the proximal end edge of the distal end portion X2.

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

  The coating layer 23 is mainly composed of a cross-linked fluororesin. The coating layer 23 is enhanced in abrasion resistance while maintaining the non-adhesiveness of the fluorine resin by crosslinking the fluorine resin. As said fluororesin, the above-mentioned PTFE, PFA, and FEP are mentioned, These can be used individually by 1 type or in combination of 2 or more types.

  In addition, the said fluororesin may contain the polymerization unit derived from another copolymerizable monomer in the range which does not impair the effect of this invention similarly to the coating layer 3 of FIG. 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. Moreover, the coating layer 23 may contain other fluororesin, other arbitrary components, etc. in the range which does not impair the effect of this invention similarly to the coating layer 3 of FIG.

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

<Manufacturing method>
The needle 21 is, similarly to the needle 1 of FIG. 1, a main body preparing step of preparing the main body 22, and a covering layer lamination of laminating the covering layer 23 on the outer surface side of at least the tip X2 of the main body 22 prepared in the main body preparing step. A process. The method of manufacturing the needle can manufacture the needle 21 of FIG. 3 easily and reliably.

Third Embodiment
<Needle>
The needle 31 of FIG. 5 is a medical needle, more specifically, an injection needle used for subcutaneous injection. The needle 31 includes a main body 2 mainly composed of a metal, a first covering layer 33 mainly composed of a cross-linked fluorine resin and laminated on the outer surface side of at least the tip portion X1 of the main body 2, and cross-linked fluorine A second covering layer 34 mainly composed of a resin and laminated on the inner surface side of at least the tip portion X1 of the main body 2 is provided. The fluorine resin is PTFE, PFA or FEP. Moreover, the friction coefficient of the coating layer 33 outer surface is 0.5 or less. The main body 2 of the needle 31 can be the same as the main body 2 of the needle 1 of FIG. 1, and the first covering layer 33 of the needle 31 is the same as the covering layer 3 of FIG. Can do. Therefore, the description of the main body 2 of the needle 31 and the first covering layer 33 is omitted.

  Since the needle 31 has the second coating layer 34 mainly composed of the crosslinked fluororesin, the adhesion between the main body 2 and the second coating layer 34 can be increased. Further, the needle 31 is excellent in the wear resistance of the second coating layer 34 because the second coating layer 34 contains the fluororesin as a main component. Therefore, the needle 31 is highly safe for the human body. Since the needle 31 includes the second coating layer 34, the needle 31 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.

(2nd covering layer)
The second covering layer 34 is laminated on the inner surface side of at least the front end X1 of the main body 2 as described above. The 2nd coating layer 34 is coat | covered on the whole inner surface side of the front-end | tip part X1. The second covering layer 34 may be stacked only on the inner surface side of the distal end portion X1 or may be stacked also on the inner surface side of the base end portion Y1. That is, the second covering layer 34 may be laminated on the entire inner surface of the main body 2.

  The main body 2 and the second covering 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 surface of the main body 2 is reversed.

<Manufacturing method>
The manufacturing method of the needle 31 includes a main body preparing step of preparing the main body 2 and a first covering layer laminating step of laminating the first covering layer 33 on the outer surface side of at least the tip X1 of the main body 2 prepared in the main body preparing step. And a second covering layer laminating step of laminating the second covering layer 34 on the inner surface side of at least the front end portion X1 of the main body 2 prepared in the main body preparing step. The main body preparation process in the manufacturing method of the said needle is the same as the main body preparation process of the manufacturing method of the needle 1 of FIG. Moreover, the 1st coating layer lamination process in the manufacturing method of the said needle can be performed in the procedure similar to the coating layer lamination process of the manufacturing method of the needle | hook 1 of FIG.

  The second coating layer lamination step may be performed before or after the first coating layer lamination step, or may be performed simultaneously with the first coating layer lamination step. The second coating layer laminating step includes a coating step of coating the composition for forming a coating layer containing the above-mentioned PTFE, PFA and FEP on the inner surface side of at least the front end portion X1 of the main body 2, and the coating formed in the coating step Irradiating the membrane with ionizing radiation. The said application process can be performed in the procedure similar to the application process in the manufacturing method of the needle | hook 1 of FIG. 1, except that the application surface with respect to the main body 2 is reverse. Moreover, the said irradiation process can be performed in the procedure similar to the irradiation process in the manufacturing method of the needle | hook 1 of FIG.

  The method of manufacturing the needle can manufacture the needle 31 of FIG. 5 easily and reliably.

[Other Embodiments]
It should be understood that the embodiments disclosed herein are illustrative and non-restrictive in every respect. The scope of the present invention is not limited to the configurations of the above embodiments, but is indicated by the claims, and is intended to include all modifications within the meaning and scope equivalent to the claims. Ru.

  Hereinafter, the present invention will be described in more detail by way of 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 outer surface height Rz of 1 μm and an outer surface friction coefficient of 0.5 was prepared. The outer surface of the needle body was coated with a dispersion in which powdery PTFE was uniformly dispersed in a dispersant. Next, the outer surface of the needle main body is heated by heating to 350 ° C. in a low oxygen atmosphere with an oxygen concentration of 10 volume ppm or less and irradiating an electron beam at a dose 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 mainly composed of a cross-linked fluororesin was laminated.

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

(Maximum height Rz)
Maximum height Rz [μm] is according to 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 (l) of 10 mm. It was measured.

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

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

[Comparative example]
[No. 3]
No. One needle body was used as a sample.

[No. 4]
No. By applying a dispersion of powdery PTFE uniformly dispersed in a dispersing agent on the outer surface of the needle main body 1 and drying it, an average thickness mainly composed of a non-crosslinked fluorine resin on the outer surface of the needle main body A sample was prepared in which a 30 μm coating layer was laminated.

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

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

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

(Peel strength)
No. 1, no. 2 and no. For the sample No. 4 in Shimadzu, the peel strength between the needle main body and the coated layer is measured according to JIS-K 6854-2 (1999) “Adhesive-Peel adhesion test method-Part 2: 180 degree peel”. Measurement was performed using “AGS 1KNX” manufactured by Seisakusho. 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。

With regard to adhesion, “10 min <” means that peeling did not occur even if it exceeds 10 minutes, and “<10 s” means that peeling occurred in less than 10 seconds.

<Evaluation results>
As shown in Table 1, No. 1 in which a covering layer composed mainly of a cross-linked fluororesin is laminated on the outer surface of the needle body. 1 and No. 1 No. 2 consists of a needle body. No. 3 in which the coefficient of friction is smaller than 3 and a coating layer mainly composed of a non-crosslinked fluororesin is laminated on the outer surface of the needle body. The adhesion and peel strength between the needle body and the cover layer are higher than that of No. 4. No. As shown in Fig. 2, by applying silicone oil to the outer surface of the coating layer mainly composed of a cross-linked fluororesin, the friction coefficient is further reduced while maintaining the adhesion and peel strength between the needle body and the coating layer. I can do it.

  As described above, since the needle according to the present invention is excellent in slidability and high in safety, it is suitable as a medical needle and a sewing needle.

1, 21, 31 needle 2, 22 main body 3, 23 coating layer 11 syringe 12 needle base 13 drug solution container 14 plunger 33 first coating layer 34 second coating layer X1, X2 tip end portion Y1 base end portion

Claims (5)

A main body mainly composed of metal;
And a covering layer made mainly of a crosslinked fluorine resin and laminated on at least the outer surface side of the tip of the main body,
The above-mentioned fluororesin is polytetrafluoroethylene, tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer or tetrafluoroethylene-hexafluoropropylene copolymer,
The needle whose coefficient of friction on the outer surface of the covering layer is 0.5 or less.   The needle according to claim 1, wherein the peel strength between the body and the covering layer is 5 N / cm or more.   The needle according to claim 1 or 2, wherein the body and the covering layer are directly laminated.   The needle according to claim 3, wherein the maximum height Rz of the surface laminated with the coating layer of the main body is 20 µm or less.   The needle according to any one of claims 1 to 4, which is a medical needle.

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