JP6374151B2 - Syringe, chemical solution injection system, sealing member, and manufacturing method of sealing member - Google Patents

Description

  The present invention relates to a seal member, in particular, a seal member having a smooth region in a portion in contact with an inner surface of a medical instrument, a syringe and a chemical solution injection system provided with the seal member, and a method for manufacturing the seal member.

  Conventionally, a medical instrument having a sliding member such as a gasket, the sliding member comprising a thermoplastic elastomer layer and a thermoplastic synthetic resin layer containing ultrahigh molecular weight polyethylene or the like coated on the outer surface side There has been known a medical device that is configured and has a thermoplastic synthetic resin layer containing a lubricating component (Patent Document 1).

JP-A-5-57018

  In general, the film described in Patent Document 1 is often a skive film (a film manufactured by a cutting method). Therefore, streak-like scratches are generated on the surface of the film by the cutting tool during the manufacturing process. And when the film which has this damage | wound is affixed on sealing members, such as a gasket, when a gasket is combined with medical instruments, such as a syringe, a slight clearance gap will arise between a syringe and a gasket. Thereby, the chemical | medical solution in a syringe may ooze out through a clearance gap.

  In order to solve the above problems, a syringe as an example of the present invention is a syringe for injecting a chemical solution, and the syringe is in contact with a cylinder and an inner surface of the cylinder and is slidable in the cylinder. A seal member, and the seal member has a base and a film affixed on the base, and the film has a smooth region in a portion of the seal member that contacts the inner surface of the cylinder. It is characterized by that.

  The seal member as another example of the present invention is a seal member used in a medical instrument, and the seal member includes a base and a film attached to the base, and the seal The film has a smooth region at the outermost part in the radial direction of the member.

  Also, another example of the method for manufacturing a seal member of the present invention is a method for manufacturing a seal member that is used in a medical instrument and includes a base and a film attached to the base. The film is smoothed at the outermost part in the radial direction of the member.

  Thereby, when a sealing member is combined with a medical instrument, a smooth region can be provided in a portion of the sealing member that contacts the inner surface of the medical instrument. Therefore, it can suppress that a clearance gap arises between a medical instrument and a sealing member, and can prevent the exudation of a chemical | medical solution.

  Further features of the present invention will become apparent from the following description of embodiments, given by way of example with reference to the accompanying drawings.

It is the schematic which shows the sealing member which affixed the film which has a damage | wound. It is the schematic which shows the sealing member of 1st Embodiment. It is the schematic which shows a syringe. It is a schematic perspective view which shows a heating apparatus. It is a schematic sectional drawing which shows a heating apparatus. It is the schematic which shows the sealing member of 2nd Embodiment. It is the schematic which shows the sealing member of 2nd Embodiment. It is a schematic perspective view of a chemical injection system. It is a schematic perspective view of a prefilled syringe. It is a schematic perspective view of a prefilled syringe.

  Hereinafter, exemplary embodiments for carrying out the present invention will be described in detail with reference to the drawings. However, dimensions, materials, shapes, relative positions of components, and the like described in the following embodiments are arbitrary and can be changed according to the configuration of the apparatus to which the present invention is applied or various conditions. Further, unless otherwise specified, the scope of the present invention is not limited to the examples specifically described below.

[First Embodiment]
FIG. 2 shows a schematic cross-sectional view showing a central cross-section of the gasket as the seal member 4 and a schematic external view when viewed from the side. In FIG. 2, a cross-sectional view is shown on the left side, and an external view is shown on the right side. Moreover, in this specification, the front means the surface of the side facing a chemical | medical solution in the state in which the sealing member was attached to the medical instrument, and the back means the surface opposite to the front. In FIG. 2, the surface when the seal member 4 is viewed from above is the front.

  The seal member 4 used for the medical instrument includes a base body 40 and a film 6 attached on the base body 40. The seal member 4 has a substantially conical shape and is in contact with the chemical solution filled in the cylinder 2, two annular protrusions 41 that are in contact with the inner surface of the cylinder 2, and the annular protrusion 41. And an annular recess 45 provided between them. Further, a recess 46 into which the tip of the plunger 3 is inserted is formed inside the seal member 4. An engagement groove 42 is formed in the recess 46, and the engagement groove 42 is engaged with a protrusion formed at the distal end of the plunger 3 by inserting the distal end of the plunger 3 through the opening 47. Can be made. It should be noted that a screw type mooring system is used in which a screw groove is provided so that the tip of the plunger 3 is formed in a male screw shape, and a screw groove is provided so that the inner surface of the recess 46 of the seal member 4 is formed in a female screw shape. You can also.

  In the present embodiment, the substrate 40 is made of halogenated butyl rubber, and is manufactured, for example, as follows. First, with respect to the chlorinated butyl rubber 100, a constituent material of the substrate 40 is prepared which contains 7 parts of silica, 1.5 parts of a triazine derivative, 3 parts of magnesium oxide, and 1 part of stearic acid. Subsequently, the constituent material is kneaded and kneaded using a kneader extruder and then extruded into a sheet shape to form a sheet-like constituent material. Thereafter, the sheet-like constituent material is cut into a predetermined size. Next, the film 6 is placed on the lower mold, and the cut constituent material is placed on the film 6. Furthermore, the upper mold is arranged so that the constituent material is sandwiched between the lower mold and the upper mold, and compression molding is performed by pressing and heating at a temperature of 160 ° C. for 10 minutes. Do. Finally, the molded substrate 40 is removed from the mold. In this way, the film 6 is bonded to the base 40 at the same time as the base 40 is manufactured, and the seal member 4 is formed. Thereafter, the sealing member 4 is subjected to a smoothing process which will be described later. The substrate 40 may be formed of styrene butadiene rubber or silicone rubber.

  As another manufacturing method, the substrate 40 may be manufactured from a thermoplastic resin such as a styrene elastomer. In this case, for example, the base body 40 is manufactured as follows. First, a constituent material of the base body 40 made of a thermoplastic resin is prepared. Subsequently, the film 6 is disposed on the lower mold, and the upper mold is disposed so that the film 6 is sandwiched between the lower mold and the upper mold. Further, the upper mold is brought into contact with the film 6, the film 6 is pushed into the lower mold and the constituent material is injected to perform injection molding. Finally, the molded substrate 40 is removed from the mold. In this way, the film 6 is bonded to the base 40 at the same time as the base 40 is manufactured, and the seal member 4 is formed. Thereafter, the sealing member 4 is subjected to a smoothing process which will be described later.

  On the other hand, the film 6 is an ultrahigh molecular weight polyethylene film having a thickness of 10 to 100 μm in this embodiment. And the adhesive film (not shown) is laminated | stacked on the film 6 so that the front-end | tip part 43, the cyclic | annular protrusion 41, and the cyclic | annular recessed part 45 of the sealing member 4 may contact | adhere. The film 6 is generally manufactured by cutting a block formed from an ultrahigh molecular weight polyethylene powder as a material to a predetermined thickness.

  In addition, an adhesive film can be formed from a thermoplastic resin whose melting | fusing point is lower than ultra high molecular weight polyethylene, for example, has a thickness of 10-100 micrometers. Examples of such an adhesive film include polyethylene film, polyvinyl alcohol film, ethylene-vinyl acetate copolymer film, ethylene-vinyl alcohol copolymer film, ethylene-methacrylic acid copolymer film, linear low density (low density). ) Polyethylene film and the like. Among these, a linear low density polyethylene film or an ethylene-vinyl acetate copolymer film is excellent in adhesiveness. The adhesive film is composed of low density polyethylene, medium density polyethylene, ionomer, ethylene-acrylic acid ester copolymer, ethylene-methacrylic acid ester copolymer, ethylene-propylene copolymer, poly (ethylene butylene) polystyrene block copolymer. Formed from a resin selected from a resin mixture comprising a coalescence and polypropylene, a hydrogenated styrene butadiene rubber and a resin mixture comprising polyethylene, a hydrogenated styrene butadiene rubber and a resin mixture comprising polypropylene, etc. You can also

  On the surface of the film 6, there are a plurality of streak-like scratches 61 that have occurred in the cutting process. Hereinafter, the scratch 61 will be described with reference to FIGS. 1 and 2. FIG. 1 shows a comparative example for comparison with the present invention, and the film 6 is not smoothed. For convenience of explanation, the size and extending direction of the scratch 61 in FIGS. 1 and 2 are illustrated in a different manner from the actual one. For example, the scratch 61 may extend in the thickness direction of the seal member 4 (vertical direction in FIGS. 1 and 2). In addition, the thickness direction is a direction from the front surface of the seal member 4 toward the back surface. Moreover, in the schematic external view of FIG.1 and FIG.2, illustration of the damage | wound 61 which exists other than an outline part is abbreviate | omitted.

  As shown in the comparative example of FIG. 1, the scratch 61 is also present in a portion of the annular protrusion 41 that contacts the inner surface of the cylinder 2. Therefore, when such a seal member 4 is combined with the cylinder 2, a gap 62 is generated between the inner surface of the cylinder 2 and the annular protrusion 41. And the chemical | medical solution with which the front side of the sealing member 4 was filled in the cylinder 2 oozes out to the back side of the sealing member 4 through the clearance gap 62.

  Therefore, in order to prevent this exudation, in the present embodiment, the film 6 has a smooth region 63 in the outermost portion 48 in the radial direction of the seal member 4. Here, the outermost part 48 means a part of the seal member 4 that comes into contact with the inner surface of the cylinder 2 when the seal member 4 is combined with the syringe 1, and is the outermost part in the radial direction of the seal member 4 (base 40). The part located in is included. In order to provide the smooth region 63, the surface of the film 6 positioned at the outermost portion of the annular protrusion 41 is subjected to a smoothing process described later. And the film 6 has a non-smooth area | region in parts other than the outermost part 48 of the sealing member 4. FIG. The radial direction of the seal member 4 means a radial direction in a plane (circle) orthogonal to the thickness direction. Further, the smooth region means a region in which the convex portion or wrinkle due to the scratch 61 is crushed, and is a region that has been subjected to a smoothing process.

  Here, it is more preferable that the film 6 has the smooth region 63 only at the outermost part 48. Thereby, since the increase in the contact area of the sealing member 4 and the cylinder 2 can be suppressed, the slidability deterioration of the sealing member 4 can be prevented. When the seal member 4 is combined with the syringe 1, the annular protrusion 41 is deformed by the elasticity of the base body 40. Therefore, actually, not only the top portion of the annular protrusion 41 but also the portion around the top portion is in contact with the inner surface of the cylinder 2. Therefore, the outermost part 48 also includes a portion around the top of the annular protrusion 41. For example, the outermost part 48 has a belt-like shape including the top and having a width of 1 mm. Therefore, the smooth region 63 is a band-like region extending on the outer periphery of the seal member 4 and has a ring shape. However, only a part of the smooth region 63 is shown in FIG.

  According to the seal member 4 according to the present embodiment, it is possible to prevent the gap 62 from being generated between the inner surface of the cylinder 2 and the seal member 4. Therefore, the exudation of the chemical solution due to the gap 62 can be prevented. In addition, when the annular recessed part 45 is not provided in the sealing member 4, for example, even when the part of the back side of the sealing member 4 has a substantially cylindrical shape, the part (seal) which contacts the cylinder 2 of the sealing member 4 A smooth region 63 can be provided in the film 6 in the radially outermost part 48) of the member 4.

  Next, with reference to FIG. 3, the syringe 1 provided with the sealing member 4 which concerns on this embodiment is demonstrated. A syringe 1 for injecting a chemical liquid includes a cylinder 2 for filling the chemical liquid to be injected, and a plunger 3 slidable in the cylinder 2. The seal member 4 is attached to the tip of the plunger 3, contacts the inner surface of the cylinder 2, and is slidable in the cylinder 2. Further, as described above, the seal member 4 includes the base body 40 and the film 6 attached on the base body 40, and the film 6 is smooth at the portion 48 of the seal member 4 that contacts the inner surface of the cylinder 2. A region 63 is included. The cylinder 2 has a hollow cylindrical portion, and a winged needle or the like is connected to the distal end portion 21 of the cylinder 2 via a tube (not shown). A slight gap is provided between the portion of the seal member 4 facing the top of the plunger 3 and the top of the plunger 3.

  In the syringe 1, when filling the chemical solution, the plunger 3 is pulled out toward the rear end portion 22 of the cylinder 2, and the chemical solution is filled into the cylinder 2 through a tube or the like. In addition, when injecting the drug solution, the plunger 3 is pushed toward the tip portion 21 of the cylinder 2 to inject the drug solution into the patient's body through a tube or the like. The cylinder 2 and the plunger 3 can be formed from hard resin, soft resin, engineering plastic, glass, or the like.

  The syringe 1 may be a prefilled syringe in which a chemical solution is filled in the cylinder 2 in advance. In the case of a prefilled syringe, it is provided with a cylinder 2 filled with a chemical solution in advance, and a tip member 21 of the cylinder 2 is provided with a sealing member for sealing the cylinder 2 so that the chemical solution does not leak. The filled chemical solution is accommodated and held in the cylinder 2 by the sealing member and the seal member 4. In addition, as a chemical | medical solution with which the syringe 1 is filled also including the case of a prefilled syringe, a contrast agent, a physiological saline, an anticancer agent etc. are mentioned, for example, However, Arbitrary chemical | medical solutions can be filled.

[Pressurized heat treatment]
Hereinafter, with reference to FIG.4 and FIG.5, a pressurization heating process is demonstrated as a smoothing process which concerns on this embodiment. As shown in FIGS. 4 and 5, the heating device 7 that performs pressure heating processing is a heating member that applies heat to the seal member 4, and holds a heat generating member 71 into which the seal member 4 is inserted, and the heat generating member 71. The insulating plate 72, the cooling water passage 73 for cooling the heat generating member 71, the stopper 74 for holding the seal member 4, and the cylindrical portion 711 of the heat generating member 71 are arranged in a spiral shape and function as a heating coil. A copper pipe 75 to be connected, and an AC power source 76 connected to the copper pipe 75. In addition, although illustration is abbreviate | omitted, in this embodiment, the high frequency induction heating apparatus (SSM-2S) by Miyaden Co., Ltd. is used as the alternating current power supply 76.

  The heating member 71 is made of SUS steel (stainless steel), carbon steel, nickel alloy, or the like. In the smoothing process, heat is applied to the sealing member 4 by the heat generating member 71. The heat generating member 71 has an insertion portion 712 that is located on the side where the seal member 4 is inserted and has a substantially funnel shape, and a cylindrical portion 711 having an inner diameter A smaller than the outer diameter of the seal member 4. Accordingly, when the seal member 4 is inserted into the cylindrical portion 711 while being compressed, the annular protrusion 41 of the seal member 4 is pressed against the inner surface of the cylindrical portion 711 by the elasticity of the seal member 4. And the film 6 on the annular protrusion 41 and the annular protrusion 41 is pressurized by the reaction force. Therefore, there is no need to provide a separate pressurizing mechanism or the like, so that pressurization and heat treatment can be performed with a simple configuration. Here, the inner diameter A of the cylindrical portion 711 with respect to the outer diameter 32.40 mm of the seal member 4 can be set to 32.00 mm, for example. It is more preferable that the inner diameter A of the cylindrical portion 711 is equal to the inner diameter of the cylinder 2 of the syringe 1 where the seal member 4 is scheduled to be combined. Thereby, when the sealing member 4 is inserted into the heat generating member 71, the portion of the sealing member 4 that contacts the cylinder 2 comes into contact with the inner surface of the cylindrical portion 711. Therefore, a smoothing process can be reliably performed on the contacted portion.

  The insulating plate 72 is a plate member made of bakelite or PBT (polybutylene terephthalate resin). The insulating plate 72 is provided with a holding hole 721 for holding the heat generating member 71 and a cooling water passage 73. The cooling water passage 73 is formed so as to go out from the outside of the insulating plate 72 through the inside of the insulating plate 72 and again to the outside. Further, the cooling water passage 73 is configured such that the cooling water passes between the insulating plate 72 and the heat generating member 71. For this reason, after the pressurization and heating process is completed, the cooling water is supplied to the cooling water passage 73 as indicated by the arrows in FIG. 4, thereby quickly cooling the heat generating member 71 and the outer surface of the seal member 4 in the heat generating member 71. can do. The copper pipe 75 is also configured to allow cooling water to flow.

  The stopper 74 is configured to be rotatable about a shaft 741 between a holding position (FIG. 5) facing the opening 713 of the heat generating member 71 and a retracted position retracted from the holding position. Then, when the seal member 4 is inserted, the stopper 74 is moved to the holding position, and the seal member 4 is held inside the heat generating member 71 so as not to drop from the opening 713. After the smoothing process is completed, the stopper 74 moves to the retracted position, and the seal member 4 can be extracted from the opening 713. In FIG. 4, the retracted position is indicated by a dotted line.

  Using such a heating device 7, pressure heating treatment is performed as follows. First, the stopper 74 is moved to the holding position. Next, the seal member 4 manufactured as described above is inserted into the cylindrical portion 711 of the heat generating member 71 while being compressed. Thereby, the film 6 on the annular protrusion 41 and the annular protrusion 41 is pressurized. Next, a smoothing process is performed on the film 6 at the outermost portion 48 in the radial direction of the seal member 4. That is, by applying an alternating current from the alternating current power source 76 to the copper tube 75, the pressurized annular protrusion 41 and the film 6 on the annular protrusion 41 are heated. According to the experiments by the inventors of the present invention, the maximum temperature reached on the outer surface of the cylindrical portion 711 was 160 ° C. when heating was performed for 0.4 seconds at 50% output.

  By this heating, the surface of the film 6 is melted to fill the scratches 61, and the surface of the film 6 is smoothed by pressurization (projections or wrinkles are crushed). And after heating is complete | finished, the film 6 is cooled with cooling air, hold | maintaining the sealing member 4 with the stopper 74, and the melted surface is solidified. This cooling is performed, for example, by blowing cooling air to the seal member 4 for 5 seconds. At the same time, cooling water flows through the cooling water channel 73 and the copper pipe 75. Then, after sufficiently cooling, the sealing member 4 is extracted from the cylindrical portion 711 of the heat generating member 71.

  Thereby, the sealing member 4 provided with the smooth area | region 63 in the outermost part 48 can be manufactured. And the manufactured sealing member 4 is combined with the syringe 1 manufactured separately. That is, the plunger 3 of the syringe 1 is inserted into the recess 46 of the seal member 4, and the protrusion formed at the tip of the plunger 3 is engaged with the engagement groove 42 in the recess 46. Then, the plunger 3 to which the seal member 4 is attached is inserted into the cylinder 2 of the syringe 1. In this way, the syringe 1 is manufactured. In the case of a prefilled syringe, the cylinder 2 is further filled with a chemical solution, and a sealing member is attached to the distal end portion 21 of the cylinder 2.

  As described above, according to the manufacturing method of the present embodiment, the smooth region 63 can be formed in the portion of the seal member 4 that contacts the cylinder 2. More specifically, the smooth region 63 can be formed in the film 6 at the outermost part 48 of the seal member 4. Thereby, it can prevent that the clearance gap 62 arises between the inner surface of the cylinder 2, and the sealing member 4. FIG. Therefore, the exudation of the chemical solution due to the gap 62 can be prevented. In addition, according to the manufacturing method of the present embodiment, the pressure heating process can be performed while the seal member 4 is held and the seal member 4 does not move. Therefore, it is possible to prevent the melted film 6 from adhering to the smoothing device (heating device) due to the movement of the seal member 4. In addition, generation of wrinkles or beards in the film 6 due to the movement of the seal member 4 can be prevented.

  Note that the heat generating member 71 can be configured by only the cylindrical portion 711 without the insertion portion 712. Further, as the heating member of the seal member 4, a plate-like member provided with a hole having an inner diameter larger than the outer diameter of the seal member 4 can be used. In this case, the heating and pressurizing process is performed by inserting the seal member 4 into the hole and passing it through while heating the plate-like member. Moreover, a roller can also be used as a heating member. In this case, the heating and pressing process is performed by pressing the roller against the outermost part 48 and applying pressure while heating the seal member 4 with the roller.

  In addition, it can replace with performing the smoothing process to the sealing member 4, and can also perform the smoothing process to the film 6 before sticking using a hot press machine. In this case, a film (ultra high molecular weight polyethylene film) manufactured by a known manufacturing method is prepared and cut to have a size of, for example, 150 cm in length and 20 cm in width to form the film 6. Thereafter, the film 6 is subjected to flat plate hot pressing. According to the experiments by the inventors of the present invention, a smoothing process is performed using a hot press machine (AH2003) manufactured by Matsuura Manufacturing Co., Ltd. under conditions of a temperature of 140 ° C., a pressure of 10 MPa, and a pressurization time of 10 seconds. As a result, the film 6 could be smoothed. In addition, although the smoothing process can also be given to the whole film 6, it is more preferable not to give a smoothing process to areas other than the area | region which adhere | attaches on the outermost part 48 in the film 6. FIG.

  Moreover, in order to perform the smoothing process to the film 6, a calendar process can also be used. In this case, the film-like material before cutting is passed between smooth rolls arranged opposite to each other, and heat and pressure are applied. Thereafter, the film-like product is cut to form the film 6. In this case as well, the entire film 6 can be smoothed, but it is more preferable that the region other than the region adhered on the outermost part 48 of the film 6 is not smoothed.

[Second Embodiment]
Next, the sealing member 4 according to the second embodiment will be described with reference to FIGS. 6A and 6B. 6A is a schematic front view of the seal member 4, and FIG. 6B is a schematic external view of the seal member 4 when viewed from the side. In FIG. 6B, the external appearance when viewed from the direction of arrow L in FIG. 6A is shown on the left side, and the external appearance when viewed from the direction of arrow R in FIG. 6A is shown on the right side. Further, the size of the scratch 61 in FIGS. 6A and 6B is illustrated in a different form from the actual one for convenience of explanation. In the description of the second embodiment, differences from the first embodiment will be described, and the same reference numerals will be given to the components described in the first embodiment, and description thereof will be omitted. Except where specifically described, the constituent elements having the same reference numerals perform substantially the same operations and functions, and the effects thereof are also substantially the same.

  A plurality of scratches 61 generated in the manufacturing process of the film 6 extend in the same direction as indicated by an arrow C in FIG. 6A. When such a film 6 is bonded to the base body 40, the scratch 61 on the outermost portion 48 intersects with a region extending in a direction parallel to the thickness direction of the seal member 4 (direction perpendicular to the paper surface of FIG. 6A). And a region extending in the direction to be generated. That is, in a part of the outermost part 48, the scratch 61 extends in the thickness direction as shown on the right side of FIG. 6B, and in the other part of the outermost part 48, as shown on the left side of FIG. 6B. The scratch 61 extends in a direction crossing the thickness direction. And the exudation of a chemical | medical solution generate | occur | produces when the clearance gap 62 extended in the thickness direction arises between the cylinder 2 and the sealing member 4 due to the wound 61 extended in the thickness direction. That is, the clearance 62 forms a flow path that connects the inside and the outside of the cylinder 2, so that the chemical liquid is oozed out. On the other hand, when the scratch 61 extends in a direction crossing the thickness direction, even if the gap 62 is generated, the scratch 61 extends in the circumferential direction of the seal member 4. Therefore, the chemical liquid does not exude through the gap 62.

  By the way, when the smooth region 63 is provided in the seal member 4, the contact area between the seal member 4 and the cylinder 2 increases. As a result, the frictional force acting between the seal member 4 and the cylinder 2 increases, so that the seal member 4 becomes difficult to slip and the slidability deteriorates. Therefore, it is more preferable to make the area of the smooth region 63 as small as possible. Therefore, in the present embodiment, in order to reduce the area of the smooth region 63, the smooth region 63 is not provided in a region that does not require smoothing. That is, the smooth region 63 is not provided in the portion where the scratch 61 extends in the direction intersecting the thickness direction of the seal member 4.

  Specifically, the film 6 is the outermost part 48 of the seal member 4, and a plurality of scratches 61 generated in the film 6 have a smooth region in a portion extending in the thickness direction of the seal member 4. Therefore, when the outermost part 48 is equally divided into four regions in the circumferential direction, a bisector B passing through the center of each of the two opposing regions 411 and 412 and the center of the seal member 4 in the circumferential direction. Four regions 411, 412, 413, and 414 are set so that is parallel to the extending direction C of the scratch 61. Then, two regions 411 and 412 arranged in the extending direction of the scratch 61 (the extending direction of the line B) are set as the smoothed regions. The remaining areas 413 and 414 are set as non-smooth areas. Thereby, the area | region which does not require smoothing can be made into a non-smooth area | region by performing a smoothing process only to the smoothing area | region 411,412. Note that the non-smoothed region 413 is indicated by a dotted line on the left side of FIG. 6B.

  In addition, as a manufacturing method of such a sealing member 4, it replaces with the cylindrical part 711 of the heat generating member 71 of 1st Embodiment, and a pair of arcuate board part is provided, and an arcuate board is provided in the non-smoothing area | region 413,414. It is conceivable to perform the pressure heat treatment so that the parts do not contact.

  According to such a seal member 4 according to the second embodiment, it is possible to prevent a gap 62 extending in the thickness direction between the inner surface of the cylinder 2 and the seal member 4 from being generated. Therefore, the exudation of the chemical solution due to the gap 62 can be prevented. Furthermore, according to the sealing member 4 which concerns on 2nd Embodiment, the area of the smooth area | region 63 can be made small compared with 1st Embodiment. Therefore, deterioration of the slidability of the seal member 4 can be prevented. In the second embodiment, the outermost portion 48 of the seal member 4 has smoothing regions 411 and 412 (smooth regions 63) in portions where the cutting direction of the film 6 is parallel to the thickness direction of the seal member 4. The film 6 can also be constructed. Even in this case, since the scratch 61 resulting from the cutting of the film 6 extends in the cutting direction, it is possible to prevent a gap 62 extending in the thickness direction of the seal member 4 from being generated.

[Third Embodiment]
FIG. 7: shows the schematic perspective view of the chemical injection system 300 provided with the syringe which has the sealing member 4 which concerns on 1st and 2nd embodiment. 8 and 9 show a prefilled syringe attached to the chemical liquid injector 320 according to the third embodiment.

  The chemical injection system 300 includes a first syringe 301 and a second syringe 302 having the above-described seal member 4 (not shown), and a chemical injection device (injector) 320 to which the first syringe 301 and the second syringe 302 are attached. . The chemical solution injector 320 includes an adapter 311 for attaching the first syringe 301 and an adapter 312 for attaching the second syringe 302 in order to inject a chemical solution such as a contrast medium into the patient. A tube 303 is connected to the first syringe 301 and the second syringe 302. Further, the head of the chemical solution injector 320 is rotatably held on an upper portion of a stand pole 317 on a movable stand base 316 placed on the floor surface. Accordingly, the head end side (the side on which the first syringe 301 and the second syringe 302 are mounted) is directed toward the floor, and the rear end side of the head (the side on which the first syringe 301 and the second syringe 302 are not mounted). ) Can be turned to a posture in which the head is directed toward the floor. The head can also be rotated in the left-right direction.

  The chemical solution injector 320 is wired or wirelessly connected to an imaging device (not shown), and various types of data are transmitted and received between the imaging device and the chemical solution injector 320 when the chemical solution is injected and when an image is taken. Examples of such an imaging apparatus include an MRI (Magnetic Resonance Imaging) apparatus, a CT (Computed Tomography) apparatus, an angio imaging apparatus, a PET (Positron Emission Tomography) apparatus, a SPECT (Single Photon Emission Computed Tomography) apparatus, and a CT angio apparatus. There are various medical imaging devices such as MR angio devices, ultrasonic diagnostic devices, and blood vessel imaging devices.

  Further, the chemical liquid injector 320 further includes a control device such as a console (not shown). The head of the chemical liquid injector 320 and the control device are wired or wirelessly connected. This control device includes a touch panel and is connected to a hand switch by wire or wirelessly and functions as a controller. Further, the control device prestores operation pattern (injection protocol) data, drug solution data, and the like. When injecting a drug solution into a patient, the operator operates the touch panel to input patient physical data such as an injection rate, an injection amount, an injection time, and a body weight, and data on the type of the drug solution. Then, the control device calculates optimal injection conditions according to the input data and data stored in advance. Thereafter, the control device determines the amount of the medical solution to be injected into the patient and the injection protocol based on the calculated injection conditions.

  The head can be connected to an AC power supply (AC power supply) via a power supply line (not shown). Further, the head can be driven by a built-in battery or a battery provided outside. In this case, the position of the head can be freely changed by moving the stand base 316 without being restricted by the power supply line. Further, the first syringe 301 and the second syringe 302 can be provided with a data carrier such as RFID or barcode. In this data carrier, information on the filled chemical solution is recorded. And the chemical | medical solution injection apparatus 320 can read the information recorded from the data carrier, and can control the injection | pouring pressure etc. of a chemical | medical solution. For example, the chemical solution injection device 320 that has read the information on the chemical solution (iodine amount, etc.) can calculate the optimal injection amount per body weight and administer the chemical solution.

  When the amount of the chemical solution and the injection protocol are determined, the control device displays predetermined data or a graph on the touch panel. Then, the operator checks the displayed data or graph and presses the start button on the head if the injection operation is actually started. When the start button is pressed, the injection of the chemical is started. Alternatively, injection can be initiated by pressing a button on the hand switch. Note that the operation pattern (injection protocol) data, drug solution data, and the like can be input from an external storage medium.

  In the third embodiment, both the first syringe 301 and the second syringe 302 are prefilled syringes. And the cylinder 2 of the 1st syringe 301 and the 2nd syringe 302 is filled with the chemical | medical solution previously. The prefilled syringe will be described with reference to FIGS. 8 and 9 by taking the first syringe 301 as an example.

  The first syringe 301 shown in FIG. 8 is a 200 ml size prefilled syringe. In addition, in FIG. 8, the schematic perspective view of the whole syringe is shown on the upper left, and the schematic perspective view which looked at the cylinder 2 from the rear end side is shown on the lower right. The first syringe 301 includes a cylinder 2 filled with a chemical solution, a plunger 3 slidable in the cylinder 2, and the above-described seal member 4 (not shown) attached to the tip of the plunger 3. Prepare. The plunger 3 is attached by screwing into the seal member 4. A sealing member (not shown) such as a cap is provided at the tip of the cylinder 2, and the sealing member is removed before the first syringe 301 is attached, and the tube 303 is connected to the tip of the first syringe 301. Is done.

  A flange is formed at the rear end of the cylinder 2. The flange includes a notch 313 for fitting in the adapter 311 (FIG. 7) of the chemical liquid injector 320, a ring-shaped rib 314, and a rib 315 that rises in the rear end direction of the cylinder 2. When mounting the first syringe 301, the flange of the first syringe 301 can be inserted into the adapter 311 of the chemical liquid injector 320 and rotated to fit the flange into the adapter 311 and be fixed. In FIG. 8, five ribs 315 are formed, but four or less ribs 315 or six or more ribs 315 may be formed.

  On the other hand, the 1st syringe 301 shown in FIG. 9 is a 100 ml size prefilled syringe. In addition, in FIG. 9, the schematic perspective view of the whole syringe is shown on the upper left, and the schematic perspective view which looked at the cylinder 2 from the rear end side is shown on the lower right. The first syringe 301 also includes a cylinder 2 filled with a chemical, a plunger 3 slidable in the cylinder 2, and the above-described seal member 4 (not shown) attached to the tip of the plunger 3. Prepare. Also in FIG. 9, a flange is formed at the rear end of the cylinder 2, and the flange includes a notch 313 for fitting in the adapter 311 (FIG. 7) of the chemical liquid injector 320 and a ring-shaped rib 314. Have. The first syringe 301 shown in FIG. 9 is different from the syringe shown in FIG. 8 in that the first syringe 301 does not have a rib 315 rising in the rear end direction. However, the plate-like rib 315 can be formed in the first syringe 301 shown in FIG.

  According to such a chemical injection system 300 according to the third embodiment, by providing the seal member 4 described above, it is possible to prevent the gap 62 from being generated between the inner surface of the cylinder 2 and the seal member 4. Therefore, the exudation of the chemical solution due to the gap 62 can be prevented. In addition, as the 1st syringe 301 or the 2nd syringe 302, syringes of various sizes, such as 200 ml, 100 ml, and 50 ml, can be used. Further, the first syringe 301 or the second syringe 302 may be a suction type syringe that sucks a chemical solution from a chemical solution bag or the like.

  The present invention has been described above with reference to each embodiment. However, the present invention is not limited to the above embodiment. Inventions modified within the scope not departing from the present invention and inventions equivalent to the present invention are also included in the present invention. Moreover, each above-mentioned embodiment and modification can be combined suitably in the range which is not contrary to this invention.

  The method for adhering the film 6 is not limited to the method described in the above embodiment. For example, the film 6 can be bonded using a three-dimensional film forming method. Specifically, adhesion of the film 6 using a three-dimensional film forming method is performed as follows. First, the base body 40 is set in the lower housing. Then, the film 6 is set between the upper casing and the lower casing facing the lower casing. Thereafter, the upper casing is lowered toward the lower casing, and the space between the upper casing and the lower casing is vacuum-sucked. And the film 6 is heated with the heater provided in the upper side housing. Next, the film 6 is adhered to the substrate 40 by atmospheric pressure or compressed air pressure.

  Furthermore, in the above embodiment, the film 6 is provided on the entire outer surface of the seal member 4. However, the film 6 may be provided only in a partial region of the outer surface of the seal member 4, for example, only in a portion that contacts the inner surface of the cylinder 2. Further, the film 6 can be adhered to the inner surface of the cylinder 2 similarly to the seal member 4.

  The film 6 is not limited to an ultrahigh molecular weight polyethylene film, and a fluororesin film, a polytetrafluoroethylene film, or the like can also be used. Further, the seal member 4 is not limited to a gasket, and may be a cap used in a mouth portion of a chemical solution container that is a medical instrument. Even in this case, by providing the smooth region 63 at the outermost portion 48 in the radial direction of the seal member 4, the exudation of the chemical solution can be prevented.

  1: Syringe, 2: Cylinder, 3: Plunger, 4: Seal member, 6: Film, 7: Heating device, 21: Front end, 22: Rear end, 40: Base body, 41: Annular projection, 42: Engagement groove, 43: tip, 45: annular recess, 46: recess, 47: opening, 48: outermost part, 61: scratch, 62: gap, 63: smooth region, 71: heating member, 72: insulating plate, 73: Cooling water passage, 74: Stopper, 75: Copper pipe, 76: AC power supply, 300: Chemical solution injection system, 301: First syringe, 302: Second syringe, 303: Tube, 311: Adapter, 312: Adapter 313: Notch, 314: Rib, 315: Rib, 316: Stand base, 317: Stand pole, 320: Chemical liquid injector, 411: Smoothing region, 412: Smoothing region, 413: Non-smoothing region, 14: unsmoothed regions, 711: cylindrical portion, 712: insertion portion, 713: opening, 721: holding hole, 741: shaft

Claims (8)

A syringe for injecting a chemical solution,
The syringe includes a cylinder and a seal member that contacts the inner surface of the cylinder and is slidable in the cylinder.
The sealing member has a base and a film attached on the base,
In the portion in contact with the inner surface of the cylinder in the seal member, the film has a smooth region,
The smooth region equally divides the outermost portion in the radial direction of the seal member into four regions in the circumferential direction, and the center of each of the two regions facing each other and the center of the seal member. When the four regions are set so that the bisector passing through the film is parallel to the extending direction of the scratches generated in the film, the syringe is two regions arranged in the extending direction.   The syringe according to claim 1, wherein the syringe is a prefilled syringe in which the cylinder is filled with a chemical solution.   A chemical injection system comprising the syringe according to claim 1 and a chemical injection device to which the syringe is attached. A sealing member used in a medical instrument,
The sealing member has a base and a film attached on the base,
At the outermost portion in the radial direction of the seal member, the film has a smooth region,
The smooth region equally divides the outermost portion into four regions in the circumferential direction, and bisects through the center of each of the two regions facing each other and the center of the seal member among the four regions. When the four regions are set so as to be parallel to the extending direction of the scratches generated on the film, the sealing member is two regions arranged in the extending direction.   The other two regions among the four regions are non-smooth regions, according to claim 4.   The seal member according to claim 4, wherein the film has the smooth region at a portion where the scratches generated on the film extend in the thickness direction of the seal member.   The sealing member according to claim 4, wherein the film has the smooth region only at the outermost part. Preparing a sealing member having a substrate with a film attached thereto;
Insert the prepared seal member into a heating member having a cylindrical portion with an inner diameter smaller than the outer diameter of the seal member,
Heat is applied to the film on the annular protrusion of the seal member by the heating member,
The manufacturing method of the sealing member which cools the said film after a heating.

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